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Eviras guideline 17012/3/en

Food Supplement Guide

for food supervisors andfood business operators

Finnish Food Safety Authority Evira


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Food Supplement Guidefor food supervisors and

food business operators



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Food Supplement Guide - Eviras guideline 17012/3/en


12/2008

Product Safety


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PROLOGUE

This Food Supplement Guide is meant for food control authorities and food business operators. The

purpose of the guide is to provide information on provisions concerning food supplements, their

application and control.

For the moment, the guide will only be published in electronic form on the Finnish Food Safety

Authoritys Evira web pages, as it is being updated as necessary.


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Contents

1 INTRODUCTION ...........................................................................................................................................5

2 DECREE ON FOOD SUPPLEMENTS.................................................................................................................62.1 Definitions ...................................................................................................................................6

2.2 Notification..................................................................................................................................6

2.3 Characteristic substanses in food supplements ........................................................................7

2.4 Labelling ............................................................................................................ ..........................9

2.4.1 General labelling ...............................................................................................................9

2.4.2 Labelling according to the Decree on Food Supplements (571/2003) ...................... 11

2.4.3 Other labelling............................................................................................................. ... 12

2.5 Marketing ............................................................................................................................... .. 13

2.5.1 Medicinal claims ............................................................................................................. 14

2.5.2 Health claims ............................................................................................................... ... 14

2.5.3 Nutritional claims ........................................................................................................... 14

2.6 Other legislation to be taken into account ............................................................................. 15

3 RESTRICTIVE DEFINITION OF FOOD SUPPLEMENT...................................................................................... 16

3.1 Difference between food supplements and medicinal products .......................................... 16

3.2 Difference between food supplements and special diet products ....................................... 19

3.3 Classification of sweets and chewing gums .......................................................................... 20

3.4 Law on novel foods and food supplements ........................................................................... 20

3.5 Alcohol legislation and food supplements ............................................................................. 20

3.6 Raw materials and product of animal origin ......................................................................... 21

4 APPLICATIONS/NOTIFICATIONS REQUIRED FROM FOOD BUSINESS OPERATORS ...................................... 22

4.1 Approval of food premises ...................................................................................................... 224.2 In-house control plans ............................................................................................................. 22

4.3 Food supplement notification ................................................................................................. 23

5 CONTROL ........................................................................................................................... ........................ 24

5.1 In-house control..................................................................................................................... .. 24

5.2 Control by the authorities ....................................................................................................... 25

5.2.1 Finnish Food Safety Authority Evira............................................................................... 25

5.2.2 State procincial offices ................................................................................................... 26

5.2.3 Municipal control authorities ......................................................................................... 26

5.2.4 Customs ....................................................................................................................... ... 28

5.2.5 Eviras unit of the veterinary border control ............................................................. 285.3 Coercive means and penalties ................................................................................................ 29

USEFULL LINKS ..................................................................................................................... ........................ 32


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1 INTRODUCTION

Food supplements are food products, even though

they may look like and be used in the same way

as medicinal products. Food supplements includeproducts for the intake of vitamins, minerals,

fibre and fatty acids and various herbal products.

The ingredients used must not have medicinal

effects and they must not have been approved

for medicinal use.

Food supplements are normally used for one of

their nutritional characteristics, for instance as

sources of vitamins, minerals or fatty acids, in

order to supplement the diet. They may also have

a physiological effect, for instance on digestion,

blood pressure or cholesterol level.

The natural product business estimates that 30-

40% of Finns in the 15-74 age bracket use food

supplements regularly and 60% occasionally.

Some 1.4 million people use products containing

one food supplement, such as iron, calcium,

selenium or chromium, mostly on an occasional

basis.

The natural product business has categorized

food supplements in the following way:

Vitamins and mineralsProducts containing plants or plant extracts

Fibre and weight control products

Lecithin and fatty acid products

Algae products

Bee products

Sports nutrients

Other food supplements

There are estimated 3,500-4,000 different

food supplements on the Finnish market

(previously known as special products and

nutritional products). The sales channels for food

supplements are natural product and health

food shops (some 330 outlets), food shops

and supermarkets (some 3,500 outlets), and

pharmacies (some 800 outlets). In addition,

gyms, sports goods stores, sports nutrient

shops, hairdressers, care institutions of various

kinds, etc. sell food supplements. The sale of

food supplements has also extended to mail

order sales, network marketing and electronic

marketing.


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2 DECREE ON FOOD SUPPLEMENTS

Food Act (23/2006)

Ministry of Trade and Industry Decree on

Food Supplements (571/2003), basedon the EU Directive on food supplements

(2002/46/EC)

Ministry of Trade and Industry Degree

672/2007 on revision of Degree on

Food Supplement 7

Ministry of Agriculture and Forestry Decree

on chargeable goods and services produced

by the Finnish Food Safety Authority

(266/2008)

2.1 Definitions

Under the Decree on Food Supplements

571/2003, food supplement means a pre-

packaged product sold in the form of a pellet,

capsule, pastille, tablet, pill, powder, concentrate,

extract, liquid or some other dosage form

marketed as a food product. Food supplements

are taken in small doses and the amount of

energy obtained from them is not significant in

terms of the diet. It is the view of the Evira that

the energy obtained from a food supplement,according to its maximum dosage instruction,

is not significant if it does not exceed 200 kJ

(50 kcal) per day. Food supplements refer to all

special products and nutritional products referred

to in the repealed Decree on Special Products

(349/1989). The concepts special product and

nutritional product are no longer used.

The purpose of food supplements is to supplement

diets through the nutrients or other substances

they contain or influence the nutritional orphysiological functions of people in some other

way. They are not meant to be used as substitutes

for a varied diet. Products classified as medicinal

-

products under the Medicines Act (395/1987)

are not food supplements.

The Decree on Food Supplements entered into

force on August 1, 2003. It is based on European

Parliament and Council Directive 2002/46/EC

(see Appendix 2). Marketing products that do not

meet the requirements of the Decree has been

prohibited since August 1, 2005. The Decree on

Special Products (349/1989) was repealed as of

August 1, 2003.

2.2 Notification

A food business actor who manufactures a food

supplement or commissions its manufacture or

imports a food supplement must submit a written

notification of the food supplement to the Eivra

when starting operations. A notification is also

required if the characteristic ingredients in the

products composition change or if the product is

withdrawn from the market. The Evira considers

the notification requirement fulfilled when the

notification is received by the Authority including

appendix and all information required.

An obligatory appendix to food supplement

notifications (section 7 of the Decree on Food

Supplements) is a model of the product labelling

showing both the statutory and voluntary

information and, as far as possible, illustrations

planned for the package.

If the party/parties signing the notification has/

have no right to sign the company name, a proxy

must be appended. Other appendixes attached tothe notification may include a product brochure,

for example.


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The Evira will send the actor an acknowledgement

of receiving the food supplement notification. If

the notification is deficient, the Authority wil l ask

the actor to complement it. Acknowledgement

does not mean that the Evira has assessed the

products composition or the legality of the

labelling or that the Authority has approved

the product as being in compliance with the

food regulations. Acknowledged notifications

including appendixes are sent for information

and control to the municipality of manufacture

or importation of the product and to the relevant

state provincial office and the Customs if the

product is imported.

If there is more than one responsible actor (e.g.

several importers) for a product, all actors mustgive a notification on the food supplement in

question. The information given in the notifications

and labelling must be identical. A notification

must always be made if the manufacturer, the

party commissioning the manufacture or the

importer changes. If a notification concerns

withdrawing a food supplement from the market,

the date of withdrawal must also be stated, e.g.

the best before date of the last batch.

A fee of EUR 28 is charged for processing food

supplement notifications (in 2008). A fee is not

charged, however, for notifications concerning

withdrawal of a food supplement product from

the market. Notifications may be made in free

form, but the Evira recommends the use of a

ready-made form. The form and instructions for

filling it are available in Finnish and Swedish (the

form is also available in English) on the Evira

website.

2.3 Characteristic substances infood supplements

A characteristic substance in a food supplement

means a nutrient such as vitamins or minerals

or some other substance with a nutritional or

physiological effect. Nutrients may also include

e.g. fibre, amino acids, edible fats, fatty acids

and carbohydrates, and other characteristic

substances may include e.g. plants, herbs or

microbes.

Under the Decree on Food Supplements (section

6, 571/2003), the amounts of characteristic

ingredients of the food supplement must be

expressed in numerical form on the labelling.

The values given must be averages based on a

product analysis made by the manufacturer.

Vitamins and minerals listed in Appendix 1 of the

Decree on Food Supplements may be used for

food supplements in the form listed in Appendix

2. Up to the end of 2009, a food supplement

may also contain other vitamins and minerals

and compounds of them if the said substance

has been used for food supplements as early as

July 12, 2002 in at least one EC Member State. In

such a case the condition is that the documents

required on the use of the substance in food

supplements have been submitted to the EU

Commission before July 12, 2005 and that theEuropean Food Safety Authority has not expressed

an unfavourable opinion in the matter. Where

necessary, actors must show the supervisory

authority that the said substance meets the

above conditions. A list of the sources of vitamins

and minerals on which documents have been

submitted to the EU Commission by July 12, 2005

is available on the following website: http://

ec.europa.eu/food/food/labellingnutrition/

supplements/index_en.htm

According to the Decree on Food Supplements,

the Ministry of Trade and Industry may issue

provisions on the minimum and maximum

quantities of vitamins and minerals in food

supplements. Such limits have not been issued

so far (December 2008).

Since these products are sold specifically as

sources of nutrients, the Evira is of the opinion

that food supplements which, if taken according

to the dosage instructions, provide at least 30%

of the daily intake reference value/daily intakerecommendation set by the EU (Ministry of Trade

and Industry Decision 1496/1993)1, meet the

criteria of section 9 of the Food Act (23/2006).

According to section 9 of the Food Act, the

labelling, presentation, advertising or other

marketing of a food product

must give truthful and sufficient information

about food taking into account section 1(1),

1(3) and 1(4) of the Act;

must not give misleading information aboutfood;

1.

2.


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must not present food as having properties

related to prevention, treatment or curing of

human diseases or refer to such information

unless otherwise provided elsewhere by

law.

The Eivra is of the opinion that sale of food

supplements as sources of vitamins and minerals

is misleading under section 9 of the Food Act if

the daily intake is below 30% of the daily intake

reference value/daily intake recommendation

3. set by the EU. If the amount of vitamins or

minerals in the daily dose is at least 15% of

the daily intake reference value, the amount

may be declared on the labelling but the said

vitamin or mineral must not be emphasized on

the labelling, e.g. in the name of the product.

As for the maximum amounts, i.e. the maximum

daily intake of nutrients, a line must be drawn

between a food product and a medicinal product.

The matter is discussed in more detail in section

3.1.

Table 1. Vitamins and minerals allowed in food supplements and their daily minimum intake

when following the dosage instructions (30% of the daily intake reference value/daily intake

recommendation).

Vitamin Daily minimum Mineral Daily minimum

Vitamin A1 240 g Calsium1 240 mg

Vitamin D1 1,5 g Magnesium1 90 mg

Vitamin E1 3 mg Iron1 4,2 mg

Vitamin K2 22,5 g Copper 2 0,3 mg

Tiamin (B1)1 0,42 mg Iodine1 45 g

Riboavine (B2)1 0,48 mg Zink1 4,5 mg

Niacin1 5,4 mg Manganese2 0,6 mg

Vitamin B61 0,6 mg Sodium2 180 mg

Folic acid1 60 g Potassium2 600 mgVitamin B

120,3 g Selenium2 16,5 g

Biotin1 0,045 mg Chromium2 12 g

Pantothenic acid1 1,8 mg Molybdenum2 15 g

Vitamin C1 18 mg Fluorine2 1,05 mg

Chlorine2 240 mg

Phosphorus1 240 mg

1Ministry of Trade and Industry Decision on the nutritional value labelling of food 1496/1993.2Scientic Committee on Food on 6 March 2003 (SCF/CS/NYT/GEN/18 nal). Opinion of the Scientic Committee on Food

on the revision of reference values for nutrition labelling. European Commission, Brussels.

In addition to nutrients, other substances used

for food supplements include plants, plant

extracts, herbs, bee products, microbes, bone

meal, dolomite, ashes, horn powder and organic

matter. No further provisions have been issued

on other substances or their concentrations in

food supplements (December 2008).

Instructions drawn up by the Evira on the purity

criteria of nutrient compounds used, are available

on the Eviras website


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2.4 Labelling


labelling of foodstuffs 1084/2004

Ministry of Trade and Industry Decision on

nutritional value labelling 1496/1993


Food Supplements 571/2003

European Parliament and Council

Regulation (EY) 1829/2003 on genetically

modified food and feed

Council Regulation on organic production

of agricultural products and indications

referring thereto on agricultural

products and foodstuffs (2092/91/EEC)

(amendment 2491/2001)

In addition, provisions and instructions onspecial labelling and warnings must be

taken into account

Pakkausmerkintopas (Labelling guide)

(Finnish Food Safety Authority Eviras guide,

updated 12/2008)

Nutritional value labelling on food

Guide for label designers and supervisors

(National Food Agency publications

12/2001)

The responsibility for labelling and its correctnessis carried by the food business actor who prepares,

packages or imports food supplements

S.ALGAE TABLETSpirulina algae tablet

Food supplement

290 tablets, 116 g

Ingredients: Spirulina algae X %, inulin,

anti-caking substance E460, E551,

separating agent E470b.

Recommended daily dose:

5 tablets a day, daily intake x g of Spirulina algae.

The recommended daily dose must not be exceeded.

The product must be kept out of reach of children.

The food supplement must not be used as a substitute

for a varied diet.

Best before: xx.yy.2011

Manufacturer: Company Ltd

Shopping Street 2,

00000 Town

Picture 1. Example of provisions laying downcriteria for labelling.

Labelling, particularly warnings, must be easily

visible, in sufficiently large print, easily readable,

understandable and made in a permanent

manner. Labelling must not be untruthful or

misleading. In principle, the labelling on food

supplements must be in Finnish and Swedish.

2.4.1 General labelling

According to general labelling provisions,

food supplement packaging must contain the

following basic information:

Name of product

The name states briefly and accurately

what food product the packagingcontains (e.g. calcium tablet, oat shoot

extract). The term food supplement,

which must also be shown, is not in

itself sufficient as a name.A trademark

or trade name cannot be used to replace

the name of the food product. The trade

name or part of the name must not

be the same as a name of a medicinal

product or a herbal medicinal product

Quantity of content

Name and address of the manufacturer,

the packager or a seller operating in the

European Union

List of ingredients

An ingredient means a substance or

product, including additives, that has

been used in the manufacture of a food

product and that remains in the final food

product in some form. All ingredients

must be listed by weight from heavier to

lighter in accordance with the formula.

The Evira is of the opinion that vitamins

and minerals should, in the interest ofconformity and clarity, be declared in

the list of ingredients by their chemical

name (e.g. ascorbic acid or thiamine

hydrochloride).

Reporting ingredients causing

hypersensitivity and preparations made

out of them is always mandatory, even

when they have not been used as

ingredients of the food product as such

but have ended up in the food productin some other way. Ingredients that it


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is mandatory to report (1084/2004 and

888/2005) are:

grains and cereals containing gluten

(wheat, rye, barley, oats, spelt,

kamut)

crustaceans and crustacean products

eggs and egg products

fish and fish products

peanuts and peanut products

soy and soy products

milk and dairy products (incl. lactose)

nuts and nut products

celery and celery products

mustard and mustard products

sesame seeds and sesame seed

products

sulphur dioxide and sulphite (over10mg/kg or 10 mg / l).

The origin of additives made of the above

ingredients must also be reported.

-

-

-

-

-

-

-

-

-

-

-

-

OAT SHOOT EXTRACT50 ml

Food supplement

Importer:

Shop Ltd.

Shoots Alley 6

00000 Municipality

www.uutekauppa.fi

Bestbefore

:xx.yy.2012

Ingredients:

Oat shoots, ethanol

Final ethanol concentrationapprox. 50% by volume

Recommend daily dose:

10-15 drops 3-5 times a day.

Recommended daily dose

(10-75 drops) contains 760-1900 mg

of fresh oat shoots.

The recommended daily dose must

not be exceeded. The food

supplement must not be used as a

substitute for a varied diet.The product must be kept out of

reach of children.

Picture 2.An example of labelling on a plant extract product.

The quantity of each ingredient must be

reported in the labelling when the ingredient

is emphasized in the labelling.

Best before marking or last date of use

Country of origin or area or origin if

omission may mislead the buyer

Identification code of the food product

batch

Instructions for use (see 2.4.2)

Warning (see 2.4.2)

Storage instructions if necessary

Alcohol content of drink and solid food if

necessary

Further information on general labelling

regulations is available in the Labelling guide onthe Eviras web pages.


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2.4.2 Labelling according to theDecree on Food Supplements(571/2003)

According to the Decree on Food Supplements,

food supplement labelling must include the

following in addition to general labelling

information:

The term food supplement (ravintolis in

Finnish and kosttillskott in Swedish)

The names of characteristic nutrients or an

indication of the nature of these nutrients

or substances

A category of characteristic nutrients

refers to a group under which a

characteristic substance in a foodsupplement may be classified. Such

categories include vitamins, minerals,

fibre, flavonoids, amino acids, fatty acids

or plant or herbal extracts. Nature, in

the case of flavonoids, for instance, may

refer to antioxidant qualities, or in the

case of lactic acid bacteria, probiotic

qualities. The category or nature may be

expressed in the food products name,

for instance.

antamia vertailuarvoja ravintoaineille(Opinion of the Scientific Committee on

Food on the revision of reference values

for nutrition labelling, expressed on 5

March 2003).

The quantities of characteristic substances

in a daily dose of food supplement

Quantities of substances characteristic

of a food supplement must be declared

on the labelling in numerical form as the

daily dose of the product recommended

by the manufacturer. The units used forvitamins and minerals are mentioned

in Appendix 1 to the Decree on Food

Supplements. The values given are

averages based on an analysis of the

product made by the manufacturer. The

husk or the binding agent must be taken

into account in declaring the nutrient

quantity. The quantities of characteristic

substances in food supplements must

always be expressed as a percentage of

the daily intake reference value if thereis a reference value for the substance

in question. The reference values for

vitamins and minerals are appended to

the Ministry of Trade and Industry Decision

on nutritional values (1496/1993). If

the Decision on nutritional values has

no reference value for the substance

in question it is possible to use the

reference values given in the Opinion of

the Scientific Committee on Food on the

revision of reference values for nutrition

labelling on 5 March, 2003.

In the case of vitamins and minerals, the

vitamin activity of the compounds must

also be taken into account and be stated

for characteristic substances in terms of

the proportion with physiological activity(e.g. thiamine hydrochloride must be

declared as free-form thiamine). For new

carotenoid correspondence coefficients

(declaring vitamin A), see our website

at http://www.evira.fi/portal/en/food/

control_and_entrepreneurs/labelling_

of_foodstuffs/vitamin_a_in_labelling/

The Evira is of the opinion that the

following deviations from the averages

and the result of the analysis may

generally be allowed:

not more than 20% below and

not more than 20% above.

In addition to this, the lack of precision in

measuring estimated by the laboratory

is taken into account.

The recommended daily dose

The recommended daily dose must not be

exceeded

The food supplement must not be used as

a substitute for a varied dietThe product must be kept out of reach of

children

The Evira recommends that the above wording

of the warnings and references be used on the

labelling.

According to the Evira, any inner packaging must

include at least the name of the food product,

the best before date or the last date of use,

instructions for use and/or the recommendeddaily dose and warnings.


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The labelling, presentation and advertising of a

food supplement must not state or indicate that

a well-balanced, varied diet does not usually

provide a sufficient nutrient intake. Neither must

statements be made about properties relating to

preventing, treating or curing human diseases

or reference be made to such information. On

certain conditions, however, it is allowed to make

nutrition-related statements in connection with

food supplements or concerning the properties

of its characteristic substances in relation to the

functions of the human organism (see section

2.5), but the statements made must not mislead

consumers.

CALCIUMDolomite tablet

350 tablets 224 g

Food supplement

Ingredients: Dolomite,

anti-caking agent E460, separat-ing agent E470b.

Recommended daily dose:

4 tablets a day.


contains calcium 430 mg (54%*)

and magnesium 260 mg (87%*)* of the reference value for daily dose


must not be exceeded. The food

supplement must not be used as

a substitute for a varied diet. The

product must be kept out of

reach of children.

Best before: xx.yy.2011

Manufacturer: Company Ltd,

Shopping Street 2, 0000 Town

Picture 3. An example of labelling a mineralproduct.

2.4.3 Other labelling

Labelling on food supplements must also take

into account labelling obligations under other

legislation such as:

If a food supplement contains genetically

modified maize, soy or other manufacturing

ingredients or additives made of

genetically modified ingredients, this must

be declared in the labelling. According to

the interpretation decided on by the EU

Commission Standing Committees GMO

section on 24 September 2004, the scope

of application of Regulation 1829/2003

does not cover fermented products made

by using a genetically modified microbe(e.g. vitamins, aromatic substances and

amino acids) that no longer have any

genetically modified microbe left.

If the dried spice herbs, spices or spice

plants contained in a food supplement

have been irradiated to improve their

microbiological quality, this must be

declared in the labelling. Irradiating may

only be carried out at facilities approved by

the EU.

NOTE: If a component has been irradiated

at a facility not approved by the EU, or if

the food supplement contains an irradiated

component the irradiation of which is

prohibited, this constitutes a serious error

which requires immediate withdrawal of

the product from the market (see Table 4).

If a food supplement is sold as an organic

product (bio, eco, organic or some other

corresponding term), provisions concerning

organic products must be taken into

account. The production, import, packaging

and wholesale of organic products are

covered by special national organic

control. The labelling of organic products

must show that they come under organic

control, i.e. carry the emblem of an organic

controller.


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If a food supplement has been sweetened

with aspartamin, the labelling must bear

a warning indicating the source of phenyl

alanine.

If a food supplement contains more than

10 per cent polyols, the labelling must bear

the text excessive use may have laxative

effects.

Marine algae products containing a lot of

iodine must carry warnings.

If a product is marketed as lactose-free

or gluten-free, the legislation relating to

special diet products must be taken into

account (see section 3.2).

If a products characteristic substance is

caffeine or an ingredient that contains

caffeine, the Evira recommends that

warnings concerning caffeine be included

on the labelling.

Etc.

Manufacturers of food supplements must find out

whether the product manufactured is suitable for

all consumers or whether warnings or restrictions

on use should be included on the labelling.

The Ministry of Trade and Industry Decision on

nutritional value labelling does not apply to food

supplements. The Food Authoritys guide on

food labelling is available on the Food Authority

website.

2.5 Marketing

Food Act 23/2006

Consumer Protection Act 38/1978



Regulation (EC) No 1924/2006 of the

European Parliament and of the Council on

nutrition and health claims made on foods

The Food Act and the Decree on Food Supplements

contain provisions on the marketing of food

supplements.

Under section 9 of the Food Act, truthful and

sufficient information must be given on a food

product in its labelling, brochures, advertisements

or otherwise in connection with marketing.

Giving misleading information is prohibited. This

also applies to websites, network marketing and

oral marketing.

The Consumer Protection Act (38/1978) also

applies to the marketing of food products. The

Act prohibits marketing procedures contrary

to good practice or inappropriate in terms of

consumers. Marketing that does not comprise

information necessary for consumers health or

economic safety is always inappropriate.

A Community Regulation on nutrition andhealth claims made on foods was adopted in

December 2006. Regulation (EC) No 1924/2006

of the European Parliament and of the Council

on nutrition and health claims made on foods

changes the practices related to nutrition and

health claims. The Regulation defines the

conditions under which such claims may be

employed and specifies common rules and

approval procedures for the use of such claims in

all Member States.

There is now a system for advance approval

and for verification of the scientific evidence

underlying the claims. The Regulation clarifies

the use of nutrition and health claims, since it

specifies that only nutrition and health claims

entered in the forthcoming Community Register

of nutrition and health claims made on foods

may be used in the marketing of foods. All other

claims will be prohibited, including claims which

make reference to recommendations of

individual doctors or health professionals,

make reference to the rate or amount ofweight loss,

suggest that health could be affected by

not consuming the food,

give rise to doubt about the safety and/or

nutritional adequacy of other foods,

encourage or condone excess consumption

of a food,

refer to changes in bodily functions which

could give rise to or exploit fear in the

consumer.


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2.5.1 Medicinal claims

Under the Decree on Food Supplements,

properties relating to the prevention, treatment or

curing of human diseases must not be presented

or referred to in the labelling, brochures or

advertising of food supplements or in any other

way.

The effects of the products must not be allowed

to give a medicinal impression, for instance by

using medical terminology or by referring to

changes, symptoms, ailments or pains caused by

a disease in the way that the marketing creates

the impression that the food product has effects

that prevent, treat or cure diseases.

Only medicinal products and herbal medicinal

products may be presented as having medicinal

purposes. The sale of such products requires

a marketing authorization from the National

Agency of Medicines that assesses the products

quality, effect and safety, for example.

Prohibited claims in the case of food

supplements, e.g.:

suitable for milk allergies and lactose-

intoleranceprotection from bacteria and viruses

helps those suffering from hypertension

Mrs Xs arteriosclerosis disappeared when

she used product Y

for aenemia

2.5.2 Health claims

According to the EU Regulation on nutrition and

health claims made on foods, a health claim is

any claim that states, suggests or implies that

a relationship exists between a food category,

a food or one of its constituents and health. A

pictorial, graphic or symbolic representation in

any form can also be considered a claim.

The following are examples of health claims:

component A of this product promotes

bowel function;

compound B strengthens your bones;

raw material C is a stimulant;

component D suppresses your appetite andhelps with weight control.

Only claims registered in the forthcoming

Community Register on nutrition and health

claims made on foods may be used in the

marketing of foods. Once the specified transition

periods have elapsed, no other claims may be

used.

Health claims shall only be permitted if the

following information is included in the labelling,

or if no such labelling exists, in the presentation

and advertising:

a statement indicating the importance of

a varied and balanced diet and a healthy

lifestyle,

the quantity of the food and pattern of

consumption required to obtain the claimed

beneficial effect,where appropriate, a statement addressed

to persons who should avoid using the

food, and

an appropriate warning for products

that are likely to present a health risk if

consumed to excess.

2.5.3 Nutritional claims

According to the EU Regulation on nutrition and

health claims made on foods, a nutrition claim

is any claim which states, suggests or implies

that a food has particular beneficial nutritional

properties with regard to nutrients or other

substances it contains, contains in reduced or

increased proportions, or does not contain. Only

the health claims listed in the Appendix to the

Regulation may be used, and then only if their

use conforms to the requirements specified in

the Regulation.

A nutrition claim is information published abouta food product which states, suggests or implies

that the food has particular beneficial nutritional

properties. This may apply to energy, amino acids,

fat, nutritional fibre or vitamins and minerals. If

such claims are made for a food supplement, the

food business operator must have evidence to

substantiate the claims made.

The following are examples of nutrition

claims:

high-fibre, or a source of fibre,high vitamin or mineral content.


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2.6 Other legislation to be takeninto account

Use of hormones in food supplements and in

other food products is prohibited (Section 7 of

the Food Act).

The use of doping substancesis also prohibited.

Doping means improving an athletes performance

by using methods alien to the human organism,

such as medicinal products. Doping may improve

sports performance but may also seriously

damage the athletes health.

Under the Penal Code (39/1889, chapter 44,

section 6), the following are deemed to be

doping offences include preparation, import anddissemination of doping substances.

Under the Penal Code (chapter 44, section 16),

doping substances are

synthetic anabolic steroids and their

derivatives

testosterone and its derivatives

growth hormones

chemical substances increasing the

production of the above hormones in the

human body.

Government Decree 705/2002 defines the

doping substances that are to be regarded as

doping substances referred to in chapter 44

section 16 of the Penal Code.

The Finnish Antidoping Agency has issued a

guide entitled The Prohibited Substances and

Prohibited Methods in Sports 2006 (www.

antidoping.fi). This guide classifies many more

substances as doping substances than the Penal

Code. Thus the provisions of the sports industry

are stricter than the Penal Code.

Endangered species in violation of the CITES

Convention must not be used as ingredients

for food supplements. CITES (Convention on

International Trade in Endangered Species of

Wild Fauna and Flora) is a convention (1973)

regulating international trade in respect of some

30,000 endangered plants and animals (e.g.

whales, certain sharks). The Convention also

applies to goods for which species covered bythe Convention or parts of them have been used.

The CITES Convention has been signed by more

than 160 countries. In Finland it entered into

force in 1976.

The EU legislation on international trade

in endangered plants and animals in force

(1997/338/EC, 2001/1808/EC) is stricter than

the CITES Convention. In addition, the EU prohibits

the import of certain CITES species to its area.

A list of the species is included in Regulation

2003/349/EC.


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3 RESTRICTIVE DEFINITION OF FOODSUPPLEMENT

Medicines Act 395/1987

National Agency for Medicines decision the

List of Medicines 1179/2006European Parliament and Council Directive

2004/24/EC amending, as regards

traditional herbal medicinal products,

Directive 2001/83/EC on the Community

code relating to medicinal products for

human use


special diet products 662/2000


Regulation 2002/178/EC laying down the

general principles and requirements of food

law, establishing the European Food Safety

Authority and laying down procedures in

matters of food safety


the labelling of food products 1084/2004


Regulation 1997/258/EC concerning novel

foods and novel food ingredients

Alcohol Act 1143/1994

Food supplements are foodstuffs but may

resemble medicinal products in appearance anduse. Food supplements are not a substitute for a

varied daily diet, since they are not significant

sources of energy. Their purpose is to supplement

the diet.

3.1 Difference between foodsupplements and medicinalproducts

According to section 3 of the Medicines Act, amedicinal product is a product or substance

intended for internal or external use to cure,

alleviate or prevent a disease or its symptoms in

humans or animals. Products or substances to be

taken internally or externally for the purposes ofestablishing the state of health or the cause of a

disease, or for restoring, correcting or modifying

physiological functions in humans or animals are

also considered to be medicinal products. Products

marketed as medicinal products must always

have a marketing authorization or be registered

by the National Agency for Medicines.

The National Agency for Medicines controls

medicinal products, their manufacture, distribution

and sales. It also controls health care equipment

and supplies. Medicinal products may be sold

to the public only from pharmacies, subsidiary

pharmacies or licensed medicine chests. A

food store may also act as a sales channel for

herbal medicinal products and homeopathic or

anthroposophic products. The National Agency

for Medicines decides on the sales outlets for

products in connection with granting a marketing

authorization or registration (the letter E indicates

this in the lists that can be downloaded from the

National Agency for Medicines website).

The National Agency for Medicines has confirmed

and issued a decision on a List of Medicines

including three appendices. Appendix 1 to the

decision lists the substances that are medicinal

products. Herbals listed in Appendix 2, i.e. plants

intended for medicinal use, and vitamins and

mineral products whose daily doses exceed the

quantities referred to in Appendix 3, may also be

classified as medicinal products. The maximum

daily vitamin and mineral contents that may not

be exceeded if the products are not classified asmedicinal products are also given in Table 2.


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Furthermore, substances and herbals to be used

in accordance with section 3 of the Medicines

Act and comparable in a medicinal sense to the

substances listed in Appendix 1 to the National

Agency for Medicines decision and to the

herbals of Appendix 2, and certain products or

substances which are used as medicinal products

but are different from ordinary medicinal

products in terms of their state, composition,

method of manufacture or effect mechanism,

e.g. radioactive medicinal products, allergen

products, vaccines and medicinal gases are

deemed to be medicinal products. Vitamins or

mineral products intended for children may be

classified as medicinal products.

Table 2. Limits for vitamins and minerals given in Appendix 3 to National Agency for Medicines

decision 1179/2003.

Vitamin Daily dose for

adults

Mineral Daily dose for adults

vitamin A 900 g calcium 900 mg

vitamin D 10 g phosphorus 800 mg

vitamin E 10 mg magnesium 350 mg

vitamin K 70 g iron 18 mg

thiamine (B1) 1,5 mg zinc 15 mg

riboavin (B2) 1,7 mg iodine 150 g

niacin 20 mg copper 2 mg

vitamin B6

2,2 mg manganese 2,5 mg

folic acid 400 g chromium 50 g

vitamin B12

3 g selenium 50 g

pantothenic acid 4 mg potassium 3500 mg

biotin 30 g

vitamin C 75 mg

beta-carotene 6 mg

In some cases, products containing substances

included in the List of Medicines and/or

herbals (e.g. Echinacea purpurea) may be sold

as food products. In such a case the use of the

product must be based on something other

than the medicinal effect of the product or a

substance or plant it contains (see purpose offood supplements, section 2.1). In some cases

then, there may be products on the market

containing similar substances or plants but to

the manufacture and sale of which different

requirements apply depending on whether they

are introduced to the market under the law on

medicinal products or the law on food.

If a food supplement contains substances or

herbal products included in the List of Medicines

or if the limits given for vitamins and minerals in

the List of Medicines are exceeded, the Evira will

recommend that the notifying party contact the

National Agency for Medicines in order to have

the need for classification assessed. The National

Agency for medicines, may classify the product

as a medicinal product on its own initiative if the

product meets the criteria set for a medicinal

product.

The labelling of a food supplement is distinctly

different from that of a herbal medicinal product

(see Picture 2). The labelling on herbal medicinal

products is determined on the basis of the

Medicines Act. The inner and outer packages of a

herbal medicinal product or a stronger (dilution

degrees D1-D3) homeopathic or anthroposophic

product that has been introduced to the market on

the basis of the law on medicinal products must

bear the words HERBAL MEDICINAL PRODUCT (in

Finnish and Swedish). The sales package must

also bear the marketing authorization number of

the herbal medicinal product (R xxx FIM).


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ST JOHSWORT PREPARATION(in Finnish and Swedish)

50 tablets

1 tablet:

Hyperici perforati herba extr. spir. sicc. (2,5-5:1) 80 mg

respond. tot. hypericin. 0,3 mg

Constit. et color. (E171) g.s. c. obd

Herbal medicinal product for adults for alleviating and treat-

ing mild depression and melancholy.

Dosage: 1-2 tablets 1-2 times a day. Not for children.

Must be kept out of reach of children.

HERBAL MEDICINAL PRODUCT.R xxx FIN

Holder of marketing authorization

Best before

Batch number

Picture 4. Example of labelling on a herbal medicinal product

The sales packages of registered homeopathic

and anthroposophic products bear the words

HOMEOPATHIC PRODUCT (in Finnish and

Swedish) OR ANTHROPOSOPHIC PRODUCT

(in Finnish and Swedish) and the registration

number (H xxx FIN). Further labelling information

on the concentrations in homeopathic and

anthroposophic products is available on the

National Agency for Medicines website. All herbal

medicinal products are controlled by the NationalAgency for Medicines.

According to the Medicines Act, it is the duty of

the National Agency for Medicines to decide when

necessary whether a substance or product is to

be regarded as medicinal. Classification decisions

are product-specific. Products are classified as

medicinal products, non-medicinal products or

health care equipment and supplies. Both the

composition of the product and the proposed

purpose of use influence the classification. If a

product is used in accordance with the definition

given in section 3 of the Medicines Act, its purpose

of use is medicinal and the product is a medicinal

product. Instructions on making a classification

request are available on the National Agency for

Medicines website.

If a product is classified as medicinal it must not

be marketed as a food product. Operators are

responsible for marketing their products and

choosing the right sales channel and for seeing

that products classified as medicinal products

are removed from the shelves of shops selling

foodstuffs (Food Act 23/2006, section 16).


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FOOD MEDICINAL

PRODUCTS

Products Conventionalfood

Novel food Foodsupplements

Some special

diet products

Medicinalproducts:

- ordinary

medicinal

products

- herbal medicinal

products

- homeopathic and

anthroposophic

products

Criteria for

entering market

No advance

control

Authorization

procedure

Notication

procedure

Authorization

procedure of

registrationAuthor ization

or notifcation

authority

Evira

EU Commission

Evira National Agecy for

Medicines

European Agency

for the Evaluation

of Medicinal

Products ( EMEA)

Control in-house control

municipal and provincial food control authorities

Customs (imports)

Evira/Border control

Evira

National Agency

for Medicines

Table 3. Food and medicinal products have different criteria for entering the market and separate

control.

In order to make a clear difference between

food and medicinal products so that consumers

can avoid misunderstandings, the Evira is of the

opinion that advertising must unambiguously

differentiate between medicinal products and

food. They must not be marketed in a misleading

manner using the same material and same

advertisements. Under section 9 of the Food Act(23/2006), truthful and sufficient information

must be given on a food product in labelling

brochures, advertisements or in some other

manner in context with marketing. Furthermore,

giving misleading information is prohibited.

Article 16 of the General Food Law Regulation of

the EU also lays down provisions on prohibiting

misleading information. Section 25b of the

Medicines Decree (693/1987) also states that

in marketing medicinal products to the public,

advertisements must make it clear that they areadvertisements marketing medicinal products.

3.2 Difference between foodsupplements and special dietproducts

Special diet products mean food products that

differ from corresponding ordinary food in

composition or manufacturing. Because of these

differences in composition or manufacturing,special diet products are suitable for persons with

absorption and metabolic disorders or persons

who because of their special physiological status

benefit from a controlled intake of substances in

certain foods.

Special diet products include baby foods, non-

gluten food and low-lactose/lactose-free dairy

products. Also some products intended for

weight control, losing weight or for athletes are

special diet products. Some of them are classifiedas food supplements on the basis of the purpose


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and manner of use and energy content. The

essential feature is that the energy content of

food supplements is minor, while special diet

products are used to substitute for meals, parts

of meals or even the normal daily diet. The Evira

is of the opinion that if the energy obtained from

a maximum daily dose of a food supplement

does not exceed 200 kJ (50 kcal) per day, it is not

significant in terms of energy intake.

Some special diet products are formulas, i.e.

preparations intended for athletes, those who

want to lose weight or others, which consist

primarily of carbohydrates, proteins and other

pure nutrients. They are used to substitute for

meals or parts of meals, and the energy intake

from them is significant in comparison withfood supplements. The law on vitaminization

does not apply to formulas and no fortification

authorization is needed for fortifying them.

Operators may decide themselves whether to

market a food product as a special diet product. In

the case of some special diet products, a market

entry notification must be submitted to the Evira.

The Evira may, as appropriate, interfere with the

classification of a food product as a special diet

product, for instance, if a need arises to assess

whether the product in question is a special diet

product or not.

3.3 Classification of sweets andchewing gums

The current difference between food

supplements and fortified foods is not in all

respects completely clear, and no common

instructions have been issued at EU level. The

Eviras principle is that sweets and chewinggums are ordinary foods or possibly fortified

food products. Sweets and chewing gums fit

in with the definition of food supplements,

however, on the basis of their form, and they

may be classified as food supplements if their

purpose of use is unambiguously characteristic

of a food supplement. Jars with safety caps and

the fact that a product is marketed clearly as a

food supplement and not as a sweet or chewing

gum are factors supporting classification as food

supplements.

3.4 Law on novel foods and foodsupplements

Novel foods mean foods and food ingredients

that have not been used to a significant extent

as foods in the European Community area before

the Regulation on novel foods entered into force

in May 1997. Novel foods may not be introduced

to the market in Europe without Community

safety assessment and approval.

In Finland, the Regulation on novel foods did

not previously apply to products sold as food

supplements. Before 2002, the classification of

food supplements varied in EU Member States, and

there was no common definition for foodstuffs.

Since 2002 foodstuffs were defined in the GeneralFood Law Regulation of the EU (2002/178/EC)

and a special directive has been issued on food

supplements (2002/46/EC). Food supplements

are foods and the Regulation on novel foods

currently applies to all food supplements. Thus

ingredients that have not been used as foodstuffs

in the European Community area before May

1997 must not be used in food supplements

without an approval under the Regulation on

novel foods. Novel food applications have been

submitted e.g. concerning the use of alfalfa leafextract, deer horn powder, noni powder, noni

leaf powder, clinoptilolite, zeaxanthin, synthetic

lycopene and plant lignan from Picea abies in food

supplements. An interpretation has been given

concerning the application of the Regulation on

novel foods to numerous other ingredients of

food supplements.

3.5 Alcohol legislation and foodsupplements

Alcohol is used as an extraction solvent in the

production of herbal products, for instance,

which means that food supplements may contain

significant quantities of alcohol. According to the

Decree on labelling of foodstuffs, the alcohol

content of liquid foods must be declared if it

exceeds 1.2 per cent by volume. Also the alcohol

content of solid foods must be declared if it

exceeds 1.8 per cent by weight.


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According to the Alcohol Act (1143/1994), an

alcoholic substance means a substance or product

that contains more than 2.8 per cent ethyl alcohol

by volume.

Food supplements classified as alcoholic

preparations may be manufactured only by

companies licensed by the National Supervisory

Authority for Welfare and Health. Alcohol products

may be imported for commercial purposes only

by parties with a wholesale licence granted

by the Product Control Agency. Retail outlets

do not need a licence for selling alcoholic food

supplements. The Product Control Agency may,

however, prohibit or interrupt retail of an alcoholic

preparation whose properties correspond to

those of an alcoholic beverage or which is usedto a significant extent as an intoxicant. In other

words, retailing may be controlled even though

it is not subject to licence.

3.6 Raw materials and products ofanimal origin

Raw materials of animal origin are used for some

food supplements, such as reindeer horn powder

or colostrum. Raw materials of animal origin are

covered by the Food Act 23/2006, the Decree

on Food Hygiene of Foodstuffs of Animal Origin

and further legal provisions issued under them,

and the control of the conditions concerning the

manufacture of materials containing said raw

materials takes place under such law.

When raw materials of animal origin are imported

to Finland from EU countries, a first destination

notification must be made to the municipality

of importation. Raw materials of animal origin

imported from third countries outside the EU fall

within the sphere of veterinary border control.

The packaging of raw materials imported for the

manufacture of food supplements containing

foodstuffs of animal origin or other products

derived from animals must always declare the

products country and institution of origin when

the products are from countries outside Europe.

Gelatine derived from cattle, sheep or goats andimported from third countries must always be

accompanied by a TSE Assurance.

When ready-made, processed ingredients

of animal origin, such as food supplements

containing fish oil, milk powder, bone meal,

lactose etc., are imported to Finland, their control

takes place under the Food Act.


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4 APPLICATIONS / NOTIFICATIONSREQUIRED FROM FOOD BUSINESSOPERATORS



Ministry of Agriculture and Forestry Decreeon chargeable goods and services produced

by the Finnish Food Safety Authority

266/2008

Food Act 23/2006

4.1 Approval of food premises

Food supplements are foodstuffs that may be

manufactured, stored, marketed, served or

otherwise handled only on food premises. A

written application for approval of establishment

or use of food premises is to be submitted to a

municipal health protection authority in good

time before starting operations. Operations must

not begin before the authority has inspected the

premises and issued a decision approving the

application. Approval under section 13 of the

Food Act must also be applied for if substantial

changes take place in the operations.

Premises in which operations comply with section

13(2) of the Food Act (23/2006), i.e. the sale orconveyance of food is minor in comparison with

the operators other business practises in the

same premises. In such cases a notification to the

municipal control authority will suffice.

Existing food premises on which a notification has

been made under the old Health Protection Act

before 1 March 2006 and on which a municipal

control authority has issued a decision before

1 March 2006 need not be re-approved until

substantial changes take place in operations(change of ownership etc.).

The above also applies to pharmacies, gyms,

sports shops, sports departments of department

stores, care institutions and hairdressers sellingfood supplements or warehouses set up for mail

order sales, network marketing or electronic

marketing. Municipal authorities give instructions

and information on what an application for

approval/notification must contain. An in-house

control plan must be appended to applications for

food premises and notifications on operations.

4.2 In-house control plans

An in-house control (referred to in the Food Act

23/2006, section 20 as own-check) plan, must

be drawn up even when the operator has no food

premises (e.g. importers). The municipal control

authority will approve the in-house control plan

when approving the food premises if the in-

house control process meets the requirements

of the law and the control authority. The control

authority may also order that an in-house control

plan must be complemented before approval.

When operations do not require approval offood premises (section 13(2) of the Food Act

23/2006), no in-house control plan is approved

either. Nevertheless an in-house control plan

meeting the criteria set for in-house control must

exist and it must be presented to the municipal

control authority when a notification is made on

operations. The control authority may order that

the in-house control plan must be supplemented

or corrected regardless of the fact that no

approval decision is given on the plan.


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Regardless of whether the approval procedure

applies to an in-house control plan or not, the

plan must be sufficient in relation to operations

and it must reflect the operators food business

operations appropriately. The matter is discussed

in more detail in section 5.1.

4.3 Food supplement notification

Manufacturers, parties commissioning the

manufacture or importers of food supplements

must submit a written notification of food

supplements entering the market to the Evira

when starting operations. A notification form and

instructions for filling it are available on the Evira

website in Finnish, Swedish and English. The

matter is discussed in more detail in section 2.2.


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5 CONTROL

Food Act 23/2006, section 19

General Food Law Regulation of the

EU, or European Parliament and CouncilRegulation 178/2002/EC laying down the

general principles and requirements of food

law, establishing the European Food Safety

Authority and laying down procedures in

matters of food safety

5.1 In-house control

Under the Food Act, manufacturers, importers

and sellers of food supplements must, like

manufacturers, importers and sellers of other

foodstuffs, have a written in-house control

plan. In-house control (own-check) under the

Food Act requires that each operator must have

truthful and sufficient information on the food

supplements they produce, manufacture, import,

export, package, market, serve or convey for

food.

In addition to the food product itself, in-house

control focuses on controlling its manufacturing,

processing, transport, storage and sales conditionsto the extent that the operator is involved in the

chain.

In manufacturing and selling food supplements,

every link in the chain is responsible for its own

operations. Information on the ingredients used

must be traceable from raw materials to the

final product. Operators must be prepared for

situations in which a defect in a food supplement

is traced backwards along the production chain. In

a situation where a product has to be withdrawn,the destination of the defective products must be

known. The traceability obligation entered into

force on 1 January 2005 with the entry into force

of article 18 of General Food Law Regulation

178/2002/EC.

In-house control consists of identification of

critical control points, their monitoring and

written documentation. In-house control also

includes an up-to-date plan for action in case

a food supplement proves to contravene

regulations. Operators draw up their own control

plans and implement them in their operations.

The municipal food control authority advises on

drawing up plans.

Compliance of products with regulations may

be monitored in the in-house control procedure

through certificates obtained from suppliers of

raw material and by checking that the formula

is followed. The compliance of labelling with

regulations must also be checked. In some cases

it will be necessary to take in-house control

samples and examine them. Where necessary,

research procedures will be applied to monitor e.g.

the microbiological quality of raw materials and

products, the composition of food supplements,

for instance vitamin and mineral contents andquantities of other characteristic substances or

the occurrence of GMO substances.

Further information on in-house control is

available on the Evira website.

Hints for in-house control of products

by manufacturers and importers of food

supplements

Steps must be taken to ensure thatthe microbiological quality of raw materials

and finished food supplements is good,


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any irradiation of dried spice herbs, spices

and spice plants is declared on the labelling

in accordance with regulations,

permitted quantities of permitted additives

are not exceeded,

raw materials do not contain hormones or

doping substances,

food supplements do not contain medicinal

products referred to in section 3 of the

Medicines Act, that no substances listed in

the List of Medicines are used and that food

supplements do not contain large doses

of vitamins and minerals; In such cases it

is recommended that a classification be

requested from the National Agency for

Medicines;

food supplements and their ingredients donot contain alien substances in quantities

that exceed the limits (environmental

toxins, heavy metals, mould toxins etc.),

labelling corresponds to the composition,

appropriate information is declared on the

labelling relating to genetically modified

ingredients or ingredients made from them

and that traceability has been ensured,

the law on novel foods has been taken into

account in relation to the use of novel raw

materials,

necessary restrictions on use and warnings

are shown,

marketing complies with regulations,

the food supplement notification submitted

to the Evira is up to date,

that traceability in accordance with the

General Food Law Regulation of the EU has

been ensured.

Hints for in-house control relating to resale

of food supplements

Operators selling food supplements should checkwith suppliers that

a food supplement notification has been

submitted to the Evira,

the necessary labelling information is given

in Finnish and Swedish,

the labelling information is easily visible

and readable,

a food supplement is not a medicinal

product and does not contain substances

included in the List of Medicines, herbals,

hormones or doping substances,if a food supplement contains genetically

modified ingredients, this is declared on

the product and that documents concerning

the genetic modification accompany the

product,

if food supplements are sold as organic

products (organic, bio, eco etc.), the

labelling shows that the product comes

under organic control, i.e. the emblem of

the organic controller,

no medicinal claims are made on the

labelling of the food supplement or in its

marketing and that the claims made in

relation to the product are truthful,

it is possible to trace the supplier and the

food supplement.

The condition of products should be inspected

when goods are received. In-house controlincludes monitoring the sales period and correct

storage temperatures, for example.

5.2 Control by the authorities

Food supplements are primarily controlled by the

food control authorities in their municipalities

of manufacturing and importation, but all

municipalities are responsible for controlling the

sale and marketing of food supplements. The

Customs controls food supplements imported

from third countries, and in addition, food

supplements imported from EU Member States

in the form of market control. The border control

unit of the Evira controls the import of raw

materials of animal origin from third countries for

the manufacture of food supplements. The Evira

steers control operations throughout the country.

5.2.1 Finnish Food Safety Authority

Evira

The Evira also plans and steers food control in

respect of food supplements through guidebooks,

letters giving instructions, by providing

information and training.

Food supplement notifications are submitted to

the Evira. Manufacturers, parties commissioning

manufacture or importers of food supplements

must submit a written notification concerning a

food supplement entering the market, includingthe required appendices, to the Evira. The matter

is discussed in more detail in section 2.2. In


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processing notifications, the Evira does not

control the compliance of food supplements with

the regulations but forwards the notifications

to municipalities, provinces and the Customs,

and where necessary to the Evira border control

unit. Municipalities and the Customs control the

truthfulness of food supplement notifications in

connection with inspection visits and research

activities or through projects where necessary.

In its plans and annual control programmes, the

Evira may start a national food supplement control

project. Such projects may focus on certain sites

(such as gyms), certain food supplement groups

(such as calcium preparations) or marketing.

Apart from this, from time to time the Authority

reserves appropriations for laboratory research inorder to control some food supplement group. The

Authority then forwards the laboratory research

findings to municipalities and state provincial

offices for information and action.

It has been agreed with the Customs Laboratory

that the Evira will send the Customs Laboratorys

own research findings and information on

action taken by the Customs to municipalities

of importation for information. If defective food

supplements have entered the domestic market,

the Evira asks the municipal authorities to carry

out actions to control food supplements.

Where necessary, the Evira may, together with

the authorities of state provincial offices and

municipalities, make inspection visits to places

where food supplements are manufactured and

to warehouses of importers or packagers.

5.2.2 State provincial offices

State provincial offices plan and guide food

supplement control and control compliance with

the law in their area. They get summary information

on food supplement notifications submitted to

the Evira and forwarded to municipalities for

purposes of control. They monitor and supervise

municipal food supplement control, e.g. actions

taken by municipalities on the basis of Customs

research findings.

The state provincial offices plan and implementmarket control projects focusing on food

supplements and included in their control

programme together with the Evira, the

municipal control authorities and the Customs.

Their representatives make inspection visits to

control sites together with the municipal control

authorities on request or on their own initiative,

e.g. in connection with control projects. State

provincial offices also train and instruct the

municipal authorities and give interpretations on

law relating to food supplements on request.

5.2.3 Municipal control authorities

The municipal food control authorities enforce

food control in practice. In the case of food

supplements, control focuses primarily on

manufacturers, packagers, importers andwholesalers.

Food premises

In principle, the manufacture, storage, sale or

other handling of food supplements and other

foods is allowed only in food premises. The control

authorities must try and include all companies

working with food supplements under their

control. This also applies to pharmacies, gyms,

sports shops, sports departments of department

stores and hairdressers selling food supplements

or warehouses set up for mail-order sales,

network marketing or electronic marketing.

Food premises must be approved by a municipal

control authority before operations may begin

(Food Act 23/2006, section 13).

Food premises referred to in section 13(2) of the

Food Act (23/2006) constitute a derogation from

the approval procedure if the sale or conveyance

of food in them is minor in comparison with

the operators other business practises in the

same premises. In such cases a notification tothe municipal control authority will suffice. The

products must, however, always comply with the

law and be safe for their user, and this activity

comes under food control in the same way as in

approved food premises.

There may be several operators involved along

the route from manufacturer to consumer. A

product may be manufactured in one country and

then imported by a company with an office and

address in one municipality and warehousingservices outsourced to a wholesaler situated in

another municipality, after which a pharmaceutical

wholesaler supplies the product via a central


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warehouse for retail sale. Food supplements are

also sold through network marketing or mail-

order sales so that the products are supplied to

clients direct from warehouses outside Finland.

Product control and supervision of in-house

control

Under the Food Act, manufacturers, importers

and sellers must always have a written in-house

control plan. This must be drawn up regardless

of whether the operator is obliged to apply

for approval of food premises or whether a

notification of operations will suffice.

Food supplement product control by the municipal

authorities focuses primarily on supervision

of the function of food business operators in-house control systems (see section 5.1). The

food business operator operating in Finland and

declared on a products labelling or some other

Finnish seller of the product is responsible for

the composition, labelling and marketing of the

product. It is important to inspect the function

of the in-house control of the food business

operator responsible for the product. If the

product labelling does not declare the name of

a Finnish food business operator, the seller of

the product must nevertheless know who the

mediator of the product is. Under the General

Food Law Regulation of the EU (178/2002),

responsibility for products and their traceability

is transferred from one operator to another in the

products chain.

If it is found in an inspection of a manufacturer

or importer that a food supplement contains

substances included in the List of Medicines or

that there are quantities of vitamins or minerals

in excess of the limits given in the List of

Medicines (Appendix 3), a municipal inspectormay, in an inspection report, request the food

business operator to obtain a National Agency

for Medicines classification for the product, since

the food business operator is responsible for

choosing the right sales channel. The matter is

discussed in more detail in section 3.1.

Products classified as medicinal products by

the National Agency for Medicines must not

be marketed as food. If a municipal authority

nevertheless finds that this is what happens,the Evira will be notified and the Authority will

forward the information to the National Agency

for Medicines. The National Agency for Medicines

has the powers to take action under the Medicines

Act. The National Agency for Medicines also

controls herbal medicinal products permitted to

be sold by food shops and anthroposophic and

homeopathic preparations.

After 1 August 2005, only food supplements

complying with the Decree on Food Supplements

may be sold. Marketing of products under the

old name nutritional product is prohibited after

the said date and they must be withdrawn from

sales outlets.

The composition and labelling of food

supplements must comply with food regulations

also when food supplements are sold bypharmacies, subsidiary pharmacies or licensed

medicine chests.

Medicinal claims on the labelling and in the

marketing of food supplements are prohibited.

The law on the marketing of food products applies

to all marketing, including network marketing.

The seller of a food supplement is responsible for

providing the buyer with correct information and

ensuring that the buyer is not misled.

Shop advertising and other local marketing is

controlled by the municipal authorities. Actions

relating to nationwide marketing fall within the

sphere of the Evira.

Customer complaints and product defects on

the market

If there is reason to suspect, as a result of in-

house control or a consumer complaint, that a

food supplement on the market does not comply

with the regulations or represents a health

hazard, the authorities of the municipality ofmanufacture or importation will be contacted,

and these authorities will start investigating

the matter. Other parties, too, may report to the

authorities if a food supplement is suspected of

not complying with the regulations.

If a food supplement proves to be a health hazard,

the food business operator must start withdrawal

without delay and notify the authorities.

Consumers must also be informed if the product

has already reached them (2002/178/EC, article19).


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The authorities should cooperate. For instance,

before taking samples, the authorities should

find out if the food supplement in question has

been investigated on the initiative of the Evira

or the Customs. It is above all the duty of the

manufacturer or the importer to show that the

product complies with the regulations.

5.2.4 Customs

The Customs has at its disposal a nationwide

sampling and control network for controlling

imported food. The Product Safety Unit of the

National Board of Customs and the five customs

districts are responsible for official operations. The

Customs Laboratory is responsible for research.

Control of food supplements manufactured

within the EU internal market is primarily the

duty of the control authorities of the country

of manufacture. According to EU food control

regulations, samples may, however, be taken at

all stages of production, distribution and sales.

Such random sampling ensures that the control in

the country of origin works and that the required

labelling information is also included in Finnish

and Swedish.

The Customs controls food supplements coming

from the internal market through samples taken

at the importers warehouses. This control is

based on an annual control plan drawn up at

the Customs as part of the national control plan.

Since these are internal market samples, use

of the products is not banned for the period of

investigation. The holder of the goods receives a

research report on the investigation carried out.

A fee laid down by Ministry of Finance Decree

is charged for the investigation. If products notcomplying with the regulations are found, the

Customs will forbid sale of the goods remaining

in storage. If there is an obvious health hazard,

the goods already on the market will also be

withdrawn. The Evira requests withdrawal and

any other action from the municipal authorities.

Food supplements are also imported to Finland

from outside the EU, primarily from the US. Control

of these products falls within the sphere of the

Customs. The Customs carries out a samplingassessment on the basis of its control plan in

connection with clearing the goods. Conveyance

of the goods from which samples are taken is

interrupted for the period of the investigation.

When the investigation is completed, the

clearing of products complying with regulations

may continue. Food supplements not complying

with regulations may, subjec

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