Member Alert

China Decree 248 – Facility Registration Numbers and Lactose

The General Administration of Customs in China (GACC) will continue to recognize existing plant registrations that export dairy and infant formula products. U.S. firms that have applied in the FDA’s Export Listing Module (ELM) and are currently listed as registered by GACC to export dairy and infant formula products to China do not need to take any action at this time related to plant registration.

Although GACC has changed its classification of lactose to fall under the sugar category (which would require a different facility registration process and therefore would produce a registration number different to the dairy plant number), GACC has advised USDEC that lactose manufacturers should not register their facility on their own on the Single Window system. There should only be one plant registration number per plant.

GACC is aware that some lactose manufacturers have already registered their plant on the Single Window system (and received a separate registration number). In the case of a diary plant that now has two registration numbers (one for lactose (via Single Window) and another for dairy products (via FDA ELM)), GACC advises that manufacturers should use the lactose registration number only when shipping lactose; GACC will consolidate internally from their end and work with the FDA to solve the issue of dairy plants having possibly two different registration numbers.

Lastly, GACC is still working with foreign competent authorities on assigning any new China registration numbers to dairy plants that are already registered. There is no timeline set for this. For the requirement to fill in the China registration number on customs declarations and labels for products shipping on and after January 1, 2022, the existing number stated in GACC’s dairy plant list (FDA ELM) must be used. 

Please contact Eddy Fetzer (efetzer@usdec.org) if you have further questions.