On May 4, 2017, the Official Journal of the European Union (OJ) releases the Council Directive (EU) 2017/774, amending the Directive 2009/48/EC on the safety of toys, in allusion to those toys that are designed for children under 36 months or could be placed in children’s mouths, to add the migration restriction of phenol and the content restriction of it when it functioned as an antiseptic. (EU) 2017/774 will come into effect on the twentieth day following that of its publication in the OJ, and the relevant restriction requirement will enforce officially from November 4, 2018.
Phenol (CAS Number 108-95-2) is commonly used as the monomer of phenolic resin in the manufacture of plywood of toys. Its source also contains the degradation of the phenolic antioxidant in polymers. Phenol might be detected out in game machines and children’s tents or tunnels, it exists in packing films, bath toys and other inflatable toys, and it also presents in polyvinyl chloride (PVC)). In addition, phenol can also be further used as the preservative of water-based liquid toys, like bubble blowing toys and water-based liquid inks.
According to the Regulation (EC) No 1272/2008 of Classification, labeling and packaging Regulation of EU, Phenol is classified as mutagenic category 2. On the basis of the requirement of point 5 of Part III of Annex II to Directive 2009/48/EC, the contents of phenol in toys should be equal to or less than 1% (10000mg/kg), which is the relevant limitation that stipulated in CLP Regulation.
This amendment aims at defining the migration limit of phenol, and at the same time adds the content restriction of phenol as a preservative. According to (EU) 2017/774, the Toy Safety Directive makes the following addition in Appendix C to Annex II to Directive 2009/48/EC:
Substance | CAS No | Limit value |
Phenol | 108-95-2 | l 5 mg/l (migration limit) in polymeric materials in accordance with the methods laid down in EN 71-10:2005 and EN 71-11:2005. l 10 mg/kg (content limit) as a preservative in accordance with the methods laid down in EN 71-10:2005 and EN 71-11:2005. |
Therefore, for phenol, it should meet the following three requirements under the Toy Safety Directive:
1. The content restriction of phenol as CMR substance: 10000mg/kg;
2. Migration limit of polymer material: 5mg/l;
3. The content restriction of preservative: 10mg/kg.
The Appendix C to Annex II of Toy Safety Directive specifies the requirements of the chemical material in toys which are designed for children under 36 months and in other toys intended to be placed in the mouth; as a result the new restrictions of phenol migration quantity and preservative content only apply to toys which are designed for children under 36 months and to other toys or parts of toys that intended to be placed in the mouth.
This directive will apply on November 4, 2018, and the members of European Union should adopt and publish relevant laws, regulations and administrative rules before that. Besides, EU Toy Safety Directive recently also amended the migration limit of lead (details on EU Toys Safety Directive Officially Amend the Migration Limit of Lead). C&K Testing informs relevant toys manufacturing corporations to pay close attention to deal with this amendment.