Biocides: Comparative analysis of regulation, effectiveness, and reclassification risks

Case study: Regulation and effectiveness of biocides
Biocides play a crucial role in disinfection, pest control, and hygiene, both human and veterinary. However, their market authorization is subject to specific regulatory requirements that vary depending on their type, composition, and expected effectiveness. In this case study, we analyze three commonly used biocides:
- Hydroalcoholic gel (PT1 – Human hygiene)
- Anti-lice spray (PT18 – Insecticide or PT19 – Repellent)
- Teat disinfectant for cows (PT3 – Veterinary hygiene)
We will examine the specificities of each based on key criteria: active substance, applicable regulatory framework, effectiveness, and risks of reclassification.
Product type (PT) and active substances
Each biocide falls under a specific regulatory category, defined by its product type (PT) and main active substance:
- Hydroalcoholic gel (PT1): Ethanol is the most common active substance.
- Anti-lice spray (PT18 or PT19): The most frequently used active substances are hydrated/cyclized eucalyptus citriodora essential oil and geraniol.
- Teat disinfectant for cows (PT3): Lactic acid is the primary active substance used.
Regulatory framework
The regulatory status primarily depends on the active substance used:
- Hydroalcoholic gel and anti-lice spray: These products still fall under the transitional framework, meaning they are subject to national regulations in each country until their active substance(s) receive official approval from the European Union.
- Teat disinfectant for cows: It falls under the established framework, requiring a marketing authorization (MA) since its active substance (lactic acid) has been approved in the EU since 2017.
Effectiveness and regulatory requirements
The effectiveness of a biocide must be demonstrated through standardized tests (when available):
- Hydroalcoholic gel: It must be proven as bactericidal, fungicidal, and often virucidal using phase 2 tests.
- Anti-lice spray: Less standardized, but there are recommendations.
- Teat disinfectant for cows: Labeling must comply with the MA, which has validated the efficacy claims.
Risks of reclassification
Certain products may be reclassified depending on their composition or mode of action:
- Hydroalcoholic gel: Its biocidal status is well-defined, with no regulatory ambiguity.
- Anti-lice spray: It can be reclassified as a medical device if its mode of action is mechanical (e.g., suffocating lice by coating them).
- Teat disinfectant: It can be reclassified as a veterinary medicine if it is used to treat a condition such as mastitis.
Conclusion
Biocides are subject to strict requirements regarding regulation, effectiveness, and classification. The transitional framework still in effect for some products (due to the active substance used) requires close monitoring of regulatory developments. Additionally, the boundary between biocide, medical device, and veterinary medicine must be carefully assessed to prevent unexpected reclassification.
All these factors must be taken into account to ensure compliance and the successful commercialization of these products in the European market.
Mastering biocide regulations
Can I use any substance I want to achieve the desired effect in my biocidal product?
No. Only specific substances listed in various regulatory frameworks can be used as biocidal active substances (AS):
- AS officially approved at the EU level (list maintained by the European Chemicals Agency – ECHA)
- AS listed in Annex I of Regulation 528/2012 (Biocidal Products Regulation – BPR)
- AS included in Regulation 1062/2014 (Review Program Regulation)
These substances are generally linked to one or more product types (PT), meaning they are approved for specific uses. This is known as the AS/PT pair.
For example, if a substance is only approved for PT1 (human hygiene), it cannot be used in a product claiming effectiveness under PT2 (surface disinfection).
Additionally, these active substances must be sourced from approved suppliers (except for AS listed in Annex I of the Biocidal Products Regulation). These suppliers are referenced on the “Article 95 list”, maintained by ECHA.
What is the procedure for placing a biocidal product on the market?
There are two main regulatory frameworks for market authorization, depending on the active substances used and the claimed effectiveness:
- Permanent framework: This is the standard procedure, which will eventually become the only applicable system. It requires obtaining a marketing authorization (MA) for each biocidal product before it can be placed on the market. This framework applies when all active substances in the product are officially approved for the claimed efficacy.
- Transitional framework: In some cases, regulations allow the placement of biocidal products on the market even if they contain active substances that have not yet been officially approved. To qualify for this framework, the product must contain an AS listed in Regulation 1062/2014. Under these conditions, an MA is generally not required (except in rare cases), as national regulations of the country where the product is marketed apply to labeling and registration requirements.