European Union Biocides Directive and Regulation Services
Intertek offers a single-source solution for compliance with the European Union's (EU) Biocides Directive and new Biocides Products Regulation.
On 12 June 2009, the European Commission adopted a proposal for a regulation concerning the placing on the market and use of biocidal products. The proposed Regulation will repeal and replace the current Directive 98/8/EC concerning the placing of biocidal products on the market. It will apply from 1st September 2013.
The proposal includes the following:
- An extension of the scope of the legislation to also cover articles and materials treated with biocidal products (including furniture and textiles) active substances generated in situ, and to biocidal products used in materials that come into contact with food.
- The authorisation of certain biocidal products at EU level (biocidal products based on new active substances and low-risk biocidal products). The European Chemicals Agency (ECHA), which is already responsible for managing the EU REACH Regulation, will carry out scientific and technical tasks related to this type of authorisation. All other biocidal products will still be subject to authorisations issued by a Member State Competent Authority, with mutual recognition in all other Member States.
- The introduction of 'exclusion criteria' to prevent authorisation of active substances with certain hazard profiles, including substances that can cause cancer, mutations, reproductive problems and hormonal imbalances. Biocidal products with problematic active substances will also be compared to ensure that only the products with the lower risk remain on the market.
- It will no longer be possible to repeat tests that have already been carried out on vertebrate animals, and information gained from such tests must be shared, in exchange for fair compensation.
Intertek has implemented compliance solutions for hundreds of manufacturers and distributors. Intertek can assess your products to determine their current and future compliance status and requirements including:
- What are the main differences between the current directive and the new regulation
- When does the new regulation come in effect and can I still register under the Biocides Directive 98/8/EC
- Data requirements
- What active substances will be phased out
- How will the rules on the inclusion of active substances change
- How will the rules on Community-wide authorisation work
- What will be the tasks of ECHA under the new Regulation
Intertek's biocides regulatory compliance solutions include:
- Regulatory Compliance Support and Consulting
- Registration of biocides
- Dossier preparation for the registration of biocidal substances as prescribed in the Directive and Regulation
- Evaluation of existing data and the compilation of a dossier and evaluation of data sets
- Design test protocols cost effectively and testing as per Directive guidelines
- Project management for test programmes and liaison between authorities and clients
- Toxicological evaluation support
Request more information to see how Intertek can help your organization with European Union Biocides Directive and Regulation Services.