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GB 31604.64-2025: National food safety standard - Food contact materials and products - Determination of migration of citrate and sebacate compounds
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GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
National Food Safety Standard – Food Contact Materials
and Products – Determination of Migration of Citrate and
Sebacate Compounds
Issued on: SEPTEMBER 2, 2025
Implemented on: MARCH 2, 2026
Issued by. National Health Commission of the People’s Republic of China;
State Administration for Market Regulation.
Table of Contents
1 Scope... 3
2 Principle... 3
3 Reagents and Materials... 3
4 Instruments and Equipment... 6
5 Analytical Procedure... 7
6 Expression of Analytical Results... 9
7 Precision... 11
8 Others... 11
Appendix A Qualitative and Quantitative Ions of the Target Analytes... 12
Appendix B Reference Chromatogram of Triethyl Citrate, Dibutyl Sebacate, Acetyl
Tributyl Citrate, Di(2-Ethylhexyl) Sebacate, Diisooctyl Sebacate, and Bis(2,2,6,6-
Tetramethyl-4-Piperidyl) Sebacate... 13
National Food Safety Standard – Food Contact Materials
and Products – Determination of Migration of Citrate and
Sebacate Compounds
1 Scope
This Standard specifies the methods for determining the migration amounts of triethyl citrate,
dibutyl sebacate, acetyl tributyl citrate, di(2-ethylhexyl) sebacate, diisooctyl sebacate, and
bis(2,2,6,6-tetramethyl-4-piperidyl) sebacate in food contact materials and products.
This Standard applies to the determination of the migration amounts of triethyl citrate, dibutyl
sebacate, acetyl tributyl citrate, di(2-ethylhexyl) sebacate, diisooctyl sebacate, and bis(2,2,6,6-
tetramethyl-4-piperidyl) sebacate in food contact materials and products such as plastics, rubber,
adhesives, coatings and paints, and paper, etc.
2 Principle
Migration tests were conducted on food contact materials and products using food simulants or
chemical substitute solvents. Aqueous, acidic, and ethanol-containing food simulant soaking
solutions were extracted with n-hexane before determination on the instrument. Fat- and oil-
containing food simulant soaking solutions were extracted with acetonitrile; and the extracts
were purified by matrix dispersion extraction and nitrogen blowing before determination on the
instrument. Soaking solutions using chemical substitute solvents (95% ethanol and isooctane)
were directly determined on the instrument. The test solutions were separated by gas
chromatography column, detected by mass spectrometry; and quantified using the external
standard method based on peak area.
3 Reagents and Materials
Unless otherwise specified, all reagents used in this method are of analytical reagent; and the
water is Grade I water as specified in GB/T 6682.During the experiment, any plastic equipment
that may contaminate the analysis shall be avoided. Glassware and equipment should be
thoroughly cleaned before use.
3.1 Reagents
3.1.1 N-hexane (C6H14). Chromatographic grade.
3.1.2 Acetonitrile (C2H3N). Chromatographic grade.
3.1.3 25% (mass fraction) ammonia water.
3.1.4 Magnesium sulfate (MgSO4).
3.1.5 Anhydrous ethanol (C2H6O). Chromatographic grade.
3.1.6 Glacial acetic acid (C2H4O2).
3.1.7 Isooctane (C8H18). Chromatographic grade.
3.1.8 Olive oil. It shall comply with the provisions of fat and oil food simulants in GB 5009.156.
3.2 Materials
3.2.1 Ethylenediamine-N-propylsilylane silica gel filler (PSA). 40 μm~60 μm.
3.2.2 Octadecylsilane chemically bonded silica gel filler (C18). 40 μm~60 μm.
3.3 Preparation of reagents
3.3.1 Acidic, ethanol-containing, and fat- and oil-containing food simulants and chemical
substitute solvents. As specified in GB 31604.1 and GB 5009.156.
3.3.2 10% (mass fraction) ammonia water. Pipette 211 mL of 25% ammonia water and 289 mL
of water; and mix well.
3.4 Reference standard
3.4.1 Triethyl citrate (C12H2O7, CAS No.. 77-93-0). Purity ≥98%, or a reference standard
certified by the state and granted a reference standard certificate.
3.4.2 Dibutyl sebacate (C18H34O4, CAS No.. 109-43-3). Purity ≥98%, or a reference standard
certified by the state and granted a reference standard certificate.
3.4.3 Acetyl tributyl citrate (C20H34O8, CAS No.. 77-90-7). Purity ≥98%, or a reference standard
certified by the state and granted a reference standard certificate.
3.4.4 Di(2-ethylhexyl) sebacate (C26H50O4, CAS No.. 122-62-3). Purity ≥ 98%, or a reference
standard certified by the state and granted a reference standard certificate.
3.4.5 Diisooctyl sebacate (C26H50O4, CAS No.. 27214-90-0). Purity ≥ 98%, or a reference
standard certified by the state and granted a reference standard certificate.
3.4.6 Bis(2,2,6,6-tetramethyl-4-piperidyl) sebacate (C28H52N2O4, CAS No.. 52829-07-9).
Purity ≥ 98%, or a reference standard certified by the state and granted a reference standard
certificate.
3.5 Preparation of standard solutions
3.5.1 Preparation of dingle standard stock solutions (1000 mg/L)
Respectively and accurately take 10 mg (accurate to 0.1 mg) of each of the following reference
standards. triethyl citrate, dibutyl sebacate, acetyl tributyl citrate, di(2-ethylhexyl) sebacate,
diisooctyl sebacate, and bis(2,2,6,6-tetramethyl-4-piperidyl) sebacate. Dissolve each reference
standard in n-hexane and then transfer to a 10 mL brown volumetric flask. Make constant
volume to the mark with n-hexane and mix well. Transfer the solution to a brown glass bottle
and store in a refrigerator at 0°C~4°C, protected from light. Shelf life is 6 months.
3.5.2 Preparation of mixed standard intermediate solution A (100 mg/L)
Respectively and accurately pipette 1.00 mL of each of the above 6 single standard stock
solutions into the same 10 mL brown volumetric flask. Accurately make constant volume to the
mark with anhydrous ethanol and mix well. Transfer the solution to a brown glass bottle and
store in a refrigerator at 0℃~4℃, protected from light. Shelf life is 3 months.
3.5.3 Preparation of mixed standard intermediate solution B (100 mg/L)
Respectively and accurately pipette 1.00 mL of each of the above 6 single standard stock
solutions into the same 10 mL brown volumetric flask. Accurately make constant volume to the
mark with n-hexane and mix well. Transfer the solution to a brown glass bottle and store in a
refrigerator at 0℃~4℃, protected from light. Shelf life is 3 months.
3.5.4 Standard working solution for acidic food simulants
Respectively pipette 5.00 mL of 4% acetic acid into six graduated glass tubes. Accurately
transfer 0 mL, 0.020 mL, 0.10 mL, 0.20 mL, 0.40 mL, and 0.50 mL of mixed standard
intermediate solution A. Add 4% acetic acid and make constant volume to 10 mL; mix well.
Accurately transfer 2.4 mL of 10% (mass fraction) ammonia water to each tube. Respectively
add 5.00 mL of n-hexane to each tube. Vortex for extraction for 5 min. Centrifuge at 4000 r/min
for 5 min. Transfer the supernatant n-hexane solution to a clean volumetric flask. Respectively
add 5.00 mL of n-hexane to each flask and repeat the above steps. Combine the two solutions
and make constant volume to 10 mL with n-hexane; and then obtain the mixed standard working
solutions with mass concentrations of 0 mg/L, 0.20 mg/L, 1.0 mg/L, 2.0 mg/L, 4.0 mg/L, and
5.0 mg/L. Prepare immediately before use.
3.5.5 Standard working solution for water- and ethanol-containing food simulants
Respectively pipette 5.00 mL of food simulants into each of 6 graduated glass tubes. Accurately
pipette 0 mL, 0.020 mL, 0.10 mL, 0.20 mL, 0.40 mL, and 0.50 mL of mixed standard
intermediate solution A. Add the corresponding amount of food simulant and make constant
volume to 10 mL; and then mix well. Accurately pipette 0.25 mL of 10% (mass fraction)
ammonia water; add 5.00 mL of n-hexane; vortex for extraction for 5 min; and centrifuge at
4000 r/min for 5 min. Transfer the supernatant n-hexane solution to a clean volumetric flask;
then respectively add 5.00 mL of n-hexane to each flask and repeat the above steps. Combine
the two solutions and make constant volume to 10 mL with hexane; and obtain the mixed
standard working solutions with mass concentrations of 0 mg/L, 0.20 mg/L, 1.0 mg/L, 2.0 mg/L,
4.0 mg/L, and 5.0 mg/L. Prepare immediately before use.
3.5.6 Standard working solution for fat- and oil-containing food simulants
Respectively take 3.0 g (accurate to 0.1 g) of olive oil into 6 glass test tubes. Accurately pipette
0 mL, 0.015 mL, 0.030 mL, 0.060 mL, 0.12 mL, and 0.15 mL of the mixed intermediate
standard solution B; mix well; and then add 0.25 mL of 10% (mass fraction) ammonia water
and 3.00 mL of acetonitrile; vortex for extraction for 5 min; allow to stand for separation; and
transfer the supernatant acetonitrile solution to a clean volumetric flask. Add 3.00 mL of
acetonitrile and repeat the extraction once more. Combine the two extracts into a 15 mL
centrifuge tube containing 900 mg of magnesium sulfate, 150 mg of PSA, and 150 mg of C18;
and centrifuge at 4000 r/min for 5 min. Take 4.00 mL of the supernatant acetonitrile solution;
blow it to near dryness with nitrogen; and then make constant volume to 1.00 mL with
acetonitrile to obtain mixed standard working solutions with mass concentrations of 0 mg/kg,
0.50 mg/kg, 1.0 mg/kg, 2.0 mg/kg, 4.0 mg/kg, and 5.0 mg/kg. Prepare immediately before use.
3.5.7 Standard working solutions for chemical alternative solvents (95% ethanol and
isooctane)
Respectively and accurately pipette 0 mL, 0.020 mL, 0.10 mL, 0.20 mL, 0.40 mL, and 0.50 mL
of mixed standard intermediate solution B into six 10 mL volumetric flasks. Make constant
volume to the mark with 95% ethanol or isooctane and mix well to obtain mixed standard
working solutions with mass concentrations of 0 mg/L, 0.20 mg/L, 1.0 mg/L, 2.0 mg/L, 4.0
mg/L, and 5.0 mg/L. Prepare immediately before use.
4 Instruments and Equipment
4.1 Gas chromatograph-mass spectrometer (GC-MS). Equipped with an electron impact ion
source.
4.2 Electronic Balance. With sensitivity of 0.0001 g and 0.1 g, respectively.
4.3 Vortex Shaker.
4.4 Pipettes. Capacities of 200 μL, 1.00 mL, and 10.00 mL.
4.5 Centrifuge. With maximum speed ≥ 4000 r/min.
4.6 Nitrogen evaporator.
5 Analytical Procedure
5.1 Preparation of test solution
5.1.1 Migration test
Food contact materials and products shall be subjected to migration tests in accordance with
the provisions of GB 31604.1 and GB 5009.156.If the soaking solution obtained from the
migration test cannot be tested immediately, it shall be stored in a refrigerator at 0℃ ~ 4℃
protected from light; and the shelf life shall not exceed 72 h. If further test is to be performed,
the soaking solution shall be brought to room temperature before use.
5.1.2 Treatment of immersion solution of acidic food simulants
Accurately pipette 10.00 mL of the immersion solution into a glass test tube; mix well; and then
accurately pipette 2.4 mL of 10% (mass fraction) ammonia water. Add 5.00 mL of n-hexane;
vortex for extraction for 5 min; centrifuge at 4000 r/min for 5 min; and transfer the supernatant
n-hexane solution to a clean volumetric flask. Add another 5.00 mL of n-hexane and repeat the
above steps. Combine the two solutions and make constant volume to 10 mL with n-hexane.
Take the clear liquid for instrumental analysis.
5.1.3 Treatment of water and immersion solution of ethanol-containing food simulants
Accurately pipette 10.00 mL of the immersion solution into a glass test tube; mix well; then
accurately pipette 0.25 mL of 10% (mass fraction) ammonia water. Add 5.00 mL of n-hexane;
vortex for extraction for 5 min; centrifuge at 4000 r/min for 5 min; transfer the supernatant n-
hexane solution to a clean volumetric flask. Add another 5.00 mL of n-hexane and repeat the
above steps. Combine the two solutions and make constant volume to 10 mL with n-hexane.
Take the clear liquid for instrumental analysis.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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