China Publishes Data Requirements for Food Packaging Petitions
The Chinese Ministry of Health (MOH) issued its Management Rules for the Administrative Approval of New Varieties of Food Related Products (the Rules) on June 1, 2011. The Rules set out procedures and requirements for the submission of petitions to clear the use of resins and additives in food packaging materials. The MOH has also released an accompanying guidance (Guidance), which details data requirements not specified in the Rules. The requirements set forth in both the Rules and the Guidance are relevant to submissions for "food related products," a term that also encompasses ingredients and additives for food, disinfectants, and detergents.
Article 3 of the Rules sets out the requirements for petitions for food-related products. Specifically, petitions should have a clear scope of use; demonstrate technical necessity; should not negatively impact human health under ordinary/reasonable uses or alter the ingredients, structure, color, or flavor of the food; and be used at the lowest possible level to achieve the desired technical effect. The data requirements are similar to those contained in the "clean-up" procedures (also known as the "grandfather petitions") that were due by June, 2010. In particular, the Rules require petitions to include the following materials and information:
- 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, and the method of determination;
- Approvals in other countries along with relevant documentation; and
- Other materials that may benefit the evaluation.
The quantity of toxicology of data required (Item 6) for a given substance is based upon its projected level of migration. In summary:
- If the migration value is less than 0.01 mg/kg, then only structural analysis and other safety data or literature is required.
- If the migration value is between 0.01 and 0.05 mg/kg, then three mutagenicity studies are required (i.e., Ames test, in vitro mammalian chromosome aberration test, and bone marrow cell micronucleus test).
- If the migration value is between 0.05 and 5.0 mg/kg, then three mutagenicity studies are required, as well as a sub-chronic oral feeding study in a rodent species.
- If the migration value is between 5.0 and 60 mg/kg, then three mutagenicity studies a sub-chronic oral feeding study in a rodent species, a teratogenicity study, a two-generation reproductive and developmental toxicity study, and a chronic toxicity and carcinogenicity bioassay are required.
All relevant changes to the data requirements for submissions are summarized below. The requirement that petitions demonstrate technical necessity (Item 3) is a new addition. Moreover, as noted, the Guidance specifies that submission materials must include an indication of the minimum level necessary to achieve the intended function. If the requested use level is deemed unnecessary, the petition may be rejected, or the use level in the final approval reduced.
The Guidance requires that the description of the manufacturing process (Item 4) include details on the raw materials and adjuvants used, a production process flow chart, as well as a description of the process and the technical parameters applicable to each step. The technical parameters may be problematic for applicants that do not produce the petitioned substance because manufacturers often treat such information as confidential business information and are not willing to disclose these details to downstream customers.
Additionally, the Rules require that quality specifications (Item 5) be accompanied by a test method and test report, and that the means of determination be made clear. Though, as expected, toxicological testing must be conducted in accordance with good laboratory practice (GLP), the Guidance clarifies that there is no requirement that testing be conducted in China. However, if the testing is indeed conducted in China, then the lab must be government-accredited. Petitions must provide information on relevant test methods to each product specification, as well as the test reports themselves.
In the case of new disinfectants and detergents for food use, details on migration and dietary exposure are not required. Further, expanded use petitions for currently approved packaging additives need only provide the materials referenced in items 1, 3, 6, and 7, as well as the requested use level and scope of use. However, documentation of approvals in other jurisdictions will be necessary.
New types of food related products that are imported to China for the first time must include: a Certificate of Free Sale, a Certificate of Good Standing, an authorization letter for applicants authorizing an agent to file the petition(s), and Chinese translations of the above referenced documents notarized by a Chinese Notary Public. Certificates of Free Sale may be difficult to obtain from government authorities in western countries. It remains unclear whether these documents will be required of food packaging materials, but this should shortly become apparent now that the first petitions have been received.
The Rules indicate that applicants should mark the contents of their petition(s) that they do not consider confidential. The Rules also designate the MOH National Center for Health Inspection and Supervision (the Center) as the responsible authority for petition review. The Guidance also includes the official application form for these petitions, which must be filled-in and submitted online at the website of the National Center for Health Inspection and Supervision (NCHIS). However, we note that hard copies and a compact disc (CD) must be submitted in person to the Center's reception desk in Beijing. Official company stamps (or "chops") must be included on each page of the submission and the CD face.
The Center intends to make an initial determination as to whether a petition is accepted within five business days of receipt. It then intends to organize an evaluation panel to review petitions within 60. If the evaluation panel needs additional information, a list of the additional information will be sent to the petitioner. Any subsequent verification tests are to be conducted by a government certified laboratory. For those materials that are not approved, the applicant will be provided with the initial conclusions of the review panel following its technical review, and must provide all supplementary data requested within one year for the petition to remain on the active docket. After a decision, the Certificate of Free Sale, Certificate of Good Standing, and authorization letters may be returned to the applicant upon request; however, the remaining materials will be retained by MOH for recordkeeping purposes.