BPR | Part 3
Borders with Other Laws
When developing and marketing biocidal products as an HI&I formulator it’s essential to ensure that your product stays within the scope of the Biocidal Products Regulation (BPR) and does not cross regulatory borders, requiring authorisation under different laws. Misaligned claims can inadvertently reclassify your product under entirely different regulations.
Examples of Regulatory Borders:
• Medicinal Products:
A product claiming to prevent disease by killing disease-causing organisms when used topically on the skin would be classified as a medicinal product, not a biocide.
• Veterinary Medicines:
A product designed to kill germs in and around animal bedding would be classified as a biocide. However, if the product is intended for direct use on the animal, it would fall under veterinary medicine regulations.
• Plant Protection Products:
A path and patio cleaner claiming to kill moss would require approval under the GB Plant Protection Products Regulation (PPPR) rather than BPR.
Key Takeaway:
When formulating and marketing biocides, ensure your product claims align with BPR regulations. Avoid inadvertently positioning your product as a medicinal, veterinary, or plant protection product by carefully reviewing claims and intended uses. Correct classification is critical to avoid non-compliance.
Understanding the COPR Regulation
The Control of Pesticides Regulations (COPR) governs the authorisation and use of certain pesticides in Great Britain. While much of COPR’s scope has been replaced by the Biocidal Products Regulation (BPR) and Plant Protection Products Regulation (PPPR), it remains relevant for specific products that have yet to transition to newer regulations.
Key Points of COPR:
Scope of COPR:
Covers pesticides not yet authorised under BPR or PPPR.
Includes certain wood preservatives, anti-fouling products, and rodenticides.
Product Authorisation:
Products must be authorised under COPR before being marketed or used in GB.
The authorisation process reviews safety, efficacy, and environmental impact.
Label Compliance:
Labels must clearly state conditions of use, safety precautions, and restrictions.
Transition to New Regulations:
Products currently authorised under COPR will eventually move to either BPR or PPPR.
Businesses must monitor deadlines and submit applications for reauthorisation under the appropriate framework.
Enforcement:
The Health and Safety Executive (HSE) enforces compliance with COPR.
Why It’s Important:
COPR ensures older pesticide products remain safe and effective as regulatory systems evolve. If your product is still regulated under COPR, it’s essential to maintain compliance until it transitions to BPR or PPPR.
For further guidance, consult the HSE Pesticides and Biocides Guidance or reach out to HSE directly.
What Does DEFRA Do?
The Department for Environment, Food and Rural Affairs (DEFRA) oversees critical regulations related to public health, agriculture, and the environment, complementing the Biocidal Products Regulation (BPR) in specific situations. DEFRA plays a significant role in managing products used during public health emergencies and agricultural biosecurity crises, amongst many other things.
DEFRA’s Role in Outbreaks
During outbreaks of notifiable animal diseases or zoonotic diseases (e.g., tuberculosis, avian influenza, or foot-and-mouth disease), only DEFRA-approved disinfectants can be used. These products undergo additional testing to ensure they meet the claims required for such outbreaks.
Where DEFRA-Approved Disinfectants Are Used:
• Animal Housing: Disinfecting infected barns, pens, or livestock facilities.
• Farm Equipment: Sanitising tools and machinery in contaminated areas.
• Vehicles: Cleaning livestock transport or farm vehicles exposed to pathogens.
• Foot Dips: Using disinfectant baths to prevent pathogen spread via footwear.
DEFRA vs BPR Approval
DEFRA-approved products are fully compliant with BPR requirements but have undergone additional testing to ensure effectiveness against specific pathogens involved in disease outbreaks.
How to Ensure Compliance
A list of DEFRA-approved disinfectants is available on their website, which is an excellent resource to confirm if the product you are using meets the necessary regulatory and performance standards.
Key Takeaway
DEFRA-approved disinfectants offer reassurance that the product is both BPR-compliant and tested to perform effectively in critical outbreak scenarios. Always verify your disinfectant against DEFRA’s approved list to ensure compliance and efficacy during notifiable disease outbreaks.
Understanding Active Substance Approval Status
Under the Biocidal Products Regulation (BPR), the status of an active substance determines whether it can be legally used in a biocidal product. Beyond approved and under-review statuses, some substances may no longer be viable for use. Here’s a breakdown:
Key Active Substance Statuses:
- Approved:
These substances have passed all regulatory assessments and are authorised for specific Product Types (PTs).
Biocidal products containing these substances can be marketed, provided they comply with other BPR requirements.
Under Review:
Substances currently being evaluated for approval.
Products containing these substances may be sold under transitional measures, but this is temporary and depends on national legislation.
No Longer Supported:
Substances for which the approval process has been stopped because the manufacturer or supplier withdrew their application or chose not to support it further.
Products containing these substances must be removed from the market by a specific deadline.
Cancelled or Expired:
Substances whose approvals have either been withdrawn or not renewed by regulatory authorities.
Products containing these substances must no longer be marketed or used after their approval expiry date.
Not Approved:
Substances explicitly rejected by the regulatory body due to safety, efficacy, or environmental concerns.
Products containing these substances are prohibited.
How to Stay Compliant:
• Check the status regularly using official lists from regulatory bodies (e.g., HSE for GB, ECHA for the EU).
• Plan for transition by reformulating or phasing out products containing substances no longer supported, cancelled, or expired.
• Use only active substances from suppliers on the Article 95 list to ensure regulatory backing.
Key Takeaway:
The approval status of active substances is crucial for regulatory compliance. Products containing substances that are not approved, no longer supported, or expired must not be marketed. Stay informed to keep your products compliant and market-ready.
