Legislation on nutrition and health claims: The role of EFSA
Legislation on nutrition and health claims: The role of EFSA
Legislation on nutrition and health claims: The role of EFSA
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<str<strong>on</strong>g>Legislati<strong>on</strong></str<strong>on</strong>g> <strong>on</strong> nutriti<strong>on</strong> <strong>and</strong> <strong>health</strong> <strong>claims</strong>:<strong>The</strong> <strong>role</strong> <strong>of</strong> <strong>EFSA</strong>Pilar Rodríguez Iglesias, M.D., Ph.D.Head <strong>of</strong> Unit,Unit <strong>on</strong> Dietetic Products, Nutriti<strong>on</strong> & Allergies (NDA)Internati<strong>on</strong>al C<strong>on</strong>gress <strong>on</strong> Nutriti<strong>on</strong> <strong>and</strong> Health Claims7-9 November 2007, Naantali, Finl<strong>and</strong>
Outline• <strong>EFSA</strong> tasks• NDA Panel• Nutriti<strong>on</strong> <strong>and</strong> Health Claims
<strong>EFSA</strong>’s TasksRiskAssessment+ScientificAdviceRiskManagement<strong>EFSA</strong>‘s tasksRiskCommunicati<strong>on</strong>European Commissi<strong>on</strong>European ParliamentMember StatesCouncil3
NDA M<strong>and</strong>ateNDA M<strong>and</strong>ate:Questi<strong>on</strong>s <strong>on</strong> human nutriti<strong>on</strong>,dietetic products <strong>and</strong> foodallergy, <strong>and</strong> other associatedsubjects such as novel foods.4
Nutriti<strong>on</strong> <strong>and</strong> Health Claims• <strong>EFSA</strong>’s scientific advice <strong>on</strong> scientific substantiati<strong>on</strong><strong>of</strong> <strong>health</strong> <strong>claims</strong>– Claims subject to authorisati<strong>on</strong> procedure• <strong>EFSA</strong> Guidance to applicants for disease risk reducti<strong>on</strong> <strong>claims</strong> +<strong>claims</strong> for development & <strong>health</strong> <strong>of</strong> children (Art. 14)• Functi<strong>on</strong> <strong>claims</strong> based <strong>on</strong> new science/proprietary data (Art. 18)– Functi<strong>on</strong> <strong>claims</strong> based <strong>on</strong> generally accepted scientific evidence(Art. 13)• <strong>EFSA</strong>’s scientific advice <strong>on</strong> nutrient pr<strong>of</strong>iles
<strong>EFSA</strong> Panel <strong>on</strong> Dietetic Products,Nutriti<strong>on</strong> <strong>and</strong> Allergies (NDA)• NDA Panel– 19 members: Chair (A. Flynn); Vice-chairs (H. Przyrembel; A.Palou)– Adopts scientific opini<strong>on</strong>s– All opini<strong>on</strong>s published - <strong>EFSA</strong> Journal (web)• Procedures for <strong>claims</strong>– NDA WG Claims prepares draft scientific opini<strong>on</strong>s– 11 Panel members currently– Additi<strong>on</strong>al independent experts will be added as needed• Evaluati<strong>on</strong> <strong>of</strong> <strong>claims</strong> in specific areas• <strong>EFSA</strong> staff– Support work <strong>of</strong> Panel <strong>and</strong> WG
<strong>EFSA</strong> scientific advice <strong>on</strong> substantiati<strong>on</strong><strong>of</strong> <strong>claims</strong> - scope• Evaluati<strong>on</strong> <strong>of</strong> <strong>claims</strong> subject to authorisati<strong>on</strong> procedure– Reducti<strong>on</strong> <strong>of</strong> disease risk <strong>claims</strong> (Art. 14, July 2007-)– Claims for development <strong>and</strong> <strong>health</strong> <strong>of</strong> children (Art 14, July 2007-)– Functi<strong>on</strong> <strong>claims</strong> based <strong>on</strong> newly developed scientific data/ proprietary(Art. 18, 2010-)• Guidance <strong>on</strong> preparati<strong>on</strong> <strong>and</strong> presentati<strong>on</strong> <strong>of</strong> applicati<strong>on</strong>sfor authorisati<strong>on</strong> (adopted for Art 14. <strong>claims</strong>, July 2007following public c<strong>on</strong>sultati<strong>on</strong>)• Evaluati<strong>on</strong> <strong>of</strong> functi<strong>on</strong> <strong>claims</strong> based <strong>on</strong> generallyaccepted scientific evidence (Art. 13, 2008-9)– Community list <strong>of</strong> permitted <strong>claims</strong> (2010)• Other– Amendments to Annex (nutriti<strong>on</strong> <strong>claims</strong>), if appropriate
Authorisati<strong>on</strong> <strong>of</strong> Article 14 <strong>claims</strong>Reducti<strong>on</strong> <strong>of</strong> disease risk/development <strong>and</strong> <strong>health</strong> <strong>of</strong>children• Applicati<strong>on</strong> submitted through Member State to <strong>EFSA</strong>– <strong>EFSA</strong> validati<strong>on</strong> <strong>of</strong> applicati<strong>on</strong>• <strong>EFSA</strong> to inform other MS, EC, publish summary• <strong>EFSA</strong> evaluati<strong>on</strong> - opini<strong>on</strong> (5 m<strong>on</strong>ths)– additi<strong>on</strong>al time (2 m<strong>on</strong>ths) if supplementary informati<strong>on</strong> needed• <strong>EFSA</strong> Opini<strong>on</strong> published, sent to EC– 30 days for comment to EC• Community authorisati<strong>on</strong> (2 m<strong>on</strong>ths)– EC adopts decisi<strong>on</strong> through Regulatory Committee, EP scrutiny?– Decisi<strong>on</strong> is notified to applicant <strong>and</strong> published in OJ
<strong>EFSA</strong> guidance <strong>on</strong> Art. 14 <strong>claims</strong>Opini<strong>on</strong> <strong>of</strong> the <strong>EFSA</strong> NDA Panel <strong>on</strong>:scientific <strong>and</strong> technical guidance for the preparati<strong>on</strong><strong>and</strong> presentati<strong>on</strong> <strong>of</strong> the applicati<strong>on</strong> for authorisati<strong>on</strong> <strong>of</strong>a <strong>health</strong> claim• Adopted 6 July 2007http://www.efsa.europa.eu/<strong>EFSA</strong>/efsa_locale-1178620753812_1178623592448.htm• <strong>EFSA</strong> C<strong>on</strong>ference <strong>on</strong> Health Claims, Bologna, 2006• C<strong>on</strong>sultati<strong>on</strong> - draft opini<strong>on</strong> published 16 May, 2007– <strong>EFSA</strong> Stakeholders C<strong>on</strong>sultative Platform, June 2006– About 300 resp<strong>on</strong>ses received– All resp<strong>on</strong>ses taken into c<strong>on</strong>siderati<strong>on</strong>
Objectives <strong>of</strong> guidance• To assist applicants in preparing <strong>and</strong>presenting their applicati<strong>on</strong>s for authorisati<strong>on</strong><strong>of</strong> Art. 14 <strong>health</strong> <strong>claims</strong>– Comm<strong>on</strong> format - for a well-structured applicati<strong>on</strong>– C<strong>on</strong>tent - informati<strong>on</strong> <strong>and</strong> data required/opti<strong>on</strong>al– Criteria for substantiati<strong>on</strong> - the key issues to beaddressed to substantiate a <strong>health</strong> claim– To be reviewed <strong>and</strong> updated in light <strong>of</strong> experiencegained in evaluati<strong>on</strong> <strong>of</strong> <strong>claims</strong>– To be reviewed <strong>and</strong> updated for Art. 18 <strong>claims</strong>
<strong>EFSA</strong> opini<strong>on</strong> (Reg. 1924/2006)• verify that– the claim is substantiated by scientific evidence– wording complies with the criteria laid down in the Regulati<strong>on</strong>• include– characteristics <strong>of</strong> the food/c<strong>on</strong>stituent– a proposal for the wording <strong>of</strong> the claim– specific c<strong>on</strong>diti<strong>on</strong>s <strong>of</strong> use <strong>of</strong> the claim• the target populati<strong>on</strong> for the intended claim• food quantity/pattern <strong>of</strong> c<strong>on</strong>sumpti<strong>on</strong> required to obtain the claimedeffect• whether this could reas<strong>on</strong>ably be c<strong>on</strong>sumed as part <strong>of</strong> a balanced diet– restricti<strong>on</strong>s <strong>of</strong> use (if appropriate)• Statement/warning for pers<strong>on</strong>s who should avoid using thefood/c<strong>on</strong>stituent• Statement/warning for <strong>health</strong> risk if c<strong>on</strong>sumed to excess• Other
Requirements for applicati<strong>on</strong>Applicati<strong>on</strong> must c<strong>on</strong>tain all scientific data pertinent tothe claim– published <strong>and</strong> unpublished, in favour/against, indicatingproprietary data– data from studies in humans required for substantiati<strong>on</strong>– interventi<strong>on</strong> <strong>and</strong> observati<strong>on</strong>al studies c<strong>on</strong>sidered• data from animals or model systems may provide supporting evidence– comprehensive review <strong>of</strong> the data from human studies– identificati<strong>on</strong> <strong>of</strong> data pertinent to the claim• systematic <strong>and</strong> transparent to show applicati<strong>on</strong> is balanced– templates provided for presentati<strong>on</strong> <strong>of</strong> data– guidance <strong>on</strong> hierarchy <strong>of</strong> evidence - relative strength <strong>of</strong> evidencefrom different types <strong>of</strong> studies
Nutrient pr<strong>of</strong>iles (Art. 4)• By 19 January 2009 the EC shall establishspecific nutrient pr<strong>of</strong>iles, including exempti<strong>on</strong>s,which foods should respect in order to bear<strong>claims</strong>• Pr<strong>of</strong>iles to be adopted by the EC throughRegulatory Committee following the advicefrom <strong>EFSA</strong>
<strong>EFSA</strong>’s scientific advice <strong>on</strong> nutrientpr<strong>of</strong>iles (1)Setting <strong>of</strong> pr<strong>of</strong>iles should include:• Dietary recommendati<strong>on</strong>s• Public <strong>health</strong>• Scientific evidence – relati<strong>on</strong>ship diet/nutriti<strong>on</strong>/<strong>health</strong>• As well as other “n<strong>on</strong>-scientific” c<strong>on</strong>siderati<strong>on</strong>s:– Industrial/commercial; cultural; <strong>and</strong> dietary/culinary nature– Pr<strong>of</strong>iles should permit product innovati<strong>on</strong>– Variability <strong>of</strong> dietary habits <strong>and</strong> traditi<strong>on</strong>s– C<strong>on</strong>cept <strong>of</strong> better regulati<strong>on</strong>– Criteria: feasibility, simplicity, ease <strong>of</strong> use (stakeholders &c<strong>on</strong>trol authorities), c<strong>on</strong>sumer protecti<strong>on</strong>
<strong>EFSA</strong>’s scientific advice <strong>on</strong> nutrientpr<strong>of</strong>iles (2)• M<strong>and</strong>ate received by <strong>EFSA</strong> (web)• <strong>EFSA</strong>’s advice will address:– Across the board/food categories• Vegetable oils, spreadable fats, dairy products, cereal products,fruit products, others (e.g. meat products)– Choice <strong>of</strong> nutrients• Fat, staurated fat, trans-fatty acids, sugars, salt/sodium• Poly- <strong>and</strong> m<strong>on</strong>o-unsaturated fats, vitamins, minerals, protein, fibre– Reference quantity• /100 g, /100 kcal, /porti<strong>on</strong>– Calculati<strong>on</strong>• Thresholds/scoring– Feasibility• Testing <strong>of</strong> models – which foods are eligible/not eligible to bear<strong>claims</strong>
<strong>EFSA</strong>’s scientific advice <strong>on</strong> nutrientpr<strong>of</strong>iles (3)• Scientific advice <strong>on</strong> nutrient pr<strong>of</strong>iles– NDA WG <strong>on</strong> Claims to prepare draft scientific opini<strong>on</strong>– NDA Panel to adopt scientific opini<strong>on</strong> by January 2008– Opini<strong>on</strong> to be published - <strong>EFSA</strong> Journal (web)• NDA Panel, WG Claims <strong>and</strong> <strong>EFSA</strong> staff to assist EC <strong>and</strong>Member States to develop a nutrient pr<strong>of</strong>ile scheme (byJanuary 2009)• C<strong>on</strong>sultati<strong>on</strong>– Reports, papers <strong>on</strong> nutrient pr<strong>of</strong>iles– <strong>EFSA</strong> C<strong>on</strong>ference <strong>on</strong> Nutriti<strong>on</strong> <strong>and</strong> Health Claims (November 2006)– <strong>EFSA</strong> Scientific Colloquium <strong>on</strong> Nutrient Pr<strong>of</strong>iling (October 2007)
Thank you for your attenti<strong>on</strong>http://efsa.europa.eu