Article 95

Under Article 95, a list is established containing all approved suppliers of each active substance/product type combination which is approved under the BPR. After 1 September 2015, biocidal products may only be made available on the market if the manufacturer or importer of the active substance, or the formulator or importer of the biocidal product, is included on this list. This provision ensures not only that the necessary data on an active substance has been generated and evaluated for the product-type into which it is to be incorporated, but also that the manufacturer or importer of the active substance has supported its approval by contributing to the costs. The list is published on the ECHA website.

In order to be included on the list, a company must submit one of the following for the active substance which they manufacture or import:

• A dossier created in accordance with Annex II of the BPR (or Annex IIA of the BPD); or
• A Letter of Access to a dossier; or
• A reference to a dossier for which all data protection periods have expired.

Where a company is participating in the review programme for an existing active substance, or has already submitted a dossier for a new active substance, they have already satisfied the first point above. These organisations therefore formed the initial list published by ECHA. Any other company wishing to supply an active substance after 1 September 2015, alone or as part of a biocidal product, must ensure they or someone above them in their EU supply chain, are also added to the list.

Those who manufacture or import active substances listed in Annex I of the BPR, or who supply active substances which were outside the scope of the BPD (e.g. in-situ generated active substances), are not required to make a submission as Article 95 does not apply to them.

Letter of Access and data sharing

One way in which inclusion onto the list of approved active substance suppliers can be achieved is by provision of a Letter of Access (LoA) to an existing dossier. In accordance with Article 61 of the Regulation, the LoA must contain:

“(a) the name and contact details of the data owner and beneficiary;

(b) the name of the active substance or biocidal product for which access to the data is authorised;

(c) the date on which the letter of access takes effect;

(d) a list of the submitted data to which the letter of access grants citation rights.”

As with the REACH Regulation, the alternative supplier and data holder must make every effort to reach an agreement on the sharing of data under fair, transparent and non-discriminatory conditions. If this cannot be achieved, the alternative supplier should inform ECHA. Where every effort can be demonstrated to have been made, and provided the alternative supplier has paid a share of the costs, then ECHA shall give the prospective applicant permission to refer to the tests. An agreement on costs must still be reached between the two parties, and ECHA will not advise or arbitrate on this. Whilst the data sharing provisions of the Biocidal Products Regulation generally only relate to the sharing of vertebrate tests, in the case of Article 95, they are extended to also cover non-vertebrate testing.

For more information on data sharing under the BPR, see the guidance document.