The US Food and Drug Administration (FDA) announced the availability of two new chapters to the Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food, designed to help food facilities comply with the preventive controls for human food rule mandated by the FDA Food Safety Modernization Act. Chapter 11—Food Allergen Program and Chapter 16—Acidified Foods—are among the chapters that have been added since the draft guidance was first issued in 2016.

Chapter 11—Food Allergen Program—explains how to establish and implement a food allergen program that ensures protection of food from major food allergen cross-contact and that the finished food is properly labeled with respect to the major food allergens. It provides many examples of ways to significantly minimize or prevent allergen cross-contact and undeclared allergens using current good manufacturing practices (CGMPs) and preventive controls. The chapter also discusses circumstances in which, despite adherence to appropriate CGMPs and preventive controls, allergen presence due to cross-contact cannot be completely avoided and options the firm can consider, including the voluntary use of allergen advisory statements when appropriate. The chapter complements the FDA’s recently released Draft Compliance Policy Guide on Major Food Allergen Labeling and Cross-Contact, which reflects the agency’s risk-based and science-based approach for the evaluation of potential allergen violations.

Chapter 16—Acidified Foods—applies to manufacturers of acidified foods (such as some processed sauces, beans, cucumbers, or cabbage that have an overall pH of 4.6 or below). It explains how these manufacturers can use procedures, practices, and processes that they have established to meet requirements in the acidified foods regulations and to meet requirements under the preventive controls for human foods rule.

Electronic comments can be submitted through the Federal eRulemaking Portal at Regulations.gov. Written comments should be sent to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. All submissions received must include the Docket No. FDA-2016-D-2343 and should be submitted within 180 days to ensure the FDA receives comments before it begins work on the final versions of the guidance documents.

Additional Information

Notice of Availability: Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry

FDA Draft Guidance Could Result in Safer Food Options for People with Allergies to Sesame, Other Food Allergens

Food Safety Modernization Act (FSMA)

FSMA Final Rule for Preventive Controls for Human Food

FSMA Technical Assistance Network (TAN)

News from AAFC’s Market Access Secretariat

On September 12, 2023, the government of Mauritius notified the WTO of new measures with regards to their food regulations. The Draft Food Regulations 2023 are intended to replace the Food Regulations of 1999, with the overarching aim of fortifying the food control framework in Mauritius to align with international food standards.

The documents notified by Mauritius are the Food Act 2022: https://mauritiusassembly.govmu.org/mauritiusassembly/wp-content/uploads/2023/03/act1222.pdf

and the Draft Food Regulations 2023:  https://health.govmu.org/health/wp-content/uploads/2023/09/DRAFT-FOOD-REGULATIONS-2023-.pdf

Comments and concerns on both documents will be accepted until November 10, 2023. The proposed date of adoption is 1 December, 2023 and the entry into force will be 6 month safter the adoption date.

Should you have any concerns, please send your input by October 27, 2023 to aafc.mas-sam.aac@agr.gc.ca.

News from AAFC’s Market Access Secretariat

Please be informed that the European Union (EU) has notified the World Trade Organization (WTO) of a draft Implementing Regulation to proposed amendments to model certificates for entry into the EU of certain products of animal origin and certain categories of animals as it relates to veterinary medicinal products (VMPs).

As you may be aware, Article 118 (1) of Regulation (EU) 2019/6 requires third country operators exporting animals or products of animal origin to the EU to respect the prohibition on the use of antimicrobial medicinal products for the purpose of promoting growth or to increase yield, and the prohibition on the use of antimicrobials that have been reserved for the treatment of certain infections in humans.

This draft Implementing Regulation amends the model certificates for the export to the Union of food-producing animals and products derived therefrom intended for human consumption to include the relevant attestations of compliance with the provisions set by Regulation (EU) 2019/6.

You are invited to review the WTO notification to determine whether your industry could be impacted by these changes. Please refer to the following link for more information: G/SPS/N/EU/656.

To enhance our understanding of the potential impacts this regulation may have on Canadian exports to the EU, we welcome your comments on the EU’s proposed amendments to the model certificates. Please submit your comments, questions, and concerns to the Market Access Secretariat at aafc.mas-sam.aac@agr.gc.ca by August 25, 2023.

News from AAFC’s Market Access Secretariat

The Government of Canada is expanding its organic equivalency arrangement with Japan. Beginning August 31, 2023, organic alcoholic beverages will be included in this arrangement.

The original equivalency arrangement between Canada and Japan came into effect on January 1, 2015, and recognizes the organic production and certification systems in each country as equivalent. In July 2020, livestock products and processed food products containing livestock ingredients were added into this arrangement.

Beginning August 31, organic alcoholic beverages certified under the Canada Organic Regime or the Japanese organic system may be sold and labelled as organic in Canada and Japan. This arrangement gives consumers more organic options and expands market access in Japan for the Canadian organic industry.

For additional information, please refer to the following webpage: Overview: Japan – Canada Organic Equivalency Arrangement (JCOEA) – Canadian Food Inspection Agency

The US Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2024 user fee rates for importers approved to participate in the Voluntary Qualified Importer Program (VQIP) and accreditation and certification bodies interested in participating in the Accredited Third-Party Certification Program (TPP). The user fee rates are authorized by the FDA Food Safety Modernization Act (FSMA) and allow the agency to assess and collect fees to cover the FDA’s cost of administering these programs.

VQIP is a voluntary, fee-based program for the expedited review and importation of foods from importers who achieve and maintain a high level of control over the safety and security of their supply chains.

The FY2024 VQIP user fee rate will be effective on August 1, 2023, and supports program benefits from October 1, 2023, through September 30, 2024. Currently, the agency is not offering an adjusted fee for small businesses. Approved VQIP applicants must pay the user fee before October 1, 2023, to begin receiving benefits for the 2024 fiscal year.

TPP is a voluntary program in which FDA recognizes “accreditation bodies” that may accredit third-party “certification bodies.” The certification bodies can conduct food safety audits and issue certifications of foreign food facilities.

The FY2024 TPP user fee rate will be effective on October 1, 2023, and will remain in effect through September 30, 2024.

Please direct any questions regarding VQIP to the VQIP Importers Help Desk at 1-301-796-8745 or FSMAVQIP@fda.hhs.gov. Questions regarding TPP can be sent to FDAthirdpartyprogram@fda.hhs.gov. You can also subscribe to receive updates about the U.S. Import programs, policies and regulations.

Additional Information

Federal Register Notice announcing the FY2024 VQIP User Fee Rates

Voluntary Qualified Importer Program (VQIP)

Federal Register Notice announcing the FY2024 Third-Party Certification Program User Fee Rates

Accredited Third-Party Certification Program

Fees under the FSMA

FDA User Fee Programs