Article 95 listing
As of September 1st, 2015 biocidal products are only allowed to be placed or used on the European market when the contained, generated or released active substance(s) are purchased from sources that either were already evaluated in the "existing" active substance approval or are listed according to Article 95 for the respective product categories. The aim of these requirements is to achieve an equal treatment of all market players and to spread the costs for the active substance application equally among all firms using and active substance (eliminating the "freerider" issues).
Similar to REACH, the BPR only allows companies located with the EU to apply for inclusion on the Article 95 list. Non-EU companies are permitted to name an EU-representative to get included on the list in their name.
To comply with the data requirements the application for listing can principally be performed in three different ways:
- Buying a "Letter of Access" to a complete dossier that has been accepted by authorities
- Using both own data and buying a "Letter of Access"
- Submission of an own complete dossier per the requirements of Annex II
CSB can offer you support for either the complete application or parts of the application (for example - communication with data holders). For a non-EU company we also offer to act as the EU-representative.
Feel free to contact us with any questions related to this topic.