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Toy and cosmetics regulations both target product safety

Both the EU-cosmetics regulation1 and the EU directive for toy safety2 aim to ensure that consumer products are safe. However, it may be confusing which of the two is applicable for borderline products, those may where the definition between toys and cosmetics may not be clear. Choosing to apply the wrong regulation or not applying both where necessary, may lead to non-compliance of the product with severe consequences.

Toy cosmetic versus kid’s cosmetic: is the product applied to a toy or to a child?

According to the EU borderline manual, the assessment of whether a product falls within the scope of the cosmetics regulation needs be performed on a case-by-case basis. Firstly, it is of great importance to ensure the consumer is clearly informed about the intended use of the product. In general, the age of the consumer on which a substance or mixture is applied does not change its function as a cosmetic product3. Therefore, as soon as a make-up product for children fulfils the definition of a cosmetic product, it must fully comply with regulation (EC) 1223/2009 for cosmetic products, including the requirement for a cosmetic product safety report (CPSR), microbiological challenge test and notification in the cosmetic product notification portal (CPNP).

Toy make-up heads and dolls are sold with toy cosmetics that are intended solely for use on dolls. These mixtures do not fulfill the definition of a cosmetic product and first need to comply with directive 2009/48/EC on toy safety including a mandatory safety assessment. However, according to annex II (10) of the same directive, toy cosmetics for dolls shall also comply with the labelling 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 it is likely that children will apply the toy cosmetics on themselves as well. Compositional compliance includes all requirements regarding compounds that must not be present in cosmetic products, or are otherwise restricted in the annexes of the cosmetic regulation, while there is no mandatory requirement to perform a cosmetic product safety report (CPSR). However, an additional CPSR may be of added value 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.

Washable, temporary tattoos for kids: is the product an article or a mixture?

According to the EU borderline manual, the moistened picture may be considered a preparation that is intended to be placed in contact with the skin in order to change its appearance. Therefore, such products fulfil the definition of a cosmetic product and need to meet its requirements. The fact that this product may also fall within the scope of the application of the toy directive, does not deprive it from its qualification as cosmetic product3.

However, if the “sticker” is not a “washable preparation” but a “plastic article” that is placed onto the skin or nail by glue, it does not fall under the cosmetics regulation because it refers to substances and preparations, but not articles. However, it is still recommended that the glue should fulfil the requirements of the cosmetics regulation.

Examples for differing limits: heavy metals and polycyclic aromatic hydrocarbons (PAH).

Confusing the applicable legal requirements may have serious consequences for the compliance of products. As limits for heavy metals for toys mostly look at bio-availability after acid digestion according to EN 71-3, heavy metals listed in annex II of the cosmetic regulation must not be present in cosmetic products.

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, touching an article for a certain period of time and maybe dissolving traces of harmful substances through contact with skin, sweat or saliva presents a different risk potential than putting a liquid preparation such as a lipstick or mascara into contact with the skin with the intention to leave 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).

References

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)

4
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (REACH regulation)

5
AfPS GS 2014:01 PAK (Prüfung und Bewertung von Polyzyklischen Aromatischen Kohlenwasserstoffen (PAK) bei der Zuerkennung des GS-Zeichens)

For more information contact your local SGS representative, and visit Cosmetic and Personal Care page.

Dr. Katja Tischler
Project Leader Personal & Homecare
SGS INSTITUT FRESENIUS Austria GmbH
t: +43 5332 77203 19