EC Proposes Adoption of Limit Values for Chemicals in Toys

September 29, 2014

Details
The European Commission (EC) has proposed draft Commission Directive amending, for the purpose of adopting specific limit values for chemicals used in toys, Appendix C to Annex II to Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys.

Phenol is used as a monomer for phenolic resins in the manufacture of plywood for toys. The degradation of phenolic antioxidants in polymers can be a further source of phenol in toys. Phenol can also be found as a preservative in water-based liquid toys such as bubble-blowing products, water based liquid inks (e.g. felt-tipped marker pens) or finger paints.

Formamide is used as a solvent, plasticizer or as a substance associated with a blowing agent used in the creation of foam toys, such as puzzle mats.

BIT, CMI and MI are used as preservatives in toys.

Proposed date of adoption: First quarter of 2015
Proposed date of entry into force: Third quarter of 2016

Why It Matters
The draft Commission Directive introduces limit values for phenol, formamide, and BIT, and CMI and MI in a ratio of 3:1, as well as CMI and MI individually in toys intended for children under 3 years or in other toys intended to be put in the mouth, in order to ensure alignment to the latest scientific evidence and increase children's safety.

SUBSTANCE	CAS NO	CLASSIFICATION	LIMIT VALUE
Phenol	108-95-2	mutagenic category 2 under Regulation (EC) No 1272/2008	5 mg/l (migration limit) as a monomer 10 mg/kg (content limit) as a preservative Compliance with both limits is to be determined in accordance with the methods laid down in EN 71-10:2005 and EN 71-11:2005
Formamide	75-12-7	toxic to reproduction category 1B under Regulation (EC) No 1272/2008	20 μg/m3 (emission limit) after a maximum of 28 days from commencement of the emission testing of foam toy materials, following a test method in accordance with the ISO 16000-6 and 16000-9 standards and under suitable conditions for sampling within products and batches of products
1,2-benzisothiazol- 3(2H)-one	2634-33-5	skin sensitizer under Regulation (EC) No 1272/2008	5 mg/kg (content limit)
reaction mass of: 5-chloro-2-methyl-4-isothiazolin-3-one [EC no. 247-500-7] and 2-methyl-2H -isothiazol-3-one [EC no. 220-239-6] (3:1)	55965-84-9		1 mg/kg (content limit)
5-Chloro-2-methylisothiazol-3(2H)-one	26172-55-4		0,75 mg/kg (content limit)
2-methylisothiazol- 3(2H)-one	2682-20-4		0,25 mg/kg (content limit)

Directive 2009/48/EC does not currently provide for a migration limit for phenol, emission limit for formamide, specific limit value for BIT, specific limit value for CMI/MI 3:1, nor for CMI or MI individually, nor a general limit value for sensitizers.

How UL Can Help
Across our global network of laboratories, UL’s third-party testing services can help ensure regulatory compliance to EU Toy Safety Directive 2009/48/EC.

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