European Regulatory Framework
The General Food Law Regulation (Reg. (EC) 178/2002) is the legal foundation on which the entire EU food safety regulatory framework is based. The legal cornerstone for the EU food supplement sector is Directive 2002/46/EC (Food Supplement Directive).
This directive harmonises:
- the list of Vitamins and Minerals that can be added to foods;
- the definition of Food Supplements;
- the specific labelling requirements contributing to the general labelling requirement for food.
This directive also envisages the provision for the ‘future’ setting of upper limits for vitamins and minerals in food supplements.
The existing EU legislation leaves three not-harmonised areas:
- Maximum amounts of vitamins and minerals;
- Other substances than vitamins and minerals;
- Obligation for product registration at national level.
National Divergence in Transposition
Contrary to Regulations, Directives have to be transposed by EU Member States in order to become National Law. Transposition is the process of actual ‘translation’ of EU laws into national laws. Yet policy transposition and implementation are not flawless, a fact that creates trade barriers and unfair market competition among EU members.
In the case of the Food Supplement Directive, in several occasions EU Member States transposed it driven mainly by stringent or medicine oriented national preferences with the result of establishing restrictive laws in the marketing of food supplements at national level. In several occasions this meant that products being lawfully manufactured and marketed in one Member State were prohibited from being marketed in another.
A relevant area was the non-harmonised area of upper limits of vitamins and minerals that could be added in food supplement. In addition, the lack of a harmonised Union list on herbal extracts / botanicals that could be added in food supplements created several borderline issues, the most prominent of which being product classification (food supplement vs medicinal status).
Mutual Recognition Principle
To ensure market access for goods that are not, or are only partly subject to EU harmonisation legislation, the European jurisprudence and legislation framed the “Mutual Recognition Principle”. It guarantees that any good lawfully sold in one EU country can be sold in another. This is possible even if the good does not fully comply with the technical rules of the other country. The principle stems from Articles 34-36 of the Treaty on the Functioning of the European Union (TFEU) and is further defined in Regulation (EU) 2019/515 (Mutual Recognition Regulation).
A health claim is a descriptor of the beneficial physiological effect of a nutrient on the human organism. The use of such claims is regulated by the Nutrition and Health Claims Regulation “NHCR” (Reg. EC 1924/2006) which aspires to facilitate informed choice, alongside the protection of consumers and the encouragement of legitimate business in the food industry.
From 2015 to 2020, the European Commission carried out the REFIT evaluation on the NHCR. The “REFIT” evaluation is designed to ensure that EU laws remain simple and that unnecessary or obsolete legislation can be adapted or removed where appropriate. The evaluation acknowledged that the objectives of the NHCR are not fully attained.
Safety assessment of other ingredients
The addition of vitamins and minerals and other substances to foods is regulated by Reg. EC 1925/2006. Art.8 of Reg. EC 1925/2006 is particularly relevant for the food supplement sector and its use in recent years has been subject of controversy. Art.8 of Reg. EC 1925/2006 provides the procedure to be followed where a substance other than vitamins or minerals, or an ingredient containing a substance other than vitamins or minerals, is added to foods or used in the manufacture of foods under conditions that would result in the ingestion of amounts of this substance greatly exceeding those reasonably expected to be ingested under normal conditions of consumption of a balanced and varied diet and/or would otherwise represent a potential risk to consumers.
Substances & Ingredients
Vitamins & Minerals in Food Supplements
Vitamins and minerals are required in small amounts for normal growth, development and on-going wellbeing. They are found naturally in diet; however, food supplements may be used to augment dietary intakes of vitamins and minerals and are specifically recommended at particular life stages, e.g. folic acid for women of childbearing age, and vitamin D in infancy.
Excess of some vitamins and minerals may have detrimental health effects; hence, the Food Supplement Directive provides for, among others, the setting of maximum safe levels of vitamins and minerals in food supplements by the European Commission. However, these are yet to be established.
Recently, the European Commission confirmed its intention to resume the work on Maximum Levels of Vitamins and Minerals. EHPM, through its Regulatory & Quality Working Group, is going to update the EHPM model on Maximum Levels that will then be shared as contribution to the upcoming EC stakeholders’ consultation on Maximum Levels of Vitamins and Minerals.
Botanicals in Food Supplements
Botanicals, herbal extracts and whole herbs are used as ingredients in food supplements. Botanicals products are marketed in several ways and only a partial level of harmonisation has been achieved to date at EU level.
Regulation (EC) 1924/2006 on Nutrition and Health Claims Regulation (NHCR) regulates the use of health claims in advertising, presentation and labelling of Foods/Food Supplements. However, an inappropriate demand for medical-style scientific proof has resulted in an impractical authorization process that is alien to the culture of the food industry and beyond its expertise and resources. As a result, the assessment process for Botanicals under the NHCR is currently on hold.
EHPM, through its Botanicals Working Group, has developed a Graded Approach to health claims, as applicable to botanical foods in general and botanical food supplements in particular. The approach has been developed to be consistent with both the fundamental requirements of the NHCR and the systematic procedures already adopted by EFSA.
Probiotics in Food Supplements
Although there is consolidated scientific proof of the value of probiotics in various physiological functions of the human body, the EU does not recognize any health or nutritional claim for probiotics. Also, based on the 2007 Guidance document on the implementation of NHCR, the European Commission considers the term “probiotic” as well as the phrase “contains probiotics” as health claims. In line with that, most Member States do not allow the use of the word “probiotic” on the products’ packaging. This creates a severe disruption of the internal market, difficulties for companies accessing the EU market as well as confusion among consumers.
EHPM, through its Probiotics Working Group, is updating its publication on probiotics considering the latest scientific evidence. EHPM believes that the use of the term “contains probiotics” should be permitted in EU, with clear and appropriate conditions of use, that authorities can verify using some simple criteria to distinguish probiotics from other live microorganisms. This will create a labelling environment that consumers can trust and will allow consumers to make informed choices about the products they purchase and consume.
Other substances in Food Supplements
Food supplements might include other substances with a nutritional or physiological effect, such as amino acids, essential fatty acids, fibre, fish oils.