efsa under the spotlight

EFSA under the spotlight

Dr. Levke Voß: 2nd April 2012 | © meyer.rechtsanwälte Partnerschaft

dr. levke voß 02.04.2012

The role of a nutrient or other substance in growth,development and the functions of the body

psychological or behavioural functions

slimming or weight-control or a reduction in the sense ofhunger or an increase in the sense of satiety or to thereduction of the available energy from the diet

Reduction of disease risk claims

Claims referring to children‘s development and health

Art

. 13

Art

. 14

Regulation 1924/2006 – 5 Specific Health Claims


Art. 13 Community list

44.000 Claims from Member States

More than 10.000 similaritiesEFSA received a consolidated list

July 2011:

4637 claims subject to assessment1548 botanicals

2758 claims assessed (60 %):

~ 222 claimsAbout 25 % positive opinions


health claims:

requiring further consideration by the risk manager

requiring further assessment by EFSA

claims on “botanical substances”

transitional measures (Art. 28) continue to apply for claims “on hold”

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

are “on hold”


Status?


Applications for authorisation of health claims

health claims should be substantiated by generally accepted scientificevidence, taking into account the totality of the available scientific data andby 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?


Food sufficiently characterised?

Information on food properties

physical and chemical properties, composition, productionconditions, 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


Claimed effect sufficiently defined?

claimed effect sufficiently defined?

• Vitality, healthy ageing, cardiovascular health

• endothelial function per se

beneficial physiological effect?

• antioxidant properties


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


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


EFSA Guidances

Specific guidances on the scientific requirements for healthclaims in selected areas:

Guidance on the scientific requirements for health claims related togut and immune function.EFSA Journal 2011, 9(4):1984 – April 2011

Guidance on the scientific requirements for health claims related toantioxidants, oxidative damage and cardiovascular health.EFSA Journal 2011;9(12):2474 – Dezember 2011

Guidance on the scientific requirements for health claims related to appetiteratings, weight management, and blood glucose concentrations.EFSA Journal 2012;10(3):2604 – March 2012


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 toneurological and psychological functions.

Draft guidance on the scientific requirements for health claims related tophysical performance released for public consultation.

Finalisation of all documents planned for July 2012

EFSA Guidances - drafts


contact

Dr. Levke Voß

meyer.rechtsanwälte PartnerschaftSophienstr. 5, III80333 MünchenFon +49 89 8563880 - 0Fax +49 89 8563880 - 22E-Mail: [email protected]: www.meyerlegal.de

efsa under the spotlight

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