On September 2, 2015, the European Chemicals Agency (ECHA) issued an updated list of biocide suppliers as required under Article 95 of the Biocidal Product Regulation (BPR). Although prior versions of the list were released previously, this list has current legal effect since Article 95 provides that, as of September 1, 2015, a biocidal product cannot be made available in European Union (EU) markets unless the active ingredient supplier or product supplier is listed for the particular product type (PT) (e.g., PT 5 (Drinking water), PT 19 (Repellents and attractants)) to which the biocide product belongs.
The purpose of Article 95 in creating a list of persons placing active substances in the EU market is to ensure the equal treatment of persons placing active substances on the market and to avoid “free riders.” Without the requirements in Article 95, a supplier of an active substance that has not supported the approval of that substance (either through the Review Programme of the biocide directive, or as a newcomer under the BPR) could still enter the market without compensating the entity that undertook the costs and effort to have the active substance listed.
There will be continued updates and revisions made to the list as new suppliers seek inclusion. In addition, ECHA states that it received 158 applications from suppliers seeking inclusion on the list, and has created a list of pending applications that ECHA is still processing. ECHA notes: “The list of pending Article 95(1) applications should not be confused with the list of relevant substances and suppliers (“Article 95 list”) and the presence of a company (per substance/PT/role) on the list of pending applications does not guarantee that the application will be successful and that the company will ultimately be included in the Article 95 list.” Updates to the list also are expected for certain substances that were not within the scope of the Biocidal Products Directive (BPD) (e.g., some in situ generated active substances, substances benefiting from derogation for food and feed in Regulation 1451/2007), and for which different BPR notification and inclusion dates apply.
Although enforcement efforts regarding the Article 95 list have not yet been tested, companies placing biocidal products in EU markets must carefully review the list to ensure that they and/or their suppliers are listed not only for the particular active ingredient and/or product at issue, but also for the product’s particular PT.
There is a one year period, until September 1, 2016, to sell existing stocks for biocide products where the suppliers are not included on the List.