Global Food

How to Use, Label and Register Substances Belong to Food Fortifiers & Novel Food Ingredients?

  Many substances can be used as food fortifiers also novel food ingredients, sometimes, food enterprises might be confused about it during food production. In fact, the quality specifications and usage requirements of using as food fortifiers and food ingredients are quite different. Therefore, Global Foodmate summarized the substances belong to food fortifiers and novel food ingredients, and their usage and labelling requirements in foods. Global Foodmate also discussed how to apply for approval of a newly occurred substance that meets the abovementioned criteria in China. 1. Substances belong to food fortifiers and novel food ingredients (1) Docosahexaenoic Acid (DHA)   Food fortifiers Novel food ingredients Standard GB 26400-2011 National Food Safety Standard-Food Additive- Docosahexaenoic Acid Oil (Fermentation) Notice No. 3 of Ministry of Health [2010] (DHA algal oil) Usage (1) Formulated milk powder (only for children): ≤ 0.5% (% total fatty acids) (2) Formulated milk powder (only for pregnant and lactating women): 300 mg/kg-1000 mg/kg (3) Cereal-based complementary foods for infants and young children: ≤ 1150 mg/kg Daily consumption: ≤300 mg/d (based on pure DHA) Usage in infant formula shall comply with relevant standards: ≤ 0.5% (% total fatty acids) (2) Arachidonic acid (AA or ARA)   Food fortifiers Novel food ingredients Standard GB 26401-2011 National Food Safety Standard-Food Additive- Arachidonic Acid Oil (Fermentation) Notice No. 3 of Ministry of Health [2010] (Arachidonic acid oil) Usage (1) Formulated milk powder (only for children): ≤ 1% (% total fatty acids) (2) Cereal-based complementary foods for infants and young children:  ≤ 2300 mg/kg Daily consumption: ≤ 600 mg/d (based on pure AA)   Usage in infant formula shall comply with relevant standards: ≤ 1% (% total fatty acids) (3) Galacto-Oligosaccharides (GOS)   Food fortifiers Novel food ingredients Standard (1) Notice No. 12 of Ministry of Health [2007] (Origin: lactose, hydrolysed by β-galactosidase) (2) Notice No. 8 of NHFPC [2016] (Origin: lactose, hydrolysed by β-galactosidase produced by Aspergillus oryzae) (3) Notice No. 8 of NHFPC [2017] (Origin: whey filtrate, hydrolysed by β-galactosidase produced by Aspergillus oryzae)  Notice No. 20 of Ministry of Health [2008] (Origin: lactose, hydrolysed by β-galactosidase) Usage Infant formula, Cereal-based complementary foods for infants and young children: as one of the sources of prebiotics, used alone or in combination, the total amount does not exceed 64.5 g/kg. Daily consumption: ≤ 15 g/d Application range: infant food, dairy products, beverages, baked products, candy (4) Polyfructose   Food fortifiers Novel food ingredients Standard Notice No. 12 of Ministry of Health [2007] (Origin: Cichorium intybus L.) Notice No. 5 of Ministry of Health [2010] (Origin: Cichorium intybus var. sativum, Asteraceae) Usage Infant formula, Cereal-based complementary foods for infants and young children: as one of the sources of prebiotics, used alone or in combination, the total amount does not exceed 64.5 g/kg. Daily consumption: ≤ 8.4 g/d Application range: milk powder for children, milk powder for pregnant and lactating women   (5) Yeast β-glucan   Food fortifiers Novel food ingredients Standard Notice No. 6 of Ministry of Health [2012] Notice No. 9 of Ministry of Health [2010] Usage Older infants and young children formula (only for young children), formulated milk powder (only for children): 0.21-0.67 g/kg. Daily consumption: ≤ 250 mg/d Application range: excluding infant food 2. How to use and label: For substances that belong to both food fortifiers and novel food ingredients, they should be used and labelled according to the actual function in the finished product. Quoted from the Q&As concerning the Standard for the usage of Food Fortifiers GB 14880-2012, “For some substances that belong to both food fortifiers and novel food ingredients, such as DHA, AA, GOS and polyfructose, if the purpose of adding is nutrition fortification, usage of the substance shall comply with this standard. If the substance is used as a food ingredient, it shall meet the requirements of relevant notices of novel food ingredients.” When the substance is used as food fortifiers, the content and NRV% (NRV% is optionally labelled in Foods for Special Uses) of the fortified nutrients shall be labelled in the nutrition facts. The labelling, including name, order, expression unit, rounding level, etc., shall comply with Table 1 of GB28050-2011 General Standard for Nutritional Labelling of Prepackaged Foods. For nutrients that are not listed in Table 1 but are allowed by GB 14880, the labeling order shall be located after the nutrients listed in Table 1. When the substance is used as food ingredients, the daily consumption and application range of it shall be labelled. 3. How to register a novel food ingredient that can be used as both food fortifier and food ingredient in China:   When registering a substance that belongs to both food fortifier and food ingredient, the purpose of adding, applicable population, application range and daily consumption shall be taken into consideration. ‘Food Fortifier’ is defined by GB 14880 as a natural or synthetic nutrient that is added into food in order to increase the nutritional value of the food. In China, food fortifiers belong to food additives, therefore, they shall be applied for approval as novel food additives. Administrative Measures for the Safety Review of Novel Food Ingredients (2013) and Regulation of Declaration and Acceptance Requirements for Novel Food Ingredients defined the ‘Novel Food Ingredients’ as the following items that are not been traditionally eaten in China: Animals, plants and microorganisms; Components separated from animals, plants and microorganisms; Components with altered original structures; Other newly developed food ingredients. Substances meet the abovementioned requirements shall be applied for registration if the substances are intended to be used in food production. If a substance is intended to be used in general foods, with varied applicable population (e.g., only excluding infants, pregnant and lactating women or without limitation), with a wide range of application (suitable for multiple types of foods) and the daily consumption is not low, it is generally to be registered as novel food ingredient. While, the allowed dosage of food fortifiers is generally small and the application range is relatively narrow. Also, the approval requires the demonstration of the necessities, effects and others of using certain food fortifier. Additionally, if a substance has been registered as food fortifier, it cannot be approved as novel food ingredient according to the Regulation of Declaration and Acceptance Requirements for Novel Food Ingredients issued in 2013. On the contrary, if a substance is firstly registered as novel food ingredient to be used in general foods, it is also possible to be approved as food fortifier afterwards, taking Yeast β-glucan as an example. Enterprises shall choose to declare, according to their own needs. Global Foodmate provide registration services of novel food ingredients and novel food additives for domestic and overseas enterprises, please feel free to contact Global Foodmate.     Please note: Original English article of Global Foodmate of Information Service and Business Department, please indicate the source from the Global Foodmate if reprint. Global Foodmate Information Service Centre provides food standards & regulations research, labeling compliance consulting/Chinese label design, industry public opinion monitoring and analysis, registration services (of Infant formula, FSMP, Health food, Novel Food Ingredients, Novel Food Additives, New Varieties of Food-Related Products and Overseas manufacturers of imported food) and other comprehensive food safety solutions for domestic and overseas enterprises and institutions in food industry.  Please feel free to contact us: +86 10 68869850, E-mail: global_info@foodmate.net

How China's Dairy Measures Affect Foreign Dairy Companies?

 On May 23, 2018, the State Council executive meeting put forward a number of measures to accelerate the revitalization of the dairy industry and guarantee the quality and safety of dairy products. What are the important measures? How will it affect foreign dairy companies? The important measures and interpretation: 1. Pursuit of high-quality milk sources: Vigorously introduce and breed good-quality cows and build national core breeding farms. Strengthen the production of high-quality forage materials. Develop standardized scale farming and build a high-quality milk source base. 2. Strengthen quality and safety supervision: Focus on strengthening the supervision of the three key links of milk farms, raw milk acquisition stations, and transportation trucks. Revise and improve national food safety standards of raw milk and sterilized milk,etc. Establish a quality tracing system throughout the whole process. Strive to significantly improve the quality, competitiveness and reputation of domestic infant formula milk powder within 3 years. 3. Financial and technological support: Strengthen the support on the financial insurance and breeding land for milk, etc. Also promotion and application of dairy-related Internet of things technology and intelligent technology equipment to create more beneficial conditions for the revitalization of the dairy industry. How will it affect foreign dairy companies? For foreign dairy companies, the above measures are dedicated to the health, standardization, and internationalization of China's dairy industry development. The revised draft of the previous dairy standard also shows that China is continuously raising national food safety standards to meet the needs of the globalization of the domestic market. In line with the international advanced level, domestic milk and imported milk are developed under the same standards to improve the quality of domestic milk. The competitiveness of foreign dairy companies in terms of quality is no longer evident, nor in price For Chinese consumers, there is a certain national sentiment. In the case of the same quality, Chinese domestic products are more preferred. China also develops the national dairy brand and will hold a series of international dairy brand promotion activities to promote the dairy companies big joint, collaboration and enhance Chinese dairy brand influence. Therefore, Foodmate predicts that the market share of foreign dairy companies is more likely to be further occupied by domestic companies. Some advice for foreign dairy companies from Foodmate: 1)       Quality Product is the KING. a)        Chinese consumers were hurt by melamine scandal. So they value quality product. b)        Time also told the Chinese consumer that not all foreign products are premium and high quality. So if you want to enter China market without “Quality first”, you will lose. 2)      Update to date Chinese regulation & consumer trend Economically Chinese is developing very fast. Its food regulation, as well as consumer trend, is also changing very fast. Master the regulation context is prerequisite for foreign companies to enter and survive in China. Today’s Chinese consumers are not still living in the year of 2008, now they need more than quality … 3)      Control your supply chain distribution If as the brand owner, you even do not know where your product is flowing to, then there is no surprise that consumers will also lose their confidence in you.

The State Administration for Market Regulation (SAMR) unveiled, Supervision on Special Food Remained the Same.

 On the morning of April 10, 2018, State Administration for Market Regulation (SAMR) officially hung up sign.  On the same day, SAMR official website entered the trial operation stage.   In the afternoon, "Announcement on the Supervision of Food and Drugs during the Institutional Reform" was co-issued by SAMR and the State Drug Administration. The announcement clearly stated that the original CFDA’s review, approval, supervise and inspection and testing and other matters of the food, health food, infant formula, and FSMP are still processed according to the original regulations before the publication of the “three decide” the stipulation by SAMR and the State Drug Administration.   So, will the supervise of special foods change due to adjustments in institutional reforms? In this regard, Global Foodmate believes: 1.There will be no change in the transition period for infant formula registration and FSMP registration. The following two regulations are still valid. “Announcement on Implementation Date of Registration of imported Infant Formula Milk Formula”: Overseas production infant formula milk powder produced after January 1st, 2018, overseas production enterprise shall obtain the product formula registration of CFDA and indicate the registration number on the label of the product sales package. “Announcement on Adjusting the Transition Period for the Registration of FSMP”: Since January 1, 2019, FSMP that are produced in China or exported to China should obtain registration certificate and indicate the registration number in the label and description.   2.The Institutional reform will not have a noticeable impact on the reform of special food registration and filing systems Due to the need for a transitional period for the institutional reforms and adjustments, the implementation of special food registration and filing systems may have a slowing pace in the short-term. However, the announcement has also been made clear that it will remain business-as-usual until the “three decide” the stipulation plan is announced to achieve a smooth transition during the institutional adjustment.   3.Overseas factory certification and registration on-site inspection may be unified. With the adjustment of institutional reforms, the integration of overseas factory certification and registered site verification is possible to be unified. based on the above analysis, Chinese special food regulatory system will not change too much. Therefore, it is recommended that relevant domestic and international special food manufacturers should not take a wait-and-see attitude and continue to work in accordance with the various systems formulated by the CFDA and pay close attention to policy development from Global Foodmate.   NOTE: Schedule for institutional reform Reform the department team before March 31; On April 10, the State General Administration of Market Supervision unveiled; Complete the establishment of the transfer before April 20; Submit a draft of “three decide” the stipulation before May 31; Declare the approval of “three decide” the stipulation before June 20; Implement the “three decide” the stipulation before the end of September; Acceptance at the end of 2018.

The China - Success Recipe for Foreign Infant Formulas

Offline trading of China infant formulas regulated and under controlled According to CFDA regulation, all infant formulas sold in China (offline and online channel, excluding cross border e-commerce) should get the registration certificate by 1st Jan 2018. With this most strict registration, food safety of China infant formulas is turning to a totally new page. By Mar 2018, up to 1200 formulas registered with CFDA by 134 companies. In the reality, starting from 1st Jan 2018 deadline all supermarkets/infant shops is selling infant formulas with a registration number. No Chinese distributors are interested anymore to distribute a foreign infant formula without a registration number and the game is over there. Meanwhile Central and local FDA already started onsite inspections on the compliance since 2017. What is happening in online e-commerce distribution of China infant formula? 1) Mainstream online trading With the booming development of China e-commerce environment, all major Chinese & foreign infant formula companies have their own flagship shop on Alibaba Tmall or Jingdong online trading platforms. Since the last 3-5 years, sales from online trading for these major Chinese & foreign infant formula companies have enjoyed great year on year growth. According to xingtu data, online trade already taken up to 40% of total China infant formula sales. If you do not have a flagship online shop on online trading platforms like Tmall or Jingdong etc., then 40% of the customers have already been lost. In general, big players sell the same registered infant formula product both online and offline and food safety of these products are also fairly under control. 2) Gray areas of online “buyer-on behalf (DaiGou) and cross board e-commerce” During the last 5-8 years, huge amount of Chinese middle class choose to oversea buy & online buyer –on behalf to buy infant formula for their babies. They see, even for the same foreign brand, oversea buy could be 30%+ cheaper than offline shops. This has created very nice business opportunities for numerous young Chinese migrants or Chinese students abroad who look for flexible ways to earn money. During the last 3 years, the China cross-border e-commerce setup has been making a step change to make oversea shopping much more easily. According to the China Cross-Border E-Commerce Development Almanac (2017), in 2016, the total volume of cross-border export and import online retail reached RMB 54.343 billion with year on year growth of 40%. based on current China cross-border e-commerce regulation, the product does not have to go through the customs inspection. For infant formulas distributed through cross-border e-commerce retail, so far it can enjoy a grace period until the end of 2018 to comply with CFDA registration regulation. Since buyer–on behalf is not regulated by the Chinese government and e-commerce regulation is still immature, so there is no surprise that wild grasses started to grow in these gray areas (product quality varies very much and it becomes to vacuum area for food safety control). Unqualified/expired/fake product can easily go to the China market through buyer-on behalf and cross-border e-commerce. Who knows which is the real one or fake one? On the other hand, for the foreign infant formulas, the brand image has been damaged by uncontrolled distributors (with uncontrolled price, uncontrolled service, uncontrolled marketing). When you search a specific foreign brand infant formula (e.g. German Hipp or French Picot) in Taobao, you can easily find 100+ results with price from 5 Euro to 30 Euro per box. Who knows where are the missing recalls? The recent example of France's Lactalis, the company has to recall 12 million cases of infant formulas infected with Salmonella. Salmonella infections can be life-threatening, particularly for young children. According to the latest update, Lactalis can hardly recall half of the infected products. Lactalis probably does not know that huge amount of their product has been sold to China by the Chinese buyer-on behalf who bought their product in French supermarkets or distributors. It is a big puzzle for Lactalis to find these infected products and it is clear that the brand reputation will be deeply damaged due to the infection as well as the failure to do the recalled puzzle. What is the government doing and what is the regulation trend for gray areas of online trading? 1)  Strengthening the market inspection & anti-smuggling On 1st Mar 2018, Shenzhen customs anti-smuggling bureau together with local authorities seized more than 100,000 pieces of buyer-on behalf merchandise, involving various infant formula and health products from Europe and Australia. With case value of >10 million RMB, this is the biggest anti-smuggling case in the past 10 years. 2)  Strengthening foreign infant formula entry control China National certification and accreditation supervision committee (CNCA) recently released the announcement that registration certificate for foreign infant formula manufacturers is valid for four years, and it needs to be re-applied once it is expired. 3)  ongoing regulation development between government and e-commerce giants Since the beginning of 2017, Alibaba and National standardization institute set up the joint team to define food safety standards for e-commerce products. The standards development will be divided into two phases: the first phase is the infant formula milk powder and health products, more than 30 other food categories in the second stage What should foreign infant formula companies do to bring another page successful business in China? 1)  Quality Product is the KING. a) Chinese consumers were hurt by melamine scandal. So they value quality product. b) Time also told the Chinese consumer that not all foreign products are premium and high quality. So if you want to enter China market without “Quality first”, you will lose. 2)  Update to date Chinese regulation & consumer trend Economically Chinese is developing very fast. Its food regulation, as well as consumer trend, is also changing very fast. Master the regulation context is prerequisite for foreign companies to enter and survive in China. Today’s Chinese consumers are not still living in the year of 2008, now they need more than quality … 3)  Control your supply chain distribution If as the brand owner, you even do not know where your product is flowing to, then there is no surprise that consumers will also lose their confidence in you. Note: This article is originally published by Rong Liu from Foodmate, please indicate the source if reprint it.

Announcement of Registration Extension for Overseas Infant Formula Manufacturers Who Export Product to China

On March 13th, China Certification and Accreditation Commission (CNCA) issued an announcement about the registration extension for overseas  infant formula manufacture, which is estimated to create lots of challenges for oversea infant formula manufacturers. 1) Tight timeline for manufacturers to go through the extension registration process and lots of dossiers for CNCA to review The regulation for oversea infant formula registration in CNCA was issued in 2014. It is estimated that about 40% of current approved manufacturers (about 100 manufactures from 19 countries) were approved at that time. Since the registration valid duration is 4 years. All of the manufactures approved in 2014 should submit extension registration dossiers by the end of 2018. Otherwise, it shall be not allowed to export infant formula to China. 2) Manufacturers are unable to reach the latest update from CNCA and hard to move forward The one who got CNCA certificate has already experienced that it was impossible to control the CNCA registration process by manufacturer itself. Due to the process is more like a government to government communication process. It seems that the manufacturers can do nothing but just wait for the final approval announcement. Therefore, if the manufacture extension registration is not finished by the end of 4 years valid time, the formula will be forbidden to export to China even the formula registered by CFDA. 3) China’s food regulation structure will be adjusted soon and responsibility of each department will be re-defined. On March 13th, 2018, the State Council institutional reform scheme was reviewed during the meeting. The reform scheme draft indicated that CNCA will be under the General Administration of Market Supervision and Management (will be newly established). Therefore, responsibility of each department will be re-defined, and the process will be not clear in a short time, which may be difficult and confused for enterprises to go through manufacture extension registration process. Suggestions: Foodmate suggests that infant formula manufactures registered in 2014 and 2015 should prepare and submit the extension registration dossier ASAP.

Guiding Opinions of Chengdu FDA About Food Label Identification

In recent years, the issues of food label identification have become the key point and focus of occupational complaints and reporting with involving more and more widespread, complex and professional label issues. And great importance isattached to label compliance from the national level as well as the provincial level.For imported products passed the inspection of the customs to all cities in thecountry, the provincial FDA (food and drug administration) will also conduct sampling inspection on product compliance. Global Foodmate analyzed and interpreted some of the complaints related to imported food in the Guiding opinions of Chengdu FDA about regulating the food label for the reference of overseas food enterprises. A Cases concerning imported products Case1: imported food products contain ingredients which may not be added by laws, regulations or standards in China, but it has the conformity certificate document issued by the CIQ. Such as some products have been complained about because the ingredients contain fish liver oil. Handling principles: the product violates the current laws and regulations in China. The conformity certificate document issued by CIQ are contrary to the laws,regulations and standards and cannot be used as the basis for the determination of the product's legal rights. Case2: The content of imported food label is suspected of violating the current laws, regulations or food safety standards in China, but it has the conformity certificate document issued by the CIQ. For example, the nutrition information of products does not meet the national standards. Handling principles: In the case of imported food labels, if the legality of the product label cannot be identified after investigation and evidence collection according to the relevant laws and regulations, the CIQ shall be required to conduct inspection and quarantine on the imported food. If the food production and trade enterprise can provide the import inspection and quarantine report of conformity, it can be concluded that the label of the involved product label is legal. B Cases concerning new food raw materials Case: Adding one or more new food raw materials which are not included in the “Chinese Pharmacopoeia”, medicinal and edible list, and do not belong to new food raw materials approved by the state in food, such as american ginseng, senecio cineraria, peach blossom and crabshell hydrolysate. Handling principles: according to the “Review measures of safety for new food raw materials”, the key to the determination is whether the food has a history of more than 30 years in food production and trade in Sichuan. If so, it can be identified as compliance. C Cases concerning the nutritional contents The handling principles of declared value of food nutritional content table not complying with the provisions of “General Rules for Nutrition Labeling of Prepackaged Foods” (GB28050-2011): 1. The determination of the accuracy of declared value of nutritional label shall bebased on the method of determining the label value of the enterprises; 2.Because the food nutritional content is unstable, it will change according to the season, origin and transportation conditions. Therefore, it is acknowledged that there may be some discrepancies between the detected values of nutritional contents. It is suggested that the involved product batches and other batches (a total of more than three batches) shall be conducted with entrustment inspection under permitted conditions to comprehensively determine whether the products in question are in conformity with the provisions; 3. Where there are large differences between detected figures and label declared value, the enterprise shall promptly analyze and correct deviation. The guiding opinion not only regulated the standard scale and case handling procedures for complaints of food label identification but also reflected that the Chinese government attaches great importance to the compliance of food label, especially the compliance of the label of imported food. It is recommended that foreign companies shall thoroughly understand China's requirements on product compliance before exporting food products to China and reduce the compliance risks after products entering the Chinese market. At the same time, we also summarize China's requirements for labels according to GB 7718-2011 “General standard for the labeling of prepackaged foods” as follows:   1. Reflect the true nature of the product actually without false information, exaggeration, not misleading and cheating. 2. Have scientific basis, no propaganda violating science as superstition and pornography,etc., and do not belittle other foods. 3. Do not perform the propaganda of having prevention, treatment and health care functions either expressed or implied. 4. Simplified Chinese Simplified Chinese must be used, other language fonts shall not be greater than the corresponding Chinese characters. 5. Legible, striking and lasting principles Separated from the food, the character height must be greater than 1.88mm, the character of net content shall be higher. 6. All label factors of corresponding food shall be identified.

A Picture to Know the Ingredient Requirements of Infant Formula

Infant formula is a sensitive product and always considered as the standard for food safety in China. Therefore, it is under the strictest supervision these years. China has already set up a complete supervision system from formula registration, product filing, and production supervision, product sampling inspection, risk monitoring and evaluation. In order to ensure the nutritional comprehensiveness and safety of infant formula, there are lots of different kinds of regulations, standards and announcements have been issued and update from time to time. It is always a great challenge for foreign infant formula companies to master all of the requirement regarding permitted and forbidden ingredient used in infant formula. Here we summarized all of the ingredient requirements and support oversea infant formula companies to understand it directly and clearly.

China Food and Drug Administration Printed and Distributed the Detailed Rules for the Implementation of the Food Safety Sampling and Inspection Plan in 2018

On January 4, 2018, in order to do well in food safety sampling and inspection according to the law, scientifically and normatively, China Food and Drug Administration formulated and issued the food safety sampling and inspection plan in 2018 according to “Food Safety Law of the People’s Republic of China” and “‘13th Five-Year’ national food safety plan”, combining with the actual food safety inspection work. In 2018, the food safety sampling and inspection plan covers 33 major food categories, 137 food species and 218 food subclasses, and a total of 1.3505 million batches will be sampled and inspected. The General Administration will sample and inspect 28.5 thousand batches, of which 20.5 thousand batches are planned sampling and inspection, and 8 thousand batches are special sampling and inspection. The major food enterprises above the scale and national large-scale wholesale markets with large market share shall be sampled and inspected. It includes infants and young children formula food, dairy products, meat products, beverages, wines, edible agricultural products and other 30 categories. For food processing products, edible oil, grease and its products, dairy products, beverages, wines, biscuits, roasted foods, nut products and other varieties, a certain amount of online shopping food and imported food will be sampled and inspected. The provincial bureaus will sample and inspect 492 thousand batches, of which 227 thousand batches of special transfer payments will be made by the General Administration, and 265 thousand batches will be matched by each provincial bureau. The production food enterprises and large catering enterprises which obtained the production licenses in the province (district or city) will be mainly inspected and sampled. There are 31 categories including foods for special dietary uses, health food, food processing products, edible oils, grease and its products, meat products, dairy products, beverages, bee products and catering food, etc.. The total amount of sampling and inspection for edible agricultural products by all cities and county bureaus in China will be 830 thousand batches. The sampling and inspection species by municipal and county-level bureau shall, as far as possible, cover vegetables, fruits, livestock and poultry meat, aquatic products, eggs and other edible agricultural products produced and sold within the administrative areas. The intensity of sampling and inspection for small workshops, small vendors, small-sized catering shall be increased appropriately. On January 18, 2018, in order to further standardize the supervision and inspection work for food safety, Food and Drug Administration organized to formulate the “Detailed rules for the implementation of the food safety sampling and inspection plan (2018 edition)”, which put forward unified requirements for the applicable scope, product species, inspection basis, sampling and inspection requirements, judgment principles and conclusion of the supervision and inspection for the 33 categories of foods. Food classification shall be judged according to the basic standards of food classification system, when it is judged according to basic standards (GB 2760, GB 2761, GB 2762, GB 2763, GB 29921). For example, the determination of the contaminants of sesame shall be attributed to nuts and seeds food according to the food classification system of GB 2762; for another example, the determination of celery contaminants shall be attributed to stem vegetables according to the food classification system of GB 2762, while the determination of its pesticide residues items shall be attributed to leaf vegetables according to the food classification system of GB 2763.

Post - Registration Era for Infants and Young Children Formula

 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   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”

Changes in China's Policy Will Further Facilitate Some Cheese Imports

 In 2017, China's soft cheese ban incident aroused widespread media attention at home and abroad as well as import and export enterprises, and some foreign media constantly reported on the matter. However, the two recent policy documents show that China's policy adjustment gradually optimizes the import of cheese. based on the review of the incident, Foodmate analyzes the recent policy changes for readers' reference. Review on the soft cheese ban incident   During August and September of 2017, some media reported that "China has completely banned the importation of a series of mould-ripened cheeses mainly from France and Italy, which was a bad news for foreigners in China." The report quoted a statement from William Fingleton, as the spokesman for the EU delegation, "The entire Chinese soft cheese market has now been completely closed down, which means that China has banned the import of the famous and traditional soft cheese from Europe; however, the safe soft cheese has been imported for decades. The reason for the ban is not sufficient because China believes that the same kind of cheeses produced domestically is safe." Another media reported that" the health authority informed the inspection and quarantine officers that colonies of moulds such as penicillium found in blue cheese were not included in the approved list of imports, and the ban on imports was subsequently promulgated. The ban, which came into effect in July, is rapidly expanding to the whole country." Another part of the media interpreted that the reason why Chinese authorities ban the import of these foreign dry cheeses was that the inspection and quarantine authorities in China found excessive amounts of bacteria in these cheeses. In response, the Director General of AQSIQ Zhi Shuping denied the release of the ban after the press conference held by the State Council Information Office on September 13, and clarified the matter is attributed to complaints on such products involving the standard for use, where the cheese is either ripened cheese or unripen cheese, and the results of the investigation would be announced on the website of AQSIQ. However, at present, AQSIQ has not released the survey results.   China allows the import of cheese ripened by certain species of bacteria   Previously, Foodmate has analyzed the cheese ban from a regulatory point of view, the main problem was the compliance of bacteria used in China, but recently we found from a file shared by users of Food Forum that NHFPC allowed the use of certain strains for the ripening of cheeses and provided a basis for the compliance of these cheeses into China through normal trade routes.   NHFPC stated, in the so-called document "Reply letter on the issues of specific mould in mould-ripened cheese" on October 11, 2017, that cheese shall be divided into three kinds (ripened cheese, mould-ripened cheese, and unripen cheese) according to "GB 5420-2010 National food safety standard Cheese". Mould-ripened cheese refers to the cheese which is promoted to be ripened through the growth of the specific mould inside the cheese and/or on the surface of the cheese. Specific moulds refer to the species specified in the standards of Codex Alimentarius Commission or other national regulatory standards, including Penicillium candidum, Geotrichum candidum, Penicillium roqueforti, etc.. Under the premise of being in line with the national food safety standard and ensuring food safety, the above-mentioned mould can be used as a specific mould in the mould-ripened cheese.   China reduced the tariff rate on imported cheese   On November 22, 2017, the Customs Tariff Commission of the State Council released a notice on adjusting the import tariffs on some consumer goods. Starting from December 1, 2017, the tariff rate on some consumer goods will be reduced by a provisional tax rate. Thereinto, various types of ground or powdered cheeses, processed cheeses (excluding grinded or powdered ones), blue cheese and other textured cheeses produced with Penicillium roqueforti, and the other cheese, MFN rates are 12%, 12%, 15% and 12% respectively. Since December 1, the tentative tax rates have been adjusted to 8%.   It can be seen from the above two policies that China's recent clarification on the species of moulds used for mould-ripened cheese and the adjustment of tax rate will help the overseas cheese enterprises to continue to export cheese products to China. Foodmate reminds companies to take the opportunity to expand their business. At the same time, Foodmate can also provide overseas companies with services such as regulation consulting, process consulting and compliance review in the process of cheese import.