Download Food Supplements

ENVIRONMENT AND FOOD AGENCY/INFORMATION AND FACTS
INFORMATION AND FACTS
August 2004
NEW REGULATION ON FOOD
SUPPLEMENTS
WHAT ARE FOOD SUPPLEMENTS?
In Iceland the concept "food supplement" has been used for most of the
products that people consume in addition to regular, traditional food,
including energy bars, protein mixes, vitamin and mineral mixes, herbal
extracts, etc.
According to the new regulation, food supplements are tablets or drops
containing vitamins and/or minerals (vitamin and/or mineral tablets) or other
substances having nutritional or physiological effects (e.g., fatty acid
capsules). However, whether such products are deemed to be food
supplements or medicines/herbal medicines can depend on the functionality
of the contents and/or the quantity. If there is any doubt, the Icelandic
Medicinal Control Agency shall make a ruling.
Protein powders, prepared protein beverages, energy bars and many other
things not intended to be consumed in small, measured doses are not
included under the definition of food supplements. These products are
subject to the general regulations on food.
PDF created with pdfFactory Pro trial version www.pdffactory.com
ENVIRONMENT AND FOOD AGENCY/INFORMATION AND FACTS
By definition food supplements are food used in addition to regular food; they have a high proportion of
vitamins and minerals or other substances with nutritional or physiological effects. These food are
intended to be consumed in small, measured doses. Food supplements consequently contain few calories
per daily dose.
CONTENTS
Food supplements shall fulfil the provisions of the Regulation on food supplements. Additives used in food
supplements shall be on the list of permissible additives in the Regulation on food additives. Food fortification
is generally forbidden unless permitted by The Environment and Food Agency.
OPERATING LICENSE
All manufacturers or distributors of food, including food supplements, shall have an operating license from the
relevant public health board.
NEW REGULATION ON FOOD SUPPLEMENTS
The Ministry for the Environment has issued Regulation No. 624/2004 on food supplements, which is based
on European Union Directive No. 2002/46 on the same subject. Until now food supplements have been
handled by the Icelandic Medicinal Control Agency; according to the regulation, food supplements are food
falling under food legislation and subject to monitoring by municipalities' public health boards under the
supervision of the Environment and Food Agency. In case of doubt, the Icelandic Medicinal Control Agency
rules on whether a product is a medicine/herbal medicine or a general consumer product (food).
IMPORTATION AND MONITORING
The Environment and Food Agency is in charge of monitoring the importation of food. Under the regulation the
agency shall be notified on the appropriate forms when a food supplement is first marketed, and a sample of
the product shall be submitted. When a product is introduced on the market, the responsibility for monitoring is
transferred to municipalities' public health boards in the same way as for other food. Monitoring visitations and
coordinated monitoring tasks are annual events when, among other things, samples are taken in food
companies and tested with regard to raw materials, marking, additives, etc.
If food comes from countries belonging to the EEA Agreement, the rule on the free flow of goods applies.
Monitoring parties are involved in monitoring foods only when they have been placed on the market.
However, there are exceptions to this main rule that authorize the Environment and Food Agency to halt
importation:
• because of repeated instances of illegal substances being found in food.
• if there is a reasonable suspicion of there being a risk to consumers.
PDF created with pdfFactory Pro trial version www.pdffactory.com
ENVIRONMENT AND FOOD AGENCY/INFORMATION AND FACTS
Similarly, the Environment and Food Agency can restrict the importation of foods from states outside the EEA if
it is suspected that the foods to be imported do not meet current food regulations.
LABELLING
Concerning the labelling of food supplements, the provisions of three regulations apply: Regulation on food
supplements, Regulation on labelling, advertisement and promotion of food and Regulation on nutritional
labelling of food. These regulations contain the following points:
• Labels shall be clear and legible in Icelandic, English or a Nordic language other than Finnish.
• They may not be deceptive to the buyer or recipient.
• Effects or characteristics may not be falsely attributed to food.
• Preventive or curative qualities regarding human disease may not be attributed to food supplements or
other food, nor may such qualities be referred to.
Packaging for food supplements shall clearly state the kind of food involved, i.e., the substances characterizing
the product. If a vitamin mixture is involved, this must be clearly stated on the product's package. In addition,
the following must be stated on the packaging of food supplements:
• Recommended daily dosage
• The text "Food Supplement" in the same visual field as the product name
• Warning not to consume more than the recommended daily dose
• Declaration to the effect that the consumption of food substances does not replace a varied, regular diet
• Warning to store food supplements out of the reach of children
• Nutritional values according to the Regulation on nutritional labelling of food
It is forbidden for any reference to be made in a label, advertisement or presentation on food supplements that a
diverse, traditional diet cannot satisfy consumers' nutritional needs.
The same provisions apply to the marketing or other promotion of food supplements.
Nutrients are vitamins, minerals
and essential fatty and amino
acids.
PDF created with pdfFactory Pro trial version www.pdffactory.com
ENVIRONMENT AND FOOD AGENCY/INFORMATION AND FACTS
CLAIMS
It is forbidden to claim anything about the characteristics of food or its content unless such is authorized
under the Regulation on labelling, advertisement and promotion of food, Regulation on nutritional labelling of
food, other special regulations or by the Environment and Food Agency, cf. Regulation on labelling,
advertisement and promotion of food.
Examples of wrong and confusing claims:
• By consuming product X you burn calories without exercising.
• You eat as much as you want without getting fat.
• Consumption of product X helps in the fight against cancer.
• Finally in Iceland.
• The wait is over.
• Reduces appetite, and the kilos melt away.
• Product X contains all the substances the body needs.
DEADLINES
Manufacturers and distributors of food supplements and other food that until now have been imported with the
endorsement of the Icelandic Medicinal Control Agency, such as energy bars, protein powders, etc., have a
reasonable period to adapt to changed circumstances. In this regard attention is especially drawn to the
following points:
• Foods falling under Regulation No. 624/2004 on food supplements shall fulfil its provisions no later than 1
August 2005.
• Foods containing additives not permitted under the Regulation on food additives are forbidden on the
Icelandic market.
• Food, for example, energy bars or protein beverages, labelled in languages not permitted under the
Regulation on labelling, advertisement and promotion of food is forbidden on the Icelandic market and shall be
relabelled immediately.
• Food, for example, energy bars or protein beverages, not falling under Regulation No. 624/2004 on food
supplements, and which violates the Regulation on labelling, advertising and presentation of food or the
Regulation on nutritional labelling of food, for example, because of claims, shall be relabelled according to
Icelandic regulations no later than 1 January 2005.
• Food, for example, energy bars or protein beverages, not falling under Regulation No. 624/2004 on food
supplements, and which contains added substances like vitamins and minerals, shall fulfil the rules on food
fortification no later than 1 August 2005.
PDF created with pdfFactory Pro trial version www.pdffactory.com
ENVIRONMENT AND FOOD AGENCY/INFORMATION AND FACTS
Manufacturers and distributors shall ensure that food is not damaging to health, cf. Article 10 of Act No.
93/1995 on food.
The Environment and Food Agency advises manufacturers, importers and distributors of food supplements to
acquaint themselves well with the laws and regulations on food in force each time.
The Environment and Food Agency
Sudurlandsbraut 24 - 108 Reykjavík
Tel: 591 2000 - Fax: 591 2020
E-mail: [email protected] • [email protected]
Home page: www.ust.is
Photographs: The Environment and Food Agency – Layout and design: Gutenberg ehf.
PDF created with pdfFactory Pro trial version www.pdffactory.com