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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) and phenol, 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 Committee4, taking into account the limits in existing FCM regulation for plastic materials and toy safety standards.
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 |
Carcinogenic 1A |
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) |
Acrylonitrile |
107-13-1 |
Carcinogenic 1B |
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) |
Acrylamide |
79-06-1 |
Carcinogenic 1B, |
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 |
Substance |
CAS# |
Substance |
CAS# |
Bisphenol A (BPA) |
80-05-7 |
Acrylamide |
79-06-1 |
Phenol |
108-95-2 |
Ethylenimine |
151-56-4 |
Formaldehyde |
50-00-0 |
2,4-Toluene-diisocyanate |
584-84-9 |
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 |
2-Methyl-1,3- butadiene |
78-79-5 |
1,3-Phenylene-diamine |
108-45-2 |
Epichlorohydrin |
106-89-8 |
Trioxane |
110-88-3 |
Acrylonitrile |
107-13-1 |
Styrene |
100-42-5 |
[1] ANEC position paper on monomers in toys, May 2018
[2] Regulation (EU) No. 10/2011 on plastic materials and articles intended to come into contact with food
[3] CLP Regulation (EC) No. 1272/2008
[4] SCHER opinion on risk from organic CMR substances in toys, May 2010
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