‘Novel food’ with exclusivity and market distortions

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chia seeds novel food with exclusivity

The latest authorization for the placing on the market of defatted chia seed powders highlights the market distortions caused by Novel Foods Regulation (EU) No 2015/2283, in the part which admits the five-year exclusivity in favor of the applicant on the basis of… nothing.

1) Chia seeds, traditional foods from third countries

The chia (Salvia hispanica L.) – as we have already had the opportunity to delve into (1) – is included among the so-called ‘pseudo-cereals’, together with quinoa, amaranth and buckwheat. (2) These are herbaceous plants which do not belong to the grass family and yet produce seeds with characteristics similar to those of cereals in terms of both methods of use and nutritional properties.

Traditional use of chia seeds for the nutrition of people dates back to the Mayan and Aztec civilizations and is still alive today, for two reasons:

– the Salvia hispanica L. is a resilient plant, thanks to its lower water requirement compared to cereals and other oilseeds,

– the tiny chia seeds have very appreciable nutritional and health properties, as we have seen. (1)

2) The long process of ‘novel food’ authorizations in the EU

The qualification of traditional food from third countries, with extensive and deep-rooted consumption experience, would now allow chia seeds to be registered in Europe through the specific simplified procedure established for this purpose in the Novel Food Regulation (EU) No 2015/2283. (3)

However, the first authorization of chia seeds as a ‘novel food’ dates back to 2009, under the validity of the first Novel Foods Regulation (EC) No 258/97, where the aforementioned simplified procedure was not yet envisaged.

The authorization process of chia seeds as ‘novel food’ is exemplary in bureaucratic complexity:

– decision 2009/827/EC of the European Commission authorized the placing on the market of chia seeds for food use, however restricting their use to bakery products only, within narrow quantitative limits,

– the subsequent decision 2013/50/EU extended its use – within narrow limits – to the majority of bakery products, breakfast cereals, fruit, nuts and seed mixtures. In addition to allowing the sale of pre-packaged chia seeds,

– in 2015 Ireland authorized the use of chia seeds in fruit juices and fruit/vegetable drinks. In 2017, Austria added fruit spreads, Spain added sterilized ready meals based on cereals, pseudocereals and/or dried legumes,

– the Commission then admitted the use of chia seeds in yoghurt, with Decision (EU) 2017/2354, and

– Regulation (EU) 2020/500 extended the authorization to use partially defatted chia seed powders in a number of foods. By removing the quantitative limits of use, without prejudice to those established on bakery products and other foods subject to heat treatments at temperatures above 120 °C, (4)

3) Chia seeds, yet another ‘novel food’ authorization with exclusivity

Regulation (EU) No 2023/2214 introduces a new authorization for the placing on the Union market of defatted chia seed powders as ‘novel food’, with exclusivity in favor of the applicant Functional Products Trading Arica SA/BENEXIA which, way back on 26 July 2021, had submitted a specific request . We focus on the ‘recitals’ of the regulation, where the European Commission notes the following:

– ‘the applicant requested to extend the use of partially defatted high fiber chia seed powder (Salvia hispanica) to a range of foods intended for the general population, in particular: pastry products, processed fruit and vegetables (including vegetable dishes), bread and rolls, pasta products and protein products‘ (recital 5),

– the applicant ‘also submitted a request to the Commission protection of data protected by industrial property relating to an acute toxicity study, a human study, a study evaluating the formation of process contaminants and certificates of analysis‘ (recital 6),

– on 23 March 2022, more than eight months after receiving the application, the European Commission consulted EFSA. Which in turn expressed a favorable opinion in the eleven, rather than nine, following months, on 27 February 2023 (recital 7,8).

3.1) Five-year exclusivity based on… nothing

The new authorization exclusively for the use of defatted chia seed powder – ‘high in fiber for use in pastry products, processed fruit and vegetables (including vegetable dishes), bread and rolls, pasta products and protein products‘ – is based on the following considerations:

– ‘the applicant declared that, at the time of submitting the application, he held the industrial property right and exclusive right of reference for human study, process contaminant formation assessment study and certificates of analysis and that access to or reference to such data or their use by third parties cannot be legally permitted‘ (recital 13),

– ‘however, the fact of limiting the authorization and the right to refer to the scientific data contained in the applicant’s dossier to the exclusive use of the latter does not prevent subsequent applicants from submitting an application for authorization to place the same novel food on the market, provided that the application is based on information lawfully obtained in support of such authorization‘ (recital 15),

3.2) Effects

Only the company Functional Products Trading Arica SA/BENEXIA, during the five years from 13 November 2023, is authorized to place on the Union market partially defatted chia seed powder (Salvia hispanica) with high fiber content for use in products of pastries, processed fruit and vegetables (including vegetable dishes), bread and rolls, pasta products and protein products,

unless a subsequent applicant obtains an authorization for that novel food without reference to the scientific data protected under Article 3 or with the consent of Functional Products Trading Arica SA/BENEXIA’ (Article 2).

Scientific data contained in the application file and fulfilling the conditions set out in Article 26(2) of Regulation (EU) 2015/2283 may not be used for the benefit of a subsequent applicant within five years of the date of entry into force of the this regulation without the consent of the company Functional Products Trading Arica SA/BENEXIA‘ (Article 3).

4) Novel Foods Regulation, objectives and data protection

The objective of the Novel Food Regulation (EU) No 2015/2283 is ‘ensure the effective functioning of the internal market, while ensuring a high level of protection of human health and consumer interests‘ (Article 1.2). Its Chapter V, data protection, however, introduces industrial property rights ex-lege which is not justified by patents or designs or industrial secrets. In apparent conflict with the general principles of intellectual property legislation, and other legislation. (6)

This level of protection has an actual meaning in cases of ‘foods with a new or deliberately modified molecular structure which was not used as a food or in a food in the Union before 15 May 1997′, i.e. the first category of substances mentioned in the definition of ‘novel food‘ (Article 2.2.a.1). Not the same, in the humble opinion of the writer, in the cases of simple studies on traditional foods from third countries (although authorized with the ordinary procedure). (7)

5) Provisional conclusions

The discipline current situation of ‘novel foods’ in the European Union – as most recently highlighted in the resolution of the European Parliament on the ‘European Policy Strategy’ (8) – must be simplified, to encourage the concrete impact of research and innovation on the agri-food systems of the Old Continent. Taking into account both the positive experience of the ‘Qualified Presumption of Safety’ applied to some microalgae, and the GRAS (Generally Recognized as Safe) procedures adopted in the USA and Canada. (9)

The reform must also consider the granting of five-year exclusivity, to be excluded in the cases of traditional foods from third countries, as well as in those of ‘novel foods’ which do not present elements of innovation such as to be able to be registered as patents. Given the risk of compromising and delaying the availability, for European consumers, of foods potentially useful for fulfilling the objectives of ‘food security’, ‘nutritional security’ and ‘sustainable development’. (10)

Dario Dongo

Footnotes

(1) Dario Dongo, Giulia Torre. Superfood, chia seeds. Green light from the EU without maximum levels of recruitment. GIFT (Great Italian Food Trade). 6.2.2020

(2) Dario Dongo, Andrea Adelmo Della Penna. Buckwheat, a resilient plant for gluten-free nutrition. GIFT (Great Italian Food Trade). 5.6.2023

(3) Dario Dongo. Notification of traditional foods from third countries such as Novel Food in the EU. GIFT (Great Italian Food Trade). 4.3.2022

(4) Dario Dongo, Andrea Adelmo Della Penna. Novel food, green light for the microalga Schyzochytrium sp. and chia seeds sold in bulk. GIFT (Great Italian Food Trade). 23.5.2021

(5) Commission Implementing Regulation (EU) 2023/2214 of 23 October 2023 amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use and the specifications of the novel foods partially defatted chia seed (Salvia hispanica) powders https://tinyurl.com/2ts9957h

(6) The compatibility of the para-patent protection introduced by the Novel Food Regulation with the protection regimes for biotechnological inventions (including microbiological ones, Dir. 98/44/EC) and plant variety rights (EC Reg. 2100) is also doubted /94)

(7) Other examples of traditional foods from third countries authorized as ‘novel foods’ with exclusivity in the EU:

– mung bean protein extracts (Vigna radiata). See Dario Dongo, Andrea Adelmo Della Penna. Novel Foods, EFSA green light for mung bean protein extracts. Eat Just’s vegetable egg. GIFT (Great Italian Food Trade). 9.11.2021

– miracle fruit (Synsepalum dulcificum). See Dario Dongo, Andrea Adelmo Della Penna. Fruit of the miracle, Novel Food authorization with yet another exclusive. GIFT (Great Italian Food Trade). 28.11.2021

– Jatropha. Regulation (EU) No 2022/965
authorizing the placing on the market of kernels from the edible variety of Jatropha curcas L. as a novel food https://tinyurl.com/2p8jchfz

– various insects. See Dario Dongo, Andrea Adelmo Della Penna. Insects as novel foods, state of the art in the European Union and the UK. GIFT (Great Italian Food Trade). 18.8.2022

– Antrodia camphorata and Agaricus bisporus mushrooms (champignons). See paragraphs 1.2-1.4 in the previous article by Dario Dongo, Andrea Adelmo Della Penna. Novel food. Green light in the EU for proteins from mushrooms, rice and peas, insects, milk and new sugars. GIFT (Great Italian Food Trade). 14.1.2023

(8) See paragraph 4 of the previous article by Dario Dongo and Andrea Adelmo Della Penna. European Protein Strategy, the new resolution. GIFT (Great Italian Food Trade). 27.10.2023

(9) Dario Dongo, Giulia Torre. Microalgae, novel food and qualified presumption of safety of microorganisms. GIFT (Great Italian Food Trade). 4.5.2022

(10) See paragraph 4.1 of the previous article by Dario Dongo, Andrea Adelmo Della Penna. Horizon4Proteins. Protein research compared with EU policies and rules. GIFT (Great Italian Food Trade). 21.5.2023

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