EU revises toy safety directive to add another restricted substance phenol

The Ningbo Inspection and Quarantine Bureau announced that recently, the Official Journal of the European Union (OJ) issued Commission Directive (EU) 2017/774, which revised the Toy Safety Directive 2009/48/EC, adding migration restrictions for phenol and content restrictions as preservatives for toys intended for children under 36 months of age that may be put in the mouth. (EU) 2017/774 will come into effect on the 20th day of OJ publication, and the relevant restrictions will be officially implemented from November 4, 2018. This is the second revision of the Toy Safety Directive in the short term, following the EU's announcement on April 27th of the revised heavy metal lead migration limit directive (EU 2017/738).

At present, the framework directive 2009/48/EC on toy safety, in Appendix C of Annex II, specifies specific migration limits for four chemicals for toys designed specifically for children under 36 months of age or other playable toys. These chemicals are bisphenol A, tri (2-chloroethyl) phosphate (TCEP), tri (2-chloropropyl) phosphate (TCPP), and tri (2,3-dichloropropyl) phosphate (TDCP). According to the new directive, phenol will be added to this list.

According to (EU) 2017/774, for phenol, it needs to meet triple requirements under the Toy Safety Directive: 1. Content limit as a CMR substance: 10000mg/kg; 2. Migration limit of polymer materials: 5mg/l; 3. Preservative content requirement: 10mg/kg. The migration limit and content limit mentioned above should be evaluated according to the methods specified in European standards EN71-10:2005 and EN71-11:2005. Appendix C of Annex II of the Toy Safety Directive specifies the requirements for chemical substances in toys intended for use by children under 36 months of age or those that can be ingested. Therefore, the newly added restrictions on phenol migration and preservative content only apply to toys or toys that can be ingested by children under 36 months of age.

Phenol, also known as carbolic acid (CAS number: 108-95-2), has a wide range of applications. The sources of phenol in toys include the degradation of phenolic antioxidants in polymers. Phenol may be present in game consoles, children's tents or game tunnels, packaging films, bath toys and other inflatable toys, and polyvinyl chloride (PVC). It is also used as a preservative for water-based liquid toys (felt pens, bubble blowing products) and as a phenolic resin monomer for manufacturing resin bonded wood used in toys. The harm of phenol to human health has attracted a lot of attention, and it is said to have blood toxicity and immune toxicity effects on humans. As for toys, children are more susceptible to the harmful effects of chemical exposure than adults, and therefore receive more widespread attention.

Prior to this, EU member states must adopt and publish relevant laws, regulations, and administrative norms. Recently, the EU has frequently revised the Toy Directive, which will have a significant impact on China's toy export enterprises. In this regard, the inspection and quarantine department reminds relevant export enterprises that the EU Toy Directive is the strictest and most important toy standard in the EU. Enterprises should track the latest developments in regulations, timely collect and master the technical regulations and standards related to toys issued by the EU, strengthen communication and cooperation with inspection and quarantine agencies or third-party testing agencies, conduct scientific safety assessments from the product design stage to the mass production stage, and ensure that relevant products meet the requirements of the new regulations as soon as possible to avoid quality risks. At the same time, we will improve the quality process management system, strengthen dynamic supervision of raw material procurement and key processes, and focus on increasing the testing of risk sensitive materials to avoid returns and unnecessary losses due to non-compliance with import country requirements.