Europe's Novel Foods crossroads
The experts agree that Novel Foods assessments have become a real headache for this industry.
Mark Tallon, chief executive officer at Legal Products Group Ltd, argues EFSA is moving further and further towards a "pharma model of safety assessment" of novel food applications in the EU.
He says "no more evidenced as their new requirements for hemp-based novel foods assessment" as EFSA expects food businesses to provide NMR (Nuclear Magnetic Resonance) spectrometry which is an analytical chemistry technique used in quality control and research for determining the content and purity of a sample as well as its molecular structure. He added that they also expect physical properties such as optical rotation "which have almost zero history in prior plant based novel foods submissions".
"In addition, EFSA requests 1000s of additional animal deaths (Ignoring the 3R approach to such testing) and extensive human data in order to demonstrate safety. If unchallenged this suggests a new bar is set for any botanical-based substance looking to gain a foothold in the EU unless a traditional food.
"If ever there was a case for scientific over-reach this, is it. It will be interesting to see if food business will press for legal challenges to overturn such requirements in 2023 or accept the new financial costs in the millions of Euros.
"It should be noted industry failed to convince the Commission hemp extracts have a history of food use despite all their press releases that there was food use. Next the trade associations face EFSA and their CBD novel foods submission.
"Hundreds of businesses are pinning their hopes on approval and promises by funding trade associations with no history of novel foods submissions to gain them access. In addition, such dossiers of combined products have never been submitted for a novel foods assessment.
"If approved this will be a return to substantial equivalence in all but name. All these barriers may be good news for the UK and its economy as the FSA seems to have taken a different view on what data is required but only time will tell. Let’s hope 2023 can result in the use of novel ingredients."
Luca Bucchini, managing director at Hylobates Consulting, agrees that there has been 'overzealous' assessments in this space.
"In our industry, this regulation has been ignored for its first decade, then become of interest to few innovative brands and to boring regulatory experts," he says. "Now, thanks to German courts, to ambiguous wording, and overzealous authorities in some Member States, it has become a major threat to industry, often unperceived.
"It has a legitimate place to protect consumers and innovation, but it should only be used with public health in mind - when a novel food application would provide useful information, such as toxicology, to bear on the use of a food substance. In 2023, I expect that the novel food regulation will emerge as an even bigger concern for the industry, as regulators will continue to apply it with administrative zeal."
UK shows its divergent stripes
Tallon points out that the UK is starting to "show its divergent stripes" after Brexit.
"At the UK level we have seen divergence already from the EU with differences in the manner of marking of copper, scientific divergence over additive safety and indeed to this point divergence over what is required for novel foods approval.
"This divergence is only set to expand with the Retained EU Law (Revocation and Reform) Bill, who will allow UK courts to depart from EU law more easily, provide ministers the power to revoke, replace or retain EU law and seek from what we see in recent FSA discussions to the removal of all EU law by the end of 2023.
"Underestimate this Bill to your peril as it will involve over 2,400 pieces of legislation, 300 policy areas and 21 sectors of the UK Economy of which Food is a biggy.
"The concern, as always, is whether this will result in a race to be bottom as regards food standards. Perhaps in the case of novel foods this may not be a bad thing. And the same goes for 13(5) health claims which are now almost non-existent in terms of new submissions."
Patrick Coppens, director scientific and regulatory affairs at Food Supplements Europe, notes that the Commission is increasingly using the Article 8 procedure of Regulation 1925/2006 to restrict the use of certain substances in food supplements.
"We have seen the prohibition of the use of Aloe in the past and this year restrictions for monacolins from red yeast rice and green tea catechins. These restrictions are driven by a cautious interpretation of the opinions by the European Food Safety Authority, which are not conclusive because of the many gaps in the knowledge database.
"Candidates for the next years are alpha-lipoic acid, fennel and plants containing berberine and hydroxycitric acid. Gathering safety data is important to safeguard the use of these and other substances in future."
Bucchini agrees that botanicals will face another difficult year in 2023, from a regulatory perspective.
"With the curcumin situation in Italy still unsolved, it is hard to disagree that proper scrutiny is warranted, but, when considering the many issues with the regulation of herbal medicines also on the safety side, there is a fair concern that an unjustified pro-pharma bias will lead regulatory efforts. This makes the dream of a single market for botanicals to rival the US even more distant, to the benefit of none."
Harmonised maximum limits
Harmonised maximum permitted limits for vitamins and minerals have been moving forward in 2022, albeit without much fanfare.
Coppens confirms the current key dossier is the Commission’s work on the setting of maximum levels for vitamins and minerals for food supplements across the EU by 2024.
"This is likely to affect 30-40 % of all food supplements and the impact may be considerable in terms of reformulation and label changes, especially when the levels agreed would not be based on safety," explains Coppens.
"FSE has developed over the years a solid risk management methodology based on real intake data and EFSA’s Upper Tolerable Intake Levels as cornerstones to guide regulators on levels that are considered safe. This model has already been influential outside the EU (e.g. in South East Asia)."
On a positive note, Coppens says one major highlight of 2022 was the organisation of the “Food Supplements in the EU, Where Next?” conference in November during which the results of the IPSOS survey were presented.
"This survey, commissioned by Food Supplements Europe requested 13,200 adult consumers in 14 EU countries about their supplement usage. The findings demonstrated that consumers in the EU use food supplements responsibly, following the instructions for use and looking at the label to ascertain the recommended dose and frequency of use. More than two-thirds of respondents said they agreed that the ingredient information provided on labels is easy to understand and nearly three-quarters agree they were confident in the safety and quality of food supplements.
"This research, conducted by IPSOS, shows that the concerns held by some governments that food supplements are widely misused by consumers are unwarranted."