Ekotox Centers are providing consultancy services and customers support in the area of EU chemicals legislation – REACH Registration, Only Representative, REACH Authorisation, REACH/CLP Screening, Safety Data Sheets, Legal Compliance Services.
We offer support and preparation of all documents. Required for registration / authorisation of a biocidal product for placing on the market in EU member states.
For example complex services for registration under transitional period or authorisation once the active substance is approved:
- Documents preparation including relevant forms and processes
- Efficacy assessment
- R4BP / IUCLID / SPC
- Biocidal product entry in the Register of EU MS or EU wide
- Material Safety Data Sheet (MSDS)
- Text part of the label
- Instructions for use, if not stated on the label
Application types Article 95: List of active substances and suppliersTechnical equivalenceIn situ generated active substancesTreated articlesRegistration/notification of biocidal products under transitional provisions
Regulation of Biocidal Products for Safety and Sustainability in the European Union
Biocides can be used by professionals and members of the public in a wide spectrum. Of use areas that are classified into product-types. To make sure the use of biocidal products do not have unacceptable risks for people. Non-target animals and the environment. However, regulatory authorities control their marketing, sale, and usage to minimize any potential risks.
The Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) addresses the marketing and use of biocidal products. These products play a crucial role in safeguarding against pests or bacteria and contain active substances that provide benefits to humans, animals, and materials. Consequently, the purpose of this regulation is to effectively enhance the EU biocidal products market. It guarantees robust protection for both humans and the environment.
The text was adopted on 22 May 2012 and will be applicable from 1 September 2013. With a transitional period for certain provisions. It will repeal the Biocidal Products Directive (Directive 98/8/EC).
The basic principle in the BPR is that a biocidal product (BP) must be authorised before it can be made available on the market or used in the European Union (EU)/ 1 European Economic Area (EEA). This takes place in two consecutive steps. Firstly, the evaluators assess the active substance, and if the criteria are met, they approve it for a designated product-type (PT). Subsequently, the second step involves the authorization of each BP consisting of, containing, or generating the approved active substance(s).
Biocidal Product Authorization Pathways: Options for Market Entry
Companies wishing to place biocidal products on the market can apply for product authorisation at National or Union level under the following application types:
- National Authorisation
- Mutual Recognition
- Union Authorisation
- Simplified Authorisation
- Biocidal Product Families
- Parallel Trade Permits
- Same Biocidal Products
You can browse all of our biocides training.