national food safety standard rubber food contact...

National Standard of the People’s Republic of

China GB 4806.11—2016

Issued on October 19, 201 Implemented on April 19, 2017

Issued by National Health and Family Planning Commission of the People’s

Republic of China

National Food Safety Standard

Rubber Food Contact Materials and

articles

(Unofficial translation)

1

GB 4806.11-2016

Foreword

This Standard replaces Hygienic standard for foodstuff rubber products (GB 4806.1-1994) and

rubber contents in MOH 2011 No 23 public announcement approves 107 resins.

Compared with above standard and public announcement, the following changes have been

made to this Standard:

- Standard name revised to “Hygienic standard for foodstuff rubber products”;

- Standard scope revised;

- Basic requirement supplemented;

- Raw material requirement supplemented;

- Physicochemical indexes supplemented;

- Migration test requirements supplemented;

- Label Identification requirements supplemented;

- Annex A supplemented.

2

National Food Safety Standard

Rubber Food Contact Materials and articles

1. Scope

This Standard is applicable to the food contact materials and articles which taking natural rubber,

synthetic rubber (including vulcanized thermoplastic elastomer) and silicone rubber as main raw

material.

2. Terms and definitions

2.1.Nature rubber

Nature rubber should be cis-1,4-polyprene from rubber tree.

1.2 . Silicon rubber

It refers to the organic silicone elastomer formed from sulfuration of substances such as

polysiloxane base polymers and hydrophobic silica etc. through heating and pressurizing.

3. General Requirements

The rubber food contact materials and articles shall comply with the provisions of GB 4806.1.

4. Technical Requirements

4.1.Requirements for raw materials

Natural rubber, synthetic rubber and silicone rubber for rubber food contact raw materials shall

comply with relevant requirements setting in Annex A and related public announcement.

Vulcanized thermoplastic elastomer resins shall comply with relevant provisions setting in the

Annex A of GB 4806.6-2016 and related public announcement.

4.2.Sensory Requirements

The sensory requirements shall comply with the requirements in Table 1.

1 Sensory Requirements

Item Requirements

Appearance Normal color; no abnormalodors, dirt, etc.

Soak The soak marinate from the migration test shall have no coloring, turbidity,

precipitation, abnormal odors or other sensory deteriorations

4.3. Physicochemical Indexes

4.3.1. Physicochemical indexes shall comply with the requirements in Table 2.

Table 2 Physicochemical Indexes

Items Indexes Inspection method

Overall migration limit(OML)(mg/dm2) ≤10 GB 31604.8

3

Consumption of potassium

permanganate/(mg/kg)in water，60℃，0.5h ≤10 GB 31604.2

Heavy metal (calculated as Pb)//(mg/kg) in 4%

acetic acid (volume fraction),(60℃，0.5h) ≤1 GB 31604.9

a. Migration values results for Rubber Food Contact Materials and articles for baby should be calculated from

mg/dm2 to mg/kg and not exceed the limit 60 mg/kg

4.3.2. Specific migration limit (SML),Specific migration limit (total) (SML(T))and Maximum

permitted quantity (QM)of monomers and other starting substances for natural rubber, synthetic

rubber and silicone rubber shall comply with relevant requirements setting in Annex A and

related public announcement. Specific migration limit (SML), Specific migration limit (total)

(SML(T))and Maximum permitted quantity (QM)of monomers and other starting substances for

vulcanized thermoplastic elastomer resins shall comply with relevant provisions setting in the

Annex A of ＧＢ 4806.6-2016 and related public announcement.

4.4. Additives

Additives in rubber food contact materials & articles shall comply with the requirements setting

in GB 9685 and other relevant public announcement.

5. Others

5.1 . Migration Test

5.1.1 . General Requirements

Migration test shall be executed in accordance with the provisions of GB 31604.1 and GB

5009.156, except as otherwise in below special requirements in this Standard.

5.1.2. Food Simulant

50% (v/v) ethanol solution may be selected as the simulants of fatty foods instead, the selection

of other food simulants shall be executed in accordance with the provisions in GB 31604.1.

5.1.3. Overall Migration Test Conditions

The overall migration test conditions for food contact temperature(T) below 40℃ ,contact time(t)

below 24h shall comply with the requirements setting in Table 3. Other migration test conditions

shall comply with the requirement in Article 5.2 of GB 31604.1-2015.

Table 3 Overall Migration Test Conditions

Anticipated application conditions Migration Test Conditions

T≤40ºC, t≤10min 40℃，10min

4

T≤40ºC, 10 min<t≤30min 40℃，30min

T≤40ºC, 30 min <t≤2 h 40℃，2h

T≤40ºC, 2 h< t≤24 h 40℃，24h

5.2. Label Identification

The labels identification shall meet the provisions in the GB4806.1, and if the product contains

natural latex, the product shall be labelled with remark as “containing natural latex”.

1

GB 4806.11-2016

Annex A

Raw material requirements on Rubber Food Contact Materials and articles

A.1 Basic polymer for synthetic rubber shall comply with the requirements setting in A.1

A.2 Basic polymer for silicone rubber shall comply with the requirements setting in A.2.

A.3 Annex B about SML（T）］and SML（T）Grouping No. is applicable to this standard too.

Table A.1 Basic Polymer for Synthetic Rubber and Use Requirements

No. Chinese Name CAS Number General Name SML/QM mg/kg SML(T)

mg/kg

SML(T)

Grouping

Number

Other Requirements

1

Polymer of 1,1,2,3,3,3-

Hexafluoroacetore-1-propylene

and 1,1 difluoroethylene

9011-17-0

ND(1,1,2,3,3,3-

Hexafluoroacetore-1-propylene:

SML, DL=0.01mg/kg); 5(1,1-

difluoroethylene: SML)

Relative molecular mass ＞

70,000

2

Copolymer of 1,1,2,3,3,3-

Hexafluoroacetore-1-propylene,

1,1 -difluoroethylene and

tetrafluoroethylene

25190-89-0

5 (1,1- difluoroethylene: SML); 0.05

(tetrafluoroethylene: SML); ND

(1,1,2,3,3,3-

Hexafluoroacetore-1-propylene:

SML, DL=0.01 mg/kg)

Relative molecular mass ＞

10,000

3

Polymer of 2-methyl-1,3-

butadiene and chlorinating-2-

methyl-1- propylene

68081-82-3 CIIR

ND(2-methyl-l,3- butadiene: SML,

DL=0.01mg/kg);

1(2-methyl-l,3-butadiene: QM)

2

4

Polymer of 2-methyl-1,3-

butadiene and

brominating-2-methyl-1-

propylene

68441-14-5 BIIR

ND (2-methyl-1,3-butadiene: SML,

DL=0.01mg/kg);

1(2-methyl-1,3-butadiene: QM)

5

Polymer of 3a, 4, 7,

7a-Tetrahydrofuran,

7-methylene-1H-indene and

ethylene- propylene (Polymer of

ethylene- propylene-

dicyclopentadiene)

25034-71-3 EPDM

6 Copolymer of styrene- butadiene 9003-55-8 SBR 1(butadiene: QM) or ND (butadiene:

SML, DL=0.01 mg/kg)

7 Copolymer of styrene and

2-methyl-1, 3- butadiene 25038-32-8

ND (2-methyl-1, 3- butadiene: SML,

DL=0.01mg/kg); 1 (2-methyl-1, 3-

butadiene: QM);

3

GB 4806.11-2016

Table A.1 (Continuous)

No. Chinese Name CAS Number General

Name SML/QM mg/kg

SML(T)

mg/kg

SML(T)

Grouping

Number

Other Requirements

8 Polymer of acrylonitrile and

butadiene; butyronitrile rubber 9003-18-3 NBR

1 (butadiene: QM) or ND (butadiene:

SML, DL=0.01 mg/kg); ND

(acrylonitrile: SML, DL=0.01mg/kg)

9

Polymer of propylene and

following one or more

monomers: maleic anhydride,

ethylene, 1- butylenes, other a-

alkene, containing 5-

ethylidene-2- norbornene as

modified monomer, among

which, the propylene accounts for

maximum mass fraction

25722-45-6

25895-47-0

29160-13-2

9010-79-1

0.05 (5- ethylidene-2- norbornene:

SML)

30

(Calculate

with

maleic

acid)

3

Without the detection

method of migration

quantity on 5- ethylidene-2-

norbornene, use

0.05mg/6dm2 (QM) as its

limit value. The ratio of the

areas that the materials and

products containing 5-

ethylidene-2-norbornene

contacted with the foods

and its food mass shall not

be more than 2dm2/kg.

10

Polymer of dimethyl succinate

and 4-hydroxyl-2 ,2, 6,

6-tetramethyl-1-piperidineethanol

65447-77-0

70198-29-7 30(SML)

4

11 Homopolaymer of low polymer

of butadiene 68441-52-1 BDR

1 (butadiene: QM) or ND (butadiene:

SML, DL=0.01mg/kg)

12

Thermoplastic Vulcanizate based

on polypropylene and crosslinked

epdm rubber (With ethylidene

norbornene as epdm rubber of the

third monomer)

TPV 0.05 [5- ethylidene-2-norbornene:

SML]

15

(Calculate

with the

methanal)

15


method of migration


norbornene, use









13

Thermoplastic Vulcanizate based

on polypropylene and crosslinked

epdm rubber (With ethylidene

norbornene as epdm rubber of the

third monomer), copolymer of

ethylene and 1- octylene,

compounds of the mineral oil

TPV 0.05 [5- ethylidene-2-norbornene:

SML]

15

(Calculate

with the

methanal)

15


method of migration


norbornene, use







5


be more than 2dm2/kg. It is

used for only wine bottle

stopper wrapper.

6

GB 4806.11-2016



Name SML/QM mg/kg SML(T) mg/kg

SML(T)

Grouping

Number

Other Requirements

14 Copolymer of the methyl

methacrylate and ethyl acrylate 9010-88-2

6 (calculate with

the propenoic

acid); 6 (calculate

with methacrylic

acid)

22, 23

15 Polybutadiene (butadiene

homopolaymer) 90003-17-2 BR

1 (butadiene: QM) or ND

(butadiene: SML,

DL=0.01mg/kg)

16 polyethyleneglycol 25322-68-3 30 (calculate with

ethylene glycol) 2

17 Polyisoprene(2- methyl-1, 3-

butadiene)

ND (2-methyl-1, 3- butadiene:

SML, DL=0.01mg/kg); 1

(2-methyl-1, 3- butadiene: QM)

18

Copolymer of three fluorine

chlorinated butadiene and

Vinylidene Fluoride

9010-75-7

5(Polyvinylidene Floride:

SML); ND (three fluorine

chlorinated butadiene: SML,

DL=0.01mg/kg)


method of migration

quantity on the relevant

three- fluorine chlorinated

butadiene, use 0.5mg/6dm2

7

(QM) as its limit value.

19

Polymers of tall oil rosin and

fumaric acid rosin and

methanal

15 (calculate with

the methanal) 15

20

Copolymer of ethylene,

propylene and ethylidene

norbornene; Polymer of 5-

ethylidene bicyclo [2,2,1]

Heptene-2- alkene and ethane,

propylene

25038-36-2 EPDM 0.05 (5- ethylidene-2-

norbornene: SML)


method of migration


norbornene, use









21

Copolymer of ethylene,

propylene, ethylidene

norbornene and

dicyclopentadiene

27026-53-5 EPDM 0.05 (5- ethylidene-2-

norbornene: SML)


method of migration


norbornene, use





8





9

GB 4806.11-2016



Name SML/QM mg/kg

SML(T)

mg/kg

SML(T)

Grouping

Number

Other Requirements

22 Copolymer of ethylene- vinyl

acetate 24937-78-8 EVA 12 (vinyl acetate: SML)

23

Copolymer of ethane and

bicyclo [2,2,1] Heptene-2-

alkene

26007-43-2 E/NB 0.05 (bicyclo [2,2,1] Heptene-2-

alkene: SML)

24 Copolymer of the isoprene-

isobutyl 9010-85-9 IIR

ND (2-methyl-1, 3- butadiene: SML,

DL=0.01mg/kg); 1(2-methyl-1, 3-

butadiene:QM)

Table A.2 Basic Polymer for Silicon Rubber and Use Requirements


Name SML/QM mg/kg

SML(T)

mg/kg

SML(T)

Grouping

Number

Other Requirements

1

[(vinyl diformazan silicon

radical) oxygen radical and

modified (trimethylsilyl) oxygen

radical] silane

68988-89-6

2 Coagulated matter of 72480-33-2

10

phenyltriethoxysilane and

(siloxane and polysiloxane)

3

Dimethyl vinylmethylsiloxane

homopolymer (siloxane and

polysiloxane) at the sealed end

of single vinyl

68951-99-5

4

Reaction product of dimethyl

(siloxane and polysiloxane) and

silicon dioxide

67762-90-7

5

Polymers of dimethyl siloxane

and polysiloxane, methyl

silsesquioxane at the sealed end

of the ethoxyl

68554-66-5

6 Dimethyl methyl hydrogenation

(siloxane and polysiloxane) 68037-59-2

7 Methyl silsesquioxane 68554-70-1 1(Methyl trimethoxy silane, QM)

8 Methylhydrosiloxane and

polysiloxane 63148-57-2

9 Methyl ethenyl dimethyl

(siloxane and polysiloxane) 67762-94-1

10

Polymer of methyl ethenyl

dimethyl (siloxane and

polysiloxane) and methylphenyl

silsesquioxane

68037-69-4

11

11 Polydimethylsiloxane 63148-62-9

9016-00-6

Relevant molecular mass is

more than 6800

12

Copolymer of

poludimethylsiloxane and

phenyl silsesquioxane

73138-88-2

13

Vinylmethylsiloxane

homopolymer at sealed end of

hydroxyl radical (siloxane and

polysiloxane)

67923-19-7

14

Dimethylsiloxane at sealed end

of the hydroxyl radical;

Dimethly (siloxane and

polysiloxane) at sealed end of

hydroxyl radical

70131-67-8

15

Dimethyl ((siloxane and


hydrogen

70900-21-9

16

Dimethyl (siloxane and


ethenyl

68083-19-2

17

Dimethyl methyl ethenyl

(siloxane and polysiloxane) at

sealed end of ethenyl

68083-18-1

18 Hydrolysis products of tetraethyl 104199-38-4

12

orthosilicate, 1, 3- divinyl-1, 1,

3, 3- tetramethyldisiloxane,

hexamethyldisiloxane

19

Polymers of tetraethyl

orthosilicate and

hexamethyldisiloxane

104133-09-7

national food safety standard rubber food contact...

Documents