Li Guiying, Medical Insurance Chamber of Commerce
1. Overview of market conditions
In Europe, dietary supplements, known as food supplements, are one of the world's major consumer markets, of which Germany, Italy, the United Kingdom, and France account for two-thirds of the total European consumption.
According to Euromonitor data, the EU food supplement retail market in 2020 is $22.69 billion, with a compound growth rate of 4.2% from 2015 to 2020; The retail market is expected to reach $31.65 billion in 2025, with a compound growth rate of 6.9% from 2020 to 2025.
In the EU, the main sales channels of food supplements are pharmacies, online channels, supermarkets, direct sales, and professional retailers, of which the pharmacy channel will account for 52% in 2020, and will be the main sales channel. Followed by online channels accounting for 19%; The share of the supermarket is 13%; Direct sales channels accounted for 7%, and specialty retail channels accounted for 5%. From the changes of food supplement sales channels in the EU from 2015 to 2020, the proportion of drugstore sales channels was relatively stable, and the proportion was slightly lower than that in 2015. The proportion of sales through online channels is growing rapidly, from 10% in 2015 to 19% in 2020. The proportion of channel sales of professional retailers did not change much, but the proportion of sales of supermarket channels showed a slight downward trend. According to Euromonitor, the main consumer categories for EU consumers are vitamins and minerals, weight management products and sports nutrition products.
Figure Proportion of food supplement channels in the EU in 2020
2. China-eu trade
China and the EU are each other's important trading partners, with strong economic complementarity, broad areas of cooperation and great potential for development. Despite the repeated delays of the COVID-19 pandemic and the slow recovery of the world economy, bilateral trade and investment between China and the EU have grown rapidly.
According to the data of the National Development and Reform Commission, from January to December 2022, the import and export volume of China and the European Union countries was 5,646.798 billion yuan, an increase of 5.6%, the export was 3,743.441 billion yuan, an increase of 11.9%, and the import was 1,903.357 billion yuan, a decrease of 4.9%.
From the perspective of the import of dietary supplements, the EU is the second largest source of China, with the import amount of US $1.20 billion in 2022, an increase of 15.7%, and the export amount of US $310 million, an increase of 12.5%.
According to the customs data, the import situation from the EU from 2014 to 2022 is analyzed. From the overall trend, the import amount shows a growth trend, and 2017 and 2021 are the growth peaks, increasing by 39.7% and 31.7% respectively. The main import countries are Germany, the Netherlands, France, Denmark, Italy and so on. For many years, Germany has been the leading source of China's imports from the EU region, and the amount of imports from Germany in 2022 is 580 million US dollars, accounting for 48.3%, accounting for half of the country.
Chart shows imports from the EU from 2014 to 2022
Data source: China Chamber of Commerce for Import and Export of Pharmaceutical and Health Products
Table of the main source countries of imports from the EU from 2014 to 2022
Data source: China Chamber of Commerce for Import and Export of Pharmaceutical and Health Products
According to the customs data, the situation of China's export of dietary nutritional supplements to the EU is analyzed. From the perspective of development trend, the export amount shows a growth state, among which the export amount to the EU in 2021 has a greater growth, reaching 270 million US dollars, an increase of 30.8%. According to the actual feedback of enterprises, the number of enterprises that pay attention to the EU market and understand the EU market management system is also increasing. China's exports are mainly for the European Union, Germany, the Netherlands, Italy, the Czech Republic, France and other countries. In terms of exports over the years, Germany and the Netherlands ranked first or second respectively.
Figure 2014 and 2022 China's export to the EU amount analysis
Data source: China Chamber of Commerce for Import and Export of Pharmaceutical and Health Products
Table of China's exports to major EU countries from 2014 to 2022
Data source: China Chamber of Commerce for Import and Export of Pharmaceutical and Health Products
3. Management structure and system
Food supplements belong to a category of foods in Europe. The regulation of food supplements in the EU is covered by the EU food regulatory system. Among them, the European Commission is the permanent executive body of the EU, responsible for food safety is the Directorate-General for Health and Food Safety and the competent authorities of the Member States. The safety and functional evaluation of food supplements is primarily the responsibility of the European Food Safety Authority (EFSA), which provides scientific advice and recommendations.
3.1 Legal and regulatory system
The core regulation of food supplements in the European Union is Directive 2002/46/EC "Food Supplements Directive", which stipulates the definition, composition requirements and dosage requirements of food supplements. Due to the differences in regulations between EU member states, resulting in the trade of food supplements in the EU, the EU issued the directive for the unified management of food supplements sold in the EU region, and pointed out that in the case of not violating the provisions of the EC treaty, if there is no relevant specific provisions before the EC, member states can adopt provisions suitable for their national conditions for regulation.
The White Paper on Food safety establishes the basic principles and framework of the EU food safety regulatory system, which is the core and foundation of the EU food safety legal system. In January 2002, the European Union adopted Regulation (EC) No 178/2002 "General Food Regulation" set out the basic principles and requirements of food law.
In addition, Its supporting regulations include Regulation (EC) No 1924/2006 on Nutrition and Health Claims in Foods, Regulation (EC) No 1170/2009 on Vitamins and minerals available in foods including food supplements and their Forms, Regulation (EU) No 1169/2011 Provision of Food Information to Consumers, etc.
The EU Food Additives Regulation (EC) No 1333/2008, Food Additives, sets out the requirements for the additives allowed in food supplements and the amount used. Regulation (EC) No 1332/2008 on Enzymes for Food sets out the requirements for enzyme preparations for food. Regulation (EC) No 1334/2008 "Flavours and Fragrances for Food" regulates the permissible use of flavours in food. Therefore, food additives used in food supplements should meet the requirements of the above three regulations.
3.2 Product marketing requirements
The European Union defines a food supplement in accordance with the Harmonized Directive on Food Supplements. "Food supplement" refers to a food used to supplement the daily diet, which contains concentrated nutrients or other substances with nutritional or physiological effects, either alone or in combination. Including but not limited to vitamins, minerals, amino acids, essential fatty acids, fiber and extracts of various plants and herbs. The regulations also add a "positive list" of vitamins and minerals and their compounds that can be used in the production of food supplements.
Food supplements can be single ingredients or mixtures, and are sold as capsules, tablets, tablets, pills, and other similar liquids or powders in small doses.
3.2.1 Product market access
For market access of food supplements, most countries in the European Union implement a pre-market filing system. Most countries stipulate that food supplements should be listed 30 days before the market (individual countries can be listed on the same day) by the manufacturer should report to the national government for the record, fill in the record form and submit product labels and other relevant information, the government does not approve. Information about the registered product is published on the website, and if it has been registered in one country, the product can be circulated in the EU without having to file with other countries in the EU.
In addition, the pre-market filing management of food supplements is not a mandatory requirement, but an optional requirement for member states, so in Austria, the Netherlands, Sweden do not need to record, the implementation of post-market supervision, by the food supplement manufacturer or responsible person to ensure compliance, the competent authority will regularly carry out market surveillance inspections.
3.2.2 Health claims
Eu Directive 2002/46/EC on Food Supplements defines the rules for nutrition and health claims for food supplements. Regulation (EC)No 1924/2006 Regulation on Food Nutrition and Health Claims effectively regulates and harmonizes the food nutrition and health claims of EU member States, and clearly stipulates the definition, scope, application for registration, general principles and scientific proof of nutrition and health claims.
Food health claims are divided into general health claims and special health claims. General health claims mainly include nutrition claims and health claims, and the EU generally adopts a permitted list management system, mainly referring to vitamins and minerals. For nutrition claims and health claims on the approved list, foods that meet the conditions for use may be labeled; For special health claims, there is an administrative licensing system, which mainly includes disease risk reduction claims, child development and health claims and other claims not included in the permitted list.
In the European Union, the labeling of special health claims must be applied for and provided with relevant scientific research proof materials, and can be labeled after approval by the European Commission. When using a disease risk reduction claim, it should also be noted on the product label, advertisement or promotional material that the claimed disease has multiple risk factors and that reducing one of these risk factors may be beneficial. New health claims that are not included in the permitted list are subject to approval, for which the EU has developed detailed and standardized application and approval procedures.
For the health claims of food supplements, the EU countries basically allow their claimed functions, but the reduction of disease risk claims are allowed in some countries and not in others. In addition, for the claims of food supplements, the content is required to be true, must not contain false, exaggerated and misleading information, must not claim to have the role of preventing or treating disease, must not encourage excessive consumption, must not use "intimidation" promotional means, and the content of the claim must have a clear scientific basis.
In the light of scientific developments and applications for health claims, the Commission may, in due course, amend, add to or withdraw the permitted list.
3.2.3 Label Management
Regulation (EU) No 1169/2011 on the Provision of Food Information to Consumers lays down the general principles, requirements and responsibilities for food labelling. In addition, the label of dietary supplements shall also comply with the special requirements of the Dietary Supplements Directive 2002/46/EC, including: (1) a classification name that can reflect the true properties or product characteristics of the nutrient or substance; (2) Recommended daily consumption; (3) A warning not to exceed the recommended daily consumption; (4) Dietary supplements cannot replace a varied diet; (5) Declare that the product should be placed out of reach of young children.
3.2.4 Supervision of production and operation
The European Union requires food supplement manufacturers to comply with the General Good Practice (GMP) requirements for food production enterprises. The traceability system is implemented at all stages of the production, processing and circulation of food supplements, and relevant records must be kept in each production procedure for inquiry. The production enterprise is mainly responsible for the quality and safety of the product, and when the product does not meet the food safety requirements, the production enterprise must have an appropriate product recall system and corresponding product recall procedures for recall. Production enterprises have the obligation to inform the national regulatory authorities of the relevant situation of the product in a timely manner, and if the enterprise believes that the product sold on the market may cause harm to human health, it should immediately notify the competent authorities. The competent authorities shall establish integrity files for the production enterprises of food supplements. If the products are found to be problematic in the supervision and random inspection after listing, the competent authorities shall take measures such as removing the products from the shelves, imposing fines or requiring production suspension or suspension of business, and record them in the integrity files. When formulating the future supervision and random inspection plan, the intensity and frequency of random inspection of the products of this enterprise shall be increased. And expose relevant issues or situations to the media.
Note: The customs data in this article is preliminary statistical data of 8-digit tariff code, including some raw materials
For more information, please contact the Secretariat of the Medical Insurance Chamber of Commerce Dietary Supplements Committee at 010-58036323