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Commission Implementing Regulation (EU) 2017/2469Show full title

Commission Implementing Regulation (EU) 2017/2469 of 20 December 2017 laying down administrative and scientific requirements for applications referred to in Article 10 of Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (Text with EEA relevance)

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Article 7Information to be included in the opinion of the Authority

1.The opinion of the Authority shall include the following information:

(a)the identity of the novel food;

(b)the assessment of the production process;

(c)compositional data;

(d)specifications;

(e)the history of use of the novel food and/or its source;

(f)the proposed uses and use levels and anticipated intake;

(g)absorption, distribution, metabolism and excretion (ADME);

(h)nutritional information;

(i)toxicological information;

(j)allergenicity;

(k)an overall risk assessment for the novel food under the proposed uses and use levels and highlighting uncertainties and limitations where relevant;

(l)when the dietary exposure exceeds the health-based guidance value identified in the overall risk assessment, the dietary exposure assessment of the novel food shall be detailed, providing the contribution to the total exposure of each food category or foodstuff for which the use is authorised or has been requested;

(m)conclusions.

2.The Commission may ask for additional information in its request for an opinion of the Authority.

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