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The Biocidal Product Regulation (BPR, (EU) 528/2012) regulates the use and marketing of active biocidal substances and biocidal products within the EU. ACA pharma concept GmbH supports you all the way when registering your biocidal substances and products, so that you can meet all the complex obligations of the BPR.

Our experts are experienced in various regulatory areas. This enables us to consult you efficiently on a vast variety of topics, including on those that relate to distinctions of borderline products concerning pharmaceuticals or medicinal products.

We prepare the dossiers and file them according to the regulatory strategy. This includes the running of completeness checks and database searches to identify bibliographic data that may be available for your product. If there are any data gaps, we suggest further necessary studies and partnering laboratories in order to fill these gaps. We also monitor studies on your behalf.

Our services include risk analyses for your active substance or biocidal product and the advice on classification and labelling of your substances or mixtures to comply with the CLP regulation (EU GHS).

ACA pharma concept GmbH offers you a complete services package, starting with, but not limited to, the development of an effective regulatory strategy for your active substances and biocidal products, including data analyses and the preparation of dossiers. We will, if you wish, also communicate on your behalf with all the relevant authorities.

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 scenarios for humans and environment

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

Usefull links

Biocidal products Regulation (BPR) – legal text

ECHA on Biocides

European Commission (EC) on Biocides

Active Substance Suppliers (art 95, BPR)

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