In the News

China Proposes New Approval Process for Food Contact Materials

Jun 4, 2009

The Ministry of Health (MOH) of the People's Republic of China proposed "Interim Measures on Administrative Permission of New Species of Food Related Products." These regulations will apply to petitions for new food contact materials not on the positive list in the Hygienic Standard for Uses of Additives in Food Containers and Packaging Materials (GB 9685-2008). The proposed measures were first published on MOH's website on May 8 and comments were due by May 17. The timeframe allowed for comments was just over one week to allow MOH to finalize the regulations prior to June 1, 2009 when the positive list was scheduled to become final. (As of June 4, the final regulations have not been issued.) While the interim measures do not mention a possible "provisional list," it is believed that one will be allowed (see the PackagingLaw.com article, Transition Period May Be Allowed For Chinese Additive List, for more information).

It is also expected that MOH will survey all Chinese producers of resins and food contact materials to determine the list of resins and food contact materials currently in use, in the Chinese market that are not on the positive list. After the survey is complete, MOH authorities are considering another round of "grandfathering," (i.e., permanent approval of certain qualifying substances without requiring them to go through the formal approval process).

The proposed measures stipulate that any food contact material, and any equipment or disinfectants for food use not on the positive list in GB 9685-2008 must be approved by MOH prior to use. The measures also outline the procedure for submitting a petition to obtain approval. Proposed data and documents requirements for new food contact materials include: chemical property data; applications and conditions of use; manufacturing process; toxicological data; and a statement, along with supporting documents on the material's clearance status in other countries. An estimate of dietary exposure would also be required for food contact substances.

The proposal requires that "GLP compliant labs" or "labs accredited by MOH" conduct the toxicological or migration testing. The proposal does not make clear what is meant by GLP. For example, potential problems could arise if the Chinese authorities require migration data for food contact substances to have been generated under Good Laboratory Practices (GLP) approved by the U.S. Food and Drug Administration (FDA). It is hoped that the final standard will clarify what is meant by GLP, and that something less than the formal FDA GLP requirements will be accepted.

The toxicological safety assessment requirements for new food packaging materials and containers, food production and operation tools, and equipments and processing additives would be based on the level of migration of the new materials to foods. Specifically,

• For migration levels less than 0.01 mg/kg, structural-activity analysis data and other safety data or literature should be provided;
• For migration level between 0.01 and 0.05 mg/kg (including 0.05 mg/kg), data from three mutagenicity studies (i.e., Ames test, in vitro mammalian chromosome aberration test, or bone marrow cell micronucleus test) should be provided;
• For migration level between 0.05 and 5 mg/kg (including 5 mg/kg), three mutagenicity studies and 90 days rat sub-chronic toxicity study should be provided; and
• For migration level between 5 and 60 mg/kg, data from acute oral toxicity study, three mutagenicity studies, 90 days rat oral sub-chronic toxicity study, reproductive toxicity study (two-generation reproduction toxicity study and teratogenicity study), chronic toxicity and carcinogenicity study should be provided.

If the petition is for a polymer, with an average molecular weight greater than 1000 Daltons, the toxicology data of the monomers should also be provided.

Applications must be in Chinese. Once an application is officially accepted, it will by reviewed by MOH within 60 days. However, it is expected that it will be at least six month before MOH is prepared to accept applications for formal approval of new substances. If any new data are required, the applicant will have one year to provide it.