Environment Canada/Health Canada has recently issued three draft screening assessment reports on certain azo disperse dyes, azo solvent dyes and monoazo pigments, summarising relevant toxicological and environmental data to determine whether they should be classified as “toxic” under Section 64 of the 1999 Canadian Environmental Protection Act (CEPA). The following conclusions were reached on human health:

  • Azo disperse dyes. On the basis of the available data regarding toxicity and estimated exposure, risk to human health is expected to be low.
  • Azo solvent dyes. Carcinogenicity, genotoxicity and haematological effects were considered critical but, as exposure to these substances is either not anticipated or is considered negligible, they are not expected to present a health risk.
  • Monoazo pigments. No concerns were raised regarding human health, with the exception of Pigment Red 4. Based on inadequate margins between estimated oral exposures (in licensed natural health products and lipstick) and the critical effect level for (liver) carcinogenicity, it was concluded that this substance “is potentially entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health”.

Environment Canada, Health Canada. Draft screening assessments (dated November 2013). Aromatic azo and benzidine-based substance grouping:

Certain azo disperse dyes.


Certain azo solvent dyes.


Certain monoazo pigments.



The above items were taken from the December 2013 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here

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