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Management of changes to authorized biocidal products

An authorisation holder seeking to change any of the information submitted in relation to the initial application for authorisation of the biocidal product shall apply to the competent authorities of relevant Member States having authorised the biocidal product concerned, or in the case of a Union authorisation, the European Chemicals Agency (ECHA).

Proposed changes of biocidal products should be classified in different categories (administrative, minor and major change), taking into account the extent to which they require a reassessment of the risk for human or animal health or the environment and of the efficacy of the biocidal product or biocidal product family. Different change types are listed in the Annex of the EU Commission’s Implementing Regulation No 354/2013 on changes of authorised biocidal products. Regulation lays down provisions concerning changes of biocidal products sought in accordance with Article 50(2) of Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products with regard to any of the information submitted in relation to the initial application for the authorisation of biocidal products or biocidal product families in accordance with Directive 98/8/EC concerning the placing of biocidal products on the market and Regulation (EU) No 528/2012.

ECHA also frequently updates issued opinions on applications for classification of a change (ECHA opinion on applications for classification of a change). The opinion can help companies understand which type of application you should submit to change your product authorisation.