This standard supersedes "Hygienic Standard for Rubber Nipple"(GB 4806.2-1994).
Compared with GB 4806.2-1994, the main changes in this standard are as follows:
- Standard name is revised as "National Food Safety Standard - Rubber Nipple of Feeding Bottle";
- Standard structure is modified;
- Standard scope is modified;
- General requirements are added;
- Raw material requirements in technical requirements are added;
- Physical and chemical indexes are modified and added;
- Requirements for natural emulsion identification are added.
National Food Safety Standard Nipple
食品安全國家標準 奶嘴
1 Scope
This standard is applicable to the nipples made of natural rubber, cis-1,4-polyisoprene rubber and silicone rubber.
This standard is not applicable to pacifier.
2 Basic Requirements
The nipple shall meet all general safety requirements for the food contact materials and their products in the relevant national food safety standards.
3 Technical Requirements
3.1 Raw material requirements
Natural rubber, cis-1,4-polyisoprene rubber and silicone rubber shall meet the requirements of the relevant national food safety standards or laws and regulations except the natural rubber, cis-1,4-polyisoprene rubber and silicone rubber, other rubber shall not be used to manufacture nipple.
3.2 Sensory requirements
Sensory requirements shall be in accordance with those specified in Table 1.
Table 1 Sensory Requirements
Item Requirements
Appearance Normal color and luster, and free from dirt or burrs etc.
Soak solution The soak solution obtained from migration test shall be free from sensory deterioration such as coloration, turbidity, sediment and abnormal odor.
3.3 Physical and chemical indexes
Physical and chemical indexes shall be in accordance with those specified in Table 2.
Table 2 Physical and Chemical Indexes
Item Index Inspection method
Overall migration/(mg/kg)
Distilled water,40℃, 24h ≤
4% (volume fraction) acetic acid,40℃, 24h ≤
50% (volume fraction) ethanol,40℃, 24h ≤
30
60
60 GB 31604.8
Potassium permanganate consumption/(mg/kg)
Distilled water, 40℃, 24h ≤
10 GB 31604.2
Heavy metal (calculated in plumbum)/(mg/kg)
4% (volume fraction) acetic acid, 40℃, 24h ≤
1 GB 31604.9
Zinc (Zn) migration/(mg/kg)
4% (volume fraction) acetic acid, 40℃, 24h ≤
5 Standard for the migration detection method of food contact materials and their products
2,6-di-tert-butyl-para cresol migration a/(mg/kg) ≤ 0.3 GB 28482-2012b
2,2'-methylenebis(4-methyl-6-tert-butylphenol) migration a/(mg/kg) ≤ 0.15
N-nitrosamine and its generable object release amount c/(mg/kg)
Artificial saliva, 40℃, 24h
N-nitrosamine ≤
Generable object of N-nitrosamine ≤
0.01
0.1
The specimen treatment and result calculation are according to GB 28482-2012d while the analysis method for instrument is based on GB/T 24153-2009
Volatile substance e/%(mass fraction) ≤ 0.5 GB 28482-2012
a This item is only applicable to natural rubber and cis-1,4-polyisoprene rubber nipples.
b The simulants and migration test conditions are the same as those of total migration amount.
c The item is calculated in the release mass of N-nitrosamine and its generable object (the substance which may generate N-nitrosamine through nitrosylation reaction under specified conditions) in nipple with unit mass.
d To meet the detection limit requirements, the sampling quantity and concentration range of standard working solution may be adjusted as required.
e This item is only applicable to nipple made of silicone rubber.
3.4 Additive
Application of the additive shall meet the requirements of GB 9685 and other relevant requirements.
