Potential Changes of GB Standards for Food Contact Materials

In November 2020, the "2020 Food Contact Material Safety Forum" was held in Beijing, which discussed the legislation program and potential regulatory changes for food contact materials. In this article, ChemLinked will introduce the schedule plan and the potential regulatory changes to the GB standards of food contact plastic and rubber. This article is written based on the forum, when the official GB standards/drafts are published, the official documents shall prevail.

1. The Schedule Plan

The schedule plan of formulating and amending FCM standards so far is listed below.

New standards in progress

Amendments in progress

Bamboo and wood product (exposure draft published)
Bonding agent (a draft has been released, but the authorities are further studying on the positive list, a new exposure draft may be published in 2021 for public comments.)
Printing ink (exposure draft published)
Cellulose material (exposure draft unpublished)
Starch-based plastic (will be incorporated into the amendment of GB 4806.7 for plastic materials and articles in contact with foodstuffs)

Composite materials and articles (exposure draft published)
Metal (exposure draft published)
Paper and paperboard (exposure draft published)
Plastic (exposure draft unpublished)
Paints and coating (exposure draft unpublished)
Rubber (exposure draft unpublished)
Silicone rubber (exposure draft unpublished)
General principles of migration test (the exposure draft is expected to be published in the first quarter of 2021)

2. Proposed Revision to Plastic Standard

According to Dr. Chen Rongfang, the revision to GB standards for food contact plastic materials involves application scope, technical requirements, labeling requirements, and etc. This project was initiated in 2018 and the draft is expected to be released in the first quarter of 2021.

2.1 Application scope and definitions

"Starch-based plastic" will be included into the application scope of GB 4806.7 Plastic Materials and Articles in Contact with Foodstuffs and the definition of starch-based plastic will be added accordingly. The definition of resin will be expanded form "chemically modified natural macromolecular substance" to "chemically modified natural or synthetic macromolecular substance".

2.2 Technical requirements

Material requirements

Edible starch and modified starch used in food contact plastic materials and articles should follow different standards. Edible starch should comply with GB 31637, modified starch should comply with GB 2760.

Physical and chemical indicators

1. Overall migration

The content of trichloromethane extract in starch-based plastic should be determined according to article 5.5.2 in GB 31604.8-2016, and the overall migration result should be determined on the basis of the trichloromethane extract content.

2. Potassium permanganate consumption

Since starch reacts with potassium permanganate and increases the consumption amount, when starch water solution is used to titrate potassium permanganate, the consumption of potassium permanganate will be higher. Thus the new standard specifies that the potassium permanganate consumption limit is "only applicable for products without modified natural biomacromolecule".

3. Maximum limit of primary aromatic amine (PAA) is added

Item

Indicator

Test method

Primary aromatic amine^d /(mg/kg)

4% (volume fraction) acetic acid ≤

ND (DL=0.01)

GB 31604.x

^d Only applicable for food contact plastic materials and articles added with aromatic isocyanate and azo colorants. The maximum detection limits for a single PAA and the sum of PAAs are both 0.01mg/kg, excluding those specified in Table A.1 of Appendix A and in relevant announcements.

2.3 Labeling requirements

Material of all resins of polymers and blends should be indicated in labels or instructions, detailed material categories (such as PA6, PA6/12, etc) should also be indicated when necessary.

2.4 New Appendixes

Apart from A.1 allowed plastic resins and A.2 specific migration limits, five new appendixes will be added, including appendixes of restrictions on food categories, restrictions on conditions of usage, and substances that should not be detected for SML, SML (T), QM., etc.

2.5 New resin varieties

Two new varieties of will be added in Appendix 1 permitted plastic resins. Nineteen varieties approved by former NHFPC and NHC announcements form 2013 to 2018 will also be incorporated. Besides, another 49 varieties are still under discussion.

Table 1. Two new varieties of resin

Name	CAS No.	Generic name	SML/QM (mg/kg)	Other requirements
Poly (1,6-hexanediol/neopentyl glycol-alt-adipic acid)	25214-14-6	Saturated polyester	0.05 mg/kg (2,2-dimethyle-1, 3-propanediol: SML); 0.05 mg/kg (1,6-hexane: SML)	When used in sheet structure, it can not be used in contact with food containing over 8% of ethanol.
Ethylene and bicyclo[2,2,1]hept-2-ene (5-ethylidene-2-norbornen) copolymer	26007-43-2	E/NB	0.05(bicyclo[2,2,1]hept-2-ene: SML )	/

3. Proposed Revision to the Rubber Standard

As revealed by Shang Guiqin, the director of National Food Contact Material Testing Laboratory, the amendment of GB 4806.11 Rubber Materials and Articles in Contact with Foodstuffs will involve the application scope, terms and definitions, material requirements, physical and chemical indicators, and requirements for the testing method.

3.1 Application scope and definitions

Currently, GB 4806.11 is applicable for natural rubber, synthetic rubber and silicone rubber. In the future, the authorities tend to regulate rubber and silicone rubber separately. Thus, the application scope of GB 4806.11 will be revised as "applicable for rubber materials and articles in contact with foodstuffs".

The definition of "rubber materials and articles in contact with foodstuffs" will be revised accordingly as: food contact materials and articles made of rubber or thermoplastic elastomer (TPE) that have contacted or are expected to contact food or food additives, or that may transfer ingredients into foodstuffs under normal cases.

3.2 Technical requirements

Current general physical and chemical indicators include overall migration, the consumption of potassium permanganate, heavy metal (calculated as Pb). The new standard is likely to add primary aromatic amine, N-nitrosamine, substances that may be generated by N-nitrosamine, volatile substance, and polycyclic aromatic hydrocarbon (PAH). Whether these new indicators will be included in the amendment is under further research.

The consumption of potassium permanganate for reusable rubber products should follow the regulations on migration test for resuable food contact materials and articles as specified in GB 31604.1, the third test result shall prevail.

Table 2. Potential physical and chemical indicators in the draft amendment

Items	Limits
Overall migration/ (mg/dm2)^a ≤	10
Consumption of potassium permanganate / (mg/kg)^b ≤ Water（60℃, 0.5h）	10
Heavy metal (calculated as Pb)/ (mg/kg) ≤ 4% acetic acid (v/v) (60℃, 0.5h)	1
Primary aromatic amine/(mg/kg) ≤	0.01
N-nitrosamine/(mg/kg) ≤	0.01
Substances that may be generated by N-nitrosamine/ (mg/kg) ≤	0.1
Volatile substance/ (%) ≤	0.5
Polycyclic aromatic hydrocarbon (PAH) (mg/kg) ≤	0.01
^a Rubber materials and articles used in contact with foods for infant and young children should transfer the result to mg/kg according to the actual area/volume ratio, and the maximum limit is ≤60mg/kg. ^b Reusable products follow the regulation of migration test for reusable food contact materials and articles as specified in GB 31604.1.

3.3 Migration test

According to current regulation, 50% ethanol solution (volume fraction) should be used as the food stimulant for oil and fat products. While plant oil is proposed to be the first choice of food stimulant for oil and fat products in the new standard. If using plant oil in the migration test is not technologically available for the material or product, or unusual changes of physical properties (deformation, melting, swelling) occur, 50% ethanol solution can be used instead.