China - Approved New Substances related to Food Contact Materials And Articles
On 20 Feb. 2021, The National Health Commission of the People's Republic of China (NHC) has published Notice No. 2 of 2021 to approve 6 kinds of substances for food contact materials and articles. This notice has already come into force. The usage conditions of the substances are shown as follows:
A．New additive of food contact material and article
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Items
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CAS No.
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Scope
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Maximum amount to be used
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Specific Migration Limit (SML)
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Maximum Residue (QM)
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Note
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Calcium hydroxide
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1305-62-0
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Plastic: Polypropylene (PP)
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0.05%
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-
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-
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-
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Alkanes, C11-15-iso-
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90622-58-5
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Ink (indirect contact with food)
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90%
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12 mg/kg
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-
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1.Quality specification requirements:
a)Boiling range: 63 °C - 260 °C
b)UV absorption value:
·260 nm - 319 nm: ≤ 1.50
· 320 nm - 329 nm: ≤ 0.08
· 330 nm - 350 nm: ≤ 0.05
c)Non-volatile matter: ≤ 0.002 g/100 mL
2.Substrate of printing ink and its specifications:
only allowed for five types of substrates including PET/PE composite materials (PET thickness ≥ 12 μm, PE thickness ≥ 100 μm), PET (thickness ≥ 12 μm), BOPP (thickness ≥ 20 μm), LDPE (thickness ≥ 40 μm), paper (paper weight ≥ 300 gsm, thickness ≥ 395 μm).
3. Conditions of use:
a)When used in PET/PE composite materials, T ≤ 100 °C, t ≤ 1h;
b) When used in PET, BOPP, LDPE and paper, shall be used for room temperature filling (including hot filling and pasteurization at temperature not exceeding 70 °C and not more than 2 hours, or not exceeding 100 °C and not more than 15 min) and long-term storage at room temperature;
c)Ink added with this substance shall not be used in contact with infant food and breast milk
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B. Expansion of the scope of additive used in food contact material and article
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Items
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CAS No.
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Scope
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Maximum amount to be used
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Specific Migration Limit (SML)
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Maximum Residue (QM)
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Note
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C.I. pigment blue 15
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147-14-8
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Plastic: Poly 1,4-cyclohexanedimethanol terephthalate (PCT)
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0.25%
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5 mg/kg (as copper)
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-
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Food contact materials and articles added with this substance shall not be used in contact with food with an ethanol content more than 50%; this substance shall meet the requirements of Appendix A to GB 9685-2016 for the purity of colorants
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Glass fiber
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65997-17-3
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Plastic: Polytetrafluoroethylene (PTFE)
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25%
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-
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-
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-
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Talc
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14807-96-6
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Adhesive
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Use as needed
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-
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-
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-
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C. New resin substance used in food contact material and article
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Items
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CAS No.
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Scope
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Maximum amount to be used
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Specific Migration Limit (SML)
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Maximum Residue (QM)
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Note
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2-Propenoic acid, 2-methyl-, polymer with N-(butoxymethyl)-2-propenamide, ethenylbenzene and ethyl 2-propenoate
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26589-46-8
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Paint and coating
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Use as needed
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· 6 mg/kg (as methacrylic acid);
· 6 mg/kg (as acrylic acid);
· ND [N-(Butoxymethyl)-2-acrylamide, DL=0.01mg/kg]
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-
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Food contact paint and coating manufactured with this substance as raw materials shall not be used in contact with acidic food, fatty food, infant food and breast milk, and the temperature of usage shall not exceed 121°C
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Note:
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ND: Not detected;
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DL: Detection limit;
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GB 9685-2016 National Food Safety Standard: Standard for the Use of Additives in Food Contact Materials and Articles
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