FORTIFIED & FUNCTIONAL FOODS IN ASIA

LEGISLATION & PRACTICE

MARKETING HEALTH SUPPLEMENTS, FORTIFIED & FUNCTIONAL FOODS IN ASIA - LEGISLATION & PRACTICE 2009
09

MARKETING HEALTH SUPPLEMENTS,

MARKETING HEALTH SUPPLEMENTS, FORTIFIED & FUNCTIONAL FOODS IN ASIA

LEGISLATION & PRACTICE

First Edition published by EAS EAS 2009 EAS Asia 3 Killiney Road #07-04 Winsland House 1 Singapore 239519 Tel: +65 6838 1270 Fax: +65 6835 9536 E-mail: info@eas.asia www.eas.asia EAS Europe 50, Rue de lAssociation B-1000 Brussels Belgium Tel: +32 2 218 14 70 Fax: +32 2 219 73 42 E-mail: info@eas.eu www.eas.eu ISBN 9789080699533
All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, without the prior permission in writing of the publisher, nor be otherwise circulated in any form of binding or cover other than that in which it is published and without a similar condition including this condition being imposed on the subsequent publisher. Designed by The Bubblegate Company Ltd

Contents

Introduction Definitions Part 1: Asian regulatory framework for health supplements, fortified and functional foods 1 Specific regulatory framework across Asia 1.1 Overview of regulations on claims in Asia - Background - International regulatory developments - Asia regulatory developments - Conventional food products - Functional (health) food products - Health supplement products - Summary/next steps 1.2 Regulatory overview of new food and health supplement ingredients in Asia - Background - Novel food regulations in China and Taiwan 1.3 Labelling requirements in Asia - Food allergen labelling - Genetically Modified (GM) food labelling - Nutrition labelling

1 2 3 5 6 6 6 8 8 9 10 11 12 12 12 14 14 16 19

2 Work towards harmonisation: Overview of ASEAN harmonisation on health supplements and food 2.1 ASEAN structure and operation - Background 2.2 Health supplements - Current status of activities towards harmonisation - Development of ASEAN Common Technical Requirements (ACTR) - Business impact assessment for the health supplements sector 2.3 Food - Current status of activities towards harmonisation - Business impact assessment for the food sector

23 24 24 26 26 27 28 29 29 31

3 Work towards international standards 3.1 The Codex Alimentarius decision-making procedure 3.2 Codex action on health supplements, fortified foods and food additives

33 34 35

Contents

Part 2: National regulations on health supplements, fortified and functional foods 1 Brunei Darussalam 2 China 3 Hong Kong 4 Indonesia 5 Malaysia 6 The Philippines 7 Singapore 8 South Korea 9 Taiwan 10 Thailand

39 40 45 51 56 62 69 75 81 86 92

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Marketing health supplements, fortified and functional foods in Asia

Introduction
Consumer demand for health and wellness products is increasing. The global market for products such as vitamins, dietary supplements, botanicals and tonics was estimated to be in excess of USD 60 billion in 2007, and the Asia Pacific region contributes more than 40% of these sales. The functional food markets in the Asia Pacific, United States and Western Europe were estimated to be worth more than USD 70 billion dollars in 2007. Approximately 50% of this market is estimated to be from the Asia Pacific region, where growing affluence and lifestyle changes are expected to keep growth rates high over the coming decade. With the growing markets comes an increased focus of government bodies to ensure that these product categories are regulated. Ensuring compliance with international standards of quality, safety and claimed benefits has become a topic of intense discussion and action across the Asian region. The facilitation of global trade and the desire for international alignment of technical standards and guidelines have stimulated a series of harmonisation discussions and initiatives among the 10 member countries of the Association of South East Asian Nations (ASEAN). In the last five years, steps towards the ASEAN harmonisation of foods, health supplements and traditional medicines have been initiated. The harmonisation of technical requirements and standards, and the development of infrastructures in the areas of training and postmarketing surveillance, will be key factors in shaping the regulatory framework for marketing products across the ASEAN member countries. In the long term, this regional integration effort is likely to have a significant impact on other countries in the Asian region. For companies, the ability to develop an effective market development strategy for their products is heavily dependent on understanding the existing and emerging legislative framework, and ensuring that their regulatory strategy is in line with this. This publication is a practical guide to the regions regulatory systems and a key tool to assist companies and authorities in navigating Asia's complex regulatory maze for health supplements, fortified and functional food products.

Introduction

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Part 1

Definitions
Across the world, terms such as supplements, fortified and functional foods are defined differently. This is also the case in the Asian region for the following expressions:

Health Supplements
Health Supplement is the general terminology used in this report. Typically, this refers to products in specific dosage form such as capsules, tablets, liquids, syrups and so forth. These products are used to supplement a diet for health maintenance and/or enhancement. Depending on the national legislation, the composition of health supplements may consist of one or more, or a combination of ingredients that have a beneficial nutritional or physiological effect. These ingredients can include: Vitamins, minerals, amino acids (natural and synthetic); Bioactive substances derived from natural sources, including animal and botanical materials in the form of extracts, concentrates and isolates. Some variations of the term 'health supplement' are used by the different Asian regulatory authorities within their regulations: Dietary Supplement Food Supplement Health Supplement Health and Functional Food Health Food Nutrient Supplement used in Malaysia used in Indonesia, Thailand and the Philippines used in Brunei and Singapore used in Korea used in China and Taiwan regulations, specific to health supplements that carry health claims used in China regulations, specific to health supplements that provide vitamins and minerals to supplement a diet

Asian regulatory framework for health supplements, fortified and functional foods

Fortified Foods
In this report fortified food is defined as a food to which nutrients or nutrient supplements have been added with the aim of improving or enriching the nutrient content of a food. Nutrient supplement, used in the food regulations of Brunei and Singapore, is defined as any amino acid, vitamin or mineral which is added to food for nutrient enrichment purposes. In most Asian countries, the nutrient substances that can be added to conventional food products include vitamins, minerals, amino acids, fatty acids, dietary fibre, and other substances such as plant based ingredients, within the stipulated national guidelines. Of the Asian markets covered in this publication, the only official national definition for the term 'fortification lies with the Philippines. In the Philippines, fortification is defined as the addition of nutrients (such as vitamins and minerals) to processed foods at levels above the natural state.

Functional Foods
In Asia there is currently no official national or harmonised regulatory definition for the term functional food. For the purposes of this publication, functional food can be defined as a food that delivers a health benefit beyond that of basic nutrition and makes a claim about this benefit. Functional foods can be whole foods or foods that naturally contain or have been fortified with nutrients (such as vitamins, minerals, amino acids and essential fatty acids) and/or bioactive substances (such as probiotics, dietary fibre, phytosterols, isoflavones and so forth) that provide a specific benefit to health.
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Labelling requirements in Asia

Part 1

- 1.3

Thailand Thailands Ministry of Public Health (MOPH) issued regulations on food obtained through genetic modification/genetic engineering in 2002. The regulations cover all soybeans, soybean products, corn and corn products, which the Thai MOPH has included in the annex of the guideline. Food products that contain 5% or more genetically modified material in each of the top 3 food ingredients according to their proportion, are required to be labelled as genetically modified XXX. In order to protect the consumer from misleading claims, a statement such as free from genetically modified food is prohibited. Voluntary GM Labelling: In countries with voluntary GM labelling, the regulators will define the requirements of the GM labelling. The Hong Kong Food and Hygiene Departments Centre for Food Safety is one of the few regulatory authorities which has introduced voluntary labelling for GM food. Hong Kong The Hong Kong GM labelling guideline was formulated by representatives from trade, consumer councils and other relevant government departments. It provides a recommended labelling approach for GM food and guides manufacturers in making truthful and informative labels for the consumer. Though the guideline is non-binding in nature, manufacturers are encouraged to adopt it. According to the guideline, any food item with 5% or more GM material in their respective food ingredients (excluding food which does not contain detectable DNA or protein) should be labelled as genetically modified. Countries which do not require GM Food Labelling: Brunei Darussalam Brunei Darussalam does not have any guidelines on GM food. However, a National Authority on Genetic Modification (NAGM) has been set up. It is expected that the NAGM will play a vital role in developing a national framework on the regulation of genetically modified organisms, including GM food labelling. Malaysia In mid 2007 a Biosafety Bill was proposed in the Malaysian Parliament. According to it, importers and manufacturers will be required to label genetically modified ingredients present in food products. Singapore Though Singapore does not have guidelines for GM food labelling, foods that contain GM material are required to be evaluated by the Genetic Modification Advisory Committee (GMAC) in accordance with the GMAC guidelines. Upon completion of the safety evaluation, GMAC will make its recommendation to the Agri-Food & Veterinary Authority (AVA), which will grant the final approval for the import or release of the food product onto the Singapore market.

Nutrition labelling
Many Asian countries have developed or are developing regulations on nutrition labelling. As in most other regions, the typical objective of the nutrition labelling regulations is to provide consumers with information to assist them in making healthy food choices and to encourage manufacturers to develop healthier food products. Apart from a few countries, for example Malaysia, Korea, and Taiwan nutrition labelling is voluntary in most Asian countries, with the exception of special categories of foods and when nutritional claims are made. Table 1 shows the current regulatory status of nutrition claims in the 10 selected Asian countries. Table 1 Mandatory nutrition labelling Hong Kong* Malaysia South Korea Taiwan Voluntary nutritional labelling Brunei Darussalam China Indonesia The Philippines Singapore Thailand

*Hong Kong will implement mandatory nutritional labelling from 1 July 2010. Mandatory Nutrition Labelling: Hong Kong From 1 July 2010, Hong Kong will implement a regulation on mandatory nutrition labelling for pre-packaged food. According to the proposed Guidelines on Nutrition Labelling and Claims, energy, protein, carbohydrates, total fat, saturated fatty acids, trans-fatty acid, sodium and sugar must all be declared on the labels of pre-packaged food. Other nutrients such as vitamins and minerals must also be declared if nutrition claims are being made. The Guidelines on Nutrition Labelling and Claims define which units must be used for the declaration of nutrients. For example, energy content must be expressed as kcal or kJ and other nutrients must be expressed in metric units (grams, milligrams or micrograms). Some pre-packaged foods are exempt from mandatory nutrition labelling. These include food packed in a container that has a surface area of less than 100cm2, individually wrapped confectionery products in a fancy form intended for sale as a single item, and pre-packaged food sold at catering establishments. However, the exemption status will be removed if nutrition claims or energy or nutrient contents are declared on the pack. Malaysia According to the Guide to Nutrition Labelling and Claims developed by the Malaysian Food Safety and Quality Division, nutrition labelling is compulsory for a variety of foods such as prepared cereal food and bread, milk products, canned foods and soft drinks. Mandatory nutritional labelling also applies to foods that have been fortified, enriched, supplemented or strengthened with specific vitamins or minerals. Mandatory nutrients to be displayed on food labels are (a) energy (b) protein (c) carbohydrates and (d) fat. For ready to drink beverages, the total sugar content must be declared. Optional nutrients or components which may be declared, are vitamins, minerals, dietary fibre, sodium, fatty acids and cholesterol, within the stipulated guidelines.

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Part 1 1.3 Labelling requirements in Asia

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Part 2

National regulations on health supplements, fortified and functional foods

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National regulations on health supplements, fortified and functional foods

Singapore

Part 2

Law

The Philippines

Registration fee: PHP 2,000 per generic product and PHP 3,000 for a branded product (excluding testing fees). A registration certificate, which is normally valid for 1 year, will be issued. The renewal of the registration will cost PHP 7,500 and PHP 10,000 for generic and branded products respectively. The renewed registration will be valid for 5 years. Timing: 3-6 months Future: ASEAN is developing a harmonised model on the regulatory process and technical requirements/standards for health supplements. This may substantially change and shape the regulatory framework for the member countries across the ASEAN region, including the Philippines.

Health Supplements Health supplements can be manufactured, imported and marketed in Singapore without pre-marketing approval and licensing from the Singapore Health Sciences Authority (HSA). Manufacturers, importers, distributors and retailers of health supplements must comply with the Guidelines For Health Supplements established by the HSA. The current legislative control of health supplements and related products can be found in the following legislation: 1. The Medicines Act 1975 and its subsidiary legislation especially: Medicines (Prohibition of Sale & Supply) Order; Medicines (Traditional Medicines, Homeopathic Medicines and Other Substances) (Exemption) Order; Medicines (Non-Medicinal Products) (Consolidation) Order; Medicines (Labelling) Regulations; Medicines (Medical Advertisements) Regulations; Medicines (Licensing, Standard Provisions & Fees) Regulations. 2. Medicines (Advertisement & Sale) Act (note section 9: The Schedule of Diseases and Conditions). 3. Sale of Drugs Act & its regulations. 4. The Poisons Act & The Poisons Rules. The onus of responsibility in ensuring the safety and quality of health supplements and compliance with the guidelines for health supplements, lies with the manufacturer, importer, distributor and/or retailer. Food The import and sale of food in Singapore (including food fortified with nutrients and food with added herbal ingredients) is governed by the Sale of Food Act and the Food Regulations, administered by the Agri-Food & Veterinary Authority (AVA). The Sale of Food Act defines food and prohibits the sale of foods unsafe for human consumption, and pre-packed food improperly labelled or labelled in a misleading manner. The Food Regulations stipulate food safety and specification standards; standards for labelling and advertising (including the use of claims); a list of permitted additives and their maximum limits, and tolerable limits for chemical residues. There is no legal definition for fortified foods and functional foods under the Sale of Food Act and the Food Regulations.

Food

Most conventional foods are classified as Category 1 food products. For a food product to be approved, manufacturers are required to demonstrate that it contains only ingredients and additives that are permitted for use in human food and in accordance with the relevant regulations issued by the BFAD. Compliance with the Codex recommended standard on the labelling of pre-packaging foods and BFAD labelling rules and regulation is also required. The documents required include an application letter, accomplished affidavit of undertaking, a valid licence to operate with supplier source, a copy of sales invoice, a commercial sample and a copy of the label. Registration fee: PHP 400 per product. The licence will be valid for 2 years. Timing: 2-3 months.

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Part 2 Singapore

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Singapore

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National regulations on health supplements, fortified and functional foods

Singapore

Part 2

Health Supplements

Fortified and functional foods

Vitamins and minerals
Permitted Vitamin and Mineral Substances The Food Regulations define a nutrient supplement as any amino acid, mineral or vitamin which, when added singly or in combination with food, improves or enriches the nutrient content of food. The vitamins and minerals, and their chemical forms, which are currently permitted as 'nutrient supplements' are listed in the regulations. These include vitamin A, vitamin A acetate, vitamin D2, vitamin D3, biotin, nicotinic acid, zinc sulphate and iron citrate. Maximum and Minimum Levels The Food Regulations specify the maximum limits for the addition of vitamins A and D, and minerals to food. The addition of vitamin A must not increase the vitamin A content to more than 750mcg of retinol activity per reference quantity for that food according to stipulated guidelines. For vitamin D, its addition must not increase the vitamin D content of the food product to more than 10mcg of cholecalciferol. The addition of minerals must not increase the mineral content of the food product to more than 3 times of the daily allowance of the mineral per reference quantity of that food as stated in the guidelines.

Singapore

Vitamins and minerals

Permissible Vitamin and Mineral Substances and Maximum Levels The Guidelines For Health Supplements specify the maximum limits for certain vitamins and minerals in health supplements. Preparations with levels above the maximum limits are subject to regulatory evaluation and approval. Examples include: Vitamin A (acetate palmitate)/ beta-carotene) at levels more than 10,000 IU of vitamin A activity per unit dose; Vitamin D at levels more than 1000 IU of vitamin D activity per unit dose. An updated version of this list can be found on the Singapore Health Sciences Authority website. Prohibited List The Guidelines For Health Supplements prohibits the sale of vitamin B15, vitamin B17 and vitamin K as health supplements. In general, health supplements containing vitamin and mineral substances at levels that are within supplemental levels will most likely not be subject to any pre-marketing approval. In cases of uncertainty, the manufacturer can seek clarification from the authority. Health supplements are subjected to advertisement controls.

Herbs

Herbs

The working definition of a health food supplement in Singapore includes substances derived from natural sources, including botanical materials in the form of extracts, isolates and concentrates. The Guidelines For Health Supplements provides a list of botanical substances that are prohibited/restricted for use in health supplements. In addition, some prohibited herbal substances are in the Schedule of the Poisons Act. Examples of prohibited herbs include Angelica archangelica, Areca catechu and Aristolochia species.

A list of Chinese Medicinal Materials (CMM) permitted for use in food products has been established by the AVA. These CMMs may be used in foods at levels which do not have therapeutic effects on the human body. In principle, in line with the nutrient supplement definition, amino acids can be added singly or in combination to improve or enrich the nutrient content of food. Additionally, carbohydrates, cholesterol, fats, fatty acids, fibre, protein, starch or sugars and prebiotics (inulin and oligofructose) can be added to food products. Permitted amino acids listed in the regulations include, for example, leucine, lysine, methionine and tryptophane. Other nutrients may be added for particular nutritional purposes to 'special food' categories such as diabetic foods, low calorie foods, energy food and infant food as long as the addition is safe and suitable for the target consumer group. These substances may need to be approved by the AVA on a case by case basis.

Other bioactive substances

Other bioactive substances

According to the working definition of a health supplement in Singapore, amino acids and substances derived from natural sources, including animal materials in the form of extracts, isolates and concentrates, can in principle be used in health supplements. Substances listed in the Schedule of Poisons Act and those in the prohibited/restricted list cannot be used in health supplements. Some examples are dimethyl sulfoxide and vitamin K. New bioactive substances are evaluated on a case by case basis by the Singapore Health Sciences Authority. Relevant quality and safety data, as well as data to support the claims, may be requested by the authority. The guidelines stipulate that health supplements shall not contain any active substance, which is a chemically defined isolated constituent of plants, animals or minerals, or a combination of these defined constituents.

Future

The AVA is considering a review of the use of health claims, in line with international guidelines and consistent with national health policies. There are also ongoing reviews on the safety aspects of the food regulations, in line with developments in technological advancements made to food additives.

Distribution

Health supplement products are distributed through pharmacies, health food stores, supermarkets or direct selling channels. A harmonised ASEAN model on the regulatory processes and technical requirements standards for health supplements is targeted for completion by 2010. This will substantially change and shape the regulatory framework for the countries across the ASEAN region, including Singapore.

Future

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Part 2 Singapore

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National regulations on health supplements, fortified and functional foods

Singapore

Part 2

Claims requirements

Singapore

Regulatory overview

Health Supplements Health supplement products are not permitted to bear claims that cannot be adequately substantiated by scientific evidence. Manufacturers/retailers found to be making false, misleading and deceptive claims, as well as claims directly or indirectly referring to the 19 diseases and conditions listed below, are liable for legal punishment. Health claims must not refer to the following 19 diseases: Table 1 1. Blindness 2. Cataract 3. Dangerous drug addiction 4. Diabetes 5. Frigidity 6. Infertility 7. Impotency 8. Leprosy 9. Paralysis 10. Tuberculosis Fortified and Functional Foods There are no specific regulations on claims for functional foods in Singapore. Vitamin and mineral claims for fortified foods are permitted within the stipulated guidelines. Nutritional claims and specific nutrient function claims are permitted by the Singapore AVA within the stipulated guidelines. 11. Cancer 12. Conception and Pregnancy 13. Deafness 14. Epilepsy or Fits 15. Hypertension 16. Insanity 17. Kidney diseases 18. Menstrual disorder 19. Sexual function

Fortified and Functional Foods Nutrient content and nutrient comparative claims may be used if they are in compliance with the requirements of nutrition labelling and nutrient claims stipulated in the Food Regulations and guidelines established by Singapores Health Promotion Board (HPB). The Food Regulations require pre-packed food products carrying nutrition claims to include on their labels a nutrition information panel in the format specified in the regulations. The regulations define nutrition claim as a representation that indicates that a food has a nutritive property and includes a reference to energy, salt, sodium or potassium, amino acids, carbohydrates, cholesterol, fats, fatty acids, fibre, protein, starch or sugars, or any other nutrients. The Handbook on Nutrition Labelling published by the HPB provides detailed guidelines for use of nutrient content claims and nutrient comparative claims. Nutrient Function Claims Nutrient function claims that can be substantiated by generally accepted scientific evidence may be allowed if the following criteria are met: The claims are about essential nutrients that have established recommended intakes and/or are of nutritional importance; There is sufficient generally accepted scientific evidence to prove the suggested functions or roles of the nutrients as claimed; The claims enable the public to understand the information provided and its significance to their overall daily diet; The nutrients mentioned are present in amounts that either meet the requirements of the Food Regulations or the requirements of the nutrient claims guidelines established by the Health Promotion Board; The products carrying the claims are labelled in accordance with the requirements of the Food Regulations for use of nutrition claims; The claim does not state or imply that the nutrients are for the prevention or treatment of a disease. A list of acceptable nutrient function claims for all foods as well as those specifically related to infant food and foods for young children is maintained by the AVA. Examples include: Vitamin B6 is important for the production of energy; Zinc is essential for growth. Vitamin and Mineral Content Claims Claims on the presence of a vitamin or mineral in a food may be used only if the specific quantity of that food contains at least one-sixth of the daily allowance of the relevant vitamin or mineral as stated in the regulation. Claims describing a food as being enriched or fortified with a vitamin or mineral may be used only if the reference quantity for that food, as stated in the regulations, contains at least 50% of the daily allowance of the relevant vitamin or mineral.

Permitted claims

Health Supplements In general, health claims must be consistent with the definition of health supplements. Health supplements must not be advertised or promoted for a specific medicinal purpose (prevention or treatment of any disease or disorder). Manufacturers/retailers must hold the evidence to support the claims and provide it to the authority when required to do so. Permitted claims may include: Relieves general tiredness, weakness; Enhances good health and growth; Supplementing nutrition; Strengthens the body (without reference to body organs); General enhancement/maintenance of healthy functions; Claims supporting healthy function of the human body, such as supporting natural physiological processes (e.g. immune system, circulation, maintaining healthy joints); Soothes sore throat; Assists in maintaining joint mobility.

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Part 2 Singapore

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National regulations on health supplements, fortified and functional foods

South Korea

Part 2

Law
Prohibited claims
Health Supplements Manufacturers/retailers are prohibited from making false, misleading and deceptive claims, as well as claims making direct or indirect reference to the 19 diseases and conditions stated in Table 1 (page 72). Fortified and Functional Foods The Food Regulations currently do not permit the use of the following types of claims on food labels and in advertisements: Claims for therapeutic or prophylactic action; Claims which could be interpreted as advice of a medical nature from any person; Claims that a food will prevent, alleviate or cure any disease or condition affecting the human body; and Claims that health or an improved physical condition may be achieved by consuming any food. The Korean Food and Drug Administration (KFDA) is responsible for setting and implementing standards and specifications for food in general, functional foods, food additives, food packaging and so forth. Food products in South Korea are governed by: KFDA Food Sanitation Act No. 3823 (1986) and Act No. 8113 (2006); Pre-Confirmation based registration system of imported foods, September 2007; Health Functional Food Act (HFFA) 2004. Health supplements in pill, tablet, capsule and liquid form are governed under the HFFA. This Act, which separated health and functional foods (HFFs) from conventional foods, was developed to enhance public health by ensuring the safety of new active ingredients. The law defined HFFs as food supplements containing nutrients or other substances (in a concentrated form) that have a nutritional or physiological effect, and whose purpose is to supplement the normal diet. HFFs are divided into two main categories: Generic Health/Functional Foods The KFDA has approved 37 categories of generic HFFs, which consist of products that carry health benefit claims such as nutrient supplements, ginseng products and soy protein containing products. There are currently 37 types of functional ingredients listed in the HFFA. Product Specific Health/Functional Foods Products containing new ingredients that are not on the authorised list of ingredients for 37 generic HFFs will be subject to individual approval by the Korean Food and Drug Administration (KFDA) for quality, safety and efficacy. The final marketing authorisation of the finished product (containing the approved active ingredient) is granted on a product by product basis, depending on the scientific evidence provided.

Registration/notification
Health supplements
There is no formal pre-marketing approval required for health supplements in Singapore, except when dosage exceeds the permitted maximum daily limit. The onus is generally on the food importer or manufacturer/retailer to ensure that products are safe and in compliance with the regulations. Registration fee: Not applicable Timing: Not applicable

Food

In Singapore there is no formal pre-marketing approval required for food products in the registration process. The onus is on the food importer or manufacturer/retailer to ensure that products are in compliance with the regulations. Registration fee: Not applicable Timing: Not applicable

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Part 2 South Korea

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South Korea

Singapore

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Strategic advice on nutritional products

MARKETING FOOD SUPPLEMENTS, FORTIFIED AND FUNCTIONAL FOODS IN EUROPE

LEGISLATION AND PRACTICE

2008

EAS

Marketing food supplements, fortified and functional foods in Europe

MARKETING FOOD SUPPLEMENTS, FORTIFIED AND FUNCTIONAL FOODS IN EUROPE

2008
Fifth Edition published by EAS EAS 2008 First Edition published 1998 Second Edition published 2000 Third Edition published 2002 Fourth Edition published 2005 EAS Europe 50, Rue de lAssociation B-1000 Brussels Belgium Tel: +32 2 218 14 70 Fax: +32 2 219 73 42 www.eas.eu EAS Asia 3 Killiney Road #07-04 Winsland House 1 Singapore 239519 Tel: +65 6 838 1270 Fax: +65 6 835 9536 E-mail: info@eas-asia.com www.eas-asia.com ISBN 9789080699533
All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, without the prior permission in writing of the publisher, nor be otherwise circulated in any form of binding or cover other than that in which it is published and without a similar condition including this condition being imposed on the subsequent publisher. Designed by The Bubblegate Company Ltd

LEGISLATION AND PRACTICE

Contents

Introduction Definitions Part 1 Food supplements, fortified and functional foods 1.1 Overview of pan-EU rules on food supplements, fortified and functional foods Impact of the EU food supplement Directive on product formulations and labelling Regulation on the addition of vitamins and minerals and of certain other substances to foods Impact of the EU Directive on traditional herbal medicines (THMPD)

1 2

7 9 18 25

Status of EU legislation on PARNUTS (foods for particular nutritional uses) 32 Summary of specific EU food law rules affecting nutritional products EU food additives rules EU flavourings rules Food improvement agents package Novel food ingredients GMO labelling and traceability rules Allergen labelling rules EU rules on irradiated food ingredients 41 41 48 49 54 63 68 71

1.2 National legislation guide on food supplements, fortified and functional foods National regulatory models How to read the national charts Austria Belgium Bulgaria Cyprus Czech Republic Denmark Estonia Finland France Germany Greece Hungary Ireland Italy Latvia Lithuania Luxembourg Malta Netherlands Norway Poland Portugal Romania Russia Slovakia Slovenia Spain Sweden Switzerland Turkey UK

75 76 79 80 83 86 89 92 96 101 103 105 108 112 116 118 120 124 126 129 131 135 138 140 144 146 149 155 158 161 165 168 172 175

1.3 Work towards international standards The Codex Alimentarius decision-making procedure Codex action on food supplements, fortified foods and food additives Part 2 Health claims 2.1 Overview of pan-EU rules on health claims The EU rules on health claims up to mid-2007 EU Regulation on nutrition and health claims 2.2 Guide on national health claims policies General national approaches to health claims Existing national health claims guidelines Belgium Finland Netherlands Norway Spain Sweden Switzerland UK 2.3 Work towards European and international standards for health claims Council of Europe Codex Alimentarius Annexes 1. Current list of EU approved vitamin and mineral substances, which may be used in food supplements 2. Current list of EU approved vitamin and mineral substances, which may be added to foods 3. Current list of EU approved substances, which may be added to PARNUTS foods 4. EU nutrition labelling RDAs 5. Nutrition labelling RDAs of non-EU countries

179 180 181

187 188 189 203 204 216 217 218 220 221 223 225 227 230 233 234 235

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Marketing food supplements, fortified and functional foods in Europe

Introduction
In the last five years the rate of change for the legislation of nutritional products across the European Union has risen significantly. The catalyst in this process can be laid at the door of the EU food supplement Directive, the EU Regulation on the addition of vitamins and minerals and other substances to food and the establishment of pan-EU rules on nutrition and health claims. These legislative changes mirror the political developments that have taken place in the European Union. With the accession of Bulgaria and Romania in 2007 the EU now encompasses 27 Member States, all of which have not only taken on existing EU law, but will be involved in debating and agreeing further legislation. The result is an internal market of more than 400 million people a huge achievement for the EU, but also a significant challenge for businesses looking to benefit from it. Now more than ever, companies must be aware of the pan-European regulatory environment. A company wishing to market a nutritional product across Europe must still comply with a combination of EU and national laws and a range of evolving market practices related to ingredients and levels, health claims, notification/authorisation procedures and distribution practices. It is essential therefore for companies to have an effective guide for negotiating the complex EU maze that currently exists. This fully updated and expanded report is designed to help companies navigate the maze. It provides a complete and up to date overview of the current regulatory landscape across all 27 Member States as well as Norway, Russia, Switzerland and Turkey, to help businesses develop and implement strategies for the marketing of their products across Europe.

Introduction

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Definitions

Definitions
At the international level definitions on food supplements, fortified foods, functional foods and claims vary widely. In Europe the following definitions are covered by European or national legislation/guidelines and relate most closely to the terminology used in this report:

Claims
Regulation 1924/2006 on nutrition and health claims made on defines the term claim as any message or representation, which is not mandatory under Community or national legislation, including pictorial, graphic or symbolic representation, in any form, which states, suggests or implies that a food has particular characteristics. Codex Alimentarius defines the term claim in its 1979 General Guidelines on Claims as any representation which states, suggests or implies that a food has particular characteristics relating to its origin, nutritional properties, nature, production, processing, composition, or any other quality.

Food supplements
The 2002 EU food supplement Directive defines food supplements as "foodstuffs that are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form(*), whose purpose is to supplement the normal diet."
(*) dose form means forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders designed to be taken in measured small unit quantities.

Nutrition Claim
Also known as nutrient content claim. Indicates the presence/absence of a nutrient in a foodstuff (or presence in reduced/increased proportion) or the energy a food provides/ does not provide (or provides at a reduced or increased rate). (EU nutrition labelling Directive 90/496) The EU Regulation on nutrition and health claims defines nutrition claims as any claim, which states, suggests or implies that a food has particular beneficial nutritional properties due to: a) the energy (calorific value) it 1) provides; 2) provides at a reduced or increased rate; or 3) does not provide; and/or b) the nutrients or other substances it 1) contains; 2) contains in reduced or increased proportions; or 3) does not contain. Examples: "low...", "contains...", "reduced", "high in...". The Codex Guidelines for use of nutrition and health claims define a nutrition claim as any representation which states, suggests or implies that a food has particular nutritional properties including but not limited to the energy value and to the content of protein, fat and carbohydrates, as well as the content of vitamins and minerals. The Guidelines include also in this category the following nutrient content claims: Nutrient Content Claim: This claim is a nutrition claim that describes the level of a nutrient contained in food. Examples: "source of...", "high/low in...". Nutrient Comparative Claim: This is a claim that compares the nutrient levels and/or energy value of two or more foods. Examples: "reduced/increased...", "less than...", fewer, more than.

Fortified foods
Most European countries define fortified foods as foods to which nutrients have been added. In some countries this term is limited to the addition of vitamins and minerals to food. In others it also includes the addition of amino acids, unsaturated fatty acids (e.g. fish oils), dietary fibres and other substances such as herbal extracts. Some countries make the distinction of: Enrichment (= addition of nutrients that have not been present in food before); Fortification (= enhancement of nutrient levels already present in the product); Restoration (= restoration of nutrient levels which have been lost within the manufacturing process, storage or handling); Substitution (= addition of a substance/product to substitute a substance/product with similar qualities, e.g. soya milk to replace dairy milk). If a claim on a specific health benefit is made for an enriched or fortified food, it can be considered as a functional food. Regulation 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods did not provide any specific definitions for these different concepts.

Functional foods
A functional food can be defined as a food delivering a benefit to health beyond that of strict nutrition and making a claim about this benefit. Functional foods can be foods, which are fortified with all kind of ingredients (or composed of ingredients) which deliver a specific benefit to health.

Probiotics Prebiotics Synbiotics

Probiotics, prebiotics and synbiotics generally belong to the category of functional foods. They are products designed to improve the intestinal microbial balance. Probiotics contain live microorganisms and, in some cases, enzymes. Lactic acid bacteria (generally lactobacilli and/or bifidobacteria) are mostly added to yoghurt and milk drinks. Prebiotics contain non-digestible nutrients (e.g. carbohydrates, oligosaccharides) which when arriving at the colon are selectively fermented by the local bacteria. They can be designed to promote the growth and/or activity of beneficial bacteria or inhibit the activity of harmful bacteria present in the colon. Synbiotics are a combination of pro- and prebiotics.
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Definitions

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Definitions

Health Claim
The EU Regulation on nutrition and health claims defines: Health Claim: any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health. Examples: contributes to a healthy heart. Reduction of Disease Risk Claim: any health claim that states, suggests or implies that the consumption of a food category, a food or one of its constituents significantly reduces a risk factor in the development of a human disease. Examples: "helps reduce the risk of cardiovascular disease. The Codex guidelines for the use of nutrition and health claims define health claims as any representation that states, suggests or implies that a relationship exists between a food or a constituent of that food and health. Health claims include the following: Nutrient Function Claim: A nutrition claim that describes the physiological role of the nutrient in growth, development and normal functions of the body. Other Function Claims: These claims concern specific beneficial effects of the consumption of foods or their constituents, in the context of the total diet on normal functions or biological activities of the body. Such claims relate to a positive contribution to health or to improvement of a function or to modifying or preserving health. Reduction of Disease Risk Claim: Claims relating the consumption of a food or food constituent, in the context of the total diet, to the reduced risk of developing a disease or health-related condition.

Medicinal Claim
Refers to the prevention or treatment of a disease. (interpretation of EU Directive 2004/27 amending the Community Code for medicines of Directive 2001/83) Examples: "prevents heart disease", "treatment of digestive disorders". Medicinal claims are always reserved to registered pharmaceuticals and therefore not permitted for products sold under food law. Directive 2000/13/EC on the labelling of foodstuffs clearly stipulates that The labelling and methods used must not: () subject to Community provisions applicable to natural mineral waters and foodstuffs for particular nutritional uses, attribute to any foodstuff the property of preventing, treating or curing a human disease, or refer to such properties. (Article 2.1.b)

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Part 1

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Marketing food supplements, fortified and functional foods in Europe

Food supplements, fortified and functional foods

1.1 Overview of pan-EU rules on food supplements, fortified and functional foods

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Overview of pan-EU rules on food supplements, fortified and functional foods

Part 1.1

The lack of pan-EU rules related to nutritional product continues to pose constant marketing problems for the industry. With the recent adoption of the EU Regulation on nutrition and health claims and new EU rules on fortified foods, the European Union has taken a considerable step towards reaching a higher level of harmonisation. However, a number of new EU rules to be applied are currently still under development, leaving companies in a period of transition while getting prepared for the imminent application of the harmonised EU rules in the pipeline. As has always been the case, many additional regulatory aspects and interpretation issues related to nutritional products are still subject to national provisions. The chart below provides an overview of the status of existing pan-EU rules affecting nutritional products, those which are in the EU drafting process and those rules which currently remain to be regulated at the national level. How specific pan-EU rules affect the marketing of food supplements, fortified and functional foods in Europe will be discussed in further detail in this chapter. Details in relation to EU rules on nutrition and health claims and applicable national transition periods will be discussed separately in part 2.1 of this report. Existing pan-EU rules PRODUCT SPECIFIC LEGISLATION Food supplements Foods with added nutrients Foods for particular nutritional uses (PARNUTS) Traditional herbal medicines FOOD LAW Nutrition and Health LEGISLATION claims AFFECTING ALL NUTRITIONAL PRODUCTS Food additives A wide range of additional rules on health claims (e.g. health claims lists, dossier guidelines, nutrient profiles) Revisions of rules for food additives EU rules on food enzymes Flavourings General food labelling requirements Rules on the authorisation and labelling of foods and food ingredients containing, consisting of or produced from GMOs Rules applied to novel food ingredients Rules on irradiated ingredients
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Timing
The chart below provides an overview of the current status and projected time scale for developments related to the EU Directive.
Timing as established by EU Directive Estimated timing

January 2011

Adoption of maximum/ minimum levels

Pan-EU rules under discussion Additional food supplement rules Additional rules on foods with added nutrients Additional PARNUTS rules

Current national rules Additional rules related to food supplements, fortified and functional foods and PARNUTS, not covered by EU legislation.

January 2010

Deadline for MS derogation/EFSA review of vitamin and mineral substances Proposal on maximum/ minimum limits

January 2009

December 2007 July 2007 Health claims rules during specific transition periods defined by the EU Regulation on nutrition and health claims Rules on permitted food enzymes August 2005 Rules on permitted types of flavourings
Requirement for all products to comply with rules of EU Directive Deadline for first submission of dossiers for the addition of other vitamin and mineral substances European Commission Report on other ingredient categories and substances

Possible national exemptions for vitamin and mineral substances not included on the EU list

Orientation Paper

Revision of rules on flavourings

August 2003

Permitted trade for products meeting EU Directive rules EU Directive in force

July 2002

Food Supplement Directive Framework

List of Approved Vitamin and Mineral Substances

Maximum/Minimum Levels for Vitamins and Minerals

List of Other Bioactive Substances

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1.2 National legislation guide on food supplements, fortified and functional foods

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National legislation guide on food supplements, fortified and functional foods

Hungary Part 1.2

Food supplements

Hungary

Law

The Hungarian Decree 37/2004 transposed the EU food supplement Directive into national food law and covers the general principles of the EU Directive, specific rules for vitamins and minerals and lays down the derogated substances. Permitted vitamin and mineral substances The Hungarian Decree permits the use of all vitamin and mineral substances mentioned in Annex II of the EU food supplement Directive. In addition, derogations are granted until the end of 2009 for the use of: DL-methyl-methionine-sulfon-chloride (vitamin U), boron, vanadium, cobalt, and the following additional mineral sources: calcium citrate malate, copper oxide, chromium (III) picolinate, selenic acid and sodium-monoflouride-phosphate. The Hungarian Decree also permits the use of amino acid chelates, yeastmetal complexes and humic acid/ fulvic acid chelates in food supplements. Maximum and minimum levels There are currently no specific maximum limits established for the use of vitamins and minerals in food supplements. The Hungarian Public Health Centre (OTI) currently evaluates the maximum permitted levels on a case by case following the safety approach. According to the Hungarian food supplement Decree the minimum level for vitamins and minerals is 15% of the RDA.

Future

OTI indicated that the Hungarian Health Authorities are in the process of drafting national guidelines on maximum levels for vitamins and minerals and certain other ingredients and a list of botanicals prohibited for use in foods including food supplements which will be used as a guide for the industry and food authorities.

Vitamins and minerals

Fortified and functional foods

Law
In July 2007 the new EU Regulation on the addition of vitamins and minerals and certain other substances to foods became applicable in Hungary. This legislation currently provides clear rules for the addition of vitamins and minerals to foods while herbal ingredients or other substances are not explicitly mentioned in the Regulation. Permitted vitamin and mineral substances The addition of the vitamin and mineral substances as listed in Annex II of EU Regulation 1925/2006 is permitted. Until 2014 national derogations for the use of other vitamin and mineral substances will be provided for certain additional vitamin and mineral substances, such as selenium yeast, which were legally present on the Hungarian market before the EU Regulation became applicable, provided that EFSA has not issued a negative opinion on the particular permitted substance. Maximum and minimum levels There are no specific maximum limits for the addition of vitamins and minerals to food. In accordance with the EU Regulation 1925/2006/EC the minimum daily level for the addition of vitamins and/or minerals to food should be 'a significant amount', meaning 15% of the EU labelling RDA, as mentioned in the Annex of Directive 90/496/EEC. Mandatory fortification There is no mandatory fortification.

Vitamins and minerals

Herbs

Herbal preparations are currently not regulated by a specific national law and are subject to the assessment of OTI. Following evaluation, these are either classified as foods or medicines. Food supplements containing other bioactive substances such as amino acids, unsaturated fatty acids, lactic acid bacteria, isoflavones, coenzyme Q10 at the levels positively evaluated by OTI in the past can be used in food supplements following a successful notification. According to the Hungarian Decree, food supplements need to be notified with OTI at the time of marketing at the latest. The notification has to include the application form, published in Annex IV of the Hungarian food supplement Decree, and a product label. If a food supplement is already launched and marketed in other EU Member State(s), it is recommended to provide an indication about these particular Member State(s) and attach copies of documents proving the legal market entry of the food supplement product (such as sales certificates from national authorities or the submitted national notification forms). After receiving the notification documents OTI will send the applicant a letter confirming the receipt of the documents. Should OTI have serious concerns regarding safety, labelling or other significant comments on the notified product these would be addressed to the applicant within one month after the payment of the notification fee at the latest. Should the comments expressed by OTI not be taken into consideration by the applicant, OTI would inform the Hungarian Food Safety Office which would initiate a control action. The suppliers and importers have full legal responsibility for the safety of their products. Safety controls are coordinated by the Hungarian Food Safety Office and carried out by the Hungarian food control authorities in the post marketing surveillance process. Notification fee: 16, 000 HUF. Timing: Food supplement products may be marketed at the time of the notification. Safety controls are carried out regularly by the Hungarian food control authorities

Other bioactive substances

Notification

Herbs

The addition of herbal extracts to food is currently not regulated and is evaluated on a case by case basis in case of a market control. The addition of other bioactive substances to food is currently not regulated. This is currently evaluated on a case by case basis in case of a market control. According to OTI the notification of fortified foods is currently not compulsory. Products can be sold via all food outlets, direct sales, mail order and other channels. The Hungarian Food Authorities are considering the introduction of a mandatory notification for foods with added nutrients. However, the final decision will be made once the Hungarian Decree implementing the EU Regulation on the addition of vitamins and minerals and of certain other substances to foods is adopted. OTI indicated that the Hungarian Food Authorities are in the process of drafting national guidelines on maximum levels for vitamins and minerals, and certain other ingredients, and a list of botanicals prohibited for use in food products which will be used as a guide for the industry and food authorities.

Other bioactive substances Notification Distribution Future

Distribution
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There are no specific restrictions on the permitted sales channels for food supplements. Notified food supplements can be sold freely via all outlets including supermarkets, health food stores, pharmacies, direct sales, mail order and other channels.
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fortified and functional foods in Europe

Part 2.1

Applicant Applies for the authorisation of a health claim based on newly developed science and/or requesting protection of proprietary data Acknowledgment of application receipt within 14 days Member State authority Forwards application to EFSA without delay

2.1 Overview of pan-EU rules on health claims

Communicates application to Member States and Commission for information

EFSA Endeavours to give its opinion within 5 months if more information is required, time period can be extended (1 month) Forwards its opinion and reasons to Commission, Member States and applicant The opinion is published

NEGATIVE OPINION Commission submits draft decision (no time limit) Within 30 days, the public can provide comments to the Commission

POSITIVE OPINION Commission Within 2 months, adopts final decision, after consulting the Member States

If protection of proprietary data IS NOT requested by applicant Standing Committee Regulatory procedure with scrutiny: after opinion of Committee (no time limits), Council and European Parliament vote within 3 to 4 months

If protection of proprietary data IS requested by applicant Standing Committee Within 3 months Member States adopt an opinion on the draft decision

Commission Without delay, informs the applicant of the decision taken and publishes it in the Official Journal

Commission Without delay, informs the applicant of the decision taken and publishes it in the Official Journal

Commission Without delay, informs the applicant of the decision taken and publishes it in the Official Journal

Community Register Any approved/rejected health claim will be included in the register

Community Register Any approved/rejected health claim will be included in the register and the proprietary data will be protected for a period of five years

Community Register Any approved/rejected health claim will be included in the register

Commission Before the end of the five-year period, the Commission must submit a proposal for the authorisation of the same claim, without restrictions of use

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Part 2.2

Claims Belgium
National guidelines
In 1998 a panel under the coordination of the Belgian Food Federation (Fevia) started working on the development of a draft Code of Conduct on health claims. Further work on this draft Code was however put on hold in 2003 in view of the forthcoming EU Regulation on health claims. The draft Code is now no longer taken into consideration by the Belgian Ministry of Health for claims evaluations. In 2005 the Belgian Ministry of Health then issued guidelines in the form of an indicative positive list of health claims/cosmetic claims. The list includes examples of health claims for food products and cosmetic claims that are not considered to be referring to preventive or curative properties. It does however not exclude the use of other or similar claims. Other similar claims can be made as long as these do not fall within the definition of a medicine and can be substantiated by scientific evidence in order not to be misleading to the consumer. Moreover, for the use of health claims the rules of the Royal Decree of 17 April 1980 on the advertisement of food products need to be respected. This decree specifically mentions that names, claims and pictures, even styled, related to organs, blood or the blood vessel/circulatory and nervous system are prohibited for food products.

2.2 Guide to national health claims policies

Claims categories / lists

The Belgian indicative list of claims currently includes nine health/cosmetic effect sections, which are divided into specific sub-categories: I. II. III. V. Head external use (hearing and equilibrium organs, eyes, mouth and teeth, hair and nails) Breathing (respiratory tract) Circulatory system (blood, limbs external use, cholesterol) Skin external use only (skin care, spots, feet, damaged skin, mother and child, consequences of physical stimuli, diverse)

IV. Digestion (appetite, stomach, intestines/bowels, digestion, intestinal flora)

VI. Locomotory system (muscles external use only, joints, bones) VII. Nerves (mood, spirit, concentration, memory, exams/learning) VIII. General physical status (fit/energy/in good health, resistance/defense/ immune system, metabolism, tiredness/performances, sleep, nutrients/plants or plant preparations) IX. Ageing (free radicals/antioxidants, menopause)

Notification / authorisation

There is no national notification/authorisation procedure for health claims in Belgium. Health claims can be made as long as these can be substantiated by scientific evidence, are not regarded as medicinal and are formulated in a style similar to the claims examples of the indicative positive list of health claims from the Belgian Ministry. The Belgian indicative list of claims applies to all food products making health claims (including nutritional food supplements, herbal food supplements, foods for particular nutritional uses, fortified and functional foods). In addition, it also applies to cosmetic products making cosmetic effect claims. In the absence of specific national health claims regulations and until the application of the EU 'Community list' of health function claims, the Belgian indicative list of claims, in combination with the national advertising law and medicinal product definition, are currently the only existing guidelines to evaluate the permission of specific health claims for food products in Belgium. As soon as the 'Community list' of health function claims will be adopted, the Belgian Ministry will however be required to adapt its health function claims rules for foods to reflect all the requirements of the EU Regulation. For food products, the indicative Belgian list will then be overruled by the positive 'Community list' (expected for adoption by 31 January 2010).

Application

Future

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For further information on European Advisory Services (EAS) and regulatory/strategic marketing advice please contact:

EAS Europe 50, Rue de lAssociation B-1000 Brussels Belgium Tel: +32 2 218 14 70 Fax: +32 2 219 73 42 E-mail: info@eas.be www.eas.eu

EAS Asia 30 Killiney Road 07-04 Winsland House 1 Singapore 239519 Tel: +65 6838 1270 Fax: +65 6835 9536 E-mail: info@eas-asia.com www.eas-asia.com

EAS 2008

Every effort has been made to ensure that the information contained in this publication is reliable. However, the regulation and marketing of food supplements, fortified and functional foods in Europe often involve legal uncertainty and differences of interpretation. EAS shall therefore have no liability whatsoever for any loss or damage resulting from the use of this publication or the information contained herein.

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EU SA RO V /S E GD 45

Two essential regulatory guides for the nutritional product business

Marketing Health Supplements, Fortified & Functional Foods in Asia and Europe
Legislation and practice 2008/2009
Asia
The 100-page EAS green guide explains the different national rules on vitamins and minerals, herbs and other functional ingredients, novel foods and health claims in 10 Asian countries. Brunei Darussalam China Hong Kong Indonesia Malaysia The Philippines Singapore South Korea Taiwan Thailand
08

EAS

Strategi

c advice on nutr itional

product

MARKE

09

TING FOO D

ENTS, PPLEM ASIA ALTH SU ODS IN TING HE NAL FO MARKE NCTIO ED & FU FORTIFI ACTICE PR ION & GISLAT LE

SUPPLE

MARKE LTH TING HEA SUPPLE MENTS ED , FORTIFI CTI & FUN ONAL FOODS CTI N & PRA ISLATIO A - LEG IN ASI 9 CE 200

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AND FUN CTI ONAL FOODS IN EUR OPE - LEGISLA TION AN D PRA CTI CE 200 8

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MARKE TING FO OD SU FORTIFI PPLEM ED AN ENTS, D FUNC LEGISL TIONA ATION L FOOD AND PR S IN EU ACTICE ROPE

Europe
The 250-page EAS blue book covers national rules on vitamins and minerals, herbs and other functional ingredients, and health claims in all EU member states as well as Switzerland, Norway, Turkey and Russia. For further information, please go to www.eas.asia or www.eas.eu

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