GB 4806.11-2016 English PDF

GB 4806.11-2016: National food safety standard - Food contact rubber materials and products
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GB 4806.11-2016
GB
NATIONAL STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
National food safety standard
Food contact rubber materials and products
ISSUED ON. OCTOBER 19, 2016
IMPLEMENTED ON. APRIL 19, 2017
Issued by. National Health and Family Planning Commission of the PRC
Table of contents
Foreword ... 3 
1 Scope ... 4 
2 Terms and definitions ... 4 
3 Basic requirements ... 4 
4 Technical requirements ... 4 
5 Others ... 5 
Appendix A Raw material requirements for food contact rubber materials and
products ... 7 
Foreword
This standard replaces GB 4806.1-1994 “Hygienic standard for foodstuff
rubber products” and the relevant information on rubber polymers in the
“Notice on the publication of 107 kinds of resins that can be used for food
packaging materials such as polyhexamethylene adipamide” (No. 23
Announcement in 2011 by the former Ministry of Health).
As compared with the above standard and announcement, the main changes
of this standard are as follows.
- CHANGE the standard name into “National food safety standard - Food
contact rubber materials and products”;
- MODIFY the scope;
- ADD the basic requirements;
- ADD the raw material requirements;
- MODIFY the physical and chemical indicators;
- ADD the migration test requirements;
- ADD the label identification requirements;
- ADD the Appendix A.
National food safety standard
Food contact rubber materials and products
1 Scope
This standard applies to the food contact materials and products made of
natural rubber, synthetic rubber (including vulcanized thermoplastic elastomer)
and silicone rubber as the main raw materials.
2 Terms and definitions
2.1 Natural rubber
It refers to the cis-1, 4-polypentadiene obtained from the plant source Brazilian
clover rubber tree.
2.2 Silicone rubber
It refers to the organic silicone elastomer formed through vulcanization of the
polysiloxane-based polymer and hydrophobic silica and other substances
under heating and pressure.
3 Basic requirements
Food contact rubber materials and products shall comply with the provisions of
GB 4806.1.
4 Technical requirements
4.1 Raw material requirements
The use of the natural rubber, synthetic rubber and silicone rubber raw
materials in the food contact rubber materials and products shall comply with
the provisions of Appendix A and the relevant announcements, AND the use of
the vulcanized thermoplastic elastomer resin shall comply with the Appendix A
of GB 4806.6-2016 and the relevant announcements.
4.2 Sensory requirements
Appendix A
Raw material requirements for food contact rubber materials and
products
A.1 The base polymer for synthetic rubber shall comply with the provisions of
Table A.1.
A.2 The base polymer for silicone rubber shall comply with the provisions of
Table A.1.
A.3 The specific migration total limit [SML (T)] and SML (T) group number in
the Appendix B of GB 9685-2016 are applicable to this standard.
Table A.1 -- Base polymer for synthetic rubber and requirements for use
No
. Chinese name
CAS
number
Generi
c class
name
SML/QM
mg/kg
SML
(T)
mg/k
SML
(T)
group
numb
er
Other
requiremen
ts
Polymer of 1, 1, 2, 3, 3,
3-hexafluoro-1-propylene and
vinylidene fluoride
9011-17-0
ND (1, 1, 2, 3, 3,
3-hexafluoro-1-prope
ne. SML, DL = 0.01
mg / kg); 5 (1,
1-difluoroethylene.
SML)
Relative
molecular
mass >
Copolymer of 1, 1, 2, 3, 3,
3-hexafluoro-1-propene and 1,
1-vinylidene fluoride and
tetrafluoroethylene
25190-89
-0
5 (1,
1-difluoroethylene.
SML); 0.05
(tetrafluoroethylene.
SML); ND (1, 1, 2, 3,
3,
3-hexafluoro-1-prope
ne. SML, DL =
0 .01mg/kg)
Relative
molecular
mass >
Polymer of 2-methyl-1,
3-butadiene and
2-methyl-1-propene chloride
68081-82
-3 CIIR
ND (2-methyl-1,
3-butadiene. SML,
DL = 0.01 mg/kg); 1
(2-methyl-1,
3-butadiene. QM)
Polymer of 2-methyl-1,
3-butadiene and
bromo-2-methyl-1-propene
68441-14
-5 BIIR
ND (2-methyl-1,
3-butadiene. SML,
DL = 0.01 mg/kg); 1
(2-methyl-1,
3-butadiene. QM)
5 Polymer of 3α, 4, 7, 7α-tetrahydro-4,
25034-71
-3 EPDM
16 Polyethylene glycol
25322-68
-3
30 (in
ethylene
glycol)
Polyisoprene
(poly-2-methyl-
1, 3-butadiene)
ND (2-methyl-1,
3-butadiene. SML, DL =
0.01 mg/kg); 1
(2-methyl-1,
3-butadiene. QM)
Copolymer of
chlorobenzene
and vinylidene
fluoride
9010-75-
5 (difluoroethylene.
SML); ND
(chlorotrifluoroethylene.
SML, DL = 0.01 mg/kg)
When there is no
corresponding
chlorobenzene
migration quantity
detection method, it
may use the 0.5 mg/6
dm2 (QM) as the limit
value.
Polymer of Tall
oil rosin and
fumarized
diacylated
rosin with
formaldehyde
15 (in
formaldehy
de)
Copolymer of
ethylene,
propylene and
ethylene
norbornene;
Polymer of
5-ethylidenebis
[2.2.1]
hept-2-ene
and ethylene
and propylene
25038-36
-2 EPDM
0.05
(5-ethylidene-2-norborn
ene. SML)
When there is no
5-ethylidene-2-norbor
nene migration
quantity detection
method, it may use
the 0.05 mg/6 dm2
(QM) as the limit
value. The ratio
between the area of
the materials and
products containing
5-ethylidene-2-norbor
nene in contact with
food AND the food
mass shall be not
greater than 2 dm2/kg.
Copolymer of
thylene,
propylene,
ethylene
norbornene
and
dicyclopentadi
ene
27026-53
-5 EPDM
0.05
(5-ethylidene-2-norborn
ene. SML)
When there is no
5-ethylidene-2-norbor
nene migration
quantity detection
method, it may use
the 0.05 mg/6 dm2
(QM) as the limit
value. The ratio
between the area of
the materials and
products containing
5-ethylidene-2-norbor
nene in contact with
food AND the food
(siloxane and
polysiloxane)
7 Methyl silsesquioxane 68554-70-1
(methyltrimethoxysilane,
QM)
Table A.2 (continued)
No. Chinese name CAS number
Generic
class
name
SML/QM
mg/kg
SML (T)
mg/kg
SML (T)
group
number
Other
requirements
8 Methyl hydrosiloxane and polysiloxane 63148-57-2
Methylvinyl dimethyl
(siloxane and
polysiloxane)
67762-94-1
Polymer of methylvinyl
dimethyl (siloxane and
polysiloxane) and
methylphenyl
silsesquioxane
68037-69-4
11 Polydimethylsiloxane 63148-62-9;9016-00-6
Relative
molecular
mass > 6800
Copolymer of
polydimethylsiloxane
and phenyl
silsesquioxane
73138-88-2
Hydroxyl-terminated
dimethylmethylvinyl
(siloxane and
polysiloxane)
67923-19-7
Hydroxyl-terminated
polydimethylsiloxane;
hydroxyl-terminated
dimethyl (siloxane and
polysiloxane)
70131-67-8
Hydrogen-terminated
dimethyl (siloxane and
polysiloxane)
70900-21-9
Vinyl-terminated
dimethyl (siloxane and
polysiloxane)
68083-19-2
Vinyl-terminated
dimethylmethylvinyl
(siloxane and
polysiloxane)
68083-18-1
Hydrolysate of tetraethyl
orthosilicate, 1,3-divinyl
1, 1, 3,
3-tetramethyldisiloxane,
and
104199-38-4
GB 4806.11-2016
GB
NATIONAL STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
National food safety standard
Food contact rubber materials and products
ISSUED ON. OCTOBER 19, 2016
IMPLEMENTED ON. APRIL 19, 2017
Issued by. National Health and Family Planning Commission of the PRC
Table of contents
Foreword ... 3 
1 Scope ... 4 
2 Terms and definitions ... 4 
3 Basic requirements ... 4 
4 Technical requirements ... 4 
5 Others ... 5 
Appendix A Raw material requirements for food contact rubber materials and
products ... 7 
Foreword
This standard replaces GB 4806.1-1994 “Hygienic standard for foodstuff
rubber products” and the relevant information on rubber polymers in the
“Notice on the publication of 107 kinds of resins that can be used for food
packaging materials such as polyhexamethylene adipamide” (No. 23
Announcement in 2011 by the former Ministry of Health).
As compared with the above standard and announcement, the main changes
of this standard are as follows.
- CHANGE the standard name into “National food safety standard - Food
contact rubber materials and products”;
- MODIFY the scope;
- ADD the basic requirements;
- ADD the raw material requirements;
- MODIFY the physical and chemical indicators;
- ADD the migration test requirements;
- ADD the label identification requirements;
- ADD the Appendix A.
National food safety standard
Food contact rubber materials and products
1 Scope
This standard applies to the food contact materials and products made of
natural rubber, synthetic rubber (including vulcanized thermoplastic elastomer)
and silicone rubber as the main raw materials.
2 Terms and definitions
2.1 Natural rubber
It refers to the cis-1, 4-polypentadiene obtained from the plant source Brazilian
clover rubber tree.
2.2 Silicone rubber
It refers to the organic silicone elastomer formed through vulcanization of the
polysiloxane-based polymer and hydrophobic silica and other substances
under heating and pressure.
3 Basic requirements
Food contact rubber materials and products shall comply with the provisions of
GB 4806.1.
4 Technical requirements
4.1 Raw material requirements
The use of the natural rubber, synthetic rubber and silicone rubber raw
materials in the food contact rubber materials and products shall comply with
the provisions of Appendix A and the relevant announcements, AND the use of
the vulcanized thermoplastic elastomer resin shall comply with the Appendix A
of GB 4806.6-2016 and the relevant announcements.
4.2 Sensory requirements
Appendix A
Raw material requirements for food contact rubber materials and
products
A.1 The base polymer for synthetic rubber shall comply with the provisions of
Table A.1.
A.2 The base polymer for silicone rubber shall comply with the provisions of
Table A.1.
A.3 The specific migration total limit [SML (T)] and SML (T) group number in
the Appendix B of GB 9685-2016 are applicable to this standard.
Table A.1 -- Base polymer for synthetic rubber and requirements for use
No
. Chinese name
CAS
number
Generi
c class
name
SML/QM
mg/kg
SML
(T)
mg/k
SML
(T)
group
numb
er
Other
requiremen
ts
Polymer of 1, 1, 2, 3, 3,
3-hexafluoro-1-propylene and
vinylidene fluoride
9011-17-0
ND (1, 1, 2, 3, 3,
3-hexafluoro-1-prope
ne. SML, DL = 0.01
mg / kg); 5 (1,
1-difluoroethylene.
SML)
Relative
molecular
mass >
Copolymer of 1, 1, 2, 3, 3,
3-hexafluoro-1-propene and 1,
1-vinylidene fluoride and
tetrafluoroethylene
25190-89
-0
5 (1,
1-difluoroethylene.
SML); 0.05
(tetrafluoroethylene.
SML); ND (1, 1, 2, 3,
3,
3-hexafluoro-1-prope
ne. SML, DL =
0 .01mg/kg)
Relative
molecular
mass >
Polymer of 2-methyl-1,
3-butadiene and
2-methyl-1-propene chloride
68081-82
-3 CIIR
ND (2-methyl-1,
3-butadiene. SML,
DL = 0.01 mg/kg); 1
(2-methyl-1,
3-butadiene. QM)
Polymer of 2-methyl-1,
3-butadiene and
bromo-2-methyl-1-propene
68441-14
-5 BIIR
ND (2-methyl-1,
3-butadiene. SML,
DL = 0.01 mg/kg); 1
(2-methyl-1,
3-butadiene. QM)
5 Polymer of 3α, 4, 7, 7α-tetrahydro-4,
25034-71
-3 EPDM
16 Polyethylene glycol
25322-68
-3
30 (in
ethylene
glycol)
Polyisoprene
(poly-2-methyl-
1, 3-butadiene)
ND (2-methyl-1,
3-butadiene. SML, DL =
0.01 mg/kg); 1
(2-methyl-1,
3-butadiene. QM)
Copolymer of
chlorobenzene
and vinylidene
fluoride
9010-75-
5 (difluoroethylene.
SML); ND
(chlorotrifluoroethylene.
SML, DL = 0.01 mg/kg)
When there is no
corresponding
chlorobenzene
migration quantity
detection method, it
may use the 0.5 mg/6
dm2 (QM) as the limit
value.
Polymer of Tall
oil rosin and
fumarized
diacylated
rosin with
formaldehyde
15 (in
formaldehy
de)
Copolymer of
ethylene,
propylene and
ethylene
norbornene;
Polymer of
5-ethylidenebis
[2.2.1]
hept-2-ene
and ethylene
and propylene
25038-36
-2 EPDM
0.05
(5-ethylidene-2-norborn
ene. SML)
When there is no
5-ethylidene-2-norbor
nene migration
quantity detection
method, it may use
the 0.05 mg/6 dm2
(QM) as the limit
value. The ratio
between the area of
the materials and
products containing
5-ethylidene-2-norbor
nene in contact with
food AND the food
mass shall be not
greater than 2 dm2/kg.
Copolymer of
thylene,
propylene,
ethylene
norbornene
and
dicyclopentadi
ene
27026-53
-5 EPDM
0.05
(5-ethylidene-2-norborn
ene. SML)
When there is no
5-ethylidene-2-norbor
nene migration
quantity detection
method, it may use
the 0.05 mg/6 dm2
(QM) as the limit
value. The ratio
between the area of
the materials and
products containing
5-ethylidene-2-norbor
nene in contact with
food AND the food
(siloxane and
polysiloxane)
7 Methyl silsesquioxane 68554-70-1
(methyltrimethoxysilane,
QM)
Table A.2 (continued)
No. Chinese name CAS number
Generic
class
name
SML/QM
mg/kg
SML (T)
mg/kg
SML (T)
group
number
Other
requirements
8 Meth...