NFHPC Issued an Announcement on Six New Varieties of Food-Related Products on 3-Aminopropyltriethoxysilane etc. by Nikolaas Tilkin-Franssens

On March 28,2018, according to the provisions of the "Food Safety Law," the review agency has organized experts to review and pass on the safety assessment materials for six new food-related products such as 3-aminopropyltriethoxysilane.

1. New Additives Varieties in Food Contact Materials and Products:

Homopolymers of distillates (petroleum), C3-6, piperylene-rich (C5) and copolymers with one or more of the following: isobutylene (C4), styrene, and alpha-methylstyrene.

2. Additives for food Contact Materials and Products that Expanding the Range of Usage or Usage Scope

3-Aminopropyltriethoxysilane

3. New Resin Varieties for food Contact Materials and Products

Polymer of adipic acid with isophthalic acid, maleic anhydride, 2-methyl-1,3-propanediol, 2,2-dihydroxymethyl butanol and dimethyl-2,6-naphthanlene dicarboxylate.

Polymer of isophthalic acid, maleic anhydride, phthalic anhydride, phosphoric acid, trimethylol propane and 2-methyl-1,3-propanediol.

Polymer of isophthalic acid and terephthalic acid, adipic acid, trimethylol propane, 2-methyl-

1,3-propanediol and ethylene glycol.

4. Resins for food Contact Materials and Products that Expand usage or usage

Polyvinyl chloride

Source: Global FoodMate

Xinhua News Agency was authorized to issue explanation of plan for institutional reform of the State Council by Nikolaas Tilkin-Franssens

On March 13,2018, State Councilor Wang Yong explained plan for institutional reform of the State Council on the 1st Session of the 13th National People's Congress. Plans regarding food supervision were as follows: China Food and Market Supervision and Administration would be established, State Administration for Industry & Commerce, General Administration of Quality Supervision, Inspection and Quarantine and China Food and Drug Administration (AQSIQ) would be canceled, and inspection and quarantine duties and team of AQSIQ were incorporated into General Administration of Customs. The final scheme should be approved by National People's Congress.

Source: Global FoodMate

China National Health and Family Planning Committee (NHFPC) Issued New Approved Food Additives by Nikolaas Tilkin-Franssens

On March 1, 2018, an announcement was issued by National Health and Family Planning Committee (NHFPC) about fructosyltransferase (also named β-fructosyltransferase) functioned as enzyme preparations for food industry and expending usage scope of 7 food additives, such as diglycerin fatty acid esters and others.

1.      New variety of enzyme preparations for food industry is fructosyl transferase (Also named β-fructosyl transferase) from Aspergillus oryzae. 

The quality of Fructosyl transferase/β-fructosyl transferase shall comply with the Enzyme Preparations for Food Industry National Standard (GB 1886.174-2016).

In addition the scope of 7 additives is expanded: Mono and Diglycerides, Dl-Tartaric Acid, Soluble Soybean Polysaccharide, Brilliant Blue, Phosphoric Acid, Lemon Yellow and Nisin.

Source: Global FoodMate

 

China 4 dairy national standards (draft) are being revised by Nikolaas Tilkin-Franssens

Feb 20, 2018, China issued four new national standard drafts about raw milk, pasteurized milk, sterilized milk and method for examination of reconstituted milk.

The drafts have been greatly improved in the three key aspects including raw milk grading, processing technology specification and packaging identification of milk product.

1. Promote the raw milk grading system

The raw milk will be graded into excellent, good and qualified grade, which on the basis of protein and fat content as well as total bacterial count and somatic cell indicators as shown in Table 1.

In order to achieve the better division of milk resources, milk in different grades are applied to different kinds of dairy products. For example, high-quality milk can be made into more profitable pasteurized milk, the milk with relatively low quality can be made into cheese or milk powder products.

3. Packaging identification of milk product

It is stipulated in the new standard that the grade of raw milk used, process parameters and quality parameters can be clearly indicated on label, which is beneficial for Chinese consumers to identify different kinds of products and have a better option

It is indicated that China are narrowing the gap between international dairy standards, and to improve the dairy industry level by marketing demands as well as technical requirement. Besides, due to hot competition in China dairy market, it is believed that China domestic dairy product will grow much stronger and more competitive under the raw milk grading supervision system.

Source: Global FoodMate

Announcement of the General Administration about standardizing the identification of health food function claim (No. 23, 2018) by Nikolaas Tilkin-Franssens

On February 13, 2018, according to the relevant provisions that the health function claimed by the health food shall have a scientific basis in “Food Safety Law of the People's Republic of China”, the relevant matters on the identification of health food function claim are announced as follows:

I. For the health food not evaluated by human consumption, the words “This product has been evaluated by animal experiment” shall be added before the health function claim indicated on the label instructions.

II. The health food production enterprises previously approved listing shall revise the label instructions according to the above-mentioned requirements when the label instructions are reprinted. By the end of 2020, all label instructions for health food shall be revised according to this requirement.

III. Since January 1, 2021, the enterprises which do not revise the label instructions according to the above-mentioned requirements, shall be investigated and treated according to the provisions of “Food Safety Law of the People's Republic of China”.

IV. The specific evaluation technical requirements and identification of the health food evaluated by the human consumption shall be specified separately.

V. This announcement will be implemented from the date of promulgation.

Source: Global FoodMate

Solicited public opinions on new varieties of food additives including L-sodium malate, etc. by Nikolaas Tilkin-Franssens

On February 11, 2018, according to the provisions of the “Measures for the management of new varieties of food additives” and “Provisions on the declaration and acceptance of new varieties of food additives”, the application for new varieties of food additives including L-sodium malate, etc. has passed the technical review by the Expert Review Committee, and is now solicited public opinions.

New varieties of food additives include: L-sodium malate; new varieties of enzyme preparations used in the food industry are as follows: lipase; food additives expanding the usage amount and use scope are as follows: propylene glycol fatty acid ester, brilliant blue, lemon yellow, sunset yellow and carmine.

Source: Global FoodMate

General Administration of Quality Supervision, Inspection and Quarantine solicits opinions on the “Standards for the implementation of the quality supervision and inspection of food related products” by Nikolaas Tilkin-Franssens

In order to strengthen the system construction of standards for the implementation of the quality supervision and inspection of food related products (hereinafter referred to as the supervision and inspection implementation standards), improve supervision and inspection technical support ability, the Product Quality Supervision Department under AQSIQ organized to draft “Standards for the implementation of the quality supervision and inspection of food related products”, involving 11 categories of 24 kinds of products, including plastic food related products of membrane bags, containers and tools, nipple products, food contact rubber materials and its products, food packaging paper products, disposable chopsticks, glass bottles, bottle products, metal material food contact products and commercial & industrial food processing equipment, tableware detergent, disinfectant in contact with food and other products. The main contents of the quality supervision and inspection implementation standard include the application scope, product classification, terms and definitions, enterprise scale division, inspection basis, sampling methods and rules, inspection requirements, judgment principles, objection handling, etc.. According to the relevant provisions of the “Measures of AQSIQ for administration of normative documents” and the “Management provisions on implementation standards for product quality supervision and inspection”, now solicit opinions on the “Standards for the implementation of the quality supervision and inspection of food related products” on the website of AQSIQ, and the deadline for publicity is on February 16, 2018.

Source: GlobalFoodMate

China Food and Drug Administration solicits opinions on the guidelines for two clinical trials of formula foods for special medical purposes by Nikolaas Tilkin-Franssens

—Formula food for kidney diseases & muscular attenuation syndrome

In order to further standardize the clinical trial work of formula foods for special medical purposes, to make the clinical research results more scientific and reliable, China Food and Drug Administration (CFDA) issued a draft of the “Guidance for clinical trials of formula foods for special medical purposes for kidney diseases (exposure draft)” and the “Guidance for clinical trials of formula foods for special medical purposes for muscular attenuation syndrome (exposure draft)” in accordance with the “Food Safety Law of the People’s Republic of China”, “Measures for the administration of registration of formula foods for special medical purposes” and “Quality management practices of formula foods for special medical purposes (trial)”. Public opinions from related companies can be submitted to CFDA before February 9, 2018.

Guidance for clinical trial of formula foods for special medical purposes for kidney diseases is a general principle for reference that needs to be considered in clinical trial research of total nutrition formula foods for kidney disease. The main contents include the test purpose, subject selection, withdrawal and termination criteria, test sample requirements, test program design, observation indicators, result judgment, data statistics and management, etc. of clinical trial, to provide guidance for the design, implementation and evaluation of the clinical trial of full nutrition formula for kidney diseases.

Guidance for clinical trials of formula foods for special medical purposes for muscular attenuation syndrome is general principle for reference that needs to be considered in clinical trial research of total nutrition formula foods for muscular attenuation syndrome. The main contents include the test purpose, subject selection, withdrawal, elimination and termination standards, test sample requirements, test program design, observation indicators, result judgment, data statistics and management, etc. of clinical trial, to provide guidance for the design, implementation and evaluation of the clinical trial of full nutrition formula for muscular attenuation syndrome.

For more information refer to formula foods for special medical purposes please also see: https://www.linkedin.com/pulse/china-food-drug-administration-issued-registration-list-rong-liu/

China Food and Drug Administration (CFDA) issued food sampling and inspection plan for 2018 by Nikolaas Tilkin-Franssens

On January 4, 2018, CFDA issued the food safety sampling and inspection plan in the purpose of improving China food safety continuously. The plan is based on the “Food Safety Law of the People’s Republic of China” and “‘13th Five-Year’ national food safety plan”, combined with the actual food safety inspection work.

The plan indicates that 33 major food categories, 137 food species and 218 food subclasses will be covered. 1,350,500 batches will be sampled and inspected in 2018, at national level, provincial level as well as city level.

On the national level, big food enterprises with large market share will be sampled and inspected. Categories include infant formula food, dairy products, meat products, beverages, wines, edible agricultural products and other 30 categories. Besides the sampling and inspection of traditional distribution channels, imported food and food sold online will be also covered in the plan.

One the provincial level, food manufacturers and large catering enterprises with a provincial production license (district or city) will mainly be inspected and sampled. The intensity of sampling and inspection for small workshops, small vendors, small-sized enterprises will be increased appropriately.

On January 18, 2018, in order to further standardize the supervision and inspection work of food safety, the CFDA issued “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 of the 33 food categories.

Food classification shall be judged according to the basic standards of food classification system, when it is judged according to basic standards (GB2760, GB 2761, GB2762, GB2763, GB29921). 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.

Source: Global FoodMate

Letter notifying the “Measures for inspection, supervision and administration of import and export - prepackaged food labels” to WTO/TBT by Nikolaas Tilkin-Franssens

To further optimize the inspection and supervision of import and export prepackaged food labels, to improve the efficiency of supervision and to make the custom clearance of products convenient, we organized to adjust the related content in the “Regulations for inspection, supervision and administration of import and export prepackaged food labels” (Announcement No. 27, 2012), and formulated the “Measures for inspection, supervision and administration of import and export prepackaged food labels” (see Attachment). Please notify it to WTO according to the prescribed procedures. The requirements of import and export for food labels of exporters and export manufacturers have been detailed in the revised draft. For importers, the requirements such as “The importers shall retain the label information of their imported foods for 2 years at least, and accept the supervision and sampling inspection on the labels of imported prepackaged foods carried out by the inspection and quarantine bodies.” has been added in the revised draft, which explains the storage period of import food labels information for importers and the acceptance of supervision and sampling inspection of related organizations.

There are no requirements stipulated for the industry and commerce business license of importers and dealers; such statement as “When the export prepackaged foods are subject to application for inspection, the specimen page of label and translation shall be provided and the declaration in conformity with the requirements stipulated in Paragraph 2, Article 3 of the Measures shall be submitted.” has been deleted in the requirements for import.

The relevant contents related to the letter of commitment of enterprise have been added in the revised draft, which shall include the following contents: 1. The import prepackaged foods have been affixed or printed with Chinese labels in consistent with the specimen page of Chinese label submitted for application, which comply with the provisions of laws and regulations in China and the requirements of national food safety standards; 2. The imported prepackaged foods shall be proactively recalled according to the provisions specified by Article 63 of “Food Safety Law” if the labels do not meet the provisions of laws and regulations in China and the requirements of national food safety standards.

In addition, the inspection for the import prepackaged food labels has been elaborated, the on-site inspection has been increased, and the release conditions for the foods unselected in the random inspection have been explained in the revised draft. The requirements for the importers when importing prepackaged foods again have been added, and the relevant demands of effectiveness and batches for the importers who are enforced with strict supervision has been made in this revised draft.

Source: Global FoodMate

China National Center for Food Safety Risk Assessment is soliciting opinions on the “National Food Safety Standard for uses of food additives” by Nikolaas Tilkin-Franssens

On 12 December 2017, the China National Center for Food Safety Risk Assessment initiated the process to review the “National Food Safety Standard for uses of food additives” as is required by the formulation & amendment project of national food safety standards of the National Health and Family Planning Commission of 2016. To that purpose it has opened a public consultation to gather the public opionion.

The definition of food additives has been revised; nutritional fortification substances have been included among the food additives; the definition of INS and CNS has been modified; the categorization system has been modified; the inquiry mode of food additives in Annex A has been revised, Table A.2 in the original standard has been deleted, which has been integrated to Table A.1; the food additives functional category in Chapter 8 and the index of provisions for uses of food additives in Chapter 9 have been added in this amendment.

The dried vegetables (dehydrated potato powder only) and dried vegetable (dehydrated potato only) in Annex A have been modified to include cereal products (dehydrated potato product only) (food category number 06.04.02.02); and other coarse cereal products (frozen french fries, frozen potato cake, frozen mashed potato, frozen sweet potato mud and dehydrated potato powder only) in Annex A have been modified to other coarse cereal products (dehydrated potato product only) (food category number 06.04.02.02): the provisions for uses of food additive of the two categories mentioned above remain the same.

Since GB 2760-2014 was issued for implementation, supervision departments have repeatedly reflected that the application range of processing aid-hydrogen peroxide listed in Table C.1 is not clear, and part of the manufacturers use this material for bleaching of chicken feet and trotters that do not belong to processing aids. In order to meet the regulatory needs, it is defined in this standard that hydrogen peroxide in Table C.1 is deleted after this amendment, which will be included in Table C.2, and the function of which is “desulfurizing agent”, the application range is “starch sugar process”.

In addition, cocoa with cocoa butter alternatives and chocolate like products with cocoa butter alternatives (food category number 05.01.03) have been modified to cocoa with cocoa butter alternatives and its products (food category number 05.01.03), and the regulations for uses of the food additives of this category remain unchanged in this amendment. The blended soybean sauce (food category number 12.04.02) and blended vinegar (food category number 12.03.02) have been classified in liquid complex condiment (excluding 12.03, 12.04) (food category number 12.10.03).

Sources: Global FoodMate

China Food and Drug Administration issues the registration list of first batch of formula food for special medical purposes and adjusts the related transitional period by Nikolaas Tilkin-Franssens

On November 20, 2017, the China Food and Drug Administration approved and published the registration of 3 formula foods for special medical purposes of two enterprises.

The formula food for special medical purposes needs to be registered with the food and drug administration departments under the State of Council according to Article 80 of the Food Safety Law.

On March 7, 2016, China Food and Drug Administration issued the “Administrative measures for the registration of formula food for special medical purposes” (No. 24 of China Food and Drug Administration).

On June 24, 2016, the China Food and Drug Administration issued an announcement about the transitional period for registration administration of formula food for special medical purposes (No. 119, 2016), which gave a transitional period till January 1, 2018.

On July 14, 2017, CFDA issued the related auxiliary documents of “Administrative Measures for Registration of FSMP” including trial editions of four document, i.e. items and requirements on composition, labelling and specification as well as requirements on stability research, the main on-site inspection points and the judgment principle.

On September 5, 2017, “Items and requirements of application materials for registration of formula food for special medical purposes (trial) (2017 revised edition)” and “Stability research requirements for formula food for special medical purposes (trial) (2017 revised edition)” (2017 revised edition) were issued.

On November 16, 2017, CFDA and AQSIQ jointly issued the announcement onadjusting the transitional period for registration of FSMP (No. 139 of 2017), which prolonged the transitional period stipulated in Announcement No. 119 of 201 with one year until January 1, 2019. Before that date, FSMP produced within the territory of our country or imported to our territory should obtain a specific FSMP registration certificate including a registration number which needs to be indicated on the label and the specification. In case the date of manufacture is before 31 December 2018 (the day itself included), the product can be sold until the expiration date within the territory of our country.

Source: Global FoodMate

China Food and Drug Administration printed and distributed the implementation plan of rectification work for food and health food fraud and false propaganda by Nikolaas Tilkin-Franssens

New requirements are published in the Notice from 9 Food safety office departments under the State Council regarding food and health food fraud and false propaganda (No 20, 2017 of Food safety Office) and a Notice for the continuation of good work in relation to rectification work on food and health food fraud and false propaganda (No 33, 2017 of Food safety Office). The purpose is to further promote on rectification work and to pay special attention to the objectives of the Chine Food and Drug Administration. The latter has formulated and published the “China Food and Drug Administration Implementation plan of rectification work on food and health food fraud and false propaganda” on November 19, 2017.

The plan calls for strengthening the organization leadership, strengthening the focus of rectification and refining the rectification measures.

The main remediation work relates to all violations of laws and regulations which covers; the production and trade of food and health food without corresponding production licenses; the incorrect labeling and use of claims on the label of food and health food; the illegal marketing and use of propaganda together with fraudulent sales of food and health food; uncensored publication of health food advertisements and the publication of false and illegal advertisements of food and health food; other violations of laws and regulations amounting to food and health food fraud and false propaganda, etc.

The labeling, claims, advertisement and propaganda of food and health food have always been one of the key elements in Chinese food safety regulation, and also a point where problems occur frequently. With the development of the internet and e-commerce and people's health care awareness, many enterprises make inhindered use of obscure claims and propaganda because of the imperfect of Chinese laws and regulations. Many manufacturers claim explicit or implicit treatment, prevention and conditioning of diseases. On the other hand, professional anti-counterfeiting agents are increasingly active. Any language descriptions on a label which are suspected to be functional claims or may have the effect to mislead consumers may be the target of their anti-counterfeiting work. Next to internal issues in relation to fraud, China's supervision on imported food products through cross-border electronic commerce has also been vague, and have led to the market entry of may non legally compliant foods, especially in the case of cross-border electronic commerce. The situation demands for further of the legal system and supervision on the labeling and marking, advertisement and propaganda of products circulating in China.

Source: Global FoodMate

Announcement of National Health and Family Planning Commission on the expansion of the use scope of several additives (National Health and Family Planning Commission, No. 10, 2017) by Nikolaas Tilkin-Franssens

On November 15, 2017, the National Health and Family Planning Commission made a public announcement on its official website announcing expansion of use for 4 varieties of additives among which the food flavoring substance 2-Acetoxy-3-butanone and food additive of β-cyclodextrin. The announcements includes an explanatory notice.

The scope of use for β-cyclodextrin is expanded to other candies other than gum based candy (food category 05.02.02) in the announcement (previously limited to pressed candy); Neotame was approved to be used in instant rice and noodle products as a sweetening agent (food category 06.07); Propylene glycol alginate was approved to be used as thickener, emulsifier and/or stabilizer in fermented flour products (food category 06.03.02.03), bread (food category 07.01), pastry (food category 07.02), baked food fillings and surface slurry (food category 07.04) and other bakery products (food category 07.05); Phosphoric acid was approved as processing aids in sugar processing (food category 06.07).

Most of the additives approved in this announcement have an international corresponding application scope.

Source: Global FoodMate

New regulations on “Measures for the Administration of Entry-exit Inspection and Quarantine Procedures” launched by Nikolaas Tilkin-Franssens

On 16 October 16 2017, the General Administration of Quality Supervision, Inspection and Quarantine of the People’s Republic of China issued the “Measures for the Administration of Entry-exit Inspection and Quarantine Procedures”, have been adopted and will take effect from 1 November 2017.

The “Measures for the Administration of Entry-exit Inspection and Quarantine Procedures” issued by the original State Administration for Entry-Exit Inspection and Quarantine (No. 386, 1999 of State Administration for Entry-Exit Inspection and Quarantine) shall be repealed at the same time.

Regulatory changes

According to the cargo risk level and the enterprise credit level, the new regulations reset the corresponding onsite and laboratory inspection and quarantine proportions of imported commodities, and stipulated the time limit of the port inspection and quarantine procedures.

The inspection of imported cakes & biscuits and wine products is adjusted from 100% (onsite inspection) to a minimum of 3% (sampling inspection). The inspection of imported sugar, tea, beverages and condiments is reduced to a minimum of 5% (sampling inspection). Imported cosmetics is lowered to a minimum of 10% (sampling inspection), and imported meat, dairy products and bee products as well as another 10 major pr3oducts are downed to a minimum of 30% (sampling inspection).

For the commodities that are inspected and need to quarantined or there is evidence to indicate that there exists an increased level of risk – where the consignee & consignor or the inspection personnel award the goods an inspection and quarantine credit at or below C level - the proportion of random inspection can be increased after risk assessment up to 100%. For the commodities whose quality safety level is steady after consecutive random inspection or the level of risk is reduced, and the consignee & consignor or the inspection personnel award the goods with an inspection and quarantine credit of A level or above, the proportion of random inspection can be reduced after risk assessment to the lowest proportion.

The new regulations point out that it is required to strive to improve work efficiency and shorten the time limit of procedures under the premise of standard operation and ensuring the working quality, and forewarn the time limit of procedures of bureaus directly under the jurisdiction by real time and bring into performance appraisal.

The introduction of these new measures means that the imported food and cosmetics enterprises will be able to enjoy more convenient measures to further reduce the corporate customs clearance time, and promote trade facilitation under the circumstances of improving their credit ratings continuously.

The Ministry of Agriculture is soliciting opinions on maximum levels for pesticide residues by Nikolaas Tilkin-Franssens

End of September 2017, the Ministry of Agriculture formulated a draft on the “Maximum residue limits for 71 kinds of pesticides including abamectin in food”, a draft on the “Maximum residue limits for 59 kinds of pesticides including benzovindiflupyr in food” and a draft on the “Determination of glufosinate-ammonium residues in plant-derived foods Liquid chromatography-mass spectrometry method”. The draft acts are now open to comments.

The named acts are mainly an addition to the pesticide residue limits set in GB 2763-2016. The anticipated acts address the shortcoming in the provisions on pesticide residues in China. In addition, it provides for test method for test methods of pesticide residue limits in plant-derived foods.

The State Council revises the “Regulations on the Safety Administration of Agricultural Genetically Modified Organisms” by Nikolaas Tilkin-Franssens

On 23 October 2017 Premier Li Keqiang of the State Council signed a decree of the State Council to announce the “Decision of State Council on amending various administrative regulations” (hereinafter referred to as the “Decision”). The Regulation will take effect from the date of promulgation. The “Regulations on the Safety Administration of Agricultural Genetically Modified Organisms” are modified by the “Decision”. Two of the exisitngart ticles in the “Regulations on the Safety Administration of Agricultural Genetically Modified Organisms” were deleted, and five articles were modified.

Regulatory changes

With the modification, units engaged in the testing of agricultural genetically modified organisms should apply for a safety certficate with the State Council at the end of the production test. It is required that a rest report is provided by the organization.

In addition, when overseas companies export agricultural genetically modified organisms to the People’s Republic of China to be used for as raw materials for processing it should obtain safety certificates. With the certificate the departments of the State Council acknowledge the testing organizations’ capability to handle GM organisms without harming the human, animal & plant, microorganism and ecological environment. This implies that China will be stricter on import inspection as well as the safety evaluation for the management of genetically modified products.

Furthermore, the competencies of the different departments responsible for the safety of genetically modified organisms is clarified. The relevant functions of the national entry-exit inspection and quarantine departments are removed by the amendment. The Ministry of Agriculture is set as the prime responsible for approval and management.

The safety of genetically modified products has been a hot topic in Chinese media and public attention. Entry-exit inspection and quarantine processing should be receive due consideration by enterprises involved.

Source: Global FoodMate

Formula registration in the process of the revision of the infants & young children formula food standard by Nikolaas Tilkin-Franssens

In recent years, infants & young children formula products have received extensive attention in both China and the world. As the study of nutrition science deepens, organizations have successively carried out the revision work for infants & young children formula product standards in recent years. For example, the Codex Alimentarius Commission started revision work for the older infants & young children formula food standard (Codex Stan 156-1987) in 2011, EU issued regulations to modify the nutritional ingredients in infants & young children formula food in 2016, the United States revised the selenium content in infants & young children formula food, Australia and New Zealand is also soliciting opinions on the revision related to infants & young children formula standard.

China released infants & young children formula food standards (GB 10765-2010, GB 10767-2010) very early. In order to promote infants & young children formula food to be more scientific and safer together with further implementation of the requirements of “most stringent standard” and enhancement of the scientificity and safety of our infants & young children formula food standards, the General Office of National Health and Family Planning Commission released the “National food safety standard project plan in 2016 (the second batch)” on December 22, 2016 including revision plan for infants, older infants and young children formula food standards.

According to the introduction of China National Center for Food Safety Risk Assessment, this revision work of infants & young children formula food standard mainly refers to the standards of Codex Alimentarius Commission, and also imitates the infants & young children formula food standards and regulations of EU, the United States and Australia, etc.. At present, the revision work of standard mainly includes the following aspects:

①     The standard framework is changed, and the original standard “Older infants and young children formula” (GB 10767) is divided into “Older infants formula food” standard and “Young children formula food” standard.

②     All nutrient contents were reevaluated.

For infants formula food, the majority of the nutrient content currently meets the needs of infants and will not incur excess risk, so it is recommended to maintain;

For older infants formula food, some data in the existing standards shall be revised according to the latest scientific evidence, the lower limit values of some nutrients need to be adjusted, and the upper limit values of most nutrients need to be set to meet the needs of infants at this age group;

For young children formula food, put forward scientific suggestive value as far as possible according to the present nutritional status of young children in China based on the existing evidence. For example, reduce the protein content range, and regulate the lower limit range of some certain nutrients (such as DHA).

③     Pay attention to the revision progress of International code and the standards of each country in real time. The Codex Alimentarius standard for nutrient contents in older infant formula food (6-12 months old) has been basically completed in revision, which reduces the content of energy and protein, and adjusts the content range of nutrients.

④     The standard revision matches with the current registration requirements;

Since many enterprises, taking into account the detection and shelf life attenuation and other factors, make the target nutrient content close to the larger value, China National Center for food Safety Risk Assessment pointed out that the minimum value in standard rather than the maximum value shall be taken as the designed goal in order to avoid potential security risks. Only the minimum value shall be set according to the requirements, while the maximum value is the index set to prevent excess and control safety.

Impact on infants & young children formula milk powder manufacturing enterprises:

In the perspective of the revision trend of new standard, the scope of some nutrient content will be changed, protein content will be reduced, and the upper or lower limit of some nutrients will also be defined, so many companies worry about whether it is needed to adjust the registered formula or reapply for formula registration. On August 26, 2017, China National Center for food Safety Risk Assessment said that the release and implementation of the new standards would be completed from the revision to administrative licensing of current standard in the next two years.

In view that overseas formula registration requires one year, the time for preparing the second declaration of formula may be shortened to half a year. The infants & young children formula food manufacturers shall follow the revision progress of standard, adjust the existing formulas in a timely manner, and rapidly response to the new standard, which is expected to register smoothly during the transition period of implementing the new standard. As overseas enterprises need a slightly longer time to declare, it will be better for them to do research on formula improvement based on the trend of standard revision in the next 2~3 years. While it may after all be accepted as a good plan for the infants & young children enterprises, which have not yet declared for formula registration to register formula after adjusting formula in accordance with the revision trend of new standards. In addition, there are a variety of micronutrients in infants & young children formula milk powder, and different testing methods may lead to differences in product quality determination results, so the detection bias in the formula design process shall be balanced.

Source: Global FoodMate

Analysis on the second extension of the transitional period for the supervision policy on retail and import of cross-border electronic commerce by Nikolaas Tilkin-Franssens

On 20 September 2017, Li Keqiang presided over the executive meeting of the State Council. On the meeting, it was decided to extend the transitional period for the  supervision policy on retail and import of cross-border electronic commerce to the end of 2018 and speed up the improvement of the system. The news immediately aroused widespread concern in the industry.

The policy document on retail and import refers to the Notice of the Ministry of Finance on the taxation policy of retail and import of cross-border electronic commerce (No.18, 2016 of Ministry of Finance and General Administration of Customs). No clear documents have been issued by the State Council or other relevant ministries. It is not clear what specific policies are included in the transitional period, especially for special categories of food, such as infant formula milk powder as covered in the “Announcement on the publishing of the commodity list of retail and import of cross-border electronic commerce” and the “Announcement on the publishing of the commodity list (second batch) of retail and import of cross-border electronic commerce” which is also the positive list of commodity referred to by industry. According to the provisions of the China Food and Drug Administration, from January 1, 2018, both domestic and imported infant formula milk powder shall be registered through the China Food and Drug Administration. The remarks in the “Commodity list of retail and import of cross-border electronic commerce” issued by the Ministry of Finance define that cross-border e-commerce products are also covered. So the industry is in urgent need of the document to be issued by relevant regulatory authorities to because the development of cross-border electronic commerce of infant formula milk powder may be affected.

The extension of the transitional period with one year creates  time for the practitioners of cross-border electronic commerce to adjust but it cannot solve the fundamental problem. Once the transitional period is over, the final policy will be released, cross-border electronic commerce will face the problems of the “positive list”, “Single quota of 2000 yuan, and annual quota of 20000” again, etc.; in the long term, although there are some uncertainties, the changes will not affect the overall trend. From the meeting of the State Council we can see that the country is supporting the development of cross-border electronic commerce. If there were adjustment in the future, adjustment may mainly focus on the taxation, category of list and buying quota.

It is known that the relevant supervision authorities of cross-border electronic commerce are the Ministry of Commerce, the Ministry of Finance, the State Administration of Taxation, AQSIQ, General Administration of Customs among others. All cross-border electronic commerce companies should keep a close eye on the latest policy developments issued by these departments, including but not limited to positive lists, negative lists (mainly referred to the listed products in “Work specification of business entity of cross-border e-commerce and commodity filing management” issued by AQSIQ”), tariffs, quotas and other types of dynamic conditions.

Source: Global FoodMate

A fresh start for the China infant formula market: 192 infant formulas have obtained a CFDA registration number by Nikolaas Tilkin-Franssens

On 25 August, China’s Food and Drug Administration (CFDA) has announced that a wave of infant nutrition companies and products have passed its new registration programme. It includes 36 enterprises and 192 formulas, including 9 overseas enterprises and 27 domestic enterprises.

In order to better regulate the infant formula market and in order to ensure formulas meet nutritional needs for growth and development of infants and young children, CFDA has implemented the “Administrative Measures for Product Formula Registration of Infants and Young Children Formula” on 1st Oct 2016. Under this regulation, each infant formula manufacturer can only produce a maximum 9 products (i.e. 3 series and 3 formulas for each series). Meanwhile, unregistered formulas (both offline channels and cross-border e-commerce channels) will be restricted from sale as from 1 January 2018. It is apparent that the implementation of this regulation will soon reshuffle China infant formula market.

On the forum on the update on infant formula registration held in Beijing on 15 August, the CFDA indicated that 769 dossiers had been received, of which 565 domestic and 174 foreign. This entailed 114 enterprises (81 domestic enterprises and 33 overseas enterprises). Meanwhile on 14 July, the CFDA also re-confirmed that the deadline is still 1st Jan 2018 and the deadline will not be extended even though 2 out of 3 overseas infant formula manufacturers still did not submit a dossier.

At present, large domestic and overseas infant formula manufactures have already obtained approval for at least 3-6 formulas (or 1-2 series) and these companies already comprise >70% of the Chinese market. A new wave of approved manufacturers and products be issued soon according to the CFDA. For the time being, formulas which have not been approved can still be sold until the indicated expiry date. Meaning that there is only a small risk of supply shortages in the market after the 1st of January 2018-deadline.

There is no doubt that the first waves of approved infant formula manufacturers already obtained a competitive advantage. Since they have more time to organize their production and marketing activities, the easier to win the trust of distributors and consumers.

According to the Regulation, unregistered imported formulas can only be sold in China market with inspection and a quarantine certificate issued before 1st Jan 2018. In general, the time from production to getting inspection and quarantine certificate in China is approx. 3 months. So for those who have already submitted dossier and not yet been approved, it is better to consider suspending or decreasing the production of the existing product. Meanwhile it is critical to make sure the product in the coming few months fully complies with China regulations. Any non-compliance during the next few months will have a negative impact on the approval of the submitted dossier.

Currently, there are still 72 infant formula manufactures which have not submitted their formula registration dossiers, of which about 45 are overseas infant formula manufacturers. Most of the foreign companies are very interested to go on to get their share in the Chinese market. But many small and medium-sized companies still face various challenges to submit their dossier. Main barriers for these companies to submit the dossier timely appear to be 1) underestimation of the complexity of the dossier preparation and insufficient investment in internal & external resources, and 2) insufficient understanding of the Regulation and its update. Registration regulations were updated and adjusted during the last 4 months, however, manufacturers and importers were not able to get reliable information and expert interpretation on time. Infant formula producing enterprises should speed up the preparation of their dossiers with proper investment to get registration approved as early as possible.

Source: Global FoodMate