The placing of microalgae and other novel foods on the single market must contend with the complex Novel Food regulations, which can be simplified, at least in part, by EFSA’s qualified presumption of safety of microorganisms. Insight.
Qualified presumption of safety
Qualified presumption of safety (QPS) is the method introduced by EFSA to optimize risk analysis on microorganisms used in agribusiness and feed supply chains.
To this end , the European Food Safety Authority, in assessing the safety of microorganisms used in products under a centralized authorization procedure (e.g., the plant protection, food and feed additives, novel food):
– Assesses the safety of the microorganism in relation to its intended use. Based on scientific and grey literature, as well as where appropriate studies and analyses produced by the applicant,
– identifies the taxonomy of the biological agent(taxonomic identity) and ascertains the absence of safety problems,
– places the microorganism on the QPS list(list of QPS-recommended biological agents for safety risk assessments carried out by EFSA).
QPS list and risk analysis
The inclusion of a microorganism on the QPS list allows EFSA to presume its safety, based on the data already collected and the previous evaluation that followed.
Risk analysis(risk assessment, RA) is thus optimized, applying a protocol that avoids repetition of work already performed on the same taxonomic biological unit.
Subject, of course, to the possible need to extend the risk assessment to uses or methods of use of microorganisms other than those already considered.
Microalgae, Novel Food and QPS List.
Three microalgae on the QPS list-Tetraselmis chuii, Euglena gracilis, and Haematococcus lacustris (or Haematococcus pluvialis)-have already been approved as novel foods. (2) In these cases, the qualified presumption of safety operates only for production, in the absence of data on direct exposure to humans and animals. (3)
The microalgae in question have been approved in the following forms and for the following uses:
– Tetraselmis chuii, in freeze-dried form, for making sauces and condiments, special salts, and food supplements. Without exclusive right (4.5),
– Euglena gracilis is authorized in dried form in granola and cereal bars, protein bars, yogurt and yogurt drinks, fruit juices and nectars, fruit-flavored beverages, meal replacement drinks, and whole food daily ration replacements for weight control, and dietary supplements. With exclusivity in favor of Kemin Foods L.C. until 12/23/25, (6)
– Haematococcus pluvialis, in astaxanthin-rich oleoresin form, for use in dietary supplements only. (7)
Preliminary Conclusions
The QPS approach – while distant and not comparable to the qualification of GRAS (Generally Recognized As Safe) by FDA (Food & Drug Administration, USA)-is a useful tool to speed up the process of evaluating the safety of microorganisms and products containing them, even to the benefit of operators other than the first applicants.
The QPS list, adopted by the EFSA Panel on Biological Hazards (BIOHAZ) in 2007, was last updated in January 2022.
Dario Dongo and Giulia Torre
Notes
(1) EFSA. Qualified Presumption of Safety. https://www.efsa.europa.eu/en/topics/topic/qualified-presumption-safety-qps
(2) Dario Dongo, Giulia Torre. Microalgae for food use and Novel Foods regulation, the state of the art in the EU. GIFT (Great Italian Food Trade). 29.1.22, https://www.greatitalianfoodtrade.it/progresso/microalghe-per-uso-alimentare-e-disciplina-dei-novel-foods-lo-stato-dell-arte-in-ue
(3) L. Herman, M. Chemaly, P. S. Cocconcelli et al. (2019). The qualified presumption of safety assessment and its role in EFSA risk evaluations: 15 years past. FEMS MIcrobiology Letters, 366, 2019.
(4) Reg. EU 2017/2470 as amended, Establishing the Union list of novel foods under Reg. EU 2015/2283 on novel foods (novel foods). Text updated 3.3.22 on Europa-Lex, https://bit.ly/3w7qC78
(5) Tetraselmis Chuii is one of four microalgae species considered in the #ProFuture research project-along with Arthrospira [Spirulina] platensis, Chlorella vulgaris and Nannochloropsis oceanica-in Horizon 2020. V. Dario Dongo. ProFuture, microalgae to feed the planet. The EU research project. GIFT (Great Italian Food Trade). 6/18/19, https://www.greatitalianfoodtrade.it/progresso/profuture-microalghe-per-nutrire-il-pianeta-il-progetto-di-ricerca-ue
(6) Dario Dongo, Andrea Adelmo Della Penna. Microalgae, Euglena gracilis. Superfood with exclusive. GIFT (Great Italian Food Trade). 10.1.21, https://www.greatitalianfoodtrade.it/innovazione/microalghe-euglena-gracilis-superfood-con-esclusiva
(7) Reg. EU 2021/1377
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
Graduated in law, master in European Food Law, she deals with agro-food, veterinary and agricultural legislation. She is a PhD in agrisystem.
