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301 Additives and 107 Resins for Food Packing Materials Approved in China

China approved 301 additives and 107 resin items for food packing materials under the "clear-up" procedures. Besides of the details specified in each list, the general requirements in GB 9685-2008 should be complied with. As for the new additives for food packing materials that have not been officially approved in the GB 9685-2008 or other MOH announcements, the Provisions on the Management of Administrative Approval for New Varieties of Food Related Products shall be met accordingly.

The Chinese Ministry of Health (MOH) released, on April 16, 2012, a notice announcing the approval of 301 additives for food packing materials in response to the "clean-up" procedures under jointed organization of seven departments. This clearance focuses on the food packing materials having potential harm to human health, which aims to sort out more additives permitted for use in food containers and packing materials other than the 959 items of additives specified in China's "Hygienic Standards for Uses of Additives in Food Containers and Packaging Materials" (GB 9685-2008).

The GB 9685-2008 takes reference from relevant EU and US regulations. It specifies principles for use of additives in food containers and packaging materials, the types of approved additives, use scope, maximum level, and specific migration limit (SML) or maximum permitted quantity (QM) as well as other restrictive requirements. This standard is applicable to production, operation and use of all additives used in food containers and packaging materials. Under GB 9685-2008, the migration of additives and their impurities from food containers and packages to food itself shall not pose a risk to human health, not change the food composition, structure, color, flavor or taste when used under the recommended conditions. And the additives listed should be used at the minimum level needed to achieve the desired effect.

The list of 301 additives in this approval is a selective combination of those from the first batch of 196 additives and second batch of 118 additives, both draft approvals open for public consultation, released respectively on February 9 and July 5, 2011. Besides following the details specified in the List of 301 Additives Used for Food Packing Materials, the general requirements in GB 9685-2008 shall also be met. In addition, a list of 116 items of resins in total to be approved for use in food packing materials was released together with the first batch, which became an official list of 107 resin items with 9 items omitted under final consideration on November 2, 2011 (MOH Announcement No.23-2011). During the clear-up procedures, many petitions sought clearance for food packaging substances not listed in GB 9685-2008 but still in use in China, through which so far 107 resin items and 301 additives in total for food packing materials have been published.

The clearance is still in process, more additives are to be released accordingly. On March 22, 2012, another draft approval of 3 new additives to be added and an expansion in use scope of an approved additive was released for consultation until April 20. Soon the final result will come out. Currently the new varieties of food related products, such as new substances and additives used for food packing, containers, production tools or equipment, etc. that have not been officially approved in GB 9685-2008 or other MOH announcements should be tackled according to the Provisions on the Management of Administrative Approval for New Varieties of Food Related Products, which requires the following materials submitted for official approval:

  • Application form;

  • Physicochemical properties;

  • Technical necessity, use, and conditions of use;

  • Manufacturing process;

  • Quality specifications, testing method, and test report;

  • Toxicological safety assessment;

  • Migration and/or residual level, estimated dietary exposure level and the assessment method;

  • Materials or documentation of use approvals at home and abroad;

  • Other materials beneficial to the assessment

In addition to the above materials, petition for new additives used for food packing materials, containers, tools and equipment should submit the materials of information about use scope and amount as well. But if the petition is for an expansion in use scope or amount, the materials of the first, third, sixth, seventh items and the information of use scope and amount are what needed.

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