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.

Deadlines
The 370 identified active substances are currently being evaluated in groups of product types in which they are used. The prio­ritisation of the product types in the re­view prog­ram­me is described most recently in Com­mission Regulation (EC) 1048/2005.

Deadlines have already passed for the submission of dossiers on active substance for 13 of the 23 product types.

By 31 July 2007 dossiers had to be sub­mitted for active substances in all disinfectants and general biocidal products, as well as for in-can pre­servatives and metalworking-fluid preservatives.

Left now, with a deadline of 31 October 2008, are dossiers on active substances for product types such as paints and other films, preservatives in technological pro­cesses (e.g. to leather, masonry, liquid-cooling systems) and products to control birds and fish.

The deadline for the removal from the market of non-notified substances and products containing them was 1 September 2006.

However, some active substances might be granted a longer deadline in specified member states. These substances must be argumented to be “es­sen­tial for health, safety, protection of cultural heritage, or critical for the function of society, or where no available technically and economically feasi­ble alter­natives” exist. Here both scientific docu­men­tation and sound reasoning are necessary.

• 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.