Month: June 2021

News

Proposed Food Safety Guidance for Novel Food Regulations Focused on Plant Breeding

Post author By Quality Smart Solutions
Post date June 23, 2021
No Comments on Proposed Food Safety Guidance for Novel Food Regulations Focused on Plant Breeding

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CFIA and Health Canada have been working on new Food Safety guidance documents pertaining to Novel foods focused on plant breeding. Two new guidance documents are available to aid in your company’s plant breeding compliance, these are:

Guidance on foods derived from products of plant breeding.
Guidance on the pre-market assessment of food products derived from retransformants of previously assessed genetically modified (GM) plants.

Health Canada’s approach is to:

allow for modernization while maintaining the health and safety of our food supply
keep the system product focused
align with other nations
ensure the oversight is risk-based
narrow the regulatory interpretation and support safe innovative foods

These documents will be added as an appendix to the existing 2006 Guidelines for the Safety Assessment of Novel Foods and will refer to the Novel Food Regulations (Division 28, Part B of the Food and Drug Regulations)

Based on Health Canada’s thorough review of DNA inserted plants and those traditionally bred, there has been no noticeable safety concerns. Health Canada has become familiar with several species/techniques and have drafted these proposed guidance documents. The guidance is intended to be risk-based in nature and refer to mainly pre-assessed species. Novel product will still require a standard (410 calendar day premarket review)

Guidance on foods derived from products of plant breeding:

Health Canada has taken time to review historical and current methods of plant breeding. This article explains their understanding of current practices and how methods and modifications result in characteristics for GM plants.

Certain plant species will not require pre-market assessment as novel foods based on plant breeding. This will also list requirements for plant characterization explained based on any breeding methods used. Breeding has been used safely within our food supply for hundreds of years. Gene editing is becoming more common, and Health Canada has developed a ‘primer’ on gene editing within this new guidance. This primer is a summary of Health Canada’s understanding and stance of current gene-editing technology. Health Canada has reinforced their stance that altered plants are not likely to impact safety.

It would always be the responsibility of the applicant to prove and ensure the product is safe for consumption. As always, Health Canada will review each situation under a risk-based approach. Novelty requests can be submitted to the Food Directorate to obtain a written opinion from the regulator prior to market or prior to filing a premarket submission.

Guidance on the pre-market assessment of food products derived from retransformants of previously assessed genetically modified (GM) plants:

Should the parent plant have already undergone premarket assessment as a retransformant plant, this guidance will help industry use that plant to make future generations. This will help industry compare their plants to already approved variants with a new premarket process that is more straightforward and expedited. This review will again be risk-based in nature.

Consultation was available from March 25 to May 24, 2021 and focused on how product will be separated into tiers (1 and 2), what information is required to be provided, and how to enter the expedited pre-market review (with a 120-day service standard)

Tier 1 – plants with identical modifications using the same methods resulting in the same characteristics as a GM plant that has undergone review. (Health Canada has already reviewed this combination).

Tier 2 – plants with identical modifications using the different methods resulting in the same characteristics as a GM plant that has undergone review.

Plants that fit the above criteria, submitted in a complete package, would be turned around by Health Canada in 120 calendar days. If any items require further questioning, an additional 45 days would be added to allow the applicant to respond to the request. Pre-submission requests are suggested for any plant that may sit on the fringe of this programme.

A successful submission would be issued a letter of No Objection. An unsuccessful submission can be issued a refusal without prejudice to resubmit.

Labelling Note:

Health Canada and industry are interested in potentially expanding the current voluntary transparency initiative for ingredients that have undergone gene-editing. We always recommend clearly declaring your ingredients/foods.

How Quality Smart Solutions can help:

Please contact our team for more information on ingredient review, food classification, formula review, labelling projects or importing. Our specialists are here to help!

Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19

Post author By Andrew Parshad
Post date June 15, 2021
No Comments on Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19

As of March 1, 2021, Interim Order No. 2 replaces Interim Order No. 1 Respecting the importation and sale of medical devices for use in relation to COVID-19. Interm Order No. 2 will continue to issue expedited authorizations for the sale or import of medical devices to deal with the current significant risk of COVID-19 to the health and safety of Canadians.

The Interim Order provides an expedited authorization pathway for:

new COVID-19 medical devices that are not yet licensed in Canada,
COVID-19 related uses for existing devices licensed under the Medical Devices Regulations or Interim Order No. 2 and
COVID-19 medical devices that leverage an authorization of a device from a trusted foreign regulatory authority, whereby the Minister would maintain the ability to request additional information on a case-by-case basis.

Interim Order No. 2 introduces new requirements for importers and distributors of COVID-19 medical devices to hold an MDEL, and for manufacturers to comply with bilingual labelling requirements. Both of these changes align with requirements in the Medical Devices Regulations.

Authorization for importation or sale by the manufacturer

Interim Order No. 2 provides COVID-19 medical device manufacturers an exemption from certain requirements of the Medical Devices Regulations, provided they have received an authorization for the importation or sale of their device(s) from Health Canada.

A manufacturer may submit an application for authorization under Interim Order No. 2. If an authorization is granted, the manufacturer may import or sell the COVID-19 medical device for which they hold an IO authorization in Canada. The manufacturer’s information and device information on the device label can then be cross-referenced against the IO authorization during importation and distribution, which is required to accompany the product during import.

Fees related to the submission of an application for a COVID-19 medical device authorization

Health Canada will waive all application fees for COVID-19 medical device authorizations subject to Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19.

Quality Management System requirements related to the submission of an application for a COVID-19 medical device

Health Canada does not require manufacturers to provide a Medical Device Single Audit Program (MDSAP) certificate with their application for a COVID-19 medical device subject to Interim Order No. 2. Manufacturers will be required to share information to demonstrate that their products are of consistent quality and effectiveness. This can be demonstrated by either providing a copy of the manufacturer’s Quality Management System certificate to ISO 13485:2016, or by submitting evidence of Good Manufacturing Practices and its proper implementation.

Documentation required for importation

Under Interim Order No. 2, each shipment of a COVID-19 medical device that is imported into Canada must be accompanied by a copy of the Interim Order authorization. This document will be issued to the applicant upon authorization and will facilitate transport of the COVID-19 medical device(s) across the border, as it will be used as a signal that the device has been authorized under the Interim Order. Importers should rely on this mechanism to demonstrate to Health Canada that a shipment containing COVID-19 medical devices should be allowed access into Canada. References to Interim Order No. 1 on the authorizations can be read to be references to Interim Order No. 2.

Incident reporting

Interim Order No. 2 requires that the holder of the COVID-19 medical device authorization for the importation or sale of the device report to Health Canada to comply with incident reporting requirements.

Importers and distributors also must comply with mandatory reporting as outlined in the Medical Devices Regulations. Importers and distributors should also note that new regulations on mandatory reporting under the Medical Devices Regulations will come into effect on June 23, 2021, at which point importers will be expected to comply with the new regulations.

Requirement for importers and distributors to hold a Medical Device Establishment Licence (MDEL)

Under Interim Order No. 1, importers and distributors were not required to hold an active Medical Device Establishment Licence (MDEL) to import or distribute COVID-19 medical devices authorized under the IO. To enable risk-based regulatory oversight on the medical device supply chain and facilitate complete and rapid recalls of problematic devices when necessary, Health Canada has added this requirement to Interim Order No. 2.

Requirement to hold an MDEL

Interim Order No. 2 requires importers and distributors of COVID-19 medical devices to hold an MDEL and comply with certain requirements set out in the Medical Devices Regulations.

COVID-19 medical device importers and distributors:

have six months from the date that Interim Order No. 2 takes effect to obtain an MDEL and comply with relevant parts of the Medical Devices Regulations as defined in section 2(2)(a) of the Order (by September 1, 2021)
must submit applications for an MDEL within sufficient time to accommodate the service standard of 120 calendar days
are required to pay application fees, as well as annual fees, for as long as they hold an MDEL

MDEL holders are subject to other regulatory requirements, including record-keeping, reporting and inspections. Health Canada inspectors verify that the MDEL holder has the ability to conduct rapid, effective recalls of problematic devices when necessary.

Consult the existing Guidance Document for Mandatory Problem Reporting for Medical Devices for information on how to comply with those sections. Importers and distributors should also note that new regulations on mandatory reporting under the Medical Devices Regulations will come into effect on June 23, 2021, at which point importers will be expected to comply with the new regulations.

MDEL fees

Importers and distributors of any medical devices (including COVID-19 medical devices) who are required to hold an MDEL, must pay the associated MDEL fee, and comply with requirements set out in the Medical Devices Regulations.

For more information pertaining to MDEL fees, please review the Fees for the Review of Medical Device Establishment Licence Applications at the official website of Health Canada.

References

www.canada.ca

Tags Health Canada, Interim Order, Mdel, medical devices

News

FDA’s Addition of the 9th Allergen (Sesame)

Post author By Quality Smart Solutions
Post date June 9, 2021
No Comments on FDA’s Addition of the 9th Allergen (Sesame)

Sesame will become the 9th major food allergen officially recognized by the United States (FDA) on January 1st, 2023. The industry will have roughly two years to incorporate labeling changes to accommodate this new requirement. This clear labeling initiative is warranted to improve transparency, reduce allergic reactions, and protect this vulnerable population.

Prevalence:

Sesame allergies are more common than one would think. Approximately 0.1% or 350,000 Americans experience allergic reactions or sensitivity to the ingredient sesame, thus justifying this major change and the addition to the Priority Allergen List (PAL). Symptoms from sesame reactions can range anywhere from hives to anaphylaxis and can even be potentially fatal to some individuals.

How to disclose allergens:

Mislabelling or misrepresentation of an allergy is a serious issue and can lead to enforcement action for your product. The proper format(s) to disclose a major allergen on food labeling in the United States is as follows: In parentheses following the name of the ingredient. Examples: “lecithin (soy),” “flour (wheat),” and “whey (milk)” or Immediately after or next to the list of ingredients in a “contains” statement. Example: “Contains wheat, milk, and soy.”

Exceptions:

When this new change comes into force, sesame must appear clearly in the ingredients listing. However, sesame will not be required to be listed if it is within a spice or flavoring. It will also not need to be listed when sesame is assumed within the common or usual name of a food (e.g. Tahini is made from sesame seed). It is important that consumers are aware of any allergens within their foods at the time of purchase. Taking precautions and clearly labeling your ingredient can help save lives. The industry is urged to transparently disclose sesame wherever possible. Taking an honest approach is always suggested when it comes to allergens. Other names for sesame are Benne, gingelly, seeds, sesamol, sesamum indicum, sim, tahini, and til. It is important that these ingredients will now be called out clearly as providing sesame to avoid where possible, any confusion, allergic reactions, and potential hospitalizations.

Enforcement:

The FDA can enforce incorrect allergen labeling similarly to an adulterated or misbranded product. They can take actions such as warning letters, recalls, import refusals, or product seizures. In most cases where incorrect labeling has been identified the company can and will recall the product voluntarily. The seriousness of incorrect labeling can be fatal and should be taken very seriously.

International Recognition:

Sesame is a recognized priority allergen in many major markets such as Canada, the EU, and now the USA. Sesame is the largest food allergy in Israel and its commonality is spreading.

Allergens:

The original/other eight major US allergens are Milk, Tree Nuts, Eggs, Peanuts, Fish, Wheat, Shellfish, and Soybeans.

How Quality Smart Solutions can help:

Please contact our team for more information on labeling of allergens, or other food labeling projects. Our specialists are here to help!

Resources:

www.fda.gov

Tags Allergies, Fda, Food, Food Allergens, Sesame

Blog

Why You Should Consider a Third-Party NHP Importer of Record?

Post author By Andrew Parshad
Post date June 3, 2021
No Comments on Why You Should Consider a Third-Party NHP Importer of Record?

Natural Health Products (NHPs) are regulated by Health Canada under the authority of the Food and Drugs Act and the Natural Health Products Regulations (NHPR) and must be licensed prior to marketing in Canada. Licensed NHPs are assigned an eight (8) digit Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM). To be classified as an NHP, all of the medicinal ingredients in the product must be in Schedule 1 of the NHPR, not include any substances listed in Schedule 2 of the NHPR and be marketed for health reasons.

NHPs include traditional medicines; health supplements/vitamins; minerals; and bulk raw materials manufactured, sold or represented for use as NHPs. Cosmetics containing NHP ingredients and that meet both the function and substance components of the NHP definition are regulated as NHPs.

Health Canada has an easy-to-follow policy on the importation of health products for commercial use. The Guidance Document on the Import Requirements for Health Products under the Food and Drugs Act and its Regulations (GUI-0117) outlines the requirements related to the importation of health products as defined by the Food and Drugs Act.

Health products commercially imported into Canada must meet all applicable requirements of the Food and Drugs Act and its Regulations including proper labelling, market authorization and establishment licenses. Here’s a summary of the licensing requirements for natural health products that are intended to be shipped to Canada for commercial purposes.

License Requirements for Natural Health Products:

Product license (NPN or DIN-HM) for each product.

All products, whether manufactured domestically or in a foreign site, must first undergo a pre-market review where it will be assessed for safety, efficacy, and quality. Evidence demonstrating this must be submitted to Health Canada by means of a product licence application (one for each product). Products, which meet the required criteria, will be authorized for sale and each issued a Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM). Further information on this process is available in the Product Licensing Guidance Document.

Site license for each importer located in Canada.

The Natural Health Products Regulations require any Canadian site where natural health products are manufactured, imported, labelled, packaged, distributed, and/or stored to have a site licence. Businesses can choose to have a single site licence for all their operations (i.e. multiple sites) or an individual licence for each site. Site licences are obtained by demonstrating that the above-mentioned activities are conducted in a manner that is congruent with the requirements of the Canadian Good Manufacturing Practices (GMPs) for NHPs.

Quality Import Solutions (QIS) has a valid Site License to import Natural Health Products and can act as an importer of record into the Canadian market. We have collaboration with fist-class third-party warehouses annexed to our site license that can provides storage services of NHPs in compliance with Canadians GMPs if needed.

The foreign manufacturer must be listed on the importer’s site license.

While site licences are only issued to Canadian sites (none are issued to foreign sites). Foreign manufacturers as well as packagers, labellers of NHPs must be annexed to a Canadian importer’s site licence. In order to annex a foreign site to importer’s site licence, each foreign site must provide GMP evidence to demonstrate compliance with Part 3, GMP, of the Natural Health Products Regulations in full.

Why Use Quality IMPORT Solutions (QIS) as a Third-Party NHPs Importer of Record

Using QIS as a third-party NHPs Importer of Record will give you the benefits outlined below:

Flexibility to use multiple distributors and/or brokers or sell direct in Canada
Acting as a neutral third party which helps eliminating packaging liability (Our Importer’s name is required on your NHP label) if you were to use a distributor as your NHP importer and if down the line the relationship doesn’t work or if you decide to switch to a new distributor, you would be required to either over-sticker or destroy packaging
Multiple geographical choices as we have warehouse and fulfillment partners (annexed to Quality IMPORT Solutions site licence) located across Canada improving speed to market based on your preferred destination point
Having the option to either sell to traditional retail outlet or to online venues like Amazon, Well.ca and others
Low resource cost as we have an experienced team of quality assurance who provide full product disposition to the Canadian market and manage your quality assurance obligations

More than 80% of Canadians consume natural health products (NHPs), so it’s a ripe market for brands that are willing to navigate the product registration and importation requirements outlined by Health Canada. Our team will help you navigate through the process of registration and importation of your NHPs.

Our Experts at Quality Smart Solutions continue to support your needs for natural health products, foods, cosmetics, OTC drugs and medical devices for North America. Contact us today to learn more about how we can support your compliance for NHPs registration and NHP importation.

Related Reading:

IOR Compliance and customs clearance

Medical Device Importer Benefits

FSVP Importer Food Importing

Tags Import, Nhp, Site Licence, Third Party

Guidance on foods derived from products of plant breeding:

Guidance on the pre-market assessment of food products derived from retransformants of previously assessed genetically modified (GM) plants:

Labelling Note:

How Quality Smart Solutions can help:

Links:

Authorization for importation or sale by the manufacturer

Fees related to the submission of an application for a COVID-19 medical device authorization

Quality Management System requirements related to the submission of an application for a COVID-19 medical device

Documentation required for importation

Incident reporting

Requirement for importers and distributors to hold a Medical Device Establishment Licence (MDEL)

Requirement to hold an MDEL

MDEL fees

References

Prevalence:

How to disclose allergens:

Exceptions:

Enforcement:

International Recognition:

Allergens:

How Quality Smart Solutions can help:

Resources:

Product license (NPN or DIN-HM) for each product.

Site license for each importer located in Canada.

The foreign manufacturer must be listed on the importer’s site license.

Why Use Quality IMPORT Solutions (QIS) as a Third-Party NHPs Importer of Record

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