G/SPS/GEN/1526  
 
17 October 2016  
(16-5630) Page: 1/2 
Committee on Sanitary and Phytosantiary Meas ures  Original: Spanish  
 
REGULATION (EC) 258/97 AND REGULATION (EU) 2015/2283 OF THE  
EUROPEAN PARLIAMENT AND  OF THE COUNCIL ON NOVEL FOODS  
COMMUNICATION FROM PERU  
The following communication, received on 13  October  2016, is being circulated at the request of 
the delegation of Peru. 
 
_______________  
 
 
1. For more than ten years now1, Peru has been re iterating  to Members of the World Trade 
Organization (WTO) its trade concern, initially r egarding Regulation (EC) 258/97  and subsequently 
regarding Regulation (EU) 2015/22832 on novel fo ods (Novel Foods Regulations) , which affect 
certain traditional products derived from the country's biodiversity and restrict their entry into the 
European market owing to the fact that they were not marketed in the European  Community prior 
to 15  May 1997.  
 
2. Confident that the European Union (EU) would take account of the comments 
and observations on Regulation (EC) 258/97 made over so man y years, Peru welcomed 
the EU's decision to amend the legislation  in question . We note with regret , however, that 
Regulation  (EU) 2015/2283 has maintained  many of the elements that make the measure 
inconsistent with multilateral trade rules.  
3. Thus, the Novel Food s Regulations violate Articles 2, 5.1 and 5.2 of the WTO Agreement on 
the Application of Sanitary and Phytosa nitary Measures (SPS Agreement). Under those provisions 
of the SPS Agreement, sanitary and phytosanitary measures must be based on scientific evidence 
and an assessment of the risks to human life or health, requirements which concern  the importing 
Members and not the exporting companies.  
4. Peru would like to explain once again the  basis for its concern with regard to these 
Regulations by referring specifically to the case of stevia  (Stevia rebaudiana bertoni ). This 
species, which is native to the tropical region of South America, is used as a sweetener  because in 
its natural form it is 30 times sweeter than conventional sugar, and 300 times sweeter in its 
processed form.  
5. As mentioned in a communication from the European Union3 this product was examined, and 
denied authorization to be placed on the market because stevia products contain stevioside, a 
sweetener for which authorization was refused on safety grounds. In 2008, however, the Joint 
FAO/WHO Expert Committee on Food Additives (JECFA) established an  acceptable daily intake for 
steviol glycosides4, confirming their food safety as a sweetener. This acceptable intake is 0 -4 mg 
of steviol per  kilogramme of body weight5, as is the case for any other sweetener on the market . 
                                                
1 On 31  March  2006, Peru expressed its trade concern regarding Regulation 258/97 concerning 
novel  foods and novel food ingredients (G/SPS/GEN/681).  
2 Regulation (EU) 2015/2283 will enter into force on 1  January  2018.  
3 G/SPS/GEN/699.  
4 Steviol glycosides are natural components of the plant Stevia Rebaudiana Bertoni , stevioside and 
rebaudioside A being the components of greatest interest for their sweetening properties and the sweet taste 
of stevia leaves.  
5 World Health Organization (200 9) Evaluation of Certain Food Additives: Sixty -Ninth Report of the Joint 
FAO/WHO Expert Committee on Food Additives (No.  952). World Health Organization.  G/SPS/GEN/1526  
 
- 2 - 
 
  The Codex, as well, considers  steviol glycoside to be an authorized  sweetener, one of its uses in 
fact being dietetic foods, including for medical use, as a replacement for sugar.  
6. According to the statistics, Peruvian exports of dr ied stevia leaves6 worldwide grew by 
about  100% in 20 15, exte nding to markets such as Brazil;  Chile;  South Korea;  Costa Rica;  
Hong Kong, China;  and others. Moreover, their production and marketing is important to the 
development of small and medium enterprises (SMEs), since dr ied stevia leaves are used in 
manufacturing infusions , liquid  extracts, sodas, chocolates, yogurts and other products in view of 
their profitability throughout the production process.  
7. The graph below shows that worldwide exports of stevia from Peru totalled more than 
a half a million dollars at the end of 2015, considerably more than in 2014 and 2013 when they 
reached only 11 % and 0.06 % of that total respectively. Meanwhile, exports to the European Union 
were non -existent during 2014. This highlights stevia's considerable  export potent ial and shows 
the extent to which  the current European legislation on novel  foods is an obstacle for  traditional 
biodiversity products like stevia.  
EXPORTS OF DR IED STEVIA LEAVES IN US DOLLARS, 2013 -2015  
$0.00$100,000.00$200,000.00$300,000.00$400,000.00$500,000.00$600,000.00
2013 2014 2015DÓLARES FOB
AÑOSEXPORTACIONES DE HOJAS SECAS DE STEVIA EN  US$ 2013 -2015 
TOTAL MUNDO
TOTAL A LA UE
 
Source:  PROMPERÚ.  
Prepared by:  Ministry of Fo reign Trade and Tourism (MINCETUR).  
  Directorate of Technical Requirements for Foreign Trade (DRTCE).  
8. In conclusion, Peru ask s the European Union to consider the observations made in this 
document on the implications of implementing its Novel Foods Reg ulations which, as has been 
mentioned in other meetings of the Committee7, constitute an unjustified obstacle to real and 
effective access to the European market for biodiversity products which is contrary to 
WTO commitments, in particular under the SPS Ag reement.  
__________  
                                                
6 Dried leaves of stevia, 121299 in the Harmonized System, national subheading 1212991000.  
7 Peru woul d also like to remind Members of its comments in previous documents submitted to 
the Committee  on Sanitary and Phytosanitary Measures (see, inter alia , documents G/SPS/GEN/1137, 
G/SPS/GEN/1218, G/SPS/GEN/1335, G/SPS/GEN/1383, G/SPS/GEN/1422).   
TOTAL WORLD  
 
TOTAL EU  
YEARS  TOTAL WORLD  
 
TOTAL EU  DOLLARS FOB