FDA is updating both its China and European Union (EU) plant lists. Details specific to both updates are below. See Volume 2 of the USDEC Export Guide China and EU documents for information on FDA plant registration. Contact Sandra Benson at sbenson@usdec.org with questions.

China

FDA has advised a deadline of September 1, 2017 for the registration of new facilities and edits to product scope of already registered facilities in the FDA China list. All manufacturers should review the July 27, 2017 plant list on the CNCA website to ensure that the facility name, plant address and products are correct. All changes to plants that are included in this listing should be submitted in FDA's Dairy Listing Module (DLM) prior to the September 1 deadline. FDA has verbally agreed that they will remove the newly added fields - estimated value, volume and unit of measure of exports over the next two years - or make them voluntary. Until this programming change takes place, manufacturers may enter dummy information in order to complete their applications.

Once manufacturers receive a confirmation email from FDA for any edits to the facility listing, they should log back into the DLM to ensure that the plant name, address and product list matches the information submitted and take a screenshot as a record of submission. Manufacturers should also ensure that a current company contact is listed in case FDA needs to follow up with the facility with any questions. Manufacturers must do their own registrations. Third parties (e.g. trading companies) cannot register for manufacturers.

FDA has just advised that all plants not included on the July 27, 2017 plant list on the CNCA website are considered to be new plants and are subject to a plant audit prior to being included on the FDA plant list. Manufacturers looking to register new plants should first request inclusion on the plant list through the DLM, and should then obtain an inspection from one of the third-party certification bodies listed in Annex 2 of the MOU. In addition, any plant shipping high risk products (fluid milk - pasteurized, sterilized or modified; fermented milk; and infant formula), must complete a questionnaire.

European Union

FDA is in the process of migrating its plant list for the EU into the FDA FURLS Dairy Listing Module (DLM). All companies that have not yet registered their plants in the DLM for the European Union must do so immediately in order to retain the plant's inclusion on the FDA EU-approved plant list. FDA had initially set a target date of August 15, 2017 for all plants to register in the DLM for the EU plant list. However, approximately 700 plants are not yet entered into the DLM for the EU. FDA has requested immediate action by September 1, 2017 if any plant has not yet completed their EU registration in the DLM. The new EU plant list created for FDA's next quarterly EU update will be the list generated from the DLM. The former EU plant list will be considered obsolete and all future plant list updates will be done through the DLM. 

All manufacturers that have already submitted an application for the EU dairy list in the DLM are encouraged to log in and review their application to verify that their facility name and address appear correctly. All users are encouraged to take a screen shot of the information submitted and retain it for their records in case questions arise at a future date.

Even if a manufacturer is not shipping to the EU, but is not eligible to be included on the AMS or IMS plant lists, registration for the FDA EU list is needed in order to obtain sanitary certificates from AMS Dairy Grading.