CA-May17-Doc.2A-Rev.1

CA-May17-Doc.2a-rev.1

DRAFT MINUTES

70thmeeting 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

15-17March 2017

1

Wednesday 15March 2017
Afternoon Session / 14:00 – 18:00
1. Adoption of the agenda / For adoption
CA-March17-Doc.1
One MS proposed to discuss one item under AOB. The draft agenda was adopted.
The
2. Adoption of the draft minutes of the previous CA meetings / For adoption
CA-March17-Doc.2a (minutes 16-18 November 2016)
For information, ED session of 28 February 2017 / Adoption of the draft minutesin the next meeting discussing the draft delegated act on EDs

The draft minutes were adopted.

3. Draft delegated acts
3.1.Amendment of Review programme Regulation / For information

The Commission informed the meeting on the state of play of the decisional process of the draft delegated act amending the Review Regulation. It was noted that the act was adopted by the Commission on 3 February 2017. Subsequently the Council and the European Parliament have 2 months to object the delegated act. So far, the Commission was informed that the Council did not object to the act.

In response to an earlier written comment from the UKa MS, the Commission indicated that the entry of copper PT21 was erroneously removed from the Annex II to the Review Regulation. Following the redefinition and subsequent approval of copper flakes PT21 in 2016, a withdrawal notice was only recently published for copper PT21 by ECHA. Hence this entry should be reintroduced in the Annex II to the Review Regulation. The Commission will make a corrigendum or include the correction when updating the Review Regulation to incorporate the in-situ generated and food and feed substances for which notifications have been received.

4. Biocidal products / For information
4.1. Renewal of anticoagulant rodenticides
(a) State of play deadline 28/02/2017 / For information

The Commission briefly informed the meeting of the state of play regarding the renewal of biocidal products:

- The deadline for the completion of the applications for renewal (28/02/2017) is over now. At the 21st meeting of the Coordination Group (CG), ECHA and MSs discussed some IT issues identified for some applications for renewal and agreed on a number of actions to be taken to facilitate a timely submission.

- Regarding the comparative assessment at the EU level, the BPC adopted an opinion by consensus at BPC-19 addressing the questions referred to the Commission. As soon as this opinion will be submitted to the Commission, it will prepare an implementing decision including the responses to those questions, so that MSs can refer to them when finalising the renewal procedures. This Commission decision is expected to be available in advance to the date when MSs would have to produce the assessment report on the application for renewal (expected by the end of August 2017).

(b) Other issues to be addressed / For discussion and endorsement
CA-March17-Doc.4.1.b

The Commission briefly introduced this agenda item by referring to document CA-March17-Doc.4.1.b. MSs made the following comments:

- Footnote 1 to the document should be deleted. The Commission agreed with that suggestion as the changes Regulation already establishes the conditions to deal with administrative changes concerning trade names.

On a more general note, a MS asked about the legal basis to reject an application for product authorisation as when the product proposes to have the same trade name than as another authorised product, in order to avoid a litigation risk. While this question is out of the scope of this paper, the Commission responded that in addition to other relevant legislation about proprietary trade names, etc., the same principles as in the changes Regulation should apply. Turning the question in the other way around, MS would need a good legal basis to accept the same trade name for two products. The Commission noted that having the same trade name for two products could be subject to litigation by the owner of the trade name of the first product.

- Paragraph 6: Two MSs raised concerns regarding the legal basis to consider that under the BPR repeated mutual recognition (MR) in the same concerned MS (cMS) is not possible. The Commission reiterated the views expressed in the document, and ECHA pointed out that repeated MR is not possible in R4BP3.

- Paragraph 7: One MS considered some of the terminology confusing and suggested that clarity could be improved if ‘sister authorisation’ was changed to ‘direct mutual’ and ‘other authorisations’ to ‘identical authorisations’.

Several MSs considered that, as the legal basis at the time of granting the product authorisations under the BPD was "mutual recognition", these authorisations could also be renewed under Regulation 492/2014. The Commission agreed with that approach provided that they are still eligible for the procedure under that Regulation. However, where one of the authorisations in the cMS is no longer eligible, it should be renewed under Article 31 of the BPR.

Upon request of a MS, the Commission clarified that where a product authorisation has been already cancelled, the trade names in that authorisation could be transferred to another authorisation through an administrative change, even if the cancelled product is still on the market during the period of grace.

With the above clarifications and agreed changes to the document (footnote 1 and paragraph 7), the Chair noted that document CA-March17-Doc.4.1.b was endorsed by the CA meeting. While supporting the document, a MS remarked that the MR procedure should, in its opinion, not be limited to a single procedure per MS as indicated in paragraph 6.

(c) Extension of the validity of the product authorisations / For discussion and endorsement
CA-March17-Doc.4.1.c

The Commission briefly introduced this agenda item by referring to document CA-March17-Doc.4.1.c.

A MS indicated that, while agreeing on the conclusions in the document, considered that the correct legal basis to repeal the extension of the authorisations until 31/08/2020 should be Article 48 of the BPR. The Commission clarified that the legal basis for the extension was Article 31(7) of the BPR and that a decision has to be taken on the on-going applications for renewal: rejection, non-renewal or renewal. In the context of any of those possible decisions, the former extension should be repealed as it was only valid for the purpose of completing the assessment of the on-going applications for renewal.

With the above clarifications, the Chair noted that document CA-March17-Doc.4.1.b was endorsed by the CA meeting, with the reservation from one MS.

On a more general note and upon request from a MS, the Commission clarified that where there is no application for renewal at all, Article 52 of the BPR does not foresee any period of grace. In those cases, the product could only stay on the market until the expiry date of the authorisation.

(d) Adaptation of products not subject to an on-going renewal to the new conditions in the AS renewal / For discussion and endorsement
CA-March17-Doc.4.1.d

The Commission briefly introduced this agenda item by referring to document CA-March17-Doc.4.1.d and clarified that, as it may have some policy and resource implications, it was not previously discussed within the CG.

Upon request from several MSs, the Commission clarified the following:

-Notifications by authorisation holders (AHs) under Article 47 of the BPR are linked to unexpected or adverse effects of biocidal products. Therefore, the Commission questioned that Article 47 provides for a legal basis to oblige AHs to notify and address the adaptation following the renewal of the active substance (AS). While Article 47 notifications always trigger an Article 48 procedure, competent authorities (CAs) do not always need an Article 47 notification to initiate an Article 48 procedure. On a more general note, the Commission wondered whether requesting national fees for notifications under Article 47 of the BPR could be seen as a disincentive for AHs to notify unexpected or adverse effects.

-While this paper introduces a procedure that would be valid for any product types (PT) in future, the proposed deadlines are only relevant to anticoagulants rodenticides in order to achieve the objective that by 1st March 2018 all the authorisations are subject to the same terms and conditions.

-For MR products, the proposed procedure is in line with Article 48(3) of the BPR, which aims at avoiding work duplication and provides the opportunity for referrals to the CG in case of disagreement. Regarding the concerns expressed in the meeting that the proposed procedure makes the cMSs dependent of the decision taken by the reference MSs (refMS), the Commission would expect that upon agreement of the relevant milestones and deadlines, the refMS should follow it in order to ensure a harmonised implementation across the EU.

-As MSs mentioned that the renewal procedures will be given high priority due to the previously agreed deadlines, the Commission asked MSs to explore the number of products that would need to be amended through Article 48. This information would help to take a more informed decision on workable timelines, taking into account the associated workload.

The Chair invited MSs and stakeholders to send written comments by April 3rd in order to continue with this discussion at the next CA meeting. He also noted the support from the CA meeting to develop a harmonised approach on this matter and that the "gentleman agreement" described in the paper, when endorsed, is expected to be respected by all MSs.

(e) Submission of data (or LoA to data) generated for the active substance renewal / For discussion
CA-March17-Doc.4.1.e

The Commission briefly introduced this agenda item by referring to document CA-March17-Doc.4.1.e. MSs made the following comments:

- Two MSs agreed that a letter of access (LoA) is needed, but questioned that it should only be submitted to the refMS. On this topic, a MS asked the Commission to clarify this issue of the submission of aLoA in MR procedures in a more general paper.

- A MS disagreed with the views expressed in the document, as the wording in Article 31(3)(a) only refers to the data generated by the "applicant" for the renewal of the product authorisation. The Commission reiterated the reasoning in the document in that respect.

- A MS asked whether the LoA should give access to all data generated for the AS renewal or perhaps only for the data that is relevant for the products in question. The Commission clarified that Article 31(3)(a) refers to "all the relevant data…", so this would indicate that some data might not be relevant for the products in question.

The Chair invited MSs and stakeholders to send written comments by April 3rd in order to continue with this discussion at the next CA meeting.

4.2. Content of applications for authorisation of a same biocidal product / For information
CA-March17-Doc.4.2.a

The Commission informed the meeting that, due to the limited input from MSs and particularly from industry representatives, the Commission was not in a position to draft a paper for discussion in this meeting.

The Chair further encouraged MSs and stakeholders to send written comments by April 3rd in order to continue with this discussion at the next CA meeting.

4.3. Linking label claims and the product authorisation / For discussion and endorsement
CA-March17-Doc.4.3

The Commission briefly introduced this agenda item by referring to document CA-March17-Doc.4.3.

Upon request from several MSs or industry representatives, the Commission clarified the following:

-While the SPC may certainly be a source of information to the users of biocidal products, it is also obvious that labels are the very first source of information.

-The SPC should not include statements on "what can/cannot be done", as the general provisions in Article 69 of the BPR already oblige the AH to produce labels in accordance with the authorised SPC.

- There is no need to indicate in the paper that the wording in the labels should be as similar as possible to the wording in the SPC, as Article 69(2) of the BPR recognises the principle that some information on the labels may be expressed in a manner which is meaningful and comprehensible to the user.

-For some "marketing claims" like those referring to comparative advertising (e.g. the best (iodine) teat disinfectant (against bacteria x) in post-milking), enforcement could also consider studies that are not in the dossier in order to substantiate the claim. Of course, any claim has also to be consistent with the authorised uses and target organisms in the SPC.

-The wording in the paper on the possibility that enforcement can also be based on other information made available by the AH should stay as it is, as otherwise it might look like an obligation to MSs.

MSs also proposed the following amendments, which were supported by the CA meeting:

- Paragraph 7 should read as follows: "(7) Article 69(2) further specifies the minimum information that shall be provided on the labels (indents a to h). Thus other information, such as claims, can be added by the AH to the label provided that it complies with the requirements referred to in the paragraph above, is consistent with the authorised uses in the SPC and is supported by the efficacy evaluation. This means that AHs are responsible of the substantiation of any claim made on the label from an enforcement point of view".

- Paragraph 12 should also introduce an example indicating that where a specific target organism is listed in the SPC, a label claim against that specific species would be consistent with the authorised SPC.

With the above clarifications and agreed changes to the document (paragraphs 7 and 12), the Chair noted that document CA-March17-Doc.4.1.b was endorsed by the CA meeting, with the reservation from a MS.

4.4. Handling the "stop of the clock" during the assessment of applications for product authorisation / For discussion and endorsement
CA-March17-Doc.4.4

The Commission introduced this agenda item by making a short presentation (post-meeting note: the presentation has been uploaded on circabc as document CA-March17-Doc.4.4 – presentation).

The following points were raised by MSs and discussed with the Commission:

- Some MSs considered that the rejection of an application may have serious consequences to the applicant and that such decision has to be carefully considered. It should also be based on a clear legal basis, as MSs would like to avoid legal challenges by the applicants in national courts. The Commission considered in that respect that Articles 30(2) of the BPR provides for a clear legal basis to reject the application if the applicant fails to submit the requested information within the given deadline.

- A MS acknowledged that if no action is taken when the stop of the clock is not respected by the applicant, all players are contributing to a "culture" where delays with no consequences are assumed.

- Several MSs considered that the stop of the clock can be applied at several points in time, as this would fit better with the internal organisation of the assessment teams within the CA. The Commission clarified that the proposal in the document (footnote 3) provides for some flexibility, and that it is always expected that the evaluating body and the applicant work in close cooperation during the whole authorisation procedure. Industry representatives considered that footnote 3 in the document provides for some flexibility regarding the interaction between the evaluating body and the applicant, and will provide further comments in writing.

- Two MSs indicated that they are currently working with a single stop of the clock period. The Commission reiterated the reasoning in the document and underlined that a more coordinated approach would facilitate that any technical and regulatory issues are identified and solved at the same time, and not several months later when other refMSs have already closed the assessment (in case of MR procedures) or granted purely national authorisations (e.g. DEET products). As a consequence, this early discussion would also avoid further delays and MR disagreements (e.g. DEET products).

- All MSs having taken the floor supported the views that the 180-day period should be respected in order to avoid any impact on the compliance with the legal deadlines. However, several MSs considered that in the 180 days several clock stops should be possible. The Commission emphasised that for the Union Authorisation (UA), the compliance with the legal deadline in Article 89 of the BPR is a key priority. In such context, the Commission will also closely monitor whether the evaluating competent authority (eCA) meets its legal deadline in Article 44 of the BPR.

- Two MSs indicated that other preventive actions should take place to ensure respect of the deadlines: improving the quality of the submitted dossier (i.e. pre-submission meetings) or timely addressing issues not solved at the AS approval stage (i.e. horizon scanning approach by ECHA). An industry representative emphasised that this aspect is particularly relevant for some in situ AS or free radicals.

The Chair invited MSs and stakeholders to send written comments by April 3rd in order to continue with this discussion at the next CA meeting.

4.5. Report from Coordination Group / For information

The Commission briefly informed the meeting of some issues discussed at the 22nd CG meeting: