This proposal highlights the effectiveness of the OTC Monograph Order Request (OMOR) pathway. Initiated by a request from DSM Nutritional Products LLC, the FDA is proposing the inclusions of bemotrizinol at concentrations up to 6% without requiring a full New Drug Application. The FDA’s review confirmed that the ingredient meets high safety standards, offering broad spectrum (UVA/UVB) protection with low skin absorption and a favorable tolerability profile.

The FDA is currently inviting public feedback on this proposal via the OTC Monograph@FDA portal. If the agency ultimately concludes that bemotrizinol is generally recognized as safe and effective (GRASE), it will issue a final order formally adding the ingredient to he OTC Monograph M020.

The post 📢 FDA Modernization in Action: The Bemotrizinol Proposal & The Future of OTC Monograph Reform appeared first on Focal Point.

Bemotrizinol, also known as BEMT or Tinosorb S, is a broad spectrum, photostable UV filter that has been widely used in Europe and Asia for years. It protects against both UVA and UBV rays, which are responsible for sunburn, premature aging, and skin cancer. Unlike some older UV filters, bemotrizinol does not degrade in sunlight, meaning it remains effective for longer. It is also more fat-soluble, which helps it to provide better broad-spectrum protection.

The approval of bemotrizinol would give sunscreen manufacturers a new, effective tool to create safer and more effective products. It could also lead to more cosmetically elegant formulas that are less likely to leave a white cast on the skin, which would be a major benefit for people with darker skin tones.

If the FDA approves bemetrizinol, it could still be several months or even years before it is available in sunscreens on the U.S. market. This is due to the time it takes for manufacturers to formulate new products. Conduct stability testing and get them on store shelves. However, the potential approval of this new ingredient is a significant step forward for sun protection in the United States.

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Here are the key takeaways from the latest update:

• Disclosure of Fragrance Allergens in Cosmetic Labeling: The anticipated date for this proposed rule has been moved to May 2026. This is a significant delay from its previous target of January 2025.
• GMP proposed Rule: The proposed rule for cosmetic Good Manufacturing Practices has been moved from the standard agenda to the “long-term actions list.” This indicates that the Agency is unlikely to publish the Notice of Proposed Rulemaking (NPRM) within the next 12 months. The previous anticipated date was October 2025.
• Formaldehyde in Hair Straightening Products: While not a direct provision of MoCRA, the FDA’s intention to ban formaldehyde and formaldehyde-releasers in these products has a new anticipated NPRM date of December 2025. This timeline has been previously pushed back from September 2024 and March 2025.
• Test Methods for Asbestos in Talc: The Final Rule for standardized testing methods for detecting asbestos in talc-containing cosmetic products is now targeted for March 2026.

These adjustments reflect the ongoing complexities of implementing major regulatory changes. Our team at Focal Point Research will continue to monitor these developments and provide updates as they become available.

The post FDA Announces Updated Timelines for Key Cosmetic Regulations appeared first on Focal Point.

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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What is it?

The Federal Plastics Registry is a pioneering effort by the Canadian government to collect detailed information from producers about the quantity and types of plastics they introduce in the Canadian market. This registry focuses on tracking how plastic moves through the economy and, critically, how it is managed at its end-of-life. By establishing a centralized database, the government aims to gather evidence-based insights to inform and measure actions to prevent plastic pollution.

Who does it apply to?

This initiative applies to the obligated Producers, defined as:

• a brand owner or intellectual property (IP) holder that resides in a province or territory.
• if the brand owner is not a resident of a province or territory, then the first person to manufacture/ import and/or distribute a product in a province is defined as the obligated producer.
• if there is no resident importer or distributor, then an obligated producer is the retailer that places plastic products on the market in a province or territory.

The phased implementation approach recognizes different sectors, including packaging, electronic and electrical equipment, agriculture, white goods, textiles, automotive, and construction, each adhering to specific reporting timelines.

These entities will be mandated to report annually to the Canadian Council of Ministers of the Environment, providing comprehensive data on the quantity and types of plastic they place on the Canadian market, how it moves through the economy, and, most importantly, how it is managed at its end-of-life.

Impact on Small Businesses:

Many provincial and territorial EPR policies offer small businesses exemptions based on criteria such as gross annual revenue, tonnage placed on the market, or other qualifying factors like the number of retail storefronts.

Small businesses that are exempted under provincial and territorial EPR policies would be subject to special rules that would minimize the government’s administrative burden and take into account the following:

• Small businesses cannot rely on Producer Responsibility Organizations (PROs), as they do not participate in provincial and territorial EPR programs.
• Utilizing data from EPR programs to cover downstream outcomes for small businesses, acknowledging their limited control over supply chains and product material composition.

To streamline data collection and improve accuracy, the Federal Plastic Registry will require exempted businesses to report only on plastics placed on the market. This approach ensures that essential data is captured, contributing to a more comprehensive nationwide understanding of EPR program outcomes.

Reportable administrative information:

The following information would be required from producers in the registry when they register on the new reporting platform:

• the producer’s (organization) name and address
• the producer’s federal Business Number as assigned by the Canada Revenue Agency (GST# for non for profits)
• the name, position, email address and telephone number of an authorized representative
• the primary 6-digit NAICS Canada code of the producer and tertiary codes, if applicable
• the provinces and territories in which the producer places plastic products on the market
• the provincial and territorial EPR programs that the producer is subject to, and
• the PROs that a producer engages and the provinces and territories in which those PROs operate on behalf of the producer

PROs would be expected to provide similar information, including their address, names of authorized representatives and a list of producers they represent.

The records of the reporting activities must be kept at the principal place of business in Canada or at any other place in Canada where they can be inspected for at least 3 years after the date on which they were made.

Data points to be reported:

The government provides guidance to assist with reporting and calculating data points. The data points (in tonnes per calendar year) to be reported are categorized as follows:

The upstream data point represents the total amount of plastics placed on the Canadian market in a given category.

Downstream data points (actual weight-based data):

• Plastics collected for diversion: Total amount of plastic collected and recycled by an extended producer responsibility (EPR) program, sent to a sorting facility for diversion.
• Plastics successfully reused: Total amount of plastic collected for reuse, sold on secondary markets without extensive repair, remanufacture or refurbishment.
• Plastics successfully repaired, remanufactured or refurbished: The total amount of plastic collected for diversion is either sold to secondary markets or returned to the original equipment manufacturer for repair, remanufacturing or refurbishment.
• Plastics successfully recycled: The total amount of plastic collected for diversion and treated by conventional mechanical activities, chemical or thermal processes.
• Plastics incinerated for energy recovery: Total amount of plastic collected for diversion and recovered for energy recovery, such as engineered fuel or mass burn.
• Plastics imported, exported: Total amount of plastic waste imported or exported for recycling or final disposal.
• Plastics sent to landfill: Total amount of plastic waste sent to final disposal.

Additional information required for each data point:

• province or territory in which plastic products were placed on the market/collected for diversion
• resin type in plastic products
• category of plastic products
• sub-category of plastic products
• whether plastics belong to residential or industrial, commercial and institutional (ICI) streams

Timeline to note:

The phased implementation approach outlines a timeline for different sectors (in 4 phases) to comply with reporting requirements. Packaging and electronics are the only sectors that report their upstream data point in Phase 1. The collection of upstream and downstream data points will follow in later phases, aligning with the government’s recognition that some sectors may require additional time to comply. The Phase 1 reporting will begin on June 1, 2025, followed by each phase in the subsequent years.

Industrial, commercial and institutional sources of plastic waste:

Additionally, the registry requires reporting on ICI (industrial, commercial and institutional) sources of plastic waste for all product categories to fill key data gaps, acknowledging the significant role of ICI sources in plastic waste generation. Producers must indicate all StatCan resin types used in plastic products they place on the market, providing a comprehensive view of the raw materials involved. Recognizing the complexity of tracking downstream data, particularly in later phases, the government proposes to seek data from various sources, including municipalities, waste management companies, and other service providers involved in value recovery. This collaborative approach aims to enhance the accuracy and completeness of the data collected.

Next Steps:

Section 46 of CEPA provides the Minister with the authority to gather the best information available for creating an inventory of data and enabling decision-making that contributes to protecting the environment and human health. The publication of a draft Section 46 notice would be followed by a public comment period, during which the government would consult partners, stakeholders and the public on the draft text. A final notice is targeted for before the end of 2024. Guidance would also be developed for those reporting to the Federal Plastics Registry to facilitate compliance.

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As an overview, the notice requires participation from any company that meets the following conditions:

• Manufactured in 2022 greater than 100 kg (Part 1 or 4) or 1000 kg (Part 2) of any substance listed in the notice, or
• Imported in 2022 greater than 100 kg (Part 1 or 4) or 1000 kg (Part 2) of any substance listed in the notice, either alone, in a mixture or in a product, or in a manufactured item at a concentration equal to or above 0.1% by weight (w/w%)

See the notice for the list of substances and exact reporting requirements. Also included is an accompanying guidance document that serves useful.

If you have any questions or need assistance with completing this mandatory survey, please do not hesitate to contact us.

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As per the proposed amendments to the Food and Drugs Act (FDA) in Bill C-47, the following changes will be implemented in terms of NHPs and cosmetics:

NHPs:

• The definition of a therapeutic product has been replaced by the following: ‘therapeutic product means a drug or device or any combination of drugs and devices’ thereby including NHPs. Consequently, all regulations pertaining to therapeutic products will also apply to NHPs, with the exception of a few sections.
• The Minister will be empowered to order a person to provide information within their control, including any new information may raise questions about the product’s effect on health and safety for the purpose of assessing serious risks to health. Additionally, the Minister may require a therapeutic product authorization holder to compile information to assess the benefits, harms, and uncertainties of a product.
• The Minister may now disclose confidential business information about a therapeutic product to a government, a person from whom the Minister seeks advice, or a person who carries out functions relating to the protection or promotion of human health or the safety of the public if the purpose of the disclosure is related to the protection or promotion of human health or the safety of the public.
• If it is deemed necessary to prevent harm to health, such as situations where the label fails to adequately reflect potential product risks, or when there are similar brand names or packaging that could result in errors in prescribing or dispensing, the Minister will now have the authority to instruct the import/sale authorization holder to revise the label of a therapeutic product to include new harm information or to change the brand name or packaging. Please re-check the labels of the products in your portfolio for the same.
• If the Minister believes that a therapeutic product presents a serious or imminent risk of injury to health, he or she may order a person who sells the product to recall the product; or send the product, or cause it to be sent, to a place specified in the order.
• The amendments include an increase in the level of fines and penalties for non-compliance to a maximum penalty of $5,000,000 or 2 years in prison to better reflect the serious nature of the offence.
• A person who knowingly makes a false or misleading statement to the Minister of Health or who knowingly or recklessly causes a serious risk of injury in contravening the Act or its regulations could face a higher fine or up to five years in jail, at the discretion of the court. An injunction power will also be added such that, upon application of the Minister of Health, a court will be able to order a person to refrain from performing an act related to the commission of an offence under the Act.
• The incorporation by reference of technical and non-technical documents relating to therapeutic products into the Food and Drug Regulations will be permitted.
• The Minister of Health will have an obligation to make any orders issued under these new powers publicly available.

Cosmetics:

• No person shall sell a cosmetic unless the person can establish the safety of the cosmetic without conducting and relying on data derived from a test performed on an animal that could cause pain, suffering or injury, whether physical or mental, to the animal, if the purpose of the test is to meet a requirement under a provision of FDA or the regulations or to meet a requirement that relates to the safety of cosmetics under the law that applies in a foreign state.
• No person shall make a claim on the label of or in an advertisement for a cosmetic that is likely to create an impression that the cosmetic was not tested on animals after the day on which this section comes into force unless the person has evidence that no such testing occurred after that day.

If you would like to know more about the proposed amendments, how it may impact your business, and more, please contact us.

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The goal of this new legislation is to provide a well-balanced risk-based approach to regulation. The CEPA will require risk assessments to consider real life exposure to the cumulative effects of certain substances on the environment as well as the public. One such amendment is the creation of a Watch List that will be available to the public for Canadians and businesses to note which substances to avoid. Another objective of Bill S-5 is the right to a healthy environment. This is to ensure that Indigenous people and other groups of colour are not disproportionately impacted by toxic pollution and environmental damages.

The framework to implement the proposed changes plans to be developed and published within the next two years. This includes plans:

• that specifies the substances to which the Ministers are satisfied priority should be given in assessing whether they are toxic or capable of becoming toxic;
• that may specify the activities or initiatives in relation to assessing, controlling or otherwise managing the risks to the environment or to human health posed by substances that are or will be undertaken under an Act of Parliament for whose administration either Minister is responsible and which the Ministers are of the opinion should be prioritized; and
• that specifies activities or initiatives to promote the development and implementation of methods not involving the use of vertebrate animals that would provide information sufficient for assessing risks to health or the environment posed by substances assessed.

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

The post Passage of Strengthening Environmental Protection for a Healthier Canada Act appeared first on Focal Point.

This guidance is comparable to one which was published in 2014 concerning cosmetic products. For the sale of cosmetic products containing nanomaterial ingredients, the FDA published recommendations for safety assessments for cosmetics to address certain important factors including characterizations of the nanomaterial ingredient, the safety assessment of nanomaterials and considerations for its toxicology when developing cosmetic products containing nanomaterials.

This guidance, which was initially drafted in 2017 will be concerning the development of OTC drug products in which a nanomaterial is present in the finished dosage form. It should be noted that this guidance should be viewed as recommendations for monograph drug manufacturers unless specific regulatory requirements are cited.

The guidance highlights the need to obtain further understanding of the interactions of nanomaterials within the body, including both intrinsic and extrinsic factors, as well as how these attributes will impact the overall product quality, safety and efficacy. These considerations presented in this guidance include drug development, safety evaluation and quality considerations

The FDA proposes a risk-based approach when developing nanomaterial-containing drugs, with a focus on the following risk factors:

• Adequacy of characterization and function of the nanomaterial
• Complexity of the nanomaterial structure
• Understanding of the mechanism by which the physiochemical properties of the nanomaterial impact its biological effects
• Predictability of in vivo release based on in vitro methods
• Physical and chemical stability
• Route of administration

The information of the structure of a specific nanomaterial can be referenced within the appropriate letter of authorization as part of the drug application or to a drug master file. This is to ensure adequate characterization of the nanomaterial and understanding of the nanomaterial’s intended use and application. It should be noted that this list is not comprehensive and other risk factors may need to be evaluated during product development.

Moreover, as a guidance document, the information issued are considerations for the industry for drug manufacturers when submitting applications, including Investigational New Drug Applications, New Drug Applications, Biological License Applications, Abbreviated New Drug Applications and Drug Master Files. The FDA suggests that as the drug product development progresses, more information will be obtained about the nanomaterial and understanding will continue to be revised based on findings.

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

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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.

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