EUROPEAN COMMISSIONHEALTH AND FOOD SAFETY DIRECTORATE GENERALFood and feed safety, innovationPesticides and Biocides

MINUTES

76th meeting of representatives of Members States Competent Authorities for the implementation of Regulation (EU) No

528/2012 concerning the making available on the market and use of biocidal products

17-19 January 2018

Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 2 299 11 11E-mail: SANTE-BIOCIDES@ec.europa.eu

1. Adoption of the agenda For adoptionCA-Jan18-Doc.1.rev3

The Chair welcomed the participants and informed the meeting on the schedule of the various sessions. He then asked for any comments or additional items to the agenda. No additional items were included. The draft agenda was adopted.

2. Adoption of the draft minutes of the previous CA meeting

For adoptionCA-Jan18-Doc.2

The draft minutes of the 75th CA meeting were adopted, with the change proposed by ECHA on section 7.1.

3. Draft delegated acts

No items for information or discussion

4. Biocidal products

4.1. Anticoagulant rodenticides

(a) Submission of data (or LoA to data) generated for the active substance renewal

For discussion/agreementCA-Jan18-Doc.4.1.a

The Commission services briefly introduced document CA-Jan18-Doc.4.1.a and thanked Member States (MS) and stakeholders for the contributions submitted during the commenting period. The Commission services explained that the drafting suggestion made by Industry was not accepted as they would consider all the data generated during the active substance (AS) renewal as being relevant for the renewal of product authorisations. At the request of a MS, the Commission services clarified that including a reference to "negative data" referred to under Article 47 of the BPR was not necessary, as it is a stand-alone provision in the BPR that applies at any time. Accordingly, there is no need to mention Article 47 in the Annex to the document as it is not particularly relevant for the renewal.

The Chair noted that document CA-Jan18-Doc.4.1.a was endorsed by the CA meeting.

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4.2. Assessment of the efficacy role of some co-formulants

For agreementCA-Jan18-Doc.4.2

The Commission services thanked Member States (MS) and stakeholders for the contributions submitted during the commenting period and then invited the initiating MS to introduce the revised paper in light of the comments received (document CA-Jan18-Doc.4.2).

The main elements raised by MSs or Industry during the discussion were the following:

- An alternative wording to aid clarity to the notion of a "known active substance" under indent 4: An approved active substance within the scope of Regulation 1107/2009/EC (PPPR), "but whether or not a substance on this list may be regarded as an active substance will have to be considered on case-by-case basis”.

- It was also suggested to change the condition ‘and’ into ‘and/or’: “When a co-formulant is a so-called ‘known active substance’ and/or is expected to have a biocidal effect, a justification why the substance is not an active substance is required.”

- Another MS noted that ‘primary’ (function) could be interpreted in multiple ways. The same MS also suggested to redraft the section with acceptable justifications.

- Stakeholders requested for including specific CEN guidance on disinfectants. ECHA and a few Member States indicated that specific CEN guidance should not be incorporated in this general document.

On account of the discussion held, the initiating MS prepared an updated proposal for final discussion. The Chair noted that the CA meeting endorsed the principles set in the final version of the document (rev. 3). The agreed document will be forwarded to the BPC for implementation.

4.3. Scope issues and referrals to the Coordination Group

For discussion/agreementCA-Jan18-Doc.4.3

The Commission services introduced this agenda item, which was a follow-up of previous discussions in the 74th CA meeting of September 2017 (see document CA-Jan18-Doc.4.3).

Several MSs supported the views expressed by the Commission services and indicated the need to check any scope issue as soon as possible after the submission of the application. However, a MSs disagreed with those views on legal grounds and as Article 3(3) procedures might take a long time. The Commission services indicated that if a decision had to be taken by the Coordination Group (CG) and a consensus agreement could not be reached in the CG because of the position of a MS, the Commission would have to deal with a decision under Article 36 and it might take a similar period of time as an Article 3(3) procedure..

On a more general note, a MS suggested that Article 3(3) decisions should provide for a period of grace for the involved product(s), so that it can be progressively phased out of the market. The Commission services indicated that the Legal Services (LS) of the Commission

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clarified that this is not legally possible, as by applying such period of grace it would exceed the mandate of the Commission in Article 3(3) of the BPR.

The Commission services indicated though that where a product being subject to a scope discussion (or Article 3(3) decision) i) is being made available on the market of a MS according to the practice or system referred to in Article 89(2) of the BPR as a biocidal product; ii) is subject to an application for product authorisation under the BPR submitted in accordance with Article 89(3) and iii) following the outcome of the scope discussion (or Article 3(3) decision), the Competent Authority of a MS or the Commission decides not to grant the authorisation, then Article 89(4) of the BPR establishes that the period of grace referred to in that Article shall apply.

The Chair concluded that the comments raised by two MSs after the 74 th CA meeting were considered by the Commission services in document CA-Jan18-Doc.4.3 and in the discussion in the CA meeting. Based on the advice of the LS and the support expressed by the other MSs it was concluded that scope issues cannot be referred to the CG. The Chair also noted that one MS could not agree with this conclusion.

4.4. Renewal of PT 8 products For discussion/agreementCA-Jan18-Doc.4.4

The Commission services invited the initiating MS to introduce document CA-Jan18-Doc.4.4. The main elements raised by MSs or Industry during the discussion were the following:

- It was clarified that compared to the approach followed for anticoagulant rodenticides, this proposal does NOT affect all the PT 8 ASs.

- All MSs having taken the floor and Industry support the rationale behind the initiative, subject to some further refinement/improvement.

- The (proposed) new classification for propiconazole might also delay the renewal of the AS, and this should be considered for the extension of the product authorisations.

- The lessons learnt from the renewal of anticoagulant rodenticides should be taken into account, particularly the time pressure under a "non-full assessment" scenario. The assessment and MR phase should also be distributed in a manner that does not block MSs with all the applications being handled at the same time. This might also impact on other BPR procedures to be handled at that time.

The Chair invited MSs and stakeholders to submit any written comments to the proposal by 5 February 2018. The initiating MS will then address those comments in a revised version, which will be handed over to the Commission services in order to prepare a draft CA document for final discussion and agreement at the next CA meeting.

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4.5. Report from Coordination Group For information

The Commission services briefly informed the meeting of some issues discussed at the 27 th

coordination group (CG) meeting:

i) In terms of MR disagreements, CG members discussed 15 formal referrals. A consensus agreement was reached in 10 cases and for the other cases (5) the discussions are still on-going. ii) The CG working party on biocides families has held its second physical meeting. The main elements under discussion were 1) the approach to consider similarity of uses based on a matrix including the uses specified in Annex V to the BPR; ii) the approach to consider similarity of composition; and some general aspects related to similarity: the need for an explanatory document on the rationale behind the family structure, how to improve and optimise pre-submission discussions and meetings and how to deal with ongoing applications when there is a change in the consideration of similarity during evaluation, mutual recognition or peer review. iii) CG members discussed how to deal with the consolidated version of the assessment report (AR) at the renewal of PTs other than PT14. CG members agreed that MSs will request applicants to provide a consolidated PAR. However, applications will not be rejected where the consolidated PAR is not submitted.

iv) Following some discussions in previous meetings, ECHA will start the drafting of some additional guidance on the submission and handling of same biocidal products applications.

For further information, the Commission services referred the meeting to the list of conclusions and actions arising from the CG-27 meeting, which had been made available on the dedicated CG CIRCABC interest group.

4.6. Executive report on referrals to the Coordination Group in accordance with Article 35 of the BPR

For informationCA-Jan18-Doc.4.6

The Chair invited the CA meeting to take note of document CA-Jan18-Doc.4.6.

4.7. Executive report on product authorisations

For informationCA-Jan18-Doc.4.7

The Chair invited the CA meeting to take note of document CA-Jan18-Doc.4.7.

4.8. Union authorisation

(a) Executive report on applications for UA

For informationCA-Jan18-Doc.4.8.a.1CA-Jan18-Doc.4.8.a.2

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The Chair invited the CA meeting to take note of documents CA-Jan18-Doc.4.8.a.1&2.

(b) Template for Implementing Regulations granting UA

For discussion/agreementCA-Jan18-Doc.4.8.b.1CA-Jan18-Doc.4.8.b.2CA-Jan18-Doc.4.8.b.3(a&b)

The Commission services briefly introduced the documents in order to receive any comments before launching the internal procedures within the Commission and to avoid discussion at a later stage within the Standing Committee. The main elements raised by MSs or Industry during the discussion concerned whether:

- The evaluating Competent Authority (eCA) and the date of submission of the product assessment report (PAR) to ECHA should be mentioned in the Implementing Regulation (IR). The Commission services indicated that this will be considered, but might also raise questions regarding delays by the eCA.

- Section C in annex 1 will only reflect conditions imposed in the BPC opinion. The Commission services confirmed that understanding.

- The IR should also grant the period of grace referred to in Article 89(4) of the BPR. The Commission services indicated that this will be considered. However, the wording in Article 89(4) indicates that it is directly applicable and does not require the Commission or MSs to grant in their decision a period of grace (as it is referred to in Article 52 of the BPR).

- The validity of the authorisation should be mentioned in the Articles of the IR. The Commission services indicated that this will also be considered.

The Chair invited MSs and stakeholders to submit any written comments to the templates by 5 February 2018. On account of the comments received, the Commission services will update the meeting at the next CA meeting.

(c) Draft EC Report on Union authorisation to the European Parliament and the Council

For informationCA-Jan18-Doc.4.8.c

The Commission services briefly updated the meeting on the state of play of the draft Report, which was about starting the internal procedures within the Commission. After the last CA meeting a limited number of contributions were submitted (see document CA-Jan18-Doc.4.8.c).

Two MSs indicated that the information on the applicable fees for the evaluation of biocidal product families should be updated in the draft report. These MSs will inform the Commission of the right figures to be included in the report by Monday 22 January.

(d) Products containing iodate For informationCA-Jan18-Doc.4.8.d

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The Commission services introduced this topic by briefly referring to the follow-up discussions within ECHA and to the document submitted by Industry representatives on this matter. At BPC-23 meeting the BPC did not support the conclusions of the APCP WG-IV 2017 and. BPC members considered that iodate could be regarded as a co-formulant and not as a new AS. The “Technical Agreements for Biocides” (TAB) will be revised to align it with the conclusions of the BPC.

4.9. Management of product authorisations for in-situ cases

For informationCA-Jan18-Doc.4.9

The Chair mentioned that this item was for information and that it is the intention to prepare a document for the next CA meeting. A MS pointed out that the BPR does not allow to authorise devices. Another MS stated that it should be analysed whether the authorisation could be linked to certain devices and referred to existing example of the use of carbon dioxide linked to mouse traps. A MS underlined that it is challenging to find an approach that addresses what is needed in practice and applying the BPR.

Member States and stakeholders were invited to send comments to the Commission's services by 5 February 2018.

5. Active substances

5.1. Progression of the review programme on active substances

For informationCA-Jan18-Doc.5.1

(a) Specific discussion on the progression of the review of active substances, on the progress on the 1st and 2nd priority lists, and on new active substances

For discussion/agreement

As a follow-up from discussions in previous CA meetings in closed sessions, the discussion continued in an open session in the presence of stakeholders representatives. The Commission services presented a number of key actions identified for the various actors involved in the process - the applicants, MS, ECHA and Commission’s services. Most of these actions could be implemented quickly.

One MS noted that they sometime face legal issues with companies and resources issues.

Industry noted in general a support for these actions but would appreciate to have time to make detailed comments. Also, Industry noted that the iterative update or change of guidance involves that the applicants should have the opportunity to provide new data. On this last point, the Commission’s services noted that MS usually give this opportunity in such cases. The Commission services clarified that the issue referred in the presentation concerns the situation when an applicant wants to generate new data although it is not requested by the eCA.

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One MS noted that it faced issues on the making of the CLP dossiers with ECHA’s CLP accordance check and priority settings for biocidal active substances, and asked ECHA Biocides to check with their CLP colleagues to align formats and discuss priority setting. . These issues generated additional workload and delays for the progress of their active substances. The Commission’s services asked ECHA to check this point.

Stakeholders were invited to send comments to the Commission's services by 14 February 2018.

(b) Overview of expected applications made on in-situ generation in March 2015

For information

The Commission informed that, at the request of the previously allocated eCAs, some substances re-defined in the context of the in situ exercise of 2015 will be re-allocated to other eCAs. Agreements have been found with the previous and the new eCAs.

5.2. Renewal of approval of active substances which are both approved and listed in Annex I to the BPR

For information

The Commission's services informed that a few legal questions still need further analysis, and it is the intention to have a discussion at the next CA meeting. They asked MS and stakeholders to refresh their knowledge about this topic by reading the previous CA documents from 2016 and 2017 on this topic in order, to be ready to have a discussion at the next CA meeting.

6. Treated articles

6.1 Scope issues related to the enforcement project

For information and discussionCA-Jan18-Doc.6.1

The Commission services introduced the agenda item and asked the MS that initiated this issue to provide further information. This MS pointed out that the Biocidal Products Regulation Subgroup of the Forum (BPRS) decided that the first common enforcement project will be on treated articles. This requires that a consistent view and interpretation exists in relation to treated articles that might have a primary biocidal function and therefore could be considered as biocidal products. In that context this MS put forward several questions to the CA meeting. At this agenda item was also discussed a borderline issue about treated article/biocidal product in relation to a dog bed treated with an insecticide.

The Commission services referred to the principles included in relevant agreed guidance and in some Article 3(3) decisions, in particular whether a good should be considered a treated article or a biocidal product if it has a primary biocidal function. In general it could be indicated that a good having the objective to protect a third party against harmful organisms, could be considered to have a primary biocidal function and consequently as being a biocidal

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product. This reasoning was already agreed in the past and included in the existing CA guidance (CA-Sept13-Doc.5.1.e). Several MSs indicated not to agree with this conclusion of the Commission services referring to the primary function of the good (e.g. clothing to protect humans from outside external factors). A MS raised the examples of toilet seats or hospital beds treated to prevent growth of micro-organisms and noted that primary marketing claim should not be confused with primary function. The Commission services indicated that the issue is whether the good can be considered to have a primary biocidal function as included in the definition of biocidal product in the BPR; the question is not what is the primary function of a good. The Commission services also underlined that the objective of BPR is to provide high protection of human health and the environment. In that context the legislators introduced a clear provision that treated articles having a primary biocidal function should be subject to authorisation in order to demonstrate that their use is safe and efficacious.

A MS proposed to have more examples in order to clarify the implementation of the principles in practice. Another MS indicated the example of dictaphones including an active substance to protect the medical staff from illness. Those goods are marketed with this unique intended use and claim. Several MSs pointed out the practical consequences of this approach that many goods would be considered biocidal products requiring an authorisation. A MS and a stakeholder pointed out the possible risks of goods treated with biocidal active substances and considered that a good should be evaluated properly. A MS referred to the General Product Safety Directive, which requires that every claim should be justified. The Commission services considered that MSs already agreed on the principles in the existing CA guidance and the reasoning in the relevant Article 3(3) decisions allows an evaluation of goods on a case by case basis. There is no need to develop further guidance at this moment; however, examples put forward by the CA meeting could be considered in the context of the existing guidance. The CA meeting was invited to provide examples and their views before the 5th of February.

7. Horizontal matters

7.1. ECHA communications For information

ECHA gave a presentation focused on the need to update the data related to product authorisation in view of the release of the new dissemination website scheduled for November 2018. The information related to authorisations that will be published is: all SPCs finalised or updated as from 1st January 2016, the public version of the product assessment report, the authorisation decisions and the BPC opinion (in case of Union authorisations). MSs were requested to make sure by September 2018 that the assets contain a public version (without confidential information) of the assessment report, an authorisation decision and a properly filled in SPC and that all documents are assigned the proper type/level of access (i.e. public, confidential or confidential for Authorities). Changing the type/level of access of the documents is possible by amending the assets. ECHA underlined that it is the eCA’s responsibility to make sure that the information is available for dissemination as provided in the BPR and that no confidential information is published.

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The Commission services also mentioned that the dissemination exercise is very important in Commission's view and invited MSs to take the necessary actions to avoid any possible delays.

7.2. ECHA guidance

(a) Procedure for developing ECHA guidance

For informationCA-Jan18-Doc.7.2.a

ECHA gave a presentation explaining the steps of the guidance consultation procedure. It was highlighted that such consultation procedure only applies to formal ECHA guidance and not to other types of guidance (e.g. practical guides, guidance notes of Committees, IT manuals).

A MS pointed out the difficulty to differentiate between formal ECHA guidance and other types of guidance affecting approval and authorisation. Another MS pointed out the need to have a clear demarcation line between formal guidance and guidance-related documents since CAs need to know the date when guidance becomes applicable and enquired on the status (formal vs. non-formal guidance) of the Emission Scenario Documents (ESDs). ECHA clarified that ECHA guidance explains the legal obligations of applicants; other documents have a different role and it should be possible to adopt them quickly. ECHA indicated that ESDs are not formal ECHA guidance.

A MS also enquired on the process to develop new guidance or addenda to existing guidance. ECHA stated that there are various ways to transmit proposals, in particular via the BPC working groups. ECHA indicated that the prioritisation of guidance development mostly takes place in the BPC working groups and the actual development depends on the availability of resources both in the working groups and in ECHA. Following the question from one MS the Commission services clarified the steps regarding the establishment of technical guidance on endocrine disruptors.

The Commission services highlighted the importance that experts identify at early stages possible issues in the guidance that might lead to regulatory consequences and mentioned the key role of the working groups Chairs in this process as the technical discussions in these groups may set precedents and have a regulatory impact.

(b) State of play ECHA guidance (on-going consultation, finalised guidance)

For informationCA-Jan18-Doc.7.2.b

ECHA presented the states of play related to BPR guidance with regard to the ongoing consultation and the finalised guidance. It was also reminded that the structure of BPR-related guidance was updated as already informed in a previous CA meeting. The Commission services indicated that it is the intention to present at each CA meeting the state of play of guidance so that the CA meeting is well informed about the development of new guidance and underlined the important role that the CAs and its experts play in developing it.

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(c) Dermal absorption. Adaptation of CA document to the latest EFSA guidance

For discussion/agreementCA-Jan18-Doc.7.2.c

The Chair invited ECHA to introduce the topic. ECHA made reference to the CA document agreed in July 2013 on principles for assessing dermal absorption of biocidal products (CA-July13-Doc.6.2.b – Final). Due to the recent change in the EFSA guidance (referred to in the CA document) it was suggested that a new guidance document is developed by ECHA and agreed at BPC level, which would supersede the mentioned CA document.

A MS highlighted the importance of such document especially in the context on the forthcoming PT 8 products renewal and enquired on the timing of availability of ECHA guidance and applicability of EFSA new guidance.

The Commission services clarified that the purpose of the document is to agree on the process, that is that new guidance for dermal absorption is developed by ECHA and not by the CA meeting as occurred for the current guidance. As for the applicability of new guidance it was mentioned that, as agreed in the past, applicants can only be obliged to follow guidance that was applicable two years before the submission of the application for product authorisation. This means that for the case of the renewals of PT 8 products it might not be compulsory to apply the new guidance. However, applicants may decide to voluntarily follow that guidance if it is beneficial to them.

ECHA mentioned that the adoption of this new guidance is a question of months and not years. However, ECHA is not in a position to indicate any exact date of adoption at this moment. A MS expressed its preference for an immediate applicability of guidance. This position was supported by another MS which also pointed out to the discrepancy in the timing of the applicability of guidance for active substances and biocidal products. It also mentioned that harmonisation of the applicability dates between these two procedures would be welcome. The Commission services reminded that the topic of the timing discrepancy was discussed recently in a CG meeting, which acknowledged that the situation differs between guidance for product authorisations and active substance approvals. In the CG meeting it was pointed out that authorisation of biocidal products often involves SMEs (which is mostly not the case for active substance approval applications) and agreed to maintain the previously agreed cut-off period of two years for the applicability. Industry wanted to emphasise that in the case of active substance approval the currently foreseen period of 6 months for the applicability of new guidance is considered not feasible in practice.

It was concluded that the meeting agreed with the process outlined in the document for establishing guidance on dermal absorption.

7.3. Endocrine disruptors

(a) State of play For information

The Commission services informed the meeting that the scientific criteria to identify endocrine disruptors under the plant protection products regulation were endorsed by EU Member States in December 2017. These criteria are under scrutiny of the co-legislators until the 9th of April 2018 and will be eventually adopted by the Commission if there are no objections from any of these institutions. It was highlighted that it is the intention to agree in the CA meeting three guidance documents concerning on-going procedures for active

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substances, approved active substances and already authorised an on-going procedures for biocidal products. These documents may be used to develop secondary legislation and regulatory guidance in order to increase legal certainty.

ECHA presented the timeline for establishing the technical guidance on EDs. It was also indicated that a workshop will take place to discuss the draft technical guidance on 1-2 February in Brussels.

(b) The implementation of scientific criteria for the determination of ED properties in the context of active substances

For discussionCA-Jan18-Doc.7.3.b

The Commission services introduced the amendments to the former version by a presentation.Several participants asked for further clarification of paragraph 10 of the draft note specifying the conclusion on ED properties in the BPC opinion. According to these participants the conclusion in the BPC opinion should point out whether the ED criteria are fulfilled or not. A Member State considered that a post-approval requirement should be included in the decision for active substances for which the assessment report was submitted before 1 September 2013 and no sufficient information is available to conclude on ED properties. Another participant did not agree with this approach. A participant considered that active substances for which the assessment report was submitted before 1 September 2013 should be non-approved if the active substance is considered to have ED properties. In response to a participant, the Commission noted that when delays are necessary to obtain more data to address the ED critieria, then justification may be provided by eCAs for not being able to meet the legal deadline for submitting a dCAR to ECHA; this would avoid non-approval.

A participant suggested to clarify in the document that the BPC opinion is based on the assessment report of the evaluating competent authority.

A participant advised to use the REACH procedures (substance evaluation, SVHC) and raised a question on the legal provisions supporting the possibilities described in paragraph 21.

Participants were invited to submit their comments before the 5th of February 2018.

(c) The implementation of scientific criteria for the determination of ED properties in the context of biocidal products

For discussionCA-Jan18-Doc.7.3.c

The Commission services introduced the amendments to the former version by a presentation.Regarding section 2.1.2 of the document (assessment of the ED properties of non-active substances in the product), some participants favoured to determine ED properties of a non-active substance only or, by preference, by REACH procedure while others favoured to have the choice between BPR and REACH procedure. A participant questioned the legal basis under BPR for being able to request more data for non-active substances. A participant stressed that the REACH procedure is a rather short process of about 5 months and ensures that alignment will take place between different legislations. A reference was also made to ECHA’s Public Activities Coordination Tool (PACT).Another MS pointed out that their legal

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advisers are not convinced that information that is available to the Member State under other legislation can be used under the BPR.

Participants were invited to submit their comments before the 5th of February 2018.

(d) The implementation of scientific criteria for the determination of ED properties in the context of approved active substances

For information

The Commission services indicated that the intention is to schedule this document as soon as possible for the CA meeting.

(e) ECHA document on the consequences of the draft note for agreement by Member States’ competent authorities “Implementation of scientific criteria to determine the endocrine-disrupting properties of active substances currently under assessment” (CA-July17.Doc.4b)

For discussion/agreementCA-Jan18-Doc.7.3.e

ECHA indicated that until the assessment of the ED properties according to the new criteria become mandatory on 7 June, a case-by-case approach will be applied for the active substances entering into the phase of peer review.

7.4. Requests from ECHA BPC and working groups

(a) Proposal for grouping of antifoulings For discussionCA-Jan18-Doc.7.4.a

The Commission services introduced this proposal and asked the Netherlands, the initiator of this item, to further clarify the amendments in the proposal. Following a discussion with CA members a revised version was presented.

As regards to the definition of the category of vessels, one MS noted that a lot of recreational vessels may also be used for commercial reasons. The initiator MS noted that there is no length threshold for commercial crafts. Another MS would support a distinction made according to the length of the boat, and would not exclude “personal watercrafts” from the definition. Further modifications were made to the concept and definition, and it was finally agreed to make the distinction between “leisure crafts” and “non-leisure vessels”.

As regards to the categories of environment, one MS noted that it is important to have efficacy of antifouling paints, but not paints which are “overly efficacious” as it could induce

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additional impacts to the environment. Instead of using “freshwater” and “saltwater”, it was agreed to use the terms “inland water” and “marine environment”.The standard 4 categories of antifouling paints to be used for product authorisation were adapted in the light of the terminology agreed above. Although not part of the scope of this document, one MS noted that it would be useful to link the category of use with the relevant ESD to be used by applicants to apply for a BP authorisation. The request was noted as part of the update of technical guidance for product authorisation managed by ECHA.Finally, option B was supported by the majority of MS, i.e. to use more descriptive sentences of the uses in the SPC of BP authorisations.

It was agreed to have a written procedure on the revised document that will be uploaded on the relevant newsgroup on CIRCABC. This would allow the MSs to consult the relevant experts. If one Member State would oppose to the revised text, the item would be scheduled for discussion in next CA meeting. MSs have up to 5 February to provide their comments and agree with or oppose the document.

7.5. Reporting under Article 65(3) For discussion/agreementCA-Jan18-Doc.7.5.(a&b)

The Commission services introduced the document, revised in light of the comments received from Member States after the two previous meetings in which it was presented. The two-step approach outlined in the document was then explained. The template for the first reporting round due in 2020 contains mostly descriptive information, while the template prepared for subsequent reporting exercises is more focused on quantitative data. The adoption of this two-step approach is meant to allow MSs to make the necessary arrangements to collect the data requested as of 2020. The Commission services presented then the main comments received from MSs and how they were addressed in the updated document. It was highlighted that in the document it is clearly indicated that information should be collected by ECHA and the Commission.

Some MSs expressed reservations with regard to possibilities of retroactive reporting (since 2013) and mentioned they might not be able to submit all the information requested for the first reporting phase. With regard to the official controls some MSs underlined the difficulty to obtain the data to be reported, also due to the limited resources available. The same was expressed on the data to be reported on the poisoning incidents, since poison centres have other priorities.

While listening to MSs remarks, the Commission services reminded that reporting on the implementation of the BPR is a legal obligation set up in Article 65 of the BPR, both for the MSs and the Commission, therefore MSs should make the efforts to collect data needed for proper reporting. The Commission services underlined that in the report to EP and Council has to be indicated in which way the objectives of the BPR are reached. For this certain information is required.

A MS suggested a semantic modification that was then incorporated in the note ("data to be collected and reported" to be replaced by "data to be reported") while another MS suggested to change the name of the proposed template for the future reporting to "preliminary template". This latter suggestion was supported by several MSs. It was agreed that based on the experiences gained this preliminary template should be re-evaluated in 2019 with a view to having an established template for future reporting from 2020. This new template should be agreed by the end of 2019 so it can be used for the second phase of reporting.

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The CA meeting agreed with the document, including the changes mentioned above, and the final note and the two templates for reporting will be uploaded after the meeting in the "Documents finalised at CA" folder in CIRCABC.

7.6. Tattoo inks For information

The Commission services reminded the participants about the restriction project under REACH concerning tattoo inks and the related ongoing public consultation on the ECHA website. Participants were invited to liaise with the REACH colleagues, since this might also be relevant for biocides (e.g. some of these substances might be preservatives that could or not be compliant with the BPR).

7.7. Research use only products and in vitro diagnostics for veterinary use

For discussionCA-Jan18-Doc.7.7.aCA-Jan18-Doc.7.7.b

Closed session

Non-closed session

The Commission services updated the participants on the developments related to research use only products and in vitro diagnostics for veterinary use. It was pointed out that this item may be scheduled for a discussion by the Committee of Permanent Representatives of the Governments of Member States in the EU.

7.8. Workshop on legal matters in PPP and Biocides on 2-3 November 2017

For information

The Commission services informed the meeting about a workshop on legal matters in the biocides and PPP area that took place in November in Berlin and in which one member of the SANTE legal team took part. It was agreed to share the workshop agenda with the meeting participants. A next meeting is scheduled in Norway in 2018.

7.9. The notification of the United Kingdom pursuant to Article 50 of the Treaty

For information

The Commission services informed the meeting that a technical meeting took place between EU-27, Switzerland and Norway in order to prepare for the withdrawal of the UK. The discussions in this meeting were structured according to biocidal products and active substances. Other meetings will be probably take place back-to-back with upcoming meetings of the Standing Committee on Biocidal Products.

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7.10. MRLs

(a) State of play interim approach For information

The Commission services indicated that in the context of the interim approach internal discussions take place in order to implement it in relation to food contact materials.

(b) Request to set maximum residue limits for DEET and icaridin – state of play

For information

The Commission services indicated that the request of Germany to set limits for DEET and icaridin was discussed in the relevant expert committee of the contaminants legislation. Member States were invited to provide monitoring data and their comments. Based on the received information the Commission services will decide on next steps.

7.11. Implementation of CIRCABC newsgroups for CA meetings For information and agreement

The Commission services presented a proposal regarding the use of the newsgroup feature in CIRCABC (in the restricted CA interest group) for the collection of comments on the CA documents. This new practice will allow comments to be grouped by topic; all comments provided will be visible to all participants. After each meeting dedicated newsgroups will be opened for each agenda item under discussion. After the commenting period the comments will be stored in the "newsgroups archive" in the same interest group in CIRCABC.

8. Requests for opinions

8.1 Use of disinfectants in irrigation systems

For discussion/agreementCA-Jan18-Doc.8.1

A competent authority asked the views of the CA meeting on the use of disinfectants in the water system for growing plants (see document CA-Jan18-Doc.8.1). Taking into account the products are used in agriculture and horticulture premises, this authority would like to have the confirmation of the CA meeting that these disinfectants are considered to be biocidal products.

Following some discussions, the Chair noted that the CA meeting agreed with the view of this competent authority to consider the described case as the use of a biocidal product.

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9. Enforcement issues

9.1 Subgroup BPR Forum For information

ECHA and the Commission services informed the meeting about the outcome of the last meeting of the Subgroup BPR Forum and pointed out that the first BPR enforcement project will be on treated articles.

9.2 Fact finding missions For information

The Commission services shared the experiences with the first fact finding mission in Hungary. A Member State indicated to be one of the upcoming Member States that will be subject to a fact finding mission and, for a proper preparation, asked whether it was possible to be informed about the scope of the mission and the type of questions that will be raised.

The Commission services indicated that Member States will receive detailed information before the fact finding mission but would liaise with Directorate F to inform this Member State as soon as possible.

10. International Matters

No item for information or discussion

11. AOB

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Next meetings:

2018 (provisional)

CG CA and SCBP BPR Subgroup Forum BPC BPC's WG

16-17 January 17-19 January - - I: 16-26/01

- - - - -

12-13 March 14-16 March 16 March 5-9 March II: 19-29/03

- - 23-27 April -

28-29 May 29-31 May - - III: 21-31/05

- - 21 June 24-29 June -

4 July 5-6 July - - -

25-26 September 26-28 September - - IV: 4-14/09

- - 9 November 15-19 October -

19-21 November 21-23 November - - V:?

- - - 10-14 December -

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