Relevant for: Toys & children's products
A consumer organisation, European Association for the Coordination of Consumer Representation in Standardization (ANEC), recently published a position paper1 that calls for specific monomers requirements in Appendix C of the Toy Directive 2009/48/EC.
Back to 2017, Germany identified 20 monomers with CMR (carcinogenic, mutagenic or toxic of reproduction) properties that are regulated in FCM Regulation (EU) No. 10/2011 for plastics2, and proposed to derive specific limits for the monomers in toys. Germany pointed out that the general CMR limits according to CLP Regulation3 in toy directive are insufficient to protect children health in some cases.
Two of the monomers, bisphenol A (BPA)4 and phenol5, are already regulated under Appendix C of TSD, and a restriction for formaldehyde is under preparation by European Commission (EC). Seventeen remaining substances are needed to investigate further and some were already identified as the priority substances that should be restricted.
In the position paper, ANEC analysed the properties, toxicities, possible exposures for 5 priority substances which are likely to be used or found in toys. Content limits are proposed for non-threshold CMR substances following the recommendations given by the Scientific Committee6 , taking into account the limits in existing FCM regulation for plastic materials and toy safety standards.
Table 1. Recommended limits for priority monomers
|Substance||CAS no.||Harmonised classification ||Recommended limit||Test method||Potential application|
|Vinyl chloride (chloroethylene)||75-01-4||Carcinogenic 1A||1 mg/kg||EN ISO 6401 Determination of residual vinyl chloride monomer||Polyvinyl chloride (PVC)|
|1,3 butadiene (buta-1,3-diene||106-99-0|
|1 mg/kg||EN 13130-4 Determination of 1,3-butadiene in plastics||Acrylonitrile butadiene styrene (ABS), thermoplastic elastomers, rubbers such as styrene-butadiene (SBR)|
|1 mg/kg||ISO 4581 Determination of residual acrylonitrile monomer content||Styrene-acrylonitrile (SAN), acrylonitrile butadiene styrene (ABS), acrylonitrile styrene acrylate (ASA), and other synthetic rubbers such as acrylonitrile butadiene (NBR)|
Toxic of reproduction 2
|1 mg/kg ||To be determined||Polyacrylamides|
|Styrene||100-42-5||Toxic of reproduction 2||0.077 mg/l stimulant||EN 71-10 Organic chemical compounds – Sample preparation and extraction||Polystyrene (PS), acrylonitrile butadiene styrene (ABS), styrene-butadiene rubber (SBR), styrene-acrylonitrile resin (SAN) and unsaturated polyesters|
Table 2: Full list of monomers with CMR properties identified by Germany
|Bisphenol A (BPA)||80-05-7||Acrylamide||79-06-1|
|Vinyl chloride (chloroethylene)||75-01-4||Diphenylmethane-2,4´-diisocyanate||5873-54-1|
|1,3 butadiene (buta-1,3-diene)||106-99-0||1,4-Dihydroxy-benzene||123-31-9|
|Ethylene oxide||75-21-8||Vinyl acetate||108-05-4|
|Propylene oxide||75-56-9||Vinylidene chloride||75-35-4|