EFSA 2021 — Chronic dietary exposure to inorganic arsenic in the European population
This 50-page EFSA scientific report, approved December 2020, presents the updated chronic dietary exposure assessment for inorganic arsenic (iAs) across the European population using measured iAs data from 13,608 analytical results (7,623 for drinking water; 5,985 for food), collected across 23 European countries between 2013 and 2018. This is a major methodological advance over the 2014 EFSA scientific report, which derived iAs from total arsenic (tAs) data using modelling assumptions — the primary source of uncertainty in that earlier assessment. Mean dietary exposure estimates (lower bound) were below the BMDL₀₁ range of 0.3–8 µg/kg bw per day established by the EFSA CONTAM Panel in 2009, but 95th percentile exposures for infants, toddlers, and other children fell within or at the lower end of that BMDL₀₁ range. The main contributors to iAs exposure across all age classes were rice, rice-based products, grain and grain-based products (no rice), and drinking water.
Key numbers
- Total analytical results: 13,608 (7,623 drinking water; 5,985 food) collected 2013–2018, 23 European countries, 44 dietary surveys covering 87,945 subjects
- Starting dataset: 67,401 analytical results on arsenic species; after cleaning, 66,025 used
- Inorganic arsenic measured directly: 6,021 of 67,401 initial results (9.0%); tAs dominated (86.1%)
- Mean exposure estimates (lower bound, LB): toddlers 0.30 µg/kg bw/day (highest among age groups); infants and toddlers both 0.61 µg/kg bw/day at upper bound (UB)
- 95th percentile LB exposure: toddlers 0.58 µg/kg bw/day; infants 1.20 µg/kg bw/day — within range of BMDL₀₁ values (0.3–8 µg/kg bw/day) for the maximum estimates in toddlers and infants
- UB estimates were 2–3 times higher than LB estimates across all age groups
- Rice-based formula consumption scenario: mean 0.30 µg/kg bw/day; high consumers 0.39 µg/kg bw/day (at or approaching BMDL₀₁ range)
- Rice and rice-based products were main contributors to iAs LB exposure across all age classes
- Comparison to 2014 EFSA report: 2021 dietary exposure estimates were 1.5–3 times lower than 2014 estimates, primarily due to use of directly measured iAs rather than modelled iAs from tAs data
- EFSA CONTAM Panel BMDL₀₁ (2009): 0.3–8 µg/kg bw/day for 1% increased risk of cancer of lung, skin, bladder, and skin lesions
- EU regulatory context: Commission Regulation 2015/1006 set MLs for iAs in rice effective 1 January 2016 (non-parboiled white rice 200 µg/kg, parboiled/husked rice 250 µg/kg, rice waffles/wafers/crackers/cakes 300 µg/kg, infant/young children rice food 100 µg/kg)
- 51 of 2,621 rice/rice-based samples (<2%) exceeded applicable MLs; most were rice brown (n=15, max 570 µg/kg) and rice popped (n=18, max 409 µg/kg)
- ~22% of cereal-based infant food samples had iAs >100 µg/kg (EU ML)
- LOQ cut-off applied: 200 µg/kg for tAs food samples; 100 µg/kg for iAs food samples (per EFSA 2018 guidance)
Methods (brief)
Occurrence data: EFSA Data Warehouse (DWH), extracted 30 April 2020, covering annual national monitoring submissions 2013–2018 per Recommendation 2015/1381/EU. Consumption data: EFSA Comprehensive European Food Consumption Database (2020 update), 44 dietary surveys, 87,945 subjects, 23 EU countries. Food classification: FoodEx2 system. Exposure calculation: chronic dietary exposure with lower bound (LB, below-LOD results = 0) and upper bound (UB, below-LOD results = LOD/LOQ value) per standard EFSA methodology. Dietary surveys with more than one reporting day per subject required; single-day subjects excluded.
Limitations
Large LB–UB gap (factor of 2–3) primarily driven by the high proportion of left-censored data (non-detects), especially in food categories with low iAs content. Consumption and occurrence data missing for some iAs-containing ingredient-specific food groups. Food preparation effects on iAs levels (cooking rice changes iAs content) inadequately captured. No specific data on iAs in gluten-free products or food for coeliac patients, who likely consume more rice. UK included as EU member during data collection period.
Implications
- Certification: This is the current European exposure baseline for HMT&C threshold-setting for iAs in rice-based infant foods. The 95th percentile exposure for infants reaching the BMDL₀₁ lower bound (0.3 µg/kg bw/day) with iAs-formula scenario exposures of 0.39 µg/kg bw/day supports aggressive HMT&C standards for infant products. Mean exposure well below BMDL₀₁ means adults are less urgent; infants and toddlers are the priority population.
- Courses: Foundational document for teaching European regulatory context for arsenic in rice. The 2021 vs. 2014 comparison (1.5–3× lower estimates once measured iAs replaces modelled-from-tAs) is a strong teaching point on why speciation methodology matters.
- App: Main dietary iAs contributors for European population: rice > rice-based products > grain-based products (no rice) > drinking water. Relevant weighting for ingredient-list risk scoring of rice-containing products.
- Microbiome: Not primary topic.