Biocidal Product Regulation (BPR)

• Biocidal product:
  1) Any substance or mixture, in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances, with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action. 2) Any substance or mixture, generated from substances or mixtures which do not themselves fall under the first indent, to be used with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action. 3) A treated article that has a primary biocidal function shall be considered a biocidal product.
• Treated article:
  Any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products.
• Biocidal product family:
  A group of biocidal products having (i) similar uses; (ii) the same active substances; (iii) similar composition with specified variations; and (iv) similar levels of risk and efficacy.
• Nanomaterial:
  1) A natural or manufactured active substance or non-active substance containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1-100 nm. 2) Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external dimensions below 1 nm shall be considered as nanomaterials. 3) For the purposes of the definition of nanomaterial, ‘particle’, ‘agglomerate’ and ‘aggregate’ are defined as follows a)’‘particle’ means a minute piece of matter with defined physical boundaries, b) ‘agglomerate’ means a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components, c) ‘aggregate’ means a particle comprising strongly bound or fused particles.

• To obtain an approval of an active substance and/or a biocidal product, a dossier must be submitted to the competent authority in a chosen member state in the EU. For the active substance, the dossier must fulfill specific information requirements, described in Annex II of the regulation, whereas the biocidal product must fulfill the information requirements set out in Annex III of the regulation.
• The data requirements consist of a Core Data Set (CDS) and an Additional Data Set (ADS). The CDS is the basis data that, in principle, must be provided for all active substances. There may, however, be cases where it is not possible to generate all data elements belonging to the CDS. This applies in special cases, where physical or chemical properties render it impossible or unnecessary to provide certain data. The ADS to be provided is determined by the physio-chemical properties of the chemical in question, for which type of products the active substance is used, and the exposure patterns that are related to that use (see paragraph 2 in Annex II and Annex III). For each endpoint in the CDS, at least one key study (or an accepted data waiving justification) must be submitted and the study has to be reliable and adequate to use for the risk assessment. According to Annex II the data submitted to support the approval of an active substance must be obtained according to the methods specified in the Test Methods Regulation. For most CDS, the relevant test methods described in the Test Methods Regulation are equivalent to OECD guidelines. If a test method is considered inadequate or not included in this regulation, it is possible to use other scientifically suitable methods; however, justification for the appropriateness of these alternative methods is required. For testing of nanomaterials the following apply: “when test methods are applied to nanomaterials, an explanation shall be provided of their scientific appropriateness for nanomaterials, and where applicable, of the technical adaptations/adjustments that have been made in order to respond to the specific characteristics of these materials” (see paragraph 5 of Annex II and Annex III for more details).

An active substance shall be approved for an initial period not exceeding 10 years if at least one biocidal product containing that active substance may be expected to meet certain criteria laid down in the regulation. The approval of an active substance shall not cover nanomaterials except where explicitly mentioned. A registrant wishing to use a given nanomaterial in a biocidal product has to be granted authorisation of that active substance.

• Risk assessment including hazard assessment, exposure assessment, dose-response assessment and risk characterization
• Comparative assessment

• The use of a biocidal product containing active substances shall be subject to appropriate risk-mitigation measures to ensure that exposure of humans, animals and the environment to those active substances is minimised.

• The Member States are required to every five years submit a report on the operation of the regulation in their respective territories, including information on the results of official controls carried out, any poisonings and, where available, occupational diseases, any available information on adverse environmental effects experienced through using biocidal products and information on the use of nanomaterials in biocidal products and the potential risks thereof.
• On the basis of the reports received, the European Commission shall draw up a composite report on the implementation of the regulation, in particular Article 58. The Commission shall submit the report to the European Parliament and to the Council.

• Member States shall make the necessary arrangements for official controls to be carried out in order to enforce compliance with the regulation. In order to facilitate such enforcement, manufacturers of biocidal products shall maintain appropriate documentation in paper or electronic format relevant for the quality and safety of the biocidal products and shall store production batch samples. See Article 65, paragraph 2, for the specific documentation requirements.