Understanding the BPR and Article 95 Compliance
What is the BPR?
The Biocidal Products Regulation (BPR) (Regulation (EU) No 528/2012) governs the placing on the market and use of biocidal products within the European Union. Its main objective is to ensure a high level of protection for human health and the environment, while improving the functioning of the internal market through the harmonization of rules for biocidal products.
Its scope covers both the approval of active substances and the authorisation of biocidal products that contain them. In addition, treated articles (i.e. articles intentionally incorporating a biocidal function) may only use active substances approved for that specific use.
Article 95 List of Suppliers
Article 95 is a key provision of the BPR intended to ensure that only responsible actors may place biocidal products (or treated articles) on the market.
As of 1 September 2015, companies who manufactures or imports a biocidal active substance or who manufactures or makes available on the EU market a biocidal product is legally required to comply with Article 95.
Companies can ensure compliance by being added to ECHA’s Article 95 list of suppliers. Alternatively, it is possible to achieve compliance by sourcing 100% of the active substance or biocidal product from an already Article 95 listed company.
To become Article 95 listed for a silver containing active substance, companies need to obtain an Article 95 letter of access (LOA) to the complete substance dossier for the particular PT, submit their own dossier, or submit a combination of data and LOAs.
Similar rules apply in the UK under GB BPR.
Member States transitional regimes for biocidal products
Many of the silver containing active substances remain under assessment and have not yet been formally approved under the BPR. In these cases, biocidal products containing these active substances are generally subject to a transitional regime applicable in each Member State. The relevant rules goverining biocidal products therefore varies depending on the jurisdiction.
In some Member States, and depending on the procedure, an application for transitional product authorization under Member State’s transitional regimes require the applicant to submit a biocidal product LOA to the active substance dossier.
Need a Letter of Access (LOA) for a silver containing active substance for the EU or Great Britain?
The complete substance dossier for each silver containing active substance under review by the BPR comprises a core silver dossier (common to all silver containing active substance) and also a substance-PT specific dossier owned by the relevant member(s). As the secretary to the STF, we are the only entity permitted to issue LOAs to the core silver dossier. We can also put you in touch with the relevant member(s) to arrange access to the other relevant data.
If your company needs a LOA to this dossier — whether for Article 95 listing or to support a product authorization — please contact us to discuss access terms, pricing, and cooperation.