New EU Chemical Requirements to Protect Children from Chemical Hazards in Toys

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 were 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.

Toy Safety Directive - New 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.

Read more about the EU Toy Directive (http://www.sgs.com/~/media/Global/Documents/Brochures/SGS%20EU%20TSD%20SGS%20services%20for%20Chem%20SA%20A4%20EN%2013%20V1.ashx).

2) Soluble elements:

- Three distinct toy material categories: 1 - dry, brittle, powder-like 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. Download the detailed list of toxic elements (http://www.sgs.com/~/media/Global/Documents/Technical%20Documents/Technical%20Bulletins/SGS%20EU%20Toy%20Directive%20Chemicals%20A4%20EN%2013%20V2.ashx).

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.

You can also download the detailed list of allergenic fragrances (http://www.sgs.com/~/media/Global/Documents/Technical%20Documents/Technical%20Bulletins/SGS%20EU%20Toy%20Directive%20Chemicals%20A4%20EN%2013%20V2.ashx) 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 require warning statement: ‘Warning. Contains fragrances that may cause allergies’.

7) Classification of substances and mixtures:

- Conform to the Classification, Labeling and Packaging (CLP) Regulation (EC) 1272/2008.

Revised 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 a completely new standard (EN 71-12:2013) was published in 2013. EN 71-4:2013 was published and harmonized 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.

Other Applicable EU Legislation on Toy Safety

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).

About SGS Toy Safety Services

Throughout a global network of laboratories, SGS has 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 EU Toy Safety Directive (http://www.sgs.com/en/Consumer-Goods-Retail/Toys-and-Juvenile-Products/Toys/EU-Toy-Directive.aspx).

Note: To show compliance with the New Toy Safety Directive the harmonized standards can be used. If a standard is harmonized, it means that it has been accepted by the EU commission and published in the Official Journal of the European Union (OJEU).

Recent Publications on Toy Safety

- EN 71-3, EN 71-5 and EN 71-12 harmonization (SafeGuards No.123/13 (http://newsletter.sgs.com/eNewsletterPro/uploadedimages/000006/sgs-safeguards-12313-eu-harmonises-toy-chemical-safety-standards-en-71-3-en-71-5-and-en-71-12-a4-en-13.pdf))
- EN 71-12:2013 (SafeGuards No. 117/13 (http://newsletter.sgs.com/eNewsletterPro/uploadedimages/000006/sgs-safeguards-11713-cen-publishes-new-toy-safety-standard-en-71-12%202013-a4-en-13.pdf))
- EN 71-5:2013 (SafeGuards No.116/13 (http://newsletter.sgs.com/eNewsletterPro/uploadedimages/000006/sgs-safeguards-11613-cen-publishes-revised-en-71-5-2013-for-chemical-toys-sets-other-than-experimental-sets-a4-en-13.pdf))
- EN 71-3:2013 (SafeGuards No.111/13 (http://newsletter.sgs.com/eNewsletterPro/uploadedimages/000006/sgs-safeguards-11113-cen-publishes-new-toy-safety-standard-en-71-3-2013-a4-en-13.pdf))
- EN 71-4:2013 (SafeGuards No.091/13 (http://newsletter.sgs.com/eNewsletterPro/uploadedimages/000006/sgs-safeguards-09113-eu-harmonises-standard-methods-for-toy-safety-a4-en-13.pdf))

For further details, please contact an SGS local sales representative or the global team.

SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 75 000 employees, SGS operates a network of over 1 500 offices and laboratories around the world.

Contact details:

SGS Consumer Testing Services
HingWo Tsang
TJP Information and Innovation Manager
SGS Hong Kong Ltd.
5/F Manhattan Centre
8 Kwai Cheong Road
Kwai Chung, NT, Hong Kong , China
t: +852 2774 7420

Email: cts.media@sgs.com
Website: http://www.sgs.com/en/Consumer-Goods-Retail/Toys-and-Juvenile-Products.aspx

This release was published on openPR.