Risk assessmentindependent cross-checkfull text checked★ key study I-SUG-03 in-depth review

EFSA: how much sugar is safe?

Tolerable upper intake level for dietary sugars.

Overview

EFSA NDA Panel et al.. EFSA J 2022 · PMID 35251356 · DOI 10.2903/j.efsa.2022.7074

EFSA found no safe intake level and advises keeping added and free sugars as low as possible.

Does the study support the specific claim? No · Methodological quality: high

Original publication

Plain-language summary

Study explained simply
What did the researchers want to find out?

Can a UL or safe level for dietary sugars be set?

How was the study done?

Regulatory scientific opinion with systematic reviews.

How many people, animals or samples were studied?

Not applicable; General population

What was actually found?

Sugars are a well-established hazard for caries; RCTs on surrogate endpoints show causal positive relationship of added/free sugars with obesity and dyslipidaemia (moderate certainty), NAFLD and T2D (low), hypertension (very low); no safe level identified; intake of added and free sugars should be as low as possible in a nutritionally adequate diet.

How large was the observed effect?

Not applicable

What do the results mean in everyday life?

Applies to sugar, honey and syrups alike.

What are the study's limitations?

Trials looked at markers (weight, liver fat, blood fats) rather than diseases; cohort studies mostly compared sugar with other calories at equal total energy; few data below 10% of energy.

What does it say about Elawady's specific claim?

Contradicts C-SUG-01, C-SUG-05 (health relevance); supports C-SOD-01.

Do the results apply to Germany and Europe?

Directly applicable in EU/Germany.

What can explicitly not be concluded from this study?

It cannot name a safe daily amount of sugar; it does not show that sugar is harmful when it does not add extra calories, except for tooth decay.

Scientific in-depth review

1. Full reference

Authors
EFSA NDA Panel et al.
Journal
EFSA J
Year
2022
Identifier
PMID 35251356 DOI 10.2903/j.efsa.2022.7074
Verification
verified – PubMed efetch 2026-10-25
Retracted
no
Corrections
none
Extent checked
full text
Conflicts of interest and funding

EFSA scientific opinion; declarations of interest of all experts published on the EFSA website (not reproduced in the full text).

2. Research question

Can a UL or safe level for dietary sugars be set?

3. Study design and population

Study design
Risk assessment – EFSA NDA Panel scientific opinion (EFSA-Q-2016-00414), following a request from five Nordic countries: protocol-based systematic reviews of RCTs and prospective cohort studies with risk-of-bias assessment, formal uncertainty analysis and probability-based levels of certainty; plus European intake assessment. Adopted 15 December 2021.
Population

General European population (children, adults, pregnant women)

Country

EU

Period

Literature per pre-specified protocol; adopted 15 December 2021

Sample size

Not applicable

Inclusion and exclusion criteria

Systematic reviews of RCTs (high vs low sugar, surrogate endpoints: body weight, liver fat, fasting glucose, fasting triglycerides, systolic BP) and prospective cohorts (incident disease) on total/added/free sugars, fructose, sugar-sweetened beverages (SSBs) and fruit juices.

4. Methods and endpoints

Exposure / intervention

Total, added and free sugars; fructose; SSBs; fruit juices

Comparator

High vs low intake (RCTs, often isocaloric); isocaloric exchange with other macronutrients (most cohort analyses)

Endpoints

Obesity, NAFLD/NASH, type 2 diabetes, dyslipidaemia, hypertension, CVD, gout, gestational diabetes, pregnancy outcomes, dental caries

Statistical methods

Systematic review and meta-analysis by sub-question, risk-of-bias appraisal, dose-response modelling, levels of certainty expressed as probability ranges (high >75-100%, moderate >50-75%, low >15-50%, very low 0-15%)

5. Actual results

Results

Dietary sugars are a well-established hazard for dental caries. RCTs on surrogate endpoints: positive and causal relationship of added/free sugars with obesity and dyslipidaemia (moderate certainty, >50-75%), NAFLD/NASH and T2DM (low, >15-50%), hypertension (very low, 0-15%). Prospective cohorts, with sugars mostly in isocaloric exchange with other macronutrients, did not support a positive relationship with any chronic metabolic disease or pregnancy endpoint. SSBs: high certainty (>75-100%) of a positive causal relationship with obesity, T2DM, hypertension and CVD; moderate for gout; low for NAFLD and dyslipidaemia; dose-response linear for T2DM, hypertension and CVD (attribution to the sugar fraction is more questionable for hypertension and CVD). Fruit juices: moderate certainty for T2DM and gout, low for CVD. Fructose: moderate for gout, low for CVD. Excess energy intake leading to positive energy balance appears to be the main mechanism; no intake level without increased risk could be identified; relationships at <10% of energy could not be explored adequately. No UL or safe level could be set; intake of added and free sugars should be as low as possible within a nutritionally adequate diet.

Absolute risks

not applicable (no UL; absolute risks not reported in the opinion's conclusions)

Authors' conclusion

A UL or safe level for total, added or free sugars could not be established; dietary sugars are a well-established hazard for dental caries; there is evidence of a causal relationship between added/free sugars and some chronic metabolic diseases; intake of added and free sugars should be as low as possible in the context of a nutritionally adequate diet.

6. Strengths

  • Protocol-driven systematic reviews with risk-of-bias assessment and explicit uncertainty analysis
  • Separate conclusions for RCTs and cohorts and for sugar types and sources
  • Directly relevant to EU/German populations

7. Weaknesses

  • RCT evidence on surrogate endpoints only, mostly at intakes >=10% of energy
  • Cohort analyses mostly isocaloric, which limits detection of energy-mediated effects
  • Added vs free sugars could not be compared; non-SSB food sources not analysed in cohorts
  • External validity of gout findings for Europe unclear (Panel)

8. Risk of bias

Orienting tool
none applicable (regulatory scientific opinion with embedded systematic reviews; structured judgement)
Type of assessment
structured assessment based on the full text by a single reviewer (no formal double review)
Full formal assessment
no
Overall risk of bias
low
Rationale

Changed from not_assessable: the opinion embeds systematic reviews with formal appraisal, allowing a structured judgement of low risk of bias. Structured single-reviewer judgement; a complete formal assessment requires two independent reviewers.

8. Risk of bias
DomainJudgementRationale
Protocol and evidence identificationlowPre-specified protocol and systematic literature searches by sub-question.
Appraisal of included studieslowFormal risk-of-bias ratings for RCTs and cohorts.
Synthesis and uncertaintylowExplicit probability-based certainty levels and uncertainty analysis; null cohort findings reported.
Directnesssome concernsRCTs use surrogate endpoints; cohorts isocaloric; data sparse below 10% of energy.
Conflicts of interestlowEFSA declarations of interest system.

Full-text review (25 October 2026): Main conclusions confirmed. Added: certainty levels for SSBs (high for obesity, T2DM, hypertension, CVD; moderate for gout), fruit juices (moderate for T2DM and gout) and fructose; excess energy intake as main mechanism; limited data <10% of energy; adoption date and question number; EFSA DoI system. Structured judgement; bias overall changed from not_assessable to low; bias_risk dimension set to low.

9. Assessment of the statistical interpretation

Not a single pooled estimate; certainty levels are probability ranges. The strongest conclusions concern SSBs (high certainty for obesity, T2DM, hypertension, CVD) and caries; for sugars in general, certainty is moderate to very low and largely mediated by excess energy intake.

10. Relevance to the specific claim

Contradicts C-SUG-01, C-SUG-05 (health relevance); supports C-SOD-01.

11. Independent contrary findings

Prospective cohorts did not show associations when sugars replaced other macronutrients isocalorically.

12. Transferability to Germany and Europe

Directly applicable in EU/Germany.

13. Overall methodological judgement

Authoritative EU position: added and free sugars should be as low as possible; no safe level identified; high certainty of harm from sugar-sweetened beverages; harm from sugars appears mainly through excess energy intake.

Multidimensional assessment
Multidimensional assessment
Authenticity of the sourceverified
Methodological qualityhigh
Risk of biaslow
Precision of resultsnot applicable
Directnessdirect
Reproducibilityreplicated
Consistency with the overall evidenceconsistent
Regional transferabilityhigh
Adequacy of the interpretation (by the archive)not applicable

14. Open questions

Effects at intakes below 10% of energy; comparison of added vs free sugars; role of non-beverage sources.

15. Linked fact checks