The EU has recently amended the Toy Safety Directive (TSD) to include the restriction of phenol in certain toys. The restriction will become effective on November 4, 2018.
In October 2014, we [1] informed you that the World Trade Organization (WTO) had circulated a proposal from the European Union (EU) to regulate six 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 to the TSD. These six chemicals are:
In November 2015, the EU published regulations to restrict BIT, CMI, CMI:MI (3:1), formamide and MI. The restriction of these five chemicals [2] will be implemented in two phases starting on May 24, 2017.
On May 4, 2017, the EU published Directive (EU) 2017/774 [3] to restrict phenol (CAS 108-95-2), a mutagenic category 2 substance, in toys falling under Appendix C of Annex II to the TSD. There are two sets of limits:
The new restrictions will become effective on November 4, 2018.
Highlights of the new law are summarized in Table 1.
| Directive (EU) 2017/774 amending Appendix C of Annex II to the TSD | |||||
|---|---|---|---|---|---|
| Substance | Scope | Toy material or application | Method | Requirement | Effective Date |
| Phenol |
| Polymeric | EN 71 Parts 10-11 | ≤ 5 mg/L (Migration) | November 4, 2018 |
| As a preservative | ≤ 10 mg/kg (Total content) | ||||
Phenol has a number of applications in toys, including:
Table 2: Definitions
| Item | Acronym | CAS | Chemical |
|---|---|---|---|
| 1 | BIT | 2634-33-5 | 1,2-Benzisothiazol- 3(2H)-one |
| 2 | CMI | 26172-55-4 | 5-Chloro-2-methylisothiazolin-3(2H)-one |
| 3 | CMI:MI (3:1) | 55965-84-9 | 5-Chloro-2-methylisothiazolin-3(2H)-one (CMI) and 2-methylisothiazolin-3(2H)-one (3:1 mixture) |
| 4 | --- | 75-12-7 | Formamide |
| 5 | MI | 2682-20-4 | 2-Methylisothiazolin-3(2H)-one |
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 harmonized 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 Hardlines Information and Innovation Manager
t: +852 2774 7420
Stay on top of regulatory changes within your industry: subscribe to SafeGuardS!
© SGS Group Management SA - 2017 - 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.
