Chemical Check - European Office for Safety and Health

Biocides / Treated Articles

The new Biocide Regulation (EC) 528/2012 has to be applied obligatory since 1 September 2013. It replaces the previous Biocide Directive 98/8/EC. Compared to the previous directive, several changes have arisen, e.g. there is now the possibility of a union authorization for biocide products or authorization of biocidal product families. Furthermore, articles treated with biocide products are covered and regulated.

Treated articles are defined as substances, mixtures or products which have been treated with one or more biocide products or to which one or more biocide products have purposely been added.

  • Do you have biocide products in your portfolio?
  • Do you need a national notification/registration/authorization?
  • Has/have the biocidal active ingredient(s) in your product already been excluded in one of the Annex I or IA or been approved according to the Biocide Regulation?
  • Do you have treated articles in your portfolio?
  • You are not sure whether your product is a biocide product or a treated article?
  • You are not sure whether your product is a medical device or a medicinal product?

Does your product contain biocidal active ingredients, which have not been included in the Annexes I or IA of the previous Directive 98/8/EC or the union list yet? Until then the national regulations of the particular member state apply in which the product is placed on the market.

Please find here the Biocide Regulation.

Further information under European Chemicals Agency: List of active substances and suppliers (Art. 95)

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