Omega-3 Concentrates to support general health Presentation for ILSI Brazil April 17, 2018 Juergen Gierke BASF, Germany
Agenda Rationale for Omega-3 High Concentrates Definition & Processing Benefits New Developments Improved Absorption 2
Natural market evolution The Development of Omega-3 Ingredients Pre 1970 COD LIVER OIL 1970 1990 FISH OIL 1990 2005 OMEGA-3 2005 EPA & DHA General Health Mythical life elixir (immunity) General Health Substitution for low fish intake Heart Health O-3 the essential fatty acid Condition Specific Therapeutic doses 3
PERCENTAGE OF ENERGY FROM FATTY ACIDS (%) Rationale for High Concentrates Restoring Balance Omega-3 vs Omega-6 40 TOTAL FAT 30 20 SATURATED FAT 10 TRANS FAT OMEGA-6 0 OMEGA-3 YRS -20,000-10,000 1800 1900 2000 HUNTER GATHERER AGRICULTURAL INDUSTRIAL 4 Source: Artemis P. Simopoulos, The Center for Genetics, Nutriton and Health, Washington DC, 2009
Rationale for High Concentrates High daily dose needed to deliver real benefits 5
European Union EFSA: Health Claims for EPA & DHA POPULATION RECOMMENDATION RATIONALE Adults 3 g EPA & DHA per day Maintenance of normal blood pressure* Adults 2 g DHA per day Maintenance of normal blood triglyceride levels* General population 250 mg DHA per day Maintenance of normal brain function* General population 250 mg DHA per day Maintenance of normal vision* General population 250 mg EPA & DHA per day Normal function of the heart* Pregnant and lactating woman Article 14 (1) (b) claim: 200mg DHA per day Normal brain & eye development of foetus or breastfed infants (via maternal nutrition)* Infants < 12 months Article 14 (1) (b) claim: 100mg DHA per day Normal visual development* Infants > 6 mths Children < 24 mths*** Adequate Intake of 100mg DHA per day Normal brain & eye development 6 Children (2-18 years)*** Dietary advice for children should be consistent with advice for the adult population: 250mg DHA per day Normal brain & eye development *EU Regulation*- Positive Assessment by EFSA** - EFSA Scientific Opinion on DRV for fats***
CLAIMED BIOAVAILABILITY EFFECT Necessary amount of soft gelatin capsules to meet EU claim for blood triglyceride maintenance EFSA: 2,000mg 11 CAPS 13 CAPS 11 CAPS 7 CAPS 3.5 CAPS (or 22 caps*) 2 CAPS Omega-3 90% concentrate 7 * Krill dosage based on EPA/DHA content, and adjusted for their claimed 2x bioavailability vs EE
Low omega-3 index leads to: High Cardiovascular Mortality Risk 8
Omega-3 Index Definition Sum of EPA and DHA in red blood cells expressed as a percentage of total fatty acids. long-term LC n 3 FA status, long-term bioavailability Conclusions on the extent to which a given drug or dietary supplement contributes to keeping the body sufficiently supplied with LC n 3 FA Information on individual factors that affect the bioavailability of LC n 3 FA Target: Conclusion about individual Omega 3 Status 9 Prof. von Schacky www.omegametrix.eu
Global Omega-3 Index Brazil in the undesirable range ( 4%) Stark et al, Progress in Lipid Research 63 (2016) 132 152 10
Agenda Rationale for Omega-3 High Concentrates Definition & Processing Benefits New Developments Improved Absorption 11
PURE Potential Benefits of Omega-3 Concentrates Fresher Cleaner More healthy lipids
What are Omega-3 Concentrates? Definition of Omega-3 Products according to CODEX STAN 329-2017 2.1 Named fish oils (anchovy, tuna, krill, menhaden, salmon) 2.2 Fish oils unnamed 2.3 Named fish liver oils 2.4 Fish liver oil 2.5 Concentrated fish oils 2.5.1 Concentrated fish oil contains 35-50 w/w% as sum of EPA&DHA 2.5.2 Highly concentrated fish oil contains more than 50 w/w% as sum of EPA&DHA 2.6 Concentrated fish oils ethyl esters 2.6.1 Concentrated fish oil ethyl esters contain 40-60 w/w% as sum of EPA&DHA 2.6.2 Highly concentrated fish oil ethyl esters contain more than 60 w/w% as sum of EPA&DHA 13
Processing of Ultra High Omega-3 Concentrates Deacidification Stripping hyl transesterification Distillation Urea complexation Distillation Bleaching Mixing and drumming 1 2 3 4 5 6 7 8 Crude fish oil 30% Refined oil 30% Stripped oil 30% hyl Ester (EE) 30% K50 EE 59 60% K70 EE 81 82% K70 EE bl. 81 82% K85 dist. 84 (90)% K85 EE 84 (90)% Other lipids and impurities Concentration of EPA and DHA Pollutants are stripped early in the process, to avoid up-concentration of pollutants at later stages. This process is patented protected and proprietary. 14
Glycerol backbone Omega-3 concentration process starting from fish oil Fish oils consists mainly of triglyceride: assay~ 30% Omega-3 Means 3 fatty acids are bound to one glycerol backbone For up-concentration of Omega-3 this triglyceride must undergo some modifications Fatty acid Omega-3 Fatty acid Approx 1/3 of the fatty acids are Omega-3 Fatty acid 15
Glycerol backbone Transesterification into hyl Ester followed by distillation Step 1: react with hanol to form hyl Esters Step 2: distillation, lower boiling fatty acids are separated from the concentrate Fatty acid Fatty acid Omega-3 FA + 3 * Fatty acid Lower boiling Fatty acid Omega-3 FA 1 Fatty acid Fatty acid Omega-3 FA 2 Omega-3 FA Higher boiling Omega-3 FA Fatty acid 16
Further up-concentration by urea precipitation Step 1: mix with urea, ethanol and cool down Step 2: Filtration Fatty acid Omega-3 FA Urea binds Saturates and Mono-unsaturates Fatty acid Filter Omega-3 FA + urea Omega-3 FA Omega-3 FA Purification Omega-3 hyl Ester High Concentrate Poly-unsaturates 17
Glycerol backbone Recombination of hyl Esters to Triglycerides Fatty acid Fatty acid Omega-3 FA + Glycerol Omega-3 FA Omega-3 High Concentrate Omega-3 FA Omega-3 FA Lipase enzyme splits ethyl ester and recombines fatty acids with glycerol Recombined triglyceride > 60% TG 18
Agenda Rationale for Omega-3 High Concentrates Definition & Processing Benefits New Developments Improved Absorption 19
Omega-3 TG concentrates purity compared to relevant monographs Parameter Dimension Ph Eur 7.0-2011 for TG products GOED voluntary monograph 2015 O-3 Concentrate Specification O-3 Concentrate typical values Organic impurities / Oxidation Acid value mg KOH/g max. 3 max. 3 max. 0.5 0.0-0.1 Peroxide value meq/kg max. 10 max. 5 max. 3.0 0.1-0.5 Anisidine value max. 30 max. 20 max. 12.0 1-4 TOTOX max. 26 max. 15 1-5 Contaminants PCBs 209 mg/kg max. 0.09 max. 0.015 0.002-0.007 congeners Dioxins and Furans pg/g WHO-TEQ max. 2 max. 2 max. 1.75 0.2-0.5 Dioxins, furanes & pg/g WHO-TEQ max. 10 max. 3 max. 3 1 dioxin-like PCBs Arsenic (As) mg/kg max. 0.1 max. 0.1 max. 0.1 < 0.025* Cadmium (Cd) mg/kg max. 0.1 max. 0.1 max. 0.01 < 0.01* Lead (Pb) mg/kg max. 0.1 max. 0.1 max. 0.02 < 0.01* Mercury (Hg) mg/kg max. 0.1 max. 0.1 max. 0.02 < 0.01* * report limit of test method 20
Extreme Quality Differences Depending on origin and/or processing US market products: PCBs-209 (upper bound) ppb 120 90 PROP 65 90 µg/day max. daily intake 60 30 0 Omega-3 concentrate according to described process Source: GOED Market Survey US Consumer Products 2012-2013 21
CLO FO CLO Squid Oil Concenrate FO Concentrate FO Concentrate FO Blend FO FO Tuna Oil FO Concentrate FO Concentrate Specification FO FO PronovaPure Spec FO Concentrate Typical values PronovaPure typical Significant Quality Differences Oxidation Ansidine value US market products: Anisidine value of market products in several countries. GOED survey 2012-2013 202.5 80 Flavoured oils anisidine test method not suitable 60 50 40 20 0 12,9 6,3 22,7 10,6 8,2 7,1 6,2 14,8 10,7 10 15,2 12 4 GOED limit for anisidine value: max. 20 Omega-3 concentrate according to described process 22
The Omega-3 Concentrate Difference: Purely the Healthy Lipids Pronova 46:38 EE High Omega-3 Concentrate Competition Standard 1812 TG Fish Oil 23
Omega-3 High Concentrates vs. High Quality Fish Oil More of the Good Fatty Acids Values presented in area-% 40 30 29,2 Fish Oil 1812 Up to 50 times less saturated fat 20 10 0 0,6 Saturated fat 60% Fish Oil Concentrate More than 2 times higher O-3 24 60 40 20 0 40,4 18,7 EPA 26,7 12,3 DHA 100 80 60 40 20 0 34,8 80,4 Total O-3
Agenda Rationale for Omega-3 High Concentrates Definition & Processing Benefits New Developments Improved Absorption 25
New Solutions to increase the potentially limited absorption of omega-3 fatty acids in dietary supplements 26 Qin et al. Lipids in Health and Disease (2017) 16:204 DOI 10.1186/s12944-017-0589-0
New study on short term and long term use of absorption enhancing formulations 27 Philip C. Calder, University of Southampton Presented at the GOED Exchange. Seattle, February 2018
Single dosing short term 28 Philip C. Calder, University of Southampton Presented at the GOED Exchange. Seattle, February 2018
Repeated dose longer term use 29 Philip C. Calder, University of Southampton Presented at the GOED Exchange. Seattle, February 2018
Improvements of the Omega-3 Index 30 Philip C. Calder, University of Southampton Presented at the GOED Exchange. Seattle, February 2018
Conclusions 31 Current diets and eating habits lead to a significant lack in long-chain polyunsaturated Omega-3 fatty acids Research on the global Omega-3 status in the general population demonstrate low levels for EPA and DHA in nearly all territories, including Brazil Low EPA and DHA levels are a risk factor for heart health and for further non-communicable diseases Omega-3 High Concentrates are highly purified oils supplying merely the desired fatty acids EPA & DHA in a convenient small dosage format. This enables the convenient intake of significant quantities for general health, but also for condition specific use New developments focus on the improved absorption / utilization of Omega-3 concentrates in dietary supplements with further benefits for the consumer
Obrigado Thank You 32
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