DIRECTORATE-GENERAL
ENVIRONMENT
Directorate A – Green Economy
ENV.A.3 - Chemicals
CA-Sept14-Doc.2
DRAFT MINUTES
56thmeeting of representatives of Members States Competent Authorities for the implementation of Regulation 528/2012 concerning the making availableon the market and use of biocidal products
14-15May 2014
Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 2 299 11 11
E-mail:
- Adoption of the agenda
CA-May14-Doc.1
The agenda was adopted with two additional items under 'any other business'.
- Adoption of the draft minutes of the previousCA meeting
CA-May14-Doc.2 - with comments from DE, FR, SE, UK and WECF
The minutes with comments from DE, FR, SE, UK and WECF were adopted.
- Draft regulatory measures
3.1.Proposal for a Commission Regulation (delegated act) concerning the review programme / For information
CA-May14-Doc.3.1
The Commission presented the revised draft regulation, and indicated that it was the final consultation on the draft before launchingthe process of adoption. The Commission asked MSs to check the annexes, in order to ensure that substances in the review programme are properly reflected (correct name, CAs number, PTs etc.).
Some minor editorial suggestions were made and accepted by the Commission.In addition, the Commission agreed, subject to further internal consultations, to include 'Without prejudice to Article 55' at the start of the first paragraph of Article 22 and to replace 'Commission' by 'applicant' in the second paragraph of Article 11.
Some MSs requested to remove the limitation on the period when an essential use can be requested. The Commission explained that the objective of that measure was to allow a continued placing on the market and use of products, and therefore, such request has to be done when the placing on the market and use can still be done. The derogation should only be temporary in order that alternatives are thought or an application to support the substance is submitted. As a consequence, such request should not be allowed to be made several years after the ban of the substance has taken place. In case of a danger that cannot be controlled by other means, the Commission pointed out that MSs could still use the provisions of Article 55(1) of the BPR.
The Commission asked for final written comments to be made by 16 May, and the text will then processed for adoption.
3.2.Commission decision concerning the placing on the market for essential use of biocidal products containing copper (3rd decision) / For informationCA-May14-Doc.3.2
CA-May14-Doc.3.2a
The Commission indicated that no additional applications were submitted since the last CA meeting, and presented the draft of the 3rd and last decision, concerning applications for essential use submitted by some Member States. They informed that the 2nd decision was under adoption, and that this 3rd decision will normally be adopted in June/July.
- Active substances
4.1.MRLs / For discussion
CA-May14-Doc.4.1
The Commission thanked the German BfR for having organised the workshop on MRL setting for biocides in Berlin in March 2014 and gave a short summary of the workshopdiscussions. A comprehensive workshopreport will become available in June and will be shared with the Member States.
The Commission will take into account the workshop outcome in their future work on the framework.
4.2.Management of in situ generated active substances in the context of the BPR / For discussionCA-May14-Doc.4.2
The Commission introduced its proposal for the Management of in situ generated active substances in the context of the BPR.
Member States shared the concerns of the Commission concerning the potential workload if all precursors have to be assessed and approved at the active substance level. However, it was pointed out that the list provided in the annex to the document could be streamlined and that it may be possible to group precursors together with a view to reduce the number of assessments. In that respect, a MS suggested to examine the approach followed under the PPP legislation for baculoviruses. Member States were also concerned that the proposal would shift the workload from the active substance approval to the product authorisation stage, but that the work still had to be done.
It was also pointed out that the precursors and their possible impurities or residues could be of relevance when assessing the safety of the active substance. This remark also triggered a discussion on the establishment of technical equivalence for these substances, which may be generated via different precursors, but also through thousands of different devices.
Lastly, CEFIC requested further clarification as to how Article 95 should be applied in the case of active substances generated in situ.
The Comission servces took note of the comments made and invited further comments in writing by 13 June. In addition, the German CA undertook to, by 30 June, go through the annex of the document, to streamline the list and to make a proposal as to how precursors could be grouped together to rationalise the number of assessments.
4.3.Interlinkage between the Water Framework Directive and the BPR / For discussionCA-May14-Doc.4.3
The Commission presented a note addressing the interactions between the BPR and the Water framework directive (WFD). Member States welcomed the document and thanked the Commission for having tabled it.
A MS asked to remove some reference to PNECs, and asked for additional explanations in the paper as for why a substance listed as a PS can still be approved under the BPR.
Another MS pointed out that besides the EU measures, the WFD also provides for each MS to identify substance of concern at national level and to put in place a monitoring for their water bodies.
A MS proposed to have a condition in the approval of such substance that risk to water bodies should be considered at the product authorisation stage. It was also proposed to clarify if some additional data could be provided during the BPC discussions on substances, as the timings in the BPC discussion was very tight.
Finally, another MS took the opportunity of this interaction between the BPR and other legislations, in order to mention that the interactions with other frameworks should be improved to ensure consistency. The example of the IPPC Directive 2008/1/EC concerning integrated pollution prevention and control, and the development of Best Available Techniques (BAT), was mentioned as some recommendations on the uses of biocides or acceptable releases of substances into the environment are made in that framework.
Taking into account these comments, the Commission agreed to review the note and provide an updated version for the next CA meeting in September.
4.4.Approvals of in-can preservatives / For discussionCA-May14-Doc.4.4
CEPE asked the attention of the MSs and of the Commission about the assessment of some active substances used for in-can preservation, and the potential consequences of a ban of these substances. CEPE explained that these substances are indeed skin sensitizers for some of them which could lead to unacceptable risks according to the draft assessment of the evaluating CAs, or could potentially meet the exclusion criteria of the BPR. CEPE requested the Commission to conduct an impact assessment in case such substances are to be banned. The Commission indicated that the BPR did not provide for such impact assessment to be performed before taking a decision not to approve substances. The Commissionhowever invited CEPE to collect further data and provide these to CAs for further discussion.
Some MSs reported concerns about the use of these substances, due to the increase number of sensitized persons in the general public. They also asked for prioritization of these substances in the harmonised C&L process, as some substance will soon be discussed in the BPC.
An NGO also emphasised that one of these substances was considered as the "contact allergen of the year" in the US, and that this was part of the objectives of the BPR to improve active substances/biocidal products with better properties on the market.
4.5.ECHA opinion on HeiQ AGS-20 / For informationCA-May14-Doc.4.5
The Commission informed MSs and stakeholders that they have received the opinion of ECHA concerning the status of the HeiQ AGS-20 material, which is considered as a nanomaterial. The opinion is available on the ECHA website. The Commission further clarified that, as consequence, this substance will pointed as a nanomaterial in the new review regulation.
- Biocidal products
5.1.Composition of biocidal products and responsibilities of authorisation holders / For discussion and endorsement
CA-May14-Doc.5.1
The Commission briefly introduced document CA-May14-Doc.5.1 explaining the main changes further the discussions held at the last CA meeting.
A Member State suggested to add the words 'is one of the elements' in point 9(d).
Another Member States, supported by several, suggested removing the first part of point 9(c) an to re-write as follows:
Where relevant, so that potentially business sensitive information is not disclosed to the applicant or the prospective authorisation holder, information can be directly submitted by the supplier of the mixture.
With these changes, document CA-May14-Doc.5.1.a was endorsed by the CA meeting.
5.2.Authorisation of skin sensitizers for the general public / For discussion and endorsementCA-May14-Doc.5.2
CA-May14-Doc.5.2.a
The Commission briefly introduced document CA-May14-Doc.5.2, which summarises the discussions and agreements at the March CA meeting, and explained the main changes in document CA-May14-Doc.5.2.a with regard to the previous version of the note for guidance.
A MS requested clarification on the scope of the paper (products classified as skin sensitisers vs. products containing active substances being skin sensitisers) and suggested to extend the scope of the document to also cover respiratory sensitisers. The Commission clarified that the scope is restricted to products classified as skin sensitisers and it was agreed to further clarify it in the title of the document and paragraph 4. This MS also suggested incorporating in paragraph 12 that the evaluating CA may, on a voluntary basis, also take into consideration whether non-chemical alternatives are available.
Another MS suggested maintaining in the second indent of paragraph 15(a) the deleted sentence referring to a more flexible approach for category 1B substances and also indicating that in such a case, the product "may" be authorised for the general public.
A MS asked for clarification concerning derogation from MR according to Article 37(1)(a) of the BPR proposed in paragraph 18(a) and whether the CMS has to provide a justification to the applicant so he can agree on the derogation. The Commission confirmed this approach and where the applicant disagrees, the issue should be referred to the Commission.
Another MS referred to the on-going discussions on the guidance document on local effects which could also be helpful when evaluating this kind of products.
With the above-mentioned changes, document CA-May14-Doc.5.2.a was endorsed by the CA meeting.
5.3.Renewal of rodenticides / For discussionCA-May14-Doc.5.3
The Commission presented a document summarising the approach to be followed on rodenticides. The objective of the paper was to provide additional guidance regarding the procedure, practical aspects and the content of the applications, both for active substances and biocidal products renewal. A MS pointed out that, in order to compare active substances between each other, there might be a need to compare the properties of the substances for the different endpoints.
Another MS pointed out the need for some guidance on the application of the derogation under Article 5(2), as the provisions require that the products can afterwards only be (re-)authorised in the MS for which the condition(s) for derogation is(are) met. Therefore, justifications for derogation should be provided for each individual MS or justifications should be provided to explain why the situation is the same in all MS across EU. An Industry representative questioned that approach that could potentially lead to an EU list of approved active substance with some restrictions on the use in Member States, and considered that this aspect should be rather looked at product authorisation stage.
The Commission shared the views of MSs that justifications should be studied for each MS or justifications should be provided to explain why the situation is the same in all MS across EU, as this would in any case help each MS to make their opinion in the Standing Committee when consulted on draft decisions on the renewal of these AS, and would ensure better predictability for the renewal of the authorisation of products.
With regard to renewal of biocidal products, a MS asked for clarification regarding the extension of the validity of existing authorisations. The Commission clarified that this has to be understood within the meaning of Article 31(7) of the BPR, as mentioned in paragraph 19(d) of the document.
Two MSs referred to the documents to be provided at the time of submission of the application, which could probably be reduced to a minimum. The Commission considered that there is no reason to postpone the submission of information that is already available at the time of application for renewal. A MS also asked for clarification regarding the changes that can be made during the renewal process and noted the clarification by the Commission on the additional 8 months counting from the BPC opinion on the renewal of the active substance that applicants will have to prepare their product assessment (i.e. 8+6 = 14 months). Regarding changes, the Commission clarified that the list to be submitted at the time of application for renewal is essential for the consideration of the eligibility of the product for the procedure under Regulation (EU) No 492/2014. The list to be submitted at the second submission step is important to reflect the changes made as from the initial submission for renewal (paragraph 28(a) of the paper).
A MS also referred to the need for clear guidance regarding the IT tools (R4BP3) and the coordination between the refMS and the CMSs. Another MS also referred to the need to address in the paper the public consultation by ECHA referred to in paragraph 39 of the document, also for the renewal of the active substances. An editorial mistake was spotted in paragraph 45, where the reference to Article 23(5) of the BPR should read Article 23(6).
Another MS asked for clarification regarding on the handling of renewals of same biocidal products.
The Chair invited the CA meeting to submit written comments by 13 June 13, also indicating that MSs should start to reflect as to whether they would want to refer the comparative assessment to the Commission in accordance with Article 23(5) of the BPR.
5.4.Classification and labelling of rodenticides / For discussionCA-May14-Doc.5.4
The Commission introduced document CA-May14-Doc.5.4, which aims to address some concerns raised by some CAs and Industry as a result of the recent RAC opinions on anticoagulant rodenticides.
A MS disagreed with the proposed approach, and would rather implement the more conservative approach for all these substances. The Commission clarified that this is not possible for those substances that already had a harmonised classification and that the impact on the use by non-professionals has to be carefully considered.
Another MS supported the approach provided that there is a clear deadline for the application of the new classification. This MS also referred to Article 48 of the BPR as a potential tool to impose some conditions in the product authorisations according to new information on the active substances. In this context, another MS requested that this case should be seen as an exception in order to not create a precedent for other substances.
A MS referred to the consequences of the new CLH in terms of reformulation of products, which could also impact on efficacy and lead to new studies that require time to be carried out; in the end, this will be time and resource demanding both for Industry and CAs.
Another MS referred to the CLP Regulation, where harmonised C&L become obligatory only after 18 months of the ATP publication.
A NGO representative asked for additional information regarding the use of these substances by the general public. The Commission referred to the on-going project on RMMs, which is expected to provide some recommendations on this matter.
The Chair noted wide support to the approach outlined in the paper and invited further written comments to be submitted by 13 June. He then indicated that an updated version of the document would be tabled for endorsement at the September CA meeting.
5.5.Stability tests for products eligible for the simplified authorisation procedure / For discussion and endorsementCA-May14-Doc.5.5
The Commission introduced document CA-May14-Doc.5.5, which is the outcome of a previous discussion at the March CG meeting and subsequent comments submitted by CG members.
Some MSs suggested deleting paragraph 7(b), as more detailed guidance addressing that aspect is available. Industry also supported the paper.
With the above-mentioned change, the document was endorsed by the CA meeting.
5.6.Handling of biocidal products with multiple names / For discussion and endorsementCA-May14-Doc.5.6
The Commission introduced document CA-May14-Doc.5.6, which aims to clarify and to reach an agreement on some important elements arising from a previous discussion within the CG.
On the SPC-label correspondence issue, some MSs supported the proposed approach with clear allocation of RMMs to the authorised uses, but would not support different SPCs for a single biocidal product. The Commission clarified that a single bocidal product will only have one SPC, and what is proposed is to change the structure of the information within that SPC.
Some MSs mentioned that names should be deleted from the examples on authorised uses at page 7. Another MS supported the current practice that also enables inspector to check if the information on the label is consistent with the authorised SPC.
A MS referred to the different use combinations covered by the initial authorisation and how new potential combinations within the authorised uses could be established (e.g. new "rats and mice" for non-professionals vs. existing "only rats" and "only mice" for non-professionals). The Commission mentioned that this issue can be further discussed and that a potential approach could be via an administrative change as described in title 1, section 2 of the Annex to the changes Regulation.
Some MSs and ECHA referred to the impact of this new approach on the existing SPC template and IT tools (e.g. SPC generator under R4BP3). The Commission mentioned that what is important is to agree on the key principles before adapting the relevant IT tools. For this purpose, further bilateral discussions with ECHA will be needed.