Protect Children from Chemical Hazards in Toys - Overview of New EU
In 2009, the European Union (EU) adopted the new Toy Safety Directive 2009/48/EC (TSD). The implementation of the TSD is essentially in 2 phases. The safety assessments, including the Chemical Safety Assessment (CSA) and non-chemical requirements were enforced in July 2011. The chemical requirements will be enforced on 20 July 2013.
Toys must be designed and manufactured in such a way to prevent exposure to harmful chemical elements that can have adverse effects upon human health. The EU TSD has strengthened the chemical requirements to protect children.
OVERVIEW ON CHEMICAL REQUIREMENTS
1. Chemical Safety Assessment (CSA) - in force since 2011:
- Toy to be assessed by the manufacturer before it is placed on the market.
- Must be included in the Technical Documentation.
For more information, click here.
2. Soluble elements:
- Three distinct toy material categories: 1 - dry, brittle, powderlike or pliable; 2 - liquid or sticky; 3 - scraped-off.
- Migration limits for 19 substances including: 2 species of chromium (chromium (III) and chromium (VI)) and 2 species of tin (tin and organic tin).
Depending on the toy material category, different limits are applied. Click here to download the detailed list of toxic elements.
3. Allergenic fragrances:
55 allergenic fragrances are restricted.
- Additional 11 fragrance substances shall be listed on the toy, on an affixed label, on the packaging or in an accompanying leaflet, if concentration exceeds 100 mg/kg.
Click here to download the detailed list of allergenic fragrances with CAS numbers.
4. Substances classified as carcinogenic, mutagenic or reprotoxic (CMRs):
- Chemicals classified as CMRs in the categories 1A, 1B and 2, unless under exemption, are prohibited.
5. n-Nitrosamines and n-nitrosatable substances:
- Restricted in toys for children under 36 months, or in other toys intended to be placed in the mouth, unless the migration levels are below 0.05 mg/kg for nitrosamines and below 1 mg/kg for nitrosatable substances.
6. Packaging for fragrances in olfactory board games, cosmetic kits and gustative games:
- Packaging containing 26 of the 66 allergenic fragrances indicated in point 3 above requires warning statement: ‘Warning. Contains fragrances that may cause allergies’.
7. Classification of substances and mixtures:
- Conform to the Classification, Labelling and Packaging (CLP) Regulation (EC) 1272/2008.
UPDATES ON ASSOCIATED TOY SAFETY STANDARDS
To accommodate the chemical requirements under the TSD previous versions of EN 71-3, EN 71-4 and EN 71-5 have been revised and completely new standards (EN 71-12:2013 and EN 71-13:2013) are published in 2013. EN 71-4:2013 was published and harmonised under the TSD in May 2013. The new versions of EN 71-3 and EN 71-5 and the completely new EN 71-12:2013 were published and harmonized under the TSD in June 2013.
APPLICABLE EU LEGISLATION OTHER THAN TOY SAFETY DIRECTIVE
A toy entering the EU market is obliged to comply with not just the TSD but all applicable rules, standards and regulations, including member state requirements. These include:
For all toys:
REACH (EC) 1907/2006 such as Annex XVII of REACH – phthalates, cadmium, azo dyes (primary aromatic amines), benzene and nickel.
Packaging Directive 94/62/EC (toy packaging not an integral part of toy or has no play value).
For electrical & electronic toys:
RoHS Recast (Directive 2011/65/EC).
WEE and WEEE Recast (Directives 2002/92/EC and 2012/19/EU).
Electromagnetic Compatibility (EMC, Directive 2004/108/EC).
Radio-controlled toys (R&TTE, Directive 1999/5/EC).
Batteries (Directive 2006/66/EC).
Low Voltage (Directive 2006/95/EC).
For toys in contact with food materials:
Food Contact Regulation (EC) 1935/2004 (overall framework) and Regulation (EU) 10/2011 (plastics).
For cosmetic toys:
Cosmetics Regulation (EC) 1223/2009.
Member state legislation is also to be considered, such as Formamide content in puzzle mats (France), Bisphenol A (BPA) content in soothers and teethers (Austria) and applicability of old 88/378/EEC heavy metal limits for toys (Germany).
HOW SGS CAN HELP
Throughout our global network of laboratories, we have an international team of professional experts equipped with a comprehensive knowledge on chemicals and restricted substances in toy safety for compliance with the chemical provisions under the Toy Safety Directive.
Table 1. Status of toy safety standards (15 July 2013)
Note: To show compliance with the New Toy Directive the harmonised standards can be used. If a standard is harmonised, that means that it has been accepted by the EU commission and published in the Official Journal of the European Union (OJEU).
EN 71-3, EN 71-5 and EN 71-12 harmonisation (SafeGuards No.123/13)
EN 71-12:2013 (SafeGuards No. 117/13)
EN 71-5:2013 (SafeGuards No.116/13)
EN 71-3:2013 (SafeGuards No.111/13)
EN 71-4:2013 (SafeGuards No.091/13)
For further details, please contact your local sales representative or the global team:
Hing Wo Tsang
Senior Technical Services Manager
SGS Hong Kong Ltd.
t: +852 2774 7420