Letter of access

A submission for inclusion in the Article 95 list can be made by submitting an LoA to ECHA. The LoA must refer to a ‘complete substance dossier’, i.e. a dossier that has been accepted or validated by a Member State in a procedure provided for by the BPR or the BPD or by ECHA in accordance with Article 95(1), second sub-paragraph, of the BPR. This could be a dossier submitted in the Review Programme, or a dossier for a new active substance submitted under the BPD or the BPR, or a third party dossier (submitted as part of a biocidal product authorisation), or a dossier submitted by an alternative supplier.

Therefore, the LoA required for the Article 95 submission should be granted by the submitter of the ‘complete substance dossier’.

If the submitter of the complete substance dossier is not the owner of the data, depending on the contractual arrangement in place, it may need to seek the agreement of the data owner to grant the LoA for the purpose of Article 95 to the alternative supplier.

It should be noted that according to Article 95(4) the substance and product supplier included in the Article 95 list to whom an LoA has been issued, are entitled to allow applicants for the authorisation of a biocidal product to make reference to that LoA for the purpose of Article 20(1) of the BPR. This also applies if the supplier to whom an LoA has been issued is itself applying for biocidal product authorisation.

According to the BPR (Article 61), an LoA should contain at least:

a) the name and contact details of the data owner and the 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. For the purposes of an Article 95 application, a list of the submitted data is not necessary if the LoA refers to a ‘complete substance dossier’ in its entirety. Information stating which PT(s) the submission concerns should be given in the LoA.