The Biocidal Product Regulation (BPR, (EU) 528/2012) regulates the use of active biocidal substances, products and treated articles within the EU. ACA-pharma concept GmbH supports you all the way in getting the marketabillity of biocidal products and treated articles.
ACA consults you efficiently on topics that are related to the distinctions of borderline products concerning pharmaceuticals, medicinal products or cosmetics.
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 necessary studies and monitor them on your behalf.
Our services include the classification and labelling of your substances or mixtures to comply with the CLP regulation (EU GHS), as well as the notification according to article 45 and annex VIII. Any biocidal product needs to be notified to the corresponding Appointed Body or the Poison Centre Notification Portal (PCN) of ECHA before placing the biocidal product on the EU market.
ACA-pharma concept GmbH offers you a complete service package, including the development of an effective regulatory strategy for your active substances and biocidal products, data analyses and dossiers preparation. We will 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
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
Risk assessment
- Toxicological and/or eco-toxicological assessment of properties of the active biocidal substances or biocidal product
- Exposition scenarios for humans and environment
