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China CFSA is Collecting Public Comments on 8 New Food Additives including Rebaudioside M and 2’-FL

from CIRS by

China,Food,Additive,New,Comments,Registration

On October 26, 2023, China National Center for Food Safety Risk Assessment (CFSA) issued 8 new food additives for public comments, including 1 new food additive, 2 new food enzymes, 1 new food nutrition enhancer and 4 food additives with expanded scope. The deadline for public comments is November 21, 2023. Details are as follows:

New food additive (1 type)

  • Name: Rebaudioside M;
  • Application scope and maximum usage level:

Category number

Food name/category

Maximum level (g/kg)

Remark

01.01.03

Modified milk

0.18

Count as steviol

01.02.02

Flavored fermented milk

0.2

03.01

Ice cream and ice milk

0.5

05.02.01

Gum-based candy

3.5

14.0

Beverages (excluding 14.01 packaged drinking water)

0.2

Count as steviol; count as the state of ready to drink, increase the usage of solid drinks according to the dilution ratio.

Quality specifications: It is applicable to the food additive Rebaudioside M, which is prepared through the efficient catalysis of sucrose synthase, β-1,3-galactosyltransferase, and β-1,2-glucosyltransferase, followed by alcohol dissolution, filtration crystallization, and drying using the the main component, Rebaudioside A, found in steviol glycosides as the raw material. The production strain of Rebaudioside M should undergo safety assessment and meet the requirements outlined in Appendix A.

Appendix A Information on the production strain of Rebaudioside M

Food additive

Source

Donor

Rebaudioside M

E.coli BL21 (DE3)

Methylocaldum szegediense a, Stevia

rebaudiana Bertoni b and Solanum tuberosum c

a is the donor of sucrose synthase

b is the donor of β-1,3-galactosyltransferase

c is the donor of β-1,2-glucosyltransferase

New food enzymes (2 types)

No.

Enzyme

Source

Donor

1

Cyclomaltodextin glucanotransferase

Anoxybacillus

caldiproteolyticus

2

Cellulase

Penicillium oxalicum

The quality specifications of food enzymes shall comply with the provisions specified in National Food Safety Standard - Food Additive - Food Enzyme (GB 1886.174).

New food nutrition enhancer (1 type)

  • Name: 2’-fucosyllactose, 2’-FL
  • Application scope, maximum usage level and quality specifications: It shall be consistent with the requirements specified in NHC Notice No. 8, 2023 (except Appendix C - Information on the production strain of 2’-fucosyllactose). Details of the the production strain are as follows.

Table 1 Information on the production strain of 2’-fucosyllactose

Nutrition enhancer

Source

Donor

2’-fucosyllactose

Escherichia coli

BL21(DE3)

Helicobacter pylori a

a is the donor of α-1, 2-fucosyltransferase

Food additives with expanded scope (4 types)

No.

Name

Function

Category number

Food name/category

Maximum level (g/kg)

Remark

1

Tomato red

Colorant

08.02.01

Seasoned meat products (adding seasonings to fresh meats)

0.12

Counted as tomato red

08.02.02

Cured meat products (e.g., salt meats, cured meats, dried salted duck, Chinese ham and sausage)

0.018

08.03.05

Sausage

0.35

08.03.07.03

Dried meat crisps

0.26

2

Polyoxyethylene (20) sorbitan monooleat

Emulsifier

16.03

Collagen casing

0.5

3

Rosemary extract

Antioxidant

04.05.02

Processed nuts and seeds

0.3

4

Vitamine E (dl-α-tocopherol, d-α-tocopherol, mixed tocopherol concentrate)

Antioxidant

16.07

Others (lutein esters only)

50

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