BPR | Part 2
In the first article, we introduced the Biocidal Products Regulation (BPR) used by HI&I formulators and, explained what defines a biocide, how Article 95 works, what a Competent Authority is, and how Product Type (PT) groups help determine product classification. We also looked at a practical PT2 example.
Now let’s look at two more scenarios and build on our understanding.
Using PT Groups: An Example for PT 1
Let’s say you’re developing a hand sanitiser. The product is non-rinse, with the primary purpose of disinfecting skin, claiming to kill 99.99% of bacteria and viruses. There are no secondary cosmetic claims, and it is not intended for clinical use to control the spread of a specific disease.
This intended use aligns with the description of a biocidal product rather than a cosmetic or medical product. Its purpose fits under Product Type (PT) 1: Human Hygiene, which covers biocidal products intended for personal disinfection.
If this product is being sold in GB, you’ll need to reference GB Article 95. By filtering the Article 95 list for PT 1, you can identify the active substances approved for use in human hygiene products, ensuring compliance with GB BPR regulations.
This approach ensures your product meets regulatory standards while maintaining its intended purpose. Always check Article 95 to stay compliant!
Example Dog Shampoo Brief
You have been briefed to produce a dog shampoo which repels ticks and fleas.
What regulation applies here? The answer lies in understanding intended use, claims, and compliance.
First and foremost, dog shampoo is not a cosmetic product. Cosmetic regulations are explicitly defined for products intended for human use, and the fact that a human handles the shampoo during application does not change the intended purpose of the product, which is for use on animals.
Such a product must comply with:
- Biocidal Products Regulation (BPR) – The tick and flea repellent claims place the product under PT19 (Repellents and Attractants). Active ingredients must be listed on Article 95 and approved or under review for PT19. If the active is approved, a dossier submission is required before the product can be placed on the market.
- Detergent Regulations – As a product designed to clean, the shampoo also falls under detergent regulations, which ensure appropriate labelling and formulation compliance.
- CLP Labelling – Proper classification and hazard labelling are compulsory, including any required pictograms and safety information.
The Takeaway: Dog shampoos are not cosmetics—they are detergent products and, in cases of repellent claims, biocidal products. Compliance with BPR, detergent regulations, and CLP labelling is mandatory to ensure safety, truthful claims, and regulatory alignment. Misclassifying such a product as a cosmetic to avoid these requirements is both non-compliant and potentially misleading.
Preserving a pH Neutral Multi-Surface Cleaner
Scenario:
To date, all your products have been either acidic or alkaline in nature and did not require preservatives due to their inherent properties. However, you’ve now been tasked with producing a pH-neutral multi-surface cleaner, which will require preservation.
You recall having used a preservative for a hand soap previously — can this be used for the new cleaner?
Key Steps to Address the Issue:
• Check the Active Substance:
Determine the active ingredient in the preservative used for your hand soap. For this scenario, assume it’s Phenoxyethanol.
• Verify BPR Compliance:
Since the multi-surface cleaning product is not biocidal, the in-can preservative must comply with Article 95 and be listed under Product Type 6 (PT6). Phenoxyethanol is included on the relevant list, but your supplier is not visible there.
• Contact Your Supplier:
If your supplier is a distributor, they may be sourcing the material from a manufacturer who is on the Article 95 list. Request documentation to confirm that the preservative is compliant for PT6.
• If Not Listed:
If the material or supplier is not compliant, explore alternatives:
- Source Phenoxyethanol from a supplier listed under PT6.
- Consider switching to a different preservative already compliant with Article 95 for PT6.
• Be Aware of Cosmetics Exemptions:
It’s important to note that cosmetic products fall under separate regulations and are exempt from Article 95 requirements. Many preservatives acceptable under cosmetic regulations may not appear on the Article 95 list. Detergent regulated products are not cosmetics and often suppliers’ cosmetic preservatives will not be regulatory supported for use in different industries such as HI&I.
Even though this product is not a biocide, the preservative used must be a biocide and compliant with the BPR regulations. This is a common mistake made by formulators who come from a personal care background.
Responsible Person for Biocidal Products
To legally place a biocidal product on the market, you must have a responsible person, referred to in the regulations as the Biocidal Product Authorisation Holder.
Key Points:
• The authorisation holder ensures the product complies with regulatory requirements, including safety, labelling, and dossier maintenance.
• They must be based in the EU or Great Britain, depending on the market, and are held accountable by the competent authorities.
• Without an authorised holder, the product cannot be legally sold.
Important Note:
If you’re based in GB and want to sell in Ireland, you’ll need an EU-based responsible person to handle compliance, as you cannot act as the authorisation holder for EU markets from GB.
