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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

dr. levke voĂ&#x; 02.04.2012


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?

dr. levke voĂ&#x; 02.04.2012


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?

dr. levke voß 02.04.2012


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

dr. levke voß 02.04.2012


Claimed effect sufficiently defined?

 claimed effect sufficiently defined? • Vitality, healthy ageing, cardiovascular health • endothelial function per se

 beneficial physiological effect? • antioxidant properties

dr. levke voß 02.04.2012


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

dr. levke voß 02.04.2012


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

dr. levke voß 02.04.2012


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

dr. levke voß 02.04.2012


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

EFSA under the spotlight  

Health Claims

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