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Table 1 Statutory text, official documents of the EFSA

From: A proposed framework for an appropriate evaluation scheme for microorganisms as novel foods with a health claim in Europe

Novel Food
Recommendation 97/618/EC Related to the scientific aspects and the presentation of information necessary to support applications to place novel foods and novel food ingredients on the market
Regulation N° 258/97 Related to novel foods and novel food ingredients of the European Parliament and of the European Council
Novel Food Class 2 Complex Novel Food from non-Genetically Modified sources according to Categories of novel foods and novel food ingredients identified in Regulation (EC) No 258/97. Intact plants, animals and microorganisms used as foods as well as food components (e.g. complex carbohydrates, fats, proteins or those substances collectively described as dietary fiber) are included. Two sub-classes can be identified:
    2.1 the source of the NF has a history of use in food in the Community.
    2.2 the source of the NF has no history of use in food in the Community.
Health claim
Regulation N° 1924/2006 Related to nutrition and health claims and establishes rules governing the Community authorization of health claims should only be authorized in the Community after a scientific assessment of the highest possible standard, to be carried out by the EFSA.