Canada Proposes to Amend Cosmetic Ingredient Hotlist

1

Basic Violet 4

Conditions being considered for addition include restricting the use of Basic Violet 4 in cosmetics to certain product types, with maximum permitted concentrations for those product types.

Further to the Chemicals Management Plan (CMP) assessment under the Canadian Environmental Protection Act, 1999 (CEPA 1999), Basic Violet 4 will be proposed for addition to the list of substances described as restricted due to potential carcinogenicity. At the time of the CMP assessment, Basic Violet 4 was associated with health effects of concern, however at levels of exposure considered in the assessment, the risk to human health was considered low. Since then, based on cosmetic notifications submitted to Health Canada after the CMP assessment period, levels of exposure have increased and may now pose a risk.

2

Basic Blue 7

Conditions being considered for addition include restricting the use of Basic Blue 7 in cosmetics to certain product types, with maximum permitted concentrations for those product types.

Conditions being considered for addition include restricting the use of Basic Blue 7 in cosmetics to certain product types, with maximum permitted concentrations for those product types.

3

Polyaminopropyl Biguanide (CAS 32289-58-0; 27083-27-8; 28757-47-3, also known as PHMB)

1. Prohibition of PHMB in cosmetic spray formulations is being considered, since inhaling PHMB through products that create mists, vapours or aerosols may affect lung function;

2. For other topically applied products where exposure by inhalation is not possible, maximum permitted concentrations will be proposed due to risk of skin sensitization.

Further to the CMP assessment under the CEPA 1999, Polyaminopropyl Biguanide will be proposed for addition to the list of substances described as restricted.

1

Symphytum spp., with the exception of Symphytum officinale

Prohibited

A revision to the entry is being considered to remove the exception of Symphytum officinale.

It was previously excluded from the entry as past studies suggested it did not contain echimidine, a hepatotoxic alkaloid. However, echimidine has since been detected in some S. officinale derivatives and S. officinale is also known to contain other carcinogenic pyrrolizidine alkaloids, such as lasiocarpine.

2

Brucine

Restricted, with a maximum concentration of 0.1%.

1. A revision to the entry to describe it as prohibited is being considered.

The substance raises safety concerns due to its high acute toxicity, known neurotoxic properties and significant potential for dermal absorption. Additionally, currently available information is considered insufficient to address potential long-term adverse health effects from repeated exposure to cosmetic products containing brucine.

2. An expansion of the entry to Brucine and its salts is also being considered

The toxicity of salts, such as brucine sulfate, is anticipated to be similar to that of brucine based on their ability to dissociate and release brucine ions.

3

Imperatorin

Prohibited

It is being considered for removal from the prohibited list. Imperatorin would instead be considered subject to the entry for Furocoumarins.

Imperatorin is expected to have phototoxic and photomutagenic effects similar to other furocoumarins.

4

Furocoumarins, except for naturally occurring in plant extracts

Restricted, with a maximum concentration of 1 ppm in sun tanning products.

A revision to the entry is being considered to indicate Furocoumarins are not permitted to be added to products as ingredients and would only be permitted at trace amounts when naturally occurring in plant extracts.

Furocoumarins have been associated with phototoxicity, photomutagenicity and photocarcinogenicity reactions when combined with exposure to UVA radiation. The current maximum permitted concentration would be proposed to apply to all leave-on products, not just sun-tanning products, because sun exposure may occur following the use of any leave-on cosmetic product.