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China Consults on Ten New FCM Additives and Four New Food Additives

Ten new FCM additives are now undergoing public consultation, which will end on March 11, 2020. Opinions on four new food additive shall be submitted prior to March 19, 2020.

On February 18th and 20th, 2020, CFSA opened ten new FCM additives and four new food additives to public feedback. The new food additives and FCM additives have already passed a technical evaluation by the expert review committee. Here are the details.

Ten New FCM Additives (CFSA Notice, February 18, 2020)

  • Two New Varieties of FCM additives

No.

Name

CAS No.

Usage scope

Maximum   usage amount/%

Specific   Migration Limit

SML/(mg/kg)

Maximum   Permitted Quantity

QM (mg/kg)

Note

1

Microfibrillated cellulose pulp

65996-61-4

Paper and paperboard

5 (calculated as dry weight of fiber)

2

2-Butenedioic acid (2E)-,   dibutyl ester, homopolymer

Painting and coatings

2

­—

Paintings and coatings added with this substance shall not contact infant formula and breast milk. The maximum using temperature is 121 ℃.

  • Two Varieties of FCM additives Expanded with Application Scope

No.

Name

CAS   No.

Usage   scope

Maximum   usage amount/%

Specific   Migration Limit

SML/(mg/kg)

Maximum   Permitted Quantity

QM   (mg/kg)

Note

1

Calcium stearate

1592-23-0

Plastic:   polyether ether ketone, PEEK

0.03

2

2,5-Furandione, dihydro-,   mono-C15~20- alkenyl derivs

68784-12-3

Plastic: PE, PP

0.48

30 (calculated as maleic acid)­

Plastic material and products added with this substance shall not contact infant formula and breast milk. The maximum using temperature is 100 ℃.

  • Six New Varieties of Resins

1.     Fatty acid, C18- unsaturated, dimers, polymers with caprolactam and hexamethylenediamine (CAS No. 2068097-08-3)

Usage scope

Maximum usage amount/%

Specific Migration Limit

SML/(mg/kg)

Maximum Permitted Quantity

QM (mg/kg)

Note

Plastic

15 (calculated as caprolactam);

 

2.4 (Hexamethylenediamine);

 

0.05 (calculated as the total amount of unhydrogenated   unsaturated fatty acid C18 dimer and hydrogenated C18-unsaturated fatty acid dimers)

Plastic material and products manufactured with this substance as the raw material shall not contact infant formula and breast milk; and shall be filled and stored under room temperature (including the hot filling and pasteurization under T≤70℃, t≤2h or T≤100℃, t≤15min)

 2.     2-Propenoic acid, 2-methyl-, polymer with N- (butoxymethyl)-2-propenamide, ethenylbenzene and ethyl 2-propenoate (CAS No. 26589-46-8)

Usage scope

Maximum usage amount/%

Specific Migration Limit

SML/(mg/kg)

Maximum Permitted Quantity

QM (mg/kg)

Note

Paintings and coatings

6 (calculated as methacrylic acid);

 

6 (calculated as acrylic acid);

 

ND (N-(butoxymethyl)prop-2-enamide, DL=0.01 mg/kg)

Food contact paintings and coatings manufactured with this substance as raw material shall not contact acid-forming food with PH value lower than 3.64, oils and fats, food with fatty surface, infant formula and breast milk. The maximum using temperature is 121 ℃.

 3.     Styrene block polymers with 2-methyl-1,3- butadiene and 1,3-butadiene, hydrogenated (CAS No. 132778-07-5)

Usage scope

Maximum usage amount/%

Specific Migration Limit

SML/(mg/kg)

Maximum Permitted Quantity

QM (mg/kg)

Note

Plastic

ND (1,3-Butadiene: SML, DL=0.01);

 

ND (2-methyl-1,3-butadiene: SML,   DL=0.01)

0.5% (styrene);

 

1mg/kg (1,3-Butadiene);

 

1mg/kg (2-methyl-1,3-butadiene)

 4.     Phenol, 4,4'-(1-methylethylidene)bis-, polymer with (chloromethyl)oxirane, benzoate (CAS No. 52907-82-1)

Usage scope

Maximum usage amount/%

Specific Migration Limit

SML/(mg/kg)

Maximum Permitted Quantity

QM (mg/kg)

Note

Paintings and coatings

19.7 (calculated as the painting formula)

0.6 (bisphenol A)

1 (epichlorohydrin)

Food contact paintings and coatings manufactured with this substance as raw material shall not contact infant formula and breast milk.

 5.     Polymer of 1,4-bis(hydroxymethyl)cyclohexane,2- methylpropane-1,3-diol, tricyclo(5.2.1.02,7)decan4,8-dimethanol,benzene-1,4-dicarboxylic acid, benzene-1,3-dicarboxylic acid, cis-butenedioic acid, 5-isocyanato-1-isocyanatomethyl-1,3,3- trimethylcyclohexane (CAS No. —)

Usage scope

Maximum usage amount/%

Specific Migration Limit

SML/(mg/kg)

QM (mg/kg)

Note

Paintings and coatings

30 (calculate as the painting formula)

5 (2-Methyl- 1,3-Propanediol);

 

0.05 (4,8-bis(hydroxymethyl)tricyclo[5.2.1.0(2,6)]decane);

 

7.5 (calculated as 1,4-dicarboxybenzene);

 

5 (calculated as ‎iso-phthalic acid);

 

30 (maleic acid)

1 (calculated as isocyanic acid)

Paintings and coatings manufactured with this substance as raw material shall not contact infant formula and breast milk.

 6.     Polymer of butanediol-1,4,ethylene glycol,propylene glycol-1,2,trimethylolpropane,dimethyl terephthalate,isophthalic acid and sebacic acid (CAS No. —)

Usage scope

Maximum usage amount/%

Specific Migration Limit

SML/(mg/kg)

QM (mg/kg)

Note

Paintings and coatings

30 (calculate as the painting formula)

5 (calculated as 1,4-butanediol);

 

30 (calculated as ethylene glycol);

 

6 (trimethylolpropane);

 

5 (calculated as iso-phthalic acid)

Paintings and coatings manufactured with this substance as raw material shall not contact infant formula and breast milk.

Opinion Feedback

Any comments should be sent to biaozhun@cfsa.net.cn prior to March 11, 2020.

Four New Food Additives (CFSA Notice, February 20, 2020)

  • New Variety of Enzyme

No.

Name

Source

Donor

Note

1

Protein glutaminase, PG

Chryseobacterium proteolyticum

-

The quality specification shall conform to GB 1886.174 Enzyme Preparations for Food Industry.

  • Food Additive with Expanded Application Scope

No.

Name

Function

Food Classification No.

Food Category

Maximum Using Amount (g/kg)

Note

1

DL-Tartaric acid

Acidity regulator

04.02.02.03

Pickled vegetables

3.0

Calculated as tartaric acid

06.05.02.01

Vermicelli

2.0

  •  Food Processing Aid with Expanded Application Scope

No.

Name

Function

Application Scope

Note

1

Manganese sulfate

Nutrient used in fermentation process

Fermentation technique

Can be used in the fermentation technique of edible fungus, dairy products, meat, etc. The specification of manganese sulfate shall refer to GB 29208-2012.

  •  Nutritional Fortifier with Expanded Application Scope

No.

Name

Function

Food   Classification No.

Food   Category

Usage   Amount (g/kg)

Note

1

6S-5-methyltetrahydrofolate   calcium, magnafolate

Nutritional   fortifier

01.01.03

Only limited to the modified dairy for the pregnant and   lactating

Conform to the standard related to folic acid in GB 14880.

Used as the compound source of folic acid.

 

The quality and specification shall refer to the No. 13 notice of the former NHFPC, 2017.

01.03.02

Only limited to the modified dairy powder for children

Only limited to the modified dairy powder for the pregnant and lactating

06.06

Instant cereal, including rolled oats (oatmeal)

14.02.03

Fruit and vegetable juice (pulp) beverage (including fermented products)

13.03

Foods for special medical purpose (except for the categories listed in 13.01)

Can be used as the source of folic acid. The usage amount goes with the standard related to folic acid in GB 29922.

Opinion Feedback

Any comments should be sent to zqyj@cfsa.net.cn prior to March 19, 2020.

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