Same biocidal products authorisation
To meet the needs of companies and reduce their administrative burdens, the Same Biocidal Products Regulation (Regulation 414/2013, amended by Regulation 2016/1802) introduces the possibility to go from wider to narrower authorisations (i.e. from a biocidal product family to a subset of one or more “family members”) or markets (i.e. from Union authorisation to national authorisation).
It is possible to apply for an authorisation for a single product (the ‘same product’), which is identical to another authorised biocidal product (the ‘reference product’), or for which an application for such authorisation has been submitted (the ‘prospective reference product’).
This can happen regardless of whether the related reference product is a single product or an individual product of a biocidal product family.
Furthermore, it is possible to apply for national authorisation starting from a (prospective) reference product having (or seeking to have) a Union authorisation.
Products subject to the simplified authorisation procedure are also covered by this regulation.
An application for an authorisation for a same biocidal product family (Union, national or simplified) starting from a (prospective) reference product family is also possible.
The same biocidal product application process will result in an independent authorisation, but with the same expiry date as for the reference product (or product family). These authorisations will have a different authorisation number from the reference product and can be changed or cancelled independently of the reference product.
Applications for a same biocidal product need to be made through R4BP 3, just like all other applications under the BPR.
Information and instructions for submitting and following up the application for a same biocidal product authorisation can be found in the relevant submission manuals available on ECHA’s website. For more regulatory information, please consult the ‘Same Biocidal Product’ chapter of the Practical Guide.