Consumers and Health

EFSA rejects health claim for olive oil polyphenols and HDL cholesterol

May 28, 2025

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The European Food Safety Authority’s (EFSA) recent rejection of a health claim for olive oil polyphenols and HDL cholesterol maintenance goes beyond a mere scientific assessment.

This opinion, from the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), serves as a critical lens on the flawed implementation of the Nutrition and Health Claims Regulation (NHCR), specifically Commission Regulation (EC) No 353/2008.

The following analysis stands out for directly challenging this implementing regulation as the root cause of disproportionate, pharmaceutical-grade evidence demands, thereby hindering innovation and denying consumers vital information about foods’ benefits for health.

Table of Contents

Background and regulatory context

The evaluation was conducted pursuant to Article 13.5 of Nutrition and Health Regulation (EC) No 1924/2006, following an application submitted by the University of Bari Aldo Moro through the Italian Competent Authority. Article 13.5 specifically addresses health claims authorisation requests based on newly developed scientific evidence or those including requests for proprietary data protection.

The applicant proposed that ‘olive oil polyphenols contribute to normal lipid metabolism‘, targeting the general population with specific conditions of use. According to the application, the olive oil should contain at least 250 mg/kg of polyphenols by expiration date, with a recommended daily consumption of 30 g (equivalent to 6 mg of hydroxytyrosol and its derivatives).

Methodology and assessment framework

Legal mandate and regulatory foundation

The EFSA Panel’s evaluation is based on Regulation (EC) No 1924/2006, specifically Article 16.3, which mandates the Authority to assess the scientific data provided by applicants and to issue opinions on the scientific substantiation of health claims. This evaluation process operates independently of commercial interests, focusing solely on the quality of scientific evidence and methodological rigour.

EFSA’s assessment does not constitute marketing authorisation or a positive safety evaluation; instead, it provides the scientific foundation for subsequent regulatory decisions by the European Commission. Importantly, the Commission may adopt decisions that diverge from EFSA’s scientific opinions, considering broader policy factors including economic impact, consumer protection, and proportionality principles.

Regulatory inconsistencies and disproportionate evidence standards

The implementation of health claims assessment has been significantly influenced by Commission Regulation (EC) No 353/2008, which established detailed rules for applications under Article 13.5 of the Nutrition and Health Claims Regulation. This implementing regulation has effectively harmonised the scientific evidence requirements across different categories of health claims, mandating that identical levels of scientific evidence are required for both general function claims (NHCR, Article 13) and disease risk reduction and child development claims (NHCR, Article 14) applications.

However, this regulatory harmonisation raises fundamental questions about the proportionality and consistency of the current framework with the original objectives of Regulation (EC) No 1924/2006. The parent regulation clearly distinguishes between different categories of health claims, establishing Article 13 for claims describing physiological functions and Article 14 for claims relating to disease risk reduction. This distinction inherently suggests that different types of claims warrant different levels of scientific substantiation, reflecting their varying implications for public health and consumer decision-making.

Critical assessment of regulatory proportionality

The current implementation through Regulation (EC) No 353/2008 appears disproportionate and inconsistent with the fundamental objectives of the Nutrition and Health Claims Regulation:

double-blind, placebo-controlled clinical trials on healthy individuals, published in high impact factor scientific journals, are required to substantiate not just disease risk reduction but also basic physiological function claims on food;
this level of evidence is stricter than pharmaceutical standards, where clinical tests are performed on patients with existing conditions, making therapeutic variations much easier to identify and correlate to treatment interventions.

This approach has created inappropriate barriers for both traditional foods with well-established histories of safe use, such as extra-virgin olive oil and botanical extracts and innovative ingredients like probiotics. The regulatory burden has resulted in systematic consequences:

discouraging research and innovation in the European Union, limiting the development of evidence-based nutrition science and hindering the translation of scientific knowledge into practical consumer information;
limiting consumers’ rights to access accurate information about the physiological benefits of foods. When functional foods cannot obtain health claim authorisation due to overly stringent evidence requirements, consumers are deprived of valuable nutritional guidance that could inform healthier dietary choices.

Three-criteria assessment framework

Despite these systemic concerns, the EFSA Panel operates within the current regulatory framework, applying a systematic three-criteria assessment methodology universally applied to all health claim evaluations. This approach requires that:

food/constituent characterisation. The food or constituent must be clearly defined and adequately characterised using appropriate analytical methods. This criterion ensures that claimed effects can be attributed to specific, measurable components rather than undefined mixtures or preparations;
claimed effect relevance. The claimed effect must either be based on the recognised essentiality of a nutrient or represent a beneficial physiological effect for the target population that can be measured in vivo in humans. This criterion establishes the biological plausibility and health relevance of the proposed claim;
cause-and-effect relationship. A clear cause-and-effect relationship must be established between consumption of the food/constituent and the claimed effect under the proposed conditions of use for the target population. This criterion represents the most stringent requirement, demanding robust evidence from appropriately designed human intervention studies.

Methodological requirements for lipid-related claims

For health claims related to blood lipid profiles, EFSA has developed specific guidance establishing additional methodological requirements. These guidelines, published in 2018, specify that:

acceptable evidence must demonstrate either LDL cholesterol reduction, HDL cholesterol increase (without LDL increase), or triglyceride reduction compared to appropriate controls;
study duration must be sufficient to demonstrate stabilised effects, typically requiring interventions of at least four weeks with evidence of sustainability over longer periods (≥8 weeks).

Characterisation of the food constituent

Within this regulatory framework, the Panel considered the food constituent to be polyphenols naturally present in olive oil. These compounds represent a diverse group of plant secondary metabolites, including flavonoids, phenolic acids, and secoiridoids. The major polyphenols in olive oil include simple phenols such as hydroxytyrosol and tyrosol, secoiridoids like oleuropein and ligstroside, and their derivatives including oleacein and oleocanthal.

The Panel noted that total polyphenol content in olive oil can be quantified using established analytical methods, particularly the Folin-Ciocalteu spectrophotometric assay. While this method lacks specificity in other food matrices due to interference from reducing compounds, the olive oil matrix inherently lacks significant amounts of these interfering substances, making the assay appropriate for this application.

Relevance of the claimed effect

The claimed effect focused on ‘the maintenance of normal HDL-c concentrations in the blood (without increased LDL-c concentrations)‘. The EFSA Panel:

recognised that high-density lipoproteins act as cholesterol scavengers involved in reverse cholesterol transport from peripheral tissues back to the liver, while low-density lipoproteins transport cholesterol to peripheral tissues, including arteries,
confirmed that maintaining normal blood HDL cholesterol concentrations without increasing LDL cholesterol represents a beneficial physiological effect for the general population. This assessment aligns with established scientific understanding of lipid metabolism and cardiovascular health.

Scientific evidence and critical analysis

The applicant submitted a published systematic review and meta-analysis by Zupo et al. (2023), examining 10 human intervention studies investigating olive oil polyphenols’ effects on blood HDL cholesterol concentrations.

The Panel focused on six randomised controlled trials conducted in adults. The most significant studies supporting the University of Bari’s health claim application included several well-designed investigations that provided substantive evidence for olive oil polyphenols’ effects on HDL cholesterol concentrations.

However, the Panel’s detailed analysis revealed significant methodological concerns with four studies, evaluated against pharmaceutical-grade evidence standards.

The EUROLIVE multicentre trial

The EUROLIVE multicentre trial (Covas et al., 2006) represented the most robust evidence supporting the health claim application. This crossover, randomised controlled study was conducted across six European centres (Finland, Denmark, Germany, Italy, Greece and Spain) and involved 200 healthy male subjects aged 20-60 years. The study design employed rigorous methodology with participants consuming 25 mL of olive oil daily with varying polyphenol content for three consecutive weeks each, separated by two-week washout periods.

The study demonstrated a statistically significant linear dose-dependent increase in HDL cholesterol concentrations. Specifically, consumption of olive oil with high polyphenol content (366 mg/kg, equivalent to 8.4 mg/day) resulted in HDL cholesterol increases of +0.045 mmol/L (95% CI = 0.02, 0.06) compared to low polyphenol olive oil. Medium polyphenol content (164 mg/kg) showed intermediate effects (+0.032 mmol/L), establishing a clear dose-response relationship that strongly supported the University of Bari’s proposed mechanism.

The study’s statistical analysis employed a general linear model with period, treatment, and centre as fixed effects, participant number as a random effect, and age and baseline values as covariates. Between-group differences in HDL cholesterol concentrations were 0.029 mmol/L (95% CI = 0.005, 0.06) for high versus low polyphenol olive oil, with a trend p-value of 0.018, providing compelling evidence for the claimed effect.

Importantly, the study found no adverse effects on LDL cholesterol concentrations, supporting the University of Bari’s claim that olive oil polyphenols could maintain normal HDL cholesterol levels ‘without increased LDL-c concentrations‘. The compliance rates were excellent, as reflected in the measurable changes in urinary tyrosol and hydroxytyrosol excretion after olive oil interventions, validating the intervention’s effectiveness.

The VOHF study supporting evidence

The VOHF (Virgin Olive Oil and HDL Functionality) study (Fernández-Castillejo et al., 2016) provided additional supporting evidence for the University of Bari’s application through its double-blind, crossover design involving 33 hypercholesterolaemic participants. This study investigated the effects of 25 mL daily consumption of olive oils with varying polyphenol content over three-week periods with two-week washouts.

The study design specifically addressed the target population considerations raised in the University of Bari application by including individuals with elevated cholesterol levels, thereby demonstrating the potential benefits in populations that might particularly benefit from HDL cholesterol maintenance. The intervention included olive oil with low polyphenol content (80 mg/kg, equivalent to 1.8 mg/day) compared to high polyphenol variants (500 mg/kg, equivalent to 11.5 mg/day).

While the study’s primary focus was on lipoprotein particle characteristics, it provided valuable supporting evidence for the biological plausibility of olive oil polyphenols’ effects on HDL metabolism. The study demonstrated good compliance rates, as reflected in measurable changes in urinary hydroxytyrosol sulphate and thymol sulphate excretion, validating the bioavailability of the polyphenolic compounds proposed in the University of Bari application.

The study’s statistical methodology employed ANCOVA to compare changes in HDL concentrations among different intervention groups while adjusting for covariates such as age, gender, sequence of olive oil administration, and baseline values. This rigorous approach supported the methodological quality requirements for health claim substantiation.

Study quality assessment

Despite the methodological rigour of the studies supporting the University of Bari’s proposed claim, four additional randomised controlled trials with smaller sample sizes (30–58 participants) failed to replicate the findings:

Konstantinidou et al. (2010) lacked quantifiable data on olive oil polyphenol consumption and failed to demonstrate independent effects on HDL cholesterol concentrations. The study design involved families consuming olive oil ad libitum without proper quantification methods;
Santangelo et al. (2016) was characterised as a sequential, non-randomised study with no washout period between interventions and a 50% attrition rate. The systematic review attributed high risk of bias to this study regarding missing outcome data;
Hernáez et al. (2014) presented subset analysis of the EUROLIVE study without providing additional information beyond what was already reported in the primary publication (Covas et al., 2006);
Weinbrenner et al. (2004) lasted only four days, insufficient to assess sustained effects on lipid metabolism according to current EFSA guidance requirements.

Mechanistic considerations

The University of Bari Aldo Moro proposed several biological mechanisms through which olive oil polyphenols might influence HDL cholesterol maintenance:

oleuropein acting as a PPAR-α agonist, potentially modulating lipid metabolism genes;
enhanced bile acid and cholesterol excretion reducing systemic cholesterol pools;
gut microbiota modulation with polyphenols acting as prebiotics;
antioxidant properties mitigating oxidative stress.

However, the EFSA Panel noted that no scientific references were provided to support the proposed mechanisms, highlighting a significant gap in the evidence base under current regulatory requirements.

Duration and sustainability concerns

A major limitation highlighted by the EFSA Panel was the short duration of the studies. EFSA’s 2018 guidance states that blood lipids typically stabilise after four weeks, with evidence of sustained effects required over periods of eight weeks or more.

All submitted intervention studies predated this guidance and lasted only three weeks per intervention, falling short of the stringent evidence standards currently applied.

Historical context and previous evaluations

The Panel noted that this represented the third evaluation of similar health claims regarding olive oil polyphenols and HDL cholesterol. Previous assessments in 2011 and 2012 under Article 13.1 of the same regulation had reached negative conclusions due to inconsistent results and lack of mechanistic evidence, demonstrating the consistent application of restrictive evidence standards.

The pattern of repeated rejections for traditional food components with established safety profiles and growing scientific support illustrates how the current regulatory framework may be failing to serve consumer interests and scientific progress. The isolated positive finding from the EUROLIVE study, while scientifically interesting, could not overcome the pharmaceutical-grade replication requirements imposed by current guidance.

Statistical and methodological rigor

The Panel applied stringent statistical criteria in evaluating the evidence, requiring intention-to-treat analysis, appropriate statistical models accounting for study design features, and correction for multiple comparisons. While these standards ensure methodological rigor, they may represent an excessive burden for physiological function claims compared to disease risk reduction claims.

Several studies failed to meet these pharmaceutical-grade standards, with inadequate power calculations, missing data handling issues, and inappropriate statistical analyses. The Panel’s assessment highlighted the tension between maintaining scientific rigor and enabling appropriate access to nutritional information for consumers.

Public health and regulatory implications

EFSA’s negative conclusion has significant implications for public health messaging and commercial health claims. While olive oil consumption as part of a Mediterranean diet continues to be associated with cardiovascular benefits in epidemiological studies, specific claims about polyphenol content and HDL cholesterol maintenance cannot be authorised under current regulatory standards.

This outcome illustrates how regulatory inflexibility may paradoxically harm public health by obstructing access to accurate nutritional information:

traditional foods with established safety and growing scientific support face systematic claim rejections, discouraging healthy choices and stifling innovation in the functional food sector;
meanwhile, the current framework favours ultra-processed foods with unbalanced nutrient profiles (i.e. Danone’s sugary drinks) and concentrated actives, undermining dietary guidelines.

This paradox is worsened by the persistent failure to implement nutrient profiles, provided in Article 4 of the NHCR (2006), as criticised by the European Court of Auditors (2024). The Court noted that consumers remain misled by claims on nutritionally poor products, while legitimate claims for healthy traditional foods are denied.

Conclusions and future research directions

The EFSA Panel concluded that ‘the evidence provided is insufficient to establish a cause-and-effect relationship between the consumption of olive oil polyphenols and the maintenance of normal HDL-c concentrations’ according to current regulatory standards. This conclusion reflects:

limited replication of positive findings across different populations,
absence of evidence for sustained effects over pharmaceutically-required time periods;
lack of mechanistic explanations meeting current evidence standards.

Strategic regulatory compliance and professional support

EFSA’s evolving assessment standards require scientific studies to align closely with current guidance for health claims and novel food authorisations. Compliance goes beyond methodology, involving strategic planning, protocol optimisation, and evidence packages tailored to EFSA’s evaluation criteria.

Our team at Wiise Benefit’s FARE (Food and Agriculture Requirements) unit provides expert regulatory analysis and strategic advice to support companies, research organisations, and consortia of all sizes. We offer regulatory pathway analysis, EFSA-aligned study design, and evidence development tailored to specific regulatory goals.

This support helps stakeholders – from start-ups to global industry leaders – navigate complex requirements, maximise research value, and accelerate the successful market entry of innovation in the functional foods and nutraceuticals sectors.

International regulatory context: FDA recognition

The restrictive European approach to olive oil health claims contrasts notably with regulatory decisions in other jurisdictions. The United States Food and Drug Administration (FDA) has recognised the cardiovascular benefits of olive oil consumption, authorising a qualified health claim for oleic acid and reduced coronary heart disease risk. The FDA’s 2018 decision (FDA, 2018) allows manufacturers to state that ‘supportive but not conclusive scientific evidence suggests that daily consumption of about 1½ tablespoons (20 grams) of oils containing high levels of oleic acid, when replacing fats and oils higher in saturated fat, may reduce the risk of coronary heart disease‘.

This FDA authorisation demonstrates that other major regulatory authorities have found sufficient scientific evidence to support health claims related to olive oil consumption, highlighting the potential inconsistency in global regulatory approaches. The FDA’s qualified health claim framework allows for communication of emerging scientific evidence while maintaining appropriate consumer protection, suggesting that alternative regulatory approaches may better balance innovation and consumer information needs.

The contrast between the US and EU approaches illustrates how regulatory frameworks can significantly impact the translation of scientific evidence into consumer information, with potential implications for public health messaging and industry innovation.

Call for urgent regulatory reform: a policy brief for EU stakeholders

The systematic failure of the current health claims framework demands immediate and comprehensive reform of Commission Regulation (EC) No 353/2008 to ensure consistency with the parent Nutrition and Health Claims Regulation (EC) No 1924/06 and address critical deficiencies that are undermining both consumer rights and European competitiveness.

Protecting consumer rights and information access

European consumers deserve access to accurate, science-based information about the physiological benefits of traditional and innovative foods. The current regulatory framework paradoxically denies consumers information about foods with centuries of safe use and emerging scientific support while permitting misleading claims on products with unbalanced nutrient profiles.

This regulatory dysfunction violates fundamental consumer rights to make informed dietary choices and contradicts EU policies promoting healthy eating and disease prevention. Reform must establish proportionate evidence requirements that distinguish between basic physiological function claims and disease risk reduction claims, enabling consumers to access valuable nutritional guidance while maintaining appropriate safety standards.

Supporting innovation and competitiveness

The current regulatory environment severely prejudices small and medium enterprises (SMEs), including start-ups, research entities, and their consortia engaged in EU-funded research projects such as Horizon programmes. These stakeholders invest substantial resources in developing evidence-based nutritional products and ingredients, with legitimate expectations of translating their research into consumer benefits and market opportunities.

The systematic rejection of Article 13 applications has created an insurmountable barrier for traditional food producers, functional food developers, and innovative ingredient manufacturers.

This regulatory inflexibility puts European companies at a disadvantage compared to international competitors. For example, the US FDA recognises olive oil’s cardiovascular benefits, while similar claims are rejected in Europe. Likewise, Japan’s FOSHU system has fostered a $6 billion functional foods market by balancing consumer protection with more pragmatic evidence requirements.

Preserving research investment and scientific progress

EU-funded research programs invest billions of euros annually in nutrition and health research, with the expectation that scientific discoveries will translate into societal benefits and economic growth. The current regulatory framework effectively renders much of this research investment economically unviable, as even robust scientific evidence cannot meet pharmaceutical-grade requirements for basic physiological function claims.

This regulatory dysfunction discourages research and development in nutrition science, limits knowledge transfer from academic institutions to industry, and undermines the EU’s competitiveness in the global functional foods and nutraceuticals markets. Reform must ensure that legitimate research investments can be exploited for the common good of improving citizens’ wellbeing through evidence-based nutritional information.

Immediate reform priorities

EU policymakers and Member State authorities must urgently address these regulatory deficiencies through comprehensive reform that:

Establishes proportionate evidence standards that distinguish between Article 13 physiological function claims and Article 14 disease risk reduction claims, as originally envisioned in the parent regulation;
Implements Article 4 of the NHCR to prevent misleading claims on products with unbalanced nutrient profiles, while enabling legitimate claims for traditional and innovative healthy foods;
Recognises traditional use and established safety profiles as relevant factors in evidence assessment for foods with long histories of safe consumption;
Supports innovation by providing clear, achievable pathways for science-based health claims that encourage research investment and knowledge translation;
Protects consumer rights by ensuring access to accurate nutritional information while maintaining appropriate safety standards.

Stakeholder mobilisation

This policy brief calls upon all stakeholders across the farm-to-fork continuum – including farmers, food processors, researchers, SMEs, consumer organisations, and policymakers – to demand immediate reform of Commission Regulation (EC) No 353/2008. The current regulatory dysfunction serves no legitimate public interest while systematically undermining consumer rights, scientific progress, and European competitiveness.

The contrast between European regulatory inflexibility and more balanced approaches adopted by other major jurisdictions demonstrates that reform is both necessary and achievable. European consumers and businesses deserve a regulatory framework that promotes both consumer protection and innovation, enabling the translation of scientific knowledge into practical benefits for citizens’ health and economic prosperity.

Future research in this area faces the challenge of meeting increasingly stringent evidence requirements that may not be scientifically justified for physiological function claims. The Panel’s assessment suggests that studies should focus on longer-duration interventions, diverse population groups, and robust mechanistic investigations, though the proportionality of such requirements for traditional food components remains questionable.

While the health claim was rejected under current regulatory standards, this does not diminish the potential benefits of olive oil consumption within balanced dietary patterns. The evaluation emphasises the tension between evidence-based regulation and regulatory proportionality, highlighting the need for reform to ensure that the European nutrition and health claims framework serves both consumer protection and public health promotion objectives effectively.

The EFSA opinion serves as another example of how current regulatory standards may be hampering rather than promoting evidence-based nutrition, demonstrating the challenges inherent in applying pharmaceutical-style evidence requirements to traditional foods and dietary components with established safety profiles and emerging scientific support.

Dario Dongo

References

Commission Regulation (EC) No 353/2008 of 18 April 2008 establishing implementing rules for applications for authorisation of health claims as provided for in Article 15 of Regulation (EC) No 1924/2006. Latest consolidated version: 21/12/2009 https://tinyurl.com/4zwetenw
Covas, M. I., Nyyssönen, K., Poulsen, H. E., Kaikkonen, J., Zunft, H. J., Kiesewetter, H., Gaddi, A., de la Torre, R., Mursu, J., Bäumler, H., Nascetti, S., Salonen, J. T., Fitó, M., Virtanen, J., & Marrugat, J. (2006). The effect of polyphenols in olive oil on heart disease risk factors: A randomized trial. Annals of Internal Medicine, 145(5), 333-341. https://doi.org/10.7326/0003-4819-145-5-200609050-00006
EFSA NDA Panel. (2011). Scientific Opinion on the substantiation of health claims related to polyphenols in olive and protection of LDL particles from oxidative damage (ID 1333, 1638, 1639, 1696, 2865), maintenance of normal blood HDL cholesterol concentrations (ID 1639), maintenance of normal blood pressure (ID 3781), ‘anti-inflammatory properties’ (ID 1882), ‘contributes to the upper respiratory tract health’ (ID 3468), ‘can help to maintain a normal function of gastrointestinal tract’ (3779), and ‘contributes to body defences against external agents’ (ID 3467) pursuant to article 13(1) of regulation (EC) No 1924/2006. EFSA Journal, 9(4), 2033. https://doi.org/10.2903/j.efsa.2011.2033
EFSA NDA Panel. (2012). Scientific Opinion on the substantiation of a health claim related to polyphenols in olive and maintenance of normal blood HDL cholesterol concentrations (ID 1639, further assessment) pursuant to article 13(1) of regulation (EC) No 1924/2006. EFSA Journal, 10(8), 2848. https://doi.org/10.2903/j.efsa.2012.2848
EFSA NDA Panel. (2018). Guidance for the scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health. EFSA Journal, 16(1), 5136. https://doi.org/10.2903/j.efsa.2018.5136
EFSA NDA Panel. (2025). Olive oil polyphenols and the maintenance of normal HDL-cholesterol concentrations: Evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006. EFSA Journal, 23(5), e9372. https://doi.org/10.2903/j.efsa.2025.9372
European Court of Auditors. (2024). Food labeling in the EU. Consumers can get lost in the maze of labels. Special Report 23/2024. Publications Office of the European Union. https://doi.org/10.2865/8152493
Fernández-Castillejo, S., Valls, R. M., Castañer, O., Rubió, L., Catalán, Ú., Pedret, A., Macià, A., Sampson, M. L., Covas, M. I., Fitó, M., Motilva, M. J., Remaley, A. T., & Solà, R. (2016). Polyphenol rich olive oils improve lipoprotein particle atherogenic ratios and subclasses profile: A randomised, crossover, controlled trial. Molecular Nutrition & Food Research, 60(7), 1544-1554. https://doi.org/10.1002/mnfr.201501068
Hernáez, Á., Fernández-Castillejo, S., Farràs, M., Catalán, Ú., Subirana, I., Montes, R., Solà, R., Muñoz-Aguayo, D., Gelabert-Gorgues, A., Díaz-Gil, Ó., Nyyssönen, K., Zunft, H. J., de la Torre, R., Martín-Peláez, S., Pedret, A., Remaley, A. T., Covas, M. I., & Fitó, M. (2014). Olive oil polyphenols enhance high-density lipoprotein function in humans: A randomised controlled trial. Arteriosclerosis, Thrombosis, and Vascular Biology, 34(9), 2115-2119. https://doi.org/10.1161/atvbaha.114.303374
Khandouzi, N., Zahedmehr, A., & Nasrollahzadeh, J. (2021). Effect of polyphenol-rich extra-virgin olive oil on lipid profile and inflammatory biomarkers in patients undergoing coronary angiography: A randomised, controlled, clinical trial. International Journal of Food Sciences and Nutrition, 72(4), 548-558. https://doi.org/10.1080/09637486.2020.1841123
Konstantinidou, V., Covas, M. I., Muñoz-Aguayo, D., Khymenets, O., de la Torre, R., Saez, G., Tormos, M. C., Toledo, E., Marti, A., Ruiz-Gutiérrez, V., Ruiz Mendez, M. V., & Fito, M. (2010). In vivo nutrigenomic effects of virgin olive oil polyphenols within the frame of the Mediterranean diet: A randomised controlled trial. FASEB Journal, 24(7), 2546-2557. https://doi.org/10.1096/fj.09-148452
Marrugat, J., Covas, M. I., Fitó, M., Schröder, H., Miró-Casas, E., Gimeno, E., López-Sabater, M. C., de la Torre, R., & Farré, M. (2004). Effects of differing phenolic content in dietary olive oils on lipids and LDL oxidation: A randomised controlled trial. European Journal of Nutrition, 43(3), 140-147. https://doi.org/10.1007/s00394-004-0452-8
Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods. Latest consolidated version: 13/12/2004 https://tinyurl.com/32wy54cr
Sanchez-Rodriguez, E., Lima-Cabello, E., Biel-Glesson, S., Fernandez-Navarro, J. R., Calleja, M. A., Roca, M., Espejo-Calvo, J. A., Gil-Extremera, B., Soria-Florido, M., de la Torre, R., Fito, M., Covas, M. I., Alche, J. D., de Martinez Victoria, E., Gil, A., & Mesa, M. D. (2018). Effects of virgin olive oils differing in their bioactive compound contents on metabolic syndrome and endothelial functional risk biomarkers in healthy adults: A randomised double-blind controlled trial. Nutrients, 10(5), 626. https://doi.org/10.3390/nu10050626
Santangelo, C., Filesi, C., Varì, R., Scazzocchio, B., Filardi, T., Fogliano, V., D’Archivio, M., Giovannini, C., Lenzi, A., Morano, S., & Masella, R. (2016). Consumption of extra-virgin olive oil rich in phenolic compounds improves metabolic control in patients with type 2 diabetes mellitus: A possible involvement of reduced levels of circulating visfatin. Journal of Endocrinological Investigation, 39(11), 1295-1301. https://doi.org/10.1007/s40618-016-0506-9
Sarapis, K., George, E. S., Marx, W., Mayr, H. L., Willcox, J., Powell, K. L., Folasire, O. S., Lohning, A. E., Prendergast, L. A., Itsiopoulos, C., Thomas, C. J., & Moschonis, G. (2022). Extra virgin olive oil improves HDL lipid fraction but not HDL-mediated cholesterol efflux capacity: A double-blind, randomised, controlled, cross-over study (OLIVAUS). British Journal of Nutrition, 130(4), 641-650. https://doi.org/10.1017/S0007114522003634
U.S. Food and Drug Administration. (2018, 19 November). Letter responding to health claim petition dated November 1, 2016: Oleic acid and the risk of coronary heart disease (Docket No. FDA-2016-Q-3247) [Letter]. Center for Food Safety and Applied Nutrition. https://www.fda.gov/media/118199/download?attachment
U.S. Food and Drug Administration. (2020, 16 July). Petition for Authorized Health Claim for Oleic Acid in Edible Oils and a Reduction in the Risk of Coronary Heart Disease (Docket No. FDA-2017-Q-0807) [Letter]. Center for Food Safety and Applied Nutrition. https://www.fda.gov/media/146894/download?attachment
Weinbrenner, T., Fitó, M., de la Torre, R., Saez, G. T., Rijken, P., Tormos, C., Coolen, S., Albaladejo, M. F., Abanades, S., Schroder, H., Marrugat, J., & Covas, M. I. (2004). Olive oils high in phenolic compounds modulate oxidative/antioxidative status in men. Journal of Nutrition, 134(9), 2314-2321. https://doi.org/10.1093/jn/134.9.2314
Zupo, R., Castellana, F., Crupi, P., Desantis, A., Rondanelli, M., Corbo, F., & Clodoveo, M. L. (2023). Olive oil polyphenols improve HDL cholesterol and promote maintenance of lipid metabolism: A systematic review and meta-analysis of randomised controlled trials. Metabolites, 13(12), 1187. https://doi.org/10.3390/metabo13121187

Dario Dongo

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Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.