EFSA under the spotlight Dr. Levke Voß: 2nd April 2012 | © meyer.rechtsanwälte Partnerschaft
Regulation 1924/2006 – 5 Specific Health Claims
Art. 13
The role of a nutrient or other substance in growth, development and the functions of the body psychological or behavioural functions
Art. 14
slimming or weight-control or a reduction in the sense of hunger or an increase in the sense of satiety or to the reduction of the available energy from the diet
Reduction of disease risk claims Claims referring to children‘s development and health dr. levke voß 02.04.2012
Art. 13 Community list 44.000 Claims from Member States More than 10.000 similarities EFSA received a consolidated list
July 2011: 4637 claims subject to assessment 1548 botanicals
2758 claims assessed (60 %): ~ 222 claims About 25 % positive opinions
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Community list Draft Regulation establishing a list of permitted health claims
upcoming: 222 permitted health claims not permitted health claims will be published in the EU register health claims: requiring further consideration by the risk manager requiring further assessment by EFSA
are “on hold”
claims on “botanical substances”
transitional measures (Art. 28) continue to apply for claims “on hold” dr. levke voß 02.04.2012
Status?
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Applications for authorisation of health claims
health claims should be substantiated by generally accepted scientific evidence, taking into account the totality of the available scientific data and by weighing the evidence
Applications for authorisation of health claims - 3 key issues: Sufficient characterisation of the food ? Claimed effect sufficiently defined & is it a beneficial physiological effect?
relevant studies in humans available?
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Food sufficiently characterised? Information on food properties
physical and chemical properties, composition, production conditions, conclusions of the stability studies, bioavailability.
Physical properties • EFSA Journal 2009; 7(9):1255 – dietary fibre
Composition • EFSA Journal 2010; 8(2):1463 – Camellia sinensis • EFSA Journal 2010; 8(2):1470 – microorganisms
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Claimed effect sufficiently defined?
claimed effect sufficiently defined? • Vitality, healthy ageing, cardiovascular health • endothelial function per se
beneficial physiological effect? • antioxidant properties
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Relevant human studies? Characterised food used in studies? • Uroval® Cranberry - EFSA Journal 2009; 7(12):1421 • Actimel® - EFSA Journal 2010; 8(12):1903 Conditions of use of the claims used in the study? • Black tea: cumulative doses - EFSA Journal (2008) 906, 1-10 Relevant endpoint/marker? • Kinder Chocolate - Calcium & growth - EFSA Journal (2009) 940, 1-8 • Caralluma fimbriata & reduce waist circumference- EFSA Journal 2010; 8(5):1602
Quality pertinent to peer-reviewed studies? • Natural Push-Up® - EFSA Journal (2009) 1100, 1-9
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Relevant human studies? appropriate study design? • Errors in blinding • Actimel® - EFSA Journal 2010; 8(12):1903 • Fish oil (_3-FS) & reduction in the number of hot flushes - EFSA Journal 2010; 8(1): 1422
• Per-protocol-analysis instead of intention-to-treat-Analysis • reduction of glycaemia - EFSA Journal (2009) 944, 1-9
duration of study sufficient? • soy isoflavones and maintenance of bone mineral density - EFSA Journal 2009; 7(9):1270
relevant target population? • Kinder Chocolate - Calcium & growth - EFSA Journal (2009) 940, 1-8 • reduction of glycaemia - EFSA Journal (2009) 944, 1-9 dr. levke voß 02.04.2012
EFSA Guidances Specific guidances on the scientific requirements for health claims in selected areas: Guidance on the scientific requirements for health claims related to gut and immune function. EFSA Journal 2011, 9(4):1984 – April 2011
Guidance on the scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health. EFSA Journal 2011;9(12):2474 – Dezember 2011
Guidance on the scientific requirements for health claims related to appetite ratings, weight management, and blood glucose concentrations. EFSA Journal 2012;10(3):2604 – March 2012
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EFSA Guidances - drafts
Draft guidance on the scientific requirements for health claims related to bone, joints, and oral health.
Draft guidance on the scientific requirements for health claims related to neurological and psychological functions.
Draft guidance on the scientific requirements for health claims related to physical performance released for public consultation.
Finalisation of all documents planned for July 2012
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contact
Dr. Levke Voß meyer.rechtsanwälte Partnerschaft Sophienstr. 5, III 80333 München Fon +49 89 8563880 - 0 Fax +49 89 8563880 - 22 E-Mail: voss@meyerlegal.de Internet: www.meyerlegal.de
dr. levke voß 02.04.2012