Borderline Cosmetics – Toys Products: How to Comply?

In the case of borderline cosmetics-toys products, both the Cosmetics Regulation and the Toys Directive aim to ensure that the products are safe for the consumer – but how should they be applied when it comes to assuring the compliance of your products?Classification of Cosmetics & Toys

In order to ensure that a product is indeed a cosmetic product, the product formulation, characteristics, as well as the sites of application and intended functions need to match the definition of cosmetic products as defined in the Scope of the Cosmetic Regulation EC 1223/2009:

“Cosmetic product means any substance or mixture intended to be placed in contact with 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 odors.” (Art. 2, p.1a)

Cosmetic products shall be safe for human health, when “under normal or reasonably foreseeable conditions of use” (Preamble, p.9).

 In order to ensure that a product is a toy product, the product’s claims, characteristics as well as its function need to match the definition of a toy product as defined in the Scope of the TSD 2009/48/EC:

 “This Directive shall apply to products designed or intended, whether or not exclusively, for use in play by children under 14 years of age (hereinafter referred to as toys).” (Article2(1)).

Borderline products

In case of borderline products it can prove to be more difficult to discern what provisions apply and which compliance procedure needs to be followed. Since the scope of borderline products is wide, the European Commission has published Guidelines helping to define the category of the product.

Compliance of a cosmetic-toy borderline product

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. The Guideline , however, provides a couple of examples that can be used when trying to discern under which legislation products fall, such as:

  1. Products which, according to their presentation, are destined to be used as make-up on children fall under the scope of the Cosmetic Regulation, regardless of the consumer’s age. The fact that this product may fall also within the scope of application of Toy Directive does not exclude it from its qualification as a cosmetic product.
  1. Bath Products for Children with a Play Value fall under :
  • the scope of the Cosmetic Regulation if the intended purpose is to be placed in contact with external parts of the human body or with a function of cleaning, perfuming, changing the appearance, protecting, correcting odors;
  • the scope of the Toy Directive if the intended purpose of the product is the entertainment of children (i.e. making a noise and colouring the water);
  • the scope of both the Toy Directive and the Cosmetic Regulation applies if the intended purpose is to be placed in contact with external parts of the human body (i.e. in cases where the skin is perfumed) and it also has the “play/entertainment value., Thus, it  has to fully comply with the Cosmetics Regulation as well. (i.e. requirements concerning ingredients, labelling, notification, etc.).

Decisions on the qualification of the products has to be made by the national Competent Authorities on a case-by-case basis by taking all the relevant elements into account, such as the presentation of the products, the ingredients, the mode of action and the claims.

If you wish to know more about classification of toys and cosmetic products, please do not hesitate to contact us. Obelis Expert Consultants, having nearly 30 years of experience with EU Regulations, will answer any question you may have and will gladly assist you in safeguarding your products’ compliance. 

Suzana Horia

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