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MHLW Proposes to Eliminate 78 Food Additives from the Existing List Based on Sales Conditions

MHLW listed 78 substances, which are scheduled to be eliminated, as they are unlikely sold on the market. Once an existing food additive is eliminated from the list, its sale or use will be prohibited.

On June 20, 2023, the Japan Ministry of Health, Labour and Welfare (MHLW) announced to initiate an investigation on 78 existing food additives from List of Existing Food Additives. MHLW believed these 78 food additives are unlikely sold on the market. As of now, 132 additives have been identified in the four previous investigations and have finally been banned for use.

The 78 items surveyed include aluminium, rice straw ash extract, oregano extract and logwood colour etc. Substances not used as food additives are not included in this investigation. However, this investigation applies to vitamins and minerals used for food fortification purposes, even if they are not used as food additives but as foods.

MHLW plans to compile the results and publicly announce the list of substances to be removed as food additives as early as mid-2024. After a correction period of six months from the date of public announcement, the existing list of food additives will be revised within one year. Stakeholders who sell existing food additives, or preparations/foods containing those 78 additives have any objection to this list, please submit the following attachments to MHLW via kizonshoujo@mhlw.go.jp before Sept. 19, 2023:

Noteworthy substances:

1. Non-calcinated eggshell calcium

In Japan, calcium is a nutrient that is often consumed in insufficient amounts. As a result, there are many calcium-fortified products on the market, such as beverages and candies. Calcium fortification in baby food is also becoming increasingly common. Non-calcinated eggshell calcium, which mainly consists of calcium salts obtained by drying eggshells, is a natural material that has been consumed for a long time. It is reported to be well-absorbed by the human body and is often used as a calcium supplement added to food. Some products containing non-calcinated eggshell calcium may still be circulating in the market.

2. Soybean saponin

Soybean saponin, which is obtained from soybean seeds and consists mainly of saponins, is used as an emulsifier in food additives. This substance is currently listed in the Non-drug List (List of ingredients (raw materials) not deemed drugs unless claiming medicinal efficacy) and is allowed to be used as a raw material for health foods. If the results of this investigation confirm the removal of the substance, it may also be removed from the Non-drug List because it is no longer an additive.

3. Coffee bean extract

Chlorogenic acid is a natural polyphenol and antioxidant found in raw coffee beans prior to roasting. Raw coffee bean extracts are high in chlorogenic acid and polyphenols, which are beneficial for cardiovascular health and reducing the risk of diabetes. The products being investigated are powdered extracts of raw coffee beans, which are water-soluble and can be used in a variety of applications, including beverages, jellies, and tablets.

4. Purple yam colour

Purple yam colour is mainly used for coloring purposes, giving a reddish-purple color. It is obtained from the yam tuberous roots and is mainly composed of cyanidin acylglucosides. It poses an extremely low risk, as it is made from natural potatoes. Besides, it is can be used as a component in health food products.

5. Buckwheat ash extract

It is a natural food improver made from the extraction and concentration of ash obtained by buckwheat stems or leaves. It has been used for a long time as a raw material for the production of "konjac," a traditional Japanese food, and as an improver for processed meat products such as ham and sausages.

Moreover, the extract is rich in minerals such as potassium, making it a useful supplement for modern people who may be deficient in this mineral, and can also be used as a low-sodium ingredient in products.

6. Sepiolite

Sepiolite is a mineral that occurs naturally and is widely used in the food industry to enhance food safety. It can adsorb harmful substances in food and prevent spoilage by absorbing moisture and oil, which helps to maintain the quality of food.

Sepiolite is primarily used as a seasoning, food additive, and preservative. For example, it is used as a seasoning in salt, sugar, soy sauce, and miso. As a food additive, it is used in jams, juices, jellies, ice cream, chocolate, and other products. Furthermore, as a food preservative, it is used to preserve meat, fish, vegetables, fruits, and other foods.

7. Sesame seed oil unsaponified matter

Sesame is one of the oldest oil-producing plants, and its seeds are rich in lipids. Sesame is mostly produced in China, India, and Myanmar, and the sesame consumed in Japan is mostly imported. Sesame seed oil unsaponifiable matter is obtained from sesame seeds and consists mainly of sesamolin.

8. Cristobalite

As a food additive, cristobalite is used as an agent in the manufacturing process of food products. It is mainly used to adjust the texture and color of food products. For example, when used in creamy foods, cristobalite is added to enhance the stability of the cream. During the cheese production, cristobalite is added to adjust the color of cheese.

However, excessive use of cristobalite can have negative health effects, especially for individuals with allergies or digestive problems, who may be at risk of health problems due to excessive intake.

9. Catalysts

Regarding catalysts, cobalt, nickel, platinum, palladium, and ruthenium are recognized as existing additives. However, cobalt already ruled out in MHLW's third investigation. Other catalysts are also all within the scope of this investigation.

Among these catalysts, nickel catalysts are the most widely used and quantitatively utilized in the food industry. They are divided into two types: sponge nickel and supported nickel, depending on their intended use. Sponge nickel catalysts are mainly used for the production of sugar alcohols, while supported nickel catalysts are used for the production of hardened oils and fats.

10. Gum base and gutta-percha

Gum base and gutta-percha are particularly noteworthy ingredients among the 78 food additives. Gum base is a plant-derived natural polymer mainly used in chewable foods such as gum and candy. In contrast, gutta-percha is a synthetic polymer made from resin and is mainly used in liquid-type foods such as beverages and ice cream.

However, both gum base and gutta-percha have the potential to cause allergic reactions. Therefore, their presence shall always be indicated on food labels.

ChemLinked's suggestions

As the substances that will eventually be removed have already been confirmed to not be used/sold on the market, their removal is not expected to have a significant impact on the actual production and operation of businesses. However, if there are any additives that concern you, please submit an application to the Ministry of Health, Labour and Welfare in a timely manner.

Under the Food Sanitation Act, if an additive is not redesignated as an additive under Article 12, it is prohibited to sell or use the additive as a food additive. Japan has a strict positive list system for additives, and exporting companies can stay informed of any changes, including those resulting from the removal of additives, by following ChemLinked platform. We provide timely updates and remove language barriers for companies seeking to export to Japan.

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