CA-May16-Doc.2 – with comments from ECHA, SE and UK
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
16-17March 2016
1
16March- Adoption of the agenda
CA-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.
- Adoption of the draft minutes of the previous CA meeting
CA-March16-Doc.2 with comments from SE, UK.
The draft minutes of the previous CA meeting with comments from SE and UK were endorsed.
- 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.
- 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.
4.2.Implementation of the new ATP Regulation in anticoagulant rodenticides / For discussionCA-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 to 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 expected 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.
The Chair invited Member States and stakeholders to send written comments by 15 April and indicated that the document will be tabled for final discussion and endorsement at the May CA meeting.
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).
The Chair noted that the CA meeting endorsed document CA-May13-Doc.5.4-Final.rev3.
4.4.Update of the note for guidance on the SPC content / For endorsementCA-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).
The Chair noted that the CA meeting endorsed document CA-May15-Doc.4.4-Final.rev3.
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 / For endorsementCA-March16-Doc.4.6 / 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 number in the Member States where the products are notified in accordance with Article 27(1) of the BPR.
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 informationThe Commission briefly informed the meeting of the main issues discussed at the 16th 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 insect 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 / For informationCA-March16-Doc.4.9
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 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.a
CA-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 informationThe Commission briefly introduced document CA-March16-Doc.4.11, which agreeds 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 toof 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 biocidal 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. One MS noted that it was this issue of primary biocidal function that was critical to the issue raised in the paper but that this element had not as yet been included in the paper.
4.13.Procedural issues and delays identified in product authorisation / For discussion / Closed sessionThe 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 refMSare 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 sessionThe Commission briefly informed the meeting of the main issues discussed at the 16th 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).
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 indicated that they would reflect on the proposals and hoped that they would help but noted that they also had to satisfy their GovernmentMinisters and public health authorities policies that require products to be available for use by as many age groups as possible and for DEET to be used at up to 50% when travelling to locations where protection against vector borne diseases is required. The MS 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. Ttime 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 already authorised dohave not have 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.