WORLD TRADE  
ORGANIZATION  G/SPS/GEN/681 
5 April 2006 
 
 (06-1618) 
Committee on Sanitary and 
Phytosanitary Measures Original:   Spanish 
 
 
 
REGULATION 258/97 OF THE EUROPEAN PARLIAMENT AND 
OF THE COUNCIL CONCERNING NOVEL FOODS 
 
Communication from Peru  
 
  The following communication, received on 31 Marc h 2006, is being circulated at the request 
of the delegation of Peru.  
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 1. Peru would like to state before the Member s of the WTO its trade concern regarding 
Regulation No. 258/97 of the European Parliament  and of the Council, the application of which 
restricts entry into the European market of cert ain foods and food ingredients (described as "novel 
foods") that were not marketed in Europe prior to 15 May 1997. 
2. Thanks to policies aimed at promoting non-trad itional exports and international cooperation 
efforts including resources from member States of th e European Communities, the trade potential of 
exotic traditional products has developed considerably over the past few decades.  High potential 
Peruvian products such as camu-camu, maca, ar aza juice, lucuma and other Amazonian fruits are 
being imported into major markets like Japan and the United States. 
3. The Andean tropics, which cover part of Peru, are the source of significant phytogenic 
resources, accounting for an estimated 35 per cent of  the world's agrifood a nd industrial production, 
contributing to world food security.  Peru is seeking to  foster the sustainable u se of this biodiversity 
through sustainable trade, in accordance with  the objectives of the Convention on Biological 
Diversity. 
4. Peru's concern is that the implementation of  the Regulation on novel foods is directly 
affecting trade in exotic traditional products fro m the country's mega-biodiversity, blocking their 
entry into the EC market.  Thus, for example, shipme nts of dehydrated lucuma that had regularly been 
entering through ports in Italy and Portugal, were detained and denied entry through the port of 
Valencia, Spain, in 2000, on the grounds that this  was a new food ingredient which had to comply 
with the said Regulation.  On 23 March of this y ear, in a letter addressed to representatives of Peru's 
private sector, the European Commission also iden tified yacon (Smallanthus sonchifolius) – a food 
consumed by the inhabitants of Peru since pre- Colombian times – as a novel food on the grounds that 
it had not been consumed on the EC market prior to 15 May 1997.  This means that it can only be 
marketed within the EC subject to an authorization under Regulation 258/97. 
5. According to Regulation No. 258/97, for food qualif ied as novel to be able to enter Europe, it 
must go through a long, complex and very costly registration process which includes providing scientific information on the safety of the produc t.  The Regulation 258/97 requirements involve G/SPS/GEN/681 
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  clinical studies that call for significant investments for each product to be re gistered, and would take 
three to five years to complete. 
6. In spite of the interest shown by various importe rs from the EC member States, the entry into 
the European market of exotic traditional products has been seriously affected by Regulation 258/97 
and way in which it is being applied. 
7. While Peru respects and understands the need to protect consumer health, Regulation 258/97 
constitutes, in practice, an unjustified barrier to tr ade.  Indeed, in the period of almost eight years 
since the Regulation was brought into force, exotic  traditional products have  suffered discrimination 
merely because they were not significantly marketed  in Europe prior to a totally arbitrary date 
(May 1997), although these products have a long histor y of safe human consumption in their countries 
of origin. 
8. This is why Peru is expressing its concern at  the inconsistency in the application of 
Regulation 258/97 with the principles and obligations set forth in the WTO Agreement on the Application of Sanitary and Phytosanitary Measures, in particular Articles 2.2, 5.1, 5.4 and 5.6 and 
Annex C of the Agreement, and at the implications of this legislation for the joint efforts of the 
European Communities and Peru to  facilitate sustainable trade. 
9. Also worth mentioning is the social and econom ic impact of the development of trade in 
exotic traditional products on the efforts of vari ous countries, including a number of EC member 
States, to reduce extreme rural poverty, to substitu te illicit crops such as Coca, and to promote the 
conservation and sustainable use of biodiversity. 
10. We understand that the main reason underlying Re gulation 258/97 was the need to regulate 
trade in genetically modified foods, which are current ly governed by their own regulation.  This is 
apparently the context in which the ongoing revision of the mentioned legislation is taking place:  as it 
currently stands, the Regulation would appear to e quate exotic traditional products that have been 
known and consumed on our continent for thousands of  years with genetically modified organisms. 
11. Peru acknowledges the EC's positive attitude and readiness to revise Regulation 258/97 and 
encourages it to continue with that effort.  In  that connection we reiterate to the European 
Communities the request submitted by the Amb assadors of the Andean countries to the 
Directorate-General for Health and Consumer Affa irs (DG SANCO) in Brussels on 27 January 2006, 
calling for: 
(a) "Exotic traditional products or food" shoul d be excluded from the scope and coverage 
of the said Regulation and from its amended ve rsion.  In other words, all unjustified 
restrictions on the entry of such foodstuffs which have a history of safe consumption 
in their country of origin should be eliminated. 
(b) There should be transparency and clarity in the procedures and definitions for 
certification, where applicable, of the history of safe consumption in the country of origin without negatively or unjustifiably undermining the exportation of such 
products. 
(c) Likewise, the requirements, tests and proce dures must be proportionate to the nature 
of the foodstuffs concerned and the risks that they could entail for the consumer. 
(d) There should be harmonization of procedures and of the competent authorities.  G/SPS/GEN/681 
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  (e) All exotic traditional products should rema in in the public domain and no private 
entity be granted privileged access to the European market. 
(f) There should be no duplication or adoption of measures that discriminate against 
exotic traditional products as regards the assessment of their safety for human 
consumption. 
12. Similarly, during the revision of Regulation No . 258/97, we reiterated the request submitted 
to the DG SANCO by the Ambassadors of the A ndean countries in Brussels on 13 March 2006 
concerning the need for the Europ ean Communities to adopt some kind  of transitional mechanism or 
measure to exclude exotic traditional products fr om the scope of the Regulation pending their 
definitive exclusion in the new, amended regulation. 
13. Finally, we would be grateful if the Eur opean Communities would explain the objectives of 
the Regulation in question and how it can be rec onciled with the above-men tioned articles of the 
Agreement on the Application of Sa nitary and Phytosanitary Measures.  We would also like to know 
how long they expect it will take to comple te the revision and issue the new Regulation. 
 
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