Biocidal Products – Definition
A biocidal product is any substance or mixture, in the form supplied to the user, consisting of, containing, or generating one or more active substances, intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on harmful organisms by means other than mere physical or mechanical action.
The definition also includes any substance or mixture manufactured from substances or mixtures not themselves falling under the above definition, where such generation occurs for the purpose of the biocidal effect. This group also includes a product with a primary biocidal function treated with biocidal products.
Categories and Product Types
Annex V to Regulation (EU) No 528/2012 classifies biocidal products into 22 product types, grouped under four main categories.
| CATEGORY 1: Disinfectants |
| This category excludes cleaning products that are not intended to have a biocidal effect, including laundry detergents and similar products. |
| Product Type 1: Human hygiene |
| Biocidal products used for human hygiene purposes, applied to the skin or scalp primarily to disinfect. |
| Product Type 2: Disinfectants and algaecides not intended for direct application to humans or animals |
| Products used for disinfection of surfaces, materials, equipment and furniture not in direct contact with food or feed. Applications include swimming pools, aquariums, bathing and other waters, air conditioning systems, and surfaces in private, public, or industrial areas. Also includes algaecides used in pools and materials, and disinfectants for air, non-drinking water, toilets, waste water, hospital waste, and soil. |
| Product Type 3: Veterinary hygiene |
| Products used to maintain veterinary hygiene, including disinfectants, antiseptic soaps, oral or body hygiene products, and disinfectants for surfaces and materials in animal transport or housing. |
| Product Type 4: Food and feed area |
| Products used to disinfect equipment, containers, utensils, surfaces or pipes involved in the production, transport, storage or consumption of food or feed, including drinking water, for humans and animals. Includes preservatives for materials in contact with food. |
| Product Type 5: Drinking water |
| Products used to disinfect drinking water for humans and animals. |
| CATEGORY 2: Preservatives |
| Unless otherwise specified, these product types are used to control microbial and algal growth. |
| Product Type 6: Preservatives for products during storage |
| Used to preserve manufactured products (excluding food, feed, cosmetics, pharmaceuticals or medical devices) from microbial deterioration. Also used in rodent/insect baits during use/storage. |
| Product Type 7: Film preservatives |
| Preservatives for films or coatings to protect the original properties of surfaces/materials (e.g. paints, plastics, sealants, binders, paper, artworks) from microbial or algal damage. |
| Product Type 8: Wood preservatives |
| Preservatives for wood and wood products to prevent or remedy damage by harmful organisms, including insects. Can be protective or curative. |
| Product Type 9: Fibre, leather, rubber and polymerized materials preservatives |
| Preserve fibrous or polymeric materials (e.g. leather, rubber, textiles, paper) from microbial degradation, odour formation or other deterioration. |
| Product Type 10: Masonry preservatives |
| Preservatives for construction materials (excluding wood) such as masonry, composites, etc., to prevent microbial or algal damage. |
| Product Type 11: Preservatives for liquid-cooling and processing systems |
| Used in cooling or processing fluids to control microbial, algal and molluscan growth. Excludes drinking water or swimming pool disinfectants. |
| Product Type 12: Slimicides |
| Used to prevent or eliminate slime on materials, equipment or structures in industrial settings, such as pulp and paper or oil extraction. |
| Product Type 13: Working or cutting fluid preservatives |
| Used to control microbial contamination in fluids used for metalworking or cutting glass and other materials. |
| CATEGORY 3: Pest control |
| Product Type 14: Rodenticides |
| Products for the control of mice, rats and other rodents other than by repelling or attracting. |
| Product Type 15: Avicides |
| Products for the control of birds other than by repelling or attracting. |
| Product Type 16: Molluscicides, vermicides and products to control other invertebrates |
| Products not covered in other groups for the control of molluscs, worms, and other invertebrates by means other than repelling or attracting. |
| Product Type 17: Piscicides |
| Products for the control of fish other than by repelling or attracting. |
| Product Type 18: Insecticides, acaricides and products to control other arthropods |
| Products used to control arthropods (e.g. insects, mites, crustaceans) by means other than repelling or attracting. |
| Product Type 19: Repellents and attractants |
| Products used to control harmful organisms (both invertebrates like fleas and vertebrates like birds, fish, rodents) by repelling or attracting, including those for human or animal hygiene. |
| Product Type 20: Control of other vertebrates |
| Products used to control vertebrates not included in other product types in this category, by means other than repelling or attracting. |
| CATEGORY 4: Other biocidal products |
| Product Type 21: Antifouling products |
| Products used to prevent settlement and growth of fouling organisms (microorganisms, plants, animals) on vessels, aquaculture equipment, or other marine structures. |
| Product Type 22: Embalming and taxidermist fluids |
| Products used for disinfection and preservation of human or animal corpses or parts thereof. |
When Can a Product Be Registered as a Biocidal Product?
To register a product as a biocidal product and obtain the appropriate authorisation, the following conditions must be met:
- The product must meet the definition of a biocidal product;
- Its intended use must fall within the product-type categories defined in Annex V of Regulation (EU) No 528/2012;
- The active substances must be listed in Annex II of Commission Delegated Regulation (EU) No 1062/2014 on the review programme of existing active substances used in biocidal products;
- Or the active substances must be approved and listed in the Union list of approved active substances under Article 9(2) of Regulation (EU) No 528/2012;
- Or all active substances must be listed in Annex I of Regulation (EU) No 528/2012 and comply with any restrictions therein.
Not all products that meet the definition of a biocidal product can be registered as such. Before initiating the registration process, it is crucial to verify the current status of the active substances in the product.
List of Biocidal Products
Biocidal products placed on the market and used within the European Union must have valid authorisation, either via national authorisation, Union authorisation, or parallel trade permits.
According to national legislation aligned with Regulation (EU) No 528/2012, authorised biocidal products are included in the national register of biocidal products.
The register includes:
- Name of the biocidal product;
- Name and address of the authorisation holder or parallel trade permit holder;
- Name and address of the manufacturer;
- Chemical name(s), EC number(s), and CAS number(s) of the active substance(s), as per Annex VI, Part I of Regulation (EC) No 1272/2008;
- Product-type group;
- Product form and intended use;
- Conditions of use and marketing;
- Type of packaging;
- Label content in the relevant national language(s);
- Validity period and authorisation number.
The register is updated regularly by the competent authority (e.g. national medicines or chemicals agency).
Which Registration Procedure Applies: National or European?
The choice depends on the approval status of the active substances in the product:
- If all active substances in the product are listed in Annex II of Regulation (EU) No 1062/2014, the product may follow national authorisation procedures.
- If the product contains both Annex II and approved active substances, it is authorised nationally until all are approved.
- Once all substances are approved under the Review Programme, European procedures must be followed.
- If only substances from Annex I of Regulation (EU) No 528/2012 are used, simplified procedure applies.
Note: Active substance status may change. It is essential to monitor updates regularly.
Information on Active Substances
Active substances in the Review Programme
Annex II of Regulation (EU) No 1062/2014 lists substances that may be used in products authorised via national procedures.
Approved active substances
A list of approved substances and those under review is published and regularly updated on the ECHA website.
Article 95 of Regulation (EU) No 528/2012
As of 1 September 2015, biocidal products containing a relevant substance listed under Article 95 must not be placed on the market unless the supplier is included in the Article 95 list for the relevant product-types.
This requirement applies to all biocidal product authorisations, including those granted through national procedures.
What Happens If Active Substances Are Not Approved?
Under Article 89(2) of Regulation (EU) No 528/2012, if a decision is made not to approve an active substance, Member States may continue to allow placing on the market for up to 12 months and use for up to 18 months following that decision.
This means national authorisations for products with non-approved active substances will be withdrawn after the grace periods expire.
What Happens After Approval of Active Substances?
If all active substances in a product are approved, an application for authorisation under the European procedures must be submitted via the R4BP system by the approval date.
Failure to submit the application on time results in withdrawal of the national authorisation after 180 days. Existing stocks may be used for up to 365 days from the date of approval of the last substance.
Are Authorisations from Other EU Member States Valid in Poland?
Authorisations issued in another Member State are valid only within that country, unless they are:
– Union Authorisations under Article 41 of Regulation (EU) No 528/2012, valid across the EU;
– Simplified Authorisations under Article 26 of the Regulation, valid EU-wide without mutual recognition, provided the competent authority is notified at least 30 days before placing the product on the market, and the labelling is adapted to the local language(s).
For transitional products, registration with the competent national authority (e.g. URPL) is still required.
What is the Difference Between Placing on the Market and Using Existing Stocks?
Existing stocks (batches already placed on the market) may either:
- Continue to be made available on the market
- Be used by end-users
“Placing on the market” is defined in Article 3(1)(i) of Regulation (EU) No 528/2012 as: any supply, whether in return for payment or free of charge, of a biocidal product for distribution or use in the course of a commercial activity.
This includes manufacturing and supplying to distributors, wholesalers, or end users. “Use” refers to consumption of the product by the final user.
Biocidal Products
https://ec.europa.eu/health/biocides/biocidal-products_en