Understanding China Food Contact Regulation
There is no unique regulation specifically on Food Contact Materials and Articles (FCMA) in China. The mother law 'Food Safety Law' gives principled requirements.
During the development of China FCMA management, FCMA management system is formed as below,
Food Contact Materials and Articles (FCMA) are any materials and articles that under normal conditions of use will or may be expected to contact with food, or their component(s) may be transferred into the food, including packaging materials and containers for packaging and containing food and food additives, tableware, kitchen ware, painting/coating/ink/adhesive etc. that may directly or indirectly contact with food (direct food contact, indirect food contact), as well as machinery, piping, conveyor belts, containers, utensils, tableware , that will directly contact with food during production, processing, packaging, transportation, storage and use of food. In shorten, FCMA include food packaging material, food container, tools and equipment. Detergents, disinfectants and public water facilities are excluded (as these are managed separately).
Food Contact Additives or food container additives (Additives used for FCMA) refer to substances that are added during the production of FCMA, which are helpful to improve quality, characteristics of FCMA, or which assist to improve quality, characteristics of FCMA so to meet their intended uses. Food Contact Additives also include processing aids that are added during the production of FCMA to ensure the production process goes smoothly while not for improving quality, characteristics of FCMA.
From the description it is clear that un-intentionally added substances do not belong to Food Contact Additives.
Allowed FCMA (including their raw materials) are these as covered by related China hygienic standards. Allowed food contact additives are these as specified by standard GB 9685 'Hygienic standards for uses of additives in food containers and packaging materials'.
New FCMA (including their raw materials), new food contact additives, as well as application scope and usage expansion of allowed FCMA (including their raw materials) and of allowed food contact additives shall be approved by NHFPA (China National Health and Family Planning Commission) in prior to the use in China. Exemptions are allowed based on TTC principle and for un-intentionally added substances.
Basic Requirement and Compliance Principle
1. Migration quantity of substance from FCMA to food shall not harm human health.
2. FCMA shall not cause change to food ingredient, food composition, food color/smell/taste, etc., and shall normally not produce technical effect to food.
3. Toxicological Threshold of Concern (TTC) principle: for new substances which do not contact directly with food and are separated from food by effective barrier layer, FCMA producer shall make safety assessment and control to them so to limit their migration quantity to food no more than 0.01mg/kg. CMR and nano materials are not applicable to TTC principle.
4. quantity of substance used in FCMA shall be minimized on the premise of being able to achieving their expected effects.
5. substances used in FCMA shall meet related quality specifications and safety standards.
6. FCMA shall meet related safety standards.
7. Un-intentionally added substances (impurities in FCMA, reaction products during the production process, decomposition products during production/usage/business of FMCA) shall be assessed and controlled, their migration to food shall meet the requirement 1 ~ 3 above.
Specifically, FCMA should provide information including main material, compliance statement on applied regulation/standards, restricted substance and their limit, assessment information on un-intentionally added substances.
FCMA shall also be stated as 'For Food Contact Use', 'For Food Packaging Use' or similar wordings, or be marked with following symbol (Spoon and chopsticks),
To apply for approval of new FCMA (including their raw materials), new food contact additives, as well as application scope and usage expansion of allowed FCMA (including their raw materials) and of allowed food contact additives, following materials shall be prepared and submitted. The evaluation and approval are responsibility of China,
1. Physi-chemical properties.
incl.: melting point, boiling point, decomposition point, solubility, impurity analysis, analysis on possible inter-reaction with food's ingredients.
2. Technical necessity, usage and usage condition.
Including expected usage, usage scope, the minimal and maximum dose for the intended effect, the type of food to contact (water-based foods, fat foods, acidic foods, foods containing ethanol, etc.), the temperature and duration for contact with food, whether the FCMA will be re-used, Specific Migration Limit (SML) if applicable, etc..
3. Production process.
4. Quality specification, test method and test report.
5. Toxicity assessment data：
If specific migration (SM) is <0.01mg/kg food: QSAR analysis and other available literature information.
If SM is 0.01~0.05 mg/kg food, then AMES, Ames test report, Mammalian Erythrocyte Micronucleus Test, In vitro Mammalian Chromosome Aberration Test or In vitro Mammalian Cell Gene Mutation Test.
If SM is 0.05~5.0t mg/kg food, then 90-day oral toxicity test is also needed.
If SM is 5.0~60 mg/kg food, then Acute Oral Toxicity Test, Two-generation Reproduction Toxicity Test, Teratogenicity, Chronic Oral Toxicity Test and Carcinogenicity Test are also needed.
For polymers (Mw>1,000 Da), toxicity information of all monomers shall be provided.
6. Migration quantity and/or residual quantity, estimated dietary intake and the assessment method.
7. Material or proof for allowing its usage in and outside China.
8. Other materials that are helpful for the approval evaluation.
China National Health and Family Planning Commission (N-HFPC) is responsible for the evaluation and approval which will take normally more than 3 months. Applicant can be present to the evaluation to give a presentation on for the application. After approval, any company can utilize the approval result.
CBI can be applied for the applied substance.
Remark: this article is written in June 2016. Some standards (for example GB 9685-2015 draft is referred. While currently GB 9685-2008 is valid) supporting information of this article are not officially published but will be soon.
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