The prodigious miracle fruit has been authorized as a novel food-as an ingredient in dietary supplements-with yet another exclusivity in favor of the applicant. (1)
However, the attribution of a right similar to industrial property rights to a naturally available fruit deserves consideration, also with a view to a reform of the ‘novel foods’ regulations.
Fruit of the miracle
The miracle fruit is the berry of a shrubby plant-Synsepalum dulcificum, family Sapotaceae-documented in 1725 in West Africa by French cartographer and explorer Étiénne Renaud des Marchais. It is characterized by its sweetening effectiveness even on very bitter foods, due precisely to ‘miraculin’. A glycoprotein that Japanese scientist Kenzo Kurihara was able to isolate in 1968. (2) The miracle fruit can also be used as a food coloring, in beverages especially, on orange-red tones. (3)
The miracle berry is also known for its antioxidant action and important functional and health properties, e.g., antioxidant, anti-diabetic, anti-tumor, contribution to blood cholesterol reduction. Due to miraculin, as well as a wide variety of phytocompounds (e.g., flavonoids, amides, alkaloids, phytosterols, lignins, triterpenes, phenolic acids). Therefore, the plant has also been introduced to other countries (e.g., Japan, Taiwan, USA) where its consumption has become commonplace. (4)
EFSA Scientific Opinion
EFSA – European Food Safety Authority – evaluated the safety of the miracle fruit in scientific opinion 27.4.21. Consumption history, processing process, chemical-physical and microbiological characteristics, nutritional aspects and conditions of use were considered favorably, subject to the reduction of maximum daily intake. From 0.9 g/day as proposed by the applicant to 0.7 g/day according to EFSA. (5)
Allergenicity studies provided by the applicant were conducted in silico, through the detection of homologous sequences of the ‘miraculin’ protein-the most important one, in the new food-and ELISA assay with other allergenic proteins. A cross-reaction was detected, in particular, with peanut allergens. And a potential cross-reaction with those of latex, peaches and soy.
Technical specifications and composition
The list of Novel Food authorized in the EU is thus enriched by ‘dried fruits of Synsepalum dulcificum‘. For use as an ingredient in dietary supplements by the adult population (max 0.7 g/day), outside of women during pregnancy and lactation. These conditions must obviously come on product labels. In contrast, no specific information is prescribed for allergic consumers.
The novel food is described in the technical specifications as being made from freeze-dried pulp and peel of the pitted fruits of Synsepalum dulcificum, the cakes of which are ground into a powder. The composition also refers to the concentration levels of miraculin, the substance that – nomen ipsum – characterizes the product. As well as applicable microbiological criteria and pesticide residue thresholds to guard food safety.
Proprietary studies
The Spanish company Baia Food Co. (Medicinal Gardens S.L.)-in submitting the application for permission to use the miracle fruit as novel food, on 14.11.18 – sought protection of scientific data of industrial property for a number of its own, unpublished studies deduced in support of the application. In particular:
– compositional studies,
– A study of acute oral toxicity in rats,
– Bacterial reverse mutation test,
– An in vivo micronucleus assay in mammalian erythrocytes,
– An in vitro micronucleus assay with mammalian cells,
– An oral toxicity study with repeated dose administration for 90 days, with a recovery period of 14 days, and
– A sensory study.
Novel food exclusively
The European Commission considered EFSA’s claims that the risk assessment was not possible without the applicant’s proprietary studies. And so decided to exclusively restrict to Medicinal Gardens S.L. both the authorization of the dried fruits of Synsepalum dulcificum and the right to report on the studies contained in the file, for the duration of five years.
Other operators may still apply for marketing authorization of the miracle fruit, ‘provided the application is based on legally obtained information supporting such authorization.’ Including, it is worth adding, studies published in scientific journals.
Among other things, it is possible-as Medicinal Gardens S.L. has not done, perhaps for the very purpose of obtaining exclusivity (5)-to use the simplified procedure provided for the notification and/or authorization of traditional foods from third countries. (6)
Non-patentability of plants and animals
The European Commission’s Communication (2016) on the application of Directive 98/44/EC on the legal protection of biotechnological inventions, it is recalled, clarified that:
– ‘Article 4 of the directive deals with the patentability of plants and animals, and specifically excludes plant varieties and animal breeds from the scope of patentable material. It also states that “essentially biological processes of plant or animal production” are not patentable.’ (7)
Novel Food discipline, areas for improvement
Reg. EU 2283/15 has undoubtedly facilitated the process of approval of novel foods in the European Union, compared with the former reg. EC 258/97. As evidenced, among other things, by the significant increase in permits issued over the past five years.
A critical element however, is constituted, in the opinion of the writer, by the granting of exclusive authorizations-comparable to industrial property rights-on traditional foods from third countries or otherwise available in kind, outside of cases where the resulting products have distinctive characteristics due to manufacturing processes covered by patents.
‘The critical element for the patentability of a plant or animal is the technical process, such as the insertion of a gene into a genome. Essentially biological processes are not technical in nature, therefore, according to the position taken by the legislature, they cannot be patentable’ (7,8).
Dario Dongo and Andrea Adelmo Della Penna
Notes
(1) Reg. EU 2021/1974, authorizing the placing on the market of dried fruits of Synsepalum dulcificum as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470. EUR-Lex, http://data.europa.eu/eli/reg_impl/2021/1974/oj
(2) Kenzo Kurihara and Lloyd M. Beidler, Taste-Modifying Protein from Miracle Fruit, in Science, vol. 161, no. 3847, Sept. 20, 1968, pp. 1241-1243, DOI:10.1126/science.161.3847.1241
Sadhana et al. (2020). Synsepalum Dulcificum: A Review. Int. J. Res. Pharm. Sci. 11(3):4208-4213, https://doi.org/10.26452/ijrps.v11i3.2629
(3) Akinmoladun et al. (2020). Nutritional benefits, phytochemical constituents, ethnomedicinal uses and biological properties of Miracle fruit plant (Synsepalum dulcificum Shumach. & Thonn. Daniell). Heliyon 6:e05837, https://doi.org/10.1016/j.heliyon.2020.e05837
(4) EFSA NDA Panel et al. (2021). Safety of dried fruits of Synsepalum dulcificum as a novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal 19(6):6600, https://doi.org/10.2903/j.efsa.2021.6600
(5) A similar case is that of the mung bean(mung bean), whose exclusive authorization for placing on the EU market as a novel food was requested and obtained by the California company Eat Just (see previous article)
(6) Regulation (EU) 2015/2283, On novel foods and amending Regulation (EU) No. 1169/2011 and repeals Regulation (EC) No. 258/97 and Regulation (EC) No. 1852/2001, see Article 3(1)(b) and (c), and Articles 14-20. Text updated as of 3/27/21 on Europa-Lex, https://bit.ly/3I0Zf3X
(7) Commission Notice on certain articles of Directive 98/44/EC of the European Parliament and of the Council on the legal protection of biotechnological inventions (C/2016/6997). On Europa-Lex, https://bit.ly/2ZyZiTb
(8) Directive 98/44/EC on the legal protection of biotechnological inventions. https://bit.ly/3DZX26t
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.
