National authorisation and mutual recognition renewal

The Biocidal Product Regulation defines the renewal of a national authorisation as "an application by or on behalf of an authorisation holder wishing to seek the renewal of a national authorisation for one or more product-types".

Supplementary rules for renewing authorisations that have been subject to mutual recognition are introduced by Commission Delegated Regulation No 492/2014.

Applications for renewing national authorisation must be re-submitted to the Member State competent authority (MSCA) who granted the first authorisation. If authorisations are subject to, or granted through, mutual recognition, the application should be sent to a reference MSCA - and at the same time to all MSCAs that have granted a related mutual recognition.

The application must be submitted at least 550 days before the expiry date of the national authorisation. If renewal is sought for more than one product-type, the application must be submitted at least 550 days before the earliest expiry date.

If an application for renewal has not been submitted, has been rejected, or additional information requested by the MSCA have not been submitted by the applicant in due time, the biocidal product must be taken off the market. This has to be done within 180 days after the expiry date of the initial authorisation. An additional maximum period of 180 days can be granted for the use of existing stocks.

The maximum validity of the renewed authorisations must not exceed that of the initial authorisations and, in any case, should not exceed 10 years.

If a concerned MSCA does not agree on the conclusions of the assessment report and/or on the summary of the biocidal product characteristics in relation to the conditions of Article 19 of the BPR, as prepared by the reference MSCA, during the mutual recognition of the renewal, the case will be referred by the reference MSCA to the Coordination Group (CG). The reference and concerned Member States have 60 days to reach an agreement by consensus within the CG. 

The CG is a body formed by representatives of the MSCAs and the Commission. ECHA provides the secretariat for the CG.

If the reference and concerned Member States cannot reach an agreement by consensus within the CG, the matter is referred to the Commission by the reference MSCA in accordance with Article 36(1) of the BPR. The Commission may ask ECHA for an opinion on the scientific or technical aspects of the case.

Comparative assessment

For those biocidal products containing one or more active substances that are candidates for substitution, the BPR foresees a comparative assessment being performed as part of the evaluation process (limited exceptions apply).

If the comparative assessment demonstrates that there are other authorised biocidal products (or non-chemical control or prevention methods) that present a significantly lower overall risk for human health, animal health and the environment, are sufficiently effective and present no other significant economic or practical disadvantages then the MSCA must prohibit or restrict the biocidal product containing the active substances identified as candidates for substitution.

An authorisation for biocidal products containing candidates for substitution can be granted (and renewed) for a maximum period of five years.