My project is on the production of a novel beer using non-traditional yeasts. At later stages, we are considering large scale production and commercialization.
The issue is, some of the yeast species that I am working on are not present in the Qualified Presumption of Safety (QPS) list of the European Food Safety Authority (EFSA), or in the Generally Recognized as Safe (GRAS) list of FDA. Although, there are articles and/or patents on their use for beer/wine production and they are present in IDF/EFFCA inventory of microbial food cultures.
The sources I found are a little confusing as I am not very familiar with this process.
My main question is, is having a QPS or GRAS status necessary for a species for their use in commercial production?
For a deeper understanding, my further questions are:
- Is it the same for filtered beer, even if the microorganism will not be in the final product?
- If we apply for QPS/GRAS, how long the process takes? - From my understanding, EFSA is updating their evaluation every 6 months, and their list every 3 years. Therefore, if I apply for a new species, the earliest possible approval would be in their next list?
- Should we apply for QPS/GRAS for a new strain of a QPS/GRAS species if we want to commercialize?
- If the new species belong to the same genus, would it help with the process? (For example, Lindnera jadinii is on the list, would it make it easier for Lindnera saturnus?)
- Is the absence of toxic/harmful effects on the human, animal, environment is sufficient for this status, or are clinical studies required?
- Would Anamorph/Teleomorph names of the same species in the list make any difference?
Thank you very much for all your help in advance.
Also check https://www.tandfonline.com/doi/full/10.1080/21645698.2019.1649531
Yeasts are natural. Looks like it might be still complicated if the yeast or product is considered 'novel'.
The regulations for commercialization of a beer made with our strains are easy to get lost within and get confused. So, I wanted to gather what I could find in the past two days.
Direct quotation from this article: https://www.ifis.org/blog/legal-status-microbial-culture
"Microbial food cultures within the EU are regulated as an ingredient and their inclusion on food labelling is mandatory, but only when the culture ends up being consumed in the final product. This is not the case for microbial food cultures used in certain technological processes, such as fermentation or ageing."
Another quotation from this article: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5488099/
"FC used for the fermentation of food is not subject to EU premarketing regulation, unless it is regarded as being novel to the EU market and its consumers."
From my understanding, if living organism is in the final product, the EU premarketing regulations apply. If not, it can be marketed with the standard regulations.
Another quotation from the NCBI article above:
"Novelty in this context means food not consumed to a significant degree within the Community before 14 May 1997 [6]. If that is the case, then the food has to comply with the updated Novel Food (NF) regulation EU 2015/2283 [7] repeating the aim from 1997 saying: “The novel foods and food ingredients concerned by this regulation are those which are not yet currently used for human consumption. This regulation applies to foods and food ingredients in the following categories: (…) foods and food ingredients which consist of microorganisms, fungi or algae (…)”. An NF has to undergo a pre-market evaluation and authorisation procedure including risk assessment by the EFSA and risk management by the EU Commission before it can be placed on the market."
From the definition part of the regulation EU 2015/2283: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32015R2283
"(...) The following definitions also apply:(a) ‘novel food’ means any food that was not used for human consumption to a significant degree within the Union before 15 May 1997, irrespective of the dates of accession of Member States to the Union, and that falls under at least one of the following categories: (....) (ii) food consisting of, isolated from or produced from microorganisms, fungi or algae; (...)"
Therefore, it is necessary to check if the microorganisms are novel or not.
Here is a small guide about it: https://ec.europa.eu/food/safety/novel_food/
And, please correct me if I'm wrong, looks like if it is decided that the food or microorganism is 'novel', EFSA and QPS evaluation is necessary as a part of premarketing regulations whether microorganisms are present in the beer or not. Other safety statuses might be taken as a reference, but they are not binding.
Still, it is very easy to lost in all the regulations and laws, especially if one does not have any experience with them in the past. This is just a brief summary of what I could find and able to understand. I would really appreciate if you let me know any missing points, or misunderstandings.
Best.
Edit: If the microorganisms are in the final beer and have potential probiotic properties, there should be further evaluations, like health claims etc. It gets more complicated from there.
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