Active Substance Approval

Authorisation of biocidal products under the Biocidal Products Regulation, and the Biocidal Products Directive before it, is a two-step process. This process means that before a biocidal product authorisation can be granted, all active substances it contains must not only be approved, but be approved for use in the specific product type in which it is to be incorporated. The active substances in a biocidal product are those which perform the action on or against harmful organisms.

Details of applying for approval of an active substance are given in the guidance below, however, in all cases the applicant will need to provide both a dossier for the active substance itself and also a representative biocidal product. Provided the required information and data are submitted, and it is proved that a biocidal product containing the active substance is sufficiently effective and has no unacceptable effects, an implementing regulation will be adopted approving the active substance and stating the conditions of the approval.

Exclusion Criteria

Where the inherent hazard of an active substance is high, approval of the active substance will only be granted when further conditions are met. For such substances, the applicant must not only provide the required dossiers and prove the efficacy of the active substance, but they must also provide evidence that one of the conditions below is met:

• The risk to humans, animals or the environment, when the substance is incorporated into a biocidal product, is negligible under realistic worst-case conditions. For example, if the product is used in enclosed systems.
• There is evidence that the active substance is essential to prevent or control a serious danger to human health, animal health or the environment.
• The impact of not approving the active substance would be disproportionately negative on society when compared with the risk to human health, animal health or the environment.

Substances meeting the exclusion criteria are those active substances:

• meeting the criteria for classification under the CLP Regulation as category 1A or 1B carcinogens, mutagens or reprotoxins;
• identified as having endocrine-disrupting properties; or
• meeting the criteria for being PBT or vPvB under the REACH Regulation.

Candidates for substitution

Where active substances of concern meeting one of the conditions given above have been approved, they will be considered as candidates for substitution. This definition is not exclusively limited to such substances however, with a number of other criteria also leading to such a consideration as described in Article 10 of the BPR and covered in the guidance below.

Where an active substance is a candidate for substitution, the approval process will include a public consultation, during which third parties may comment on the availability of alternative active substances for use in the product type specified in the application.

Transitional measures

The Biocidal Products Regulation defines two groups of active substances:‘existing active substances’ are those that were on the market, as an active substance of a biocidal product, on 14 May 2000 for any purposes other than scientific or process-orientated research and development; ‘new active substances’ are those which were not. Applications for existing active substances were submitted under the Biocidal Products Directive and, whilst some active substances were approved under that Directive, many applications are still to be evaluated.

For those active substance dossiers which have not yet been evaluated, a programme has been developed to ensure the review is complete by 2024. This program is structured so that active substances incorporated into the same product type are evaluated in the same year allowing, therefore, for a similarly structured approach to the authorisation of biocidal products. As these applications were submitted to comply with the requirements of the Biocidal Products Directive, but are being reviewed against the requirements of the BPR, it is possible that there will be required data missing from the dossiers. Where such a case occurs, the applicant will be given the opportunity to provide the additional information required.

As well as the measures relating to the evaluation of submitted dossiers, transitional measures also exist under Article 95 of the Regulation concerning access to these dossiers by other applicants. This provision is intended to prevent so called ‘free-riders’ from benefitting from the time and expense put in by applicants, without paying fair compensation. Those manufacturers or importers who wish to place an active substance on the market for use in a biocidal product type must submit to ECHA either a dossier for that active substance, or a Letter of Access to such a dossier. Those organisations who have done so, either under the Biocidal Product Directive, or subsequent to 1 September 2013, will be identified on a list of ‘approved active substance suppliers’ maintained by ECHA and accessible online.