The 104th meeting of the Competent Authorities (CA) took place on June 19 and 20, 2024. During this meeting, the European Commission presented its intention to review Regulation (EU) 414/2013 concerning the procedure for the authorization of SAME biocidal products.
In the documents presented [1][2], and following previous discussions among the CAs, the European Commission indicated its desire to strengthen the existing link between the reference product and the SAME product, and to clarify the renewal process for SAME biocidal products.
One of the major points concerns the reaffirmation of the concept of similarity between the reference product and the SAME product. A SAME product must remain identical to its reference product throughout its entire period of use, except for the information specified in Article 22(2)(a), (b), (d), (f), and (g) of the BPR Regulation (EU/528/2012), namely:
- The trade name of the biocidal product;
- The name and address of the authorization holder;
- The authorization number of the biocidal product and, in the case of a biocidal product family, the suffixes to be applied to individual biocidal products belonging to the biocidal product family;
- The manufacturers of the biocidal product;
- The manufacturers of the active substances.
While up until now, SAME product authorizations could be subject to minor and/or major changes independently of the reference product authorization, this will no longer be possible. Their renewal cannot be carried out under a “SAME product” type procedure.
Furthermore, any minor/major change to the reference product must be reflected in the SAME products. If not, it would result in the cancellation of the SAME product authorization. Cancellation could also occur if the reference product is no longer authorized. Thus, the link between the holder of the reference product rights and those exploiting SAME products would no longer be limited to acquiring a letter of access. It would then be necessary to maintain regular relations between the two parties over the long term, at the risk of having a non-compliant SAME product and therefore facing the cancellation of its authorization. Long-term commercial relationships also imply much more complex and financially demanding contractual arrangements.
Thus, the sustainability of these products, their uses, and even the SAME process as a whole may soon come into question.
Comments from Member States are expected during future discussions within the Standing Committee on Biocidal Products.
If you are affected by this issue and have questions or wish to continue the discussion, please do not hesitate to contact us by email at the following address: contact@equitox.eu.
#Biocides #SAME #BPR #Biocial Product Authorisation
[1] https://circabc.europa.eu/sd/a/520bbabb-1325-4c1e-b1b3-1a6d382d24e0/CA-June24-Doc.4.3.a%20-%20SBP%20Regulation(1).docx
[2] https://circabc.europa.eu/sd/a/796c0d43-64f3-4254-9b0e-98a2ad36da68/CA-June24-Doc.4.3.b%20-%20SBP%20Regulation.pptx
