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Agroscience Services >> Regulatory Consultancy >> Biocides

Biocides

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Biocidal Products Regulation - challenging for small and medium size companies

The Eurofins Agroscience Regulatory (EAR) Biocide team has extensive experience gained from working under the previous European legislation Biocidal Products Directive (BPD, Dir.98/8/EC) and the current legislation, Biocide Products Regulation (BPR, EC Reg. 528/2012).

Our Regulatory Managers offer ‘end-to-end’ regulatory consultancy to guide you through the many complexities of the BPR from your initial requirements all the way through to post-submission evaluation by the ECHA or any other national competent authority.

  • Analysis of business objectives and proposals for the best regulatory time and cost strategies
  • Development of Biocidal Product Family structure (meta-SPCs and SPC editor)
  • Literature searches (where required)
  • Data-gap analysis including evaluation of quality, relevance and reliability of existing information
  • Study monitoring of GLP studies, including efficacy
  • Project management
  • Preparation of IUCLID dossiers for active substance approvals and product authorisations
  • Advice on in-situ generated actives
  • Human health risk assessment and environmental risk assessment including environmental modelling
  • Classification and labelling (CLP) of actives and products
  • Assistance with Article 95 listing as a supplier of an active substance (or precursor)
  • Support with technical equivalence applications
  • Assistance with the BPR transitional requirements
  • Project management

Through our global Eurofins network we can also offer a full range of testing services required for your biocidal product.

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Our promise to you:

The commitment to provide the highest quality service for all your regulatory needs.

For further information, please contact us