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. 

The post Canadian Cosmetic Hotlist Updates appeared first on Focal Point.

The post Changes to the Canadian Cosmetic Notification (CNF) form requirements as of October 9, 2024 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.

The post New French Language Requirements per Québec – Bill 96 appeared first on Focal Point.

As a DIN Owner, you should have received your Annual DIN Renewal package from Health Canada. These are due to be submitted by July 29, 2022. Should you require assistance with this, please reach out.

FDA User Fees For OTC Monograph Drug Facility

On June 1^st 2022, OTC Monograph Drug Facility User Fees for the fiscal year of 2022 were due to the US FDA. The fee for 2022 is $24,178 for facilities that manufacture or process a finished dosage form and $16,119 for contract manufacturing facilities. The annual facility fees for covered OTC drug facilities were introduced in 2021 to help fund FDA regulatory activities.

Facilities that are exempt from these fees include sanitizer manufacturers that distributed hand sanitizer products under the COVID-19 public health emergency as well as facilities that only manufacture active pharmaceutical ingredients, produce clinical research supplies, or conduct testing.

If you are unsure about whether your US-based drug facility has any fees due to the FDA, we can help determine which applicable fee applies to your establishment. Feel free to contact us.

Reminder for Drug Listings

Should you have any Drug Listing updates, now is a good time to file. If you require assistance, we are happy to help.

The post Reminders appeared first on Focal Point.

In addition to the labelling required, the manufacturer or party responsible for the labelling of a product, will be required to participate in a collection study conducted in collaboration with wastewater agencies to understand consumer behaviour. Annual reporting to specified legislative committees and the State Water Resources Control Board under this program is also mandatory.

Please note that enforcement provisions have been established, including a civil penalty not to exceed $2,500 per day, up to a maximum of $100,000 per violation, to be imposed on the manufacturer or party responsible for labelling and therefore in violation of the provisions.

To avoid last minute label changes, it will be imperative to act now. Should you have any questions or require any additional information, please do not hesitate to contact us.

The post California Assembly Bill No. 818 appeared first on Focal Point.

As this bill is now in the final stages of the legislative process and is expected to become law this spring, in advance of the upcoming provincial election, it will be important for companies to be prepared for changes needed to comply with the proposed changes.

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

The post Amendment to the Quebec Charter of the French Language 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.

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

Spoiler alert: The FY 2022 facility fees rates are an increase of approx. 19% in comparison to the FY 2021 facility fee rates.

Application fees are as follows:

• Monograph Drug Facility (MDF) Facility Fee – USD 24,127
• Contract Manufacturing Organization (CMO) Facility Fee – USD 16,119

The fees also apply to the submitter of OTC Monograph Order Request (OMOR) and is as follows:

• Tier 1 Monograph Fee – USD 507,021
• Tier 2 Monograph Fee – USD 101,404

The OTC monograph drug facility fees are due on June 1, 2022.

If you need any assistance or have any questions related to whether this fee program applies to your company or have any concerns about payment options, do not hesitate to contact us.

The post FDA OTC MONOGRAPH DRUG USER FEE RATES FOR FISCAL YEAR 2022 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.

• Register your 2020 tonnage with RPRA (Deadline to Register – October 1st)
• Pay your 2021 registry Fee when submitting your 2020 supply data
• Join a Producer Responsibility Organization (PROs)

If you would like further information on this, please do not hesitate to contact us

The post Full Producer Responsibility for Post Consumer Waste in Ontario appeared first on Focal Point.