“Positive EU regulatory environment” primed for cognitive market growth

David Pineda Ereno, marketing director at DPE international consulting, covered the topic during his presentation in Geneva last week, emphasising the current growth of the cognitive health category, which he attributed to the heightened consumer demand for holistic well-being.

Specifically, he said that consumers are seeking support for sleep, stress, and anxiety-related issues.

He emphasised: “We are expecting more and more products on the market with health claims with these benefits. We have found that the market trend reports highlight the fastest growing supplement claims to be mental acuity and insomnia.

“In terms of EU regulatory trends for nutraceuticals, [companies] need to look at how these different categories are classified, as well as the ingredients that are permitted, in terms of those that are harmonised across countries and those with their own rules,” he added.

With regards to the key ingredients used within cognitive health nutraceuticals, he explained: “Studies have found that deficiencies in vitamin D can increase the risk of developing depression, low mood, or decreased cognitive performance. Studies have also found vitamin B12 deficiencies to be associated with Alzheimer’s disease.”

He also spotlighted caffeine for boosting alertness​, as well as creatine and DHA for supporting​ brain health and function. He added that probiotics containing specific strains have been noted​ to be linked to mental wellbeing whilst improving sleep quality.

The EFSA approved health claims in the cognitive health space are related to key nutrients:

1)     Contribute to normal functioning of nervous system - vitamin C and copper.

2)     Contribute to normal cognitive function – iodine and iron.

3)     Contribute to the maintenance of normal brain function – carbohydrates and docosahexaenoic acid (DHA).

4)     Contribute to normal mental performance – pantothenic acid.

5)     Contribute to normal psychiological function – folate and vitamin B12.

6)     Contribute to reduction of time taken to fall asleep / the alleviation of subjective feelings of jet lag – melatonin.

General law​

The general principals of food regulation derive from the EU General Food Regulation No.178/2002​ by EFSA, which contain the guidelines with regards to nutrition and health claims, as well as labelling requirements.

“When we look at the use of vitamins and minerals in food supplements, it is harmonised across the EU. But, for other substances we need to look at the regulations on a national level. In addition, very importantly, we need to check the status of the ingredients as to whether they are novel,” Errena explained.

The list of harmonised food supplements appears in directive 2002/46/EC​. Those for fortified foods are given on the regulation 1925/2006​, which contains a further list of substances other than vitamins and minerals that are prohibited or restricted.

Regarding this list of restricted substances, he stressed: “In recent years, we are seeing that this list is starting to be filled, particularly with herb extracts. This is something that needs to be looked at, as this negative list is also harmonised [across the EU states].”

He highlighted the importance of looking at the national rules in relation to vitamins, minerals and botanicals, as minimum and maximum levels are established at a national level. He said that for botanicals, there can be positive and negative lists, whilst authorisation is required on a case-to-case basis.

Nutrition and health claims​

Errena explained that the list of approved nutritional health claims is held within regulation no. 1924.2996​: ‘Commercial communications – labelling, advertising’: “We have more than 200 health claims approved. Most are generic health claims, or reduction of disease claims, or relating to the development of children.”

He highlighted the example of Article 14 for iron, whereby the approved claim states: ‘Iron contributes to the normal cognitive development of children’.

EFSA released guidance in 2012 to clarify the scientific requirements for cognitive and emotional health claims, , with key areas of focus being the appropriateness of study outcomes and whether the observed effect is considered beneficial.

He recalled the key EFSA clarifications: ‘Improvement, maintenance or reduced loss of the functions of the nervous system is generally considered a beneficial physiological effect.’, and ‘an increase, maintenance or reduced loss of cognitive function in one or more of its domains is a beneficial physiological effect.’

Drawing attention to the procedures for entering the market with food supplements in the EU, he notedthe majority of countries require notification prior to entry, with the exclusions of Austria, Netherlands and Sweden.

For fortified foods, countries that do and do not require notification is more evenly split, highlighting the need to companies to check these guidelines.