Biocides

Following its departure from the European Union in 2021, the United Kingdom has implemented a new regulation for biocidal products, the GB Biocidal Products Regulation (BPR-GB), in addition to the existing Control of Pesticides Regulations (COPR). If you plan to market biocidal products in the UK, it is essential to note that the new BPR-GB closely resembles the EU Biocidal Products Regulation (BPR-EU) but includes some specific requirements tailored to the UK.

What requirements must suppliers of active substances in the UK meet?

Biocidal products marketed in the UK must only include active substances from suppliers listed in the Article 95 List.

• To market products in Great Britain, check that your suppliers are listed under the Article 95 List for BPR-GB.
• To market products in Northern Ireland (NI), your suppliers must appear on the Article 95 List for BPR-EU.

What authorization process applies to marketing biocidal products?

The process depends on the evaluation status of the active substance in your product:

• If the active substance is still under review, you will need to apply for authorization under the existing COPR.
• If the active substance has been approved, your application must comply with the BPR-GB.

You can check the evaluation status of active substances here.

What is Control of Pesticides Regulations (COPR)?

COPR control the marketing of biocidal products in Great Britain (GB) and Northern Ireland (NI) while their active substances are under evaluation. Only certain types of biocidal products are covered under COPR. Products falling into the following categories require registration:

1. Anti-fouling products: Applied to ship hulls, oil platforms, fishing nets, aquaculture equipment, and other artificial structures.
2. Aquatic algaecides: Used to control algae and aquatic weeds in ponds and lakes.
3. Aquatic molluscicides: Designed to control slugs and snails in ponds and lakes.
4. Avicides and bird-stunning baits: Used to control pest or nuisance birds.
5. Biocidal paints: Interior surface paints that prevent the growth of mold, fungi, and algae.
6. Insect repellents: Products used to repel pests like insects or arthropods in homes or on animals (but not directly on human skin).
7. Insecticides: Products used to control insects and arthropods that cause public health concerns or annoyance.
8. Surface biocides: Used to remove or prevent growths like lichens, mold, or fungi on internal and external surfaces. This excludes disinfectants.
9. Vertebrate repellents: Products designed to repel vertebrates such as cats or dogs.
10. Wood preservatives: Used to protect wood from damage or discoloration caused by fungi or insects.

What is required to market under COPR?

To market biocidal products under COPR, you need to:

1. Ensure your supplier of active substances is listed in the relevant Article 95 List.
2. Prepare a comprehensive dossier with all necessary product information.
3. Submit the dossier to the Competent Authority for evaluation.

Important Reminder! Before engaging in any activity with your biocidal product in the UK, you must obtain authorization from the Competent Authority.

Get in touch today to learn how we can support you in meeting COPR requirements and ensuring compliance for your biocidal products in the UK!

Quaternary ammoniums are a group of substances that stand out for their biocidal properties and are often used in the most common disinfectant cleaning products. Among them are DDAC and BKC. Are you ready for BPR approval?

DDAC and ADBAC/BKC C12-C16 are two of the most widely used quaternary ammoniums and are included in the Active Substances Review Programme established by the European Commission.

DDAC	Didecyldimethylammonium chloride	CAS 7173-51-5 EC 230-525-2
ADBAC/BKC C12-C16	Alkyl (C12-16) dimethylbenzyl ammonium chloride	CAS 68424-85-1 EC 270-325-2

Companies wishing to place biocidal products containing DDAC or ADBAC/BKC C12-C16 on the market must ensure that they comply with the BPR and have the relevant marketing authorisation.

On the publication date of this article, the evaluation status of DDAC and ADBAC/BKC C12-C16 is as follows:

Active substance	Product types
	Approved and approval date	Under evaluation
DDAC	PT1 – 01/02/2024 PT2 – 01/02/2024 PT3 – 01/11/2022 PT4 – 01/11/2022 PT8 – 01/02/2015	PT6 PT10 PT11 PT12
ADBAC/BKC C12-C16	PT1 – 01/07/2024 PT3 – 01/11/2022 PT4 – 01/11/2022 PT8 – 01/02/2015	PT2 PT10 PT11 PT12 PT22

Companies marketing or wishing to market biocidal products containing at least one of these two active substances must ensure that the following applies to their product prior to the final approval date:

• They have an authorisation granted in accordance with the transitional measures.
• They have submitted an application for BPR authorisation.

The approval dates for these two substances vary depending on the type of product, and some product types are still under evaluation, therefore, companies are sometimes in doubt as to which steps they need to take and by which dates.

Some cases and the steps to be taken by companies wishing to market these products are detailed below: 

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A. A company is currently marketing a biocidal product with DDAC, such as PT2 and PT4:

• DDAC will be approved for PT2 on 1 February 2024.
• DDAC was approved for PT4 on 1 November 2022.
• The company has authorisation for that biocidal product according to the transitional measures for PT2 and PT4, in each of the countries where it is placing the product on the market.

✔ The company must submit an application for BPR authorisation for that biocidal product by 1 February 2024 in order to be able to continue to market the product without interruption after the approval date.

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B. A company is marketing a biocidal product with DDAC, such as PT2 and PT4:

• DDAC will be approved for PT2 on 1 February 2024.
• DDAC was approved for PT4 on 1 November 2022.

❌The company does not have an authorisation for that biocidal product in accordance with the transitional measures.

The company must submit an application for authorisation for that biocidal product under the transitional measures, such as PT2 and PT4, in each of the countries where it is placing the product on the market before 1 February 2024, and

The company must submit an application for BPR authorisation before 1 February 2024 in order to be able to continue to market the product without interruption.

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C. A company wants to start marketing a product with DDAC and ADBAC/BKC C12-C16, such as PT2 and PT4:

• DDAC will be approved for PT2 on 1 February 2024.
• DDAC was approved for PT4 on 1 November 2022

❌ADBAC/BKC C12-C16 is still under evaluation for PT2.

• ADBAC/BKC C12-C16 was approved for PT4 on 1 November 2022.

❌The company does not have an authorisation in accordance with the transitional measures.

The company must submit an application for authorisation in accordance with the transitional measures in each of the countries where it wants to market the product as soon as possible.

It must also periodically review the approval status of ADBAC/BKC C12-C16 for PT2, as once the approval date for this PT is published, it must start work on submitting its application for BPR authorisation in time.

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D. A company wants to start marketing a product with DDAC and ADBAC/BKC C12-C16 for PT4:

• DDAC was approved for PT4 on 1 November 2022.
• ADBAC/BKC C12-C16 was approved for PT4 on 1 November 2022.

The approval date for both substances and product types has already expired, therefore, the company must submit an application for BPR authorisation as soon as possible and wait to receive the authorisation decision before starting to market the product.

As mentioned in another article, the costs of applying for authorisation under the BPR are high, so in order to reduce these costs, companies opt to:

• Submit applications for authorisation of families of biocidal products, grouping, as far as possible, several similar products into the same authorisation.
• Submit applications for authorisation of families of biocidal products, grouping, as far as possible, several similar products into the same authorisation.
• Accept the proposal of an authorised active substance supplier that has its own application for authorisation for a number of generic formulations and offers its customers access to this application under a commercial agreement.

The strategy for marketing biocidal products based on DDAC and/or ADBAC/BKC C12-C16 must be studied case by case, assessing not only the costs of the authorisation application, but also the viability of marketing in different European countries, the links of the agreements signed with other groups of companies, consortia or even suppliers of the active substance.

At ServiREACH, we can help you to assess your situation, evaluate the pros and cons of each option, and come up with the most appropriate strategy for your specific case.

If you require more information, please contact us.

The European Parliament and Council Regulation (EU) No. 528/2012 on the commercialization and use of biocides entered into force eight years ago. The European Commission has recently published a report on the application of the Biocidal Products Regulation for the period September 1, 2013, to December 31, 2019.

The Biocidal Products Regulation sets the rules regarding the commercialization and use of biocides. Biocidal products play an essential role in the protection of public health. Products such as insecticides and disinfectants are essential to help control vector-borne diseases, foodborne diseases or nosocomial infections.

Nevertheless, we cannot ignore that these products can also have a level of toxicity, which requires the regulation of their use and commercialization to guarantee a high level of protection for the health of humans, animals and the environment.

The Biocidal Product Regulation sets out a two-step approach to achieve its objectives of improving the functioning of the EU biocides market:

• Active substances, which are the ingredients in biocides responsible for acting against the target organism or organisms, must be approved at the European Union level or be listed in Annex I of the Biocidal Products Regulation, which includes the so-called “biocides of low risk”. Active substances are approved in relation to specific product types according to Annex V of the Biocidal Products Regulation, where 22 product types (PT) are defined.
• Biocidal products which contain these active substances require authorization, at the national or European Union level, in order to be marketed and used. As an exception, biocidal products containing active substances that are included in the review program schedule may be placed on the market and used in accordance with the national legislation of the corresponding Member State, pending a final approval decision on the active substances contained therein. The possibility of establishing exceptions to the rules of the Biocidal Regulation in case of risk to human or animal health or to the environment has also been envisaged. In such situations, Member States may grant temporary permits to market unauthorized products.

The report reveals clear delays in the approval process for active substances through the review program. As of December 31, 2019, only 35% of the work related to the program had been completed.

Since the Biocidal Products Regulation came into force, only ten new active substances have been evaluated, of which nine were approved, covering a total of thirteen active substance combinations with product types

As a result of the delays in the review program, the majority of the products placed on the market continue to only comply with national legislation. This legislation varies greatly between different Member States.

Between 2014 and 2019, a total of nine Member States availed themselves of the possibility provided for in Article 55 and granted a total of 135 temporary permits for products that they considered necessary to combat a danger to the health of humans, animals or the environment. As of March 2020, almost all Member States have made extensive use of this provision, in order to authorize the commercialization of more disinfectants, necessary to meet the enormous demand that has arisen in order to control the spread of COVID-19. Between March and November 2020, the Commission received almost 600 national permit notifications. Eight months after the start of the pandemic, it can be concluded that this emergency measure of the Biocides Regulation has made it possible to respond to the unprecedented situation caused by the pandemic and to address the severe shortage of disinfectant supply following an exponential increase in demand.

The main issues identified in the report are the slow progress in the evaluation of the active substances included in the review program, and the continued delays in both the approval of active substances and product authorization processes.

Completing the review program is key to achieving the objectives of the Biocidal Products Regulation. The longer the completion of the review program is postponed, the more biocidal products containing active substances can be placed on the market without having had their safety and efficacy evaluated.

The European Commission has approved hypochlorous acid as an active substance for use in type 1, 2, 3, 4 and 5 biocides. The approval date for PTs 2, 3, 4 and 5 is 01 July 2022 and 01 July 2021 for PT1s.

(EU) Commission Implementing Regulation 2021/347 of 25 February 2021, which approves active chlorine released from hypochlorous acid as an active substance for use in biocides of types 2, 3, 4 and 5.

And (EU) Commission Implementing Regulation 2021/365 of 26 February 2021, which approves active chlorine released from hypochlorous acid as an active substance for use in type 1 biocides.

The respective appendices of both Regulations establish the specifications and conditions that need to be met for the approval of hypochlorous acid as an active substance in each of the uses.

Appendix V of the Regulation on biocides establishes the following groups according to the type of product:

• PT1 Human hygiene – The products in this group are biocides used for the purpose of human hygiene, applied to or in contact with the skin or scalp, with the primary aim of disinfecting the skin or scalp.
• PT2 Disinfectants and algaecides not intended for direct use in people or animals – Used to disinfect surfaces, materials, equipment and furniture not used in direct contact with food or feed. The scope of use includes, among others, swimming pools, aquariums, bathing water and others; air conditioning systems, and the walls and floors of private and public places, industrial areas and other areas used for professional activities. Used for the disinfection of air, water not intended for human or animal consumption, chemical toilets, wastewater, hospital waste and soil. Used as algaecides for the treatment of swimming pools, aquariums and other water and for the restorative treatment of construction materials. Intended for use in textiles, fabrics, masks, paint and other articles or materials in order to obtain articles treated with disinfectant properties.
• PT3 Veterinary hygiene – Used for the purposes of veterinary hygiene, such as disinfectants, disinfectant soap, oral and body hygiene products and products with antimicrobial functions. Used for the disinfection of materials and surfaces related to the accommodation or transportation of animals.
• PT4 Food and feed – Used in the disinfection of equipment, containers, utensils for consumption, surfaces and pipes related to the production, transportation, storage and consumption of food or feed (including drinking water) for humans and animals. Used to impregnate materials that could come into contact with food..
• PT5 Drinking water – Used for the disinfection of drinking water, both for humans and animals.

Furthermore, active chlorine generated from sodium chloride through electrolysis has been approved as an active substance for use in type 1, 2, 3, 4 and 5 biocides. The approval date for PTs 2, 3, 4 and 5 is 01 July 2022 and 01 July 2021 for TP1s.

(EU) Commission Implementing Regulation 2021/345 of 25 February 2021 approves the use of types 2, 3, 4, and 5 in biocides.

And (EU) Commission Implementing Regulation 2021/364 of 26 February 2021, which approves the use of the same in type 1 biocides.

Both Regulations establish the specifications and conditions for the approval of the substance in each of the uses.