Author Archives: Hiroyuki Kawai

About Hiroyuki Kawai

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

Trends in 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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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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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.

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


Newsletter Signup

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

Related Service

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