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compliant How to stay 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 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 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 makes it difficult to keep up or mainly to cleaning them, suggests, is responsible for the with everything. In order to stay perfuming them, changing their safety of the products and their compliant, it is important to get appearance, protecting them, compliance with the regulation. It well acquainted with the relevant keeping them in good condition is important to know that the RP regulations and to stay informed or correcting body odours’. has to be established within the about any regulatory changes. There are a number of EU and it can be the manufacturer,
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Cosmetic regulation in the EU products that are considered cosmetics in the EU. However, product classification is not importer, distributor, or a third person, who accepts this role in writing.
Cosmetic products placed on the always straightforward and
European Union’s market have to sometimes products that may Product Information File comply with the Regulation (EC) seem to be cosmetics do not The RP has to keep a Product 1223/2009 on cosmetics products. actually fall into this category. Information File (PIF) for every
According to this regulation, a The classification should, product he/ she places on the EU cosmetic product is defined as: therefore, be done on a case by market at the address specified on
‘any substance or mixture intended case basis, considering all the the product label. The PIF includes to be placed in contact with the characteristics of the product. information about the safety and
quality of the product. It should include the following information (Article 11 of EU Cosmetics Regulation 1223/2009): • A description of the cosmetic product • The Cosmetic Product
Safety Report (CPSR) • A description of the method of manufacturing and either a good manufacturing practice certificate or a statement on compliance with good manufacturing practice (ISO 22716) • Where justified by the nature or the effect of the cosmetic product, a proof of the effect claimed for the cosmetic product • Any data on animal testing • Product labelling The most important part of the PIF is the CPSR, which consists of two parts, Part A and Part B. Part A includes all the information on the safety of cosmetic products, while Part B is a cosmetic product safety assessment.
Product composition
Before the product is put on the market, it is also important to check the formulation in order to see if it is in line with the Annexes provided by the EU Cosmetics Regulation. The Annexes are the following: • Annex II: List of substances prohibited in cosmetic products • Annex III: List of substances restricted in cosmetic products • Annex IV: List of colorants allowed in cosmetic products • Annex V: List of preservatives allowed in cosmetic products • Annex VI: List of UV filters allowed in cosmetic products
Labelling and claims
One of the important aspects of the cosmetic product is also the labelling. It has to be compliant with the labelling requirements laid down in the Regulation 1223/2009. According to the regulation, the container and the outer packaging of cosmetic products have to bear the following information in indelible, easily legible and visible lettering: • The name and address of the RP • The country of origin (for products imported from countries outside of the EU) • Nominal content of the product at the time of packaging, given by weight or volume • Date of minimum durability or
Period After Opening (PAO) • Precautions for use (may appear on the outer label only but in this case, an open book symbol has to be placed on the container label, which indicates that the information may be found elsewhere) • Batch number of manufacture or the reference for identifying the cosmetic product • The function of the cosmetic product, unless it is clear from its presentation • List of ingredients (which may be indicated on the outer packaging alone). The ingredient list shall be preceded by the term
‘ingredients’. Ingredients have to be listed by their INCI names and in descending order of weight at the time when they are added to the cosmetic product (by concentration). Ingredients in the concentration of less than 1% may be listed in any order after those in concentrations of more than 1%. Colorants other than colorants intended to colour the hair may be listed in any order after the other cosmetic ingredients and shall be listed by their colour index CI. Perfume and aromatic compositions shall be referred to by the terms ‘parfum’ or ‘aroma’. It is important to note that the EU consists of many countries, each with its own official language. The regulation requires that certain parts of the labelling have to be translated into the official language of the Member State in which the product will be sold.
Furthermore, claims are also an important factor of cosmetic labelling and sometimes define how the product is classified. Claims have to be properly substantiated and in line with the six common criteria for cosmetics: • Legal compliance • Truthfulness • Evidential support • Honesty • Fairness • Informed decision-making Unlike in many other countries, the EU prohibits the use of many ‘free from’ claims as well as all ‘animal testing’ related claims. It is important to note that these rules apply to all claims, whether they appear on the packaging, online, on social media posts, on advertorials etc., and whether they are text, images, symbols etc.
Product notification
The last step of the compliance process in the EU is product notification. Every product sold in the EU has to be notified through the Cosmetic Product Notification Portal (CPNP) before being placed on the EU market. The notification is done by the RP, and one notification is valid in all the EU Member States. PB
Tjaša Grum has a Bachelor’s degree in Cosmetic Science and a Master’s degree in Biochemistry from the University of Ljubljana, Slovenia. She is a Regulatory Consultant at CE.way Regulatory Consultants Ltd, which offers regulatory and testing services for cosmetic products.
