G/SPS/GEN/1472  
 
1 March 2016  
(16-1226)  Page: 1/2  
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
NEW EU LEGISLATION ON NOVEL FOODS 
COMMUNICATION FROM THE EUROPEAN UNION 
The following communication, received on 29 Februa ry 2016, is being circulated at the request of 
the Delegation of the European Union. 
 
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 1  THE REGULATION 
1.1.  Regulation (EU) 2015/2283 on novel foods was adopted on 25 November 2015. The new 
Regulation makes it easier for food businesses to bring new and innovative foods to the 
EU market, while maintaining a high level of food  safety for European consumers. The new rules 
will apply from 1 January 2018 . 
1.2.  The general criteria for the definition of a novel food remain unchanged : novel foods are 
foods and food ingredients not consumed in the European Union to a significant degree before 
15 May 1997 (i.e. before the entry into force of the original Regulation on novel foods
1). 
1.3.  The main improvements  introduced by the new Regulation are the following: 
a. The authorization procedure  will be streamlined by centralising authorizations at 
EU level and granting generic authorizations. The European Commission will process all the applications and will grant the authorizations, which will be generic. As a result, all 
food business operators will be able to place an authorised novel food on the market, as 
long as its conditions for use and labelling requirements are respected. 
b. Safety evaluations  will be carried out by the European Food Safety Authority (EFSA). 
The European Commission will consult EFSA on the applications and base its 
authorization decisions on the outcome of EFSA's evaluations. 
c. Efficiency and transparency  will be improved by establishing deadlines for the safety 
evaluation and authorization procedure, thus  reducing the overall time required for 
approvals. 
d. Faster and more proportionate safety assessments  for traditional foods from third 
countries. To facilitate trade in novel foods which are traditional foods in countries 
outside the European Union, the new Regulation introduces a simplified assessment 
procedure. If the traditional food in question can historically be demonstrated to be safe and there are no safety concerns raised by EU member States or EFSA, it will be allowed 
to be placed on the EU market on the basis of a notification from the applicant. 
e. Promotion of innovation  by granting an individual authorization for five years based 
on protected data. Specific data protection provisions are included in the new 
Regulation. 
                                               
1 Regulation (EC) No 258/97. G/SPS/GEN/1472 
 
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  2  EFSA GUIDANCE 
2.1.  Following the adoption of the new Regulation on Novel Foods, the European Commission 
requested EFSA to update and develop scientific and technical guidance  for the preparation 
and presentation of applications for authorization of novel foods and for notifications of traditional 
foods from third countries. 
2.2.  On 18 February 2016, EFSA launched an open consultation  on two draft guidance 
documents. The first document  specifies the requirements that applicants need to meet when 
submitting applications for the authorization of novel foods. 
2.3.  The second document  addresses the preparation and presentation of a notification for 
authorization of traditional foods from third countries. This document aims to assist applicants in preparing and presenting the data on the hi story of safe food use in a third country. 
2.4.  The EFSA public consultation, to which all interested parties are invited to submit written 
comments, is open until 21 April 2016. Further information on the public consultation is available at the following EFSA's website: http://www.efsa.europa.eu/en/press/news/160218b . 
2.5.  EFSA also invites stakeholders to a meeting on the two draft guidance documents  to be 
held on 11 April 2016 in Brussels. Registration for the meeting is open until 14 March 2016. The meeting gives stakeholders, international organisations, academic institutions, NGOs and 
representatives of the private sector the opportuni ty to exchange views with EFSA experts on both 
documents. More information on the event is available at following EFSA's website: http://www.efsa.europa.eu/e n/events/event/160411 . 
2.6.  More information about novel foods is available on the European Commission's website: 
http://ec.europa.eu/food/safety/novel_food/index_en.htm . 
 
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