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:
- Four preservatives (BIT, CMI:MI (3:1), CMI and MI)
- Formamide
- Phenol
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:
- No more than 5 mg/L for migration from polymeric materials
- No more than 10 mg/kg for content when used as a preservative
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:
- As an antioxidant in polymers
- As a monomer for phenolic resins in the manufacture of resin-bonded wood
- As a preservative in toys containing water (water-based liquid toys) such as bubble-blowing products and felt-tipped marker pens
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
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