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[06] Section 6medium risk#5 ADR trigger

Proposed Uses and Use Levels / Anticipated Intake

23 clock-stopped issues across 23 opinions. Exposure modelling errors directly undermine the toxicological assessment: if intake is underestimated, the entire safety evaluation is compromised. The 17% inadequacy rate reflects how often applicants fail to model combined intake from multiple food categories or miss vulnerable population groups.

23Opinions with ADR on this section
23Clock-stopped issues
17%End inadequate or partially adequate
Common gaps

The specific issues EFSA most frequently flags in this section. Each of these has caused a clock stop in at least one published case.

  • 1Use level inconsistencies across food categories
  • 2Exposure modelling not performed or not using EFSA’s FAIM tool
  • 3No consideration of high-percentile consumers (P95/P97.5)
  • 4Combined exposure from multiple food categories not calculated
  • 5Use levels not justified relative to the intended technological or nutritional effect
  • 6Missing population-specific intake estimates (toddlers, children, elderly)
What EFSA expects

Proposed uses and use levels for each food category, with justification for the technological or nutritional need. Dietary exposure assessment using EFSA’s Comprehensive European Food Consumption Database and the FAIM tool. Estimates for mean and high-percentile consumers (P95) across all relevant population groups including toddlers, children, adolescents, adults, and elderly. Combined intake from all proposed food categories must be calculated.

From the case law

Real findings from EFSA panel opinions. Each quote is verbatim from a published assessment.

“The Panel considers that the range of foods to which betaine is intended to be added is still too broad. It is extremely difficult to estimate betaine intake also because the applicant plans to add this substance not only to individual foodstuffs but to a wide range of food categories.”
ON-191Betaine (anhydrous and monohydrate)Chemical nutrientUnfavorable
“The applicant did not provide an intake estimate based on consumption data of the proposed food categories to which the novel food ingredient is intended to be added.”
ON-1685Lentinex® (β-glucan extract from Lentinula edodes)Biomass fermentationFavorable
“Intake from the proposed levels of use would lead to intake levels that will substantially increase the overall dietary intake of lycopene, and could lead to total daily intakes up to 9.8 to 14.5 mg/day at the mean and 23 to 51 mg/day as high intakes.”
ON-893Lycopene from Blakeslea trisporaFermentationFavorable with conditions
Category-specific notes

How this section plays out differently depending on your novel food type.

HMOs

Uses and use levels are the main sticking point, especially for infant formula where safety margins are tighter and population-specific exposure is critical.

Chemical nutrients

Total intake from all sources (food, supplements, water) must be considered. Upper tolerable intake levels (ULs) must not be exceeded at P95.

Check your dossier against this pattern.

Paste your proposed uses and use levels / anticipated intake section and Borgh will flag the gaps that matter.

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