CA-Nov14-Doc.4.5 - Final

58th 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

Further guidance on the procedures related to the examination of the exclusion criteria and the conditions for derogation under article 5(2)

1.  Purpose of the document

The purpose of this document is to provide guidance on the procedures related to the examination of the conditions for derogation to exclusion criteria under article 5(2) of the BPR.

2.  Application of Article 5(2) of BPR

As previously agreed during the discussion on the principles for approval of active substances[1], the exclusion criteria established under Article 5(1) must be assessed for all active substances.

Nevertheless, a distinction is to be made between active substances for which the draft assessment report was submitted before 1st September 2013, and those for which the draft assessment report is submitted as from 1st September 2013, as the principles of approval of the BPD are indeed to be followed for active substance / product-type (AS/PT) dossiers for which the draft CAR was submitted before 1st September 2013.

As a consequence:

–  for AS/PT for which the draft CAR was submitted before 1st September 2013, the exclusion principle does not apply and there is therefore no need to provide information at the approval stage to demonstrate that at least one of the conditions for derogation set out under Article 5(2) is met.

–  for AS/PT for which the draft CAR is submitted as from 1st September 2013, the exclusion principle applies, and the active substance shall not be approved unless information is submitted in order to justify/demonstrate that at least one of the conditions for derogation set out under Article 5(2) is met.

3.  Procedure for AS/PT dossiers for which the draft assessment report was submitted before 1st September 2013

For these AS/PT dossiers, the normal process of review will be followed. ECHA will carry out the public consultation foreseen under Article 10(3) if the substance technically meets the exclusion criteria, in order to gather elements on potential alternatives to facilitate the comparative assessment to be performed at the product authorisation stage.

4.  Procedure for AS/PT dossiers for which the draft assessment report is submitted as from 1st September 2013

The following process has been agreed:

(1)  It is highly preferable and therefore strongly recommended that Member States submit their draft CAR only when the RAC, PBT subgroup or ED expert group, as the case may be, has given its opinion, in order to take into account these opinions before submitting the draft CAR[2]. The evaluation of the dossier may have to be suspended by the evaluating CA while awaiting the opinion from the RAC, PBT subgroup or ED expert Group.

(2)  In any case, the C/M/R status, PBT/vPvB status or ED status[3] has to be confirmed before the dossier starts to be processed by the BPC. This would:

  1. simplify the procedure and administrative burden for the applicant, Member States and Commission in case it is eventually concluded that the active substance does not meet the exclusion criteria,
  2. avoid the risk that a non-approval opinion is adopted by the BPC and published and a decision of non-approval is taken, although the active substance does finally not meet the exclusion criteria, and
  3. ensure better certainty in the whole process for stakeholders and economic operators.

(3)  Once the C/M/R status, PBT/vPvB status or interim ED criteria[4] is confirmed, the following process shall apply:

  1. The dossier can be integrated into the planning of the BPC by ECHA, and its review can start.
  2. The normal process of review of the BPC applies. In particular, ECHA will carry out the public consultation foreseen under Article 10(3) in order to gather elements on potential alternatives that can serve later in the decision making-process at Standing Committee level, and to facilitate the product authorisation stage if the active substance is eventually approved.

Stakeholders will also have later in the process the opportunity to provide elements to demonstrate whether one or several of the conditions for derogation to exclusion set out under Article 5(2) are met, or not. The start of the public consultation will inform them that the active substance meets the exclusion criteria, and stakeholders should therefore be prepared to submit this information in due time.

  1. The BPC shall focus its review on the hazard, efficacy and risk assessment, and shall not be responsible to provide an opinion on the conditions for derogation to exclusion. Accordingly, the BPC shall propose and indicate in its opinion that "the substance should not be approved as the exclusion criteria are met unless one of the derogations in Article 5(2) of BPR applies". In case it is finally decided by the Commission to approve the active substance, the conclusions of the risk assessment provided in the opinion will be useful to set the conditions of approval.
  2. The applicant, the Member States and the stakeholders will have the opportunity to submit to the Commission elements to demonstrate whether one or several of the conditions for derogation set out under Article 5(2) are met, or are not.

These submissions shall be made at the latest 60 days after the date of the opinion of the BPC[5].

  1. The Commission will made publicly available the information received.
  2. On the basis of the information received, if any, the Commission will decide whether or not to propose to derogate to the principle that the substance shall not be approved. Where appropriate, the Commission may decide to refer some specific questions to ECHA in accordance with Article 75(1)(g).
  3. The draft decision on the substance (non) approval will then be submitted to the Standing Committee for discussion before formally seeking the opinion of the Committee. Where relevant, the applicant and stakeholders may be invited to attend the discussion.

5.  Guidance on the information to be submitted to demonstrate that the conditions for derogation set out under Article 5(2) are met.

According to the BPR, active substances meeting the exclusion criteria may be approved if it is shown that at least one of the following conditions is met:

(a)  the risk to humans, animals or the environment from exposure to the active substance in a biocidal product, under realistic worst case conditions of use, is negligible, in particular where the product is used in closed systems or under other conditions which aim at excluding contact with humans and release into the environment;

(b)  it is shown by evidence that the active substance is essential to prevent or control a serious danger to human health, animal health or the environment; or

(c)  not approving the active substance would have a disproportionate negative impact on society when compared with the risk to human health, animal health or the environment arising from the use of the substance.

Robust justifications and strong evidence shall therefore be submitted in order to demonstrate that one or several of these conditions are met. In particular, concerning the criterion under point c, the guidance document established under REACH on socio-economic analysis may be considered for the establishment of the justifications[6].

2

[1] CA-March14-Doc.4.1 - Final - Principles for substance approval.doc

[2] See document CA-Sept13-Doc.8.3 - Final - Review programme of AS.doc.

[3] For the C/M/R status, it means having received the RAC opinion on the establishment or change of the harmonised C&L. For PBT, it means having received the PBT subgroup confirmation, when there is a need for this confirmation on borderline cases. For ED, it means having received the opinion of the ED expert group when there is a need for it (the 1st interim ED criterion does not require the involvement of the ED expert group, as a RAC opinion on a C2 and R2 classification is sufficient).

[4] For the C/M/R status, it means having received the RAC opinion on the establishment of change of the harmonised C&L on the active substance.

[5] This 60-day period is considered proportionate and appropriate, considering that the applicant, Member States and stakeholders will have been aware long ago that the substance potentially meets the exclusion criteria, and that the confirmation would be given even before the BPC starts to work on the dossier and delivers its opinion. Applicants concerned by such potential active substance should therefore anticipate and be prepared to submit this information.

[6] http://echa.europa.eu/support/socio-economic-analysis-in-reach