EU member state officials voted to impose strict phenol restrictions on certain toys. On January 10, 2017, EU member states formally approved a bill to restrict the use of phenol in toys designed for children under 3 years old and other toys that may be put in the mouth. This move opens the door for the formal adoption and implementation of the bill across the EU. Currently, Framework Directive 2009/48/EC on toy safety lists specific migration limits for four chemicals in Annex C of Schedule II for toys designed for children under 36 months or other toys that may be put in the mouth. These chemicals are bisphenol A, tris(2-chloroethyl) phosphate (TCEP), tris(2-chloropropyl) phosphate (TCPP), and tris(2,3-dichloropropyl) phosphate (TDCP). The bill will add phenol to this list. Phenol, also known as carbolic acid, has a wide range of uses. Phenol is found in polyvinyl chloride (PVC), game consoles, bathtubs, inflatable toys, and synthetic fibers used to make children's tents and play tunnels. It is also used as a preservative in water-based liquid toys (felt-tipped pens, bubble-blowing products) and as a phenolic resin monomer in the manufacture of resin-bonded wood for toys. The health hazards of phenol have attracted considerable attention, reportedly causing hemotoxicity and immunotoxicity in humans. Children are more susceptible to the harmful effects of chemical exposure than adults, making toys a greater concern. The EU's main regulation on the classification, labeling and packaging of substances and mixtures (CLP Regulation) classifies phenol as a Group 2 mutagen. Furthermore, Annex II, Part III, Point 5 of Directive 2009/48/EC on toy safety restricts the use of phenol in all toys and stipulates that, according to the CLP Regulation, Group 2 mutagens can be present in toys, but their content is limited to 10,000 mg/kg or 1%. In addition, European standards have been developed to address phenol in toys. EN 71-19:2005+A1:2007, EN 71-10:2005, and EN 71-11:2005 detail the limits for phenol in toy materials: 15 mg/L (migration limit) when used as a monomer and 10 mg/kg (content limit) when used as a preservative in liquid toy materials. However, considering the existing scientific evidence and the need to provide an adequate level of protection against phenol exposure, the European Commission considers it necessary to exercise its powers under Directive 2009/48/EC on toy safety to impose specific limits on chemicals used in toys intended for children under 36 months of age or other toys that may be put in the mouth. The Commission adopted this position based on a recommendation from the Scientific Committee on Health and Environmental Risks, which recommended that the migration limit of 15 mg/L specified in European standards be reduced by at least half to decrease the likelihood of harmful exposure. Furthermore, in 2013, the European Food Safety Authority's Panel on Food Contact Materials, Enzymes, Flavorings and Processing Aids lowered the acceptable daily intake (ADI) of phenol from 1.5 mg/kg body weight to 0.5 mg/kg body weight. Based on these recommendations, the Toy Safety Expert Group's Chemicals Panel recommended on 26 March 2014 and 18 February 2015 that the concentration of phenol in toys intended for children under 36 months of age be limited to a maximum of 5 mg/L (migration limit) in polymer materials and 10 mg/kg (content limit) when present as a preservative. The Toy Safety Expert Group subsequently voted in favor of this recommendation on 14 January 2016. Shortly thereafter, the European Commission submitted a legislative bill to the Council of Member States incorporating the recommendation into the final text, which was approved by the Council on 10 January 2017. Therefore, the European Commission can adopt this measure and publish it in the Official Journal. The specific amendment in the new proposal is that restrictions on phenol for toys that may be put in the mouth or otherwise designed for children under 3 years old will be included in Annex II of Directive 2009/48/EC on toy safety. The amendment introduces migration and content limits for phenol. The legislation implemented by Member States will also be amended accordingly. Article 1 of the proposed directive sets limits on the maximum concentration of phenol in toys at 5 mg/L (migration limit) when analyzed as a polymer and 10 mg/kg (content limit) when analyzed as a preservative. According to Article 1, both migration and content limits shall be assessed according to the methods specified in European standards EN 71-10:2005 and EN 71-11:2005. These European standards specify the procedures for sample preparation and extraction when determining the release of organic compounds from toys. EN 71-10:2005 requires extraction of 10 square centimeters of toy material with 100 mL of water within one hour. Article 2 of the proposed directive stipulates that Member States are obligated to transpose the revised migration limits into law no later than 18 months after their publication in the Official Journal of the European Union. Member States must implement the new limits from that date and notify the European Commission of the transposition measures. Following approval from the Council of Member States, the proposal is expected to be published in the Official Journal soon. Source: HKTDC Trade Research (2017-02-10)
