New guidance for submitting novel food applications in the EU should help to speed up the risk assessment process, according to the European Food Safety Authority.
Mandatory for ingredients without a history of consumption in the EU prior to 15 May 1997, novel foods authorization enables companies to bring truly innovative food supplements to market. New sources of minerals like iron, insect preparations and a mushroom powder containing vitamin D2 have all been authorized for sale as food supplements through this route, while numerous applications for approval of cannabidiol in supplements are currently being assessed.
“The updated guidance should help streamline the application process by making the requirements clearer and reducing the chances of missing information,” commented EFSA scientific officer Ermolaos Ververis.
With the novel foods regulation having been in place since 2018, EFSA has “learnt a lot” from assessing applications in that time, Ververis explained. “This experience helped us clarify definitions and data requirements, so applicants can submit higher-quality applications, which in turn should lead to a more efficient risk assessment process.”
More Detail
Indeed, the main change introduced by the new guidance is more detail on the information and data required by companies when submitting an application, according to Dr Mari Eskola, team leader, regulatory science and reports at consultancy Oy Medfiles Ltd.
“EFSA gives more details to guide the applicant towards what it wants,” Eskola said, which will in particular benefit those attempting to navigate the safety assessment process for the first time.
“Since the novel food regulation, which describes the data requirements, did not change, the data requirements in the new guidance did not change either. They are only more detailed now,” Eskola told HBW Insight.
Eskola – who previously spent 10 years at EFSA carrying out risk assessments of contaminants in foods and feeds – said she is hopeful that the additional details shared by the agency will help companies to “submit the correct data already in the first dosser submission and not to go back and forth many times in order to satisfy EFSA.”
Dr Jérôme Le Bloch, head of scientific affairs at consultancy FoodChain ID, told HBW Insight that the setting out of more detailed requirements for applicants in the guidance represents “huge progress” by EFSA towards increased transparency.
However, in listing the information it expects companies to provide, EFSA has highlighted “the difficulty of such applications,” Le Bloch argued. “EFSA has increased once again the level of requirements, and this may be discouraging for many companies.”
Le Bloch bemoaned a lack of clarity from EFSA. “Of course EFSA cannot anticipate all specific cases, but the guidance remain too general, and lacks concrete information. It’s not possible to submit a pertinent application based only on the guidance, and experience is still needed for that.”
“It’s better for me, as companies still need support from consultants,” he said candidly, “but being too general is not acceptable. This will lead to applications which will require years of evaluation due to this lack of precision.”
While offering a more favorable view of the guidance, Eskola emphasized the need for companies to seek out expert advice when trying to navigate the application process. “It is good to remember that EFSA guidance is guidance and not a rule book. So, the better you know the risk/safety assessment process, the easier it is to conclude which data are actually needed. Not all data which EFSA lists are necessarily needed to demonstrate safety.”
Major Differences
According to Le Bloch, the new documents have “many major differences compared to previous guidance” which companies must navigate when preparing an application.
“It’s not possible to list all new requirements, but overall, it will be harder to obtain an approval as EFSA requires more and more data,” he argued.
To illustrate this, Le Bloch pointed to the section on compositional data – describing accepted analytical methods and how to address compositional variability – within the scientific requirements guidance. “Accreditation of laboratories performing analyses should be provided as before, but now it is also mandatory to show that the matrix analyzed is in the scope of the accreditation. Overall, EFSA requires [applicants] to have justification for everything, for instance the parameters selected for specifications, or the selection of batches for variability analysis.”
Furthermore, Le Bloch observed that the accompanying administrative guidance for the preparation of an application also introduces “major changes” to both the suitability checklist – used by applicants to verify that all the information that should be submitted to EFSA is provided – and in the appendix which summarizes the findings of toxicological studies.
In Vivo Studies
“I think EFSA is going in the right direction trying to reduce in vivo toxicological studies,” Eskola commented.
“Very careful considerations need to be made prior to embarking on any in vivo toxicity studies,” she pointed out. “EFSA lists several in vitro studies which have to be done first and also literature data need to be comprehensively assessed. Also, full compositional data need to be submitted.”
“With this EFSA tries to avoid any unnecessary animal toxicity studies in line with the 3R principles (replace, reduce and refine). Recently, EFSA mentioned in one of its communications that if unnecessary animal studies are submitted, it will note this down in the scientific opinion. This also impacts the data protection granted by the European Commission as if the study was not needed to establish safety, it will not get the data protection status.”
Alongside the updates to toxicology requirements, Eskola also highlighted the need for applicants to include information on compliance with the EU food contact material (FCM) regulations for materials used in manufacturing, as well as Whole Genome Sequencing (WGS) data (FASTA files) on a routine basis.
Both Eskola and Le Bloch pointed out that much more detailed information on allergenicity is now required by EFSA.
“This section in the new guidance has expanded a lot. The reason to this is the hype [related to] alternative proteins. Thus, is it very understandable from the safety viewpoint that more data on immunotoxicity and/or allergenicity are therefore needed,” Eskola explained.
Le Bloch noted that for protein sources EFSA has completely reviewed the part of the guidance covering to allergenicity. “It simplifies and clarifies the requirements for products for well-known sources. However, for ingredients from sources for which allergenicity is not known, a deep assessment of the risk of allergic reaction is needed.”
With the updated guidance EFSA has provided applicants with more detail, especially on scientific requirements. But are their gaps that still need to be addressed?
“For future guidance I wish to have more detailed information on methods for allergenicity testing, omics methods and new approach methods (NAMs) for toxicity studies,” Eskola said. “EFSA was not able to do these in the new guidance because loads of scientific improvements in these areas are still needed including their reliability and validation of these methods.”
