EVALUATION AND FITNESS CHECK (FC) ROADMAP. A. Purpose

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1 EVALUATION AND FITNESS CHECK (FC) ROADMAP TITLE OF THE EVALUATION/FC LEAD DG RESPONSIBLE UNIT Evaluatin f a) Regulatin (EC) N 1924/2006 n nutritin and health made n fd with regard t nutrient prfiles and health made n plants and their preparatins and f b) the general regulatry framewrk fr their use in fds DG SANTE UNIT E4 DATE OF THIS ROADMAP 10/ 2015 TYPE OF EVALUATION Evaluatin Ex-pst Mixed PLANNED START DATE PLANNED COMPLETION DATE 01 / / 2017 PLANNING CALENDAR This indicative radmap is prvided fr infrmatin purpses nly and is subject t change. (A.1) Purpse A. Purpse Regulatin (EC) N 1924/2006 n nutritin and health made n fds ( the Regulatin ) was adpted in 2006 t gvern the use f these in the labelling, presentatin and advertising f fds. It aimed in particular at enabling cnsumers t make healthier chices by prtecting them frm misleading infrmatin and ensuring a level playing field fr fd business peratrs within the internal market. Nutritin are statements like 'lw fat', 'high fibre', while health make the link between a fd cnstituent and health, like 'Vitamin D is needed fr the nrmal grwth and develpment f bne in children'. The purpse f this evaluatin is t assess whether tw specific elements required fr the implementatin f the Regulatin have prven t be fit fr purpse and whether the Regulatin, t date, with respect t these elements, has achieved, at minimum burden, its verall bjectives n truthful infrmatin t cnsumers and the facilitatin f the free mvement f fds bearing. The evaluatin will examine whether nutrient prfiles prvided fr in the Regulatin, which have nt yet been adpted, are warranted and adequate t ensure the bjectives f the Regulatin. These nutrient prfiles are threshlds f nutrients such as fat, salt and sugars abve which nutritin and health are restricted, thus preventing a psitive health message n fd high in these nutrients 1. This evaluatin will als examine whether the current rules cncerning health n plants and their preparatins used in fds are adequate, and hw the use f such interacts with the current applicable fd regulatry framewrk n plants and their preparatins. The results f this evaluatin will be used t decide n the next steps regarding this plicy area. (A.2) Justificatin In its Better Regulatin Cmmunicatin f 19 May , the Cmmissin annunced t carry ut an evaluatin f the Regulatin. This evaluatin will fcus n nutrient prfiles and health n plants and their preparatins added t fds. It will als cnsider the mre general regulatry framewrk fr the use f such substances in fds since it is clsely related t the use f health. 1 2 Nutrient prfiles are nt cmpsitin standards but nly cnditins fr making nutritin and health. Nutrient prfiles d nt appear n labels and are nt cmmunicated t cnsumers. COM(2015) 215 final. COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS. Better regulatin fr better results - An EU agenda.

2 Since its adptin in 2006, the implementatin f the Regulatin remains incmplete since nutrient prfiles, that the Cmmissin was requested t set by January 2009, have nt been established and due t the fact that health n plants and their preparatins used in fds are still unregulated. In additin, the situatin with regard t the unregulated health n plants and their preparatins has led t a brader reflectin regarding the use f plants and their preparatins used in fds. (B.1) Subject area B. Cntent and subject f the evaluatin Befre the adptin f the Regulatin, nutritin and health were nt harmnised. Member States tk different rientatins, ranging frm the ban f health t an absence f any legislatin, leading t internal market fragmentatin. The aim is that the setting f lists f authrised nutritin and health at EU level wuld ensure the free mvement f fds within the internal market. While certain fd business peratrs invested in research and develpment t substantiate the nutritin and health they made n their fds, thers used nutritin and health as a marketing tl withut ensuring that their were scientifically justified. This situatin led t unfair cmpetitin and jepardized the trust that cnsumers culd have in scientifically justified. The Regulatin stipulates that nutritin and health made n fd must be based n and substantiated by generally accepted scientific evidence and that health shuld nly be authrised fr use in the Unin after a thrugh scientific assessment by the Eurpean Fd Safety Authrity (EFSA). The Regulatin als prvides fr a list f permitted nutritin and fr an authrisatin prcedure t establish the list f permitted health. In additin, the Regulatin bliges the Cmmissin t set nutrient prfiles, after cnsulting EFSA, which cnsist in maximum levels in fds f nutrients such as sugars, salt and fat, abve which nutritin wuld be limited and health prhibited. A. Nutrient Prfiles The Eurpean Fd Safety Authrity adpted a scientific pinin n the setting f nutrient prfiles in 2008, and the Cmmissin started t cnsult the Member States and the stakehlders n a draft Cmmissin Regulatin establishing a nutrient prfiles system. The setting f nutrient prfiles has been pstpned, due t the cmplexity f the subsequent discussins in relatin t scientific issues and ptential ecnmic impacts. The currently applicable prvisins f Regulatin (EU) N 1169/2011 n fd infrmatin t cnsumers maintained the previus rules already in place when the Regulatin was adpted and requiring that nutritin r health can nly be made if the fd fr which they are made is labelled with a factual indicatin ( nutritin declaratin, ften in table frmat) f the nutritinal cntent f the fd. This nutritin infrmatin relates t the energy value and the amunts f fat, saturates, carbhydrate, sugars, prtein and salt. As f December 2016, such nutritin declaratin will becme mandatry fr all fds. Thus, while there is currently n legal link between certain levels f fat, sugars and salt and the pssibility t make health and nutritin, the cnsumer is prvided with factual infrmatin n the nutritinal value f the fd in questin. B. Plants and their preparatins used in fds In the cntext f the implementatin f the Regulatin, mre than 500 n plants and their preparatins received an unfavurable assessment frm EFSA in the cntext f their scientific assessments, and this raised many cncerns amng Member States and many stakehlders regarding health made n plants and their preparatins used in fd. T date, the remaining ver 1500 submissins cncerning such health have nt yet undergne the scientific evaluatin by EFSA. The Regulatin prvides that all health, including thse n plants and their preparatins used in fd, shuld be assessed n the basis f scientific evidence at 'the highest pssible standard'. In this cntext, EFSA cnsiders human studies as essential fr the substantiatin f. Hence, EFSA cnsidered that evidence cllected n the basis f experience gained ver time with the actual cnsumptin f the plants and preparatins ( traditinal use' ) alne cannt be cnsidered sufficient t allw fr the scientific substantiatin f a health claim made n fds. Under the legislatin n medicinal prducts fr human use, herbal medicinal prducts may underg a simplified registratin prcedure instead f an authrisatin prcedure n the basis f criteria specified 2

3 in the legislatin n medicinal prducts fr human use such as evidence n medicinal use thrughut a perid f at least 30 years 'traditinal use' 3. Accrding t the latter legislatin, the lng traditin f the medicinal prduct makes it pssible t reduce the need fr clinical trials, in s far as the efficacy f the medicinal prduct is plausible n the basis f lng-standing use and experience. Pre-clinical tests are nt cnsidered necessary, where the medicinal prduct n the basis f the infrmatin n its traditinal use prves nt t be harmful under specified cnditins f use. Nevertheless, these medicines remain subject t general prvisins applying t all medicines such as pharmacvigilance, gd manufacturing practices etc. Under the current EU rules, it is pssible fr a Member State n a case-by-case basis t classify a prduct as fd r as medicine depending n its presentatin and claimed effect. Therefre it is pssible that differences exist between Member States in the classificatin f prducts. In ther wrds, as EU law stands, it is pssible that the same prduct is classified as a fdstuff in ne Member State and as a medicinal prduct in anther. Pending further actin t regulate health n plants and their preparatins, health made n such substances and which were submitted in the cntext f the establishment f the list f permitted health, may still be used pursuant t the transitinal perids freseen in Article 28(5) f the Regulatin which requires that health cmply with the Regulatin and with the existing natinal prvisins applicable t them. The Regulatin prvides fr the substantiatin f health made n plants and their preparatins used in fds by demnstrating the causal link between cnsumptin f such fds and the claimed beneficial effect. This precludes any safety cnsideratins by EFSA n the use f the substance in fds when assessing the claim. This has given rise t increased cncerns amngst the Member States n the authrisatin f health n certain substances when n regard is given t the safety aspects f their use in fds. These cncerns emerged strngly during the cnsultatin f the Member States n the ptins fr the way frward fr thse health n plants and their preparatins that are n hld 4. An Overview Reprt 5 which was finalised in 2015 based n a series f fact finding missins carried ut by the Fd and Veterinary Office (FVO) in Member States in 2013 and 2014 in rder t gather infrmatin regarding the cntrls n fd supplements highlights the prblems that Member States face due t differing natinal rules fr the use f plants and their preparatins in fds. The reprt als highlights issues with enfrcement f existing rules in view f the increase in internet sales f such prducts. The Cmmissin cncluded in a reprt adpted in 2008 n the use f substances ther than vitamins and minerals in fd supplements 6 that substances "ther than vitamins and minerals" (i.e. plants and plant preparatins) have a very varied cnsumptin pattern and that harmnisatin in this area was currently nt desirable. The reprt als stresses that the Cmmunity legal instruments described in this reprt already cnstitute a sufficient legislative framewrk fr regulating this area and des nt cnsider it pprtune t lay dwn specific rules fr substances ther than vitamins and minerals fr use in fdstuffs. Hwever, in thse cnclusins, the Cmmissin did nt rule ut the pssibility, at a later stage, f carrying ut a supplementary analysis in rder t check whether they are still valid. Such supplementary analysis shuld examine the legislative framewrk applicable t the additin f substances ther than vitamins and minerals as well as the evlutin f the market f the prducts cncerned. (B.2) Original bjectives f the interventin 1. Objectives fr the EU measure n health and nutritin in general (see interventin lgic in Annex 1): - T ensure a high level f cnsumer prtectin and t facilitate healthier fd chices; - t imprve the free mvement f fds with nutritin and health within the internal market and t increase legal certainty fr ecnmic peratrs; - t ensure fair cmpetitin when nutritin and health are being used and t prmte and prtect innvatin in the area f fds. 2. Objectives f applicable rules cvering plants and their preparatins: - T ensure that cnsumers are crrectly infrmed n nutritinal/health value f plants and their preparatins Defined as medicinal use thrughut a perid f at least 30 years preceding the date f the applicatin, including at least 15 years within the Unin "Discussin Paper n health n btanicals used in fds", July 2012 Overview reprt n a series f fact finding missins carried ut in Member States in 2013 AND 2014 in rder t gather infrmatin regarding the cntrls n fd supplements (DG(SANTE) MR): COM(2008)824, final ( ) 3

4 cntained in fd and t allw them t make an infrmed chice n a healthy diet; - t ensure that fds cntaining plants and their preparatins that are placed n the market are safe; - t ensure the free mvement f fds cntaining plants and their preparatins within the internal market. (B.3) Hw the bjectives were t be achieved Nutrient prfiles (see interventin lgic in Annex 1) Fds prmted with nutritin r health might be perceived by cnsumers as having a nutritinal, physilgical r ther health advantage ver similar r ther prducts withut. The applicatin f nutrient prfiles aims at aviding a situatin where nutritin r health culd mislead cnsumers as t the verall nutritinal quality f a fd prduct when trying t make healthy chices in the cntext f a balanced diet. Health n plants and their preparatins (see interventin lgic in Annex 1) The Regulatin shuld ensure reliable infrmatin t cnsumers, when trying t make healthier chices, by prviding scientific justificatin f nutritin and health. This is aimed t be achieved by establishing an authrisatin prcedure, which requires a scientific assessment f the "the highest pssible standard". As a result thrugh creatin f a level playing field it shuld lead t securing investment and prmting innvatin. Plants and their preparatins used in fds The legislative framewrk with regard t ther substances 7, such as plants and their preparatins, is such that there is n specific harmnised legislatin at EU level. Nevertheless, fd prducts cntaining the substances in questin are cvered by varius Unin legislative texts f general applicatin, such as Regulatin (EC) N 178/2002 n the general principles f fd law, and ther legal acts applicable t certain categries f fds, such as Regulatin (EC) N 1925/2006 n the additin f vitamins and minerals and f certain ther substances t fds. Regulatin (EC) N 1925/2006 was adpted at the same time as Regulatin (EC) N 1924/2006 in 2006, and was cnsidered t be cmplementary t that Regulatin. Article 8 f Regulatin (EC) N 1925/2006 lays dwn a prcedure whereby the use f ther substances in fds may be prhibited, restricted r placed under Unin scrutiny if a harmful effect n health has been identified. This prvisin allws the regulatin at EU-level f substances already n the market and fr which ptential safety cncerns have been raised. Hwever, this prvisin nly allws the banning and restrictin f plants and plant preparatins in fd. It des nt cnstitute a "psitive list" f permitted plants and plant preparatins in fd. T date, this prvisin has been used fr tw plants and their preparatins. In the absence f applicable secndary EU law, the primary EU law n free mvement f gds applies. This is gverned by Articles 34 and 36 f the Treaty n the Functining f the Eurpean Unin (TFEU). C. Scpe f the evaluatin/fc (C.1) Tpics cvered This evaluatin, cvering the 28 EU Member States, aims at cvering the fllwing aspects f the Regulatin: 1. Nutrient prfiles and 2. Health n plants and their preparatins. In this cntext, the evaluatin will, where necessary, extend t ther regulatry aspects, such as safety requirements fr the use f plants and their preparatins in fd. This evaluatin excludes frm its scpe ther aspects f the Regulatin, besides the tw mentined abve. The reasn is that an evaluatin f the Regulatin in its entirety wuld be premature at this stage given that the list f authrised health nly came int applicatin in December This evaluatin aims at cvering the situatin n the EU market since the applicatin f the Regulatin in July (C.2) Questins/issues t be examined 7 Regulatin (EC) N 1925/2006 defines ther substance as a substance ther than a vitamin r a mineral that has a nutritinal r physilgical effect. 4

5 1. Nutrient prfiles 1. Effectiveness 8 2. Efficiency 9 3. Relevance Cherence 11 Did the nn-setting f nutrient prfiles at EU level prevent the realisatin f the bjectives f the Regulatin? If yes, t what extent and why? What are the bjectives that are nt met and t what extent? Which main factrs have cntributed t r std in the way f achieving these bjectives and t what extent? Beynd these bjectives, has the nn-setting f nutrient prfiles at EU level entailed negative r psitive impacts, especially n the use f natinal r private nutrient schemes, such as nutritinal lgs? What are the csts and benefits assciated with the absence f nutrient prfiles in the cntext f the applicatin f the Regulatin? What are the alternatives t the setting f nutrient prfiles at EU level that culd achieve similar bjectives but with a less burdensme measure? T what extent nutrient prfiles at EU level are still relevant and needed taking int accunt the evlutin f the market and the evlutin f the regulatry framewrk, especially fllwing the adptin f the new EU Regulatin n fd infrmatin t cnsumers? T what extent can nutritin and health be cnsidered as accurate and reliable given the nnsetting f nutrient prfiles at EU level? Hw and t what extend des the nn-setting f nutrient prfiles at EU level affect the trade f fds? T what extent wuld the setting f nutrient prfiles at EU level be cnsidered cherent with ther initiatives in the cntext f the EU Platfrm n Diet, Physical Activity and Health? 5. EU added value Withut nutrient prfiles at EU level, hw d Member States integrate the cncept f nutrient prfiles in the gvernance f nutritin and health n their market? 2. Plants and their preparatins used in fds 1. Effectiveness What prgress has been made ver time twards achieving the bjectives f the legislative framewrk intrduced by Regulatin (EC) N 1924/2006? Is this prgress in line with the initial expectatins? Did the absence f a decisin n the authrisatin r rejectin f health n plants and their preparatins used in fds prevent the realisatin f the bjectives f the Regulatin, and if s hw? What are the bjectives that are nt met and t what extent? T what extent the legislative framewrk applicable t plants and their preparatins used in fds has allwed achieving its bjectives with respect t placing f safe fd n the EU market and facilitating free mvement f gds? 2. Efficiency What are the csts and benefits (mnetary and nn-mnetary) assciated with the absence f a final decisin n the authrisatin f health n plants and their preparatins used in fds in the The degree t which smething is successful in prducing a desired result and the degree t which bjectives are achieved and the extent t which targeted prblems are slved. The ability t d smething r prduce smething withut wasting materials, time r energy: the quality r degree f being efficient. T knw the relevance f smething is t knw why it matters r hw it is imprtant. Frming a unified whle. 5

6 cntext f the applicatin f Regulatin (EC) N 1924/2006? What is the specific cst impact f authrisatin prcedures required fr health n micr- small and medium sized enterprises? What are the alternatives, t the current prvisins fr regulating health n plants and their preparatins used in fds, which culd achieve similar bjectives t the bjectives f the Regulatin, but with less burdensme requirements? What are the csts and benefits f the legislative framewrk applicable t plants and their preparatins used in fds? 3. Relevance T what extent is the legislative framewrk intrduced by Regulatin (EC) N 1924/2006 still relevant t address current needs and trends in relatin t health made n plants and their preparatins used in fds? Are there any ther bjectives that shuld be cnsidered? T what extent is the legislative framewrk applicable t plants and their preparatins used in fds still relevant t deal with issues related t the evlutin f the market with regard t plants and their preparatins used in fds? 4. Cherence T what extent are the requirements set ut in Regulatin (EC) N 1924/2006 cherent with EU legislatin applicable t plants and their preparatins, including the part f the legislatin n medicines fr human use dealing with traditinal herbal medicinal prducts? Hw and t what extent des the regulatry framewrk fr the use f nutritin and health affect the trade f fds bearing? Hw cherent is it t have a psitive list at EU level f permitted health fr plants and their preparatins while the there is n psitive list at EU level f permitted plants and plant preparatins fr use in fd? 5. EU added value What are the merits and disadvantages in terms f the EU added value f the current gvernance f health n plants and their preparatins used in fds? What wuld be the merits and disadvantages in terms f the EU added value f a psitive list f plants and their preparatins fr use in fds? (D.1) Evidence frm mnitring D. Evidence base Minutes f the Standing Cmmittee n Plants, Animals, Fd and Feed (PAFF Cmmittee): DG SANTE rganises regular meetings (five - six meetings yearly) with Member States representatives in the frm f a "Cmitlgy Cmmittee" t discuss practical prblems f implementatin f the relevant EU fd legislatin. Outcme f discussins in varius Wrking Grup meetings with Member State experts, cnferences and seminars with stakehlders. (D.2) Previus evaluatins and ther reprts Scientific Opinin f the Panel n Dietetic Prducts, Nutritin and Allergies - The setting f nutrient prfiles fr fds bearing nutritin and health pursuant t Article 4 f the Regulatin (EC) N 1924/ Adpted n 31 January The EFSA Jurnal (2008) 644, Reprt by Cmmissin t EP and Cuncil n advisability f establishing specific rules fr the use f substances with a nutritinal r physilgical effect ther than vitamins and minerals COM(2008)824, final ( ) 6

7 Scientific Opinins f the Panel n Dietetic Prducts, Nutritin and Allergies n health n plants and their preparatins. Fd and Veterinary Office (FVO) Overview Reprt n the series f fact finding missins in 2013 and 2014 in rder t gather infrmatin regarding the cntrls n fd supplements, Ntified measures n natinal lists f plants and their preparatins used in fds permitted t be used in fds r prhibited fr use in fds. (D.3) Evidence frm assessing the implementatin and applicatin f legislatin (cmplaints, infringement prcedures) (D.4) Cnsultatin Transparency and stakehlder invlvement are vital fr the success f the evaluatin t be undertaken. The fllwing cnsultatins are planned in the cntext f this evaluatin: 1) One pen public cnsultatin n the substance f the evaluatin, based n a questinnaire with clsed questins, which will run fr a perid f 12 weeks in the cntext f the preparatin f the Cmmissin's evaluatin reprt. The intentin is t launch this cnsultatin twards the secnd half f Received cmments in the cntext f this public cnsultatin will be published n the website "Yur vice in Eurpe", the Cmmissin's prtal t public cnsultatins. 2) One stakehlders' cnsultatin, which will run fr a perid f 8 weeks and which will be launched twards the secnd half f This cnsultatin, which will be carried ut in cperatin with DG GROW, will be based n a questinnaire f clsed questins and it will specifically target SMEs. Stakehlders t be cnsulted are prvided in the table belw: Actrs Member States Primary prducers, fd manufacturers, fd retailers, advertisers, cnsumers, NGOs (cnsumer rganisatins, public heath rganisatins), etc. Frum Standing Cmmittee n Plants, Animals, Fd and Feed (PAFF) and Wrking Grup n Nutritin and Health Advisry Grup fr the Fd chain, including the fd industry representatives f varius sectrs and cnsumer and public health rganisatins (D.5) Further evidence t be gathered One external study, which will be carried ut thrugh the Framewrk Cntract, will feed int this evaluatin. The intentin is t launch this study in the first half f The cntractr will be required t cllect quantitative and qualitative data n the state f play in the field cvered by the evaluatin. The way evidence will be gathered will be discussed and agreed with the cntractr depending n the available means. E. Other relevant infrmatin/ remarks Cdex Guidelines n the use f nutritin and health. The results f this evaluatin will feed int the evaluatin reprt required by Article 27 f the Regulatin. 7

8 Annex 1: Interventin lgic fr health and nutritin DRIVERS PROBLEMS General OBJECTIVES Operatinal OBJECTIVES INPUTS: Actins by public authrities, fd business peratrs, EFSA OUTPUTS RESULTS Absence f scientific criteria fr making nutritin and health n fds Different rules gverning the use f nutritin and health made n fds in different Member States Lack f truthful, clear, reliable and useful infrmatin fr cnsumer n the nutritinal status f fds Fds cntain false health and thus mislead the cnsumer Prblems with the free circulatin f fds bearing nutritin and health in the Internal Market N level playing field fr fd business peratrs fr making health and nutritin n fds High level f cnsumer prtectin frm untruthful and misleading and facilitating cnsumers' healthier fd chices Imprve the free mvement f fds bearing nutritin and health within the Internal Market Ensure fair cmpetitin in the area f fds bearing nutritin and health Guarantee legal certainty fr fd business peratrs n the use f nutritin and health Ensure the same level f scientific evidence fr the substantiatin f nutritin and health Ensure that nly authrised nutritin and health may be used n the EU market Ensure that nutritin and health are cherent with nutritinal advice Regulatry framewrk requiring scientific substantiatin f nutritin and health Prcedure fr the establishment f the list f authrised health by the cllectin f natinal lists by Member States, scientific evaluatin by EFSA, adptin f the list f authrised health by Cmmissin Prcedure fr authrisatin f new health via applicatin by Fd Business Operatrs, scientific evaluatin by EFSA, authrisatin by Cmmissin Cnditins fr the use f nutritin and health A harmnised list f permitted nutritin A harmnised list f authrised health Nutrient prfiles the establishment f nutrient prfiles Restrictin f n alchlic beverages - Harmnised use f nutritin and health - Better alignment f nutritin and health with nutritinal advice by public health authrities - Increased trust f cnsumer in nutritin and health - Reductin f misleading nutritin and health n fds marketed in the EU - Smther functining f the internal market - Legal certainty fr fd business peratrs when using health and nutritin - Fair cmpetitin in the area f fds bearing nutritin and health by creating a level playing field fr fd business peratrs 8

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