On 31 October 2012, the European Commission (EC) submitted to the World Trade Organisation (WTO) its draft regulation on amending the restriction of polycyclic aromatic hydrocarbons (PAH), entry 50. The amendment is expected to be published by the 2nd half of 2013 and will apply in mid-2015. This extends the current PAH restriction to include rubber and plastic materials in consumer products such as toys, household utensils, tools for domestic use, sports equipment, footwear and clothing. If those articles fail to meet the PAH requirements, they cannot be placed on the EU market.
Germany proposed the amendment to EC in 2010 with the same list of PAH as the one currently restricted under REACH (see Table A). This is the first time a restriction is proposed using the fast track procedure under REACH Article 68.2, which allows substances that could be used by consumers and meeting the classification as carcinogenic, mutagenic or toxic to reproduction, category 1A or 1B, to be placed under restriction faster than the standard procedure.
PAHs are found in oil, coal and tar deposits and in extender oils used for the production of tyres and in some plastic or rubber product components such as the handles of tools. They are not added to the products intentionally but are present as impurities. The scope of the proposed amendment is limited to rubber and plastic components which come into direct and prolonged contact with the human skin or the oral cavity. The proposal aims at safeguarding consumers’ health by addressing the risks that may be posed by those articles through dermal adsorption and ingestion.
For a comparison of the current and the proposed restriction, please refer to Table B for details.
Table A: PAH under REACH Annex XVII, entry 50
Table B: Comparison of current and proposed PAH restriction scope and limit under REACH Annex XVII, entry 50
REACH Annex XVII, entry 50
Extender oils and tyres for vehicles
≤1 mg/kg (BaP) or
≤10 mg/kg (sum of all listed PAH)
Extended to include rubber or plastic components that may come into direct and prolonged contact with the human skin or the oral cavity, under normal or reasonably foreseeable conditions of use
≤ 1 mg/kg by weight of the component for any of the listed PAH