On June 5, 2024, the EU Biocidal Products Committee released four new opinions on active substances and seven Union authorization decisions from its May session. Details are provided in the table below.
Four Recommendations
| Substance Name | Product-type（PT） | Description | Opinion |
| Medetomidine | PT21(Antifouling products) | To manage the growth and attachment of biological pollutants, like microorganisms and larger plant or animal species, on ships, aquaculture equipment, or other water structures. | not support renewal |
| Dinotefuran | PT18(Insecticides, acaricides and products to control other arthropods) | For controlling arthropods, such as insects, spiders, and crustaceans, through means other than repellents or attractants. | support renewal |
| 5-Chloro-2-methyl-2H-isothiazol-3-one (CIT) | PT6(Preservatives for products during storage) | For extending the shelf life of non-food products by preventing microbial spoilage. Also used as preservatives for storing or using rodenticides, insecticides, or other baits. | not support approval |
| Polymeric betaine | PT8(Wood preservatives) | For preserving wood, including sawmill lumber, or wood products by preventing damage from biological organisms, including insects. This includes both preventive and remedial treatments. | support approval |
Seven Authorization Decisions
| Substance Name | Product-type（PT） | Description | Opinion |
| propan-2-ol | PT2(Disinfectants and algaecides not intended for direct application to humans or animals) | Primarily for disinfecting non-food contact surfaces, this product is ideal for swimming pools, air conditioning systems, and public areas. It also sanitizes air, non-potable water, and wastewater, and acts as an algaecide for pools and aquariums. It can also be added to textiles and paints. | support |
| propan-1-o | |||
| propan-2-ol | PT1(Human hygiene) | For personal hygiene, this disinfectant is applied directly to the skin or scalp to sanitize these areas. | support |
|
Margosa extract from cold-pressed oil of the kernels of Azadirachta Indica extracted with super-critical carbon dioxide |
PT19(Repellents and attractants) | This product controls harmful organisms, including invertebrates and vertebrates, providing direct sanitary protection for humans and animals and indirect protection for their environments. | support |
|
Glutaral (Glutara ldehyde); Reaction mass of 5-chloro-2- methyl-2h-isothiazol-3-one and 2-methyl-2h-isothiazol-3-one (3:1) |
PT6(Preservatives for products during storage) | Used as a preservative for non-food products, it extends shelf life by preventing microbial spoilage. It is also effective for preserving rodenticides, insecticides, and baits. | support |
| PT11(Preservatives for liquid-cooling and processing systems | In cooling and processing systems, this agent controls microorganisms, algae, and mussels, ensuring water and liquid cleanliness and safety. | ||
| PT12(Slimicides) | In industrial processes, it prevents slime growth on materials, equipment, and structures, such as wood, pulp, and in sand layers during oil extraction. | ||
|
Reaction mass of 5-chloro-2-methyl-2h-isothiazol 3-one and 2-methyl-2h-is thiazol-3-one (3:1) |
PT4(Food and feed area) | Disinfects equipment, containers, utensils, surfaces, or pipelines used in food and feed production, transportation, storage, or consumption, including drinking water. Also treats materials that contact food. | support |
| PT11(Preservatives for liquid-cooling and processing systems | Keeps water and other liquids in cooling and processing systems clean by controlling harmful microorganisms, algae, and mussels. | ||
| PT12(Slimicides) | Prevents or manages slime growth in industrial processes on materials, equipment, and structures, like wood, pulp, and porous sand layers in oil extraction. | ||
| Peracetic acid | PT2(Disinfectants and algaecides not intended for direct application to humans or animals) | Disinfects non-food contact surfaces such as swimming pools, air conditioning systems, and public areas. Also treats air, non-potable water, wastewater, and acts as an algaecide in pools and aquariums. Can be added to textiles and paints. | support |
| PT3(Veterinary hygiene) | For veterinary hygiene, the product line includes various disinfectants and antibacterial soaps and cleansers. These are also used to sanitize animal habitats and items touched during transport. | ||
| PT4(Food and feed area) | Disinfects equipment, containers, utensils, surfaces, or pipelines used in food and feed production, transportation, storage, or consumption, including drinking water. Also treats materials that contact food. | ||
| Hydrogen peroxide | PT4(Food and feed area) | Disinfects equipment, containers, utensils, surfaces, or pipelines used in food and feed production, transportation, storage, or consumption, including drinking water. Also treats materials that contact food. | not support |
In the EU's biocidal product regulation, decision-making is crucial. The Biocidal Products Committee (BPC) Chair emphasizes the importance of comprehensive data on active substances. Insufficient data may lead to non-approval or removal of substances from the EU market. Below is an overview of this regulatory process.
1. BPC Active Substance Review
(1) Substance Data Submission: Companies must provide extensive scientific data on the active substances in their biocidal products, focusing on safety, efficacy, and environmental effects.
(2) Assessment Outcome: The Biocidal Products Committee (BPC) reviews this data over 270 days and submits its recommendations to the European Commission and member states to guide decision-making.
2. EU Commission Decisions
If the European Commission designates a substance as active, it grants authorization for up to ten years. Substances marketed before May 14, 2000, and reassessed with new criteria are also treated as existing active substances.
Furthermore, substances deemed potentially harmful to public health or the environment may be identified for substitution and progressively replaced with safer alternatives.
3. Public Feedback
Following expert advice and industry submissions, the European Commission will revise regulations on the use of active substances. When an active substance is flagged for substitution, ECHA will initiate a public consultation to gather information, including alternatives.
4. Approval and Authorization of Alternative Candidates
Active substances identified for substitution will have their approval limited to seven years. If they meet exclusion criteria, the approval is limited to five years.
5. Market Trends
Manufacturers and suppliers must update their products to comply with these new standards, ensuring all biocidal products meet market regulations.
