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MARKETING HEALTH SUPPLEMENTS,

FORTIFIED & FUNCTIONAL FOODS IN ASIA

LEGISLATION & PRACTICE

M

ARKETI NGHEALTHSUPPLEM

ENTS

FORTI FI ED&FUNCTI O

NALFOODSI NASI A

LEGI S

LATI ON&PRACTI CE2009

9


2/29

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: [email protected]

www.eas.asia

EAS Europe

50, Rue de lAssociationB-1000 Brussels

Belgium

Tel: +32 2 218 14 70

Fax: +32 2 219 73 42E-mail: [email protected]

www.eas.eu

ISBN 9789080699533

All rights reserved. No part o this publication may be reproduced, stored in a retrieval system, or transmitted, in any orm or

by any means, without the prior permission in writing o the publisher, nor be otherwise circulated in any orm o 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

MARKETING HEALTH SUPPLEMENTS,

FORTIFIED & FUNCTIONAL FOODS IN ASIA

LEGISLATION & PRACTICE


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Introduction

Definitions

Part 1: Asian regulatory framework for health supplements,

fortified and functional foods

1 Specific regulatory framework across Asia

1.1 Overview o regulations on claims in Asia

- Background

- International regulatory developments

- Asia regulatory developments

- Conventional ood products

- Functional (health) ood products

- Health supplement products

- Summary/next steps

1.2 Regulatory overview o new ood and health supplement

ingredients in Asia

- Background

- Novel ood regulations in China and Taiwan

1.3 Labelling requirements in Asia

- Food allergen labelling

- Genetically Modiied (GM) ood labelling

- Nutrition labelling

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 o activities towards harmonisation

- Development o ASEAN Common Technical Requirements (ACTR)

- Business impact assessment or the health supplements sector

2.3 Food

- Current status o activities towards harmonisation

- Business impact assessment or the ood sector

3 Work towards international standards

3.1 The Codex Alimentarius decision-making procedure

3.2 Codex action on health supplements, ortiied oodsand ood additives

Contents

1

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3

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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

Contents

39

40

45

51

56

62

69

75

81

86

92


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Page 1

EAS Marketing health supplements,ortiied and unctional oods in Asia

Introduction

Introduction

Consumer demand or health and wellness products is increasing. The global marketor products such as vitamins, dietary supplements, botanicals and tonics was estimated

to be in excess o USD 60 billion in 2007, and the Asia Paciic region contributes more

than 40% o these sales. The unctional ood markets in the Asia Paciic, United Statesand Western Europe were estimated to be worth more than USD 70 billion dollars in 2007.

Approximately 50% o this market is estimated to be rom the Asia Paciic region, where

growing aluence and liestyle changes are expected to keep growth rates high over thecoming decade.

With the growing markets comes an increased ocus o government bodies to ensure that

these product categories are regulated. Ensuring compliance with international standards

o quality, saety and claimed beneits has become a topic o intense discussion and actionacross the Asian region.

The acilitation o global trade and the desire or international alignment o technicalstandards and guidelines have stimulated a series o harmonisation discussions and initiativesamong the 10 member countries o the Association o South East Asian Nations (ASEAN).

In the last ive years, steps towards the ASEAN harmonisation o oods, health supplements

and traditional medicines have been initiated. The harmonisation o technical requirementsand standards, and the development o inrastructures in the areas o training and post-

marketing surveillance, will be key actors in shaping the regulatory ramework or marketing

products across the ASEAN member countries. In the long term, this regional integrationeort is likely to have a signiicant impact on other countries in the Asian region.

For companies, the ability to develop an eective market development strategy or their

products is heavily dependent on understanding the existing and emerging legislative

ramework, 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 toassist companies and authorities in navigating Asia's complex regulatory maze or health

supplements, ortiied and unctional ood products.


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EAS

Marketing health supplements, ortiied and unctional oods in AsiaPage 2

Across the world, terms such as supplements, ortiied and unctional oods are deined

dierently. This is also the case in the Asian region or the ollowing expressions:

Health Supplements

Health Supplement is the general termino logy used in this report. Typically, this reers to

products in speciic dosage orm such as capsules, tablets, liquids, syrups and so orth.These products are used to supplement a diet or health maintenance and/or enhancement.

Depending on the national legislation, the composition o health supplements may consist

o one or more, or a combination o ingredients that have a beneicial nutritional or

physiological eect. These ingredients can include:

Vitamins, minerals, amino acids (natural and synthetic);

Bioactive substances derived rom natural sources, including animal and botanical materialsin the orm o extracts, concentrates and isolates.

Some variations o the term 'health supplement' are used by the dierent Asian regulatory

authorities within their regulations:

Dietary Supplement used in Malaysia

Food Supplement used in Indonesia, Thailand and the Philippines

Health Supplement used in Brunei and Singapore

Health and Functional Food used in Korea

Health Food used in China and Taiwan regulations, specifc to health

supplements that carry health claims

Nutrient Supplement used in China regulations, specifc to health

supplements that provide vitamins and minerals

to supplement a diet

Fortified Foods

In this report ortiied ood is deined as a ood to which nutrients or nutrient supplements

have been added with the aim o improving or enriching the nutrient content o a ood.Nutrient supplement, used in the ood regulations o Brunei and Singapore, is deined as

any amino acid, vitamin or mineral which is added to ood or nutrient enrichment purposes.

In most Asian countries, the nutrient substances that can be added to conventional oodproducts include vitamins, minerals, amino acids, atty acids, dietary ibre, and other

substances such as plant based ingredients, within the stipulated national guidelines.

O the Asian markets covered in this publication, the only oicial national deinition or theterm 'ortiication lies with the Philippines. In the Philippines, ortiication is deined as theaddition o nutrients (such as vitamins and minerals) to processed oods at levels above the

natural state.

Functional Foods

In Asia there is currently no oicial national or harmonised regulatory deinition or the term

unctional ood. For the purposes o this publication, unctional ood can be deined as a

ood that delivers a health beneit beyond that o basic nutrition and makes a claim aboutthis beneit.

Functional oods can be whole oods or oods that naturally contain or have been ortiied

with nutrients (such as vitamins, minerals, amino acids and essential atty acids) and/orbioactive substances (such as probiotics, dietary ibre, phytosterols, isolavones and so orth)

that provide a speciic beneit to health.

Definitions

Asian regulatory ramework

or health supplements,

ortiied and unctional oods

Part1


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Marketing health supplements, ortiied and unctional oods in AsiaPage 18 E

AS2008

Page 19

Labelling requirements in Asia

Thailand

Thailands Ministry o Public Health (MOPH) issued regulations on ood obtained through

genetic modiication/genetic engineering in 2002. The regulations cover all soybeans,

soybean products, corn and corn products, which the Thai MOPH has included in the annexo the guideline. Food products that contain 5% or more genetically modiied material in

each o the top 3 ood ingredients according to their proportion, are required to be labelled

as genetically modiied XXX. In order to protect the consumer rom misleading claims, astatement such as ree rom genetically modiied ood is prohibited.

Voluntary GM Labelling:

In countries with voluntary GM l abelling, the regulators will deine the requirements o the

GM labelling. The Hong Kong Food and Hygiene Departments Centre or Food Saety isone o the ew regulatory authorities which has introduced voluntary labelling or GM ood.

Hong Kong

The Hong Kong GM labelling guideline was ormulated by representatives rom trade,consumer councils and other relevant government departments. It provides a recommended

labelling approach or GM ood and guides manuacturers in making truthul and i normative

labels or the consumer. Though the guideline is non-binding in nature, manuacturers areencouraged to adopt it. According to the guideline, any ood item with 5% or more GM

material in their respective ood ingredients (excluding ood which does not contain

detectable DNA or protein) should be labelled as genetically modiied.

Countries which do not require GM Food Labelling:

Brunei Darussalam

Brunei Darussalam does not have any guidelines on GM ood. However, a National Authority

on Genetic Modiication (NAGM) has been set up. It is expected that the NAGM will play avital role in developing a national ramework on the regulation o genetically modiied

organisms, including GM ood labelling.

Malaysia

In mid 2007 a Biosaety Bill was proposed in the Malaysian Parliament. According to it,

importers and manuacturers will be required to label genetically modiied ingredients

present in ood products.

Singapore

Though Singapore does not have guidelines or GM ood labelling, oods that contain

GM material are required to be evaluated by the Genetic Modiication Advisory Committee

(GMAC) in accordance with the GMAC guidelines. Upon completion o the saety evaluation,GMAC will make its recommendation to the Agri-Food & Veterinary Authority (AVA), which will

grant the inal approval or the import or release o the ood product onto the Singapore market.

Part 1 - 1.3

Part 1 1.3 Labelling requirements in Asia

Nutrition labelling

Many Asian countries have developed or are developing regulations on nutrition labelling.

As in most other regions, the typical objective o the nutrition labelling regulations is to

provide consumers with inormation to assist them in making healthy ood choices andto encourage manuacturers to develop healthier ood products.

Apart rom a ew countries, or example Malaysia, Korea, and Taiwan nutrition labelling is

voluntary in most Asian countries, with the exception o special categories o oods and when

nutritional claims are made. Table 1 shows the current regulatory status o nutrition claims inthe 10 selected Asian countries.

Table 1

Mandatory nutrition labelling Voluntary nutritional labelling

Hong Kong*

MalaysiaSouth Korea

Taiwan

Brunei Darussalam

ChinaIndonesia

The Philippines

SingaporeThailand

*Hong Kong will implement mandatory nutritional labelling rom 1 July 2010.

Mandatory Nutrition Labelling:

Hong Kong

From 1 July 2010, Hong Kong will implement a regulation on mandatory nutrition labelling or

pre-packaged ood. According to the proposed Guidelines on Nutrition Labelling and Claims,

energy, protein, carbohydrates, total at, saturated atty acids, trans-atty acid, sodium and sugarmust all be declared on the labels o pre-packaged ood. Other nutrients such as vitamins and

minerals must also be declared i nutrition claims are being made. The Guideli nes on Nutrition

Labelling and Claims deine which units must be used or the declaration o nutrients. Forexample, 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 oods are exempt rom mandatory nutrition labelling. These include

ood packed in a container that has a surace area o less than 100cm2, individually wrappedconectionery products in a ancy orm intended or sale as a single item, and pre-packaged

ood sold at catering establishments. However, the exemption status will be removed inutrition 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

Saety and Quality Division, nutrition labelling is compulsory or a variety o oods such asprepared cereal ood and bread, milk products, canned oods and sot drinks. Mandatory

nutritional labelling also applies to oods t hat have been ortiied, enriched, supplemented

or strengthened with speciic vitamins or minerals. Mandatory nutrients to be displayedon ood labels are (a) energy (b) protein (c) carbohydrates and (d) at. For ready to drink

beverages, the total sugar content must be declared. Optional nutrients or components

which may be declared, are vitamins, minerals, dietary ibre, sodium, atty acids andcholesterol, within the stipulated guidelines.


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Part2

National regulations on

health supplements, ortiied

and unctional oods


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EAS


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Page 75

Registration fee: PHP 2,000 per generic product and PHP 3,000 or a branded product(excluding testing ees). A registration certiicat e, which is normally valid or 1 year, will be

issued. The renewal o the registration will cost PHP 7,500 and PHP 10,000 or generic

and branded products respectively. The renewed registration will be valid or 5 years.

Timing: 3-6 months

Future: ASEAN is developing a harmonised model on the regulatory process and

technical requirements/standards or health supplements. This may substantially change

and shape the regulatory ramework or the member countries across the ASEAN region,including the Philippines.

Most conventional oods are classiied as Category 1 ood products. For a ood productto be approved, manuacturers are required to demonstrate that it contains only

ingredients and additives that are permitted or use i n human ood and in accordance

with the relevant regulations issued by the BFAD. Compliance with the Codex

recommended standard on the labelling o pre-packaging oods and BFAD labellingrules and regulation is also required.

The documents required include an application letter, accomplished aidavit oundertaking, a valid licence to operate with supplier source, a copy o sales invoice,

a commercial sample and a copy o the label.

Registration fee: PHP 400 per product. The licence will be valid or 2 years.

Timing: 2-3 months.

ThePhilippines

Food

National regulations on health supplements,ortiied and unctional oods

Singapore

Part 2 Singapore

Health Supplements

Health supplements can be manuactured, imported and marketed in Singapore withoutpre-marketing approval and licensing rom the Singapore Health Sciences Authority

(HSA). Manuacturers, importers, distributors and retailers o health supplements must

comply with the Guidelines For Health Supplements established by the HSA.

The current legislative control o health supplements and related products can be ound

in the ollowing legislation:

1. The Medicines Act 1975 and its subsidiary legislation especially:

Medicines (Prohibition o 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 o Diseases and Conditions).

3. Sale o Drugs Act & its regulations.

4. The Poisons Act & The Poisons Rules.

The onus o responsibility in ensuring the saety and quality o health supplements andcompliance with the guidelines or health supplements, lies with the manuacturer,

importer, distributor and/or retailer.

Food

The import and sale o ood in Singapore (including ood ortiied with nutrients andood with added herbal ingredients) is governed by the Sale o Food Act and the Food

Regulations, administered by the Agri-Food & Veterinary Authority (AVA).

The Sale o Food Act deines ood and prohibits the sale o oods unsae or human

consumption, and pre-packed ood improperly labelled or labelled in a misleading manner.

The Food Regulations stipulate ood saety and speciication standards; standards or

labelling and advertising (including the use o claims); a list o permitted additives and

their maximum limits, and tolerable limits or chemical residues.

There is no legal deinition or ortiied oods and unctional oods under the Sale o

Food Act and the Food Regulations.

Law

Singapore

Part 2


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Singapore

Permissible Vitamin and Mineral Substances and Maximum Levels

The Guidelines For Health Supplements speciy the maximum limits or certain vitaminsand 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 o vitamin A activity per unit dose;

Vitamin D at levels more than 1000 IU o vitamin D activity per unit dose.

An updated version o this li st can be ound on the Singapore Health Sciences

Authority website.

Prohibited List

The Guidelines For Health Supplements prohibits the sale o vitamin B15, vitamin B17and vitamin K as health supplements.

In general, health supplements containing vitamin and mineral substances at levels that arewithin supplemental levels will most likely not be subject to any pre-marketing approval.

In cases o uncertainty, the manuacturer can seek clariication rom the authority.

Health supplements are subjected to advertisement controls.

The working deinition o a health ood supplement in Singapore includes substances

derived rom natural sources, including botanical materials in the orm o extracts,isolates and concentrates.

The Guidelines For Health Supplements provides a list o botanical substances that areprohibited/restricted or use in health supplements. In addition, some prohibited herbal

substances are in the Schedule o the Poisons Act. Examples o prohibited herbs includeAngelica archangelica, Areca catechu andAristolochia species.

According to the working deinition o a health supplement in Singapore, amino acids

and substances derived rom natural sources, including animal materials in the orm oextracts, isolates and concentrates, can in principle be used in health supplements.

Substances listed in the Schedule o Poisons Act and those in the prohibited/restrictedlist cannot be used in health supplements. Some examples are dimethyl suloxide and

vitamin K.

New bioactive substances are evaluated on a case by case basis by the Singapore HealthSciences Authority. Relevant quality and saety 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 deined isolated constituent o plants, animals or minerals, or a

combination o these deined constituents.

Health supplement products are distributed through pharmacies, health ood stores,

supermarkets or direct selling channels.

A harmonised ASEAN model on the regulatory processes and technical requirements

standards or health supplements is targeted or completion by 2010. This will

substantially change and shape the regulatory ramework or the countries acrossthe ASEAN region, including Singapore.

Future

Herbs

Otherbioactivesubstances

Distribution

Vitaminsand minerals

Health Supplements

Singapore

Part 2 Singapore

Permitted Vitamin and Mineral Substances

The Food Regulations deine a nutrient supplement as any amino acid, mineral orvitamin which, when added singly or in combination with ood, improves or enriches the

nutrient content o ood.

The vitamins and minerals, and their chemical orms, 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 speciy the maximum limits or the addition o vitamins A and D,

and minerals to ood. The addition o vitamin A must not increase the vitamin A

content to more than 750mcg o retinol activity per reerence quantity or that oodaccording to stipulated guidelines. For vitamin D, its addition must not increase the

vitamin D content o the ood product to more than 10mcg o cholecalcierol.

The addition o minerals must not increase the mineral content o the ood product tomore than 3 times o t he daily allowance o the mineral per reerence quantity o that

ood as stated in the guidelines.

A list o Chinese Medicinal Materials (CMM) permitted or use in ood products has

been established by the AVA. These CMMs may be used in oods at levels which do not

have therapeutic eects on the human body.

In principle, in li ne with the nutrient supplement deinition, amino acids can be added

singly or in combination to improve or enrich the nutrient content o ood. Additionally,carbohydrates, cholesterol, ats, atty acids, ibre, protein, starch or sugars and pre-

biotics (inulin and oligoructose) can be added to ood products.

Permitted amino acids listed in the regulations include, or example, leucine, lysine,

methionine and tryptophane.

Other nutrients may be added or particular nutritional purposes to 'special ood'categories such as diabetic oods, low calorie oods, energy ood and inant ood as long

as the addition is sae and suitable or the target consumer group. These substances

may need to be approved by the AVA on a case by case basis.

The AVA is considering a review o the use o health claims, in l ine with international

guidelines and consistent with national health policies.

There are also ongoing reviews on the saety aspects o the ood regulations, in line

with developments in technological advancements made to ood additives.

Future

Herbs

Otherbioactivesubstances

Fortified and functional foods



Part 2


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Health Supplements

Health supplement products are not permitted to bear claims that cannot be adequatelysubstantiated by scientiic evidence. Manuacturers/retailers ound to be making alse,

misleading and deceptive claims, as well as claims directly or indirectly reerring to the

19 diseases and conditions listed below, are liable or legal punishment.

Health claims must not reer to the ollowing 19 diseases:

Table 1

1. Blindness 11. Cancer

2. Cataract 12. Conception and Pregnancy

3. Dangerous drug addiction 13. Deaness

4. Diabetes 14. Epilepsy or Fits

5. Frigidity 15. Hypertension

6. Inertility 16. Insanity

7. Impotency 17. Kidney diseases

8. Leprosy 18. Menstrual disorder

9. Paralysis 19. Sexual unction

10. Tuberculosis

Fortified and Functional Foods

There are no speciic regulations on claims or unctional oods in Singapore. Vitaminand mineral claims or ortiied oods are permitted within the stipulated guidelines.

Nutritional claims and speciic nutrient unction cl aims are permitted by the Singapore

AVA within the stipulated guidelines.

Health Supplements

In general, health claims must be consistent with the deinition o health supplements.

Health supplements must not be advertised or promoted or a speciic medicinal purpose(prevention or treatment o any disease or disorder). Manuacturers/ret ailers 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 reerence to body organs);

General enhancement/maintenance o healthy unctions;

Claims supporting healthy unction o the human body, such as supporting naturalphysiological processes (e.g. immune system, circulation, maintaining healthy joints);

Soothes sore throat;

Assists in maintaining joint mobility.

Singapore

Claims requirements

Permittedclaims

Regulatoryoverview

Singapore

Part 2 Singapore


Nutrient content and nutrient comparative claims may be used i they are in compliancewith the requirements o 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 ood products carrying nutrition claims to

include on their labels a nutrition inormation panel in the ormat speciied in the

regulations. The regulations deine nutrition claim as a representation that indicates

that a ood has a nutritive property and includes a reerence to energy, salt, sodium orpotassium, amino acids, carbohydrates, cholesterol, ats, atty acids, ibre, protein, starch

or sugars, or any other nutrients.

The Handbook on Nutrition Labelling published by the HPB provides detailed guidelines

or use o nutrient content claims and nutrient comparative claims.

Nutrient Function Claims

Nutrient unction claims that can be substantiated by generally accepted scientiicevidence may be allowed i the ollowing criteria are met:

The claims are about essential nutrients that have established recommended intakesand/or are o nutritional importance;

There is sufcient generally accepted scientifc evidence to prove the suggestedunctions or roles o the nutrients as claimed;

The claims enable the public to understand the inormation provided and itssignifcance to their overall daily diet;

The nutrients mentioned are present in amounts that either meet the requirements othe Food Regulations or the requirements o the nutrient claims guidelines established

by the Health Promotion Board;

The products carrying the claims are labelled in accordance with the requirements othe Food Regulations or use o nutrition claims;

The claim does not state or imply that the nutrients are or the prevention ortreatment o a disease.

A list o acceptable nutrient unction claims or all oods as well as those speciicallyrelated to inant ood and oods or young children is maintained by the AVA.

Examples include:

Vitamin B6 is important or the production o energy;

Zinc is essential or growth.

Vitamin and Mineral Content Claims

Claims on the presence o a vitamin or mineral in a ood may be used only i the speciic

quantity o that ood contains at least one-sixth o the daily allowance o the relevant

vitamin or mineral as stated in the regulation.

Claims describing a ood as being enriched or ortiied with a vitamin or mineral may beused only i the reerence quantity or that ood, as stated in the regulations, contains atleast 50% o the daily allowance o the relevant vitamin or mineral.


Part 2


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Singapore

Health Supplements

Manuacturers/retailers are prohibited rom making alse, misl eading and deceptiveclaims, as well as claims making direct or indirect reerence to the 19 diseases and

conditions stated in Table 1 (page 72).


The Food Regulations currently do not permit the use o the ollowing types o cl aims onood labels and in advertisements:

Claims or therapeutic or prophylactic action;

Claims which could be interpreted as advice o a medical nature rom any person;

Claims that a ood will prevent, alleviate or cure any disease or condition aecting thehuman body; and

Claims that health or an improved physical condition may be achieved by consumingany ood.

There is no ormal pre-marketing approval required or health supplementsin Singapore, except when dosage exceeds the permitted maximum daily limit.

The onus is generally on the ood importer or manuacturer/retailer to ensure that

products are sae and in compliance with the regulations.

Registration fee: Not applicable

Timing: Not applicable

In Singapore there is no ormal pre-marketing approval required or ood products in the

registration process. The onus is on the ood importer or manuacturer/retailer to ensurethat products are in compliance with the regulations.

Registration fee: Not applicable

Timing: Not applicable

Food

Prohibitedclaims

Registration/notification

Healthsupplements

South Korea

Part 2 South Korea

The Korean Food and Drug Administration (KFDA) is responsible or setting and

implementing standards and speciications or ood in general, unctional oods, oodadditives, ood packaging and so orth.

Food products in South Korea are governed by:

KFDA Food Sanitation Act No. 3823 (1986) and Act No. 8113 (2006);

Pre-Confrmation based registration system o imported oods, September 2007;

Health Functional Food Act (HFFA) 2004.

Health supplements in pill, tablet, capsule and liquid orm are governed under the

HFFA. This Act, which separated health and unctional oods (HFFs) rom conventional

oods, was developed to enhance public health by ensuring the saety o new activeingredients. The law defned HFFs as ood supplements containing nutrients or other

substances (in a concentrated orm) that have a nutritional or physiological eect, 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 o generic HFFs, which consist o products thatcarry health beneft claims such as nutrient supplements, ginseng products and soy

protein containing products. There are currently 37 types o unctional ingredients listed

in the HFFA.

Product Specific Health/Functional FoodsProducts containing new ingredients that are not on the authorised list o ingredients or

37 generic HFFs will be subject to individual approval by the Korean Food and Drug

Administration (KFDA) or quality, saety and efcacy. The fnal marketing authorisationo the fnished product (containing the approved active ingredient) is granted on a

product by product basis, depending on the scientifc evidence provided.

Law

So

uthKorea


Part 2


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MARKETING FOOD SUPPLEMENTS,

FORTIFIED AND FUNCTIONAL FOODS IN EUROPELEGISLATION AND PRACTICE

SAE stcudorplanoitirtunnoecivdacigetartS

2008


15/29

Fifth Edition published by EAS

EAS 2008

First Edition published 1998

Second Edition published 2000Third 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


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

Marketing food supplements,

fortified and functional foods in Europe

EAS

MARKETING FOOD SUPPLEMENTS,

FORTIFIED AND FUNCTIONAL FOODS IN EUROPE

LEGISLATION AND PRACTICE

2008


16/29

Introduction 1

Definitions 2

Part 1 Food supplements, fortified and functional foods

1.1 Overview of pan-EU rules on food supplements, 7


Impact o the EU ood supplement Directive on product 9

ormulations and labelling

Regulation on the addition o vitamins and minerals and 18

o certain other substances to oods

Impact o the EU Directive on traditional herbal medicines (THMPD) 25

Status o EU legislation on PARNUTS (oods or particular nutritional uses) 32

Summary o speciic EU ood law rules aecting nutritional products 41

EU ood additives rules 41

EU lavourings rules 48

Food improvement agents package 49

Novel ood ingredients 54

GMO labelling and traceability rules 63

Allergen labelling rules 68

EU rules on irradiated ood ingredients 71

Contents


17/29

1.3 Work towards international standards 179

The Codex Alimentarius decision-making procedure 180

Codex action on ood supplements, ortiied oods 181

and ood additives

Part 2 Health claims

2.1 Overview of pan-EU rules on health claims 187

The EU rules on health claims up to mid-2007 188

EU Regulation on nutrition and health claims 189

2.2 Guide on national health claims policies 203

General national approaches to health claims 204

Existing national health claims guidelines 216

Belgium 217

Finland 218

Netherlands 220

Norway 221

Spain 223

Sweden 225

Switzerland 227

UK 230

2.3 Work towards European and international standards 233

for health claims

Council o Europe 234

Codex Alimentarius 235

Annexes

1. Current list o EU approved vitamin and mineral substances, 238which may be used in ood supplements

2. Current list o EU approved vitamin and mineral substances, 240

which may be added to oods

3. Current list o EU approved substances, which may be added 242

to PARNUTS oods

4. EU nutrition labelling RDAs 246

5. Nutrition labelling RDAs o non-EU countries 247

1.2 National legislation guide on food supplements, 75


National regulatory models 76

How to read the national charts 79

Austria 80

Belgium 83

Bulgaria 86

Cyprus 89

Czech Republic 92

Denmark 96Estonia 101

Finland 103

France 105

Germany 108

Greece 112

Hungary 116

Ireland 118

Italy 120

Latvia 124

Lithuania 126

Luxembourg 129

Malta 131

Netherlands 135

Norway 138

Poland 140

Portugal 144

Romania 146

Russia 149

Slovakia 155

Slovenia 158

Spain 161

Sweden 165

Switzerland 168

Turkey 172

UK 175


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Page 1

EAS Marketing ood supplements,ortiied and unctional oods in Europe

Introduction

In the last ive years the rate o change or the legislation o nutritional products across theEuropean Union has risen signiicantly.

The catalyst in this process can be laid at the door o the EU ood supplement Directive,

the EU Regulation on the addition o vitamins and minerals and other substances to ood

and the establishment o pan-EU rules on nutrition and health claims.

These legislative changes mirror the political developments that have taken place i n

the European Union. With the accession o Bulgaria and Romania in 2007 the EU now

encompasses 27 Member States, all o which have not only taken on existing EU l aw,but will be involved in debating and agreeing urther legislation.

The result is an internal market o more than 400 million people a huge achievement or

the EU, but also a signiicant challenge or businesses looking to beneit rom it. Now more

than ever, companies must be aware o the pan-European regulatory environment.

A company wishing to market a nutritional product across Europe must still comply witha combination o EU and national laws and a range o evolving market practices related to

ingredients and levels, health claims, notiication/authorisation procedures and distribution

practices. It is essential thereore or companies to have an eective guide or negotiatingthe complex EU maze that currently exists.

This ully updated and expanded report is designed to help companies navigate the maze.

It provides a complete and up to date overview o the current regulatory landscape acrossall 27 Member States as well as Norway, Russia, Switzerland and Turkey, to help businesses

develop and implement strategies or the marketing o their products across Europe.

Introduction


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Page 3

At the international level deinitions on ood supplements, ortiied oods, unctional oods

and claims vary widely. In Europe the ollowing deinitions are covered by European ornational legislation/guidelines and relate most closely to the terminology used in this report:

Food supplements

The 2002 EU ood supplement Directive deines ood supplements as "oodstus that areconcentrated sources o nutrients or other substances with a nutritional or physiological

eect, alone or in combination, marketed in dose orm(*), whose purpose is to supplement

the normal diet."

(*) dose orm means orms such as capsules, pastilles, tablets, pills and other similar orms, sachets o powder, ampoules

o liquids, drop dispensing bottles, and other similar orms o liquids and powders designed to be taken in measured

small unit quantities.

Fortified foods

Most European countries deine ortiied oods as oods to which nutrients have been added.In some countries this term is limited to the addition o vitamins and minerals to ood. In others

it also includes the addition o amino acids, unsaturated atty acids (e.g. ish oils), dietary ibres

and other substances such as herbal extracts. Some countries make the distinction o:

Enrichment (= addition o nutrients that have not been present in ood beore);

Fortifcation (= enhancement o nutrient levels already present in the product);

Restoration (= restoration o nutrient levels which have been lost within the

manuacturing process, storage or handling);

Substitution (= addition o a substance/product to substitute a substance/product withsimilar qualities, e.g. soya milk to replace dairy milk).

I a claim on a speciic health beneit is made or an enriched or ortiied ood, it can be

considered as a unctional ood.

Regulation 1925/2006 on the addition o vitamins and minerals and o certain othersubstances to oods did not provide any speciic deinitions or these dierent concepts.

Functional foods

A unctional ood can be deined as a ood delivering a beneit to health beyond that o strictnutrition and making a claim about this beneit.

Functional oods can be oods, which are ortiied with all kind o ingredients (or composed

o ingredients) which deliver a speciic beneit to health.

Probiotics Prebiotics Synbiotics

Probiotics, prebiotics and synbiotics generally belong to the category o unctional oods.

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 biidobacteria) are mostly added to yoghurt and

milk drinks.

Prebiotics contain non-digestible nutrients (e.g. carbohydrates, oligosaccharides) whichwhen arriving at the colon are selectively ermented by the local bacteria. They

can be designed to promote the growth and/or activity o beneicial bacteria or

inhibit the activity o harmul bacteria present in the colon.

Synbiotics are a combination o pro- and prebiotics.

Claims

Regulation 1924/2006 on nutrition and health claims made on deines the term claim

as any message or representation, which is not mandatory under Community or nationallegislation, including pictorial, graphic or symbolic representation, in any orm, which states,

suggests or implies that a ood has particular characteristics.

Codex Alimentarius deines the term claim in its 1979 General Guidelines on Claims as

any representation which states, suggests or implies that a ood has particular characteristicsrelating to its origin, nutritional properties, nature, production, processing, composition, or

any other quality.

Nutrition Claim

Also known as nutrient content claim. Indicates the presence/absence o a nutrient

in a oodstu (or presence in reduced/increased proportion) or the energy a ood 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 deines nutrition claims as any claim, which

states, suggests or implies that a ood has particular beneicial nutritional properties due to:

a) the energy (calorifc 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 or use o nutrition and health claims deine a nutrition claim as

any representation which states, suggests or implies that a ood has particular nutritionalproperties including but not limited to the energy value and to the content o protein, at

and carbohydrates, as well as the content o vitamins and minerals.

The Guidelines include also in this category the ollowing nutrient content claims:

Nutrient Content Claim:This claim is a nutrition claim that describes the level o a nutrient contained in ood.

Examples: "source o...", "high/low in...".

Nutrient Comparative Claim:

This is a claim that compares the nutrient levels and/or energy value o two or more oods.

Examples: "reduced/increased...", "less than...", ewer, more than.

Deinitions

Deinitions

Definitions


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Health Claim

The EU Regulation on nutrition and health claims deines:

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 o 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 ahuman disease.

Examples: "helps reduce the risk o cardiovascular disease.

The Codex guidelines or the use o nutrition and health claims deine health claims as any

representation that states, suggests or implies that a relationship exists between a food or aconstituent of that food and health.

Health claims include the ollowing:

Nutrient Function Claim:

A nutrition claim that describes the physiological role o the nutrient in growth, development

and normal unctions o the body.

Other Function Claims:

These claims concern speciic beneicial eects o the consumption o oods or their

constituents, in the context o the total diet on normal unctions or biological activities o the

body. Such claims relate to a positive contribution to health or to improvement o a unctionor to modiying or preserving health.

Reduction o Disease Risk Claim:

Claims relating the consumption o a ood or ood constituent, in the context o the totaldiet, to the reduced risk o developing a disease or health-related condition.

Medicinal Claim

Reers to the prevention or treatment o a disease.

(interpretation of EU Directive 2004/27 amending the Community Code for medicines

of Directive 2001/83)

Examples: "prevents heart disease", "treatment o digestive disorders".

Medicinal claims are always reserved to registered pharmaceuticals and thereore not

permitted or products sold under ood law.

Directive 2000/13/EC on the labelling o oodstus 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 ofpreventing, treating or curing a human disease, or refer to such properties. (Article 2.1.b)

Deinitions

Deinitions


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Page 7


1.1 Overview of pan-EU rules on

food supplements, fortifiedand functional foods

Food supplements,ortiied and unctional oods

Part1


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Page 9

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

Existing

pan-EU rules

Pan-EU rules

under discussion

Current

national rules

PRODUCT

SPECIFIC

LEGISLATION

Food supplements Additional food

supplement rules

Additional rules

related to food

supplements, fortifiedand functional foods

and PARNUTS, not

covered by EU

legislation.

Foods with added

nutrients

Additional rules on

foods with added

nutrients

Foods for particular

nutritional uses(PARNUTS)

Additional PARNUTS

rules

Traditional herbal

medicines

FOOD LAW

LEGISLATIONAFFECTING ALL

NUTRITIONAL

PRODUCTS

Nutrition and Health

claims

A wide range of

additional rules on

health claims (e.g.health claims lists,

dossier guidelines,

nutrient profiles)

Health claims

rules during specific

transition periodsdefined by the EU

Regulation on nutrition

and health claims

Food additives Revisions o f rules

for food additives

EU rules on food

enzymes

Rules on permitted

food enzymes

Flavourings Revi si on of r uleson flavourings

Rules on permittedtypes of flavourings

General food

labelling requirements

Rules on the

authorisation and

labelling of foods andfood ingredients

containing, consisting of

or produced from GMOs

Rules applied to

novel food ingredients

Rules on irradiatedingredients

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 andhealth 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 ina 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 affectingnutritional 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 infurther detail in this chapter. Details in relation to EU rules on nutrition and health claims and

applicable national transition periods will be discussed separately i n part 2.1 of this report.

Part 1.1

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

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

July 2002

August 2003

August 2005

July 2007

January 2010

Food SupplementDirective

Framework

List of ApprovedVitamin and Mineral

Substances

Maximum/MinimumLevels for Vitamins

and Minerals

List of OtherBioactive

Substances

EU Directive inforce

Permitted tradefor productsmeeting EUDirective rules

Requirement forall products to

comply with rulesof EU Directive

Possible nationalexemptionsfor vitaminand mineralsubstances notincluded on theEU list

Deadline for MSderogation/EFSAreview of vitaminand mineralsubstances

Orientation Paper

Proposalon maximum/minimum limits

Adoptionof maximum/minimum levels

EuropeanCommissionReport onother ingredientcategories andsubstances

December 2007

January 2009

Deadline forfirst submission

of dossiers forthe addition ofother vitaminand mineralsubstances

January 2011


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Page 75


1.2 National legislation guide

on food supplements,fortified and functional foods


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The Hungarian Decree 37/2004 transposed the EU ood supplement Directive intonational ood law and covers the general principles o the EU Directive, speciic rulesor vitamins and minerals and lays down the derogated substances.

Permitted vitamin and mineral substancesThe Hungarian Decree permits the use o all vitamin and mineral substances mentionedin Annex II o the EU ood supplement Directive.

In addition, derogations are granted until the end o 2009 or the use o:

DL-methyl-methionine-sulon-chloride (vitamin U), boron, vanadium, cobalt, and

the ollowing additional mineral sources: calcium citrate malate, copper oxide,chromium (III) picolinate, selenic acid and sodium-monofouride-phosphate.

The Hungarian Decree also permits the use o amino acid chelates, yeastmetalcomplexes and humic acid/ ulvic acid chelates in ood supplements.

Maximum and minimum levelsThere are currently no speciic maximum limits established or the use o vitamins andminerals in ood supplements. The Hungarian Public Health Centre (OTI) currentlyevaluates the maximum permitted levels on a case by case ollowing the saety approach.

According to the Hungarian ood supplement Decree the minimum level or vitaminsand minerals is 15% o the RDA.

Herbal preparations are currently not regulated by a speciic national law and aresubject to the assessment o OTI. Foll owing evaluation, these are either classiiedas oods or medicines.

Food supplements containing other bioactive substances such as amino acids,unsaturated atty acids, lactic acid bacteria, isolavones, coenzyme Q10 at the levelspositively evaluated by OTI in the past can be used in ood supplements ollowinga successul notiication.

According to the Hungarian Decree, ood supplements need to be notiied with OTI atthe time o marketing at the latest. The notiication has to include the application orm,published in Annex IV o the Hungarian ood supplement Decree, and a product label.I a ood supplement is already launched and marketed in other EU Member State(s), itis recommended to provide an indication about these particular Member State(s) andattach copies o documents proving the legal market entry o the ood supplementproduct (such as sales certiicates rom national authorities or the submitted nationalnotiication orms).

Ater receiving the notiication documents OTI will send the applicant a letter

conirming the receipt o the documents.Should OTI have serious concerns regarding saety, labelling or other signiicantcomments on the notiied product these would be addressed to the applicant withinone month ater the payment o the notiication ee at the latest. Should the commentsexpressed by OTI not be taken into consideration by the applicant, OTI would inormthe Hungarian Food Saety Oice which would initiate a control action.

The suppliers and importers have ull legal responsibility or the saety o their products.Saety controls are coordinated by the Hungarian Food Saety Oice and carried out bythe Hungarian ood control authorities in the post marketing surveillance process.

Notiication ee: 16, 000 HUF.

Timing: Food supplement products may be marketed at the time o the notiication.

Saety controls are carried out regularly by the Hungarian ood control authorities

There are no speciic restrictions on the permitted sales channels or ood supplements.Notiied ood supplements can be sold reely via all outlets including supermarkets,health ood stores, pharmacies, direct sales, mail order and other channels.

Hungary Part 1.2

1.2 National legislation guide on ood supplements, ortiied and unctional oods

Food supplements

National legislation guide on ood supplements,ortiied and unctional oods

Law


Herbs

Other bioactivesubstances

Notifcation

Distribution

Hungary

OTI indicated that the Hungarian Health Authorities are in the process o dratingnational guidelines on maximum levels or vitamins and minerals and certain otheringredients and a list o botanicals prohibited or use in oods including oodsupplements which will be used as a guide or the industry and ood authorities.

In July 2007 the new EU Regulation on the addition o vitamins and minerals andcertain other substances to oods became applicable in Hungary. This legislationcurrently provides clear rules or the addition o vitamins and minerals to oods whileherbal ingredients or other substances are not explicitly mentioned in the Regulation.

Permitted vitamin and mineral substancesThe addition o the vitamin and mineral substances as listed in Annex II o EU Regulation1925/2006 is permitted.

Until 2014 national derogations or the use o other vitamin and mineral substanceswill be provided or certain additional vitamin and mineral substances, such as seleniumyeast, which were legally present on the Hungarian market beore the EU Regulationbecame applicable, provided that EFSA has not issued a negative opinion on theparticular permitted substance.

Maximum and minimum levels

There are no speciic maximum limits or the addition o vitamins and minerals to ood.

In accordance with the EU Regulation 1925/2006/EC the minimum daily level or theaddition o vitamins and/or minerals to ood should be 'a signiicant amount', meaning15% o the EU labelling RDA, as mentioned in the Annex o Directive 90/496/EEC.

Mandatory fortificationThere is no mandatory ortiication.

The addition o herbal extracts to ood is currently not regulated and is evaluated ona case by case basis in case o a market control.

The addition o other bioactive substances to ood is currently not regulated. Thi s iscurrently evaluated on a case by case basis in case o a market control.

According to OTI the notiication o ortiied oods is currently not compulsory.

Products can be sold via all ood outlets, direct sales, mail order and other channels.

The Hungarian Food Authorities are considering the introduction o a mandatorynotiication or oods with added nutrients. However, the inal decision will be madeonce the Hungarian Decree implementing the EU Regulation on the addition o vitaminsand minerals and o certain other substances to oods is adopted.

OTI indicated that the Hungarian Food Authorities are in the process o dratingnational guidelines on maximum levels or vitamins and minerals, and certain otheringredients, and a list o botanicals prohibited or use in ood products which will beused as a guide or the industry and ood authorities.

Law


Herbs

Other bioactivesubstances

Notifcation

Distribution

Future

Fortiied and unctional oods

Future


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Page 193

EFSA

Endeavours to give its opinion within5 months if more i nformation is

required, time period can be extended(1 month)

Forwards its opinion and reasonsto Commission, Member States

and applicant

The opinion is published

Community Register

Any approved/rejected health claimwill be included in the register and

the proprietary data will be protectedfor a period of five years

Applicant

Applies for the authorisation of ahealth claim based on newly developedscience and/or requesting protection of

proprietary data

Acknowledgmentof application receipt

within 14 days

Member State authority

Forwards application to EFSAwithout delay

Communicatesapplication to MemberStates and Commission

for information

Standing Committee

Regulatory procedure with scrutiny:after opinion of Committee (no time

limits), Council and EuropeanParliament vote within 3 to 4 months

CommissionWithout delay, informs the applicantof the decision taken and publishes it

in the Official Journal

Standing Committee

Within 3 months Member States adoptan opinion on the draft decision



Community Register

Any approved/rejected health claim willbe included in the register

Community Register

Any approved/rejected health claim willbe included in the register

Commission

submits draft decision (no time limit)

Commission

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

Within 30 days, thepublic can providecomments to the

Commission

NEGATIVE OPINION POSITIVE OPINION

If protection of proprietary dataIS NOT requested by applicant

If protection of proprietary dataIS requested by applicant

Commission

Before the end of the five-year period,the Commission must submit a proposalfor the authorisation of the same claim,

without restrictions of use



2.1 Overview o pan-EU rules

on health claims

Marketing ood supplements,ortiied and unctional oods in Europe

Part 2.1


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Part 2.2

2.2 Guide to national health claims policies

2.2 Guide to national health

claims policies

Claims Belgium

In 1998 a panel under the coordination o the Belgian Food Federation (Fevia) started

working on the development o a drat Code o Conduct on health claims. Furtherwork on this drat Code was however put on hold in 2003 in view o the orthcoming

EU Regulation on health claims. The drat Code is now no longer taken into

consideration by the Belgian Ministry o Health or claims evaluations.

In 2005 the Belgian Ministry o Health then issued guidelines in the orm o an

indicative positive list o health claims/cosmetic claims. The list includes exampleso health claims or ood products and cosmetic claims that are not considered to be

reerring to preventive or curative properties. It does however not exclude the use o

other or similar claims. Other similar claims can be made as long as these do not all

within the deinition o a medicine and can be substantiated by scientiic evidence inorder not to be misleading to the consumer.

Moreover, or the use o health claims the rules o the Royal Decree o 17 April 1980on the advertisement o ood products need to be respected. This decree speciically

mentions that names, claims and pictures, even styled, related to organs, blood or theblood vessel/circulatory and nervous system are prohibited or ood products.

The Belgian indicative list o claims currently includes nine health/cosmetic eect

sections, which are divided into speciic sub-categories:

I. Head external use (hearing and equilibrium organs, eyes, mouth and teeth, hair

and nails)

II. Breathing (respiratory tract)

III. Circulatory system (blood, limbs external use, cholesterol)

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

V. Skin external use only (skin care, spots, eet, damaged skin, mother and child,

consequences o physical stimuli, diverse)

VI. Locomotory system (muscles external use only, joints, bones)

VII. Nerves (mood, spirit, concentration, memory, exams/learning)

VIII. General physical status (t/energy/in good health, resistance/deense/ immune

system, metabolism, tiredness/perormances, sleep, nutrients/plants or plant

preparations)

IX. Ageing (ree radicals/antioxidants, menopause)

There is no national notiication/authorisation procedure or health claims in Belgium.Health claims can be made as long as these can be substantiated by scientiic evidence,

are not regarded as medicinal and are ormulated in a style similar to the claims

examples o the indicative positive list o health claims rom the Belgian Ministry.

The Belgian indicative list o claims applies to all ood products making health claims

(including nutritional ood supplements, herbal ood supplements, oods or particularnutritional uses, ortiied and unctional oods). In addition, it also applies to cosmetic

products making cosmetic eect claims.

In the absence o speciic national health claims regulations and until the application

o the EU 'Community list' o health unction claims, the Belgian indicative list o claims,

in combination with the national advertising law and medicinal product deinition, arecurrently the only existing guidelines to evaluate the permission o speciic health claims

or ood products in Belgium. As soon as the 'Community list' o health unction claims

will be adopted, the Belgian Ministry will however be required to adapt its healthunction claims rules or oods to relect all the requirements o the EU Regulation.

For ood products, the indicative Belgian list will then be overruled by the positive

'Community list' (expected or adoption by 31 January 2010).

Nationalguidelines

Claimscategories/lists

Notifcation/authorisation

Application

Future

Marketing ood supplements,ortiied and unctional oods in Europe


27/29

EAS

Marketing ood supplements, ortiied and unctional oods in EuropePage 250E

AS2008

For urther inormation 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


EAS Asia

30 Killiney Road

07-04 Winsland House 1

Singapore 239519

Tel: +65 6838 1270

Fax: +65 6835 9536


www.eas-asia.com

EAS 2008

Every eort has been made to ensure that the inormation contained in this publication is reliable. However,

the regulation and marketing o ood supplements, ortiied and unctional oods in Europe oten involve

legal uncertainty and dierences o interpretation. EAS shall thereore have no liability whatsoever or anyloss or damage resulting rom the use o this publication or the inormation contained herein.


28/29

Marketing Health Supplements,Fortified & Functional Foodsin Asia and Europe

Legislation and practice 2008/2009

For further information,please go to www.eas.asiaor www.eas.eu

Two essential regulatory guidesfor the nutritional product business

www.eas.eu www.eas.asia

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