Final Screening Assessment Shows Monoazo Pigments Pose No Risk to Human Health, Environment

Findings in a recent screening assessment published by Environment and Climate Change Canada and Health Canada (the Ministries)  found that 32 of 33 monazo pigments, including C.I. Pigment Red 4, do not require risk management action, which is a victory for the Color Pigments Manufacturers Association, Inc. (CPMA) and the color pigments industry.  

The Final Screening Assessment for Certain Monoazo Pigments, released May 28, concludes that C.I. Pigment Red 4, which is used in lipstick formulations, does not pose a risk to either human health or the environment based on information CPMA and the Canadian Cosmetic, Toiletry and Fragrance Association (CCTFA) shared with the Ministries. Collective input clarified use of C.I. Pigment Red 4 in lipstick formulations and current regulations in Europe and the United States. This information is reflected in the revised conclusion of the final assessment which ensures the continued safe use of C.I. Pigment Red 4 in lipstick applications. 

“This is an example of the effectiveness of the Canadian Chemicals Management Plan in action and the importance of collaborative engagement in this science- and risk-based approach that is the hallmark of the Canadian sound management of chemicals program,” Beta Montemayor, CCTFA director, environmental science and regulation.

The final assessment, published as part of the Second Phase of the Canadian Chemicals Management Plan, provides the most comprehensive government review to date of the ecological and toxicological characteristics and safety of the monoazo pigments, considering uses in sensitive applications such as cosmetics, art and craft materials for children and tattoos, as well as end use environmental scenarios, such as deinking of printed paper.

“CPMA continues to work with the Ministries to successfully inform and guide the regulatory process in Canada,” said John Marten, CPMA president. “The outcome of the final assessment is another example of the positive impact CPMA’s collaborative efforts have had on the industry in North America.”  

The final assessment also concludes:

• The Significant New Activity in Canada (SNAC) rule previously issued for C.I. Pigment Red 3 as a result of the First Phase of the Canada Chemicals Management Plan remains unchanged. 

• Four previously assessed substances were found not to be potentially persistent, bioaccumulative and inherently toxic (PBiT). As a result, the Ministries proposed to immediately rescind the existing SNAC rules for C.I. Pigment Yellow 60, C.I. Pigment Red 251, NANPAP and NAPNPA.

• With respect to the bioavailability of pigments, the final assessment concludes: “Bioavailability of monoazo pigments is expected to be low based on the particulate character of these substances and their low solubility in water. As a result, the potential to bioaccumulate in pelagic organisms is expected to be low, which is confirmed by the results of bioconcentration studies.”