Food supplements (as defined by Article 2 of Decree No. 2006-352 ) are regulated by Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements and transposed into French law by Decree 2006-352. On the basis of this decree, 3 important orders have been issued:
- Order of May 9, 2006 amended relating to nutrients that can be used in the manufacture of food supplements;
- Order of 24 June 2014 establishing the list of plants, other than mushrooms, authorized in food supplements and the conditions for their use;
- Order of 26 September 2016 establishing the list of substances for nutritional or physiological purposes authorized in food supplements and the conditions for their use.
As such, special conditions of use and precautions for use are required:
- Food supplements should be used as part of a healthy lifestyle and not be used as substitutes for a varied and balanced diet
- Keep out of reach of young children
- Do not exceed the recommended daily dose
- Comply with the instructions for use indicated
- To be consumed preferably before the expiry date indicated on the box (article 24 of Regulation (EU) 1169/2011 )
- Store in a cool, dry place away from light.
Laboratories and manufacturers of food supplements are also subject to very strict regulations that must include certain mandatory information on their food supplement, such as those mentioned above, but not only...
The mandatory labeling information as specified in Article 9, §1 of Regulation (EU) 1169/2011 (the so-called INCO Regulation) is:
a) the sales name must include "food supplement" followed by the name of the substances or categories of substances with a nutritional or physiological purpose;
b) the list of ingredients;
c) any ingredient or processing aid listed in Annex II of Regulation (EU) No 1169/2011 or derived from a substance or product listed in Annex II causing allergies or intolerances, used in the manufacture or preparation of a foodstuff and still present in the finished product, even in a modified form;
d) the quantity per daily portion of ingredients (plants, plant-based preparations, vitamins and minerals) for nutritional or physiological purposes as well as their percentage in nutritional reference value;
e) net quantity of foodstuff;
f) the date of minimum durability or the expiry date;
g) the special storage and/or use conditions;
h) the name or business name and address of the food business operator referred to in Article 8(1);
i) the country of origin or the place of provenance when provided for in Article 26;
j) instructions for use, when its absence would make it difficult to use the foodstuff appropriately;
k) for beverages containing more than 1.2% alcohol by volume, the acquired alcoholic strength by volume;
(l) a nutrition declaration.
They are regulated by European Directive n°96-8 of February 26, 1996 of the Commission n°968 relating to foodstuffs intended for use in low-calorie diets intended for weight loss. This provides that:
- their name includes, depending on the case, either the words "substitute for the total daily ration for weight control", or the words "meal replacement for weight control".
- their nutritional declaration indicates the available energy value expressed in kilojoules (kJ) and kilocalories (kcal) and the protein, carbohydrate and lipid content, expressed in numerical form, per specified quantity, offered for consumption, of the ready-to-eat product. 'job. It is also necessary to indicate on the labeling the average quantity of each mineral salt and each vitamin, the minimum quantity of which is indicated in point 5 of appendix I of Directive 96/8/EC, expressed in numerical form per specified quantity, offered for consumption, of the ready-to-use product. In addition, for meal replacements, the information relating to vitamins and minerals appearing in table point 5 of Annex I must also be expressed as a percentage of the nutritional reference values.
- their instructions for use clearly indicate on the labeling the instructions concerning the appropriate preparation of the product, with mention of the need to follow these instructions.
- a statement indicating that it is important to maintain an adequate daily fluid intake appears on the label.
For substitutes in the total daily ration, the following must also be indicated on the label:
- a statement indicating that the product provides sufficient quantities of all essential nutrients for one day;
- a statement indicating that the product cannot be consumed for more than three weeks without medical advice.
For meal replacements, a statement must be indicated on the labeling indicating that they only have the desired effect in the context of a low-calorie diet and that, in this context, they must be supplemented by other food.
The dietary products of the effort are regulated by the Order of July 20, 1977 and classified in 2 categories:
- balanced foods both in their protein, carbohydrate and lipid intakes and in their intakes of protective substances;
- foods whose composition comprises a carbohydrate or lipid predominance but in which a balance is achieved between the caloric intake and the intake of protective substances.
Foods that are balanced both in their protein, carbohydrate and lipid intakes and in their intakes of protective substances must specify certain specific information:
- their name must include the expression "balance of effort";
- the labeling must mention that the product can, for sportsmen, replace a meal when the circumstances do not allow a usual diet.
In addition, the presentation given to these foods may state quantified guarantees relating to their levels of vitamins B1, B6 and C as well as their magnesium content, without such presentation necessarily implying the application of the regulatory provisions. specific to dietetic products with a guaranteed content of certain vitamins and dietetic products with a guaranteed content of magnesium.
As regards foods whose composition comprises a carbohydrate or lipid predominance but in which a balance is achieved between the caloric intake and the intake of protective substances, their name must include the expressions "of effort" and " carbohydrate intake” or “lipid intake” as the case may be.
It must be indicated on the labeling that the product is intended, taking into account a normal diet, to meet the needs of an immediate muscular effort carried out in particular during a competition or in special environmental conditions.
The presentation given to these foods may state quantified guarantees relating to their vitamin B1 content, without such presentation necessarily implying the application of specific regulatory provisions to dietetic products with a guaranteed content of certain vitamins.
The latter clearly defines what a health claim is:
“Any claim which asserts, suggests or implies the existence of a relationship between, on the one hand, a category of foodstuffs, a foodstuff or one of its constituents and, on the other hand, health. »
This piece of legislation also deals with reduction of disease risk claims, which are defined as a health claim which states, suggests or implies that the consumption of a category of food, foodstuff or one of its components substantially reduces a risk factor for the development of a human disease.
The European Food Safety Authority (EFSA), the competent French authority in the control of health claims, gives another more explicit definition:
"A health claim is any statement used on labels, in marketing or advertising campaigns, that the consumption of a given food or one of its ingredients - such as, for example, vitamins and minerals , fiber and “probiotic” bacteria – may have health benefits. There are different types of health claims. For example, claims that a food can help strengthen the body's natural defenses or improve learning abilities are called generic function claims. There are also claims relating to the reduction of the risk of diseases or to the presence of substances likely to improve or modify the normal functions of the organism, for example: "Phytosterols help to lower cholesterol levels, a risk factor in the development of coronary heart disease" or "calcium can help improve bone density". »
It is this same Regulation (EC) n°1924/2006 of the European Parliament and of the Council of December 20, 2006 which stipulates that the control of claims must henceforth be carried out upstream of the commercial use of food supplements. Thus, they must have been scientifically assessed by EFSA, the national body responsible for establishing the scientific validity of nutritional claims and health claims. It must give a favorable opinion and then include this new claim on the list of claims authorized by the European Commission. This list was established in Commission Regulation (EU) No 432/2012 of 16 May 2012 establishing a list of authorized health claims made on foodstuffs, other than those referring to the reduction of disease risk as well as as well as child development and health. This regulation therefore establishes the list of 222 validated health claims and gives their conditions of use. You will find the exhaustive list in the appendix of these regulations , of which here are some examples:
Eicosapentaenoic acid and docosahexaenoic acid (EPA/DHA)
Claim : Eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) contribute to normal heart function
Conditions for use of the claim : The claim may only be used for a foodstuff which is at least a source of EPA and DHA within the meaning of the claim SOURCE OF OMEGA-3 FATTY ACIDS defined in the Annex to Regulation (EC) No 1924/2006. The claim can be used if the consumer is informed that the beneficial effect is obtained by the daily consumption of 250 mg of EPA and DHA.
Beta-glucans
Claim : Beta-glucans contribute to the maintenance of normal cholesterol levels
Conditions for the use of the claim : The claim may only be used for a foodstuff containing at least 1 g of beta-glucans from oats, oat bran, barley, barley bran , or from more than one of these sources, per quantified portion. The claim may be used if the consumer is informed that the beneficial effect is obtained by the daily consumption of 3 g of beta-glucans from oats, oat bran, barley, barley bran or from several of these sources.
Charcoal
Claim : Activated charcoal helps reduce excess flatulence after meals
Conditions for the use of the claim : The claim may only be used for a foodstuff containing 1 g of activated carbon per quantified portion. The claim may be used if the consumer is informed that the beneficial effect is obtained by consuming 1 g at least 30 minutes before the meal and 1 g just after it.
Chitosan
Claim : Chitosan contributes to the maintenance of normal cholesterol levels
Conditions for the use of the claim : The claim can only be used for a foodstuff which guarantees a daily consumption of 3 g of chitosan. The claim can be used if the consumer is informed that the beneficial effect is obtained by the daily consumption of 3 g of chitosan.
Chromium
Claim : Chromium contributes to normal macronutrient metabolism
Conditions for use of the claim : The claim may only be used for a food which is at least a source of trivalent chromium within the meaning of the claim SOURCE OF [NAME OF VITAMINS] AND/OR [NAME OF MINERALS ] as defined in the Annex to Regulation (EC) No 1924/2006.
Claim : Chromium contributes to the maintenance of normal blood sugar levels
Conditions for use of the claim : The claim may only be used for a food which is at least a source of trivalent chromium within the meaning of the claim SOURCE OF [NAME OF VITAMINS] AND/OR [NAME OF MINERALS ] as defined in the Annex to Regulation (EC) No 1924/2006.
Creatine
Claim : Creatine improves physical capacity in the event of successive series of very intense exercises of short duration
Conditions for the use of the claim : The claim can only be used for a foodstuff which guarantees a daily consumption of 3 g of creatine. The claim can be used if the consumer is informed that the beneficial effect is obtained by the daily consumption of 3 g of creatine.
Fluoride
Claim : Fluoride helps maintain tooth mineralization
Conditions for use of the claim : The claim may only be used for a foodstuff which is at least a source of fluoride within the meaning of the claim SOURCE OF [NAME OF VITAMINS] AND/OR [NAME OF MINERALS] defined in the Annex to Regulation (EC) No 1924/2006.
Glucomannan (konjac mannan)
Claim : Glucomannan contributes to the maintenance of normal cholesterol levels
Conditions for the use of the claim : The claim can only be used for a foodstuff which guarantees a daily consumption of 4 g of glucomannan. The claim can be used if the consumer is informed that the beneficial effect is obtained by the daily consumption of 4 g of glucomannan.
Claim : Glucomannan consumed as part of a calorie-restricted diet contributes to weight loss
Conditions of use of the claim : The claim may only be used for a foodstuff containing 1 g of glucomannan per quantified portion. The claim may be used if the consumer is informed that the beneficial effect is obtained by the daily consumption of 3 g of glucomannan in three doses of 1 g each, taken with 1 to 2 glasses of water, before meals and in as part of a low calorie diet.
Melatonin
Claim : Melatonin helps reduce the effects of jet lag
Conditions for the use of the claim : The claim may only be used for a foodstuff containing at least 0.5 mg of melatonin per quantified portion. The claim can be used if the consumer is informed that the beneficial effect is obtained by consuming at least 0.5 mg just before bedtime on the first day of travel and the few days following the day of arrival at destination .
Claim : Melatonin helps reduce sleep time
Conditions of use of the claim : The claim may only be used for a foodstuff containing 1 mg of melatonin per quantified portion. The claim may be used if the consumer is informed that the beneficial effect is obtained by consuming 1 mg of melatonin before bedtime.
Molybdenum
Claim : Molybdenum contributes to the normal metabolism of sulfur amino acids
Conditions for use of the claim : The claim may only be used for a foodstuff which is at least a source of molybdenum within the meaning of the claim SOURCE OF [NAME OF VITAMINS] AND/OR [NAME OF MINERALS] defined in the Annex to Regulation (EC) No 1924/2006.
Monascus purpureus (red yeast rice)
Claim : Monacolin K from red yeast rice contributes to the maintenance of normal cholesterol levels
Conditions for the use of the claim : The claim can only be used for a foodstuff which guarantees a daily consumption of 10 mg of monacolin K from red yeast rice. The claim may be used if the consumer is informed that the beneficial effect is obtained by the daily consumption of 10 mg of monacolin K from fermented red yeast rice preparations.
Nut
Claim : Walnuts help improve the elasticity of blood vessels
Conditions for the use of the claim : The claim can only be used for a foodstuff which guarantees a daily consumption of 30 g of nuts. The claim can be used if the consumer is informed that the beneficial effect is obtained by the daily consumption of 30 g of nuts.
Polyphenols present in olive oil
Claim : The polyphenols found in olive oil help protect blood lipids against oxidative stress
Conditions for the use of the claim : The claim can only be used for olive oil containing at least 5 mg of hydroxytyrosol and its derivatives (such as oleuropein complex and tyrosol) per 20 g of olive oil. The claim can be used if the consumer is informed that the beneficial effect is obtained by the daily consumption of 20 g of olive oil.
Potassium
Claim : Potassium contributes to the normal functioning of the nervous system
Conditions for use of the claim : The claim may only be used for a food which is at least a source of potassium within the meaning of the claim SOURCE OF [NAME OF VITAMINS] AND/OR [NAME OF MINERALS] defined in the Annex to Regulation (EC) No 1924/2006.
Claim : Potassium contributes to normal muscle function
Conditions for use of the claim : The claim may only be used for a food which is at least a source of potassium within the meaning of the claim SOURCE OF [NAME OF VITAMINS] AND/OR [NAME OF MINERALS] defined in the Annex to Regulation (EC) No 1924/2006.
Claim : Potassium contributes to the maintenance of normal blood pressure
Conditions for use of the claim : The claim may only be used for a food which is at least a source of potassium within the meaning of the claim SOURCE OF [NAME OF VITAMINS] AND/OR [NAME OF MINERALS] defined in the Annex to Regulation (EC) No 1924/2006.
Plant sterols and plant stanols
Claim : Plant sterols/plant stanols contribute to the maintenance of normal cholesterol levels
Conditions for use of the claim : The claim may be used if the consumer is informed that the beneficial effect is obtained by the daily consumption of at least 0.8 g of plant sterols/plant stanols.
Vitamin E
Claim : Vitamin E helps protect cells against oxidative stress
Conditions for use of the claim : The claim may only be used for a food which is at least a source of vitamin E within the meaning of the claim SOURCE OF [NAME OF VITAMINS] AND/OR [NAME OF MINERALS ] as defined in the Annex to Regulation (EC) No 1924/2006.
Vitamin K
Claim : Vitamin K contributes to normal blood clotting
Conditions for use of the claim : The claim may only be used for a food which is at least a source of vitamin K within the meaning of the claim SOURCE OF [NAME OF VITAMINS] AND/OR [NAME OF MINERALS ] as defined in the Annex to Regulation (EC) No 1924/2006.
Claim : Vitamin K contributes to the maintenance of normal bones
Conditions for use of the claim : The claim may only be used for a food which is at least a source of vitamin K within the meaning of the claim SOURCE OF [NAME OF VITAMINS] AND/OR [NAME OF MINERALS ] as defined in the Annex to Regulation (EC) No 1924/2006.
The European Commission also has a comprehensive European Register of Health Claims and Nutrition Claims at your disposal. It tells you which claims have been authorized, which are in progress and which have been denied. This wealth of information is unfortunately only in English.
Following this list established by Regulation (EU) No. 432/2012 , many products based on plants, mushrooms, algae... no longer had the right to have claims in terms of benefits. potential for health on their packaging, the EFSA having considered that most of the substances evaluated did not have a sufficient level of scientific evidence.
The use of plants in food supplements must, on the one hand, comply with the requirements of EC Regulation 178/2002 , which establishes the general principles and requirements of food law in the EU, and, on the other hand , have been submitted to the European Medicines Agency (EMA) established by Council Regulation (EEC) No. 2309/93 of July 22, 1993 . It is therefore the EMA which is responsible for assessing the safety and efficacy of herbal preparations used as medicinal products. However, the primary legal responsibility for the safety of products placed on the market rests with commercial operators.
EFSA is also there to ensure that there are no possible risks of chemical or microbiological contamination or that the concentrations of bioactive agents do not exceed a safe limit. In effect, it provides a science-based approach to those responsible for assessing the safety of herbal ingredients, as well as to food industry manufacturers who are responsible for ensuring the safety of the products they place on the market. Thus, a toolbox has been set up in which we find a compendium of plant species reported to contain substances likely to present a health problem when used in food or food supplements. In English only, it is nevertheless an impressive mine of reliable information.
Particularities of the medical deviceThere are several categories of medical devices, but those closest to food supplements are ingestible medical devices which are health products governed by Directive 93/42/EC and transposed into French law in the Public Health Code ( article L5211-1 and following).
They are all the more difficult to distinguish from dietary supplements as some also incorporate plant substances. The specificity of the medical device lies in its physical mode of action (a mechanical action, a physical barrier, etc.). To be considered as a medical device, rather than as a food supplement, the product must not cause any pharmacological or immunological effect, nor any modification of the metabolism, due to the presence of a plant substance in its composition. They must bring a proven health benefit and are aimed at a sick population.
Another difference is that the food supplement is under the authority of the General Directorate for Competition, Consumption and the Repression of Fraud (DGCCRF), in accordance with the requirements of Articles 15 and 16 of Decree No. 2006-352 , whereas the medical device is under the authority of the National Medicines Safety Agency (ANSM).
They must have CE marking issued by a notified body which assesses the CE marking application file before placing it on the market, in accordance with the requirements of the directive governing medical devices. This evaluation takes into account the quality, safety and efficacy of the product as well as the conformity of the quality management system, in accordance with the ISO 13485 standard.
- Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements
- Decree No. 2006-352
- Regulation (EU) n°1169/2011 of the European Parliament and of the Council of October 25, 2011
- European Directive n°96-8 of February 26, 1996 of the Commission n°968 relating to foodstuffs intended for use in low-calorie diets intended for weight loss
- Order of July 20, 1977 taken for the application of the decree of July 24, 1975 on dietary and diet products
- Regulation (EC) n°1924/2006 of the European Parliament and of the Council of 20 December 2006 concerning nutritional and health claims made on foodstuffs
- Commission Regulation (EU) No 432/2012 of 16 May 2012 establishing a list of authorized health claims made on foodstuffs, other than those referring to the reduction of the risk of illness and to the development and child health
- Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 establishing the general principles and general requirements of food law, establishing the European Food Safety Authority and laying down procedures relating to food safety foodstuffs
- Council Regulation (EEC) No. 2309/93 of 22 July 1993 establishing Community procedures for the authorization and monitoring of medicinal products for human and veterinary use and establishing a European agency for the evaluation of medicinal products
- EU Register on nutrition and health claims
- Order of May 9, 2006 amended relating to nutrients that can be used in the manufacture of food supplements
- Order of 24 June 2014 establishing the list of plants, other than mushrooms, authorized in food supplements and the conditions for their use
- Order of 26 September 2016 establishing the list of substances for nutritional or physiological purposes authorized in food supplements and the conditions for their use
- Council Directive 93/42/EEC of 14 June 1993 relating to medical devices
- Public Health Code
-Synadiet , national union of food supplements
