The Issue

Biocidal products ('or biocides') include products such as disinfectants, preservatives, rodenticides, insecticides and anti-fouling products that are used to control various types of harmful organisms. There are in total 23 product types, as defined within the Regulations.

After much revision and clarification by the Commission during the last few years, the legal definition of a biocide is now formally agreed to be "an active substance or preparation containing one or more active substances, put up in the form in which they are supplied to the user, intended to destroy, deter, render harmless, prevent the action of, or other exert a controlling effect on any harmful organism by chemical or biological means".

Because biocides are designed to kill or control harmful organisms, they also have the capacity to harm human, other non-target organisms and the environment. Legislation to control the marketing and use of biocides is designed to minimise such risks. In the European Union, this is controlled by Directive 98/8/EC, also known as the Biocides Directive. These regulations do not affect products which are defined as Cosmetics, Human Medicines or Veterinary Medicines, as the sale and supply of these are controlled by other Directives.

Active substances and their use in 'biocidal products' shall not be allowed for sale or supply if ANY of the following positions apply:

1. if data is not supplied to the relevant authority for evaluation by the due date
2. if submitted data is deemed insufficient or incompatible to allow for the complete evaluation of the potential risk to humans, non-target organisms or the environment
3. the resultant evaluation identifies risks to man and the environment which are deemed to be unacceptable

EC review programme for biocides under Directive 98/8/EC began in 2000 and is planned for completion by 2010. Active substances are evaluated at EC level, whereas the products themselves are evaluated at Member State level. Dossiers of information are required for each the active substances together with each of the 23 types for which products intend to be supplied. Each product type has a support and evaluation timetable.

Details of the legislation are available at: http://ecb.jrc.it/biocides/

In the UK, the authority responsible for the management and control of approvals to allow the sale and supply of biocides is the Health & Safety Executive. More details of their work is available at: http://www.hse.gov.uk/biocides/issues.htm