If you require any assistance, require formulation reviews, have any questions or would like to understand more about how this impacts your business, please do reach out to us.

Retinal (CAS No. 116-31-4 – Retinaldehyde) – added as a restricted ingredient.

a) Permitted in leave-on products intended for full body application at a maximum concentration of 0.01%.

b) Permitted in other cosmetics at a maximum concentration of 0.05%.

Thioglycolic acid esters (CAS No. 30618-84-9; CAS No. 25103-09-7 – Glyceryl thioglycolate; Isoocytl thioglycolate)  – added as a prohibited ingredient.

Mixed cresols and derivatives – entry revised to reflect:

Prohibition of p-Cresol and mixtures thereof – CAS No. 106-44-5; 1319-77-3 – Mixed cresols

m-Cresol (CAS 95-48-7; 108-39-4) restricted as follows:

a) Not permitted in cosmetics intended to be used on or around mucosal membranes such as eyes, mouth or nose.

b) Restricted in other cosmetics at a maximum of 0.1%, and product label must bear the warning “Do not use in the area of the eye, mouth or nose”.

o-Cresol (CAS 95-48-7;108-39-4) restricted as follows:

a) Not permitted in cosmetics intended to be used on or around mucosal membranes such as eyes, mouth or nose.

b) Restricted in other cosmetics at a maximum of 0.1%, and product label must bear the warning “Do not use in the area of the eye, mouth or nose”.

Peroxide and peroxide-generating compounds (CAS No. – 124-43-6; 1305-79-9; 7722-84-1; 1335-26-8; 7632-04-4; 1314-22-3 – Urea peroxide / Urea (carbamide) peroxide; calcium peroxide; calcium dioxide; hydrogen peroxide; magnesium peroxide; sodium perborate; zinc peroxide) – entry revised to:

• Introduce a maximum permitted concentration of 10% (as applied) for hair products.

• Introduce conditions for eyelash and eyebrow products, which include a maximum permitted concentration of 10%, that such products must be sold for professional use only and the requirement for the statements “For professional use only” and “Avoid contact with eyes and, in the event of contact with eyes, rinse immediately with plenty of water and seek medical attention” to be listed on labels.

• Indicate that these ingredients are not permitted for use in products intended for application to the genital area.

Conditions of use for oral products were not changed from the previous version.

Benzoyl peroxide (CAS No. 94-36-0) – entry revised to indicate that the ingredient may only be used in nail products for professional use, along with a requirement for the statements “For professional use only”, “Avoid skin contact” and “Read directions carefully before using” to be included on labels.

Retinol and its esters (CAS No. 68-26-8; 127-47-9; 79-81-2;631-89-0; 7069-42-3 – Vitamin A; Retinyl acetate; Retinyl palmitate; Retinyl linoleate; Retinyl propionate) – entry revised to reflect a reduced maximum concentration in leave-on products intended for full body application to 0.2% total retinol equivalents. Other cosmetics continue to be restricted to a maximum restricted concentration of 1% retinol equivalents. 

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The post Canadian Cosmetic Regulations Updated! appeared first on Focal Point.

• Additions to the Hotlist
• Changes to the conditions for existing entries on the Hotlist
• Changes to include additional substance identifiers or make minor corrections

A detailed list of proposed updates to the Hotlist can be found here.

This Notice to Stakeholders is being issued approximately three months before the consultation period. As such, those selling cosmetics in Canada should start to determine which of their products could be impacted by the potential updates and consider any necessary changes to product formulations, distribution and sales. Health Canada will not respond to any information or comments received at this stage.

Don’t hesitate to contact us if you have any questions about the updates or would like our assistance determining if this proposal could impact your products.

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The amended regulations would inform consumers of the presence of certain fragrance allergens within a cosmetic product, outside of the term “fragrance/parfum”. This change in labelling will allow for consumers the choice of avoiding products containing fragrance allergens to which they may be sensitive.

As this will affect labels of many cosmetic products, Health Canada will determine an appropriate coming-into-force strategy for the cosmetic industry. The opportunity for the industry to provide comments will be expected to take place in spring 2022 and last 70 days.

If you have any questions on this, please do not hesitate to contact us.

The post Health Canada To Amend Cosmetic Regulations – Enhance Regulatory Oversight appeared first on Focal Point.

• Certain cosmetics contain chemicals called per- and polyfluoroalkyl substances (PFAS). The Government of Canada assessed three groups of PFAS (salts and precursors of perfluorooctanoic acid (PFOA), long-chain perfluorocarboxylic acids (LC-PFCAs), and perfluorooctane sulfonate (PFOS) and concluded they are toxic under the Canadian Environmental Protection Act, 1999. They were subsequently prohibited in Canada under the Regulations. A detailed list of toxic substances can be found at https://lawslois.justice.gc.ca/eng/regulations/SOR-2012-285/FullText.html
• Ingredients that are associated with this group of substances may include, for example, pigments and bulking agents treated with PFAS, such as mica and talc, and fluorinated versions of polymers, such as fluorinated dimethicone and fluorinated silicone.
• These chemicals in cosmetics increase wear, durability, spreadability, and water and oil resistance of applied cosmetics. Example- Foundations, Liquid Lipsticks, and Waterproof Mascara.
• Importers must carefully import cosmetics into Canada from other countries. Although prohibited in Canada, some substances may still be legally manufactured or used in different countries and integrated into products.
• To know more about the exemptions to the Regulations and measures that can be undertaken to comply, visit- https://www.canada.ca/prohibited-chemical-substances

If you need any assistance or have any questions about whether this notification applies to your company or have any concerns, do not hesitate to contact us.

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Substances that are imported or manufactured with respect to use patterns beyond the scope of the Food and Drugs Act are subject to notification requirements.

If your company manufactured or imported any applicable substance, in 2019 or 2020, in a total quantity greater than 100 kg, and that is in, or is intended to be in, an applicable product. The list of applicable substances can be found at: https://canadagazette.gc.ca/rp-pr/p1/2022/2022-03-12/html/notice-avis-eng.html#na2.

Every person to whom this notice applies shall comply with this notice within the timeframe specified. Responses to this notice shall be submitted to the Minister of the Environment, no later than September 14, 2022, using the online reporting system available through Environment and Climate Change Canada’s Single Window.

Should you not meet the requirements of the notice and have no interest in the substances, you may submit a Declaration of Non-Engagement (DNE).

If you require any assistance in determining whether or not this notice applies to your company or if you need assistance with gathering information and responding to the notice, please do not hesitate to contact us.

The post NOTICE WITH RESPECT TO CERTAIN SUBSTANCES ON THE REVISED IN COMMERCE LIST (R-ICL) appeared first on Focal Point.

Talc is a naturally occurring mineral that can be found in a number of self-care products, including cosmetics, non-prescription drugs and natural health products (NHPs). The final assessment identified the following:

1. It may cause ovarian cancer when present in products intended for use in the genital area such as wipes, baby powder, diaper and rash creams, bath bombs, and genital antiperspirants or deodorants;
2. It is potentially harmful to your lungs if you breathe in loose powder products such as body, baby and face powders;
3. It does not present any health concerns if used in pressed powder products, dry shampoos, foot powders, products that come into contact with skin excluding the genital area and non-prescription products or NHPs intended to be ingested;
4. It is not harmful to the environment.

Talc is currently listed on the Cosmetic Ingredient Hotlist and is restricted in cosmetic products intended to be used on children. Given the results of the risk assessment, Health Canada is proposing further action to lower talc exposure from products that could be inhaled or used in products intended for the genital area. The proposed actions include:

• Adding talc to the Toxic Substances List in Schedule 1 of the CEPA – this would not restrict its use, manufacture or import, but rather enable the Government to take risk management actions under CEPA
• Changing existing entries on the Cosmetic Ingredient Hotlist and NHP Ingredient Database to include measures to reduce exposure to talc from products which may be inhaled or result in perineal exposure

Industry and other interested stakeholders are invited to participate in an electronic consultation on the proposed Risk Management Approach until Jun. 23, 2021.

If you have any questions or concerns or would like further clarification on the implications of the risk assessment and risk management approach, please feel free to contact us.

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The proposed new additions to the Cosmetic Ingredient Hotlist, as released by Health Canada, are as follows:

Ethylhexyl Ethylhexanoate

This entry is proposed to be restricted in body lotions to a maximum concentration on 0.1%, in foot lotions to a maximum concentration of 0.5% and in face make-up to a maximum concentration on 0.6%. Health Canada is considering the addition of Ethylhexyl Ethylhexanoate to the Cosmetic Ingredient Hotlist “due to health concerns, as assessed by the Government of Canada’s Chemicals Management Plan (CMP) under the Canadian Environmental Protection Act, 1999 (CEPA 1999).”

Azelaic acid and its salts

Azelaic acid and its salts are proposed to be restricted in leave-on products to a maximum concentration of 0.3% and in rinse-off products to a maximum concentration of 10%. The addition of this entry is being considered “due to therapeutic properties at certain concentrations and risk of skin irritation at high concentrations”.

The proposed amendments to existing Hotlist entries, as released by Health Canada, are as follows:

Retinoic acid or its salts or derivatives

It is proposed this entry be on the list of ingredients that are prohibited for use in cosmetic products. The purpose of this revision is to “clarify that derivatives and salts of retinoic acid are captured by the entry. These substances are currently captured under the Prescription Drug List entry for “Tretinoin or its salts or derivatives”.”

Alpha-Hydroxy Acids including polyhydroxy acids and bionic acids with alpha hydroxyl groups, and their salts

This entry is proposed to be revised to “clarify that PHAs and bionic acids with alpha-hydroxyl groups, as well as their salts, are captured by the existing entry.”

Eucalyptus oil

A modification to this entry is proposed to “better mitigate risk of unintentional ingestion, particularly in pediatric populations” by adding the following warnings and cautionary statements to cosmetics in non-solid forms:

“This product contains eucalyptus”

“Keep out of reach of children”

 “In case of accidental ingestion, call a Poison Control Centre or doctor immediately.”

Peroxide and peroxide-generating compounds

The proposed amendment for this entry is states that “If an oral cosmetic contains more than 3% hydrogen peroxide (or equivalent), notifiers must submit a clinical study to demonstrate the salivary peroxide levels do not exceed 3% during the use of the product as per the directions of use.” This is a modification from the current restriction which requires proof of the hydrogen peroxide levels in saliva, as well as within the soft tissue of the oral cavity.”

p-Hydroxyanisole

“A revision to the entry is being considered to expand the permitted nail product categories, including products for consumer use, and increase the maximum concentration permitted for these products” to 0.1%.

There is now a 60 day consultation period, ending December 12, 2020, during which individuals and stakeholders from the Canadian public have the opportunity to submit comments on the proposed updates. A full list of these proposed updates, as well as information on where to submit comments, can be found here.

For more information, please contact Focal Point Research Inc.  We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA.

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During this time of increased cannabis cosmetic products, there have been many changes to regulatory protocols internationally, which we have previously reported on. The original varying regulatory protocols made the market for cannabis containing cosmetics more accessible for independent manufacturers rather than international cosmetic manufacturers. However, as regulations have become more solid and clear throughout the years, both independent and international companies entered the cannabis cosmetic market.

A recent example of an international company entering the cannabis cosmetic market is Colgate with their new Hello Products. This line of products includes oral care and lip balms containing CBD. The oral care line comprises of mouthwashes and toothpastes both with and without fluoride. Avon has also recently released a CBD line of topical creams in their new distillery collection. These creams have been advertised to promote hydrated and healthier looking skin. Some international companies not only had to overcome complicated regulations, but complications in formulations. For example, earlier this year Gelest created a new CBD isolate that was compatible with their silicone-based products.

Despite the extreme success, there are still some gaps in our knowledge regarding CBD in oil drops, foods, cosmetics, topical lotions, and creams. The US FDA continues to research the effects of cumulative use, co-administration with other drugs, and impacts on vulnerable populations such as children and pregnant women. Overall, the FDA suggests consulting with a medical physician before beginning to use any cannabis products. There is also research outside of the government, such as the research at the University of Mississippi. There, scientists are exploring various levels of CBD and THC

in cosmetic products and their dermal penetration. In the end, the cannabis cosmetic market is will continue to gain momentum and the research behind it is advancing to support it.

For more information, please contact Focal Point Research Inc. We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA

Emily Campbell

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