4 Legislation

Survey and Health Assement of the exposue of 2-year-olds to chemical substances in Consumer Product

The following describes the relevant legislation for the product groups tested in the survey in this project:

The statutory order on toys – relevant for toys (soft toys) and for bath soap packaging (cosmetic products for children), which the Danish Safety Technology Agency categorises as toys.
The statutory order on the use of phthalates in toys – relevant for toys (soft toys) and for bath soap packaging (cosmetic products for children), which the Danish Safety Technology Agency categorises as toys.
REACH regulation, Annex XVII, entry 43 on azo colouring agents in textiles – relevant for outdoor clothes, mittens, soft toys and bed linen.
The statutory order on cosmetics – relevant for suntan lotion and oil-based cream.
Regulation of other substances such as nickel, brominated flame retardants, TRIS, TEPA, PBB, PFOS, arsenic and mercury – relevant for products with textiles (mainly in REACH).
Regulation of nitrosamines – relevant for pacifiers
General regulations for limitation of use of various substances (transferred to REACH regulation as of 1 June 2009

4.1 Toys

4.1.1 Safety requirements for toys

The statutory order on safety regulations for toys and products which, due to their appearance, can be mistaken for foodstuffs (BEK no. 1116, 2003) applies to toys. Toys are defined as “any product or material designed, or clearly intended for use in play by children younger than 14 years of age”. Thus, the statutory order on safety regulations for toys also applies to cosmetic products designed for children, that resemble a popular article or figure, such as a dragon, Barbie, Mickey Mouse, mobile telephone etc.

According to the statutory order on Toys (BEK 1116, 2003), toys can only be placed on the market if they satisfy EU legislation on safety requirements for toys, or if they are produced in compliance with a prototype that has been approved by a competent body in an EU country. Toys that meet these safety conditions must be marked with a CE mark before they can be placed on the market.

The EU legislation on safety requirements for toys also includes the standards covered in the statutory order on Toys annex 3 (BEK 1116, 2003). These are the EN71 series on safety requirements for toys and the High Voltage Declaration for electrical toys. One of the points covered by EN71-3 (Section 3: Migration of specific substances) concerns threshold limits for the migration of metals when children put toys into their mouths.

In addition, toys must not contain dangerous substances or preparations, as defined in directive 67/548/EEC and 88/379/EEC in amounts that can harm the health of children.

A revised toy directive has recently been passed by the EU.

4.1.2 Ban on phthalates in toys

The statutory order on the ban on phthalates in toys and childcare products that came into force in September 2009 (BEK 855, 2009) includes a ban on phthalates in childcare products and toys for children up to 3 years of age.

According to REACH, Annex XVII, entries 51 and 52, it is forbidden to use, import or sell toys and childcare products for children less than 14 years of age containing the phthalates DEHP, DBP and BBP in concentrations above 0.1%. DINP, DIDP and DNOP are forbidden to use, import or sell in concentrations above 0.1% in toys and childcare products that children are able to put in their mouths.

According to the statutory order it is forbidden to use all other phthalates in concentrations above 0.05% in all toys and childcare products for children from 0-3 years of age.

4.1.3 REACH

The REACH regulation 1907/2006 also covers aromatic toys (products which intentionally have a smell). In these cases, the aroma produced by the toy must be registered with the Chemicals Agency if the amount equals or exceeds 1 ton per year (EU regulation no. 1907/2006)

4.2 Textiles

Textiles must not contain a number of chemical substances. The regulations also include textiles used in toys:

Brominated flame retardants, penta -and octabromodiphenylethers (penta and octa-BDE) are banned for any usage, including textiles. (REACH, Annex XVII, entries 44 and 45) Threshold limit is 0.1% (w/w).
Impregnants tris (2, 3-dibrompropyl) phosphate (TRIS), tris (1-aziridinyl) phosphineoxide (TEPA), (CAS no. 5455-55-1) and polybrominated biphenyls (PBB) (CAS no. 59536-65-1) must not be used in textiles which are intended to come into contact with the skin, e.g. articles of clothing or linen. The ban covers both import and sale (REACH, Annex XVII, entries 4, 7 and 8).
Import, sale and export of mercury or products containing mercury are prohibited (BEK 627, 2003). This ban also includes textiles.
The sale, import or production of products containing cadmium is banned (BEK 858, 2009) if the cadmium is used as a stabiliser in plastic, cadmium coatings or pigmentation. Cadmium is also regulated in REACH, Annex XVII, entry 23.
The import or sale of products containing lead is prohibited (BEK 856, 2009). The ban also includes textiles.
Textiles must not contain pentachlorophenol (PCP). The import, export, sale or use of products containing 5ppm or above of pentachlorophenol, or of its salts or esters is prohibited (BEK 854, 2009)
Textiles must not contain certain azo colouring agents. The regulations also apply for textiles used in toys. It is prohibited to import, sell or use a specific blue azo colouring agent and azo colouring agents, which can release carcinogenic substances, as well as certain other products, which contain azo colouring agents (REACH, Annex XVII, enry 43).
Products which are designed for direct or long-term contact with the skin must not contain nickel if the nickel emission exceeds 0.5 mg/cm2/week (REACH, Annex XVII, entry 27).
In accordance with REACH, Annex XVII, entry 53 PFOS (perfluorooctane sulfonate and its derivatives) are prohibited in products, including textiles, from 27 June 2008. Special notice should be taken of the ban on textiles or other materials with a coating, if the amount of PFOS comprises 1 µg/m2 or more of the coated material.

4.3 Statutory order on cosmetics

Cosmetic products for children are, like other cosmetic products, regulated by the statutory order on Cosmetic Products (BEK 422, 2006) and its amendments. The statutory order implements European resolutions on cosmetics and contains a number of decisions relating to the use of chemical substances in cosmetics and their marking. The cosmetic directive has recently been revised and will become applicable throughout the EU.

In accordance with the statutory order on Cosmetics, section10, products marketed in the EU must not be harmful to health when they are used under “normal conditions, or under conditions that can be reasonably predicted”. An evaluation must be conducted prior to marketing on the safety with regards to human health at use of the finished cosmetic product. This must include specific evaluation of the cosmetic products intended for children younger than three years old.The statutory order on Cosmetics also imposes a number of limitations on use of chemical substances in cosmetic products. Companies or organisations marketing cosmetics are responsible for making sure that the rules are adhered to in accordance with the statutory order.

4.3.1 List of ingredients

The following special conditions are applicable for the list of ingredients for cosmetic products (BEK 422 section 25, 2006:

Impurities present in raw materials are not considered ingredients.
Perfume and aromatic compounds and raw materials for these will be declared as either “perfume”, or “aroma”. In accordance with Annex 3 of the statutory order, 26 allergens in perfumes and aromas substances must be indicated in the list of ingredients if their concentration exceeds 0.001% in leave-on products, and 0.01% in rinse-off products. This rule on the 26 allergens in perfumes and aromas came into force in 2005 and applies to all cosmetics produced after 10 March 2005.
Ingredients with a concentration of less than 1% can be declared in any order following those with a concentration higher than 1%.
Colouring agents can be declared in any order after those with a colour index number (or name from Annex 4 on colouring agents).
Ingredients can be declared by their common name, in accordance with common nomenclature (INCI name) for cosmetic ingredients.
With small cosmetic products, or packaging that is so small that it is impossible to print a list of ingredients of contents, the ingredients must be printed on an accompanying label, tape, or card that can be attached to the product. If it is not possible to fasten information of this type onto the product, the list of ingredients must be clearly displayed close by.

INCI is an abbreviation for “International Nomenclature Cosmetic Ingredients” and is a common nomenclature for use on lists of ingredients of content for cosmetic products in the EU. An INCI name can cover many different chemical substances. The INCI list is indicative, which means that it is not a list of permitted ingredients in cosmetics, but indicates which ingredients have been used. If there is no INCI name for a substance, its chemical name must be used and an INCI name must be applied for (BEK 422, 2006)

4.3.2 Substances with restrictions on use in cosmetic products

The statutory order on Cosmetics (BEK 422, 2006) places a number of restrictions on use of substances in cosmetic products, e.g. which substances may not be used in cosmetic products, which substances may only be used under certain conditions (e.g. maximum concentration), and which substances may only be used (positive lists) within a specific group (e.g. colouring agents, preservatives).

Substances which are not permitted in cosmetic products

In accordance with the statutory order on Cosmetics section 12, substances which are included in Annex 2 of the statutory order must not be used as ingredients in cosmetic products.

Substances which are permitted in cosmetic products with certain restrictions

In accordance with the statutory order on Cosmetics section 13, substances which are included in Annexes 3-6 can only be allowed in cosmetic products in accordance with the stipulated restrictions and conditions of the annexes.

Colouring agents permitted in cosmetic products

The statutory order on Cosmetics section 14, states that cosmetic products (with the exception of the colouring agents used exclusively in hair colours) may only contain the colouring agents and sprays, salts and pigments, which are named in Annexes 3 and 4, including their stipulated limitations and conditions.

Preservatives permitted in cosmetic products

In accordance with the statutory order on Cosmetics section 15, cosmetic products must not contain preservatives other than those named in Annex 5. There are exceptions, which can be seen in section 15 of the statutory order.

UV filters permitted in cosmetic products

In accordance with the statutory order on Cosmetics section16, cosmetic products must not contain UV filters other than those named in Annex 6 (of the statutory order). There are, however, other UV filters, which are only used in cosmetic products to protect the products themselves from being broken down by UV radiation, which are not included in Annex 6.

4.4 Pacifiers

For pacifiers, see Directive 93/11/EEC from 15 March 1993 on the emission of N-nitrosamines and N-nitrosatable substances from baby’s bottle teats and pacifiers made with elastomers and rubber (Directive 93/11, 1993).

This states that pacifiers and bottle teats must not release N-nitrosamines and N-nitrosatable substances, which are dissolvable in saliva in amounts that exceed the following:

0.01 mg total amount released N-nitrosamines/kg (from those parts of the pacifier or bottle teat made with elastomers or rubber).
0.1 mg total amount emitted N-nitrosatable substances/kg (from those parts of the pacifier or bottle teat made with elastomers or rubber).

4.5 General regulations for limitations on use of certain substances

There is a comprehensive list of regulations on the limited usage of certain substances, which in many cases apply generally.

These general limitations on use are:

(EU/DK) REACH, Annex XVII, entry 23 and Statutory order No. 858 of 5 September 2009 on the ban on sale, import and production of goods containing cadmium.
(DK) Statutory order No. 854 of 5 September 2009 on the ban on import, sale, use and export of goods containing pentachlorophenol (PCP)
(EU) REACH, Annex XVII, entry 27 on ban on the import and sale of certain products containing nickel (metal parts and parts with long-term contact with the skin).
(EU) REACH, Annex XVII, entry 43 on the ban on import, sale and use of certain azo colouring agents.
(EU) REACH, Annex XVII, entry 53 on the limitation of import, sale and use of perfluorooctane sulphonates (PFOS).
(EU/DK) REACH, Annex XVII, entries 51 and 52 and Statutory order No. 855 of 5 September 2009 on the ban on phthalates in toys and childcare articles.

4.6 Foodstuffs, assessment of pollution from EFSA (European Food Safety Authority)

Substances such as pesticides, phthalates and bisphenol A, mentioned in this report, are assessed by the EFSA based on studies on possible health risks. Pesticides require 2^nd generation studies, which include studies on potential endocrine disrupting effects.

The analysis typically concludes with a figure for tolerable daily intake (TDI), which is given as mg/kg body mass/day, or acceptable daily intake (ADI). Legislated threshhold limits are set using this evaluation, and are intended to ensure that there are no health risks associated with intake of these substances during a lifetime.

The the threshold limits for phthalates in food contact materials and articles, have been set taking into account substances originating in other sources.