/ EUROPEAN COMMISSION
DIRECTORATE-GENERAL
ENVIRONMENT
Directorate A–Green economy
ENV.A.3 – Chemicals
CA-Nov14-Doc.5.15 - Final

Note for Guidance

This document is an attempt to provide guidance in the interest of consistency, and has been drafted by the Commission services responsible for biocidal products with the aim of finding an agreement with all or a majority of the Member States' Competent Authorities for biocidal products. Please note,however, that Member States are not legally obliged to follow the approach set out in this document, since only the Court of Justice of the European Union can give authoritative interpretations on the contents of Union law.

Subject:Submission of applications for product authorisations of PT08 products containing DDAC or ADBAC/BKC

  1. Issue

The Commission has been informed that some clarifications were needed with regard to applications for product authorisation to be submitted by 1st February 2015 on biocidal products containing DDAC (CAS 7173-51-5) and ADBAC/BKC (CAS 68424-85-1) for PT8.

For each of these 2 substances, separate dossiers were submitted by different applicants (USQC and EQC Task forces). The approval regulation was based on the assessment finalised of the dossiers submitted by USQC. The review of the two other dossierssubmitted by EQC is currently under finalisation at the RMS and BPC level in order to make combined assessment reports, including one combined list of endpoints (LoE) for each active substance.

It will however be difficult to have these documents finalised before 1st February 2015[1], and companies submitting applications for product authorisation by that date cannot therefore use such combined LoE in their product assessment. The deadline of 1st February 2015 applies for all companies, whether they use USQC, EQC or another supplier, as a source of active substance for their products.

  1. Way forward

This is not the first time that the approval of an active substance has been based on the application submitted by one participant, due to some delay in the assessment of the application(s) of the other(s) participants for the same active substance/product type combination. This ishowever the first time that the combined LoE is not established before the deadline for submitting applications for product authorisation.

In the current absence of combined ARs and LoE, the following has been agreed :

(1)The rapporteur Member State for DDAC and ADBAC/BKC (IT) shall take appropriate measures to ensure that the combined Assessment Reports for DDAC and ADBAC/BKCare discussed at the BPC meeting of April 2015, as foreseen under the BPC work programme.

(2)Meanwhile, prospective applicants, using USQC or EQC as the source of active substance for their products and having to submit their application for product authorisation by 1st February 2015,can use the LoEderived from the data to which they haveaccess, which can be data from USQC, EQC or an alternative supplier, if any.

(3)The evaluatingCompetent Authorities receiving applications for product authorisation will have to perform their assessment on the basis of the combined LoE, which, would be available by the time they start their assessments.

This situation should hopefully remain exceptional and be avoided in the future by the application of the new principles for the evaluation of dossiers, whereby multiple dossiers will only be discussed in BPC, when the assessment reports from all applications are available[2].

1

[1] The schedule the discussion of the combined Assessment Reports for DDAC and ADBAC/BKC for the BPC in April next year.

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