Business Tips
12
How to stay
compliant on your way into the global cosmetics market
In this first instalment of a two-part series of articles, TJAŠA GRUM of CE.way reveals how cosmetic business owners wanting to register their products in different countries across the globe can navigate the maze of regulatory requirements.
R
egulations vary from country to country, and each one requires a separate compliance approach, which makes it difficult to keep up with everything. In order to stay compliant, it is important to get well acquainted with the relevant regulations and to stay informed about any regulatory changes.
Cosmetic regulation in the EU Cosmetic products placed on the European Union’s market have to comply with the Regulation (EC) 1223/2009 on cosmetics products. According to this regulation, a cosmetic product is defined as: ‘any substance or mixture intended to be placed in contact with the
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external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view of exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours’. There are a number of products that are considered cosmetics in the EU. However, product classification is not always straightforward and sometimes products that may seem to be cosmetics do not actually fall into this category. The classification should, therefore, be done on a case by case basis, considering all the characteristics of the product.
Responsible person The EU Cosmetics Regulation sets out the requirement of a responsible person (RP). Every product sold in the EU has to have an RP, which, as the name already suggests, is responsible for the safety of the products and their compliance with the regulation. It is important to know that the RP has to be established within the EU and it can be the manufacturer, importer, distributor, or a third person, who accepts this role in writing.
Product Information File The RP has to keep a Product Information File (PIF) for every product he/ she places on the EU market at the address specified on the product label. The PIF includes information about the safety and
