Abstract
Many substances enter the human body via the consumption of food, and this can account for a large amount of the consumer exposures to particular substances. According to the views of Lioy and co-authors (2013) and as pointed out in Sect. 3.2.5, food is not always the primary source of substances for consumers, because the origin is in the general environment. From this view, in the EU guidance documents for exposure assessment, food presents a pathway of exposure for the environmental exposure of humans. In standard food exposure evaluations, however, and from practical reasons, food is deemed as the (primary) source. The impact of the food chain for consumer exposure is pointed out in this Sect. 4.12. In addition, substances called process contaminants that may be formed from constituents in the food during the process of preparation of meals are having an increasing impact on food risk assessment.
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Notes
- 1.
- 2.
Flavouring substances are regulated according to Regulation (EC) No 1334/2008 (EU 2008d) and food enzymes according to Regulation (EC) No 1332/2008 (EU 2008b); Regulation (EC) No 1331/2008 (EU 2008a) established a common authorisation procedure for food additives, food enzymes and food flavourings. While processing aids are defined in Article 3 of Regulation (EC) No 1333/2008 (EU 2008c), their use does, apart from extraction solvents, not require an approval in the European Union. For extraction solvents used in the production of foodstuffs and food ingredients, the Directive 2009/32/EC (EU 2009) of the European Parliament and of the Council is applicable.
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- 4.
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- 7.
Regulation (EC) No 1333/2008, all Commission Regulations amending its annexes as well as the current consolidated version of this regulation are available at http://eur-lex.europa.eu/legal-content/en/ALL/?uri=CELEX:32008R1333
- 8.
An updated FAIM version is available at https://www.efsa.europa.eu/en/applications/foodingredients/tools
- 9.
Food additives were evaluated by the ANS Panel until June 2018. Since then, they are evaluated by the FAF Panel.
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- 12.
According to Article 3 of Regulation (EC) No 1333/2008, ‘quantum satis’ shall mean that no maximum numerical level is specified and substances shall be used in accordance with good manufacturing practice, at a level not higher than is necessary to achieve the intended purpose and provided the consumer is not misled.
- 13.
This term refers to plants, including algae, fungi and lichens, and parts of plants as a whole or cut.
- 14.
This term refers to preparations obtained by all kind of processing, e.g. pressing, extraction, fractionation, concentration, drying and/or fermentation.
- 15.
This guidance was replaced in 2012 by the “Guidance for submission for food additive evaluations by the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS)” (EFSA 2012d).
- 16.
In the EU, nanotechnology applications in the food and feed sector need to undergo an approval procedure before being placed on the market. This is achieved by incorporating nano-specific provisions in existing legislation. For instance, food consisting of engineered nanomaterials (including vitamins, minerals, or other substances that contain or consist of engineered nanomaterials) are considered novel food and are regulated according to the relevant provisions (Regulation EU 2015/2283). Authorisation is based on a scientific evaluation by the European Food Safety Authority (EFSA), which requires the adoption of state-of-the-art approaches - both in terms of testing methods and measurement methodologies - to demonstrate safety. The same applies to, e.g. nano-sized food additives, additives used in food contact materials, feed additives, and nanopesticides. The existing guidance of the EFSA Scientific Committee on the risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain (EFSA 2011k) is being updated and the new guidance is expected to become available in 2018.
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EFSA (2006b) Opinion of the scientific committee related to uncertainties in dietary exposure assessment. EFSA J 438:1–54. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2007.438/abstract. Accessed 27 Oct 2019
EFSA (2007) EFSA calculation model pesticide residues intake model PRIMo revision 2. www.efsa.europa.eu/applications/pesticides/tools. Accessed 27 Oct 2019
EFSA (2008a) Opinion of the scientific panel on plant protection products and their residues to evaluate the suitability of existing methodologies and, if appropriate, the identification of new approaches to assess cumulative and synergistic risks from pesticides to human health with a view to set MRLs for those pesticides in the frame of Regulation (EC) 396/2005). EFSA J 6(5):705. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2008.705/abstract. Accessed 27 Oct 2019
EFSA (2008b) Opinion of the scientific panel on contaminants in the food chain on a request from the European Commission on marine biotoxins in shellfish – okadaic acid and analogues. EFSA J 589:1–62. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2008.589/full. Accessed 27 Oct 2019
EFSA (2008c) Guidance document for the use of the Concise European Food Consumption database in exposure assessment. http://www.efsa.europa.eu/sites/default/files/efsa_rep/blobserver_assets/datexfooddbguidance.pdf. Accessed 27 Oct 2019
EFSA (2008d) Statement of EFSA on the risks for public health due to the presence of dioxins in pork from Ireland. EFSA J 911:1–15. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2008.911/full. Accessed 27 Oct 2019
EFSA (2009a) Scientific opinion of the panel on contaminants in the food chain on a request from the European Commission on cadmium in food. EFSA J 980:1–139. http://www.efsa.europa.eu/en/efsajournal/pub/980. Accessed 27 Oct 2019
EFSA (2009b) Uranium in foodstuffs, in particular mineral water. EFSA J 1018:1–59. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2009.1018/full. Accessed 27 Oct 2019
EFSA (2009c) Safety assessment of botanicals and botanical preparations intended for use as ingredients in food supplements. EFSA J 1249:1–19. http://www.efsa.europa.eu/en/efsajournal/pub/1249.htm. Accessed 27 Oct 2019
EFSA (2009d) Guidance of the scientific committee on a request from EFSA on the use of the benchmark dose approach in risk assessment. EFSA J 1150:1–72. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2009.1150/full. Accessed 27 Oct 2019
EFSA (2009e) General principles for the collection of national food consumption data in the view of a pan-European dietary survey. Document 1435. EFSA J 7(12):1–51. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2009.1435/abstract. Accessed 27 Oct 2019
EFSA (2009f) Advice on the EFSA guidance document for the safety assessment of botanicals and botanical preparations intended for use as food supplements, based on real case studies. EFSA J 7(9):280. http://www.efsa.europa.eu/en/supporting/doc/280r.pdf Accessed 27 Oct 2019
EFSA (2010a) Scientific opinion on the reevaluation of lutein (E 161b) as a food additive on request of the European Commission. EFSA J 8(7):1678. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2010.1678/full. Accessed 27 Oct 2019
EFSA (2010b) Scientific opinion on lead in food. EFSA J 8:1570, 1147 pp. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2010.1570/full. Accessed 27 Oct 2019
EFSA (2010c) Management of left-censored data in dietary exposure assessment of chemical substances. EFSA J 8(3):1557, 96 pp. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2010.1557/full. Accessed 27 Oct 2019
EFSA (2010d) Standard sample description for food and feed. EFSA J 8(1):1457, 54 pp. https://www.efsa.europa.eu/de/efsajournal/pub/1457. Accessed 27 Oct 2019
EFSA (2010e) Guidance on the data required for the risk assessment of flavourings to be used in or on foods. EFSA J 8(6):1623. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2010.1623/epdf. Accessed 27 Oct 2019
EFSA (2010f). Guidance on human health risk-benefit assessment of food. EFSA J 8:1673. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2010.1673/abstract. Accessed 8 Mar 2018
EFSA (2011a) Use of the EFSA comprehensive european food consumption database in exposure assessment. EFSA J 9(3):2097. http://www.efsa.europa.eu/en/food-consumption/comprehensive-database. Accessed 27 Oct 2019
EFSA (2011b) Scientific opinion on the re-evaluation of lutein preparations other than lutein with high concentrations of total saponified carotenoids at levels of at least 80%. EFSA J 9(5):2144. http://www.efsa.europa.eu/de/efsajournal/doc/2144.pdf. Accessed 27 Oct 2019
EFSA (2011c) Scientific opinion on the risks for public health related to the presence of opium alkaloids in poppy seeds. EFSA J 9(11):2405. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2011.2405/pdf. Accessed 27 Oct 2019
EFSA (2011d) Scientific opinion on pyrrolizidine alkaloids in food and feed. EFSA J 9(11):2406. http://www.efsa.europa.eu/de/efsajournal/doc/2406.pdf. Accessed 27 Oct 2019
EFSA (2011e) Update on furan levels in food from monitoring years 2004–2010 and exposure assessment. EFSA J 9(9):2347. https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2011.2347
EFSA (2011f) Report on the development of a Food Classification and Description System for exposure assessment and guidance on its implementation and use. EFSA J 9(12): 2489. 84 pp. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2011.2489/abstract. Accessed 27 Oct 2019
EFSA (2011g) Overview of the procedures currently used at EFSA for the assessment of dietary exposure to different chemical substances. EFSA J 9(12):2490. https://www.efsa.europa.eu/de/efsajournal/pub/2490. Accessed 27 Oct 2019
EFSA (2011h) Technical report – The food classification and description system FoodEx 2 (draft-revision 1). Supporting Publications 2011: 215 [438pp.]. http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2011.EN-215/abstract. Accessed 27 Oct 2019
EFSA (2011i) Evaluation of the FoodEx 2 the food classification system applied to the development of the EFSA comprehensive European food consumption database. EFSA J 9(3):1970. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2011.1970/full. Accessed 27 Oct 2019
EFSA (2011j) Guidance for risk assessment of food and feed from genetically modified plants. EFSA J 9(5):2150. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2011.2150/abstract. Accessed 27 Oct 2019
EFSA (2011k) Scientific opinion of the scientific committee on Guidance on the risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain. EFSA J 9(5):2140. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2011.2140/full. Accessed 27 Oct 2019
EFSA (2011l) Scientific opinion on the risk to public health related to the presence of high levels of dioxins and dioxin-like PCBs in liver from sheep and deer. EFSA panel on contaminants in the food chain (CONTAM panel). EFSA J 9(7):2297. doi: https://doi.org/10.2903/j.efsa.2011.2297. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2011.2297/full. Accessed 27 Oct 2019
EFSA (2012a) Cadmium dietary exposure in the European population. EFSA J 10(1):2551, 37 pp. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2012.2551/full. Accessed 27 Oct 2019
EFSA (2012b) Scientific opinion on ergot alkaloids in food and feed. EFSA J 10(7):2798. http://www.efsa.europa.eu/en/efsajournal/doc/2798.pdf. Accessed 27 Oct 2019
EFSA (2012c) Guidance on the use of probabilistic methodology for modelling dietary exposure to pesticide residues. EFSA J 10(10):2839, 95 pp. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2012.2839/full. Accessed 27 Oct 2019
EFSA (2012d) Guidance for submission for food additive evaluations. EFSA J 10(7):2760. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2012.2760/epdf. Accessed 27 Oct 2019
EFSA (2012e) Food additives intake model (FAIM) Template – Version 1.0 – December 2012. http://www.efsa.europa.eu/sites/default/files/assets/faimtemplateinstructions.pdf. Accessed 27 Oct 2019
EFSA (2012f) Compendium of botanicals reported to contain naturally occurring substances of possible concern for human health when used in food and food supplements. EFSA J 10(5):2663. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2012.2663/full. Accessed 27 Oct 2019
EFSA (2012g) EFSA’s approach to identifying emerging risks in food and feed: taking stock and looking forward. EFSA J 10:s1015. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2012.s1015/abstract. Accessed 27 Oct 2019
EFSA (2013a) Scientific opinion on the identification of pesticides to be included in cumulative assessment groups on the basis of their toxicological profile. EFSA J 11(7): n/a–n/a. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2013.3293/full. Accessed 27 Oct 2019
EFSA (2013b) Guidance on methodological principles and scientific methods to be taken into account when establishing Reference Points for Action (RPAs) for non-allowed pharmacologically active substances present in food of animal origin. EFSA J 11(4):3195 [24 pp.]. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2013.3195/abstract. Accessed 27 Oct 2019
EFSA (2013c) Scientific opinion on safety evaluation of Ephedra species in food. EFSA J 11(11):3467. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2013.3467/epdf. Accessed 27 Oct 2019
EFSA (2013d) Scientific opinion on the evaluation of the safety in use of Yohimbe (Pausinystalia yohimbe (K. Schum.) Pierre ex Beille). EFSA J 11(7):3302. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2013.3302/epdf. Accessed 27 Oct 2019
EFSA (2013e) Guidance of EFSA – standard sample description ver.2.0. EFSA J 11(10):3424. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2013.3424/full. Accessed 27 Oct 2019
EFSA (2013f) Food Additives Intake Model (FAIM). http://www.efsa.europa.eu/en/applications/foodingredients/tools. Accessed 8 Mar 2018
EFSA (2013g) Scientific opinion on tropane alkaloids in food and feed. EFSA J 11(10):3386. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2013.3386/epdf. Accessed 27 Oct 2019
EFSA (2013h) European Food Safety Authority. Refined exposure assessment of ethyl lauroyl arginate based on revised proposed uses as a food additive. EFSA J 11(6):3294, 15 pp. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2013.3294/full. Accessed 27 Oct 2019
EFSA (2013i) European Food Safety Authority. Refined exposure assessment for amaranth (E 123). EFSA J 11(10):3442. 18 pp. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2013.3442/full. Accessed 27 Oct 2019
EFSA (2014a) Statement on a conceptual framework for the risk assessment of certain food additives re-evaluated under Commission Regulation (EU) No 257/2010. EFSA J 12(6):3697. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2014.3697/abstract. Accessed 27 Oct 2019
EFSA (2014b) Re-evaluation of Indigo Carmine (E 132) as a food additive. EFSA J 12(7):3768, 51 pp. https://www.efsa.europa.eu/de/efsajournal/pub/3768. Accessed 27 Oct 2019
EFSA (2014c) Guidance on the assessment of exposure of operators, workers, residents and bystanders in risk assessment for plant protection products. EFSA J 12(10):3874–n/a. https://www.efsa.europa.eu/de/efsajournal/pub/3874. Accessed 27 Oct 2019
EFSA (2014d) Dietary exposure to inorganic arsenic in the European population. EFSA J 12(3):3597–3665. Fab/pop. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2014.3597/full. Accessed 27 Oct 2019
EFSA (2014e) Scientific Opinion on the risks to public health related to the presence of perchlorate in food, in particular fruits and vegetables. EFSA J 12(10):3869. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2014.3869/full. Accessed 27 Oct 2019
EFSA (2014f) Scientific opinion on the revised exposure assessment of steviol glycosides (E 960) for the proposed uses as a food additive. EFSA J 12(5):3639, 23 pp. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2014.3639/full. Accessed 27 Oct 2019
EFSA (2014g) Refined exposure assessment for curcumin (E 100). EFSA J 12(10):3876, 43 pp. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2014.3876/full. Accessed 8 Mar 2018
EFSA (2015a) Use of EFSA comprehensive European food consumption database for estimating dietary exposure to genetically modified foods. EFSA J 13(2):4034, 11 pp. https://www.efsa.europa.eu/de/efsajournal/pub/4034. Accessed 27 Oct 2019
EFSA (2015b) The 2013 European Union report on pesticide residues in food. EFSA J 13(3):4038, 169 pp. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2015.4038/full. Accessed 27 Oct 2019
EFSA (2015c) Shaping the future of food safety, together: proceedings of the 2nd EFSA scientific conference. Milan, Italy, 14–16 October 2015. EFSA J 13(10):s1310, 137 pp. https://www.efsa.europa.eu/de/events/event/151014. Accessed 27 Oct 2019
EFSA (2015d) Scientific opinion on acrylamide in food. EFSA J 13(6):4104, 321 pp. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2015.4104/abstract. Accessed 27 Oct 2019
EFSA (2015e) Scientific opinion on the re-evaluation of octyl gallate (E 311) as a food additive. EFSA J 13(10):4248, 39 pp. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2015.4248/references. Accessed 27 Oct 2019
EFSA (2015f) The food classification and description system FoodEx2 (revision 2): EFSA supporting publication 12(5):EN-804, 90 pp. http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2015.EN-804/abstract. Accessed 27 Oct 2019
EFSA (2015g) Scientific opinion on the risks for human health related to the presence of tetrahydrocannabinol (THC) in milk and other food of animal origin. EFSA J 13(6):4141. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2015.4141/epdf. Accessed 27 Oct 2019
EFSA (2015h) Refined exposure assessment for Quinoline Yellow (E 104). EFSA J 13(3):4070, 33 pp. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2015.4070/abstract. Accessed 27 Oct 2019
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EFSA (2015j) Statement on the benefits of fish/seafood consumption compared to the risks of methylmercury in fish/seafood. EFSA J 13(1):3982 [36 pp.]. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2015.3982/full. Accessed 27 Oct 2019
EFSA (2015k) European food safety authority. Refined exposure assessment for Azorubine/Carmoisine (E 122). EFSA J 13(3):4072, 35 pp. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2015.4072/full. Accessed 27 Oct 2019
EFSA (2015l) European food safety authority. Refined exposure assessment for Ponceau 4R (E 124). EFSA J 13(4):4073, 34 pp. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2015.4073/full. Accessed 27 Oct 2019
EFSA (2016a) Scientific opinion on the risks for human health related to the presence of 3- and 2-monochloropropanediol (MCPD) and their fatty acid esters, and glycidyl fatty acid esters in food. EFSA J 14(5):4426, 159 pp. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2016.4426/full. Accessed 27 Oct 2019
EFSA (2016b) The 2014 European Union report on pesticide residues in food. EFSA J 14(10):4611, 139 pp. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2016.4611/full. Accessed 27 Oct 2019
EFSA (2016c) Acute health risks related to the presence of cyanogenic glycosides in raw apricot kernels and products derived from raw apricot kernels. EFSA J 14(4):4424, 47 pp. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2016.4424/full. Accessed 27 Oct 2019
EFSA (2016d) Re-evaluation of titanium dioxide (E 171) as a food additive. EFSA J 14(9):4545, 83 pp. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2016.4545/references. Accessed 27 Oct 2019
EFSA (2016e) Review of the threshold of toxicological concern (TTC) approach and development of new TTC decision tree. EFSA J 13(3):1006E. http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2016.EN-1006/abstract. Accessed 27 Oct 2019
EFSA (2016f) Guidance on the preparation and presentation of an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283. EFSA J 14(11):4594, 24 pp. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2016.4594/full. Accessed 27 Oct 2019
EFSA (2016g) Dietary exposure assessment to pyrrolizidine alkaloids in the European population. EFSA J 14(8):4572. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2016.4572/full
EFSA (2016h) Statement on the refined exposure assessment of tertiary-butyl hydroquinone (E 319). EFSA J 14(1):4363, 26 pp. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2016.4363/full. Accessed 27 Oct 2019
EFSA (2016i) Update: the use of the benchmark dose approach in risk assessment. EFSA J 15(1):4658, 41 pp. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2017.4658/full. Accessed 27 Oct 2019
EFSA (2017a) Re-evaluation of fatty acids (E 570) as a food additive. EFSA J 15(5):4785, 48 pp. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2017.4785/abstract. Accessed 27 Oct 2019
EFSA (2017b) Re-evaluation of glycerol (E 422) as a food additive. EFSA J 15(3):4720, 64 pp. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2017.4720/full
EFSA (2017c) Guidance on the risk assessment of substances present in food intended for infants below 16 weeks of age. EFSA J 15(5):4849, 58 pp. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2017.4849/full. Accessed 27 Oct 2019
EFSA (2017d) Re-evaluation of sorbitan monostearate (E 491), sorbitan tristearate (E 492), sorbitan monolaurate (E 493), sorbitan monooleate (E 494) and sorbitan monopalmitate (E 495) when used as food additives. EFSA J 15(5):4788, 56 pp. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2017.4788/full. Accessed 27 Oct 2019
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Abraham, K. et al. (2019). Exposure to Substances via Food Consumption. In: Heinemeyer, G., Jantunen, M., Hakkinen, P. (eds) The Practice of Consumer Exposure Assessment. Springer, Cham. https://doi.org/10.1007/978-3-319-96148-4_4
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