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Physical Performance, Weight Management and Healthy Aging in the light of the Health Claim Regulation Prof. Dr. Alfred Hagen Meyer: May 2013 | Š meyer.lawyers


Reg. 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 prof. dr. alfred hagen meyer | 04.06.13


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

prof. dr. alfred hagen meyer | 04.06.13


Art. 13 Community list

•  only 222 permitted health claims •  not permitted health claims are published in the EU register •  health claims “on hold”: o  requiring further consideration by the risk manager o  requiring further assessment by EFSA o  claims on “botanical substances” •  transitional measures (Art. 28) continue to apply for claims “on hold” prof. dr. alfred hagen meyer | 04.06.13


Applications for Authorisation

•  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 - 3 key issues: •  Sufficient characterisation of the food ? •  Claimed effect sufficiently defined & is it a beneficial physiological effect?

•  Relevant studies in humans available?

prof. dr. alfred hagen meyer | 04.06.13


Physical performance permission how many?

food

3

Calcium, Potassium, Vitamin D

1

Carbohydrate-electrolyte solutions

1

Carbohydrate-electrolyte solutions

claim … contributes to normal muscle function … contribute to the maintenance of endurance performance during prolonged endurance exercise … enhance the absorption of water during physical exercise

1

Creatine

… increases physical performance in successive bursts of short-term, high intensity exercise

2

Protein

… contributes to a growth in muscle mass

In total: 8 permissions prof. dr. alfred hagen meyer | 04.06.13


Physical performance rejections how many?

Food

29

Amylopectin, Carnosine, Coffein, Creatine aso

26

BCAA, whey protein, amino acids

19

BCAA, Carnitine, Taurine aso

8 8

Beta-Alanin Carnitine, whey protein, Glutamine

6

Sodium, Tyrosine, Zinc aso

6

Carnosine, whey protein aso

6

Beta-Alanine, Coffein

„Increase in physical performance during shortterm high-intensity exercise”

5

BCAA, Carbohydrate-electrolyte solutions

„Reduction in the rated perceived exertion/ effort prof. dr. alfred hagen meyer | 04.06.13 during exercise”

In total: 113 rejections

Claim „Increase in endurance performance/ capacity” „Growth or maintenance of muscle mass” „Faster recovery from fatigue after exercise” „Increase in time to exhaustion” „Skeletal muscle tissue repair“ „Maintenance of/ Contribution to normal muscle function” „Increase in muscle strength/ power“


Weight Management permissions how many?

food

claim

1

Glucomannan (konjac mannan)

‌ in the context of an energy restricted diet contributes to weight loss

1

1

Meal replacement for weight control

Substituting one daily meal of an energy restricted diet with a meal replacement contributes to the main-tenance of weight after weight loss

Meal replacement for weight control

Substituting two daily meals of an energy restricted diet with meal replacements contributes to weight loss

In total: 3 permissions prof. dr. alfred hagen meyer | 04.06.13


Weight Management rejections how many? 49

22

8 6 6

food

claim „Maintenance or conjugated linoleic acid, Docosahexaenoic achievement of a normal acid, oat grain fibre aso body weight” „Increase in satiety Barley beta-glucan, Lysine, Pectins, leading to a reduction in Xanthan gum aso energy intake” Chitosan, Medium-chain Triglycerides, „Reduction in body weight” Phaseolamine „Increase in lean body conjugated linoleic acid, whey protein aso mass” „Reduction in waist Ethanol-Water Extract Caralluma fimbriata circumference“

in total: 91 rejections prof. dr. alfred hagen meyer | 04.06.13


Healthy Aging

permissions how many?

7

food

claim

Copper, Manganese, Selenium, ‌ contributes to the protection of cells from oxidative stress Zinc; Vitamin B2, C, E

in total: 7 permissions

prof. dr. alfred hagen meyer | 04.06.13


Healthy Aging

rejections how many?

˃ 100

20

11

claim „…contributes to the protection of cells from oxidative stress” „Antioxidant, antioxidant content, and antioxidant properties” „Protection of cells from premature aging”

why? not „well-established“ „No beneficial physiological effect“ „general and nonspecific“ claim

in total: ˃ 131 rejections

prof. dr. alfred hagen meyer | 04.06.13


Chances of Approval for Applications

•  Provide sufficient characterization and specification of food. •  Only submit claims if their formulations comply with those of the “beneficial physiological effects” accepted by the EFSA so far. •  Use only study populations and markers which have already been previously characterized as appropriate by the EFSA for the respective claim. •  Consider all information in the guidelines for the respective claim which include clear specifications.

prof. dr. alfred hagen meyer | 04.06.13


Kontakt

Prof. Dr. Alfred Hagen Meyer meyer.lawyers Sophienstrasse 5 D-80333 Munich, Germany Fon +49 (0) 89- 85 63 88 0 - 0 E-Mail: meyer@meyerlegal.de Internet: www.meyerlegal.de Blog: http://meyerlegal.wordpress.com Twitter: meyer.tweets

prof. dr. alfred hagen meyer | 04.06.13


Meyer advances in nutrtion, london 2013 ppt