GOED Commitee

Date: 31 January 2023

EU Novel Food Regulation – DHA and EPA Ethyl Esters Oil from Schizochytrium sp.
Microalga

 On 14 December 2022, the Food Safety Authority of Ireland (FSAI) published its opinion that
‘DHA and EPA ethyl esters oil from Schizochytrium sp. microalga’ are outside the
specifications of the authorised novel food in the Union List and therefore must be authorized
before placing them on the market.
 Article 4 of the novel food Regulation (EU) 2015/2283 requires food business operators to
verify if the food they intend to place on the EU market falls within the scope of the novel food
Regulation (EU) 2015/2283. That is, is the food novel or not.
 If after considering all the information available food business operators are still unsure about
a food as novel, they may consult the competent authorities of the EU country where they first
intend to place the food (called ‘the recipient EU country’) on the market. Commission
Implementing Regulation (EU) 2018/456 lays down the information requirements that need to
be included in the consultation request, including provisions on the confidentiality of the
request, and the procedural steps business operators must follow for the consultation process.
 Once the recipient EU country reaches its conclusion on the novel food status of a food, the
Commission will publish that information on the Commissions website.
 Paul: This is not surprising to me.
 Hywel: Does anyone know whether that applies if you pass through EE stage and
reformulate to triglycerides (i.e. rTGs)?
 Jose: If you read letter from FSAI, it mentions that the EE form does not meet TG
specifications, so I assume that if you reesterify and meet the specifications in the Union list
that it should be ok.
 Harry: So it doesn’t seem to be about the manufacturing process as long as you meet the
specifications?
 Jose: Yes, that’s my interpretation.
 Geeta: If you read the novel food opinion, the manufacturing process is specific to just algal
oil grown in media, extracted and refined, so the specification for the TG form is specific to
the manufacturing process written, but it could be interpreted differently base on the FSAI
opinion.
 Paul: Does the means to an end matter?
 Bill: For clarification, the TG form is found in nature; whereas, the EEs are not, so that
would be the argumentation why the rTG form would be ok?
 Jose: Yes. The FSAI opinion is that the EEs are not authorized based on the novel food
specification.
 James: The first time I read the opinion, I wondered what this meant for rTGs. I think it may
remain unknown until someone approaches the authorities and asks the specific question
about rTGs.
 Paul: Or puts it on the market and sees how far they can go with it.
 Kristine: The scope of the approval specifies TGs, so even if you meet all the specifications,
but it’s an EE, then it would not be allowed?
 Paul: Yes, it seems to be about the form. In the United States, EEs determined to be a new
dietary ingredient (NDI) and in Canada hits expected to be the same.
 Oliver: I would agree. The interesting part is the rTG. I would expect that the rTG would not
be covered by the existing novel food catalog entries for the TG algal oils. If you look into
the manufacturing process, and that manufacturing process involves novel foods, then I
don’t think you can circumvent that by taking an intermediate step via an EE. As long as it’s
not covered by the novel food, then I don’t think it will get anyone anywhere.
 Hywel: An interesting philosophical question is whether you can take a novel food and turn
it into a non novel food?
 Jose: So when do novel foods become traditional foods?
 Oliver: No more. I think 1997 was the date. I don’t think that’s possible anymore.