Understanding of the "Termination of Review" of New Food Raw Materials

At present, there are three types of review conclusions for "three new foods": recommended approval; recommended disapproval; and postponement of re-examination. While the review conclusions of new food raw materials also include a unique form of review conclusions-termination of review. What is the termination of review? What is the characteristic of the product that received the termination of review? What products are included in the list? What will the "termination of review" impact on the applied enterprise? CIRS Group will take you understand the details.

What is “termination of review”?

Article 15 of the "Administrative Measures for the Safety Review of New Food Raw Materials" stipulates: "For products that are substantially equivalent to food or the announced new food raw materials, a decision to terminate the review shall be made and the applicant shall be notified".

So what is substantial equivalence? Substantial equivalent means that a newly declared food material is the same as the food or the announced new food material in terms of species, source, biological characteristics, main ingredients, edible parts, usage, scope of use, and population. The adopted technology and quality requirements are the same, and it can be considered that they are equally safe and substantially equivalent.

It can be seen from this that the termination of review initially served for substantive equivalence. Nowadays, according to the products that have concluded the termination of the review, it also includes "general food management", as "local specialty food management" and "other special management" situations. Generally, "termination of review" in most cases recognized that the declared product can be used as a food raw material.

Analysis of the catalog of “termination of review”

As of May 25, 2021, a total of 61 products have been included in the termination review catalog (see Table 1). Among them, there are 20 products under substantially equivalent, 22 products under general food management, 10 products under local specialty food management, and 9 products under other special circumstances.


Table 1 Summary of the product catalog for the termination of review (as of 05.25, 2021)

Item

Quantity

products

Substantially equivalent

20

L-arabinose, γ-aminobutyric acid (2 types), Medium and long chain triglycerides, Medium and long chain fatty acid structure oil (also renamed medium and long chain fatty acid edible oil), Milk minerals, Panax ginseng adventitious root, Panax ginseng tissue culture (later renamed as ginseng tissue culture adventitious root), Chitosan oligosaccharides (2 types), wild ginseng tissue culture adventitious root (later renamed ginseng tissue culture adventitious root), Ashitaba extract (later renamed Ashitaba juice powder), Mulberry leaf extract, Phosphatidylserine, Krill oil, DHA algae oil from Schizochytrium sp., Haematococcus pluvialis oil (astaxanthin oil), Fish oil (3 types).

General food management

22

Whey fermented product (original liquid), whey fermented product (powder), Cardamine, Elastin (also renamed bonito elastin peptide), Clinacanthusnutans (Burm.f.) Lindau, Xanthoceras sorbifolium bunge oil, Star oil vine protein powder (later renamed as plukenetia volubilis linneo protein), Pangasiushypophthalmus oil, Heveabrasiliensis seed oil, Idesia polycarpa oil (oil grape oil), Milk protein concentrate, Trehalose, Caramel syrup, Caramel powder, Avena sativa seedlings, Milk phospholipids, Yishengtang brand Tiangua powder (also renamed Tiangua powder), Buckwheat seedlings (also renamed tartary buckwheat seedlings), Enzymatically hydrolyzed bone meal, Non-denatured type II collagen (also renamed cartilage powder containing type II collagen), Potato extract, LyciumruthenicumMurr.

Local specialty food management

10

Panax notoginseng flower, Panax notoginseng stems and leaves, Ranbo (Polygonum vulgare fruit powder), Niu Dali powder, Sweet tea, Aquilaria sinensis (Lour.) Sprengel leaf, Forsythia leaves, Golden thread lotus (later renamed Anoectochilus roxburghii), Dendrobium officinale leaf, Dendrobium officinale flower.

Other special circumstances

9

Cultivation of Takifugu fasciatus, Cultivation of Takifugu rubripes, Eurotium cristatum (CGMCCNO. 8730), Famous cheese brand garlic oil, Soybean oligosaccharides, Angelica, Cistanche deserticola Y. C. Ma, Trollius chinensis Bunge, Dendrobium officinale.

The significance or impact of the termination of the review on the enterprise

1. Termination of review ≠ recommendation of disapproval

"Recommendation of disapproval" generally includes the following situations:

1)    Does not have the characteristics of food raw materials;

2)    Do not meet the nutritional requirements;

3)    Safety cannot be guaranteed;

4)    The application materials or samples are untrue;

5)    Others do not comply with the relevant laws and regulations of China.

The technical review conclusions of the "termination of review" include the following situations:

1)    It is a general food or is substantially equivalent to general food;

2)    It is substantially equivalent to the announced new food raw materials;

3)    Other circumstances of termination of review.

It can be seen that there is an essential difference between "terminating examination" and "recommendation of disapproval". In most cases, termination of review is another result of obtaining approval.

2. The significance or impact of termination of review

It can be seen from the conclusion of the termination of the reviewed product. In addition to the substantive equivalents, some raw materials having a long-term edible history or consumption habits are possibly under the general food management category, or may also under the local specialty food management category. Therefore, for the new food raw material declaration, getting "general food management" and "local specialty food management" also means the raw material is approved.

The NHC should issue the "Notice of Administrative License of Termination Review" and inform the reasons to the products that eventually determine the "termination of review".

Conclusion

For new food raw materials, in addition to the "recommended approval" conclusion, "termination of review" can also meet the application needs of the company.

For raw materials that are different from or cannot meet the requirements of the announced raw materials can register new food raw material and review by relevant authorities. CIRS will hold a free webinar for introducing the registration of new food raw materials in China, please click the link for more details.

If you have any needs or questions, please contact us at service@cirs-reach.com.