In June 2016, China Food and Drug Administration (CFDA) issued the “Measures for the administration of formula registration for infants and young children formula milk powder products” which came into effect on October 1st and later announcement from CFDA indicated the transitional period will be ended in January 1st, 2018. Now only two weeks left from the deadline, China infant formula will enter the post-registration era soon. Here we will discuss the challenges that overseas infant formula enterprises shall pay attention.
I. Overview of infant formula registration for oversea infant formula manufactures
Till December 7th, there are 795 formulas registered, including 160 formulas from 29 overseas enterprises. Currently, there are 90 overseas production enterprises approved to export infant formula to China. CFDA indicated that current China infant formula market demands can be fully met within the approved formulas. Thus, there will be no transition for infant formula registration anymore.
There are still nearly 70% oversea production enterprises have not get formula registration. They are not allowed to export any infant formulas to China after two weeks.
II. By passing the registration, is the road of cross-border e-commerce feasible?
Besides general trade, infant formula trading volume via cross border ecommerce are also booming in these years. Since there are about 60 oversea infant formula manufactures have not get any formula registered, is it possible for them to win China market through cross border ecommerce?
From CFDA’s registration regulation issued till now, there were several announcement published about infant formula supervision. The lasted announcement issued on November 22nd, 2017 showed that infant formula produced by overseas enterprises shall label the number issued from CFDA when export to China. While for the “export” model (either general trade or cross border ecommerce) were not clearly defined.
As far as we know, even if it is not necessary to register the formulas via cross border ecommerce in short term. We suggest oversea companies should submit formula registration dossier as soon as possible. Due to the frequent updating of cross border ecommerce regulation, it is very possible to get a note soon that ecommerce will be under the same supervision as general trade. Besides, it is unreasonable to strictly control the general trade and implement a different supervision for cross border. Which is also unfair to those who have already get formula registration.
III. Registration is not done once and for all
In registration regulation indicated that besides dossier review, CFDA will also organized experts to conduct on-site audit review for overseas manufactures. Besides AQSIQ and CFDA are also strengthening market supervision and sampling inspection for infant formula. Therefore, formula registration just kicked off the new stage of China infant formula controls. Here we just take some examples who have already get China CNCA registration or formula registered by CFDA.
During CFDA flight inspection for domestic infant formula factories, one of the enterprises named Xinjiang Western Animal Husbandry Dairy was suspended and required to be reorganized. Thus, obtaining the formula registration does not mean that everything is fine. The enterprises must maintain the corresponding production conditions and management system to ensure the safety of production.
Another one is a French infant formula enterprise Lactalis. Due to Salmonella infection, China CNCA suspended the factory immediately and recalled the product from market. Up to now, there are 4 overseas production enterprises suspended by CNCA due to quality reasons.
Here we shall remind that the formula registration is only preconditions for overseas enterprises to enter the Chinese market, if you want to ensure the long-term healthy development of Chinese market, you must comply with the existing laws and pay close attention to the latest changes of regulations. Therefore, we have sorted out the relevant regulations on infants and young children formula milk powder in China as follows.
IV. Relevant standards and regulations on infants and young children formula milk powder in China
(I). Formula related:
GB 10765 “National food safety standard Infant formula”
GB 10767 “National food safety standard Older infants and young children formula” (The two standards are being revised, and the official versions will be issued in 2020).
(II) Label related:
GB 13432 “National food safety standard Labeling of prepackaged foods for special dietary uses”
GB 28050 “National food safety standard General standard for nutrition labeling of prepackaged foods”
GB 7718 “National food safety standard General standard for the labeling of prepackaged foods”
“Technical guidelines for the specification of labeling for the formula registration of infants and young children formula milk powder products (trial)”
“Announcement (No. 150, 2017) of China Food and Drug Administration about relevant matters on label changes in formula registration of infants and young children formula milk powder products”
(III) Ingredients and packaging related:
GB 19301-2010 “National food safety standard Raw milk”
GB 19644 “National food safety standard Milk powder”
GB 11674 “National food safety standard Whey powder and whey protein powder”
GB 2716 “Hygienic standard for edible vegetable oil”
GB 25595 “National food safety standard Lactose”
GB 26687 “National food safety standard General standard for compound food additives”
GB 2760 “National food safety standard Standard for the use of food additives”
GB 14880 “National food safety standard Standard for the use of food nutritional fortification substances”
GB 5749 “Sanitary standard for drinking water”
GB 4806.7-2016 “National food safety standard Food contact plastic materials and articles”
GB 2761 “National food safety standard Maximum levels of mycotoxins in foods”
GB 2762 “National food safety standard Maximum levels of contaminants in foods”
(IV) Other relevant laws and regulations:
“Food Safety Law of the People's Republic of China”
“Measures for the administration of formula registration for infants and young children milk powder products”
“Application material items and requirements of formula registration for infants and young children formula milk powder products (trial) (2017 revised edition)”
“Key points and judgment principles of on-site inspection of formula registration for infants and young children formula milk powder products (trial)”
“Announcement on the implementation date of formula registration for imported infants and young children formula milk powder products”
“Regulations on the supervision and administration of the quality and safety of dairy products”
“Detailed rules for the review of production licensing of infants and young children formula milk powder (2013 edition)”
“Provisions on the administration of the registration of overseas production enterprises of imported foods”
“Measures for supervision and administration of inspection and quarantine of import and export dairy products”