Labeling of food containing designated ingredients, etc. enforced on June 1.

"Food containing designated ingredients, etc." refers to foods that contain ingredients designated by the Minister of Health, Labour and Welfare as ingredients requiring special precautions.

The law to partially amend the Food Sanitation Act was promulgated on June 13th, 2018. One of the outlines of the revision is "Collecting health hazards information from foods containing ingredients requiring special precautions: Business operators are required to submit a notification of health and hazards information to the relevant administrative organ every time they obtain information that any of such foods cause or may cause human health damage from the standpoint of preventing the occurrence of health hazards. I quoted the background for this as follows.

Some of the so-called "Health foods" contain ingredients (alkaloids, hormones, etc.) that may cause harmful effects to the human body depending on their usage. This system was established in order to prevent cases where some products have adversely affected the consumer's health from re-occurring in the future, due to:
- inappropriate production control leading to a nonuniformity of content of the product
- inadequate intake guidelines/recommendations with no scientific evidence and so on.

Food labeling standards have been partially revised to stipulate the labeling of foods containing designated ingredients, etc., from the following points,
- From the viewpoint of food hygiene,
- The labeling of foods containing designated ingredients, etc. can supplement the purpose of the notification system of health hazards information for foods containing designated ingredients,
- From the viewpoint of providing information to consumers,
- The labeling will lead to securing voluntary and rational selection opportunities.

At present, the following four ingredients are designated as those requiring special precautions.

"Coleus forskohlii", "Celandine", "White Kwao Krua", "Black Cohosh"

I will quote the typical examples of alias names of the designated ingredients in "About the establishment of regulations associated with the enforcement of Article 8 of Food Sanitation Act (after the revision following the ordinance partially amending said Act)".

(1) (JA: コレウス・フォルスコリー) Coleus,Forskolin, Coleus forskohlii
(2) (JA: ドオウレン) (JA: クサノオウ, ハックツサイ, ヨウシュクサノオウ, グレーターセランディン), Celandine, Greater celandine, Swallow-wort, Chelidonium majus
(3) (JA: プエラリア・ミリフィカ) (JA: 白ガウクルア), White Kwao Krua, Pueraria mirifica
(4) (JA: ブラックコホシュ) (JA: ラケモサ), Black cohosh, Black snakeroot, Actaea racemosa

Now take a look at the specific labeling items and methods for labeling on foods containing designated ingredients, etc. referring to Food Labeling Standards.

[ Article 3 Paragraph 2 ]

Foods containing designated ingredients, etc. (means foods containing designated ingredients as prescribed in Article 8, paragraph 1 of the Food Sanitation Act. The same shall apply hereinafter.)

Labeling items Labeling methods
Indication that it is a food containing designated ingredients, etc. It is displayed as "指定成分等含有食品(○○)", which means "food containing designated ingredients, etc.(xx)" (xx is the name of the designated ingredient etc. (designated ingredients etc. stipulated in Article 8, paragraph 1 of Food Sanitation Act. Hereafter the same applies in this paragraph and the item of the food containing designated ingredients, etc. in Appended table 20.))
Contact information of the food-related business operators Display the telephone number of the person who is responsible for the labeling contents among the food related business operators.
Indication that it is an ingredient or material which requires special precaution from the viewpoint of preventing food sanitation hazards regarding designated ingredients, etc. The indication "指定成分等とは、食品衛生上の危害の発生を防止する見地から特別の注意を必要とする成分又は物です。", which means "Designated ingredients are ingredients or materials which requires special precaution from the viewpoint of preventing food sanitation hazards", must be indicated on the label.
Indication that if you feel something unusual in your physical condition, you should immediately stop the intake and consult a doctor and also contact the food-related business operator. The indication "体調に異変を感じた際は、速やかに摂取を中止し、医師に相談してください。 加えて、体調に異変を感じた旨を表示された連絡先に連絡してください。", which means "If you feel something unusual in your physical condition, please stop the intake immediately and consult a doctor. In addition, please get in touch with the contact on the label to inform you feel unusual in your physical condition. " must be indicated.

[ Appended table 20 (Article 8) ]

Style Labeling method
According to the provisions of Appendix 1 The indications of "food containing designated ingredients, etc." and "ingredients or materials which require special precaution from the viewpoint of preventing food sanitation hazards" must be labeled by uniform characters with a size of 14 points or more specified in JIS Z 8305 as well as the provisions of each item of Article 8 (excluding item 3).

In addition to the above, the wording "food containing designated ingredients, etc." is added to the table of Article 5 Paragraph 1(Special Exceptions of mandatory labelling), Article 10 Paragraph 1 (mandatory labelling), the table of Article 11 Paragraph 1 (Special Exception of mandatory labelling), Article 15 (mandatory labelling), and Appendix Table 23.

For those who handle foods containing designated ingredients and others, on top of the above, it is also necessary to establish a system that can receive information on health damage from consumers, etc., appropriately evaluate it, and notify it to the prefectural governor, etc.

The currently designated ingredients are considered to be related mainly to the tasks for those handling health foods.  Even for those who do not, it may be useful to go through the relevant part of the mandatory labeling items for ingredients in your products.

Regarding enforcement of Food Labeling Standards for foods (food containing designated ingredient, etc.) containing ingredients that require special precautions, such as Pueraria Mirifica (Consumer Affairs Agency)
Food containing designated ingredients, etc.(related laws and regulations)(the Ministry of Health, Labour and Welfare)

August 2020