CA-Nov15-Doc.2

DRAFT MINUTES

61st 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

16-18September 2015

Starting at 14h00 on 16 September– Ending at 13h30 on 18 September

1

  1. Adoption of the agenda
/ For adoption
CA-Sept15-Doc.1

The draft agenda was adopted.

  1. Adoption of the draft minutes of the previous CA meeting
/ For adoption
CA-Sept15-Doc.2 – with comments from BE, UK and AISE

The draft minutes with comments from BE, UK and AISE were endorsed.

  1. Draft delegated acts

3.1.Corrigendum to Annex II of Commission Delegated Regulation (EU) No 1062/2014 / For information

The Commission informed about the publication on 28/07/2015 of the Corrigendum to Commission Delegated Regulation (EU) No 1062/2014.

  1. Biocidal products

4.1.Amendment of the same biocidal product Regulation / For discussion
CA-Sept15-Doc.4.1-rev1

The Commission introduced the document and explained that the format of the proposal still had to be adapted to an amending Regulation. The Commission also informed the meeting that at the 13thmeeting of the Coordination Group (CG-13), mutual recognition in sequence of national authorisations granted pursuant to Regulation (EU) No 414/2013 (the SBP Regulation) was discussed. Several Member States shared concerns that this mutual recognition in sequence might lead to practical problems and suggested that these could be prevented by introducing a restriction in the context of the review of the SBP Regulation. The Commission responded that the legal basis for a mutual recognition in sequence of a national authorisation is in Regulation (EU) No 528/2012 (the BPR) and that such restriction could only be set by amending the BPR and not the SBP Regulation.

Upon request of a Member State, the Commission clarified that applications for a SBP of a product authorised under the simplified procedure shall be always sent to the evaluating Competent Authority (eCA) and not to Member States where the product is placed on the market in accordance with Article 27 of the BPR. Once authorised, the SBP must then be notified to the Member States on the market of which it is going to be placed in accordance with Article 27.

Another Member State, while recognising the issue of the legal basis, stressed again the practical problems linked to mutual recognition in sequence of a SBP and referred to further written comments regarding the confidentiality of some data and the renewal of the reference and same products.

Industry representatives encouraged Member States and the Commission to achieve a speedy adoption of the revision, as companies need to benefit from the proposed changes as soon as possible. They also referred to some market freeze in Member States under the national transitional rules.

Upon request of a stakeholder organisation, the Commission clarified that the wording in Article 6 is identical to other Regulations and that "interesting parties" and "stakeholders" should be read as synonyms.

The Chairman invited the meeting to send any comments in writing by 25 September.

4.2.Update of document CA-May15-Doc.4.4 - Final - Q&A on SPC content / For discussion and endorsement
CA-Sept15-Doc.4.2

The Commission introduced document agreed by the CG at CG-12.

A Member State proposed clarifying the sentence in brackets in the first paragraph of the answer, which should read: (except sites that perform filling operations).

With this change, the Chairman noted the agreement of the CA meeting on the Q&A, whichwill be added to the document compiling the Q&A pairs on the content of the SPC.

4.3.Implementation and enforcement of Article 95 for in situ generated active substances / For discussion and endorsement
CA-Sept15-Doc.4.3

The Commission introduced the document, which was welcomed by Member States.

A Member State suggested that it would still be useful to clarify the position of users and manufacturers of devices with regard to Article 95 and whether they could be listed under the list established by ECHA for the purpose of compliance. The Commission undertook to clarify the matter for the next CA meeting.

A representative from SMEs draw Member States attention to a translation error in the German version of the BPR, which under Article 95(2) uses the words ‘placing on the market’ instead of ‘making available’.

The Commission responded that the Council Secretariat had been made aware of the error and was preparing a corrigendum.

An industry representative regretted that the approach proposed did not address all systems in the same manner and that it would therefore fail to establish a level playing field, which is the main objective of Article 95.

The Commission noted the concern but explained that the objective of a level playing field only applies to substances currently supported under the review programme. For those for which applications will be submitted later, by virtue of Article 13 of the review programme Regulation or of Article 93 of the BPR, the obligation will only apply once these applications are submitted. Furthermore, there are systems, for which the obligation cannot apply due to the very nature of the systems.

After some editorial changes were suggested and agreed by the Commission,Member States took note of the final document.

4.4.Implementation of paragraph 10 of Annex VI / For information

The Commission informed the meeting that, in the context of some recent findings, it was considered appropriate to include this agenda item to remind Member States that paragraph 10 of Annex VI applies to any application for authorisation of products containing an active substance meeting the exclusion criteria, even for those applications submitted under Directive 98/8/EC (the BPD) (i.e. by virtue of Article 91). Therefore, in such cases, Member Statesmust first consider whether or not the conditions for derogation in Article 5(2) are met for their territory before assessing the product or carrying out any comparative assessment.

A Member State asked whether paragraph 10 in Annex VI would also apply for the assessment of applications for a change to products authorised under the BPD. The Commission responded that while the provisions on comparative assessment are clearer (i.e. it applies to product authorisations and renewals only), this element could be subject to interpretation. Further, information on this will be provided at the next CG meeting.

Another Member State asked the Commission whether such consideration is for the reference Member State only or also for the concerned Member States, and noted that in the absence of harmonised guidance each Member State might follow different approaches. The Commission responded that any Member State would have to consider these elements and that, in principle, there is no need for a fully harmonised guidance, as the situation in the Member States might be very different.

4.5.Report from Coordination Group / For information

The Commission briefly informed the meeting of the main issues discussed at the 13th CG meeting:

i) Joost Van Galen, from the Netherlands, was elected in July as chairperson for an 18-month mandate. The Commission thanked the previous chairperson, Anna Norberg from Sweden, for the great job done under her mandate. As no nomination for the vice-chair position was received, a rotational approach according to the EU presidency was agreed. Patrick Thyes, from Luxembourg, is thus thevice-chairperson.

ii) In terms of MR disagreements, one formal referral was discussed and closed with a CG agreement by consensus. No formal or informal referrals are currently on-going.

iii) The working procedures have been updated to improve efficiency and transparency.

iv) The CG agreed two notes for guidance, which will be referred to the 62nd CA meeting for formal endorsement, on "Handling of changes to the classification and labelling of authorised biocidal products" and on "Submission of example labels, instructions for use, safety data sheets and models or drafts of the packaging, labelling and leaflets within an application for product authorisation".

v) The CG agreed the mandate and objectives for a working party on the standardisation of sentences for the different sections of the SPC for anticoagulant rodenticides

vi) Other issues discussed were the mutual recognition in sequence of a SBP as indicated above, and some IT issues related to R4BP3, namely some rules blocking mutual recognition in sequence procedures in concerned Member States where the reference Member State has not uploaded a complete SPC in xml format for the first authorisation, and the dissemination of SPCs by ECHA.

For further information, the Commission referred the meeting to the agreed list of conclusions and actions arising from the CG-13 meeting, which will be made available on the dedicated CG CIRCABC interest group once agreed by CG members.

4.6.Executive report on product authorisations / For information
CA-Sept15-Doc.4.6

The Commission briefly introduced document CA-Sept15-Doc.4.6 and CA-Sept15-Doc.4.6.a, which shows the total number of product authorisations per Member State, and number of product authorisations per Member State indicating the different asset types. It was noted that the figures on the total number of product authorisations currently available in the ECHA website (5.049 on 1/9/15) are higher than those in the reports from R4BP3 (4.434 on the same date), as the expired assets are not excluded. ECHA will look at this discrepancy to ensure consistency between figures.

4.7.Executive report on applications for Union authorisation / For information
CA-Sept15-Doc.4.7

ECHA briefly introduced document CA-Sept15-Doc.4.7, which has been updated to address the requests at the last CA meeting (e.g. including the evaluating CA and the relevant deadlines for application for product authorisation). ECHA mentioned that an application has been submitted without any pre-submission and the Commission encouraged companies to do so well in advance of the above-mentioned deadline.

A Member State clarified that, for one on-going case, their agreement to act as eCA has not been confirmed yet. ECHA mentioned that at the pre-submission step sometimes companies have not received yet a formal confirmation from the eCA, which is only mandatory at the stage of the submission of the application. Therefore, the table will clarify whether or not the eCA has formally agreed to do so.

The Commission encouraged the four eCAs involved in applications for iodine-containing products to make an effort of additional coordination. For this purpose, ECHA informed the CA that it had has already assigned the same dossier manager to all the applications.

4.8.Executive report on referrals to the Coordination Group in accordance with Article 35 of the BPR / For information
CA-Sept15-Doc.4.8

The Commission briefly introduced document CA-Sept15-Doc.4.8, underlining the fact that only 2 cases out of the 15 received by the CG have been referred to the Commission for a Decision.

  1. Active substances

5.1.Management of in situ generated active substances under the BPR
5.1.a.Nitrogen / For information

The Commission explained that it had not received any input on the matter since the last meeting, especially with regard to oxygen scavengers. It therefore explained that it considered the matter closed and that the question of oxygen scavengers should be addressed in the context of the guidance provided through the Manual of Decisions having become obsolete (see also item 7.9).

5.1.b.Free radical-ions and photocatalysts / For discussion and endorsement
CA-Sept15-Doc.5.1.b-rev1

The Commission introduced the document.

The discussion focused on the how the substance should be defined at the approval stage. After a tour de table, it appeared that a majority of Member States supported the Commission proposal to only mention, for the sake of simplification, the free radical without reference to the precursor(s) or method of generation.

The section of the note dealing with compliance with Article 95was removed, as it needed some further analysis, and the Commission undertook to provide further clarification on the matter at the next CA meeting.

It was also agreed to develop as a matter of priority some more detailed guidance as to the data that should be submitted for the purpose of substance approval. One Member State undertook to prepare a proposal for discussion and endorsement at the next CA meeting.

A revision 2 of the note was circulated during the meeting and eventually endorsed.

5.2.Progression of the review programme on active substances / For information
CA-Sept15-Doc.5.2

The Commission presented a state of play of the progress of the review programme of existing active substances for the 1st and 2nd priority lists. In particular, the Commission informed that letters are about to be sent to Member States in order to stress the importance of allocating enough resources for the implementation of the BPR, including for the examination of biocidal actives substances. The Commission also stressed the importance to submit the remaining reports for the 1st list and to submit report from the 2nd priority list now in order to avoid to high workload for the BPC in the next couple of years.

The Commission invited Member States concerned by the deadlines of the 1st and 2nd priority lists to contact ECHA to inform about their progress and plans on these dossiers.

5.3.Renewal of anticoagulant rodenticides / For discussion
CA-Sept15-Doc.5.3

The Commission briefly introduced document CA-Sept15-Doc.5.3 and underlined the key elements to be considered in order to achieve the renewal of AS within the agreed deadlines:

- Overall, the Commission does not expect a complete reassessment of the active substances. Member States are rather invited to reflect on how these substances can be used in such a way as to minimise their negative impacts.

- In principle, there should be no clock stop, as all the elements for the discussion should be available within the applications. If an eCA considers stopping the clock, that eCA should consult ECHA and the Commission to see whether it is really worth it.

- Regarding the public consultation, it could be initiated soon since the applications have been submitted and since there is no need to wait for the eCAs assessment reports.

- Regarding the 'comparison of the respective effects and efficacy of these substances', what is expected from the BPC is a discussion of the relevant risk mitigation measures with a view to design a policy regarding the use of these substances (e.g. to recommend whether some of these substances should be restricted to professional uses, whether, if allowed for amateur use, they should be restricted to indoor use only, whether for some of them there is evidence of resistance, etc...).

- In order to facilitate the process, a template for both the AR and the BPC opinion would be developed by ECHA by the next CA meeting. The annex to the document just provides a very preliminary idea of what could be at the end the structure of the BPC opinion/approval of the AS.

- ECHA should play a key coordination role between eCAs.

A Member State asked the Commission how to deal with applications for renewal of an active substance for which the first approval contains one safe use only (e.g. a first generation anticoagulant not including mice as target organism) and whether the new ongoing ATP might have an impact on the active substance renewal (see also item 10.1). This MemberState also mentioned that the proposed approach might lead to extra work at BPC working group level. The Commission clarified that where relevant, ad hoc meetings before the relevant BPC meetings should be organised and that this should be included in the revised work programme for 2016. The Commission also clarified that the active substance renewal should be conducted independently from the ongoing ATP, as the new ATP will only affect products containing active substances above the proposed Specific Concentration Limits (i.e. some reformulated products might still be available for non-professionals).

Another Member State suggested that a safe use should be demonstrated according to the new emission scenario documents.Regarding the question of the safe use, the Commission clarified that now that products containing these active substances are authorised, it was less interested in determining whether there is a safe use than to have a critical comparison of these substances to establish what restrictions and conditions of uses could be harmonised at the active substance level.

A Member State supported the views of having some extra WG meetings to deal with such comparison and asked the Commission how the ATP procedure could impact on the agreed deadlines. The Commission clarified that an update on the ATP will be provided under agenda item 10.1 and that in principle, the changes to the existing authorisations would occur at the time of the renewal of the product authorisation with on impact on the active substance renewal. Upon request from this Member State, it was also clarified that for products containing warfarin sodium, for which no application for renewal has been submitted, the period of grace in Article 52 of the BPR will not apply. This Member State also reminded that at the work-shop a minimum pack-size for professional users was suggested.

Another Member State mentioned that the eCA should have the right to consider all the available information to them. Upon request of that Member State, the Commission clarified that for warfarin sodium no assessment report has to be produced. A Member State noted however that for transparency reasons, the ECHA website should clearly reflect the expired active substances.