Regulation (EU) No 528/2012 of the European Parliament and of the CouncilShow full title

2. The data elements set down in this Annex comprise a Core Data Set (CDS) and an Additional Data Set (ADS). The data elements belonging to the CDS are considered as the basic data which should, in principle, be provided for all active substances. However, in some cases the physical or chemical properties of the substance may mean that it is impossible or unnecessary to provide specific data elements belonging to the CDS. U.K.

With regard to the ADS, the data elements to be provided for a specific active substance shall be determined by considering each of the ADS data elements indicated in this Annex taking into account, inter alia, the physical and chemical properties of the substance, existing data, information which is part of the CDS and the types of products in which the active substance will be used and the exposure patterns related to these uses.

Specific indications for the inclusion of some data elements are provided in column 1 of the Annex II table. The general considerations regarding adaptation of information requirements as set out in Annex IV shall also apply. In light of the importance of reducing testing on vertebrates, column 3 of the Annex II table gives specific indications for the adaptation of some of the data elements which might require the use of such tests on vertebrates. The information submitted shall, in any case, be sufficient to support a risk assessment demonstrating that the criteria referred to in Article 4(1) are met.

The applicant should consult the detailed technical guidance regarding the application of this Annex and the preparation of the dossier referred to in point (a) of Article 6(1), which is [F1 to be made available online by the competent authority].

Textual Amendments

F1 Words in Annex 2 para. 2 substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 140(2)(a); 2020 c. 1, Sch. 5 para. 1(1)

[F2 The applicant must initiate a pre-submission consultation with the competent authority. In addition to the obligation set out in Article 62(2), the applicant may also consult with the competent authority with regard to the proposed information requirements and in particular the strategy for avoiding new testing on vertebrates alongside any testing on vertebrates that the applicant proposes to carry out. The applicant must document such pre-submission consultations and their outcomes and must include the relevant documents in the application.]

Textual Amendments

F2 Words in Annex 2 point 2 substituted (6.4.2024) by The Biocidal Products (Health and Safety) (Amendment and Transitional Provision etc.) Regulations 2024 (S.I. 2024/352), reg. 1(2), Sch. 1 para. 1(2) (with reg. 3)

Additional information may need to be submitted if it is necessary to carry out the evaluation as indicated in Article 8(2).