Guidance on the Biocidal Products Regulation Volume II Efficacy - Assessment and Evaluation (Parts B+C) Version 4.1 February 2022
LEGAL NOTICE This document aims to assist users in complying with their obligations under the Biocidal Products Regulation (BPR). However, users are reminded that the text of the BPR is the only authentic legal reference and that the information in this document does not constitute legal advice. Usage of the information remains under the sole responsibility of the user. The European Chemicals Agency does not accept any liability with regard to the use that may be made of the information contained in this document.
Guidance on the BPR: Volume II Efficacy - Assessment and Evaluation (Parts B+C) Reference: ECHA-22-G-01-EN Cat. Number: ED-05-22-027-EN-N ISBN: 978-92-9468-105-8 DoI: 10.2823/479316 Publ.date: February 2022 Language: EN © European Chemicals Agency, 2022 If you have questions or comments in relation to this document please send them (quote the reference and issue date) using the information request form. The information request form can be accessed via the Contact ECHA page at: http://echa.europa.eu/contact. European Chemicals Agency Mailing address: P.O. Box 400, FI-00121 Helsinki, Finland Visiting address: Telakkakatu 6, FI-00150 Helsinki, Finland
PREFACE The Guidance on the Biocidal Products Regulation (BPR) is to be applied to applications for active substance approval and product authorisation as submitted from 1 September 2013, the date of application (DoA) of the Biocidal Product Regulation (the BPR). This document describes the BPR obligations and how to fulfil them. The scientific guidance provides technical scientific advice on how to fulfil the information requirements set by the BPR (Part A) and how to asses and evaluate the efficacy to establish the benefit arising from the use of biocidal products and to prove that it is sufficiently effective (Parts B+C). In addition to the BPR guidance, the Biocidal Products Directive (BPD) guidance and other related documents are still considered applicable for new submissions under the BPR in the areas where there are no BPR guidance or it is under preparation. Furthermore these documents are still valid in relation to the applications for active substance approval submitted under the BPD that may still be under evaluation. Also the Commission has addressed some of the obligations in further detail in the Biocides Competent Authorities meetings documents which applicants are advised to consult. Please see ECHA Biocides Guidance website for links to these documents: [https://echa.europa.eu/guidancedocuments/guidance-on-biocides-legislation]. Applicability of Guidance Guidance on applicability of new guidance or guidance related documents for active substance approval is given in the published document “Applicability time of new guidance and guidance-related documents in active substance approval” available on the BPC Webpage1 and for applicability of guidance for product authorisation, please see the CAdocument CA-july2012-doc6.2d (final), available on the ECHA Guidance page [CA-July12- Doc.6.2.d - Relevance of new guidance].
1. General Introduction Evaluation and Assessment The process of evaluation of active substance applications is given in Article 8 (BPR) and the common principles for the evaluation of dossiers for biocidal products (including the representative biocidal product in the context of the active substance approval) is given in Annex VI (BPR). The evaluating or receiving CA uses the data submitted in support of an application for active substance approval or authorisation of a biocidal product to make a risk assessment based on the proposed use of the (representative) biocidal product. The general principles of assessment are given in Annex VI (BPR) and the evaluation is carried out according to these general principles. The evaluating body will base its conclusions on the outcome of the evaluation and decide whether or not the biocidal (representative) product complies with the criteria for authorisation set down in Article 19(1)(b) and/or whether the active substance may be approved. Efficacy data are a fundamental component in the regulatory management and decision making process for biocidal products. Efficacy data are required to establish the benefit arising from the use of biocidal products and must be balanced against the risks their use poses to man and the environment. Authorisation of a biocidal product will only be granted according to Art. 19 (1) b of the BPR if that product is shown to be sufficiently effective. Even for the requirement to limit the use to the minimum necessary and the general requirement of sustainable use of biocidal products (Art. 17 and 18 BPR), it is crucial that the biocide in questions delivers the expected effect. The information and data required relevant to the effectiveness of the active substance(s) to be employed in biocidal products are outlined in Annex II, BPR, title 1 No. 6 and 7 and title 2 No 5 and 6. For biocidal products the data required are set out in Annex III, Title 1 No 6 and 7, and title 2, No 6 and 7. These general sections at the beginning of this guidance, (namely sections 1, 2 and 3), provide a general overview for the efficacy evaluation; the more specific requirements for each Product Type (PT), which must be met and should be followed in the first instance, are described in the later sections. 2. Claims 2.1 Introduction The evaluation of the efficacy of a biocidal product is carried out in order to determine whether the claims made for the activity of the active substance (within the product) or the product itself, are supported by suitable efficacy data. A claim is the precondition and base for efficacy testing. Claims should comprise of the description of the problem and the way it is suggested to be solved by the biocidal treatment. Claims include information given in an active substance dossier, information on the label of a product, information provided on a web-site or in product-associated leaflets. All claims should be consistent. Guidance on the BPR: Volume II Parts B+C Version 4.1 February 2022 27 Claims can range from simple to complex, depending on the activity and benefits the applicant wishes to claim as resulting from the use of the active substance/biocidal product. This should include as a minimum the following information: • The purpose of the claim (e.g. prevent destruction of material by insect infestations, disinfect surface); • The function of the product (e.g. insecticide, wood preservative, disinfectant, etc.); • The (group of) target organisms which will be controlled; • In-use concentration; • Use conditions and area of use; • The effect which will result from using the product on the target organisms (e.g. kill, control, repel, prevent, etc.); • Any products, organisms or objects to be protected. Some examples are available in the different claim matrices and PT specific guidance sections (see later sections). However this basic information can be supplemented by additional claims which further describe the effects of the active substance/product where appropriate, such as: • How fast the effect is produced; • The duration of the effect (residuality) or lifespan; • The types of surface on which the product can be used (e.g. hard porous and nonporous surfaces, softwood). For products used to treat articles, additional information should be provided: • Durability of the effect in relation to the expected life-span of the treated article; • Resilience towards ageing, weathering or other use conditions as for instance washing; • Where relevant, leaching/migration data for different materials or different use conditions. All claims made should be supported by data or a suitably robust scientifically based reasoned case. 2.2 Label claims and directions for use The directions for use and the claims made for the biocidal product are included in a summary of biocidal product characteristics (SPC) in accordance with Article 22(2) (BPR). A label claim is information which is provided to the user which describes the biocidal effects that will result from using a biocidal product under its normal conditions of use (e.g. when it is used at the recommended dose/application rate, by the recommended application method(s) and in the appropriate areas, etc.). The product label can only include claims that are in line with the authorised uses, as given in the SPC. Label claims should be as specific as possible, or if more general claims (such as “fast acting”) are made, then they should be further clarified on the label where possible (e.g. “fast acting – acts within 5 minutes”). If no clarification is provided, the evaluating Competent Authority should ask the applicant to specify the claim. A judgement as to what a normal user would reasonably expect from the claim should be made. Evaluation should be made according to this claim and the directions for use should be taken into account. 28 Guidance on the BPR: Volume II Parts B+C Version 4.1 February 2022 An application for a product authorisation must include a draft SPC and additionally should include a copy of the draft product label containing the claims made for the product. Applications for product families should include the entire range of the claims proposed for the products within the family. 3. General considera
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