Reporting and interpretation of uncertainties for risk management ILSI workshop on Assessing and Reporting Uncertainties in Dietary Exposure Analysis 6 February 2014, Brussels, Belgium 1
Main condition of use Food additives (Regulation (EC) No 1333/2008, Art.6) May be included in the Union list if it does not, on the basis of the scientific evidence available, pose a safety concern to the health of the consumer at the level of use proposed. Flavourings or food ingredients with flavouring properties (Regulation (EC) No 1334/2008, Art.4) May be used in or on foods if they do not, on the basis of the scientific evidence available, pose a safety risk to the health of the consumer. 2
Regulation (EC) No 1331/2008 Authorisation procedure For updating the Union list, the Commission shall seek the opinion of the European Food Safety Authority. Regulation (EU) No 234/2011, implementing measure In the application dossier information shall be provided on a dietary exposure assessment based on normal and maximum intended use. The opinion of EFSA shall include: a dietary exposure assessment for the European population taking into account other possible sources of dietary exposure when the dietary exposure exceeds the health-based guidance, it shall be detailed, providing where possible the contribution to the total exposure of each food category or foodstuff for which the use is authorised or has been requested 3
Regulation (EU) No 257/2010 Re-evaluation programme All additives authorised before 20 January 2009 Colours completed by 31.12.2015 Sweeteners completed by 31.12.2020 All other additives completed by 31.12.2018 Preservatives and antioxidants by 31.12.2015 Emulsifiers, stabilisers, gelling agents, Silicon dioxide, Glutamates by 31.12.2016 Data requested from business operators includes: information on the human exposure to the food additives from food (e.g. consumption pattern and uses, actual use levels and maximum use levels, frequency of consumption and other factors influencing exposure) 4
The reports of the Scientific Committee on Food Benzoic acid - benzoate (E 210-213 Sulphur dioxide - sulphites (E 220-228) Butylated hydroxyanisole (E 320) Stearoyl Lactylates (E 481-482) Aspartam (E 951) (1994) ADI 5 mg/kg bw; No info on exposure (1994) ADI 0,7 mg/kg bw; No info on exposure (1987) ADI, 0,5 mg/kg bw; all antioxidants up to 14 mg/person per day; daily intake of BHA in the Netherlands estimated at 4 mg. (1978) ADI, 20 mg/kg bw, substance is toxicological acceptable; no info on exposure (1984) ADI 40 mg/kg bw; No info on exposure 5
Report from the Commission COM (2001)542 final Benzoic acid - benzoate (E 210-213 Adults < 84 % of ADI; Children < 96 %, moved to tier 3 Sulphur dioxide - sulphites (E 220-228) Adults up to 266 % of the ADI, Children up to 1227 %, moved to tier 3 Butylated hydroxyanisole (E 320) Adults < 37 % of the ADI, children, no info Stearoyl Lactylates (E 481-482) Adults up to 114 % of the ADI; children to 268 % moved to tier 3 Aspartam (E 951) (1984) not exceeded at tier 1 ACS meeting 8-9 April 2013 6
European Food Safety Authority Benzoic acid - benzoate (E 210-213 Re-evaluation by end 2015 Sulphur dioxide - sulphites (E 220-228) Re-evaluation by end 2015 Butylated hydroxyanisole (E 320) ADI of 1.0 mg/kg bw/day, 70 % of ADI at tier 2 Stearoyl Lactylates (E 481-482) (2013) ADI 22 mg/kg, Toddlers up to 1000 % of ADI at tier 2 Aspartam (E 951) (2013) toddlers up to 90 % of the ADI 7
Qualitative evaluation of influence of uncertainties (e.g. Aspartam) Sources of uncertainties Consumption data: different methodologies / representativeness / under reporting / misreporting / no portion size standard Extrapolation from food consumption survey of few days to estimate chronic exposure Direction +/- + Linkage between reported use levels and food items in the consumption database: uncertainties on which precise types of food the use levels refer. Occurrence data: maximum reported use levels within a food category + +/- Exposure model: uncertainty in possible national differences in use levels of food categories, data set not fully representative of foods on the EU market, exposure calculations based on the maximum reported use levels (no use of typical use levels when available) + 8
Exposure assessment of sucrose esters of fatty acids (E 473) EFSA 2010, 2012 For children, high level consumers, the estimated intake exceeds by 7% the group ADI of 40 mg/kg, tier 3 exposure assessment The exposure resulting from the additional use of sucrose esters of fatty acids in clear flavoured soft drinks would only represent less than 0.1% of the ADI. In France, a survey carried out in included milk based desserts (27), flavoured desserts (27), powdered hot beverages (16), and soups/broths (23), none of which were found to contain the additive In Ireland, a database on ingredients (National Food Ingredient Database - NFID) of more than 1800 foodstuffs only identified 4 foodstuffs containing the additive. 9
Sucrose esters of fatty acids REGULATION (EU) No 818/2013 authorised the use in flavourings for water based clear flavoured drinks Statement at SCoFCAH of 17 April 2013: "According to the EFSA opinion the present intake of sucrose esters of fatty acids is too high and for some individuals exceeds the ADI. Swedish assessments conclude that the addition from extended use could be nearly 4% of the ADI. Bearing in mind that the ADI already is exceeded any extension of use should not be accepted. It is especially sensitive as the intended extension of use is for products that are consumed by children. Therefore Sweden votes against the proposal." 10
Caramels (E 150a-d) EFSA 2011, 2012 Refined exposure assessment, ADI for E 150c was exceeded by 5-51% in five Member States for caramel. After considering more detailed national information about the real uses of ammonia caramel (E 150c), the Member States concerned demonstrated that the actual intake is significantly lower. Taking into account that beer is the main contributor to the exposure in adults, it is appropriate to amend the conditions of use and to establish maximum use levels for ammonia caramel (E 150c) in food subcategory 14.2.1 'Beer and malt beverages' to guarantee a high level of protection of human health. Draft measure will be presented at SCoFCAH of 20.02.14 11
Flavouring substances Regulation (EU) No 872/2012 established the Union list of authorised flavouring substances after evaluation by EFSA. Exposure assessement: Maximised Survey-derived Daily Intake (MSDI) may underestimate the exposure "modified Theoretical Added Maximum Daily Intake (mtamdi) conservative estimation of exposure More reliable exposure data are required. On the basis of such additional data, these flavouring substances should be reconsidered along the steps of the Procedure. Follow-up needed 12
What is needed? Refined data Different approach for existing versus new substances Member States imput New models to be developed and validated Priorities should be set Communication 13
THANK YOU FOR YOUR ATTENTION European Commission, DG Website: http://ec.europa.eu/food/food/faef/additives/index_en. htm 14