Author Archives: Hiroyuki Kawai

About Hiroyuki Kawai

Label bank Co., Ltd. CEO (Founder) Born in Japan. Working on solving various issues related to food labeling operations. Also regularly gives lectures for various organizations in Japan. Co-author of 'Latest edition: Guide book Food Labeling Law and related business practical points - from scratch (Japanese version only)' (DAI-ICHI HOKI CO., LTD/2019).

Trends in plant-based food labelling standards in various countries

In January 2025, the U.S. Food and Drug Administration’s (FDA) released Labeling of Plant-Based Alternatives to Animal-Derived Foods: Draft Guidance for Industry. I’d like to provide an overview of the latest trends in plant-based food labelling regulations across various countries, viewed from Japan.

The U.S.

As mentioned above, the guidance on alternatives for animal-derived foods was released in January of this year. The scope of this guidance includes plant-based alternatives to eggs, seafood, poultry, meat, and dairy products (excluding plant-based milk alternatives). For guidance on labelling plant-based milk alternatives and voluntary nutrient statements, please refer to Draft Guidance for Industry released in February 2023.

The guidance primarily aims to prevent misleading labels regarding product names. The main points of the guidance are as follows,

– Plant-based alternative foods, which do not have established definitions or identity standards, are classified as “non-standardized foods”

– Labels for these non-standardized foods should clearly indicate the specific plant source(s) (e.g., soy, lentil, walnut, etc.)

– Simply labelling them as “meat-free” or “dairy-free” is not recommended The guidance on plant-based milk alternatives includes nutritional guidance, such as labelling to highlight differences in nutritional values between plant-based milk alternatives and milk (referring to Appendix 1) and recommending indication of lower amounts of certain nutrients than found in milk. (Other examples of cautionary labelling for the nutritional content of milk alternatives can also be found in the labelling standards of Australia and New Zealand (2018))

Canada

In October 2024, Proposed guidance: How to label and represent plant-based alternatives to egg products was released. In addition to font size and words, there are provisions to prevent misleading impressions from images (e.g., Image of a farm). Claims such as “30% less fat than chicken’s eggs” must meet the specific requirements for nutrient content claims. For claims such as “egg free”, allergen labelling must also be considered.

France, Czech Republic

In January 2025, the Council of State of France annulled the decrees prohibiting the use of terms such as “steak” on plant-based products. The decrees were initially established in June 2022 and February 2024, but were subsequently opposed by the Court of Justice of the European Union in October 2024, leading to the repeal. Following this announcement, indicating terms such as “soy steak” and “vegetable sausage” are now permitted again. In January 2025, the Ministry of Agriculture of the Czech Republic announced it would not implement any changes to the requirements concerning meat, fishery products, eggs, and their products (regarding the regulation of “meat” labelling for plant-based products, 2024). (Note: EU has established requirements regarding the labelling of milk products (whey, cream, butter, etc.))

Thailand

In July 2024, the Thai Food and Drug Administration (FDA) announced that it is actively preparing to enter the plant-based protein market. Thai FDA solicited public comments on a draft proposal outlining labelling requirements and other regulations for plant-based protein alternatives in May 2024. The relevant standards are expected to be published after further review.

In Japan, the Q&A on Labelling Plant-Based (Plant-Derived) Foods was released in 2021, requiring indications such as “made from soy” in addition to the product name to prevent any confusion. Additionally, in 2022, Textured soy protein products under the Japanese Agricultural Standards (JAS) were established, stipulating requirements on labelling such as “肉を使用していません(En: This product does not contain meat)”.

Labelling for plant-based foods has been a topic of significant interest, along with FOP (Front-of-Pack) labelling, HFSS (High in Fat, Sugar, or Salt) regulations, and PAL (Preventive Allergen Labelling). We would like to take up any major revisions or updates to these regulations in this Newsletter in the future.

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Draft Amendments to the Food Labelling Standards and the Classification of Cashew Nuts and Pistachios as Allergens (Japan)

The draft amendments to the Food Labelling Standards (in Japanese), scheduled to be implemented in April 2025, have been published. The public comments for the amendments have been collected up to January 28.

As for allergen labelling, the 7th Advisors’ Meeting on Food Allergen (21 January, 2025) (in Japanese) proposed that cashew nuts be included in the mandatory allergen labelling list, and pistachios be added to the recommended allergen labelling list.

The outline of the proposed amendment to the Food Labelling Standards is as follows.

(1) Deletion of labelling exemption regulations for food additives for nutritional fortification purposes

(2) Amendment of the standard values for nutritional labelling

<1> Amendment of the standard values for nutritional labelling

<2> Amendment of the tolerance range for dietary fiber and addition of guideline for the amount that can be labelled as “zero”

<3> Amendment of the method of measurement and calculation of Vitamin B group.

(3) Review of labelling rules for individual food items

With the amendment of (1) (mentioned above), the labelling of food additives used for nutritional fortification will be required on all processed foods, including those previously exempt from labelling.

The amendment to (2)<1> updates the standard values of nutrients based on the Dietary Reference Intakes for Japanese (2025 Edition) including the addition of salt equivalent. Accordingly, the criteria for nutrient content claims (such as “contains”, “high in”, and “fortified with”) will also be amended. (Notably, the standard values for Vitamin B12 and Vitamin D have significantly increased.)

As for (3), the following points have been reviewed for the amendments.

-Standards of identity
-Labelling rules for individual food items (Legal name, Ingredients list, Additives, Net weight)
-Regulations for legal names
-Additional labelling items
-Labelling format
-Prohibited labelling items

The following are the food categories for which individual labelling rules have been abolished or amended.
-Partial abolition and amendment
　12 items such as miso, retort pouch foods, etc.
-Partial abolition
　1 item: margarines
-Complete abolition
　7 items such as prepared frozen foods, instant noodles, etc.
22 items including soy sauce and ham are scheduled for review this year.

The future schedule (the implementation schedule and transitional period) about Food Labeling Standards is as follows:

  Implementation schedule Transitional period
(1) Article 3, Paragraph 1, Appended table 4, 24 April 1, 2025 5 years
(2) ＜1＞Appended table 10, 12 April 1, 2025 3 years
＜2＞＜3＞Appended table 9 April 1, 2025 –
(3) Appended table 3, 4, 5, 19, 20, 22 April 1, 2025 5 years
Among the above, the amendment of “prepared frozen foods” April 1, 2026 5 years

The draft amendment to the Food Labelling Standards, incorporating feedback from the public comments, is expected to be published shortly. Additionally, the draft amendment for allergen labelling, as previously mentioned, is anticipated to take effect sometime in fiscal year 2025. For those of you who can read Japanese, we advise to look through the survey results in the meeting materials, including the background information on the rapidly increasing number of allergy cases related to nuts. We will keep everyone informed of any progress on this topic here in this newsletter!

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Summary of the status of legal changes on food labelling in Japan (2)~ Amendment of the Standard Values for Nutritional Labelling and Progress Report on Reviewing Labelling Rules for Individual Food Items (Categories)~

This article continues the previous article, Summary of the status of legal changes on food labelling in Japan (1).

The Food Labelling Advisory Committee (held on 13 December 2024) (Japanese) reviewed the draft amendment to the standard values for nutritional labelling. At the meeting, the progress of reviewing the labelling rules for each individual food item (from the 1st to the 7th meeting) by the subcommittee was also reported.

Amendments of the standard values for nutrients labelling

The standard values for nutritional labelling will be revised based on the Dietary Reference Intakes for Japanese (2025 Edition) published by the Ministry of Health, Labour and Welfare (11 October 2024). Some standard values for nutrient labelling, such as those for calcium and vitamin D, will be increased. For further details of the amendment, please refer to the Draft Amendment to Nutrition Labelling (Japanese). With the revision of standard values for nutrient labelling, the standards for nutrient content claims (such as “contains,” “high in,” and “fortified with”) are also expected to be updated. Therefore, business operators who use these claims on their products should ensure they comply with the new standards.

Review of labelling rules for individual food items

The review has been made to align with the “horizontal” standards that apply to all foodstuffs. Some opinions and requests have been presented at the discussions so far, such as: “There were food items for which individual rules were already abolished (7 out of 22 items already discussed by the subcommittee)”, “Definitions and names under the labelling rules for each individual food item should remain on the label“, “It is preferable to maintain the individual labelling rules according to the characteristics of the food item“, etc. For details, refer to The Sub-Committee for the review of labelling rules for individual products (Japanese). The remaining 22 items with current individual mandatory labeling will continue to be reviewed by the subcommittee and will be reported to the Advisory Meeting in the next fiscal year (March 2026).

Regarding the items to be revised and future steps

The anticipated amendments to the Food Labelling Standards are outlined in the Advisory Meeting materials titled Regarding the Amendments of Food Labelling Standards (Japanese). This document includes the specific Articles and Appended Tables that are subject to revision. Here is an excerpt from the material.

  1. Mandatory labelling of additives for nutritional fortification purposes
    Article 3, Paragraph 1
    Appended Table 4 – Labelling rules for individual food item
    (Legal name, Ingredients list, Additives, Net weight)
    Appended Table 24 – Individual labelling items for general fresh foods
  2. Amendment of the standard values for nutritional labelling
    Appended Table 9 – Units for labelling nutritional components and energy, measurement methods, tolerance ranges, and contents that can be labelled as “zero”
    Appended Table 10 – Standard values for nutritional labelling
    Appended Table 12 – Standard values for claims on nutrient supplementation
  3. Review of labelling rules for individual food items
    Appended Table 3 – Standards of identity
    Appended Table 4 – Labelling rules for individual food item
    (Legal name, Ingredients list, Additives, Net weight)
    Appended Table 5 – Rules for legal names
    Appended Table 19 – Additional labelling items
    Appended Table 20 – Labelling form
    Appended Table 22 – Prohibited labelling items

A public consultation on the draft amendments to the Food Labelling Standards is expected to take place within this fiscal year (until March 2025). Although the exact timeline for the amendments remains uncertain*, it is believed that changes to allergen labelling, including adding cashew nuts to the mandatory list, are being considered. As such, it would be a good time to begin preparing for these anticipated changes.

* The amendments are now scheduled to enter into force on 1 April 2025. The public consultation on the amendments closed on 28 January 2025.

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Summary of the status of legal changes on food labelling in Japan (1)

Looking back the year 2024, there have been various amendments to the food labelling system this year, and we would like to reiterate the domestic situation.

Status of amendments in 2024

The main amendment announced this year was the addition of “macadamia nuts” to the list of Voluntary allergen labelling items (and the deletion of “matsutake mushroom”).  There is no transitional period for these measures, but there currently is one for “walnuts”, which was added to the mandatory allergen list in March 2023 and will end on 31 March 2025.  The addition of cashew nuts to the mandatory allergen list is also under consideration at the moment. This is due to the fact that in the “2024 Report of the Research and Study Project on Food Labelling Related to Food Allergy (Japanese)”, the number of shock cases involving cashew nuts increased significantly, making it the fifth most common causative food.

March 2023“Walnuts” added to the list of mandatory allergen labelling (Japanese)
March 2023End of the period for transitional measures for revision of ‘non-GM labelling criteria (Japanese)(revised in April 2019)
March 2024End of the period for transitional measures for “the guideline of additive labeling for use of ‘non-use (Japanese)’” (published in March 2022)
March 2024Addition of “macadamia nuts” and deletion of “matsutake mushrooms” to the list of the allergens for recommended labeling (Japanese) (no period for transitional measures)
March 2025Period for transitional measures for mandatory allergen labelling of “walnuts” ends
2025- (under review)Addition of “cashew nuts” to the list of mandatory allergen labelling

Other major changes include the transfer of the food sanitation standards administration (e.g. designation of food additives and formulation of standards), previously under the jurisdiction of the Ministry of Health, Labour and Welfare, to the Consumer Affairs Agency (Japanese) from April 2024.

Themes under consideration and future amendments

Several discussions on food labelling systems have been held between last year and this year. “The Sub-Committee for the review of labelling rules for individual products (Japanese)” is studying the labelling rules (labelling items, labelling methods, prohibited labelling items, etc.) for individual products, such as bacon, ham, carbonated drinks and fruit drinks, with the aim of making the rules more comprehensive.  The public comments on these draft amendments are expected to take place by March 2025.  In addition to reviewing the setting of expiry date labels, “The review discussion on guidelines for setting food expiry date labels” (Japanese) is also considering the ‘handling of food that has reached its expiry date and can still be eaten’.  The draft amendments are also expected to be published by March 2025.

In addition, “The discussion on Front-of-package Nutrition Labelling in Japan” (Japanese) is considering the direction of voluntary labelling with reference to front-of-package nutrition labelling systems in other countries.  “The Sub-Committee to Study the Use of Digital Tools for Food Labelling” (Japanese) is also scheduled to study specific methods of utilizing digital tools with reference to initiatives in other countries. In January 2023, “The 3rd Food Labelling Advisory Committee (Japanese)” also discussed “the labelling of additives used for nutritional fortification purposes (Japanese)”.. It is expected that a draft amendment will be drawn up after conducting a fact-finding survey. (Japanese)

The above is a brief summary of the upcoming amendments to the food labelling system, which are likely to have a significant impact in practice, particularly with regard to “cashew nuts”, “labelling rules for individual items” and “labelling of additives used for nutritional fortification purposes”. We hope that you will take the opportunity to review each of the amendments once again.

Additional information: 19 December 2024

The 2024 Food Labelling Advisory Committee (held on 13 December) (Japanese) presented a proposal to revise the standard values for nutrient labelling (the standard values for nutritional claims are also scheduled to be revised), and public comments will be invited in the future.

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Current food waste issues triggered by expiry date labeling, Proposed legislation to uniform food expiry date labelling in California/USA, and General Situation around the world (including Japan)

On 28 September 2024, the State of California, USA, announced that a bill to uniform food expiry date labelling had been signed. Until now, the state has allowed for the use of “Sell by”, “Best by/before”, ‘Expired by’ as well as other recommended labelling methods such as “Best if Used By” and “Use By”, when displaying expiry dates, but from 1 July 2026, uniform labelings such as “Best if Used By”, “Best by/before”, “Expired by” will become mandatory. Such uniform labelling is said to help ensure a sustainable future by reducing the likelihood of confusion over quality and safety, whereas the various expiry date labels have been confusing for consumers and have led to unnecessary food waste.

In the US, there are no federal regulations on food expiry date labelling, except for infant formula, and consequently a legislation was proposed in May 2023 for the Food Date Labeling Act, which also aims to uniform on “Best If Used By”, “USE By” and so on to prevent consumer confusion and help solve the problem of food waste.

The relationship between expiration date labels and food waste has been an issue in many countries, with the EU estimating that up to 10% of food waste may be related to a lack of understanding of expiration date labels, and a revision of the Regulation on the provision of food information to consumers (FIC Regulation (EU) 1169/2011) is planned. Improvements are being considered in terms of terminology, format and visual presentation to avoid consumer misunderstanding the “use by” and “best before” labelling methods.

In April 2024, the Food Standards Agency of Australia and New Zealand (FSANZ) released its “2023 CONSUMER INSIGHTS,” and the following information is a good illustration of the current situation of food waste that is past its expiration date.

“Most people correctly understood best before and use-by dates, but up to a third expressed an incorrect understanding.”

“Among people with a correct understanding of date marking, up to a third reported behavior inconsistent with their understanding.”

In Japan, a ‘Study Group to Review Guidelines for Setting Food Expiry Dates’ has been convened since May 2024, and in addition to reviewing the setting of expiry date labels, it is also considering the “handling of food that has reached its best before date and can still be eaten”. The revised guidelines are due to be published in March 2025.

The above is a brief summary of the current situation in each country regarding expiration date labeling, which may be a trigger for food waste. In practice, especially when exporting food products to Japan or another country, it is necessary to review local labeling methods about expiry date labeling. By deepening our understanding that time limit labeling is related to the problem of food waste as a background, we believe that it will be easier to respond and prepare for future labeling creation.

Supplement

The expiration date labeling, which is often printed at the time of manufacture, is a labeling item that is prone to error when importing or exporting due to differences in labeling methods between countries. (In particular, the order in which expiration dates are printed is confusing, as some countries use “day-month-year” or “month-day-year,” while Japan uses “year-month-date”). In the design stage of labeling, it is recommended that the space for the expiration date not be left blank, but that the difference be easily recognized in advance by writing “YYYYY.MM.DD”, “DD.MM.YYYYY”, “MM.DD.YYYYY”, and so on.

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Trends in the revision of standards for allergen labeling in various countries

More than six months have passed since Japan ‘s Food Labeling Standards were revised on March 28, 2024, adding macadamia nuts to the list of recommended allergen labeling items (while also removing matsutake mushrooms). Since the number of 28 items (8 mandatory and 20 recommended) remains the same, it is difficult to see the changes as far as containers and packaging are concerned, but we believe that the situation is gradually being addressed. In this issue, we would like to extend our scope to outside Japan and look at some of the revised information on allergen labelling that was announced worldwide this year.

In February 2024, the Australian Department of Agriculture, Fisheries and Forestry (DAFF) and the New Zealand Ministry of Primary Industries (MPI) announced that new allergen labeling requirements ( DAFF Notice and MPI Notice ) had come into effect. Changes include labeling allergens in bold, labeling “contains 00,” and more. The transitional period is until February 25, 2026.

In July 2024, the Food and Drug Administration (FDA) of the Thai Ministry of Public Health promulgated and implemented the “Labeling of Prepackaged Foods (No. 450)” (original in Thai). The English version has also been published. Shellfish, mollusks and their products were added to the list of items subject to allergen labeling. The transitional measures period is until July 19, 2026.

In August 2024, the Saudi Food and Drug Administration (SFDA) published a draft standard for Labeling of Food Allergens on Prepackaged Food. In addition to a list of items subject to allergen labeling, the draft also shows how to label items by bolding, underlining, and highlighting in color, as well as by using illustrations with accompanying text.

In September 2024, the UK Food Standards Agency (FSA) released an update on its work on Precautionary Allergen Labelling (PAL). We previously covered developments in PAL in the U.K. (in our issue of November 2023); this latest update makes public further proposals for the use of allergen thresholds (standardization by ‘Eliciting Dose’ (Note) ).

(Note: This is a unit known as the one to indicate the amount of allergen that causes a reaction with objective symptoms (abbr. ED). Please go to the link above: “update on its work on Precautionary Allergen Labelling (PAL)” for the details.)

Also, by the end of 2024, the U.S. FDA is expected to release a draft guidance for the industry titled “ Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry.”

The above is simply a general overview of examples of recent changes from various countries around the world. It should be noted that the Thailand case is a comprehensive revision of the labeling standards. Other examples of comprehensive amendments to labeling standards include Malaysia’s Food (Amendment) (No. 4) Regulations 2020 (January 2024) and Turkey’s Food Codex Regulations Amendment on Consumer Information and Food Labeling (April 2024).

On a further note, the Codex Alimentarius Commission is currently discussing allergen labeling, and in August 2024, will begin soliciting opinions on “General Standard for the Labelling of Pre-packaged Foods Provisions relevant to allergen labelling” and “Guidelines on the use of precautionary allergen labelling”. In particular, reference doses (mg/kg) standardized based on induced doses will be set for each item (e.g., almond 1.0, peanut 2.0, hazelnut 3.0, wheat 5.0, buckwheat 10, crustacean 200) for preventive allergen labeling (PAL), and the proposed revisions clarify the threshold values, which is a trend that we believe will require close attention. The allergen labeling system is expected to change in the future in line with changes in consumer behavior and technological advances. If you are considering exporting food products to foreign countries and are interested in future trends, it would be a good idea to check the proposed amendment.

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Food Labeling Standards partly amended in relation to FFC (Japan)

Note: This article discusses the changes in Japan FFC systems, following the Beni-Koji Incident that happened earlier this year.

On August 23, 2024, a partial amendment to the Food Labeling Standards (Japanese) has been published (some of which came into effect on September 1).  The following are excerpts of the outline of the amendment organized in the Summary of the amendment history of the Food Labeling Standards (Japanese).

●In light of the Future Measures Regarding the labeling system for Foods with Function Claims (FFC) in response to the Beni-Koji (rice fermented with red yeast) products Incident (compiled at the Ministerial Meeting on Measures for the Beni-Koji Products on May 31, 2024), the following amendments have been made:

  • As matters to be complied with for notifiers (when an incident happens), it is stipulated that they must collect information on suspected health hazards and that it must be promptly provided to the prefectural governor and other relevant authorities as well as to the Commissioner of the Consumer Affairs Agency (CAA) in the event that such information is obtained.
  • It is stipulated that foods will no longer meet the requirements for FFC in the event that the accumulation of scientific knowledge (after the date of notification of such foods) leads the Commissioner of the CAA to the conclusion that it is no longer appropriate to make claims about expected specific health benefits related to their functional ingredients.
  • As matters to be complied with for notifiers, it is stipulated that Good Manufacturing Practice (GMP) -based manufacturing control is required for foods in the form of tablets, capsules, and similar dosage forms
  • How and where to label the information such as the following has been reviewed.
    – “The product has not been evaluated by the government for its functionality and safety”
    – “The product is not intended for the diagnosis, treatment, or prevention of any diseases”
    – and precautions for consumption such as specific warnings about interactions with medications, prevention of excessive intake
  • As further matters to be complied with for notifiers, it is stipulated that the notifier must conduct a self-check of their adherence to the compliance matters every year after the initial notification and must report the results annually to the Commissioner of the CAA.
  • The specific contents of the following information to be notified to the Commissioner of the CAA are stipulated as well as the forms to notify them to be notified by the Cabinet Office.
    a) the content of the labeling
    b) basic information on the food-related business operator, such as their name and contact information
    c) information on the evidence for safety and functionality
    d) information on the production, manufacturing, and quality control
    e) system for collecting information on health hazards
    f) other necessary information
  • For new functional ingredients with no prior notification records, if the Commissioner of the CAA recognizes that it would take particularly long to confirm the notification documents, it is stipulated that the deadline for submitting the notification documents prior to sale can be exceptionally extended from the standard 60 business days to 120 business days as a special provision.

And the specific revision points are as follows (although it is easier to check them by referring to the old and new comparison table) (This link and all links below are in vertical Japanese).

Enforcement date and transitional measures (vertical Japanese)

The amendment has generally been enforced from September 1, 2024, but some of the provisions in Appended Table 26 and Appended Table 27 will be enforced from April 1, 2025.

The transitional period is planned to be until August 31, 2026.

There is a two-year transitional period for the provisions of Article 3, paragraph 2, Article 22, paragraph 1, Appended Table 20 and Appended Table 27　paragraph 2, item 1 (the stipulation in the case of notification as foods such as tablets and capsules made from natural extracts, etc. in these provisions) (effective September 1, 2024). Since the labeling method (e.g., restrictions on indicating a part of the functionality) has also been revised this time, many FFC products will be expected to have their labeling reviewed. From the results of the public comment on the amendment draft (Japanese) where the CAA’s views are listed in response to each of these comments, you can also check the purpose of the amendment and the views on the comments, so it would be good to go through them as well (if you have any questions or trouble while doing so, please let us know!).

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Call for public comment on draft notification to make GMP mandatory in accordance with the revision of the system for FFC (Japan)

On July 12, 2024, the Consumer Affairs Agency (CAA) began soliciting opinions on the standards for the manufacture or processing of tablets, capsules, and other Foods with Functional Claims (FFC) that Use natural extracts as ingredients (draft) (Japanese). The public comment was closed on August 16th.

The draft notice is based on the decision made at the ministerial meeting onFuture Measures Regarding FFC Labeling System in response to the Incident Involving Red Koji Supplements, where it was decided that for supplements with functional claims, manufacturing management based on GMP (Good Manufacturing Practices) will be a compliance requirement for the notifier under the Food Labeling Standards. The content of the draft follows Annex 2 (Japanese) of the GMP Guidelines (No. 0311 No. 2, March 11, 2024) (Japanese)The draft notice (Japanese) as well as the GMP guidelines also provides the definitions of certain terms (Article 2). Here are some excerpts. The provisions regarding the responsibilities of the notifier and the creation and management of documents and records have also been stipulated.

  1. “Ingredients” mean all the ingredients used in the manufacturing of a product.
  2. “Source materials” mean animals and plants, or specific parts thereof, microorganisms, chemicals, minerals and other substances used to manufacture ingredients.
  3. “A Product“ means a food product that has completed all processes such as manufacturing.
  4. “Intermediate products” mean items produced during the intermediate stages of product manufacturing.
  5. “Equivalents to ‘a Product’” include ingredients, containers and packaging, products, and intermediate products.
  6. “Lot” means a group of products manufactured to have homogeneity through a series of processes within a single manufacturing period. (Hereafter abbreviated)

The following image explains the scope of GMP ([Reference Document 5-1] the Scope of GMP Notification (the 74th Food Labeling Subcommittee))(Japanese).

The enforcement date is scheduled on September 1, 2024. This draft notification covers the contents of Annex 2 (related to manufacturing site) in the above figure.
Regarding the contents of Annex 1 (related to ingredients), it is expected that a draft notification will be compiled in the future.

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“Future Measures Regarding FFC Labeling System in response to the Case* Involving “Beni Koji” Supplements” (Japan)

On May 27, 2024, the Consumer Affairs Agency (CAA) released the “Report of Discussion on Foods with Functional Claims (FFC)(Japanese). Subsequently, on May 31, Future Measures Regarding FFC Labeling System in response to the Incident Involving Red Koji Supplements(Japanese). was published as the materials for the Ministerial Meeting on Measures Regarding Red Koji-Related Products(Japanese).

* A recent case involved a pharmaceutical company’s Beni-Koji (rice fermented with red yeast)-related products, which caused a series of health issues among users of its dietary supplement products.

<Overview of future measures regarding the FFC system>

  1. For all FFC, make it mandatory for business operators to collect and provide information on health hazards linked to their products（enables to implement the administrative measure based on the Food Labeling Standards and the Food Sanitation Act）
  2. Measures to enhance the reliability of the FFC system (Establishment of GMP (Good Manufacturing Practices) requirements, etc.)
  3. Digital transformation of information provision and strengthening consumer education
  4. Roles sharing between the national and local governments

The following are excerpts from the proposal in the report on Discussion on FFC.

Obligation to collect health hazards and provide information to government agencies

Since the current notification guidelines cover all FFC, including processed foods, fresh foods, not just supplements, it is appropriate to make it mandatory to collect and provide information on health hazards linked to all types of FFC without limiting the scope to only supplements.

Management of manufacture/quality

In response to this case, it is appropriate to make it a legal obligation to conduct manufacturing and quality control of FFC in supplement form in accordance with GMP stipulated by the regulations at the time of notification and during the sales period after notification to ensure quality in the manufacturing process management of FFC in the form of supplements and to enhance the reliability of FFC, (snip). Specifically for ingredients containing functional components, the manufacturers of products in the form of supplements (final products) must ensure to embrace the principles of equivalence and homogeneity of all the components of the ingredients (with the ones for which the evidence was notified) at the stage of their receipt in accordance with GMP, under the responsibility of the notifier (who is the person responsible for labeling).

How to convey information on FCC to consumers

-As an indication related to the requirement of “not for the purpose of diagnosis, treatment or prevention of disease”, labeling “not a drug” must be clearly stated on the same panel as indications of FFC claims.
-An indication of “FFC” and the notification number must be displayed in close proximity to each other to enhance identification.
-Improve the labeling method to one clearly indicating that safety and functionality of the food product was not assessed by the government.
And state clearly that information on the scientific basis of functionality and safety, can be confirmed on the CAA website unlike so-called ‘health foods’.

As a further issue to be considered, it is expected that the Foods for Specified Health Uses will be also made mandatory to provide information on health hazards and to establish GMP requirements. In the future, the Food Labeling Act and the Food Sanitation Act are expected to be revised, as well as the Guidelines for Notification of FFC. We recommend that business operators who handle not only Foods with Functional Claims but also labels related to health read them.

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We verify the conformity of ingredients and additives with the standards for use in Japan based on specifications such as formulation lists. We also verify the conformity of the proposed labeling of ingredient names, nutrients, etc. with the labeling standards based on specifications such as formulation lists.

Label Claims and Import/Export (Japan)

The transitional period of the guideline of additive labeling for use of ‘non-use’ (March, 2022)*1 ended at the end of March, 2024. During this period, there’s been a gradual change observed in the labeling of food products in stores　in terms of changes made in accordance with the content of these guidelines. This article summarizes practical precautions and potential challenges related to label claims including “non-use labeling” and labeling for products intended for import and export. (Partly excerpt from the material used for the seminar on the 11th April, 2024 at Anuga Select Japan 2024).

*1(see our past article: The revised draft of the guideline of “non-use” additive labeling released after inviting comments (Japan))

Various types of claims and “non-use” labels

Types of claims can be mainly divided into the following two categories in the regulation.
-Health claims (focus on nutrients and functional components of a product)
-Quality claims (focus on the quality of ingredients in a product such as their origins like “natural”)
As other types according to other classification methods
-(addition-type) some ingredients/components used, contained, or used more
-(subtraction-type) some ingredients/components not used, not contained, or used less The subtraction-type claims such as “non-use of additives” and “non-use of sugars” have noticeably increased in recent years. Compared with claims for used ingredients, claims for contained components can be less noticeable to general consumers (not those engaged in food related business). Checking the subtraction-type can be another challenge. In addition to checking for the absence of specific ingredients/components, checking the subtraction-type claims also requires verifying that no alternative ingredients (or components) are used. Even more items need to be checked when it comes to products for export and import, such as checking whether alternative ingredients to replace the ‘non-use’ ingredients can be used in the target country.

Confirming the standards for use of ingredients related to label claims

Many countries as well as Japan set the standards of use for ingredients and additives. For example, in the case of labeling fruit juice beverage products with calcium lactate contained claimed as “Rich in Calcium” (addition-type claims), the process of its preliminary research is
1. Check if the product is categorized as “Fruit juice beverage” in the target country (check the food standards)
2. If so, check if “Calcium Lactate” is permitted to be used for Fruit juice beverage (check the standards for use)
3. If so, check if the claims such as “Rich in Calcium” are permitted to be labeled (check the labeling standards)
When the presence of ingredients or additives that is directly related to the product’s characteristics is clear, as in this example, it is easier for food business operators such as an exporter and an importer (not the manufacturer) to be able to check and confirm the information at an early stage.
On the other hand, for products (with subtraction-type claims) labeled as “no sweeteners used”, for example, there are no ingredients subject to confirmation of use as mentioned above in 2. While such products may contain ingredients that replace sweeteners (often food materials that are not considered additives), it can be difficult to recognize the presence of these alternative ingredients or additives that directly affect the product’s characteristics unless they are clearly labeled as “use of XX instead of sweeteners”. This lack of clear labeling can lead to last-minute checks by the food business operators before importing or exporting these products.
And since just giving up labeling the claims such as “free of XX” is not enough anymore to get the situation better in the case where these ingredients and additives turn out to be not permitted to be used after such last-minute checks, it is still important to check the ingredients at an early stage.

While a product can be labeled as “no sugars used” in Japan, in some other countries it may be required to be labeled as “contains naturally occurring sugars” if it contains sugars derived from food ingredients. The definition of “sugars” in the labeling standards is not consistent across different countries (especially be careful about “carbohydrates”). In the case of import/export, careful confirmation is needed on the points such as standards of identity for foods. While it is important to confirm that claims labeling is permitted in your target country, it is also essential to make sure that ingredients/additives are permitted to be used (or contained) from the early stage.

Newsletter Signup

We issue monthly e-newsletters, which provide you with the latest updates on food labeling/regulations in Japan.
If you want to make sure to not miss any issue, please click below.

Related Service

Research Services on Ingredients & Food Labeling -For the Japanese Market-
We verify the conformity of ingredients and additives with the standards for use in Japan based on specifications such as formulation lists. We also verify the conformity of the proposed labeling of ingredient names, nutrients, etc. with the labeling standards based on specifications such as formulation lists.