At the upcoming Active Nutrition Summit hosted by NutraIngredients, Luca Bucchini, managing director of Hylobates Consulting, will be discussing how to “navigate the noise” in a session on the latest regulatory updates, the main challenges brands face when balancing innovation and compliance, and the best practices are for transparent communication.
Speaking with NutraIngredients ahead of the summit, Bucchini said novel food regulation in both the EU and the UK plays a key role in food safety, but its scope is overly broad, its interpretation and application are stricter than safety alone demands, and approval timelines are excessively long
He noted that if the European Food Safety Authority (EFSA) and the Commission were to allocate resources more efficiently, keep the application process proportionate and focus on safety, it would significantly reduce approval times—providing an opportunity for the EU to reposition itself as the go-to global hub for novel food approvals.
“Many companies used to go to the US first for a GRAS affirmation or an NDI notification and then go for Europe while leveraging the steps taken in the US internationally,” he added.
If the EU were to reform its process and establish itself as primary market for novel food approvals, companies may shift focus from the US to Europe given current regulatory uncertainties in the US.
Unfortunately, regulatory changes affecting sports nutrition products seem unlikely in the near future given the EU’s strict stance on health and performance claims.
“There is little appetite for food law reform in these uncertain times,” Bucchini said.
Regulatory harmony?
While the EU once strongly pushed for harmonizing food and supplement regulations, that momentum faded about 15 years ago. Since then, the European Commission has reportedly shown less interest, Bucchini noted, with European countries struggling to reach consensus on new frameworks.
“Member States have very different levels of enforcement and widely different interpretations that case law often does not resolve,” he said.
Even though some states continue to undermine the consistent application and interpretation of EU law, the market itself drives harmonization, Bucchini explained. Since many countries evaluate the same products, there is a natural push toward uniform application of EU rules, and therefore if a company legally sells a product in 26 Member States, it is much harder for the 27th to reject it as non-compliant than if it were only sold domestically.
“I think we have to hope that the Commission understands that a competitive EU needs a Commission that acts forcefully as guardian of the treaties,” he said.
Furthermore, the UK’s regulatory divergence from the EU continues to directly impact the sports nutrition market, especially for manufacturers working in both regions.
Initially, the UK’s push for a “not for EU” label caused significant disruptions, however now most concerns stem from the EU side, particularly around the maximum permitted levels for vitamins and minerals, Bucchini said.
Manufacturers are also facing challenges due to inconsistent enforcement, which is driving up compliance costs in an already competitive market, both within the EU and between the EU and UK.
“As we move forward, with potential rules in the EU on vitamin levels and diverging approvals of novel foods, we may see more challenges for manufacturers,” Bucchini said.
The rise of holistic health management
While traditional sports supplements like protein powders, creatine and branched-chain amino acids (BCAAs) remain popular, there is a growing interest in alternatives like adaptogens and nootropics, a trend driven by a broader, more holistic view of athletic performance that includes mental resilience, recovery and long-term health.
However, as these non-traditional ingredients gain traction, regulatory frameworks in the EU are unlikely to undergo major changes to keep up, at least in the near term, Bucchini said.
While companies and regulatory authorities are actively assessing which frameworks are best suited to these emerging products, it may be medicinal regulations that that restrict the legal marketing of certain nootropics and serve as the primary enforcement tool.
But for now, Bucchini said food supplement law continues to serve as the main regulatory category, although it raises complex issues around product composition and marketing claims, especially as companies test the limits of what qualifies as a food supplement.
“The challenges follow in terms of composition and claims when the boundaries of what a food supplement is are pushed,” he added.
Regulatory challenges of personalized nutrition
Consumers are also driving a surge in personalized nutrition, demanding tailored sports supplements based on their genetic makeup, microbiome and performance data, and while European regulations currently address some aspects of personalized nutrition through existing legal tools, challenges remain under the current framework.
Certain issues require interpretation or additional guidance, possibly from the industry or the EU, even if not through new regulations, Bucchini noted.
“There are real questions and it is an area where some interpretation is necessary, or perhaps industry or EU guidance, although not in the form of a regulation,” he said.
“It’s an interesting area, and I look forward to seeing more ideas and innovation put forward in this area. Health is perhaps more advanced right now, and sports nutrition may learn from other sectors to personalize effectively the combination of personal evaluation and nutrition.”
Tickets are now available for the Active Nutrition Summit, where industry experts will delve into regulation and explore many other session pillars in active nutrition.