Assistance With Active Substance Applications

All biocidal products require an authorisation before they can be placed on the market, and the active substances contained in that biocidal product must be previously approved.

The approval of active substances takes place at Union level and the subsequent authorisation of the biocidal products at Member State level. This authorisation can be extended to other Member States by mutual recognition.

The Biocidal Product Regulation (BPR, Regulation (EU) 528/2012) aims to harmonise the market at Union level; simplify the approval of active substances and authorisation of biocidal products. It also promotes the reduction of animal testing by introducing mandatory data sharing obligations and encouraging the use of alternative testing methods.

An application needs to be submitted to ECHA through R4BP v3

All active substance manufacturers and importers placing active substances on the EU market, either on their own or in a biocidal product, that have not already submitted their own dossier on the active substances under the Biocidal Products Directive (BPD) or the Biocidal Products Regulation (BPR) must either submit a dossier, a letter of access, or if all data protection periods have expired, a reference to an existing dossier to ECHA. This information must comply with the data requirements of Annex II of the BPR or of Annex II A of the BPD.

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Each application must only refer to one source and only to substances that have been approved for inclusion in the Union list of approved active substances

Applications for an assessment of technical equivalence aim to determine the similarity, with regards to the chemical composition and hazard profile of a substance produced from a source different to the reference source, or from the reference source but following a change to the manufacturing process and/or manufacturing location, compared to the substance of the reference source.

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Scope: Articles 12 to 14 of BPR

An application for the approval of an active substance renewal for one or more product types, need to be submitted to ECHA at least 550 days before the earliest expiry date in the approval.

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Small or medium-sized enterprise (SME) may be entitled to a reduced fee

Applications for the approval of an active substance are submitted through the Register for Biocidal Products, R4BP v3. The approval of an active substance concerns only the product types for which relevant data is provided in the application. Active substances meeting the exclusion criteria will only be approved in special cases.

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Scope: Articles 62, 63 and 95 of the BPR

An inquiry to share data is obligatory before performing any tests or studies involving vertebrates. This step determines whether such tests or studies have already been submitted under the Biocidal Products Directive (BPD) or the Biocidal Products Regulation (BPR).

The purpose of data sharing is to avoid unnecessary or repeat testing, in particular on vertebrate animals and to support resolutions on data sharing disputes (Article 63 of the BPR).

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Small or medium-sized enterprise (SME) may be entitled to a reduced fee

An application for the approval of an active substance in additional product types, can be submitted either together with the initial application for active substance approval, or at any time after that.

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Small or medium-sized enterprise (SME) may be entitled to a reduced fee

Any person wishing to apply for an amendment to the conditions of an approved active substance must submit an application to ECHA through the Register of Biocidal Products, R4BP 3.

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Entry point for all regulatory services related to: Biocides, Biocidal Products Authorisation