In December 2013 the European Chemical Agency (ECHA) added 54 new substances to the candidate list of Substances of Very High Concern (SVHC) of which two are also approved for use in plastic food contact materials. Methyloxirane Propylene oxide (CAS 75-56-9) and 1-Methyl-2-pyrrolidone (CAS 872-50-4) were listed because of their toxicological properties. They have been identified as carcinogenic/mutagenic and as toxic for reproduction, respectively. The two substances have been approved for use in food contact materials in Europe and are listed as authorized monomers, starting substances, macromolecules obtained from microbial fermentation, additives and polymer production aids in Annex I of Regulation EC/10/2011. Methyloxirane Propylene oxide is listed as a monomer with a migration limit of 1mg/kg food and an 1-Methyl-2-pyrrolidone is listed as an additive with a specific migration limit of SML = 60mg/kg.
Already before December 2012, 8 substances authorized for use in plastic food contact materials could also be found in the list of Substances of Very High Concern including dibutyl phthalate (DBP), bis(2-ethylhexyl)phthalate (DEHP) boric acid and acrylamide. They were all categorized as SVHC either due to their carcinogenic and mutagenic potential or because they are considered as toxic for reproduction.
SVHC are candidate substances for inclusion in the Annex XIV of REACH (EC/1907/2006). The Member State Committee of ECHA nominates substances from the candidate list for inclusion in Annex XIV. Inclusion in Annex XIV requires approval by the European Commission. The use of substances listed in Annex XIV of REACH requires specific authorization by the European Commission. Substances listed in Annex XIV of REACH shall eventually be phased out.
European Chemical Agency (ECHA). Candidate list of Substances of Very High Concern. Retrieved February 20, 2013 from the website of ECHA.