WORLD TRADE  
ORGANIZATION  G/SPS/GEN/699 
8 June 2006 
 (06-2740) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
 
 
REPLY OF THE EUROPEAN COMMUNITIES TO THE COMMUNICATION FROM PERU 
CONCERNING REGULATION  258/97 ON NOVEL FOODS 
 
Communication from the European Communities
 
  
 The following communication, received on 6 June 2006, is being circulated at the request of 
the Delegation of the European Communities.  
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I. BACKGROUND 
1. In document G/SPS/GEN/681 of 5 April 2006, Pe ru raises concerns regarding against the 
European Communities.  According to Peru, the application of the Novel Foods Regulation (NFR) 
258/97
1 restricts entry into the European market of certain foods and food ingredients (described as 
"novel foods") that were not marketed in Europe prior to 15 May 1997. 
2. Peru draws attention to the significant contribution made by the Andean region to the phyto-
genetic sources consumed worldwide and its ongoing  programmes on sustainable trade, in accordance 
with the objectives of the Convention on Biological  Diversity.  Peru recognizes the international 
cooperation provided by the European Communities, which in combination with its national policies 
aimed at promoting exports of traditional and non-tr aditional products has deve loped considerably in 
special products such as camu-camu , maca , araza juice , lucuma  and other Amazonian fruits.  
Nevertheless, as a consequence of the implementation of the NFR, exports of dehydrated lúcuma 
meal2 and yacon3 have been stopped.  According to the document, obtaining an authorization under 
the NFR is (sic) "A complex and very costly registration pro cess which includes providing scientific 
information on the safety of the product….. invo lving clinical studies that call for significant 
investments for each product to be registered , and would take three to five years to complete ".  
According to Peru, this is in c ontradiction with Articles 2.2, 5.1,  5.4 and 5.6 and Annex C of the SPS 
Agreement, as well as with the joint efforts of the European Communities and Peru to facilitate 
sustainable trade.  Finally, in document G/SPS/GE N/681 (5 April 2006), a proposal to modify the 
NFR by the Ambassadors of the Andean countries is mentioned. 
3. A common feature of this document as well as other comments the European Communities 
has received from Andean countries is the reluctance  to accept the deadline of 15 May 1997 for entry 
into force of the Regulation and to prepare applica tions to demonstrate safety under the claim that the 
Novel Food Regulation is a non-tariff ba rrier harming their exports of f oods they believe are safe.  In 
                                                      
1 Regulation (EC) No. 258/97 of the European Parliament and of the Council of 27 January 1997 
concerning novel foods and novel food ingredients (Official Journal L43, 14 February 1997, p. 1 – 6). 
2 "Harina de Lúcuma" ( Lucuma obovata  fam of Sapotaceae ) 
3 Yacon ( Smallanthus sonchifolius).  G/SPS/GEN/699 
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  this line, in the SPS Committee meeting on 29 Ma rch 2006, Colombia, Ecuador and Peru raised 
concerns about the EC Novel Food Regulation, claiming that it was a clear barrier to trade.
4  They 
were supported by many other interventions from South American and African countries. 
II. RESPONSE BY THE EUROPEAN COMMUNITIES 
A. FOREWORD  
4. The EC legislation was developed to creat e uniform marketing conditions avoiding 
differences between national laws that  could hinder the free movement of foodstuffs.  Article 3 of this 
regulation provides that foods and food ingredients falling within its scope must not present a danger 
or mislead the consumer.  They also must be clearly defined so clear directions to consumers can be given if these are requested. 
5. Peru will appreciate that the food control author ities, when authorizing the selling of whatever 
food, must be sure that its norma l consumption would not be disadvantageous for the consumer, either 
due to the composition of the food itself or because  sufficient cultural knowledge is required on how 
to handle it.  This is normal worldwide and as an example we may mention certain energy drinks or 
condiments which are normally produced and c onsumed in the European Communities but whose 
marketing and sale is not authorized in all EC member States.
5 
B. COMPLIANCE WITH THE SPS  AGREEMENT  
6. First of all, the European Communities believes the scope of this legislation falls mostly 
within the scope of the WTO Agreement on Tec hnical Barriers to Trade (the TBT Agreement), 
together with much food and drink legislation that aims at a clear product identification and labeling;  
this area is being harmonized at interna tional level by several Codex Committees. 
7. In spite of the above, any food concerns based on toxicity information eventually leading to a 
marketing suspension of the alleged products may fall within the scope of the SPS Agreement, but 
this is not the case at hand since this regulation deals with registration requirements  and not 
prohibitions .  (See  also paragraph 13 and footnote 7 of this text.) 
8. Further to what is mentioned above, the Eu ropean Communities cannot accept the statement 
made by Peru in paragraph 8 of G/SPS/GEN/681 (sic) " inconsistency in the application of Regulation 
258/97 with the principles and obligations set fo rth 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 legi slation for the joint efforts of the European 
Communities and Peru to facilitate sustainable trade. " 
9. In effect the NFR complies with Article 2.2.  In fact, it was created with the aim to ensure 
uniform trade conditions within the European Co mmunities while protecting human health, based on 
scientific principles.  Another aim of this legi slation is to provide the food authorities of the 
EC member States with clear definitions on prod uct composition and expected variation so that 
nutritional guidance can be provided if requested by European consumers not familiar with these 
products.  It also complies with Article 5.1 becau se provisions are made to ensure that the product 
authorizations are made based on assessments of  the risks to humans, taking into account risk 
assessment techniques developed by the relevant international organizations where these exist. 
                                                     
 
4 See the report by the WTO Secretariat " Activities of the SPS Committee and other relevant WTO 
activities since January 2006 " (Codex Document CAC/29 INF/5, April 2006). 
5 Certain caffeinated soft drinks, certain beers and wines of low alcoholic graduation considered not to 
be "wines" and many others.  G/SPS/GEN/699 
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  10. Furthermore, the legislation excluded from the re quirement for registration products marketed 
in the EC market prior to 15 May 1997.  The intent ion of this measure was to minimize the effect on 
existing trade  in compliance with Article 5. 4 and 5.6 of the SPS Agreement. 
11. From all the above, it follows that the NF R although falling under the scope of the TBT 
Agreement, also complies with Annex C of the SPS Agreement. 
C. RECENT DEVELOPMENTS  
12. The Andean countries have closely followed the Novel Food regulation revision process and 
actively commented.  In addition, the Unite d Nations Conference on Trade and Development 
(UNCTAD) works with partners in developing countri es to promote trade in biodiversity products and 
services (BIOTRADE initiative) and has taken the in itiative to find solutions for the problems of the 
Andean countries. 
13. Despite these complaints, the European Comm unities has not received applications from the 
countries concerned.  The Commission and the EC me mber States authorities have advised and helped 
to establish whether certain foods were on the market before the deadline, for example " maca6" 
(mentioned in the letter of Peru) was not found to  be on the market before 1997.  The European 
Commission therefore advises potential producers of e xotic traditional foods to follow the procedures 
for placing a novel food on the EC market.  One of th e essential pillars in this application is the 
provision of a safety assessment.  The Regulation and guidelines indicate what is meant by such a 
safety assessment.  The safety assessment is carried out on a case-by-case basis. 
14. In practice, the European Communities has only approved a small number of traditional foods 
from outside the European Communities (e.g. noni juice7).  According to the EC member States and 
the European Food Safety Agency (EFSA), there is often insufficient information to establish safety.  
Furthermore, there are cases like food derived from Stevia rebaudiana8, where the application was 
connected to misleading and unsubstantiated clai ms through diffusion of leaflets and internet 
information.  Moreover, Stevia  products contain steveoside, a swee tener, for which authorization has 
been refused on safety grounds following the opinion of the relevant EC Scientific Committee.  The 
Scientific Committee on Food also e xpressed concern about the safety of Stevia  products.9  
Consequently, the authorization was not granted.10  Moreover, the generic concept of "products of 
biodiversity" should not obscure the reality th at there is unsafe food outside the European 
Communities with risk of damage to health. 
15. Peru and other Andean countries, having realized  that the revision will take some time, also 
requested transitional measures to exclude their tr aditional exotic products from the Regulation (letter 
dated 13 March 2006).  However, the present Regula tion does not allow such derogations and any 
amendment would need more or less the same time as a revision. 
                                                      
6 Lepidium Peruvianum  Extensive information is available recommending consumption of maca in 
menopause, rectile dysfunction, hot flashes, perimenopa use, fatigue, night sweats, fertility and infertility 
problems, etc. 
7 Noni are fruits of various evergreen trees or shrubs of the madder family Gen. Morinda (e.g. Morinda 
citrifolia).  
8 Hierba dulce, Stevia del norte de  Paraguay, Yerba dulce, Caá-ché. 
9 Scientific Committee for Food:  Opinion on Stev ioside as a Sweetener. CS/ADD/EDUL/167 final. 
(17 June 1999) Available from http://ec.europa.eu/food/fs/sc/scf/out34_en.pdf   
10 Commission Decision 2000/196/EC, of 22 February 2000 refusing the placing on the market of 
Stevia rebaudiana  Bertoni: plants and dried leaves as a novel food or novel food ingredient under Regulation 
(EC) No 258/97 of the European Parliament and of the Council. (Official Journal L61, 8 March 2000 p.:14.) G/SPS/GEN/699 
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  D. R
EITERATION OF REQUEST BY ANDEAN COUNTRIES OF 27 JANUARY 2006 
16. Peru is reiterating the request of the Andean countries from the beginning of this year to 
exclude exotic traditional foods from the scope of the Novel Food Regulation.  Furthermore, Peru 
asks for definitions for certification;  e.g., histor y of safe consumption, proportionate requirements, 
harmonization of procedures and competent authorities;  as well as that the exotic traditional foods 
should remain in the public domain.  Finally, ther e should be no duplication or adoption of measures 
that discriminate against exotic traditional produc ts concerning their safety assessment for human 
consumption. 
17. The European Communities is in the process of  reviewing the Regulation and has identified 
the issue of the Andean countries as an important one to resolve.  An impact assessment will be 
carried out on the changes to be introduced.  Th e safety assessment and management could be better 
tailored to different types of foods, allowing foods  with data of safe use outside the European 
Communities to enter the European Communities more easily than is presently the case.  A move to a 
centralized safety assessment and authorization pro cedure of novel foods is being considered.  In 
addition to the latter issues, the impacts of diffe rent kinds of authorization decisions, including a 
decision that would allow generic authorizations, w ill be assessed.  Furthermore, a specific resolution 
procedure could allow fast and transparent determ inations of foods as novel foods.  The Commission 
intends to present a proposal in 2007. 
18. The European Communities would appreciate information on the number of such foods for 
which the Andean countries consider a market exis ts, but which are not submitted for approval under 
the Novel Food Regulation.  Foods that have been successfully submitted for approval in other export 
markets would be of special interest.  This information would be very helpful in assessing the impact 
of the review and in discussions with the EC memb er States and the European Parliament to support 
any changes in the existing authorization procedure. 
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