Regulatory experts 2023 review: Market primed for runaway success but path laden with hurdles

Giving her thoughts for NutraIngredients’ end of year regulatory review, Livia Menichetti, Director General at The European Federation of Associations of Health Product Manufacturers (EHPM), asserts that one of the most significant challenges for the sector in 2023, is the partial harmonisation of the regulatory landscape and the different national approaches to the implementation of the Novel Foods Regulation.  

Novel Foods

“Member States have divergent approaches on what constitutes acceptable proof of consumption before May 1997," Menichetti explains, "which in some occasions leads to legal uncertainty on products already on the market and overall creates barriers to trade." 

David Pineda Ereño, Managing Director DPE International Consulting, notes that during 2023 the European Commission (EC) regularly reviewed the Novel Foods Catalogue due to inconsistencies found on how Member States interpret the status of ingredients.   

“It is worth noting the striking case of many plants on the national lists of plants authorised for use in food supplements in Belgium, France and Italy​, which are now considered as novel ingredients due to the revisions undertaken particularly by Belgium," he asserts.  

EHPM has been supporting its members in collecting and sharing pre-1997 proof of consumption with European and National Authorities and has set up a dedicated task force to help FBOs navigate this. 

The EC has developed a new structure to present the information in the Novel Food Catalogue, published in November​.  

Setting maximum levels 

The setting of maximum levels of vitamins and minerals is said to be a priority for the EC (whose mandate ends next year).  

Menichetti explains that, apart from countries where specific national approaches exist (such as Ireland, Italy and France), the industry has been self-regulating over the past 20 years on the basis of European and international safety data "that have led to the production and marketing of safe, high-quality products".  

However, at the request of a group of Member States, the EC resumed work on setting maximum levels of vitamins and minerals, “a restrictive approach to the regulation of maximum levels could have a major impact on the food supplement market,” she argues.

Patrick Coppens, Director Scientific and Regulatory Affairs at Food Supplements Europe (FSE), explains this work has been ongoing for almost two years but no proposal is expected until the new Commission is in place next year, if at all.  

He asserts: “This is a critical issue for FSE, both in terms of securing the products that are currently sold in EU markets and ensuring that the EU is globally competitive in this area.” 

Luca Bucchini, Managing Director at Hylobates Consulting Srl, argues that some regulators at the EU level and at the national level are “failing to provide fit-for-purpose regulation” and predicts that harmonisation at the EU level seems likely to be “derailed”, meaning the industry can expect “the opening of a can of worms, with fallout in the coming years”. 

Article 8 procedure 

Article 8 authorises the European Commission (EC) to initiate the procedure to prohibit, restrict or put under Union scrutiny a substance that is used in foods, either on the EC's own initiative or at the request of Member States. 

Bucchini says the hope is that European Food Safety Authority (EFSA) will look at the scientific evidence in a balanced manner but he predicts “further harmonisation will remain elusive”, as "Member States traditionally opposed to food supplements show no flexibility and interest in finding common ground for the benefit consumers and of the EU's economy.” 

Pineda Ereño notes that the EFSA has been requested to carry out safety assessments on fennel, berberine or hydroxycitric acid, adding, “at the same time, other developments such as for example the ban of ashwagandha now in Denmark​ and the decision in Germany to consider ginkgo biloba dry extract as a functional medicinal product​, require a very close follow-up on the status and consideration of these and other botanical ingredients in the coming months in the EU.”  

Menichetti notes EHPM has collected data to support the safety of alpha lipoic acid and launched a vigilance pilot project to collect data in the context of the scrutiny period for monacolins from red yeast rice.

Botanicals 

Prohibition of Aloe preparations and restrictions on green tea extracts have resulted from safety assessments based on toxicological effects of pure substances rather than the matrix of the whole plant, argues Coppens, and he suggests Rheum, Senna, Frangula, Fennel, Berberis, and Garcinia may soon follow.   

He adds: “It has not been an easy year for this part of the supplement category, but FSE will continue to work hard to defend the category in regulation and policy.” 

Bucchini asserts: “The recent effort of the European Parliament's subcommittee on public health (SANT) to press the Commission for better regulation of botanicals - on claims, safety and quality - shows once more that there is a determined group of MEPs and of stakeholders that will block any attempt for proportionate regulation of botanicals.  

“This determination is in part to protect other industrial sectors; as a consequence, the initial effort has been blunted, or even reversed, despite the ponderous evidence.  

“Therefore, the difficult outlook for botanicals is not changed at the regulatory level unless the European elections and the new Commission see that a proportional solution at the EU level is the best outcome.  

“May 2024 bring BelFRIT, the joint harmonisation effort on botanicals of the last decade, back to life? Not yet, I would say. Even if this happens, expect furious opposition to any effort to regulate botanical claims and plants in a reasonable manner.”  

French DGAL 

In 2022, French authorities assigned the monitoring of missions related to food safety and the role of “single police​” in charge of food safety controls to the DGAL​ (Direction générale de l'alimentation)​. 

Bucchini argues this new body is proving to “an inexperienced regulator, with limited respect for EU law”. He adds: “Hopefully stakeholders will step in to improve the work of French regulators, who have an indispensable role in Europe.”  

He notes that the DGAL is bringing the regulatory approach of European Medicines Agency (EMA) to traditional medicines to food supplements and “the outcome will be interesting to watch.” 

Outlook for 2024  

In April 2023, EHPM launched the third edition of the EHPM Quality Guide​: the first pan-European Quality Guide to support companies in tackling European legislation and ensuring the production of high-quality products. 

Manichetti concludes: “Regulatory complexities and institutional scepticism require careful consideration and strategic planning. However, the rising health consciousness of consumers and opportunities for innovation, presents a promising landscape for companies in the sector. Success will hinge on a proactive approach to meet regulatory requirements, a transparent dialogue with European and National Institutions, and a commitment to meeting evolving consumer needs.” 

Bucchini points out that 2024 will see European elections come up, and a new European Commission (EC), with a new policy agenda which may encompass better regulation of food supplements.