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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


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


Recital 4


(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


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


Recital 4 a (new)


(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


Recital 5


(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


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


Recital 5 a (new)


(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


Recital 6


(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.



of risk communication. In this connection,


managers should be taken into account,

while guaranteeing their independence.

Amendment 8


Recital 8


(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









communication.

Amendment 9


Recital 9


(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


Recital 10

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(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


Recital 11


(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.








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


Recital 12

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(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.



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


Recital 13


(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.



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


Recital 14


(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.



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




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


Recital 15

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(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


Recital 16


(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







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


Recital 16 a (new)


(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


Recital 17


(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.



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


Recital 18


(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.





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



authorisation or renewal has been made

public in accordance with the applicable

rules on transparency.

Amendment 20


Recital 20


(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




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




provide for a consultation of third parties in

order to identify whether other relevant




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


Recital 21


(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




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






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


Recital 21 a (new)


(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


Recital 22


(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
















Commission should, in case of divergent

scientific findings, be responsible for


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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).





stake in the risk assessment process (for

example new scientific developments

becoming available).

Amendment 24


Recital 23 a (new)


(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


Recital 24


(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





application23 .

__________________ __________________

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


Recital 25 a (new)


(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


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Recital 27


(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.


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


Recital 27 a (new)


(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


Recital 30


(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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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









while preventing conflicts of interests. For

the purpose of ensuring the transparency,

independence, sustainability and


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).








p. 1).

25 Regulation (EU) 2016/679 of the


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).








Regulation) (OJ L 119, 4.5.2016, p. 1).

Amendment 30


Recital 31


(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.





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


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).








p. 13).

Amendment 31


Recital 33


(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.




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


Recital 33 a (new)


(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


Recital 35


(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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Recital 36


(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


process, including those flowing from the

Aarhus Convention1, against the rights of


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.





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



those set out in Regulation (EC)

No 178/2002. The provisions on active


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.

_____________________________



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


Recital 36 a (new)


(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


Recital 37


(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



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









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Amendment 37


Recital 37 a (new)


(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


Recital 38


(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





Regulation.

Amendment 39


Recital 39 a (new)

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(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


Recital 40 a (new)


(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


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


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Article 1 – paragraph 1 – point -1 a (new)




(-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


Article 1 – paragraph 1 – point 1


Article 8a


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



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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


food chain;

(fa) informing consumers about risk

prevention strategies; and

(fb) combating the dissemination of

false information and the sources thereof.

Amendment 44


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Article 8b


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





(c) take into account risk perceptions; (c) address risk perceptions;

(d) facilitate understanding and

dialogue amongst all interested parties;

and,

(d) facilitate understanding and


(e) be accessible, including to those not

directly involved in the process, while

taking into account confidentiality and

protection of personal data.




protection of personal data; and

(ea) formulate approaches to better

communicate the difference between

hazard and risk.

Amendment 45




Article 8c


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:







shall:

(a) identify the key factors that need to

be taken into account when considering the

type and level of risk communications’

activities needed;




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



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.




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




Article 8d (new)


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


Article 1 – paragraph 1 – point 1 a (new)


Article 9


(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


Article 1 – paragraph 1 – point 1 b (new)


Article 10


(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


Article 1 – paragraph 1 – point 1 c (new)

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(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


Article 1 – paragraph 1 – point 1 d (new)


Article 23 – paragraph 1 – point b


(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


Article 1 – paragraph 1 – point 2 – point b


Article 25 – paragraph 1a


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



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





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


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Article 1 – paragraph 1 – point 2 – point c




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


Article 1 – paragraph 1 – point 3 – points a and b


Article 28 – paragraphs 5 to 5g


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


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



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


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


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



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


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


Article 1 – paragraph 1 – point 3 – point c




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


Article 1 – paragraph 1 – point 3 – point c a (new)


Article 28 – paragraph 9 – point g a (new)


(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






(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




Article 32a

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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




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




Article 32b – paragraph 1


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




Article 32b – paragraph 1 a (new)


1a. Any studies commissioned shall

take account of Directive 2010/63/EU on

the protection of animals used for

scientific purposes.

Amendment 60






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





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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




Article 32b – paragraph 2 b (new)


2b. The subject matter shall not be

authorised unless all data from all

registered studies are submitted.

Amendment 63






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






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




Article 32b – paragraph 4 b (new)


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




Article 32c – paragraph 1


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


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






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


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




Article 32d


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







Member States or of the third countries

concerned.

Amendment 69




Article 32e


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.





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




Article 32e – paragraph 1 a (new)


Any studies commissioned shall take into

account Directive 2010/63/EU on the

protection of animals used for scientific

purposes.

Amendment 71




Article 33 – paragraph 1 – point d a (new)


(4a) In Article 33(1), the following

point is added:

“(da) combinatorial and accumulated

effects.”

Amendment 72


Article 1 – paragraph 1 – point 5 – point a


Article 38 – paragraph 1 – introductory part


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




Article 38 – paragraph 1 – point a


(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




Article 38 – paragraph 1 – point c


(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






requests from the European Parliament, the

Commission and the Member States for a


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




Article 38 – paragraph 1 – point d

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(d) the information on which its

scientific outputs, including scientific

opinions are based, taking into account

protection of confidential data and


with Articles 39 to 39f;

(d) the information on which its


opinions are based, taking into account the

overriding public interest in disclosure

and the protection of confidential data and



Amendment 76




Article 38 – paragraph 1 – point h a (new)


(ha) information on the name of the

applicant and the title of the application;

Amendment 77




Article 38 – paragraph 1 – point i


(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


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Article 38 – paragraph 1 – subparagraph 2


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




Article 38 – paragraph 1a – subparagraph 1 – introductory part


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



PE623.765v03-00 52/150 RR\1170767EN.docx

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Article 38 – paragraph 1a – subparagraph 1 – point a


(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




Article 38 – paragraph 1a – subparagraph 2


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.






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




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Article 38 – paragraph 3 a (new)


(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






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.


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


treatment has been requested and granted

in application of the conditions laid down

in this Article.

Amendment 84






(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


(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


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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






(3) commercial information revealing

sourcing, market shares or business

strategy of the applicant; and


sourcing, innovative ideas for the

product/substance, market shares or

business strategy of the applicant;




Amendment 86






(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



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(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






(b) information which forms part of

conclusions of scientific outputs, including

scientific opinions, delivered by the

Authority and which relate to foreseeable

health effects.





effects on public health, animal health

and the environment.

Amendment 89




Article 39 – paragraph 4 – point b a (new)


(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.

PE623.765v03-00 56/150 RR\1170767EN.docx

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Amendment 90




Article 39 – paragraph 4 – point b b (new)


(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






4a. This Article is without prejudice to

Directive 2003/4/EC and Regulations

(EC) No 1049/2001 and (EC) No

1367/2006.

Amendment 92




Article 39a – paragraph 2


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








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




applicant shall clearly indicate verifiable

justifications and evidence on the basis of

which confidentiality is requested for the

different pieces of information.

Amendment 93




Article 39b – paragraph 1 – subparagraph 1 – point c


(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.






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




Article 39b – paragraph 1 – subparagraph 1 – point d


(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,



the observations of the applicant within

eight weeks from the date of receipt of the






the Member States, in every case, of its

decision; and,

Amendment 95




Article 39b – paragraph 1 – subparagraph 1 – point e


(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).




not earlier than four weeks after the



Amendment 96




Article 39b – paragraph 1 – subparagraph 2

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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




Article 39d – paragraph 2


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








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






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.












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




Article 39e – paragraph 1 – point c


(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




Article 39e – paragraph 2


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.




vertebrate animals shall be deemed to

significantly harm the privacy and the




Amendment 101




Article 39f – paragraph 1


(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


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




Article 39f – paragraph 2 a (new)


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




Article 39g – paragraph 1


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




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






Where environmental information is

concerned, Articles 6 and Article 7 of


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,


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.

__________________ __________________



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).









25.9.2006, p. 13).

Amendment 105





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(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


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


Authority shall each designate a contact

point, which shall be a member of the

network.”

Amendment 106


Article 1 – paragraph 1 – point 9 b (new)




(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






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




Article 61


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.




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



Directive 2001/18/EC



(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






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.





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






1a. The obligation to proactively



Article 30 of this Regulation, and in line





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(EC) No 1367/2006.

Amendment 112







paragraph is added:


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






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






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




Article 18 – paragraph 3 b (new)


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







disseminate information set out in


Articles 38 and 39 of Regulation (EC) No

178/2002, is without prejudice to the right

of any natural or legal person to access



No 1367/2006.”

Amendment 117







paragraph is added:



paragraph 1 of this Article, including

Article 20 of this Regulation, and Articles

38 and 39 of Regulation (EC) No



document upon request as set by


No 1367/2006.”

Amendment 118



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Regulation No 1935/2004



(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



Regulation No 1935/2004



(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




Article 11


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


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



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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.



paragraph 1 of this Article, in Article 12

of this Regulation and Articles 38 and 39




document upon request as set by


No 1367/2006.

Amendment 121






1b. The obligation to proactively



Article 12 of this Regulation and in line






(EC) No 1367/2006.

Amendment 122





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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


Amendment 123




Article 23 – paragraph 1 – last sentence


(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






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






2. In addition to Article 39(2) of


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



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






(5a) in Article 63, paragraph 3 is


3. This Article is without prejudice to


Parliament and of the Council of 28

January 2003 on public access to

environmental information





environmental information and to


No 1367/2006.

Amendment 127






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






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






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



Regulation (EU) No 2015/2283


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paragraph is added:


disseminate the information set out in this

Regulation, in line with Articles 38 and 39






No 1367/2006.”

Amendment 131


Article 9 a (new)


Article 9a

Transparency of risk management


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 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


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


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


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


Recital 8 a (new)


(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


Recital 11




















Member States as well as representatives

of civil society and industry in the



have experience in particular on risk

assessment.

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Amendment 3




Article 8a – paragraph 1 – point b





(b) promote consistency, transparency

and clarity in formulating risk


Amendment 4




Article 25 – paragraph 1a – point a


a) two members and the alternate



right to vote.

a) two members and two alternate

members, appointed by the Commission


right to vote.

Amendment 5




Article 25 – paragraph 1a – point b


b) one member appointed by the


vote.

b) one member and one additional

member, appointed by the European

Parliament, with the right to vote.

Amendment 6




Article 25 – paragraph 1a – point c

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(c) four members with the right to vote




















(c) six members with the right to vote





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











The Commission's Food and Veterinary

Office (FVO) experts shall perform


assurance that testing facilities in the

Union and in third countries comply with

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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

















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


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


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


Recital 2


(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


Recital 3


(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


Recital 4



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.


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


Recital 5



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.


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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Recital 6






managers.





managers, while guaranteeing their

independence.

Amendment 6


Recital 7


(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


Recital 8






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










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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communication.


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


Recital 10




the Authority to the Common Approach on

decentralised agencies, in accordance with

the Joint Statement of the European



decentralised agencies of 201222.



the Authority to the Common Approach on

decentralised agencies, in accordance with

the Joint Statement of the European



decentralised agencies of 201222, while

also taking into account the withdrawal of

the United Kingdom from the EU and the

legal effects resulting therefrom.

_________________ _________________


union/sites/europaeu/files/docs/body/joint_

statement_and_common_approach_2012_e

n.pdf.


union/sites/europaeu/files/docs/body/joint_

statement_and_common_approach_2012_e

n.pdf.

Amendment 9


Recital 11

















Member States, including representatives

PE623.765v03-00 98/150 RR\1170767EN.docx

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of civil society and industry, in the



have experience in particular in assessing

and managing risks and problems and

that they have no conflict of interest with

the applicants.

Amendment 10


Recital 12




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.



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


Recital 13








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.







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


Recital 14




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



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




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



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


Recital 16


(16) Authorisations procedures are (16) Authorisations procedures are

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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.







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


Recital 17
































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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.



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


Recital 18














authorisation has been made public in

accordance with the applicable rules on

transparency.













authorisation or renewal has been

submitted and the Authority has published

its official scientific opinion.

Amendment 16


Recital 20





on industry studies. The Authority already




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




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




provide for a consultation of third parties

in order to identify whether other relevant




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


studies are available.

Amendment 17


Recital 21





sectoral food law usually comply with









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.




sectoral food law usually refer to




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


Recital 21 a (new)

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(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


Recital 22

















Commission should be responsible for






stake (for example new scientific

developments becoming available).















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


Recital 23

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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.


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


Recital 23 a (new)


(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


Recital 24

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(24) The European Citizens’ Initiative

“Ban glyphosate and protect people and the





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





application23 .

__________________ __________________









Amendment 23


Recital 25


(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


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


Recital 27



disclosure strikes the appropriate balance,

the relevant rights of the public to


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


Recital 27 a (new)


(27a) The provisions on active


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


Recital 28


(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


Recital 30


(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


Parliament and of the Council24 and







(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


Parliament and of the Council and








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while preventing conflicts of interests.


while preventing conflicts of interests. For

the purpose of ensuring the transparency,

independence, sustainability and


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.

__________________ __________________








p. 1).








p. 1).








Regulation) (OJ L 119, 4.5.2016, p. 1).








Regulation) (OJ L 119, 4.5.2016, p. 1).

Amendment 28


Recital 31








order to ensure uniform conditions for the

implementation of Regulation (EC) No

178/2002 with regard to the adoption of








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.

_________________ _________________








p. 13).








p. 13).

Amendment 29


Recital 32


(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


Recital 33






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





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


Recital 35


(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


Recital 36











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










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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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


_________________ _________________









25.9.2006, p.13).









25.9.2006, p.13).

Amendment 33


Recital 37


(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



agri-food chain. It is of particular












(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




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Amendment 34


Recital 38


(38) In order to enable the Authority and

the business operators to adapt to the new





Regulation.

(38) In order to enable the Authority,


business operators to adapt to the new





Regulation.

Amendment 35




Article 8a – paragraph 1 – point a


(a) promote awareness and



process;

(a) promote transparency, clarity,

awareness and understanding of the

specific issues under consideration during

the entire risk analysis and management

processes;

Amendment 36




Article 8a – paragraph 1 – point b

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(b) promote a high level of health and

environmental protection, maximum

reliability and transparency in formulating

risk management recommendations;

Amendment 37




Article 8a – paragraph 1 – point c


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




Article 8a – paragraph 1 – point d




confidence in its outcome;



accountability in its outcome, and restore

consumer trust in the Union and its

institutions;

Amendment 39




Article 8a – paragraph 1 – point f


(f) ensure appropriate exchange of (f) ensure appropriate exchange of

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food chain.



food chain and strategies to avoid them.




Amendment 40




Article 8a – paragraph 1 – point f a (new)


(fa) combat sources and dissemination of

false and misleading information;

Amendment 41




Article 8b – paragraph 1 – point b


b) provide transparent information at





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


Amendment 42




Article 8b – paragraph 1 – point c


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




Article 8b – paragraph 1 – point d


d) facilitate understanding and


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




Article 8b – paragraph 1 – point e





protection of personal data.



taking into account the protection of

personal data.

Amendment 45




Article 8c – paragraph 2 – introductory part

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shall:





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




Article 8c – paragraph 2 – point a





activities needed;

(a) identify the factors that need to be

taken into account when considering the


activities needed;

Amendment 47




Article 8c – paragraph 2 – point b


b) identify the appropriate main tools



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


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




Article 8c – paragraph 2 – point c





risk managers and ensure an open dialogue

amongst all interested parties.




risk managers and ensure an open dialogue

and constant interaction amongst all

interested parties, while acknowledging

scientific divergent opinions where they

exist.

Amendment 49






(b) one member appointed by the


vote.

(b) two members and two alternate

members appointed by the European

Parliament, with the right to vote.

Amendment 50






(c) four members with the right to vote (c) five members with the right to vote

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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








Amendment 51




Article 25 – paragraph1b


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


Article 1 – paragraph 1 – point 2 – point d


Article 25 – paragraph 5 – subparagraph 2


“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






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







made by Member States, the Executive






made by Member States on the basis of the

expressions of interest, the Executive




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nominations received do not allow him,

given the criteria for selection set up in

point d) of this paragraph, to draw up a



for appointment.



nominations received do not allow her/

him, given the criteria for selection set up

in point d) of this paragraph, to draw up a



for appointment.

Amendment 55




Article 28 – paragraph 5a – point e


e) The Management Board shall



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




Article 28 – paragraph 5d



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


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


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








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




Scientific Panels.



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






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















authorisation. This provision does not

apply to the submission of any

supplementary information by the


process.










authorisation.

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Amendment 60















Member States.



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










authorisation, the Commission, in

exceptional circumstances, may request

the Authority to commission scientific



process. The studies commissioned may

have a wider scope than the evidence

subject to verification.;





authorisation, the Authority may, where

scientific data and findings are in conflict

with each other, commission scientific



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




Article 32e – paragraph 1a (new)


Any studies commissioned shall take into

account Directive 2010/63/EU on the

protection of animals used for scientific

purposes.

Amendment 63




Article 38 – paragraph 1 – subparagraph 1 – introductory part


The Authority shall carry out its activities

with a high level of transparency. It shall in


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


Amendment 64




Article 38 – paragraph 1 – subparagraph 1 – point a


(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


Article 1 – paragraph 1 – point 5 – point а


Article 38 – paragraph 1 – subparagraph 1 – point c


c) scientific data, studies and other






requests from the European Parliament,


for a scientific output, including a

scientific opinion, taking into account

protection of confidential information and



deleted

Amendment 66




Article 38 – paragraph 1 – subparagraph 1 – point d


d) the information on which its


opinions are based, taking into account

protection of confidential data and



deleted

Amendment 67




Article 38 – paragraph 1 – subparagraph 1 – point i

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i) advice provided by the Authority to

potential applicants at pre-submission

phase pursuant to Article 32a and 32c.

deleted

Amendment 68


Article 1 – paragraph 1 – point 5 – point а a (new)


Article 38 – paragraph -1a (new)


(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






requests from the European Parliament,

the Commission and the Member States,

taking into account the protection of

confidential information and the



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




Article 38 – paragraph 1a – subparagraph 2







content to be used, reproduced, or

otherwise exploited and its use by third

parties shall not engage the responsibility

of the European Union.






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




Article 38 – paragraph 3a


(ca) the following paragraph 3a is

inserted:





environmental information, to Regulation

(EC) No 1049/2001 and to Regulation

(EC) No 1367/2006.

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Amendment 71







38, the Authority shall not make public


treatment has been requested under the

conditions laid down in this 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


treatment has been requested and granted

in application of the conditions laid down

in this Article.

Amendment 72






(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





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sourcing, market shares or business

strategy of the applicant; and


sourcing, innovative ideas for the

product/substance, market shares or

business strategy of the applicant;




Amendment 74










health effects.;




Authority which indicate risks of possible

effects on, and threats to, public and

animal health or the environment.;

Amendment 75







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













shall be without the information the

applicant deems confidential in accordance

with paragraphs 2 and 3 of Article 39. The



information the applicant deems




applicant shall clearly indicate the grounds

on the basis of which confidentiality is

requested for the different pieces of

information.








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



information the applicant considers




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




Article 39b – paragraph 1 – point c







disagrees with the assessment of the

Authority it may state its views or

withdraw its application within two weeks






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




Article 39b – paragraph 1 – point d




the observations of the applicant within ten

weeks from the date of receipt of the






the Member States, as appropriate, of its

decision; and,



the observations of the applicant within

eight weeks from the date of receipt of the






the Member States, in every case, of its

decision; and,

Amendment 79




Article 39b – paragraph 1 – point e





not earlier than two weeks after the






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




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EN










the Authority and has become definitive.

The Commission and the Member States

shall also take the necessary measures so

that information for which confidential






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


also take the necessary measures so that




Amendment 81






















not make public the information for which

confidentiality has been requested.

















not make public any information relating

to the planned application.

Amendment 82

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Article 39e – paragraph 1 – point e


(a) the name and address of the

applicant;

(a) the name of the applicant;

Amendment 83





















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




Article 39g – paragraph 1





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




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






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












mandate, tasks, procedures and location, in

accordance with Commission guidelines.







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






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






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



PE623.765v03-00 136/150 RR\1170767EN.docx

EN





paragraph 3a is inserted:




Article 25, and in line with Articles 38 and

39 of Regulation (EC) No 178/2002, is






Amendment 90






4. Where the relevant Scientific

Committee is consulted under paragraph 1,

it shall make public the

notification/application, relevant



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



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





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applicant, as well as its scientific opinions

and opinions from the competent






Regulation.





applicant, at the same time as its scientific

opinion and opinions from the competent






Regulation..

Amendment 92









Article 30, and in line with Articles 38 and

39 of Regulation (EC) No 178/2002, is






Amendment 93






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



(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



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Article 7 – paragraph 2 – point c


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









disseminate information set out in this

Article and in line with Articles 38 and 39







Amendment 96











in accordance with Article 38, Articles 39






opinion, in accordance with Article 38,

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EN

to 39f and Article 40 of Regulation (EC)


mutandis.

Articles 39 to 39f and Article 40 of


apply mutatis mutandis.

Amendment 97






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






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


Amendment 99

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EN




Article 7 – paragraph 2 – point c – point ii


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



information supplied by the applicant,

when it publishes its scientific opinion, in

accordance with Articles 14 and 15.

Amendment 100










applicant as well as its scientific opinions,



No 178/2002.;

1. The Authority shall make public, at

the same time as its scientific opinion, the




applicant as well as its scientific opinions,



No 178/2002.;

Amendment 101











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EN

Articles 38 and 39 of Regulation (EC) No






Amendment 102






(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




Article 9 – paragraph 1 – point c – point ii


(ii) ensure public access to the



information supplied by the applicant, in

accordance with Articles 19 and 20;

ii) ensure public access to the



information supplied by the applicant, at

the same time as to its scientific opinion, in accordance with Articles 19 and 20.

Amendment 104





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mutandis and Article 20 of this

Regulation.”;






opinion, in accordance with Article 38,

Articles 39 to 39f and Article 40 of


apply mutatis mutandis and Article 20 of

this Regulation.”;

Amendment 105




Article 19 – paragraph 2a (new)


(2a) in Article 19, the following




paragraph 1 is without prejudice to the

right of any natural or legal person to


in Regulation (EC) No 1049/2001 and


Amendment 106






The obligation to proactively disseminate

information set out in paragraph 1 of this

Article, in line with Article 12 and in line




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in Regulation (EC) No 1049/2001 and


Amendment 107






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






(5a) in Article 63, paragraph 3 is






environmental information





environmental information and to



Amendment 109

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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




Article 16 – paragraph 2 – last sentence


The Authority shall ensure public access to

the application, relevant supporting


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







opinion in accordance with Articles 10(3)

and 16 of this Regulation, the Authority

shall make public the application for

authorisation, relevant supporting


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 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 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



Regulation (EU) No 2015/2283






disseminate the information set out in this

Regulation, in line with Articles 38 and 39







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PROCEDURE – COMMITTEE ASKED FOR OPINION


chain




ENVI

28.5.2018

Opinion by


JURI

28.5.2018

Rapporteur

Date appointed

Jiří Maštálka

23.4.2018

Discussed in committee 3.9.2018



–:

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

PE623.765v03-00 148/150 RR\1170767EN.docx

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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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PROCEDURE – COMMITTEE RESPONSIBLE


chain


Date submitted to Parliament 11.4.2018



ENVI

28.5.2018

Committees asked for opinions


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



–:

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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