Clarifying doubts about Same Biocidal Products (Regulation (EU) No 414/2013)
Background: This article summarizes the conclusions on the 104th CA meeting about the discussions held at past CA meetings (91st-99th, January 2021 – March 2023). These discussions focused on interpreting and applying the Same Biocidal Products Regulation.
Key Updates and Explanations:
General Rules and Concept:
- Identical Formulation Required: Same biocides must be exact copies of their corresponding reference product, with exceptions for details listed in Article 22(2)(a-g) of the Biocidal Products Regulation (BPR, EU No 528/2012). This includes branding, manufacturer information, and authorization numbers.
- Authorization Process: Companies can apply for a same biocide authorization when the reference product is either a single biocide or an entire product family (not individual members). This aligns with the concept of «identical nature» in authorization.
- Maintaining Consistency: Any changes (administrative, minor, or major) made to the reference product must also be applied to the linked same-formula biocides at the same time. Failure to do so will result in authorization cancellation for the same-formula products.
- Authorization Cancellation: If the reference product’s authorization is revoked, the authorizations for all linked same biocides will be cancelled as well. Phasing-out provisions outlined in Article 52 of the BPR will apply.
- National vs. Union Authorization: Applications for national authorization of a same biocide follow the national procedure if the reference product has a Union authorization (and vice versa).
Renewal of Same Biocidal Products:
The document outlines the renewal process for same biocides based on the authorization type (national or Union) of the reference product and any applicable mutual recognition procedures.
- Nationally or Union-Authorized Reference Product: Renewal follows the corresponding national or Union authorization procedure defined in the BPR (Articles 31 & 45) with further details provided in the SBP Regulation.
- Mutually Recognized Reference Product: Renewal for the same biocide follows the national procedure (Article 31 of the BPR with details from the SBP Regulation). The renewal for the mutually recognized reference product itself will follow a new regulation on mutual recognition renewals.
- Mutually Recognized Same Biocide: Renewal follows the procedure set out in the new regulation on mutual recognition renewals
Do you need help to prepare your biocidal product application for authorization? Nordiik can help, contact us!
Source: CIRCA
