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registration of "novel food" in Italy.
“Novel food” is a concept that has come along with the Regulation (EC) No 258/97 of the European Parliament and the Council.
"Novel food" or "novel food ingredient" may be food for general consumption (or its components), or enriched foodstuff, or food for special nutritional purposes, as well as a dietary supplement.
The EU Regulation No. 258/97, is directly applicable in all member States of the European Union.
What is the procedure for registration of "novel foods" in Italy?
The producers that want to enter the community market for "novel foods" must first apply for authorization to the Ministry of Health.
The application must contain a "dossier", which includes medical records of the product in accordance with the principle of equivalence in fact, that endorses that a genetically modified food product should be as safe as its natural counterpart.
The application for authorization of a novel food has preliminary assessment by the Ministry. The applicant is also required to submit a copy of the application to the European Commission.
Ministry gives the product a special code (eg i5ih2/56478), which is used for product identification, and facilitates further communication with the Ministry. The procedure of authorization takes normally 90 days.
To apply for an authorization is needed:
-Application form for the marketing of the product in accordance with the principle of effective equivalence (I5ih5-NFSE).
-Charge-transfer application to the Ministry of Health in the amount of 3,098.74 euros.
-A copy of the applicant's identity card in electronic format. Jacek Kępski
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