Letter of access (Alternative suppliers)

In Article 95 of BPR, transitional measures have been described regarding the right to access an active substance dossier. Anyone who wants to place biocidal active substances on the EU market on its own or in biocidal products must have access to the required data.

 

In this context the term “alternative suppliers” is used. It refers to manufacturers or importers of active substances who did not participate in the review programme of active substances under the Biocidal Product Directive, and did not contribute to the approval of active substance. Such persons are, however, entitled to place an active substance on the market if the active substance has been approved for biocidal use or because it is under evaluation.

 

According to BPR, alternative suppliers have to submit to ECHA either a dossier, a letter of access, or if all data protection periods have expired, a reference to an existing dossier. The information should comply with the data requirements of Annex II of BPR or of Annex IIA of the previous directive.

 

ECHA is responsible for the implementation of this provision and it shall publish a list of those who have submitted the required information. At the first stage, the Commission has asked participants of the review programme and applicants for new active substances to send the information through the Biocidal Product Register to be published on the ECHA list.

 

A biocidal product cannot be placed on the market from 1 September 2015 onwards unless the manufacturer or importer of the active substances contained in the biocidal product, or where relevant the importer of the biocidal product, is on this list.

 

 

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