Amazon Seller Compliance

Month: May 2022

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Cosmetic Ingredients: Potential Presence of Toxic Substances

Potentially Toxic Ingredients in Cosmetic Products

Potentially Toxic Ingredients in Cosmetic ProductsWhat is a cosmetic?

Under Section 2 of the Food and Drugs Act, a cosmetic is defined as “any substance or mixture of substances manufactured, sold or represented for use in cleaning, improving or altering the complexion, skin, hair or teeth, and includes deodorants and perfumes.”. This is different than drug and natural health products even though they are all regulated under the Food and Drug Act. The classification of the product depends on its function, purpose, and representation for use (such as claims or recommended purposes). Ingredients in the formula may also help determine the classification. For example, in Canada, ingredients like corticosteroids can only be licensed as drugs whereas Green Tea Leaf Extract may be licensed as a cosmetic product or a Natural Health Product.

Prohibited Ingredients and Restricted Ingredients

All cosmetic products sold in Canada are required to meet the requirements listed in Food and Drugs Act and Cosmetics Regulations. Health Canada has compiled a cosmetic ingredient hotlist and identified all prohibited and restricted ingredients. Prohibited cosmetic ingredients are ingredients that must not be present in the cosmetic products sold in Canada. An example is Benzyl Chloride. Restricted cosmetic ingredients are ingredients that are permitted only within certain conditions of use or when cautionary statements are present. These cosmetic ingredients are permitted with an upper limit on concentration. For example, benzethonium chloride is not permitted in products to be applied to mucous membranes. However, it is permitted in leave-on products, at a concentration equal to or less than 0.2%, and rinse-off products, at a concentration equal to or less than 0.3%. This list gets updated periodically and it is your responsibility as the manufacturer to keep them up to date and make sure your cosmetic products and cosmetic ingredients are compliant with the regulations.

Potential Presence of Toxic Substances

Health Canada sent out a notice on behalf of Environment and Climate Change Canada on April 1, 2022, to increase awareness that some cosmetics contain prohibited toxic substances called per- and polyfluoroalkyl substances (PFAS). They are a group of chemicals used to increase the wear, durability, spread, and water and oil resistance of applied cosmetics. They are generally found in products such as foundations, liquid lipsticks, and waterproof mascaras to be wear-resistant to water and oils and long-lasting. These PFAS include perfluorooctanoic acid (PFOA), its salts and precursors; long-chain perfluorocarboxylic acids (LC-PFCAs), their salts and precursors; and perfluorooctane sulfonate (PFOS), its salts and precursors.

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Under the Canadian Environmental Protection Act, of 1999, these PFAS groups are toxic and prohibited in Canada. Precursors are defined as compounds that consist of a perfluorinated alkyl group that has the molecular formula CnF2n+1 in which n = 7 or 8 and that is directly bonded to any chemical moiety other than a fluorine, chlorine or bromine atom; compounds that consist of a perfluorinated alkyl group that has the molecular formula CnF2n+1 in which 8 ≤ n ≤ 20 and that is directly bonded to any chemical moiety other than a fluorine, chlorine or bromine atom; and compounds that contain one of the following groups: C8F17SO2, C8F17SO3 or C8F17SO2N. Under Prohibition of Certain Toxic Substances Regulations, 2012, these toxic substances are harmful to the environment or human health and can be persistent and bioaccumulative. Though they may be allowed in other countries, they are prohibited in Canada, and it is the importer’s responsibility to avoid regulatory violations in Canada.

Quality Smart Solutions offers regulatory services from registering your cosmetic products and reviewing your cosmetic ingredients. We also offer a cosmetic product label compliance solution. Our experts are here to help and offer any cosmetic-related regulatory advice!

References

https://www.canada.ca/en/health-canada/services/consumer-product-safety/cosmetics/notification-cosmetics/guidance-document-complete-cosmetic-notification-form.html#5

https://www.canada.ca/en/health-canada/services/consumer-product-safety/cosmetics/cosmetic-ingredient-hotlist-prohibited-restricted-ingredients.html

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Insider scoop on Selling, Importing & Registering your VHPs in Canada

Veterinary Health Products in Canada

Veterinary Health Products in Canada

Introduction:

The market for animal and pet products is growing at a rapid pace. With that, there is also a constant need for compliance, with many Veterinary Health Products being rushed to market. This blog will aim to steer you toward compliance with your Veterinary Health Products (VHPs) or Animal Supplements in Canada. We will highlight key points on how to register, import, and sell your VHP products in Canada.

Registering your Veterinary Health Products in Canada:

Previously, the VHP notification program was voluntary, but as of November 2017, the new formal notification program was put in place. It is important to first classify the product properly as a VHP, as veterinary drugs and animal feed products are not regulated under the VHP framework.  

This is to be done by examining the dosage form, the proposed use, or claims being made and ensuring all ingredients are properly listed in the Permitted Substance List (PSL), amongst other criteria. Any ingredients that are not present or do not reflect the purpose as used in your product, within the PSL, can be added or amended via a PSL Notification. This must be done before filing the VHP notification.

 

It is required for a company that is located outside of Canada to arrange and provide the contact information for a Canadian Representative. QSS can act as your Canadian representative for VHP applications and throughout the product lifecycle.  It is also required that a company located outside of Canada lists the importer or product receiver on the notification form. 

The Notification Form is completed online on the Health Canada portal and is submitted there as well. Companies are required to notify their VHPs to Health Canada: At least 30 days before selling a VHP in Canada, at least 30 days before making a change to a VHP that is already notified in Canada, and before importing a VHP into Canada. We recommend waiting for approval before finalizing the label or going to market.

There are fees payable to Health Canada associated with the notification. The current fee is $503 (subject to an annual increase). Please know that your company may qualify for a reduction or fee waiver based on the first application or company size.

The current standard Health Canada timeline for review of ingredient and product notifications is ~2 months, based on recent submissions.

During the review, Health Canada will review your VHP claims and ingredients. They may ask for revisions to ensure the product is safe, efficacious, and of high quality for the Canadian market. After their review, they will issue a licensing decision and if approved, issue a Notification Number (NN).

VHP Selling in Canada:

The product owner or notifier must ensure the product is properly labeled. This includes bilingual label text, adding the NN to the label, and calling out ‘Veterinary Health Product’ on the front panel, amongst other requirements. It is important that your product is not labeled in a way that is misleading or false. The best way to avoid this is to only use verbiage that is approved within your notification.

Also, while on market, it is required that companies report any serious adverse drug reactions to Health Canada.

Furthermore, should you wish to make a post-notification change to your product, you would need to determine whether the change requires a new NN or if a revision can be made to the existing NN.

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VHP Importing (CFIA Requirements):

All animal products and tissues being imported must be notified and adhere to CFIA import requirements. This can be confirmed, researched, and verified on the AIRS webpage for animal/commodity-specific requirements. You may require documentation such as veterinary health product certificates or import permits for specific materials/ingredients.

All commercial shipments must be handled properly to ensure all duties and taxes are paid to Canada Revenue Agency (CRA) and/or Canada Border Services Agency (CBSA). This can be handled through a customs broker.

The product owner must ensure the import documentation shows the VHP Notification Number. The sites/contacts that are involved in processing, importing, and storing your products as per your VHP application. The Canadian Representative should also be listed here. You should be prepared to answer questions from the CBSA at the time of import.

Summary/Conclusion:

It is important to ensure compliance during the whole product lifecycle to reduce enforcement action from any regulatory body. Working with a regulatory consultant such as Quality Smart Solutions can help get your product notified, labeled, and launched into the Canadian Market. We can also consult Health Canada on your behalf for any unique questions you may have.

Please reach out to our team of specialists for any questions regarding your VHPs in Canada. Such as ingredient and formula review, Canadian representative solutions, notification submission, labeling, bilingual translation, and post-licensing changes. We are happy to help!

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7 Principles of HACCP: Everything you need to know before building a HACCP plan

HACCP

What is HACCP?

A common question that comes up in regulated industries, such as food manufacturing and processing, is “What is HACCP?”. HACCP stands for Hazard Analysis Critical Control Point. HACCP is a widely recognized food processing concept that was developed to enhance the production of safe food.

7 principles of HACCP Infographic

When is HACCP Used?

HACCP is designed for use in all segments of the food industry from growing, harvesting, processing, manufacturing, distributing, and merchandising to preparing food for consumption. Food safety systems based on the HACCP principles have been successfully applied in food processing plants, retail food stores, and foodservice operations.

How does HACCP work?

The HACCP system involves reviewing each step of the food manufacturing process, from start to finish, to identify every possible hazard or source of contamination. Hazards can be biological (e.g., pathogenic microorganisms), chemical (e.g., pesticides, allergens), or physical (e.g., extraneous material). For every identified hazard or source of contamination, a reliable control or procedure is put in place to ensure that contamination does not occur or is controlled to an acceptable level. Prerequisite programs such as current Good Manufacturing Practices (cGMPs), which address areas such as pest control, traceability & recall, hygiene, and sanitation, are an essential foundation for the development and implementation of successful HACCP plans.

What are the 7 key principles of HACCP?

HACCP outlines seven principles that are key to ensuring the safety of food:

1. Conduct a Hazard Analysis – The initial process of identifying potential hazards that could occur in a food business.

2. Identify Critical Control Points – A Critical Control Point (CCP) is a point in the food preparation process where hazards can be reduced, eliminated, or prevented.

3. Establish Critical Limits – A critical limit is a maximum or minimum value to which a food safety hazard (biological, chemical, or physical) must be controlled. Often critical limit guidelines are set by government regulators.

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4. Monitor Critical Control Points – Monitoring each CCP is essential to make sure that hazards don’t go beyond the critical limits set. Generally, monitoring can be broken down into four different categories: observation, sensory, chemical, and physical.

5. Establish Corrective Actions – If a hazard exceeds its critical limit, corrective action must be taken. Corrective actions are either immediate or preventative.

6. Establish Record-Keeping – Comprehensive and up-to-date records must be kept of any hazard along with details of any corrective actions. These records are kept together in a living document called a Food Safety Plan which is part of a Food Safety Program.

7. Establish Verification Procedures – Verification procedures can help determine if your Food Safety Plan works to prevent the hazards identified. It is important to perform an audit of your Food Safety Plan at least once a year to ensure that everything is working.

Why is HACCP important?

HACCP principles are essential for any business involved in the food industry, including yours. A Food Safety Plan can protect your business from being the cause of a foodborne illness outbreak or severe allergic reaction from food allergens. These incidents can cause your customers to become ill or injured, and your brand and bottom line to suffer.

Proper implementation of a HACCP program helps reduce the likelihood of customer complaints or a recall by identifying and controlling potential hazards which may come from raw materials, facility processes, and human error.

References

https://www.foodsafety.ca/haccp-programs/what-is-haccp

https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/hazard-analysis-critical-control-point-haccp

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Update on Performance Standards and System Updates for NHP Applications

NNHPD Monograph

COVID had significantly impacted the processing of NHP product license applications with delays in the processing of all classes of applications with respect to the established service standards outlined in the Natural Health Products Management of Applications Policy. Similar delays were observed for NHP site license submissions. After the worst of the COVID-19 pandemic had passed, the NNHPD ramped up the review process to clear the backlog of non-priority product, site, and post-license submissions. As a result, regular updates are being provided by the NNHPD via the Performance standards for NHP applications Stakeholder Meetings, with the most recent one being March 23, 2022.

For non-COVID submissions (April 2021 to February 2022) 9,297 NHPs were licensed which includes 53% Class I; 13% Class II; 34% Class III applications. 718 sites were licensed/renewed. As per the recent performance standards for Class I applications, 93.4 % of new applications and amendments were processed within the service standard (60 calendar days) while for class II (service standard – 90 calendar days) and class III applications (service standard – 210 calendar days), these numbers were 87.8% and 59.6% respectively.

Post-licensing submissions are subdivided into two categories: amendments and notifications. Amendments are defined changes to an NHP that may have an impact on the safety, efficacy, and/or quality of the product. On the other hand, notifications are defined as changes to an NHP that do not significantly impact the product’s safety, efficacy, and/or quality.  Product license amendments follow the service standards as applicable for the relevant class of application while notifications have no established service standards. As per the recent data released on performance standards, 98% and 71% of notifications received in 2021 and 2022 respectively were processed.

Within the past year, the NNHPD has managed to achieve 50% year-to-date performance for new applications and amendments for non-COVID stream I Site Licence Applications while for stream II the numbers were 81% year-to-date performance for new applications and amendments. 318 site licence renewals were completed this fiscal year

System updates for Product Licence Applications

The web-based Product Licence Application (web PLA) form is an integral component of any natural health product license submission package. The basis of developing this web-based platform is to allow web PLA form searches and ease of populating data from the Natural Health Products Ingredients Database (NHPID). Earlier version 3 and version 4 were available. Web PLA version 4 allowed in-form compendial (NNHPD monograph) (class I) validation as opposed to web PLA version 3.

Several system improvements have been implemented to support priorities for Product Licence Applications. New web PLA version 4 was released on April 9, 2022. 

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With the release of this latest version of web-based PLA, it was announced that web version 3 will be discontinued for new product license applications. Access to NNHPD web PLA previously finalized using version 3 will still be available for responding to IRNs. Also, these version 3 applications will be available for viewing using any browser and responding to IRNs until the end of November 2022.

It was also announced that moving forward, web PLA version 4 will support the selection and population of both validated and non-validated monographs. The validation supported monograph table was removed from the system. Following changes/updates were proposed for the new NNHPD web PLA version 4.

  • As per the Natural Health Products Management of Applications Policy, class I applications are required to comply with all the parameters of an individual monograph. The number of NNHPD monographs that can be referenced is subject to the maximum of one for class I applications while this number can be two or more NNHPD monographs for class II applications. Earlier web PLA version 3 was recommended for all classes of applications based on non-validation supported NNHPD monographs, but the recent version can be used for all monographs including the ones that are not validation-supported. These monographs will be included in the picklist and marked as “(validation unavailable)”. Such applications will be finalized without validation with the status being displayed as “Not validated”.
  • Aside from the above changes, several other changes have been made to the web PLA to make it more user-friendly and sensical. For example – the option to choose a dual-route of administration to support aromatherapy submissions, excluding pregnant and breastfeeding risk statements for products intended for male sub-population only, etc.

System updates for Web Site Licence Application (web SLA)

Version 3.0 of the web SLA was released in April 2022. Several updates have been made to make this new version more intuitive and detailed. Some of these changes include the addition of options to include qualification of the Quality Assurance Person, new validation features, the addition of an NPN lookup in the Product Information module, etc.

The ever-present changes with these updates in system and performance standards make it increasingly challenging to keep up with the most up-to-date regulatory information.  Planning is a critical component of any product launch or site licensing activities; hence it is crucial to be keep abreast with the impacts of these changes to the plans for your products, sites, and their operational activities. 

References

https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-health-products/legislation-guidelines/guidance-documents/management-product-licence-applications-attestations.html

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Quality Smart Solutions is a global consulting firm, engaged in providing strategic support for products including NHPs, pharmaceuticals, and medical devices, in areas such as Regulatory Support, Site Licensing, Clinical Development and more.

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