Cosmetics, safety and vulnerable population groups

All products (natural, organic, conventional) placed on the EU market must first comply with the EU Cosmetics Regulation (EC) No. 1223/2009. The Articles of this legislation provide not only a definition for a cosmetic product, but also set requirements for product manufacture according to Good Manufacturing Practice (GMP), mandate each product is evaluated for its safety by a qualified safety assessor, and designate that a responsible person must evaluate the overall compliance of the product, including its safety, its claims and labelling, and its notification to the authorities in order to be placed on the market.

Safety Baseline

Consequently, for a cosmetic product placed on the market it must be assessed as safe by law, and be in a position to demonstrate this if/when asked by an authority within EU Member States. Safety is the utmost principle of the law, and so where there are any concerns over the safety of an ingredient these are brought to the attention of the EU Commission by the EU Member State authorities who subsequently can ask its independent risk assessment body, the Scientific Committee on Consumer Safety (SCCS), for a review and its official Opinion to assist the development of new legislation of that substance.

For the safety of all consumers, assessments take account of targeted consumer groups (e.g., people with sensitive, damaged or compromised skin), as well as the exposure to substances by vulnerable members of the population, such as children under three years of age, elderly people, pregnant and breast-feeding women and persons with compromised immune responses, which can be assessed separately.

Cosmetic product packaging is, understandably, the first point of contact for a consumer before trying it

Vulnerable Population Groups – Tools for Guidance

The SCCS “Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation”, now on its 11th revision, is a transparent and freely available document, which contains the relevant information on the different aspects of testing and safety evaluation of cosmetic substances in Europe. The SCCS notes of guidance focuses on cosmetic ingredients but indirect guidance is given for the safety assessment of finished products.

The guidance includes references for detailed exposure data for cosmetic products, including information related to children and babies for specific product categories such as toothpastes, sunscreens, and baby care products. In addition, guidance is provided for specific areas of use on a child’s body such as around the eyes for children under three years old (e.g., the microbiological quality of the finished cosmetic), and reference to the use of aerosol products and routes for nasal and oral exposure. Moreover, a special safety assessment needs to be issued in case the products are intended for use on children under 3 years old.

When considering a specific subpopulation such as babies and children, the safety assessment takes into account aspects such as the physio-chemical properties of the ingredients, the exposure, and the site of application. For example, for a leave-on cosmetic like nappy creams, the potential impact of irritation on dermal absorption of the ingredients needs to be considered by the safety assessor, or for other baby care products like wet wipes, there is the need to take into account pH differences and skin compatibility.

Labelling

Outside the immediate topic of safety assessment, cosmetic product packaging is, understandably, the first point of contact for a consumer before trying it. Therefore, it is the place where consumers want, and should, acquire useful information about the product and how to use it.

Labelling requirements for cosmetic products are set by law under the EU Cosmetics Regulation. To this end, all cosmetic products must provide defined information on-pack such as an ingredients list, and particularly relevant to those with children, any wording of conditions of use and warnings that might be necessary (e.g., “keep out of reach of children” or “not to be used for children under 3 years of age”).

For the safety of all consumers, assessments take account of targeted consumer groups

As an example of a legal labelling requirement to protect vulnerable population groups, like children, is sodium fluoride, which is a permitted substance with restricted limits for safe use (i.e., Annex III of the EU Cosmetics Regulation) that helps to fight cavities while strengthening enamel. EU law states that for any toothpaste containing 0.1 to 0.15 % fluoride that is not already labelled as not for children (e.g., ‘for adult use only’) that the manufacturer must inform the consumer with a defined on-pack communication; namely: ‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’. To this end, toothpastes formulated for children may also include the age the product is designed for or for children under six toothpastes may exclude sodium fluoride altogether.

Protection against Misrepresentation

A final aspect associated with safety is to ensure a product should not endanger health and safety is its presentation; for example, consumers should not confusion a cosmetic with foodstuffs as per Directive 87/357/EEC. The EU Cosmetics Regulation specifically mentions this point in recital (10), and in 2022 a recent Judgment, C‑122/21, from the CJEU (Court of Justice of the European Union) ruled in favour of the Lithuanian national authorities, who had ordered the withdrawal from the market of bath bombs that looked like foodstuffs. The ruling emphasised that the national authorities must, when making that assessment, take into account the vulnerability of individuals and specific groups of consumers, including in particular children.

Author: Mark Smith, NATRUE Director

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