National Food Safety Standard Rubber Food Contact...
Transcript of 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
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.
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
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
5
and its food mass shall not
be more than 2dm2/kg. It is
used for only wine bottle
stopper wrapper.
6
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
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)
Without the detection
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)
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.
21
Copolymer of ethylene,
propylene, ethylidene
norbornene and
dicyclopentadiene
27026-53-5 EPDM 0.05 (5- ethylidene-2-
norbornene: SML)
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-
8
ethylidene-2-norbornene
contacted with the foods
and its food mass shall not
be more than 2dm2/kg.
9
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
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
No. Chinese Name CAS Number General
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
polysiloxane) at sealed end of
hydrogen
70900-21-9
16
Dimethyl (siloxane and
polysiloxane) at sealed end of
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