In this edition of the Weekly Compliance Digest, we cover changes to food packaging regulations in China.
GB 4806.1-2016 & GB 9685-2016
What is it?
On November 18, 2016, China’s National Health and Family Planning Commission (NHFPC) finalized two standards on food packaging.
GB 4806.1-2016 on General Safety Requirements for Food-Contact Materials and Articles specifies that the migration of unlisted substances from layers behind a “functional barrier” into foods must not exceed 0.01mg/kg (10 parts per billion). Known carcinogens, mutagens, reproductive toxins and nanomaterials are not allowed regardless of migration level. A “functional barrier” is a barrier in food-contact materials, made of one layer or multi-layer materials, that prevents non-permitted substances from migrating to food.
GB 4806.1-2016 also defines impurities in food contact materials as substances that are not intentionally added (NIAS), including those derived from raw and auxiliary materials, decomposition products, pollutants, and residual reaction intermediates resulting from production and use.
GB 9685-2016 updates the Chinese standard for Uses of Additives in Food Containers and Packaging Materials. The GB 9685 definition of food contact materials and articles includes inks, adhesives, lubricating oils, and any other substance that may directly or indirectly contact food. Appendix A of the standard includes 1,294 authorized substances. Appendix B of the standard includes restrictions on total specific migration. The maximum permitted sum of two or more substances released into food or food simulants is expressed in terms of a designated substance, or category of substances. The limits are derived from the EU Regulation 10/2011 on plastic materials and articles for food contact.
Who is affected?
Companies potentially affected by the standards include:
- Chinese manufacturers or importers of:
- Food & beverage products
- Food packaging materials
- Foreign manufacturers or distributors of:
- Food & beverage products exported into China
- Food packaging materials exported into China
What are the provisions?
GB 4806.1-2016 requires that producers of food packaging materials perform safety assessments to ensure their safety, and control unlisted substances behind the functional barrier. Explicit approvals are not required for NIAS provided that the manufacturer performs an assessment and confirms safety. In addition, consistent with the EU Plastics Regulation, GB 4806.1-2016 allows the use of unlisted substances used behind a barrier provided that the substance migrates at less than 0.01 mg/kg, and is not a carcinogen, mutagen, reproductive toxin (CMR) or nano substance. This helps to bring China’s food-contact regulations in line with requirements in other jurisdictions.
GB 9685-2016 allows the use of 1,294 authorized substances in food contact materials (e.g. sodium, potassium, calcium salts, acids, alcohols and phenols) as long as they comply with applicable specific migration limits.
It’s important to note that many substances currently allowed in the U.S. and Europe are not yet cleared under the Chinese system, according to the law firm Keller and Heckman, which is involved with food contact materials. The warning is mentioned by Chemical Watch.
Chemical Watch also mentions that a pre-market approval from Chinese authorities must be obtained before introducing a new type of food packaging or food contact material. Submissions must include details on the composition of the material, manufacturing process details, safety data, etc. The documents are then evaluated by a panel of experts that often requests more data and information. Even though it’s not explicitly mentioned in the regulations, reviewers will generally require that the substance has already been cleared in two other major jurisdictions for food contact use, Chemical Watch reports.
What is next?
Standards GB 4806.1-2016 and GB 9685-2016 will take effect on October 19, 2017.
Here are links to articles with more details on the standards:
- All Wrapped Up: China Finalizes Long-Awaited Standards for Food Packaging
- China Develops Food Packaging Standards
- China Food Law: Year in Review 2016 – Out with the Monkey, In with the Rooster: A look back and a look ahead on China’s Food Safety System
- China’s food packaging rules present unique challenges
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