Dietary supplements (as defined in Article 2 of Decree No. 2006-352) are regulated byDirective 2002/46/ECof the European Parliament and of the Council of June 10, 2002, on the approximation of the laws of the Member States relating to food supplements, and transposed into French law by Decree 2006-352. Based on this decree, three important orders were issued:
As such, specific conditions of use and precautions must be observed:
Laboratories and manufacturers of dietary supplements are also subject to very strict regulations requiring certain mandatory information to appear on their dietary supplements, such as the information mentioned above, but not limited to that…
The mandatory labeling information as specified in Article 9, §1 ofRegulation (EU) No. 1169/2011(the so-called INCO Regulation) are:
They are regulated byEuropeanCommissionDirective No. 96/8 of February 26, 1996, regarding foods intended for use in low-calorie diets for weight loss. This directive stipulates that:
For meal replacements, the label must include a statement indicating that they are effective only as part of a low-calorie diet and that, in this context, they must be supplemented with other foods.
Sports nutrition products are regulated bythe Order of July 20, 1977, and classified into two categories:
Furthermore, the presentation of these foods may include specific numerical claims regarding their levels of vitamins B1, B6, and C, as well as their magnesium content, without such presentation necessarily implying the application of the specific regulatory provisions for dietetic products with a guaranteed content of certain vitamins and for dietetic products with a guaranteed magnesium content.
As for foods whose composition is predominantly carbohydrate- or fat-based but in which a balance is achieved between caloric intake and the intake of protective substances, their name must include the terms “for exercise” and “carbohydrate-based ” or “fat-based,” as appropriate.
The label must indicate that the product is intended, within the context of a normal diet, to meet the needs of immediate muscular exertion, particularly during competition or under special environmental conditions.
The presentation of these foods may include numerical claims regarding their vitamin B1 content, without such presentation necessarily implying the application of the specific regulatory provisions for dietary products with a guaranteed content of certain vitamins.
The Regulation clearly defines what constitutes a health claim:
“Any claim that states, suggests, or implies a relationship between, on the one hand, a category of food, a food, or one of its components and, on the other hand, health.”
This legislation also addresses claims regarding the reduction of a disease risk, which are defined as a health claim that states, suggests, or implies that the consumption of a category of food, a food, or one of its components significantly reduces a risk factor for the development of a human disease.
The European Food Safety Authority (EFSA), the French authority responsible for regulating health claims, provides another, more explicit definition:
“A health claim is any statement used on labels, in marketing or advertising campaigns, stating 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, statements claiming that a food can help strengthen the body’s natural defenses or improve learning abilities are called generic functional claims. There are also claims regarding the reduction of disease risk or the presence of substances that may improve or modify the body’s normal functions, for example: "Phytosterols help lower cholesterol levels, a risk factor in the development of coronary heart disease" or "calcium may help improve bone density."
It is this sameRegulation (EC) No. 1924/2006of the European Parliament and of the Council of December 20, 2006, that stipulates that the review of claims must now take place prior to the commercial use of dietary supplements. Thus, they must have beenscientificallyevaluated by the EFSA, the national body responsible for establishing the scientific validity of nutrition and health claims. It must issue a favorable opinion and then include this new claim on the list of claims authorized by the European Commission. This list was established in CommissionRegulation (EU) No. 432/2012of May 16, 2012, establishing a list of authorized health claims regarding foodstuffs, other than those referring to the reduction of disease risk and to child development and health. This regulation therefore establishes a list of 222 validated health claims and specifies their conditions of use. You will find the complete list inthe annex to this regulation; here are a few 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 food that is at least a source of EPA and DHA within the meaning of the claim “SOURCE OF OMEGA-3 FATTY ACIDS” as defined in the annex to Regulation (EC) No. 1924/2006. The claim may be used if the consumer is informed that the beneficial effect is obtained through the daily consumption of 250 mg of EPA and DHA.
Beta-glucans
Claim: Beta-glucans contribute to the maintenance of normal blood cholesterol levels
Conditions for use of the claim: The claim may only be used for a food containing at least 1 g of beta-glucans derived from oats, oat bran, barley, barley bran, or from several of these sources, per quantified portion. The claim may be used if the consumer is informed that the beneficial effect is obtained by daily consumption of 3 g of beta-glucans derived from oats, oat bran, barley, barley bran, or a combination of these sources.
Activated charcoal
Claim: Activated charcoal helps reduce excess flatulence after a meal
Conditions for use of the claim: The claim may only be used for a food product containing 1 g of pharmaceutical-grade activated charcoal per quantified serving. 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 a meal and 1 g immediately after the meal.
Chitosan
Claim: Chitosan contributes to the maintenance of normal cholesterol levels
Conditions for use of the claim: The claim may only be used for a food that ensures a daily intake of 3 g of chitosan. The claim may be used if the consumer is informed that the beneficial effect is obtained by consuming 3 g of chitosan daily.
Chromium
Claim: Chromium contributes to normal macronutrient metabolism
Conditions for use of the claim: The claim may only be used for a food that 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 glucose levels
Conditions for use of the claim: The claim may only be used for a food that 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 performance during successive sets of very intense, short-duration exercises
Conditions for use of the claim: The claim may only be used for a food that ensures a daily intake of 3 g of creatine. The claim may be used if the consumer is informed that the beneficial effect is obtained by a daily intake of 3 g of creatine.
Fluoride
Claim: Fluoride contributes to the maintenance of tooth mineralization
Conditions for use of the claim: The claim may only be used for a food that is at least a source of fluoride 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.
Glucomannan (konjac mannan)
Claim: Glucomannan contributes to the maintenance of normal blood cholesterol levels
Conditions for use of the claim: The claim may only be used for a food that ensures a daily intake of 4 g of glucomannan. The claim may be used if the consumer is informed thatthe beneficial effect of konjac is obtained through a daily intake of 4 g of glucomannan.
Claim: Glucomannan consumed as part of a reduced-calorie diet contributes to weight loss
Conditions for use of the claim: The claim may only be used for a food 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 consuming 3 g of glucomannan daily in three doses of 1 g each, taken with 1 to 2 glasses of water, before meals and as part of a low-calorie diet.
Melatonin
Claim: Melatonin helps alleviate the effects of jet lag
Conditions for use of the claim: The claim may only be used for a food containing at least 0.5 mg of melatonin per quantified portion. The claim may 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 for a few days following the day of arrival at the destination.
Claim: Melatonin helps reduce the time it takes to fall asleep
Conditions for use of the claim: The claim may only be used for a food 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-containing amino acids
Conditions for use of the claim: The claim may only be used for a food that is at least a source of molybdenum 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.
Monascus purpureus (red yeast rice)
Claim: Monacolin K from red yeast rice contributes to the maintenance of normal cholesterol levels
Conditions for use of the claim: The claim may only be used for a food that ensures a daily intake 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 through a daily intake of 10 mg of monacolin K from fermented red yeast rice preparations.
Walnuts
Claim: Walnuts help improve the elasticity of blood vessels
Conditions for use of the claim: The claim may only be used for a food product that ensures a daily intake of 30 g of walnuts. The claim may be used if the consumer is informed that the beneficial effect is obtained by consuming 30 g of walnuts daily.
Polyphenols in olive oil
Claim: The polyphenols in olive oil help protect blood lipids against oxidative stress
Conditions for use of the claim: The claim may only be used for olive oil containing at least 5 mg of hydroxytyrosol and its derivatives (such as the oleuropein complex and tyrosol) per 20 g of olive oil. The claim may be used if the consumer is informed that the beneficial effect is obtained by consuming 20 g of olive oil daily.
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 that is at least a source of potassium 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: Potassium contributes to normal muscle function
Conditions of use of the claim: The claim may only be used for a food that is at least a source of potassium 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: Potassium contributes to the maintenance of normal blood pressure
Conditions for use of the claim: The claim may only be used for a food that is at least a source of potassium 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.
Plant sterols and plant stanols
Claim: Plant sterols/plant stanols help maintain normal blood 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 a daily intake 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 that 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 that 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 that 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 provides acomprehensive European Register ofHealth and NutritionClaims. It lists authorized claims, those under review, and those that have been rejected. Unfortunately, this wealth of information is available only in English.
Following the list established byRegulation (EU) No. 432/2012, many products made from plants, mushrooms, algae, etc. are no longer permitted to include claims regarding potential health benefits on their packaging, as the EFSA determined that most of the evaluated substances lacked sufficient scientific evidence.
The use of plants in dietary supplements must, on the one hand, comply with the requirements ofRegulation (EC) No. 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 byCouncil Regulation (EEC) No. 2309/93 of July 22, 1993. The EMA is therefore responsible for assessing the safety and efficacy of herbal preparations used as medicines. However, the primary legal responsibility for the safety of products placed on the market lies with the commercial operators.
EFSA is also there to ensure that there are no potential risks of chemical or microbiological contamination and that concentrations of bioactive agents do not exceed safe limits. In practice, it provides a scientific approach to those responsible for assessing the safety of plant-based 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 toolkit has been established that includes a compendium of plant species reported to contain substances that may pose a health risk when used in foods or dietary supplements. Although available exclusively in English, it is nonetheless an impressive source of reliable information.
There are several categories of medical devices, but those most closely resembling dietary supplements are ingestible medical devices, which are health products governed byDirective 93/42/ECand transposed into French law in thePublic Health Code(Article L5211-1 et seq.).
They are all the more difficult to distinguish from dietary supplements because some also contain plant-based substances. The distinctive feature of a medical device lies in its mode of physical action (a mechanical action, a physical barrier, etc.). To be considered a medical device rather than a dietary supplement, the product must not produce any pharmacological or immunological effects, nor alter metabolism, due to the presence of a plant-based substance in its composition. They must provide a proven health benefit and are intended for a patient population.
Another difference is that dietary supplements fall under the authority of the General Directorate for Competition, Consumer Affairs, and Fraud Control (DGCCRF), in accordance with the requirements of Articles 15 and 16 ofDecree No. 2006-352, whereas medical devices fall under the authority of the French National Agency for Medicines and Health Products Safety (ANSM).
They must bear a CE mark issued by a notified body that evaluates the CE marking application dossier prior to market authorization, in accordance with the requirements of the directive governing medical devices. This assessment takes into account the quality, safety, and effectiveness of the product, as well as the compliance of the quality management system with ISO 13485.
-Directive 2002/46/EC of the European Parliament and of the Council of June 10, 2002on the approximation of the laws of the Member States relating to food supplements
-Decree No. 2006-352
-Regulation (EU) No. 1169/2011 of the European Parliament and of the Council of October 25, 2011
-European Commission Directive No. 96-8 of February 26, 1996, No. 968, on foodstuffs intended for use in low-calorie diets for weight loss
-Order of July 20, 1977, issued for the implementation of the Decree of July 24, 1975, on dietary and dietetic products
-Regulation (EC) No. 1924/2006 of the European Parliament and of the Council of December 20, 2006, on nutrition and health claims made on foods
-Commission Regulation (EU) No. 432/2012 of May 16, 2012establishing a list of permitted health claims made on foods, other than those referring to the reduction of disease risk and to children’s development and health
-Regulation (EC) No. 178/2002 of the European Parliament and of the Council of January 28, 2002, 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
-Council Regulation (EEC) No. 2309/93 of July 22, 1993, laying down Community procedures for the authorization and supervision 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
-Decree of May 9, 2006, as amended, concerning nutrients that may be used in the manufacture of dietary supplements
-Order of June 24, 2014establishing the list of plants, other than mushrooms, authorized in food supplements and the conditions for their use
-Order of September 26, 2016establishing 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 June 14, 1993, on medical devices
-Public Health Code
-Synadiet, National Union of Dietary Supplements
