IFAC Regulatory Update December 2020 - Food Ingredient Facts

IFAC Regulatory Update
                                        December 2020
TO: IFAC Regulatory Committee

Happy New Year! Following is the December 2020 IFAC Regulatory Update.

IFAC Updates

IFAC 2021 Virtual Annual Meeting Slated for January 11-14
As you may be aware, the 2021 IFAC Annual Meeting is being held virtually from January 11-14 due to
the ongoing COVID-19 public health emergency. The final Schedule of Events is attached and calendar
invitations have been circulated. Final agendas and meeting materials are being sent out this week. If
you have not received a particular calendar invite and would like to participate, please notify staff.

IFAC GMP Guide Webinar
On December 3, IFAC in partnership with the Institute of Food Technologists (IFT) hosted a free webinar
on the IFAC GMP Guide and Audit Guides. The webinar was recorded and is posted on the IFT website.
The webinar recording is free to download for IFT members and non-members, please share the
recording with your colleagues by sharing this link. Additionally, staff has attached the final webinar
slides for your records.

U.S. Updates
FDA Issues Uniform Compliance Date for Final Food Labeling Regulations
On January 4, 2021, the U.S. Food and Drug Administration (FDA) announced that January 1, 2024, will
be the uniform compliance date for final food labeling regulations that are issued in calendar years 2021
and 2022. This action does not change existing requirements for compliance dates contained in final
rules published before January 1, 2021.

The FDA periodically announces uniform compliance dates for new food labeling requirements to
minimize the economic impact on the food industry of having to respond separately to each labeling
change. The FDA generally encourages industry to comply with new labeling regulations as quickly as
feasible. However, companies whose products are subject to the new uniform compliance date have
until January 1, 2024, to comply with the appropriate labeling regulations when initially introducing
products into interstate commerce.

Outbreak Investigations – CORE Investigation Table Update
On December 23, the FDA updated the Coordinated Outbreak Response and Evaluation (CORE)
Network’s CORE Investigation Table, a list of outbreak investigations which is managed by FDA’s CORE
Response Teams. Investigations are in a variety of stages, meaning that some outbreaks have limited
information, and others may be near completion. The table will be updated weekly.

Following are the latest updates as of December 23:
  • There is a new Salmonella Potsdam outbreak in an unknown food.
  • There is an active Salmonella Thompson in an unknown food.

•   There is an active E. coli outbreak linked to leafy greens.
  •   All other outbreaks related to Salmonella and E. coli have been closed.

USDA Announces Proposal to Regulate Agricultural Animal Biotechnology
On December 21, the U.S. Department of Agriculture (USDA) released an Advanced Notice of Proposed
Rulemaking to seek comment on a contemplated regulatory framework that, if finalized, would
transition portions of the FDA’s pre-existing animal biotechnology regulatory oversight to USDA. USDA
proposes to use its existing authorities under the Animal Health Protection Act, the Federal Meat
Inspection Act, and the Poultry Products Inspection Act to provide end-to-end regulatory oversight from
pre-market reviews through post-market food safety monitoring for livestock, horses, Siluriformes
(including catfish) and poultry that are intended for agricultural purposes and that are modified or
developed using genetic engineering.

The deadline to comment is February 26. Staff does not plan to develop IFAC comments unless
otherwise advised by Friday, January 29. For more information, please see this related article from IFAC
regulatory counsel, Covington.

2018 Annual Report on the Sources of Foodborne Illness by the IFSAC
On December 18, the Interagency Food Safety Analytics Collaboration (IFSAC) published the newest
report for sources of foodborne illness in 2018, “Foodborne Illness Source Attribution Estimates for 2018
for Salmonella, Escherichia coli O157, Listeria monocytogenes, and Campylobacter Using Multi-year
Outbreak Surveillance Data, United States”. In an ongoing effort to understand sources of foodborne
illness in the United States, IFSAC collects and analyzes foodborne illness outbreak data for these four
pathogens and specific foods and food categories that are responsible for foodborne illness in the
United States. The data is analyzed by calendar year and released in an annual report. The Centers for
Disease Control and Prevention estimates that, together, these four pathogens cause nearly two million
cases of foodborne illnesses in the U.S. each year.

FDA Proposes to Revoke the Standard of Identity for French Dressing
On December 21, the FDA published a proposal to revoke the definition and standard of identity for
French dressing. The FDA states the standard does not appear necessary to ensure that the product
meets consumer expectations, and has tentatively concluded that it is no longer necessary to promote
honesty and fair dealing in the interest of consumers and may limit flexibility for innovation. The
comment period for this proposal closes on March 22. IFAC does not plan to submit comments to the
FDA unless otherwise advised by Friday, January 29.

Final Guidance on an Alternate Name for Potassium Chloride
On December 18, the FDA issued final guidance for the Use of an Alternate Name for Potassium Chloride
in Food Labeling, which advises food manufacturers of the agency’s intent to exercise enforcement
discretion for the name potassium salt in the ingredient statement on food labels as an alternative to
potassium chloride to better inform consumers that it is a salt substitute.

FDA Proposes to Revoke Standard of Identity for Frozen Cherry Pie
On December 18, the FDA published a proposal to revoke the definition and standards of identity and
quality for frozen cherry pie. The FDA notes the standards do not appear necessary to ensure that these
products meet consumer expectations, and has tentatively concluded that they are no longer necessary
to promote honesty and fair dealing in the interest of consumers and may limit flexibility for innovation.

The comment period for the proposal closes on March 18, 2021. IFAC does not plan to submit
comments to the FDA unless otherwise advised by Friday, January 29.

FDA Extends Comment Period for Sugars that Metabolize Differently than Traditional Sugars
On December 18, the FDA extended the comment period on their Request for Information to receive
information about the nutrition labeling of sugars that are metabolized differently than traditional
sugars (e.g., allulose, d-tagatose, and isomaltulose). The comment period is open until February 16. IFAC
does not plan to submit comments to the FDA unless otherwise advised by Friday, January 29.

FDA Extends Comment Period for the Food Traceability Proposed Rule
On December 17, the FDA extended the comment period for the proposed rule entitled Requirements
for Additional Traceability Records for Certain Foods and related information collection provisions until
February 22. The proposed rule originally included a 120-day comment period for the proposal and a 60-
day comment period for the information collection provisions, which closed on November 23, 2020. The
comment period for public comment on the proposed rule and the comment period for information
collection are now aligned and will close on February 22. IFAC does not plan on submitting comments to
the FDA unless otherwise notified by Friday, January 29.

FDA Biennial Registration Renewal Period & DUNS Guidance
On December 1, the FDA reminded U.S. and foreign human and animal food facilities that they are
required to register with the FDA and must renew their registration this year before December 31.
The FDA will consider the registration of a food facility to be expired if the facility does not renew its
registration by December 31, 2020. There is no fee associated with registration or renewal. Owners and
operators of food facilities must submit their renewal information electronically through their FDA
Industry Systems account, unless they have received a waiver to submit a paper submission.

Additionally, the FDA expects all registrants to provide their DUNS number with their registration or
renewal submission before December 31, 2020, the Agency recognizes that there may be a delay in
obtaining a DUNS number. To address stakeholder concerns with obtaining a DUNS number in a timely
manner, the FDA has released guidance, Enforcement Policy for Providing an Acceptable Unique Facility
Identifier (UFI) for the 2020 Food Facility Registration Biennial Renewal Period, with information on
what facilities should do if they are unable to obtain a DUNS number prior to the end of the renewal
period.

International Updates
UK Risk Analysis Process and Authorization for Food
The United Kingdom (UK) Food Standards Agency (FSA) recently hosted a webinar on the UK risk analysis
process and authorization of substances in food and feed, including new food additives and novel foods.
Attached is a copy of the presentation slides from the webinar. Additionally, attached is a document
summarizing the key themes and questions put to the panel during the Q&A sessions.

Additionally, FSA shared the following information is available on their website:
 • The food and animal feed risk analysis process
 • Requirements for regulated products applications
 • How to apply for authorization of a regulated product

Finally, the FSA latest Chief Scientific Adviser’s report gives an overview of the risk analysis process with
an emphasis on the role that risk assessment plays in that process.

Health Canada – Modified Vinegar as a Preservative
On December 22, Health Canada announced that, after completing a premarket safety assessment, the
agency has as enabled the use of modified vinegar as a preservative in certain meat and poultry
products and preparations and updated the Lists of Permitted Food Additives accordingly.

‘Use by’ or ‘best before’? – EFSA Launches a New Tool to Support Food Operators
The European Commission (EC) estimates that up to 10% of the 88 million tons of food waste generated
annually in the European Union (EU) is linked to date marking on food products. Therefore, the
European Food Safety Authority (EFSA) has developed a tool to help food business operators decide
when to apply the ‘use by’ or ‘best before’ date to their products. The “use by” date on food is about
safety – foods can be eaten until this date but not after, even if they look and smell fine. “Best before”
refers to quality – the food will be safe to eat after this date but may not be at its best.

Report of 90th JECFA Meeting
The 90th meeting of Joint Food and Agriculture Organization (FAO) / World Health Organization (WHO)
Expert Committee on Food Additives (JECFA) took place October 26 – November 6, with an additional
day, November 24, to adopt the report. This meeting was originally planned to take place at the WHO
headquarters in Geneva, was instead held virtually due to the various pandemic-related restrictions in
place.

The Committee evaluated trichothecenes (T-2 and HT-2) and a number of substances that may occur as
previous cargoes. The summary and conclusions of the meeting is available here.

EU Organic Implementation
On December 11, the EC issued the implementing regulation (EU) 2020/2042 which amends the
implementing regulation (EU) 2020/464 as it regards its date of application and certain other dates that
are relevant for the application of Regulation (EU) 2018/848 of the European Parliament and of the
Council on organic production.

JECFA Updates Principles and Methods for the Risk Assessment of Chemicals in Food
In December, Dr. Markus Lipp (FAO/WHO/JECFA) notified industry that the “Principles and methods for
the risk assessment of chemicals in food” was recently updated.

Since the publication in 2009 science has further evolved as well as risk assessment practices. FAO and
WHO have started several projects to update (sub)chapters as follows:
    • Section 4.5 Genotoxicity
        The updated section 4.5 on genotoxicity published in November 2020 will be incorporated in the
        online version of the Environmental health criteria 240 in the coming months.
    • Chapter 5: Dose-Response Assessment and Derivation of Health-Based Guidance Values
        The updated chapter 5 on dose-response assessment and derivation of health-based guidance
        published in December 2020 will be incorporated in the online version of the Environmental
        Health Criteria 240 in the coming months.
    • Chapter 6: Dietary Exposure Assessment of Chemicals in Food
        The updated chapter 6 on Dietary Exposure Assessment of Chemicals in Food published in

November 2020 will be incorporated in the online version of the Environmental health criteria
        240 in the coming months.
    •   Section 9.1.4.2 Enzymes
        The updated section 9.1.4.2 on enzymes published in November 2020 will be incorporated in
        the online version of the Environmental health criteria 240 in the coming months.

Organic Regulations in the UK post Brexit
The European Union (EU) has confirmed they will recognize the UK organic control bodies as equivalent,
meaning that goods certified as organic by a UK organic control body can continue to be sold as organic
in the EU.

Additionally, on December 7, the UK announced a delay in requiring goods from the EU, European
Economic Area (EEA), or Switzerland to have a Certificate of Inspection (COI) to July 1, 2021. The delay
does not impact imports from other third countries which will still need a COI to be imported into the
UK starting January 1, 2021.

Finally, the UK Department for Environment Food & Rural Affairs (DEFRA) has provided a few helpful
links, below, and produced the attached power point which explains more about the new organic
procedures.
     • The Border Operating Model guide
     • How to Create a COI
     • Draft EU regulation updating Regulation (EC) 1235/2008

DATEM Draft Standard Amendment in Taiwan
On December 3, Taiwan notified the World Trade Organization (WTO) in notice G/SPS/N/TPKM/556 the
amendment of the standard to the definition of Diacetyl Tartaric Acid Esters of Mono- and Diglycerides
(DATEM). The amended draft is in alignment with JECFA standard for DATEM. Comments are due
February 2 and IFAC does not plan to submit comments unless notified by members.

As a general reminder, the IFAC members-only website is available for use. Content includes a library of
statements, comments, regulatory documents and committee documents as well as monthly regulatory
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feedback about the site, please let staff know.