Fact sheet
Biocidal products directive1
Issue No. 1 - July 1997
Purpose
This note provides briefing for makers and users of biocidal products to keep them up to date with the progress of this Directive and its implementation in the UK. It will be revised at intervals to take account of significant events.
What is a biocidal product?
- A biocidal product is a chemical or biological substance or preparation used to control harmful organisms in situations other than to kill weeds or otherwise protect plants from pests. The Directive will not apply to certain products already subject to European legislation (including human medicines and veterinary medicines, such as sheep dip), to products that act by physical means, nor to non-biocidal uses of products and active substances.
- The Directive has a very wide scope: as well as non-agricultural pesticides currently dealt with under the Control of Pesticides Regulations 1986 (ie wood preservatives, public hygiene insecticides, masonry biocides and antifouling paints), it covers disinfectants and a number of other specialist products. A full list of the 23 product types appears at the end of this sheet.
What will the Directive do?
- The proposed Directive aims to remove barriers to trade in biocides by harmonising controls for marketing and use across Europe, whilst ensuring a high level of health and environmental protection. This will be done through a product authorisation scheme.
- The first step for any applicant will be to check whether there is an Annex I listing for the active substance(s) in their product. If not, they must obtain one, by supplying data to a Competent Authority. The data is evaluated and a decision on listing is made at Community level (there will be an administration fee). Active substances which are new to the European market after the date of implementation of the Directive will be considered immediately on submission, but existing actives will be subject to a review Regulation (which has yet to be discussed).
- Once an active substance is listed on Annex I, products containing it can be authorised by national Competent Authorities for marketing in individual Member States, provided any necessary data have been supplied and the Annex I conditions are met. Once authorised in the first Member State (normally the applicant's home country), a product will be mutually recognised and therefore quickly authorised by other Member States (provided relevant conditions are similar). Again there will be an administration fee for this process.
- Both Annex I listing and product authorisation will be based on an assessment of risks for people and the environment, and efficacy. It is hoped that the final Directive will contain streamlined measures for 'low risk' biocides and commodity substances (ie general industrial chemicals which have a minor biocidal use, such as ethanol). There will also be a fast-track procedure for products that are very similar to others that have already been authorised (eg where they only differ in colour or fragrance).
When will the Directive affect my products?
- The Directive is not yet finalised but is expected to be implemented between mid-1999 and early 2000. Products containing an active substance new to the European market after this date will be subject to the authorisation scheme described above.
- However, there will be a minimum ten year transition period during which current controls for products containing existing active substances (ie those that were on the market before the implementation date) will remain in place until the active substances have been reviewed. This means that for many products the Directive will have no direct effect for several years.
Is there any guidance available?
Not yet, but by the time the Directive is in force there will be a range of HSE and European Community guidance covering such topics as the Regulations themselves, data requirements, risk assessment, transitional measures and applications for authorisation.
What do I need to do now?
- If you are a manufacturer, formulator, importer or user of biocidal products, you should write to HSE now to register your interest (through your trade association, if you are in one). This will allow us to include you in relevant consultations, such as compiling the list of existing active substances and our plans for implementing the Directive, at the appropriate time.
For further information contact:
Chemicals Assessment Schemes Unit (CASU)
Health and Safety Executive
Building 1, 3rd Floor
Redgrave Court
Merton Road
Bootle
Merseyside
L20 7HS
e-mail: biocides@hse.gsi.gov.uk
Product types covered by the Biocidal Products Directive
Main group 1: Disinfectants and general biocidal products
These product types exclude cleaning products that are not intended to have a biocidal effect, including washing liquids, powders and similar products.
Product-type 1: Human hygiene biocidal products
used to reduce concentrations of biological agents on the human body.
Product-type 2: Private area and public health area disinfectants and other biocidal products
used for the disinfection of air, surfaces, materials, equipment and furniture which are not used for direct food or feed contact in private, public and industrial areas, including hospitals, as well as products used as algicides. Usage areas include swimming pools, aquariums, bathing and other waters; air-conditioning systems; walls and floors in health and other institutions; chemical toilets, waste water, hospital waste, soil or other substrates (in playgrounds).
Product-type 3: Veterinary hygiene biocidal products
Includes products used in areas in which animals are housed, kept or transported
Product-type 4: Food and feed area disinfectants
used for the disinfection of equipment, containers, consumption utensils, surfaces or pipework associated with the production, transport, storage or consumption of food, feed or drink (including drinking water) for humans and animals.
Product-type 5: Drinking water disinfectants (for both humans and animals)
Main group 2: Preservatives
Product-type 6: In-can preservatives
used for the preservation of manufactured products, other than foodstuffs or feedingstuffs, in containers by the control of microbial deterioration to ensure their shelf life.
Product-type 7: Film preservatives
used for the preservation of films or coatings in order to protect the initial properties of the surface of materials or objects such as paints, plastics, sealants, wall adhesives, binders, papers, art works, etc.
Product-type 8: Wood preservatives
for wood from and including the saw-mill stage, and wood products (including both preventive and curative products).
Product-type 9: Fibre, leather, rubber and polymerised materials preservatives
includes preservation of fibrous materials, such as paper or textile products
Product-type 10: Masonry preservatives
used for preservation and remedial treatment of masonry or other construction materials other than wood by the control of microbiological and algal attack.
Product-type 11: Preservatives for liquid-cooling and processing systems
used for the preservation of water or other liquids used in cooling and processing systems by the control of harmful organisms such as microbes, algae and mussels (not drinking water preservation products).
Product-type 12: Slimicides
used for the prevention or control of slime growth on materials, equipment and structures, used in industrial processes, e.g. on wood and paper pulp, and porous sand strata in oil extraction.
Product-type 13: Metalworking-fluid preservatives
Main group 3: Pest control
Product-type 14: Rodenticides (control of mice, rats or other rodents)
Product-type 15: Avicides (control of birds)
Product-type 16: Molluscicides (control of molluscs, eg snails that may clog pipes)
Product-type 17: Piscicides (control of fish; excludes products for the treatment of fish diseases)
Product-type 18: Insecticides, acaricides and products to control other arthropods (eg crustaceans)
Product-type 19: Repellents and attractants used to control harmful organisms (invertebrates such as fleas, vertebrates such as birds), by repelling or attracting, including those that are used for human or veterinary hygiene either directly or indirectly
Main group 4: Other biocidal products
Product-type 20: Preservatives for food or feedstocks
used for the preservation of food or feedstuffs by control of harmful organisms
Product-type 21: Antifouling products
used to control growth and settlement of fouling organisms (microbes and higher forms of plant or animal species) on vessels, aquaculture equipment or other structures used in water.
Product-type 22: Embalming and taxidermist fluids
used for the disinfection and preservation of human or animal corpses, or parts thereof.
Product-type 23: Control of other vertebrates (ie vermin)
1 The text of the Directive at Common Position (EC no. 10/97) was published in the Official Journal of the European Communities on 5 March 1997 (OJ C69, Vol. 40)
[N.B. this is only the latest draft of the Directive, not the final text]
