Botanicals and botanical preparations in the EU: evolution through time towards full harmonisation. Opportunities and challenges.

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1 Botanicals and botanical preparations in the EU: evolution through time towards full harmonisation. Opportunities and challenges.part III- Marketing botanical food supplements in Italy Vittorio Silano II University of Rome, Tor Vergata, and EFSA CEF Panel

2 Disclaimer This presentation does not reflects the viewpoints of EFSA, but only those of the Author.

3 No share of the market in Italy between botanical food supplements and traditional medicinal products in Italy Annual sales of traditional botanical products being marketed in selected countries as food supplements and medicinal products (Expert Estimates) Country Botanical Food Total (i.e. Botanical Supplements Food Supplements plus Botanical Medicinal Products ) Italy Germany France (+)Millions of euros

4 Only a partial harmonization has been achieved by the European legislation Since 2002, only general definitions, labelling, publicity and vitamins and minerals which can be used have been harmonized at the European level, but not the marketing procedures, which remain under the responsibilities of Member States. In some (but not all) EU MS, including Italy. food supplement labels must be notified before marketing and in some MSs lists of botanical species are used to prohibit or to make possible the use of particular botanical species to manufacture food supplements, but no Community or national authorization is needed before marketing.

5 Harmonized regulations at the EU level (including Italy)

6 DIR. 2002/46: DEFINITION OF FS Foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients (vitamins and minerals) or other substances with a nutritional or physiological effect, alone or in combination marketed in dose form designed to be taken in measured small unit quantities.

7 Vitamins and Minerals 2002/46: VITAMINS AND MINERALS ALLOWED IN FS ANNEX I REGULATION (EC) No 1170/2009

8 Vitamins and Minerals THE ANNEX I OF DIRECTIVE 46/ Vitamins 2. Minerals Vitamin A (µg RE) Calcium (mg) Vitamin D (µg) Iron (mg) Magnesium (mg) Vitamin E (mg α-te) Copper (µg) Vitamin K (µg) Iodine (µg) Vitamin B1 (mg) Zinc (mg) Vitamin B2 (mg) Manganese (mg) Niacin (mg NE) Sodium (mg) Pantothenic acid (mg) Potassium (mg) Vitamin B6 (mg) Selenium (µg) Folic acid (µg) Chromium (µg) Vitamin B12 (µg) Molybdenum (µg) Biotin (µg) Fluoride (mg) Vitamin C (mg) Chloride (mg) Phosphorus (mg)

9 Vitamins and Minerals LIST OF PERMITTED SOURCES OF VITAMIN OR MINERAL THAT MAY BE USED IN FS ANNEX II Dir. 2002/46 DIRECTIVE 2006/37/EC; REGULATION (EC) No 1170/2009 ; REGULATION (EU) No 1161/2011

10 THE ANNEX II OF DIRECTIVE 46/2002 (VITAMIN FORMULATIONS) 1. VITAMIN A 4. VITAMIN K (a) retinol (a) phylloquinone (b) retinyl acetate (phytomenadione) (c) retinyl palmitate 5. VITAMIN B1 (d) beta-carotene (a) thiamin hydrochloride (b) thiamin mononitrate 2. VITAMIN D 6. VITAMIN B2 (a) cholecalciferol (a) riboflavin (b) ergocalciferol (b) riboflavin phosphate, sodium 3. VITAMIN E 7. NIACIN (a) D-alpha-tocopherol (a) nicotinic acid (b) DL-alpha-tocopherol (b) nicotinamide (c) D-alpha-tocopheryl acetate (d) DL-alpha-tocopheryl acetate (CONTINUES) (e) D-alpha-tocopheryl acid succinate

11 When to use the denominations of Annex I or those of Annex II for general information The denominations of vitamins and minerals reported in the Annex I are those relevant for the nutritional declaration of food supplements. -The denominations of vitamins and minerals reported in Annex II are those rlevant for the list of ingredients.

12 INCLUSION OF VITAMINS AND MINERALS IN THE ANNEX II Vitamin and mineral substances may be considered for inclusion in the lists following the evaluation of an appropriate scientific dossier,provided by the FBO applicant, concerning the safety and bioavailability of the individual substance by the European Food Safety Agency (EFSA).

13 2002/46: SETTING MINIMUM AMOUNTS OF VITAMINS AND MINERALS IN FS AT THE EU LEVEL Directive 90/496/EEC 15% of the recommended allowance in 100 g or 100 ml According to Reg.1924/2006, 15% of the recommended allowance has to be present if a nutrition claim is made that the food is a source of a vitamin or a mineral.

14 2002/46: SETTING MINIMUM AMOUNTS OF VITAMINS AND MINERALS IN FS AT THE EU LEVEL According to Reg.1169/2011 that, among others, has repealed Directive 90/496: Significant amount of vitamins and minerals : 15 % of the nutrient reference values in 100 g or 100 ml in the case of products other than beverages or per portion if the package contains only a single portion, 7,5 % of the nutrient reference values the case of beverages. supplied by 100 ml in

15 Harmonized regulations at the EU level -CONSUMER S INFORMATION ON FOOD SUPPLEMENTS :Reg. (UE) 1169/2011 (1) the name under which the product is sold; (2) the list of ingredients; (3) the quantity of certain ingredients or categories of ingredients (4) the net quantity; (5) the date of minimum durability or, in the case of foodstuffs which, from the microbiological point of view, are highly perishable, the use by date; (6) any special storage conditions or conditions of use; (7) the name or business name and address of the manufacturer or packager, or of a seller established within the Community. (8) particulars of the place of origin or provenance where failure to give such particulars might mislead the consumer to a material degree as to the true origin or provenance of the foodstuff; (9) instructions for use when it would be impossible to make appropriate use of the foodstuff in the absence of such instructions; (10) with respect to beverages containing more than 1,2 % by volume of alcohol, the actual alcoholic strength by volume.

16 Harmonized regulations at the EU level /46/EC: MANDATORY LABELLING REQUIREMENTS The name under which FS are sold shall be food supplement ; The labelling, presentation and advertising must not attribute to food supplements the property of preventing, treating or curing a human disease, or refer to such properties; The names of the categories of nutrients or substances that characterise the product or an indication of the nature of those nutrients or substances ; The portion of the product recommended for daily consumption (serving); A warning not to exceed the stated recommended daily dose; A statement to the effect that food supplements should not be used as a substitute for a varied diet; A statement to the effect that the products should be stored out of the reach of young children; The labelling, presentation and advertising of food supplements shall not include any mention stating or implying that a balanced and varied diet cannot provide appropriate quantities of nutrients in general.

17 Harmonized regulations at the EU level 2002/46/EC: MANDATORY LABELLING REQUIREMENTS The amount of the nutrients or substances with a nutritional or physiological effect present in the product shall be declared on the labelling in numerical form. The amounts of the nutrients or other substances declared shall be those per portion of the product as recommended for daily consumption on the labelling. Information on vitamins and minerals shall also be expressed as a percentage of the reference values mentioned, as the case may be, in the Annex to Directive 90/496/EEC as updated in Annex XIII of Reg. EU 1169/ 2011.

18 Non harmonized regulations on botanical food supplements ( used only in Italy)

19 Non-harmonized regulations at the EU level The maximum amounts of vitamins and minerals shall be adopted at the EU level (but this has not happened yet) Pending the setting of such maximum amounts at the EU level, Member States are allowed to maintain or set such rules at national level, without prejudice to the provisions of the treaty on the functioning of the european union. The Italian Ministry of Health updates its guidelines on the maximum amounts of vitamins allowed in food supplements by Ministerial Decrees. The last updating guideline went was adopted on 21/12/2011.

20 Non harmonized nutrients and substances It was not considered opportune at an European level to lay down specific rules for the use of nutrients or substances other than vitamins and minerals harmonized at an European level, For these non-harmonized nutrients and substances States have the power to enforce national provisions. Member To ensure botanical food supplements safety, the Italian Government has adopted a list of herbal substances and compositions authorized for food supplements with the Ministerial Decree of 9 July 2012 (Discipline on the use of food supplements of herbal substances and preparations), as amended by the Decree of 27 March 2014 (available at 6). As a consequence, in Italy only those botanicals included in the list may be use in food supplements, unless the principle of mutual recognition applies.

21 The Italian Decree of 27 March 2014 On 27 March 2014, the Italian Ministry of Health adopted a Decree, which amended the Ministerial Decree of 9 July 2012, regarding the use of botanicals in food supplements. The adoption of this new Decree is the first result of the joint work carried out in recent years by Italy, France and Belgium, to develop a project (the so-called BELFRIT Project) in order to establish, on the basis of scientific evidence, harmonized rules regarding the use of botanicals in food supplements. Considering the fact that in this field national rules still apply, the first BELFRIT Project's aim was to prepare a common list of admitted plants in order to ensure their harmonization in at least these three countries.

22 The Italian Decree of 27 March 2014 The Italian Ministerial Decree of 9 July 2012 already provides a positive national list of botanicals (and their parts) that may be used in the manufacture of food supplements. This positive list is considered as a safety parameter elaborated by the Italian authorities for the manufacture of food supplements. Therefore, all botanicals which are therein included are considered as safe, according to the rules laid down in Article 14 of the Regulation (EC) No 178/2002. The limit is given by the quantities of botanical used in the product, since their usage shall not pose any risk to human health. Furthermore, the economic operator remains responsible for ensuring that the specific botanical substance used in his food supplement is not considered "novel" according to Regulation (EC) No 258/1997, for instance, due to the application of a production process not currently used.

23 The Mutual recognition procedure: the Italian specificity With regard to to principle of mutual recognition, it should be noted that the Italian Government, through the «Guidelines on the documentation for the use of herbal substances and compositions(botanicals in food supplements», representing the Italian interpretation of the legally-binding law provisions, revised in January 2015, (available at emname_2_file.pdf), has introduced a restriction by requiring a certificate of origin, to be issued by the competent Authority of the Member State, attesting that the food supplement containing botanicals is lawfully marketed in that State and that the same is not considered a «novel food» for purposes of its use in food supoplements. As the competent Authorithies of some Member States not always issue such a certificate, as it may not be contemplated in their administrative procedures, the food business operator may not be able to rely on the principle of mutual recognition for marketing their products in Italy.

24 The «Guidelines on the documentation for the use of herbal substances and compositions(botanicals in food supplements)» This Guideline of the Italian Ministry of Health prescribes also other obligations for both producers and distributors of food supplements containing botanicals concerning the availability of of a complete dossier for each product comprising, among others,: (i) the specifications for all its ingredients and their compositional features; (ii) the documentation pertaining to the methods and modalities of analysis conducted for the determination and control of the quantities of active substances indicated on the label ( Art.6,sedtion 4,letters a,b of the Legislative Decree 169/2004); (iii) the description of the preparation and and transformation process of the ingredients together with the a detailed identification of the plant through specific markers and of substances of toxicological concern possibly present.

25 The «Guidelines on the documentation for the use of herbal substances and compositions(botanicals in food supplements)» In the mentioned guideline, the Italian Ministry of Health also provides specific remarks regarding: (i) The indication of the recommended daily dosage; (ii) The rationality of botanical «associations», (iii) Additional warnings; (iv) The indication of the «shelf life»; and (v) The indication of the physiological effects on health (health claims).

26 The indication of the physiological effects on health (health claims). According to guidance provided by the Italian Ministry of Health, to ensure the safe use of botanical food supplements, the food business operators should also provide to the consumer the information on physiological effects of the product as specified in the Italian Registry based on long term use (see the Ministerial guidelines of reference for the physiological effects available at NormsanPdf?anno=0&codLeg=48636&parte=2&serie=). This has caused a major problem as most of the health claims, basically corresponding to the physiological effects included in the ministerial guidelines of reference, proposed in the context of the art.13(1) procedure did not get the support of EFSA and were put «on hold» where they still are.

27 The indication of the physiological effects on health (health claims). Also the attempt of the Italian Ministry of Health to incorporate the Ministerial guidelines of reference for the physiological effects in a draft Decree that was notified to the European Commission was not successful as the Commission noted the overlap with the claims regulation and objected to the notification. Therefore, the Ministerial guidelines of reference for the physiological effects do not constitute authorized health claims, but only a mere guidance with no legal value. Making use of the physiologica effects described in the Ministerial Guidance leaves with the food business operators the responsibility of demonstrating the validity of the physiological effect,especially in the cases where a negative evaluation of EFSA is already available.

28 The indication of the physiological effects on health (health claims). It is not surprising,therefore, that recently the Antitrust Italian Authorithy has considered misleading the advertisement of a food supplement containing bioflavonoids, centella,horse chestnut and vitaminc, aimed at ascribing to the product, among others, enhancing effects effect on ther bloodstream and on the strenghtening of blood vessels. Therefore, considering the very severe sanctions which can be imposed by the Antitrust Italian Authorithy, in spite of what is said in the Ministerial guidelines of reference for the physiological effects, in Italy it is a food business operator duty to verify the availability of reliable scientific studies that validate the advertised effects.

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