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The European Cosmetics Regulation (1223/2009/EC) has the following definition for cosmetic products:
"all substances or mixtures intended to be brought into contact with the parts of the human body surface (epidermis, hair, hair, nails, lips and external genital organs) or with the teeth and the mucous membranes of the mouth, for the sole or principal purpose of cleaning them, perfuming them, modifying their appearance and/or protecting or keeping the aforementioned parts of the body in good condition or correcting body odors."
Lipstick, mascara and foundation, as well as products such as toothpaste, shaving cream and baby wipes, fall within the scope of the Cosmetics Regulation. Such products must meet strict rules before you can sell them on the European market. You may also sell products for which you are not sure whether the cosmetics regulations apply, such as lubricant, perfumed wipes or fake eyelashes. Now how do you determine whether these products must comply with the cosmetics regulation, or perhaps are subject to other legislation?
In addition to whether or not your product is cosmetics, your product may appear to fall into two different product categories. Such a product is also known as a borderline product. Your cosmetic product may interface with medicines, health products, medical devices and biocides, as well as toys. With each category, there are different additional obligations. Your product can only fall under one of these categories at a time. Which category your product falls under and which legislation applies to your product depends, among other things, on the ultimate purpose of the product and the advertising claims. So a lot to take into account.
The European Commission working group on cosmetic products has prepared a document in which they try to clear up as many of these ambiguities as possible: "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))."
This document is not legally binding, but serves as a guide in determining applicable legislation. Your products will always require a case-by-case review to determine the appropriate safety requirements. Below are some common examples covered in the document:
Lubricant:
The definition of cosmetics indicates that products that come into contact with specific parts of the body and have a cosmetic effect are considered cosmetics. This explicitly mentions only external genital organs. So the vagina is clearly excluded from this, and your lubricant in this case does not fall under the cosmetics regulation.
If your lubricant is sold as lubricant and massage oil in one, and your product is attributed a characteristic such as "caring for the skin," the product may well be considered cosmetics. In this case, the main purpose of the product and the other advertising claims must be considered.
The Medical Devices Directive 93/42/EEC could also apply to your product. If your lubricant is intended for body massage or to stimulate intercourse, this directive does not apply, but if its main purpose is to relieve pain or combat vaginal dryness it would be covered.
Skin-bleaching products:
Skin bleaching is usually done from a cosmetic point of view. It intentionally alters the appearance. If your product is intended to treat pigmentary disorders such as melasma or chloasma, for example, Directive 2001/83/EC on medicinal products applies.
Only a few substances are allowed for cosmetic skin bleaching. Other substances such as hydroquinone and glucocorticoid are prohibited in cosmetics. If your product contains these ingredients, the product also falls within the scope of Directive 2001/83/EC on pharmaceuticals.
Are you planning to trade products on the European market and you are not sure whether the Cosmetics Regulation applies? Or do you want to know what your obligations are if your product falls under the Cosmetics Regulation? Précon Quality Services can support you with this! Feel free to contact us at +31 (0)30 - 65 66 010 or info@precongroup.com.
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