The origins of the Belfrit project - salute.gov.it · Conclusions of the Report on the use of...

Dipartimento della sanità pubblica veterinaria,della sicurezza alimentare e degli organi collegiali per la tutela della salute

Direzione generale per l'igiene e la sicurezza degli alimenti e la nutrizione

The The originsorigins ofof the the BelfritBelfrit projectproject

Bruno ScarpaBruno Scarpa

RomeRome, 18 , 18 AprilApril 20132013

DIRECTIVE 2002/46/ECDIRECTIVE 2002/46/EC

HarmonizationHarmonization providedprovided just just forfor the the useuseofof vitaminsvitamins and and mineralsminerals

UseUse ofof plantsplants in in foodfoodsupplementssupplements

Conclusions of the Report on the use of substances other thanvitamins and minerals in food supplements:

Specific provisions are not justified , the existents provisions are sufficient

. Regulation (EC) 178/2002

. Article 8 du Regulation (EC) 1925/2006 on the addition of vitaminsand minerals and certain other substances to food

. Regulation (EC) 258/97 concerning novel food and novel food ingredients

. National laws and principle of mutual recognition

EUROPEAN COMMISSION December 2008

EUROPEAN COMMISSION EUROPEAN COMMISSION December 2008 December 2008

DRAFT OF THE NATIONAL DECREEDRAFT OF THE NATIONAL DECREE ON THE USE OF ON THE USE OF ““BOTANICALSBOTANICALS”” IN FOOD SUPPLEMENTS IN FOOD SUPPLEMENTS

NOTIFIED TO THE EU COMMISSION NOTIFIED TO THE EU COMMISSION OctoberOctober 20, 2011 20, 2011 favorablefavorable opinionopinion

POSITIVE LISTPOSITIVE LISTofof plantsplants and and partsparts ofof plantsplants allowedallowed

NOTIFICATION PROCEDURENOTIFICATION PROCEDUREofof the the labellabel toto the the MinistryMinistry ofof HealthHealth

asas requiredrequired forfor foodfood supplementssupplements

UseUse ofof substancessubstances and and herbalherbal preparationspreparations in food supplements

(D.M. 9 July 2012)(D.M. 9 July 2012)

HEALTH CLAIMS HEALTH CLAIMS on on botanicalsbotanicals

since 2010

“on hold" for the out of proportion difference regarding the

TRADITIONAL USE as evidence of efficacy between food supplements

and traditional herbal medicinals products

The BELFRIT ProjectThe BELFRIT ProjectIn 2011 the In 2011 the collaborationcollaboration betweenbetween

BELBEL--giumgium

FRFR--anceance

ITIT--alyaly

hashas startedstarted in in orderorder toto definedefine a common positive a common positive listlist, , derivingderiving fromfrom the the comparisoncomparison ofof nationalnational listslists, and , and toto

harmonizeharmonize eventuallyeventually theirtheir approachapproach toto the the assessmentassessmentofof plantsplants in food supplements

The BELFRIT ProjectThe BELFRIT Project

WHAT ARE THE WHAT ARE THE REASONS TO DO IT REASONS TO DO IT

??

The BELFRIT ProjectThe BELFRIT ProjectFood supplements containing botanicals are widely Food supplements containing botanicals are widely

available on the market of Italy, France and Belgiumavailable on the market of Italy, France and Belgium

GivenGiven the the lacklack of of harmonisation, harmonisation, the the mutualmutual recognitionrecognitionhas to be applied on a case by case basis


isnisn’’itit betterbetter toto arrivearrivetoto a common a common agreement agreement insteadinstead??

The idea came up during the meeting of the AdvisoryBoard of PlantLIBRA in May 2011 in Brasov (Romania)

PlantLIBRA is a European project that aims to provide data and information useful tothe safety and efficacy of “botanicals” in food supplements

MUTUAL RECOGNITIONMUTUAL RECOGNITION


the the ““case case byby casecase”” mutualmutual recognitionrecognitionapproachapproach can can bebe avoidedavoided ifif therethere isis a a

common common listlist ofof plantsplants allowedallowed in in foodfoodsupplementssupplements

OnlyOnly the the preparationspreparations ofof listedlisted plantsplants thatthat havehave a a traditionaltraditional historyhistory ofof useuse can can bebe usedused in in foodfood

supplementssupplements


IncreasedIncreased levellevel ofof consumersconsumers protectionprotection

FacilitatedFacilitated mutualmutual recognitionrecognition applicationapplicationbyby the the otherother membermember StatesStates

SHARING OF EXPERIENCESSHARING OF EXPERIENCES

The BELFRIT Project The BELFRIT Project

containingcontaining plantsplants consideredconsidered safesafe on the basis of the on the basis of the traditional use and of the whole complex of available traditional use and of the whole complex of available scientific evidence, and that can be used because of scientific evidence, and that can be used because of

their their ““physiologicalphysiological effectseffects““

AfterAfter oneone yearyear and a and a halfhalf ofof workingworking togethertogether wewe definedefine a a common common listlist ofof the the threethree membermember StatesStates::

THE BELFRIT LISTTHE BELFRIT LIST


We are very satisfied withthe achieved result, but weare aware that this is onlythe starting point and not

the end


WHAT ARE WHAT ARE THETHE

NEXT STEPS NEXT STEPS ??


ADOPTION ADOPTION ofof the common the common listlist in the in the threethree membermember StatesStates

legislationlegislation

JOINT MANAGEMENT OF THE LISTJOINT MANAGEMENT OF THE LISTtoto keepkeep the common position the common position reachedreached

JOINT MANAGEMENT OF THE JOINT MANAGEMENT OF THE BELFRIT LIST (1)BELFRIT LIST (1)

DefinitionDefinition ofof additionaladditional provisionsprovisions on the on the basisbasisofof developmentdevelopment in in scientificscientific knowledgeknowledge and and ofof

newnew data data collectedcollected throughthrough phytovigilancephytovigilancesystem, system, suchsuch asas::

. . additionaladditional warningswarnings forfor the the labelinglabeling

. . maximummaximum levelslevels ofof substancessubstances ""ofof concernconcern""

. . dosagedosage ofof the the plantplant or the part or the part usedused

. . typetype ofof preparationpreparation permittedpermitted forfor useuse asas ingredientsingredients

ApplicationApplication ofof the the principleprinciple ofof mutualmutual recognitionrecognitiontoto foodfood supplements supplements thatthat are are legallylegally marketedmarketed

in in anyany otherother MemberMember StatesStates

ItIt shouldshould alsoalso bebe notednoted thatthat itit isis veryvery difficultdifficult totohavehave a a validvalid proofproof thatthat the the productproduct isis legallylegally

marketedmarketed in in anan otherother MemberMember State State

JOINT MANAGEMENT OF THE JOINT MANAGEMENT OF THE BELFRIT LISTBELFRIT LIST (2)(2)

The BELFRIT List: The BELFRIT List: a work in progressa work in progress

ToTo join the BELFRIT project join the BELFRIT project mightmight bebe ofof interest interest totootherother MemberMember StatesStates sharingsharing a a similarsimilar approachapproach

relatedrelated toto the the useuse ofof ““botanicalsbotanicals”” in in foodfoodsupplementssupplements

The BELFRIT ListThe BELFRIT List

can serve as a tool for anEuropean harmonization

doesdoes notnot affectaffect the the possibilitypossibility byby a a MemberMember State State toto givegive prioritypriority toto the the

pharmaceuticalpharmaceutical legislationlegislation on the on the basisbasis ofof the the currentcurrent europeaneuropean


EUROPEAN HARMONISATION EUROPEAN HARMONISATION ON BOTANICALS ON BOTANICALS

EUROPEAN HARMONISATIONEUROPEAN HARMONISATION

HEALTH CLAIMSHEALTH CLAIMSREGULATION (EU) 432/2012 – Recital 1717

The addition of substances to or the use of substances in foodstuffs is governed by specific Union and national legislation, as is the classification of products as foodstuffs or medicinal products. Any decision on a health claim in accordance with Regulation (EC) No 1924/2006 such as inclusion in the list of permitted claims referred to in Article 13(3) thereof does not constitute an authorisation to the marketing of the substance on which the claim is made, a decision on whether the substance can be used in foodstuffs, or a classification of a certain product as a foodstuff.

NOVEL FOOD NOVEL FOOD ProposalProposal for a new for a new RegulationRegulation on on novelnovel foodfood –– RecitalRecital 8a 8a

The The provisionsprovisions ofof DirectiveDirective 2001/83/EC on the Community 2001/83/EC on the Community code code relatingrelating toto medicinalmedicinal productsproducts forfor humanhuman useuse shouldshouldapplyapply wherewhere, , takingtaking intointo account account allall itsits charateristicscharateristics, a , a productproduct maymay fallfall withinwithin the the definitiondefinition ofof ““medicinalmedicinal productproduct””and and withinwithin the the definitiondefinition ofof a a productproduct coveredcovered byby otherotherCommunity Community legislationlegislation. . In In thisthis respectrespect, a , a MemberMember State State maymay, , ifif itit establishesestablishes in in accordanceaccordance withwith DirectiveDirective 2001/83/EC 2001/83/EC thatthat a a productsproducts in a in a medicinalmedicinal productproduct, , restrictrestrict the the placingplacing on the market on the market ofof suchsuchproductproduct in in accordanceaccordance withwith Community Community lawlaw


NOVEL FOOD CATALOGUE NOVEL FOOD CATALOGUE

EU EU countriescountries maymay restrictrestrict the the marketing marketing ofof a a productproduct throughthrough specificspecific



TRADITIONAL USETRADITIONAL USE

BotanicalsBotanicals: :

The The traditionaltraditional useuse acceptedaccepted asasproofproof ofof safetysafety shouldshould alsoalso bebeacceptedaccepted asas proofproof ofof efficacyefficacy

TRADITIONAL USETRADITIONAL USE

AccordingAccording to the to the RegulationRegulation258/97/EC258/97/EC

a a botanicalbotanical thatthat havehave beenbeen usedused forforhumanhuman consumptionconsumption toto a a significantsignificant

degreedegree withinwithin the Community the Community isis allowedallowed forfor foodfood supplementssupplements

Novel food catalogue Novel food catalogue

BetulaBetula pendulapendula


BetulaBetula pendulapendula= = notnot novelnovel foodfood supplementsupplement

Not NOVEL FOOD: Not NOVEL FOOD: STATUS DEFINITIONSTATUS DEFINITION

The The plantplant isis consideredconsidered notnot novelnovel foodfood becausebecause ofof the the traditionaltraditional amountamount ingestedingested……andand notnot throughthrough

appropriate appropriate dosedose--relatedrelated studiesstudies in in humanshumans

""detoxifyingdetoxifying and and drainingdraining ""

WHY have this amount been used by consumers?in relation to its physiological effects


MonascusMonascus purpureuspurpureus -- monacolinemonacoline

MonascusMonascus purpureuspurpureus –– monacolinmonacolin KK

STANDING COMMITTEE ON THE FOOD CHAIN AND ANIMAL HEALTHSTANDING COMMITTEE ON THE FOOD CHAIN AND ANIMAL HEALTHSECTION ON GENERAL FOOD LAWSECTION ON GENERAL FOOD LAWSummary Record of Meeting of 26 January 2010

3. Exchange of views on the consideration of fermented red yeast rice in foodsupplement as a novel food (requested by Belgium)

ITALY CONFIRMED that food products meeting the definition offood supplements (Directive 2002/46/EC) were on the market in Italy already before the entering into force of the Novel FoodRegulation.The Committee therefore concluded, that ''fermentedfermented redred yeastyeastricerice'' when used in or as food supplement, should not be consideredas subject to the novel food Regulation

MonascusMonascus purpureuspurpureus –– monacolinmonacolin KKMonacolin for physiological purposes:

max 3 mg in Italy

Regulation (EU) 432/2012 on health claims (art. 13.1 reg 1924/2006)

Monacolin K from red yeast rice contributes to the maintenance of normal blood cholesterol levels

10 mg of monacolin K

MonascusMonascus purpureuspurpureus –– monacolinmonacolin kk

EFSA Journal 2013; 11 (2): 3084

10 mg10 mg of monacolin K

The opinion does not constitute … a positive assessment of itssafety, nor a decision on wether red yeast rice is, or not, classified as foodstuff

It should be noted that such an assessment is not foreseen in the framework of Regulation (EC) 1924/2006

Food supplements Food supplements withwith 10 mg10 mg of monacolin K

Is not applicable Regulation (EC) 258/97

Is applicable Regulation (EC) 1925/2006on the addition of vitamins and minerals and of certain other substances to foods

Article 8Substances prohibited, restricted or under Community scrutiny

1. The procedure provided for in this Article shall be followed where a substance other thanvitamins or minerals, or an ingredient containing a substance other than vitamins or minerals, isadded to foods or used in the manufacture of foods under conditions that would result in the ingestion of amounts of this substance greatly exceeding those reasonably expected to beingested under normal conditions of consumption of a balanced and varied diet and/or wouldotherwise represent a potential risk to consumers.

REGULATION (EU) No 307/2012 of 11 April 2012 establishing implementing rules for the application of

Article 8 of Regulation (EC) No 1925/2006

WeWe hopehope thatthat the BELFRIT project the BELFRIT project willwill bebe anan

USEFUL TOOL FOR THE HARMONIZATION USEFUL TOOL FOR THE HARMONIZATION AT EUROPEAN LEVELAT EUROPEAN LEVEL

ofof botanicalsbotanicals in in foodfood supplements supplements

CONCLUSIONS CONCLUSIONS

WeWe alsoalso relyrely on the on the importanceimportance ofofTRADITIONAL USE TRADITIONAL USE

asas proofproof toto supportsupport healthhealth claimsclaims on on botanicalsbotanicals

in in orderorder toto deal deal proportionallyproportionally withwith the the ““pendingpending”” currentcurrent situationsituation

CONCLUSIONS CONCLUSIONS

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