The EU list of novel food has recently been updated with a variation on the specifications of a new food already authorised, phytosterols and phytostanols from sunflower, concerning the content of ‘other sterols/stanols’. (1)
The European Commission has recognised the interested operator, after 25 months from the submission of the relevant application, data protection and exclusive authorisation for 5 years.
The measure will not change the fortunes of the functional foods market but offers an opportunity to reflect on the advisability of reforming the Novel Food Regulation (EU) 2015/2283, NFR, to simplify its burdensome procedures.
Phytosterols and phytostanols vs. animal sterols
Phytosterols and phytostanols are sterols of plant origin, synthesised by plants. From a chemical standpoint, they belong to the terpene family (more precisely, in the subgroup of triterpenes). In analogy with animal sterols, such as cholesterol, these molecules perform a structural function in cell membranes (in plant cells in the first case, in animal cells in the second). Unlike animal sterols, however, phytosterols and phytostanols are characterised both by the absence of a double bond in stanols, and by the ability to reduce blood cholesterol levels in humans, when regularly introduced with the diet (2,3).
The two plant molecules are also distinguished by their low concentration in foods. Their average content in plant foods is highly variable, with higher levels in oils, oil seeds and cereals (especially the germ), lower in fruit and vegetables. Following are their typical ranges, expressed in mg sterol/stanol per 100 g of food:
- vegetable oils (e.g. olive oil, sunflower seeds, wheat germ, maize, soya): 154 – 919;
- nuts (e.g. peanuts, walnuts, hazelnuts, almonds, pistachios): 104 – 360;
- cereals and derivatives (e.g. rice, bread, flour from various cereals, bran and wheat germ): 20 -344;
- vegetables (e.g. tomatoes, fennel, carrots, broccoli): 4-50;
- fruit (e.g. apples, pears, peaches, oranges): 1- 44.
The average intake of these plant molecules in the diet is generally less than 10 mg/day compared to an estimated potential requirement of 200-400 mg/day (up to 1000 mg/day for vegetarians and vegans). Both classes of compounds, however, present fractional and reduced intestinal absorption, equal to about 0.5–2% for plant sterols and 0.04–0.2% for plant stanols, reaching concentrations approximately 500 and 10,000 times lower than those of cholesterol respectively.
Phytosterols/phytostanols, the first authorisations as novel food in the EU
Phytosterols/phytostanols are already included in the list of novel food authorised in the EU – as defined by reg. (EU) 2017/2470 and subsequent amendments – following authorisations already granted under the validity of the first Novel Foods Regulation (EC) No. 258/97. They are currently authorised:
- in the form of oil enriched with phytosterols/phytostanols;
- in their pure form, to be used as ingredients in a series of foods such as spreads, dairy products (e.g. yoghurt), soya-based beverages, dressings and hot sauces, rye bread and food supplements.
For each type of food, a maximum limit of 3 g per serving is provided, including supplements whose labels must indicate a maximum intake level of 3 g/day.
Request for variation on specifications
The Argentine company Advanced Organic Materials SA, based in Spain, submitted on 29 June 2023 an application to modify the specifications of the novel food phytosterols/phytostanols. With the objective of increasing the maximum level of ‘other sterols/stanols’ – from 3.0% to 7.0%, compared to the total phytosterols – to better reflect the natural proportions of phytosterols/phytostanols contained in sunflower.
On this occasion, the operator also requested from the Commission the protection of the following data protected by industrial property:
- product composition;
- certificate of analysis on microbiological parameters, heavy metals, pesticides, aflatoxins and sulphated ash;
- test report on dioxins and polychlorinated biphenyls (PCBs), polycyclic aromatic hydrocarbons (PAHs) and residual solvents;
- report on particle size distribution;
- stability study report;
- document validating the internal method for determining phytosterol content by gas chromatography.
EFSA’s green light
The European Food Safety Authority (EFSA), at the request of the Commission, adopted a scientific opinion supporting the application to modify the specifications submitted by the applicant. This opinion was published on 27 January 2025, that is 578 days (1 year, 6 months and 29 days) after the application submitted by the applicant. (4)
EFSA identified four phytosterols from the ‘other sterols/stanols’ fraction (i.e. delta-5-avenasterol, delta-7-avenasterol, delta-7-stigmastenol, delta-5,24-stigmastadienol), which represent at least two-thirds of this fraction when phytosterols/phytostanols are produced from sunflower oil.
Considering the higher proportion of the ‘other phytosterols’ fraction in phytosterols/phytostanols obtained from sunflower, EFSA deemed it appropriate to increase the authorised level of ‘other sterols/stanols’ from < 3.0% to < 7.0%. On 25 July 2025 – that is 757 days (2 years and 26 days) after the application – the Commission authorised the modification of the specifications.
‘In the opinion the Authority concluded that phytosterols/phytostanols are safe based on the proposed modification of the specifications. This scientific opinion therefore presents sufficient reasons to establish that the modification of the specifications of the novel food phytosterols/phytostanols meets the conditions‘ for its placing on the market (Commission implementing regulation EU) 2025/1509, recital 10).
Granting of data protection
Data protection may be granted to an applicant for novel food authorisation provided that:
- the applicant produces new scientific evidence or data protected by industrial property, at the time of submission of the application, over which it exercises exclusive right of reference;
- such data proves to be effectively indispensable to EFSA to be able to draw conclusions on the safety of the novel food without the aforementioned information.
Data protection has a duration of five years and prevents any other applicant from using such information for a subsequent application, unless consent is obtained from the original applicant. (5)
The modification of specifications falls among the cases of authorisation of a novel food for which data protection may be granted, analogously to what is provided for the inclusion of a novel food in the Union list. (6)
In the specific case, EFSA declared that the information submitted by the applicant was necessary to draw conclusions on the safety of the novel food. Consequently, the Commission decided to grant the new authorisation with data protection, without however modifying the pre-existing authorisation (relating to a value of ‘other sterols/stanols’ below 3.0%).
Novel foods Regulation (EU) 2015/2283, the necessary reform
The application of the Novel Food Regulation (EU) 2015/2283 continues to highlight serious criticalities in terms of inefficiency and obstacles to innovation and competitiveness in the food sector:
- a simple modification of part of the specifications (‘other sterols/stanols’, in the case in question) required 757 days, equal to 2 years, between the submission of the application and the relative authorisation;
- the gestation times for a new application for the authorisation of a novel food can instead exceed 4 years of time;
- data protection and the granting of authorisation with exclusivity, on novel food authorisation applications as well as on those for modification of existing authorisations, should be justified by substantial studies (Dongo, 2023).
The reform of the Novel Food Regulation (EU) 2015/2283, urged by the European Parliament in the EU Protein Strategy (2023), is increasingly necessary to simplify evaluation procedures, shorten authorisation times and guarantee legal certainty, now lost in the exemplary cases of probiotics and botanicals. Without obviously compromising the protection of food safety. Such reform should amongst other things include, in the opinion of the writers – the restoration of the principle of substantial equivalence between novel foods already authorised.
Principle of substantial equivalence, the dear departed
The principle of substantial equivalence – introduced in the first Novel Food Regulation (EC) No 257/97, in article 3.4 – allowed operators to access a notification procedure (article 5), rather than authorisation, for the simplified evaluation of novel foods that were:
- already authorised in other EU Member States, or
- approved in third countries with evaluation systems recognised as equivalent, as well as
- substantially similar to traditional foods for composition, nutritional value and intended use. (7)
The European legislator suppressed this principle – which had been used precisely for the extensions of use of phytosterols/phytostanols as ingredients in various food categories – without any justification, with the unfortunate regulation (EU) 2015/2283.
Provisional conclusions
The suppression of the principle of equivalence forced a food sector operator to resort to a burdensome and complex novel food authorisation procedure for a simple variation with respect to a ‘novel food’ authorised in the Old Continent since the year 2000 (8,9).
The restoration of the substantial equivalence system already established in the first Novel Food Regulation (EC) No 257/97 would have allowed considerable savings in costs and bureaucracy, shortening from 757 to 60 days the time-to-market of a simple variation in the specifications of a novel food already authorised for a quarter of a century.
A substantial reform of the Novel Food Regulation (EU) 2015/2283 is indispensable and urgent to favour both innovation and competitiveness in the sector, as well as food security and productive autonomy of the Old Continent, as well as the availability of foods potentially useful for improving the health of its citizens and consumers.
Dario Dongo e Andrea Adelmo Della Penna
Endnotes
(1) Commission Implementing Regulation (EU) 2025/1509 of 25 July 2025 amending Implementing Regulation (EU) 2017/2470 as regards the specifications of the novel food phytosterols/phytostanols. http://data.europa.eu/eli/reg_impl/2025/1509/oj
(2) Ruscica M. et al. (2025) Phytosterols and phytostanols in context: From physiology and pathophysiology to food supplementation and clinical practice. Pharmacological Research 214:107681, https://doi.org/10.1016/j.phrs.2025.107681
(3) Regulation (EU) No 432/2012 authorises a health claim regarding the effect of plant sterols and stanols in contributing to the maintenance of normal blood cholesterol levels. The same health claims have been authorised for other substances such as oleic and linoleic acid, beta-glucans and pectins.
(4) EFSA NDA Panel (2025) Safety of a change of specifications of phytosterols/phytostanols as a novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal 23(1):e9162, https://doi.org/10.2903/j.efsa.2025.9162
(5) Reg. (EU) 2015/2283, articolo 26, paragrafi 1 e 2
(6) Reg. (EU) 2015/2283, articoli 9.2.c e 10.1
(7) Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients. Consolidated text: 07/08/09. http://data.europa.eu/eli/reg/1997/258/2009-08-07 No longer in force
(8) 2000/500/EC: Commission Decision of 24 July 2000 on authorising the placing on the market of ‘yellow fat spreads with added phytosterol esters’ as a novel food or novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council. http://data.europa.eu/eli/dec/2000/500/oj
(9) Commission Regulation (EC) No 608/2004 of 31 March 2004 concerning the labelling of foods and food ingredients with added phytosterols, phytosterol esters, phytostanols and/or phytostanol esters. http://data.europa.eu/eli/reg/2004/608/oj. No longer in force, Date of end of validity: 12/12/2014; Repealed by Regulation (EU) No 1169/11
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
Graduated in Food Technologies and Biotechnologies, qualified food technologist, he follows the research and development area. With particular regard to European research projects (in Horizon 2020, PRIMA) where the FARE division of WIISE Srl, a benefit company, participates.
