What is the "specific additional form" ("Statut du produit biocide sur le marché français") and where can I obtain it?
The company therefore certify the placing of the product on the French market, and must supply the French Ministry of Ecology and the French National Research and Safety Institute ( INRS) with inventory codes. This document is available in the "Dossier Submission" section and is entitled "Statut du produit biocide sur le marché français".
What is the "technical dossier"?
The technical dossier contains documents I, IIA, IIB, IIC, IIIA, and IIIB (see EC Regulation 1451/2007, Annex IV) as mentioned in the TNsG on Dossier Preparation and Study Evaluation and the TNsG on Product Evaluation, available from the Joint Research Centre website. It does not contain the studies and publications found in documents IVA and IVB. In a "product" dossier, documents IIA and IIIA can generally be "supplied" via letters of access.
When submitting my application, should I use the European format of the dossier or is another format (national) available?
In which language do the documents and dossier need to be submitted?
Depending on the documents required, French or English must be used.
French must be used for the following information:
- The explanatory letter accompanying the type of application required
- The R4BP form
- The specific additional form (entitled: "Statut du produit biocide sur le marché français")
- The classification, the safety data sheets and the label of the biocidal product
- A copy of the letters of access
In English or French: the technical dossier, only in electronic format. Note: English is the preferred language for technical dossiers in mutual recognition applications.