As regulatory pressures mount, businesses are increasingly taking a proactive stance in challenging decisions.
The regulatory landscape for 2025 may be more litigious and scrutinized, where companies are no longer passive recipients of decisions but are actively contesting them in court, Brian Kelly, partner at Covington & Burling, told NutraIngredients.
“We’ve seen companies more willing to hold the European Food Safety Authority (EFSA), the Commission and national authorities to account in how their ingredients are assessed, with the courts appearing more interested in interrogating matters,” he said.
‘Threats and delays’
The industry faced a turbulent 2024, marked by regulatory inconsistencies, mounting legal challenges and growing concerns over ingredient safety, according to Dr. Mark Tallon, managing partner at the food law firm Legal Foods.
He said the year was defined by “threats and delays” as businesses grappled with fragmented enforcement across the EU in areas like botanical claims and traffic light labeling, creating barriers to the free movement of goods.
“Now, pressure continues to rise in a bid to force the Commission to adapt the current legal frameworks, which in many cases distorts free movement,” Dr. Tallon said.
Furthermore, concerns about ashwagandha’s safety have surfaced over the past couple of years, especially after negative reports from the World Health Organization (WHO), the Technical University of Denmark (DTU) and the German Federal Institute for Risk Assessment (BfR).
However, according to Dr. Tallon, the most impactful report came from the Heads of Food Safety Agencies (HoA) Working Group on Food Supplements.
Although the HoA includes representatives from 26 member states, the report appears to be most influenced by Germany. It lists 117 substances, including ashwagandha, that should not be used in food supplements due to potential health risks.
“We believe this will now be looked at closely in the development of additional restrictions applied to botanicals in 2025,” Dr. Tallon said.
“This may begin with ashwagandha of which the UK FSA has already closed a consultation (call for evidence) on safety.
“Industry must now fight back and begin to develop its dossiers to prove safe use in a manner that is not reactive to any final conclusions. If the defense is left too late, then we may see consumer choice significantly limited in regards to plant substances.”
However, he also explained there were some “notable wins for those in industry that have decided they will no longer allow regulators to simply implement legislation in a manner not consistent with good legal interpretation.”
In the UK, a critical ruling clarified that the term “raw” in relation to honey is not misleading, a decision that is expected to have broader implications for EU regulatory interpretation.
“The take-home is that all honey is not created equal, and there is room for slight differences in standards that can result in certain claims,” Dr. Tallon said.
Similarly, the Administrative Courts in the UK quashed the Food Standards Agency’s (FSA) decision to classify luo han guo, a sweet fruit, as a novel food.
The court also recognized flaws in the FSA’s method for assessing pre-1997 consumption history, signaling a need for more rigorous and fair evaluations.
And in France, a contentious regulation mandating the Triman recycling logo on packed products, including food, raised concerns about hefty fines of up to €15,000 for legal persons.
“This was a major concern for business, and most including those we have advised applied the logo in the absence of a final infringement ruling against France for breach of mutual recognition,” Dr. Tallon said.
“The next step will be a referral to the European courts in early 2025.”
Regulatory changes in botanicals, probiotics and novel ingredients
Katia Merten-Lentz, partner at Food Law Science and Partners, told NutraIngredients that last year was one of as-of-yet still pending changes, with a particular focus on clearer labeling, health claims for botanical ingredients, and probiotics.
As she explained, The European Parliament (EP) took a critical step in January 2024, adopting a resolution disapproving the continued suspension of evaluations of botanical health claims.
The EP highlighted legal concerns over the prolonged use of “on-hold” claims under the Nutrition and Health Claims Regulation’s transitional measures and emphasized the urgency of reviewing these claims for consumer protection.
The resolution urged the EFSA and the European Commission to expedite the review process.
Additionally, the Court of Justice of the European Union (CJEU) began deliberating whether advertising health claims for botanical substances is permissible when no decision has been made regarding their inclusion in authorized lists.
“The advocate general’s opinion suggests that such claims are precluded under current regulations, though the court’s final ruling is pending,” Merten-Lentz said.
The probiotics sector also saw developments, with the International Probiotics Association (IPA) challenging the lack of a clear regulatory framework.
“Although the European Commission’s 2007 guidance categorizes the term ‘probiotics’ as a health claim, this interpretation has faced resistance, with some national authorities permitting its use,” Merten-Lentz said.
“In response, IPA filed a complaint with the Ombudsman to urge a reassessment of this guidance or its interpretation.”
In terms of finalized decisions, 2024 saw the approval of several novel ingredients, demonstrating the continuous trend for innovation in fields like anti-aging, beauty, menopause and weight management.
These approved ingredients include:
- Monosodium salt of L-5-methyltetrahydrofolic acid
- Beta-glucan from Euglena gracilis microalgae
- Escherichia coli W (ATCC 9637)
- Water lentil protein concentrate
- Calcidiol monohydrate
- Lacto-N-fucopentaose I and 2′-Fucosyllactose mixture produced using a derivative strain of Escherichia coli K-12 DH1
- Ashitaba stem juice
- Magnesium L-threonate
- Trimagnesium dicitrate
Furthermore, new guidance from EFSA was published to make it easier for food business operators to navigate the Novel food procedure.
This included guidance on both the scientific requirements for an application for the authorization of a novel food and for notification and application for the authorization of traditional foods from third countries.
EU MPLs, novel food regulation and nutrition claims
Last year was a mixed one for the supplement sector according to Luca Bucchini, managing director at Hylobates Consulting Srl.
He criticized France’s proposal on Maximum Permitted Levels (MPLs) for vitamins and minerals as “a proposal with such shallow scientific and legal foundations the likes of which had not been seen in decades.”
Similarly, the European Union’s MPL discussions have been criticized for unnecessary and unjustified secrecy, with leaked proposals failing proportionality standards.
Furthermore, the Novel Food Regulation continues to hinder innovation, said Bucchini, and the Nutrition and Health Claims Regulation, heralded as an international model when published back in 2006, “has not been working for years.”
However, some positives emerged, such as the General Court of the EU overturning the Commission’s stance on aloe and other plants, which Bucchini noted signaled a push for fair and balanced regulation.
The UK court decision affirming that monk fruit infusions are not novel foods also demonstrated legal support for the sector, he explained, as did Member States adopting a more balanced approach to novel food status decisions.
“I hope 2025 will bring some welcome rethinking on botanicals from the Commission and a better approach to levels of vitamins and minerals as the European Union ponders how to remain competitive,” Bucchini said.
Regulatory uncertainty challenges businesses on sustainability
According to Dominic Watkins, partner at Global Regulatory Compliance and Investigations, last year saw a “tsunami of incoming law for food businesses to deal with,” with many focused on sustainability.
Often, these laws face last-minute delays after businesses have already spent months and resources preparing for compliance, he explained.
“Ultimately, the conclusion was if it is too hard let’s just delay it, usually at the last minute and usually after those impacted have been trying to comply for many months.
“They are then left wondering, will this come into force at all, and have I just wasted all that money on compliance?”
The previous UK Government “were particularly guilty of doing this in a huge way with most environmental policy,” he added, however, the new government, in an attempt to tackle some of the laws, has shown a tendency to introduce them unexpectedly.
In contrast, the EU has reopened and revised existing legislation, which has led to a different kind of uncertainty.
“The newly constituted EU Parliament and EU bodies appear to want to reopen laws and change what has already been agreed,” Watkins said.
For example, the EU Deforestation Regulation faced practical delays due to unresolved issues with the mandatory tech system, but additional proposed changes further disrupted trust in the process.
Now, businesses are facing similar uncertainty with the potential revision of directives like the EU’s Corporate Sustainability Reporting Directive (CSRD) and the Taxonomy Directive before full implementation, which Watkins notes undermines the incentive for businesses to proactively comply with laws, as there is no assurance the regulations will remain stable.
“All eyes are on what will happen with the so-called ‘omnibus’ directive,” he said. “If this occurs it will again undermine certainty and trust in the law being agreed.”