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).

“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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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.

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Regarding Food Labeling Standards, Food Labeling Standards Q&A revised (Japan)-Addition of macadamia nuts and deletion of “matsutake mushroom” from the list of recommended labeling for allergens-

On March 28, 2024, the Consumer Affairs Agency (CAA) announced revisions to Regarding Food Labeling Standards and Food Labeling Standards Q&A. The main contents of this revision include the addition of “macadamia nuts” and deletion of “matsutake mushroom” from the list of recommended labeling for allergens. The following is the summary of the main points of the revisions.

The main points of the revision of Regarding Food Labeling Standards

Macadamia nuts were added and matsutake mushrooms were deleted from the list of the recommended labeling for allergens. The number of allergen items for recommended labeling has not changed as it remains 20 items. The total number of allergen items (for mandatory and recommended labeling) stays the same at 28 items.

After the revision Before the revision
Almond, Abalone, Squid, Salmon roe, Orange, Cashew nut, Kiwifruit, Beef, Sesame seed, Salmon, Mackerel, Soybean, Chicken, Banana, Pork, Macadamia nut, Peach, Yam, Apple, Gelatin Almond, Abalone, Squid, Salmon roe, Orange, Cashew nut, Kiwifruit, Beef, Sesame seed, Salmon, Mackerel, Soybean, Chicken, Banana, Pork, Matsutake mushroom, Peach, Yam, Apple, Gelatin

Appended Table 1 Scope of allergen items (for mandatory or recommended labeling)　(pg7)

Allergen item name
(for mandatory or recommended labeling)		 Classification Number (1) Classification Number (2) Major classification Intermediate classification Minor classification
Macadamia Nuts 69 8599 Edible nuts Other edible nuts Edible nuts, n.e.c.

Appended Table 2 Examples of labeling for additives derived from allergen items (for mandatory or recommended labeling)(pg16)

Legal names of allergens for recommended labelingClassificationAdditive namesRecommended labelingRemarks
Macadamia Nuts――――

Appended Table 3 (List of substitute labeling for allergen items (for mandatory or recommended labeling) (pg18)

Items stipulated in the Notice
(Regarding Food Labeling Standards)		 Substitute labeling Extended labeling
(labeling examples)
Indication that differs in labeling methods and words, but can be recognized as the same item for recommended labeling stipulated in the Notice Examples of indication that includes the name of allergens for recommended labeling or its substitute labeling so that they can be recognized as food products using these ingredients
マカダミアナッツ*
*One of the descriptive variations in Japanese meaning “Macadamia nuts” 		マカデミアナッツ*
*One of the descriptive variations in Japanese meaning “Macadamia nuts” 		 

The main points of the revision to Food Labeling Standards Q&A

Q&A (D-2) 18 regarding the scope of macadamia nuts has been added.

(D-18) What is the scope of macadamia nuts, which is one of allergens for recommended labeling?

 (Answer) Macadamia nuts are not categorized as specific individual edible nuts in the Japan Standard Commodity Classification but are categorized in a general group as Edible nuts, n.e.c. Macadamia nuts belong to the genus Macadamia in the family Proteaceae. The main varieties covered by this definition are the integrifolia species, the tetraphylla species, and their hybrid varieties. Additionally, it is important to note that macadamia nut oil and macadamia nut milk, etc. are also allergens.

Information on the scope of labeling is also provided in Q&A (E-23). Again, note that the total number of allergen items for both mandatory and recommended labeling remains the same.

(E-23) Should the scope of labeling be mentioned? (whether the label of the product includes allergens for recommended (not mandatory) labeling)?

(Answer) … omitted unrelated content …
Please indicate clearly in a location close to the allergen information frame whether the information only applies to the 8 allergens for mandatory labeling or if it also includes the 28 allergens for both mandatory and recommended labeling.
However, the above-mentioned labeling alone may not clearly indicate whether it follows the pre- or post-revision allergen list due to factors such as the transitional period for the revisions to the Cabinet Order and the Notices. There is no problem if the labeling includes a clear list of target allergen items or illustrations representing all the allergen items covered. If not, additional information can be included so that consumers can identify which specific Cabinet Order or Notices the labeling is based on.

Upcoming schedules

Similar to the past case of the addition of almonds to the list of recommended labeling in September 2019, no transitional period for this revision has been clarified because it is also not mandatory labeling. Therefore, businesses are encouraged to comply with this revision as soon as possible. Especially ingredient suppliers should take an early action since their customers (food manufacturers) will need to verify ingredient specifications to ensure compliance. Special attentions should be paid to food products with imported ingredients used. Some countries treat nuts under the general name of “Tree Nuts”, so confirming if macadamia nuts as well as walnuts, cashew nuts, almonds are included in “Tree Nuts” is needed. The above-mentioned Q&A will especially provide useful information on allergens when switching the label on your products.

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About Labeling Rules for Individual Food Items (Japan)

On January 30, 2024, at the Third Fiscal 2023 Food Labeling Discussion Meeting the revision of the labeling rules set for individual food items was discussed. A useful material has been provided as an easy-to-understand summary of the current issues titled [Reference] Labeling Rules for Individual Items and I would like to go through it here.

Overview

  • While some food items have their own individual rules (aside from cross-sectional labeling rules applied to all food items), others do not.
  • For the food items with their own individual rules, their individual rules take precedence over the cross-sectional labeling rules.

Appended Table 3 Standards of Identity
Appended Table 4 Individual Labeling Rules (Legal name, Ingredient name, Additives, Net weight)
Appended Table 5 Rules for Legal names
Appended Table 19 Additional Labeling items (Precautions for Use, Cooking Method, Shape/form, Content rate of Specific Ingredients, etc.)
Appended Table 20 Labeling style
Appended Table 22 Prohibited labeling items

For example, according to the provisions of “Macaroni” in the Appended Table 4 of the Food Labeling Standards, the names that can be labeled differ depending on their shape/form, size, and thickness.

Examples of differences in labeling

Even if products look similar, the “legal name” for them can differ depending on the product form.
For example, in fettuccine,
-“Dried” fettuccine must be labeled as “名称：マカロニ類” (EN: Legal name: Macaronis) according to the individual rule for “Macaronis” of dried noodle
-“Frozen” fettuccine must be labeled as “名称：フェットチーネ等” (EN: Legal name:fettuccines) according to the individual rule for “prepared frozen food” of frozen food
-“Fresh” fettuccine must be labeled as “名称：フェットチーネ等” (EN: Legal name:fettuccines) according to the cross-sectional rules because there are no individual rules for “fresh” fettuccine

Even for products using the same ingredients, the “Legal name” can be different depending on the container and packaging of the product.

For example, in the case of Japanese-styled meat sauce:
-If a product is packaged in a retort pouch (with light shielding), it must be labeled as “名称：ミートソース” (EN: Legal name: Meat Sauce) according to the individual rules for retort pouch foods
-If a product is packaged in a transparent pouch (without light shielding), it must be labeled as “名称：和風パスタソース” (EN: Legal name: Japanese-style Pasta Sauce) according to the cross-sectional rules as it does not meet the identity for retort pouch food.

Furthermore, there the cases where labeling methods differ depending on the storage temperature and distribution method of a product.

For example,
-“Frozen” gyoza (dumpling)- categorized as “prepared frozen food”
It must be labeled according to its individual rules (Firstly, compare the weight of “the ingredients excluding the skin (wrapper)” and “the skin”. Then, list both in descending order by weight, including the breakdowns of each, also in descending order by weight).
-“Chilled” gyoza- categorized as “chilled gyoza”
It must be labeled according to its individual rules (First compare the weight of (i) meat, (ii) fish meat, (iii) vegetables, (iv) filler, (v) skin, and (vi) other ingredients. Then indicate them in descending order by weight, including the breakdowns of each).
-Gyoza other than the above two categories such as those of which storage methods are “refrigerated”, “room temperature” It must be labeled according to the cross-sectional rules (simply list all the ingredients in descending order, including the breakdowns of each) because there are no individual rules.

These regulations were originally established under the former JAS Act and were later transferred to the Cabinet Office Ordinance on Food Labeling. There are remaining issues (with the current systems) that are to be considered by officials, in regards to rational choices of food products by consumers and the burden on business operators.

Further meetings will follow and focus on the discussion on establishing cross-sectional rules to achieve maximum possible unification while ensuring alignment with international standards, based on the process and backgrounds of labeling rules for individual food items. We will keep an eye on the specific labeling methods for each food item in the future (and inform you accordingly). During the meeting, other topics were also discussed. Among them it was reconfirmed that additives for nutritional fortification purposes should be labeled on all processed foods in principle. The proposed revision and its timing will be clarified in future meetings.

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Trends in Nutritional Content and Health Claims in other countries viewed from Japan

This time, I would like to summarize the trends in nutrition and health labeling in the US, Australia, South Korea, and the UK.

The US: Front-of-Pack Nutrition Labeling

On December 14, 2023, a press release was made by the members of the US Senate and House of Representatives regarding a bill toward mandatory front-of-pack nutrition labeling.
The main requirements of the full text of the bill (PDF) are (i) appear in a consistent location on the principal display panels across products; (ii) have a prominent design that visually contrasts with existing packaging design; and (iii) be sufficiently large to be easily legible.  A recent survey shows front-of-package nutrition labeling has broad support from the US consumers, with 75 percent of respondents in favor of a mandatory front-of-package nutrition labeling policy. Understanding the consumer needs will be beneficial for preparing food exports to the US. Speaking of which, we took note that on November 2, 2023, the Japanese government started considering the introduction of FOPNL.

Australia: Voluntary labeling for added sugars

Meanwhile, on November 14, 2023, the Food Standards Authority of Australia and New Zealand (FSANZ) announced that it had approved a revised standard for the voluntary labeling for added sugars. The draft revised standard will not permit ‘no added sugar(s)’ claims when a food:

  1. contains, or is, an ‘added sugar’ as defined in the Code
  2. does not contain ‘added sugar’ but contains more sugars (i.e. monosaccharides and disaccharides) than:
    10.0 g /100 g for solid food
    7.5 g /100 mL for liquid food.

In Japan, there are no labeling standards for added sugars, but there are standards on labeling claims that no sugars are added such as “No sugars used”
(For your reference, the following requirements must be met in order to indicate the statement that no sugars are added:

  1. No sugars are added,
  2. No alternative ingredients of sugars or additives are used,
  3. The sugars content of the food does not exceed the amount contained in the ingredients and additives,
  4. The sugars content is indicated.

)

South Korea: Labeling of “sugar-free” and “contains sweetener”

On December 28, 2023, the Korea Food and Drug Safety Administration (MFDS) published a draft revision of the Food Labeling Standards. The standard for nutritional content in the proposed revision states that in case the claims “sugar-free”, “unsweetened” or similar are used on the label for products containing sweetener(s), information on calories and indication that “sweetener(s) are used” shall be displayed. (Other proposals such as “calories for alcoholic beverages shall be displayed in larger and bolder letters to improve visibility”
are included)
In Japan, on the contrary, there are no labeling standards regarding the use of sweeteners. However, note that the “No Sweeteners Added” indication is subject to Guidelines for use of “No Food Additive Used” labeling of food additives on food labels.

The UK: Restriction on advertisements for “less healthy” food and drink products

On December 13, 2023, self-regulatory organizations related to advertisements, ASA and CAP announced that, in line with the UK government policies, they will start regulating advertisements for unhealthy products from October 2025. They will prohibit ads for identifiable less healthy products (a subset of products classified as high fat, salt or sugar (“HFSS”)) from being included in Ofcom-regulated TV services and ODPS between 5:30 am and 9:00 pm, and from being placed in paid-for space in online media at any time. There are no similar regulations in Japan, but voluntary standards are in place for the advertisements of liquors.

—

As you can see, there are various trends in each country, but the background of any revision is often described in the materials of its draft revision bill. I think it is important to know the interests of your target country when you consider importing or exporting foods, so it will likely be insightful to read them through.

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Revision Draft to add “macadamia nuts” to and delete “matsutake mushroom” from the list of the allergens for recommended labeling announced (Japan)

The Consumer Affairs Agency (CAA) announced that it planned to revise “Regarding Food Labeling Standards” within the current fiscal year (by the end of March, 2024) in a set of the materials of the “The 6th Advisors’ Meeting on Food Allergen (13 December, 2023)”.

The main points of the revision are as follows.

  • To add macadamia nuts to and delete matsutake mushrooms from the list of the allergens for recommended labeling.
  • After the revision, food-related business operators shall review their labels as soon as possible.

After the revision (New) Before the revision (Old)
Specified raw material equivalents (for recommended labeling for allergen stipulated in the Regarding Food Labeling Standards) Specified raw material equivalents (for recommended labeling for allergen stipulated in the Regarding Food Labeling Standards)
Almond, Abalone, Squid, Salmon roe, Orange, Cashew nuts, Kiwifruit, Beef, Sesame seed, Salmon, Mackerel, Soybean, Chicken, Banana, Pork, Macadamia Nuts (newly added), Matsutake mushroom (deleted), Peach, Yam, Apple, Gelatin Almond, Abalone, Squid, Salmon roe, Orange, Cashew nuts, Kiwifruit, Beef, Sesame seed, Salmon, Mackerel, Soybean, Chicken, Banana, Pork, Matsutake mushroom, Peach, Yam, Apple, Gelatin

The addition of macadamia nuts to the list of recommended labeling for allergens is based on the following requirements being met.
– In the results of the two most recent national fact-finding surveys of allergens, those that are in the top 20 items in terms of the number of immediate allergy cases.

On the other hand, the removal of matsutake mushroom from the list is based on the following requirements being met.
– In the results of the four most recent national fact-finding surveys of allergens, those that are not in the top 20 items in terms of the number of immediate allergy cases.
– In the inspection results of the four most recent national fact-finding surveys of allergens, the number of shock cases is extremely small.

In addition to Changes in the Number of Immediate-Type Cases and Shock Cases (p.g. 7) for each target product, the table, Changes in the Number of Cases and Import Volume of Macadamia Nuts, etc. (p.g.9) is also included in the materials. As you can see, the number of cases of macadamia nut allergy cases has increased along with walnut and cashew nut cases over the past 10 years (The numbers of immediate-type and shock cases of macadamia nut allergy have increased from 1 to 45 and 1 to 5, respectively, from 2011 to 2020). In addition, the information such as
– Designation of nuts as allergens in other countries (p.g. 8) (e.g. macadamia nuts are designated in the United States, the European Union, Switzerland, Australia, New Zealand, and Canada, etc.)
– The results of the fact-finding survey on processed foods using macadamia nuts (p.g.11)  (e.g.The fact that more food businesses have started to sell products containing macadamia nuts since the beginning of the 2020s, and the use of them in a ground form (as opposed to whole) has increased since 2022.)
is provided.

It would be helpful to read the materials shown above when reviewing the labels of your products so that you can check the number of cases and the related information for each allergen including the ones in your products. We will post more if there are any updates on the allergens in Japan.

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About Food Label Creation and Checking

I explained the importance of understanding the overall outline of the Food Labeling Standards　(the Standards, the Notifications, the Guidelines) and cross-sectional/individual, structure in an external lecture entitled “Food Labeling Standards and Important Points in Practice” the other day. At that time, I mentioned how difficult to operate “tasks seemingly easy to do without special pieces of knowledge”, but I would like to take this opportunity to provide further insights on this topic to our overseas readers as well. Below, I will quote the relevant parts from our “Guide book Food Labeling Law and Related Business Practical Points – from scratch, the 2nd edition (originally in Japanese only)” that was released in the past.

“You can create (incorrect) food labels without knowing the packaging/sales methods of the product” (Part 3, Chapter 1).

One day you might be surprised to see an indication on the draft product package design, which claims “Made with carefully selected locally-grown ingredients from XX Prefecture! Rich in XX (nutrients). This product is natural-oriented and has a positive effect on beauty”. Then you might want to inform your project leader that either the ingredients or the claims on the package design of the product must be changed. The project leader might get upset saying, “It’s too late! The launch date is just around the corner”. A bigger problem (than being scolded) for you would be that the project leader might make a wrong decision, which would be to sell the products as they are without changing the ingredients or the package design of their product because they are running out of time for the product launch. And the wrong decision you might eventually make could be to “do nothing despite noticing the possibility of trouble in the future”.

“Checking Is Harder” (Part III, Chapter 2)

While creating food labels is the process of accumulating facts one by one, checking food labels is, on the other hand, similar to the process of breaking down into elements one by one. A checker is supposed to confirm a label that has not been created by himself/herself without knowing with what intentions the creator of the label has accumulated the facts on the food label. Therefore, the checker needs to expand their imagination, for example, by making a hypothesis about the creator’s intention. In this respect, checking is more difficult than creating. This is because, while the creation process aims at a single point, the check process must pursue various possibilities.

The former example was about understanding an overview of the product plan before the creation of the food label, so that the standards and rationale for the claim of the product could be checked in advance. However, due to various circumstances, there are many cases where the necessary information cannot be obtained in advance. In addition to that, creating labels and the claims on them can be done without the outline information of the product plan in many cases. What I would like to emphasize is the importance of understanding the general outline of the product planning before creating a food label. The latter is about a principle. In many situations, checking without understanding the creator’s intention can be effective and it is important to make a mechanical check according to the manual without being bound by the creator’s intention. However, I think you should always keep in mind that “checking is difficult” in principle.

“A task that can be done somehow without relying on a systematic framework“ as shown on the parable above may be applied to the other jobs too. Aside from the risks and other aspects, it is important to consider whether organizational improvement opportunities are being missed because many tasks can be done without the need for the verbalization or systematization of the tasks. (However, even when the verbalization and systematization are in place, the periodic reviews of those task flows should be implemented.) While working on the second edition of this book, I’ve been reminded of the importance of reviewing even familiar tasks with a fresh perspective. This point will be a key focus in my upcoming lectures.

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Japanese version of FOPNL now under consideration

On October 26, 2023, the Consumer Affairs Agency (CAA) announced that they would hold discussions about the basic direction of the Japanese version of the “Front-of-Pack Nutrition Labeling (FOPNL)”. This time, I would like to summarize the FOPNL system, which is currently under consideration, based on the documents published at the 1st Discussion Meeting on Easy-to-Understand labeling of nutrition facts (hereinafter referred to as the “the Discussion Meeting”) held on November 2.

Background

Some countries have introduced FOPNL in order to promote consumers’ understanding of the nutritional value of foods and food choices based on the health and nutrition policies of each country　in addition to their mandatory labeling system. In November 2021, the Codex committee adopted the guidelines for FOPNL. In response to these situations, from the perspective of international consistency, the Japanese version of FOPNL has started to be discussed based on the contents of the guidelines published by international organizations. The main point of the discussion is to improve the visibility and understandability of the labels.

What is FOPNL?

The material attached to the report of the Discussion Meeting: About the situations on FOPNL includes some labeling examples of other countries. The following are images of labels in Australia, France and the U.K.(voluntary).

AustraliaFranceThe U.K.

In Canada, FOPNL became mandatory for prepackaged foods that meet or exceed set levels for sodium, sugars or saturated fat in July 2022, causing controversy.
(See our past article: Canadian mandatory front-of-pack labeling: the important points)

The guidelines of WHO and Codex

The above-mentioned material summarizes the main points of the guidelines. For examples,
–A single system should be developed to improve the impact of the FOPL system (WHO)
–Only one FOPNL System should be recommended by the government in each country (Codex)
–A monitoring and review process should be developed as part of the overall FOPL system (WHO)
The details of the Codex guidelines can be　summarized in the Guidelines on Front-of-Pack Nutrition Labeling (CAA).

Future schedules

The main issues to be discussed are as follows, (The material　attached to the report of the Discussion Meeting): Direction / Main Points of Discussion for Promotion of the Easy-to-Understand Nutrition Facts labeling (Draft) )(CAA)

  • Nutritional issues to be addressed through FOPNL, in line with the Japan’s health and nutrition policy
  • Effective measures to make it easier for consumers to utilize Nutrition Facts labels in their daily diet
  • This initiative is intended to be beneficial to consumers, while ensuring the viability for food-related businesses from the perspective of promoting the “healthy and sustainable food environments”.

A basic direction will be presented by the end of the current fiscal year at the Discussion Meeting. Since this revision is related to all food products, I advise our readers to keep an eye on this topic through our newsletter.

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UK: About Precautionary allergen labelling (PAL)

The Food Standards Agency(FSA) updated the Technical Guidance on food allergen labelling and information requirements on the 4th September, 2023. The guidance recommends that food business operators, in particular, review the use of precautionary allergen labels (PALs*).
(*PAL is used to inform consumers of the possible unintended presence of allergens in food. e.g. “May Contain Nuts”)

  • A PAL should only be used if there is an unavoidable risk of allergen cross-contact that cannot be sufficiently controlled by segregation and cleaning.
  • Business operators are being asked to specify which of the 14 major allergens the PAL refers to, for example, “may contain peanuts” rather than a generic “may contain nuts” statement.
  • A PAL should be used in combination with a vegan label where a risk of cross-contact with an allergen has been identified.
    (A ‘vegan’ label communicates different information to a ‘free-from’ claim　which is about food safety aimed at different consumer groups.)

The purpose of the guidance is to support the effectiveness of appropriate allergen labeling by companies, while not to unnecessarily limit the food choices of consumers with allergens. The updated guidance indicates labeling for food safety such as “free-from” cannot have a PAL statement for the same allergen. The guidance also provides information about No Gluten Containing Ingredient (NGCI).

Some other countries also have been operating PAL with cautions. For example, the Singapore Food Agency (SFA) states that the use of PAL should be
–Accompanied by a thorough risk assessment for any actual cross-contamination along the production chain, which poses potential risk to allergenic consumers
–Used only as necessary, as this would limit food choices for allergenic consumers
The SFA recommends referring to the Voluntary Incidental Trace Allergen Labelling (VITAL) Program (initiated by the Allergen Bureau in Australia and New Zealand), which not only assists food product manufacturers in assessing the risk of allergen cross contact in each of their products but also specifies which a particular precautionary allergen statement to be used according to the level of cross contact.

As for the development of an international guidance, PAL is currently on the agenda of the Codex Alimentarius Commission. Main subjects for the 47th Codex Committee on Food Labelling (CCFL) (held in May 2023) provide the following information;
-the 45th CCFL agreed to develop guidance on PAL or advisory labeling
-the draft guidance on the use of PAL should be developed after the results of discussions by the Joint FAO/WHO Expert meeting.
(In addition, in the subject on the regular allergen labeling individual items are specified with the scope of nuts.)

In Japan, labeling of the possibility of allergens corresponding to “May Contain xx” is prohibited. If the possibility of cross-contamination cannot be eliminated even after thorough measures to prevent contamination are taken, advisory labeling(e.g., “The manufacturing plant of this product produces products containing xx”) are recommended (Attachment of Regarding Food Labeling Standards, Labeling on foods containing allergens, 1-3 – (5), (6)) .

Looking at these trends in other countries, we can see once again that the Japanese allergen labeling systems are stricter compared to other countries, considering the establishment of the official test methods and thresholds of 10 μ g / g for protein content from allergens in each product, and the operation of the “judgment tree”. In the practice of exporting food products overseas, it must be noted to confirm the difference in the systems between your country and the target countries. Therefore, I think it would be good to use this as an opportunity to reconfirm the system of your country when investigating international trends.

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Guidelines for Notification of Foods with Function Claims partially revised (Japan)

On September 29, 2023, the Consumer Affairs Agency (CAA) announced the partial revision of the Guidelines for Notification of Foods with Function Claims (FFC) ([For food-related business operators] About notification of FFC). As outlined in the partial revision draft for Guidelines for Notification of FFC (Summary), the major points of the revision are compliance with the “PRISMA*(the Preferred Reporting Items for Systematic Reviews and Meta-Analyses) Statement (2020) “ in the systematic review and the indication of the implementation date.

*PRISMA is a globally recognized evidence-based minimum set of items for reporting in systematic reviews and meta-analyses.

Main revisions

 (See underlined parts in red in Table 1 and Table 2 of the “Old / New Comparison”.)

(1) Compliance with the PRISMA Statement (2020) for systematic reviews

-Revision of the PRISMA Statement Checklist (2020) (changes to each checklist item)
-Addition of PRISMA statement abstract checklist (2020)

(2) Clarification of responsibility for the content of the notification

-Adding the item, the content has been confirmed by the notifier (or its representative of the company), in the Checklist for preparation of notification documents for FFC

(3) Other technical matters

–Pre-registration of research plans shall be conducted in accordance with Appendix 2, Section 2.3 (2) B (A) a of Points to Consider When Preparing Application Forms for Foods for Specified Health Uses in Permission for Labeling of Foods for Specified Health Uses, etc.
-When the results of clinical studies (human trials) using the final product are used as the scientific basis for the functionality of FFC, the registration code for FFC for the public database  must be indicated.
-The notification documents must specifically state the rational reasons that led to the judgment that the product’s functionality is approved for labeling based on the assessment of certainty (or reliability) from the perspective of “totality of evidence” (meaning comprehensive evaluation of evidence, regardless of outcome).

The Q&A for FFC has also been revised, and the questions about the following contents have been added:
–Pre-registration of research plans
–When the content is updated, the title should include the updated content so that it can be understood
-Workflows when creating a research review for the first time and when updating it

The Operation that aims to announce or return the notification by an authorized organization within a period not exceeding 30 days was abolished by this revision.

Implementation date and transitional measures

(1) Regarding the compliance of systematic reviews with the “PRISMA Statement (2020)”, (I) new notifications are to be submitted on or after April 1, 2025, and (II) existing notifications shall be submitted “as needed”. There is no transitional period for (2) clarification of responsibility for the content of the notification and (3) other technical matters. Regarding the existing transitional measures for notification, the Summary of the Opinions and Views on the Opinions in the public comments also mentioned “as needed”. In the future, more systematic reviews will be reexamined for many products by official bodies (including existing notifications), so it is advisable to carefully confirm the contents of the revisions.

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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.