Product authorisation

No product may be placed on the market unless it has been authorised in accordance with the provisions of Directive 98/8/EC.

In accordance with Article 5(1), Member States shall authorise a biocidal product only if its active substances are included in Annex I or IA of the Directive.

Products containing new active substances

For products containing new active substances, an application for product authorisation can be submitted in parallel to the application for the inclusion of the active substance in Annex I or IA of the Directive.

In accordance with Article 15(2), Member States may also grant provisional authorisations to products containing new active substances until an active substance is listed in Annex I or IA. Such authorisation may however only be granted after the application submitted for the active substance has been evaluated and pending a final decision to include the active substance in Annex I or IA.

Products containing existing substances

Article 16 of the Directive provides however a derogation allowing the placing on the market of products containing existing substances, whilst they are being evaluated under the review programme for existing active substances (List of existing active substances under evaluation).

Products containing existing active substances can be placed on the market in accordance with the rules and practices of Member States until the inclusion of their active substance(s) in Annex I or IA of the Directive.

Following such inclusion decisions, products must be authorised in accordance with the terms of the Directive and applications submitted to the Member States, where such authorisations are to be granted.

In case of a non-inclusion decision, products containing existing active substances shall be phased out within 12 months of the decision being published (List of non-inclusion decisions).

Mutual Recognition

Following the granting of a first authorisation, an application for mutual recognition can be submitted in other Member States in order to obtain other authorisations in these Member States.

Frame Formulations

The Directive provides for simplified authorisation procedures for products having very similar compositions and belonging to a frame formulation.

Register for Biocidal Products (R4BP)

Applicants for product authorisations are expected to use the Register for Biocidal Products (R4BP) to generate the harmonised application forms, which shall then be attached to their dossier.

This R4BP is available on-line at the following address: https://webgate.ec.europa.eu/env/r4bp2

Please note that, the former version of the R4BP (available at: https://webgate.ec.europa.eu/env/r4bp) remains available to manage applications created until 16 December 2011.

Applicants are kindly invited not to wait until the final deadline for the submission of the applications for product authorisation or mutual recognition in order to avoid saturation of the system.

More information on product authorisation is available from the Notes for Guidance to applicants for product authorisation available here.