I. Definition of Novel Food
Novel Food is defined in the Regulation EU 2015/2283 as food that had not been consumed to a significant degree by humans in the EU before 15 May 1997.
'Novel Food' can be newly developed, innovative food, food produced using new technologies and production processes, which is subject to ‘authorization’. ‘Novel food’ can also be food which is or has been traditionally eaten outside of the EU for at least 25 years, which is subject to notification.
The underlying principles underpinning Novel Food in the European Union are that Novel Foods must be:
* Safe for consumers
* Properly labeled, so as not to mislead consumers
* If novel food is intended to replace another food, it must not differ in a way that the consumption of the Novel Food would be nutritionally disadvantageous for the consumer.
Regulation EU 2015/2283 does not apply to:
(a) genetically modified foods falling within the scope of Regulation (EC) No 1829/2003;
(b) foods when and in so far as they are used as:
(i) food enzymes falling within the scope of Regulation (EC) No 1332/2008;
(ii) food additives falling within the scope of Regulation (EC) No 1333/2008;
(iii) food flavourings falling within the scope of Regulation (EC) No 1334/2008;
(iv) extraction solvents used or intended to be used in the production of foodstuffs or food ingredients and falling within the scope of Directive 2009/32/EC.
II. Timeline
It takes around 2-3 years for authorization and 8-12 months for notification.
II. Procedure
III. Required Dossier
1. The application for authorization shall include:
(a) the name and address of the applicant;
(b) the name and description of the novel food;
(c) the description of the production process(es);
(d) the detailed composition of the novel food;
(e) scientific evidence demonstrating that the novel food does not pose a safety risk to human health;
(f) where appropriate, the analysis method(s);
(g) a proposal for the conditions of intended use and for specific labeling requirements which do not mislead the consumer or a verifiable justification why those elements are not necessary.
2. The application for notification shall include:
(a) the name and address of the applicant;
(b) the name and description of the traditional food;
(c) the detailed composition of the traditional food;
(d) the country or countries of origin of the traditional food;
(e) documented data demonstrating the history of safe food use in a third country;
(f) a proposal for the conditions of intended use and for specific labeling requirements, which do not mislead the consumer or a verifiable justification for why those elements are not necessary.
IV. Our Services
* Feasibility Analysis
* Novel Food Submission
* Safe Assessments
* Other Customized Consultancy
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