+49 341 33 73 33 60

Biocides – Regulatory Consulting

  • Distinction and definition on borderline products
  • Distinction between biocidal products and treated goods
  • Development of effective regulatory strategies
  • Legal Compliance
  • Evaluation of your marketing claims to ensure they adhere with regulatory requirements

Data collection

  • Data analysis, identification of missing data (“Data gap analysis”)
  • Development of test strategies including outsourcing to laboratories
  • Evaluation of effectiveness
  • Cost analysis
  • Study monitoring

Risk assessment

  • Toxicological and/or eco-toxicological assessment of properties of the active biocidal substances or biocidal product
  • Exposition scenario for humans, animals and environment

Biocides – Registration Dossiers

  • Dossier for biocidal active substances or products for authorisation in the EU (98/8/EC and EU 528/2012)
  • Preparation and filing of dossier with ECHA in IUCLID (R4BP3)
  • Article 95 – Application to be included in the list of suppliers of active biocidal substances and biocidal product
  • Classification and labelling of biocidal products in accordance with the CLP regulation (EU) 1272/2008

Training and Professional development at BioCity in Leipzig or in-house at your premises

  • Registration and authorisation of biocidal products and treated goods
  • In-situ-Systems
  • Dossier preparation and filling, using IUCLID and R4BP3
  • Classification and labelling according to the CLP regulation (EU) Nr. 1272/2008

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