Food:

  • On February 3, the China Food and Drug Administration (CFDA) published its plan for food sampling inspections in 2016, covering 33 food categories with 1,293,300 batches of products. Companies producing food, food additives, and health food, as well as wholesale markets and distributers for edible agricultural products, and catering service providers will be subject to the inspections.
  • On February 17, CFDA published the first batch of approvals for health food raw materials. This first batch mainly includes raw materials for nutrient supplements. Any materials intended for use in health foods not already listed on the directory must seek approval in accordance with Administrative Measures on Health Food Raw Material Directory and Health Function Directory.
  • On February 27, CFDA promulgated the Administrative Measures on the Registration and Record Filing of Health Foods, which will become effective on July 1, 2016. The Measures strengthen the regulation of health food registration certificates and specify the information required in the certificates and their attachments. The Measures also reinforce the penalties for compliance failures.
  • On March 10, CFDA promulgated the final version of Administrative Measures for Registration of Foods for Special Medical Purpose, which will be become effective from July 1, 2016. This regulation applies to all Foods for Special Medical Purposes (FSMP), although special distinction is made for FSMPs for infants (0-12 months). In addition to registration, the Measures describe the requirements for field inspection and technical review.
  • On March 24, the Ministry of Finance, the General Administration of Customs, and the State Administration of Taxation jointly issued a notice about the new tax policy on cross-border E- commerce of imported commodities at retail (B2C). The policy stipulates that as of April 8, 2016, the current parcel tax will be no longer levied. The new tax on online imported commodities will include customs duties, a value added tax, and a consumption tax. Food, infant food, and health food (i.e., dietary supplements), as commonly imported commodities, are expected to be seriously impacted by this new policy.
  • On April 7, the Administration of Quality Supervision,Inspection and Quarantine (AQSIQ) published the Practice for Inspection and Supervision of Imported Food Contact Materials, which became effective on April 10, 2016. The regulation applies to containers, utensils, and tableware made of paper, bamboo & wood, metal, enamel, ceramics, plastics, rubber, natural fiber, chemical fiber, and glass, or their compound materials, that are used in contact with food or food additives. It provides the requirements for recordkeeping, product inspection, and product traceability procedures.
  • On April 18, CFDA released supplementary requirements for FSMP registration in China. Public comments are due by May 15, 2016. The new requirements supplement the Administrative Measures for Registration of Foods for Special Medical Purpose, discussed above, with detailed explanations of: (1) The requirements for FSMP registration application materials; (2) FSMP labeling requirements anddirections for use; (3) Quality management practice for FSMP clinical trials; (4) Requirements for FSMP stability research; (5) Field inspection checkpoints and judgment principles for FSMP manufacturers.

Chemicals:

  • On March 28, China Ministry of Transport issued the newly drafted Measures for the Safety Administration of Road Transport of Dangerous Goods, which will be promulgated by a joint order of six departments when finalized, namely the Ministries of Transport, Public Security, Industry and Information Technology, and Environmental Protection, and the State Administration of Work Safety and AQSIQ .  The new regulation consists of 71 articles and 11 chapters addressing areas such as consignment, cargo carriage, limited quantities and excepted quantities, loading and unloading, DG vehicles & portable tanks & tank containers, transport routes, emergency response, supervision and multi- department collaboration, and legal liabilities