REGULATORY ASSISTANCE

BIOCIDAL PRODUCTS

BIOCIDAL PRODUCTS, as cited in art. 3 of the Regulation (EU) n. 528/2012 of the European Parliament and Council, relate to:

  • any substance or mixture, in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances, with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action
  • any substance or mixture, generated from substances or mixtures which do not themselves fall under the first indent, to be used with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action
Biocidal products, thus defined, include: disinfectants, preservatives, control of harmful animals, anti-fouling products.

The Biocidal Technical-Regulatory Area of Bio Basic Europe assists the client by offering consulting services and producing the necessary documentation for the trading of the products, in line with the current regulations concerning safety and protection of public health.

Below is a list of the main technical-regulatory services offered by Bio Basic Europe for producers and manufacturers of biocidal products and other REACH products:

  • Advisory services concerning industry regulations
  • Identification of legal obligations within supply chain of a product, according to the criteria set by the reference regulation
  • Contacts with national and international Authorities to meet regulatory requests
  • Evaluation of the category to which a product belongs, in case of "borderline" classification
  • Analysis of the documentation necessary for biocide registration
  • Advice on the analysis required by the relevant regulation
  • Documentation audit concerning electronic devices and CB reports, and labelling advice
  • Aerosol labelling advice and opinions on the metrological obligations according to vertical and horizontal regulations
Bio Basic Europe is also expert in performing laboratory tests to substantiate the safety and efficacy of Biocidal products.

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