WWW Webapps Webapp Evira 2 Data Products 1285599413807 5536 Food Supplement Guide

Eviras guideline 17012/3/en
Food Supplement Guide

for food supervisors and food business operators
Finnish Food Safety Authority Evira
Food Supplement Guide

for food supervisors and food business operators
Eviras guideline 17012/3/en
Food Supplement Guide - Eviras guideline 17012/3/en
Eviras guideline 17012/3/en 12/2008 Product Safety
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.
Contents
1 INtRODUCtiON ............................................................................................................................................5 2 DeCRee ON fOOD sUppLeMeNts. .................................................................................................................6 2.1 Denitions....................................................................................................................................6 2.2 Notication..................................................................................................................................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 Classication 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. ...................................................................................................... 22 4.2 In-house control plans. ............................................................................................................. 22 4.3 Food supplement notication.................................................................................................. 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 ofces.................................................................................................... 26 5.2.3 Municipal control authorities.......................................................................................... 26 5.2.4 Customs........................................................................................................................... 28 5.2.5 Eviras unit of the veterinary border control.............................................................. 28 5.3 Coercive means and penalties................................................................................................. 29 USEFULL LINKS.............................................................................................................................................. 32
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 include products for the intake of vitamins, minerals, bre 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 3040% 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 minerals Products 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.
2 DECREE ON FOOD SUPPLEMENTS

Food Act (23/2006) Ministry of Trade and Industry Decree on Food Supplements (571/2003), based on 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) 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 2.1 Definitions

Under the Decree on Food Supplements 571/2003, food supplement means a prepackaged 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 signicant 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 signicant 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 inuence the nutritional or physiological functions of people in some other way. They are not meant to be used as substitutes for a varied diet. Products classied as medicinal
6
A food business actor who manufactures a food supplement or commissions its manufacture or imports a food supplement must submit a written notication of the food supplement to the Eivra when starting operations. A notication 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 notication requirement fullled when the notication is received by the Authority including appendix and all information required. An obligatory appendix to food supplement notications (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 notication has/ have no right to sign the company name, a proxy must be appended. Other appendixes attached to the notication may include a product brochure, for example.
The Evira will send the actor an acknowledgement of receiving the food supplement notication. If the notication is decient, the Authority will 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 notications including appendixes are sent for information and control to the municipality of manufacture or importation of the product and to the relevant state provincial ofce 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 must give a notication on the food supplement in question. The information given in the notications and labelling must be identical. A notication must always be made if the manufacturer, the party commissioning the manufacture or the importer changes. If a notication 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 notications (in 2008). A fee is not charged, however, for notications concerning withdrawal of a food supplement product from the market. Notications may be made in free form, but the Evira recommends the use of a ready-made form. The form and instructions for lling it are available in Finnish and Swedish (the form is also available in English) on the Evira website.
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 the European 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 specically 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 intake recommendation 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 1. must give truthful and sufcient information about food taking into account section 1(1), 1(3) and 1(4) of the Act; must not give misleading information about food;
2.3 Characteristic substances in food 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. bre, 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
2.
3.
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
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 Vitamin A1 Vitamin D Vitamin E
1 1
Daily minimum 240 g 1,5 g 3 mg 22,5 g

1 1
Mineral Calsium1 Magnesium Iron

1 1
Daily minimum 240 mg 90 mg 4,2 mg 0,3 mg 45 g 4,5 mg 0,6 mg 180 mg 600 mg 16,5 g
2 2
Vitamin K2 Tiamin (B1) Niacin1 Vitamin B6 Folic acid1 Vitamin B12 Biotin
1 1
Copper2 Iodine Zink

1 1
0,42 mg 0,48 mg 5,4 mg 0,6 mg 60 g 0,3 g 0,045 mg 1,8 mg 18 mg
Riboflavine (B2)
Manganese2 Sodium
2
Potassium2 Selenium Chromium Fluorine

2 2
12 g 15 g 1,05 mg 240 mg 240 mg
Pantothenic acid1 Vitamin C

1
Molybdenum2 Chlorine
Phosphorus1
1 2
Ministry of Trade and Industry Decision on the nutritional value labelling of food 1496/1993. Scientific Committee on Food on 6 March 2003 (SCF/CS/NYT/GEN/18 final). Opinion of the Scientific 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
2.4 Labelling
Ministry of Trade and Industry Decree on labelling of foodstuffs 1084/2004 Ministry of Trade and Industry Decision on nutritional value labelling 1496/1993 Ministry of Trade and Industry Decree on Food Supplements 571/2003 European Parliament and Council Regulation (EY) 1829/2003 on genetically modied 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 on special 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)
Labelling, particularly warnings, must be easily visible, in sufciently 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 briey and accurately what food product the packaging contains (e.g. calcium tablet, oat shoot extract). The term food supplement, which must also be shown, is not in itself sufcient 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 nal 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 of conformity 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 product in some other way. Ingredients that it
The responsibility for labelling and its correctness is carried by the food business actor who prepares, packages or imports food supplements
S.ALGAE TABLET
Spirulina 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: Manufacturer: xx.yy.2011 Company Ltd Shopping Street 2, 00000 Town
Picture 1. Example of provisions laying down criteria for labelling.
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 - sh and sh 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 (over 10mg/kg or 10 mg / l). The origin of additives made of the above ingredients must also be reported.
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 Identication 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 on the Eviras web pages.
OAT SHOOT EXTRACT

Best before: xx.yy.2012
50 ml Food supplement
Ingredients: Oat shoots, ethanol Final ethanol concentration approx. 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.
Importer: Shop Ltd. Shoots Alley 6 00000 Municipality www.uutekauppa.fi
Picture 2. An example of labelling on a plant extract product.
10
2.4.2 Labelling according to the Decree 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 food supplement may be classied. Such categories include vitamins, minerals, bre, avonoids, amino acids, fatty acids or plant or herbal extracts. Nature, in the case of avonoids, 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 Scientic 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 for vitamins 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 there is 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 Scientic 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 coefcients (declaring vitamin A), see our website at http://www.evira./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 diet The 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 recommended daily dose and warnings.
11
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 sufcient 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.
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 modied maize, soy or other manufacturing ingredients or additives made of genetically modied 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 modied microbe (e.g. vitamins, aromatic substances and amino acids) that no longer have any genetically modied 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.
CALCIUM
Dolomite tablet 350 tablets 224 g Food supplement Ingredients: Dolomite, anti-caking agent E460, separating agent E470b. Recommended daily dose: 4 tablets a day. The recommended daily dose contains calcium 430 mg (54%*) and magnesium 260 mg (87%*)
* of the reference value for daily dose
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. Best before: xx.yy.2011 Manufacturer: Company Ltd, Shopping Street 2, 0000 Town
Picture 3. An example of labelling a mineral product.
12
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.
Under section 9 of the Food Act, truthful and sufcient 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 and health 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 denes the conditions under which such claims may be employed and species 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 verication of the scientic evidence underlying the claims. The Regulation claries the use of nutrition and health claims, since it species 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 of weight 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.
Manufacturers of food supplements must nd 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 Ministry of Trade and Industry Decree on Food Supplements 571/2003 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.
13
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 lactoseintolerance protection from bacteria and viruses helps those suffering from hypertension Mrs Xs arteriosclerosis disappeared when she used product Y for aenemia
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 specied 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 benecial 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 benecial 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 specied in the Regulation. A nutrition claim is information published about a food product which states, suggests or implies that the food has particular benecial nutritional properties. This may apply to energy, amino acids, fat, nutritional bre 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-bre, or a source of bre, high vitamin or mineral content.
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 and helps with weight control.
14
2.6 Other legislation to be taken into account

Use of hormones in food supplements and in other food products is prohibited (Section 7 of the Food Act). The use of doping substances is 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 and dissemination 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 denes 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.). This guide classies 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 by the 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.
15
3 RESTRICTIVE DEFINITION OF FOOD SUPPLEMENT

Medicines Act 395/1987 National Agency for Medicines decision the List of Medicines 1179/2006 European 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 Ministry of Trade and Industry Decree on special diet products 662/2000 European Parliament and Council 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 Ministry of Trade and Industry Decree on the labelling of food products 1084/2004 European Parliament and Council Regulation 1997/258/EC concerning novel foods and novel food ingredients Alcohol Act 1143/1994 alleviate or prevent a disease or its symptoms in humans or animals. Products or substances to be taken internally or externally for the purposes of establishing 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 conrmed 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 classied as medicinal products. The maximum daily vitamin and mineral contents that may not be exceeded if the products are not classied as medicinal products are also given in Table 2.
Food supplements are foodstuffs but may resemble medicinal products in appearance and use. Food supplements are not a substitute for a varied daily diet, since they are not signicant sources of energy. Their purpose is to supplement the diet.
3.1 Difference between food supplements and medicinal products

According to section 3 of the Medicines Act, a medicinal product is a product or substance intended for internal or external use to cure,
16
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 classied as medicinal products.
Table 2. Limits for vitamins and minerals given in Appendix 3 to National Agency for Medicines decision 1179/2003. Vitamin vitamin A vitamin D vitamin E vitamin K thiamine (B1) riboflavin (B2) niacin vitamin B6 folic acid vitamin B12 pantothenic acid biotin vitamin C beta-carotene Daily dose for adults 900 g 10 g 10 mg 70 g 1,5 mg 1,7 mg 20 mg 2,2 mg 400 g 3 g 4 mg 30 g 75 mg 6 mg Mineral calcium phosphorus magnesium iron zinc iodine copper manganese chromium selenium potassium Daily dose for adults 900 mg 800 mg 350 mg 18 mg 15 mg 150 g 2 mg 2,5 mg 50 g 50 g 3500 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 of food 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 classication 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).
17
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 treating 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
D O T O N F E T EM O N PL P SU
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 National Agency 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. Classication decisions are product-specic. Products are classied as medicinal products, non-medicinal products or
health care equipment and supplies. Both the composition of the product and the proposed purpose of use inuence the classication. If a product is used in accordance with the denition 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 classication request are available on the National Agency for Medicines website. If a product is classied 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 classied as medicinal products are removed from the shelves of shops selling foodstuffs (Food Act 23/2006, section 16).
18
Table 3. Food and medicinal products have different criteria for entering the market and separate control. FOOD Products Conventional food Novel food Food supplements Some special diet products MEDICINAL PRODUCTS Medicinal products: - ordinary medicinal products - herbal medicinal products - homeopathic and anthroposophic products Authorization procedure of registration 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
Criteria for entering market Authorization or notification authority
No advance control
Authorization procedure Evira EU Commission
Notification procedure Evira
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 sufcient 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 are advertisements marketing medicinal products.
3.2 Difference between food supplements and special diet products

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 benet from a controlled intake of substances in certain foods. Special diet products include baby foods, nongluten 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 classied as food supplements on the basis of the purpose
19
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 signicant 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 signicant in comparison with food supplements. The law on vitaminization does not apply to formulas and no fortication 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 notication must be submitted to the Evira. The Evira may, as appropriate, interfere with the classication 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.
3.4 Law on novel foods and food supplements

Novel foods mean foods and food ingredients that have not been used to a signicant 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 classication of food supplements varied in EU Member States, and there was no common denition for foodstuffs. Since 2002 foodstuffs were dened in the General Food 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 leaf extract, 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.
3.3 Classification of sweets and chewing gums

The current difference between food supplements and fortied 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 chewing gums are ordinary foods or possibly fortied food products. Sweets and chewing gums t in with the denition of food supplements, however, on the basis of their form, and they may be classied 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 classication as food supplements.
3.5 Alcohol legislation and food supplements

Alcohol is used as an extraction solvent in the production of herbal products, for instance, which means that food supplements may contain signicant 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.
20
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 classied 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 used to a signicant extent as an intoxicant. In other words, retailing may be controlled even though it is not subject to licence.
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 rst destination notication 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 and imported from third countries must always be accompanied by a TSE Assurance. When ready-made, processed ingredients of animal origin, such as food supplements containing sh oil, milk powder, bone meal, lactose etc., are imported to Finland, their control takes place under the Food Act.
3.6 Raw materials and products of animal 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,
21
4 APPLICATIONS / NOTIFICATIONS REQUIRED FROM FOOD BUSINESS OPERATORS

Ministry of Trade and Industry Decree on Food Supplements 571/2003 Ministry of Agriculture and Forestry Decree on chargeable goods and services produced by the Finnish Food Safety Authority 266/2008 Food Act 23/2006 The above also applies to pharmacies, gyms, sports shops, sports departments of department stores, care institutions and hairdressers selling food 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/notication must contain. An in-house control plan must be appended to applications for food premises and notications on operations.
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 or conveyance of food is minor in comparison with the operators other business practises in the same premises. In such cases a notication to the municipal control authority will sufce. Existing food premises on which a notication 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.).
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 inhouse 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 of food 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 notication 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.
22
Regardless of whether the approval procedure applies to an in-house control plan or not, the plan must be sufcient in relation to operations and it must reect the operators food business operations appropriately. The matter is discussed in more detail in section 5.1.
supplements entering the market to the Evira when starting operations. A notication form and instructions for lling it are available on the Evira website in Finnish, Swedish and English. The matter is discussed in more detail in section 2.2.
4.3 Food supplement notification

Manufacturers, parties commissioning the manufacture or importers of food supplements must submit a written notication of food
23
5 CONTROL
Food Act 23/2006, section 19 General Food Law Regulation of the EU, or European Parliament and Council Regulation 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 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 identication 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 certicates 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 and quantities 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 that the microbiological quality of raw materials and nished food supplements is good,
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 sufcient 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 conditions to 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 nal 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
24
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 classication be requested from the National Agency for Medicines; food supplements and their ingredients do not 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 modied 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 notication submitted to the Evira is up to date, that traceability in accordance with the General Food Law Regulation of the EU has been ensured.
the product and that documents concerning the genetic modication 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 control includes 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.
Hints for in-house control relating to resale of food supplements Operators selling food supplements should check with suppliers that a food supplement notication 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 modied ingredients, this is declared on
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 notications are submitted to the Evira. Manufacturers, parties commissioning manufacture or importers of food supplements must submit a written notication concerning a food supplement entering the market, including the required appendices, to the Evira. The matter is discussed in more detail in section 2.2. In
25
processing notications, the Evira does not control the compliance of food supplements with the regulations but forwards the notications 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 notications 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 in order to control some food supplement group. The Authority then forwards the laboratory research ndings to municipalities and state provincial ofces for information and action. It has been agreed with the Customs Laboratory that the Evira will send the Customs Laboratorys own research ndings 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 ofces and municipalities, make inspection visits to places where food supplements are manufactured and to warehouses of importers or packagers.
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 ofces 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 and wholesalers. 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 notication to the municipal control authority will sufce. 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 ofce and address in one municipality and warehousing services outsourced to a wholesaler situated in another municipality, after which a pharmaceutical wholesaler supplies the product via a central
5.2.2 State provincial offices

State provincial ofces plan and guide food supplement control and control compliance with the law in their area. They get summary information on food supplement notications 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 ndings. The state provincial ofces plan and implement market control projects focusing on food supplements and included in their control
26
warehouse for retail sale. Food supplements are also sold through network marketing or mailorder 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 notication of operations will sufce. Food supplement product control by the municipal authorities focuses primarily on supervision of the function of food business operators inhouse 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 inspector may, in an inspection report, request the food business operator to obtain a National Agency for Medicines classication 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 classied as medicinal products by the National Agency for Medicines must not be marketed as food. If a municipal authority nevertheless nds that this is what happens, the Evira will be notied 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 by pharmacies, 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 inhouse 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 of manufacture 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, article 19).
27
The authorities should cooperate. For instance, before taking samples, the authorities should nd 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 ve customs districts are responsible for ofcial 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 not complying 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 sampling assessment 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, subject to consideration and on condition that the control authorities grant permission to do so, be returned to a foreign seller or manufacturer, taken out of the country, destroyed under Customs control or altered to comply with regulations. A fee laid down by the Ministry of Finance is charged for investigations. The Evira distributes information on the investigations carried out by the Customs to municipalities for the supervision of in-house control by importers of food supplements. In various countries, classication of preparations as medicinal products is markedly different from the classication applied in Finland. In ambiguous cases the Customs always consults the National Agency for Medicines for an interpretation before taking control action.
5.2.5 Evira unit of the veterinary border control

The Act on Veterinary Border Inspection (1192/1996) lays down requirements for food derived from animals and other products of animal origin coming from outside the EU. In the case of food supplements these requirements (approved country and institution of origin and health certicate) usually only apply to raw materials imported for the manufacturing of food supplements. Thus import requirements for food derived from animals and other products of animal origin do not apply to nished food supplements packed e.g. in capsule or tablet form for retail sale to end users (e.g. colostrum capsules, royal jelly tablets). In such food supplements the food derived from animals or other product of animal origin is part of the ingredient content of the food supplement, in which case the nal product, i.e. the nished food supplement, is not dened as a food product of animal origin. In the case of some raw materials, importation requires a special import licence. Apart from import requirements, current legislation requires that a veterinary border inspection be carried out when raw materials are imported to the EC
28
area for the manufacture of food supplements. Veterinary border control applies to raw materials whose CN code is mentioned in the Annex to Commission Decision 2002/349/EC. The CN code of the product to be imported must be checked with the Customs before importation. As far as raw materials containing a substance of animal origin to be imported for the manufacture of food supplements from outside the EU are concerned, Evira/ border veterinarians control the fullment of import requirements. An advance notication must be made to the relevant border control station on raw materials to be imported for the manufacture of food supplements and subject to veterinary border control not later than the weekday preceding import during the opening hours of the border control station. The notication must be made electronically using the TRACES data system.
The food control authorities may use a request which is milder than an order or prohibition in situations involving no actual health hazard or intentional misleading. A correctional request should, however, always be given in writing and a deadline should be set for complying with the request. A temporary prohibition may be used if, for instance, the labelling of the food supplement must be corrected or a notication has not been made to the Evira in spite of a request to do so. A conditional ne is imposed in situations involving repeated violation of provisions and control authority orders or when the situation is otherwise serious enough to warrant sanctions. Under the Food Act a municipal food control authority may where necessary request executive assistance from the police. In addition to coercive means the Food Act includes penal provisions.
5.3 Coercive means and penalties

Food Act 23/2006 sections 55-69
Actions concerning food supplements are carried out on the basis of the Food Act.
Indicative examples of control authority action in various situations: Example 1. No food supplement notication has been submitted. The notication must be made to the Evira when starting operations. Control authority of the municipality of manufacture or importation Customs Gives a written suggestion to submit a notication and sets a deadline. If a notication is not made to the Evira in due time, the products are placed under a temporary prohibition until a food supplement notication is made to the Evira. Places the imported batch under a ban on conveyance and use until the operator submits a food supplement notication to the Evira.
Example 2. Food supplements are sold/imported without labelling in Finnish and in Swedish. Control authority of the municipality of manufacture or importation or of the municipality of sale Customs Places the food supplements under a temporary prohibition until the labelling bears the correct information.
Prohibits import of the product until the labelling bears the correct information.
29
Example 3. A food supplement contains a substance included in Appendix 1 to the List of Medicines or a herbal included in appendix 2 or the vitamin and mineral content limits given in appendix 2 are exceeded. Control authority of the municipality of manufacture or importation Customs Requests to see the classication decision of the National Agency for Medicines. If it does not exist, requests the operator to obtain one or to contact the National Agency for Medicines in order to have the need for classication assessed. Requests to see the classication decision of the National Agency for Medicines. If it does not exist, requests the operator to obtain one or to contact the National Agency for Medicines in order to have the need for classication assessed.
Example 4. A food supplement is suspected of causing/having caused health damage. Places the products in storage under a sales prohibition and Municipal control authority, primarily of the municipality of contacts the Evira. Requests the food business operator to manufacture or importation withdraw the product from the market and informs consumers when necessary. Customs Evira/Border veterinarian Evira Forbids import of the product and contacts the food business operator and the Evira. Where necessary carries out national actions and makes a Rapid alert System for Food and Feed (RASFF) notication
Example 5. A food supplement is marketed using medicinal claims. Municipal control authorities Forbid sale of the food supplement until the medicinal claims have been removed from the food supplement labelling. Request the operator to stop other medicinal marketing than that on the labelling. If the request is not followed, a report is made to the Evira. Forbids import of the food supplement until the medicinal claims have been removed from the labelling. Forbids other medicinal marketing than that on the labelling of food products. Where necessary, a sanction of a conditional ne is imposed.
Customs Evira
Example 6. The seller of a food supplement does not have an in-house control plan or the plan is decient Control authority of the municipality of sale Orders the business operator to draw up an in-house control plan within a xed time period.
Example 7. The manufacturer, packager or importer of a food supplement does not have an in-house control plan or it is decient. Control authority of the municipality of manufacture, packaging or importation Orders the business operator to draw up or supplement the inhouse control plan within a xed time period.
30
Example 8. The composition of a food supplement does not correspond to the labelling but there is no health hazard. Control authority of the municipality of manufacture, packaging or importation Assesses whether the error is major or minor. If, for instance, the product is sold as a source of substance x and the product does not contain such a substance or contains only very little of the said substance, it is considered a major error. Untruthful labelling information on additives, ingredients missing from the list, distinct deviation from the quantities of nutrient etc. are also major errors. The product is placed under a temporary ban on conveyance and a request is issued to correct either the composition or the labelling and to make a new food supplement notication to the Evira. In the case of a labelling error that may cause a health hazard (e.g. a substance causing hypersensitivity is not declared), the procedure given in Example 4 is followed. In the case of a major error, forbids import until the labelling information has been corrected. In the case of a minor error, requests the importer to correct the labelling before importing the next batch.
Customs
Example 9. Genetically modied soy has been used for a food supplement but this is not declared on the labelling. Control authority of the municipality of manufacture or importation Customs Requests the operator to change the labelling or the raw material. If the error is repeated by the same operator, the food supplements are placed under a sales prohibition until the labelling is complete. Forbids the import of the products until information on the genetically modied ingredients is entered on the labelling of the products in the importers warehouse.
Example 10. A food supplement causing a health hazard is sold via the Internet. Municipal control authority Finds out the sellers contact information. If the Internet seller is Finnish and the warehouse is located in Finland, the municipality of domicile carries out the action together with the Evira. If the seller is foreign, the customs or Evira/the border veterinarian tries to nd out the sellers contact data with the Evira. The Evira informs the control authorities of the country concerned through a RASFF notication.
Customs Evira/Border veterinarian Evira
Example 11. A food supplement contains an irradiated component the irradiation of which is not permitted according to Decree 852/2000 of the Ministry of Trade and Industry or which has been irradiated at a facility not approved by the EU. Municipal control authority Places the products in storage under a sales prohibition and contacts the Evira. Requests the food business operator to withdraw the product from the market and informs consumers when necessary. Forbids import of the product and contacts the food business operator and the Evira. Where necessary carries out national actions and makes a RASFF (Rapid Alert System for Food and Feed)) notication.
Customs Evira/Border veterinarian Evira
31
USEFULL LINKS
Food supplement notication form and instructions for lling it in http://www.evira./portal/en/food/control_and_entrepreneurs/food_supplements/ Food Supplement Guide http://www.palvelu./evi/les/55_519_470.pdf Law: Finnish law, http://www.nlex./en/ EU law, http://europa.eu.int/eur-lex/ Finnish Food Safety Authority Evira http://www.evira./portal/en/food/ Nutritive value labelling of food products (publications of the Food Authority 12/2001) Labelling guide (control guide series 12/2008) (Finnish and Swedish) Health claims guide (control guide series 3/2002) Food supplements: http://www.evira./portal/en/food/control_and_entrepreneurs/food_supplements/ Law on food supplements Food supplement notication Purity criteria for ingredients and additives On food supplements in Swedish: http://www.evira./portal/se/livsmedel/tillsyn_och_foretagare/kosttillskott/ On food supplements in English: http://www.evira./portal/en/food/control_and_entrepreneurs/food_supplements/
National Agency for Medicines http://www.nam./index.html List of Medicines: http://www.laakelaitos./pharma_industry/classication/list Information the classication of medicinal products Submitting a request for classication Valid marketing authorizations for herbal medicinal products Anthroposophic and homeopathic preparations regarded as herbal medicinal products on account of their strength Information on the labelling of concentrations in homeopathic and anthroposophic preparations
32
Finnish Antidoping Committee http://www.antidoping./view.cfm?page=E6A9858A-E534-4A55-AF84-A574CA28A308&CFID=1085132 8&CFTOKEN=ad15ec36d2940d0b-9506FD80-E081-2D10-37B3FEDDA2F70E8B Consumer Agency and Consumer Ombudsman http://www.kuluttajavirasto./en-GB/ E.g. information on network marketing With detailed and specic problems, economic operators are recommended to turn to consultants or companies offering expert services in the eld.
33
Finnish Food Safety Authority Evira Mustialankatu 3, FI-00790 Helsinki, Finland Tel. +358 20 69 0999, +358 20 77 2003 Fax +358 20 77 24350 www.evira.
Cover picture: Plugi, Barbro Wickstrm

WWW Webapps Webapp Evira 2 Data Products 1285599413807 5536 Food Supplement Guide

Enviado por

Dados do documento

Descrição original:

Título original

Direitos autorais

Formatos disponíveis

Compartilhar este documento

Compartilhar ou incorporar documento

Opções de compartilhamento

Você considera este documento útil?

Este conteúdo é inapropriado?

Direitos autorais:

Formatos disponíveis

WWW Webapps Webapp Evira 2 Data Products 1285599413807 5536 Food Supplement Guide

Enviado por

Direitos autorais:

Formatos disponíveis

Eviras guideline 17012/3/en

Food Supplement Guide

Finnish Food Safety Authority Evira

Food Supplement Guide

Food Supplement Guide - Eviras guideline 17012/3/en

Eviras guideline 17012/3/en 12/2008 Product Safety

Food Supplement Guide - Eviras guideline 17012/3/en

Food Supplement Guide - Eviras guideline 17012/3/en

Food Supplement Guide - Eviras guideline 17012/3/en

Food Supplement Guide - Eviras guideline 17012/3/en

2 DECREE ON FOOD SUPPLEMENTS

2.2 Notification 2.1 Definitions

Food Supplement Guide - Eviras guideline 17012/3/en

2.3 Characteristic substances in food supplements

Food Supplement Guide - Eviras guideline 17012/3/en

Daily minimum 240 g 1,5 g 3 mg 22,5 g

Mineral Calsium1 Magnesium Iron

Copper2 Iodine Zink

0,42 mg 0,48 mg 5,4 mg 0,6 mg 60 g 0,3 g 0,045 mg 1,8 mg 18 mg

Potassium2 Selenium Chromium Fluorine

12 g 15 g 1,05 mg 240 mg 240 mg

Pantothenic acid1 Vitamin C

Food Supplement Guide - Eviras guideline 17012/3/en

2.4.1 General labelling

Picture 1. Example of provisions laying down criteria for labelling.

Food Supplement Guide - Eviras guideline 17012/3/en

OAT SHOOT EXTRACT

Importer: Shop Ltd. Shoots Alley 6 00000 Municipality www.uutekauppa.fi

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

Food Supplement Guide - Eviras guideline 17012/3/en

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

Food Supplement Guide - Eviras guideline 17012/3/en

2.4.3 Other labelling

Picture 3. An example of labelling a mineral product.

Food Supplement Guide - Eviras guideline 17012/3/en

Food Supplement Guide - Eviras guideline 17012/3/en

2.5.1 Medicinal claims

2.5.3 Nutritional claims

2.5.2 Health claims

Food Supplement Guide - Eviras guideline 17012/3/en

2.6 Other legislation to be taken into account

Food Supplement Guide - Eviras guideline 17012/3/en

3 RESTRICTIVE DEFINITION OF FOOD SUPPLEMENT

3.1 Difference between food supplements and medicinal products

Food Supplement Guide - Eviras guideline 17012/3/en

Food Supplement Guide - Eviras guideline 17012/3/en

Picture 4. Example of labelling on a herbal medicinal product

Food Supplement Guide - Eviras guideline 17012/3/en

Criteria for entering market Authorization or notification authority

Authorization procedure Evira EU Commission

Notification procedure Evira

3.2 Difference between food supplements and special diet products

Food Supplement Guide - Eviras guideline 17012/3/en

3.4 Law on novel foods and food supplements

3.3 Classification of sweets and chewing gums

3.5 Alcohol legislation and food supplements

Food Supplement Guide - Eviras guideline 17012/3/en

3.6 Raw materials and products of animal origin

Food Supplement Guide - Eviras guideline 17012/3/en

4 APPLICATIONS / NOTIFICATIONS REQUIRED FROM FOOD BUSINESS OPERATORS

4.1 Approval of food premises

4.2 In-house control plans