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SAFEGUARDS | Toys & Juvenile Products NO. 106/15

SafeGuardS kid plays toy

The European committee for toy safety has recently agreed to restrict 4 preservatives in certain toys. The committee also set a requirement for formamide content in foam toy materials, with formamide emission as an alternative to the content limit. The enforcement date is dependent on the nature of the chemical and will start in 18 months after publication in the Official Journal. 

In October 2014, we informed you that the European Commission (EC) had notified the World Trade Organization (WTO) of a proposal [1] to restrict 6 chemicals in toys intended for children under 36 months or other toys intended to be placed in the mouth*. That proposal would amend the chemical requirements under Appendix C of Annex II in the Toy Safety Directive 2009/48/EC (TSD). The 6 chemicals are:

  1. 1,2-Benzisothiazol- 3(2H)-one (1, BIT, CAS 2634-33-5)
  2. 5-Chloro-2-methylisothiazolin-3(2H)-one (CMI) and 2-methylisothiazolin-3(2H)-one (MI) (2, CMI:MI = 3:1, CAS 55965-84-9)
  3. 5-Chloro-2-methylisothiazolin-3(2H)-one (3, CMI, CAS 26172-55-4)
  4. 2-Methylisothiazolin-3(2H)-one (4, MI, CAS 2682-20-4)
  5. Formamide (5, CAS 75-12-7)
  6. Phenol (6, CAS 108-95-2)

On 8 June 2015, the Danish Environmental Protection Agency (EPA) [2] announced that an agreement was made by the European committee for toy safety to restrict four preservatives (1-4) under Appendix C of Annex II in the TSD.

According to the draft Commission Directive on formamide dated 8 June 2015, the committee also set a restriction of no more than 200 mg/kg for formamide (5) content in foam toy materials. It also has an emission limit of 20 μg/m³ after a maximum of 28 days as an alternative to the formamide content limit.  

The committee did not have sufficient time to vote for phenol (6).

The enforcement dates are dependent on the nature of the chemical:

  • 18 months after publication in the Official Journal of the European Union (OJEU) for chemicals (1, 5 and 6)
  • 24 months after publication in the OJEU for chemicals (2, 3 and 4)   

Highlights of the latest draft Commission Directives for the 6 chemicals are summarized in Table 1

Table 1

Proposed amendment to Appendix C of ANNEX II to Toy Safety Directive 2009/48/EC



Method, unless otherwise stated, is not defined

Requirement, unless otherwise stated, is total content

(Toy material)

Enforcement Date

(months after [publication in OJEU]

Associated document in dossier CMTD(2015)0495

(Comitology Register)


  • Toys intended for children under 36 months
  • Other toys intended to be placed in the mouth

EN 71 Parts 10-11

≤ 5 mg/kg  (aqueous)




≤ 5 mg/l migration as polymeric materials

≤ 10 mg/kg as preservative




ISO 16000-6 &

ISO 16000-9

≤  200 mg/kg otherwise

≤ 20 μg/m³ emission after a maximum of 28 days



CMI and MI (3:1)


≤ 1 mg/kg (aqueous)




≤ 0.75 mg/kg (aqueous)


≤ 0.25 mg/kg (aqueous)

Throughout our global network of laboratories, we are able to provide a range of services, including analytical testing and consultancy, for restricted substances in toys for the EU and international markets. Please do not hesitate to contact us for further information.

For enquiries, please contact:

Hing Wo Tsang
Global Toys and Juvenile Products
t: +852 2774 7420

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