Handling of food additive list and food/drug category list in Japan
Recently, we have held a webinar hosted by REACH24H Consulting Group, a Chinese corporation that provides consulting on regulatory-related matters about chemicals for various countries. I talked mainly about the title of this article although the theme I received was "Regulatory Requirements of Food Ingredients/Additives Used in Japan".
I had some questions from the audience at the webinar, but many of them seemed the same as the questions I have often been asked when explaining the Japanese additive system to people overseas. I would like to briefly summarize some of them here.
By the way, the contents of the Web seminar itself were as follows.
- Part 1: Standards of use for additives
- Part 2: Use of ingredients having medicinal effects/functions
- Part 3: Application procedure for new food additives
- Part 4: Updates regarding standards of use for additives (or newly accepted ones)
- Part 5: Example of violation cases concerning the standards of use of additives in imported food products
First, I’ll talk about the food additive list and the food/drug category list.
Regarding the positive list of food additives
There are the lists below.
- "List of Designated Additives", the list of the additives permitted to be used based on the application.
- "List of Existing Food Additives", the list of the additives approved for many years of use results.
On the other hand, in addition to that, there are
- "List of plant or animal sources of natural flavorings", the list of original source of flavourings derived from animals or plants.
- "List of substances which are generally provided for eating or drinking as foods and which are used as food additives", the list of foods and drinks commonly used as additives.
(Here, "Flavours", which are often treated as "Food" in many countries other than Japan, must be treated as "Food Additives" in Japan.)
Regarding food ingredients
There are no standards of use of ingredients with no medical effects/functions, but there are for those with medical effects/functions in Japan.
There are also similar concerns arise when exporting products from Japan to overseas, and I feel that there are many questions about "use of ingredients that are not on the list".
For example, the followings are matters of concern which people overseas seem to have.
- As for natural flavours, can flavours derived from animals and plants that are not listed as original materials be used?
- Is a notification required when using foods other than those listed in the list of foods and drinks commonly used as additives?
- Can the only ingredients listed in the food/drug category list be used for supplements?
- What are the developments and trends in regulations on novel foods in Japan?
For novel foods, unlike the EU where there is a restriction on foods without eating experience, there is no similar regulations in Japan currently. Therefore, it seems hard to understand the use of food ingredients that are not listed in the food/drug category list, the list of flavours derived from animals and plants, or the list of foods and drinks commonly used as additives.
To summarize the points,
- It is allowed to use foods other than those with medicinal effects/functions listed in the list.
- For natural flavours and foods and drinks commonly used as additives, those listed are just examples and some other ingredients can be used as additives.
If you are considering exporting foods to Japan, I think it is necessary to confirm, as one "example", what kind of foods, or animals and plants as original materials are included in the food/drug category list, "List of plant or animal sources of natural flavorings", or "List of substances list which are generally provided for eating or drinking as foods and which are used as food additives".