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Ensuring Compliance: Common Biocidal Product Errors in the Veterinary Sector

Disinfectant products play a crucial role in safeguarding people and animals from harmful microorganisms, but to do this, they often contain hazardous chemicals. In this blog post, we will explore key factors to consider when selecting a surface disinfectant for your organisation, ensuring that it performs as intended and is fully compliant with the law.

Disinfectants used in veterinary hygiene in Great Britain (GB), Northern Ireland (NI) and the European Union (EU) are classified as Product Type 3 (PT3) biocides under the Biocidal Products Regulation (BPR).

To ensure the safety of users and those in contact with them, strict regulations are in place such as the BPR. However, it is important to note that not all products available on the market comply with these regulations. Ongoing compliance requires constant vigilance of multiple regulations by a qualified and experienced biocidal regulatory manager, and many companies do not have access to such resources internally and instead rely upon information being passed to them from active materials suppliers.

Whether or not a veterinary surface disinfectant complies with the regulations depends upon several factors.

Formulation composition and use of approved active substances

Biocidal products typically consist of a mixture of ingredients, including active substances responsible for the biocidal action (e.g., bactericidal, fungicidal, yeasticidal, and virucidal properties), as well as co-formulants serving other functions such as soil removal or fragrance.

To be supplied in the EU, NI and GB, the active substance(s) used in the product must be listed in the EU or GB Article 95 list, respectively, dependent on where the product is sold.

Active substances approved for one area (e.g., food contact – PT4) may not be approved for other areas (e.g., veterinary hygiene – PT3), therefore it’s important to check which product type the active substance(s) contained in your product has been approved for.

For use in environments where animals are kept, treated, housed or transported, the active substances must be approved for PT3 and supplied by a company listed on the GB Article 95 list or EU Article 95 list for PT3.

Efficacy to correct European test standards

Biocidal products must demonstrate efficacy against bacteria and yeast as a minimum requirement, but often animal health organisations need to ensure protection against a much wider and more challenging range of pathogens such as viruses, protozoa, or fungi. The BPR outlines specific tests that are necessary based on the product’s claims and its intended use.

If a product is marketed for use in PT3, in veterinary clinics and hospitals, welfare and rehoming charities, zoos, and wildlife parks, it must have been tested to the European PT3 veterinary standards. PT3 tests are conducted in higher soil levels and at lower temperatures, to ensure the products will be efficacious in use as well as in the laboratory.

It’s crucial to determine your organisation’s specific biosecurity needs and balance those against the risks of using stronger disinfectants which may have health & safety implications or cause unnecessary corrosion to equipment and surfaces.

Test methods can be updated, or added over time, so it’s important for manufacturers to review their data and retest their products as necessary. Test data which is over a decade old raises some questions as to whether the product would comply if tested today.

Notifiable diseases and outbreak management

In England, Scotland and Wales if your organisation requires a Defra-approved disinfectant for use to manage outbreaks of notifiable diseases such as Avian Influenza, then you should select a product from the Defra list of approved disinfectants. Not all veterinary surface disinfectants are suitable for this purpose. In Northern Ireland, a product should be DAERA approved, and in the Republic of Ireland, the product should be included on the List of Disinfectants for Use Against Certain Exotic Diseases

It is important to note that not all products on this list are approved for use in all cases, for example, Avian Influenza requires a disinfectant approved to Poultry Orders. The Defra website also confirms the dilution ratio required to achieve this level of disinfection and this information must also be present on the product label.

Prohibited claims and advertising guidelines

As well as strict requirements for testing and formulating, all biocidal products must adhere to strict labelling and advertising regulations.

Like any chemical product, disinfectant products must comply with the GB Classification, Labelling & Packaging (CLP) regulations, which determine information such as the presence and size of hazard symbols and precautionary statements that must be included on the product label. These are confirmed by the safety data sheet for the product, which should be periodically reviewed and updated by the manufacturer.

Labels and advertising materials must not mislead customers about the risks associated with human, animal and environmental health. It is the manufacturer’s responsibility to ensure disinfectants comply with the GB biocidal product regulation guidelines on advertising and marketing.

Certain phrases, including “low-risk”, “non-toxic”, “harmless”, “natural”, “environmentally friendly”, “animal-friendly”, and similar terms are explicitly prohibited by this regulation and could result in products being withdrawn from the market at the request of the Health & Safety Executive (HSE).

Emphasis should be placed on the safe use of biocidal products and users should always be instructed to read the product label and safety data sheet before use.

Changing regulations

The majority of biocidal products used by animal health professionals in GB, NI and the EU are in the “transitionary period”. This means that one or more active substances contained in the product are still under review.

Once all active substances in the product are approved, a dossier must be compiled and submitted for review by the manufacturer. The dossier compilation typically takes 1-2 years, with an additional 3-5 years (or longer) expected for approval.

If the product being used is not supported prior to the approval of the last active substance, it must be withdrawn within 180 days. As we approach the end of the active substance review programme, it is crucial to engage with the supplier of your biocidal product to ensure their commitment to supporting it through the BPR. Many organisations need a substantial period of time to validate the use and then train their teams on a new disinfectant. A hasty withdrawal of a product from the market could leave customers scrambling for alternatives, which risks compliance and end-user health & safety.

Reviewing the points mentioned above in relation to the biocidal product you are using will provide insight into their preparedness for compiling a BPR dossier and their intention to keep their product on the market long-term.

How the reclassification of active substances affects end-users

As active substances are reviewed in the EU and GB, this may change the classification of a substance that was previously approved for use and listed on Article 95.

Certain active substances, like Polyhexamethylene biguanide or PHMB, have been classified as Candidates for Substitution due to their hazardous nature. PHMB, for instance, is suspected to be a carcinogen and possesses skin-sensitising properties, warranting consideration of alternative active substances. Consequently, products containing PHMB are expected to be subject to stricter risk assessments in the coming years or may even be reformulated with other active substances.

This reclassification process can cause active substance manufacturers to withdraw materials from the market, causing supply constraints and resulting in disinfectant manufacturers having to urgently reformulate their products.

It could also mean that disinfectant product manufacturers remove their products from certain markets, where the active is no longer approved for use. A product could also feasibly be legally compliant for use in human health environments, but no longer compliant in veterinary environments.

How to protect your organisation and prepare for any changes

To avoid using products which are not legally compliant, it is important to engage in a dialogue with your supplier and ask for documentation and proof rather than accepting general or vague assurances. Responsible manufacturers will likely be delighted to demonstrate their current compliance and discuss their plans for the future of their products.

Questions to ask your disinfectant supplier

The following list of essential questions may help to confirm the compliance of biocidal products with the regulations:

  1. Are the active substances in the product approved for use in PT3? (You can verify this on the GB & EU Article 95 lists using the links above)
  2. Has the biocidal product undergone the necessary PT3 testing to support the efficacy claims made?
  3. If necessary for your biosecurity needs, is the product approved by Defra in England, Scotland and Wales, or DAERA in Northern Ireland?
  4. Is the labelling of the product compliant with CLP?
  5. Does the biocidal product make any prohibited claims?
  6. Does your supplier have plans to support the biocidal product through the BPR (both in GB and EU+NI)?
  7. Are any of the active substances in the product candidates for substitution? This may affect the chances of achieving full BPR approval.
  8. Is the product registered under transitionary rules in the country where you use it?

By addressing these questions with your supplier, you can ensure that the biocidal product you choose is compliant with the BPR and meets the necessary regulatory standards. Byotrol’s team are happy to answer any questions you may have and discuss the future of our products and plans for BPR submissions.