24 Dec 2015
Toys Become Subject to New EU Laws Restricting Flame Retardants As Well As BPA
By 21 December 2015, all EU Member States were required to adopt, publish and begin applying provisions which transposed two EU Directives relating to the safety of toys. Both Directives were adopted by the European Commission in 2014, allowing some time for producers to adjust their production processes to the new legal provisions.
Directive 2014/79/EU restricting certain flame retardants, and Directive 2014/81/EU restricting Bisphenol A (BPA), amended the EU’s framework Toy Safety Directive back in 2014, when they were adopted during the summer of that year.
Now that the transitional period for implementation by national governments has expired, toy sellers will have to ensure that the toys they place on the EU market comply with all of the new restrictions.
Commission Directive 2014/79/EU: This EU law sets out strict restrictions on certain flame retardants found in toys. The flame retardants are named as TCEP, TCPP and TDCP, and the toys that are concerned by the new restrictions are those intended for use by children under 36 months, or other toys intended to be placed in the mouth.
The Commission notes in Directive 2014/79/EU that the substance tris(2-chloroethyl) phosphate (TCEP) has previously been classified as carcinogenic and toxic for reproduction. Furthermore, a risk assessment of 2009 showed that TCEP can easily migrate, and, when ingested, results in kidney, liver and brain toxicity, damaging health and possibly causing cancer.
However, since 2001 there has apparently been no TCEP production within the EU, and its use in the EU has also declined, the substance being progressively replaced by other flame retardants. Nevertheless, the presence of TCEP in toys cannot – according to the Commission – be excluded, as most toys available on the EU market are imported, and thus were manufactured outside the EU. That said, TCEP has been permitted in toys in concentrations equal to or smaller than 0.5% as from 20 July 2013 and 0.3% as from 1 June 2015.
In a new risk assessment, this time by the EU’s Scientific Committee on Health and Environmental Risks (SCHER), the health dangers posed by TCEP have been further highlighted. SCHER concluded that, due to the exposure to TCEP from sources other than toys, e.g. air or dust, no additional exposure from toys can be considered as safe. It thus recommended to the Commission to set a stricter limit for TCEP in toys: at the detection limit of a sufficiently sensitive analytical method.
Due to SCHER’s findings, the Commission therefore believes that the permitted generic limit values of 0.5% and 0.3% (noted above) for toys appear to no longer be appropriate. Instead, the so-called detection limit of a sufficiently sensitive analytical method for TCEP has been set at 5mg/kg.
Hong Kong’s toy manufacturers may also be familiar with two further substances, i.e. TCEP’s halogenated alternatives, namely, tris[2-chloro-1-(chloromethyl)ethyl] phosphate (TDCP), and tris(2-chloro-1-methylethyl) phosphate (TCPP). According to SCHER’s risk assessment of these additional substances, there is sufficient information supporting a conclusion of potential concern for carcinogenicity in respect of both these alternative substances.
The Commission therefore decided to amend framework Directive 2009/48/EC on the safety of toys accordingly, by means of Directive 2014/79/EU. The latter Directive stipulates as follows, in Appendix C of Annex II to Directive 2009/48/EC:
Hong Kong’s toy sellers have to ensure that, as from 21 December 2015, they are complying with the Member States’ implementation, by means of national provisions, which transpose Commission Directive 2014/79/EU. Please click on the following to view Commission Directive 2014/79/EU.
Commission Directive 2014/81/EU: This Directive sets a strict limit for Bisphenol A (BPA) in toys intended for use by children under 36 months or in other toys intended to be placed in the mouth. The Directive notes that BPA is a high volume chemical that is widely used in the production of a large variety of consumer products. BPA is used as a monomer in the manufacture of polycarbonate plastics which can be used, in turn, in the manufacture of toys.
The Directive notes that standards restricting BPA in toys already exist. European standard EN 71-9:2005+A1:2007 provides a migration limit of 0.1 mg/l for BPA, while other European standards provide the relevant test methods. The limits and methods for BPA that are set out in these standards are, it is stated, being used voluntarily by the European toy industry, as a reference, to ensure that there is no unsafe exposure from BPA in toys. However, the standards have not been recognised as harmonised EU standards.
BPA is classified in the EU as toxic for reproduction, category 2. In the absence of any specific requirements, BPA can be contained in toys in concentrations equal to or under 5% as from 20 July 2013 and 3% as from 1 June 2015. However, the Directive notes that these figures could, conceivably, lead to an increased exposure of small children to BPA, compared to the migration limit of 0.1 mg/l found in the European standards. While uncertainties over the risks to children – in relation to BPA – remain, the Commission deems it necessary to impose the lower threshold. If new scientific information were to become available, this threshold limit would then need to be reviewed.
In sum, Directive 2014/81/EU amends framework Toy Safety Directive 2009/48/EC as follows. It lays down a strict limit value for BPA in toys intended for use by children under 36 months or in other toys intended to be placed in the mouth. This limit value is 0.1mg/l (migration limit), in accordance with the methods laid down in European standards EN 71-10:2005 and EN 71-11:2005. Hong Kong companies will have had to begin complying with the measure as from 21 December 2015.
Please click on the following to view Commission Directive 2014/81/EU. The European standards which contain the test methods may be obtained from any national member of CEN (European Committee for Standardisation), the contact details of which can be found via the following link: CEN.