DIRECTORATE-GENERAL
ENVIRONMENT
Directorate A – Green economy
ENV.A.3 - Chemicals
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: Compilation of available information on approved active substances with regard to certain criteria[1] with a view to facilitate product authorisation
1.- Background and purpose of the document
(1) In order to comply with the requirements of Articles 23 and 91of Regulation No 528/2012[2] (BPR) whereby, in particular, products containing substances meeting the criteria listed in Article 10(1) shall be authorised in accordance with Article 23, Competent Authorities (CAs) requested the Commission and ECHA to make available a list of the active substances on which an approval decision has been taken, specifying whether they meet the criteria listed in Article 10(1) and 5(1).
(2) The Commission and Industry representatives also supported this initiative. Since then, ECHA has been working on such a list with the support of the Member States through the Biocidal Products Committee (BPC) and the Coordination Group (CG) to confirm the correctness of the information provided in that list for the active substances they were Rapporteur Member State in the evaluation process.
(3) This document aims to make publicly available the above mentioned list, explaining what is the main purpose of the list, how the information contained therein has been generated and how that information will be maintained up to date when a new approval decision is taken or new relevant information with regard to specific exclusion/substitution criteria has been generated by the relevant ECHA Committees or Expert Groups (e.g. RAC or PBT Expert Group).
2.- Purpose of the list
(4) As requested by CAs, the purpose of this list is to provide a common source of information to be used by CAs at product authorisation in a harmonised way avoiding thus different approaches for the same active substance by different MSs. This list should therefore contribute to a better predictability for stakeholders and to facilitate mutual recognition procedures.
(5) The list aims at assisting CAs in the implementation of Articles 23[3] and 91 of the BPR, read in conjunction with paragraph 8 in Annex VI, by providing a compilation of the latest available information with regard to the listed exclusion or substitution criteria, taking into account the outcome of different existing or on-going evaluations of those criteria (See section on the content of the list).
3.- Content of the list
(6) The list only contains information on active substances on which an approval decision has been taken - either under Directive 98/8 (BPD[4]) or the BPR - and will be updated when a new approval decision is taken.
(7) In accordance with the agreed principles for taking decisions on the approval of active substances under the BPR (CA-March14-Doc.4.1-Final), the assessment of whether an active substance meets the criteria of Article 10(1) is only based on the consideration of Article 10(1)(a), (b) and (d) criteria for the time being. For assessing if a substance has endocrine disrupting (ED) properties in line with Article 5(1)(d), the temporary criteria listed in the second paragraph of Article 5(3) have been used.
(8) The list is made available in an Excel format, so allowing users to generate more refined output by applying filters in the different fields/columns (e.g. substances meeting a given criterion, etc.).
(9) The information available so far in the list comes from two main sources of information:
(a) For active substances on which an approval decision has been taken under the BPR, the approval Regulation, which shall specifically mention whether the active substance is a candidate for substitution and which criteria in Article 10(1) of the BPR are met.
(b) For the active substances on which an approval decision was taken under the BPD rules, the Assessment Report (AR) for the inclusion in Annex I to BPD.
(10) However, for the purpose of the use of the list in the context of product authorisation (i.e. use any reliable scientific information available to CAs) and the subsequent update of its content, the following remarks have to be done with regard to the listed criteria:
(11) P/B/T status:
(12) For PBT criteria, the list includes the information collected from the active substance approval Regulation or, as relevant, from the AR accompanying the decision to include the substance in Annex I to BPD. This information will be updated with the conclusions on the PBT/vPvB properties of the substance provided by the ECHA PBT Expert Group when available, even if not formalised by a BPC opinion or a Commission decision amending the active substance approval.
(13) A status "potential P", "potential B" or "potential T" means that the substance may have the respective properties as listed in REACH Annex XIII but that there is need for further consideration before it can be concluded whether the Annex XIII criteria for the respective endpoint are indeed met. Where a change on this "potential" status would lead to a substance meeting the substitution or exclusion criteria, then the matter would need further examination and should involve the ECHA PBT Expert Group.
For the purpose of transparency and information, these substances are kept in the list but they are not considered for the time being as "P", "B" or "T". As a consequence, a status of “potential” exclusion and “potential” substitution has to be considered as not fulfilling those criteria.
(14) C/M/R status:
(15) For C/M/R properties, the list includes either:
(a) the existing harmonised classification of the substance in accordance with the CLP Regulation[5] or
(b) the proposal for a harmonised classification by the MS in accordance to that Regulation in the AR for the inclusion in Annex I to BPD.
This information will be updated according to new RAC opinions, even if these have not yet been reflected in inclusions into Annex VI to the CLP Regulation.
(16) ED properties:
(17) The interim criteria as stated above are used for this purpose. The new ED criteria when available will be used for new assessments.
4.- Making available and updating of the list
(18) The list will be made available on the CIRCABC Biocides – Regulation 528/2012 – Public, within one specific folder.
(19) ECHA will maintain the list up to date by including:
(a) substances which are subject to an approval decision for the first time,
(b) new information becoming available on the different criteria in accordance with paragraphs 12 and 15 of this document.
Annex
Information on active substances on which an approval decision has been taken with regard to certain exclusion/substitution criteria
Link to the CIRCABC folder containing the information
5/5
[1] The exclusion and substitution criteria considered in this list are those agreed in document CA-March14-Doc.4.1-Final (Principles for taking decisions on the approval of active substances under the BPR).
[2] OJ L167 27.06.12 p.1.
[3] A specific reference to this document has been included in the existing Note for guidance on "Comparative assessment of biocidal products" (Document CA-March14-Doc.5.4; consolidated version of CA-Sept13-Doc.5.1.f – Final and CA-Dec13-Doc.5.1.k –Final).
[4] OJ L 123, 24.4.1998, p. 1.
[5] Regulation (EU) No 1272/2008 - OJ L 353, 31.12.2008, p. 1.