The European Union (EU) has recently amended the Toy Safety Directive 2009/48/EC (TSD) to include the restriction of formamide and 4 preservatives in certain toys.

SAFEGUARDS | Toys and Juvenile Products NO. 202/15

The enforcement dates are dependent on the nature of the restricted substance and will start on 24 May 2017.

In June 2015, we informed you that the European Commission (EC) had notified the World Trade Organisation (WTO) of a proposal [1] to restrict 6 chemicals in toys for children less than 36 months or other toys intended to be placed in the mouth under Appendix C of Annex II in the TSD. We also informed you that the Danish Environmental Protection Agency (EPA) announced that an agreement was made by the European Committee for toy safety to restrict 4 preservatives from this proposal.

On 24 November 2015, the EU published Directives (EU) 2015/2115 [2], 2015/2116 [3] and 2015/2117 [4] restricting the use of 5 chemicals in toys for children under 36 months or other toys intended to be placed in the mouth under Appendix C of Annex II in the TSD. These 5 chemicals are:

1. 1,2-Benzisothiazol- 3(2H)-one (BIT, CAS 2634-33-5)

2. 5-Chloro-2-methylisothiazolin-3(2H)-one (CMI) and 2-methylisothiazolin-3(2H)-one (MI) (CMI:MI = 3:1, CAS 55965-84-9)

3. 5-Chloro-2-methylisothiazolin-3(2H)-one (CMI, CAS 26172-55-4)

4. 2-Methylisothiazolin-3(2H)-one (MI, CAS 2682-20-4)

5. Formamide (CAS 75-12-7)

According to the Directives, the chemicals 1 to 5 are known to be used in the following toy applications:

  • Chemical 1 is used as a preservative in water-based toys, including hobby paints and finger paints.
  • Chemicals 2, 3 and 4 are used as preservatives in water-based toys, including hobby paints, finger paints, window / glass paints, glues and soap bubbles.
  • Chemical 5 (formamide) is used as a solvent, plasticiser or as a chemical associated with a blowing agent used in the manufacture of foams such as used for toy puzzle mats.

It is interesting to note that Directive (EU) 2015/2115 places a restriction of no more than 200 mg/kg formamide content in foam toy materials, including an emission limit of no more than 20 μg/m³ as an alternative.

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

  • 24 May 2017 for chemicals 1 and 5
  • 24 November 2017 for chemicals 2, 3 and 4

Highlights of the new laws are summarised in Table 1.

Amendment to Appendix C of Annex II under Toy Safety Directive 2009/48/EC

[Chemical Number]
Citation Scope Method Requirement, unless otherwise stated, is total content Enforcement Date


Directive (EU) 2015/2116
  • Toys intended for children under 36 months
  • Other toys intended to be placed in the mouth
EN 71 Parts 10-11:2005 ≤ 5 mg/kg


24 May




Directive (EU) 2015/2115


ISO 16000-6 and

ISO 16000-9

≤ 200 mg/kg otherwise

≤ 20 μg/m³ emission (max. 28 days)

(Foam toy materials)

24 May


CMI and MI (3:1) [2] Directive (EU) 2015/2117 Not stated

≤ 1 mg/kg


24 November 2017
CMI [3] Not stated

≤ 0.75 mg/kg


MI [4] Not stated

≤ 0.25 mg/kg


SGS offers a wide range of services to ensure that your products comply with the EU Toy Safety Directive. We offer training, safety/risk assessment, technical documentation check, labelling review, testing according to harmonised standards, SVHC screening, inspections and audits. With the largest global network of toy experts and testing facilities around the world - around 20 toy labs worldwide including 3 EU Notified Bodies (France, Germany and Netherlands), SGS is the partner to trust. Please do not hesitate to contact us for further information or visit our website.

For enquiries, please contact:

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

Stay on top of regulatory changes within your industry: subscribe to SafeGuardS!

© SGS Group Management SA – 2015– All rights reserved - SGS is a registered trademark of SGS Group Management SA. This is a publication of SGS, except for 3rd parties’ contents submitted or licensed for use by SGS. SGS neither endorses nor disapproves said 3rd parties contents. This publication is intended to provide technical information and shall not be considered an exhaustive treatment of any subject treated. It is strictly educational and does not replace any legal requirements or applicable regulations. It is not intended to constitute consulting or professional advice. The information contained herein is provided “as is” and SGS does not warrant that it will be error-free or will meet any particular criteria of performance or quality. Do not quote or refer any information herein without SGS’s prior written consent.