At an event in the European Parliament held on 14thJune, the European Federation of Associations of Health Product Manufacturers (EHPM) marked the success of the landmark Food Supplements Directive 20 years after it entered into force. EPHM Chair Antonino Santoro praised the improved regulatory environment that the Directive ushered in, saying that it had contributed to the success of the sector which now employs over 100,000 people and brings an estimated value of more than €12 billion to Europe’s economy.
While much has been achieved, Santoro said it is time to address the remaining challenges, such as the need for harmonised maximum and minimum levels of vitamins and minerals, as well as a clear way forward for other substances with nutritional and physiological effects, including botanicals and probiotics.
EHPM Vice-Chair Michel Horn described the situation before the Directive as “chaotic” with serious barriers to those companies who wanted to trade across borders. Horn was a pioneer in the field, instrumental in drafting Belgium’s plant preparations decree in 1997, he argued for a wider European approach to remove barriers to trade and that consumers are becoming more aware of the implications of nutrition on health.
The event was welcomed by MEPs active in the Parliament’s industry and environment, public health and food committees. MEP Pascal Arimont (BE, EPP) described the Food Supplements Directive as a game changer: “This Directive laid the foundation for food supplements in Europe. It recognised the role of supplements for optimal nutrition and was the result of a constructive dialogue between European, national policymakers and stakeholders. As a result, European citizens benefited from better consumer protection due to better control of the sector.”
Livia Menichetti, EHPM Director General, pointed to the positive and proactive approach of the association. The sector has looked at the existing challenges of the European regulatory environment and has put forward concrete proposals that are geared to helping consumers, regulators and the further development of this growing sector. Magdalini Selanikli, EHPM Vice-Chair, said there is a need to raise awareness of the role of supplements for optimal nutrition as well as for reducing the healthcare costs by reducing the risk factor of developing certain diseases.
National authorities and regulators are also anxious for progress in this field. Dr Tatiana Onisei from Romania and Dr Valeria di Giorgi from Italy both called for action at the EU level to improve the situation, particularly when it comes to traditional remedies used over decades, sometimes centuries.
Maintaining a healthy lifestyle
“Europe's population is getting older and there is a rise in non-communicable and chronic diseases which are often diet-related. This threatens our health-care systems,” said Italian MEP Alessandra Moretti (S&D) who underlined the importance of supplements for our well-being. “With busy lifestyles it’s harder to have access to nutrient-rich foods, this is why food supplements are considered to be an important tool in combination with a healthy lifestyle and diet to achieve an optimal nutritional status”.
“The Food Supplements Directive that we are celebrating today represents an important milestone, but there is still work to do to further harmonise the European rules governing the sector. This requires a joint effort from European and national regulators, as well as industry stakeholders.”
Basil Mathioudakis, a food and nutrition consultant and former Commission official, who was a key actor in the Directive’s development said that while the European Food Safety Agency (EFSA) argues that the key to good nutrition is a varied and balanced diet, the reality of people’s busy lives means that most people find this difficult to achieve. He conjectured that while progress is being made on maximum and minimum levels of vitamins and minerals, lack of institutional resources and political will is delaying progress in the field of botanicals.
More than 2,000 botanicals health claims on hold since 2010
In the EU the enactment of the Nutrition and Health Claims Regulation (EC 1924/2006) (‘NHCR’), which sets out the rules for using health claims on foods, has been highly problematic for botanical foods and in particular for botanical food supplements. In fact the approach applied to the assessment of such claims does not take into account tradition of use but is based on a scientific assessment of the highest possible standard and by reference to generally accepted scientific evidence. Such approach has been effective in authorising claims for nutrients based on generally recognised science, but not so effective for the many other claims associated with more complex foodstuffs. As a result, in 2010, 2000 botanical health claims were placed ‘on hold’ because they could not be assessed through the initial approach adopted. This uncertainty increases the danger of consumers being misled.
Jonathan Griffith, Chair of the EHPM Botanicals Working Group, laid out the need for a new approach to botanical health claims. This could be introduced by reform to the Nutrition and Health Claims Regulation. Griffith outlined the EHPM graded approach to botanical health claims; one that offers a useful, honest, accurate and meaningful guide to consumers. Grade A would apply to “scientifically established claims”. Grade B would indicate “scientifically well-supported claims”, which would indicate that product A could contribute to a defined health benefit. Finally, Grade C would apply to “traditional use claims” based on demonstrated tradition and plausible science.
Dr Valeria di Giorgi said: “It is becoming clearer at an EU-Commission level that it is time for a change”. She underlined that “traditional use”, in particular, should be taken into consideration when safety as well as botanicals claims. She said that Italy had tried hard, along with Belgium and France to have a common list and a common approach, but it was difficult to arrive at an EU agreement.
SAFE (Safe Food Advocacy Europe), an NGO dedicated to consumer health, presented the “Know Your Botanicals” campaign. Federica Dolce explained that the lack of harmonisation across EU Member States makes it difficult for consumers to make informed choices on botanical food supplements.
MEP Simona Bonafè (IT, S&D) called for a tailored approach to the safety assessment of botanicals: “Citizens in the EU enjoy a high level of food safety standards, our food system is recognised as one of the best in the world. EU citizens need to have proper information.”
She called on the European Commission to work with regulators and the industry to improve food supplement information available for consumers, taking a “bottom-up approach” bringing all stakeholders around the table.