What is the Article 95 list?
The BPR stipulates that the costs associated with active substance approval are to be shared among the suppliers of a given active substance. In order to promote fair competition (and prevent “free-riding”), ECHA has compiled the so-called “Article 95 list”. This list includes only suppliers who demonstrably possess or have access to a complete EU active substance dossier for a specific substance/Product Type combination.
You must apply for inclusion in the Article 95 list if you are:
- a substance supplier, who manufactures an active substance or imports it into the EU – on its own or in biocidal products
- a product supplier, who manufactures or makes available on the market a biocidal product consisting of, containing or generating an active substance
Please note: If you formulate biocidal products or put them on the market, you do not have to apply for inclusion, but you must ensure that the active substances contained in the products have been supplied by a supplier included in this list. You must be able to demonstrate your supplier’s compliance when applying for (renewal of) biocidal product authorisation, when changing to another supplier and during an inspection.