Scientific opinion on the exposure of children and adolescents in the Republic of Croatia to acrylamide from food

Summary Acrylamide is a natural by‐product of the reaction that occurs during the baking or frying food at temperatures above 120°C in industry and in households. The main mechanism of acrylamide formation in food is the Maillard reaction, in which the free amino acid asparagine, which is found in many types of cereals and potatoes, reacts with reducing sugars (e.g. glucose, fructose). It is known that acrylamide can also be present in cigarette smoke, and some individuals can be exposed to it in the workplace through skin absorption or inhalation (EFSA, 2015). The Centre for Food Safety, Croatian Agency for Agriculture and Food initiated the preparation of this Scientific Opinion on the exposure of children and adolescents in the Republic of Croatia to acrylamide from food, in order to gain insight into the exposure of this particularly vulnerable population and consequently assess the health risk. In 2015, the European Food Safety Agency (EFSA) stated in its opinion that experiments on animals show that acrylamide and its metabolites are genotoxic and carcinogenic because they damage deoxyribonucleic acid (DNA). Evidence from human studies that exposure to acrylamide causes tumors is currently limited and inconclusive, but despite this, acrylamide remains on the list of substances that are potentially carcinogenic to humans until more detailed studies are conducted to prove the opposite. Due to its small molecular weight, it is quickly and easily absorbed in the intestines and then distributed throughout the body via the circulatory system. According to the International Agency for Research on Cancer (IARC), acrylamide is classified as a group 2A carcinogen (probably carcinogenic to humans) (IARC, 1994). Due to all of the above, it is desirable that the level of reference values of acrylamide in food be as low as possible within technological possibilities. Since the maximum levels (ML) of acrylamide in food are not defined by legal regulations in 2017 was adopted Commission Regulation (EU) 2017/2158 of 20 November 2017 establishing mitigation measures and benchmark levels for the reduction of the presence of acrylamide in food, which established benchmark levels for acrylamide. Additionally, in 2019, the European Commission issued Commission Recommendation (EU) 2019/1888 of 7 November 2019 on the monitoring of the presence of acrylamide in certain foods with the aim of enabling competent authorities in member states to regularly monitor the presence of acrylamide and its levels in food. In accordance with Regulation and Recommendation of the European Commission, in the past period, the Republic of Croatia continuously controlled the presence of acrylamide in food as part of national monitoring. The results of the food monitoring for acrylamide in the Republic of Croatia for a period of four years (2020, 2021, 2022, 2023) were used for the purpose of drafting the opinion. Out of a total of 470 samples, in 159 (33.83 %) acrylamide was determined in amounts below the limit of quantification (< LOQ). Based on the obtained results, it was determined that the highest average concentration of 373,37 μg/kg for the LB ‐ UB approach was determined in the food category “Coffee, cocoa, tea and other infusions”, then in the category “Composite dishes” (259.51 ‐ 264.75 μg/kg for the LB ‐ UB approach), while it is slightly lower in the category of “Cereals and cereal‐based products” (106.07 ‐ 121.86 μg/kg for the LB ‐ UB approach). Food consumption data were obtained from national surveys, the first of which was conducted in the period 2017 ‐ 2022 on the population of children aged 3 months to 9 years, and the second in the period 2019 ‐ 2023 on the population aged 10 to 99 years. As with the acrylamide occurrence data, the food was divided into groups according to EFSA's FoodEx2 classification. Considering that acrylamide is a contaminant with carcinogenic and genotoxic effects, for the purpose of determining the risk, the chronic exposure of children and adolescents in the Republic of Croatia was calculated for the S1 and S2 scenarios. In the S1 scenario, the exposure was calculated based on the data for acrylamide levels, also considering the data where the measured value exceeded the benchmark levels. However, to assess the impact of such data on the overall exposure assessment, S2 scenario was also carried out, in which the data of non‐compliant samples were excluded. The obtained data showed that the impact of excluding such data on the exposure results was very small, and therefore these results are not presented in this opinion. After that, the calculations of the margin of exposure were started using the MOE (eng. Margin of exposure) approach. The BDML10 value used for neoplastic effects is 170 μg/kg bw/day, and for the end point of neurotoxicity 430 μg/kg bw/day. The MOE for neoplastic effects (170 μg/kg bw/day) for average exposure range from 697 (UB) for other children to 2 082 (LB) for infants. The MOE for neurotoxicity (430 μg/kg bw/day) for average exposure range from 1 763 (UB) for other children to 5 267 (LB) for infants. The MOE for neoplastic effects (170 μg/kg bw/day) for P95 exposure range from 264 (UB) for other children to 565 (LB) for infants. The MOE for neurotoxicity (430 μg/kg bw/day) for P95 exposure range from 667 (UB) for other children to 1 429 (LB) for infants. The MOE value is considered safe if it exceeds 10 000. Considering the obtained MOE values (BMDL10 170 and 430 μg/kg bw/day), which are below 10 000, it can be concluded that potential adverse health effects indicates for all age groups a concern from a public health point of view. This opinion recommends that the competent authorities and experts must work with the food business operators to minimize the acrylamide content in the final product and that consumers must be educated about how to reduce their consumption of foods that may contain acrylamide.