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 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.

How may this affect your business?

Notable changes brought by Bill 96 include narrowing the recognized trademark exception (that applies to registered and unregistered marks) to only apply to registered trademarks on product packaging. Even if your non-French mark is registered, any generic or descriptive portions included in your registration will have to appear in French elsewhere on the product permanently affixed to it. Other changes include a prohibition on making available commercial publications, invoices, receipts, and other documents in another language unless the French translation is unavailable.

Businesses will have three years to comply, and these requirements come into force on June 1, 2025. Fines will be imposed for non-compliance ranging from $700 to $7000 (for individuals) and $3000 to $30,000 (for companies).

For additional information on this or if you have any questions, please do not hesitate to contact us.

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• 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.

The post Potential Presence of Toxic Substances in Cosmetics appeared first on Focal Point.

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.

The FDA will provide companies with guidance on limitations and warnings needed when certain ingredients are incorporated in a product. Other powers brought forth by this bill includes authority over recall. If a company refuses to conduct a recall, the FDA will have the authority to issue recalls on any product that is likely to cause significant harm. 

Other highlights :

• Registration with the FDA, disclosure of ingredients and attest to safety records 

• Must report adverse events within 15 days and annual reporting of all reported adverse health events

• banning of products that intentionally contain the harmful chemical PFAS (perfluoroalkyl or polyfluoroalkyl substances).

• Issuing regulations that will outline GMP for personal care products 

• Flexibility for small businesses 

• Website only business models will be required to provide full labeling including ingredients and warnings

• Authority to seize counterfeit products and seek civil penalties for any violations 

• State safety laws in effect prior to the date of enactment will remain in effect

• To collect user fees from manufacturers to help fund oversight activities

• This bill is being supported by many companies and associations

For more information on this article and to understand how this may affect your business’ day-to-day activities and future pipeline planning, please contact us

The post Senators Introduce Bill – Modernizing the Safety of Personal Care Products appeared first on Focal Point.

According to Medical Design & Outsourcing, the FDA has warned the public of a potential medical device shortage as a result of the plant shutdown. Roughly 90% of the products sterilized at the Sterigenics Willowbrook facility were medical devices and manufacturers of those products will be greatly impacted by this plant shutdown.

Health Canada has issued a clarification notice on what sort of changes to sterilization procedures would require Medical Device Licence (MDL) amendments. According to Emergo, Health Canada has advised that facility changes alone do not warrant a new MDL application submission. However, MDL amendments are required for changes to sterilization procedures, equipment or cycle parameters. MDL amendments are also required for the following:

• Changes that increase bioburden alerts or action levels;
• Changes that introduce organisms more resistant to sterilization effects;
• Device design and material changes that introduce features more difficult to sterilize;
• Changes in density or configuration of a sterilization load;
• Changes to quality control verification and validation processes.

As a result, moving the sterilization facility may result in one or more of the above changes, therefore leading to potential MDL amendments for several medical devices.

If you require assistance complying with medical device regulatory requirements or would like more information on the matter, 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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According to Cosmetics Design USA, vice president of global digital services at Amway, Mike Edwards, states: “If you look at companies like Uber, they didn’t do anything unique. It’s still the taxi industry. But they leveraged digital tools to make that a very compelling opportunity. It’s the same thing if you look at direct selling and you look at Amway. If we don’t disrupt the industry by leveraging digital tools, we’ll become irrelevant.”

The overarching purpose of the app developments is to help Amway Business Owners (ABO) serve their customers better and drive mobile sales, while strengthening the relationship between the ABO and customer through digital technology. By storing components of the app on a global cloud storage space, standardization becomes easier to achieve between apps, and allows for brand consistency among markets in different countries.

Brian Hart, vice president of ABI customer solutions and IT at Amway, declares that the app development plan will save a substantial amount of money while allowing the company to gain international brand awareness and further improve customer experience. “Everyone has a mobile phone, but not everyone has a computer,” observes Hart. By leveraging this common device, Amway reduces the possibility of an external competitor disrupting their business with app development solutions in the future.

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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