SKPolish (Poland)Čeština (Česká republika)EN
Biocides PDF 

The Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) concerns the placing on the market and use of biocidal products, which are used to protect humans, animals, materials or articles against harmful organisms, like pests or bacteria, by the action of the active substances contained in the biocidal product.

The Regulation becomes applicable on 1st September 2013. From that date onwards, companies will have two options to request permission to place their products on the market. The first (Union Authorisation), which is likely to be used by large firms, requires companies to submit an application to ECHA and if the product is judged safe, it may be sold throughout the EU. The second may appeal more to the numerous small and medium-sized enterprises in this business, as it requires companies to submit an application to their own national authority, to sell a product in their home country. If the authorisation is granted, they can subsequently put the product on the market of other Member States, according to the mutual recognition principle.

Union authorisation allow companies to place these biocidal products on the market in the entire Union, without the need to obtain a national authorisation followed by mutual recognition. This authorisation will give the same rights and obligations in all the Members States as those issued by the national authorisation. Union authorisation will be granted to biocidal products with similar conditions of use across the Union, except those containing active substances meeting the exclusion criteria and certain product-types (14, 15, 17, 20 and 21). Depending upon the product types, Union authorisation will be available in three different stages:

  • from 1 September 2013 for product types 1, 3, 4, 5, 18 and 19
  • from 1 January 2017 for product types 2, 6 and 13
  • from 1 January 2020 onwards to the remaining products types 7, 8, 9, 10, 11, 12, 16 and 22.

The authorisation process starts with the submission of a dossier by a company to ECHA. The evaluating competent authority that has previously been chosen by the applicant, evaluates the dossier and forwards the result to ECHA's Biocidal Products Committee to prepare an opinion within 180 days. Finally, the European Commission takes a decision based upon ECHA's opinion.

Approval of active substances: companies have to apply for the approval of an active substance by submitting a dossier to ECHA. After the validation check has been performed by the Agency, the evaluating competent authority carries out a completeness check and an evaluation. The result is forwarded to ECHA's Biocidal Products Committee, which prepares an opinion within 270 days. This is then submitted to the European Commission for decision-making. A similar process takes place for the renewal of the approval of an active substance.

The European Commission keeps a register of Biocidal Products on "R4BP" which is published on the website https://webgate.ec.europa.eu/env/r4bp/user.login.cfm. It is recommended to make the first part of his application prestredníctvo that register and indicate both your potential interest in the product on the basis of mutual recognition in other EU Member States. Sign in R4BP is possible only through an account created in the system, ECAS (European Commission's authentication service). Issues related to R4BP application if necessary, consult directly with the administrator This e-mail address is being protected from spambots. You need JavaScript enabled to view it

We offer preparation of all documents needed for registration of a biocidal product for marketing:

  • Form for notification of a biocidal product
  • Material Safety Data Sheet (MSDS)
  • Text of the label
  • Instructions for use unless it is stated on the packaging

In cooperation with certified laboratories will also offer our laboratory services, if necessary, testing the active substances contained in biocidal products. More information.

LEGISLATION

  • EU legislation:

Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products

 

Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market

Commission Regulation (EC) No 1896/2000 on the first phase of the programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council on biocidal products

Commission Regulation (EC) No 1687/2002 on an additional period for notification of certain active substances already on the market for biocidal use as established in Article 4(1) of Regulation (EC) No 1896/2000,

Commission Regulation (EC) No 2032/2003 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market, and amending Regulation (EC) No 1896/2000

Commission Regulation (EC) No 1451/2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market

An exhaustive list of 23 product types:

Disinfectants and general biocidal products

Product-type 1: Human hygiene biocidal products

Product-type 2: Private area and public health area disinfectants and other biocidal products

Product-type 3: Veterinary hygiene biocidal products

Product-type 4: Food and feed area disinfectants

Product-type 5: Drinking water disinfectants

Preservatives

Product-type 6: In-can preservatives

Product-type 7: Film preservatives

Product-type 8: Wood preservatives

Product-type 9: Fibre, leather, rubber and polymerised materials preservatives

Product-type 10: Masonry preservatives

Product-type 11: Preservatives for liquid-cooling and processing systems

Product-type 12: Slimicides

Product-type 13: Metalworking-fluid preservatives

Pest control

Product-type 14: Rodenticides

Product-type 15: Avicides

Product-type 16: Molluscicides

Product-type 17: Piscicides

Product-type 18: Insecticides, acaricides and products to control other arthropods

Product-type 19: Repellents and attractants

Other biocidal products

Product-type 20: Preservatives for food or feedstocks

Product-type 21: Antifouling products

Product-type 22: Embalming and taxidermist fluids

Product-type 23: Control of other vertebrates

 

Biocidal product-types and their descriptions as referred to in article 2(1)

 

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.

Product-type 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.

Product-type 2: Disinfectants and algaecides not intended for direct application to humans or animals

Products 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.

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

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

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

Product-type 3: Veterinary hygiene

Products used for veterinary hygiene purposes such as disinfectants, disinfecting soaps, oral or corporal hygiene products or with anti-microbial function.

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

Product-type 4: Food and feed area

Products 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.

Products used to impregnate materials which may enter into contact with food.

Product-type 5: Drinking water

Products 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.

Product-type 6: Preservatives for products during storage

Products used for the preservation of manufactured products, other than foodstuffs, feedingstuffs, cosmetics or medicinal products or medical devices by the control of microbial deterioration to ensure their shelf life.

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

Product-type 7: Film preservatives

Products 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.EN 27.6.2012 Official Journal of the European Union L 167/105

Product-type 8: Wood preservatives

Products 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.

Product-type 9: Fibre, leather, rubber and polymerised materials preservatives

Products 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.

Product-type 10: Construction material preservatives

Products used for the preservation of masonry, composite materials, 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

Products 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.

Product-type 12: Slimicides

Products 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.

Product-type 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

Product-type 14: Rodenticides

Products used for the control of mice, rats or other rodents, by means other than repulsion or attraction.

Product-type 15: Avicides

Products used for the control of birds, by means other than repulsion or attraction.

Product-type 16: Molluscicides, vermicides and products to control other invertebrates

Products used for the control of molluscs, worms and invertebrates not covered by other product-types, by means other than repulsion or attraction.

Product-type 17: Piscicides

Products used for the control of fish, by means other than repulsion or attraction.

Product-type 18: Insecticides, acaricides and products to control other arthropods

Products used for the control of arthropods (e.g. insects, arachnids and crustaceans), by means other than repulsion or attraction.

Product-type 19: Repellents and attractants

Products 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.EN L 167/106 Official Journal of the European Union 27.6.2012

Product-type 20: Control of other vertebrates

Products 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

Product-type 21: Antifouling products

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.

Product-type 22: Embalming and taxidermist fluids

Products used for the disinfection and preservation of human or animal corpses, or parts thereof.

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:167:FULL:EN:PDF