DRAFT MINUTES
49th meeting of representatives of Members States Competent Authorities for the implementation of Directive 98/8/EC concerning the placing of biocidal products on the market
12-14December 2012
1
- Adoption of the agenda
CA-Dec12-Doc.1
No amendments were proposed. The agenda was adopted.
- Adoption of the draft minutes of the CA meeting held on 19-21September 2012
CA-Dec12-Doc.2 – with comments from AISE,CEFIC, EDANA, FR, SE and UK
One amendment was proposed to item 5.1.k, for which it was suggested to remove The discussion was closed and to rephrase the last sentence as follows: The Commission invited participants to send further written comments by end of October. With that amendment theminutes were adopted.
- Final discussions on draft regulatory measures
3.1.Proposal for a Commission Regulation amending Commission Regulation No 1451/2007 to allow additional active substances to be examined under the review programme / For discussion
CA-Dec12-Doc.3.1 Rev.1
The Commission introduced the new draft.
Following questions and suggestions from Member States, the Commission made the following clarifications: The initiative to use the new procedure should be open to Member States, in order to avoid a situation where they need to ask a company to inform the Commission of a problem of which they are already aware themselves. It is important to keep the new procedure open for an undetermined period of time, in order to allow the correction of misinterpretations which are currently unknown and will be discovered in the future. The procedure can only apply to existing active substances, since the Commission is not empowered to legislate on other active substances.
One CA suggested that the 2nd subparagraph of Article 3a(3) be amended so as to allow a participant in the review programme to opt out of supporting the new product-type. The Commission undertook to make that amendment.
The Chairman concluded that a revised version would be submitted for a vote by written procedure to the Standing Committee in January 2013.
One CA asked for the Manual of Decision to be updated in light of the Söll judgment.
3.2.Draft Commission Directive and draft assessment report for the inclusion of chlorfenapyr for PT 8 into Annex I to Directive 98/8/EC / For discussionRMS: PT
CA-Dec12-Doc.3.2
CA-Dec12-Doc.3.2a
The RMS introduced the modifications made to the assessment report (AR) since the last CA meeting to cover the comments made by CAs and the applicant. In particular, references to the PT18 product were removed from the report, and cross references madeto appropriate data.
Some CAs questioned if this substance should rather be included for a 5 year-period due to the concerns raised on the PBT status. It was clarified during the meeting that, so far, chlorfenapyr was considered as T, not B and that it may be persistent; its metabolite was not T, not B, and may be persistent. Considering those elements, the proposal for a 10-year inclusion was maintained as neither chlorfenapyr nor its metabolite were considered as PBT so far. It was agreed that the case should be referred to the ECHA PBT Working Group.
Should the substance or its metabolite meet the criteria to be considered as PBT in the future, the Commissionstated that it could then review the inclusion to restrict or remove the entry according to Article 15(2) of the BPR.
One CA requested that some provisions be added in the inclusion directive to the effect that the labels of wood treated with chlorfenapyr would indicate that such wood shall not be used for outdoor applications. The CA argued that if it was not foreseen in the inclusion, the labelling would not be mandatory according to Article 58 of the BPR.
It was however agreed that, for a matter of consistency and considering that the BPD only addresses the placing on the market of biocidal products and not that of treated articles, such requirement should not be added in the inclusion.
Nevertheless, as the concerns were considered justified, the Commission undertook to study how to address them, notably at the occasion of the transition from inclusions to approvals of substances already included into Annex I of the BPD, as it might be relevant for other substances.
With the clarifications on the PBT criteria and other editorial modifications, an agreement was reached on this substance on the AR and the draft inclusion directive.
The Chairman concluded the discussions and indicated that the draft could be submitted to the meeting of the Standing Committee for biocidal products of 14 December.
CA-Dec12-Doc.3.3
The Commission introduced the draft Decision rejecting the request made by Germany to restrict the authorisation by excluding food protection from the authorised intended uses of the product. Commission explained that it considered that, as the main purpose of the product is hygiene rather than the protection of plants or plant products, the contested claim is not excluded from the scope of Directive 98/8/EC by virtue of Article 1(2) of that Directive.
There were no comments or reactions from CAs to this draft Decision.
The Chairman concluded the discussions and indicated that the proposal would be submitted to the Standing Committee by written procedure in January.
3.4.Draft Commission Implementing Decision regarding restrictions of authorisations of biocidal products containing difenacoum notified by Germany in accordance with Directive 98/8/EC of the European Parliament and of the Council / For discussionCA-Dec12-Doc.3.4-rev1
The Commission introduced the draft Decision on the request made by Germanyto restrict the first authorisations to use by trained or licensed professionals, as well as by excluding food protection from the authorised intended uses of the contested products.
The Commission proposed to accept the restriction to professional users in line with previous Decisions on notifications sent by Germany for difethialone and difenacoum containing products. The Commission considered the restriction to professional users to be an appropriate and available risk mitigation measure for the authorisation of products containing difenacoum in Germany, taking into account that resistance against this substance in rats is reported to have been found and to be developing in the country. Furthermore, the Commission noted that Germany has a well-functioning infrastructure of trained pest control operators and licensed professionals, which means that the proposed restriction does not hinder infestation prevention.
For the food protection exclusion, Commission indicated that it also considered the main purpose of the product to be hygiene rather than the protection of plants or plant products, and that the contested claim was therefore acceptable in the context of Directive 98/8/EC.
There were no comments or reactions from CAs to this draft Decision.
The Chairman concluded the discussions and indicated that the draft could be submitted to the meeting of the Standing Committee for biocidal products of 14 December.
3.5.Draft Commission Implementing Decision approvingrestrictions of authorisations of biocidal products containing difenacoum notified by Germany in accordance with Directive 98/8/EC of the European Parliament and of the Council / For discussionCA-Dec12-Doc.3.5
The Commission introduced the draft Decision, approving the request made by Germany to restrict the first authorisations to use by trained or licensed professionals on the basis of the grounds mentioned above.
There were no comments or reactions from CAs to this draft Decision.
The Chairman concluded the discussions and indicated that the draft could be submitted to the meeting of the Standing Committee for biocidal products of 14 December.
3.6.Proposal for a Commission Implementing Regulation on changes to product authorisation / For discussionCA-Dec12-Doc.3.6-rev1
The Commission introduced the new draft.
CAs put forward the following comments and suggestions: The revised draft SPC required by Article5(1)(e) of the current draft should be requested at the end of the process instead of at the time of application;The draft Regulation does not contain any provisions for mutual recognition in sequence;The draft does not contain any provision in the implementation of minor changes of products authorised by national authorisation;The mutual recognition process should be divided into two phases; The mixture classification rules are not “new” requirements of the C&L legislation, since they are already adopted, albeit not yet applicable; The draft revised SPC is not mentioned in the draft Article6. The Commission undertook to reflect on all these issues when revising the draft.
ECHA urged Member States to accept the draft SPC in English for union authorisations. ECHA also called for the provision of a fee for the ECHA opinion. The Commission indicated that such a fee was already included in the proposal concerning fees payable to ECHA.
Industry representatives pointed out that DG SANCO recently released guidance on changes of plant protection products. They also called for rules on changes to products for which the application for authorisation is pending. The Commission undertook to reflect on this last point.
Two CAs expressed the opinion that the evaluation deadline for major changes should not be 180 days, but one year, since such an evaluation can require as much work as that of an entirely new product. In this context, a CA asked for clarification of the borderline between a major change and an entirely new product. The Commission indicated that, in its view, one year would be disproportionate, and the system would have to be tried before it could be discussed where to draw the line between a major change and a new product.
A CA questioned why changes to the classification and labelling should at all be considered as changes to the product. The Commission explained that, in its view, such changes would have to be notified, since the relevant statements on the label are authorised.
The Chairman invited participants to send written comments on the draft by the end of January in order to allow the Commission to table a final draft for discussion in the February 2013 CA meeting and for vote in the adjacent Standing Committee meeting.
3.7.Proposal for a Commission Implementing Regulation on the authorisation of the same biocidal products / For discussionCA-Dec12-Doc.3.7-rev3
The Commission introduced the new draft.
Two CAs indicated that it would be difficult to use this procedure for products with reduced claims, since it will not be obvious which risk mitigation measures are relevant for which uses.
Industry representatives voiced concerns that the procedure will not be used, since companies will not be interested to have different authorisation holders if the products have to be virtually identical.
The Chairman invited participants to send written comments on the draft by the end of January in order to allow the Commission to table a final draft for discussion in the February 2012 CA meeting and for vote in the adjacent Standing Committee meeting.
3.8.Proposal for a Commission Regulation (delegated act) on the extension of the duration of the review programme / For discussionCA-Dec12-Doc.3.8
The Commission introduced the new draft.
Whereas some CAs considered that an extension of 10 years is too long, other CAs and the Commission thought that this timeline was realistic. Industry representatives asked Member States to make a collective effort to meet the new target, and to be transparent about their lack of resources. One CA replied that in many cases the applicant’s failure to submit relevant information contributes to the delay.
One CA requested the Commission to setproduct-type specific milestones for the completion of the review programme. The Commission replied that Member States will be invited by the Commission to communicate their roadmaps, which they will then be expected to follow.
The Chairman indicated that the Commission intended to adopt the draft Regulation in January 2013.
3.9.Proposal for a Commission Regulation (delegated act) amending annex III of the new Regulation (to include evidence of technical equivalence as a data requirement for product authorisation) / For discussionCA-Dec12-Doc.3.9
The Commission introduced the new draft.
One CA requested the Commission to make sure that technical equivalence checks by national CAs, which have been started before 1 September 2013 but will be finalised after that date, are also recognised. The Commission undertook to look into this in a revised version.
ECHA indicated that it cannot establish technical equivalence before the reference source has been established, i.e. not before the substance approval. Several CAs found this very disappointing, pointed out that companies usually want technical equivalence to be established before buying data access, and expressed the opinion that ECHA should hereinafter be responsible for all technical equivalence checks.
The Chairman indicated that the Commission intended to circulate a revised version of the draft Regulation before adopting it.
3.10.Proposal for a Commission Decision concerning the non-inclusion of formaldehyde for product-type 20 in Annex I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market / For discussionCA-Dec12-Doc.3.10
The Commission introduced the new draft.
One CA commented that the Applicant should not be unfairly treated as a result of this decision. The Commission responded that there was an appropriate legal basis for the non-inclusion decision and that the deadline of 1 July 2015 was agreed following discussion with the Applicant.
The chairman concluded that the draft could be submitted to the meeting of the Standing Committee for biocidal products of 14 December.
3.11.Proposal for a Commission Implementing Regulation on fees payable to ECHA for biocides-related activities / For discussionCA-Dec12-Doc.3.11
CA-Dec12-Doc.3.11.a
The Commission introduced the new draft.
Several MemberStates and industry representatives expressed concerns about the general levels of the fees. The Commission explained that the proposed fee levels are currently considered necessary to cover ECHA’s costs, but will be revised downwards if ECHA’s costs are lowered thanks to the experience gained.
The Chairman concluded that a revised draft would be circulated to the Standing Committee for biocidal products in January for a vote by written procedure.
- First discussions on draft regulatory measures
4.1.Draft Commission Directive and draft assessment report for the inclusion of d-phenothrin for PT 18 into Annex I to Directive 98/8/EC / For discussion
RMS: IE
CA-Dec12-Doc.4.1
CA-Dec12-Doc.4.1a
The RMS introduced the assessment report of the substance. Two main issues were discussed: the PBT status of the substance in relation with the duration for inclusion, and the identity of the substance to be included.
With regards to the PBT status, serious concerns were expressed in the assessment report, as d-phenothrin was considered to be a potential PBT. It is the reason why it was proposed to include that substance only for 5 years. Both the RMS and the applicant however questioned whether that proposal was proportionate and consistent with the current practice, as the substance was only a potential PBT. They considered that it should not deserve the same treatment as proven PBT substances. According to one CA, the B criteria should be assessed following REACH guidance documents, and not the TGD. It should also be considered whether it was an endocrine disrupter, and reference should be made in the assessment report to the EU working list of 2002. Another CA insisted that the mandate of the ECHA PBT Working Group should be extended to Biocides. On that point, the Commission confirmed that, following discussions with ECHA, this WG would also work on biocides.
Concerning the identity issue, the Commission was in favour to include not only the 98:2 trans:cis ratio of d-phenothrin, corresponding to the substance as manufactured by the applicant, but also the 80:20 trans:cis ratio of d-phenothrin because most the data used to perform the assessment on human health and environment was based on that substance, and because notifications made between 2000 and 2003 covered both trans:cis ratios. If only the 98:2 trans:cis ratio is covered by the inclusion directive, the Commissionexplained that it had concerns that it would exclude other suppliers of the 80:20 form of d-phenothrin from the market. Additional information on phys/chem data would nevertheless be needed on the 80:20 form in order to be included into Annex I.
The applicant pointed out that it had some data on phys/chem, but that this data might be old, and that companies placing on the market the substance could succeed to produce the 98:2 ratio, which has a safer profile compared to the 80:20 form. The RMS pointed out that it originally proposed to include 80:20 or higher forms of d-phenothrin, but TM concluded that the substance defended by the applicant was only the mono-constituent substance. The Commission did not contest the TM conclusions, but pointed out that it was a policy matter that has not been considered during the TM discussions.
The Commission concluded that it will reflect on the most appropriate duration of inclusion with regards to the PBT issue and on the identity of the substance. The Commission invited CAs to send after the meeting their views on both issues, and particularly on the identity. The applicant undertook to come back to the Commission concerning available phys/chem data on the 80:20 ratio of d-phenothrin.