EUROPE AND UK
When it comes to cosmetic products, both the European Union and the UK take safety and compliance seriously. Whether it's that perfect lipstick shade or a refreshing face cleanser, there are regulations in place to ensure that these products meet certain standards. Let's delve into the world of cosmetic regulations and discover what it takes for a product to be deemed compliant.
In EU and in UK, the following key regulations respectively govern cosmetic products: Regulation EC 1223/2009 and Schedule 34 of the Product Safety and Metrology Statutory Instrument. Both the UK Regulation and the EU Regulation share fundamental principles that prioritize safety and compliance.
The first criterion to consider when formulating a compliant product is the definition of a cosmetic product itself. According to the regulations (Article 2 of the UK Cosmetics Regulation (EC) No. 1223/2009 (UKCR) and the EU Cosmetic Products Regulation (EC) No. 1223/2009 (CPR) a ‘cosmetic product’ shall mean ‘any substance or mixture intended to be placed in contact with the 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 exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours’.
To determine if a product can be legally classified as a cosmetic, there are a few preliminary questions to address. Firstly, the site of application is crucial. If a product is not intended for external use (such as eye drops or ingested tablets) aimed at improving appearance, it falls outside the scope of cosmetics. Secondly, the purpose of the product plays a significant role. If the primary function does not align with cleaning, perfuming, appearance alteration, odour correction, protection, or maintenance, it's unlikely to be considered a cosmetic.
For example: a ‘Hair Growth Serum with Medicinal Claims" advertised as a treatment for baldness.
Reason for Non-Compliance: According to the European and UK cosmetic definition, a cosmetic product is intended to be placed in contact with the external parts of the human body. While hair care products, including serums, can fall under the cosmetic category, the primary purpose of this specific product is to treat a medical condition, namely baldness. It makes medicinal claims and implies that it can address hair growth issues beyond the cosmetic level.
Therefore, the "Hair Growth Serum with Medicinal Claims" would not be compliant with the European and UK cosmetic definition and would be subject to different regulatory frameworks governing medical treatments rather than cosmetics.
The second criterion focuses on the composition of the product. To ensure compliance with the regulations, the formula must adhere to specific guidelines. There are prohibited and restricted substances listed in the regulations, outlined in Annex II and Annex III, respectively. Furthermore, only approved colours, preservatives, and UV filters mentioned in Annexes IV, V, and VI can be used in cosmetics. Any substance not listed in these annexes can be used freely if it's not a colour, preservative, or UV filter, isn't classified as Carcinogenic, Mutagenic, or Reprotoxic (CMR), and has appropriate safety data. The UKCR also contains Annexes with the same resources (Warning! Slight differences are appearing in content as divergence occurs)
Substances classified as CMR under the Classification, Labelling, and Packaging Regulation (CLP) are strictly prohibited unless specifically permitted for use in cosmetics. These substances are outlined in Annexes III, IV, V, or VI, with conditions for their usage.
The primary purpose, claims, composition, and importantly how consumers are likely to use and perceive the product are all considered when determining its regulatory classification. Depending on these criteria, a product may fall under other sector-specific legislations, such as medicines, medical devices, biocidal products, or general products.
With regard to the Cosmetic Supervision and Administration Regulation, Cosmetics refer to chemical industrial products for daily use that are applied on our human body surfaces such as skin, hair, nails, lips and so on. Application methods include rubbing, spraying or other similar techniques for the purpose of cleansing, protecting, beautifying or grooming.
Comparing two definitions, the definition of cosmetics in China is similar to the one in EU and UK. The application field is body surface. This means any products consumed by ingestion or ingestion are not deemed as cosmetics. Another essential criteria is cosmetics shall not involve any function or claims of medical treatment.
Thought the big umbrella covering cosmetics seems similar, some products that are considered as cosmetics in UK/EU may not be the case in China, and vice versa. For instance, Toothpaste is considered as cosmetics in UK/EU, but it is not considered as cosmetics in China.
Unlike in the UK/EU, where cosmetics are generally regulated under a single framework, cosmetics are divided into two categories in China, namely general cosmetics and special cosmetics. Special cosmetics refer to cosmetic products with claims of hair dye, hair perm, anti-hair loss, sunscreen, spot-removing, whitening, and other new efficacy claims. All the other cosmetic products are deemed as general cosmetics. Special cosmetics are subject to registration, while general cosmetics are subject to notification. Generally, compared to notification of general cosmetics, registration of special cosmetics requires a more extensive set of documents and tests, and therefore takes longer time and higher expense to finish the regulatory procedure.
The UK/EU regulations detail a series of substances that are prohibited (Annex II) and lists all the substances that are subject to restrictions (Annex III). Similarly, China has lists of ingredients allowed to be used, prohibited to be used, and allowed to be used under certain conditions, which are listed in the Safety and Technical Standards for Cosmetics. However, these allowed, prohibited or restricted ingredients are not identical to the UK/EU regulation. In other words, some ingredients that are allowed to be used in the UK/EU might be prohibited in China, and vice versa; or the ingredients are under different restrictions, e.g. the maximum concentrations. Thus, To ensure compliance with Chinese regulations, it is advisable to refer to the lists of ingredients in the Safety and Technical Standards for Cosmetics before introducing your products to the market.
It's essential to understand that each country or region may have distinct regulatory frameworks governing cosmetic products. Therefore, while a product might not align with the European and UK cosmetic definition, it could still comply with the criteria and regulations set by other countries, such as China, based on their specific guidelines and safety evaluations.
In conclusion, by understanding the criteria for classification and the regulations surrounding composition, manufacturers and consumers can navigate between the European/UK and China cosmetic markets with confidence.