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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• 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.

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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Health Canada published an updated timeline for the various phases in the framework’s implementation process.  Due to the upcoming Canadian Federal Election, there have been changes to the original schedule. After public consultations, the updated approach to regulating self-care products is targeted to be phased in over the next few years:

Phase I (Spring 2020) – Health Canada will introduce labelling amendments to Natural Health Products (NHPs). The changes will include improving the facts table for easier comparison between similar self-care products, as well as plain language on labels for consumers to easily understand.

Phase II (Spring 2020) – Health Canada will introduce a risk-based approach to regulating non-prescription drugs under the Food and Drug Regulations (FDR). The approach will include expedited pathways for lower-risk products such as sunscreens and acne products to align with regulations for self-care products with similar risk level.

Phase III (2021) – Health Canada will introduce regulatory amendments to address health claim evidence standards and extend regulatory oversight with a risk-based approach. Phase III will also seek additional controls for Health Canada such as having the ability to require recall or label change for all self-care products.

These changes to the regulatory framework are anticipated to support the safe and intended use of self-care products to help Canadians make more informed decisions when buying products. It is also intended to establish proportional regulatory rules based on risk, which would result in significant cost reduction for health care businesses..

For more information, please do not hesitate to contact Focal Point Research Inc.  We are leading Canadian regulatory and Health Canada consultants for Natural Health Products, OTC Drugs, Cosmetics, and other personal care products.

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A risk assessment is an integral part of maintaining both the health of Canadians and the environment. Risk assessments are executed by Environment and Climate Change Canada under the CEPA (Canadian Environmental Protection Act) and are used to “determine whether there are risks resulting from exposure of Canadians to the substance or releases of the substance into the environment, and the specific ways Canadians or the environment can be affected”. The assessment of chemicals allows for proper regulatory measures to be taken.

What risks does talc pose to human health?

The assessment mainly focuses on the risks talc poses within self-care products and concludes that it be classified as CEPA toxic. This conclusion is due to two associated risks with loose powder forms of talc. One of the two risks discussed is the inhalation of talc from loose powder products. This risk encompasses products such as baby powder and industrial applications in which talc is airborne. Warning labels have already been required on products like baby powder that are marketed for the use on infants, cautioning to avoid inhalation of the product by the infant. Inhalation of talc can lead to respiratory problems including “coughing, difficulty breathing, decreased lung function and scarring of the lung tissue”. Perhaps more serious of the risks is the possible associations with ovarian cancer. When used on the perineal region in women it was found that it is possible for talc to migrate and find itself lodged in the reproductive system. This judgement comes off the heels of the July verdict of the class action lawsuit of Johnson & Johnson by 22 women who claimed consistent use of J&J Baby Powder on the perineal area had led to their ovarian cancer (due to alleged contamination of talcum powder with asbestos). Johnson & Johnson was found guilty, with the court ruling in favour of those affected. Several studies have also been conducted to observe the possible risks associated with talc, these are included in the documentation provided by CEPA. It is important to note that, in pressed form or consumables (ie. Some cosmetics or foods or drugs), Health Canada did not find talc harmful.

Where does this leave Talc?

The findings show talc as a health threat, but that it presents no threat to the environment. In terms of talc as an ingredient in self-care products; those that are non-airborne, don’t come in contact with the perineal area or are consumed are deemed safe. However, in the meantime, consumers are left to make the decision themselves if they would like to stay away from talc-based products.

Despite these published documents, nothing is set in stone until the final assessment.  A 60-day comment period has opened allowing for comments to be made upon the presented information and conclusions. If passed, the proposed conclusions published by Health Canada would result in the following outcomes as means of risk management:

• Possible modifications to the Cosmetic Ingredients Hotlist to prohibit or restrict talc and its use in cosmetics and perennial products
• Possible modifications to the Natural Health Products Database and associated monographs to reduce the exposure of talc to consumers in NHPs and OTC drugs that have risks of being inhaled or usage associated with the perineal area

Important Dates to Note

• The draft screening assessment was posted online by Health Canada on December 5^th, 2018
• A 60-day comment period has opened and will close on February 6^th, 2019

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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The study was performed by the University of Surrey and involved the irradiation of subjects with whole-body blue light at 450nm, roughly comparable to that of a dose of sunlight. Unlike its cousin ultraviolet (UV) light, blue light is non-carcinogenic and does not share the potential cancer-causing concerns. The results of the study showcased a significant decrease in systolic blood pressure comparable to the effects seen with medication targeted to have similar effects for those with hypertension.

A surprise to the unassuming consumer, blue light’s reputation may see a shift from positive to negative as more and more studies are aimed at finding natural treatments to common physical ailments and shortcomings. A potential solution to those who are difficult to treat with oral pill form solutions for hypertension, this study showcases a potential solution to a common disorder that affects hundreds of thousands of people each year.

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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