[08] Section 8low risk#9 ADR trigger

Nutritional Information

4 clock-stopped issues across 4 opinions — rarely a standalone ADR trigger. But critical when the novel food replaces a conventional food or is a novel protein source. Protein quality (DIAAS) is mandatory for protein sources but frequently missing. Anti-nutritional factors are a recurring gap for insects and legume-derived products.

4Opinions with ADR on this section
4Clock-stopped issues
11%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.

  • 1No nutritional impact assessment when the NF replaces a conventional food
  • 2Missing comparison with the nutritional profile of the food being replaced
  • 3Anti-nutritional factors not addressed (phytates, trypsin inhibitors, chitin)
  • 4No assessment of bioavailability of key nutrients
  • 5Impact on overall diet quality not discussed
  • 6Protein quality (DIAAS) not provided for novel protein sources
What EFSA expects

Assessment of the nutritional impact of introducing the novel food into the diet. For products replacing conventional foods: comparison of nutritional profiles. Consideration of anti-nutritional factors. For novel protein sources: amino acid composition and protein quality (DIAAS). For fortification uses: contribution to total nutrient intake versus upper tolerable intake levels.

From the case law

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

Based on the DIAAS value obtained for the age group 6 months to 3 years (which should be used to assess the overall quality of new protein sources according to FAO, 2013), the NF cannot be considered a good source of protein, for which the DIAAS range has been set from 75 to 99.
ON-9631Rapeseed protein–fibre concentrateProtein isolateFavorable with conditions1 ADR
Based on the composition and maximum proposed use levels of the NF, magnesium intake would be up to 400 mg/day, which exceeds the established UL for supplemental magnesium of 250 mg/day.
ON-9528Magnesium orotate dihydrateChemical nutrientUnfavorable
The Panel cannot conclude on the nutritional assessment of the NF because of the high levels of glucosinolates in the NF and the lack of a relevant health‑based guidance value.
ON-7706Whole rapeseed (Brassica napus) seedsWhole foodUnfavorable4 ADRs
Category-specific notes

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

Insects

Protein quality assessment (DIAAS) expected. Anti-nutritional factors (chitin) must be addressed.

Cell culture

DIAAS for cultured meat products. Comparison with conventional meat nutritional profile.

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