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Inspection and Quarantine (No. 386, 1999 of State Administration for Entry-Exit Inspection and Quarantine) shall be repealed at the same time.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

Revised draft of the PRC Food Safety Regulation submitted to WTO. Analysis of its influence on overseas food companies by Nikolaas Tilkin-Franssens

This August, the China Food and Drug Administration (CFDA) officially notified the “Regulation on the Implementation of the Food Safety Law of the People’s Republic of China (revised draft)” (hereafter referred to as the “draft”) to World Trade Organization (WTO). The draft is a detailed refinement of the current Chinese food safety law framework with some elements have a great potential impact on overseas food factories & exporters. The following provides an overview of those changes which might have to be taken into account.

1.      The Influence on imported foods for which there are no applicable national food safety standards in China

The import of foods for which no national standards exist under Chinese law will be restricted. Essentially, they will have to await the introduction of specific standards. The draft did however exclude the categories mentioned in general food safety standards, such as GB2760. This is positive for some products which before could not be imported, as for example for whey cheese.

At the moment, those who want to export to China without the existence of Chinese standards (e.g. cereal or sport bars) may submit the original or international standards to the Health Department administration of the State Council. The products may be imported into Chine once it is defined that they comply with food safety requirements. This may be positive as well for some products sold overseas but which before were not allowed for importation in China.

In addition, the China national food safety standards are updated and revised constantly. It is of importance that importers pay close attention to the progress of formulation and revision of the national food safety standards. Those products which cannot be imported to China will have standards soon. Take lactic acid as an example, it was only allowed to be imported in powdered form before 2016, after the standard revised recently lactic acid in liquid is also allowed to be imported.

2. Influence on special foods; including infant formula/health foods/food for special medical purposes

The labeling of infant formula and young children food:

1)     Shall indicate the specific source of raw materials

2)     Shall not name the presence of optional ingredients (optional nutrients can be found in GB10765 and GB10767), like DHA xx formula, taurine XX formula food

3)     Functional claims are forbidden to be used

4)     shall be in accordance with the registered or filed label

Importers of health foods and food for special medical purposes will be required to provide a registration certificate for these special food.

3. Food safety control measures for overseas food manufactures

In the occurrence of food safety incidents due to tampered materials provided by registered overseas food manufactures, or as a result of other attributable reasons, the national inspection and quarantine departments shall revoke registration and make a public announcement.

Therefore, be informed that related enterprises authorized in China should pay close attention to the formulation and revision dynamics of the laws and regulations of certification system. Adjustments should be made in time to ensure accordance with the latest requirements of the Chinese certificate system.

When found that imported food do not meet the statutory requirements, the overseas food manufactures , exporters, importers, inspection person, and agents will be included in the list of bad records; the ones that have illegal acts and subject to administrative penalties, can be included in the list of illegal enterprises.

4. Food safety incidents occurring outside China

According to the draft, China entry-exit inspection and quarantine departments can promptly carry out control measures including warnings, return or destruction of the goods, suspension or prohibition to import once a food safety incident has occurred outside of China but which may have an impact on the Chinese territory. In addition, laws and regulations require overseas food manufacturers and importers to pay attention to major food safety incidents occurred abroad as much as possible, and to take preventive measure and make the necessary adjustments.

Source: Global FoodMate

Reply letter of the Office of CFDA defining the transition period for formula product by Nikolaas Tilkin-Franssens

Letter No. 466, 2017 of the Department of Special Food Registration under the Office of CFDA

The CFDA has released the “Reply Letter of the Office of CFDA about Defining the Date of the Transitional Administration Period Implementing Product Formula Registration for imported Formula Food for Special Medical Purposes and Infants & Young Children Formula Milk Powder” on the official website on July 14, 2017. The letter specifies the transition period for “Overseas milk powder” not registered at formula again.

According to the letter of the CFDA, the foods for special medical purposes and infant & young children formula powder produced overseas that has been approved for entry before January 1, 2018 but not yet registered, may be sold until the expiry date in accordance with the related requirements of the CFDA.

This statement is consistent with the “Announcement of the CFDA on the transitional period for product formula registration management of infants & young children formula milk powder (No. 160, 2016)” as published by CFDA on the official website on June 29, 2016.

According to the latter document, the infants and young children formula milk powder produced in our country or exported to our country need to be accompanied by the corresponding product formula registration certificate from January 1, 2018. The label and specification documents should include the registration number. The infants and young children formula milk approved to be produced and sold in our country or exported to our country can be sold till the expiry date before January 1, 2018.

The infants and young children formula milk powder registration system has been implemented since October 1, 2016. CFDA had promised to release document to grant a certain transition period in the market supply of infants and young children formula milk powder.

The transitional period had been foreseen by manufacturers and distributors, and is finally published indicating that the formula registration enters the final state directly. But if product suppl are still left, the milk powder provided with the official approval of importation can still be sold after the deadline in the following year, which ensures the stability of market. However, the registration will be mandatory for newly produced products.

Analysis on the transitional period of infants & young children formula milk power and foods for special medical purposes

1. All the products that have been approved to be produced in domestic and imported by the related departments can be sold until their provided expiry dates and ultimately until January 1, 2018.

2. The infants & young children formula milk power and foods for special medical purposes approved after January 1, 2018 must obtain the formula registration certificate approved by CFDA. The domestic enterprise that has not obtained the certificate needs to suspend production, and the product of its overseas enterprise can’t be imported.

3. “January 1, 2018” refers to the date calculated according to the date of manufacture for domestic enterprises, and the date issuing certificate according to CIQ for imported enterprises, which explained that the declaration date need to be brought forward one month to November, 2017. It needs a shorter time if it is declared by air transportation, while the date of declaration has to be brought forward if it is by sea transportation or others.

4. In face of the above provisions specified by CFDA, the importating enterprises have to declare for entry before the end of the year. The consequence is that the product can only be returned instead of importing.

5. It is estimated that the first batch of infants & young children milk powder registration certificate will be approved in August if it is successful. Enterprises still need to consider affairs such as production license, and import label. In consideration of the registration period, the enterprises that have not submitted for registration need should do so soon.

6. For the current situation, the enterprises without certificate may take into consideration of stocking up. The several following factors shall be comprehensively considered for the amount of inventory: transitional time limit, plant capacity, inventory of dealer and rentable warehouse. However, there is certain risk for stocking up. When the first batch of products with certificate is put into market, the ones without certificate will be disadvantaged.

7. The focus is on registration, and at the same time, it can’t be ignored that the transitional period for cross-border E-commerce is also as on January 1, 2018.
 

Source: Global FoodMate

Specifications regarding the name of formula food for special medical purposes by Nikolaas Tilkin-Franssens

On July 24, 2017, the CFDA issued the “Notice of General office of China Food and Drug Administration on the public consultation for specifications on the name of formula food for special medical purposes”. The document opens the public consultation with a deadline on August 6, 2017.

The draft specifies the product name of formula food for special medical purposes, and clearly states that the product name shall not include the naming rules of content and the general name.

Before, formula food for special medical purposes did not have a corresponding name under national legislation. The anticipated act will provoke a major change for manufactures and distributors and shall improve the disparities in the market regarding the designation of such products to a certain degree. It will prove important to stay up to date with the regulatory changes.

Product Name

The product name of formula food for special medical purposes is made up of a product name and a general name. Each product can have only one product name which may not be the same as the approved product name for formula food for special medical purposes. Except for trademarks, the product name shall use the standard Chinese characters. The product name can be accompanied by a corresponding English product name. Different parts of the general name shall not be marked separately.

The product name of formula food for special medical purposes may use, among others, a trademark name and a grade name. It shall not be the same as the approved and registered brand name of a drug and health food. Where the trademark is used in the product name, the product name needs to comply with the provisions on the product name. Product names shall not include the following;

(I) False, exaggerated and absolute contents and those in violation of scientific principles, such as “Golden packaged”, “Super”, “Upgrade”, “Special grade”, “Top grade”, Ultimate”, “Transcendency”, “Doctor”, “Champion”,Special effects”, “Full effect” and “Comprehensive”, etc.;

(II) Particulars concerning the function of prevention, remission and treatment of disease, such as “Reducing blood sugar”, “Losing weight”, “Weight reduction”, “Treatment”, “Anti-inflammation”, etc.;

(III) Elements explicitly or implicitly declaring functions, such as “Beneficial to intellectual development”, “Increase the resistance or immunity” and “Protect the intestinal function”, or “Reinforcing intelligence”, “Probiotics”, “Easily-digestible”, “Gastrointestinal protection”, “Boost immunity”, “Body training”, etc.;

(IV) Words such as “Upper class”, etc.;

(V) Other words that can mislead the consumer.

Naming rules of general name

The general name of formula food for special medical purpose shall reflect the true nature of the food, use the category name or equivalent name specified in the relevant national food safety standards.

According to the product category, the general name shall be named according to the following rules:

(I) The format of general name of infant formula food for special medical purpose is “Special medical purpose + infant formula food + (product category name)”, such as infant formula food for special medical purpose (no lactose formula).

(II) The format of general name of full nutritional formula food is “Special medical purpose+ full nutritional formula food”, such as “Full nutritional formula food for special medical purpose”.

(III) The format of general name of specific full nutritional formula food is “Formula food for special medical purpose+(product category name)”, such as formula food for special medical purpose (full nutritional formula for obesity surgery).

(IV) The format of general name of non-full nutritional formula food is “Non-full nutritional formula food for special medical purpose + (product category name)”, such as non-full nutritional formula food for special medical purpose (Carbohydrate module).

Interpretation on the“National Nutrition Plan (2017-2030)” with a view on standards and regulations by Nikolaas Tilkin-Franssens

The General Office of the Chinese State Council has distributed the “National Nutrition Plan (2017-2030)” (hereafter referred to as the “Plan”) on July 13, 2017. The Plan includes the national nutrition strategies for 2020 and 2030 and aims to push forward legislation and policy developments in relation to nutrition.

Formulation and revision of standards in relation to nutrition

The Plan revises the currently existing standards on the following points;

1.     The formulation of new recommended dietary reference intakes,

2.     the adoption of recognized investigation methodologies,

3.     screening of general malnutrition risks,

4.     establishment of dietary guidance for diabetics,

5.     formulation of general rules on nutritious food for the elderly,

6.     introduction of nutrition labelling for catered foods, and

7.     nutritional research on the Chinese population, and

8.     investigation of industrial standards.

Furthermore, the Plan aims to step up the progress in the revision of the general standards on the labelling of prepacked foods, the standards on fortified foods, the standards on infant formula together with complementary or other national food safety standards. Additionally, the improvement of the standards on foods for special medical purposes is pursued.

Regarding sport foods, a modification of national and industrial standards is aimed for on a short notice. It aspires to improve the R&D capabilities in the field of sports nutrition to fuel industrial development in the field.

Prior to the adoption of the Plan, the China National Center For Food Safety Risk Assessment (or in short the “CFSA”) had organized a seminar on the Nutrition plan and neutrino related standards on 10 March 2017. The meeting highlighted the progress made in the field of nutrition related standards such as those mentioned above. In addition, it also made mention of the Operational Guidance on Nutritious Student Meals and the establishment of a coordinating group.

As it stands, the development of additional standards or amends and guidance documents in relation to nutritional policy are expected.

Further completion of the list of articles that are both food and traditional Chinese medicine

The Plan also aims to further complete the list of articles which are both food and traditional Chinese medicinal materials.

The National Health and Family Planning Commission had released a draft, but up until today no official version has been released.

Source: Global FoodMate

Comparison between formal edition and exposure draft of “Technical guidelines on labeling normalization for product formula registration of infants and young children formula milk powder (trial)” by Sebastian MELCHOR

For enterprises involved, the greatest highlight is that the formal edition has allowed the labeling of product advertisement, enterprise propaganda and relevant certification information, and defined the requirements for relevant claims. Moreover, the interpretation document has defined several specific requirements as well.

(I). Formal edition & exposure draft

1. Product name

Compared with exposure draft, the basic principle of “Six Prohibitions” is not changed; however, in the formal edition, the examples of “Six Prohibitions” have been completely deleted, which have been included in the interpretation document, with some adjustments.

2. Standard code is not required to be indicated for imported formula milk powder

The formal edition has clearly specified as follows: The domestic manufacturer needs to indicate the standard code executed by the enterprise, while the product standard code is not required to be indicated for imported infants and young children formula milk powder.

3. There are small changes on the highlighted display of product name

Compared with exposure draft, the formal edition makes a simple and clear requirement on the highlighted display of product name, deletes some requirements on “position of product name, and typeface and color of trade name”, and only makes relevant provisions on the total area of typeface and font size.

4. The contents of product advertisement and enterprise propaganda, etc. are allowed to be indicated

The formal edition has deleted the requirement of prohibition on labeling of product advertisement and enterprise propaganda, etc.; which is an undoubted benefit to the enterprises.

5. Claims and certification marks can be optionally marked

The exposure draft has no explanation on claims and other marking, while the formal edition makes clear provisions as follows: the conforming function claim, content claim and the related certification marks can be indicated on the label, but may not appear in the principal display panel, to avoid taking this as a selling point and the excessive packaging of products. It shall note that the claim must be displayed in text, not in a graph or a symbol.

6. Relevant requirements on labeling of raw milk and raw milk powder

The formal edition clearly specifies that the enterprise shall provide relevant evidentiary materials if the source of raw milk and raw milk powder is required to be indicated, which was not mentioned in the exposure draft. This requirement is mainly specific to imported raw materials.

(II). Contents defined in interpretation document

1. There are some changes in the examples of “Six Prohibitions” principle for labeling of product name

2. Conditions for taking the registered trademark as trade name are further defined

3. Requirements on labeling of claims are defined

4. Principal display panel and the contents that can be indicated on the principal display panel are defined

5. Labeling for goat milk powder is defined

6. The requirement that the list of ingredients and nutrition information in the sample of label shall be consistent with that in the application materials and that filled on line is defined.

In general, compared with exposure draft, the formal edition is more reasonable and normative. The enterprise can display personalized information, rather than machine-made template; while the consumer can also have more awareness of products or enterprises, which will facilitate p personalized consumption.

Source: Global FoodMate

NHFPC approves ten new kinds of novel foods by Sebastian MELCHOR

On June 13, 2017, National Health and Family Planning Commission of the People’s Republic of China (NHFPC) issued the announcement on approval of safety assessment material review of ten new kinds of novel foods including Shea butter, etc. FoodMate summarized relevant information as follows:

List of ten kinds of novel foods

1. Shea butter (Sheanut oil, Shea oil)

Source: kernel of Butyrospermum parkii

Limited Applications: confectionary, ice cream, bakery, frying oil.

2. Zeaxanthin

Source: Tagetes erecta L.

Principal component: (3R, 3’R)-dihydroxy-β-carotene

CAS: 144-68-3

Limited Daily Intake: ≤4mg/day (expressed as (3R, 3’R)-dihydroxy-β-carotene)

Note: the usage scope excludes infants and young children food.

3. Borojo powder

Source: fruit of Borojo patinoi Cuatrec

Limited Daily Intake: ≤30g/day

Note: it is not suitable for consumption by infants and young children. The labels and instructions shall be indicated with unsuitable crowds.

4. Sialic acid

Structural formula:

Limited Daily Intake: ≤500 mg/day
Processing: fermented on food grade dextrose and corn pulp by E. coli strain SA-8

5. Cis-15-Tetracosenoic Acid

Source: rapeseed oil

Limited Daily Intake: ≤300mg/day

Limited Applications: edible oil, fat and emulsified fat product, solid beverage, dairy, candy, instant food.

Note: it is not suitable for consumption by infants and young children. The labels and instructions shall be indicated with unsuitable crowds.

6. Aqueous Extract of Seed of Broccoli

Source: seed of Brassica oleracea var. italica Plenck

Limited Daily Intake: ≤1.8g/day

Note: the usage scope excludes infants and young children food.

7. Rice bran fatty alcohol

Source: Rice bran

Principal components: octacosanol, triacontanol, dotriacontanol

Limited Daily Intake: ≤300mg/day

Note: it is not suitable for consumption by infants and young children, and pregnant women. The labels and instructions shall be indicated with unsuitable crowds.

8. γ-linolenic Acid Oil

Source: Cunninghamella echinulata (Thaxter) Thaxter

Processing: mycelium of C. echinulate Thaxter is produced through drying, extraction and refining.

Limited Daily Intake: ≤6g/day

9. Calcium β- hydroxy -β- methyl butyrate (CaHMB)

Structural formula:

Limited Daily Intake: ≤3g/day

Limited Applications: beverage, dairy, cocoa product, chocolate product, candy, bakery, sports nutrition food, formula food for special medical use.

Note: it is not suitable for consumption by infants and young children, children, pregnant and lactating women. The labels and instructions shall be indicated with unsuitable crowds and consumption limit.

10. Lithocarpus litseifolius folium (young leaf)

Source: Lithocarpus litseifolius (Hance) Chun

Processing: young leaf of L. litseifolius is processed through deactivation, rolling, drying.

Limited Daily Intake: ≤10g/day (as dry product)

Consumption instruction: brewing

Note: it is not suitable for consumption by infants and young children. The labels and instructions shall be indicated with unsuitable crowds.

Introduction of novel foods in China

Novel foods refer to the following items in China without traditional eating habits: (I) animals, plants and microorganisms; (II) components separated from animals, plants and microorganisms; (III) food components that have changed in their original structure; (D) other newly developed food raw materials.

For novel foods exported to China, “Administrative measures for safety review of novel foods” requires that except submitting the specified general materials, the evidentiary materials for allowing the products to be produced or sold in local country (area) issued by relevant departments and institutions of exporting country (area), evidentiary materials for production enterprises review or certification issued by relevant institutions and organizations in the country (area) where the production enterprise located shall be submitted.

Source: Global FoodMate

 

 

CFSA asks for opinions on various food additives by Sebastian MELCHOR

As a kind of nutrient supplement of selenium, rich selenium malt powder can be added into wheat flour and various coarse cereals to process rich selenium steamed bun, fine dried noodles, steamed corn bread, bread, biscuit and other foods;

The maximum usage amount of sucrose fatty acid ester applied to add in other oil and fat or oil and fat products (02.05) is 1.2%;

As a kind of preservative, thiamine dilaurylsulfate is used in soy sauce, with additive amount of 20-200mg/kg;

As a kind of nutrient supplement, sodium ferrous citrate is used in modified milk, modified milk powder, confections except chewing gum, and instant cereal including rolled oat (oatmeal), beverage and jelly;

As a kind of enzymic preparation of processing aid used in food industry, chitosanase is applied in the production process of chitosan oligosaccharide, as required in production;

As a kind of acidity regulator, lactic acid is used in flavor fermented milk (01.02.02), as required in production;

As a kind of depilatory of processing aids, paraffin wax is used for depilation process of livestock and poultry, as required in production;

As a kind of antioxidant, Vitamin E is used in pastry (07.02), confection (05.02.02), chocolate and chocolate product (05.01.02) and cocoa product except that in 05.01.01, with maximum usage amount of 0.2g/kg;

As a kind of coating agent, mono-and diglycerides of fatty acids are used for surface-treated fresh fruit (04.01.01.02) and surface-treated fresh vegetable (04.02.01.02), as required in production.

Source: Global FoodMate

New rules for auxiliary materials and processing of health food filing product by Sebastian MELCHOR

 

According to the “Administrative measures for registration and filingmanagement of health food”, the State will implement filing management for the health food in which the used raw materials have been included in the “List of raw materials of health food”and the health food that is imported at the first timeincludedthe supplemented vitamin,mineral and other nutrients.

On May 2, 2017, CFDA has formulated and published the “Auxiliary materials available for health food filing product and application regulations thereof (trial)”and “Main production process of health food filing product (trial)”.The auxiliary materials available for health food filing product and main production process will be modified and supplemented as appropriate depending on the approval of health food registration.

“Auxiliary materials available for health food filing product and application regulations thereof (trial)”

Auxiliary materials available for health food filing product mainly refer to common food additives and other auxiliary materials in health food. The “Auxiliary materials available for health food filing product and application regulations thereof (trial)”issued this time mainly stipulates the list of availableauxiliary materials and application principle thereof as well as application scope, dosage,etc.

This Regulation defines the index that the health food manufactures shall conform to in actual production and filing, which also has a standardized significancefor the health food exported to China by overseas health food enterprises.

“Main production process of health food filing product (trial)”

“Main production process of health food filing product (trial)”mainly stipulates the main production process of tablets, hard capsules, soft capsules, oral liquid, granules and other forms of health food (nutrient supplements)supplementing vitamin, minerals and other nutrients.

(Source: Yantai Foodmate Information Technology Co., Ltd. Food Regulatory Information Express in China)

China FDA issues guidelines for the filing of health food by Sebastian MELCHOR

According to the “Administrative Measures for Registration and FilingManagement of Health Food”, the State will implement filing management for the health food in which the used raw materials have been included in the “List of raw materials of health food”and the health food that is imported at the first timeincludedthe supplemented vitamin, mineral and other nutrients.

On May 2, 2017, CFDA has formulated and published the “Guideline for filing of health food (trial)”, and it has taken effect since the date of promulgation.

The filing of health food refers to such process that the health food manufactures submit the materials indicating the safety, health functions and quality control of the products to the food and drug administration department for filing, publicity and future reference in accordance with legal procedures, conditions and requirements.

This guideline mainly stipulates theapplication scope, filing subject, filing process and requirements, requirements of filing materials format of health food filing, as well as the requirements of the filing materials for domestic & imported health food. 

Application Scope

This guidelineapplies to the filing of health food stipulated in the “Administrative measures for registration and filingmanagement of health food”.

Filing Subject

This guideline provides technical guidance for the filing of health food. Domestic and imported health food enterprises shallstrictly follow thisGuideline.

Filing process

1 Obtain the login ID of filing system

2 Fill and submit the filing information of product

3 Release the filing number, file and make it public. Food Regulatory Information Express in China

The items for filing materials of domestic health food

1.      The registration form for filing of health food, and letter of commitment on legal liability of filing person responsible for the authenticity of the submitted materials

2.      The supporting document of subject registration of the filing person

3.      The product formula materials

4.      The materials of product manufacturing process

5.      Materials of evaluation on safety and healthcare function

6.      The type, name and standards of packaging materials directly contacting with health food

7.      The manuscript of product label and instruction

8.      The materials of product technical requirements

9.      The all-items inspection report issued by the inspection agency entitled with legal qualification and in conformity with the product technical requirements

10.   Related searchin gmaterials of product name

11.   The other materials indicating the safety and health function of products

The items for filing materials of imported health food

In addition to the relevant materials submitted as domestic products, the following materials shall also be submitted:

1.      The supporting documents for registrationof filing person subject

2.      The supporting documents certifyingthat thehealth food has been put intothe market for more than one year

3.      The original texts of technical regulations or standards related to the filed health food of producing country (region) or international organizations

4.      The actual samples of packaging, label and specification of product sold in the producing country (region)

5.      Where thefiling affairs are handled by the permanent representative organization to China of the overseas filing person, the scanned copyof “Registration Certificate of the Permanent Representative Organization to China of Foreign Enterprises” shall be submitted

6.      The original supporting documents, and power of attorney (agreement), etc. issued by overseas organizations

7.       The supporting documents of production and sales, quality management system or GMP, and manufacturing consignment agreement

(Source: Yantai Foodmate Information Technology Co., Ltd. Food Regulatory Information Express in China)