Summary of Compliance on Additives Used for Food Contact Materials and Articles

Additives for food contact materials and articles refer to substances and processing aids, which are defined as: substances used during the production process of food contact materials and articles intended to improve or assist to improve quality and characteristics; processing aids added during the production process of the food contact materials and articles to assist the production process but not intended to improve the quality and characteristics of the final articles.

Do you know about additives used for food contact materials and articles? Do you know which additives are acceptable and how to use them? CIRS Group made a systematic introduction and analysis summary of the positive list, the use restrictions, the test requirements and other compliance points of additives used for food contact materials and articles.

1. Positive list of additives used for food contact materials and articles

1) GB 9685-2016 Standard for the Uses of Additives in Food Contact Materials and Articles

GB 9685-2016 is a revision of GB 9685-2008, it’s a basic standard and well suited to all food contact materials (FCMs). Meanwhile, it’s a positive list of 1,294 additives used for food contact materials and articles, including 731 kinds of plastic, 492 kinds of coating and coating film, 167 kinds of rubber, 189 kinds of inks, 521 kinds of adhesives, 579 kinds of paper and paperboard, and 12 kinds of silicone and other food contact materials and articles. Obviously, some additives have multiple uses.

2) New food contact substances approved by National Health Commission of the People’s Republic of China (NHC, former NHFPC)

After the revision of GB 9685-2016, NHC has issued 13 announcements until August 31, 2019, including the approvals of 90 additives used for food contact materials and articles (38 of them are food contact additives with expanded scope and/or using amount). The specific information of announcements is shown in Table 1.

Table 1: Announcements issued by NHC

S.N.

Date

Notices No. (Link)

1

2016-04-29

2016 NHFPC Notice No.5

2

2016-06-08

2016 NHFPC Notice No.7

3

2016-08-08

2016 NHFPC Notice No.10

4

2016-11-17

2016 NHFPC Notice No.13

5

2017-02-24

2017 NHFPC Notice No.2

6

2017-10-31

2017 NHFPC Notice No.9

7

2017-11-27

2017 NHFPC Notice No.11

8

2018-03-22

2018 NHFPC Notice No.3

9

2018-09-13

2018 NHC Notice No.9

10

2018-09-30

2018 NHC Notice No.11

11

2018-12-12

2018 NHC Notice No.15

12

2019-05-29

2019 NHC Notice No.2

13

2019-07-22

2019 NHC Notice No.4

3) Other additives permitted to use for food contact materials and articles

  • In the absence of a chemical reaction, the mixtures of substances listed in GB 9685-2016 Tables A.1 to A.7 (The use of the mixtures shall comply with all relevant provisions of all additives);
  • Under the condition of not affecting the natural properties of the food, the substances listed in Table A.2 of GB 2760-2014 can be used as food contact additives, and the application shall meet the relevant stipulations in GB 9685-2016;
  • The sodium salt, calcium salt and potassium salt (including the acidic salt and double salt) of the acids, alcohols and phenols listed in GB 9685-2016 Annex A can also be used as food contact additives, and the application shall meet the corresponding stipulation of the sodium salt, calcium salt and potassium salt; for the sodium salt, calcium salt and potassium salt which have already been listed in GB 9685-2016, the application shall meet this standard;
  • The crystalline hydrate of the substances listed in the appendix of GB 9685-2016 can be used as food contact additives, and the application shall meet the restriction stipulation for the corresponding substances;
  • The polymers (molecular weight higher than 1000 Dalton) of the approved additives (except for substances produced by microbial fermentation) can be used as food contact additives, and the application shall meet the corresponding restriction stipulation of polymers.

2. Applications of additives used for food contact materials and articles

The use of additives for food contact materials and articles shall comply with the corresponding use regulations on the premise of satisfying the use principle of GB 9685-2016, including the application scope and maximum dosage, SML/QM, SML(T) and other requirements. For example, 2-Propenoic acid, butyl ester, polymer with ethenyl acetate, its use in plastic food contact materials and articles according to GB 9685-2016 is shown in the following table.

FCA No.

Name

CAS No.

Application scope and maximum dosage (%)

SML/QM

(mg/kg)

SML(T)

(mg/kg)

SML(T) Classification No.

Other requirement

FCA

0198

2-Propenoic acid, butyl ester, polymer with ethenyl acetate

25067-01-0

ABS, AS, PA, PC, PE, PET, PP, PS, PVC, PVDC, UP: Appropriate level

12 (SML, Count as vinyl acetate)

6

22

 

  • “Application scope and maximum dosage” lists the types of plastic resins this substance can be used in and the maximum dosage in the corresponding resin;
  • “SML/QM” sets the specific migration limit for the substance, namely, SML ≤ 12 mg/kg (count as vinyl acetate);
  • “SML(T)” & “SML(T) Classification No.” means that this substance has the total specific migration limit, and the restrictions should be searched with “22” according to the Annex B of GB 9685-2016.

Note: The migration of the additive shall not exceed 60 mg/kg if there are no requirements on SML and SML (T).

In addition, for some special additives, there will be some “Other requirements”, such as the colorant’s purity restrictions, the molecular weight limit. Enterprises shall pay attention to the corresponding requirements when using these additives.

3. Test requirements of additives used for food contact materials and articles

1) The migration and/or residual test shall be done for final products if the additives which have SML/QM or SML(T) limit are added, and the test should be conducted according to the types and use conditions of the final product (such as expected contacted food category, contact temperature and contact time, repeated use or not, etc.).

For more information on migration test, you can click “migration” to get it.

2) In addition, for products with added colorants, there are additional testing requirements: 

* The finish product should do the decolor test according to GB 31604.7-2016 Decolor Test of Food Contact Materials and Articles;

* The colorant should be tested according to GB 9685-2016, the colorant’s purity restrictions which list on the annex of GB 9685-2016 are shown in Table 2.

Table 2: Colorant’s purity restrictions

S.N.

Items

Limits

1

The impurities extracted from the colorant with 0.1 mol/L Hydrochloric Acid shall comply with the requirements

Antimony (Sb) ≤ 0.05%

Arsenic (As) ≤ 0.01%

Barium (Ba) ≤ 0.01%

Cadmium (Cd) ≤ 0.01%

Chromium (Cr) (VI) ≤ 0.1%

Lead (Pb) ≤ 0.01%

Mercury (Hg) ≤ 0.005%

Selenium (Se) ≤ 0.01%

2

Other impurities in the colorant shall comply with the requirements

PCBs ≤ 0.0025%;

Primary aromatic amines (count as aniline) ≤ 0.05%, the content of benzidene, β-naphthlyamine and 4-aminobiphenyl, singly or in total shall not exceed 0.001%.

4. Declaration of Compliance (DoC)

Article 7 of GB 4806.1-2016 General Safety Requirements of Food Contact Materials and Articles emphasizes the traceability of food contact materials and articles. Additives are chemical substances, the manufacturer shall organize production in accordance with GB 31603-2015, and provide the DoC to downstream firm to indicate the authorization conditions and restrictions on the use of the additive, and ensure the quality specifications of this additive satisfy the requirements for FCMs producing. If necessary, the manufacturer shall provide the special instructions on the safety and proper use of the additive, and help the downstream firm to do the risk assessment of final products.

5. Conclusion

Above is the analysis and summary of the positive list, the use principle and the test requirements of additives used for food contact materials and article.

On one hand, the manufacturer of additive shall carry out the necessary tests, and issue an eligible DoC to downstream firm. On the other hand, finish product enterprises should evaluate and select the additive supplier, and ask the supplier for DoC to build the traceability of additives. If necessary, they should conduct the quality verification to strengthen the management of raw & auxiliary materials. Meanwhile, they should make reasonable use of additives in accordance with the use principle, try to reduce and eliminate the production process risk, and do the regulatory compliance test of finished product, strengthen the risk assessment to ensure the safety and compliance of food contact materials and articles.

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