SAFEGUARDS | Toys & Juvenile ProductsNO. 169/19
In December 2018, the World Trade Organization (WTO) circulated a proposal from the European Union (EU) announcing its intention to include formaldehyde as a restricted substance under Appendix C to Annex II of Directive 2009/48/EC, the Toy Safety Directive (TSD, SafeGuardS 09/19).
On November 20, 2019 the EU published Directive (EU) 2019/1929 to restrict formaldehyde in specific toy materials under Appendix C to Annex II of the TSD. The new law establishes three levels of formaldehyde restriction – migration, emissions and content.
Since publication of the TSD in 2009, the number of substances in Appendix C to the TSD has increased to 11 (Directive 2009/48/EC consolidated version of November 26, 2018). These substances are:
- Tris (2-chloroethyl) phosphate (TCEP, CAS 115-96-8)
- Tris (2-chloro-1-methylethyl) phosphate (TCPP, 13674-84-5)
- Tris [2-chloro-1-(chloromethyl)ethyl] phosphate (TDCP, 13674-87-8)
- Bisphenol A (BPA, CAS 80-05-7)
- Formamide (CAS 75-12-7)
- 1,2-Benzisothiazol- 3(2H)-one (BIT, CAS 2634-33-5)
- 5-Chloro-2-methylisothiazolin-3(2H)-one (CMI, CAS 26172-55-4)
- 2-Methylisothiazolin-3(2H)-one (MI, CAS 2682-20-4)
- 3 to 1 mixture of 5-chloro-2-methylisothiazolin-3(2H)-one (CMI) and 2-methylisothiazolin-3(2H)-one (MI) (CMI:MI (3:1), CAS 55965-84-9)
- Phenol (CAS 108-95-2)
- Formaldehyde (CAS 50-00-0)
Some of these substances are carcinogenic, mutagenic or reprotoxic substances (CMR substances). Unless under exemption, it is important to note that the TSD prohibits all CMR substances.
According to the new Directive, formaldehyde has the following uses:
- As a monomer in the manufacture of polymeric materials
- Formaldehyde resins, including phenol-formaldehyde (PF), urea-formaldehyde (UF), melamine-formaldehyde (MF) and polyacetal (polyoxymethylene (POM) resins in the manufacture of resin-bonded wood products, such as particleboards (PB), oriented-strand boards (OSB), high-density fiberboards (HDF), medium-density fiberboards (MDF) and plywood (PW)
- Manufacture of textile and leather toy materials
- As a preservative in water-based toys, such as soap bubbles and ink in felt-tip pens, as well as in dry materials intended to be mixed with water prior to use
Highlights of formaldehyde restrictions in the new Directive are summarized in Table 1.
| Directive (EU) 2019/1929 amending Appendix C under Annex II to TSD
‘Toys intended for children under 36 months or other toys intended to be placed in the mouth’
|Substance||Method (Preamble)||Toy material||Requirement||Effective Date|
|Formaldehyde migration||EN 71-10:2005 and
|Polymeric||≤ 1.5 mg/L||
May 21, 2021
|Formaldehyde emission||EN 717-1:2004||Resin-bonded wood||≤ 0.1 mL/m³|
|Formaldehyde content||EN ISO 14184-1:2011||Textiles||≤ 30 mg/kg|
|EN ISO 17226-1:2008’||Leather||≤ 30 mg/kg|
|EN 645:1993 and EN 1541:2001||Paper||≤ 30 mg/kg|
|EQDM method*||Water-based||≤10 mg/kg|
|*Determination of free formaldehyde in cosmetic products by the European Directorate for the Quality of Medicines & Healthcare|
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.
Stakeholders are advised to comply with the latest toy safety requirements for the EU market.
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