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.

Commission launches IT tool to boost cooperation on possible fraudulent practices

The European Commission has today launched a dedicated IT tool, on the ground of articles 34-40 Reg. (EC) No 882/2004, known as the Administrative Assistance and Cooperation (AAC) system to facilitate the exchange of administrative information between national authorities working to combat cross-border violations in Europe.

In the wake of the horsemeat scandal of 2013, the Commission developed an action plan to strengthen controls of the food supply chain. One of these measures was to set up a pan-European mechanism to ensure the rapid exchange of information between national authorities and the Commission in cases of suspected food fraud cases. As a result, the European Food Fraud Network (FFN) was born and tasked with handling requests for cross-border cooperation. Each Member State has appointed a contact point to handle requests from contact points in the other Member States that form part of the network. This network has been operational since July 2013 and since its creation, the Commission has observed a marked increase in the number of exchanges from 30 in 2013 to 90 so far in 2015, adding up to 180 cases in total since its creation.

Cross border cooperation helps to improve the capability of national authorities to:

  • detect and prevent cross border breaches of EU food chain rules; and if necessary
  • collect the information that is needed to refer a case for further investigation and to ensure appropriate enforcement action

The AAC system will ensure that the Food Fraud Network works even more efficiently and is able to respond more swiftly to information requests.

The Activity Report of the FFN for 2014 reveals that exchanges on suspected frauds mostly relate to mislabelling (for instance with regard to date marking, adding water or ingredients), falsified certification and/or documents and substitution, such as replacement of a higher value species with a lower value species (for example substituting pollock for cod). Importantly, however, statistical conclusions cannot be drawn from these data given that Member States may also exchange information outside of the FFN and that cases which do not have a cross-border dimension, i.e. which occur at purely national level, are not exchanged via the Network.

Next steps and main issues

The system will be used in the first phase by the Food Fraud Network. At a later stage, it will be made available also to the liaison bodies working on cases of Administrative Assistance and Cooperation not related to fraudulent practices.

The details about the AAC systems are provided by Commission Implementing Decision (EU) No 2015/1918, establishing the Administrative Assistance and Cooperation system (‘AAC system’) pursuant to Regulation (EC) No 882/2004 of the European Parliament and of the Council on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules, published on the Official Journal of the European Union on 22nd October 2015.

Key points for a smooth functioning of the systems will be:

  • coordination with other existing IT systems, namely RASFF and TRACES;
  • confidentiality.

On the first point, the whereas (9) of the Decision is clear:

“In certain cases, information concerning non-compliance with food or feed law is disseminated by and among the competent authorities in the Member States through the Rapid Alert System for Food and Feed (RASFF), established in accordance with Regulation (EC) No 178/2002 of the European Parliament and of the Council , and through the Trade Control and Expert System (TRACES), established by Commission Decision 2004/292/EC. In order to avoid unnecessary duplication, that information should be made available through the AAC system to the liaison bodies designated in accordance with Regulation (EC) No 882/2004, so that the Member State notifying that information to the RASFF or TRACES is not required to upload the same information onto the AAC system for the purposes of administrative assistance and cooperation. Accordingly, the RASFF and TRACES applications should be enabled to provide data to the AAC system in order to streamline the process.”

Regarding data protection and security, art. 10-12 provide a general framework, which is well summarized in the whereas (13) of the Decision. These provisions are necessary to ensure an effective investigative and prosecution activity:

“Where the exchange of information provided for in Regulation (EC) No 882/2004 and in this Decision involves the processing of personal data, a careful assessment should be carried out to ensure that the processing is strictly necessary to achieve the purposes of efficient administrative assistance and cooperation, and that such processing is in accordance with the national provisions implementing Directive 95/46/EC of the European Parliament and of the Council and with Regulation (EC) No 45/2001 of the European Parliament and of the Council.

Where exemptions and restrictions of certain rights of the data subjects and obligations of the data controller laid down by Directive 95/46/EC and Regulation (EC) No 45/2001 are considered in order to safeguard the interests referred to in Article 13(1)(d) and (f) of Directive 95/46/EC and in Article 20(1)(a) and (e) of Regulation (EC) No 45/2001, those exemptions and restrictions may only be adopted if they are necessary and proportionate to the objective pursued.

Restrictions to the rights of data subjects should constitute a necessary measure to prevent interference with the official control tasks of the competent authorities and with the assessment of compliance with food law or feed law.

In particular, rights of the data subjects may be restricted, in accordance with Directive 95/46/EC and Regulation (EC) No 45/2001, during the period in which actions are carried out for the purpose of sighting or discrete surveillance, where granting them would jeopardise or undermine the purpose of official controls or investigations.

In order to guarantee a high level of data protection, it is appropriate to establish a maximum timeframe to ensure that personal data do not remain in the AAC system longer than it is necessary to achieve compliance with the rules laid down in Title IV of Regulation (EC) No 882/2004. In particular, a retention period of 5 years, starting from the closure of the administrative assistance and cooperation procedure, should be established, after which time personal data should be removed from the AAC system. The length of the retention period is necessary to give the possibility to the liaison bodies and the Commission to consult the information over a sufficient period of time after the administrative assistance and cooperation procedure has been closed, in order to ascertain the timely identification of reoccurring, connected or widespread non-compliance with food or feed law.”