Children’s Make-Up Faces Up To RealityTo ensure that consumer products are safe, the EU issues various regulations and directives, and manufacturers must comply with those that are relevant. For example, the EU-cosmetics regulation1 and the EU directive for toy safety2 govern the activities of manufacturers in those industries. However, there may be confusion over which rules apply to so-called borderline products where the overlap between toys and cosmetics is less than clear. Applying the wrong regulation, or failing to apply both where necessary, may lead to a product’s non-compliance and even more severe consequences.
Defining the borders
According to the EU borderline manual, each product must be considered on its own merits to determine whether or not it falls within the scope of the cosmetics regulation.
As a first step, the intended use of the product must be made clear to the consumer, since the function of a cosmetic substance or mixture3 isn’t changed by the age of the user. Therefore, as soon as make-up for children (for example) fulfills the definition of a cosmetic product, it must fully comply with regulation (EC) 1223/2009 for cosmetic products. These rules include the requirement for a cosmetic product safety report (CPSR), a microbiological challenge test, and notification in the cosmetic product notification portal (CPNP).
Sometimes, toy cosmetics are intended solely for use on dolls, in which case they do not fulfill the definition of a cosmetic product. However, they do need to comply with directive 2009/48/EC on toy safety, which includes a mandatory safety assessment.
Even so, annex II (10) of the same directive states that toy cosmetics for dolls shall also comply with the labeling and compositional requirements laid down in cosmetics directive 76/768/EEC (now replaced by the cosmetics regulation (EC) No. 1223/2009)3. This is because of the likelihood of children applying the toy cosmetics on themselves, as well as on their dolls.
There are a number of requirements regarding the compounds that must not be present in cosmetic products, or which are otherwise restricted in the annexes of the cosmetic regulation. Although there is no mandatory requirement to perform a cosmetic product safety report (CPSR) e.g. for toy cosmetics for use on dolls, it may be useful to do one to ensure that the compositional requirements of the cosmetic regulation are actually fulfilled.
If a product falls within the scope of the cosmetics regulation, this does not necessarily exclude the application of the toy regulation and vice versa. In such cases, and on a case-by-case basis, further consultancy and testing should be conducted.
According to the EU borderline manual, the moistened picture of a washable, temporary tattoo may be considered a preparation that is intended to contact the skin and change its appearance. Therefore, such products fulfill the definition of a cosmetic product and must comply with the appropriate regulation. The fact that this product may also fall within the scope of the toy directive does not disqualify it as a cosmetic product3.
If the “sticker” is not a “washable preparation” but a “plastic article” that is glued onto the skin or nail, it does not fall under the cosmetics regulation. However, it is still recommended that the glue should fulfill the requirements of the cosmetics regulation.
According to EN 71-3, the limits on the levels of heavy metals in toys are concerned mostly with bio-availability after acid digestion. In contrast, the heavy metals listed in annex II of the cosmetic regulation must not be present in cosmetic products at all, unless its traces are safe and technically unavoidable (safety alone is not sufficient).
Another example for different limits is polycyclic aromatic hydrocarbons (PAH). Toys fall within the application of the REACH-regulation4 and AfPS for granting a safety seal5 that define residue levels of 0.2 mg/kg and above, dependent on the duration of the skin contact. However, the possibility of dissolving traces of harmful substances through such contact (or via sweat or saliva) presents a different risk potential compared to putting a liquid preparation such as a lipstick or mascara into contact with the skin, and with the intention of leaving it there for a full day. According to Regulation (EU) N°1223/2009, PAH listed in Annex II (e.g. Anthracene, Pyrene) must not be present in cosmetic products.
In any case, traces and residues of prohibited substances should always be covered as part of a cosmetic product safety assessment (CPSR).
For more information, contact your local SGS representative, visit our Cosmetic and Personal Care page, or contact:
Dr. Katja Tischler
Project Leader Personal & Homecare
SGS INSTITUT FRESENIUS Austria GmbH
t: +43 5332 77203 19
1 Regulation (EC) No. 1223/2009 of the European Parliament and the Council of 30 November 2009 on cosmetic products (cosmetics regulation)
2 Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (toy directive)
3 Manual on the Scope of the Application of the Cosmetics Regulation (EC) no 1223/2009 of November 2013 (borderline manual)
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 85,000 employees, SGS operates a network of over 1,800 offices and laboratories around the world.
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