In the News

China Finalizes Procedures for "Grandfathering" Food-Contact Substances

Mar 9, 2010

The Nutrition and Food Safety Institute of China's Ministry of Health (MOH) published final guidance documents regarding procedures and data requirements for submitting petitions to list food-contact substances that present no health or safety concerns and are currently are marketed and used in China, but are not, specifically approved for food-contact use. The deadline by which to submit petitions to MOH for currently used food packaging materials is June 1, 2010. China is expected to publish a list of approved substances in response to the petitions on or before December 31, 2010. The Chinese authorities also indicated that they do not intend to bring any enforcement actions against unapproved substances until the beginning of 2011. (The link to the published materials (in Chinese) may be accessed here: http://www.chinafoodsafety.net/.)

The "grandfathering" petition and approval process for food packaging materials not otherwise cleared in China applies to resins and substances that currently are produced or sold in China, provided they present no safety problems and are approved for use in other countries. The guidance documents do not specify a minimum number of existing regulatory approvals that are required for clearance. In addition, the Chinese authorities have indicated their willingness to consider grandfather approval for substances that can be demonstrated to have a lawful status based on opinions by trade associations and "related industry organizations."

The guidance documents establish a number of requirements for grandfather applications, including chemical identity, intended use, migration data, and toxicity information on the substances of interest. The Chinese authorities do require full reports of migration and toxicity testing be submitted as part of the application; summary descriptions will not suffice. If an applicant lacks a complete set of data as spelled out by the authorities, however, petitions may be considered on a case-by-case basis if the applicant can demonstrate in a given circumstance why certain data are not required to establish safety.