Registration of biocidal products
Biocides are chemicals in many types of products that kill or inhibit unwanted organisms. Such organisms are anything from bacteria to barnacles to rats. Biocidal products are for instance insect repellents, disinfectants, rat poison, chlorine for swimming pools, and preservatives in cooling systems.
The Biocidal Products Directive
The EU's Biocidal Products Directive (BPD, Directive 98/8/EC) sets the stage for registration and re-registration of biocidal products.
The Directive was adopted in 1998. By May 2000, member states had to transpose the directive into national law. The detailed implementation is prescribed in a number of subsequent EU regulations.
Two of the basic principles of the Directive, which covers 23 different product types, are that all existing active substances must be assessed for safety and for efficacy before being included in the Directive’s Annex I. These decisions are made at Community level. Any completely new active substance will be evaluated by a member state before being included in Annex I.
Products containing an approved active substance must also be authorised, but at the member state level.
DHI services
- DHI services are based on integration of our expertise in human toxicology and our expertise in efficacy testing.
- DHI provides services in the field of compilation of a dossier and evaluation of data.
- DHI prepares complete dossiers for the registration of biocidal substances as prescribed in the Technical Notes for Guidance (TNsG).
- DHI also evaluates dossiers on behalf of the competent authorities.
- DHI services include national applications, considering specific national requirements and contact with the competent authorities.
- DHI manages test programmes for companies and consortia that develop and market biocidal products.
- DHI is experienced in consortium management and handling of confidential information to ensure that partners are selectively informed with due respect to considerations of confidentiality of individual partners.