Contradictory approaches to 100kg/year reporting threshold taken
29 March 2017 / Canada, CMRs, Environmental Protection Act, Personal care, Risk assessment
A Canadian draft screening assessment has found that 2-ethylhexyl 2-ethylhexanoate is harmful under section 64 of the Canadian Environmental Protection Act, 1999 (Cepa, 1999).
The conclusion would lead the government to designate the substance as ‘toxic’ and add it to schedule 1 of the Act, triggering regulatory action to manage the risks. Correspondingly, the authorities have published a risk management scope document.
In Canada, 2-ethylhexyl 2-ethylhexanoate is used in cosmetic products, such as face make-up and foot lotion. In contrast, its use in cosmetics is prohibited in the EU. This is because it has a mandatory category 2 reproductive toxicity classification under CLP.
The Canadian assessment proposed to find that the substance meets the section 64 criterion relating to human health, on account of its reproductive toxicity.
In contrast with previous assessments, the conclusion of harm was reached despite there being no reports of manufacture or import above the reporting threshold of 100kg/year.
Earlier this month, the Canadian government reversed its draft conclusion on 73 textile dyes based specifically on the threshold. The draft assessment found that the dyes were harmful but, in the final assessment, the government decided this was not the case. Instead, it ruled that eight low molecular weight dyes with potential to harm aquatic organisms were not used commercially in Canada because none exceeded the 100kg/year reporting threshold.
The government assessed calcium 2-ethylhexanoate as part of the same draft. It concluded that the substance was not harmful under section 64 of Cepa, 1999.
Occupational exposures were outside the scope of the assessment.
The government has initiated a 60-day public comment period for the assessment and the 2-ethylhexyl 2-ethylhexanoate risk management scope document. Interested parties have until 24 May to submit comments.