Article 95 Listing
The BPR provides that the costs associated with active substance approval are to be shared among the suppliers of a given active substance.
To promote fair competition (and prevent “free-riding”), ECHA has compiled the so-called “Article 95 list”. This list includes only suppliers who verifiably possess or have access to a complete EU active substance dossier for a specific substance/product type combination. Article 95 listing by the supplier or the formulator/manufacturer himself is mandatory if an active substance is to be used as biocide within a product.
Like 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 basically be made in three 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
We support your Article 95 listing and take care of the entire procedure or only assume responsibility for individual steps (e.g. communication with data owners, etc.).
For non-EU providers we can also take over the function of the EU representative.
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