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.

These regulations will come into force on Jun. 01, 2025. Any existing products, that are manufactured before Jun. 01, 2025 and have no French version of a trademark registered as of today, may continue to be distributed through to Jun. 01, 2027. 

Please do reach out to us if you have any specific questions on these regulations.

The post Update: Final Amendments to the Charter of the French Language regulations published today appeared first on Focal Point.

What you need to know:

• Cosmetics Direct is part of a larger portal known as FDA Direct (previously CDER Direct).
  • If you previously held a CDER Direct Account, you are likely to already have access to FDA Direct. However, you may need to obtain access to Cosmetics Direct. This is yet to be confirmed.
  • First Time Users will need to sign up by selecting ‘Create New Account ‘.
• An account will be needed for your company, but you will be able to add multiple users, who would be able to assist with compilation and filing of your facility registration and/or product listings.
• For Facility Registrations, the following are mandatory fields:
  • Facility Name, FEI No., Street Address, City, State/Province, Country, Zip/Postal Code, Email, Phone No., Name of the Owner and/or Operator of the Facility
  • For foreign companies: US Agent Name, Phone No., Email
  • Brand names of cosmetics manufactured or processed at the facility, the respective Responsible Person (as listed on the label) and the product category
• For Product Listings, the following are mandatory fields:
  • Responsible Person Name (as listed on label) and Phone No.
  • Product Name, confirmation of whether it contains Fragrance or Flavor, Product Category Code, Ingredient UNII Name
    • You will be able to enter each ingredient separately or upload a prefilled ingredients file.  Details of what this file should contain are not yet available.
  • Manufacturing/Processing Facility Name, Street Address, City, State/Province, Country, Zip/Postal Code, Confirmation of if it is a small business, FEI Number

You may view the draft content released for comments by the FDA here or here. If you have any questions at all, please do not hesitate to reach out. 

The post MoCRA Updates appeared first on Focal Point.

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.

These proposals will be completed in phases, with Phase I involving the improvement of labelling of Natural Health Products, which has been completed as of 5th July, 2022. This amendment will include:

• Product fact tables
• Formatting requirements
• Improving allergen labelling
• Tamper evidence alignment under CUSMA
• Modernized contact information

The following Phase II will introduce expedited pathways for lower-risk non-prescription drug products, with Phase III expanding the efficiencies and modernization pertaining to non-prescription drugs to NHPs.

The period in which new products will phase in the amended regulations is 3 years, with an additional 3 years for existing products. Additional details such as the associated guidance documents accompanying the regulation changes will follow via the NNHPD.

Click here to view the original article published by the Canada Gazette.

If you have any questions on the updates or would like assistance with NHP compliance, please contact us.

The post Amendments to the NHP Regulation 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.

The post Final FDA Guidance for Drugs & Biologics Containing Nanomaterials appeared first on Focal Point.

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.

The state government aims to have this act become effective July 1, 2022. However, it should be noted that this bill has only passed the first reading in the house (on April 13, 2021). Since then, there has been no update. The bill must still undergo Referral to Committee and its Second and Third Readings prior to approval.

Since this bill has only passed the initial reading, there is no action needed as yet. However, once this act becomes effective, your company will be required to update your website if selling cosmetic products in North Carolina.

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

The post New Legislation for North Carolina appeared first on Focal Point.

• Effective Dec. 31, 2021, you must cease all production of alcohol-based hand sanitizers.
• If you cease production of alcohol-based hand sanitizers, you must deregister.
• The deadline to sell any alcohol-based hand sanitizer produced on or before Dec. 31, 2021 is Mar. 31, 2022.
• If you wish to continue production, you may do so provided you comply with the OTC topical antiseptics tentative final monograph and other requirements, including FDA cGMP.

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

The post FDA Withdrawal of Temporary Guidances for Alcohol-Based Hand Sanitizers appeared first on Focal Point.