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RR\1170767EN.docx PE623.765v03-00
EN United in diversity EN
European Parliament 2014-2019
Plenary sitting
A8-0417/2018
29.11.2018
***I REPORT
on the proposal for a Regulation of the European Parliament and of the Council
on the transparency and sustainability of the EU risk assessment in the food
chain amending Regulation (EC) No 178/2002 [on general food law], Directive
2001/18/EC [on the deliberate release into the environment of GMOs],
Regulation (EC) No 1829/2003 [on GM food and feed], Regulation (EC) No
1831/2003 [on feed additives], Regulation (EC) No 2065/2003 [on smoke
flavourings], Regulation (EC) No 1935/2004 [on food contact materials],
Regulation (EC) No 1331/2008 [on the common authorisation procedure for
food additives, food enzymes and food flavourings], Regulation (EC) No
1107/2009 [on plant protection products] and Regulation (EU) No 2015/2283
[on novel foods]
(COM(2018)0179 – C8-0144/2018 – 2018/0088(COD))
Committee on the Environment, Public Health and Food Safety
Rapporteur: Renate Sommer
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PR_COD_1amCom
Symbols for procedures
* Consultation procedure
*** Consent procedure
***I Ordinary legislative procedure (first reading)
***II Ordinary legislative procedure (second reading)
***III Ordinary legislative procedure (third reading)
(The type of procedure depends on the legal basis proposed by the draft act.)
Amendments to a draft act
Amendments by Parliament set out in two columns
Deletions are indicated in bold italics in the left-hand column. Replacements
are indicated in bold italics in both columns. New text is indicated in bold
italics in the right-hand column.
The first and second lines of the header of each amendment identify the
relevant part of the draft act under consideration. If an amendment pertains to
an existing act that the draft act is seeking to amend, the amendment heading
includes a third line identifying the existing act and a fourth line identifying
the provision in that act that Parliament wishes to amend.
Amendments by Parliament in the form of a consolidated text
New text is highlighted in bold italics. Deletions are indicated using either
the ▌symbol or strikeout. Replacements are indicated by highlighting the
new text in bold italics and by deleting or striking out the text that has been
replaced.
By way of exception, purely technical changes made by the drafting
departments in preparing the final text are not highlighted.
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CONTENTS
Page
DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION ................................. 5
EXPLANATORY STATEMENT ............................................................................................ 80
OPINION OF THE COMMITTEE ON FISHERIES .............................................................. 84
OPINION OF THE COMMITTEE ON LEGAL AFFAIRS ................................................... 92
PROCEDURE – COMMITTEE RESPONSIBLE ................................................................. 149
FINAL VOTE BY ROLL CALL IN COMMITTEE RESPONSIBLE .................................. 150
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DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION
on the proposal for a Regulation of the European Parliament and of the Council on the
transparency and sustainability of the EU risk assessment in the food chain amending
Regulation (EC) No 178/2002 [on general food law], Directive 2001/18/EC [on the
deliberate release into the environment of GMOs], Regulation (EC) No 1829/2003 [on
GM food and feed], Regulation (EC) No 1831/2003 [on feed additives], Regulation (EC)
No 2065/2003 [on smoke flavourings], Regulation (EC) No 1935/2004 [on food contact
materials], Regulation (EC) No 1331/2008 [on the common authorisation procedure for
food additives, food enzymes and food flavourings], Regulation (EC) No 1107/2009 [on
plant protection products] and Regulation (EU) No 2015/2283 [on novel foods]
(COM(2018)0179 – C8-0144/2018 – 2018/0088(COD))
(Ordinary legislative procedure: first reading)
The European Parliament,
– having regard to the Commission proposal to Parliament and the Council
(COM(2018)0179),
– having regard to Article 294(2) and Articles 43, 114 and 168(4)(b) of the Treaty on the
Functioning of the European Union, pursuant to which the Commission submitted the
proposal to Parliament (C8-0144/2018),
– having regard to the opinion of the Committee on Legal Affairs on the proposed legal
basis,
– having regard to Article 294(3) of the Treaty on the Functioning of the European Union,
– having regard to the opinion of the European Economic and Social Committee of 19
September 20181,
– having regard to the opinion of the Committee of the Regions of 10 October 20182,
– having regard to Rule 59 of its Rules of Procedure,
– having regard to the report of the Committee on the Environment, Public Health and
Food Safety and the opinions of the Committee on Fisheries and the Committee on
Legal Affairs (A8-0417/2018),
1. Adopts its position at first reading hereinafter set out;
2. Calls on the Commission to refer the matter to Parliament again if it replaces,
substantially amends or intends to substantially amend its proposal;
3. Instructs its President to forward its position to the Council, the Commission and the
national parliaments.
1 Not yet published in the Official Journal. 2 Not yet published in the Official Journal.
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Amendment 1
Proposal for a regulation
Citation 1
Draft legislative resolution Amendment
Having regard to the Treaty on the
Functioning of the European Union, and in
particular Articles 43, 114, and 168(4)(b)
thereof,
Having regard to the Treaty on the
Functioning of the European Union, and in
particular Articles 43, 114, 168(4)(b) and
192(1),
Justification
The authorisation to cultivate or to put into circulation genetically modified organisms, plants
or animals as well as the authorisation of active substances of pesticides has considerable
impacts on the natural environment and on human health; the protection of human health
forms part of the EU environmental policy.
Amendment 2
Proposal for a regulation
Recital 2 a (new)
Text proposed by the Commission Amendment
(2a) Risk management, assessment and
communication activities should be based
on a thorough application of, inter alia,
the precautionary principle.
Amendment 3
Proposal for a regulation
Recital 4
Text proposed by the Commission Amendment
(4) It is therefore necessary to ensure a
comprehensive and continuous risk
communication process throughout risk
analysis, involving Union and national risk
assessors and risk managers. That process
should be combined with an open dialogue
between all interested parties to ensure the
(4) It is therefore necessary to ensure a
transparent, independent, continuous and
inclusive risk communication process
throughout risk analysis, involving Union
and national risk assessors and risk
managers. That process should regain
citizens' trust that the whole process is
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coherence and consistency within the risk
analysis process. underpinned by the objective of this
Regulation, which is to ensure high level
of human life and health and the
protection of consumers' interests. That
process should also be capable of
contributing to a participatory and open
dialogue between all interested parties
particularly the public, to ensure
prevalence of public interest only,
accuracy, comprehensiveness,
transparency, consistency, and
accountability within the risk analysis
process.
Justification
In order to win public's trust, any communication and marketing of the process, should have a
real content which will concretely demonstrate and prove that the things have improved.
Otherwise any change is doomed to failure.
Amendment 4
Proposal for a regulation
Recital 4 a (new)
Text proposed by the Commission Amendment
(4a) On signing trade agreements, the
Union needs to ensure that the food
legislation of third-country partners is at
least as protective of food safety as Union
law, so as to guarantee consumer safety
and prevent unfair competition with
European products.
Amendment 5
Proposal for a regulation
Recital 5
Text proposed by the Commission Amendment
(5) Particular emphasis should be
placed on explaining in a coherent,
appropriate and timely manner not only
risk assessment findings themselves but
also how these are utilized to help inform
(5) Particular emphasis should be
placed on explaining in an accurate, clear,
objective and timely manner not only risk
assessment findings themselves but also
how these are utilized to help inform risk
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risk management decisions along with
other legitimate factors, where relevant.
management decisions along with other
legitimate factors, where relevant.
Amendment 6
Proposal for a regulation
Recital 5 a (new)
Text proposed by the Commission Amendment
(5a) There is no definition of 'other
legitimate factors' in the General Food
Law in relation to its objective. This
principle should always be applied on a
case-by-case basis, but as there are no
general guidelines on the application and
interpretation of the principle, there is a
lack of consistency in its application. The
Commission should therefore draft
general guidelines on the application of
this principle.
Amendment 7
Proposal for a regulation
Recital 6
Text proposed by the Commission Amendment
(6) To this effect, it is necessary to
establish general objectives and principles
of risk communication, taking into account
the respective roles of risk assessors and
managers.
(6) To this effect, it is necessary to
establish general objectives and principles
of risk communication. In this connection,
the respective roles of risk assessors and
managers should be taken into account,
while guaranteeing their independence.
Amendment 8
Proposal for a regulation
Recital 8
Text proposed by the Commission Amendment
(8) The general plan should identify the
key factors to be taken into account when
risk communications’ activities are
(8) The general plan should lay down
the practical arrangements for making
available to the public the necessary
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considered, such as the different levels of
risk, the nature of the risk and its potential
public health impact, who and what are
directly or indirectly affected by the risk,
the levels of risk exposure, the ability to
control risk and other factors that influence
risk perception including the level of
urgency as well as the applicable
legislative framework and relevant market
context. The general plan should also
identify the tools and channels to be used
and should establish appropriate
mechanisms to ensure coherent risk
communication.
information to achieve a high level of
transparency in the risk management
process. It should identify the key factors
to be taken into account when risk
communications’ activities are considered,
such as the different levels of risk, the
nature of the risk and its potential impact
on public health, animal health and the
environment, who and what are directly or
indirectly affected by the risk, the levels of
risk exposure, the ability to minimise or
control risk and other factors that influence
risk perception including the level of
urgency as well as the applicable
legislative framework and relevant market
context. The general plan should also
identify the tools and channels to be used
and should establish appropriate
mechanisms to ensure coherent risk
communication.
Amendment 9
Proposal for a regulation
Recital 9
Text proposed by the Commission Amendment
(9) Transparency of the risk assessment
process contributes to the Authority
acquiring greater legitimacy in the eyes of
the consumers and general public in
pursuing its mission, increases their
confidence in its work and ensures that the
Authority is more accountable to the Union
citizens in a democratic system. It is
therefore essential to maintain the
confidence of the general public and other
interested parties in the risk analysis
process underpinning Union food law and
in particular in the risk assessment,
including the organisation and
independence of the Authority and
transparency.
(9) Improving transparency of the risk
assessment process would contribute to the
Authority acquiring greater legitimacy in
the eyes of the consumers and general
public in pursuing its mission, increase
their confidence in its work and ensure that
the Authority is more accountable to the
Union citizens in a democratic system. It is
therefore essential to rebuild the
confidence of the general public and other
interested parties in the risk analysis
process underpinning Union food law and
in particular in the risk assessment,
including the organisation, functioning and
independence of the Authority and
transparency.
Amendment 10
Proposal for a regulation
Recital 10
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Text proposed by the Commission Amendment
(10) It is appropriate to align the
composition of the Management Board of
the Authority to the Common Approach
on decentralised agencies, in accordance
with the Joint Statement of the European
Parliament, the Council of the European
Union and the European Commission on
decentralised agencies of 201222 .
deleted
__________________
22 https://europa.eu/european-
union/sites/europaeu/files/docs/body/joint
_statement_and_common_approach_2012
_en.pdf.
Amendment 11
Proposal for a regulation
Recital 11
Text proposed by the Commission Amendment
(11) Experience shows that the role of
the Management Board of the Authority is
focussed on administrative and financial
aspects and does not impact on the
independence of the scientific work
performed by the Authority. It is thus
appropriate to include representatives of all
Member States in the Management Board
of the Authority, while providing that those
representatives should have experience in
particular on risk assessment.
(11) Experience shows that the role of
the Management Board of the Authority is
focussed on administrative and financial
aspects and does not impact on the
independence of the scientific work
performed by the Authority. It is thus
appropriate to include representatives of all
Member States, the Commission, the
European Parliament, as well as civil
society and industry associations in the
Management Board of the Authority, while
providing that those representatives should
have experience in particular on risk
assessment and that any conflict of
interest is avoided.
Amendment 12
Proposal for a regulation
Recital 12
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Text proposed by the Commission Amendment
(12) The Management Board should be
selected in such a way as to secure the
highest standards of competence and a
broad range of relevant experience
available amongst the representatives of
the Member States, the European
Parliament and the Commission.
(12) The Management Board should be
selected in such a way as to secure the
highest standards of competence and
commitment to the protection of health
and the environment and a broad range of
relevant experience available amongst the
representatives of the Member States, the
European Parliament and the Commission.
Amendment 13
Proposal for a regulation
Recital 13
Text proposed by the Commission Amendment
(13) The Fitness Check of the General
Food Law identified certain shortcomings
in the long-term capability of the Authority
to maintain its high-level expertise. In
particular, there has been a decrease in the
number of candidates applying to be
members of the Scientific Panels. The
system has thus to be strengthened and
Member States should take a more active
role to ensure that a sufficient pool of
experts is available to meet the needs of
the Union risk assessment system in terms
of high level of scientific expertise,
independence and multidisciplinary
expertise.
(13) The Fitness Check of the General
Food Law identified certain shortcomings
in the long-term capacity of the Authority
to maintain its high-level expertise through
expert personnel. Moreover, there has
been a decrease in the number of
candidates applying to be members of the
Scientific Panels, and the reason for this
decline should be examined. Six Member
States provide two thirds of the experts on
the scientific panels. As the United
Kingdom currently provides
approximately 20% of the national
experts, the problem will be further
exacerbated with the withdrawal of the
United Kingdom from the Union. In order
to tackle this phenomenon more
effectively, the system has thus to be
strengthened and promoted, must
encourage candidates to apply and
Member States should support the
dissemination of the Authority’s calls for
expressions of interest for membership of
the Scientific Panels and Scientific
Committee, to ensure that a sufficient pool
of independent experts is available, by
undertaking support actions and using
incentives and rewards to increase the
level of participation and the degree of
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interest in seeking to engage in it.
Justification
Explanation of the causes of the Authority’s human resources problems.
Amendment 14
Proposal for a regulation
Recital 14
Text proposed by the Commission Amendment
(14) To preserve the independence of
the risk assessment from risk management
and from other interests at Union level, it is
appropriate that the nomination of the
members of the Scientific Panels by the
Member States, their selection by the
Executive Director of the Authority and
their appointment by the Management
Board of the Authority are based on strict
criteria ensuring the excellence and
independence of the experts while ensuring
the required multidisciplinary expertise for
each Panel. It is also essential to this end
that the Executive Director whose function
is to defend EFSA’s interests and in
particular the independence of its expertise
has a role in the selection and appointment
of those scientific experts. Further
measures should also be put in place to
ensure that scientific experts have the
means to act independently.
(14) To preserve the independence of
the risk assessment from risk management
and from other interests at Union level, it is
appropriate that the nomination of the
members of the Scientific Panels, their
selection by the Executive Director of the
Authority and their appointment by the
Management Board of the Authority are
based on strict criteria ensuring the
excellence and independence of the experts
while ensuring the required
multidisciplinary expertise for each Panel.
It is also essential to this end that the
Executive Director, who is the legal
representative of the Authority and whose
function is to defend EFSA’s interests and
to monitor its performance and in
particular the independence of its expertise
has a role in the selection and appointment
of those scientific experts. Further
measures, including proper financial
compensation, should also be put in place
to ensure that scientific experts have the
means to act independently and to dedicate
sufficient time to their risk assessment
work for the Authority.
Amendment 15
Proposal for a regulation
Recital 15
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Text proposed by the Commission Amendment
(15) It is essential to ensure the efficient
operation of the Authority and to improve
the sustainability of its expertise. It is
therefore necessary to strengthen the
support provided by the Authority and the
Member States to the work of the
Authority’s Scientific Panels. In particular,
the Authority should organise the
preparatory work supporting the Panels’
tasks, including by requesting the
Authority’s staff or national scientific
organisations networking with the
Authority to draft preparatory scientific
opinions to be peer-reviewed and adopted
by the Panels.
(15) It is essential to ensure the efficient
operation of the Authority and to improve
the sustainability of its expertise. It is
therefore necessary to strengthen the
support provided by the Authority and the
Member States to the work of the
Authority’s Scientific Panels. In particular,
the Authority should organise the
preparatory work supporting the Panels’
tasks, including by requesting the
Authority’s staff or national scientific
organisations networking with the
Authority to draft preparatory scientific
opinions to be peer-reviewed and adopted
by the Panels. This should be without
prejudice to the independence of the
Authority’s scientific assessments.
Amendment 16
Proposal for a regulation
Recital 16
Text proposed by the Commission Amendment
(16) Authorisations procedures are
based on the principle that it is for the
applicant to prove that the subject matter of
an authorisation procedure complies with
Union safety requirements given the
scientific knowledge in its possession. This
principle is based on the premise that
public health is better protected when the
burden of proof is on the applicant since it
has to prove that a particular subject matter
is safe prior to its placing on the market,
instead of the public authorities having to
prove that a subject matter is unsafe in
order to be able to ban it from the market.
Moreover, public money should not be
used to commission costly studies that will
in the end help the industry to place a
product on the market. According to this
principle and in accordance with applicable
regulatory requirements, in support of
(16) Authorisations procedures are
based on the principle that it is for the
applicant to prove that the subject matter of
an authorisation procedure complies with
Union safety requirements given the
scientific knowledge in its possession. This
principle is based on the premise that
public health and the environment are
better protected when the burden of proof
is on the applicant since it has to prove that
a particular subject matter is safe prior to
its placing on the market, instead of the
public authorities having to prove that a
subject matter unsafe in order to be able to
ban it from the market. Moreover, public
money should not be used to commission
costly studies that will in the end help the
industry to place a product on the market.
According to this principle and in
accordance with applicable regulatory
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applications for an authorisation under
Union sectoral food law applicants are
required to submit relevant studies,
including tests, to demonstrate the safety
and in some cases the efficacy of a subject
matter.
requirements, in support of applications for
an authorisation under Union sectoral food
law applicants are required to submit
relevant studies, including tests, to
demonstrate the safety and in some cases
the efficacy of a subject matter.
Amendment 17
Proposal for a regulation
Recital 16 a (new)
Text proposed by the Commission Amendment
(16a) A comparison of Union agencies
shows that the Authority needs up to 55
months for an authorisation procedure or
five times longer than the European
Medicines Agency (EMA). This
discourages firms from investing in
innovative products and reduces Union’s
competitiveness in the long run. In
addition, long authorisation procedures
weaken confidence in the Authority. It is
therefore urgently advisable to ensure the
efficiency of the risk assessment by means
of better human and financial resources.
Amendment 18
Proposal for a regulation
Recital 17
Text proposed by the Commission Amendment
(17) Provisions exist on the content of
applications for authorisations. It is
essential that the application for
authorisation submitted to the Authority for
its risk assessment meets the applicable
specifications to ensure the best quality
scientific assessment by the Authority.
Applicants and in particular small- and
medium-sized enterprises do not always
have a clear understanding of these
specifications. It should be thus appropriate
that the Authority provides advice to a
potential applicant, upon request, on the
(17) Provisions exist on the content of
applications for authorisations. It is
essential that the application for
authorisation submitted to the Authority for
its risk assessment meets the applicable
specifications to ensure the best quality
scientific assessment by the Authority.
Applicants and in particular small- and
medium-sized enterprises do not always
have a clear understanding of these
specifications. It should be thus appropriate
that the Authority provides advice to a
potential applicant, upon request, on the
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applicable rules and the required content of
an application for authorisation, before an
application is formally submitted, while
not entering into the design of the studies
to be submitted that remain the
applicant’s responsibility. To ensure the
transparency of this process, the advice of
the Authority should be made public.
applicable rules and the required content of
an application for authorisation, before an
application is formally submitted. By 36
months after the entry into force of this
Regulation, the Commission should
evaluate the impact of the general advice
provided on the functioning of the
Authority. In particular, the Commission
should evaluate its impact on the
allocation of the Authority's resources
and on its independence.
Amendment 19
Proposal for a regulation
Recital 18
Text proposed by the Commission Amendment
(18) The Authority should have
knowledge of the subject matter of all
studies performed by an applicant with a
view to a future application for an
authorisation under Union food law. To
this end, it is necessary and appropriate
that business operators commissioning the
studies and laboratories carrying them out
notify those studies to the Authority when
commissioned. Information about the
notified studies should be made public only
once a corresponding application for
authorisation has been made public in
accordance with the applicable rules on
transparency.
(18) The Authority should have
knowledge of the subject matter of all
studies performed by an applicant with a
view to a future application for an
authorisation or renewal under Union food
law. To this end, it is necessary and
appropriate that business operators
commissioning the studies and laboratories
carrying them out notify those studies to
the Authority when commissioned in the
Union or beyond. Information about the
notified studies should be made public only
once a corresponding application for
authorisation or renewal has been made
public in accordance with the applicable
rules on transparency.
Amendment 20
Proposal for a regulation
Recital 20
Text proposed by the Commission Amendment
(20) There are certain public concerns
about the Authority’s assessment in the
area of authorisation being primarily based
on industry studies. The Authority already
makes searches in scientific literature to be
(20) There are certain public concerns
about the Authority’s assessment in the
area of authorisation being primarily based
on industry studies. In the case of a new
application for an authorisation or a
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able to consider other data and studies
existing on the subject matter submitted to
its assessment. In order to provide an
additional level of guarantee ensuring that
the Authority can have access to all
relevant scientific data and studies
available on a subject matter of an
authorisation procedure, it is appropriate to
provide for a consultation of third parties in
order to identify whether other relevant
scientific data or studies are available. To
increase the effectiveness of the
consultation, the consultation should take
place when the studies submitted by
industry included in an application for
authorisation are made public, under the
transparency rules of this Regulation.
renewal procedure, the Authority should
always conduct searches in scientific
literature to be able to consider other data
and studies existing on the subject matter
submitted to its assessment and, where
necessary, demand additional studies. The
Authority should provide public access to
all relevant scientific literature on the
matter, which it holds. In order to provide
an additional level of guarantee ensuring
that the Authority can have access to all
relevant scientific data and studies
available on a subject matter of an
authorisation procedure, it is appropriate to
provide for a consultation of third parties in
order to identify whether other relevant
scientific data or studies are available. To
increase the effectiveness of the
consultation, the consultation should take
place immediately after the studies
submitted by industry included in an
application for authorisation have been
made public, under the transparency rules
of this Regulation.
Amendment 21
Proposal for a regulation
Recital 21
Text proposed by the Commission Amendment
(21) Studies, including tests, submitted
by business operators in support of
applications for authorisations under Union
sectoral food law usually comply with
internationally recognised principles,
which provide a uniform basis for their
quality in particular in terms of
reproducibility of results. However, issues
of compliance with the applicable
standards may arise in some cases and this
is why national systems are in place to
verify such compliance. It is appropriate to
provide an additional level of guarantees to
reassure the general public on the quality
of studies and to lay down an enhanced
auditing system whereby Member State
controls on the implementation of those
(21) Studies, including tests, submitted
by business operators in support of
applications for authorisations under Union
sectoral food law should be based on
scientific open literature or comply with
internationally recognised standards and
Good Laboratory Practice (GLP)
principles, which provide a uniform basis
for their quality in particular in terms of
reproducibility of results. However, issues
of compliance with the applicable
standards may arise in some cases and this
is why national systems are in place to
verify such compliance. It is appropriate to
provide an additional level of guarantees to
reassure the general public on the quality
of studies and to lay down an enhanced
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principles by the laboratories carrying out
such studies and tests would be verified by
the Commission.
auditing system whereby Member State or
third country controls, in collaboration
with the Commission’s Directorate for
Health and Food Audits and Analysis on
the implementation of those principles by
the laboratories carrying out such studies
and tests in the Union and in third
countries would be verified by the
Commission.
Amendment 22
Proposal for a regulation
Recital 21 a (new)
Text proposed by the Commission Amendment
(21a) Sufficient flexibility ought to be
built into the process so that new insights
into serious health adverse effects can be
promptly taken into consideration, even
when they are not specifically covered by
regulatory data requirements.
Amendment 23
Proposal for a regulation
Recital 22
Text proposed by the Commission Amendment
(22) Food safety is a sensitive matter of
prime interest for all Union citizens. While
maintaining the principle that the burden is
on the industry to prove compliance with
Union requirements, it is important to
establish an additional verification tool to
address specific cases of high societal
importance where there is a controversy on
safety issues, namely the commissioning of
additional studies with the objective of
verifying evidence used in the context of
risk assessment. Considering that it would
be financed by the Union budget and that
the use of this exceptional verification tool
should remain proportionate, the
Commission should be responsible for
triggering the commissioning of such
verification studies. Account should be
(22) Food safety is a sensitive matter of
prime interest for all Union citizens. While
maintaining the principle that the burden is
on the industry to prove compliance with
Union requirements, it is important to
establish an additional verification tool to
address specific cases of high societal
importance where there is a controversy on
safety issues, namely the commissioning of
additional studies with the objective of
verifying evidence used in the context of
risk assessment. Considering that it would
be financed by the Union budget and that
the use of this exceptional verification tool
should remain proportionate, the
Commission should, in case of divergent
scientific findings, be responsible for
triggering the commissioning of such
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taken of the fact that in some specific cases
the studies commissioned may need to
have a wider scope than the evidence at
stake (for example new scientific
developments becoming available).
verification studies. Account should be
taken of the fact that in some specific cases
the studies commissioned may need to
have a wider scope than the evidence at
stake in the risk assessment process (for
example new scientific developments
becoming available).
Amendment 24
Proposal for a regulation
Recital 23 a (new)
Text proposed by the Commission Amendment
(23a) The Aarhus Convention
establishes a number of rights of the
public with regard to the environment.
The Aarhus Convention provides for the
right of everyone to receive environmental
information that is held by public
authorities, the right to participate in
environmental decision-making, and the
right to review procedures to challenge
public decisions that have been made
without respecting the two
aforementioned rights or environmental
law in general.
Amendment 25
Proposal for a regulation
Recital 24
Text proposed by the Commission Amendment
(24) The European Citizens’ Initiative
“Ban glyphosate and protect people and the
environment from toxic pesticides” further
confirmed concerns regarding transparency
with respect to studies commissioned by
the industry and submitted in authorisation
application23 .
(24) As a Party to the Aarhus
Convention, the Union has recognised
that, in the field of the environment,
improved access to information and
public participation in decision-making
enhance the quality and the
implementation of decisions, contribute to
public awareness of environmental issues,
give the public the opportunity to express
its concerns and enable public authorities
to take due account of such concerns. The
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European Citizens’ Initiative “Ban
glyphosate and protect people and the
environment from toxic pesticides” further
confirmed concerns regarding transparency
with respect to studies commissioned by
the industry and submitted in authorisation
application23 .
__________________ __________________
23 Communication from the Commission
on the ECI “Ban glyphosate and protect
people and the environment from toxic
pesticides”, C(2017) 8414 final.
23 Communication from the Commission
on the ECI “Ban glyphosate and protect
people and the environment from toxic
pesticides”, C(2017) 8414 final.
Amendment 26
Proposal for a regulation
Recital 25 a (new)
Text proposed by the Commission Amendment
(25a) Using the Board of Appeal of the
European Chemicals Agency as its model,
as set out in Articles 89 to 93 of
Regulation (EC) No 1907/2006 of the
European Parliament and of the
Council1a, an EFSA Board of Appeal
should be established by means of
delegated acts.
_______________
1a Regulation (EC) No 1907/2006 of the
European Parliament and of the Council
of 18 December 2006 concerning the
Registration, Evaluation, Authorisation
and Restriction of Chemicals (REACH),
establishing a European Chemicals
Agency, amending Directive 1999/45/EC
and repealing Council Regulation (EEC)
No 793/93 and Commission Regulation
(EC) No 1488/94 as well as Council
Directive 76/769/EEC and Commission
Directives 91/155/EEC, 93/67/EEC,
93/105/EC and 2000/21/EC (OJ L 396,
30.12.2006, p.1).
Amendment 27
Proposal for a regulation
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Recital 27
Text proposed by the Commission Amendment
(27) To determine what level of
disclosure strikes the appropriate balance,
the relevant rights of the public to
transparency in the risk assessment
process, should be weighted up against the
rights of commercial applicants, taking into
account the objectives of Regulation (EC)
No 178/2002.
(27) To determine what level of
proactive disclosure strikes the appropriate
balance, the need to ensure transparency in
the risk assessment process, should be
weighted up against the rights of
commercial applicants, taking into account
the objectives of Regulation (EC) No
178/2002 of a high level of protection of
human life and health, the protection of
consumers' interests, as well as the
protection of animal health and welfare,
plant health and the environment.
Justification
Wording of article 5(1) of Reg 178/2002.
Amendment 28
Proposal for a regulation
Recital 27 a (new)
Text proposed by the Commission Amendment
(27a) The provisions on active
dissemination laid down in this
Regulation are not meant to limit, in any
manner, the scope of the rights provided
for by Regulations (EC) No 1049/2001
and (EC) No 1367/2006.
Amendment 29
Proposal for a regulation
Recital 30
Text proposed by the Commission Amendment
(30) It is also necessary to set out
specific requirements with respect to the
protection of personal data for the purposes
of the transparency of the risk assessment
process taking into account Regulation
(30) It is also necessary to refer, for the
protection and confidentiality of personal
data for the purposes of the transparency of
the risk assessment process, to Regulation
(EC) No 45/2001 of the European
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(EC) No 45/2001 of the European
Parliament and of the Council24 and
Regulation (EU) 2016/679 of the European
Parliament and of the Council25 .
Accordingly, no personal data should be
made publicly available under this
Regulation, unless it is necessary and
proportionate for the purposes of ensuring
the transparency, independence and the
reliability of the risk assessment process,
while preventing conflicts of interests.
Parliament and of the Council and
Regulation (EU) 2016/679 of the European
Parliament and of the Council25 .
Accordingly, no personal data should be
made publicly available under this
Regulation, unless it is necessary and
proportionate for the purposes of ensuring
the transparency, independence and the
reliability of the risk assessment process,
while preventing conflicts of interests. For
the purpose of ensuring the transparency,
independence, sustainability and
reliability of the risk assessment process,
in particular to avoid conflicts of interest,
it is considered necessary and
proportionate to publish the names of any
individual designated by the Authority to
contribute to the Authority’s decision
making process, including in the context
of the adoption of guidance documents.
__________________ __________________
24 Regulation (EC) No 45/2001 of the
European Parliament and of the Council of
18 December 2000 on the protection of
individuals with regard to the processing of
personal data by the Community
institutions and bodies and on the free
movement of such data (OJ L 8, 12.1.2001,
p. 1).
24 Regulation (EC) No 45/2001 of the
European Parliament and of the Council of
18 December 2000 on the protection of
individuals with regard to the processing of
personal data by the Community
institutions and bodies and on the free
movement of such data (OJ L 8, 12.1.2001,
p. 1).
25 Regulation (EU) 2016/679 of the
European Parliament and of the Council of
27 April 2016 on the protection of natural
persons with regard to the processing of
personal data and on the free movement of
such data, and repealing Directive
95/46/EC (General Data Protection
Regulation) (OJ L 119, 4.5.2016, p. 1).
25 Regulation (EU) 2016/679 of the
European Parliament and of the Council of
27 April 2016 on the protection of natural
persons with regard to the processing of
personal data and on the free movement of
such data, and repealing Directive
95/46/EC (General Data Protection
Regulation) (OJ L 119, 4.5.2016, p. 1).
Amendment 30
Proposal for a regulation
Recital 31
Text proposed by the Commission Amendment
(31) For the purposes of increased
transparency and in order to ensure that
(31) For the purposes of increased
transparency and in order to ensure that
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requests for scientific outputs received by
the Authority are processed in an effective
manner, standard data formats and
software packages should be developed. In
order to ensure uniform conditions for the
implementation of Regulation (EC) No
178/2002 with regard to the adoption of
standard data formats and software
packages, implementing powers should be
conferred on the Commission. Those
powers should be exercised in accordance
with Regulation (EU) No 182/2011 of the
European Parliament and of the Council26.
requests for scientific outputs received by
the Authority are processed in an effective
manner, standard data formats and
software packages should be developed. In
order to ensure uniform and harmonised
conditions for the implementation of
Regulation (EC) No 178/2002 with regard
to the adoption of standard data formats
and software packages, implementing
powers should be conferred on the
Commission. Those powers should be
exercised in accordance with Regulation
(EU) No 182/2011 of the European
Parliament and of the Council26.
_________________ _________________
26 Regulation (EU) No 182/2011 of the
European Parliament and of the Council of
16 February 2011 laying down the rules
and general principles concerning
mechanisms for control by Member States
of the Commission’s exercise of
implementing powers (OJ L 55, 28.2.2011,
p. 13).
26 Regulation (EU) No 182/2011 of the
European Parliament and of the Council of
16 February 2011 laying down the rules
and general principles concerning
mechanisms for control by Member States
of the Commission’s exercise of
implementing powers (OJ L 55, 28.2.2011,
p. 13).
Amendment 31
Proposal for a regulation
Recital 33
Text proposed by the Commission Amendment
(33) Furthermore, in order to assess the
effectiveness and efficiency of the different
provisions applying to the Authority, it is
also appropriate to provide for a
Commission evaluation of the Authority,
in accordance with the Common
Approach on Decentralised Agencies. The
evaluation should, in particular, review the
procedures for selecting the members of
Scientific Committee and Panels, for their
degree of transparency, cost-effectiveness,
and suitability to ensure independence and
competence, and to prevent conflicts of
interests.
(33) Furthermore, in order to assess the
effectiveness and efficiency of the different
provisions applying to the Authority, it is
also appropriate to conduct an
independent evaluation of the Authority.
The evaluation should, in particular, review
the procedures for selecting the members
of Scientific Committee and Panels, for
their degree of transparency, cost-
effectiveness, and suitability to ensure
independence and competence, and to
prevent conflicts of interests.
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Amendment 32
Proposal for a regulation
Recital 33 a (new)
Text proposed by the Commission Amendment
(33a) The Seventh European
Environment Action Programme has
prioritised the development and
realisation of pathways to address the
combined effects of chemicals on human
health and the environment. Assessment
of ‘cocktail effects’ requires a cross-
sectoral approach, closer cooperation
between monitoring agencies at European
level and the formulation of suitable
procedures.
Justification
This amendment seeks the adoption of a coordinated approach by all relevant sectors to the
European chemicals evaluation process, giving EFSA a key role. In addition, it is important
for those carrying out the evaluations to take account of cocktail effects also so that the
appropriate management measures can be implemented.
Amendment 33
Proposal for a regulation
Recital 35
Text proposed by the Commission Amendment
(35) For the purposes of ensuring
transparency of the risk assessment
process, it is also necessary to extend the
scope of Regulation (EC) No 178/2002,
currently limited to food law, to also cover
applications for authorisations in the
context of Regulation (EC) No 1831/2003
as regards feed additives, Regulation (EC)
No 1935/2004 as regards food contact
materials and Regulation (EC) No
1107/2009 as regards plant protection
products.
(35) For the purposes of ensuring the
transparency and independence of the risk
assessment process, it is also necessary to
extend the scope of Regulation (EC) No
178/2002, currently limited to food law, to
also cover applications for authorisations in
the context of Regulation (EC) No
1831/2003 as regards feed additives,
Regulation (EC) No 1935/2004 as regards
food contact materials and Regulation (EC)
No 1107/2009 as regards plant protection
products.
Amendment 34
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Proposal for a regulation
Recital 36
Text proposed by the Commission Amendment
(36) To ensure that sectoral specificities
with respect to confidential information are
taken into account, it is necessary to weigh
up the relevant rights of the public to
transparency in the risk assessment
process, including those flowing from the
Aarhus Convention1, against the rights of
commercial applicants, taking into account
the specific objectives of sectoral Union
legislation as well as experienced gained.
Accordingly, it is necessary to amend
Directive 2001/18/EC, Regulation (EC) No
1829/2003, Regulation (EC) No
1831/2003, Regulation (EC) No 1935/2004
and Regulation (EC) No 1107/2009 to
provide for additional confidential items to
those set out in Regulation (EC)
No 178/2002.
(36) To ensure that sectoral specificities
with respect to confidential information are
taken into account, it is necessary to weigh
up the relevant rights of the public to
transparency, including the right to benefit
from proactive information related to the
risk assessment process, against the rights
of commercial applicants, taking into
account the specific objectives of sectoral
Union legislation as well as experienced
gained. Accordingly, it is necessary to
amend Directive 2001/18/EC, Regulation
(EC) No 1829/2003, Regulation (EC) No
1831/2003, Regulation (EC) No 1935/2004
and Regulation (EC) No 1107/2009 to
provide for additional confidential items to
those set out in Regulation (EC)
No 178/2002. The provisions on active
dissemination laid down in this
Regulation and the assessment of a
confidentiality request by the Authority
should not in any manner limit the scope
of the rights provided by Regulations (EC)
No 1049/2001 and (EC) No 1367/2006.
_____________________________
1 Regulation (EC) No 1367/2006 of the
European Parliament and of the Council
of 6 September 2006 on the application of
the provisions of the Aarhus Convention
on Access to Information, Public
Participation in Decision-making and
Access to Justice in Environmental
Matters to Community institutions and
bodies (OJ L 264, 25.9.2006, p.13).
Amendment 35
Proposal for a regulation
Recital 36 a (new)
Text proposed by the Commission Amendment
(36a) The Fitness Check of the General
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Food Law also highlighted a lack of
transparency of the risk management
process. There is a need to better inform
the public on the risk management
options under consideration, the level of
protection to consumer and animal health
and the environment that each of these
options would achieve, as well as on the
factors, other than the results of the risk
assessment, which are taken into account
by the risk managers, and how they are
weighed up against each other in the
decision-making process.
Amendment 36
Proposal for a regulation
Recital 37
Text proposed by the Commission Amendment
(37) In order to further strengthen the
link between risk assessors and risk
managers at Union and national levels as
well as the coherence and consistency of
risk communication, the power to adopt
acts in accordance with Article 290 of the
Treaty should be delegated to the
Commission to adopt a general plan on risk
communication on matters covering the
agri-food chain. It is of particular
importance that the Commission carries out
appropriate consultations during its
preparatory work, including at expert level,
and that those consultations be conducted
in accordance with the principles laid down
in the Interinstitutional Agreement on
Better Law-Making of 13 April 2016. In
particular, to ensure equal participation in
the preparation of delegated acts, the
European Parliament and the Council
receive all documents at the same time as
Member States’ experts, and their experts
systematically have access to meetings of
Commission expert groups dealing with the
preparation of delegated acts.
(37) In order to improve the interactive
exchange of information, throughout the
risk analysis process, amongst the risk
assessors and risk managers at Union and
national levels, as well as with other
stakeholders of the food chain such as
economic operators, consumer and other
civil society organisations, the power to
adopt acts in accordance with Article 290
of the Treaty should be delegated to the
Commission to adopt a general plan on risk
communication on matters covering the
agri-food chain. The general plan on risk
communication should lay down the
practical arrangements for making
available to the public the necessary
information to achieve a high level of
transparency of the risk management
process. Therefore, it is of particular
importance that the Commission carries out
appropriate consultations during its
preparatory work, including at expert level,
and that those consultations be conducted
in accordance with the principles laid down
in the Interinstitutional Agreement on
Better Law-Making of 13 April 2016. In
particular, to ensure equal participation in
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the preparation of delegated acts, the
European Parliament and the Council
receive all documents at the same time as
Member States’ experts, and their experts
systematically have access to meetings of
Commission expert groups dealing with the
preparation of delegated acts.
Amendment 37
Proposal for a regulation
Recital 37 a (new)
Text proposed by the Commission Amendment
(37a) Provisions regarding what
information should be made public should
be without prejudice to Regulation (EC)
No 1049/2001, as well as national or
Union law regarding public access to
official documents.
Amendment 38
Proposal for a regulation
Recital 38
Text proposed by the Commission Amendment
(38) In order to enable the Authority and
the business operators to adapt to the new
requirements while ensuring that the
Authority continues its smooth operation, it
is necessary to provide for transitional
measures for the application of this
Regulation.
(38) In order to enable the Authority,
Member States, the Commission and the
business operators to adapt to the new
requirements while ensuring that the
Authority continues its smooth operation, it
is necessary to provide for transitional
measures for the application of this
Regulation.
Amendment 39
Proposal for a regulation
Recital 39 a (new)
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Text proposed by the Commission Amendment
(39a) Since the amendments contained
in this proposal serve to transfer far-
reaching competencies for risk
assessment and confidentiality checks to
the Authority, a significant increase in the
budget for the Authority pursuant to
Annex 3 of the Commission’s proposal is
necessary. The financing proposal is
compatible with the current multiannual
financial framework but may entail the
use of special instruments as defined in
Council Regulation (EU, Euratom) No
1311/2013. Should discussions between
the European Parliament and the
Member States on the Union budget not
leave sufficient room for the necessary
budgetary resources, then the
Commission would have to propose an
alternative financing proposal under a
delegated act.
Justification
Given the impact of Brexit on the EU budget, the outcome of the negotiations on the
multiannual financial framework is still completely uncertain. Should the Council of Ministers
and the European Parliament not be able to agree on an appropriate budget for the EFSA, we
would be saddling the Authority with a mandate that it could simply not carry out with the
existing financial and human resources. The negotiations on the Commission proposal should
also cover an alternative to take account of this eventuality.
Amendment 40
Proposal for a regulation
Recital 40 a (new)
Text proposed by the Commission Amendment
(40a) Recent food safety incidents have
demonstrated the need to establish
appropriate measures in emergency
situations ensuring that all foods,
whatever their type and origin, and all
feed should be subject to common
measures in the event of a serious risk to
human health, animal health or the
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environment. This comprehensive
approach to emergency food safety
measures should enable effective action to
be taken, avoiding artificial disparities in
the treatment of any serious risk to food
or feed through a harmonised joint food
alerts management procedure.
Justification
Regulation (EC) No 178/2002 (Articles 50 to 54), establishes the RASFF, together with its
basic provisions, scope and operation. Weaknesses were subsequently identified, requiring
rectification through the adoption of Regulation (EU) No 16/2011, which did not include
harmonised procedures to be followed by all MS or the necessary enhancement of the
Commission’s powers for dealing with alerts. A joint, compulsory and enhanced procedure
for managing food alerts is necessary.
Amendment 41
Proposal for a regulation
Article 1 – paragraph – point -1 (new)
Regulation (EC) No 178/2002
Article 6 – paragraph 2
Present text Amendment
(-1) In Article 6, paragraph 2 is
replaced as follows:
2. Risk assessment shall be based on
the available scientific evidence and
undertaken in an independent, objective
and transparent manner.
“2. "Risk assessment shall be based on
all available scientific evidence and
undertaken in an independent, objective
and transparent manner."
(This amendment applies throughout the
text. Adopting it will necessitate
corresponding changes throughout.)
Justification
On Glyphosate, the applicant submitted only 52% available scientific publications, along its
own studies. Through the “Klimisch score” by the German Federal Institute for Risk
Assessment, rapporteur for EFSA, most of these studies were classified of ‘limited value’, with
little influence on the outcome of its assessment. That leads EFSA to grant greater weight to
the applicant’s own studies. A rejection of peer-reviewed publications shouldn't be possible in
a risk analysis.
Amendment 42
Proposal for a regulation
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Article 1 – paragraph 1 – point -1 a (new)
Regulation (EC) No 178/2002
Article 7 – paragraph 1
Present text Amendment
(-1a) In Article 7, paragraph 1 is
replaced as follows:
1. In specific circumstances where,
following an assessment of available
information, the possibility of harmful
effects on health is identified but scientific
uncertainty persists, provisional risk
management measures necessary to ensure
the high level of health protection chosen
in the Community may be adopted,
pending further scientific information for a
more comprehensive risk assessment.
"1. In specific circumstances where,
following an assessment of available
information, the possibility of harmful
effects on health is identified but scientific
uncertainty persists, risk management
measures necessary to ensure the high level
of health protection chosen in the
Community shall be adopted, pending
further scientific information for a more
comprehensive risk assessment."
Justification
add Shall" instead of may" In the Glyphosate file, the precautionary principle should have
guided EFSA and COM in the decision making, as there was a “possibility of harmful effects
on health is identified but scientific uncertainty persists”, according to Article 7. Instead of
taking “provisional risk management measures” (Article 7), authorities seem to have applied
“the doubt should benefit the substance”. Therefore, provisional risk management measures
shall be taken when the pcp is applicable, and not "may" be taken
Amendment 43
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8a
Text proposed by the Commission Amendment
Article 8a Article 8a
Objectives of risk communication Objectives of risk communication
Risk communication shall pursue the
following objectives, while taking into
account the respective roles of risk
assessors and risk managers:
Risk communication shall pursue the
following objectives, while taking into
account the respective roles of risk
assessors and risk managers:
(a) promote awareness and
understanding of the specific issues under
consideration during the entire risk analysis
(a) promoting awareness and
understanding of the specific issues under
consideration during the entire risk analysis
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process; and management process;
(b) promote consistency and
transparency in formulating risk
management recommendations;
(b) promoting consistency,
transparency and clarity in formulating
risk management options,
recommendations and decisions;
(c) provide a sound basis for
understanding risk management decisions;
(c) providing a sound scientific basis
for understanding risk management
decisions; including information on:
(i) how the risk management option
chosen reflects the degree of uncertainty
of the risk assessment, and the level of
consumer and animal health and
environmental protection it would
achieve;
(ii) as referred to in Article 6(3), the
factors, other than the results of the risk
assessment, which were considered by the
risk managers, and how these factors
were weighed up against each other;
(d) foster public understanding of the
risk analysis process so as to enhance
confidence in its outcome;
(d) fostering public understanding of
the risk analysis process so as to enhance
confidence in its outcome, including the
provision of clear and consistent
information regarding the respective
tasks, powers and responsibilities of risk
assessors and risk managers;
(e) promote appropriate involvement
of all interested parties; and,
(e) promoting the balanced
involvement of all interested parties,
including economic operators of the food
chain, consumers and other civil society
organisations;
(f) ensure appropriate exchange of
information with interested parties in
relation to risks associated with the agri-
food chain.
(f) ensuring a transparent and
equitable exchange of information with the
interested parties referred to in point (e) in
relation to risks associated with the agri-
food chain;
(fa) informing consumers about risk
prevention strategies; and
(fb) combating the dissemination of
false information and the sources thereof.
Amendment 44
Proposal for a regulation
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Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8b
Text proposed by the Commission Amendment
Article 8b Article 8b
General principles of risk communication General principles of risk communication
Taking into account the respective roles of
risk assessors and risk managers, risk
communication shall:
Taking into account the respective roles of
risk assessors and risk managers, risk
communication shall:
(a) ensure that accurate, appropriate
and timely information is interactively
exchanged, based on the principles of
transparency, openness, and
responsiveness;
(a) ensure that accurate, complete and
timely information is interactively
exchanged with all interested parties,
based on the principles of transparency,
openness, and responsiveness;
(b) provide transparent information at
each stage of the risk analysis process from
the framing of requests for scientific advice
to the provision of risk assessment and the
adoption of risk management decisions;
(b) provide transparent information at
each stage of the risk analysis process from
the framing of requests for scientific advice
to the provision of risk assessment and the
adoption of risk management decisions;
(c) take into account risk perceptions; (c) address risk perceptions;
(d) facilitate understanding and
dialogue amongst all interested parties;
and,
(d) facilitate understanding and
dialogue amongst all interested parties;
(e) be accessible, including to those not
directly involved in the process, while
taking into account confidentiality and
protection of personal data.
(e) be accessible, including to those not
directly involved in the process, while
taking into account confidentiality and
protection of personal data; and
(ea) formulate approaches to better
communicate the difference between
hazard and risk.
Amendment 45
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8c
Text proposed by the Commission Amendment
Article 8c Article 8c
General plan for risk communication General plan for risk communication
1. The Commission, in close 1. The Commission is empowered to
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cooperation with the Authority, the
Member States and following appropriate
public consultations shall be empowered to
adopt delegated acts in accordance with
Article 57a establishing a general plan for
risk communication on matters relating to
the agri-food chain, taking into account the
relevant objectives and general principles
set out in Articles 8a and 8b.
adopt, in close cooperation with the
Authority, the Member States and
following appropriate public consultations,
delegated acts in accordance with Article
57a which supplement this Regulation by
establishing a general plan for risk
communication on matters relating to the
agri-food chain, taking into account the
relevant objectives and general principles
set out in Articles 8a and 8b.
2. The general plan for risk
communication shall promote an integrated
risk communication framework to be
followed both by the risk assessors and the
risk managers in a coherent and systematic
manner both at Union and national level. It
shall:
2. The general plan for risk
communication shall promote an integrated
risk communication framework to be
followed both by the risk assessors and the
risk managers in a coherent and systematic
manner both at Union and national level. It
shall:
(a) identify the key factors that need to
be taken into account when considering the
type and level of risk communications’
activities needed;
(a) identify the key factors that need to
be taken into account when considering the
type and level of risk communications’
activities needed;
(b) identify the appropriate main tools
and channels to be used for risk
communication purposes, taking into
account the needs of relevant target
audience groups; and,
(b) identify the appropriate main tools
and channels to be used for risk
communication purposes, taking into
account the need to ensure the balanced
involvement of all interested parties,
including economic operators of the food
chain, and consumer and other civil
society organisations;
(c) establish appropriate mechanisms
in order to strengthen coherence of risk
communication amongst risk assessors and
risk managers and ensure an open
dialogue amongst all interested parties.
(c) establish appropriate mechanisms
in order to strengthen coherence of risk
communication amongst risk assessors and
risk managers, including by systematically
acknowledging and explaining
divergences in scientific assessment or in
the perception of the acceptable level of
risk;
(ca) lay down the practical
arrangements and a timeline for making
the information referred to in Article
55a(1) available to the public.
3. The Commission shall adopt the
general plan for risk communication within
[two years from the date of application of
this Regulation] and shall keep it updated,
taking into account technical and scientific
3. The Commission shall adopt the
general plan for risk communication within
[two years from the date of application of
this Regulation] and shall keep it updated,
taking into account technical and scientific
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progress and experience gained."; progress and experience gained.";
Amendment 46
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8d (new)
Text proposed by the Commission Amendment
Article 8d
Transparency of risk communication
1. The Commission, the Authority
and the Member States shall carry out
their tasks as regards risk communication
in relation to food law with a high level of
transparency.
2. The Commission may issue
appropriate guidelines.
Amendment 47
Proposal for a regulation
Article 1 – paragraph 1 – point 1 a (new)
Regulation (EC) No 178/2002
Article 9
Present text Amendment
(1a) Article 9 is replaced by the
following:
Article 9 "Article 9
Public consultation Public consultation
There shall be open and transparent public
consultation, directly or through
representative bodies, during the
preparation, evaluation and revision of
food law, except where the urgency of the
matter does not allow it.
There shall be open and transparent public
consultation, directly or through
representative bodies, during the risk
analysis, as well as during the preparation,
evaluation and revision of food law, except
where the urgency of the matter does not
allow it."
Justification
add: "the risk analysis as well as during.." This amendment on the principle of transparency
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governing Regulation n°178/2002 is in line with Commission’s intention to reinforce
transparency during the risk analysis process.
Amendment 48
Proposal for a regulation
Article 1 – paragraph 1 – point 1 b (new)
Regulation (EC) No 178/2002
Article 10
Present text Amendment
(1b) Article 10 is replaced by the
following:
Article 10 “Article 10
Public information Public information
Without prejudice to the applicable
provisions of Community and national law
on access to documents, where there are
reasonable grounds to suspect that a food
or feed may present a risk for human or
animal health, then, depending on the
nature, seriousness and extent of that
risk, public authorities shall take
appropriate steps to inform the general
public of the nature of the risk to health,
identifying to the fullest extent possible the
food or feed, or type of food or feed, the
risk that it may present, and the measures
which are taken or about to be taken to
prevent, reduce or eliminate that risk.
1. Without prejudice to the applicable
provisions of Community and national law
on access to documents, where there are
reasonable grounds to suspect that a food
or feed may present a risk for human or
animal health, then public authorities shall
take appropriate and timely steps to inform
the general public of the nature of the risk
to health, identifying to the fullest extent
possible the concerned products, the risk
that they may present, and the measures
which are taken or about to be taken to
prevent, reduce or eliminate that risk. This
paragraph shall also apply in case of
suspected non-compliances resulting from
possible intentional violations of
applicable Union legislation perpetrated
through fraudulent or deceptive practices.
2. For the purpose of ensuring the
uniform implementation of paragraph 1,
the Commission shall adopt implementing
acts on the modalities of its application by
12 months after the entry into force of this
Regulation.”
Amendment 49
Proposal for a regulation
Article 1 – paragraph 1 – point 1 c (new)
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Regulation (EC) No 178/2002
Article 22 – paragraph 7
Present text Amendment
(1c) In Article 22 (7), the second
subparagraph is replaced by the
following:
It shall act in close cooperation with the
competent bodies in the Member States
carrying out similar tasks to these of the
Authority.
“It shall act in cooperation with the other
European Union evaluation agencies.”
Justification
This amendment is intended to facilitate EFSA's legal mandate and inter-agency
coordination, given the need to take into account across the board all possible scenarios
involving exposure of the public and the environment to chemicals.
Amendment 50
Proposal for a regulation
Article 1 – paragraph 1 – point 1 d (new)
Regulation (EC) No 178/2002
Article 23 – paragraph 1 – point b
Present text Amendment
(1d) In the first paragraph of Article
23, point (b) is replaced by the following:
(b) to promote and coordinate the
development of uniform risk assessment
methodologies in the fields falling within
its mission;
“(b) to promote and coordinate in a
cross-cutting approach the development of
uniform methods for risk assessment in the
areas within its mission, in particular
taking into account the “cocktail effects”
of chemical substances which may have
an impact on human health and the
environment;”
Justification
This amendment seeks the adoption of a coordinated approach by all relevant sectors to the
European chemicals evaluation process, giving EFSA a key role. In addition, it is important
for those carrying out the evaluations to take account of cocktail effects also so that the
appropriate management measures can be implemented.
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Amendment 51
Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point b
Regulation (EC) No 178/2002
Article 25 – paragraph 1a
Text proposed by the Commission Amendment
1a. In addition to members and
alternate members referred to in paragraph
1, the Management Board shall include:
1a. In addition to members and
alternate members referred to in paragraph
1, the Management Board shall include:
(a) two members and the alternate
members appointed by the Commission
and representing the Commission, with the
right to vote.
(a) two members and the alternate
members appointed by the Commission
and representing the Commission, with the
right to vote.
(b) one member appointed by the
European Parliament, with the right to
vote.
(b) two representatives appointed by
the European Parliament, with the right to
vote.
(c) four members with the right to vote
representing civil society and food chain
interests namely, one from consumers
organisations, one from environmental
non-governmental organisations, one from
farmers organisations and one from
industry organisations. Those members
shall be appointed by the Council in
consultation with the European Parliament
on the basis of a list drawn up by the
Commission which includes more names
than there are posts to be filled. The list
drawn up by the Commission shall be
forwarded to the European Parliament,
together with the relevant background
documents. As quickly as possible and
within three months of notification, the
European Parliament may submit its views
for consideration to the Council, which
shall then appoint those members.
(c) six members with the right to vote
representing civil society and food chain
interests namely, one from consumers
organisations, one from environmental
non-governmental organisations, one from
public health non-governmental
organisations, one from farmers
organisations, one from the agro-chemical
organisations and one from food industry
organisations. Those members shall be
appointed by the Council in consultation
with the European Parliament on the basis
of a list drawn up by the Commission
which includes more names than there are
posts to be filled. The list drawn up by the
Commission shall be forwarded to the
European Parliament, together with the
relevant background documents. As
quickly as possible and within three
months of notification, the European
Parliament may submit its views for
consideration to the Council, which shall
then appoint those members.
Amendment 52
Proposal for a regulation
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Article 1 – paragraph 1 – point 2 – point c
Regulation (EC) No 178/2002
Article 25 – paragraph 2
Text proposed by the Commission Amendment
2. The term of office of members and
alternate members shall be four years.
However, the term of office of the
members referred to in paragraph 1a (a)
and (b) shall not be limited in duration.
The term of office of the members referred
to in paragraph 1a(c) may be renewable
only once.
2. The term of office of members
referred to in point (b) of paragraph 1a
shall be maximum 2,5 years. The term of
office of the members referred to in points
(a) and (c) of paragraph 1a shall be five
years The term of office of the members
referred to in point (c) of paragraph 1a may
be renewable only once.
Amendment 53
Proposal for a regulation
Article 1 – paragraph 1 – point 3 – points a and b
Regulation (EC) No 178/2002
Article 28 – paragraphs 5 to 5g
Text proposed by the Commission Amendment
5. The members of the Scientific
Committee who are not members of
Scientific Panels and the additional
members referred to in paragraph 5b shall
be appointed by the Management Board,
acting upon a proposal from the
Executive Director, for a five year term of
office, which may be renewable, following
publication in the Official Journal of the
European Union, in relevant leading
scientific publications and on the
Authority’s website of a call for
expressions of interest.”,
5. The members of the Scientific
Committee who are not members of
Scientific Panels and the members of the
Scientific Panels shall be appointed by the
Management Board for a renewable five
year term of office in accordance with the
following procedure:
5a. The members of the Scientific
Panels shall be appointed by the
Management Board for a renewable five
year term of office in accordance with the
following procedure:
(a) The Executive Director, after
consulting the Management Board, shall
send to the Member States the request for
the specific multidisciplinary expertise
needed in each Scientific Panel and shall
indicate the number of experts to be
(a) The Executive Director, after
consulting the Management Board, shall
publish a call for expression of interest in
the Official Journal of the European
Union, in relevant leading scientific
publications and on the Authority`s
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nominated by the Member States. The
Executive Director shall notify the
Member States of the Authority’s
independence policy and implementing
rules applicable to Scientific Panels’
members. Member States shall launch a
call for interest as a basis for their
nominations. The Executive Director
shall inform the Management Board of
the requests sent to the Member States.
website, and shall inform the Member
States. The call shall lay down the specific
multidisciplinary expertise needed in each
Scientific Panel and shall indicate the
number of experts required.
(b) Member States shall nominate
experts with a view to collectively reach
the number indicated by the Executive
Director. Each Member State shall
nominate at least 12 scientific experts.
Member States may nominate nationals of
other Member States.
(b) Member States shall ensure the
broad dissemination of the call for
expression of interest across the scientific
community. They may also nominate
experts for the fields indicated, provided
that such nominations are made on the
basis of a national call for expression of
interest.
(c) On the basis of the nominations
made by Member States, the Executive
Director shall draw for each Scientific
Panel a list of experts larger than the
number of members to be appointed. The
Executive Director may not draw up such a
list where he/she can justify that the
nominations received do not allow him,
given the criteria for selection set up in
point d) of this paragraph, to draw up a
larger list. The Executive Director shall
submit the list to the Management Board
for appointment.
(c) On the basis of the applications
and nominations received and in
accordance with the Authority’s
independence policy and implementing
rules applicable to Scientific Panels’
members, the Executive Director shall
draw for each Scientific Panel a list of
experts larger than the number of members
to be appointed. The Executive Director
may not draw up such a list where he or
she can justify that the applications and
nominations received do not allow him or
her, given the criteria for selection set up
in point (d) of this paragraph, to draw up a
larger list. The Executive Director shall
submit the list to the Management Board
for appointment.
(d) The nominations by the Member
States, the selection by the Executive
Director and the appointments by the
Management Board shall be made on the
basis of the following criteria:
(d) The nominations by the Member
States, the selection by the Executive
Director and the appointments by the
Management Board shall be made on the
basis of the following criteria:
(i) A high level of scientific expertise; (i) A high level of scientific expertise;
(ii) Independence and absence of
conflict of interests in accordance with
Article 37(2) and the Authority’s
independence policy and implementing
rules on the independence of the Scientific
(ii) Independence and absence of
conflict of interests in accordance with
Article 37(2) and the Authority’s
independence policy and implementing
rules on the independence of the Scientific
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Panels’ members; Panels’ members;
(iii) Meeting the needs for the specific
multi-disciplinary expertise of the Panel to
which they will be appointed and the
applicable language regime.
(iii) Meeting the needs for the specific
multi-disciplinary expertise of the Panel to
which they will be appointed and the
applicable language regime.
(e) The Management Board shall
ensure that the broadest possible
geographical distribution is achieved in the
final appointments.
(e) The Management Board shall
ensure that the broadest possible
geographical distribution is achieved in the
final appointments.
5b. When the Authority identifies that
specific expertise is missing in a Panel or
several Panels, the Executive Director shall
propose additional members of the Panel(s)
for appointment to the Management Board
in accordance with the procedure laid
down in paragraph 5.
5a. When the Authority identifies that
specific expertise is missing in a Panel or
several Panels, the Executive Director shall
propose additional members of the Panel(s)
for appointment to the Management Board
in accordance with the procedure laid
down in paragraph 5.
5c. The Management Board shall
adopt, on the basis of a proposal of the
Executive Director, rules on the detailed
organisation and timing of the procedures
set up in paragraphs 5a and 5b of the
present Article.
5b. The Management Board shall
adopt, on the basis of a proposal of the
Executive Director, rules on the detailed
organisation and timing of the procedures
set up in paragraphs 5 and 5a of the present
Article.
5d. The Member States shall put in
place measures ensuring that the members of the Scientific Panels act
independently and remain free from
conflict of interests as provided for in
Article 37(2) and the Authority’s internal
measures. Member States shall ensure that
the members of the Scientific Panels have
the means to dedicate the necessary time
and effort to contribute to the work of the
Authority. Member States shall ensure
that the members of the Scientific Panels
do not receive any instruction at any
national level and that their independent
scientific contribution to the risk
assessment system at Union level is
recognised as a priority task for the
protection of the safety of the food chain.
5c. Members of the Scientific Panels
shall act independently and remain free
from conflict of interests as provided for in
Article 37(2) and the Authority’s internal
measures. They shall have the means to
dedicate the necessary time and effort to
contribute to the work of the Authority,
shall not receive any instruction at any
national level, and their independent
scientific contribution to the risk
assessment system at Union level shall be
recognised as a priority task for the
protection of the safety of the food chain.
5e. Member States shall ensure that the
public bodies employing those scientific
experts and those having responsibility for
the setting of priorities of the scientific
bodies employing those experts implement
the measures provided for in paragraph 5d.
5d. As appropriate, Member States
shall ensure that the public bodies
employing those scientific experts and
those having responsibility for the setting
of priorities of the scientific bodies
employing those experts implement the
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measures which are necessary to ensure
that the conditions referred to in
paragraph 5c are met.
5f. The Authority shall support the
tasks of the Panels by organising their
work, in particular the preparatory work to
be undertaken by the Authority’s staff or
by designated national scientific
organisations referred to in the Article 36
including by organising the possibility for
preparing scientific opinions to be peer-
reviewed by the Panels before they adopt
them.
5e. The Authority shall support the
tasks of the Panels by organising their
work, in particular the preparatory work to
be undertaken by the Authority’s staff or
by designated national scientific
organisations referred to in the Article 36
including by organising the possibility for
preparing scientific opinions to be peer-
reviewed by the Panels before they adopt
them.
5g. Each Panel shall include a
maximum of 21 members.
5f. Each Panel shall include a
maximum of 21 members.
5fa. The Authority shall offer members
of Panels comprehensive training on the
risk assessment process.
Amendment 54
Proposal for a regulation
Article 1 – paragraph 1 – point 3 – point c
Regulation (EC) No 178/2002
Article 28 – paragraph 9 – point b
Text proposed by the Commission Amendment
The number of members in each Scientific
Panel within the maximum provided for in
paragraph 5g.;
(b) The number of members in each
Scientific Panel within the maximum
provided for in paragraph 5f.
Amendment 55
Proposal for a regulation
Article 1 – paragraph 1 – point 3 – point c a (new)
Regulation (EC) No 178/2002
Article 28 – paragraph 9 – point g a (new)
Text proposed by the Commission Amendment
(ca) In Article 28(9), the following
point is added:
(ga) the possibility for applicants to
address, in a maximum period of six
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months unless otherwise agreed with the
Authority, and previous to the publication
of the draft opinion of the Authority,
critical areas of concern by new data.
Justification
During the process in which EFSA reviews a dossier, the agency may come across some
critical areas of concern (which is in many cases related to a consideration related to lack of
specific data) which are then reflected in its final Scientific Opinion. However, once these
concerns are included in the final EFSA Opinion, the process does not allow applicants to
address such concerns, even if in many cases these would be easily solved with specific
already existing data.
Amendment 56
Proposal for a regulation
Article 1 – paragraph 1 – point 3 a (new)
Regulation (EC) No 178/2002
Article 29 – paragraph 6
Text proposed by the Commission Amendment
(3a) The following sentence is added at
the end of Article 29(6):
"They shall not allow a priori exclusion
of certain scientific evidences, especially
when these have been published after a
peer-review process.";
Justification
In the Glyphosate file, the applicant submitted only 52% of available scientific publications,
along its own studies. Most of these studies were classified of ‘limited value’, and hence had
little influence on the outcome of its assessment. That methodological bias, led EFSA to grant
greater weight to the applicant’s own studies. Quite on the contrary, CIRC was guided in its
analysis by peer-reviewed publications only. Such a priori rejection of peer-reviewed
publications should not be possible in a risk analysis guided by the precautionary principle,
pursuant to Article 7.
Amendment 57
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32a
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Text proposed by the Commission Amendment
At the request of a potential applicant for a
food law authorisation, the staff of the
Authority shall advise on the relevant
provisions and the required content of the
application for authorisation. The advice
provided by the staff of the Authority shall
be without prejudice and non-committal as
to the subsequent assessment of
applications for authorisation by the
Scientific Panels.
The Authority shall publish a guidance
document that includes a list of questions
and answers regarding the administrative
and scientific requirements of an
application for authorisation. At the
request of a potential applicant for a food
law authorisation, the Authority shall also
offer consultation sessions to explain
what information is required and how the
various tests and studies necessary to
prove the quality, safety and efficacy of
the planned product are to be carried out.
The advice provided by the Authority shall
be without prejudice and non-committal as
to the subsequent assessment of
applications for authorisation by the
Scientific Panels. The staff of the
Authority providing the advice shall not
be involved in any preparatory scientific
work that is directly or indirectly relevant
to the application that is the subject of the
advice.
Within ... [36 months after the entry into
force of the amending Regulation], the
Commission shall assess the impact of
this Article on the functioning of the
Authority. Particular attention shall be
paid to the additional workload and
mobilisation of staff, and whether it has
led to any shift in the allocation of the
Authority’s resources, at the expense of
activities of public interest.
Amendment 58
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32b – paragraph 1
Text proposed by the Commission Amendment
1. A Union register of studies
commissioned by business operators to
obtain an authorisation under Union food
1. A Union register of studies
commissioned by business operators
seeking to obtain an authorisation or
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law is hereby established. Business
operators shall notify, without delay, to the
Authority the subject matter of any study
commissioned to support a future
application for an authorisation under
Union food law. The register shall be
managed by the Authority.
renewal under Union food law is hereby
established. Business operators shall
notify, without delay, to the Authority the
subject matter of any study commissioned
in the Union and beyond to support a
future application for an authorisation or
renewal under Union food law. The
register shall be managed by the Authority.
Amendment 59
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32b – paragraph 1 a (new)
Text proposed by the Commission Amendment
1a. Any studies commissioned shall
take account of Directive 2010/63/EU on
the protection of animals used for
scientific purposes.
Amendment 60
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32b – paragraph 2
Text proposed by the Commission Amendment
2. The notification obligation under
paragraph 1, also applies to Union
laboratories carrying out those studies.
2. The notification obligation under
paragraph 1 also applies to any institution
carrying out the studies, including
laboratories, institutes or universities.
Amendment 61
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32b – paragraph 2 a (new)
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Text proposed by the Commission Amendment
2a. Data from a test commissioned but
not registered shall not be used in a risk
assessment.
Justification
Provision that safeguards that the applicants won't make a cherry picking of the convenient
for them research results, but all of them will be known and available allowing for a complete
assessment.
Amendment 62
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32b – paragraph 2 b (new)
Text proposed by the Commission Amendment
2b. The subject matter shall not be
authorised unless all data from all
registered studies are submitted.
Amendment 63
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32b – paragraph 3 a (new)
Text proposed by the Commission Amendment
3a. Where the Authority requests and
receives additional data by an applicant,
this data is, marked as such, also added to
the Union register and made available to
the public.
Justification
This provision was added on recommendation of the Ombudsman, in order to avoid any
public perception that the file is incomplete.
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Amendment 64
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32b – paragraph 4 a (new)
Text proposed by the Commission Amendment
4a. The Commission shall adopt
delegated acts in accordance with Article
57a supplementing this Regulation by
establishing penalties for breaches of the
notification obligation.
Amendment 65
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32b – paragraph 4 b (new)
Text proposed by the Commission Amendment
4b. This Article shall not be applicable
to studies commissioned before ... [the
date of entry into force of this amending
Regulation].
Justification
The obligation to publish studies shall not have retroactive effect.
Amendment 66
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32c – paragraph 1
Text proposed by the Commission Amendment
1. Where Union food law provides
that an authorisation may be renewed, the
potential applicant for the renewal shall
notify the Authority of the studies it
intends to perform for that purpose.
1. Where Union food law provides
that an authorisation may be renewed, the
potential applicant for the renewal shall
notify the Authority of the studies it
intends to perform for that purpose.
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Following this notification, the Authority
shall launch a consultation of stakeholders
and the public on the intended studies for
renewal and shall provide advice on the
content of the intended renewal application
taking into account the received comments.
The advice provided by the Authority shall
be without prejudice and non-committal as
to the subsequent assessment of the
applications for renewal of authorisation by
the Scientific Panels.
Following this notification, the Authority
shall launch a consultation of stakeholders
and the public on the intended studies for
renewal and shall provide advice on the
content of the intended renewal application
taking into account the received comments
which are relevant for the risk assessment
of the intended renewal. The advice
provided by the Authority shall be without
prejudice and non-committal as to the
subsequent assessment of the applications
for renewal of authorisation by the
Scientific Panels.
Amendment 67
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32c – paragraph 2
Text proposed by the Commission Amendment
2. The Authority shall consult
stakeholders and the public regarding the
studies supporting applications for
authorisation once they are made public by
the Authority in accordance with Article 38
and Articles 39 to 39f in order to identify
whether other relevant scientific data or
studies are available on the subject matter
concerned by the application for
authorisation. This provision does not
apply to the submission of any
supplementary information by the
applicants during the risk assessment
process.
2. The Authority shall, within two
months, consult stakeholders and the
public regarding the studies supporting
applications for authorisation once they are
made public by the Authority in
accordance with Article 38 and Articles 39
to 39f in order to identify whether other
relevant scientific data or studies that are
based on independent peer-reviewed
literature or have been carried out in
accordance with international guidelines
and Good Laboratory Practices (GLP) are
available on the subject matter concerned
by the application for authorisation, and
are without prejudice to the Authority’s
own obligations under Article 33. This
provision does not apply to the submission
of any supplementary information by the
applicants during the risk assessment
process.
Justification
The consultation period must be clearly defined in order to provide a clear structure for the
overall duration of the authorisation process. Public consultation should not be seen as the
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panacea for good quality and exhaustive risk assessment. Indeed public consultations
generally touch a very narrow audience. This responsibility lies with the EFSA. The rigorous
identification of relevant scientific data should be done by the Authority itself, as laid down in
Article 33. Public consultation should not exempt EFSA from this obligation.
Amendment 68
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32d
Text proposed by the Commission Amendment
The Commission experts shall perform
controls, including audits, to obtain
assurance that testing facilities comply
with relevant standards for carrying out
tests and studies submitted to the Authority
as part of an application for an
authorisation under Union food law. These
controls shall be organised in cooperation
with the competent authorities of the
Member States.
The Commission’s Directorate for Health
and Food Audits and Analysis experts
shall perform controls, including audits, to
obtain assurance that testing facilities in
the Union and in third countries comply
with relevant standards for carrying out
tests and studies submitted to the Authority
as part of an application for an
authorisation under Union food law. These
controls shall be organised in cooperation
with the competent authorities of the
Member States or of the third countries
concerned.
Amendment 69
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32e
Text proposed by the Commission Amendment
Without prejudice to the obligation of
applicants for authorisations under food
law to demonstrate the safety of a subject
matter submitted to a system of
authorisation, the Commission, in
exceptional circumstances, may request
the Authority to commission scientific
studies with the objective of verifying
evidence used in its risk assessment
process. The studies commissioned may
have a wider scope than the evidence
subject to verification.
Without prejudice to the obligation of
applicants for authorisations under food
law to demonstrate the safety of a subject
matter submitted to a system of
authorisation, in the event of divergent
scientific findings, the Commission may
request the Authority to commission
scientific studies with the objective of
verifying evidence used in its risk
assessment process. The studies
commissioned may have a wider scope
than the evidence subject to verification in
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the risk assessment process.
Amendment 70
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32e – paragraph 1 a (new)
Text proposed by the Commission Amendment
Any studies commissioned shall take into
account Directive 2010/63/EU on the
protection of animals used for scientific
purposes.
Amendment 71
Proposal for a regulation
Article 1 – paragraph 1 – point 4 a (new)
Regulation (EC) No 178/2002
Article 33 – paragraph 1 – point d a (new)
Text proposed by the Commission Amendment
(4a) In Article 33(1), the following
point is added:
“(da) combinatorial and accumulated
effects.”
Amendment 72
Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point a
Regulation (EC) No 178/2002
Article 38 – paragraph 1 – introductory part
Text proposed by the Commission Amendment
1. The Authority shall carry out its
activities with a high level of transparency.
It shall in particular make public without
delay:
1. The Authority shall carry out its
activities with a high level of transparency
in line with Regulation (EC) No
1367/2006 and without prejudice to
Regulation (EC) No 1049/2001. It shall in
particular make public without delay:
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Amendment 73
Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point a
Regulation (EC) No 178/2002
Article 38 – paragraph 1 – point a
Text proposed by the Commission Amendment
(a) agendas and minutes of the
Scientific Committee and the Scientific
Panels and their Working Groups;
(a) agendas, participants lists, and
minutes of the Management Board, the
Advisory Committee, the Scientific
Committee and the Scientific Panels and
their Working Groups;
Amendment 74
Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point a
Regulation (EC) No 178/2002
Article 38 – paragraph 1 – point c
Text proposed by the Commission Amendment
(c) scientific data, studies and other
information supporting applications for
authorisation under Union food law,
including supplementary information
supplied by applicants, as well as other
scientific data and information supporting
requests from the European Parliament, the
Commission and the Member States for a
scientific output, including a scientific
opinion, taking into account protection of
confidential information and protection of
personal data in accordance with Articles
39 to 39f.
(c) scientific data, studies and other
information supporting applications for
authorisation under Union food law,
including supplementary information
supplied by applicants, as well as other
scientific data and information supporting
requests from the European Parliament, the
Commission and the Member States for a
scientific output, including a scientific
opinion, taking into account the overriding
public interest in disclosure and the protection of confidential information and
protection of personal data in accordance
with Articles 39 to 39f.
Amendment 75
Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point a
Regulation (EC) No 178/2002
Article 38 – paragraph 1 – point d
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Text proposed by the Commission Amendment
(d) the information on which its
scientific outputs, including scientific
opinions are based, taking into account
protection of confidential data and
protection of personal data in accordance
with Articles 39 to 39f;
(d) the information on which its
scientific outputs, including scientific
opinions are based, taking into account the
overriding public interest in disclosure
and the protection of confidential data and
protection of personal data in accordance
with Articles 39 to 39f;
Amendment 76
Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point a
Regulation (EC) No 178/2002
Article 38 – paragraph 1 – point h a (new)
Text proposed by the Commission Amendment
(ha) information on the name of the
applicant and the title of the application;
Amendment 77
Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point a
Regulation (EC) No 178/2002
Article 38 – paragraph 1 – point i
Text proposed by the Commission Amendment
(i) advice provided by the Authority to
potential applicants at pre-submission
phase pursuant to Article 32a and 32c.
(i) the general advice provided by the
Authority to potential applicants at pre-
submission phase pursuant to Articles 32a
and 32c.
Justification
In order to support the competitiveness and capacity for innovation of SMEs, it is essential for
them to receive advice before they lodge an application. The crucial source of costs is often
the studies required for the authorisation process. The advice should therefore also cover
these aspects in order to avoid unnecessary or misdirected studies.
Amendment 78
Proposal for a regulation
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Article 1 – paragraph 1 – point 5 – point a
Regulation (EC) No 178/2002
Article 38 – paragraph 1 – subparagraph 2
Text proposed by the Commission Amendment
Those items referred to in the first
subparagraph shall be made public on a
dedicated section of the Authority’s
website. That section shall be publicly
available and easily accessible. The
relevant items shall be available to
download, print and search through in an
electronic format.
Those items referred to in the first
subparagraph shall be made public on a
dedicated section of the Authority’s
website. That section shall be publicly
available and easily accessible subject to
clear undertakings recorded electronically
by those accessing it and subject to
measures and penalties which are
effective, proportionate and dissuasive
against any commercial use. The relevant
items shall be available to download, print
with a watermark for traceability and
search through in an electronic format,
which is machine-readable. Those
measures shall focus on the commercial
use of documents and their submission.
Such measures shall be designed to
protect effectively against commercial use
of items referred to in the first
subparagraph both within the Union and
in third-countries.
Amendment 79
Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point b
Regulation (EC) No 178/2002
Article 38 – paragraph 1a – subparagraph 1 – introductory part
Text proposed by the Commission Amendment
1a. The disclosure of the information
mentioned in paragraph (1)(c) to the
public shall be without prejudice:
1a. The disclosure of the information
mentioned in points (c), (d) and (i) of
paragraph 1 to the public shall be without
prejudice:
Amendment 80
Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point b
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Regulation (EC) No 178/2002
Article 38 – paragraph 1a – subparagraph 1 – point a
Text proposed by the Commission Amendment
(a) to any intellectual property right
which may exist over documents or their
content; and,
deleted
Justification
There is no reason to put the whole disclosure requirements with reservation as regards
intellectual property rights (IPR). Moreover, there is no need to refer to IPR at this point:
‘Hard IPRs’, such as patents, copyrights or trademarks will already be protected under
Article 38.1a (b). ‘Soft IPRs’ (trade secrets) will be covered by Article 39(2).
Amendment 81
Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point b
Regulation (EC) No 178/2002
Article 38 – paragraph 1a – subparagraph 2
Text proposed by the Commission Amendment
The disclosure to the public of the
information mentioned in paragraph (1)(c)
shall not be considered as an explicit or
implicit permission or license for the
relevant data and information and their
content to be used, reproduced, or
otherwise exploited and its use by third
parties shall not engage the responsibility
of the European Union.
The disclosure to the public of the
information mentioned in paragraph (1)(c)
shall not be considered as an explicit or
implicit permission or license for the
relevant data and information and their
content to be commercially used,
reproduced, or otherwise exploited for
commercial purposes. For the avoidance
of doubt, the information published may
be used for the purpose of public scrutiny
of the results, including a better
understanding of the potential adverse
effects on health and the environment and
its use by third parties for that purpose
shall not engage the responsibility of the
Union.
Amendment 82
Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point c a (new)
Regulation (EC) No 178/2002
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Article 38 – paragraph 3 a (new)
Text proposed by the Commission Amendment
(ca) the following paragraph 3a is
added:
“3a. This Article is without prejudice to
Directive 2003/4/EC of the European
Parliament and of the Council to
Regulation (EC) No 1049/2001 and to
Regulation (EC) No 1367/2006.”
Amendment 83
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Regulation (EC) No 178/2002
Article 39 – paragraph 1
Text proposed by the Commission Amendment
1. By way of derogation from Article
38, the Authority shall not make public
information for which confidential
treatment has been requested under the
conditions laid down in this Article.
1. By way of derogation from Article
38 and without prejudice to Regulation
(EC) No 1049/2001 and Directive
2003/4/EC and the general principle that
the interests of public health always
prevail over private interests, the
Authority shall not make public
information for which confidential
treatment has been requested and granted
in application of the conditions laid down
in this Article.
Amendment 84
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Regulation (EC) No 178/2002
Article 39 – paragraph 2 – point 1
Text proposed by the Commission Amendment
(1) the method and other technical and
industrial specifications relating to that
method, used to manufacture or produce
the subject matter of the request for a
scientific output, including a scientific
(1) the method and other technical and
industrial specifications relating to that
method, used to manufacture or produce
the subject matter of the request for a
scientific output, including a scientific
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opinion; opinion, except when relevant to
understanding the potential effects on
health and the environment, and provided
that the applicant demonstrates with
verifiable justification that such method
does not entail information about
emissions in the environment and about
impacts on health and environment;
Amendment 85
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Regulation (EC) No 178/2002
Article 39 – paragraph 2 – point 3
Text proposed by the Commission Amendment
(3) commercial information revealing
sourcing, market shares or business
strategy of the applicant; and
(3) commercial information revealing
sourcing, innovative ideas for the
product/substance, market shares or
business strategy of the applicant;
(This amendment applies throughout the
text. Adopting it will necessitate
corresponding changes throughout.)
Amendment 86
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Regulation (EC) No 178/2002
Article 39 – paragraph 2 – point 4
Text proposed by the Commission Amendment
(4) quantitative composition of the
subject matter of the request for a scientific
output, including a scientific opinion.
(4) quantitative composition of the
subject matter of the request for a scientific
output, including a scientific opinion,
except when relevant to understanding the
potential effects on health and the
environment.
Amendment 87
Proposal for a regulation
Article 1 – paragraph 1 – point 6
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Regulation (EC) No 178/2002
Article 39 – paragraph 4 – point a
Text proposed by the Commission Amendment
(a) Where urgent action is essential to
protect public health, animal health or the
environment, such as in emergency
situations, the Authority may disclose the
information referred to paragraphs 2 and 3;
and,
(a) Where urgent action is essential to
protect public health, animal health or the
environment, such as in emergency
situations, the Authority may disclose the
information referred to paragraphs 2 and 3;
or,
Amendment 88
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Regulation (EC) No 178/2002
Article 39 – paragraph 4 – point b
Text proposed by the Commission Amendment
(b) information which forms part of
conclusions of scientific outputs, including
scientific opinions, delivered by the
Authority and which relate to foreseeable
health effects.
(b) information which forms part of
conclusions of scientific outputs, including
scientific opinions, delivered by the
Authority and which relate to foreseeable
effects on public health, animal health
and the environment.
Amendment 89
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Regulation (EC) No 178/2002
Article 39 – paragraph 4 – point b a (new)
Text proposed by the Commission Amendment
(ba) where an overriding public interest
in disclosure exists.
Justification
This provision is, already today, included in the pesticides Regulation, and should not be
abolished.
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Amendment 90
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Regulation (EC) No 178/2002
Article 39 – paragraph 4 – point b b (new)
Text proposed by the Commission Amendment
(bb) any information for which there is
an overriding public interest in disclosure
as per Article 4(2) of Regulation
1049/2001 and Article 6 of Regulation
1367/2006, in particular where the
information relates to emissions into the
environment.
Amendment 91
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Regulation (EC) No 178/2002
Article 39 – paragraph 4 a (new)
Text proposed by the Commission Amendment
4a. This Article is without prejudice to
Directive 2003/4/EC and Regulations
(EC) No 1049/2001 and (EC) No
1367/2006.
Amendment 92
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39a – paragraph 2
Text proposed by the Commission Amendment
2. Where an applicant submits a
request for confidentiality, it shall provide
a non-confidential version and a
confidential version of the information
submitted in accordance with standard data
formats, where they exist, pursuant to
Article 39f. The non-confidential version
shall be without the information the
2. Where an applicant submits a
request for confidentiality, it shall provide
a non-confidential version and a
confidential version of the information
submitted in accordance with standard data
formats, where they exist, pursuant to
Article 39f. The non-confidential version
shall edit, with black bars, the information,
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applicant deems confidential in
accordance with paragraphs 2 and 3 of
Article 39. The confidential version shall
contain all information submitted,
including information the applicant deems
confidential. Information requested to be
treated as confidential in the confidential
version shall be clearly marked. The
applicant shall clearly indicate the grounds
on the basis of which confidentiality is
requested for the different pieces of
information.
for which confidential treatment has been
requested by the applicant in accordance
with paragraph 2 and 3 of Article 39. The
confidential version shall contain all
information submitted, including
information the applicant considers as
confidential. Information requested to be
treated as confidential in the confidential
version shall be clearly marked. The
applicant shall clearly indicate verifiable
justifications and evidence on the basis of
which confidentiality is requested for the
different pieces of information.
Amendment 93
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39b – paragraph 1 – subparagraph 1 – point c
Text proposed by the Commission Amendment
(c) inform the applicant in writing of
its intention to disclose information and the
reasons for it, before the Authority
formally takes a decision on the
confidentiality request. If the applicant
disagrees with the assessment of the
Authority it may state its views or
withdraw its application within two weeks
from the date on which it was notified of
the Authority’s position.
(c) inform the applicant in writing of
its intention to disclose information and the
reasons for it, before the Authority
formally takes a decision on the
confidentiality request. If the applicant
objects to the assessment of the Authority
it may (1) state its views, (2) withdraw its
application, or (3) request a review to the
Authority’s Board of Appeal within four
weeks from the date on which it was
notified of the Authority’s position. The
applicant may provide written notice to
the Authority that it wishes to request a
re-examination of the opinion to the
Authority’s Board of Appeal. In that case
the applicant shall forward to the
Authority the detailed grounds for the
request within 60 days after receipt of the
opinion. Within 60 days after receipt of
the grounds for the request, the
Authority’s Board of Appeal shall re-
examine its opinion;
Justification
Both EMA and EFSA has a Board of Appeal of some sort. This is to provide the applicant the
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possibility for a re-examination of the opinion. The Commission should, by means of a
delegated act, set up this same possibility in EFSA.
Amendment 94
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39b – paragraph 1 – subparagraph 1 – point d
Text proposed by the Commission Amendment
(d) adopt a reasoned decision on the
confidentiality request taking into account
the observations of the applicant within ten
weeks from the date of receipt of the
confidentiality request with respect to
applications for authorisation and without
undue delay in the case of supplementary
data and information and notify the
applicant and inform the Commission and
the Member States, as appropriate, of its
decision; and,
(d) adopt a reasoned decision on the
confidentiality request taking into account
the observations of the applicant within
eight weeks from the date of receipt of the
confidentiality request with respect to
applications for authorisation and without
undue delay in the case of supplementary
data and information and notify the
applicant and inform the Commission and
the Member States, in every case, of its
decision; and,
Amendment 95
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39b – paragraph 1 – subparagraph 1 – point e
Text proposed by the Commission Amendment
(e) make public any additional data and
information for which the confidentiality
request has not been accepted as justified
not earlier than two weeks after the
notification of its decision to the applicant
has taken place, pursuant to point (d).
(e) make public any additional data and
information for which the confidentiality
request has not been accepted as justified
not earlier than four weeks after the
notification of its decision to the applicant
has taken place, pursuant to point (d).
Amendment 96
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39b – paragraph 1 – subparagraph 2
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Text proposed by the Commission Amendment
Decisions taken by the Authority pursuant
to this Article may be subject to an action
before the Court of Justice of the European
Union, under the conditions laid down in
Articles 263 and 278 of the Treaty
respectively.
Decisions taken by the Authority pursuant
to this Article may be subject to an action
before the Authority’s Board of Appeal,
which shall be established by the
Commission by means of delegated acts.
Those delegated acts shall be adopted in
accordance with Article 57a of this
Regulation. A submission of an appeal
pursuant to this paragraph shall have
suspensive effect. The applicant may
provide written notice to the Authority
that he wishes to request a re-examination
of the opinion to the Authority’s Board of
Appeal. In that case the applicant shall
forward to the Authority the detailed
grounds for the request within 60 days
after receipt of the opinion. Within 60
days after receipt of the grounds for the
request, the Authority’s Board of Appeal
shall re-examine its opinion. In case of a
contesting decision taken by the
Authority’s Board of appeal, a case may
be brought before the Court of Justice of
the European Union under the conditions
laid down in Article 263 of the Treaty.
Amendment 97
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39d – paragraph 2
Text proposed by the Commission Amendment
2. The Commission and the Member
States shall take the necessary measures so
that information received by them under
Union food law for which confidential
treatment has been requested is not made
public until a decision on the
confidentiality request has been taken by
the Authority and has become definitive.
The Commission and the Member States
shall also take the necessary measures so
2. The Commission and the Member
States shall take the necessary measures so
that information received by them under
Union food law for which confidential
treatment has been requested is not made
public until a decision on the
confidentiality request has been taken by
the Authority and has become definitive,
except for when access to information is
requested in accordance with Directive
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that information for which confidential
treatment has been accepted by the
Authority is not made public.
2003/4/EC or national law on access to
documents. The Commission and the
Member States shall also take the
necessary measures so that information for
which confidential treatment has been
accepted by the Authority is not made
public, except for when access to
information is requested in accordance
with Directive 2003/4/EC or national law
on access to documents.
Justification
Clarification needs to be made regarding when EFSA:s obligation to confidentiality decision
applies, notably only when the authorities proactively publish information. When access to
information is requested, an individual assessment must be made, even if the institution
previously have decided on confidentiality.
Amendment 98
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39d – paragraph 3
Text proposed by the Commission Amendment
3. If an applicant in the context of an
authorisation procedure withdraws or has
withdrawn an application, the Authority,
the Commission and the Member States
shall respect the confidentiality of
commercial and industrial information as
accepted by the Authority in accordance
with Articles 39to 39f. The application
shall be considered withdrawn as of the
moment the written request is received by
the competent body that had received the
original application. Where the withdrawal
of the application takes place before the
Authority has decided on the relevant
confidentiality request, the Authority, the
Commission and the Member States shall
not make public the information for which
confidentiality has been requested.
3. If an applicant in the context of an
authorisation procedure withdraws or has
withdrawn an application, the Authority,
the Commission and the Member States
shall respect the confidentiality of
commercial and industrial information as
accepted by the Authority in accordance
with Articles 39to 39f. The application
shall be considered withdrawn as of the
moment the written request is received by
the competent body that had received the
original application. The Authority shall
not publish any information, confidential
or non-confidential, should an applicant
decide to withdraw its application.
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Amendment 99
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39e – paragraph 1 – point c
Text proposed by the Commission Amendment
(c) the names of all participants in
meetings of the Scientific Committee and
the Scientific Panels and their Working
Groups.
(c) the names of all participants and
observers in meetings of the Scientific
Committee and the Scientific Panels, their
Working Groups and any other ad hoc
Group meeting on the subject.
Amendment 100
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39e – paragraph 2
Text proposed by the Commission Amendment
2. Notwithstanding paragraph 1,
disclosure of names and addresses of
natural persons involved in testing on
vertebrate animals or in obtaining
toxicological information shall be deemed
to significantly harm the privacy and the
integrity of those natural persons and shall
not be made publicly available, unless
there is an overriding public interest.
2. Notwithstanding paragraph 1,
disclosure of names and addresses of
natural persons involved in testing on
vertebrate animals shall be deemed to
significantly harm the privacy and the
integrity of those natural persons and shall
not be made publicly available, unless
there is an overriding public interest.
Amendment 101
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39f – paragraph 1
Text proposed by the Commission Amendment
(1) For the purposes of Article 38(1)(c)
and in order to ensure the efficient
processing of requests to the Authority for
a scientific output, standard data formats
(1) For the purposes of Article 38(1)(c)
and in order to ensure the efficient
processing of requests to the Authority for
a scientific output, standard data formats
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and software packages shall be adopted to
allow documents to be submitted, searched,
copied and printed, while ensuring
compliance with regulatory requirements
set out in Union food law. These draft
standard data formats and software
packages shall not be based on proprietary
standards and shall ensure interoperability
with existing data submission approaches
to the extent possible.
and software packages shall be adopted to
allow documents to be submitted, searched,
copied and printed, while ensuring
compliance with regulatory requirements
set out in Union food law and feasibility
for small and medium-sized enterprises.
These draft standard data formats and
software packages shall not be based on
proprietary standards and shall ensure
interoperability with existing data
submission approaches to the extent
possible.
Justification
SMEs have limited technical possibilities. It should nonetheless also be possible for them to
use the standard data formats without knowledge or possession of the latest software
programmes.
Amendment 102
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39f – paragraph 2 a (new)
Text proposed by the Commission Amendment
2a. The standard data formats and
software packages shall only apply to data
generated after adoption of the
implementing acts in accordance with
point (b) of paragraph 2.
Amendment 103
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39g – paragraph 1
Text proposed by the Commission Amendment
The information systems operated by the
Authority to store its data, including
confidential and personal data shall be
designed to a high level of security
The information systems operated by the
Authority to store its data, including
confidential and personal data shall be
designed in a way that guarantees that the
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appropriate to the security risks at stake,
taking into account Articles 39 to 39f of
this Regulation. Access shall be based at
the minimum on a system requiring two
factor authentication or providing an
equivalent level of security. The system
shall ensure that any access to it is fully
auditable.
highest standards of security appropriate
to the security risks at stake will be
attained, taking into account Articles 39 to
39f of this Regulation. Access shall be
based at the minimum on a system
requiring two factor authentication or
providing an equivalent level of security.
The system shall ensure that any access to
it is fully auditable.
Amendment 104
Proposal for a regulation
Article 1 – paragraph 1 – point 9
Regulation (EC) No 178/2002
Article 41 – paragraph 1
Text proposed by the Commission Amendment
Where environmental information is
concerned, Articles 6 and Article 7 of
Regulation (EC) No 1367/2006 of the
European Parliament and of the Council39
shall also apply.
The Authority shall ensure wide access to
the documents, held by it. Where
environmental information is concerned,
Regulation (EC) No 1367/2006 of the
European Parliament and of the Council39
shall also apply. Articles 38 to 39 of this
Regulation shall apply without prejudice
to the application of Regulations (EC) No
1049/2001 and (EC) No 1367/2006.
__________________ __________________
39 Regulation (EC) No 1367/2006 of the
European Parliament and of the Council of
6 September 2006 on the application of the
provisions of the Aarhus Convention on
Access to Information, Public Participation
in Decision-making and Access to Justice
in Environmental Matters to Community
institutions and bodies (OJ L 264,
25.9.2006, p. 13).
39 Regulation (EC) No 1367/2006 of the
European Parliament and of the Council of
6 September 2006 on the application of the
provisions of the Aarhus Convention on
Access to Information, Public Participation
in Decision-making and Access to Justice
in Environmental Matters to Community
institutions and bodies (OJ L 264,
25.9.2006, p. 13).
Amendment 105
Proposal for a regulation
Article 1 – paragraph 1 – point 9 a (new)
Regulation (EC) No 178/2002
Article 50 – paragraph 1
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Present text Amendment
(9a) In Article 50, paragraph 1 is
replaced by the following:
1. A rapid alert system for the
notification of a direct or indirect risk to
human health deriving from food or feed is
hereby established as a network. It shall
involve the Member States, the
Commission and the Authority. The
Member States, the Commission and the
Authority shall each designate a contact
point, which shall be a member of the
network. The Commission shall be
responsible for managing the network.
“1. A rapid alert system for the
notification of a direct or indirect risk to
human health deriving from food or feed is
hereby established as a network. It shall
involve the Member States, the
Commission and the Authority. The
Member States, the Commission and the
Authority shall each designate a contact
point, which shall be a member of the
network.”
Amendment 106
Proposal for a regulation
Article 1 – paragraph 1 – point 9 b (new)
Regulation (EC) No 178/2002
Article 51 – paragraph 1 a (new)
Text proposed by the Commission Amendment
(9b) In Article 51, the following
paragraph is inserted:
“1a. The Commission shall adopt a
delegated act in accordance with Article
57a to develop a harmonised food alert
network management system between the
Commission and the Member States.”
Justification
Regulation (EC) No 178/2002 (Articles 50 to 54), establishes the RASFF, together with its
basic provisions, scope and operation. Weaknesses were subsequently identified, requiring
rectification through the adoption of Regulation (EU) No 16/2011 which did not include
harmonised procedures to be followed by all MS or the necessary enhancement of the
Commission’s powers for dealing with alerts. A joint, compulsory and enhanced procedure
for managing food alerts is necessary.
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Amendment 107
Proposal for a regulation
Article 1 – paragraph 1 – point 10
Regulation (EC) No 178/2002
Article 57a – paragraph 2
Text proposed by the Commission Amendment
2. The powers to adopt delegated acts
referred to in Article 8(c) shall be
conferred upon the Commission for an
indeterminate period of time from [date of
entry into force of this Regulation].
2. The powers to adopt delegated acts
referred to in Article 8(c), 32b(4a),
subparagraph 2 of Article 39b(1) and
Article 51(1a)shall be conferred upon the
Commission for a period of five years from
[date of entry into force of this
Regulation].
Amendment 108
Proposal for a regulation
Article 1 – paragraph 1 – point 11
Regulation (EC) No 178/2002
Article 61
Text proposed by the Commission Amendment
Article 61 Article 61
Review clause Review clause
1. The Commission shall ensure the
regular review of the application of this
Regulation.
1. The Commission shall ensure the
regular review of the application of this
Regulation.
2. Not later than five years after the
date referred to in Article [entry into force
of the Regulation amending the GFL], and
every five years thereafter, the
Commission shall assess the Authority’s
performance in relation to its objectives,
mandate, tasks, procedures and location,
in accordance with Commission
guidelines. The evaluation shall address
the possible need to modify the mandate of
the Authority, and the financial
implications of any such modification.
2. Not later than five years after the
date referred to in Article [entry into force
of the Regulation amending the GFL], and
every five years thereafter, the Authority
jointly with the Commission shall
commission an independent external
evaluation of their performance and
achievements in relation to their
objectives, mandates, tasks, procedures
and locations. The evaluation shall be
based on the Management Board’s work
programme in agreement with the
Commission. It shall assess the working
practices and the impact of the Authority
and address the possible need to modify
the mandate of the Authority, including the
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financial implications of any such
modification. It shall, furthermore,
address the possible need to coordinate
and dovetail the Authority’s activities
more closely with those of the competent
bodies in the Member States and other
Union agencies. The evaluation shall take
into account the views of the stakeholders,
at both Union and national level.
2 a. The Management Board shall
examine the conclusions of the evaluation
and issue recommendations to the
Commission, which may concern changes
in the Authority.
3. Where the Commission considers
that the continuation of the Authority is
no longer justified with regard to its
assigned objectives, mandate and tasks, it
may propose that the relevant provisions
of this Regulation be amended
accordingly or repealed.
4. The Commission shall report to the
European Parliament, the Council and the
Management Board on the evaluation
findings. The findings of the evaluation
shall be made public.
4. The evaluations and
recommendations referred to in
paragraphs 2 and 2a shall be forwarded to the Commission, the Council, the
European Parliament and the Management
Board. The findings of the evaluation and
the recommendations shall be made
public.
Amendment 109
Proposal for a regulation
Article 2 – paragraph 1 – point 2 a (new)
Directive 2001/18/EC
Article 24 – paragraph 2 a (new)
Text proposed by the Commission Amendment
(2a) In Article 24, the following
paragraph is added:
“2a. The obligation to proactively
disseminate the information set out in
paragraph 1 of this Article, in line with
Article 25 of this Directive, and in line
with Articles 38 and 39 of Regulation
(EC) No 178/2002, is without prejudice to
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the right of any natural or legal person to
access documents upon request as set out
in Regulations (EC) No 1049/2001 and
(EC) No 1367/2006.”
Amendment 110
Proposal for a regulation
Article 3 – paragraph 1 – point 9
Regulation (EC) No 1829/2003
Article 29 – paragraph 1
Text proposed by the Commission Amendment
1. The Authority shall make public the
application for authorisation, relevant
supporting information and any
supplementary information supplied by the
applicant, as well as its scientific opinions
and opinions from the competent
authorities referred to in Article 4 of
Directive 2001/18/EC, in accordance with
Article 38, Articles 39 to 39f and Article
40 of Regulation (EC) No 178/2002 and
taking into account Article 30 of this
Regulation.
1. The Authority shall make public the
application for authorisation, relevant
supporting information and any
supplementary information supplied by the
applicant, monitoring reports as well as its
scientific opinions and opinions from the
competent authorities referred to in Article
4 of Directive 2001/18/EC, in accordance
with Article 38, Articles 39 to 39f and
Article 40 of Regulation (EC) No 178/2002
and taking into account Article 30 of this
Regulation.
Justification
This provision is taken from the current Regulation 1829/2003, Article 29.
Amendment 111
Proposal for a regulation
Article 3 – paragraph 1 – point 9
Regulation (EC) No 1829/2003
Article 29 – paragraph 1 a (new)
Text proposed by the Commission Amendment
1a. The obligation to proactively
disseminate the information set out in
paragraph 1 of this Article, in line with
Article 30 of this Regulation, and in line
with Articles 38 and 39 of Regulation
(EC) No 178/2002, is without prejudice to
the right of any natural or legal person to
access documents upon request as set out
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in Regulations (EC) No 1049/2001 and
(EC) No 1367/2006.
Amendment 112
Proposal for a regulation
Article 4 – paragraph 1 – point 1 a (new)
Regulation (EC) No 1831/2003
Article 17 – paragraph 2 a (new)
Text proposed by the Commission Amendment
(1a) In Article 17, the following
paragraph is added:
“2a. The obligation to proactively
disseminate information set out in this
Article and in line with Articles 38 and 39
of Regulation (EC) No 178/2002, is
without prejudice to the right of any
natural or legal person to access
documents upon request as set out in
Regulations (EC) No 1049/2001 and (EC)
No 1367/2006.”
Amendment 113
Proposal for a regulation
Article 4 – paragraph 1 – point 2
Regulation (EC) No 1831/2003
Article 18 – paragraph 3
Text proposed by the Commission Amendment
3. In addition to Article 39(2) of
Regulation (EC) No 178/2002 and
pursuant to Article 39(3) of that
Regulation, the Authority may also accept
to provide confidential treatment to the
following information, the disclosure of
which may be deemed, upon verifiable
justification, to significantly harm the
interests concerned:
deleted
(a) the study plan for studies
demonstrating the efficacy of a feed
additive in terms of the aims of its
intended use as defined in Article 6(1) and
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Annex I to this Regulation; and,
(b) specifications of the impurities of
the active substance and the relevant
methods of analysis developed internally
by the applicant, except for impurities that
may have adverse effects on animal
health, human health, or the
environment.
Amendment 114
Proposal for a regulation
Article 4 – paragraph 1 – point 2
Regulation (EC) No 1831/2003
Article 18 – paragraph 3 a (new)
Text proposed by the Commission Amendment
3a. The Authority shall apply the
principles of Regulation (EC) No
1049/2001 of the European Parliament
and of the Council when handling
applications for access to documents held
by the Authority.
Amendment 115
Proposal for a regulation
Article 4 – paragraph 1 – point 2
Regulation (EC) No 1831/2003
Article 18 – paragraph 3 b (new)
Text proposed by the Commission Amendment
3b. The Member States, the
Commission and the Authority shall keep
confidential all the information identified
as confidential under paragraph 2 except
where it is appropriate for such
information to be made public in order to
protect human health, animal health or
the environment. Member States shall
handle applications for access to
documents received under this Regulation
in accordance with Article 5 of
Regulation (EC) No 1049/2001.
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Amendment 116
Proposal for a regulation
Article 5 – paragraph 1 – point 2
Regulation (EC) No 2065/2003
Article 14 – paragraph 1 a (new)
Text proposed by the Commission Amendment
1a. The obligation to proactively
disseminate information set out in
paragraph 1 of this Article, in line with
Articles 38 and 39 of Regulation (EC) No
178/2002, is without prejudice to the right
of any natural or legal person to access
documents upon request as set out in
Regulations (EC) No 1049/2001 and (EC)
No 1367/2006.”
Amendment 117
Proposal for a regulation
Article 6 – paragraph 1 – point 2 a (new)
Regulation (EC) No 1935/2004
Article 19 – paragraph 2 a (new)
Text proposed by the Commission Amendment
(2a) In Article 19, the following
paragraph is added:
“2a. The obligation to proactively
disseminate information set out in
paragraph 1 of this Article, including
Article 20 of this Regulation, and Articles
38 and 39 of Regulation (EC) No
178/2002, is without prejudice to the right
of any natural or legal person to access
document upon request as set by
Regulations (EC) No 1049/2001 and (EC)
No 1367/2006.”
Amendment 118
Proposal for a regulation
Article 6 – paragraph 1 – point 3
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Regulation No 1935/2004
Article 20 – paragraph 2 – point a
Text proposed by the Commission Amendment
(a) any information provided in
detailed descriptions of starting
substances and preparations used to
manufacture the substance subject to the
authorisation, the composition of
preparations, materials or articles in
which the applicant intends to use this
substance, the manufacturing methods of
these preparations, materials or articles,
impurities, and migration testing results;
deleted
Amendment 119
Proposal for a regulation
Article 6 – paragraph 1 – point 3
Regulation No 1935/2004
Article 20 – paragraph 2 – point b
Text proposed by the Commission Amendment
(b) the trademark under which the
substance, shall be marketed as well as
the tradename of the preparations,
material or articles in which it shall be
used, where applicable; and,
deleted
Amendment 120
Proposal for a regulation
Article 7 – paragraph 1 – point 2
Regulation (EC) No 1331/2008
Article 11
Text proposed by the Commission Amendment
Where the Commission requests its opinion
in accordance with Article 3(2) of this
Regulation, the Authority shall make
public the application for authorisation,
relevant supporting information and any
supplementary information supplied by the
applicant, as well as its scientific opinions,
1. Where the Commission requests its
opinion in accordance with Article 3(2) of
this Regulation, the Authority shall make
public the application for authorisation,
relevant supporting information and any
supplementary information supplied by the
applicant, as well as its scientific opinions,
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in accordance with Article 38, Articles
39to 39f and Article 40 of Regulation (EC)
No 178/2002. It shall also make public any
request for its opinion as well as any
extension of period pursuant to Article 6(1)
of this Regulation.”;
in accordance with Article 38, Articles
39to 39f and Article 40 of Regulation (EC)
No 178/2002. It shall also make public any
request for its opinion as well as any
extension of period pursuant to Article 6(1)
of this Regulation.
1a. The obligation to proactively
disseminate information set out in
paragraph 1 of this Article, in Article 12
of this Regulation and Articles 38 and 39
of Regulation (EC) No 178/2002, is
without prejudice to the right of any
natural or legal person to access
document upon request as set by
Regulations (EC) No 1049/2001 and (EC)
No 1367/2006.
Amendment 121
Proposal for a regulation
Article 7 – paragraph 1 – point 2
Regulation (EC) No 1331/2008
Article 11 – paragraph 1 b (new)
Text proposed by the Commission Amendment
1b. The obligation to proactively
disseminate information set out in
paragraph 1 of this Article, in line with
Article 12 of this Regulation and in line
with Articles 38 and 39 of Regulation
(EC) No 178/2002, is without prejudice to
the right of any natural or legal person to
access documents upon request as set out
in Regulations (EC) No 1049/2001 and
(EC) No 1367/2006.
Amendment 122
Proposal for a regulation
Article 7 – paragraph 1 – point 3
Regulation (EC) No 1331/2008
Article 12 – paragraph 3 a (new)
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Text proposed by the Commission Amendment
3a. The provisions on active
dissemination laid down in Articles 11
and 12 of this Regulation, and Articles 38
and 39 of Regulation (EC) No 178/2002,
are without prejudice to the right of
access to documents upon request set in
Regulation (EC) No 1049/2001.
Amendment 123
Proposal for a regulation
Article 8 – paragraph 1 – point 4 a (new)
Regulation (EC) No 1107/2009
Article 23 – paragraph 1 – last sentence
Present text Amendment
(4a) In Article 23, the last sentence of
paragraph 1 is replaced by the following:
For the purpose of this Regulation, an
active substance which fulfils the criteria
of a ‘foodstuff’ as defined in Article 2 of
Regulation (EC) No 178/2002 shall be
considered as a basic substance.
“For the purpose of this Regulation, an
active substance which fulfils the criteria
of a ‘foodstuff’ as defined in Article 2 of
Regulation (EC) No 178/2002 shall be
considered as an approved basic
substance.”
Justification
add: and “approved” This is an amendment of clarification, as many doubts remain on which
substances may be considered as basic substances.
Amendment 124
Proposal for a regulation
Article 8 – paragraph 1 – point 5
Regulation (EC) No 1107/2009
Article 63 – paragraph 1
Text proposed by the Commission Amendment
1. In accordance with the conditions
and the procedures laid down in Article 39
of Regulation (EC) No 178/2002 and this
article, the applicant may request certain
1. In accordance with the conditions
and the procedures laid down in Article 39
of Regulation (EC) No 178/2002 and this
Article, except for information that is
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information submitted under this
Regulation to be kept confidential,
accompanied by verifiable justification.
considered toxicologically,
ecotoxicologically or environmentally
relevant, the applicant may request certain
information submitted under this
Regulation to be kept confidential,
accompanied by adequate and verifiable
justification. The justification shall
include verifiable evidence to show that
the disclosure of the information might
undermine his commercial interests, or
the protection of privacy and the integrity
of the individual.
Justification
This is a clarification, this is provided for in Article 63 of Regulation 1107/2009.
Amendment 125
Proposal for a regulation
Article 8 – paragraph 1 – point 5
Regulation (EC) No 1107/2009
Article 63 – paragraph 2
Text proposed by the Commission Amendment
2. In addition to Article 39(2) of
Regulation (EC) No 178/2002 and
pursuant to Article 39(3), confidential
treatment may be accepted with respect to
the following information, the disclosure
of which may be deemed, upon verifiable
justification, to significantly harm the
interests concerned:
deleted
(a) the specification of impurity of the
active substance and the related methods
of analysis for impurities in the active
substance as manufactured, except for the
impurities that are considered to be
toxicologically, ecotoxicologically or
environmentally relevant and the related
methods of analysis for these impurities;
(b) results of production batches of
the active substance including impurities;
and,
(c) information on the complete
composition of a plant protection
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product.;
Amendment 126
Proposal for a regulation
Article 8 – paragraph 1 – point 5 a (new)
Regulation (EC) No 1107/2009
Article 63 – paragraph 3
Present text Amendment
(5a) in Article 63, paragraph 3 is
replaced by the following:
3. This Article is without prejudice to
Directive 2003/4/EC of the European
Parliament and of the Council of 28
January 2003 on public access to
environmental information
3. This Article is without prejudice to
Directive 2003/4/EC of the European
Parliament and of the Council of 28
January 2003 on public access to
environmental information and to
Regulations (EC) No 1049/2001 and (EC)
No 1367/2006.
Amendment 127
Proposal for a regulation
Article 9 – paragraph 1 – point 1 – point a
Regulation (EC) No 2015/2283
Article 10 – paragraph 1
Text proposed by the Commission Amendment
1. The procedure for authorising the
placing on the market within the Union of
a novel food and updating of the Union list
provided for in Article 9 of this Regulation
shall start either on the Commission’s
initiative or following an application to the
Commission by an applicant, in accordance
with standard data formats, where they
exist pursuant to Article 39f of Regulation
(EC) No 178/2002. The Commission shall
make the application available to the
Member States without delay.
1. The procedure for authorising the
placing on the market within the Union of
a novel food and updating of the Union list
provided for in Article 9 of this Regulation
shall start either on the Commission’s
initiative or following an application to the
Commission by an applicant, in accordance
with standard data formats, where they
exist pursuant to Article 39f of Regulation
(EC) No 178/2002. The Commission shall
make the application available to the
Member States and the summary of the
application publicly available without
delay.
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Amendment 128
Proposal for a regulation
Article 9 – paragraph 1 – point 4
Regulation (EC) No 2015/2283
Article 23 – paragraph 4 a (new)
Text proposed by the Commission Amendment
4a. The provisions on active
dissemination laid down in Article 23 of
this Regulation, and Articles 38 and 39 of
Regulation (EC) No 178/2002, are
without prejudice to the right of access to
documents upon request set in Regulation
(EC) No 1049/2001.
Amendment 129
Proposal for a regulation
Article 9 – paragraph 1 – point 4
Regulation (EC) No 2015/2283
Article 23 – paragraph 4 b (new)
Text proposed by the Commission Amendment
4b. The Commission may, by means of
implementing acts, adopt detailed rules on
the implementation of paragraphs 1 to 4
of this Article. Those implementing acts
shall be adopted in accordance with the
examination procedure referred to in
Article 30(3).
Justification
Regulation (EU) 2283/2015 foresaw in Article 23 (8) that the Commission may, by means of
implementing acts, adopt detailed rules on the implementation of paragraphs 1 to 6. This is
required because of the specificities of Novel Foos that can cover aspects that are new and
not known today. This provision must remain.
Amendment 130
Proposal for a regulation
Article 9 – paragraph 1 – point 4 a (new)
Regulation (EU) No 2015/2283
Article 25 – paragraph 1 a (new)
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Text proposed by the Commission Amendment
(4a) In Article 25, the following
paragraph is added:
“1a. The obligation to proactively
disseminate the information set out in this
Regulation, in line with Articles 38 and 39
of Regulation (EC) No 178/2002, is
without prejudice to the right of any
natural or legal person to access
documents upon request as set out in
Regulations (EC) No 1049/2001 and (EC)
No 1367/2006.”
Amendment 131
Proposal for a regulation
Article 9 a (new)
Text proposed by the Commission Amendment
Article 9a
Transparency of risk management
1. The Commission and the Member
States shall carry out their risk
management activities in the context of
the legislative acts referred to in Articles 1
to 9 with a high level of transparency.
They shall in particular make public
without undue delay:
(a) at an early stage of the risk
management process, any envisaged the
draft risk management measures;
(b) the agendas and proceedings,
detailed summary reports of meetings,
and the draft measures, to be adopted, as
appropriate, in the form of delegated or
implementing acts, including the results
and explanations of votes by individual
Member States in committees within the
meaning of Regulation (EU) No
182/20111a, including the appeal
committees, which assist the Commission
in the implementation of [Regulation
(EC) No 178/2002, Directive 2001/18/EC,
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Regulation (EC) No 1829/2003,
Regulation (EC) No 1831/2003,
Regulation (EC) No 2065/2003,
Regulation (EC) No 1935/2004,
Regulation (EC) No 1331/2008,
Regulation (EC) No 1107/2009 and
Regulation No 2015/2283], where and in
which the risk management measures are
discussed and put to a vote; and
(c) the agendas and the detailed
minutes of meetings of the Member States
working groups in which the risk
management measures are discussed;
2. For the purposes of paragraph 1,
the Commission shall attach to each draft
measure to be adopted on in accordance
with Article 58 [of the GFL Regulation],
Article 30 of Directive 2001/18/EC,
Article 35 of Regulation (EC) No
1829/2003, Article 22 of Regulation (EC)
No 1831/2003, Article 19 of Regulation
(EC) No 2065/2003, Article 23 of
Regulation (EC) 1935/2004, Article 14 of
Regulation (EC) 1331/2008, Article 79 of
Regulation (EC) No 1107/2009, and
Articles 30 and 32 of Regulation EU (No)
2015/2283 an explanatory statement
comprising:
(a) the reasons for and objectives of
the measure;
(b) the justification of the measure
taking into consideration both need and
proportionality;
(c) the impact of the measure on
public and animal health, the
environment, on the society and on food
manufacturers as indicated by the impact
assessment; and
(d) the results of any public
consultation, including pursuant to
Article 9 [the GFL Regulation].
_______________
1a Regulation (EU) No 182/2011 of the
European Parliament and of the Council
of 16 February 2011 laying down the
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rules and general principles concerning
mechanisms for control by the Member
States of the Commission’s exercise of
implementing powers (OJ L 55, 28.2.2011,
p. 13).
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EXPLANATORY STATEMENT
1. Background
Following a number of serious food scandals, Regulation (EC) No 178/2002 established the
independent European Food Safety Authority with responsibility for scientific risk
assessment. Risk management is a matter for the Institutions of the Union, notably the
Commission. Today, food safety in the Union is considered the best in the world. Through a
Fitness Check, the Commission established that the Regulation met the objectives of ensuring
a high level of food safety and harmonisation of the internal market.
Widespread scepticism with regard to GMOs and the associated herbicide glyphosate resulted
in a public controversy regarding herbicides and pesticides in general, which gave rise to a
citizens’ initiative. In view of the success of this citizens’ initiative, the Commission
concluded that there was a need to improve public confidence in risk assessment and pledged
to put forward a corresponding legislative proposal.
2. Commission proposal
In April 2018, the Commission submitted to Parliament and the Council a proposal for a
recast of Regulation (EC) No 178/2002 comprising the following key points:
- a tightening of the rules on transparency of the EFSA;
- stricter rules to guarantee reliability, objectivity and independence of studies used by the
EFSA in its risk assessment;
- improvement of the functioning and governance of the EFSA;
- greater involvement of the Member States;
- making the EFSA more attractive to scientific experts;
- a comprehensive and effective risk communication strategy, involving the Commission,
Member States and the EFSA.
In the interests of coherence, eight legal acts relating to the sector are to be harmonised as
regards transparency and confidentiality.
3. Rapporteur’s comments
In principle, your rapporteur welcomes the Commission's proposal for a regulation. The
EFSA publishes a lot of information but it has to date not been legally obliged to do so. As
result, the only way the public can gain access to information from the applications and
studies submitted is by asserting the rights conferred under Regulation EC No 1049/2001 on
public access to documents. A comparison with other EU agencies and the debate on the
authorisation procedures for plant protection products show that the EFSA transparency rules
are in need of revision. In addition, the EFSA is finding it increasingly difficult to find experts
for the scientific panels.
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The proposed amendments, however, are more likely to create new problems than solve
existing ones. Moreover, the timing of the publication, the significant shortening of the
consultation period and the absence of an impact assessment run counter to the Commission’s
better law-making principles.
Your rapporteur is particularly critical of the following:
Lack of an impact assessment
Whereas the REFIT of the basic Regulation referred to the general principles of food law as
well as to the rapid alert system and crisis management, the Commission is now proposing
amendments to articles which were not covered by REFIT. The proposed transparency rules
could seriously damage the innovative strength and competitiveness of the European food
industry. It would have been appropriate to consider different options with regard to the time
of publication of sensitive data from applications. It is equally hard to understand why the
Commission chose not to carry out an impact assessment. Similarly, no impact assessments
were carried out for the eight sectoral legislative acts.
The Commission provides for a significant increase (+80 %) in the EFSA’s budget. Should
the European legislator, however, not be able to come to an agreement as regards the budget,
then the Authority would not be able to fulfil its mandate in accordance with the revised
regulation. An impact assessment with different funding models would also have been
necessary in this connection.
Timing of the Commission proposal
The Commission essentially justified its proposal with the need to respond to the Citizens’
Initiative ‘Ban glyphosate and protect people and the environment from toxic pesticides’. In
March 2018, the European Parliament set up a special committee (PEST) to look into the
authorisation procedure and propose possible courses of action. The Commission ignored this
process of democratic opinion forming and pre-empted its outcome.
By cutting the consultation period from the usual twelve weeks to eight, the Commission left
the stakeholders scant time for consultation. Moreover, it was also only possible to react to
general questions but not to the specific plans of the Commission. The publication of the
Commission proposal shortly after the completion of the public consultation suggests that the
draft regulation had already been finalised and that it was a consultation in name only.
Owing to time constraints in view of the 2019 European elections, there is hardly any
possibility for the European Parliament to exercise due diligence and to obtain external
expertise. Your rapporteur hopes that this was not the intention.
Rules on transparency
Unlike with the ECHA and EMA, which publish information and underlying studies in
relation to applications simultaneously with their scientific opinions, the Commission
proposes that in the authorisation procedures under food law such information be published
already at the time of the submission of applications. This could, however, have far-reaching
consequences for the competitiveness and innovative capacity of applicants. Competitors
from third countries could tap into product ideas and realise them already whilst the European
authorisation process is still on-going, particularly since innovations in the food sector cannot,
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as a rule, be protected by patents. The Commission proposal therefore puts important jobs in
jeopardy. Moreover, the new rules could lead companies to transfer their research and
development activities to third countries. In addition, such early publication might potentially
expose the EFSA to public pressure.
As it is, in controversial cases, the EFSA already grants interested parties the opportunity to
comment on the studies commissioned as part of a consultation following the publication of
its draft scientific opinion. In the case of aspartame, for example, this consultation led to the
EFSA reviewing its opinion.
Appointment of members of scientific panels
The involvement of the Member States in the appointment of members of scientific panels
through the obligation to nominate numerous experts could result in political interference with
the EFSA. Moreover, it is questionable whether all disciplines would be appropriately
covered if each Member State issued its own call for expressions of interest. A constant
exchange of information between Member States on the state of play in their search for
experts would result in a further significant increase in the additional administrative burden,
which is already enormous. It would therefore be appropriate to allow Member States to
nominate experts but not to oblige them to do so. Ultimately, EFSA should draw up the lists
of experts from as many Member States as possible and make the appointments on the basis
of such lists.
4. Rapporteur’s amendments
Your rapporteur proposes to bring the EFSA rules on transparency into line with those of
other agencies so that non-confidential information from applications, studies and
consultation sessions are only made accessible when the EFSA publishes its scientific opinion
and not at the time of the submission of the application. This is the only way to eliminate the
theft of ideas. Information should only be published if an application is maintained.
The requirement for stringent transparency should also apply in the areas of risk management
and risk communication. The Commission and Member States should be required to publish
minutes of working group meetings and voting results in standing committees.
The audit obligation should also extend to laboratories in third countries commissioned by
European companies to carry out studies. This should fall under the responsibility of the
Commission’s Food and Veterinary Office (FVO).
Your rapporteur welcomes the involvement of stakeholder representatives in the EFSA
Management Board, as is the case with the ECHA and EMA. However, in view of the broad
range of products covered by Regulation 178/2002, your rapporteur considers it necessary to
include not one but two representatives of industry (GMOs/plant protection products as well
as foodstuffs/additives). This is also envisaged for non-governmental organisations
(environment and consumer protection).
5. Conclusions
Regulation (EC) No 178/2002 on general food law is a success story. With it, the EU created
the world’s highest food safety standards for its internal market. The Fitness Check of the
basic Regulation confirmed this.
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The structure and transparency of EFSA should be brought into line with those of other EU
agencies. The Commission’s proposals, however, go well beyond the ECHA and EMA rules.
This is just as hard to understand as the fact that the Commission intends to envelop the whole
of the food sector with new rules liable to threaten the very survival of undertakings simply
because of the public discourse on the authorisation procedure for a plant protection product
and it intends to do so without the due impact assessment.
The Commission proposal also lacks precision. Many details are to be determined later in the
Authority’s internal rules, making the evaluation of the proposals difficult. This is equally
true for risk communication, which constitutes an important element if the EU is to restore
public confidence in food safety.
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11.10.2018
OPINION OF THE COMMITTEE ON FISHERIES
for the Committee on the Environment, Public Health and Food Safety
on the proposal for a regulation of the European Parliament and of the Council on the
transparency and sustainability of the EU risk assessment in the food chain amending
Regulation (EC) No 178/2002 [on general food law], Directive 2001/18/EC [on the deliberate
release into the environment of GMOs], Regulation (EC) No 1829/2003 [on GM food and
feed], Regulation (EC) No 1831/2003 [on feed additives], Regulation (EC) No 2065/2003 [on
smoke flavourings], Regulation (EC) No 1935/2004 [on food contact materials], Regulation
(EC) No 1331/2008 [on the common authorisation procedure for food additives, food
enzymes and food flavourings], Regulation (EC) No 1107/2009 [on plant protection products]
and Regulation (EU) No 2015/2283 [on novel foods]
(COM(2018)0179 – C8-0144/2018 – 2018/0088(COD))
Rapporteur: Ricardo Serrão Santos
SHORT JUSTIFICATION
The rapporteur:
- considers that it is crucial for EU citizens that the safety of food on the market is
guaranteed and that high safety standards continue;
- stresses the importance of the European Food Safety Authority (EFSA), particularly as
a provider of scientific advice to the Commission, Parliament and the Member States;
- takes a positive view of the Commission proposal to update the General Food Law
(GFL) Regulation, particularly where it concerns the clarification of transparency rules for
risk assessment and strengthening the guarantees of reliability, objectivity and independence
of the studies that EFSA uses in its risk assessment;
- believes that the conditions must be created under which EU citizens have full
confidence in Union agencies and authorities like EFSA, and that this confidence can only be
gained and maintained by applying transparent and clear rules and methodologies;
- stresses that EFSA’s capacity must be increased if it is to achieve a high level of
scientific expertise in all its areas of work;
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- believes that in a number of contexts, including the above context, decisions need to
be based on the best available scientific knowledge and considers it important to increase
EFSA’s capacity by hiring scientists known for their scientific panels;
- stresses that a risk assessment can only be carried out quickly if a comprehensive and
effective risk communication strategy, involving all the parties throughout the risk assessment
process and maintaining an open dialogue, is in place;
- is concerned that, in the Commission’s proposal, fishing, particularly aquaculture, is
overlooked, and points out that fishery products are one of the most important and healthiest
sources of animal protein, and that the EU is the biggest market for and consumer of such
products in the world, and it currently imports 68% of them from third countries;
- stresses the importance as a food source of fishery products, which were the subject of
a scientific opinion, ‘Food from the Oceans’, presented by the Scientific Advice Mechanism’s
High Level Group to the Commission in November 2017.
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AMENDMENTS
The Committee on Fisheries calls on the Committee on the Environment, Public Health and
Food Safety, as the committee responsible, to take into account the following amendments:
Amendment 1
Proposal for a regulation
Recital 8 a (new)
Text proposed by the Commission Amendment
(8a) No GMOs should be deliberately
released into the environment or placed
on the market, as or in products, in
contravention of the precautionary
principle and when there is no scientific
knowledge of the implications for each of
the areas concerned (the environment,
health, biodiversity, etc.).
Amendment 2
Proposal for a regulation
Recital 11
Text proposed by the Commission Amendment
(11) Experience shows that the role of
the Management Board of the Authority is
focussed on administrative and financial
aspects and does not impact on the
independence of the scientific work
performed by the Authority. It is thus
appropriate to include representatives of all
Member States in the Management Board
of the Authority, while providing that those
representatives should have experience in
particular on risk assessment.
(11) Experience shows that the role of
the Management Board of the Authority is
focussed on administrative and financial
aspects and does not impact on the
independence of the scientific work
performed by the Authority. It is thus
appropriate to include representatives of all
Member States as well as representatives
of civil society and industry in the
Management Board of the Authority, while
providing that those representatives should
have experience in particular on risk
assessment.
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Amendment 3
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8a – paragraph 1 – point b
Text proposed by the Commission Amendment
(b) promote consistency and
transparency in formulating risk
management recommendations;
(b) promote consistency, transparency
and clarity in formulating risk
management recommendations;
Amendment 4
Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point b
Regulation (EC) No 178/2002
Article 25 – paragraph 1a – point a
Text proposed by the Commission Amendment
a) two members and the alternate
members appointed by the Commission
and representing the Commission, with the
right to vote.
a) two members and two alternate
members, appointed by the Commission
and representing the Commission, with the
right to vote.
Amendment 5
Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point b
Regulation (EC) No 178/2002
Article 25 – paragraph 1a – point b
Text proposed by the Commission Amendment
b) one member appointed by the
European Parliament, with the right to
vote.
b) one member and one additional
member, appointed by the European
Parliament, with the right to vote.
Amendment 6
Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point b
Regulation (EC) No 178/2002
Article 25 – paragraph 1a – point c
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Text proposed by the Commission Amendment
(c) four members with the right to vote
representing civil society and food chain
interests namely, one from consumers
organisations, one from environmental
non-governmental organisations, one from
farmers organisations and one from
industry organisations. Those members
shall be appointed by the Council in
consultation with the European Parliament
on the basis of a list drawn up by the
Commission which includes more names
than there are posts to be filled. The list
drawn up by the Commission shall be
forwarded to the European Parliament,
together with the relevant background
documents. As quickly as possible and
within three months of notification, the
European Parliament may submit its views
for consideration to the Council, which
shall then appoint those members.
(c) six members with the right to vote
representing civil society and food chain
interests namely, one from consumers
organisations, one from environmental
non-governmental organisations, one from
farmers organisations, one from fisheries
and aquaculture organisations, one from
the agrochemical industry and one from
the food industry. Those members shall be
appointed by the Council in consultation
with the European Parliament on the basis
of a list drawn up by the Commission
which includes more names than there are
posts to be filled. The list drawn up by the
Commission shall be forwarded to the
European Parliament, together with the
relevant background documents. As
quickly as possible and within three
months of notification, the European
Parliament may submit its views for
consideration to the Council, which shall
then appoint those members.
Justification
The interests of producers in the field of GMOs and plant protection products, on the one
hand, and those of producers of foodstuffs and additives, on the other, are different. Likewise
agriculture and fisheries/aquaculture. The Board should also include a representative of
fisheries and aquaculture organisations. The Board should therefore also include two
separate representatives of industry.
Amendment 7
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32d – paragraph 1
Text proposed by the Commission Amendment
The Commission experts shall perform
controls, including audits, to obtain
assurance that testing facilities comply
with relevant standards for carrying out
tests and studies submitted to the Authority
The Commission's Food and Veterinary
Office (FVO) experts shall perform
controls, including audits, to obtain
assurance that testing facilities in the
Union and in third countries comply with
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as part of an application for an
authorisation under Union food law. These
controls shall be organised in cooperation
with the competent authorities of the
Member States.
relevant standards for carrying out tests
and studies submitted to the Authority as
part of an application for an authorisation
under Union food law. These controls shall
be organised in cooperation with the
competent authorities of the Member States
or of the third countries concerned.
Justification
The Food and Veterinary Office works to assure effective control systems and to evaluate
compliance with EU standards within the EU, and in third countries exporting to the EU. This
is done mainly through inspections carried out by the Food and Veterinary Office in the
Member States and in third countries exporting to the EU.
Amendment 8
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39e – paragraph 2
Text proposed by the Commission Amendment
2. Notwithstanding paragraph 1,
disclosure of names and addresses of
natural persons involved in testing on
vertebrate animals or in obtaining
toxicological information shall be deemed
to significantly harm the privacy and the
integrity of those natural persons and shall
not be made publicly available, unless
there is an overriding public interest.
2. Notwithstanding paragraph 1,
disclosure of names and addresses of
natural persons involved in testing or in
obtaining toxicological information shall
be deemed to significantly harm the
privacy and the integrity of those natural
persons and shall not be made publicly
available, unless there is an overriding
public interest.
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PROCEDURE – COMMITTEE ASKED FOR OPINION
Title Transparency and sustainability of the EU risk assessment in the food
chain
References COM(2018)0179 – C8-0144/2018 – 2018/0088(COD)
Committee responsible
Date announced in plenary
ENVI
28.5.2018
Opinion by
Date announced in plenary
PECH
28.5.2018
Rapporteur
Date appointed
Ricardo Serrão Santos
31.5.2018
Discussed in committee 20.6.2018 29.8.2018
Date adopted 9.10.2018
Result of final vote +:
–:
0:
21
1
0
Members present for the final vote Marco Affronte, Clara Eugenia Aguilera García, Renata Briano, Alain
Cadec, David Coburn, Richard Corbett, Diane Dodds, Linnéa
Engström, João Ferreira, Sylvie Goddyn, Mike Hookem, Ian Hudghton,
Carlos Iturgaiz, Werner Kuhn, António Marinho e Pinto, Barbara
Matera, Gabriel Mato, Norica Nicolai, Liadh Ní Riada, Ulrike Rodust,
Annie Schreijer-Pierik, Remo Sernagiotto, Ricardo Serrão Santos,
Isabelle Thomas, Ruža Tomašić, Jarosław Wałęsa, Peter van Dalen
Substitutes present for the final vote Izaskun Bilbao Barandica, José Blanco López, Nicola Caputo, Ole
Christensen, Rosa D’Amato, Norbert Erdős, Giuseppe Ferrandino, John
Flack, Elisabetta Gardini, Jens Gieseke, Anja Hazekamp, Maria
Heubuch, Czesław Hoc, Yannick Jadot, France Jamet, Seán Kelly,
Verónica Lope Fontagné, Linda McAvan, Francisco José Millán Mon,
Ana Miranda, Nosheena Mobarik, Cláudia Monteiro de Aguiar,
Rolandas Paksas, Maria Lidia Senra Rodríguez, Daciana Octavia Sârbu,
Nils Torvalds
Substitutes under Rule 200(2) present
for the final vote
Klaus Buchner
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FINAL VOTE BY ROLL CALL IN COMMITTEE ASKED FOR OPINION
21 +
ALDE António Marinho e Pinto, Norica Nicolai
ECR Nosheena Mobarik, Remo Sernagiotto, Ruža Tomašić
EFDD Rosa D'Amato
ENF Sylvie Goddyn
PPE Alain Cadec, Carlos Iturgaiz, Werner Kuhn, Gabriel Mato, Francisco José Millán Mon
S&D Clara Eugenia Aguilera García, Renata Briano, Ole Christensen, Giuseppe Ferrandino,
Ulrike Rodust, Ricardo Serrão Santos
VERTS/ALE Marco Affronte, Klaus Buchner, Linnéa Engström
1 -
GUE/NGL Anja Hazekamp
0 0
Key to symbols:
+ : in favour
- : against
0 : abstention
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15.10.2018
OPINION OF THE COMMITTEE ON LEGAL AFFAIRS
for the Committee on the Environment, Public Health and Food Safety
on the proposal for a regulation of the European Parliament and of the Council on the
transparency and sustainability of the EU risk assessment in the food chain amending
Regulation (EC) No 178/2002 [on general food law], Directive 2001/18/EC [on the deliberate
release into the environment of GMOs], Regulation (EC) No 1829/2003 [on GM food and
feed], Regulation (EC) No 1831/2003 [on feed additives], Regulation (EC) No 2065/2003 [on
smoke flavourings], Regulation (EC) No 1935/2004 [on food contact materials], Regulation
(EC) No 1331/2008 [on the common authorisation procedure for food additives, food
enzymes and food flavourings], Regulation (EC) No 1107/2009 [on plant protection products]
and Regulation (EU) No 2015/2283 [on novel foods]
(COM(2018)0179 – C8-0144/2018 – 2018/0088(COD))
Rapporteur for opinion: Pavel Svoboda
SHORT JUSTIFICATION
Assessing the proposal
This long awaited European Commission proposal for the disclosure of confidential industry
studies used in the European Food Safety Authority’s (EFSA) risk assessments contains
positive elements but fails to enable meaningful independent scrutiny of the data.
The proposal amends Regulation 178/2002 (hereafter the General Food Law (GFL)) and
several related Regulations and Directives. The rapporteur considers that there are some
positive changes in the proposal concerning transparency, however, he has also identified a
number a provisions that need to be changed or strengthened in order to achieve what the
European Commission intends on doing.
To that aim, the rapporteur has adopted a comprehensive stance, building on the
Commission’s proposal in order to fully implement a much needed reform of the risk
assessment process conducted by EFSA, thus allowing the EU as a whole to abide by the
Aarhus Convention (Convention on Access to Information, Public Participation in Decision-
making and Access to Justice in Environmental Matters).
The two main features of the proposal, automatic and pro-active publication of data in a
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machine-readable format and the creation of a register of studies aimed at preventing industry
cherry-picking of favourable studies, along with some minor changes with regard to risk
communication, consultation of third parties, reform of the composition of EFSA’s
management board are positive steps in the right direction.
The rapporteur considers however, that if the proposed industry authorisation for any
publication and use of independent data cross checks is indeed to be mandated, the usefulness
of these two provisions will be rather limited. Indeed, the proposal introduces a new provision
stating that the disclosure of scientific data and studies regarding applications for
authorisations under food law, authorisations for GMOs or additives in food, ‘shall be without
prejudice to’ ‘any intellectual property right which may exist over documents or their
content’. Furthermore, the proposal introduces a presumption with regard to categories of
information that the disclosure of such information ‘may be deemed to significantly harm
commercial interests’.
The impossibility of re-using the data without permission would compromise the possibility
to reduce the overall number of toxicity studies, hinder the public scrutiny of the results,
including a better understanding of the potential adverse effects on health and the
environment. The peer review process that is essential to ensure the full effectiveness of the
risk assessment conducted is essentially at risk.
Notwithstanding the changes with a positive effect on transparency in the proposal, the
rapporteur deems necessary to amend the Commission’s proposal in order to maintain and
expand the current level of transparency under European Union food law with regard to
several categories of information, within the several directives that are amended under this
proposal.
A real overhaul of the EU’s risk assessment in the food chain
The rapporteur does not consider that it is reasonable to “weigh up the relevant rights of the
public to transparency in the risk assessment process, including those flowing from the
Aarhus Convention, against the rights of commercial applicants” as stated in the European
Commission’s proposal. Nor that the EU should grant more protection to commercial parties
than the Aarhus legislation already provides for (implemented through Regulations 1049/2001
and 1367/2006). He is also firmly opposed to the use of the EU taxpayers money granted to
EFSA to give advice to the private companies that are applicants.
The rapporteur aims to make transparency the rule and confidentiality the exception. The
exceptions to the principle of transparency must be interpreted strictly to fully guarantee
public and independent scrutiny. That translates into several amendments made to the GFL
regulation.
Proposed amendments to the proposal within the sectorial regulations targeted are set to close
the existing loopholes in the obligation to disclose information gathered when there is an
“overriding public interest in disclosure” related to food safety. Then he considers appropriate
to lay down in the GFL a horizontal and non-exhaustive list of information items which can
never be kept secret.
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AMENDMENTS
The Committee on Legal Affairs calls on the Committee on the Environment, Public Health
and Food Safety, as the committee responsible, to take into account the following
amendments:
Amendment 1
Proposal for a regulation
Recital 2
Text proposed by the Commission Amendment
(2) Regulation (EC) No 178/2002
defines “risk analysis” as a process
consisting of three interconnected
components: risk assessment, risk
management and risk communication. For
the purposes of risk assessment at Union
level, it establishes the European Food
Safety Authority (“the Authority”), as the
responsible Union risk assessment body in
matters relating to food and feed safety.
Risk communication is an essential part of
the risk analysis process.
(2) Regulation (EC) No 178/2002
defines “risk analysis” as a process
consisting of three distinct but
interconnected components: risk
assessment, risk management and risk
communication. For the purposes of risk
assessment at Union level, it establishes the
European Food Safety Authority (“the
Authority”), as the responsible Union risk
assessment body in matters relating to food
and feed safety. Risk communication is an
essential part of the risk analysis process
and presupposes the interactive exchange
of information and opinions throughout
the risk analysis process as regards
hazards and risks, risk-related factors and
risk perceptions amongst risk assessors,
risk managers, consumers, feed and food
businesses, the academic community,
including the explanation of risk
assessment findings and the basis of risk
management decisions.
Amendment 2
Proposal for a regulation
Recital 3
Text proposed by the Commission Amendment
(3) The evaluation of Regulation (EC)
No 178/200221 , (“Fitness Check of the
General Food Law”), found that risk
communication is overall, not considered
to be effective enough, which has an
(3) The evaluation of Regulation (EC)
No 178/200221 , (“Fitness Check of the
General Food Law”), found that risk
communication is overall, not considered
to be effective enough, which can have a
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impact on consumers’ confidence on the
outcome of the risk analysis process.
negative an impact on the outcome of the
risk analysis process.
__________________ __________________
21 Commission Staff Working Document,
“The REFIT evaluation of the General
Food Law (Regulation (EC) No
178/2002)”, SWD(2018)38 final, dated
15.1.2018.
21 Commission Staff Working Document,
“The REFIT evaluation of the General
Food Law (Regulation (EC) No
178/2002)”, SWD(2018)38 final, dated
15.1.2018.
Amendment 3
Proposal for a regulation
Recital 4
Text proposed by the Commission Amendment
(4) It is therefore necessary to ensure a
comprehensive and continuous risk
communication process throughout risk
analysis, involving Union and national risk
assessors and risk managers. That process
should be combined with an open dialogue
between all interested parties to ensure the
coherence and consistency within the risk
analysis process.
(4) It is therefore necessary to ensure a
comprehensive, transparent, independent
and continuous risk communication
process throughout risk analysis, involving
Union and national risk assessors and risk
managers. That process should be capable
of contributing to a participatory and open
dialogue between all interested parties to
ensure prevalence of public interest only,
accuracy, comprehensiveness,
transparency and consistency of the risk
analysis process.
Amendment 4
Proposal for a regulation
Recital 5
Text proposed by the Commission Amendment
(5) Particular emphasis should be
placed on explaining in a coherent,
appropriate and timely manner not only
risk assessment findings themselves but
also how these are utilized to help inform
risk management decisions along with
other legitimate factors, where relevant.
(5) Particular emphasis should be
placed on explaining in an accurate, clear
and timely manner not only risk
assessment findings themselves but also
how these are utilized to help inform risk
management decisions along with other
legitimate factors, where relevant.
Amendment 5
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Proposal for a regulation
Recital 6
Text proposed by the Commission Amendment
(6) To this effect, it is necessary to
establish general objectives and principles
of risk communication, taking into account
the respective roles of risk assessors and
managers.
(6) To this effect, it is necessary to
establish general objectives and principles
of risk communication, taking into account
the respective roles of risk assessors and
managers, while guaranteeing their
independence.
Amendment 6
Proposal for a regulation
Recital 7
Text proposed by the Commission Amendment
(7) Based on these general objectives
and principles, a general plan on risk
communication should be established in
close cooperation with the Authority and
the Member States, and following relevant
public consultations.
(7) Based on these general objectives
and principles, a general plan on risk
communication in real time should be
established in close cooperation with the
Authority and the Member States, and
following the organisation of the relevant
public consultations.
Amendment 7
Proposal for a regulation
Recital 8
Text proposed by the Commission Amendment
(8) The general plan should identify the
key factors to be taken into account when
risk communications’ activities are
considered, such as the different levels of
risk, the nature of the risk and its potential
public health impact, who and what are
directly or indirectly affected by the risk,
the levels of risk exposure, the ability to
control risk and other factors that influence
risk perception including the level of
urgency as well as the applicable
legislative framework and relevant market
context. The general plan should also
(8) The general plan should identify the
key factors to be taken into account when
risk communications’ activities are
considered, such as the different levels of
hazard and risk, the nature of the hazard
and its potential environmental and public
health and environmental impacts, what
groups of the population can directly or
indirectly be affected by the risk, the levels
of risk exposure, the ability to control
exposure and risk, the ways of managing it
and other factors that influence risk
understanding including the level of
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identify the tools and channels to be used
and should establish appropriate
mechanisms to ensure coherent risk
communication.
urgency as well as the applicable
legislative framework. The general plan
should also identify the tools and channels
to be used and should establish appropriate,
exhaustive and expeditious mechanisms to
ensure accurate risk communication.
Amendment 8
Proposal for a regulation
Recital 10
Text proposed by the Commission Amendment
(10) It is appropriate to align the
composition of the Management Board of
the Authority to the Common Approach on
decentralised agencies, in accordance with
the Joint Statement of the European
Parliament, the Council of the European
Union and the European Commission on
decentralised agencies of 201222.
(10) It is appropriate to align the
composition of the Management Board of
the Authority to the Common Approach on
decentralised agencies, in accordance with
the Joint Statement of the European
Parliament, the Council of the European
Union and the European Commission on
decentralised agencies of 201222, while
also taking into account the withdrawal of
the United Kingdom from the EU and the
legal effects resulting therefrom.
_________________ _________________
22 https://europa.eu/european-
union/sites/europaeu/files/docs/body/joint_
statement_and_common_approach_2012_e
n.pdf.
22 https://europa.eu/european-
union/sites/europaeu/files/docs/body/joint_
statement_and_common_approach_2012_e
n.pdf.
Amendment 9
Proposal for a regulation
Recital 11
Text proposed by the Commission Amendment
(11) Experience shows that the role of
the Management Board of the Authority is
focussed on administrative and financial
aspects and does not impact on the
independence of the scientific work
performed by the Authority. It is thus
appropriate to include representatives of all
Member States in the Management Board
(11) Experience shows that the role of
the Management Board of the Authority is
focussed on administrative and financial
aspects and does not impact on the
independence of the scientific work
performed by the Authority. It is thus
appropriate to include representatives of all
Member States, including representatives
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of the Authority, while providing that those
representatives should have experience in
particular on risk assessment.
of civil society and industry, in the
Management Board of the Authority, while
providing that those representatives should
have experience in particular in assessing
and managing risks and problems and
that they have no conflict of interest with
the applicants.
Amendment 10
Proposal for a regulation
Recital 12
Text proposed by the Commission Amendment
(12) The Management Board should be
selected in such a way as to secure the
highest standards of competence and a
broad range of relevant experience
available amongst the representatives of
the Member States, the European
Parliament and the Commission.
(12) The Management Board should be
selected in such a way as to secure the
highest standards of competence and
commitment to the protection of health
and the environment and a broad range of
relevant experience available amongst the
representatives of the Member States, the
European Parliament and the Commission.
Amendment 11
Proposal for a regulation
Recital 13
Text proposed by the Commission Amendment
(13) The Fitness Check of the General
Food Law identified certain shortcomings
in the long-term capability of the Authority
to maintain its high-level expertise. In
particular, there has been a decrease in the
number of candidates applying to be
members of the Scientific Panels. The
system has thus to be strengthened and
Member States should take a more active
role to ensure that a sufficient pool of
experts is available to meet the needs of the
Union risk assessment system in terms of
high level of scientific expertise,
independence and multidisciplinary
expertise.
(13) The Fitness Check of the General
Food Law identified certain shortcomings
in the long-term capability of the Authority
to maintain its high-level expertise. In
particular, there has been a decrease in the
number of candidates applying to be
members of the Scientific Panels. In order
to tackle this phenomenon more
effectively, the system has thus to be
strengthened and promoted, and Member
States should take a more active role to
ensure that a sufficient pool of experts is
available, by undertaking support actions
and using incentives and rewards to
increase the level of participation and the
degree of interest in seeking to engage in
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it, to meet the needs of the Union risk
assessment system in terms of high level of
scientific expertise, independence and
multidisciplinary expertise.
Amendment 12
Proposal for a regulation
Recital 14
Text proposed by the Commission Amendment
(14) To preserve the independence of
the risk assessment from risk management
and from other interests at Union level, it
is appropriate that the nomination of the
members of the Scientific Panels by the
Member States, their selection by the
Executive Director of the Authority and
their appointment by the Management
Board of the Authority are based on strict
criteria ensuring the excellence and
independence of the experts while ensuring
the required multidisciplinary expertise for
each Panel. It is also essential to this end
that the Executive Director whose function
is to defend EFSA’s interests and in
particular the independence of its expertise
has a role in the selection and appointment
of those scientific experts. Further
measures should also be put in place to
ensure that scientific experts have the
means to act independently.
(14) preserve the independence of the
risk assessment from risk management and
from vested private interests at Union
level, it is appropriate that the nomination
of the members of the Scientific Panels by
the Member States, their selection by the
Executive Director of the Authority and
their appointment by the Management
Board of the Authority are based on strict,
transparent criteria ensuring the
excellence and independence of the experts
while ensuring the required
multidisciplinary expertise for each Panel.
It is also essential to this end that the
Executive Director whose function is to
safeguard EFSA’s accountability, and in
particular the independence of its expertise,
has a role in excluding scientific experts
who oppose the publication of their name
or who have conflicts of interest, from
risk assessment. Adequate budgetary measures should be put in place to ensure
that scientific experts have the means to act
independently. To this effect, it is
necessary to implement new and adequate
budgetary measures.
Amendment 13
Proposal for a regulation
Recital 16
Text proposed by the Commission Amendment
(16) Authorisations procedures are (16) Authorisations procedures are
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based on the principle that it is for the
applicant to prove that the subject matter of
an authorisation procedure complies with
Union safety requirements given the
scientific knowledge in its possession. This
principle is based on the premise that
public health is better protected when the
burden of proof is on the applicant since it
has to prove that a particular subject matter
is safe prior to its placing on the market,
instead of the public authorities having to
prove that a subject matter is unsafe in
order to be able to ban it from the market.
Moreover, public money should not be
used to commission costly studies that will
in the end help the industry to place a
product on the market. According to this
principle and in accordance with applicable
regulatory requirements, in support of
applications for an authorisation under
Union sectoral food law applicants are
required to submit relevant studies,
including tests, to demonstrate the safety
and in some cases the efficacy of a subject
matter.
based on the principle that it is for the
applicant to prove that the subject matter of
an authorisation procedure complies with
Union safety requirements given the
scientific knowledge in its possession. This
principle is based on the premise that
public health and the environment are
better protected when the burden of proof
is on the applicant since it has to prove that
a particular subject matter is safe prior to
its placing on the market, instead of the
public authorities having to prove that a
subject matter unsafe in order to be able to
ban it from the market. Moreover, public
money should not be used to commission
costly studies that will in the end help the
industry to place a product on the market.
According to this principle and in
accordance with applicable regulatory
requirements, in support of applications for
an authorisation under Union sectoral food
law applicants are required to submit
relevant studies, including tests, to
demonstrate the safety and in some cases
the efficacy of a subject matter.
Amendment 14
Proposal for a regulation
Recital 17
Text proposed by the Commission Amendment
(17) Provisions exist on the content of
applications for authorisations. It is
essential that the application for
authorisation submitted to the Authority for
its risk assessment meets the applicable
specifications to ensure the best quality
scientific assessment by the Authority.
Applicants and in particular small- and
medium-sized enterprises do not always
have a clear understanding of these
specifications. It should be thus appropriate
that the Authority provides advice to a
potential applicant, upon request, on the
applicable rules and the required content of
an application for authorisation, before an
(17) Provisions exist on the content of
applications for authorisations. It is
essential that the application for
authorisation submitted to the Authority for
its risk assessment meets the applicable
specifications to ensure the best quality
scientific assessment by the Authority.
Applicants and in particular small- and
medium-sized enterprises do not always
have a clear understanding of these
specifications. It should be thus appropriate
that the Authority provides advice to a
potential applicant, upon request, on the
applicable rules and the required content of
an application for authorisation, before an
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application is formally submitted, while
not entering into the design of the studies
to be submitted that remain the applicant’s
responsibility. To ensure the transparency
of this process, the advice of the Authority
should be made public.
application is formally submitted, while
not entering into the design of the studies
to be submitted that remain the applicant’s
responsibility. To ensure the transparency
of this process and provide wide and non-
discriminatory access to information, the
advice of the Authority should be made
public.
Amendment 15
Proposal for a regulation
Recital 18
Text proposed by the Commission Amendment
(18) The Authority should have
knowledge of the subject matter of all
studies performed by an applicant with a
view to a future application for an
authorisation under Union food law. To
this end, it is necessary and appropriate
that business operators commissioning the
studies and laboratories carrying them out
notify those studies to the Authority when
commissioned. Information about the
notified studies should be made public only
once a corresponding application for
authorisation has been made public in
accordance with the applicable rules on
transparency.
(18) The Authority should have
knowledge of the subject matter of all
studies performed by an applicant with a
view to a future application for an
authorisation under Union food law. To
this end, it is necessary and appropriate
that business operators commissioning the
studies and laboratories carrying them out
notify those studies to the Authority when
commissioned. Information about the
notified studies should be made public only
once a corresponding application for
authorisation or renewal has been
submitted and the Authority has published
its official scientific opinion.
Amendment 16
Proposal for a regulation
Recital 20
Text proposed by the Commission Amendment
(20) There are certain public concerns
about the Authority’s assessment in the
area of authorisation being primarily based
on industry studies. The Authority already
makes searches in scientific literature to be
able to consider other data and studies
existing on the subject matter submitted to
its assessment. In order to provide an
(20) There are public concerns about the
Authority’s assessment in the area of
authorisation being primarily based on
industry studies. The Authority already
makes searches in scientific literature to be
able to consider other data and studies
existing on the subject matter submitted to
its assessment. In order to ensure that the
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additional level of guarantee ensuring that
the Authority can have access to all
relevant scientific data and studies
available on a subject matter of an
authorisation procedure, it is appropriate to
provide for a consultation of third parties
in order to identify whether other relevant
scientific data or studies are available. To
increase the effectiveness of the
consultation, the consultation should take
place when the studies submitted by
industry included in an application for
authorisation are made public, under the
transparency rules of this Regulation.
Authority includes all relevant scientific
data and studies available on a subject
matter of an authorisation procedure, it is
appropriate to provide for a public
consultation, once a corresponding
application for authorisation or renewal
has been made public, in order to identify
whether other relevant scientific data or
studies are available.
Amendment 17
Proposal for a regulation
Recital 21
Text proposed by the Commission Amendment
(21) Studies, including tests, submitted
by business operators in support of
applications for authorisations under Union
sectoral food law usually comply with
internationally recognised principles,
which provide a uniform basis for their
quality in particular in terms of
reproducibility of results. However, issues
of compliance with the applicable
standards may arise in some cases and this
is why national systems are in place to
verify such compliance. It is appropriate to
provide an additional level of guarantees
to reassure the general public on the
quality of studies and to lay down an
enhanced auditing system whereby
Member State controls on the
implementation of those principles by the
laboratories carrying out such studies and
tests would be verified by the Commission.
(21) Studies, including tests, submitted
by business operators in support of
applications for authorisations under Union
sectoral food law usually refer to
internationally recognised principles,
which provide a uniform basis for their
quality in particular in terms of
reproducibility of results. However, non-
compliance with the applicable standards
may arise and this is why national systems
are in place to verify such compliance. In
order to ensure the quality of studies it is
appropriate to enhance the auditing
system whereby Member States control
and ensure the implementation of those
principles by the laboratories carrying out
such studies and tests and whereby
Member States’ controls are to be verified
by the Commission.
Amendment 18
Proposal for a regulation
Recital 21 a (new)
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Text proposed by the Commission Amendment
(21 a) Sufficient flexibility must be built
into the process so that new insights into
serious health adverse effects can be
promptly taken into consideration, even
when they are not specifically covered by
regulatory data requirements.
Amendment 19
Proposal for a regulation
Recital 22
Text proposed by the Commission Amendment
(22) Food safety is a sensitive matter of
prime interest for all Union citizens. While
maintaining the principle that the burden is
on the industry to prove compliance with
Union requirements, it is important to
establish an additional verification tool to
address specific cases of high societal
importance where there is a controversy on
safety issues, namely the commissioning of
additional studies with the objective of
verifying evidence used in the context of
risk assessment. Considering that it would
be financed by the Union budget and that
the use of this exceptional verification tool
should remain proportionate, the
Commission should be responsible for
triggering the commissioning of such
verification studies. Account should be
taken of the fact that in some specific cases
the studies commissioned may need to
have a wider scope than the evidence at
stake (for example new scientific
developments becoming available).
(22) Food safety is a sensitive matter of
prime interest for all Union citizens. While
maintaining the principle that the burden is
on the industry to prove compliance with
Union requirements, it is important to
establish an additional verification tool to
address specific cases of high societal
importance where there is a controversy on
safety issues, namely the commissioning of
additional studies with the objective of
verifying evidence used in the context of
risk assessment. Considering that it would
be financed by the Union budget and that
the use of this exceptional verification tool
should remain proportionate, the Authority
should be responsible for triggering the
commissioning of such verification studies.
Account should be taken of the fact that in
some specific cases the studies
commissioned may need to have a wider
scope than the evidence at stake (for
example new scientific developments
becoming available).
Amendment 20
Proposal for a regulation
Recital 23
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Text proposed by the Commission Amendment
(23) The Fitness Check of the General
Food Law demonstrated that although the
Authority has made considerable progress
in terms of transparency, the risk
assessment process, especially in the
context of authorisation procedures
covering the agri-food chain, is not always
perceived as fully transparent. This is also
partly due to the different transparency
and confidentiality rules that are laid
down not only in Regulation (EC) No
178/2002 but also in other Union
legislative acts covering the agri-food
chain. Their interplay can impact on the
acceptability of the risk assessment by the
general public.
(23) The Fitness Check of the General
Food Law demonstrated that the Union
has promoted a considerable number of
measures to protect the quality and safety
of food and products (Regulation (EC) No
2073/2005; Regulation (EC) No
853/2004; Regulation (EC) No 854/2004;
and in particular Recital 12 of Directive
2009/128/EC) and, although the Authority
has made considerable progress in terms of
transparency, the risk assessment process,
especially in the context of authorisation
procedures covering the agri-food chain, is
not yet fully transparent.
Amendment 21
Proposal for a regulation
Recital 23 a (new)
Text proposed by the Commission Amendment
(23a) The Aarhus Convention
establishes a number of rights of the
public with regard to the environment.
The Convention provides for the right of
everyone to receive environmental
information that is held by public
authorities, the right to participate in
environmental decision-making, and the
right to review procedures to challenge
public decisions that have been made
without respecting the two
aforementioned rights or environmental
law in general.
Amendment 22
Proposal for a regulation
Recital 24
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Text proposed by the Commission Amendment
(24) The European Citizens’ Initiative
“Ban glyphosate and protect people and the
environment from toxic pesticides” further
confirmed concerns regarding transparency
with respect to studies commissioned by
the industry and submitted in authorisation
application23 .
(24) As a Party to the Aarhus
Convention, the Union has recognized
that, in the field of the environment,
improved access to information and
public participation in decision-making
enhance the quality and the
implementation of decisions, contribute to
public awareness of environmental issues,
give the public the opportunity to express
its concerns and enable public authorities
to take due account of such concerns. The
European Citizens’ Initiative “Ban
glyphosate and protect people and the
environment from toxic pesticides” further
confirmed concerns regarding transparency
with respect to studies commissioned by
the industry and submitted in authorisation
application23 .
__________________ __________________
23 Communication from the Commission
on the ECI “Ban glyphosate and protect
people and the environment from toxic
pesticides”, C(2017) 8414 final.
23 Communication from the Commission
on the ECI “Ban glyphosate and protect
people and the environment from toxic
pesticides”, C(2017) 8414 final.
Amendment 23
Proposal for a regulation
Recital 25
Text proposed by the Commission Amendment
(25) It is therefore necessary to
strengthen the transparency of the risk
assessment process in a proactive manner.
Public access to all scientific data and
information supporting requests for
authorisations under Union food law as
well as other requests for scientific output
should be ensured, as early as possible in
the risk assessment process. However, this
process should be without prejudice to
existing intellectual property rights or to
any provisions of Union food law
protecting the investment made by
(25) To further the accountability and
to regain public support for decisions of
the Authority and in order to ensure the
liability of the Authority, it is therefore
necessary to strengthen the transparency
and clarity of the risk assessment process
in a proactive manner. In order to ensure
public scrutiny, public access to all
scientific data and information supporting
requests for authorisations under Union
food law as well as other requests for
scientific output should be ensured, as
early as possible in the risk assessment
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innovators in gathering the information
and data supporting relevant applications
for authorisations.
process.
Amendment 24
Proposal for a regulation
Recital 27
Text proposed by the Commission Amendment
(27) To determine what level of
disclosure strikes the appropriate balance,
the relevant rights of the public to
transparency in the risk assessment
process, should be weighted up against
the rights of commercial applicants,
taking into account the objectives of Regulation (EC) No 178/2002.
(27) The present Regulation intends to
ensure transparency in the risk
assessment process and give the fullest
possible effect to the right of the public to
transparency of information and access to
documents of the Authority and is to be
read in conjunction with Regulation No
1049/2001 and 1367/2006.
Amendment 25
Proposal for a regulation
Recital 27 a (new)
Text proposed by the Commission Amendment
(27a) The provisions on active
dissemination laid down in this
Regulation are not meant to limit, in any
manner, the scope of the rights provided
for by Regulation (EC) No 1049/2001 and
(EC) No 1367/2006.
Amendment 26
Proposal for a regulation
Recital 28
Text proposed by the Commission Amendment
(28) Accordingly and with respect to
the procedures governing requests for
authorisation procedures provided in
Union food law, experience gained so far
has shown that certain information items
(28) Any information having a direct
impact on health or the environment
should therefore always be made public. It
is appropriate to lay down, in Regulation
(EC) No 178/2002, an exhaustive
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are generally considered sensitive and
should remain confidential across the
different sectoral authorisation
procedures. It is appropriate to lay down in
Regulation (EC) No 178/2002 a horizontal
list of information items whose disclosure
may be considered to significantly harm
the commercial interests concerned and
should not therefore be disclosed to the
public, (“general horizontal list of
confidential items”). Only in very limited
and exceptional circumstances relating to
foreseeable health effects and urgent
needs to protect human health, animal
health or the environment, such information should be disclosed.
horizontal list of information items which
may be kept confidential as they would significantly undermine the protection of
commercial interest. However, it should
only be possible for this information to be
kept secret if the company opposing its
dissemination can verifiably prove that
the proactive disclosure of the
information item would significantly
undermine its commercial interests
(“general horizontal list of confidential
items”). The exceptions to the principle of
transparency must be interpreted strictly.
However, even if the disclosure of the
information is considered to undermine
the commercial interests of an economic
operator, the information should, in case
there is an overriding public interest in
the disclosure, not be kept confidential as
the interests of public health prevail over
commercial interests. It is appropriate to
lay down, in Regulation (EC)No178/2002,
a horizontal exhaustive list of information
items for which it should not be possible
to keep them confidential, since they
relate to circumstances where an
overriding public interest in their
disclosure is deemed to exist.
Amendment 27
Proposal for a regulation
Recital 30
Text proposed by the Commission Amendment
(30) It is also necessary to set out
specific requirements with respect to the
protection of personal data for the purposes
of the transparency of the risk assessment
process taking into account Regulation
(EC) No 45/2001 of the European
Parliament and of the Council24 and
Regulation (EU) 2016/679 of the European
Parliament and of the Council25 .
Accordingly, no personal data should be
made publicly available under this
Regulation, unless it is necessary and
proportionate for the purposes of ensuring
(30) It is also necessary to refer, for the
protection and confidentiality of personal
data for the purposes of the transparency of
the risk assessment process, to regulation
(EC) No 45/2001 of the European
Parliament and of the Council and
Regulation (EU) 2016/679 of the European
Parliament and of the Council25 .
Accordingly, no personal data should be
made publicly available under this
Regulation, unless it is necessary and
proportionate for the purposes of ensuring
the transparency, independence and the
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the transparency, independence and the
reliability of the risk assessment process,
while preventing conflicts of interests.
reliability of the risk assessment process,
while preventing conflicts of interests. For
the purpose of ensuring the transparency,
independence, sustainability and
reliability of the risk assessment process,
in particular to avoid conflicts of interest,
it is considered necessary and
proportionate to publish the names of any
individual designated by the Authority to
contribute to the Authority’s decision
making process, including in the context
of the adoption of guidance documents.
__________________ __________________
24 Regulation (EC) No 45/2001 of the
European Parliament and of the Council of
18 December 2000 on the protection of
individuals with regard to the processing of
personal data by the Community
institutions and bodies and on the free
movement of such data (OJ L 8, 12.1.2001,
p. 1).
24 Regulation (EC) No 45/2001 of the
European Parliament and of the Council of
18 December 2000 on the protection of
individuals with regard to the processing of
personal data by the Community
institutions and bodies and on the free
movement of such data (OJ L 8, 12.1.2001,
p. 1).
25 Regulation (EU) 2016/679 of the
European Parliament and of the Council of
27 April 2016 on the protection of natural
persons with regard to the processing of
personal data and on the free movement of
such data, and repealing Directive
95/46/EC (General Data Protection
Regulation) (OJ L 119, 4.5.2016, p. 1).
25 Regulation (EU) 2016/679 of the
European Parliament and of the Council of
27 April 2016 on the protection of natural
persons with regard to the processing of
personal data and on the free movement of
such data, and repealing Directive
95/46/EC (General Data Protection
Regulation) (OJ L 119, 4.5.2016, p. 1).
Amendment 28
Proposal for a regulation
Recital 31
Text proposed by the Commission Amendment
(31) For the purposes of increased
transparency and in order to ensure that
requests for scientific outputs received by
the Authority are processed in an effective
manner, standard data formats and
software packages should be developed. In
order to ensure uniform conditions for the
implementation of Regulation (EC) No
178/2002 with regard to the adoption of
standard data formats and software
(31) For the purposes of increased
transparency and in order to ensure that
requests for scientific outputs received by
the Authority are processed in an effective
manner, standard data formats and
software packages should be developed. In
order to ensure uniform and harmonised
conditions for the implementation of
Regulation (EC) No 178/2002 with regard
to the adoption of standard data formats
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packages, implementing powers should be
conferred on the Commission. Those
powers should be exercised in accordance
with Regulation (EU) No 182/2011 of the
European Parliament and of the Council26.
and software packages, implementing
powers should be conferred on the
Commission. Those powers should be
exercised in accordance with Regulation
(EU) No 182/2011 of the European
Parliament and of the Council26.
_________________ _________________
26 Regulation (EU) No 182/2011 of the
European Parliament and of the Council of
16 February 2011 laying down the rules
and general principles concerning
mechanisms for control by Member States
of the Commission’s exercise of
implementing powers (OJ L 55, 28.2.2011,
p. 13).
26 Regulation (EU) No 182/2011 of the
European Parliament and of the Council of
16 February 2011 laying down the rules
and general principles concerning
mechanisms for control by Member States
of the Commission’s exercise of
implementing powers (OJ L 55, 28.2.2011,
p. 13).
Amendment 29
Proposal for a regulation
Recital 32
Text proposed by the Commission Amendment
(32) Having regard to the fact that the
Authority would be required to store
scientific data, including confidential and
personal data, it is necessary to ensure that
such storage is carried out in accordance
with a high level of security.
(32) Having regard to the fact that the
Authority would be required to store
scientific data, including confidential and
personal data, it is necessary to ensure that
such storage is carried out in a way that
ensures complete security.
Amendment 30
Proposal for a regulation
Recital 33
Text proposed by the Commission Amendment
(33) Furthermore, in order to assess the
effectiveness and efficiency of the different
provisions applying to the Authority, it is
also appropriate to provide for a
Commission evaluation of the Authority, in
accordance with the Common Approach on
Decentralised Agencies. The evaluation
should, in particular, review the procedures
for selecting the members of Scientific
(33) Furthermore, in order to assess the
effectiveness and efficiency of the different
provisions applying to the Authority, it is
also appropriate to provide for a
Commission evaluation of the Authority, in
accordance with the Common Approach on
Decentralised Agencies. The evaluation
should, in particular, review the procedures
for selecting the members of Scientific
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Committee and Panels, for their degree of
transparency, cost-effectiveness, and
suitability to ensure independence and
competence, and to prevent conflicts of
interests.
Committee and Panels, for their degree of
transparency, cost-effectiveness, and
suitability to ensure independence,
vigilance and competence, and to prevent
conflicts of interests.
Amendment 31
Proposal for a regulation
Recital 35
Text proposed by the Commission Amendment
(35) For the purposes of ensuring
transparency of the risk assessment
process, it is also necessary to extend the
scope of Regulation (EC) No 178/2002,
currently limited to food law, to also cover
applications for authorisations in the
context of Regulation (EC) No 1831/2003
as regards feed additives, Regulation (EC)
No 1935/2004 as regards food contact
materials and Regulation (EC) No
1107/2009 as regards plant protection
products.
(35) For the purposes of ensuring the
transparency and independence of the risk
assessment process, it is also necessary to
extend the scope of Regulation (EC) No
178/2002, currently limited to food law, to
also cover applications for authorisations in
the context of Regulation (EC) No
1831/2003 as regards feed additives,
Regulation (EC) No 1935/2004 as regards
food contact materials and Regulation (EC)
No 1107/2009 as regards plant protection
products.
Amendment 32
Proposal for a regulation
Recital 36
Text proposed by the Commission Amendment
(36) To ensure that sectoral specificities
with respect to confidential information are
taken into account, it is necessary to weigh
up the relevant rights of the public to
transparency in the risk assessment
process, including those flowing from the
Aarhus Convention35, against the rights of
commercial applicants, taking into account
the specific objectives of sectoral Union
legislation as well as experienced gained.
Accordingly, it is necessary to amend
Directive 2001/18/EC, Regulation (EC) No
1829/2003, Regulation (EC) No
1831/2003, Regulation (EC) No 1935/2004
(36) To ensure that sectoral specificities
with respect to confidential information are
taken into account, it is necessary to weigh
up the relevant rights of the public to
transparency in the risk assessment
process, including those flowing from the
Aarhus Convention35, against the rights of
commercial applicants, taking into account
the specific objectives of sectoral Union
legislation as well as experienced gained,
while, however, bearing in mind that,
where there are specific grounds for
concern about public welfare and public
health, public interest prevails over
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and Regulation (EC) No 1107/2009 to
provide for additional confidential items to
those set out in Regulation (EC) No
178/2002.
commercial interests. Accordingly, it is
necessary to amend Directive 2001/18/EC,
Regulation (EC) No 1829/2003, Regulation
(EC) No 1831/2003, Regulation (EC) No
1935/2004 and Regulation (EC) No
1107/2009 to provide for additional
confidential items to those set out in
Regulation (EC) No 178/2002.
_________________ _________________
35 Regulation (EC) No 1367/2006 of the
European Parliament and of the Council of
6 September 2006 on the application of the
provisions of the Aarhus Convention on
Access to Information, Public Participation
in Decision-making and Access to Justice
in Environmental Matters to Community
institutions and bodies (OJ L 264,
25.9.2006, p.13).
35 Regulation (EC) No 1367/2006 of the
European Parliament and of the Council of
6 September 2006 on the application of the
provisions of the Aarhus Convention on
Access to Information, Public Participation
in Decision-making and Access to Justice
in Environmental Matters to Community
institutions and bodies (OJ L 264,
25.9.2006, p.13).
Amendment 33
Proposal for a regulation
Recital 37
Text proposed by the Commission Amendment
(37) In order to further strengthen the
link between risk assessors and risk
managers at Union and national levels as
well as the coherence and consistency of
risk communication, the power to adopt
acts in accordance with Article 290 of the
Treaty should be delegated to the
Commission to adopt a general plan on risk
communication on matters covering the
agri-food chain. It is of particular
importance that the Commission carries out
appropriate consultations during its
preparatory work, including at expert level,
and that those consultations be conducted
in accordance with the principles laid down
in the Interinstitutional Agreement on
Better Law-Making of 13 April 2016. In
particular, to ensure equal participation in
the preparation of delegated acts, the
European Parliament and the Council
receive all documents at the same time as
(37) In order to safeguard the
independence of the risk assessment and
risk management stages at Union and
national levels as well as the accuracy and
consistency of risk communication, the
power to adopt acts in accordance with
Article 290 of the Treaty should be
delegated to the Commission to adopt a
general plan on risk communication on
matters covering the agri-food chain. It is
of particular importance that the
Commission carries out appropriate
consultations during its preparatory work,
including at expert level, and that those
consultations be conducted in accordance
with the principles laid down in the
Interinstitutional Agreement on Better
Law-Making of 13 April 2016. In
particular, to ensure equal participation in
the preparation of delegated acts, the
European Parliament and the Council
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Member States’ experts, and their experts
systematically have access to meetings of
Commission expert groups dealing with the
preparation of delegated acts.
receive all documents at the same time as
Member States’ experts, and their experts
systematically have access to meetings of
Commission expert groups dealing with the
preparation of delegated acts.
Amendment 34
Proposal for a regulation
Recital 38
Text proposed by the Commission Amendment
(38) In order to enable the Authority and
the business operators to adapt to the new
requirements while ensuring that the
Authority continues its smooth operation, it
is necessary to provide for transitional
measures for the application of this
Regulation.
(38) In order to enable the Authority,
Member States, the Commission and the
business operators to adapt to the new
requirements while ensuring that the
Authority continues its smooth operation, it
is necessary to provide for transitional
measures for the application of this
Regulation.
Amendment 35
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8a – paragraph 1 – point a
Text proposed by the Commission Amendment
(a) promote awareness and
understanding of the specific issues under
consideration during the entire risk analysis
process;
(a) promote transparency, clarity,
awareness and understanding of the
specific issues under consideration during
the entire risk analysis and management
processes;
Amendment 36
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8a – paragraph 1 – point b
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Text proposed by the Commission Amendment
(b) promote consistency and
transparency in formulating risk
management recommendations;
(b) promote a high level of health and
environmental protection, maximum
reliability and transparency in formulating
risk management recommendations;
Amendment 37
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8a – paragraph 1 – point c
Text proposed by the Commission Amendment
c) provide a sound basis for
understanding risk management decisions;
c) provide a scientific basis for
identifying the best decisions on risk
management;
Amendment 38
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8a – paragraph 1 – point d
Text proposed by the Commission Amendment
(d) foster public understanding of the
risk analysis process so as to enhance
confidence in its outcome;
(d) foster public understanding of the
risk analysis process so as to enhance
accountability in its outcome, and restore
consumer trust in the Union and its
institutions;
Amendment 39
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8a – paragraph 1 – point f
Text proposed by the Commission Amendment
(f) ensure appropriate exchange of (f) ensure appropriate exchange of
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information with interested parties in
relation to risks associated with the agri-
food chain.
information with interested parties in
relation to risks associated with the agri-
food chain and strategies to avoid them.
(This amendment applies throughout the
text. Adopting it will necessitate
corresponding changes throughout.)
Amendment 40
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8a – paragraph 1 – point f a (new)
Text proposed by the Commission Amendment
(fa) combat sources and dissemination of
false and misleading information;
Amendment 41
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8b – paragraph 1 – point b
Text proposed by the Commission Amendment
b) provide transparent information at
each stage of the risk analysis process from
the framing of requests for scientific advice
to the provision of risk assessment and the
adoption of risk management decisions;
b) constantly provide up-to-date and
transparent information at each stage of the
risk analysis process from the framing of
requests for scientific advice to the
provision of risk assessment and the
adoption of risk management decisions;
Amendment 42
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8b – paragraph 1 – point c
Text proposed by the Commission Amendment
c) take into account risk perceptions; c) take into account the level of risk,
its possible consequences and risk
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perceptions;
Amendment 43
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8b – paragraph 1 – point d
Text proposed by the Commission Amendment
d) facilitate understanding and
dialogue amongst all interested parties;
and,
d) facilitate understanding, dialogue
and cooperation amongst all interested
parties, such as consumers and consumer
associations, environmental groups,
animal welfare organisations, health
organisations, citizens’ associations,
scientific research centres, trade unions
and also cooperatives, associations of
producers and farmers, representatives of
small and medium-sized enterprises, and
the research and innovation sectors; and,
Amendment 44
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8b – paragraph 1 – point e
Text proposed by the Commission Amendment
(e) be accessible, including to those not
directly involved in the process, while
taking into account confidentiality and
protection of personal data.
(e) be accessible, including to those not
directly involved in the process, while
taking into account the protection of
personal data.
Amendment 45
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8c – paragraph 2 – introductory part
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Text proposed by the Commission Amendment
2. The general plan for risk
communication shall promote an integrated
risk communication framework to be
followed both by the risk assessors and the
risk managers in a coherent and systematic
manner both at Union and national level. It
shall:
2. The general plan for risk
communication shall promote an integrated
risk communication framework to be
followed both by the risk assessors and the
risk managers in an accurate and
systematic manner both at Union and
national level, while acknowledging
diverging scientific opinions where they
exist. It shall:
Amendment 46
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8c – paragraph 2 – point a
Text proposed by the Commission Amendment
(a) identify the key factors that need to
be taken into account when considering the
type and level of risk communications’
activities needed;
(a) identify the factors that need to be
taken into account when considering the
type and level of risk communications’
activities needed;
Amendment 47
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8c – paragraph 2 – point b
Text proposed by the Commission Amendment
b) identify the appropriate main tools
and channels to be used for risk
communication purposes, taking into
account the needs of relevant target
audience groups; and,
b) identify the appropriate main tools
and channels (a clear, effective and
accessible website) to be used for risk
communication purposes, taking into
account the specific needs of relevant
target audience groups and in particular
arranging for specific communication in
situations in which emergencies are
managed that might arise in the field of
food or the environment, which
presuppose an increase in dedicated
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communication tools and measures
(helplines, a suitably identified section of
the EFSA website, apps and specific
information campaigns); and,
Amendment 48
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Regulation (EC) No 178/2002
Article 8c – paragraph 2 – point c
Text proposed by the Commission Amendment
(c) establish appropriate mechanisms
in order to strengthen coherence of risk
communication amongst risk assessors and
risk managers and ensure an open dialogue
amongst all interested parties.
(c) establish appropriate mechanisms
in order to strengthen coherence of risk
communication amongst risk assessors and
risk managers and ensure an open dialogue
and constant interaction amongst all
interested parties, while acknowledging
scientific divergent opinions where they
exist.
Amendment 49
Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point b
Regulation (EC) No 178/2002
Article 25 – paragraph 1a – point b
Text proposed by the Commission Amendment
(b) one member appointed by the
European Parliament, with the right to
vote.
(b) two members and two alternate
members appointed by the European
Parliament, with the right to vote.
Amendment 50
Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point b
Regulation (EC) No 178/2002
Article 25 – paragraph 1a – point c
Text proposed by the Commission Amendment
(c) four members with the right to vote (c) five members with the right to vote
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representing civil society and food chain
interests namely, one from consumers
organisations, one from environmental
non-governmental organisations, one from
farmers organisations and one from
industry organisations. Those members
shall be appointed by the Council in
consultation with the European Parliament
on the basis of a list drawn up by the
Commission which includes more names
than there are posts to be filled. The list
drawn up by the Commission shall be
forwarded to the European Parliament,
together with the relevant background
documents. As quickly as possible and
within three months of notification, the
European Parliament may submit its views
for consideration to the Council, which
shall then appoint those members.
representing civil society and food chain
workers interests namely, one from
medical/health organisations, one from
consumers organisations, one from
environmental non-governmental
organisations, one from farmers
organisations and one from agrochemical
or food industry organisations. Those
members shall be appointed by the Council
in consultation with the European
Parliament on the basis of a list drawn up
by the Commission which includes more
names than there are posts to be filled. The
list drawn up by the Commission shall be
forwarded to the European Parliament,
together with the relevant background
documents. As quickly as possible and
within three months of notification, the
European Parliament may submit its views
for consideration to the Council, which
shall then appoint those members.
Amendment 51
Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point b
Regulation (EC) No 178/2002
Article 25 – paragraph1b
Text proposed by the Commission Amendment
1b. The members of the Management
Board and where relevant, the alternate
members shall be appointed taking into
account high competence in the area of
food safety risk assessment as well as
competences in the food chain safety
legislation and policy, and relevant
managerial, administrative and
budgetary/financial skills.,
1b. The members of the Management
Board and where relevant, the alternate
members shall be appointed taking into
account high competence in the area of
food safety risk assessment as well as
competences in the food chain safety
legislation and policy, and relevant
managerial, administrative and
budgetary/financial skills.”,
Justification
Alternate members are empowered to vote in place of full members, which means that they
must have the same qualifications.
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Amendment 52
Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point d
Regulation (EC) No 178/2002
Article 25 – paragraph 5 – subparagraph 2
Text proposed by the Commission Amendment
“Unless otherwise provided, the
Management Board shall act by a majority
of its members. Alternate members shall
represent the member in his absence and
vote on his behalf .”;
“Unless otherwise provided, the
Management Board shall act by a majority
of its members. Alternate members shall
represent the member in her or his absence
and vote on her or his behalf .”;
Amendment 53
Proposal for a regulation
Article 1 – paragraph 1 – point 3 – point b
Regulation (EC) No 178/2002
Article 28 – paragraph 5a – point b
Text proposed by the Commission Amendment
b) Member States shall nominate
experts with a view to collectively reach
the number indicated by the Executive
Director. Each Member State shall
nominate at least 12 scientific experts. Member States may nominate nationals of
other Member States.
b) Member States may nominate
experts for the fields indicated on the
basis of a call for expressions of interest.
Member States may also nominate
nationals of other Member States.
Amendment 54
Proposal for a regulation
Article 1 – paragraph 1 – point 3 – point b
Regulation (EC) No 178/2002
Article 28 – paragraph 5a – point c
Text proposed by the Commission Amendment
(c) On the basis of the nominations
made by Member States, the Executive
Director shall draw for each Scientific
Panel a list of experts larger than the
number of members to be appointed. The
Executive Director may not draw up such a
(c) On the basis of the nominations
made by Member States on the basis of the
expressions of interest, the Executive
Director shall draw for each Scientific
Panel a list of experts larger than the
number of members to be appointed. The
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list where he/she can justify that the
nominations received do not allow him,
given the criteria for selection set up in
point d) of this paragraph, to draw up a
larger list. The Executive Director shall
submit the list to the Management Board
for appointment.
Executive Director may not draw up such a
list where he/she can justify that the
nominations received do not allow her/
him, given the criteria for selection set up
in point d) of this paragraph, to draw up a
larger list. The Executive Director shall
submit the list to the Management Board
for appointment.
Amendment 55
Proposal for a regulation
Article 1 – paragraph 1 – point 3 – point b
Regulation (EC) No 178/2002
Article 28 – paragraph 5a – point e
Text proposed by the Commission Amendment
e) The Management Board shall
ensure that the broadest possible
geographical distribution is achieved in the
final appointments.
e) The Management Board shall
ensure that the broadest, most
comprehensive and most participatory possible geographical distribution is
achieved in the final appointments.
Amendment 56
Proposal for a regulation
Article 1 – paragraph 1 – point 3 – point b
Regulation (EC) No 178/2002
Article 28 – paragraph 5d
Text proposed by the Commission Amendment
5d. The Member States shall put in
place measures ensuring that the members
of the Scientific Panels act independently
and remain free from conflict of interests
as provided for in Article 37(2) and the
Authority’s internal measures. Member
States shall ensure that the members of the
Scientific Panels have the means to
dedicate the necessary time and effort to
contribute to the work of the Authority.
Member States shall ensure that the
members of the Scientific Panels do not
receive any instruction at any national level
and that their independent scientific
5d. The Member States shall put in
place measures ensuring that the members
of the Scientific Panels nominated by them
act independently and remain free from
conflict of interests as provided for in
Article 37(2) and the Authority’s internal
measures. Member States shall ensure that
the members of the Scientific Panels have
the means to dedicate the maximum time
and effort which is necessary in order to
contribute to the work of the Authority.
Member States shall ensure that the
members of the Scientific Panels do not
receive any instruction and are not subject
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contribution to the risk assessment system
at Union level is recognised as a priority
task for the protection of the safety of the
food chain.
to pressure and influence at any national
level and that their independent scientific
contribution to the risk assessment system
at Union level is perceived as a priority
task for the protection of the safety of the
food chain.
Amendment 57
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32a – paragraph 1
Text proposed by the Commission Amendment
At the request of a potential applicant for a
food law authorisation, the staff of the
Authority shall advise on the relevant
provisions and the required content of the
application for authorisation. The advice
provided by the staff of the Authority shall
be without prejudice and non-committal as
to the subsequent assessment of
applications for authorisation by the
Scientific Panels.
At the request of a potential applicant for a
food law authorisation, the staff of the
Authority may, in written form, advise on
the relevant provisions and the required
content of the application for authorisation.
The staff of the Authority providing the
advice referred to in the first sentence
shall not be involved in any scientific
work, including within the meaning of
paragraph 5f of Article 28, that is directly
or indirectly relevant to the application
which is the subject of the advice. The advice provided by the staff of the
Authority shall immediately be
documented and published on the
Authority’s website. It shall contribute to
the development of a Frequently Asked
Questions document with the purpose of
developing more comprehensive
guidelines for applicants and reducing the
need for individual correspondence.
The advice provided shall be without
prejudice and non-committal as to the
subsequent assessment of applications for
authorisation by the Scientific Panels.
Within [36 months after the entry into
force of this regulation], the Commission
shall assess the impact of this article on
the functioning of the Authority.
Particular attention shall be paid to the
additional workload and mobilisation of
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staff, and whether it has led to any shift in
the allocation of the Autority’s resources
at the expense of activities of public
interest.
Amendment 58
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32b – paragraph 3
Text proposed by the Commission Amendment
3. The notified information shall be
made public only in case a corresponding
application for authorisation has been
received and after the Authority has
decided on the disclosure of the
accompanying studies in accordance with
Article 38 and Articles 39 to 39f.
3. The notified information shall be
made public if a corresponding application
for authorisation has been received and
after the Authority has decided on the
disclosure of the accompanying studies
and its scientific opinion in accordance
with Article 38 and Articles 39 to 39f.
Amendment 59
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32c – paragraph 2
Text proposed by the Commission Amendment
2. The Authority shall consult
stakeholders and the public regarding the
studies supporting applications for
authorisation once they are made public by
the Authority in accordance with Article 38
and Articles 39 to 39f in order to identify
whether other relevant scientific data or
studies are available on the subject matter
concerned by the application for
authorisation. This provision does not
apply to the submission of any
supplementary information by the
applicants during the risk assessment
process.
2. The Authority shall consult
stakeholders and the public regarding the
studies supporting applications for
authorisation once they are made public by
the Authority in accordance with Article 38
and Articles 39 to 39f in order to identify
whether other relevant scientific data or
studies are available on the subject matter
concerned by the application for
authorisation.
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Amendment 60
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32d – paragraph 1
Text proposed by the Commission Amendment
The Commission experts shall perform
controls, including audits, to obtain
assurance that testing facilities comply
with relevant standards for carrying out
tests and studies submitted to the Authority
as part of an application for an
authorisation under Union food law. These
controls shall be organised in cooperation
with the competent authorities of the
Member States.
The Commission experts shall perform
controls, including audits, to obtain
assurance that testing facilities are
independent, transparent and staffed by
highly skilled persons and comply with
relevant standards for carrying out tests
and studies submitted to the Authority as
part of an application for an authorisation
under Union food law. These controls shall
be organised in cooperation with the
competent authorities of the Member
States.
Amendment 61
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32e – paragraph 1
Text proposed by the Commission Amendment
Without prejudice to the obligation of
applicants for authorisations under food
law to demonstrate the safety of a subject
matter submitted to a system of
authorisation, the Commission, in
exceptional circumstances, may request
the Authority to commission scientific
studies with the objective of verifying
evidence used in its risk assessment
process. The studies commissioned may
have a wider scope than the evidence
subject to verification.;
Without prejudice to the obligation of
applicants for authorisations under food
law to demonstrate the safety of a subject
matter submitted to a system of
authorisation, the Authority may, where
scientific data and findings are in conflict
with each other, commission scientific
studies with the objective of verifying
evidence used in its risk assessment
process, with the aim of obtaining greater
assurance about food or feed safety. The
studies commissioned may have a wider
scope than the evidence subject to
verification.;
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Amendment 62
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Regulation (EC) No 178/2002
Article 32e – paragraph 1a (new)
Text proposed by the Commission Amendment
Any studies commissioned shall take into
account Directive 2010/63/EU on the
protection of animals used for scientific
purposes.
Amendment 63
Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point a
Regulation (EC) No 178/2002
Article 38 – paragraph 1 – subparagraph 1 – introductory part
Text proposed by the Commission Amendment
The Authority shall carry out its activities
with a high level of transparency. It shall in
particular make public without delay:
The Authority shall ensure a high level of
transparency, in line with the Aarhus
Convention and Regulation (EC) No
1367/2006, without prejudice to
Regulation (EC) No 1049/2001, as well as
in line with with Directive 2003/4/EC,
providing for an active and systematic
dissemination to the public of
environmental information. It shall in
particular make public without delay:
Amendment 64
Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point a
Regulation (EC) No 178/2002
Article 38 – paragraph 1 – subparagraph 1 – point a
Text proposed by the Commission Amendment
(a) agendas and minutes of the
Scientific Committee and the Scientific
Panels and their Working Groups;
(a) agendas, participants lists, and
minutes of the Scientific Committee and
the Scientific Panels and their Working
Groups;
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Amendment 65
Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point а
Regulation (EC) No 178/2002
Article 38 – paragraph 1 – subparagraph 1 – point c
Text proposed by the Commission Amendment
c) scientific data, studies and other
information supporting applications for
authorisation under Union food law,
including supplementary information
supplied by applicants, as well as other
scientific data and information supporting
requests from the European Parliament,
the Commission and the Member States
for a scientific output, including a
scientific opinion, taking into account
protection of confidential information and
protection of personal data in accordance
with Articles 39 to 39f.
deleted
Amendment 66
Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point а
Regulation (EC) No 178/2002
Article 38 – paragraph 1 – subparagraph 1 – point d
Text proposed by the Commission Amendment
d) the information on which its
scientific outputs, including scientific
opinions are based, taking into account
protection of confidential data and
protection of personal data in accordance
with Articles 39 to 39f;
deleted
Amendment 67
Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point а
Regulation (EC) No 178/2002
Article 38 – paragraph 1 – subparagraph 1 – point i
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Text proposed by the Commission Amendment
i) advice provided by the Authority to
potential applicants at pre-submission
phase pursuant to Article 32a and 32c.
deleted
Amendment 68
Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point а a (new)
Regulation (EC) No 178/2002
Article 38 – paragraph -1a (new)
Text proposed by the Commission Amendment
(аа) The following paragraph -1a is
inserted:
(-1a) At the time of publication of its
scientific opinion, the Authority shall also
make the following public:
(а) scientific data, studies and other
information supporting applications for
authorisation under Union food law,
including supplementary information
supplied by applicants, as well as other
scientific data and information supporting
requests from the European Parliament,
the Commission and the Member States,
taking into account the protection of
confidential information and the
protection of personal data in accordance
with Articles 39 to 39f.
b) the information on which its scientific
outputs, including scientific opinions, are
based, taking into account the protection
of confidential data and the protection of
personal data in accordance with Articles
39 to 39f;
c) information concerning the
consultation sessions with applicants
conducted by the Authority pursuant to
Article 32a and 32c prior to their
applications.
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Amendment 69
Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point b
Regulation (EC) No 178/2002
Article 38 – paragraph 1a – subparagraph 2
Text proposed by the Commission Amendment
The disclosure to the public of the
information mentioned in paragraph (1)(c)
shall not be considered as an explicit or
implicit permission or license for the
relevant data and information and their
content to be used, reproduced, or
otherwise exploited and its use by third
parties shall not engage the responsibility
of the European Union.
The disclosure to the public of the
information mentioned in paragraph (1)(c)
shall not be considered as an explicit or
implicit permission or license for the
relevant data and information and their
content to be commercially used,
reproduced, or otherwise exploited for
commercial purposes. For the avoidance
of doubt, the information published may
be used for the purpose of public scrutiny
of the results, including a better
understanding of the potential adverse
effects on health and the environment and
its use by third parties for that purpose
shall not engage the responsibility of the
European Union.”
Amendment 70
Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point c a (new)
Regulation (EC) No 178/2002
Article 38 – paragraph 3a
Text proposed by the Commission Amendment
(ca) the following paragraph 3a is
inserted:
3a. This Article is without prejudice to
Directive 2003/4/EC of the European
Parliament and of the Council of 28
January 2003 on public access to
environmental information, to Regulation
(EC) No 1049/2001 and to Regulation
(EC) No 1367/2006.
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Amendment 71
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Regulation (EC) No 178/2002
Article 39 – paragraph 1
Text proposed by the Commission Amendment
1. By way of derogation from Article
38, the Authority shall not make public
information for which confidential
treatment has been requested under the
conditions laid down in this Article.
1. By way of derogation from Article
38 and without prejudice to Regulation
(EC) No 1049/2001 and Directive
2003/4/EC and the general principle that
the interests of public health always
prevail over private interests, the
Authority shall not make public
information for which confidential
treatment has been requested and granted
in application of the conditions laid down
in this Article.
Amendment 72
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Regulation (EC) No 178/2002
Article 39 – paragraph 2 – point 2 a (new)
Text proposed by the Commission Amendment
(2a) innovative commercial elements
and models, formulae and products
covered by patents the protection of which
might be threatened by any failure to
maintain confidentiality during the initial
study request procedure, thus exposing
the requester to damage and risks of
market distortion and unfair competition
Amendment 73
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Regulation (EC) No 178/2002
Article 39 – paragraph 2 – point 3
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Text proposed by the Commission Amendment
(3) commercial information revealing
sourcing, market shares or business
strategy of the applicant; and
(3) commercial information revealing
sourcing, innovative ideas for the
product/substance, market shares or
business strategy of the applicant;
(This amendment applies throughout the
text. Adopting it will necessitate
corresponding changes throughout.)
Amendment 74
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Regulation (EC) No 178/2002
Article 39 – paragraph 4 – point b
Text proposed by the Commission Amendment
(b) information which forms part of
conclusions of scientific outputs, including
scientific opinions, delivered by the
Authority and which relate to foreseeable
health effects.;
(b) information which forms part of
conclusions of scientific outputs, including
scientific opinions, delivered by the
Authority which indicate risks of possible
effects on, and threats to, public and
animal health or the environment.;
Amendment 75
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Regulation (EC) No 178/2002
Article 39 – paragraph 4 a (new)
Text proposed by the Commission Amendment
4a. This Article is without prejudice to
Directive 2003/4/EC and Regulations
(EC) No 1049/2001 and 1367/2006
Justification
This formulation is necessary for the benefit of transparency
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Amendment 76
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39a – paragraph 2
Text proposed by the Commission Amendment
2. Where an applicant submits a
request for confidentiality, it shall provide
a non-confidential version and a
confidential version of the information
submitted in accordance with standard data
formats, where they exist, pursuant to
Article 39f. The non-confidential version
shall be without the information the
applicant deems confidential in accordance
with paragraphs 2 and 3 of Article 39. The
confidential version shall contain all
information submitted, including
information the applicant deems
confidential. Information requested to be
treated as confidential in the confidential
version shall be clearly marked. The
applicant shall clearly indicate the grounds
on the basis of which confidentiality is
requested for the different pieces of
information.
2. Where an applicant submits a
request for confidentiality, it shall provide
a non-confidential version and a
confidential version of the information
submitted in accordance with standard data
formats, where they exist, pursuant to
Article 39f. The non-confidential version
shall edit, with black bars, the information
for which the applicant requests
confidential treatment in accordance with
paragraphs 2 and 3 of Article 39. The
confidential version shall contain all
information submitted, including
information the applicant considers
confidential. Information requested to be
treated as confidential in the confidential
version shall be clearly marked. The
applicant shall clearly indicate the
verifiable justifications on the basis of
which confidentiality is requested for each
of the different pieces of information.
Amendment 77
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39b – paragraph 1 – point c
Text proposed by the Commission Amendment
(c) inform the applicant in writing of
its intention to disclose information and the
reasons for it, before the Authority
formally takes a decision on the
confidentiality request. If the applicant
disagrees with the assessment of the
Authority it may state its views or
withdraw its application within two weeks
(c) inform the applicant in writing of
its intention to disclose information and the
reasons for it, before the Authority
formally takes a decision on the
confidentiality request. If the applicant
objects to the assessment of the Authority
it may state its views or withdraw its
application within two weeks from the date
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from the date on which it was notified of
the Authority’s position.
on which it was notified of the Authority’s
position.
Amendment 78
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39b – paragraph 1 – point d
Text proposed by the Commission Amendment
(d) adopt a reasoned decision on the
confidentiality request taking into account
the observations of the applicant within ten
weeks from the date of receipt of the
confidentiality request with respect to
applications for authorisation and without
undue delay in the case of supplementary
data and information and notify the
applicant and inform the Commission and
the Member States, as appropriate, of its
decision; and,
(d) adopt a reasoned decision on the
confidentiality request taking into account
the observations of the applicant within
eight weeks from the date of receipt of the
confidentiality request with respect to
applications for authorisation and without
undue delay in the case of supplementary
data and information and notify the
applicant and inform the Commission and
the Member States, in every case, of its
decision; and,
Amendment 79
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39b – paragraph 1 – point e
Text proposed by the Commission Amendment
(e) make public any additional data and
information for which the confidentiality
request has not been accepted as justified
not earlier than two weeks after the
notification of its decision to the applicant
has taken place, pursuant to point (d).
(e) make public any additional data and
information for which the confidentiality
request has not been accepted as justified
not earlier than two weeks and no later
than four weeks after the notification of its
decision to the applicant has taken place,
pursuant to point (d).
Amendment 80
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
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Article 39d – paragraph 2
Text proposed by the Commission Amendment
2. The Commission and the Member
States shall take the necessary measures so
that information received by them under
Union food law for which confidential
treatment has been requested is not made
public until a decision on the
confidentiality request has been taken by
the Authority and has become definitive.
The Commission and the Member States
shall also take the necessary measures so
that information for which confidential
treatment has been accepted by the
Authority is not made public.
2. The Commission and the Member
States shall take the necessary measures so
that information received by them under
Union food law is not made public until a
decision on the confidentiality request has
been taken by the Authority and its
scientific opinion has been published. The
Commission and the Member States shall
also take the necessary measures so that
information for which confidential
treatment has been accepted by the
Authority is not made public.
Amendment 81
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39d – paragraph 3
Text proposed by the Commission Amendment
3. If an applicant in the context of an
authorisation procedure withdraws or has
withdrawn an application, the Authority,
the Commission and the Member States
shall respect the confidentiality of
commercial and industrial information as
accepted by the Authority in accordance
with Articles 39to 39f. The application
shall be considered withdrawn as of the
moment the written request is received by
the competent body that had received the
original application. Where the withdrawal
of the application takes place before the
Authority has decided on the relevant
confidentiality request, the Authority, the
Commission and the Member States shall
not make public the information for which
confidentiality has been requested.
3. If an applicant in the context of an
authorisation procedure withdraws or has
withdrawn an application, the Authority,
the Commission and the Member States
shall respect the confidentiality of
commercial and industrial information as
accepted by the Authority in accordance
with Articles 39to 39f. The application
shall be considered withdrawn as of the
moment the written request is received by
the competent body that had received the
original application. Where the withdrawal
of the application takes place before the
Authority has decided on the relevant
confidentiality request, the Authority, the
Commission and the Member States shall
not make public any information relating
to the planned application.
Amendment 82
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Proposal for a regulation
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39e – paragraph 1 – point e
Text proposed by the Commission Amendment
(a) the name and address of the
applicant;
(a) the name of the applicant;
Amendment 83
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39e – paragraph 2
Text proposed by the Commission Amendment
2. Notwithstanding paragraph 1,
disclosure of names and addresses of
natural persons involved in testing on
vertebrate animals or in obtaining
toxicological information shall be deemed
to significantly harm the privacy and the
integrity of those natural persons and shall
not be made publicly available, unless
there is an overriding public interest.
2. Notwithstanding paragraph 1,
disclosure of names and addresses of
natural persons involved in testing on
vertebrate animals or in obtaining
toxicological information shall be deemed
to significantly harm the privacy and the
integrity of those natural persons,
constituting a threat to their independence
and autonomous judgement, and shall not
be made publicly available, unless there is
an overriding public interest.
Amendment 84
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Regulation (EC) No 178/2002
Article 39g – paragraph 1
Text proposed by the Commission Amendment
The information systems operated by the
Authority to store its data, including
confidential and personal data shall be
designed to a high level of security
appropriate to the security risks at stake,
taking into account Articles 39 to 39f of
this Regulation. Access shall be based at
The information systems operated by the
Authority to store its data, including
confidential and personal data shall be
designed in a way that guarantees that the
highest standards of security appropriate
to the security risks at stake will be
attained, taking into account Articles 39 to
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the minimum on a system requiring two
factor authentication or providing an
equivalent level of security. The system
shall ensure that any access to it is fully
auditable.;
39f of this Regulation. Access shall be
based at the minimum on a system
requiring two factor authentication or
providing an equivalent level of security.
The system shall ensure that any access to
it is fully auditable.;
Amendment 85
Proposal for a regulation
Article 1 – paragraph 1 – point 10
Regulation (EC) No 178/2002
Article 57a – paragraph 6
Text proposed by the Commission Amendment
6. A delegated act adopted pursuant to
Article 8(c) shall enter into force only if no
objection has been expressed either by the
European Parliament or by the Council
within a period of two months of
notification of that act to the European
Parliament and the Council or if, before the
expiry of that period, the European
Parliament and the Council have both
informed the Commission that they will
not object. That period shall be extended
by two months at the initiative of the
European Parliament or of the Council.;
6. A delegated act adopted pursuant to
Article 8(c) shall enter into force only if no
objection has been expressed either by the
European Parliament or by the Council
within a period of two months of
notification of that act to the European
Parliament and the Council or if, before the
expiry of that period, the European
Parliament and the Council have both
informed the Commission that they will
not object. That period may be extended by
two months at the initiative of the
European Parliament or of the Council.;
Amendment 86
Proposal for a regulation
Article 1 – paragraph 1 – point 11
Regulation (EC) No 178/2002
Article 61 – paragraph 2
Text proposed by the Commission Amendment
2. Not later than five years after the
date referred to in Article [entry into force
of the Regulation amending the GFL], and
every five years thereafter, the
Commission shall assess the Authority’s
performance in relation to its objectives,
mandate, tasks, procedures and location, in
accordance with Commission guidelines.
2. Not later than five years after the
date referred to in Article [entry into force
of the Regulation amending the GFL], and
every five years thereafter, the
Commission shall assess the Authority’s
performance in relation to its objectives,
mandate, tasks, procedures and location, in
accordance with Commission guidelines.
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The evaluation shall address the possible
need to modify the mandate of the
Authority, and the financial implications of
any such modification.
The evaluation shall address the possible
need to modify the mandate of the
Authority, and the financial implications of
any such modification. Conversely, if the
evaluation shows that the set objectives
are being attained and the tasks assigned
are being performed, the possibility to
increase investment in order to secure
more ambitious results shall be explored.
Amendment 87
Proposal for a regulation
Article 1 – paragraph 1 – point 11
Regulation (EC) No 178/2002
Article 61 – paragraph 3
Text proposed by the Commission Amendment
3. Where the Commission considers
that the continuation of the Authority is
no longer justified with regard to its
assigned objectives, mandate and tasks, it
may propose that the relevant provisions
of this Regulation be amended
accordingly or repealed.
deleted
Amendment 88
Proposal for a regulation
Article 1 – paragraph 1 – point 11
Regulation (EC) No 178/2002
Article 61 – paragraph 4
Text proposed by the Commission Amendment
4. The Commission shall report to the
European Parliament, the Council and the
Management Board on the evaluation
findings. The findings of the evaluation
shall be made public.
4. The evaluations and
recommendations referred to in
paragraphs 1 and 2 shall be forwarded to
the Council and the European Parliament,
and shall be made public.
Amendment 89
Proposal for a regulation
Article 2 – paragraph 1 – point 2 a (new)
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Directive 2001/18/EC
Article 24 – paragraph 3 a (new)
Text proposed by the Commission Amendment
(2a) In Article 24, the following
paragraph 3a is inserted:
“3a. The obligation to proactively
disseminate the information set out in
paragraph 1 of this Article, in line with
Article 25, and in line with Articles 38 and
39 of Regulation (EC) No 178/2002, is
without prejudice to the right of any
natural or legal person to access
documents upon request as set out in
Regulation (EC) No 1049/2001 and
Regulation (EC) No 1367/2006.”
Amendment 90
Proposal for a regulation
Article 2 – paragraph 1 – point 4
Directive 2001/18/EC
Article 28 – paragraph 4
Text proposed by the Commission Amendment
4. Where the relevant Scientific
Committee is consulted under paragraph 1,
it shall make public the
notification/application, relevant
supporting information and any
supplementary information supplied by the
notifier/applicant, as well as its scientific
opinions, in accordance with Article 38
and Articles 39 to 39f of Regulation (EC)
No 178/2002, which shall apply mutatis
mutandis, and Article 25 of this
Directive.”.
4. Where the relevant Scientific
Committee is consulted under paragraph 1,
it shall make public the
notification/application, relevant
supporting information and any
supplementary information supplied by the
notifier/applicant, at the same time as its
scientific opinion, in accordance with
Article 38 and Articles 39 to 39f of
Regulation (EC) No 178/2002, which shall
apply mutatis mutandis, and Article 25 of
this Directive.
Amendment 91
Proposal for a regulation
Article 3 – paragraph 1 – point 9
Regulation (EC) No 1829/2003
Article 29 – paragraph 1
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Text proposed by the Commission Amendment
1. The Authority shall make public the
application for authorisation, relevant
supporting information and any
supplementary information supplied by the
applicant, as well as its scientific opinions
and opinions from the competent
authorities referred to in Article 4 of
Directive 2001/18/EC, in accordance with
Article 38, Articles 39 to 39f and Article
40 of Regulation (EC) No 178/2002 and
taking into account Article 30 of this
Regulation.
1. The Authority shall make public the
application for authorisation, relevant
supporting information and any
supplementary information supplied by the
applicant, at the same time as its scientific
opinion and opinions from the competent
authorities referred to in Article 4 of
Directive 2001/18/EC, in accordance with
Article 38, Articles 39 to 39f and Article
40 of Regulation (EC) No 178/2002 and
taking into account Article 30 of this
Regulation..
Amendment 92
Proposal for a regulation
Article 3 – paragraph 1 – point 9
Regulation (EC) No 1829/2003
Article 29 – paragraph 1 a (new)
Text proposed by the Commission Amendment
1a. The obligation to proactively
disseminate the information set out in
paragraph 1 of this Article, in line with
Article 30, and in line with Articles 38 and
39 of Regulation (EC) No 178/2002, is
without prejudice to the right of any
natural or legal person to access
documents upon request as set out in
Regulation (EC) No 1049/2001 and
Regulation (EC) No 1367/2006.
Amendment 93
Proposal for a regulation
Article 3 – paragraph 1 – point 10
Regulation (EC) No 1829/2003
Article 30 – paragraph 2
Text proposed by the Commission Amendment
2. In addition to Article 39(2) and
pursuant to Article 39(3) of Regulation
(EC) No 178/2002, the Authority may also
2. Information relating to the
following shall not be considered
confidential:
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accept to provide confidential treatment to
the following information, the disclosure
of which may be deemed, upon verifiable
justification, to significantly harm the
interests concerned:
(a) DNA sequence information, except for
sequences used for the purpose of
detection, identification and
quantification of the transformation
event; and,
(a) name and composition of the GMO,
food or feed referred to in Articles 3(1)
and 15(1) and, where appropriate,
indication of the substrate and the micro-
organism;
(b) breeding patterns and strategies. (b) general description of the GMO and
the name and address of the
authorisation-holder;
(c) physico-chemical and biological
characteristics of the GMO, food or feed
referred to in Articles 3(1) and 15(1);
(d) effects of the GMO, food or feed
referred to in Articles 3(1) and 15(1) on
human and animal health and on the
environment;
(e) effects of the GMO, food or feed
referred to in Articles 3(1) and 15(1) on
the characteristics of animal products and
its nutritional properties;
(f) methods for detection, including
sampling and identification of the
transformation event and, where
applicable, for the detection and
identification of the transformation event
in the food or feed referred to in Articles
3(1) and 15(1);
(g) information on waste treatment and
emergency response.
Justification
Paragraph 2 simply reinstates the current wording of Regulation 1829/2003. If the aim of the
proposal is to strengthen transparency, then, instead of enlarging the list of information
which can be kept confidential, the current provisions relating to information that can never
be kept confidential must be kept.
Amendment 94
Proposal for a regulation
Article 4 – paragraph 1 – point 1 – point b
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Regulation (EC) No 1831/2003
Article 7 – paragraph 2 – point c
Text proposed by the Commission Amendment
c) ensure public access to the
application and any information supplied
by the applicant, in accordance with Article
18.”;
c) ensure public access to the
application and any information supplied
by the applicant, and at the same time to
its scientific opinion, in accordance with
Article 18”;
Amendment 95
Proposal for a regulation
Article 4 – paragraph 1 – point 1 a (new)
Regulation (EC) No 1831/2003
Article 17 – paragraph 2 a (new)
Text proposed by the Commission Amendment
(1a) In Article 17, the following
paragraph 2a is inserted:
“2a. The obligation to proactively
disseminate information set out in this
Article and in line with Articles 38 and 39
of Regulation (EC) No 178/2002, is
without prejudice to the right of any
natural or legal person to access
documents upon request as set out in
Regulation (EC) No 1049/2001 and
Regulation (EC) No 1367/2006.”
Amendment 96
Proposal for a regulation
Article 4 – paragraph 1 – point 2
Regulation (EC) No 1831/2003
Article 18 – paragraph 1
Text proposed by the Commission Amendment
1. The Authority shall make public the
application for authorisation, relevant
supporting information and any
supplementary information supplied by the
applicant, as well as its scientific opinions,
in accordance with Article 38, Articles 39
1. The Authority shall make public the
application for authorisation, relevant
supporting information and any
supplementary information supplied by the
applicant, at the same time as its scientific
opinion, in accordance with Article 38,
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to 39f and Article 40 of Regulation (EC)
No 178/2002, which shall apply mutatis
mutandis.
Articles 39 to 39f and Article 40 of
Regulation (EC) No 178/2002, which shall
apply mutatis mutandis.
Amendment 97
Proposal for a regulation
Article 4 – paragraph 1 – point 2
Regulation (EC) No 1831/2003
Article 18 – paragraph 3 a (new)
Text proposed by the Commission Amendment
3a. The Authority shall apply the
principles of Regulation (EC) No
1049/2001 of the European Parliament
and of the Council of 30 May 2001
regarding public access to European
Parliament, Council and Commission
documents when handling applications
for access to documents held by the
Authority.
Amendment 98
Proposal for a regulation
Article 4 – paragraph 1 – point 2
Regulation (EC) No 1831/2003
Article 18 – paragraph 3 b (new)
Text proposed by the Commission Amendment
3b. The Member States, the
Commission and the Authority shall keep
confidential all the information identified
as confidential under paragraph 2 except
where it is appropriate for such
information to be made public in order to
protect human health, animal health or
the environment. Member States shall
handle applications for access to
documents received under this Regulation
in accordance with Article 5 of
Regulation (EC) No 1049/2001.”
Amendment 99
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Proposal for a regulation
Article 5 – paragraph 1 – point 1 – point а
Regulation (EC) No 2065/2003
Article 7 – paragraph 2 – point c – point ii
Text proposed by the Commission Amendment
ii) ensure public access to the
application, relevant supporting
information and any supplementary
information supplied by the applicant, in
accordance with Articles 14 and 15.”;
(ii) ensure public access to the
application, relevant supporting
information and any supplementary
information supplied by the applicant,
when it publishes its scientific opinion, in
accordance with Articles 14 and 15.
Amendment 100
Proposal for a regulation
Article 5 – paragraph 1 – point 2
Regulation (EC) No 2065/2003
Article 14 – paragraph 1
Text proposed by the Commission Amendment
1. The Authority shall make public the
application for authorisation, relevant
supporting information and any
supplementary information supplied by the
applicant as well as its scientific opinions,
in accordance with Article 38, Articles 39
to 39f and Article 40 of Regulation (EC)
No 178/2002.;
1. The Authority shall make public, at
the same time as its scientific opinion, the
application for authorisation, relevant
supporting information and any
supplementary information supplied by the
applicant as well as its scientific opinions,
in accordance with Article 38, Articles 39
to 39f and Article 40 of Regulation (EC)
No 178/2002.;
Amendment 101
Proposal for a regulation
Article 5 – paragraph 1 – point 2 a (new)
Regulation (EC) No 2065/2003
Article 14 – paragraph 1 a (new)
Text proposed by the Commission Amendment
(2a) In Article 14, the following
paragraph 1a is inserted:
“1a. The obligation to proactively
disseminate information set out in
paragraph 1 of this Article, in line with
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Articles 38 and 39 of Regulation (EC) No
178/2002, is without prejudice to the right
of any natural or legal person to access
documents upon request as set out in
Regulation (EC) No 1049/2001 and
Regulation (EC) No 1367/2006.”
Amendment 102
Proposal for a regulation
Article 5 – paragraph 1 – point 3
Regulation (EC) No 178/2002
Article 15 – paragraph 1 – point b
Text proposed by the Commission Amendment
(b) and, the Authority shall assess the
confidentiality request submitted by the
applicant.
(b) and, the Authority shall assess the
confidentiality request submitted by the
applicant and shall be required to respond
- and provide the necessary justification -
within two months of receipt of the
application.
Amendment 103
Proposal for a regulation
Article 6 – paragraph 1 – point 1 – point а
Regulation (EC) No 1935/2004
Article 9 – paragraph 1 – point c – point ii
Text proposed by the Commission Amendment
(ii) ensure public access to the
application, relevant supporting
information and any supplementary
information supplied by the applicant, in
accordance with Articles 19 and 20;
ii) ensure public access to the
application, relevant supporting
information and any supplementary
information supplied by the applicant, at
the same time as to its scientific opinion, in accordance with Articles 19 and 20.
Amendment 104
Proposal for a regulation
Article 6 – paragraph 1 – point 2
Regulation (EC) No 1935/2004
Article 19 – paragraph 1
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Text proposed by the Commission Amendment
1. The Authority shall make public the
application for authorisation, relevant
supporting information and any
supplementary information supplied by the
applicant, as well as its scientific opinions,
in accordance with Article 38, Articles 39
to 39f and Article 40 of Regulation (EC)
No 178/2002, which shall apply mutatis
mutandis and Article 20 of this
Regulation.”;
1. The Authority shall make public the
application for authorisation, relevant
supporting information and any
supplementary information supplied by the
applicant, at the same time as its scientific
opinion, in accordance with Article 38,
Articles 39 to 39f and Article 40 of
Regulation (EC) No 178/2002, which shall
apply mutatis mutandis and Article 20 of
this Regulation.”;
Amendment 105
Proposal for a regulation
Article 6 – paragraph 1 – point 2 a (new)
Regulation (EC) No 1935/2004
Article 19 – paragraph 2a (new)
Text proposed by the Commission Amendment
(2a) in Article 19, the following
paragraph 2a is inserted:
“2a. The obligation to proactively
disseminate information set out in
paragraph 1 is without prejudice to the
right of any natural or legal person to
access documents upon request as set out
in Regulation (EC) No 1049/2001 and
Regulation (EC) No 1367/2006.”
Amendment 106
Proposal for a regulation
Article 7 – paragraph 1 – point 2
Regulation (EC) No 1331/2008
Article 11 – paragraph 1 a (new)
Text proposed by the Commission Amendment
The obligation to proactively disseminate
information set out in paragraph 1 of this
Article, in line with Article 12 and in line
with Articles 38 and 39 of Regulation
(EC) No 178/2002, is without prejudice to
the right of any natural or legal person to
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access documents upon request as set out
in Regulation (EC) No 1049/2001 and
Regulation (EC) No 1367/2006.
Amendment 107
Proposal for a regulation
Article 7 – paragraph 1 – point 3
Regulation (EC) No 1331/2008
Article 12 – paragraph 3 a (new)
Text proposed by the Commission Amendment
3a. The Commission, the Authority
and the Member States shall, in
accordance with Regulation (EC) No
1049/2001, take the necessary measures to
ensure appropriate confidentiality of the
information received by them under this
Regulation, except for information which
must be made public if circumstances so
require in order to protect human health,
animal health or the environment.
Amendment 108
Proposal for a regulation
Article 8 – paragraph 1 – point 5 a (new)
Regulation (EC) No 1107/2009
Article 63 – paragraph 3
Present text Amendment
(5a) in Article 63, paragraph 3 is
replaced by the following:
3. This Article is without prejudice to
Directive 2003/4/EC of the European
Parliament and of the Council of 28
January 2003 on public access to
environmental information
3. This Article is without prejudice to
Directive 2003/4/EC of the European
Parliament and of the Council of 28
January 2003 on public access to
environmental information and to
Regulation (EC) No 1049/2001 and
Regulation (EC) No 1367/2006.
Amendment 109
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Proposal for a regulation
Article 9 – paragraph 1 – point 1 – point b
Regulation (EC) No 2015/2283
Article 10 – paragraph 3
Text proposed by the Commission Amendment
3. Where the Commission requests an
opinion from, the European Food Safety
Authority (‘the Authority’), the Authority
shall ensure public access to the
application in accordance with Article 23
and shall give its opinion as to whether the
update is liable to have an effect on human
health.”;
3. Where the Commission requests an
opinion from the European Food Safety
Authority (‘the Authority’), the Authority
shall ensure public access to the
application in accordance with Article 23
when it publishes its opinion as to the
question of whether the update is liable to
have an effect on human health.”;
Amendment 110
Proposal for a regulation
Article 9 – paragraph 1 – point 3 – point b
Regulation (EC) No 2015/2283
Article 16 – paragraph 2 – last sentence
Text proposed by the Commission Amendment
The Authority shall ensure public access to
the application, relevant supporting
information and any supplementary
information supplied by the applicant in
accordance with Article 23.;
The Authority shall ensure public access to
the non-confidential elements of the
application, and to the notification
concerning safety concerns under Article
15, at the same time as it publishes its
scientific opinion in accordance with
Article 23.”;
Amendment 111
Proposal for a regulation
Article 9 – paragraph 1 – point 4
Regulation (EC) No 2015/2283
Article 23 – paragraph 1
Text proposed by the Commission Amendment
1. Where the Commission requests its
opinion in accordance with Articles 10(3)
and 16 of this Regulation, the Authority
shall make public the application for
authorisation, relevant supporting
1. Where the Commission requests its
opinion in accordance with Articles 10(3)
and 16 of this Regulation, the Authority
shall make public the application for
authorisation, relevant supporting
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information and any supplementary
information supplied by the applicant, as
well as its scientific opinions, in
accordance with Article 38, Articles 39 to
39f and Article 40 of Regulation (EC) No
178/2002 and with this Article.
information and any supplementary
information supplied by the applicant, as
well as its scientific opinions, in
accordance with Article 38, Articles 39 to
39f and Article 40 of Regulation (EC) No
178/2002 and with this Article, at the same
time as it publishes its opinion concerning
the application.
Amendment 112
Proposal for a regulation
Article 9 – paragraph 1 – point 4 a (new)
Regulation (EU) No 2015/2283
Article 25 – paragraph 1 a (new)
Text proposed by the Commission Amendment
(4a) In Article 25, the following
paragraph 1a is inserted:
“1a. The obligation to proactively
disseminate the information set out in this
Regulation, in line with Articles 38 and 39
of Regulation (EC) No 178/2002, is
without prejudice to the right of any
natural or legal person to access
documents upon request as set out in
Regulation (EC) No 1049/2001 and
Regulation (EC) No 1367/2006.”
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EN
PROCEDURE – COMMITTEE ASKED FOR OPINION
Title Transparency and sustainability of the EU risk assessment in the food
chain
References COM(2018)0179 – C8-0144/2018 – 2018/0088(COD)
Committee responsible
Date announced in plenary
ENVI
28.5.2018
Opinion by
Date announced in plenary
JURI
28.5.2018
Rapporteur
Date appointed
Jiří Maštálka
23.4.2018
Discussed in committee 3.9.2018
Date adopted 10.10.2018
Result of final vote +:
–:
0:
12
5
6
Members present for the final vote Max Andersson, Joëlle Bergeron, Jean-Marie Cavada, Kostas
Chrysogonos, Mady Delvaux, Rosa Estaràs Ferragut, Enrico Gasbarra,
Lidia Joanna Geringer de Oedenberg, Heidi Hautala, Sajjad Karim,
Sylvia-Yvonne Kaufmann, Gilles Lebreton, António Marinho e Pinto,
Pavel Svoboda, József Szájer, Axel Voss, Francis Zammit Dimech,
Tadeusz Zwiefka
Substitutes present for the final vote Geoffroy Didier, Pascal Durand, Angel Dzhambazki, Angelika Niebler,
Virginie Rozière, Tiemo Wölken
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EN
FINAL VOTE BY ROLL CALL IN COMMITTEE ASKED FOR OPINION
12 +
ALDE António Marinho e Pinto
ECR Angel Dzhambazki, Sajjad Karim
PPE Geoffroy Didier, Rosa Estaràs Ferragut, Angelika Niebler, József Szájer, Axel Voss,
Francis Zammit Dimech, Tadeusz Zwiefka
S&D Enrico Gasbarra, Virginie Rozière
5 -
GUE/NGL Kostas Chrysogonos
S&D Lidia Joanna Geringer de Oedenberg
VERTS/ALE Max Andersson, Pascal Durand, Heidi Hautala
6 0
ALDE Jean-Marie Cavada
EFDD Joëlle Bergeron
ENF Gilles Lebreton
S&D Mady Delvaux, Sylvia-Yvonne Kaufmann, Tiemo Wölken
Key to symbols:
+ : in favour
- : against
0 : abstention
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EN
PROCEDURE – COMMITTEE RESPONSIBLE
Title Transparency and sustainability of the EU risk assessment in the food
chain
References COM(2018)0179 – C8-0144/2018 – 2018/0088(COD)
Date submitted to Parliament 11.4.2018
Committee responsible
Date announced in plenary
ENVI
28.5.2018
Committees asked for opinions
Date announced in plenary
BUDG
28.5.2018
ITRE
28.5.2018
IMCO
28.5.2018
AGRI
28.5.2018
PECH
28.5.2018
JURI
28.5.2018
Not delivering opinions
Date of decision
BUDG
23.4.2018
ITRE
24.4.2018
IMCO
19.6.2018
Rapporteurs
Date appointed
Renate Sommer
3.5.2018
Discussed in committee 30.8.2018
Date adopted 27.11.2018
Result of final vote +:
–:
0:
43
16
1
Members present for the final vote Margrete Auken, Pilar Ayuso, Zoltán Balczó, Ivo Belet, Paul Brannen,
Nessa Childers, Birgit Collin-Langen, Miriam Dalli, Seb Dance, Mark
Demesmaeker, Stefan Eck, Bas Eickhout, Karl-Heinz Florenz,
Elisabetta Gardini, Gerben-Jan Gerbrandy, Jens Gieseke, Julie Girling,
Françoise Grossetête, Jytte Guteland, György Hölvényi, Anneli
Jäätteenmäki, Karin Kadenbach, Kateřina Konečná, Urszula Krupa,
Giovanni La Via, Jo Leinen, Peter Liese, Lukas Mandl, Jiří Maštálka,
Valentinas Mazuronis, Joëlle Mélin, Susanne Melior, Rory Palmer,
Massimo Paolucci, Piernicola Pedicini, Bolesław G. Piecha, John
Procter, Julia Reid, Frédérique Ries, Michèle Rivasi, Annie Schreijer-
Pierik, Davor Škrlec, Renate Sommer, Adina-Ioana Vălean, Jadwiga
Wiśniewska
Substitutes present for the final vote Nikos Androulakis, Christophe Hansen, Martin Häusling, Anja
Hazekamp, Jan Huitema, Ulrike Müller, Alojz Peterle, Keith Taylor,
Tiemo Wölken
Substitutes under Rule 200(2) present
for the final vote
Martina Anderson, Edward Czesak, Jens Geier, Jude Kirton-Darling,
Vladimír Maňka, Virginie Rozière
Date tabled 29.11.2018
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FINAL VOTE BY ROLL CALL IN COMMITTEE RESPONSIBLE
43 +
ALDE Gerben-Jan Gerbrandy, Jan Huitema, Anneli Jäätteenmäki, Valentinas Mazuronis,
Ulrike Müller, Frédérique Ries
ECR Edward Czesak, Mark Demesmaeker, Urszula Krupa, Bolesław G. Piecha, John Procter,
Jadwiga Wiśniewska
EFDD Piernicola Pedicini
ENF Joëlle Mélin
GUE/NGL Martina Anderson, Stefan Eck, Anja Hazekamp, Kateřina Konečná, Jiří Maštálka
NI Zoltán Balczó
PPE Françoise Grossetête
S&D Nikos Androulakis, Paul Brannen, Nessa Childers, Miriam Dalli, Seb Dance, Jens
Geier, Jytte Guteland, Karin Kadenbach, Jude Kirton Darling, Jo Leinen, Vladimír
Maňka, Susanne Melior, Rory Palmer, Massimo Paolucci, Virginie Rozière, Tiemo
Wölken
Verts/ALE Margrete Auken, Bas Eickhout, Martin Häusling, Michèle Rivasi, Davor Škrlec, Keith
Taylor
16 -
PPE Pilar Ayuso, Ivo Belet, Birgit Collin Langen, Karl Heinz Florenz, Elisabetta Gardini,
Jens Gieseke, Julie Girling, Christophe Hansen, György Hölvényi, Giovanni La Via,
Peter Liese, Lukas Mandl, Alojz Peterle, Annie Schreijer Pierik, Renate Sommer, Adina
Ioana Vălean
1 0
EFDD Julia Reid
Key to symbols:
+ : in favour
- : against
0 : abstention
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