IFAC Regulatory Update January 2021 - Food Ingredient Facts

IFAC Regulatory Update
                                           January 2021
TO: IFAC Regulatory Committee

IFAC Activities and Updates
Annual Meeting Follow Up
We enjoyed seeing many of you during the IFAC 2021 Virtual Annual Meeting, which took place January
11-14. The sessions were all very well attended and extremely productive. For those who were not able
to attend or missed sessions, copies of all slide presentations – including the State of the Association,
U.S. Regulatory Update, and EU Regulatory Update – as well as recordings of these three sessions are
posted on the IFAC members-only website. Please let staff know if you need your login info re-sent.

Staff will be circulating all meeting minutes in the coming days. In addition, we are asking all IFAC
members to please complete this 10-15 minute survey, regardless of whether you participated in the
Annual Meeting, to help us with future programming and most importantly membership development
efforts. If you have not already done so, please complete the survey by Friday, February 12.

China Response to IFAC Comments on NFS for Nutrition Labeling
As a reminder, in November 2020, IFAC submitted comments to China’s National Health Commission
(NHC) regarding its “Draft National Food Safety Standard General Rules for Nutrition Labeling of
Prepackaged Foods.” IFAC also co-submitted comments with the Association of Manufacturers and
Formulators of Enzyme Products (AMFEP) and the Enzyme Technical Association (ETA). IFAC provided a
number of comments related to the scope of the standard, the calculation for energy, the definition for
carbohydrates, the definition/scope for sugars, and other sections. In late January, IFAC received the
attached detailed response from NHC, notes IFAC feedback that was incorporated into the final
standard. If you have any questions, please let staff know.

CCFA Meeting Update
The 52nd Session of the Codex Committee on Food Additives (CCFA52) has again been postponed and is
now rescheduled for September 6-10, 2021. This update has been posted to the CCFA52 website, with
the following information:
    • Due to the COVID-19 pandemic, the 52nd meeting of the Codex Committee on Food Additives
         (CCFA) has been rescheduled to take place from 6 to 10 September 2021.
    • In collaboration with the China National Health Commission and the CCFA Host Secretariat, the
         Codex Secretariat will assess whether the meeting can be held physically, or if has to take place
         virtually.
    • Information regarding how work will continue and other updates will be published as soon as
         they become available.

IFAC has been in contact with the CCFA U.S. delegation, but at this time no information is available
regarding how this rescheduling will impact the progress of the various physical and electronic Working
Groups, nor the progression of JECFA related activities. Additional information will be shared as it
becomes available.

U.S. Updates

‘FDA Voices’ Addresses Allergens
On January 28, the U.S. Food and Drug Administration (FDA) published an “FDA Voices” by Dr. Susan
Mayne, Director of FDA’s Center for Food Safety and Applied Nutrition, which discusses FDA’s increased
efforts to protect consumers from food allergens. FDA Voices is a periodic communication that shares
perspectives from FDA leadership on key topics. The FDA Voices on allergens can be accessed here.

HHS SUNSET Final Rule
On January 19, the Department of Health and Human Services (HHS) published the final rule for Securing
Updated and Necessary Statutory Evaluations Timely (SUNSET) in the Federal Register. The rule goes
into effect on March 22 and requires HHS and it’s subagencies to assess their regulations every ten years
to determine whether they are subject to review under the Regulatory Flexibility Act (RFA), which
requires regular review of significant regulations. IFAC and numerous other food industry stakeholders
commented in opposition to the proposed rule and urged its withdrawal.

There are a few key differences between the proposed rule and final rule. In the final rule:
   • Extends from two years to five years the deadline for assessing and reviewing regulations that
        are more than 10 years old
   • Allows the Secretary to extend the review deadline one time per regulation by up to one year
   • Exempts certain device, food, and OTC drug-specific regulations
   • Exempts the annual Notice of Benefit and Payment Parameters update rules
   • Requires the Department to announce in the Federal Register (not just on the HHS website)
        each month which new assessments and reviews it has begun
   • Allows the public to comment on assessments and reviews via the regular Regulations.gov
        procedures

Additionally, the final rule excludes the Standards of Identity for food as outlined in 21 CFR* as exempt
from sunset review. Of note for IFAC members, the final rule does not exempt from sunset review the
regulations which outline direct and indirect food additives, food additive petitions, and GRAS
substances which are also in 21 CFR.**
*21 CFR parts 131, 133, 135-137, 139, 145, 146, 150, 152, 155, 156, 158, 160, 161, 163-166, 168, and 169
** 21 CFR parts 170 – 180 and 182

FDA Extends Comment Period for Food Traceability Proposed Rule
On January 12, the FDA made two updates to its materials for stakeholders regarding the proposed rule,
“Requirements for Additional Traceability Records for Certain Foods” (Food Traceability Proposed Rule).
First, the agency has made clarifying edits to the Food Traceability List (FTL), which lists the foods for
which the additional traceability recordkeeping requirements in the proposed rule would apply. The
edits to certain commodity descriptions were made for clarity and do not reflect a change in which
foods are on the FTL. All of the specific edits are described in a memo titled “Food Traceability List for
‘Requirements for Additional Traceability Records for Certain Foods’ Proposed Rule - Clarified
Language.” Second, the FDA has published an FAQ, addressing questions that the agency has received
about the proposed rule (e.g. during the public meetings, through the FSMA Technical Assistance
Network, and during other outreach engagements) to assist stakeholders who are considering providing
feedback during the comment period.

Additionally, the FDA released additional resources for industry including a tool designed to allow users
to explore the results of the Risk-Ranking Model for Food Tracing used in the development of the FTL.

Finally, the FDA held a series of three virtual one-day public meetings discussing the proposed rule. The
meeting transcripts and videos can be found here. For more information, please see this related article
from IFAC regulatory counsel, Covington.

As a reminder, on January 19, IFAC co-signed a Food & Beverage Issue Alliance (FBIA) letter requesting
the FDA further extend the comment period an additional 30 days, to March 24. As of today, the
comment period for the proposed rule will close on February 22. IFAC does not plan on submitting
comments to the FDA unless otherwise notified by Friday, February 12. Staff will continue to monitor
for possible comments from the FBIA and share with members for consideration.

Outbreak Investigations – CORE Investigation Table Update
Every week, the FDA updates 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.

Following are the January updates:
    • For Salmonella Thompson in an unknown food, the Investigation Status is now closed (January
        6)
    • For Salmonella Potsdam in an unknown food, an on-site inspection has been initiated (January
        6)
    • New item: Salmonella Miami in an unknown food (January 13)
    • The case count for Salmonella Miami has increased to 50 cases (January 21)
    • The E. coli in leafy greens investigation status has changed to "closed". (January 27)
    • The S. Miami outbreak has increased to 51 cases. (January 27)
    • The S. Potsdam outbreak has a newly checked box: sampling collection and analysis initiated.
        (January 27)

Public Comment on Recall Information Collection
On January 8, the FDA announced an opportunity for public comment on information collection
provisions associated with recalls for products regulated by the FDA. The FDA invites comments on
these topics: (1) Whether the proposed collection of information is necessary for the proper
performance of FDA's functions, including whether the information will have practical utility; (2) the
accuracy of FDA's estimate of the burden of the proposed collection of information, including the
validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of
the information to be collected; and (4) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection techniques, when appropriate, and
other forms of information technology. Public comments are due March 9, IFAC does not plan on
submitting comments to the FDA unless otherwise notified by Friday, February 12.

2020-2025 Dietary Guidelines for Americans Released
On December 29, the U.S. Department of Agriculture (USDA) and HHS released the 2020-2025 edition of
the U.S. Dietary Guidelines for Americans. The guidelines are released every five years and inform
nutrition and labeling recommendations in the U.S. New this year is guidance based on healthy dietary
patterns by life stage and the inclusion of birth to 24 months as well as pregnant and lactating women.
There are no recommendations related to specific food additives, but there are recommendations

related to increased fiber intake and low-calorie sweeteners. For your information attached please find
a summary document of this new edition.

CA Prop 65 Updates
In January, California’s Office of Environmental Health Hazard Assessment (OEHHA) released without
advanced notice a proposal to revise Proposition 65’s short-form safe harbor warnings. Following is the
current short-form warning, followed by some of OEHHA’s proposed changes:

   WARNING: Cancer and Reproductive Harm - www.P65Warnings.ca.gov.

Proposed changes:

        •   Requires that all short-form warnings identify at least one chemical for each endpoint
            (cancer and reproductive toxicity);
        •   Limits the use of short-form warnings to products with labels that are 5 square inches or
            less;
        •   Eliminates the use of short-form warnings on the internet or in a catalog; and
        •   Confirms that the new short-form warning can be used on food products.

The California Chamber of Commerce (CalChamber) and Consumer Brands Association (CBA) hosted a
stakeholder meeting on January 21 to discuss next steps. Based on this meeting, last week CalChamber
and CBA met with OEHHA to share industry concerns. OEHHA believes the changes will not result in
significant impact on businesses so CalChamber now plans to request a public hearing to raise the
profile of this issue. IFAC is following this situation and will consider opportunities to support industry
efforts as appropriate. Please notify staff with questions or feedback.

International Updates
Health Canada – Caramel in Flavoured Cheddar Cheese
On January 22, Health Canada announced that, after completing a premarket safety assessment, the
agency has as enabled the use of Caramel in Flavoured Cheddar Cheese and updated the Lists of
Permitted Colouring Agents accordingly.

Health Canada – Pectinase from Aspergillus niger
On January 5, Health Canada announced that, after completing a premarket safety assessment, the
agency has as enabled the use of Pectinase from Aspergillus niger in unstandardized fruit and vegetable
products and updated the Lists of Permitted Food Enzymes accordingly.

EFSA FAF Panel Meeting on TiO2
The 19th Plenary Meeting of the European Food Safety Authority’s (EFSA) Food Additives and Flavourings
(FAF) panel was held January 26 – 28. The only specific additive on the agenda was titanium dioxide. The
18th Plenary Meeting of EFSA FAF was held December 15 – 16. The additives discussed during the
meeting include pectin (E440i), amidated pectin (E440ii), titanium dioxide (E171), lecithins (E322), and
pullulan (E1204). For more information, please see the meeting notes.

EFSA – Transparency Regulation – Practical Arrangements

Recent EU legislation – known as the Transparency Regulation – means that important changes to the way
EFSA operates will come into application in a few months. The aim of this new Regulation, which becomes
applicable on 27 March 2021, is to increase the transparency of risk assessment in the food chain.
Strengthening the reliability, objectivity and independence of the scientific studies submitted to EFSA and
reinforcing the governance of EFSA to ensure the Authority’s long-term sustainability are key aspects of
this Regulation. Further background information on the Transparency Regulation is available on the
European Commission website.

As part of the implementation process for this legislation, EFSA has published details of how the new
rules and measures specified in the regulation will operate in practice. The arrangements are aimed
primarily at EFSA’s stakeholders, such as applicants who want to place food products on the EU market.
The “practical arrangements” (PAs) for implementing the regulation will help stakeholders to better
understand how the new processes and tools affect them and what adjustments they need to make to
operate effectively in the new environment. The PAs cover areas such as proactive transparency,
confidentiality, notification of studies, pre-submission advice and consultation of third parties. EFSA has
already published PAs on the processing of applications for access to documents held by EFSA.

India – Amendments to Food Product Standards and Food Additives
On December 22, India notified the World Trade Organization (WTO) in notice G/SPS/N/IND/258 of the
draft amendment of the Food Safety and Standards (Food Product Standards and Food Additives)
Regulations, 2011. The amendments primarily address finished food specifications, namely the physical
characteristics and microbiological requirements for grain products, honey, seeds, edible oils, dried
vegetables, and dried basil. There are two changes to food additive regulations (1) omitting “Tatrazine”
Food Category System 14.1.4 (Water-based flavoured drinks), (2) the addition of “No colours permitted
in iced tea and iced tea mixes” and omitting “Tatrazine” and “Sunset yellow FCF” for Food Category
Systems 14.1.4.2 and Food Category Systems 14.1.4.3. The comment period for public comment closes
on February 22. IFAC does not plan on submitting comments unless otherwise notified by Friday,
February 12.

Korea – Food Additive Amendments
On December 14, Korea notified the WTO in notice G/SPS/N/KOR/703 of the draft amendment to the
Standards and Specifications for Food Additives. The amendments include the following changes:
    • The use level of the following six food additives is revised: Sorbic acid, Calcium sorbate,
       Potassium sorbate, Ethyl acetate, Isopropyl alcohol, nisin.
    • The analytical methods for the following eight food additives are revised: (Food additives)
       Calcium phosphate Tribasic, Disodium 5'-Inosinate, Disodium 5'-Ribonucleotide, Ferrous
       Fumarate, Oleoresin Paprika, Sodium Molybdate, Spice Oleoresins, Yeast.

The comment period for public comment closes on February 12. If you are interested in IFAC submitting
comments, please notify staff by Friday, February 12.

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
updates and other information/resources. Content is updated quarterly. If you have any questions or
feedback about the site, please let staff know.