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 preparation of all documents required for registration of a biocidal product and place on the market in EU member states 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
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, they are regulated to control their marketing, sale and use in order to minimise any risk.
The Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) concerns the placing on the market and use of biocidal products, which are used to protect humans, animals, materials or articles against harmful organisms like pests or bacteria, by the action of the active substances contained in the biocidal product. This regulation aims to improve the functioning of the biocidal products market in the EU, while ensuring a high level of protection for 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. As the first step, the active substance is evaluated and, provided the criteria are fulfilled, is then approved in a specified product-type (PT). The second step is the authorisation of each BP consisting of, containing or generating the approved active substance(s).
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