New Rules of Registration and Filing of Food Supplements in China

Today I publish an excellent new article from our food contributor from China: regulatory specialist and former food law advisor for the Food and Drug Administration of Beijing Kun Hou. Hopefully it will be the first of a new series about food supplements Chinese market and regulations.

The food supplements market in China has become a diamond mine and its market value is estimated to have reached RMB 1 trillion in 2015 and it’s still growing with a continuous 20% pace annually regardless of the dim GDP growth in China. The 12th Five-year Food Industry Development Plan issued by the National Development and Reform Commission has lifted the food supplements manufacturing business to a national strategy yet the market maturity and consumer consciousness are still to be developed and nurtured.

I myself handled dozens of cases when I was in FDA of Beijing. Many senior citizens in Beijing aged 60 to 75 filed reports concerning food supplements violations, food fraud, false propaganda and other problems on a daily basis. The number of people who feel they have been deceived of the quality increases every day, so as the market value, which shows exactly how strong the market is. Seniors aged over 60 in Beijing get up early to attend meetings held in some hotel at 5 am. Of course they are lured and just curious to see what the offer is at the very beginning. It all ends up with them paying a great sum of money for some food supplements which claim to be healthy or even cancer-preventing yet of no functional values. When they go back home and several days later they start to realize that what they bought is not what they want. They go to FDA with a receipt that provides limited clue and FDA can do ‘nothing’ because they think it’s a guerrilla war they can never win. Those who sell food supplements in China like PERFECT and INFINITUS mostly among friends and relatives are still disliked by people around them. What’s more intriguing is that so many people still cry in their heart for high-quality food supplements which can earn their fundamental trust with a grandeur brand image. So the affluent ask their friends or children to buy it in a foreign country and carry with them overseas. The environment pollution and the food crisis have further implanted a distrust in people’s mind which will need decades to be uprooted.

A Few Tips on the Regulation

The Regulation on the Registration and Filing of Food Supplements in China has just come into force on 1st July 2016.

Food supplements first imported into China mainland excluding those vitamins and minerals food supplements shall be registered by CFDA. By first imported, it means food supplement produced by the same manufacturer from the same country using the same formula. Any food supplement which does not fulfill the three conditions simultaneously shall be deemed food supplements first imported into China mainland and thus needs to be registered. For vitamins and minerals food supplements, filing is required instead of registration. Both the registration and filing shall be initiated by the manufacturer itself. Difference however exists between the two process. Registration shall be conducted by a resident representative in China or an agent located in China. Such requirement does not apply to filing, which means the manufacturer can do this all by himself.

Here I will give a brief introduction on the filing of food supplements and I will leave the registration in a subsequent article which will also feature some comparison between the FS regulations of China and EU&UK.

Basic Requirements

(1)The nutrients of vitamins and minerals shall fall within the category of Ingredients Catalogue of Food Supplements;

(2)The product formula, the name and usage of the raw and supplementary ingredients, efficacy, manufacturing technique, etc shall be in conformity to Chinese laws, regulations, compulsory standards and the technical requirements of Ingredients Catalogue of Food Supplements;

Required Filing Materials

(1) Material of the product formula including the name and usage of the raw and supplementary ingredient, manufacturing technique and quality standard; when it becomes necessary, more materials have to be submitted to demonstrate the provisions according to which the raw material is being used, specifications concerning which part of the raw ingredient has been used, inspection certificate and variety identification;

(2) Introduction to the manufacturing process including production diagram and specification, the critical controlling point and illustration;

(3) Material of the assessment for the safety and nutrition function appraisal including the test material for the ingredients, products excluded by the Ingredients Catalogue of Food Supplements and appraisal material of human consumption; test report of the effective composition or primary composition, hygiene, steadiness, bacteria identification and toxicity; test report of stimulant, prohibited medicine component,etc;

(4) The type, name and relevant standards of the package material that directly contact the food;

(5) Template of the product label and instructions; search material proving that the general name of the product does not contradict the name of a registered drug;

(6) Filing form and undertaking paper of the authenticity of the materials submitted;

(7) Copy of the registration certificate of the company who initiates the filing;

(8) Materials of the technical requirements for the products;

(9) Full-item inspection report issued by a legally qualified institution;

(10) Other materials showing the safety and nutrition function of the products;

(11) Witness statement issued by competent government authorities or legal service providers showing that the applicant is the legal manufacturer the marketed food supplement;

(12) Witness letter issued by competent government authorities showing that the product has been in circulation for at least one year or safety report about the sales of the product and human consumption;

(13) Technical regulations or standards of the country/region where the product has been manufactured or of the international organization;

(14) The actual version of the package, label and instruction of the product in the country where it has been manufactured and circulated;

(15) Registration certificate or business license if the application is been conducted by a resident representative in China or an agent located in China.

The saddest thing in China is the power of law does not always exercise as what is stated in agreed terms. So never assume something is predictable just because it is written on paper. The government has so many that need further and absolute disclosure. Under most circumstances, what kills a cat is not curiosity, it’s opacity. Nevertheless I still believe openness and sharing will ease the way of food circulation around the world.

China and wine: the new norm on terminology translation of imported wine terms

I receive and gladly publish an extremely interesting article by Mariagrazia Semprebon – AgriLegal Consulting. Thanks Mariagrazia!

Many wine companies look eagerly forward to the Chinese market.

By now it is clear that there are some difficulties to penetrate the Chinese wine market and also some critical issues, but with ta good partner and some important preventive measures, it is possible to obtain great satisfactions.

One of the obvious trouble for the exporter is the language, the commercial communication barrier, that risks to cause mischievous misunderstanding.

First of all, the exporter company must translate his commercial name in Chinese characters, otherwise the importer or the Chinese consumer would transliterate the name of the brand in his place (and with little if no care at all).

In addition, it is important to match the brand with Protected Designation of Origin (PDO), Protected Geographical Indication (PGI), after ensuring the legitimacy of the indication according to Chinese laws.

It is also important:

– to clearly identify which is which among the product brand, its origin and the designation of origin – to translate it in order to made it clear to Chinese consumers where the product comes from.

The strength of a collective brand is in fact more incisive when consistently translated in the language of a country with a potential and strong developing market.

To prevent confusion and mistakes and to promote the Chinese wine market advancement, the Chinese government has drafted a standard document which includes many Italian and foreign wine terms translated in Chinese, and also some import regulations.

The Chinese Chamber of Commerce, the Agricultural Institute and its Wine Academy have completed an official guide on the matter.

The “Norm of Terminology Translation of Imported Wines”, 进口葡萄酒相关术语翻译规范, was enacted by the Chinese Ministry of Internal Trade and came into force on 1st September 2015.

It is applicable to all wine businesses which want to export in China.

This “Norm” is the first of its kind in the Chinese wine market, before there were only translation guidelines granted from wine commercial authorities.

The translated terms mainly concern wine grapes types, the most important wine regions and the biggest wine companies of the eleven examined producing countries.

It is structured as a table, according to the English alphabetic order and it is divided into four parts:

– the first chapter concerns norms;

– the second chapter includes label terminology;

– the third chapter involves the fundamental global wine grapes varieties (excluding China), with the type name, the origin country and the grapes color;

– the fourth and last chapter includes the most important wine region and wine cellars, with the name of the main producers.

This is not a binding transliteration, the operator is still free to choose his favorite translation, but it is clear that the standard, once adopted and legitimated, will be asserted by the Chinese government.

It is presumable that this standard translation will spread soon across the wine sector and, consequently, it will be convenient to comply with it to communicate more incisively.

Another fact must be bear in mind, and is that the Chinese names suggested by the guide are not made up by the Chinese Chamber of Commerce, they were already present on the Chinese market from long time, and have been gathered in the “Norm”.

After the implementation of the “Norm of Terminology Translation of Imported Wines”, the Chinese names included in the list will be, probably, adopted by distributors, importers and also from media.

The “Norm of Terminology Translation of Imported Wines” is a perfect instrument for the wine maker, that still does not have registered his brand in China, to verify if his brand transliteration correspond to the one proposed by the guide and to orient himself into the Chinese market.

To the producers who have a Chinese registered brand it is possible to adjust it according to the new norm, or also to try to integrate it into this new norm, when revised.

The Chinese Ministry of Commerce has in fact declared that it will be possible to revise the guide after September 2018 (the Chinese Ministry of Commerce regulation provides in fact that a standard can be modified after three years from its publication to follow market innovations and new technologies).

In the prospect of the seen revision wine cellars, which have a registered brand in China and want to put into the norm of terminology translation (as Zenato has already done), could ask for the integration of their name in the guide.

There are some other advices for wine makers who intend to enter the Chinese market, once transliterated the name of their brands and the product information according to the norm, it is important to register the brand also in China.

Before to do it, it is necessary to control if the brand is already registered or filed in China by somebody else.

If so, wine cellar can claim its brand before a Chinese court but it is an expensive way, it could be better even to consider to change the brand name to some extension for the Chinese market.

What is absolutely to avoid is to register or simply introduce in China a brand without a comprehensive research on the potential prior use of the same brand in the Chinese market, because it can expose the producer to the risk of legal challenges in China.

Finally, the brand registration should not be limited to continental China, but it should include also Taiwan, Hong Kong and Macao.

In the end, to commerce in the Chinese market, it is better not only to take into consideration big cities as Bejing or Shangai, but also think about other areas, for example the so-called “food capital” of China: Guangzhou.

Click here for the Norm.

Linked below are some related articles:

http://www.novagraaf.com/en/news?newspath=/NewsItems/en/wineries-face-new-norm-china

http://www.decanterchina.com/en/?article=1017

http://www.ilfattoalimentare.it/vini-in-cina-mercato.html

A book (available on Amazon) on a conference about wine and China held in 2014 in Montepulciano:

http://www.amazon.it/Il-vino-Cina-conference-Bilingual-ebook/dp/B00JUL31OM