28 Nov 2019
New EU Law Restricts Formaldehyde in Different Types of Material Used in Toys
On 20 November 2019, the Official Journal published Commission Directive 2019/1929, amending a specific section of the EU’s framework law, Directive 2009/48/EC on the safety of toys. The newly published Directive adopts specific limit values as regards formaldehyde used in a number of different materials in toys.
Hong Kong’s exporters of toys destined for European consumers will likely be aware that Directive 2009/48/EC (the framework law concerning toy safety) establishes certain requirements for chemical substances that are classified as carcinogenic, mutagenic or toxic for reproduction. Appendix C to Annex II to Directive 2009/48/EC lays down specific limit values for chemicals that are used in toys either intended for use by children under 36 months, or used in other toys intended to be placed in the mouth.
Formaldehyde is currently not listed in Appendix C to Annex II to Directive 2009/48/EC. Yet, it is classified as carcinogenic category 1B under the EU’s classification rules. Thus, until now, pursuant to point 4(a) of Part III of Annex II to Directive 2009/48/EC, formaldehyde is allowed to be used up to a concentration of 0.1%, which corresponds to 1,000 mg/kg (content limit).
The Expert Group on Toys Safety, established by the European Commission to advise it in the preparation of legislative proposals and policy initiatives in the area of toy safety (subgroup Chemicals) has provided detailed advice and recommendations on formaldehyde. These have now been transformed into the new Commission Directive 2019/1929, the salient features of which are covered below.
Formaldehyde is used as a monomer in the manufacture of polymeric materials, which are, in turn, frequently used in toys. Children may therefore ingest formaldehyde when mouthing toys containing polymeric materials. The subgroup Chemicals has recommended a formaldehyde migration limit of 1.5 mg/l in polymeric materials when the migration of formaldehyde is determined in accordance with the test method in standards EN 71-10:2005 and EN 71-11:2005.
Formaldehyde is also used in the manufacture of resin-bonded wood products such as particle board, oriented-strand board, high-density fibre board, medium density fibre board and plywood. Formaldehyde resins include phenol-formaldehyde (PF), urea-formaldehyde (UF), melamine-formaldehyde (MF) and polyacetal (polyoxymethylene — POM) resins. POM tends to be used only for small internal components and not in whole toys. The subgroup Chemicals has recommended a formaldehyde emission limit of 0.1 ml/m3 when the emission of formaldehyde is determined in such materials in accordance with the test chamber method in standard EN 717-1:2004.
Formaldehyde may also be present in textile toy material, due to its use during the manufacture of textiles. It is reported that the lowest threshold concentration for allergic contact dermatitis from formaldehyde is 30 mg/kg. On that basis and in order to protect also the most sensitised individuals, the subgroup Chemicals has recommended a formaldehyde content limit of 30 mg/kg when the content of formaldehyde is determined in accordance with the water extraction method in standard EN ISO 14184-1:2011.
Formaldehyde may, furthermore, be present in leather toy material due to its use during the manufacture of leather. Since leather toy material may lead to an exposure similar to textile toy material the subgroup Chemicals has recommended a formaldehyde content limit of 30 mg/kg when the content of formaldehyde is determined in accordance with standard EN ISO 17226-1:2008.
In addition, formaldehyde in paper toy material should have a content limit of 30 mg/kg according to the recommendation of the subgroup Chemicals, when determined in accordance with the water extraction method in standard EN 645:1993 and with standard EN 1541:2001. That conclusion was based on the consideration that paper toy material may lead to an exposure similar to textile and leather toy material.
Formaldehyde may also be present in water-based toy material due to its function as a preservative. It could be used in water-based toy materials such as soap bubbles or inks in felt-tip pens, and also in dry materials intended to be mixed with water prior to use. The subgroup Chemicals has recommended a formaldehyde limit of 10 mg/kg in water-based toy material when the content of formaldehyde is determined according to the test method published by the European Directorate for the Quality of Medicines & HealthCare of the Council of Europe (the EDQM method) on the Determination of free formaldehyde in cosmetic products. The recommended limit is close to the lowest value that can be reliably determined by the EDQM method and takes account of traces of formaldehyde that certain other preservatives may release.
As a result of the abovementioned recommendations put to the Commission, Directive 2019/1929 stipulates that in Appendix C to Annex II to Directive 2009/48/EC (the EU’s framework toy safety law), the following entry is added:
|Substance||CAS No||Limit value|
1.5 mg/l (migration limit) in polymeric toy material
0.1 ml/m3 (emission limit) in resin-bonded wood toy material
30 mg/kg (content limit) in textile toy material
30 mg/kg (content limit) in leather toy material
30 mg/kg (content limit) in paper toy material
10 mg/kg (content limit) in water-based toy material’
Member States are required to adopt and publish, by 20 May 2021 at the latest, the laws, regulations and administrative provisions necessary to comply with Directive 2019/1929 concerning formaldehyde in toys. Hong Kong toy sellers should note that all such provisions must then begin to be applied by Member States from 21 May 2021.