Brief overview of EU regulation

Food supplements are defined by current legislation as: “food products intended to supplement the common diet and constituting a concentrated source of nutrients, such as vitamins and minerals, or other substances having a nutritional or physiological effect, in particular, but not exclusively, amino acids, essential fatty acids, fibers and extracts of vegetable origin, both mono-composed and multi-composed, in pre-dosed forms”. Food supplements are increasingly used not only in Italy, but worldwide. The products that can integrate a diet, however, must follow certain rules in terms of production activities performed and the type of ingredients that they contain, in respect of safety and health. In the European Union, for many aspects, food supplements are regulated in the same way as foods. For this purpose, it was created a harmonized body of legislation that defines the vitamins and minerals as well as the substances as their sources, which can be used in the production of food supplements. Also for ingredients other than vitamins and minerals, the European Commission has established harmonized rules in order to protect the consumers from potential health risks and has established a list of substances known to have or suspected of having harmful effects on health and whose use is therefore restricted.

We out-licence succesful food supplements and medical devices since 2002

The reference EU legislation in the field of food supplements is Directive 2002/46 /EC, which establishes harmonized lists of vitamins and minerals that can be used in the manufacture of food supplements and labelling requirements for these products. EFSA (European Food Safety Authority) provides scientific opinions to support the European Commission’s evaluations. The Directive 2002/46/EC establishes rules applicable only for the use of vitamins and minerals. The use of substances other than vitamins or minerals may be regulated by national rules or may be subject to other specific EU legislation.

This is the case for:

• substances without documentation certifying their safe use in the EU before 1997, to be assessed under Regulation (EC) No 2015/2283 on novel foods;
• substances added to food supplements to perform certain technological functions, such as colorants, sweetening or preserving, which are evaluated as food additives under Regulation (EC) No 1333/2008;

• EFSA has prohibited certain substances at European level. These substances, contained in Annex III of Regulation EC 1925/2006, cannot be used in food supplements because they are considered dangerous or not sufficiently safe.

How does Italy behave?

Italian legislation follows the guidelines of EU Regulation 2002/46.

The EU regulation does not establish the allowed levels of vitamin-mineral intake. It only indicates how to do so, based essentially on the definition of tolerable levels resulting from a risk assessment rather than nutritionally adequate intake levels. In Italy, with the Legislative Decree n. 169 of 21 May 2004, some aspects not harmonized at European level have been defined. Subsequently to Legislative Decree 169/2004, Ministerial Decrees were issued to define the use of vegetable, prebiotic and probiotic substances:  in March 2018 and August 2018. The Italian Ministry periodically reviews the lists and quantities of admitted substances. The last revision on vitamin and mineral list has been released in April 2019, the revision for the other substances has been released in September 2019. The list of vegetable substances has been already revised on January 2019 and July 2019.

Differences between EU and Italy

With reference to the maximum daily intake levels of nutrients, the Community guideline is to take as a general reference levels within the safety limits (upper safe level: UL), while taking into account the NRV (Nutrient Reference Values) in fact, the intake of vitamins and minerals in excessive amounts can give rise to adverse reactions to health and, for this reason, maximum levels that can be contained in food supplements under safe conditions have been set; these levels should ensure that the normal use of the product in the way indicated by the manufacturer does not cause risks for the consumer. Maximum levels of vitamins and minerals in food supplements for each daily intake recommended by the manufacturer will be set taking into account both the tolerable levels of vitamins and minerals resulting from risk assessment carried out within the context of recognized scientific studies and from intakes of vitamins and minerals from other dietary sources. In the European Union, each Member State has their own national regulation on substances authorized for use in FS. Not every European country has lists of ingredients recognized in food supplements with the corresponding daily dosage allowed. Let us take for example Acetylcysteine and Melatonin.

Acetylcysteine:

• In Italy, the allowed daily dose for this aminoacid is 600 mg.
• In Germany Acetylcysteine is used in the treatment of acute cough and cold with a dosage of 200 or 600 mg per day and is therefore classified as a prescription drug.
• In Czech Republic acetylcysteine is included in the list of substances prohibited in the production of food according to national regulation on food supplements and food composition. It is therefore a substance that must not be use in food production and its use in food supplements is thus prohibited.
• In Poland there is currently no positive list of substances authorized for use in food supplement in Poland. N-Acetylcysteine is listed as substances in the notification platform, and is therefore considered as authorized.

Melatonin:

• In Italy, in 2013, the amount of melatonin allowed in supplements has been reduced to 1 mg per day
• In Spain, Melatonin-based food supplements present in the Spanish market represent a significant part of the market, being marketed in doses not exceeding 2 mg/day by more than 50 companies operating in the para pharmacy, pharmacy and herbal-dietetic channels.
• In France, melatonin has been included in the List of poisonous substances since 2011 for use in human medicine. Currently the dietary supplements containing less than 2 mg of melatonin per intake are authorized by administrative decision of the DGCCRF6.
• In Germany, the Federal Institute for Medicines and Medical Devices (BfArM) has already classified products containing melatonin as medicines independently of the dosage in September 2011. The Federal Institute for Risk Assessment (BfR) also supports this position. Melatonin is a substance with a pharmacological effect and is therefore not a food or food supplement. The final decision, however, lies with the control authorities of the individual federal states. Meanwhile, the BfArM has decided that products containing melatonin with a daily dose of between 0.5 and 5 mg are generally drugs and are therefore subject to authorization.
• In the Czech Republic, Decree no. 58/2018 Coll. – Decree on food supplements and composition of food indicates the prohibition of the use of melatonin in foods

Conclusion

As you can see each European country up to now has the freedom to decide substances and limits allowed in supplements. The last remarkable information at the end of this article is on Regulation 2019/515/EC in force since April 2020. As we’ve seen, in the absence of specific EU legislation, Member States are free to adopt national rules to establish the requirements with which products must comply. Such national requirements may coexist in several Member States, but if they are divergent, they may create barriers to intra-EU trade. According to this rule, Member States may not prohibit the sale on their territory of goods that are legally marketed in another Member State, even if these goods have been produced in accordance with different technical rules. However, the principle of mutual recognition is not absolute since Member States may restrict the placing on the market of goods lawfully marketed in another Member State if the restrictions are justified by Article 36 TFEU (Treaty on the Functioning of the European Union) or on the basis of other reasons relating to the public interest recognized by the case law of the Court of Justice of the European Union in relation to the free movement of goods, and if such restrictions are proportionate to the objective pursued. The safety of food supplements at European level is always under the direct responsibility of those who produce, import and distribute these types of products. These parties are responsible for ensuring that food supplements are safe for the consumer and comply with regulations. EU countries have the right to request a notification every time a supplement is placed on their territory, in order to monitor the product and control it.

We out-licence succesful food supplements and medical devices since 2002

References:

1. Directive 2002/46/EC
2. Regulation (EC) n. 2015/2283
3. Regulation (EC) n. 1333/2008
4. Regulation (EC) n. 1925/2006
5. Legislative Decree n. 169/2004
6. Regulation (EC) n. 515/2019
7. European Commission/Food Supplements
8. Italian Ministry of Health/food integrators and ministerial guidelines http://www.salute.gov.it/portale/temi/p2_6.jsp?lingua=italiano&id=1267&area=Alimenti%20particolari%20e%20integratori&menu=integratori
9. Main reference legislation – Federsalus, 02/11/2020 http://www.italiaue.it/normative-ue/la-vendita-degli-integratori-alimentari-secondo-il-diritto-europeo/ http://www.integratoriebenessere.it/il-quadro-normativo/