Biocidal Products

A biocidal product is a product with an active substance that is intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on harmful or undesired organisms.

Biocidal Products Directive (Directive 98/8/EC) and Biocidal Products Regulation (Regulation (EU) No 528/2012).

Authorisation of biocidal products

All biocidal products must get an authorisation before they can be made available on the market. Companies can choose between several alternative processes, depending on their product and the number of countries where they wish to sell it.

National authorisation and mutual recognition

If the product will be placed only on a single market, authorisation from that country is sufficient.

If a company wishes to place the product on the market in several countries, it can apply for mutual recognition for the product authorisation.

National authorisation and mutual recognition renewal

The authorisation holder can apply for the renewal of an authorisation to the Member State competent authority (MSCA) who granted the authorisation. In case of mutual recognition authorisation, the application for renewal should be submitted to the reference MSCA and all MSCAs concerned.

Union authorisation

The Biocidal Products Regulation introduces a new alternative for companies that wish to apply for an EU-wide authorisation in one go.

Product-types

In Annex V to the BPR the biocidal products are classified into 22 biocidal product-types, grouped in four main areas.

Main group 1: Disinfectants

These product types exclude cleaning products that are not intended to have a biocidal effect, including washing liquids, powders and similar products.

PT 1     Human hygiene          Products in this group are biocidal products used for human hygiene purposes, applied on or in contact with human skin or scalps for the primary purpose of disinfecting the skin or scalp.

PT 2     Disinfectants and algaecides not intended for direct application to humans or animals   Used for the disinfection of surfaces, materials, equipment and furniture which are not used for direct contact with food or feeding stuffs. Usage areas include, inter alia, swimming pools, aquariums, bathing and other waters; air conditioning systems; and walls and floors in private, public, and industrial areas and in other areas for professional activities.

Used for disinfection of air, water not used for human or animal consumption, chemical toilets, waste water, hospital waste and soil.

Used as algaecides for treatment of swimming pools, aquariums and other waters and for remedial treatment of construction materials.

Used to be incorporated in textiles, tissues, masks, paints and other articles or materials with the purpose of producing treated articles with disinfecting properties.

PT 3     Veterinary hygiene     Used for veterinary hygiene purposes such as disinfectants, disinfecting soaps, oral or corporal hygiene products or with anti-microbial function.

Used to disinfect the materials and surfaces associated with the housing or transportation of animals.

PT 4     Food and feed area    Used for the disinfection of equipment, containers, consumption utensils, surfaces or pipework associated with the production, transport, storage or consumption of food or feed (including drinking water) for humans and animals.

Used to impregnate materials which may enter into contact with food.

PT 5     Drinking water            Used for the disinfection of drinking water for both humans and animals.

Main group 2: Preservatives

Unless otherwise stated these product-types include only products to prevent microbial and algal development.

PT 6     Preservatives for products during storage    Used for the preservation of manufactured products, other than foodstuffs, feeding stuffs, cosmetics or medicinal products or medical devices by the control of microbial deterioration to ensure their shelf life.

Used as preservatives for the storage or use of rodenticide, insecticide or other baits.

PT 7     Film preservatives      Used for the preservation of films or coatings by the control of microbial deterioration or algal growth 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.

PT 8     Wood preservatives   Used for the preservation of wood, from and including the saw-mill stage, or wood products by the control of wood-destroying or wood-disfiguring organisms, including insects. This product type includes both preventive and curative products.

PT 9     Fibre, leather, rubber and polymerised materials preservatives     Used for the preservation of fibrous or polymerised materials, such as leather, rubber or paper or textile products by the control of microbiological deterioration.

This product-type includes biocidal products which antagonise the settlement of micro-organisms on the surface of materials and therefore hamper or prevent the development of odour and/or offer other kinds of benefits.

PT 10   Construction material preservatives Used for the preservation of masonry, composite materials, or other construction materials other than wood by the control of microbiological and algal attack.

PT 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.

Products used for the disinfection of drinking water or of water for swimming pools are not included in this product-type.

PT 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, porous sand strata in oil extraction.

PT 13   Working or cutting fluid preservatives          Products to control microbial deterioration in fluids used for working or cutting metal, glass or other materials.

Main group 3: Pest control

PT 14   Rodenticides   Used for the control of mice, rats or other rodents, by means other than repulsion or attraction.

PT 15   Avicides           Used for the control of birds, by means other than repulsion or attraction.

PT 16   Molluscicides, vermicides and products to control other invertebrates     Used for the control of molluscs, worms and invertebrates not covered by other product types, by means other than repulsion or attraction.

PT 17   Piscicides        Used for the control of fish, by means other than repulsion or attraction.

PT 18   Insecticides, acaricides and products to control other arthropods  Used for the control of arthropods (e.g. insects, arachnids and crustaceans), by means other than repulsion or attraction.

PT 19   Repellents and attractants     Used to control harmful organisms (invertebrates such as fleas, vertebrates such as birds, fish, rodents), by repelling or attracting, including those that are used for human or veterinary hygiene either directly on the skin or indirectly in the environment of humans or animals.

PT 20   Control of other vertebrates  Used for the control of vertebrates other than those already covered by the other product types of this main group, by means other than repulsion or attraction.

Main group 4: Other biocidal products

PT 21   Antifouling products   Used to control the 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.

PT 22   Embalming and taxidermist fluids     Used for the disinfection and preservation of human or animal corpses, or parts thereof.

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