China's National Health and Family Planning Commission (NHFPC), which was established in March of this year by merging the Ministry of Health (MOH) with another government authority, recently issued final approvals for food packaging materials petitioned under the country's "clean‑up" procedures.
The "clean-up" procedures allowed manufacturers of unapproved food packaging materials to file petitions prior to 1 June 2010, seeking an appropriate clearance.
This project was essentially a “grandfathering process,” which provided industry with an opportunity to submit dossiers to MOH for unapproved packaging materials (eg, additives, polymer resins, etc.), Ettinger told FoodProductionDaily.com.
Three batches of approvals have now been issued: 258 food contact additives finalised in April of this year; 301 food contact additives in April 2012; and 107 food contact resins in October 2011.
The additive approvals will ultimately be incorporated into China's Hygienic Standards for Uses of Additives in Food Containers and Packaging Materials (GB 9685-2008) upon its revision later this year.
NHFPC has not determined how the newly approved resins will be handled, but it is expected that they will be incorporated into existing Chinese standards or become subject to new standards.
Petitions for Approval
Now that the “clean-up” project has concluded, petitions for unapproved food packaging substances in China must be filed in accordance with the Management Rules for the Administrative Approval of New Varieties of Food Related Products.
Once a substance is cleared via petition, other companies also can use that product in accordance with the official clearance. According to Ettinger, there have been a number of filings so far; however, obtaining final approval can take some time.
Petition dossiers must contain substantial information on the substance, including quality specifications, details on the manufacturing process, migration and toxicological data, as well as proof of other international approvals on the petitioned substance.
Dossiers are reviewed every even month (February, April, June, etc.), but they must first be accepted by the reception division. If the petition is accepted for review, the petitioner has the opportunity to meet with an expert panel of reviewers to discuss the petition dossier and answer questions about the substance and its use.
Ettinger noted that many questions are coming out of the expert panel, potentially causing the process to take six to 12 months, and in some cases even longer. The panel may request all manner of data in order to demonstrate the safety of the substance, and it is not uncommon for them to request additional data to support the safety of the substance, such as additional toxicity testing, further characterization of impurities.
Additional challenges exist because questions from the expert panel can be vague and ambiguous.
For example, the expert panel could respond to a petitioner by stating, “need more information on migration.”
A deficiency response like this is difficult to handle because the panel’s concerns are not clearly identified and, for example, when it comes to migration data, there can be many factors to consider, such as food simulants, time and temperature conditions, methodology.
Unlike the US system, there is little opportunity to have an ongoing dialogue with the authorities so there can be repeated requests for supplemental data.
Since it is a relatively new system, the expert panel has been “understandably cautious.”
However, Ettinger is hopeful that, over time, the panel will become more adept at reviewing these petitions and that will shorten the amount of time needed to clear a substance.
The US and European system is more mature, and it is not terribly surprising to see wrinkles in the system, but they should be ironed out over time, he added.
Enforcement
Ettinger noted that most of the companies seeking approvals are located outside of the country --many having joint ventures or subsidiaries in China -- who want to penetrate the food packaging arena, while most domestic companies are watching from the sidelines.
Whether foreign imports or domestic production, the marketing of food packaging substances in China that are not officially approved are considered unlawful and subject to enforcement action.