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

CA-May16-Doc.2

DRAFT MINUTES

63rd 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

16-17 March 2016

Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 2 299 11 11

E-mail: [email protected]

16 MARCH

1. Adoption of the agenda For adoptionCA-March16-Doc.1

The draft agenda of the 63rd 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 (CA meeting) was adopted as proposed.

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

For adoptionCA-March16-Doc.2 with comments from SE, UK.

The draft minutes of the previous CA meeting with comments from SE and UK were endorsed.

3. Draft delegated acts

3.1. Amendment of Review programme Regulation For information

CA-March16-Doc.3.1

The Commission informed the CA meeting of the upcoming amendment of the Review Regulation as presented in document CA-March16-Doc.3.1 with a view to update Annex II in the light of the recent calls for taking over of active substances (e.g. nanomaterials, in situ generated active substances, QUATs).

The Chair invited Member States and stakeholders to check the changes made to the substances/product type combinations listed in Annex II and to send written comments by 15 April.

The Chair also invited Member States to signal their interest to be evaluating Competent Authority (eCA) for the active substance dialuminium chloride pentahydroxide.

4. Biocidal products

4.1. C&L of biocidal products For discussion & endorsement CA-March16-Doc.4.1

The Commission briefly introduced document CA-March16-Doc.4.1 and the reasons for the proposed update of document CA-May13-Doc.5.4-Final. The Commission also informed the CA meeting that the updated version of the document was agreed with the services responsible for the CLP Regulation (DG GROW and DG ENV).

The Chair noted that the CA meeting endorsed document CA-May13-Doc.5.4-Final.rev1.

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4.2. Implementation of the new ATP Regulation in anticoagulant rodenticides

For discussion CA-March16-Doc.4.2

The Commission introduced document CA-March16-Doc.4.2 with the support of a presentation (which has been uploaded on Circabc – see document CA-March16-Doc.4.2 - meeting presentation).

Upon request from several Member States, the Commission clarified the following:

- The notification of administrative changes does not operate with a reference Member State (refMS), as the notifications are directly submitted to all the Member States where a product is authorised. However, where a Member State rejects an administrative change, that Member State shall inform the other Member States in accordance with Article 6(3) of the changes Regulation.

- Where an authorisation holder (AH) wants to change the product composition below the specific concentration limit (SCL) to maintain the general public as a user category, this change may be handled as an application for a major change without requiring an application for a new, different application for product authorisation (unless the AH wishes to do so). It was recommended that such application for a major change is submitted to the relevant CA(s) as soon as possible, so that the change can be agreed before the entry into application of the 9th ATP (adaptation to technical progress) Regulation.

- The case referred to in the footnote 2 of Annex I is just an example based on an earlier implementation of the harmonised classification and labelling (CLH) by 01/01/2017.

- The reference to Article 48 of the BPR in document CA-Nov14-Doc.5.2-Final is no longer relevant, as the new CLH can only be implemented (in already authorised products) before the date of application of the 9th ATP Regulation on a voluntary basis.

For the sake of reducing the administrative burden both for companies and CAs, Industry representatives suggested that, where a company does not intend to keep the general public as a user category, the notification of the administrative change is omitted and the relevant CA then removes the use by the general public when resolving the application for renewal of the product. Industry representatives also stressed that CAs need to deliver on time with the applications for renewal of the applications, as in this process there is no more a 3-year transitional period that would allow existing products to remain on the market while waiting for the final decision of the CAs.

Concerning the proposal of Industry to optimise the workload and benefiting from the synergies of the renewal process, on account of the high number of products that might be affected by the new CLH and considering that the renewal process is expect to end by the time when the 9th ATP will enter into application, the Commission invited Member States to consider this suggestion back home in order to close the discussion at the next CA meeting.

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4.3. The Chair invited Member States and stakeholders to send written comments by 15 April 15. The document will be tabled for final discussion and endorsement at the May CA meeting.Update of Annex IV to note for guidance on the BPF concept

For endorsement CA-March16-Doc.4.3

The Commission briefly introduced document CA-March16-Doc.4.3 and the reasons for the proposed update of document CA-Nov14-Doc.5.8 – Final.Rev2, as agreed by the Coordination Group (CG).


4.4. Update of the note for guidance on the SPC content

For endorsement CA-March16-Doc.4.4

The Commission briefly introduced document CA-March16-Doc.4.4 and the reasons for the proposed update of document CA-May15-Doc.4.4-Final.rev2, as agreed by the Coordination Group (CG).


4.5. Update of Note for guidance CA-Dec13-Doc.11.3 – Final (use of food & feed as repellents or attractants)

For endorsementCA-March16-Doc.4.5

The Commission briefly introduced document CA-March16-Doc.4.5 and the reasons for the proposed update of document CA-Dec13-Doc.11.3 – Final, in connection with the Commission Decision pursuant to Article 3(3) of the BPR on a product consisting of dry lavender blossoms.

The Chair noted that the CA meeting endorsed document CA-Dec13-Doc.11.3 – Final.rev1.

4.6. Q&A document on the simplified authorisation procedure


If agreed by the CG

The Commission briefly introduced document CA-March16-Doc.4.6.rev1, reflecting some minor changes introduced by the CG at its 16th meeting. The Commission informed the CA meeting that the document had been agreed by the CG with a reservation from a Member State on Q&A pair 11 (Article 95 check for category 6 substances).

At the request of a Member State, the Commission clarified that products authorised under the simplified authorisation procedure shall not be given an authorisation in the Member States where the products are notified in accordance with Article 27(1) of the BPR.

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Another Member State pointed out that the guidance on Substances of Concern (SoC) referred to in Q&A pair number 13 does not cover the environmental part, which is nearly finished by ECHA. This Member State also suggested slightly amending the wording of this Q&A pair, which was agreed by the CA meeting.

With the above-mentioned changes, the Chair noted that the CA meeting endorsed document CA-March16-Doc.4.6.rev1.

4.7. Report from Coordination Group For information

The Commission briefly informed the meeting of the main issues discussed at the 16 th CG meeting:

i) In terms of MR disagreements, four formal referrals were discussed and closed with a CG agreement by consensus.

ii) The authorisation of DEET containing products was discussed, including both technical and regulatory aspects (see also agenda item 4.14). Austria is also working on a workshop to further address some technical aspects that are relevant for repellent products.

iii) Two notes for guidance were agreed and formally referred to the CA meeting for endorsement (see agenda items 4.6 and 4.15).

iv) CG members agreed to set up a Working Party to support the preparation of SPCs and the harmonisation of their translation, taking into account that translations are not in the scope of the Working Party and also noting the limited availability of resources in Member States.

For further information, the Commission referred the meeting to the list of conclusions and actions arising from the CG-16 meeting, which is going to be agreed via written procedure soon and then made available on the dedicated CG CIRCABC interest group.

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

For informationCA-March16-Doc.4.8

The Commission briefly introduced document CA-March16-Doc.4.8, underlining that the four last referrals have now been closed with a CG agreement at CG-16.

4.9. Executive report on product authorisations


The Commission briefly introduced document CA-March16-Doc.4.9. It was clarified that products authorised under the simplified authorisation procedure (SAP) are listed in the histogram under the "EU" bar. The Commission and some Member States asked ECHA to consider keeping this "EU" area for products to be authorised under the Union authorisation (UA) procedure.

A Member State also requested ECHA to fix the problem that products authorised under the SAP are not available in ECHA's dissemination website. This means in practice that those

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products can only be identified or checked by persons with full access to R4BP3, which is not always the case for inspectors. ECHA will address these two elements.

4.10. Executive report on applications for Union authorisation

For informationCA-March16-Doc.4.10.aCA-March16-Doc.4.10.b

ECHA briefly introduced documents CA-March16-Doc.4.10.a&b, as there are two documents now: one for pre-submissions and another for applications already submitted.

The Commission suggested that eCAs responsible for the assessment of applications for authorisation of products containing the same active substance should have some kind of coordination at a point in time within the 1-year evaluation period (e.g. by month 6) in order to see the main issues identified in the applications so that those issues are addressed in a similar way when requesting clarifications to applicants (as it is done in other regulatory fields like medicines – list of questions).

Industry representatives asked the Commission about the status of the draft implementing decisions regarding hand disinfectants, as the deadline for the submission of the UA applications is quickly approaching (1/07/2016). The Commission responded that the draft Commission decision, which considers the products as falling within the scope of the BPR, will be discussed at the Standing Committee for biocidal products (SCBP) later this week and that the SCBP will be formally consulted as soon as the TBT consultation is closed (due by the 3rd week of April).

4.11. Request from the Netherlands for the extension of an action taken under Article 55(1)

For information

The Commission briefly introduced document CA-March16-Doc.4.11, which agrees with the request sent by the Netherlands to extend the derogation granted in accordance with Article 55(1) of the BPR.

The Commission also mentioned that France has also recently informed the Commission and Member States of another derogation in accordance with Article 55(1).

4.12. Differentiation between substance, mixture and article

For discussionCA-March16-Doc.4.12

The Commission briefly informed the meeting that, without prejudice of any change needed on REACH guidance, the CG will discuss at its next meeting some regulatory guidance on how best to handle this type of biocidal products, particularly those which are treated articles with a primary function (e.g. nets, bracelets, blankets, etc...). It was reminded that this discussion was as a follow-up action of a CG agreement reached for a formal referral.

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4.13. Procedural issues and delays identified in product authorisation

For discussion Closed session

The Commission introduced this topic, with the support of a presentation (which has been uploaded on Circabc restricted to CAs: see document CA-March16-Doc.4.13 - meeting presentation late procedures).

Regarding the still on-going BPD procedures with decisions due by 31/12/2015, the Commission thanked Member States for having reduced the number of open cases since November last year (nearly 800 cases). The Commission encouraged Member States to continue with the two following priority actions:

1.- To close obsolete cases and,

2.- To close cases for which the product authorisation has already been granted, provided that the CA has checked before closing the case and creating the corresponding asset that: i) the case type is correct (e.g. NA-MRP or NA-MRS instead of NA-APP) and ii) the case is correctly linked to the right reference case (for MR-P) or reference asset (for MR-S), as any corrections have to be made before closing the case (phase 3 of the spring cleaning). If needed, CAs are encouraged to contact ECHA IT team. A Member State noted that the information in R4BP2 would be helpful to establish the links between applications.

Regarding the late applications submitted under the BPR, the Commission warned Member States about the high rate of late on-going procedures (cases) for MR-S, and also focused on the key role of refMSs, as a few late procedures would lead to a higher number of late procedures in the concerned Member States (CMSs). Particular attention was given to some applications where the delays in the refMS are above 12 months (e.g. deltamethrin containing products), which means in practice that 2 out of the 3 years provided for in Article 89(2) of the BPR have been already consumed.

A Member State mentioned that it would be important to know what the issues behind those significant delays are in order to find a solution. The Commission responded that it is up to the Member States to make an analysis of their internal situation, as there are some Member States that seem to be able to meet the deadlines in the BPR.

The Commission insisted again that actions should be taken as soon as possible, as the number of applications is expected to significantly increase in the near future as a consequence of the higher number of active substance approvals per year (e.g. from 10-15 to 50).

4.14. Authorisation and MR of DEET containing products

For discussion Closed session

The Commission briefly informed the meeting of the main issues discussed at the 16 th CG meeting, with the support of a presentation (which has been uploaded on Circabc restricted to CAs: see document CA-March16-Doc.4.14 - meeting presentation DEET products).

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Regarding the feedback from ECHA's WG on HH exposure and the discussion on whether some RMMs expected to be observed by the general public, the main conclusion reached by the CG was that the use of long clothing was not considered to be an acceptable RMM, since several member states argued that this RMM is not likely to be observed or to be effective. Therefore long clothing will not be applied in the assessment.

The consequence of this decision is that, as such RMM (i.e. “wear long-sleeved shirts and trousers”) cannot be used to reduce exposure, then there is an unacceptable risk for a given age group (children) and the condition in Article 19(1)(b)(iii) is not met.

The CG also agreed, as per previous CG discussions, that products classified with "H 315" are not allowed to be applied on the skin, unless product-specific data shows the product is not skin irritant.

The CG also supported a regulatory way forward presented by the Commission to close the on-going procedures in accordance with Articles 19(5) and 37 of the BPR, which addresses the needs of refMSs and does not block MR procedures. As a result, CA representatives were encouraged to implement the agreed way forward and speed up the authorisation of the pending applications. Applicants and Member States are also encouraged to follow MR-P, so that any outstanding issue can be solved in all the Member States at the same time. Otherwise, any change to the product authorisation in the refMS would have to be triggered by a CG agreement or a COM decision.

On a more general note, the ECHA's WG on HH exposure is expected to re-start the discussions in order to develop an agreed exposure assessment model to be used for other insect repellents (e.g. icaridine, IR 3535) and at the renewal of DEET products. Furthermore, the Austrian CA is going to organise a Workshop in June 2016, which will be a key opportunity to identify any outstanding issue on the assessment of insect repellents (HH, ENV or EFF) to be addressed by ECHA WGs. Austria will coordinate the dates with ECHA to avoid overlapping with the dates for the BPC and WGs meetings.

A Member State mentioned that the CG decision on products with the hazard statement "H315" might affect a high number of products (around 50%) and that a non-authorisation decision might have to be checked with the public health authorities. Time would be needed to provide data showing that the products are not skin irritant via a condition in the products authorisation. The Commission responded that the BPR already provides for a clock stop in order to allow the applicant to provide further data (Article 30(2) of the BPR), but it seems that this step is already over. Regarding the possibility to grant conditional authorisations, the Commission mentioned that Member States should perhaps consider whether DEET products without that controversial H statement (as some applicants could have already produced the required data) or products containing another AS(s) are already available on the market.

At the request of another Member State, the Commission clarified that the CG also supported that already authorised products have not to be reviewed as a result of the above-mentioned CG agreement. This does not prevent though that a particular product can be subject to a referral to the CG in the context of MR-S, and where relevant, be subject to some amendments.

Two Member States mentioned that there is no detailed guidance on how to use Article 19(5) of the BPR. In that respect, the Commission responded that Member States are expected to make a judgement of the situation in their country, as it is done to consider whether or not the

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condition in Article 5(2) of the BPR are met for products containing an AS meeting the exclusion criteria.

Upon request of another Member State, the Commission clarified that a decision to authorise a product in accordance with Article 19(5) of the BPR has to be clearly mentioned in the authorisation decision; e.g. "This certificate of authorisation is granted in exercise of the powers conferred by Articles 19(1), 19 (5) and 30 (1) of Regulation (EU) No 528/2012….".

Finally, the Commission warmly encouraged Member States' representatives in the ECHA's WGs, as well as ECHA's colleagues in charge of those WGs, to early identify any issues that might pose regulatory issues at the product authorisation and MR stages, so that those issues are properly addressed within the CG before the relevant deadlines for product authorisation are over.

4.15. Cut-off dates for paragraph 8(a) of Annex VI to the BPR


The Commission briefly introduced document CA-March16-Doc.4.15, had been already agreed by the CG with a reservation from a Member State on some of the examples provided in the annex of the document. Another Member State also noted that the derogation in paragraph 13 of the document could be interpreted on a case by case basis, on account of the relevance of the information becoming available to the refMS/eCA.

At the request of Member States, the Commission clarified the following:

- Where new data on the AS is available, for example due to the introduction of a use which was not assessed during the active substance approval, this case would not fall under the scope of this paper since the information was submitted by the applicant within the application and has therefore to be assessed accordingly by the refMS/eCA. In other words, it is neither expected that this information is made available to the refMS/eCA once the assessment of the application has been finalised within the 365 period nor raised by the CMSs.

- As in other guidance documents, the list of examples is non-exhaustive and the aim at illustrate how the principles in the paper can be implemented.

- In the context of UA applications, the peer review phase within the BPC will provide Member States the same level of interaction with the eCA as during the MR phase for MR procedures.

- Regarding the example in the annex "when the AS meets now the substitution criteria", the product will be treated as other similar products having been authorised before the new relevant information on the AS was available, that is, for 10 years.

The Chair noted that the CA meeting endorsed document CA-March16-Doc.4.15.

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5. Active substances

5.1. Data requirements for free radical-ions

For discussion and agreementCA-March16-Doc.5.1CA-March16-Doc.5.1.aCA-March16-Doc.5.1.b

The NL CA presented a preliminary draft guidance document on the evaluation of free radicals, discussed during a workshop held in the Netherlands on 8 February 2016. A number of agreements was reached during this workshop but several questions are still pending.

Some Member States indicated that they needed more time to look at the document. In addition, further reflexion was needed on certain question of policy, like on the management of product authorisation in relation to devices. It was recognised that stakeholders need guidance on how to build their application.

The Commission invited for comments to be submitted by 15 April. In the meantime, companies could already rely on this document as a preliminary draft to help them to build their application. This work will then be forwarded to ECHA, for taking over as it relates to technical guidance.

5.2. Progression of the review programme on active substances


The Commission presented a state of play of the progress of the review programme. In particular, it was highlighted that progresses have been made since a year, but that there was needed to focus more on the 1st and 2nd priority lists. Around 60 to 70 reports have to be submitted by member States on the 2nd list by the end of the year, and a dozen missing report from the 1st list must also be submitted as soon as possible.

Member States were also requested to submit as soon as possible the reports from the 2 nd list, and not a few weeks before the deadline, so that ECHA can better organise the work within the BPC and achieved the objectives fixed within Regulation (EU) No 1062/2014.

5.3. Public consultation on substances meeting exclusion/substitution criteria

For discussion and endorsementCA-March16-Doc.5.3

The Commission presented some proposals in order to improve the collection of information during the public consultation, as well as a proposal in order to get more added valued from the BPC in its opinions on alternatives to the concerned substances.

The BPC Chairman recognised the need for improvement and proposed to make a distinction in term of output between substances meeting the exclusion criteria and substances meeting only the substitution criteria. He expressed also concerns about the limited time available during BPC activities (9 months to deliver an opinion), but recognised the added value that the committee can bring.

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In relation with the improvement of the collection of information, a Member State pointed out the difficulty to reach the real concerned persons (e.g. users of products). Actors vary across sector, product-types and uses. Member States proposed to use the Helpnet channel to spread the information, as well as improve its communication to other EU agencies (e.g. ECDC, EFSA). ECHA agreed to investigate these possibilities. An NGO also pointed that this public consultation period should not be the only period when data or information should be collected on alternatives, and that Member States should also use updated information at the time of product authorisation. This NGO also regretted its own lack of resources to collect information on alternatives and contribute to these public consultations.

In relation to expected work from the BPC, several Member States expressed concerns about the recourse to the methodology of the comparative assessment, the workload for the rapporteur Member State, and the lack of expertise on practical and economic disadvantages. CEFIC shared the concerned expressed by these Member States and considered that contributions sent during the public consultation phase should be valued.

The Commission clarified that it does not expect the BPC to make a comparative assessment but to make a preliminary work of analysis of the identified alternatives, in particular using the expertise of the BPC on substances already approved or reviewed by the BPC for the concerned uses. In addition, by better organising the work and better following the order of the priority lists, the BPC could ensure to examine exclusion/substitution substances for a PT after having reviewed all the other existing active substances assessed for the same PT. Finally, the Commission highlighted that the overall objective is to help the decision-making process, both for active substance approval and product authorisation. On a more general note, the above-mentioned identification and analysis would also encourage the formulators of biocidal products to switch from the candidates for substitution to more suitable alternatives, which is the final objective of the BPR.

The CA meeting agreed that this specific work to be done by the BPC should not delay the delivery of the opinions, and should be integrated into BPC's workflow and the global timing of 9 month for BPC's work.

The Commission asked for comments on the proposals presented in the document and for further proposals from Members States, ECHA and stakeholders on the work expected from ECHA/BPC by 15 April. A revised version will be tabled for the next CA meeting.

5.4. Renewal of anticoagulant rodenticides For information

The Commission informed the meeting of the main developments since the last meeting on this topic, namely the coordination meetings between the eCAs for the renewal of the active substances, the public consultation linked to this process and the activities of the WP for the development of standardised sentences for the SPC sections of anticoagulant rodenticides.

Regarding the coordination meetings between the eCAs, a physical meeting took place in Helsinki on February 16th, followed by a WebEx meeting on March 8th. The outcome of those meetings has been very useful with a view of having more harmonised ARs, which will facilitate the peer review process. The ARs are expected to be submitted by the end of March and that submission will be followed by a commenting period and final discussion at the June BPC.

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Regarding the public consultation, the contributions on alternatives have been rather limited and sometimes containing contradictory information. This outcome also shows that the public consultation process needs to be improved (see agenda item 5.3 above).

Regarding the working party (WP) for the development of standardised sentences for the SPC, a first meeting took place in Madrid in January 2016. Comments were submitted to the proposals made by the Commission and an updated version of them will be send soon to the WP for further comments. A physical meeting could be scheduled in May back to back to the CG meeting if needed. The Commission also clarified that the final output of the WP needs to be postponed until the BPC opinions will be available, in order to ensure consistency with the agreed RMMs attached to the renewal of the anticoagulant ASs.

5.4.a User categories & Art. 37 of the BPR For discussion CA-March16-Doc.5.4.a

The Commission briefly introduced document CA-March16-Doc.5.4.a, which does not aim at setting legal definitions of those categories but at achieving a common understanding of the different user categories of anticoagulant rodenticides. Moreover, it aims at providing guidance on how Member States can adapt the user categories to their national policies in the context of mutual recognition procedures by using the provisions in Article 37 of the BPR.

Several Member States thanked the Commission for this paper and agreed with its content. A Member State asked the Commission including a new case in the annex where the CMS only has one category (trained professionals).

Some Member States mentioned that in order to implement the proposed approach, it is also important to know the national policy of the refMS, which might not be easy for the CMSs. The Commission responded that the SPC of the refMS will clearly indicate in each table which use has been assessed/authorised for which user category. Apart from that, the renewal of the AS will clearly limit some uses to some user categories (e.g. use in sewers, open areas, waste dumps, etc. to trained professionals only). Therefore, each CMS will know to which user category in tis territory a given use may be authorised.

At the request of another Member State, the Commission clarified that in the context of MR procedures, the refMS is expected to propose a draft SPC in EN using the three user categories described in the paper and then the CMSs may adapt these categories in accordance with Article 37 of the BPR.

Industry representatives asked the Commission whether a CMS can authorised some user categories that are not authorised by the refMS because of some national policies, while the risk assessment led to a safe use (as it was done during the first round of authorisations under the BPD). The Commission will further investigate whether this practice is still consistent with the BPR, particularly for MR in sequence, as the product authorisation has already been granted by the refMS and in principle uses that are not authorised by the refMS could not be mutually recognised by the CMSs.

The Chair invited Member States and stakeholders to send written comments by 15 April. The document will be tabled for final discussion and endorsement at the May CA meeting.

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5.5. Notifications submitted to ECHA for taking over of the role of participants

For information CA-March16-Doc.5.5

Member States took note of the preliminary Commission findings on the acceptance of declarations of interest submitted pursuant to Articles 15(a) and (c) of Regulation (EU) No 1062/2014, upon which they had already been consulted in writing.

At the request of the notifier, a detailed discussion was held, first in presence of the notifier, and then in closed session, concerning the preliminary conclusions of the Commission on silver nitrate for use in product-type 9, which Member States agreed with.

The Commission then informed Member States that these conclusions would be transmitted to ECHA for further action on their part.

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6. Treated articles

6.1. September 2016 deadline For information

The Commission indicated that a "banner" for emails had been developed by ECHA on the September 2016 deadline and invited the competent authorities to use it.

Also was pointed out that trade representatives of third countries were informed about the upcoming deadline.

6.2. Verifying the Efficacy of Biocidal Products and Treated Articles


Sweden provided the conclusions of the Nordic project "Verifying the Efficacy of Biocidal Products and Treated Articles". The Chair took note of it

7. Horizontal matters

7.1. ECHA communications For information

ECHA made a presentation on the trend in applications since the beginning of 2016 and on the disinfectant project. ECHA highlighted the expected benefits of the project for the eCAs and called for their participation.

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The Commission also encouraged eCAs to use the support offered through the disinfectant project. Some CAs questioned the timing of the project in relation to the second priority list and ECHA clarified that the project was mainly targeting the third priority list. ECHA also highlighted that it was a first trial of such an approach to see if this fits the needs of the eCAs and that if the experience proves to be beneficial similar projects could be set up for other product types and would start well ahead of the deadlines.

7.2. ECHA R4BP security requirements and SON meeting

For information

The Chair informed the meeting about the upcoming Security Officers Network (SON) meeting in May.

It was noted that at that meeting a discussion will be held with regard to the implementation of the current ECHA R4BP security requirements. The Chair invited the members to use this opportunity to exchange experiences and to reflect upon possible improvements.

7.3. Helpex For discussion and agreementCA-March16-Doc.7.3

ECHA presented the approach proposed in the document. The aim of the paper is to streamline the interactions between Member States, the Commission and ECHA for handling BPR scope questions in HelpEx (replacement of e-consultations under the BPD and questions related to the revoked Manual of Decisions).

ECHA first clarified the responsibilities in accordance with the legal requirements and highlighted the issues that arose with the current practice: i) backlog of ‘unsolved questions’; ii) parallel discussion in different bodies (Coordination Group, CA meetings, HelpEx, BPC); iii) Commission not actively contributing in HelpEx; iv) concerns whether further legal validation of scope discussions is needed (i.e. Article 3.3 request).

The following way forward was proposed: i) ECHA to continue providing responses on topics within its remit; ii) questions outside ECHA’s remit to be handled by the national biocides helpdesks who decide on and take care of the appropriate follow-up actions (e.g. closure with dissenting views - questions to be taken forward to the right body for discussion); FAQs to be published on ECHA’s website if in ECHA’s remit (following consensus among HelpNet members).

Several questions and comments were received from CAs and stakeholders regarding in particular ECHA’s remit, availability for CAs and/or industry of consultations closed by consensus and some of them were addressed during the discussion. The need to clarify what are the topics in ECHA/NHDs remit and the way ECHA/Commission disseminate the relevant information was identified. Some improvements of the HelpEx platform were suggested.

The Chair noted that the way forward presented in the paper was accepted and invited ECHA, as requested by Member States, to provide for the next meeting a clarification on topics within its remit.

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7.4. Maximum residue limits For discussion and agreementCA-March16-Doc.7.4

The Commission presented the amended version of the note on a policy approach for the establishment of maximum residue limits (MRLs) for residues of biocidal active substances.

The main amendment was highlighted compared to the former version that an applicant has to submit an analytical method. Also was stressed the need to have an approach that takes into account the available resources at authorities and companies.

Several Member States and stakeholders provided written comments on the amended note and in the meeting. In relation to the analytical method some Member States expressed to prefer having an analytical method validated in accordance with ECHA guidance. The Commission pointed out that the provided in-house validated method by an applicant could be submitted to EU a reference laboratory if a Member State would have serious doubts.

Several Member States stated that it is necessary to further strengthen in the it is an interim approach. It was agreed that this in the note will be further stressed.

One Member State stressed that the approach have to find a balance between ensuring microbiological safety and levels of residues.

One stakeholder stated that this approach diminished legal certainty for both biocidal product formulators and food processing companies as the focus has moved from residue risk assessment to monitoring. Therefore it is unclear which levels will be applied by enforcement authorities with the risk that companies could suddenly be considered non-compliant. According to stakeholders, it is not appropriate to apply the default value as included in Regulation 396/2005 to substances that are only used in biocides. In order to ensure compliance, biocidal product formulators have no other option any more than to set specific levels under Regulation 396/2005 before a biocidal product is authorised.

The Commission pointed out to discuss this with the colleagues responsible for Regulation 396/2005.

The Chair concluded that most Member States could accept the way forward presented in the draft note and invited participants to the meeting to send comments before the end of the week. The Chair then indicated that endorsement of the approach would be sought at the next CA meeting.

7.5. Interpretation of Article 23(7) of the BPR

For discussion CA-March16-Doc.7.5

The Commission briefly introduced document CA-March16-Doc.7.5, which followed from a formal question submitted to the Commission by a Member State.

A Member State suggested amending paragraph 10(b), as the automatic cancellation of some of the authorised uses after 4 years would in practice result in an amendment of the product authorisation. The CA meeting agreed with such proposal.

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With the above-mentioned change, the Chair noted that the CA meeting endorsed document CA-March16-Doc.7.5.

7.6. Data collection For discussion CA-March16-Doc.7.6

Austria presented the so-called 'eBiozide', an IT-tool used for the systematic collection of data on biocidal products and active substances in Austria. It was highlighted that this tool aims to provide information on the quantities of active substances placed on the market in Austria per year.

Member States and industry supported the suggestion made by Austria to discuss a harmonised data format in order to facilitate exchange of information and enforcement in the EU. Some Member States noted that the involvement of, and the coordination by ECHA and the Commission in this initiative would be important.

The Chair invited the CA to send possible comments and inform whether a similar system is in place by their respective countries by 15 April.

7.7. Endocrine Disruptors For information

The Commission provided an update on the state of play on setting criteria for endocrine disruptors. It was pointed out that the process is at final stages.

In relation to the Court judgement it was indicated that the Commission has every intention to comply with the judgement and the Commission decided to continue with the impact assessment. The intention is to present draft measures before the 2016 summer break (draft delegated act for biocides and draft implementing act for pesticides). It is then expected that the first meeting of the expert group to discuss the draft delegated act for biocides would take place in September.

The Commission referred to the email of Sweden on this agenda point. It was indicated that the Commission would not like to discuss in this meeting in detail the endocrine disruptor issue because of the limited time for this CA meeting and there will be ample opportunity to discuss the draft measure once the Commission has adopted and made its draft measure public. Denmark and France stated to share the concerns expressed by Sweden in its email.

The Chair indicated to inform the CA as soon as possible about the planning for the discussion of the draft delegated act.

7.8. Aircrafts disinsection For information

The Commission informed about discussion with the UK in connection with aircraft disinsection and the disappearance of d-phenothrin, which was finally not supported in the review programme.

The Commission highlighted that other alternatives seems to be currently used in EU, like 1R-transphenothrin or permethrin.

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The Commission invited Member States to check which products are placed on the market for aircraft disinsection, and check their national rules in relation to aircraft disinsection, to ensure that there will be no issues when d-phenothrin will be removed from the market, and ensure that any recommendations made by the national authorities are in compliance in the BPR (ex: on recommended products to be used at national level).

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8. Requests for opinions

8.1. Products to be administered orally For discussionCA-March16-Doc.8.1

The Commission briefly introduced document CA-March16-Doc.8.1, which content is limited to the use of products to be administered orally for repellent purposes.

Regarding the second example (e.g. products aiming at having a repellent effect on the faeces), a Member State considered that it could also be affected by the provisions on double regulation referred to in the last subparagraph of Article 2(2) of the BPR. Another Member State considered that the product having an effect of the blood taste would not be considered as a veterinary medicinal product but perhaps a feed additive.

The Chair noted a wide support of the CA meeting to the proposals outlined in the document. Where relevant, a Member State may request the Commission to take a decision pursuant to Article 3(3) of the BPR on any specific product.

8.2. Paraffin oil for use in egg oiling operations for the purpose of controlling bird populations

For discussionCA-March16-Doc.8.2

The Commission briefly introduced document CA-March16-Doc.8.2, which follows from a formal request from a Member State under Article 3(3) of the BPR.

The Member State having submitted the request clarified that the mode of action is the creation of a mere physical barrier, as if a plastic bag was put around the eggs. Another Member State mentioned that some written comments would be sent in writing.

The Chair noted a wide support of the CA meeting to the proposals outlined in the document. The Commission will therefore proceed with the drafting of the decision pursuant to Article 3(3) of the BPR.

8.3. Water preservation For discussionCA-March16-Doc.8.3

The Commission briefly introduced document CA-March16-Doc.8.2, which follows from a previous discussion at the 62nd CA meeting and has now been agreed with the colleagues in the Unit responsible for food additives.

A Member State suggested that the term "reservoirs" should be replaced by "tanks". Another Member State asked the Commission whether Article 2(2) of the food additives Regulation would still cover products used for the treatment of water for human consumption when they are used as food additives. In this respect, the Commission clarified that substances used for the treatment of water for human consumption may also be used for other purposes (e.g. preserving food) and therefore, those uses would still fall under the food additives Regulation.

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At the request of a stakeholder representative, the Commission clarified that the provisions of the drinking water Directive were also considered when developing the paper.

At the request of a Member State the Commission clarified that, as the use discussed in the document falls under the scope of the BPR, biocidal products currently placed on the market of Member States can only contain active substance(s) that are either approved or in the review programme for product-type 5.

9. Enforcement issues

9.1. Report from BEG meeting For information

The Commission reported about the outcome of the first meeting of the Biocides Enforcement Group at ECHA, back-to-back with the ECHA Forum.

9.2. FVO questionnaire For information

The Commission reported that the Food and Veterinary Office of DG SANTE is working on the questionnaire and that it was the intention to discuss it at the next meeting.

10. New policy developments which may affect the biocides regulatory framework

10.1. Proposal for a Regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009

For information

The Commission updated the meeting on the state of play.

It was pointed out that a new definition is proposed on medical devices that may have an impact on biocidal products (for example, biocidal products used in/with medical devices may be considered a medical device). Participants were advised to discuss issue with colleagues responsible for medical devices.

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11. International Matters

11.1. OECD For information

The Chairman informed the meeting that there was no new development to be reported under this item.

12. AOB

12.1. List of Competent Authorities and other Contact Points


The Chairman invited the Committee to take note of the list and to inform the Commission by email of any update or correction to be made to that list.

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