Successfully reported this slideshow.
We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. You can change your ad preferences anytime.

EU Dietary Intake Estimates - Focus on Enzymes - March 2016

585 views

Published on

Intertek EU Regulatory Update Series, Session 2 16 March 2016. Presented by Danika Martyn, PhD, Scientific & Regulatory Consultant, Food & Nutrition Group, Intertek Scientific & Regulatory Consultancy, UK.
To access the webinar on demand: http://www.intertek.com/knowledge-education/eu-dietary-intake-estimates-enzymes-webinar/

Published in: Food
  • Be the first to comment

  • Be the first to like this

EU Dietary Intake Estimates - Focus on Enzymes - March 2016

  1. 1. www.intertek.com1 EU Dietary Intake Estimates – Focus on Enzymes Danika Martyn, PhD Scientific & Regulatory Consultant, Food & Nutrition Group, Intertek Scientific & Regulatory Consultancy, U.K.
  2. 2. www.intertek.com2 What is dietary exposure assessment? “ ’Tis the dose that makes the poison ” -Paracelsus Anything when consumed in sufficient quantities can be toxic Exposure = Amount food consumed * Amount component in food (mg/kg bw/day) (kgfood/kg bw/day) (mg/kgfood) Enzymes
  3. 3. www.intertek.com3 Typical approach to estimating exposure 1. Screening methods • Makes broad assumptions on food and beverage consumption and proportion of foods containing compound 2. National dietary survey summary statistics • Provide mean and upper percentile exposure estimations • Presentation for food categories; entire population or fixed population groups; including body weight data 3. Individual food consumption data • Provide distribution of exposure estimates • Presentation for individual foods; allows calculation for population group of interest; individual body weight data • Probabilistic assessments - use of market share, brand loyalty etc.
  4. 4. www.intertek.com4 Typical approach to estimating exposure Enzymes Additives Novel Foods Flavourings Budget method with no factors • Simple FAIM • Simple • Provides % breakdown by food group FAIM (?) • Simple • Provides % breakdown by food group Added Portion Exposure Techniques • Simple – standard portion sizes provided A: EFSA Comprehensive • User-friendly format B: Budget method with specific factors • Data may be available from literature EFSA Comprehensive • User-friendly format • Provides intake values per survey, per age group, on an absolute and body weight basis EFSA Comprehensive • User-friendly format • Provides intake values per survey, per age group, on an absolute and body weight basis Individual Food Consumption Data (e.g., NDNS) • Distribution of intakes • Most realistic estimate • Not dependant on summary statistics and assumptions re heavy level intakes
  5. 5. www.intertek.com5 Typical approach to estimating exposure Enzymes Additives Novel Foods Flavourings Budget method with no factors • Unrealistic FAIM • Broad categories results in overestimation FAIM (?) • Novel ingredient are rarely intended for use in categories FCS Added Portion Exposure Techniques • No further refinement available A: EFSA Comprehensive • Difficult for applicant to obtain information required for use • Requires assumptions to be made • Resource intensive B: Budget method with specific factors • Case-by-case – no guidance EFSA Comprehensive • Summary statistics • Requires assumptions to be made • Resource intensive • Range must be presented per age group EFSA Comprehensive • Summary statistics • Requires assumptions to be made • Resource intensive • Range must be presented per age group Individual Food Consumption Data (e.g., NDNS) • Resource intensive • Require input regarding use level of product in final foods – issue for enzymes (as per Comprehensive)
  6. 6. www.intertek.com6 Enzymes Food Enzyme: “means a product obtained from plants, animals or micro-organisms or products thereof including a product obtained by a fermentation process using micro-organisms: i. containing one or more enzymes capable of catalyzing a specific biochemical reaction; and ii. added to food for a technological purpose at any stage of the manufacturing, processing, preparation, treatment, packaging, transport or storage of foods;” Regulation (EC) No. 1332/2008
  7. 7. www.intertek.com7 Basic considerations • “Food enzymes” are in most cases not a pure isolated enzyme – exposure must be calculated on the basis of the “total organic solids” • Food enzymes are generally added on the basis of their activity. Thus the lower the activity, the more TOS is added • Enzyme exposures should be expressed as mg/kg bodyweight/day considering the lowest activity level (i.e. highest TOS) • EFSA has identified a margin of exposure of 3001 1 Factor 10 for inter-species difference, factor 10 for intra-species difference and factor 3 for the extrapolation from short-term studies to chronic studies (EFSA Scientific Committee, 2012)
  8. 8. www.intertek.com8 EFSA Safety Evaluation of Food Additives Critical issues of risk assessment: • The source • The food enzyme • Intended and unintended reaction products • The dietary exposure of the consumer Depends on the residual concentration of the food enzyme(s) and other constituents of the food enzyme in the foods at the time of consumption and the amount and frequency of their consumption 1 http://www.efsa.europa.eu/en/efsajournal/pub/1305
  9. 9. www.intertek.com9 Dietary Exposure “Potential human exposure to the food enzyme and to any other constituent or by- product of concern should be assessed considering all proposed uses. A conservative technique such as the “budget method” (Hansen, 1966; Hansen 1979; Douglass et al., 1997; European Commission 1998; FAO/WHO 2008) should be used to assess potential dietary exposure in a standard adult of 60 kg body weight consuming large amounts of the categories of foods and beverages for which use levels have been proposed, assuming that they always contain the food enzyme at its proposed upper use level. If needed, the technique should be adapted to consider the potential higher consumption per kg body weight of these foods and beverages in children. All assumptions and data used for the dietary exposure assessment should be clearly described and justified. In case the use of the food enzyme is proposed for products specifically designed for infants (0-12 months) or young children (12-36 months) as defined in the Commission Directive 2006/141/EC, ad hoc conservative exposure estimates must be produced taking specifically into account these population groups.”
  10. 10. www.intertek.com10 Budget Method Assumptions: • Food and non-milk beverage intake (0.05 kg and 0.1 L per kg bw/day) • Percentage of foods and beverages that are processed (~50%) • Percentage of processed foods and beverages containing the food additive (~25-50%) Consumption of Foods and Beverages (kg/kg bw/day) Consumption of Foods and Beverages for 70-kg adult1 (kg/day) Percentage of Processed Products (%) Percentage of Processed Products Containing Additive (%) Consumption of Foods and Beverages Containing Additive (kg/day) Solid foods 0.05 3.5 50 50 0.875 Non-Milk Beverages 0.10 7.0 50 50 1.75 Total 2.625 1 http://www.efsa.europa.eu/sites/default/files/scientific_output/files/main_documents/2579.pdf
  11. 11. www.intertek.com11 Issues with approach 1. Budget method assumptions (or standard factors) not validated for enzymes • Additives have a technological function in the final food 2. Missing data on residual levels in foodstuffs as consumed • Use levels often presented for substrate – requires information on conversion factors (‘substrate’ to ‘product’) • No information on use level of ‘product’ in final foods and beverages
  12. 12. www.intertek.com12 EFSA Draft Statement Draft Statement published1 Info session held2 ‘Traditional’ budget method not suitable for enzymes and there needs to be guidance on refinements steps New tiered approach proposed: • Tier 1: Budget method without standard factors • Tier 2A: EFSA Comprehensive Database • Tier 2B: Budget method with specific factors 1 http://www.efsa.europa.eu/sites/default/files/consultation/160216.pdf 2 http://www.efsa.europa.eu/en/events/event/160203#documents
  13. 13. www.intertek.com13 EFSA Proposed Tier 1 Budget method without standard factors
  14. 14. www.intertek.com14 Tier 1: Budget method without standard factors Consumption of Foods and Beverages Processed with Enzyme (kg/kg bw/day) Consumption of Foods and Beverages for 70-kg adult Processed with Enzyme (kg/day) Percentage of Processed Products (%) Percentage of Processed Products Containing Additive (%) Consumption of Foods and Beverages Containing Additive (kg/day) Solid foods 0.05 3.5 50 50 0.875 Non-Milk Beverages 0.10 7.0 50 50 1.75 Total 10.5 2.625
  15. 15. www.intertek.com15 Considerations Removal of standard factors: • Results in intake levels that are highly unrealistic – 10.5 kg of foods and beverages per day processed with enzyme • Food enzymes are processing aids – therefore some factor to account for proportion of foods/beverages that are processed • No factor for ingredients Dossiers submitted may have an exposure level which is 4- to 6- times higher than the level estimated using the suggested approach
  16. 16. www.intertek.com16 EFSA Proposed Tier 2A EFSA Comprehensive Database (Nutrition Surveys)
  17. 17. www.intertek.com17 Tier 2A: EFSA Comprehensive Database • Database of summary statistics based on survey data from EU Member States • Apply concentration of food enzyme to FoodEx categories • Calculate upper percentile for total population • Tiered approach recommended FoodEx Level 1 Milk and dairy products FoodEx Level 4 Acidophilus milk
  18. 18. www.intertek.com18 Considerations Comprehensive Database1 is user-friendly… 1 http://www.efsa.europa.eu/en/food-consumption/comprehensive-database
  19. 19. www.intertek.com19 Considerations
  20. 20. www.intertek.com20 Considerations Comprehensive Database1 is user-friendly, however points such as: 1. Calculation of upper percentiles • Need to consider trends of intake (food groups which may be consumed together) • EFSA Guidance document2 2. Selection of suitable food groups need to be considered carefully, particularly at lower (more refined) FoodEx levels 1 http://www.efsa.europa.eu/en/food-consumption/comprehensive-database 2 http://www.efsa.europa.eu/en/efsajournal/pub/2097
  21. 21. www.intertek.com21 Considerations • Difficulty in obtaining all required data to conduct assessment • However, allows “educated overestimates” the levels of consumption are likely to be far more realistic than Proposed Tier 1 Activity of enzyme TOS of enzyme Conversion rate to ingredient Maximum level of ingredient in final food Enzyme Producer × × Ingredient Producer × × × Final food Producer × × × Applicant
  22. 22. www.intertek.com22 EFSA Proposed Tier 2B Adjusted Budget Method with Specific Factors
  23. 23. www.intertek.com23 Tier 2B: Budget method with specific factors Proposed for use when it is not possible to obtain information necessary to conduct the EFSA Comprehensive Activity of enzyme TOS of enzyme Conversion rate to ingredient Maximum level of ingredient in final food Enzyme Producer × × Ingredient Producer × × × Food Producer × × × Applicant
  24. 24. www.intertek.com24 Tier 2B: Budget method with specific factors ‘Adjusted’ budget method Case-by-case basis • Comprehensive Database • Literature • Food industry Consumption of Foods and Beverages (kg/kg bw/day) Consumption of Foods and Beverages for 70-kg adult (kg/day) Percentage of Processed Products (%) Percentage of Processed Products Containing Enzyme (%) Consumption of Foods and Beverages Containing Enzyme (kg/day) Solid foods 0.05 3.5 ? ? ? Non-Milk Beverages 0.10 7.0 ? ? ? Total ?
  25. 25. www.intertek.com25 Considerations • Alternative when information is not available • Not based on actual consumption data • Burdensome • Case-by-case – difficult for applicants to ensure robustness of approach • Submit without assurance whether approach is acceptable? • Will EFSA perform own assessment and result in an MOE below 300?
  26. 26. www.intertek.com26 Next Steps?
  27. 27. www.intertek.com27 Next Steps for Process • Finalise statement after public consultation (deadline: 31/03/2016) • Requests for data • Preparation of a FAIM-like tool? • Mutually-exclusive food categories? Case-by-case Activity of enzyme TOS of enzyme Conversion rate to ingredient Maximum level of ingredient in final food Enzyme Producer × × Ingredient Producer × × × Food Producer × × ×
  28. 28. www.intertek.com28 Conclusions In order to conduct exposure assessments, information on final concentration of TOS in foods as consumed is needed and it is not always easy to get. Thus there will always need to be assumptions made EFSA’s current guidance for enzymes intakes is based on the ‘traditional’ Budget Method that assumes ~2.6 kg of foods and beverages per day contain enzyme Proposed Tier 1 ~quadruples that Proposed Tier 2A will probably provide a much more accurate overestimation but requires a lot of information Proposed Tier 2B is suitable if there is no way to get information on the final applications, but still requires considerable input, and has a lot of uncertainties A 300-fold safety factor is required when compared against the safety level
  29. 29. www.intertek.com29 Thank you! danika.martyn@intertek.com www.intertek.com/food/consulting Danika Martyn, PhD Scientific & Regulatory Consultant, Food & Nutrition Group, Intertek Scientific & Regulatory Consultancy, U.K.
  30. 30. Asian Food Regulation Information Service is a resource for the food industry. We have the largest database of Asian food regulations in the world – and it’s FREE to use. We publish a range of communication services (free and paid), list a very large number of food events and online educational webinars and continue to grow our Digital Library. Feel free to contact us anytime to talk about your specific requirements, offer comments, complaints or to compliment us. We look forward to hearing from you soon! www.asianfoodreg.com admin@asianfoodreg.com

×