Borderline Products

As we reach the half-way point on the biocidal product decision tree (4/8). Our attention turns to borderline products.

Borderline products are those which lie close to the boundary between multiple regulations. Examples include biocidal products, biocidal carriers, treated articles, cosmetic products, medical devices, medicinal products, herbal medicines or food supplements.

These are complex healthcare products which require further investigation to determine which regulatory framework applies to their registration and are determined on a case-by-case basis by national competent authorities. They are called borderline products until their status has been decided.

An example of a borderline product could be a hand cleansing gel. If the purpose of the gel is simply to clean hands, it would fall within the scope of the cosmetic regulation. If however the gel is used for disinfecting hands, disinfection indicates a biocidal action therefore the product would be deemed a biocide.

If an applicant is unclear about which regulatory framework their product falls under, they can provide information to the national authority regarding the product’s composition and constituents, as well as a scientific explanation of the mode of action, and the intended purpose of the product, to help come to a decision. It is important to note that it is possible for each competent authority to individually come to a different decision, meaning a product may need to follow one regulation for registration in one country, but another regulation for registration elsewhere. 

A particularly challenging area is that of defining biocidal carriers, biocidal products, and treated articles. The term ‘biocidal carrier’ is designated in borderline cases where products fall between ‘treated articles’ and ‘biocidal products’.

Guidance has recently been agreed by EU expert committees which outlines information to be provided regarding the carrier’s composition and properties, and allows for a distinction of three carrier types.

• Type A – where the function of the carrier component is a simple carrier matrix, for example, form giving plastics, tissues or paper for window stickers or disinfecting wipes.
• Type B – which extends the treated articles category for coated or impregnated biocides as a secondary function of the product, such as treated nets, clothing and facial masks.
• Type C – for specific types of packaging that are not removed before use, including hangers with insect repellent enclosed in a device, or prefilled bait stations. 

To learn more about borderline products and the BPR, look out for our “Introduction to the Biocidal Products Regulation” eBook, coming soon.

If you need advice or support with a borderline product, This email address is being protected from spambots. You need JavaScript enabled to view it..