DIRECTORATE-GENERAL
ENVIRONMENT
Directorate A – Green Economy
ENV.A.3 - Chemicals
CA-March14-Doc.2 – Draft minutes
MINUTES
54thmeeting of representatives of Members States Competent Authorities for the implementation of Regulation (EU) No 528/2012 concerning the making availableon the market and use of biocidal products
11-13 December 2013
Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 2 299 11 11
E-mail:
- Adoption of the agenda
CA-Dec13-Doc.1
At the request of the German Competent Authorities (CA), a point of information on a workshop was added to the agenda under point 14.2.
With this amendment, the agenda was adopted.
- Adoption of the draft minutes of the previousCA meeting
Draft minutes with comments from DK, FR, SE and UK
The Danish CA requested that the minutes explicitly state that Denmark expressed concern with the delay of the adoption of the scientific criteria for endocrine disruptors.
With this amendment, and two editorial suggestions from the Commission services, the minutes were adopted.
- Final discussions on draft regulatory measures
3.0Notes on the principles for taking decisions on the approval of active substances – POP assessment / For endorsement
CA-Dec13-Doc.3.0
CA-Dec13-Doc.3.0.a
Based on the comments received after the previous CA meeting, the Commission services presented a proposal to modify the principles to be taken into account for taking the decisions on approvals, in order to include the assessment of properties of persistent organic polluents (POP). Indeed, these criteria shall be assessed by the mere application of the Biocidal Products Regulation (BPR) and Regulation (EC) 850/2004 on POPs. The Commission services clarified that POP substances are de facto covered by the exclusion criteria, as a POP is a substance that is vPvB. All Member States agreed on this modification.
Denmark referred to their letter, in which they regret the delay for the adoption of criteria for endocrine disruptors (ED), and requests another approach on the application of the ED temporary criteria by considering also the consistency with decisions taken on a given substance within the context of other legislations. Denmark asked also for the consideration of the expert judgement, and was supported by several Member States.
In addition, Sweden referred also to their letter where they regret that some exclusion / substitution criteria are left aside until further guidance is developed, which might take some time. They consider that experts can sometimes easily conclude on critical effects, and therefore consider that those criteria shall be applied in clear-cut cases.
The Commission services undertook toinclude these elements in a revised version of the document to be presented at the next CA meeting.
3.1.Draft Commission implementing Regulation and draft assessment report for the approval of cyproconazole for PT 8 / For discussionRMS: IE
CA-Dec13-Doc.3.1
CA-Dec13-Doc.3.1a
The Rapporteur Member State (RMS) presented the revised assessment report (AR) on Cyproconazole for product-type (PT) 8. A discussion took place on the duration of the proposed approval, as the assessment report concludes that cyproconazole meets the criteria for being classified as toxic for reproduction category 1B in accordance with Regulation (EC) No 1272/2008, which is an exclusion criterion according to the BPR. In addition, the report concludes that the substance meets the criteria for being very persistent (vP) and toxic (T) according to Annex XIII to Regulation (EC) No 1907/2006, which is a substitution criteria.
The RMS proposed to have a longer period than a 3-year approval. A Member State proposed to delay the approval, whereas the applicant supported the fact that a decision should be taken now on basis of the existing harmonised C&L. In view of the practical disadvantages of a 3-year approval, the Commission services agreed to amendtheir proposal although no essentiality had really been demonstrated on the substance, as normally needed in accordance with the principles for approval endorsed at the last CA meeting. It was finally agreed between the Commission services and Member States that a 5-year approval would be proposed.
Several Member States pointed out issues with the discussion of CLH dossiers within the Risk Assessment Committee of ECHA (RAC), and asked in particular for a better coordination between the work of the RAC and the biocides review programme, as well as better flexibility from the RAC on the acceptance of biocides template documents.
The Chairman invited any remaining comments to be sent to the RMS and the Commission services by 24 January at the latest.
The Chairman then concluded that the discussions were finalised and the draft Regulation would be submitted to the Standing committee, either through written procedure towards the end of January or the beginning of February, or at its next meeting in March.
3.2.Draft Commission implementing Regulation and draft assessment report for the approval of silicon dioxide for PT 18 / For discussionRMS: FR
CA-Dec13-Doc.3.2
CA-Dec13-Doc.3.2a
The RMS presented the revised AR on Synthetic amorphous silicon dioxide for PT18. The Commission services explained that the drafting of the Regulation was trying to avoid pre-empting horizontal discussions across legislations on the identification nanomaterials. It was nevertheless important to note that the present assessment was based on a stable aggregates > 1 µm which fulfils the legal definition of a nanomaterial, but that the effect and risks of individual particles of nano-size where not assessed because the aggregates are not supposed to dissociate. The approval should therefore not cover other kind of aggregates.
A Member State requested that the column describing the structural characteristics in the Annex of the Approval is renamed “Reference structural characteristics”.
Another Member State pointed out that the wording in point 5 of the section 3.3 of the assessment report should be slightly modified to reflect that the statement that personal protective equipment(PPE) was not needed was based on the assessment of the reference product, and that the conclusion might be different for other products or on the basis of new information.
The Chairman invited any remaining comments to be sent to the RMS and the Commission services by 24 January at the latest.
The Chairman then concluded that the discussions were finalised and the draft Regulation would be submitted to the Standing committee, either through written procedure towards the end of January or the beginning of February, or at its next meeting in March.
3.3.Draft Commission implementing Regulation and draft assessment report for the approval of transfluthrin for PT 18 / For discussionRMS: NL
CA-Dec13-Doc.3.3
CA-Dec13-Doc.3.3a
The RMS presented the revised AR on Transfluthrin for PT18, indicating that editorial modifications were still needed in the approval Regulation.
A Member State wanted to have the usual conditions on the establishment of an MRL, like in the approval of other PT18 active substances. It was eventually agreed that such condition seemed not needed in the present case, as the assessment showed that potential residue levels in food will be negligible based worst case intake calculations for reference products. A paragraph could however be added in section 3.3 of the assessment report to indicate that attention should be paid on the matter at the product authorisation stage.
The Chairman invited any remaining comments to be sent to the RMS and the Commission services by 24 January at the latest.
The Chairman then concluded that the discussions were finalised and the draft Regulation would be submitted to the Standing committee, either through written procedure towards the end of January or the beginning of February, or at its next meeting in March.
3.4.Draft Commission implementing Regulation and draft assessment report for the approval of IR3535 for PT 19 / For discussionRMS: BE
CA-Dec13-Doc.3.4
CA-Dec13-Doc.3.4a
The RMS presented the revised AR on IR3535 for PT19, and indicated that it still needs to check some element on phys/chem properties and the specifications of the substance.
A Member State noted its disagreement on the conclusion on dermal absorption, and considered that the extrapolation of the value of 14% from a 20% water/ethanol formulation to a notified product should be considered at product authorization level in a case by case approach. The RMS disagreed and argued that the point had been discussed and validated in TM. Further bilateral discussions were needed.
Another Member State noted the need for some editorial modifications in the assessment report to reflect that the use of a deterrent was not requested as an approval condition.
A debate took place on the need to have, in the section 3.3 of the assessment report, a paragraph reflecting that products containing IR3535 should be used with precaution on children, in particular bellow one year-old, even though a safe use was demonstrated. Some Member States considered that it was rather a best practise than the application of the precautionary principle as no evidence of risk was available, and that a statement might be confusing. On the other hand, other Member States and the Commission services considered useful to have a factual paragraph that gives some direction when companies and users would have to choose products, as no specific concerns for children were highlighted for this substance compared to DEET for instance.
It was agreed that further work was needed on this specific paragraph, and that a drafting proposal would be circulated after the meeting with a view to reach an agreement on the matter before consultation of the Standing Committee.
The Chairman invited any remaining comments to be sent to the RMS and the Commission services by 24 January at the latest.
The Chairman then concluded that apart from the above-mentioned paragraph, the discussions were finalised and the draft Regulation would be submitted to the Standing committee, either through written procedure towards the end of January or the beginning of February, or at its next meeting in March.
3.5.Draft Commission implementing Regulation and draft assessment report for the approval of lauric acid for PT 19 / For discussionRMS: DE
CA-Dec13-Doc.3.5
CA-Dec13-Doc.3.5a
The RMS presented the revised AR on Lauric acid for PT19.
A Member State asked for clarifications about the reference to life cycle stages production of the active substance and biocidal products in section 3.3 of the assessment report, including the need the production and formulation processes as described by the applicant still apply and the application instructions refer to use.
The RMS pointed out that this statement is usually made in each of its assessment report. The Commission services reminded past discussions on the matter, and re-stated that the scope of the BPD or BPR does not cover the assessment of the risks at the production stage, but is focused on the use and consequences of the use of the biocidal product. It was therefore agreed to remove the statement.
The Chairman invited any remaining comments to be sent to the RMS and the Commission services by 24 January at the latest.
The Chairman then concluded that the discussions were finalised and the draft Regulation would be submitted to the Standing committee, either through written procedure towards the end of January or the beginning of February, or at its next meeting in March.
3.6.Draft Commission implementing Regulation and draft assessment report for the approval of copper pyrithione for PT 21 / Postponed to forthcoming CA meetingRMS: SE
The Commission informed delegates that this issue had been referred to ECHA for discussion in a BPC Working Group and subsequent BPC opinion. No more CA meeting discussion was therefore foreseen.
3.7.Draft Commission implementing Regulation and draft assessment report for the approval of DCOIT for PT 21 / For discussionRMS: NO
CA-Dec13-Doc.3.7
CA-Dec13-Doc.3.7a
The RMS presented the revised AR on DCOIT for PT21. The RMS expressed its concerns that the generic condition on PPE for non-professional users may be misleading as the substance is a strong skin sensitizer and should not be authorised for non-professional users. Another Member State supported the RMS and considered that there was a particular concern on the sensitization for non-professional users since the threshold was low.
The Commission services recalled that the current practise has always been to only ban specific uses at the time of the approval when it was assessed or based on a specific concern which will be relevant for all products containing the substance. In the case of DCOIT, no specific assessment for non-professional users has been made as the use was not requested by the applicant. The applicant indeed currently markets the substance only for professional use, noting that this choice is in particular due to the sensitizing properties of the substance.
A Member State considered that approval decision was not the right place to impose good practises on the use of products. On the other hand, the Commission services reminded the objective to ensure consistency with a general approach on the management of antifouling previously agreed by Member States under agenda point 8.4.
After a debate, it was agreed to remove from the draft approval Regulation the condition related to the wear of PPE for non-professional users in the case of DCOIT.
The Chairman invited any remaining comments to be sent to the RMS and the Commission services by 24 January at the latest.
The Chairman then concluded that the discussions were finalised and the draft Regulation would be submitted to the Standing committee, either through written procedure towards the end of January or the beginning of February, or at its next meeting in March.
3.8.Draft Commission decision concerning the non-approval of certain substances / For discussionCA-Dec13-Doc.3.8
A Member State raised concerns about the identity of silver chloride, and the Commission asked it to send its concerns in written.
At the request of several Member States, the Commission undertook to indicate in a recital that the phase-out periods are those provided for by Article89 of BPR.
The Chairman invited any remaining comments to be sent to the Commission services by 24 January at the latest.
The Chairman then concluded that the discussions were finalised and the draft decision would be submitted to the Standing committee, either through written procedure towards the end of January or the beginning of February, or at its next meeting in March.
3.9.Proposal for a Commission implementing Regulation specifying the procedures to amend Annex I / For discussionCA-Dec13-Doc.3.9
The Commission introduced the revised proposal.
A Member State requested that it should be possible for a substance to be included in one of the categories 1-5, even if additional data was requested during the evaluation. This was important because of the list provided for by Article95, which when it becomes product-type specific may prevent the placing on the market of a product belonging to another PT than that indicated in the list. It was agreed that the text would be redrafted, so as to allow this possibility, and to provide for inclusion in category6 following a request for additional data only if a full data package was submitted and the applicant so requested.
A Member State requested that a 'may' be inserted in recital3, to reflect the fact that AnnexI-inclusion does not always require les data than substance approval. The Commission services agreed to this request.
It was agreed to clarify the scope of the Regulation in Articles 1-3, and to ensure consistency between those Articles in that respect. In particular, it was agreed to clarify that the Regulation applies to both inclusions and subsequent amendments of restrictions, and that it does not cover inclusion in Category 7.
Regarding the fact that the Regulation does not cover Category 7, the German CA requested that a recital should clarify that the reason was merely uncertainty due to lack of experience at this stage, and not a principle position against inclusions in category 7. The Commission services declined to include a recital not corresponding to any operative provision of the Regulation, which in their view would go against good legislative practice, but confirmed the German understanding of the reason for not covering Category7 at this stage, and undertook to clarify this in the minutes of the Standing Committee meeting.
On request of a Member State, it was agreed that the scope of the draft Regulation should be extended to cases where a substance has been evaluated for approval.
The Commission submitted a revised version reflecting the agreed changes with view to seeking the opinion of the Standing Committee in its meeting scheduled for 13December2013.
3.10.Commission decision concerning the placing on the market for essential use of biocidal products containing copper / For discussionCA-Dec13-Doc.3.10;
CA-Dec13-Doc.10.1
The Commission services presented a summary of all the applications received so far, as well as the draft decision on the 2nd wave of applications. A few corrections were requested in the Annex with regards to uses requested by some Member States.
A Member State questioned the need to apply for an essential use derogation for ships, questioning whether it was falling under the scope of the “use” of a biocidal product under the BPR.
Another Member State was of the opinion that the rules applying on the boat are the ones of the country in which it is flagged. No conclusion could be reached on this specific point.
In addition, the Commission services explained that NO had to apply to the EFTA Surveillance Authority (ESA) if they wanted a derogation for essential use on Copper and that NO would therefore be removed from the current draft decisions.
The Commission services urged Member States that are still planning to ask for essential use derogation to submit the demand without delay, as it was important to now close this issue.
3.11.Draft Commission implementing Decision regarding restrictions of authorisations of biocidal products containing IPBC notified by Germany in accordance with Directive 98/8/EC of the European Parliament and of the Council / For informationCA-Dec13-Doc.3.11
CA-Dec13-Doc.3.11.a
The Commission services briefly introduced document CA-Dec13-Doc.3.11, which covers four notifications received from Germany concerning a concern with automated dipping. This decision is addressed to all Member States in accordance with Article 36(4) of the BPR. Upon request from a Member State before the meeting, the Commission services clarified some general aspects regarding the impact of Commission Decisions taken in the context of mutual recognition (MR) disagreements: