Category Archives: News

Small Entity Compliance Guides (SECGs) are designed to help small businesses meet federal standards. They are among the resources that the FDA is providing to support compliance with the new FDA Food Safety Modernization Act (FSMA) standards.

The FDA announced the availability of an SECG to help small businesses comply with the Final Rule on Mitigation Strategies to Protect Food Against Intentional Adulteration (or Intentional Adulteration Rule), mandated by FSMA.

The SECG was prepared in accordance with the Small Business Regulatory Enforcement and Fairness Act. It provides nonbinding recommendations on such topics as developing a food defense plan and records management.

The compliance date for small businesses under the Intentional Adulteration Rule is July 27, 2020. Very small businesses are exempt from the rule, except for a documentation requirement described in the SECG, which has a compliance date of July 26, 2021.

Please visit FDA.gov for more information about the FSMA rules and compliance dates.

To help businesses meet the requirements of the Food Safety Modernization Act (FSMA) Final Rule for Preventive Controls for Human Food, the US Food and Drug Administration is releasing a new software tool to help owners and operators of food facilities create a food safety plan specific to their facilities.

The Food Safety Plan Builder (FSPB) is a free software application, developed by FDA, that businesses can download from the FDA’s website to guide them, step-by-step, through the creation of a food safety plan, as required by FSMA.

The user is taken through a series of sections (tabs) in the application that prompt the user to answer questions and/or fill in information specific to their business and facility. Once all the tabs have been completed, the file may be saved or printed, and the firm will have a food safety plan to use in its operations and to provide when the FDA conducts an inspection.

While the Food Safety Plan Builder was primarily designed for use by small manufacturers, which may have limited resources, any size manufacturer can opt to use it. Although manufacturers are not required to use the program, the FDA designed this program to help companies organize their food safety information and minimize the burden of creating their food safety plan.

To assist users, the FDA has also developed an overview video about the application, as well as individual videos that demonstrate how to navigate the various tabs. These videos are posted on Youtube and may be accessed via the Food Safety Plan Builder webpage. The FDA has also provided a User Guide with individual chapters devoted to each tab. Manufacturers with questions about how to use the tool can access further assistance by contacting the FDA through the email address FoodSafetyPlanBuilder@fda.hhs.gov.

The program and educational materials are modeled after the successful Food Defense Plan Builder, which was created to assist owners and operators of food facilities with developing personalized food defense plans for their facilities.

If you are a food producer covered by FDA’s regulations for low-acid canned foods, juice HACCP, or seafood HACCP, how do the rules that implement the FDA Food Safety Modernization Act (FSMA) affect you?

To answer this question, the FDA has published three guidances to help producers of food commodities covered by these earlier regulations understand which parts of the FSMA rules apply to them and how the FSMA rules may affect their operations.

FDA’s HACCP (Hazard Analysis and Critical Control Point) and Low-Acid Canned Foods (LACF) regulations were in place long before the FSMA rules became final. FDA’s HACCP regulations for juice and seafood processors require processors to perform a hazard analysis and develop a HACCP plan to address biological, chemical, and physical hazards, monitor the conditions and practices, and make corrections as needed. FDA’s Low-acid canned foods regulation addresses biological hazards such as Clostridium botulinum unique to such foods, which include canned vegetables.

FSMA recognizes that FDA has previously-established regulations that are specific to seafood, juice, and LACF and so some exemptions have been made in the FSMA rules for these products. However, there are still some requirements in the FSMA regulations that apply to processors of the seafood, juice, and LACF products.

The new guidances aim to help industry identify these exemptions and understand the juice, seafood, and LACF regulations in connection with some of the new FSMA requirements. The overarching goal of many of the new FSMA requirements is to reduce the number of foodborne illnesses attributed to the preventable contamination of FDA-regulated food products.

For More Information:

Low-Acid Canned Foods and FSMA
Juice HACCP and FSMA
Seafood HACCP and FSMA

The Government of Canada is pleased to announce that federal-provincial-territorial ministers of agriculture have endorsed the Plant and Animal Health Strategy for Canada.

Over the last year, governments, industry, academia and others who play a role in plant and animal health came together to chart a path to collaboratively safeguard Canada’s plant and animal resources through development of this Strategy. They would like to thank everyone who contributed to this endeavour, including during the most recent consultation in April, from which they received excellent feedback on the Strategy. The Strategy was revised based on your comments and is now available online.

It is now time to set implementation of the Strategy in motion, and they look forward to continuing to work with you to achieve the results identified in the Strategy. A key first step will be establishing implementation coordinating councils to lead implementation, as outlined in the Strategy, focused on plant and animal health, respectively.

They will continue to provide updates as implementation progresses. For more information, please email PAHS-SSVA@inspection.gc.ca or visit www.inspection.gc.ca/CanPAH.

After conducting a systematic review of the available scientific data, the US Food and Drug Administration (FDA) now intends to exercise enforcement discretion over the use of a qualified health claim characterizing the relationship between consumption of macadamia nuts and reduced risk of coronary heart disease. The claim, which manufacturers can use immediately, reads:

“Supportive but not conclusive research shows that eating 1.5 ounces per day of macadamia nuts, as part of a diet low in saturated fat and cholesterol and not resulting in increased intake of saturated fat or calories may reduce the risk of coronary heart disease. See nutrition information for fat [and calorie] content.”

Qualified health claims are supported by scientific evidence, but do not meet the more rigorous “significant scientific agreement” standard required for an authorized FDA health claim. As such, they must be accompanied by a disclaimer or other qualifying language so that the level of scientific evidence supporting the claim is accurately communicated.

For More Information

FDA Response to Petition for a Qualified Health Claim for Macadamia Nuts and Reduced Risk of Coronary Heart Disease
Questions and Answers: Qualified Health Claims in Food Labeling
Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims
Qualified Health Claims: Letters of Enforcement Discretion

In order for Canada to implement and administer its international obligations under the Comprehensive Economic and Trade Agreement (CETA) with the European Union (EU), Canada is proposing the creation of new regulations and amendments to existing regulations made under the authority of the Export and Import Permits Act. Please be advised that the July 15, 2017 edition of the Canada Gazette has published for comment the following proposed regulations that relate to these obligations:

· Order Amending the Export Control List
· Order Amending the Export Permits Regulations
· Order Creating Export Permits Regulations (Non-strategic Products)
· Order Creating Export Allocations Regulations
· Order Amending the Import Control List

The regulations may be reviewed at the following website: http://www.canadagazette.gc.ca/gazette/home-accueil-eng.php.

The comment period begins July 15th and ends July 29th. Interested persons may make representations concerning the proposed Regulation(s) within 15 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Reuben East, Deputy Director, Trade Controls, Global Affairs Canada, 111 Sussex Drive, Ottawa, Ontario K1N 1J1 (tel. : 343-203-4365; fax : 613-996-0612; email: Reuben.East@international.gc.ca).

Update July 12th – The Consulate General in Dubai has received confirmation from the Dubai Municipality that Canadian halal certification bodies that were previously approved by the Ministry of Climate Change and Environment (MOCCAE) and are currently undergoing an assessment for accreditation by the Emirates International Accreditation Centre (Dubai Accreditation Centre) will have temporary approval to certify halal products, under the scope defined by their previous MOCCAE accreditation. This transitional measure applies for products entering the UAE through Dubai.

It will be valid until the certification body is assessed and accredited under the new Emirates Authority for Standardization and Metrology (ESMA) halal regime.


Update May 29 – Agriculture and Agri-Food Canada  received today written confirmation from the Emirates Authority for Standardization and Metrology (ESMA) that they are providing flexibility in the application of the May 31st deadline. The May 31st deadline will refer to the certificate issuance date. Therefore, if a shipment is on route to the UAE and certified before June 1, 2017, by a halal certification body approved under the old halal regime by the Ministry of Climate Change and Environment , the product will be accepted, even if it arrives after May 31, 2017.

After May 31, 2017, only ESMA approved certification bodies can provide halal certification for products exported to the UAE. Please see the following link to the ESMA website , which provides the list of ESMA registered and approved CBs: http://halal.ae/en-us/Open-Data/Pages/Navigation.aspx.


Update – May 11th – The consulate General of Canada in Dubai met today with the Emirates Authority for Standardization and Metrology (ESMA) regarding the United Arab Emirates’ (UAE) new halal regulations for the accreditation of halal certification bodies (CBs).

ESMA confirmed that the authority for accreditation of halal CBs has been fully transferred from the Ministry of Climate change and Environment (MOCCAE) to ESMA. As the UAE is transitioning from the old to its new system, the ESMA website currently carries two lists: (1) EMSA registered halal CBs and (2)CBs registered with the MOCCAE under the previous halal system. The MOCCAE list will expire on May 31, 2017, and from that point forward only ESMA registered CBs will be able to certify halal products entering the UAE market. The two Canadian halal CBs on the MOCCAE approved and registered list, IFANCC and ISNA, are not currently on the ESMA approved and registered list.

Canadian exporters need to seek the certification services of an ESMA registered and approved CB for exports anticipated to arrive at the UAE after May 31, 2017. Please see the following link to the ESMA website , which provides the list of ESMA registered and approved CBs: http://halal.ae/en-us/Open-Data/Pages/Navigation.aspx.

Please inform Agriculture and Agri-Food Canada’s Market Access Secretariat (mas-sam@agr.gc.ca) if there any shipments expected to arrive at the UAE, after May 31st, with a halal certificate from a CB not registered with ESMA.

They will continue to keep you apprised if there any further developments.


Update – April 13th – This is a follow up to the original post below:  The Consulate General of Canada in Dubai has made an official request to the Emirates Authority for Standardization and Metrology (ESMA) for an extension of the deadline for Canadian exporters to present halal certificates issued by certification bodies accredited by ESMA under the new UAE halal regime. The request pointed out that it was not feasible for a single accredited North American CB to cover the entire North American market, and that an extension should be granted until more North American CBs have achieved accreditation under the new halal regime.

The Consulate has followed up several times for a response from ESMA. Today ESMA indicated that an official response is being prepared and will be sent to the Consulate via the diplomatic channels.
At this point, no indication has been given by UAE officials regarding an extension of the March 31 deadline. At this point, the recognition of halal certificates at the ports in the UAE is still based on the Ministry of Climate Change and Environment’s (MOCCAE) list of approved halal CBs. The MOCCAE list  was most recently updated on April 5th and the Canadian CBs that were approved based on the previous halal regime are still on that list.  However, the Government of Canada cannot make any guarantees as to whether these certificates would be accepted by UAE authorities, or if or when the Canadian CBs currently on the MOCCAE list might be removed.

The government hopes to have another update next week.


The United Arab Emirates (UAE) has introduced new halal regulations for the accreditation of halal certification bodies (CBs). Under, the new halal regime, the Emirates Authority for Standardization and Metrology (ESMA) is responsible for authorizing halal CBs.

The requirement for a halal certificate extends to more than just meat, it also includes products containing animal products. Exporters need to consult the UAE standards to determine whether a halal certificate is applicable or not.

As of March 31, 2017, Canadian products that enter the UAE market, which require a halal certificate, must be accompanied by a halal certificate issued by certification body registered with ESMA. At this time, there are no Canadian certification bodies that have completed the process to be accredited under the UAE’s new halal regime, and therefore there are no Canadian halal CBs currently registered with ESMA. A company, can however, use an American Certification body registered with ESMA to provide halal certification for products exported to the UAE market. There is currently one American CB registered with ESMA, based in Omaha, Nebraska. A number of American CBs have completed the process to be accredited under the new UAE halal regime, and the ESMA list is expected to be updated shortly to include a number of other American CBs.

Please see the following link for a list of CBs registered with ESMA: http://halal.ae/en-us/Open-Data/Pages/LIST-OF-HALAL-CERTIFICATION-BODIES-REGISTERED-WITH-ESMA.aspx

If you have any questions, please contact the Market Access Secretariat at mas-sam@agr.gc.ca

On July 5th, 2017, the Russian Federation announced its decision to extend the embargo on certain food imports from the EU, the US, Canada, Australia, Norway, Ukraine, Albania, Montenegro, Iceland and Liechtenstein until December 31, 2018. This announcement refers to the Russian President’s Executive Order No 293 of 30 June 2017 on Extending Certain Special Economic Measures to Ensure the Security of the Russian Federation.

The official announcement can be found here: http://government.ru/en/docs/28304/

The President’s Executive Order No. 293 (in Russian) can be found here:

http://publication.pravo.gov.ru/Document/View/0001201706300013

Background: In response to sanctions imposed against it for its actions in Ukraine and Crimea, Russia first announced the imposition of a one-year embargo on food imports from the above mentioned countries on August 7, 2014. The embargo was subsequently extended until December 2017.

Update – July 6, 2017 – Two Gulf Cooperation Council (GCC) member states (Kuwait and Bahrain) have issued a World Trade Organization (WTO) notification, on June 13, 2017 and June 29, 2017 respectively that the GCC Guide for Control on Imported Foods (Food Guide) will not be implemented until further notice. The remaining four member states (Saudi Arabia, United Arab Emirates, Qatar, Oman) have not issued such a notification, but Agriculture and Agri-Food Canada are following up to seek clarity whether these countries intend to also suspend implementation. The United Arab Emirates, through meetings with senior Canadian government officials, has verbally indicated that it is not planning to implement the Food Guide at this time. The GCC member countries have previously notified to the WTO that the Food Guide will come into force on October 1, 2017.

The Food Guide provides requirements for the export to the GCC of agrifood and seafood products including processed food, plant meat, milk, eggs, fish, and honey products. The Food Guide was originally notified to the WTO in 2015, but the June 1, 2015 implementation date was delayed due to concerns raised by trading partners, including Canada.

Since April 2015, Canada has made representations on the GCC Food Guide through letters to the GCC Secretariat and to the respective GCC competent authorities, as well as through meetings between Canadian and GCC government officials in the region.

While some of Canada’s concerns have been taken into consideration in the current version of the Food Guide, some issues remain, and Canada continues to engage with the GCC to address outstanding concerns.


March 30, 2017 The Gulf Cooperation Council (GCC) Food Safety Committee hosted a forum on March 9, 2017 for trading partners to provide information and answer questions on the GCC Food Guide. The GCC Secretariat announced some changes to the Food Guide and indicated that it will come into force on October 1, 2017. AAFC expects to receive a revised version of the GCC Food Guide that we will share with you once available.

One of the key changes announced during the forum is the transferring of the attestation that meat products “have not been derived from animals fed with animal protein…” from the veterinary health certificate to the halal certificate. Some of Canada’s concerns with the Food Guide still remain including the requirement to attest compliance with GCC requirements for residues. The Government of Canada continues to engage with the GCC Secretariat and GCC member states to address outstanding issues.

If you have any questions, please email Agriculture and Agri-Food Canada’s Market Access Secretariat at mas-sam@agr.gc.ca

The US Department of Agriculture’s (USDA) Agricultural Marketing Service has posted 30 questions for stakeholder input regarding the establishment of a National Bioengineered Food Disclosure Standard (click here to re-direct to the questions). As you may recall, the National Bioengineered Food Disclosure Standard Law was enacted by Congress on July 29, 2016 (Bill S. 764). This law creates a national mandatory system in which food makers must disclose GMO data using: on-package text; a USDA-created symbol; or an internet link (e.g., QR code) directing consumers to more information.

The USDA is seeking input from stakeholders in order to establish the final rule by the mandated July 2018 deadline. The USDA has indicated that they will use the input received when they are drafting a proposed GM labelling rule. The public will also have the opportunity to comment on further rulemaking through the Federal Register process.

Official feedback related to the USDA questions must be submitted to GMOlabeling@ams.usda.gov by July 17, 2017.

The Government of Canada would like you to share your views and any officials comments you submit to the USDA. You can share this by email to mas-sam@agr.gc.ca prior to the July 17, 2017 deadline.