December 13, 2019 - The European Union (EU) has published legislation to restrict the use of formaldehyde in certain toy materials under Appendix C to Annex II of Directive 2009/48/EC, the so-called Toy Safety Directive (TSD).
Issued on November 20, 2019, Directive (EU) 2019/1929 introduces three levels of formaldehyde restriction:
• Migration
• Emission
• Content
The directive establishes formaldehyde as being used in the following ways:
• Polymeric materials - as a monomer in the manufacturing process
• Resin-bonded woods - 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)
• Textiles and leather - during manufacture
• Water-based toys - as a preservative (e.g. in soap bubbles, ink in felt-tip pens, and dry materials intended to be mixed with water before use)
Directive (EU) 2019/1929 makes the following restrictions on ‘toys intended for children under 36 months or other toys intended to be placed in the mouth’:
• Formaldehyde migration (polymeric toy materials): ≤ 1.5 mg/L.
Test methods: EN 71-10:2005 and EN 71-11:2005
• Formaldehyde emission (resin-bonded wood toy material): ≤ 0.1 mL/m³
Test method: EN 717-1:2004
• Formaldehyde content:
o Textiles: ≤ 30 mg/kg Test method: EN ISO 14184-1:2011
o Leather: ≤ 30 mg/kg Test method: EN ISO 17226-1:2008’
o Paper: ≤ 30 mg/kg Test method: EN 645:1993 and EN 1541:2001
o Water-based: ≤ 10 mg/kg Test method: EQDM method
TSD was published in 2009. Since then, several substances have been added to Appendix C, including:
1. Tris (2-chloroethyl) phosphate (TCEP, CAS 115-96-8)
2. Tris (2-chloro-1-methylethyl) phosphate (TCPP, 13674-84-5)
3. Tris [2-chloro-1-(chloromethyl)ethyl] phosphate (TDCP, 13674-87-8)
4. Bisphenol A (BPA, CAS 80-05-7)
5. Formamide (CAS 75-12-7)
6. 1,2-Benzisothiazol- 3(2H)-one (BIT, CAS 2634-33-5)
7. 5-Chloro-2-methylisothiazolin-3(2H)-one (CMI, CAS 26172-55-4)
8. 2-Methylisothiazolin-3(2H)-one (MI, CAS 2682-20-4)
9. 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)
10. Phenol (CAS 108-95-2)
11. Formaldehyde (CAS 50-00-0)
Some of these substances have been identified as carcinogenic, mutagenic or reprotoxic substances (CMR substances). Unless under exemption, it is important to note that the TSD prohibits all CMR substances.
The requirements of Directive (EU) 2019/1929 will come into effect on May 21, 2021.
SGS EU Toy Directive Services
SGS offers a wide range of services to ensure that products comply with the EU Toy Safety Directive. They offer training, safety/risk assessment, technical documentation check, labelling review, testing according to harmonized standards, SVHC screening, inspections and audits. They have the world’s largest network of toy experts and testing facilities, including around 20 toy laboratories and three 3 EU Notified Bodies (France, Germany and Netherlands). Learn more about SGS’s EU Toy Directive Services. [www.sgs.com/en/Consumer-Goods-Retail/Toys-and-Juvenile-Products/Toys/EU-Toy-Directive.aspx]
SGS SafeGuardS keep you up to date with the latest news and developments in the consumer goods industry. Read the full EU Restricts Formaldehyde in Certain Toys SafeGuardS. [www.sgs.com/en/news/2019/11/safeguards-16919-eu-restricts-formaldehyde-in-certain-toys]
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