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Biocides Regulation (EU) No.528/2012

The new regulation on biocidal products (EU Reg.528/2012 (BPR) governs the rules for the placing on the market of biocidal products . This Regulation which
abrogates Directive 98/8 concerning the placing on the market of biocidal products, even if it maintains the general structure of the Directive, which
provided the evaluation of active substances at EU level and the subsequent evaluation of the products containing them at the national level, introduces
important new concepts. In particular, it introduces the concept of “Union authorization”, that is the possibility, with an unique authorization, to place
the product into all Member States, the identification of ECHA as the authority responsible for carrying out certain activities, the introduction of a
series of simplifications to facilitate industry and the simplified authorization procedure.

Our main services
  • Verification of Company compliance to the Regulation
  • Preparation of the authorization dossier for the placing on the market of biocidal products
  • Definition of a testing strategies for the evaluation of the effectiveness and safety of biocidal products
  • Definition and development of hazard labelling
  • Toxicological evaluations (hazard, exposure and/or risk assessment)
  • Testing strategies
  • Testing strategies and toxicological evaluations (hazard, exposure and/or risk assessment) both in vivo/in vitro and using specific tools (eg. QSAR models, read-across techniques, in silico models for the estimation of exposure)

For further information on our consultancy contact us
Biocides Consultancy Normachem
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