Officials from EU member states voted in favor of imposing strict phenol restrictions on certain toys. On January 10, 2017, EU member states formally approved a bill to impose phenol restrictions on toys designed for children under 3 years old and other toys that are put into the mouth. Usage Restrictions. This move will open the door to the bill's formal adoption and EU-wide implementation. At present, the Framework Directive 2009/48/EC on the safety of toys is listed in Appendix C of Schedule 2 and stipulates 4 chemicals for toys designed for children under 36 months of age or other toys that can be put into the mouth. specific migration limits for the product. These chemicals are bisphenol A, tris(2-chloroethyl)phosphate (TCEP), tris(2-chloropropyl)phosphate (TCPP), and tris(2,3-dichloropropyl)phosphate ( TDCP). The bill above would add phenol to that list. Phenol, also known as carbolic acid, has a wide range of uses. Phenol has been 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 tip pens, bubble blowing products) and as a phenolic resin monomer in the manufacture of resin-bonded wood used in toys. The harm of phenol to human health has attracted a lot of attention, and it is said that it may cause hematotoxicity and immunotoxicity in humans. When it comes to toys, children are more susceptible to the harmful effects of chemical exposure than adults and are therefore of greater general concern. The EU's Principal Regulation on the Classification, Labeling and Packaging of Substances and Mixtures (CLP Regulation) has classified phenol as a Category II mutagenic substance. In addition, point 5 of Part 3 of Annex 2 of Directive 2009/48/EC on the safety of toys stipulates restrictions on the use of phenol in all toys, and stipulates that substances classified as Category 2 mutagenic substances can be present in toys under the CLP Regulation , but its content is limited to 10,000 mg/kg or 1%. In addition, European standards have been developed to deal with phenol contained in toys. EN 71-19:2005+A1:2007, EN 71-10:2005 and EN 71-11:2005 detail the limit value of phenol in toy materials, that is, when used as a monomer, it is 15 mg/L (migration limit) , and when used as a preservative in liquid toy materials, it is 10 mg/kg (content limit). However, taking into account the available scientific evidence and the need to provide an adequate level of protection against phenol exposure, the European Commission considers it necessary to apply its powers under Directive 2009/48/EC on the safety of toys intended for children under 36 months of age. Specific limits are imposed on chemicals used in toys or other toys that are placed in the mouth. The European Commission took this position following a recommendation from the Scientific Committee on Health and Environmental Risks. The committee recommends that the migration limit of 15 mg/l specified in European standards should be reduced by at least half to reduce the possibility of harmful exposure. In addition, in 2013, the European Food Safety Authority's Food Contact Materials, Enzymes, Flavorings and Processing Aids Group lowered the daily allowable intake of phenol from 1.5 mg/kg body weight per day to 0.5 mg/kg body weight per day. . Based on these recommendations, the Chemical Subcommittee of the Toy Safety Expert Group recommended on 26 March 2014 and 18 February 2015 that phenol be restricted in toys that are placed in the mouth or are intended for children under 36 months of age. That is, the highest concentration when present in polymer materials is 5 mg/L (migration limit), and when present as a preservative, it is 10 mg/kg (content limit). Subsequently, the Toy Safety Expert Group voted in favor of the recommendation on January 14, 2016. Shortly after, the European Commission submitted a legislative proposal to the Council of Member States to incorporate the proposal into the final text, which was approved by the Council on January 10, 2017. Therefore, the European Commission can adopt the measure and publish it in the Official Journal. The specific revision of the new bill is that for toys that can be put into the mouth or are designed for children under 3 years old, the restrictions on phenol will be included in Annex II of Directive 2009/48/EC on the safety of toys. The revision is to introduce migration and content limits of phenol. The legislation implemented by each member state will also be subject to the same changes. Article 1 of the proposed directive sets limits on the maximum concentration of phenol in toys, which is 5 mg/liter (migration limit) when analyzed as a polymeric material and 10 mg/kg (content limit) when analyzed as a preservative. According to Article 1, both migration limits and content limits should be evaluated according to the methods specified in European standards EN 71-10:2005 and EN 71-11:2005. The above-mentioned European standard specifies sample preparation and extraction procedures for the determination of organic compounds released from toys. The EN 71-10:2005 standard requires the 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 obliged to transpose the revised migration limits into legislation no later than 18 months after 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. After receiving the approval from the Council of Member States, the bill is expected to be published in the Official Gazette soon. Source: HKTDC Economic and Trade Research (2017-02-10)
