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EU: European Commission proposes formaldehyde restriction in toys

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EU: European Commission proposes formaldehyde restriction in toys

december 2018- Relevant for: Toys and children's products

In 2016, we share with you that the European consumer voice in standardisation (ANEC) called for formaldehyde requirements¹ in toys which are intended for use by children under 36 months or other toys intended to be placed in the mouth. On 18 December 2018, the European Commission (EC) has finally notified the World Trade Organization (WTO) of the draft Directive² setting specific limits for formaldehyde in toys that are intended for use by children under 36 months or other toys that are intended to be placed into mouth. The feedback period opens until 16 February 2019.

The amendment would be made under Appendix C to Annex II to the Toy Safety Directive 2009/48/EC. Summary of the proposed limit values in different materials and suggested test methods are listed below.

Toy materials	Proposed limit values	Test methods	Remarks
Polymers	1.5 mg/l (migration limit)	EN 71-10 and EN 71-11	Lower than current requirement in EN 71-9 (2.5 mg/l)
Resin-bonded wood	0.1 ml/m3 (emission limit)	EN 717-1	Different from the method adopted by EN 71-9 (EN 717-3)
Textile	30 mg/kg	EN ISO 14184-1	In line with current requirement in EN 71-9
Leather	30 mg/kg	EN ISO 17226-1	-
Paper	30 mg/kg	EN 645 and EN 1541	In line with current requirement in EN 71-9
Water-based	10 mg/kg	EDQM method³	Lower than current requirement in EN 71-9 (0.05 %)

Formaldehyde is classified as Carcinogenic category 1B under Regulation (EC) No 1272/2008 which subject to general ban under Toy Directive. In light of the scientific evidence provided by ANEC, the subgroup “Chemicals” of the Expert Group on Toys Safety advised the Commission to regulate the use of formaldehyde in toys.

Below are the toy materials in which formaldehyde is known to exist:

Polymers: Formaldehyde is used as a monomer in the manufacture of polymeric materials, which can be ingested by children. The migration limit is determined based on the tolerable daily intake (TDI) set by the World Health Organisation (WHO).
Resin-bonded wood: Products such as particle board, medium density fibre board (MDF), plywood, phenolformaldehyde (PF) and melamine-formaldehyde (MF) often contain formaldehyde. An emission limit was set out to lower the risk of sensory irritation and cancer.
Paper, textile and leather: Formaldehyde may be used during the manufacture. In order to prevent allergic contact dermatitis occurrence in children and even the most sensitised individuals, a content limit has been determined.
Water-based materials: Formaldehyde may be present in water-based toy material as preservative such as soap bubbles or inks in felt-tip pens. It can be also found in dry materials that are intended to be mixed with water prior to use. Based on the recent scientific opinion ⁴, it was agreed that formaldehyde should not exist in toys.

[1] ANEC proposes formaldehyde restriction in toys, Oct 2016
[2] WTO Notification
[3] Test method published by the European Directorate for the Quality of Medicines & HealthCare of the Council of Europe
[4] Opinion of the SCHER on the risk assessment of organic chemicals in toys