10 Feb 2017
Member State Officials Vote in Favour of Stringent Limits for Phenol in Certain Toys
On 10 January 2017, Member States formally approved a proposal to introduce a restriction on the use of phenol in toys intended for children less than three years and in other toys intended to be placed in the mouth. Hong Kong traders which export such toys to the EU should note that this clears the path for the proposal’s official adoption and implementation EU-wide.
Currently, framework Directive 2009/48/EC on the safety of toys lays down, by means of a table, in Appendix C of Annex II, specific migration limits for four chemicals used in toys intended for children under 36 months or in other toys intended to be placed in the mouth. These chemicals are Bisphenol A, TCEP, TCPP and TDCP. It is now proposed to add phenol to that list.
Phenol, also known as carbolic acid, has a wide variety of uses. Its presence has been identified in PVC, game consoles, bath and inflatable toys, and also the synthetic fibres used to make children’s tents and play tunnels. It is also used as a preservative in water-based liquid toys (felt-tip markers, bubble-blowing products) and as a monomer for phenolic resins in the manufacture of resin-bonded wood for toys. As such, Hong Kong sellers will appreciate the wide scope of products that would potentially be affected by the future ban.
Some concern has been expressed about the hazards that exposure to phenol poses to human health. It is believed that it may have haemotoxic and immunotoxic effects on humans. In the context of toys, to this must be added the general
concern that young humans are more susceptible to the harmful effects of chemical exposure in comparison to adults.
The core EU Regulation on the classification, labelling and packaging of substances and mixtures (the CLP Regulation) has already classified phenol as mutagenic category 2. Moreover, a restriction on the use of phenol in all toys is set down in point 5 of Part III of Annex II to Directive 2009/48/EC on the safety of toys, which provides that substances classed as mutagenic category 2 under the CLP Regulation may be present in toys subject to a content limit of 10,000 mg/kg or 1%.
In addition, European Standards have been developed to deal with the presence of phenol in toys. EN 71-19:2005+A1:2007, EN 71-10:2005 and EN 71-11:2005 detail the limit values for phenol in toy materials, namely 15mg/l (migration limit) when used as a monomer and 10 mg/kg (content limit) when used as preservative in liquid toy materials.
However, taking into account existing scientific evidence and the need to offer a sufficient level of protection from phenol exposure, the Commission has considered it necessary to use its power under Article 46 (2) of Directive 2009/48/EC on the safety of toys to adopt specific limit values for chemicals used in toys intended for children under 36 months or in other toys intended to be placed in the mouth.
The Commission’s stance comes in light of a recommendation from the Scientific Committee on Health and Environmental Risk (SCHER) that the migration limit value of 15mg/l set out in the European Standards should be reduced by at least a factor of 2 to reduce the likelihood of harmful exposure.
Moreover, in 2013, the European Food Safety Authority (EFSA)’s Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) reduced the tolerable daily intake (TDI) of phenol from 1.5 mg/kg body weight per day to 0.5 mg/kg body weight per day.
In light of those recommendations, the subgroup “Chemicals” of the Expert Group on Toy Safety recommended on 26 March 2014 and 18 February 2015 to limit phenol in toys - intended to be placed in the mouth or intended for children less than 36 months - to a maximum concentration of 5 mg/l (migration limit) when present in polymeric materials and to 10mg/kg (content limit) when present as a preservative. On 14 January 2016, the Expert Group on Toy Safety subsequently voted to support the recommendation.
Not long afterwards, the Commission sent a legislative proposal, incorporating the recommendation into a finalised text, to the Council where it was approved by the Council of Member States as a matter of formality and without debate on 10 January 2017. The Council’s approval has given the Commission permission to adopt the measure and to publish it in the Official Journal.
As regards the specific changes introduced by the new proposal, for toys intended to be placed in the mouth or in other toys intended for children less than three years’ old, the limits for phenol will be contained in one row, in Annex II of Directive 2009/48/EC on the safety of toys. The amendment signifies introducing both a migration and content limit for phenol. The implementation in Member State law will lead to the same change.
Article 1 of the proposed Directive limits phenol in toys to a maximum concentration of 5 mg/l (migration limit) when analysed in polymeric materials, and 10mg/kg (content limit) when analysed as a preservative.
According to Article 1, both the migration limit and the content limit are to be assessed according to the methods laid down in European Standards EN 71-10:2005 and EN 71-11:2005. These European Standards specify sample preparation and extraction procedures for establishing the release of organic compounds from toys. The EN 71-10:2005 standard requires that 10cm2 of a toy material be extracted with 100ml of water during one hour.
Article 2 of the proposed Directive sets out the obligation for Member States to transpose the amended migration limit into law, at the latest, by the date falling 18 months after publication in the EU’s Official Journal. Member States are required to start applying the new limits from that date, and to communicate the transposition measures to the European Commission.
Having received the Council of Member States’ seal of approval, the proposal is expected to be published in the Official Journal very soon. Given that this future law is likely to impact on many of Hong Kong’s toy exports to the EU, its date of publication in the Official Journal should be closely monitored.