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How to sell food supplements in Italy
Each country has its own requirements for marketing food supplements. In this post, we explain what the main legislative and administrative requirements are to be able to sell food supplements in Italy.
What are the legislative requirements regarding the notification of placing food supplements on the market?
It must be taken into account that food supplements are considered food products and therefore must comply with specific legislation on food supplements and also with food safety legislation that affects all types of food products.
The regulations mentioned below apply at European level and, therefore, Italy must comply with them in the field of food supplements.
- Directive 2002/46 on the approximation of the laws of the member states on food supplements. This is the only regulation at European level specific to food supplements. It determines certain mandatory aspects for all food supplements, such as which vitamins and minerals are permitted and which delivery forms can be used.
- Regulation (EU) 2015/2283 on novel foods.
- Regulation (EU) 2017/2470, of December 20, 2017, establishing the Union list of novel foods.
- Regulation (EU) 1169/2011 on food information. This regulation affects all types of food products and establishes the obligations regarding information that consumers must have at their disposal.
- Regulation (EC) 1333/2008 on food additives. Determines which additives are allowed and in what quantities they can appear in food products.
- Regulation (EC) No. 1924/2006 on nutritional and health claims on foods. This regulation harmonizes the nutritional claims that can be used on foods and the requirements for their use.
- Regulation (EC) No 432/2012 on the establishment of a list of permitted health claims on foods, other than those referring to the reduction of the risk of diseases and the development and health of children.
- Regulation (EC) No. 852/2004 on the hygiene of food products. It is the main regulation regarding food safety, where there are aspects that any company that works with food must comply with.
What are the legislative requirements on the composition of food supplements in Italy? (For example, about the use of a certain amount of vitamins)?
The Italian Ministry of Health has established a list to regulate the maximum daily intake of vitamins and minerals, which should not be exceeded in the case of food supplements.
It should also be noted that for some minerals such as zinc, fluorine, boron and potassium there are some specific indications to take into account.
At the European level, the limits set by the EFSA (European Food Safety Authority) must be taken into account, as well as the permitted forms of food established by Directive 2002/46/EC.
On the other hand, the Italian Ministry of Health has also determined the maximum amounts allowed for other nutrients and substances with nutritional or physiological effects that should be taken into account. Some of these substances must be accompanied by the warnings established in their internal regulations. For example, in the case of creatine, Italy requires the following warning to appear on the product label: “Due to the presence of creatine, the product is intended for adults only. Do not use during pregnancy.”
There is also a list of botanical species permitted in Italy for use as ingredients in food supplements. It lists the scientific names of the permitted plants, as well as the parts of the plants that can be used and in some cases some warnings that must appear on the label or maximum quantities that must not be exceeded.
In addition to meeting the requirements of the Italian Ministry of Health, it is essential that the ingredients used in the composition of a food supplement are not considered “Novel Food” at European level according to the novel foods catalogue.
If an ingredient appears as a novel food on this list, its use would not be permitted in any member state of the European Union.
What are the administrative requirements to market food supplements in Italy?
First of all, you need to register on the Italian food supplement notification platform. To access this platform, you must have the following documentation:
- Sworn translation into Italian that justifies that the company is categorized as FBO (Food Business Operator).
- Copy of the identity document of the company administrator certified before a notary.
- Letter addressed to the Italian health authorities that includes all the information regarding the company.
- Self-declaration by the entity in question confirming that all data is true.
Once all the documentation detailed above is available, the request for credentials can be submitted to the Italian health authorities who, after a few weeks, will inform the company of the access credentials to the notification portal for food supplements in Italy.
Once you have access to the notification platform for placing food supplements on the market, what are the next steps to follow?
When we are going to market a food supplement in Italy and after obtaining access to the notification platform, prior to its sale we must enter the data that makes up the food supplement, among which the following stand out:
- Tradename
- Form of presentation (powder, capsules, tablets, etc.).
- Recommended daily dose
- Ingredients and quantities per recommended daily dose
Once this documentation is completed, it is necessary to provide the product label in Italian, as well as proof of transfer to the specific bank account related to the Italian Ministry of Health of the fee whose amount amounts to €160.20 per product.
When the product notification is finalized, can I start the sales process in Italy?
Yes, since once the notification of the food supplement is completed, a certificate is issued that enables the marketing of the product in said country. The notification of the food supplement in Italy is an immediate process, that is, there is no need to wait for the Italian health authorities to review the documentation and information provided in relation to the product, and it can be marketed from the moment it is notified through the platform. notification.