Case study: regulation and effectiveness of teat disinfectants for cows

Regulation and effectiveness of teat disinfectants (PT3)
Teat disinfectants for cows, used before and after milking, are classified as biocidal products of type PT3 (veterinary hygiene). Their purpose is to ensure optimal hygiene to reduce the risk of milk contamination and cross-contamination between cows.
Active substance
Lactic acid (CAS No. 79-33-4) is the most commonly used active substance in these products.
Regulatory framework
PT3 products containing lactic acid as an active substance fall under the established framework. This means that a marketing authorization (MA) is required for each product, as the active substance has been approved at the European level since 2017.
Effectiveness
These products must demonstrate bactericidal and fungicidal efficacy and are often virucidal as well.
Efficacy claims made on product labels must comply with the MA decisions.
Risk of reclassification
Regulations require vigilance regarding the boundary between biocides and veterinary medicines. If a disinfectant is used for a curative purpose (e.g., treating an ailment like mastitis), it could be reclassified as a veterinary medicine.
Conclusion
Teat disinfectants for cows are well-regulated biocidal products that require an MA (depending on the active substance used) to be marketed. However, their use must be clearly defined to avoid any reclassification as a veterinary medicine.
Understanding biocide regulations
Why are teat disinfectants for cows (containing lactic acid) subject to the established framework?
Unlike other biocides, they require a marketing authorization (MA) if they contain lactic acid as an active substance, because it has already been approved as such in the EU.
What tests must be conducted to ensure the effectiveness of a teat disinfectant
They must demonstrate bactericidal and fungicidal efficacy, and sometimes virucidal efficacy. If the product has an MA, the claimed efficacies must align with this authorization.
Can a teat disinfectant be reclassified as a veterinary medicine?
Yes, if it is used to treat a disease (e.g., mastitis) rather than for prevention and hygiene, it could be considered a veterinary medicine.