SHALL WE PRODUCE FOR YOU?
WE HAVE ENTERED INTO LICENSING AGREEMENTS WITH our suppliers, which allows our customers to produce their biocide product with their own label.
WE WOULD LIKE TO TELL YOU ABOUT THE GREAT OPPORTUNITIES IT OPENS FOR YOUR COMPANY.
If you would like to get more information, please press here and we will get in touch with you.
GET IT APPROVED AND YOU ARE READY TO GO
There are extensive requirements to documentation that needs to be submitted for approval of an active substance both to the EU authorities and to the Environmental Protection Agency.
To get a biocide product approved, the applicant needs to provide sufficient documentation demonstrating that the product is not particularly harmful for the environment and health, and that the product is effective. The documentation typically consists of research data. The Environmental Protection Agency assesses internally the danger for the environment and health, while the effectiveness is often assessed by external parties, such as the Pest Infestation Laboratory.
REQUIREMENTS TO THE DOCUMENTATION DEPEND UPON WHETHER YOU ARE APPLYING FOR APPROVAL IN SWEDEN AS A FIRST EU COUNTRY OR FOR MUTUAL ACCEPTANCE.
The deadline for submission of application is less than two years of the date on which the active substance was formally included in Annex I under one or several product types. If a product contains several active substances, then the deadline for the product is calculated starting from the most recent date when an active substance was included.
It is permitted to sell the product on the Swedish market while the Environmental Protection Agency is considering the application for approval.
what happens if you do not apply on time
If no application is submitted, then the product becomes illegal, and its import, production and sale must be terminated within six months after the application deadline. This applies even if the old approval has not expired. In Sweden, the subsequent sale, warehousing and use of the product must be terminated within two years of the application deadline. It covers the use of both the products available to consumers and the products used in production.
GET READY FOR BIOCIDES
how to get ready
importers and sellers of biocidal products are responsible for getting them approved. those who use a biocidal product in their business are responsbile for making sure the product is legal.
How should one comply with these duties at the practical level? The following tips and tricks are a good starting point:
1. Find out whether you import, sell or use biocidal products in your business. Do any of your products fall under the 22 product types?
2. Prepare a summary of the biocidal substances and products you use.
3. Trace the EU approvals of active substances on the EU website, biocidinfo.dk or ECHA´s website.
This way you can see which active substances can stay on the market, which ones are on their way out, and which ones are still being assessed.
4. Write a status for each product:
Are the active substances approved or being assessed in the EU? Are the products approved?
5. Ask your suppliers about the product approval plan according to the biocide regulations.
6. Are there any of the products for which you will be seeking an approval yourself?
7. Make sure your biocide products are reported to the Product Register.
8. If you are in doubt, look for more information at organizations in your industry, your counsel or the Environmental Protection Agency.
VARIOUS TYPES OF APPROVAL
Various types of biocidal product approval
1. National approval
- Full product dossier.
- Letter of Access (LoA) for active substances.
- Fees to the authorities (1 active substance, 1 PT) SEK 300,000 + various fees (texts etc).
2. Mutual acceptance
- When approval from the 1st country (national approval) already exists, one can apply for mutual acceptance in the country of their own choice (price varies from country to country).
- Price varies depending on country - 120,000 SEK in Sweden.
3. EU approval
- Approval for all EU countries at the same time.
- Full product dossier.
- Letter of Access (LoA) for active substances.
- A major investment (> 15 countries). Fee (national authorities + ECHA) => about 1,950,000 SEK
- - For further information about KEMI's fees click here (Swedish).
4. Simplified approval procedure
- Active substances must be listed on Annex 1.
- Accessed by the EU authorities within 90 days.
- Approval is valid for all EU countries.
- Fee (DKK) about SEK 60,000 + SEK 8,000 per application.
5. Identical products (national approval of an identical product)
- Biocidal product is produced by the same company, a company associated with it or under a license in accordance with the same production process.
- MST fee = SEK 20,000.
TIMELINE – APPROVAL OF BIOCIDE (ACTIVE SUBSTANCE)
Companies have less than two years to submit an application on approval of their product after the active substance was approved by the EU.
TYPES OF BIOCIDAL PRODUCTS (PT)
The biocide legislation classifies products into 22 product types, and each active substance is approved or declined under one or several of these product types (PT). The product must fall under one of the 22 product types to be considered a biocide product.
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
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.
Product type 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.
Product type 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.
Product type 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.
Product type 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.
Product type 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. DA 27.6.2012 The European Union Gazette L 167/105
Product type 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.
Product type 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.
Product type 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.
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.
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
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
Used for the control of mice, rats or other rodents, by means other than repulsion or attraction.
Product type 15: Avicides
Used for the control of birds, by means other than repulsion or attraction.
Product type 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.
Product type 17: Piscicides
Used for the control of fish, by means other than repulsion or attraction.
Product type 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.
Product type 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. DA L 167/106 The European Union Gazette 27.6.2012
Product type 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: OTHE RBIOCIDAL PRODUCTS
Product type 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.
Product type 22: Embalming and taxidermist fluids
Used for disinfection and preservation of human or animal corpses, or parts thereof.