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).

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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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.

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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FSANZ published a draft food regulatory (Australia/New Zealand)Measure for Carbohydrate and sugar claims on alcoholic beverages

On the 24th July, 2023, Food Standards Australia New Zealand (FSANZ) called for public comment to clarify requirements with respect to carbohydrate and sugar claims on alcoholic beverages. Standard 1.2.7 in the Food Standards Code currently permits voluntary claims about carbohydrate content in alcoholic beverages. However, the Code lacks clarity around the extent of these content claims. FSANZ is proposing to amend the standard to clarify what content claims are permitted for carbohydrate and sugar on food containing more than 1.15% ABV.

Over the last decade there has been an increase in the prevalence of alcoholic beverages that carry nutrition content claims about sugar and/or carbohydrate according to Proposal P1049  (submission deadline: 4 September 2023). In 2020, FSANZ undertook a limited, qualitative survey of nutrition information on the labels of alcoholic beverages for sale at major liquor retail outlets and supermarkets. The actual claims on the labels (Table 2) found from the survey were “Low carb”, “Lower carb”, “X% less carbs”, “No carbs” and so on for carbohydrate claims, and “Low sugar”, “Lower sugar”, “X% less sugar”, “No sugar”, “Zero sugar” and so on for sugar claims.

In 2022, FSANZ undertook a rapid systematic review to examine the available evidence on consumer value, perceptions and behaviours in response to carbohydrate and sugar claims on alcoholic beverages and concluded that consumers generally have a poor understanding of the nutritional properties of alcoholic beverages. Therefore, sugar/carbohydrate claims may cause consumers to make inaccurate assumptions about alcohol and energy in alcoholic beverages.

The new draft (Draft variation to the Australia New Zealand Food Standards Code (Attachment A) ) clarifies the scope of labeling for carbohydrate and sugar claims for a food that contains more than 1.15% alcohol by volume. The draft variation also contains amendments, which if approved, would prohibit nutrition content claims about specifically named sugars (e.g. fructose) and about components of carbohydrate other than sugar (e.g. fibre) .

sugar means, unless otherwise expressly stated, any of the following:
(a) white sugar;
(b) caster sugar;
(c) icing sugar;
(d) loaf sugar;
(e) coffee sugar;
(f) raw sugar.

(1) A nutrition content claim or health claim must not be made about:
(a) kava; or
(b) an infant formula product; or
(c) a food that contains more than 1.15% alcohol by volume, other than a nutrition content claim about:
(i) salt or sodium content of a food that is not a beverage;
(ii) carbohydrate content;
(iii) energy content;
(iv) gluten content;
(v) sugar content; or
(vi) sugars content.

(2) A nutrition content claim about sugars content of a food that contains more than 1.15% alcohol by volume must not name or refer to any specific sugars.
Example A nutrition content claim that refers to fructose is not permitted.

(3) A nutrition content claim about carbohydrate content of a food that contains more than 1.15% alcohol by volume must not name or refer to a component of carbohydrate other than sugar or sugars.

(See Standard 1.1.2 for the definition of sugars (pg9))

Additionally, this proposal includes overseas regulations such as EU, United States and Canada. If you consider exporting your products to Australia and New Zealand, it is recommended that you check your own country’s standards against those of Australia and New Zealand for better understanding.

F.Y.I. (the Japanese regulation)
Article 7 of the Food Labeling Standards: “A statement of the ability of a food to ensure the proper intake of certain nutrients/calories” (and “Appended Table 13”) (no sugar, low sugar, sugars X% off, etc.), Article 7 of the same Standards: “A statement that no sugars* is added” (no sugars added, no sugar used, etc.).
*: must be Monosaccharides of Disaccharides and confined to “non sugar alcohol”

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Request for re-verification of notified documents for Foods with Function Claims issued (Japan)

On July 3, 2023, the Consumer Affairs Agency (CAA) requested in writing that relevant organizations re-verify the scientific evidence for Foods with Function Claims (FFC), and the reverification request has already been notified to and made public by CAA (Re-Verification of Notification Documents Concerning FFC (Request)). Furthermore, CAA published the Measures for FFC based on the Food Labeling Act in Light of the Administrative Order under the Act against Unjustifiable Premiums and Misleading Representations as an important announcement on its website on July 7.

Notice Summary

On June 30, 2023, the CAA issued an administrative order based on the Act against Unjustifiable Premiums and Misleading Representations. The CAA judged that the information displayed on the food products that have been already notified to and published by the CAA as FFC, including data on the scientific evidence for their functionality, was not acceptable as reasonable evidence in order to comply with the FFC standards.

Based on this case, the CAA requested that the following be made known to all concerned organizations.

1. Re-verify the scientific evidence for the safety and functionality of the food products already notified to the CAA

2. The preparation and submission of the documents of the products must be conducted appropriately based on the latest the Guidelines for submitting a notification of FFC, FAQs on FFC and the Guidelines for Ensuring Transparency of Ex Post Facto Regulations (Ex Post Facto Checks) Based on Acts and Regulations Concerning Food Labeling, etc., for Foods with Function Claims

Background

The measure order (issued this time by the CAA), clarify that the agency had requested the company to submit materials that provide reasonable evidence to support the functional claims displayed on the label, however, none of the subsequently submitted materials were deemed to provide such reasonable evidence to support the label for FFC. Noticeably, it is the first instance that the already submitted content of scientific evidence has been considered as insufficient since the system was launched in 2015. This makes clear that even FFC that has already been notified to the CAA will now need to be re-verified to determine whether the scientific basis for their claims is actually appropriate.

On the same day, the CAA also pointed out questionable scientific evidence of 88 other products (and their claims: DHA/EPA, monoglucosyl hesperidin, and olive-derived hydroxytyrosol) that are sharing the same ingredients and scientific evidence with the products subject to the administrative order this time, and requested that those companies of the products respond to submit convincing scientific evidence for FFC.　Subsequently, on July 27, the CAA website published 15 withdrawals (from the FFC system) by food companies and a list of the other 73 products and their companies’ contact information for which no withdrawals were yet made, together with the information on the notified content (functionality) of their products. (*According to the latest information, 86 withdrawals were reported on August 29)

Re-confirm the guidelines

The notice states that appropriate verification shall be conducted based on the Guidelines for Ensuring Transparency of Ex Post Facto Regulations (Ex Post Facto Checks) Based on Acts and Regulations Concerning Food Labeling, etc., for Foods with Function Claims as well as the latest Guidelines, and FAQs on FFC. This guideline provides the basic concept regarding the scientific evidence for FFC:

– FFC is not a product for which the government has conducted an examination and the Commissioner of CAA has made an individual evaluation of its functionality to be labeled

– Therefore, if the notified scientific evidence supporting the labeling is found to lack rationality, the labeling may be considered inappropriate in an ex post facto check.

The guideline also includes examples of what is not considered to be appropriate scientific evidence. 

As for the guideline, a request for comments on the proposed partial revision started on July 24.

When considering the sales of FFC in the Japanese market, we highly recommend taking into account this news and ensure to provide evidence that is in line with the expectation of the CAA. When re-verifying the scientific evidence based on the above-mentioned documents for submission to the CAA, it is also recommended that you check the contents of the proposed partial revision of the guidelines (Compliance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) Statement (2020) on systematic reviews and Clarification of where responsibility lies for the contents of the submission for FFC).

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Research and practical points for food standards on such as additives, food labeling for exports from Japan

　(*This article is mainly aimed at companies in Japan, but can also be used as a reference for any companies doing export (including to Japan).)
In this article, we would like to inform you of research and practical points for food standards regarding mainly additives, food labeling among other topics for exports from Japan. (Content partly edited from a lecture given at the Food Safety Symposium（Aiming at food export promotion measures and compliance with foreign acts and regulations in food export）held in Tokyo on March 9, 2023)

Procedures of research for the standards of a target country

At the time of research, it is a good idea to start by grasping a systematic overview of the target country. You can do your own research, use a tool, or ask an outside party to do it for you. If you are new to research tasks, one of our suggestions is to search “Import Regulations” in GAIN(USDA) to see if they have the information you need.

Before you begin your research, you need to organize your research categories as shown below. Take Japanese regulations as an example. Review an overview of the standards primarily from the following perspectives: Note that rules are not always consolidated into one set of rules, so check for other related rules.

A. What are the regulations that set food standards (definitions and requirements)? (Enforcement Regulation of Food Sanitation Act (e.g. for bacteria), Pesticide residues, etc.)

B. What regulations establish the use of additives (Designated additives (by the Minister of Health, Labor and Welfare), Existing additives (with a long history of eating and use in Japan and approved for use), Standards for Use of Food Additives, etc.)

C. What regulations establish labeling standards (Food Labeling Standards)

As you search the details of each regulation, you will find various types of documents, such as acts, standards, and notices. First, check if your target country has its “Guide for Businesses”(Food standards/additives, Food labeling) and check its reference information for the regulations on which it is based. Some non-English speaking countries only provide an overview without detailed information in English, so it is important to check the local language version afterwards.
(If you are familiar with research tasks in English, you may find it helpful to use tools such as gComply (The global database of regulatory standards)).

Understand the relationship with surrounding standards

In the research of the standards for use of additives, you may encounter many cases such as “stipulated as an additive in some countries but not in Japan” and vice versa (e.g. flavorings are treated as additives (Japan)). There are also cases where the definitions of functions such as processing aids are the same between some countries, but some of these countries have a restriction for use of the additives with such functions and the others don’t.  In other cases, in some countries, some additives listed with their standards for use even have further standards depending on their intended use.

Since the standards for use of additives and labeling standards vary depending on the food category, it is necessary to confirm these with special attention to their relationship. For example, regulations on the uses/ amounts of additives that can be allowed are all listed in the “standards for use of additives” regulation in one country, while in another country they may also be listed in surrounding regulations such as “food standards” (e.g. use of preservatives for foods packed in containers and sterilized by pressurization and heating (Japan)) or labeling standards (use of preservatives in tomato juice (Japan)).

When researching standards, especially if you find a document in a table form (e.g. the standards for use of additives), it is important to check if there are other standards as well. In some cases, labeling regulations also require research of their notification/permission systems and advertising regulations. In addition to labeling, checks about a wide variety of other regulations are required, including safety regulations and standards/regulations for containers and packaging (food contact materials).

Practical issues

Furthermore, even after identifying these rules and documents that need to be confirmed, you may encounter various issues in practice, such as
– Difficulty to judge some ingredients that do not fall under additives because there is little information available
– Difficulty to confirm if the translation is appropriate for words without terminology standards
– Some cases where not enough information has been found to confirm the standards for use
– Difficulty to predefine information required for labeling

As the number of target countries and the number of food products increase, it becomes difficult to collect and organize necessary information in advance. The challenge is to find the “right balance” of how much research to do, whether to collect all the information or only the information you need depending on your company’s situation.

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Mandatory allergen labeling for walnuts and others:“Food Labeling Standards”, ”Regarding Food Labeling Standards”, ”Food Labeling Standards Q&A” Revised (Japan)

On March 9, 2023, the Consumer Affairs Agency(CAA) announced revisions to “Food Labeling Standards”, “Regarding Food Labeling Standards”, and “Food Labeling Standards Q&A”. The main revisions include the mandatory labeling of allergens for walnuts and the addition of rapeseed producing EPA / DHA* to the list of specified genetically modified agricultural products**. In this article, we would like to organize the details of the mandatory allergen labeling for walnuts as follows.
(*Please refer to past article for the information on the addition of rapeseed producing EPA / DHA to the list of specified genetically modified agricultural products.)
(**Agricultural products whose composition, nutritional value, etc. are significantly different from those of regular agricultural products because they were produced using recombinant DNA technology. See in the reference “Old and New Comparison table (Food Labeling Standards Q&A(the 15th revision)” pg. 24))

The main points of the revision of “Food Labeling Standards”

Walnuts were added to Appended Table 14, and the number of specified raw materials (mandatory labeling items for allergens in Japan) was changed from seven to eight.

Before the revision (Old)After the revision (New)
Shrimp
Crab
Wheat
Soba (Japanese buckwheat)
Egg
Milk
Peanut		Shrimp
Crab
Walnut
Wheat
Soba (Japanese buckwheat)
Egg
Milk
Peanut

The main points of the revision of “Regarding Food Labeling Standards”

Walnut was removed from the list of “specified raw materials equivalents”(recommended labeling items for allergens in Japan) and the number of items on the new list was changed from 21 to 20 items.

Before the revision (Old)After the revision (New)
Almond, Abalone, Squid, Salmon roe, Orange, Cashew nuts, Kiwifruit, Beef, Walnut, Sesame seed, Salmon, Mackerel, Soybean, Chicken, Banana, Pork, Matsutake mushroom, Peach, Yam, Apple, GelatinAlmond, Abalone, Squid, Salmon roe, Orange, Cashew nuts, Kiwifruit, Beef, Sesame seed, Salmon, Mackerel, Soybean, Chicken, Banana, Pork, Matsutake mushroom, Peach, Yam, Apple, Gelatin

The description of Appended Table 1 (the scope of the definition of specified raw materials) remains unchanged. However, “the scope” of the definition of walnut has been added to Food Labeling Standards Q&A (see below *1).

Specific raw materials, etc.Classification Number (1)Classification Number (2)Broad classificationMedium classificationSmall classification
Walnut698591Drupe-like nutsOther drupe-like nutsWalnut

No labeling examples have been added to Appended Table 2 (Examples of labeling for additives derived from specified raw materials, etc. ), same as before the revision.

name of specified raw materialsClassificationAdditivelabeling of specified raw materialsRemarks
Walnut––––

No labeling examples have been added to Appended Table 3 (substitute declarations for specified raw materials and so on), same as before the revision.

specified raw materials (items stipulated in Food Labeling Standards)Substitute descriptionExtended description
A different description substituting the original by how it is described or words used, but can be understood to correspond to the same specified raw material.Examples of descriptions that include the names of specified raw materials or alternative descriptions so that they can be understood as food products using these ingredients.
Walnut Walnut Walnut bread, Walnut cake

“2.2 Qualitative testing method” now includes the additional descriptions of real-time PCR method and nucleic acid chromatography.

Before the revision (Old)After the revision (New)
Qualitative testing methods include western blotting method and PCR method. Generally, western blotting method is used for egg and milk. As for wheat, buckwheat, shrimp, crab,  and peanut, PCR method is commonly used.
It is acceptable to use a qualitative testing method other than western blotting method or PCR method, however, it shall have the same or more accuracy than those methods.
(Omitted)		Qualitative testing methods include western blotting method, PCR method, real-time PCR method, and PCR-nucleic acid chromatography. Generally, western blotting method is used for egg and milk. On the other hand,
– PCR method is use for shrimp and crab
– PCR method or real-time PCR method is used for wheat, buckwheat, and peanut
– Real-time PCR method or nucleic acid chromatography is used for walnut
It is acceptable to use a qualitative testing method other than western blotting method, PCR method, real-time PCR method, and PCR-nucleic acid chromatography, however, it shall have the same or more accuracy than those methods.
(Omitted)

In relation to this addition, the details of the Qualitative testing methods have been added and the “About the judgment tree” has been changed. If you would like to confirm the test method, you can check them.

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

Food Labeling Standards Q&A (D-3) regarding the scope of walnut (*1) has been added.

(D-3) What is the scope of “walnut” as specified raw materials?
(Answer) The term “walnut” refers to walnuts stipulated in the Japan Standard Commodity Classification Number 698591, and in addition to the overseas species (Chandler, Howard, etc.) that are mainly distributed, Japan’s species (Amigurumi, Shiurim, Himegurumi, and so on) are also subject to labeling.. Please note that walnut oil, walnut butter (and so on) are also allergens.

Although not included in this article, some additions and changes have been made to Food Labeling Standards Q&A in relation to the “Addition of rapeseed producing EPA / DHA as a specified genetically modified agricultural product (addition to Appended Table 18)”. In addition, Food Labeling Standards Q&A on how to label the Nutrition Facts for “foods sold and usually consumed together in sets”(e.g. a set product of undo (Japanese) noodle and soup) has been added. Please check if you handle related food products.

Period for transitional measures and upcoming schedules

As shown below, the period is until the end of March 2025.

The labeling for processed foods (excluding processed foods for business use) which are manufactured, processed, or imported from the date of enforcement of this the Cabinet Office Ordinance to March 31, 2025 and processed foods for business use which are sold by March, 31, 2025 shall remain applicable notwithstanding the provisions of Appended Table 14 of the Food Labeling Standards revised by said revised provisions.

The revision was made in response to the 2018 Report on the Survey on food labeling regarding food allergy. The report revealed there has been a significant increase in health hazards caused by immediate-type allergies to nuts, particularly walnuts.

The survey conducted in 2021 revealed the cases of allergy have been on the rise since then. So, even during the period for transitional measures, it is important to reconfirm information management, such as ingredient specifications to be able to respond to inquiries from consumers.

References

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Report of the discussion on the Act against Unjustifiable Premiums and Misleading Representations published (Japan)

On January 13, 2023, the Consumer Affairs Agency (CAA) published “the report of the discussion on the Act against Unjustifiable Premiums and Misleading Representations”.  The report was compiled after 10 rounds of discussions starting in March 2022. The report summarized issues to be considered in the future including the “introduction of Commitment Procedure that allows a business operator to apply for a corrective action plan (see *1 for details)” and “increased surcharges (penalties) for repeated violations” and so on.

This time, I would like to provide you with an overview of the background and summary of these discussions.

Background of the discussions

The purpose of the discussions held in March 2022 was as follows.

The Act on Unjustifiable Premiums and Misleading Representations, which aims to ensure an environment in which general consumers can voluntarily and rationally select products and services, was revised in 2014.
The discussions were intended to be held to discuss necessary measures from the viewpoint of securing consumer interests in light of the facts that
-a certain period of time has passed since the enforcement of that revised Act
-changes in the social environment surrounding the Act against Unjustifiable Premiums and Misleading Representations, such as the progress of digitalization

As for changes in the social environment in Japan, the following are to be considered.
-Electronic commerce has become popular due to the progress of digitization
-Advertisements for electronic commerce have become mainstream on the Internet
-International transactions are also becoming popular

In addition, under the recent operation of the Act against Unjustifiable Premiums and Misleading Representations, it is said that a sufficient number of necessary measures has not been taken for the following reasons.
-The introduction of the surcharge system (that imposes economic disadvantages (penalties) on businesses that misrepresent) has increased the time needed to process cases.
-Despite the fact that triggering cases are on the rise, the number of the cases are not on the rise where sufficient penalty measures are taken In addition to these, the existence of “business operators that repeatedly commit violations” was taken up as one of the background factors for the discussions. The following cases are listed as examples of malicious violations.

<Case 1: Misleading representations concerning the quality/standard of a product or service>
A business operator that sells supplements to the general consumers posted a message on its SNS account as if certain effects could be achieved by taking the supplements. However, as a result of the investigation, the business operator did not have any material showing the grounds to support the indication.

Issues to be considered

The report divides the issues to be considered into two categories;
-those that should be addressed early
-those that should be addressed in the medium to long term
and summarizes them as follows.

1. Issues to be addressed early

(1) Promotion of voluntary efforts (see *1 below) by business operators (introduction of Commitment Procedure)

(2) Promotion of refund measures under the surcharge (penalty) system (utilization of electronic money, etc.)

(3) Strengthening deterrence against violations
(Application of increased surcharge (penalty) calculation rate, estimation of sales amount to be used as basis for calculation of surcharge (penalty), etc.)

(4) Utilization of criminal punishment

(5) Responding to internationalization (How to enforce measures against overseas companies and so on)

(6) Reorganization of concepts related to buy-back services

(7) Cooperation with qualified consumer groups

(8) Coordination with other systems in law enforcement

(9) Cooperation with prefectural governments

(10) Burden of proof, etc. in civil proceedings in relation to advertising content that has not been demonstrated

2. Issues to be addressed in the medium to long term

(1) Expansion of the scope of surcharges (penalties)

(2) Obligation to preserve digital representations

(3) Expansion of the scope of restriction to those who do not meet the supply requirements (“goods or services supplied by the business operator”) (4) Dark pattern (Deceptive design pattern)

Of the above, I would like to point out two points that should be noted by business operators: “introduction of Commitment Procedure that allows a business operator to apply for a corrective action plan” and “increased surcharges (penalties) for repeated violations”. The summary of the report is as follows.

(1) Promotion of voluntary efforts by business operators (introduction of Commitment Procedure)

Under the current Act on Unjustifiable Premiums and Misleading Representations (snip) even when a business operator unintentionally misrepresents its product and actively tries to take voluntary actions to improve labeling and so on, if a violation is found, the business operator is subject to an order to take actions, etc. Until now, legal actions against cases of misrepresentation have been taken by a measure order or surcharge payment (penalty) order. However, in the case where business operators are expected to be able to reliably handle the situation sufficiently on their own and so on, encouraging the business operators to take voluntary initiatives will result in faster corrections rather than issuing these orders.

In addition, the report also stated that “the Guidelines should clearly state what to do” in case where the Commitment is not fulfilled.

(3) Strengthening deterrence against violations (Application of increased surcharge (penalty) calculation rate, estimation of sales amount to be used as basis for calculation of surcharge (penalty), etc.)

Some business operators repeatedly commit violations even though they have a history of committing violations of the Act against Unjustifiable Premiums and Misleading Representations in the past and receiving an order to take actions or surcharge payment (penalty) order. Since the current system is not a sufficient deterrent for such operators, it is necessary to strengthen the penalty in response in such cases.

In the Act on Unjustifiable Premiums and Misleading Representations, (snip) an increased calculation rate should be applied to the business operators that repeatedly commit violations in order to increase the deterrent effect.

In addition, with regard to the issue of calculating the surcharge (penalty) due to “the failure of submitting materials by a violating business operator in the investigation by the Fair Trade Commission and so on” the report stated that “provisions should include a reasonable method to estimate the sales amount, etc. subject to surcharge.”

Upcoming schedules

In response to the suggestions in the report, the CAA will work to revise the Act against Unjustifiable Premiums and Misleading Representations. If you are in charge of food labeling and, especially, if you handle health foods and other products with health and functional labels, we hope you find this report useful and helpful. Besides, anyone in charge of checking advertisements should read the “Report of on stealth marketing by the discussion group” published on December 28 last year.

References

Discussions on the Act against Unjustifiable Premiums and Misleading Representations (CAA)

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Report on mandatory allergen labeling for walnut: The period of transitional measures is until March 31, 2025 (Japan) ~Summary on other future revisions and transitional measures~

On December 13, 2022, a report was submitted in response to a proposal for partial revision of Food Labeling Standards (such as mandatory allergen labeling for walnuts). According to the report, the transitional period from recommended to mandatory allergen labeling for walnuts is March 31, 2025. The partial revision is expected to be promulgated and enforced in the near future. Taking this opportunity, I would like to summarize incoming (and some of recently completed) revisions of the food labeling system and the transitional measures period for the next few years.

Transitional measures period for each revision

The following is a summary of major revisions and their transitional measures including the ones for several years in the past as well as future plans. Some of them have already passed their period of transition, and for some there is not much time left. I would like to summarize them here for your review.

Main revisions (Transitional Measures)
New labeling for countries of origin of ingredients The transitional period ended at the end of March 2022 (ended).
Labeling of additives (removal of the terms, “Artificial” and “Synthetic”) The transitional period ended at the end of March 2022 (ended).
“non-GM” labeling The transitional period will end at the end of March 2023
The guideline of ‘non-use’ labeling of additives (e.g. “No preservatives used”) The transitional period will end at the end of March 2024
Mandatory allergen labelling for walnuts The transitional period will end at the end of March 2025

The partial revision of Food Labeling Standards reported on December 13, 2022, also includes the addition of rapeseed producing EPA and DHA to the list of specified genetically modified agricultural products. In addition, in December 2022, “Matters to be Noted relating to Health Foods under the Act against Unjustifiable Premiums and Misleading Representations and the Health Promotion Act” was revised.

“non-GM” labeling

The following two revisions were made in April 2019.

The requirements for a “non-genetically modified” labeling will be made stricter, from their current state (i.e. “a rate of unintentional presence of genetically modified soybeans and corn should be equal to or lower than 5%”), to “not detected.”
The case where the contamination rate is 5% or less, voluntary labeling indicating separate production and management is appropriately implemented is allowed.

The revision was made to avoid misleading, based on the opinion that allowing the labeling of “non-GM” on a product with a maximum contamination rate of 5% is misleading.

The main point to note from the revision is that, from April 1, 2023, “non-GM” labeling will be allowed only for soybeans, corn, and processed foods (made from these agricultural products as ingredients) that have been properly sorted and controlled for distribution and are found to be free of the ones genetically modified.

For example, some products (already on the market) containing soybeans (of which separate production and distribution management is properly implemented) have changed their labeling from “Soybeans (non-genetically modified)” to “Soybeans (separate production and distribution management implemented)” or “Soybeans (preventative measures for GM presence taken)” and so on.

The guideline of ‘non-use’ labeling of additives

In March 2022, 10 types of ‘non-use’ labeling of additives to be noted were published.

Type 1: Mere “not added” labeling
Type 2: Labeling terms not stipulated in Food Labeling Standards
Type 3: Labeling on foods with use of additives not permitted by the regulation
Type 4: Labeling on foods with food additives having same function / similar function
Type 5: Labeling on foods with ingredients having same function / similar function
Type 6: Labeling associating with health and safety
Type 7: Labeling associating with something other than health and safety
Type 8: Labeling on foods with use of additives not expected
Type 9 Labeling on food with a processing aid or carry-over (or cannot be confirmed not to be used)Type 10: Excessive claims

Based on the current ambiguous Food Labeling Standards Q&A, some business operators voluntarily put labels such as “XXX-free”. This is probably one of the reasons why some consumers do not understand labels such as “XXX-free” clearly, which was found in the consumer intention survey. Such situation led to establishment of the guideline.

The main point to note according to the guidelines is that the cases where the ‘non-use’ labeling of additives falls under the prohibited labeling items arise not only from being true for the example of each type items directly but also depending on various aspects of the product as a whole such as its property.

In June 2022, the Consumer Affairs Agency published “Educational Flyers and Posters” (with some revisions) and “Illustrations for 10 type items” as supplementary information to the Guidelines, which may also be referred to.

Mandatory allergen labelling for walnuts

Walnuts are to be added to Appended Table 14 (the list of mandatory allergen labeling items) under the partial revision of Food Labeling Standards reported on December 13, 2022.

Appended Table 14 (before the revision) Appended Table 14 (after the revision)
Shrimp
Crab
Wheat
Soba (Japanese buckwheat noodle)
Egg
Milk
Peanuts		 Shrimp
Crab
Walnut
Wheat
Soba (Japanese buckwheat noodle)
Egg
Milk
Peanuts

The revision was made in response to the 2018 Report on the Survey on food labeling regarding food allergy. The report revealed there has been a significant increase in health hazards caused by immediate-type allergies to nuts, particularly walnuts.

The number of cases has been increasing even more in the subsequent survey conducted in 2021.

Substance that causes allergy Classification Fiscal 2012 Fiscal 2015 Fiscal 2018 Fiscal 2021
Walnut Number of immediate allergy cases 40 74 251 463
Number of shock cases 4 7 42 58

The above is a summary of some of the current revisions to the food labeling system and their transitional measures. Particularly, because of the background mentioned above regarding the allergen, “walnut”, Products containing “walnut” but only labeling the current 7 mandatory allergen labeling items would need immediate actions to ensure the compliance of their labels with the new standards.
In the future, we will ensure to any new revision information on food labeling in this column.

Reference

Report (regarding partial revision of Food Labeling Standards) (Japan)

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Japan’s System for the Operation of Geographical Indication Protection reviewed

The Geographical Indication (GI) Protection System is a system to protect names of products with properties such as quality and social reputation, and so on that have been nurtured by natural, human, and social factors and environments unique to the region as regional intellectual property. The system has already been introduced in more than 100 countries around the world, and was introduced in Japan in 2015.

What is GI?

Taking the Ichida persimmon (One of the famous varieties in Japan)　as an example, the relationship between “product (place of production and properties)” and labeling is as follows.

Product GI
Place of production Properties

-Only “Ichida persimmon” originated in Takamori-cho, Shimoina-gun (former Ichida-mura) is used.
-The large temperature difference between day and night produces persimmons with high sugar content.
-River fog from late fall to early winter in that area brings excellent temperature and humidity conditions for the production of dried persimmons.
-Slow drying, firm kneading

-“Ichida persimmon” has especially high sugar content.
-Glutinous texture
-Beautiful amber color
-Small in size, easy to eat
-White powder that gives the surface fine smoothness as if it were makeup

 Ichida Persimmon

GI is a registration given to a producer organization for a product and used by its members. The registration details are described in the specification and producer organizations provide their members with the guidance to comply with the production method. One of the features of the system is that the administration will crack down on any illicit use of the GI labeling.

For any illicit labeling found, such as “TROPICAL KOBE BEEF” for the beef from South America on the restaurant’s menu in Spain, “Wagyu ‘Kobe-Style'” labeling for wagyu beef from New Zealand in a supermarket in Germany and so on, EU authorities will be requested to take appropriate measures against such labeling that will be removed by the guidance by the authorities under the framework of mutual protection system with European countries.
The Japanese GI system has focused on ensuring superior quality control to other products, stricter control over the manufacturing process than other products and the strengthening of product brands through the exclusion of imitation products. However, as a result of the gradual tightening of such control operations, GI labeling has been disproportionately implemented on the products mainly from local farms or traditional vegetables with smaller crops and so on, that are organized by region because they are easily differentiated in their quality over other standard products.

Outline on review of the operation

The operation of the GI system has been under review since November 1, 2022. The aim is to further encourage export of products by widening the scope of registration to include not only traditional regional vegetables but also processed products and products for overseas.

The outline of the revision is as follows.

１. Review of evaluation criteria

-Even without differentiated quality, promoting judgement based on the evaluation of the unique and varied properties of the product, such as quality, production method, reputation, and story, which have been nurtured in the natural, human, and social factors and environment of the region
-Flexible judgment about whether or not to register products considering other rules such as the name recognition even without 25 years or more of production experience as required in the current registration rule

２. Review of procedures before and after the registration

-As for genuine GI products which do not harm the interests of consumers who purchase the products, enable continuous use of registered names even with a new name added which divides the original form of registered names (e.g. “Kasumigaseki XX Apple” for the registered name, “Kasumigaseki Apple”) so that such unification with the new name would never hamper the consensus formation on the application
-Promote simplification for compliance items to be followed by producers. As for production process control operations, shift to a method of checking production procedures and systems, rather than final products, by abolishing the annual performance report

３. Expand exposure in the GI market

-Clarify the rules for using the GI mark on GI processed products
-Propel the development and promotion of collaborative products and services with other industries, such as food service, food, and tourism, by utilizing the GI mark effectively

In the GI system in Europe, where processed products account for the majority and many products are also exported, products are valued not for their superiority to other products, but for their unique attractiveness and strengths linked to the region. The review for the Japanese system is aimed at expanding the use of this system by pursuing more simplified procedures, while reviewing the evaluation criteria with reference to such overseas systems.

The labeling and the future of GI products

This operational review will not have a significant impact on food labeling practices themselves. The same points to note regarding Japanese registered GI (122 products**) and foreign GI* (112 products**) protected in Japan remain unchanged.

(* Refer to “Geographical Indication” →”Information on designated GIs” (MAFF’s website) e.g.: Grana Padano (natural cheese)) ** as of Dec.9,2022Taking a look at the revision of the GI system will be useful especially for those who export food products from Japan to overseas. EU is also considering a revision of the GI labeling system to include “sustainability” as a requirement for GI labeling. It would be good to confirm this together with these current trends.

References

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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.