Survey of Chemical Substances in Consumer Products, No. 88 2007 – A survey and health assessment of cosmetic products for children

A survey and health assessment of cosmetic products for children

3 Legislation

3.1 the Cosmetics Statutory Order
3.2 Toys
- 3.2.1 Safety requirements to toys
- 3.2.2 Ban on phthalates in toys for children

In the following there is a short description of the legislation which is relevant for cosmetic products for children. It is the Cosmetics Statutory Order (Danish: Kosmetikbekendtgørelsen) which is relevant for all cosmetic products for children and the Toys Statutory Order (Danish: Legetøjsbekendtgørelsen) which is only relevant for the cosmetic products for children being assessed as toys on basis of the indicative statement of the Danish Safety Technology Authority.

3.1 The Cosmetics Statutory Order

Cosmetic products for children are like other cosmetic products regulated in “Cosmetics Statutory Order” – Statutory Order no. 422 dated 4 May 2006 (Stat. Ord. 422, 2006). The statutory order implements the European provisions in the cosmetics area and includes a number of provisions about apply of chemical substances in cosmetics as well as about labelling of the products.

According to § 10 of the Cosmetics Statutory Order cosmetic products that are marketed in the EU must not be harmful to human health when they are used under normal conditions or under conditions which reasonably can be foreseen. The Cosmetics Statutory Order states among other things a number of restrictions of application of chemical substances that form a part of cosmetic products.

The one who markets the cosmetics product has the responsibility that the regulations are kept according to the statutory order.

3.1.1 Labelling of cosmetic products for children

Cosmetic products (among these also products for children) have to be labelled with the following information on the actual product (Stat. Ord. 422, 2006):

Company name and address of the manufacturer who within the EU is responsible for the marketing (§ 19).
Content in weight or volume (if more than 5 g or more than 5 ml (§ 20)).
Durability date (if the shelf life is below 30 months (§ 21)).

When specifying the durability a symbol with an open cream box is used stating the durability in months and years.

Safety regulations for application (§ 22).
The number of the production batch or the reference specification so that date and place of production can be identified (§ 23).
The function of the agent (unless it appears from its presentation (§ 24).
Declaration of contents, i.e. a list of the constituents of the product arranged in order after descending weight at that time the constituents are added to the cosmetic agent (§ 25).

3.1.2 Declaration of contents

The following special circumstances have their effects on the declaration of contents of cosmetic products (Stat. Ord. 422 § 25, 2006):

Impurities are not considered to be constituents.
Scented or aromatic compounds shall only be stated by the term “perfume” or “aroma” respectively. According to appendix 3 of the statutory order 26 fragrances which the EU regards as allergenic have to be stated in the declaration of contents irrespective of their function in the products when the concentration is higher than 0.001% in products which are not to be cleansed and 0.01% in products which are to be cleansed. This regulation with special statement of the 26 fragrances mandatory to declare became effective in 2005 and applies for all cosmetics being produced after 10 March 2005.
Constituents in a concentration less than 1% can be mentioned in any order after the constituents with a concentration higher than 1%.
Hair dyes can be mentioned with a colour index number (or indication from appendix 4 on colouring agents) in any order after the other constituents.
The constituents are stated by their usual name according to the common nomenclature (INCI name) for cosmetics ingredients.
Regarding small cosmetic products or packaging of such a form that in practice it is impossible to state the declaration of content clearly enough the ingredients must be stated on an enclosed notice, label, strip or card which is fastened to the cosmetics product. If it is impossible to fasten a message or similar to products (because for instance they are too small) the declaration of content must be stated in a notice close to the products.

INCI is an abbreviation of ”International Nomenclature Cosmetic Ingredients” and is a common nomenclature for apply in declarations of contents for cosmetic products in the EU. An INCI name can cover several different chemical units. The INCI list is indicative, this means it is not a list of approved constituents in cosmetics but a list indicating the constituents that are used (Pharmacos, 2001). If an INCI name for a constituent is not available the chemical name of the substance is to be used and an application for an INCI name for the substance shall be sent (Stat. Ord. 422, 2006).

3.1.3 Restrictions in apply of chemical substances in cosmetic products

The Cosmetics Statutory Order (Stat. Ord. 422, 2006) sets a number of restrictions in apply of cosmetic products. Among others, which substances that are not allowed to be used in cosmetic products, which substances that only are allowed to be used under special conditions (for instance, at a maximum concentration) as well as which substances that only are allowed to be used (positive lists) within a special group (f. ex. hair dyes, preservatives).

Substances which are not allowed in cosmetic products

According to §12 of the Cosmetics Statutory Order “substances which are entered in the appendix 2 (of the statutory order) are not allowed as constituents in cosmetic products”.

Allowed substances with limitations in cosmetic products

According to §13 of the Cosmetics Statutory Order substances listed in appendix 3 may be used in cosmetic products under the limitations and the conditions stated in the appendix.

Allowed hair dyes in cosmetic products

According to §14 of the Cosmetics Statutory Order ”cosmetic products (except the hair dyes exclusively intended to hair dyeing) are only allowed to contain the hair dyes as well as lacquers, salts and pigments from the lists which are entered in the appendix 3 and 4 (of the statutory order) and with those restrictions and conditions stated in these”.

Allowed preservatives in cosmetic products

According to § 15 of the Cosmetics Statutory Order ”cosmetic products are not allowed to contain other preservatives than those entered in the appendix 5 (of the statutory order)”.

Allowed U.V. absorbers in cosmetic products

According to § 16 of the Cosmetics Statutory Order ”cosmetic products are not allowed to contain other U.V. absorbers than those entered in the appendix 6 (of the statutory order)”. However, other U.V. absorbers exclusively used in cosmetic products to protect the products themselves against decomposition of U.V. radiation are not included in the appendix 6 (of the statutory order).

3.2 Toys

3.2.1 Safety requirements to toys

For toys the ”Statutory order on safety requirements to toys and products which due to their appearance can be confused with food” applies (Stat. Ord. 1116 dated 12 December 2003). Toys are defined as products ”which clearly are designed or determined for play purposes for children below 14 years”. This means when the cosmetic products for children are designed as a figure (a dragoon, Barbie, Mickey Moapply, a mobile phone or similar) then the statutory order on safety requirements to toys must also be met.

According to the Toys Statutory Order (Stat. Ord. 1116, 2003), a toy is only allowed to be sold if it meets the EU legislation on safety requirements to toys or if it is manufactured in accordance with a customs-approved prototype (and approved by a regulatory body in an EU country). Toys meeting these safety requirements must be assigned with a CE label before it is sold on the market.

The EU legislation on safety requirements includes the standards stated in the appendix 3 of the Toys Statutory Order (Stat. Ord. 1116, 2003). These are the EN71 series on safety requirements to toys as well as the Statutory Order regarding high voltage current for electrical toys. Furthermore, toys are not allowed to contain hazardous substances or compounds as defined in directive 67/548/EØF and 88/379/EØF in quantities which can be harmful to health for the children using it.

3.2.2 Ban on phthalates in toys for children

According to statutory order no. 151 dated 15 March 1999 “Statutory order on ban on phthalates in toys for children in the age 0-3 years as well as certain child care articles” it is prohibited to produce, sell or import products containing more than 0.05% (w/w) phthalates for the following types of products:

Toys that is clearly designed or intended for play purposes for children in the age 0-3 years.
Child care articles for children in the age 0-3 years, i.e. products that are intended to or must be expected to be put into the mouth (dummies, bibs, jewelries as well as bathing equipment etc.).
Products that must be expected to be used as toys by children in the age 0-3 years as a consequence of the product construction and design including choice of subject.

However, this statutory order is replaced by a new ”Statutory order on ban on phthalates in toys and child care articles” which became effective as per April 2007 (Stat. Ord. 786, 2006; Stat. Ord. 1074, 2006). The new regulations include ban on six phthalates in child care articles and in toys for children up to 14 years.

According to the new statutory order it is prohibited to apply, import and sell products containing the phthalates DEHP, DBP and BBP in concentrations above 0.1%. Furthermore, it is prohibited to apply, import and sell the phthalates DINP, DIDP and DNOP in concentrations above 0.1% in products which children might put into the mouth.

Finally, it is prohibited to apply all other kind of phthalates in concentrations above 0.05% in toys for children from 0-3 years as well as in child care articles for children in the age of 0-3 years which is intended or may normally be expected to be put into the mouth by the children.