Mastertitelformat bearbeiten. consulting & clinical research

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1 Mastertitelformat bearbeiten consulting & clinical research

2 a&r Mastertitelformat bearbeiten Examining the impact of changing regulatory environment on the digestive health market Food Matters Live 2015, London, :25h Christiane Alexander, PhD

3 Mastertitelformat Agenda bearbeiten What is digestive health? The digestive health market What are health claims? Winners and loosers of the health claim regulation What is the future?

4 Mastertitelformat bearbeiten What is digestive health? Complaints related to digestive health: Stomach: acidity of stomach fluids Intestine: problems with digestion of food, cleaveage of proteins, fats, polysaccherides, etc. Colon: constipation, gas formation, bloating, flatulance, transit time Digestive disease? IBS, IBD, heart burn, severe constipation, diarrhia, travellers disease, etc.

5 Mastertitelformat bearbeiten The digestive health market Several regulatory categories can be of interest for digestive health products: dietary supplements functional foods herbal drugs food for special groups OTC medical devices

6 Mastertitelformat bearbeiten Examples of gut health products Herbal drug Functional foods Dietary supplement Medical device FSMP

7 Mastertitelformat EU vs world-wide usage bearbeiten of GI claims Percentage of food&drink launches caying digestive health claims: World-wide EU USA % 2.4% 3.3% % 2.2% 3.6% Innova Market Insight, Nutraingredients, 2014

8 Drug Food Health vs medicinal claims Nutritional claim low fat, high in..., source of... Generic claim (Art. 13.1; closed) Claims from the community list Innovative claim (Art. 13.5) Claims based on new scientific data, individually accepted, protected Risk reduction and claims referring to children (Art. 14) Scientific proof is mandatory, individually accepted, protected Medicinal claim Claims, which refer to the healing, alleviation and prevention of diseases 8

9 Accepted generic gut claims Food ingredient Claim Conditions of use Calcium Chloride contributes to normal function of enzymes contributes to normal digestion by prod. of HCL in the stomach Source of Live yoghurt cultures Improves lactose digestion cfu of starter cultures/g Lactase Improves lactose digestion FCC/lactose containing meal Rye fibre contributes to normal bowel function Barley bran fibre Wheat bran fibre contributes to an increase in faecal bulk High fibre Wheat bran fibre contributes to an acceleration of intestinal transit High fibre, 10g/d 9

10 Accepted innovative gut claims Food ingredient Sugar beet fibre Transitech / hydroxyanthr acene derivatives Claim Year Opinion Increasing fecal bulk 2011 positive improves bowel function 2013 positive Inulin (Beneo) Normal defaction by increasing stool frequency 2015 positive 10

11 Probiotics have not won a claim yet! Probiotics can affect the microbiota composition. The change in the presence of certain bacterial populations was regarded as a beneficial effect by the industry. EFSA (European Food Safety Authority) does not accept such changes as a health effect per se. All probiotic health claim applications failed. The word probiotic was regarded as a claim in itself. The probiotic strains can be mentioned on pack. What kind of substantitation is required to win a health claim? Guidance paper for gut + immune health by EFSA published in 2010 New research was required!

12 1. EFSA guidance for gut claims Normal frequency of bowel movements Complete evacuation Normal stool concistency Increased fecal bulk Reduction in GI discomfort Reduced flatulence Reduced bloating Reduced exessive gas formation Based on 1. guidance paper for gut and immune claims by EFSA; 2011

13 Important revisions ongoing 2. guidance for HC related to the GI tract, the immune system (expected 2016) Public consultation on the draft general scientific guidance for stakeholders on health claim applications (outcome expected 2016) Evaluation of a) Regulation (EC) No 1924/ with regard to nutrient profiles and health claims made on plants (expected for 06/2017) Guidance for Foods for special medical purposes (FSMP) (expected for 2016) 13

14 What is the future? a&r recommendation: Carefully study the revised legislation + guidances Compare the clinical requirements for the various regulatory product categories Evaluate the options for claim wordings and for positioning of your product Identify the adequate regulatory category for your ingredient/product Before you start running clinical trials...

15 Mastertitelformat bearbeiten Thank you Thank you for your attention

16 Mastertitelformat bearbeiten the natural way to success analyze & realize GmbH. Waldseeweg Berlin Dr. Christiane Alexander Business Development phone: website: