Botanicals and botanical preparations in the EU: evolution through time towards full harmonisation . Opportunities and challenges“. Part III- Marketing botanical foodsupplements in Italy

Vittorio SilanoII University of Rome, Tor Vergata, and

EFSA CEF Panel

Disclaimer

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

No share of the market in Italy between botanical foodsupplements and traditional medicinal products in Italy

Annual sales of traditional botanical products being marke ted in selectedcountries as food supplements and medicinal products (Expe rtEstimates)

Country Botanical Food Total (i.e. BotanicalSupplements Food Supplements

plus Botanical Medi-cinal Products )

------------- -------------- -------------------------� Italy 1454 15 00� Germany 841 2400� France 532 1500

____________________(+)Millions of euros

Only a partial harmonization has beenachieved by the European legislation

� Since 2002, only general definitions, labelling,publicity and vitamins and minerals which can beused have been harmonized at the European level,but not the marketing procedures, which remainunder the responsibilities of Member States .

� In some (but not all) EU MS, including Italy. foodsupplement labels must be notified before marketingand in some MSs lists of botanical species are usedto prohibit or to make possible the use of particularbotanical species to manufacture food supplements,but no Community or national authorization is neededbefore marketing.

Harmonized regulations at the EU level(including Italy)

DIR. 2002/46: DEFINITION OF FS

Foodstuffs

� the purpose of which is to supplement the normal di et and

� which are concentrated sources of nutrients (vitami ns and minerals) or other substances with a nutritional or physiological effect, alone or in combination

� marketed in dose form…designed to be taken in measur ed small unit quantities.

Vitamins and Minerals

2002/46: VITAMINS AND MINERALSALLOWED IN FS

ANNEX I

REGULATION (EC) No 1170/2009

Vitamins and Minerals

� THE ANNEX I OF DIRECTIVE 46/2002 � 1. 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) Man ganese (mg)

Niacin (mg NE) Sodium (mg)� Pantothenic acid (mg) Pota ssium (mg)� Vitamin B6 (mg) Sel enium ( µg)� Folic acid ( µg) Chromium ( µg)� Vitamin B12 ( µg) Molybdenum ( µg)� Biotin ( µg) Fluoride (mg)� Vitamin C (mg) Chloride (mg)� Phosphorus (mg)

Vitamins and Minerals

LIST OF PERMITTED SOURCES OF VITAMIN OR MINERAL THA TMAY BE USED IN FS

ANNEX II Dir. 2002/46DIRECTIVE 2006/37/EC; REGULATION (EC) No 1170/2009 ;

REGULATION (EU) No 1161/2011

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. VITAMI N B1� (d) beta-carotene (a) thiam in 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

When to use the denominations of AnnexI or those of Annex II for general information

� The denominations of vitamins and mineralsreported in the Annex I are those relevant for the nutritional declaration of foodsupplements.

� -The denominations of vitamins and mineralsreported in Annex II are those rlevant for the list of ingredients .

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).

2002/46: SETTING MINIMUM AMOUNTS OF VITAMINS AND MINERALS IN FS AT THE EU LEVEL

Directive 90/496/EEC

15% of the recommended allowancein 100 g or 100 ml

_________________________________________________________� According to Reg.1924/2006, 15% of the recommended al lowance

has to be present if a nutrition claim is made that the food is a “source” of a vitamin or a mineral.

2002/46: SETTING MINIMUM AMOUNTS OF VITAMINS AND MINERALS IN FS AT THE EU LEVEL

According to Reg.1169/2011 that, among others, has rep ealedDirective 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 t he package contains only a single portion,

� — 7,5 % of the nutrient reference values supplied by 100 ml in the case of beverages.

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 categori es 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 ma nufacturer or

packager, or of a seller established within the Com munity.• (8) particulars of the place of origin or provenanc e where failure to give

such particulars might mislead the consumer to a ma terial degree as to the true origin or provenance of the foodstuff;

• (9) instructions for use when it would be impossibl e to make appropriate use of the foodstuff in the absence of such instruc tions;

• (10) with respect to beverages containing more than 1,2 % by volume of alcohol, the actual alcoholic strength by volume.

Harmonized regulations at the EU level - 2002/46/EC:MANDATORY LABELLING REQUIREMENTS

� The name under which FS are sold shall be ‘food sup plement’;� The labelling, presentation and advertising must no t 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 substan ces that characterise the product or an indication of the nat ure of those nutrients or substances ;

� The portion of the product recommended for daily co nsumption (serving);

� A warning not to exceed the stated recommended dail y dose;� A statement to the effect that food supplements sho uld 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 foo d supplements shall

not include any mention stating or implying that a balanced and varied diet cannot provide appropriate quantities of nutri ents in general.

Harmonized regulations at the EU level –2002/46/EC: MANDATORY LABELLINGREQUIREMENTS

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.

Non harmonized regulations onbotanical food supplements ( usedonly in Italy)

Non-h armonized regulations at the EU level

The maximum amounts of vitamins and mineralsshall 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 nationallevel, without prejudice to the provisions of the treaty on thefunctioning of the european union.

� The Italian Ministry of Health updates its guidelines on the maximumamounts of vitamins allowed in food supplements by MinisterialDecrees. The last updating guideline went was adopted on21/12/2011 .

Non harmonized nutrients and substances

� It was not considered opportune at an European level to laydown specific rules for the use of nutrients or substances ot herthan vitamins and minerals harmonized at an European level,

� For these non-harmonized nutrients and substances MemberStates have the power to enforce national provisions.

� To ensure botanical food supplements safety, the ItalianGovernment has adopted a list of herbal substances andcompositions authorized for food supplements with theMinisterial Decree of 9 July 2012 (Discipline on the use of fo odsupplements of herbal substances and preparations), asamended by the Decree of 27 March 2014 (available athttp://www.trovanorme.salute.gov.it/norme/dettaglio Atto?id=48636).

� As a consequence, in Italy only those botanicals included in thelist may be use in food supplements, unless the principle ofmutual recognition applies.

The Italian Decree of 27 March 2014

� On 27 March 2014, the Italian Ministry of Health adopted aDecree, which amended the Ministerial Decree of 9 July 2012,regarding the use of botanicals in food supplements. Theadoption of this new Decree is the first result of the joint wo rkcarried out in recent years by Italy, France and Belgium, todevelop a project (the so-called BELFRIT Project) in order t oestablish, on the basis of scientific evidence, harmonized rulesregarding the use of botanicals in food supplements.Considering the fact that in this field national rules still apply, thefirst BELFRIT Project's aim was to prepare a common list of ad-mitted plants in order to ensure their harmonization in at le astthese three countries.

The Italian Decree of 27 March 2014

� The Italian Ministerial Decree of 9 July 2012 already provid es apositive national list of botanicals (and their parts) that may beused in the manufacture of food supplements. This positive l istis considered as a safety parameter elaborated by the Italia nauthorities for the manufacture of food supplements. There fore,all botanicals which are therein included are considered as safe,according to the rules laid down in Article 14 of the Regulati on(EC) No 178/2002. The limit is given by the quantities of bota nicalused in the product, since their usage shall not pose any risk tohuman health. Furthermore, the economic operator remainsresponsible for ensuring that the specific botanical subst anceused in his food supplement is not considered "novel" accord ingto Regulation (EC) No 258/1997, for instance, due to the appl ica-tion of a production process not currently used.

The Mutual recognition procedure: the Italianspecificity

� With regard to to principle of mutual recognition, it should benoted that the Italian Government , through the «Guidelines onthe documentation for the use of herbal substances andcompositions(botanicals in food supplements», represent ing theItalian interpretation of the legally-binding law provisi ons ,revised in January 2015, (available athttp://www.salute.gov.it/imgs/C_17_pagineAree_1424_ listaFile_itemName_2_file.pdf ), has introduced a restriction by requiring acertificate of origin , to be issued by the competent Authori ty ofthe Member State, attesting that the food supplement contai ningbotanicals is lawfully marketed in that State and that the sa meis not considered a «novel food» for purposes of its use in foo dsupoplements.

� As the competent Authorithies of some Member States notalways issue such a certificate , as it may not be contemplate din their administrative procedures, the food business oper atormay not be able to rely on the principle of mutual recognition formarketing their products in Italy.

The «Guidelines on the documentation for the use of herbal substances and compositions(botanicals in foodsupplements)»

This Guideline of the Italian Ministry of Health prescribes alsoother obligations for both producers and distributors of fo odsupplements containing botanicals concerning the availab ility ofof a complete dossier for each product comprising, amongothers,:� (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 andcontrol of the quantities of active substances indicated onthe label ( Art.6,sedtion 4,letters a ,b of the Legislative D ecree169/2004);

� (iii) the description of the preparation and and transforma tionprocess of the ingredients together with the a detailedidentification of the plant through specific markers and ofsubstances of toxicological concern possibly present.

The «Guidelines on the documentation for the use of herbal substances and compositions(botanicalsin 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 heal th

(health claims).

The indication of the physiological effects on health (health claims).

� According to guidance provided by the Italian Ministry o f Health, to ensure the safe use of botanical food supplements, t he foodbusiness operators should also provide to the consumer the information on physiological effects of the product a sspecified in the Italian Registry based on long term use (see the Ministerial guidelines of reference for the physiologi cal effectsavailable at http://www.trovanorme.salute.gov.it/norme/render-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 in cluded in the ministerial guidelines of reference, proposed in t he contextof the art.13(1) procedure did not get the support of EFSA and were put « on hold» where they still are.

The indication of the physiological effectson health (health claims).

� Also the attempt of the Italian Ministry of Health to in corporate the Ministerial guidelines of reference for the physio logical ef-fects in a draft Decree that was notified to the European Com-mission 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 physio-logical effects do not constitute authorized health claim s, butonly a mere guidance with no legal value.

� Making use of the physiologica effects described in the Ministe-rial Guidance leaves with the food business operators t he res-ponsibility of demonstrating the validity of the physi ologicaleffect,especially in the cases where a negative evalua tion of EFSA is already available.

The indication of the physiological effectson health (health claims).

� It is not surprising ,therefore, that recently the Antit rust ItalianAuthorithy has considered misleading the advertisement o f a food supplement containing bioflavonoids, centella,hor se ches-tnut and vitaminC, aimed at ascribing to the product, a mongothers, 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 spi te of what issaid in the Ministerial guidelines of reference for the physiolo-gical effects, in Italy it is a food business operator d uty to verifythe availability of reliable scientific studies that val idate the advertised effects.