Relevant for: Toys
The European Commission (EC) has recently notified the World Trade Organisation (WTO) of two draft Directives proposing to restrict bisphenol A (BPA) and three flame retardants (TCEP, TCPP and TDCP) in toys by listing them in Appendix C of Annex II to the Toy Safety Directive 2009/48/EC (TSD).
The proposed restrictions apply to toys which are intended for use by children under three years old or other toys intended to be placed in the mouth. If adopted, the Member States will need to apply the requirements, at the latest, 18 months after publication of the amendment in the Official Journal of the European Union. Highlights on the draft amendments are summarised in Table A below.
Table A. Proposed restrictions of 4 substances to be listed in Appendix C of Annex II to the Toy Safety Directive 2009/48/EC (TSD)
Proposed application date
0.1 mg/l (migration limit)
in accordance with the methods laid down in EN 71-10 and EN 71-11
Member States are required to adopt the requirements at the latest 18 months after publication of the amendment in the Official Journal of the European Union
5 mg/kg (content limit)
5 mg/kg (content limit)
5 mg/kg (content limit)
As a general rule, substances that are classified as carcinogenic, mutagenic or toxic for reproduction (CMR) under the CLP Regulation* are not allowed to be used in toys, in components of toys or in micro-structurally distinct parts of toy unless these components or parts of toys are inaccessible to children and the individual concentrations are below the limits in the CLP Regulation for the classification of mixtures.
To further protect children’s health and where appropriate, specific limit values for such CMR substances can be set out for toys intended for use by children under three years old or other toys intended to be placed in the mouth. These limits are listed in Appendix C of Annex II to the TSD.
* Regulation (EC) No 1272/2008 on the classification, labelling and packaging of substances and mixtures.
a) Bisphenol A
Despite classified as toxic for reproduction category 2 under the CLP Regulation, BPA is widely used as a monomer in the manufacturing of polycarbonate plastics, which are used in the production of a wide range of consumer products, including toys. Plastic materials in children’s books have been found to contain BPA.
Prior to the application of the new chemical requirements under the TSD on 20 July 2013, the toy industry had been using the migration limit of 0.1 mg/l for BPA given in the European standard EN 71-9, together with the testing methods provided by EN 71-10 and EN 71-11. However, unless specifically restricted, the concentration limit for BPA in toys under the TSD can be 5% as from 20 July 2013 and 3% as from 1 June 2015, respectively. As it cannot be excluded that these concentrations may lead to increased exposure of small children to BPA, the proposed restriction will maintain the existing level of protection of children’s safety until further scientific information becomes available.
b) TCEP, TCPP and TDCP
TCEP is a phosphate ester that is used as a flame retardant plasticiser in polymers. The building, furniture and textile industries are the main industrial users of this substance. TCEP is classified as carcinogenic category 2 and toxic for reproduction category 1B. It easily migrates, and when ingested, results in toxicity in the kidney, liver and brain, causing health damages and potentially cancer. Based on studies carried out in 2004 and 2006, the Danish Environmental Protection Agency (Danish EPA) considered that children, when exposed to toys containing TCEP, will ingest, due to their mouthing behavior, 50% of the amount of TCEP present in the toys.
There is currently no specific requirement for TCEP in toys, and according to the general requirements on CMR substances under the TSD, TCEP can be used at concentrations 0.5% as from 20 July 2013 and 0.3% as from 1 June 2015, respectively.
Although there has been no manufacture of TCEP in the EU since 2001 and that its use has declined and is being progressively replaced by other flame retardants, the presence of TCEP in imported toys cannot be excluded. In 2012 the EU Scientific Committee on Health and Environmental Risks (SCHER) assessed the health effects of TCEP and taking into considered the latest scientific information, a detection limit of 5mg/kg for TCEP is recommended.
Due to the similar structures, physical-chemical properties, toxicokinetics and mutagenic profiles of TCEP’s halogenated substitutes, TCPP and TDCP are also proposed to be restricted under the same conditions as TCEP.