Assistenza per la Commercializzazione 

integratori-620x300Definizione (Art. 2. D.lgs. 169/04)

A. INTRODUCTION
Means “food supplements” means foodstuffs intended to supplement the common diet and which are concentrated sources of nutrients, such as vitamins and minerals, or other substances with a nutritional or physiological effect, in particular but not exclusively amino acids , essential fatty acids, fiber and various plant and herbal extracts, alone or in combination, in unit dose form.

B. REFERENCE STANDARDS
The main European Directives that regulate foodstuffs intended for particular nutritional uses are different, namely: Council Directive 89/395 / EEC, 89/396 / EEC, 89/398 / EEC, 90/496 / EEC, etc. These Directives define the labeling, advertising, presentation, etc. of foodstuffs.

 C. MARKETING OF A FOOD SUPPLEMENT PRODUCT IN THE EU
Time: marketing contextual notification

Currently, in the absence of a specific rule, the marketing of food supplements is subject to the notification procedure, ie the transmission to the Ministry of Health of the label template used for marketing, in accordance with art. 7, law. 27/01/92, n. 111.
To standardize the methods of notification was issued Circular of the Ministry of Health 17/07/2000, n. 11. This notification is contextual marketing (marketing could begin immediately after transmitting the label to the Ministry).
Upon receipt of the label, the Ministry, if it considers necessary investigations on the properties of a product within 90 days (after which applies the procedure of tacit approval) may require the undertaking scientific documentation to support the property, the objectives or the nutritional characteristics of the ingredients and their suitability for use with food.

The notification must be made individually for each product. For each notification must make a deposit of Euro 160,20 to c / c n. 11281011 payable to the State Provincial Treasury – Viterbo (concerning the rights of the Ministry of Health in accordance with DM 02.14.91 amended by Ministerial Decree 06/05/03).

D. MARKETING OF A FOOD SUPPLEMENT PRODUCT IN NON-EU COUNTRIES
Time: 90 days (tacit consent)

The above notification must be made 90 days prior to release. In this case we must then wait for the comments to the Ministry.
The notification must be accompanied by:

– Three copies of the label dated, stamped and signed (for each package and for each flavor), of which a revenue stamp;
– Three copies of leaflets for each product (if any), including one in the stamp;
– Certificate of free sale of the product issued by the authorities of the country of origin
– Indicate whether the product is already marketed in another EU country (possibly be issued with a declaration by the manufacturer) and attach a copy of the label used for marketing in that State;
– Statement on the stability of the product on the basis of tests performed, signed by the head office or by the attorney of the company;
– Documentation on the purpose, the dietary value and on particular elements of the composition of the product;
– Sheets of raw materials;
– Analytical methods or copy of the extract in the case of published methods codified;
– Certification of the analytical composition proximate the product;
– Statement concerning the compliance of packaging materials to DPR 23/08/1982, n. 777, as amended by Decree. 25/01/1992, n. 108, signed by the legal guardian or by the attorney of the company;
– Payment of € 160.20

E. PRODUCTION AND PACKAGING
Time: 120 days

Production and / or packaging of food supplements to take place in establishments authorized under law. 111/92

This means that even for the only packaging must request authorization.

The Qua.Ser. the request can provide a list of documentation to be submitted along with the instance.

In summary, the assistance carried out by Qua.Ser. are the following:

1. Marketing of a dietary supplement product in the European Union and / or countries ExraEuropei
2. Authorization of the manufacturing plant
3. Authorization to advertising

The above is carried out taking the following action:

– Management and evaluation of the documentation produced by the customer.
– Review of the application and the documentation itself.
– Presentation of the instance.
– Management of the practice / application with the competent authorities.
– Assistance during the eventual Audit by the competent authorities.