G/SPS/GEN/1361  
6 October 2014  
(14-5623)  Page: 1/2  
Committee on Sanitary and Phytosanitary Measures  Original: Spanish  
 
  COMMENTS ON THE PROPOSAL FOR A REGULATION OF THE EUROPEAN PARLIAMENT 
AND OF THE COUNCIL ON NOVEL FOODS (DOCUMENT G/SPS/N/EU/64) 
COMMUNICATION FROM PERU 
The following communication, received on 3 October 2014, is being circulated at the request 
of the delegation of Peru. 
 
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  1.  Peru reiterates its concern regarding the proposal for a Regulation of the European Union 
repealing Regulation (EC) No. 258/97 on novel fo ods, notified to this Committee in document 
G/SPS/N/EU/64 and addenda thereto. 
2.  In addition to its comments contained in document G/SPS/GEN/1335, Peru would like to 
address the procedure set forth in Article 9 of the proposal (The procedure for authorizing the 
placing on the market within the Union of a novel food and updating the Union list), which stipulates that it is incumbent on the applicant requesting access for novel foods to the European 
market, not on the European Union (EU), to present the scientific evidence demonstrating that the 
novel food in question does not po se a safety risk to human health. 
3.  Under the WTO Agreement on the Application of Sanitary and Phytosanitary Measures (the 
SPS Agreement), Members are required to base their sanitary or phytosanitary measures on a risk 
assessment. In practice, however, the restrictions  placed on the marketing of novel foods under 
the proposed EU Regulation are not based on a ri sk assessment carried out by the EU (Member to 
which the obligation applies) but on the applicant's alleged inability to provide evidence of the 
safety of the product it seeks to place on the market within the Union. 
4.  The proposed Regulation appears to run contra ry to the obligation in Article 2.2 of the 
SPS Agreement, which requires that any sanitary or phytosanitary measure be applied only to the 
extent necessary to protect human, animal or plant life or health, be based on scientific principles, 
and not be maintained without sufficient scientific evidence. 
5.  The proposed Regulation also appears to be inconsistent with Articles 5.1 and 5.2 of the 
SPS Agreement, in that Members are under the obligation to ensure that their sanitary or 
phytosanitary measures are based on an assessment of the risks to human life or health, and this 
obligation may not be waived by requiring those marketing novel foods to demonstrate the safety of the latter in order to gain access to the European market. 
6.  Failure to secure scientific evidence of a health risk posed by the entry of novel foods into the 
EU market would be contrary to the SPS Agreement, as this would mean assuming from the very outset that every new food product presents a he alth risk, instead of scientifically demonstrating 
the need to impose a sanitary of phytosanitary measure (in this case, the proposed Regulation) 
that ensures the level of sanitary protection with  respect to the import of a novel food which is 
consumed safely outside of Europe. Thus, the Member's obligation to demonstrate, by means of a risk assessment, the need for a sanitary or phytosanitary measure to protect the life or health of 
the population in the least trade-restrictive manner possible is reversed, placing the onus on the 
applicant to demonstrate, by means of scientific evidence, that the products which the applicant wishes to export to the European market do not pose any risk to human life or health. Moreover, it 
should be recalled that many of the food products classified as "novel foods" by the EU Regulation G/SPS/GEN/1361 
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  are freely marketed in countries outside the Union,  subject to presentation of the certificates 
issued by Peru, such as the Certificate of Free Sa le (CLV) and the Official Sanitary Certificate for 
exports of food and beverages for human consumption. 
7.  In view of the foregoing, Peru requests that  the European Union provide the scientific basis 
underpinning the proposal for a Regulation on Novel Foods notified to the WTO. 
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