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Post - Registration Era for Infants and Young Children Formula

放大字体  缩小字体 Date:18 Dec 2017  Source:Foodmate  Writer:Sun Guoliang  Views:266
 In June 2016, China Food and Drug Administration issued the “Measures for the administration of formula registration for infants and young children formula milk powder products” which came into effect on October 1. On September 30 of the same year, China Food and Drug Administration issued “Announcement about the transitional period for the administration of formula registration for infants and young children formula milk powder products”, specified that from January 1, 2018, the infants and young children formula milk powder produced in China or exported to China shall obtain the formula registration certificate for infants and young children formula milk powder according to the law. Now the deadline of transitional period is coming, the infants and young children formula milk powder enters the post-registration era. based on the relevant policy background, Foodmate.net will discuss the problems that overseas formula registration enterprises shall pay attention to in the post-registration era.
 
I. Overview of infants and young children formula milk powder registration at home and abroad
 
According to the statistics of Foodmate.net, by December 7, the formulas of 795 infant and young children formula milk powder products of 110 enterprises had been registered, including 635 formulas of 81 domestic enterprises and 160 formulas of 29 overseas enterprises. Recently, China Food and Drug Administration indicated that, they are striving for completing the approval of about 900 formulas before the end of 2017, in accordance with the plan of regulatory department, nearly 90% formula approval work of the annual plan has been completed, the domestic infant formula milk powder market has already been able to get basic supplies, and there will not be a transitional period for infant formula registration work anymore.

Table 1 Statistics of overseas production enterprises that have been passed formula registration

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By December 7, Certification and Accreditation Administration of the People’s Republic of China has approved 90 overseas production enterprises (including 4 liquid milk production enterprises) of infants and young children formula milk powder of 19 counties to register in China. According to statistics of Foodmate, only 30% of the 90 enterprises have obtained the formula registration (see Table 1 for details) at present, the remaining nearly 70% production enterprises will not be able to enter Chinese market with general trade pattern from January 1, 2018, if they fail to obtain the product formula registration certificates of China Food and Drug Administration within the following one month.
 
II. Bypassing the registration, is the road of cross-border e-commerce feasible?
 
On November 22, 2017, General Administration of Quality Supervision, Inspection and Quarantine of the People’s Republic of China and China Food and Drug Administration jointly issued "Announcement about the implementation date of the formula registration of imported infants and young children formula milk powder products", which explicitly mentioned that "Infants and young children formula milk powder exported to China produced after January 1, 2018 (including January 1, 2018) by overseas production enterprises shall obtain the formula registration of China Food and Drug Administration, and shall indicate the registration number on the labels of  the product sale packaging", as for whether the “infants and young children formula milk powder exported to China" includes the products imported from cross-border e-commerce channels, the industry views are different. Some people think that infants and young children formula milk powder imported from cross-border e-commerce is not required to be registered; and some people hold a different view that after January 1, 2018, the infants and young children formula milk powder imported from cross-border e-commerce or through general trade pattern all have to obtain the formula registration certification of China Food and Drug Administration, because the announcement does not specify the import method, "exporting to China" shall be applicable to all import methods, and the Foodmate is more inclined to the first view.
 
On August 2013, the General Office of the State Council forwarded the Notice of Ministry of Commerce and other departments about “Opinions on the implementation of relevant policies on supporting the cross-border e-commerce retail export”, in order to accelerate the development of cross-border e-commerce in China, and support the cross-border e-commerce retail export. In June 2015, the General Office of the State Council and China Food and Drug Administration issued relevant documents on promoting the healthy, rapid development of cross-border e-commerce and strengthening the inspection supervision work successively.
 
In April 2016, the Ministry of Finance issued "List of retail imported commodities through cross-border e-commerce", and it is mentioned in the relevant commodities notes and instructions to the “List” issued subsequently that, "From January 1, 2018, the infants and young children formula milk powder sold in China, including the infants and young children formula milk powder retail imported through cross-border e-commerce, must obtain the product formula registration certificate according to the law". This is also the reason why some people think the above-mentioned announcement includes imported products by cross-border e-commerce.
 
However, the “Notice of the General Office of General Administration of Customs about relevant matters on implementing the new regulatory requirements for retail import of cross-border e-commerce” issued on May 24, 2016 pointed out that "The registration requirements for infants and young children formula milk powder in the note of ‘List’ shall not be implemented temporarily during the transitional period". Moreover, new cross-border e-commerce comprehensive pilot area was required in the executive meeting of the State Council held on September 20, 2017, and the transitional period policy for regulatory of cross-border e-commerce was extended to one year to the end of 2018. It can be seen that the "extension" of the "transitional period" means that the supervision methods for that "registration requirements for infants and young children formula milk powder in the note of ‘List’ will not be implemented temporarily" will be further effective.
 
In recent years, the relevant policy for cross-border purchase of infants and young children formula milk powder has been constantly adjusted and changed, so that overseas companies who have not yet obtained product formula registration are turning to cross-border purchase, hoping to occupy the Chinese market through cross-border purchase. However, even if it is not necessary to register in the short term, in the long run, China will not open the cross-border e-commerce trade only over the strict regulation of traditional trade. For the orderly development of the future market, the regulation for the cross-border purchase of infants and young children formula food will be gradually standardized in the future, and will eventually lead to the product formula registration. Therefore, that the overseas production enterprises enter the Chinese market through cross-border e-commerce are only temporary solutions and not for long term. On the other hand, Center for Health Food evaluation and relevant departments of China Food and Drug Administration have accelerated the progress of the approval under the premise of strict approval, greatly reduced the formula approval time to ensure that the qualified enterprises to obtain the registration timely and ensure the market supply. The overseas enterprises shall seize this opportunity to perform the declaration of product formula registration but not to wait repeatedly or enter the Chinese market via the cross-border purchase.

III. Registration is not done once and for all
 
For regulation of infants and young children formula food production enterprises registration, in addition to the audit of the formula itself, the Certification and Accreditation Administration has organized experts to carry out the special review and on-site review for the overseas infants and young children formula milk powder enterprises that has registered, General Administration of Quality Supervision, Inspection and Quarantine and China Food and Drug Administration are also strengthening market supervision and sampling inspection. So it's not absolutely safe even if obtain the formula registration, for example:
 
The French infants and young children formula milk powder production enterprises including CELIA-LAITERIE DE CRAON (also known as Lactalis) issued on December 5, 2017, due to the suspected Salmonella infection of infants and young children formula milk powder, were immediately suspended the registration in China by CNCA. Up to now, there are 4 overseas production enterprises with hidden problems suspended the registration in China by CNCA.
 
Secondly, China Food and Drug Administration also continued to carry out flight inspection and related treatment to a number of domestic enterprises. In view of the results of flight inspection in July 2017, on November 28th, China Food and Drug Administration issued a letter on the inspection of the food safety production standard system of Xinjiang Western Animal Husbandry Dairy. The letter pointed out that there were many problems in the production, personnel and food safety supervision. The factory was ordered to be reorganized again. 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 the infants and young children formula milk powder produced.
 
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. We will sort 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”
 

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