Borderline Products in the EU: Cosmetic Products or Not?

1) The product nature, the application site, and the intended purpose are three criteria to determine whether a product qualifies as a cosmetic product; 2) Biocides, medicinal products, medical devices, and toys are common borderline products in relation to cosmetics. A case-by-case evaluation should be conducted to differentiate cosmetic products from these borderline products.

Properly classifying a product is crucial in determining its pre- and post-market compliance requirements in the EU. Therefore, when developing cosmetic products, it is essential to possess a comprehensive understanding about whether the products being developed fall under the scope of Regulation (EC) No 1223/2009 on Cosmetic Products (Cosmetics Regulation).

The Cosmetics Regulation specifies the criteria of being classified as a cosmetic product, along with the essential compliance requirements for cosmetic product's entry into the EU market. Despite the provided definition, there are cases where uncertainty arises regarding the classification of certain products as cosmetics, or other types of products as per other sectorial legislation. These products are termed as "borderline products" in the EU. To provide guidance on determining whether a borderline product falls within the scope of the Cosmetics Regulation, the European Commission has published the Manual of The Working Group on Cosmetic Products (Sub-group on borderline products) on the Scope of Application of the Cosmetics Regulation (EC) No 1223/2009 (Art. 2(1)(A)) (Manual). In this article, ChemLinked explores the key points of the Manual, and its latest updates.