Active substances and suppliers

The Biocidal Products Regulation (BPR) has as one of its objectives the establishment of a level playing field for parties dealing with active substances. This is achieved through Article 95 of the BPR and the creation of a nominative list known as “the list of relevant substances and suppliers” (“Article 95 list”).

A biocidal product consisting of, containing, or generating a “relevant substance”, cannot be made available on the EU market if the “substance supplier” or “product supplier” is not included on the Article 95 list for the product types (“PT”) to which the product belongs. The legal definition of “relevant substance” and “product/substance supplier” is indicated on Article 95 (1) of the BPR.

Inclusion on the Article 95 list is contingent on the EU supplier having submitted a “complete substance dossier”, as defined in the first subparagraph of Article 95(1) of the BPR, for a relevant substance, in accordance with the aforementioned legal provision. Often this will translate to an application (“Article 95 application”) having to be made to ECHA, in accordance with the second paragraph of Article 95(1) of the BPR. The Article 95 application can take the shape of either (i) a complete substance dossier, (ii) a letter of access (LoA) to a complete substance dossier, (iii) a combination of a LoA and data covering specific endpoints or (iv) reference to a complete substance dossier for which all the data protection periods have expired.

Special arrangements exist for Article 95 applications as far as data sharing is concerned, following Article 95(3) of the BPR. In the context of the Article 95 list, and limited to active substances in the review programme, Article 63(3) of the BPR applies to all toxicological, ecotoxicological and environmental fate and behaviour studies, including any studies not involving tests on vertebrates. 

N.B. The application of Article 95 of the BPR extends to Norway, Iceland, Liechtenstein and Switzerland, and substance or product suppliers established in those territories. Companies established outside of these countries and the EU have the option – it is non-compulsory – to be represented by an EU representative, for the purpose of Article 95, and be indicated on the Article 95 list next to their EU representative.

Maintenance of one’s Article 95 listing (Article 95(7) of the BPR)

When the approval of an active substance/PT combination is renewed, all concerned parties listed on the Article 95 list, who were not the applicants involved in the active substance renewal process, need to submit a LoA to the “relevant renewal data”, as identified by the evaluating Competent Authority, within 12 months of the Active substance/PT renewal in order to comply with Article 95(7) of the BPR. A failure to do so means removal from the Article 95 list. For further information, please see the CA document “CA-Sept20-Doc.7.1.b - Relevant Renewal Data under Article 95_FINAL”. 

To facilitate data sharing negotiations with the aim of securing a LoA for Article 95(7) compliance, information regarding the data submitted in support of the active substance/PT renewal, along with an indication of whether the data is considered relevant renewal data by the evaluating Competent Authority, is published on the ECHA website around the same time as the Biocidal Products Committee’s opinion. This information can be found in the fact sheet of the concerned active substance/PT combination, retrievable from the ’information on biocides’ page. The identities of the data submitters can be obtained via the inquiry process under Article 62(2) BPR, if not disclosed.