STC Number - 238

Application and modification of the EU Regulation on Novel Foods

Maintained by: European Union
Raised by: Colombia; Ecuador; Peru
Supported by: Argentina; Benin; Bolivia, Plurinational State of; Brazil; Chile; China; Costa Rica; Cuba; Dominican Republic; El Salvador; Guatemala; Honduras; India; Indonesia; Mexico; Nicaragua; Paraguay; Philippines; Uruguay; Venezuela, Bolivarian Republic of
First date raised: March 2006 G/SPS/R/40, paras. 21-29
Dates subsequently raised: June 2006 (G/SPS/R/42, paras. 35-37)
October 2006 (G/SPS/R/43, paras. 140-143)
February 2007 (G/SPS/R/44, para. 64)
April 2008 (G/SPS/R/49, paras. 48-52)
October 2008 (G/SPS/R/53, paras. 19-23)
October 2009 (G/SPS/R/56, paras. 53-55)
June 2011 (G/SPS/R/63, paras. 32-35)
October 2011 (G/SPS/R/64, paras. 72-73)
March 2012 (G/SPS/R/66, paras. 50-52)
July 2012 (G/SPS/R/67, paras. 56-58)
October 2012 (G/SPS/R/69, paras. 26-28)
March 2013 (G/SPS/R/70, paras. 3.37-3.39)
October 2013 (G/SPS/R/73, paras. 3.52-3.54)
March 2014 (G/SPS/R/74, paras 3.15-3.18)
July 2014 (G/SPS/R/75, paras 4.38-4.40)
October 2014 (G/SPS/R/76, paras 3.6-3.8)
March 2015 (G/SPS/R/78, paras 3.13-3.15)
July 2015 (G/SPS/R/79 paras 3.24-3.26)
October 2015 (G/SPS/R/81 paras 3.19-3.22)
March 2016 (G/SPS/R/82, paras. 3.26-3.29)
October 2016 (G/SPS/R/84, paras. 3.24-3.26 )
March 2017 (G/SPS/R/86, para. 9.8)
Number of times subsequently raised: 22
Relevant documents: G/SPS/GEN/681, G/SPS/GEN/699, G/SPS/GEN/700, G/SPS/GEN/713, G/SPS/GEN/714, G/SPS/GEN/733, G/SPS/GEN/735, G/SPS/GEN/1087, G/SPS/GEN/1117, G/SPS/GEN/1137, G/SPS/GEN/1218, G/SPS/N/EU/64, G/SPS/N/EU/64/Add.1 and G/SPS/N/EU/64/Add.2, G/SPS/GEN/1329, G/SPS/GEN/1361, G/SPS/GEN/1383, G/SPS/GEN/1422, G/SPS/GEN/1444, G/SPS/GEN/1477, G/SPS/GEN/1526
Products covered: 21 Miscellaneous edible preparations
Primary subject keyword: Food safety
Keywords: Control, Inspection and Approval Procedures; Food safety; Human health; Risk assessment
Status: Not reported
Solution:
Date reported as resolved:

Extracts from SPS Committee meeting summary reports

In March 2006, Colombia raised concerns on the application of the EC Regulation on Novel Foods (Regulation No 258/97) and with the draft project of the European Commission to amend the regulation, foreseen to enter into force in 2007. The amendment could directly affect the trade potential of traditional and exotic foods. Some traditional and exotic products already had substantial presence in the US and Japanese food markets, and European consumers were now becoming interested in these food products. It was important to recall, however, that these traditional foods had been consumed in South America for thousands of years. This was in contrast to genetically modified products which could be considered as real Novel Foods. Increased trade in traditional and exotic products also had important socio-economic impacts, as the export of these products represented a measure to decrease extreme rural poverty in South America and had potential to address specific social and environmental issues, such as providing alternatives to both the growing of narcotic crops and to the illegal felling of protected forests.

Colombia was aware of the importance of protecting consumer health. However, the amount of information on the safety of these traditional food products required by the EC regulation and the costs to undertake scientific studies were not proportional to health risks and were excessive especially for small scale farmers and exporters. The proposed amendment of Regulation (EC) No. 258/97 would result in a non-tariff barrier to trade with negative effects on the introduction of traditional foods into European markets, contrary to Articles 2.2 and 5.6 of the SPS Agreement. Colombia requested the European Communities to consider the following points regarding the amendment of Regulation (EC) No. 258/97: (i) the non-application of Regulation (EC) No. 258/97 to exotic, traditional products with a history of safe consumption in their region of origin; (ii) greater transparency and clarity in the procedures and definition, giving credit to a safe consumption history of food in the country of origin; requirements, tests, and procedures in proportion with the nature of the foods concerned and the risks they could imply for consumers; and (iii) all exotic traditional products to remain in the public domain and no private entity to be granted privileged access to the European market.

Ecuador reported that the amendment would also affect the trade potential of traditional and exotic food from its country. In light of Ecuador's great biodiversity, over the last decade international organizations like UNCTAD had been promoting the development of new export products ("Bio-Comercio"). In Ecuador, the export of traditional and exotic foods also had a major socio-economic impact and related closely to efforts to overcome rural poverty. Ecuador invited the European Communities to carefully consider Colombia's recommendations regarding the amendment. The amendment of the regulation and its impact were of importance for many developing countries.

Peru added that currently, within the Convention on Biological Diversity, countries were discussing measures and mechanisms for the preservation and sustainable use of biodiversity. Contrary to that approach, the application of Regulation No. 258 would restrict greater sustainable use of traditional and exotic products, by diminishing their export potential. Peru stressed the high costs and the long period of time needed for products to be registered under Regulation (EC) No. 258/97 to allow them to enter the European market. Peru also supported Colombia's recommendations regarding the amendment (G/SPS/GEN/681).

Brazil, Chile, Costa Rica and Paraguay reported that their exports had also been affected by Regulation (EC) No. 258/97. Benin requested more information on how a product was considered as "novel". Argentina and Mexico both indicated that they were still in the process of analysing the implications of the regulation. El Salvador, Honduras, India, Uruguay and Venezuela expressed their interest in the topic and shared the concerns of Colombia, Ecuador and Peru.

The European Communities confirmed that Regulation (EC) No. 258/97 was being reviewed and recognized that some modifications were needed. A 40-page document which might answer a lot of questions would be circulated as an SPS document shortly. The document clearly set out the purpose and scope of the Regulation, which was targeted at new food technologies, including genetically modified products. As the food industry was investing in different new technologies, Regulation (EC) No. 258/97 aimed to reassure European consumers of the safety of those technologies. The vast majority of applications for authorization of novel foods had been from within the European Communities. The European policy was aimed at striking the right balance between encouraging technical innovation and ensuring that consumers are protected. Some products marketed as "products of biodiversity" had in the past turned out to be unsafe and harmed the users. Dealing with such products was thus in the interest of all stakeholders, considering the damage to the image of products if they were marketed in an unsafe manner. The European Communities invited interested stakeholders to submit comments and make their views known.


In June 2006, Peru raised further concerns regarding the EC novel food regulation. In Peru's view, one of the major problems of the EC regulation was that it did not distinguish between new foods that had not been consumed before anywhere, and those that were new only to the European Communities, which was the case for most of the traditional exotic products originating from developing countries. Peru requested that the European Communities provide information showing that it was necessary to apply this measure to traditional exotic products, in accordance with the provisions of the SPS Agreement. Peru considered that the regulation constituted an unnecessary and unjustified barrier to trade due to the cost and time required to gain approval for Novel Foods, even if they had a history of safe consumption in their countries of origin, and requested the exclusion of traditional exotic products from the novel food category. Peru also requested that the European Communities explain how special needs of developing countries had been taking into account in accordance with Article 10 of the SPS Agreement (G/SPS/GEN/713).
Bolivia, Brazil, Colombia, Ecuador, India, Paraguay and the Philippines shared the concerns raised by Peru. Ecuador indicated that a study on the impact of the novel food regulation was about to be finalized. Preliminary results of this study showed that this regulation could have negative economic and social consequences for Ecuador's production system by having an effect both on current exports and on products with export potential in the European Communities that were currently marketed in other countries (G/SPS/GEN/714). Bolivia and Colombia highlighted that some of the products were currently being promoted inter alia by policies supporting alternatives to narcotic crops, some of which were funded by the European Communities or its member States. The Philippines indicated that the effects of the novel food regulation and of EC regulations on genetically modified food were still being evaluated.
The European Communities stressed that the concerns expressed were being taken seriously, and that the novel food regulation was currently under review (G/SPS/GEN/699 and G/SPS/GEN/700). The original intention of the novel food regulation had been trade-creating; its purpose was to authorize trade in Novel Foods. In addition, products that had already been traded prior to 1997 had been exempted. The regulation had been targeted mainly at EC companies. The regulation had been successful in that new foods were being approved on the basis of safety assessments. A statement that a product had been consumed for centuries was not sufficient. The European Communities highlighted that very few applications for approval of traditional exotic products had been received, so that there were very few case studies. 'Traditional exotic products' was a broad category including some items where there had been safety concerns. In the context of the review of the regulation, the European Communities indicated that it would be helpful to receive more information on these products, including a clear definition of the products at issue whether they had been approved in other export markets, and safety-related data available, as well as information on the socio-economic impact.

In October 2006, Colombia, Ecuador and Peru reiterated concerns relating to EC Regulation 258/97 on Novel Foods (G/SPS/GEN/733 and G/SPS/GEN/735). They considered that the regulation constituted a non-justified barrier to trade in these products as it was not flexible and made no distinction between novel (GMO) foods and traditional foods with no known risks. They noted that exotic products originating from Latin America were not the result of any type of genetic modification but rather formed part of the biodiversity of the region and were consumed traditionally. Also there were inconsistencies in the way this regulation was applied throughout the European Communities. The European Communities had not considered the fact that many of the traditional products had been marketed in a number of countries with very strict sanitary standards as they posed no health risks to consumers.
The European Communities was requested to promptly review Regulation 258/97, and to exclude from its scope of application exotic traditional products resulting from biodiversity. The European Communities was also encouraged to take into account scientific assessments and relevant evidence from other countries and competent international organizations when risk assessments were made, and to establish different procedures for foods of known risk and no known risk in the European Communities. The European Communities was also requested take into account the history of the product, the consumption patterns and traditional knowledge relating to its use and preparation, so as to provide for greater flexibility in the application of the regulation and facilitate the entry of exotic traditional products into the European market.
Bolivia, Brazil and the Philippines shared the concerns of Peru, Ecuador and Colombia. The Philippines highlighted the fact that the regulation could become an unjustified non-tariff barrier to the EC market in view of the unclear technical distinction between these products and other products. The Philippines expressed hope that progress would be made on the issue and a mutual solution found as soon as possible.
The European Communities reminded the Committee that the issue had been discussed in the SPS Committee on previous occasions and there had been various exchanges of communications between the Members concerned. The European Communities acknowledged the problem with traditional products, which were not in the EC market prior to 1997 and noted that the regulation was not discriminatory as EC producers had to undergo similar risk evaluations. Nonetheless, the European Communities imported an enormous volume of foods and vegetables. They reiterated the request that the Members concerned submit data on the volume of trade and risk assessments carried out in other developed countries. The European Communities indicated that the EC Commission was putting forward a new proposal that addressed the genuine concerns of Members. A public consultation had been held on the matter and the European Communities appreciated the contributions from the concerned Members.

In February 2007, Peru noted that although it had not requested that this issue be on the agenda for this meeting, it would welcome an update from the European Communities on current developments. The European Communities indicated that the Novel Foods Regulation was being revised. It had initially been designed to cover a full range of Novel Foods, from GMO foods to products of biological diversity. Following public consultations and the consideration of the views and comments received, revised legislation was being prepared. The European Communities anticipated that the result would be a two-tiered process, with products that had a long history of safe use subjected to less rigorous procedures than other Novel Foods. The European Communities was looking to address the concerns identified by trading partners, while ensuring consumer safety.

In April 2008, Colombia, speaking on behalf of Bolivia, Chile, Costa Rica, Ecuador, Mexico, Paraguay and Peru recalled the concerns previously expressed regarding the proposed revision of the EC Regulation 258/97, as contained in COM(2007)872. The proposed regulation had been notified to the TBT Committee, however these Members considered that it was appropriate to continue to consider this issue in the SPS Committee. These Members welcomed the proposed recognition of traditional food products from third countries, resulting from their biodiversity and with a history of safe use for large proportions of the populations of these countries. This recognition could facilitate trade, which was particularly important as the production of these traditional products was often part of programs to diversify agricultural production and exports.
Colombia noted that a number of concerns remained. The proposed definition of a traditional foodstuff was that it had been part of the diet of a large part of the population for at least one generation. This definition could restrict those products that were part of the dietary traditions of certain subpopulations or regions of the country. It would also be useful to clarify how a "generation" was to be defined. Another concern was that requests for authorization would have to come from commercial operators, hence excluding such requests from the competent governmental authorities or producer associations. These Members suggested that information regarding safe use of the traditional food in other countries should also be considered. The concerned Members recognized that although the proposed process had been considerably simplified, a period of five months was still foreseen for consideration of a request, and they suggested that three months should be sufficient. These Members remained concerned that the definition of a novel food remained a product that had not been consumed in the EC market prior to 1997, which seemed to bear no relation to the scientific evidence regarding the safety of a product.
Brazil indicated that it supported the concerns raised by Colombia on behalf of eight countries. Brazil was still analysing the relevant documents, but considered the issues raised by Colombia to be very important.
The European Communities noted that it was currently revising legislation, in particular the provisions on traditional products and products of biological diversity, in response to concerns raised by various developing countries. A much simplified procedure was now being developed. A range of legitimate and reasonable concerns had been expressed, and these should be communicated directly to the relevant EC services, since the legislation was currently under consideration. While the concern was that the EC legislation might be a barrier to trade in traditional products, this should be seen in the broader context: the European Communities was by far the world's largest importer of fruits and vegetables, especially from developing countries, hence the import regime in general was extremely import-friendly.

In October 2008, Peru requested that there should be a notification to the SPS Committee regarding the modification of the EC Novel Foods Regulation. Many exporting Members failed to understand the content of the regulation, why some products were banned while others were not. Also, the regulation gave exporting countries, many of which were developing countries, the burden of proof that their products were safe and complied with the EC Regulation. Brazil, Colombia, Costa Rica, Cuba, Ecuador, Mexico, Paraguay and the Philippines shared Peru's concerns regarding the EC Regulation on Novel Foods.
UNCTAD reported that it was contributing to the review of the EC Regulation on Novel Foods in three specific areas: (1) revising the procedure, which required more scientific clarification; (2) facilitating dialogue between the European Communities and developing countries; and (3) analysing legal aspects of current regulations in the context of multilateral agreements.
The European Communities stated that the existing legislation was too ambitious in covering a whole range of Novel Foods. For this reason, the European Communities planned to revise the regulation, as had been notified to the TBT Committee. This proposal had been under negotiation in the EC Parliament and Council. However, there were concerns regarding the approval of some products. For instance, matters became complicated when exporters requested the classification of food supplements as Novel Foods, rather than whole fruits and vegetables. However, the revised procedure was expected to be more flexible, and some Novel Foods had already been approved for entry into the EC market. The European Communities noted that in this specific case, the legal advice had been to only notify the proposed revision to the TBT Committee since it covered approval procedures for Novel Foods in general. This did not preclude that the issue could be discussed at the SPS Committee. In response to a query, the Secretariat clarified that it generally recommended that draft regulations with any SPS content should be notified to the SPS Committee, even if these regulations were also notified to the TBT Committee.

In October 2009, Peru recalled that the entry of traditional exotic products to the EC market had been seriously affected by the EC regulation on novel foods. The measure contravened the activities that the European Communities themselves had been undertaking to support small producers and to open the EC market to new and exotic products. Various exotic products had been certified by the Health and Environment Authority of Peru, which certified the safety and compliance with a HACCP system, and these products were fit for human consumption and could be marketed internationally. Peru expressed concern about the continuous loss of business opportunities due to this measure and asked for an update on the modification progress. Brazil, Colombia, Ecuador, and Mexico supported Peru's concerns regarding the EC regulation on Novel Foods.
The European Communities stated that on 15 January 2008, the EC Commission had submitted to the Council and the European Parliament a proposal for the revision of the Novel Food Regulation. The proposal was notified to WTO Members in March 2008 under the TBT Agreement. The revised procedure was expected to be more flexible and some novel foods had already been approved for entry into the EC market. The reference period for establishing a history of safe food use had been changed to a period of 25 years, and consumption data could originate from any third country and not necessarily from the country that submitted the application. The possibility to apply for a novel food authorization had also been opened to any interested party. The proposal kept the main rules currently applicable to novel goods, but simplified EC market access for traditional foodstuffs from third countries which had a history of safe use and put in place proportionate regulatory measures. The proposal was still under negotiation and its adoption was foreseen for July 2010.
Colombia was aware of the importance of protecting consumer health. However, the amount of information on the safety of these traditional food products required by the EC regulation and the costs to undertake scientific studies were not proportional to health risks and were excessive especially for small scale farmers and exporters. The proposed amendment of Regulation 258 would result in a non-tariff barrier to trade with negative effects on the introduction of traditional foods into European markets, contrary to Articles 2.2 and 5.6 of the SPS Agreement. Colombia requested the European Communities to consider the following points regarding the amendment of the Regulation 258/97: (i) the non-application of Regulation 258 to exotic, traditional products with a history of safe consumption in their region of origin; (ii) greater transparency and clarity in the procedures and definition, giving credit to a safe consumption history of food in the country of origin; requirements, tests, and procedures in proportion with the nature of the foods concerned and the risks they could imply for consumers; and (iii) all exotic traditional products to remain in the public domain and no private entity to be granted privileged access to the European market.
Ecuador reported that the amendment would also affect the trade potential of traditional and exotic food from its country. In light of Ecuador's great biodiversity, over the last decade international organizations like UNCTAD had been promoting the development of new export products ("Bio-Comercio"). In Ecuador also the export of traditional and exotic foods had major socio-economic impacts and related closely to efforts to overcome rural poverty. Ecuador invited the European Communities to consider carefully Colombia's recommendations regarding the amendment. The amendment of the regulation and its impacts were of importance for many developing countries.
Peru added that currently, within the Convention on Biological Diversity, countries were discussing measures and mechanisms for the preservation and sustainable use of biodiversity. Contrary to that approach, the application of Regulation 258 would restrict greater sustainable use of traditional and exotic products, by diminishing their export potential. Peru stressed the high costs and the long period of time needed for products to be registered under Regulation 258 to allow them to enter the European market. Peru also supported Colombia's recommendations regarding the amendment (G/SPS/GEN/681).
Brazil, Chile, Costa Rica and Paraguay reported that their exports had also been affected by Regulation 258/97. Benin requested more information on how a product was considered as "novel". Argentina and Mexico both indicated that they were still in the process of analysing the implications of the regulation. El Salvador, Honduras, India, Uruguay and Venezuela and expressed their interest in the topic and shared the concerns of Colombia, Ecuador and Peru.
The European Communities confirmed that Regulation 258/97 was being reviewed and recognized that some modifications were needed. A 40-page document which might answer a lot of questions would be circulated as an SPS document shortly. The document set out clearly the purpose and scope of the regulation, which was targeted at new food technologies, including genetically modified products. As the food industry was investing in different new technologies, Regulation 258 aimed to reassure European consumers of the safety of those technologies. The vast majority of applications for authorization of Novel Foods had been from within the European Communities. The European policy was aimed at striking the right balance between encouraging technical innovation and ensuring that consumers are protected. Some products marketed as "products of biodiversity" had in the past turned out to be unsafe and harmed the users. Dealing with such products was thus in the interest of all stakeholders, considering the damage to the image of products if they were marketed in an unsafe manner. The European Communities invited interested stakeholders to submit comments and make their views known.

In June 2011, Peru again raised concerns about Regulation 258/97, that particularly affected trade in Peruvian traditional foods that were safely sold in the United States and Japan (G/SPS/GEN/1087). Colombia shared the concern of Peru, as this regulation was an unjustified barrier to trade of traditional foods and consequently impeded economic activities. In 2009, the European Union had agreed to change this regulation in a way that would take into account traditional foods. This modification had not been implemented, however, because of disagreements that the European Council and the European Parliament had regarding products of cloned animals, although there was general agreement on traditional foods. Colombia encouraged the European Union to separate these issues and resolve the matter of traditional foods by the end of 2011. Brazil, Chile, China, Costa Rica, Indonesia, Mexico and Paraguay supported the concerns raised by Peru and Colombia.
The European Union stated that foods were considered novel under the present Regulation 258/97 if they were derived from new technological processes or if they had no significant history of consumption in Europe. On 15 January 2008, steps were taken to update the existing novel food rules in an effort to facilitate applications for novel food authorizations and to simplify market access to the European Union for traditional foodstuffs from third countries which had a history of safe food use. However, the initial proposal submitted to the co-legislators was not adopted. The main stumbling blocks related to provisions regarding food from cloned animals and nanotechnology. Any new regulation would contain a centralized and quicker authorization procedure for novel foods and specific measures for traditional foods, as agreement had indeed already been reached on this issue between the European co-legislators.

In October 2011, Peru recalled its concerns about Regulation 258/97 (G/SPS/GEN/1117). Brazil, Chile, Colombia, Costa Rica, Ecuador, Mexico and Paraguay shared the concerns raised by Peru.
The European Union reiterated the explanation that it had provided in June 2011 regarding the definition of novel foods and the current process of revision of the regulation.

In March 2012, Peru recalled its previously raised concerns about the EU Novel Foods regulation (258/97) that restricted foods which were not marketed in the European Union before May 1997 (G/SPS/GEN/1137). The Regulation did not distinguish between foods and ingredients that were new in the strict sense and traditional products derived from the biodiversity of developing countries. The EU measures were unnecessary and excessive as they applied to products that had a history of safe consumption in other markets and presented no risk for consumer health. Recalling the provisions of the SPS Agreement, Peru urged the European Union to refrain from applying Regulation No. 258/97 to traditional products with a history of safe consumption outside the EU market.
Cuba supported the concerns of Peru and indicated that the measure was discriminatory. Colombia also supported Peru's concerns and urged the European Union to accelerate the modification of the regulation on novel foods, highlighting the unnecessary and unjustified effect that the delay was having on the access of traditional products to the EU market. Argentina, Brazil, Chile and Paraguay indicated that they shared the concerns and were closely following the issue.
The European Union restated the observations presented during the 2011 June and October meetings.

In July 2012, Peru once again recalled its concerns about the EU novel foods regulation. Peru considered that its traditional products were a sign of the sustainable use of its biodiversity and argued that this regulation particularly affected trade in traditional foods. This regulation had negative economic and social impacts, including the loss of trade revenue, the administrative costs faced by importers and the potential effect on the general health of consumers worldwide as a result of the decrease in consumption of traditional products with high nutritional value. Peru urged the European Union to refrain from applying Regulation No. 258/97 to traditional products or to facilitate the entry of products with a history of safe consumption outside the EU market.
Cuba supported the concerns of Peru and indicated that the measure was discriminatory, highlighting the unjustified effect that the measure was having on the access of traditional products to the EU market. Colombia and Ecuador also supported Peru's concerns and urged the European Union to implement the reforms to the regulation on novel foods.
The European Union explained that revision of the novel foods rules had started in January 2008 in an effort to facilitate applications for novel foods authorizations and to simplify EU market access for traditional foodstuffs from third countries with a history of safe use. However, the co-legislators had not agreed to the proposed revision and the European Union was now engaged in preparing the next steps in the hope of facilitating the consensus necessary to allow a revised novel food regulation to be adopted into law. The European Union would make public the next steps it was taking once these were agreed. The Commission was currently preparing a legislative proposal based on the overall agreement reached with EU co-legislators, with adoption expected in 2013. Any new regulation on novel foods would contain a centralized and quicker authorization procedure for novel foods and specific measures would be put in place for traditional foods from third countries to access EU markets. A related legislative proposal on animal cloning was planned to be adopted by the Commission in 2013, based on the results of an impact assessment which was currently underway.

In October 2012, Peru reiterated its concern that the application of Regulation 238/97 continued to restrict access of traditional products into the European Union. Regulation 238/97 was in practice an unnecessary and unjustified barrier to trade, not adopted on the basis of an appropriate risk assessment taking into account scientific evidence, thus contrary to Article 5 of the SPS Agreement. Peru reiterated its request that the European Union exclude from the regulation traditional products arising from biodiversity and remove the unjustified hindrances to trade.
Brazil, Chile, Colombia, Costa Rica, Cuba, Ecuador and Venezuela supported Peru's concern and asserted that Regulation 238/97 constituted an unnecessary barrier to trade because it targeted products that were not widely traded in the EU market before 1997 without considering the history of safe consumption in other countries. Colombia regretted the EU delay in reforming this Regulation to bring it into compliance with WTO obligations. Brazil, Chile and Costa Rica reiterated their interests in developments regarding the reform of this Regulation.
The European Union recalled that at the last meeting it had provided a detailed explanation on the state of play of the Novel Foods dossier; it was now engaged in preparing a new legislative proposal on Novel Foods, expected to be adopted in 2013. The European Union would keep Members informed on the progress of the novel food negotiations, on future measures applicable to traditional foods from third countries, and would notify the new draft legislation to the WTO for comments. In order to help producers, importers and those responsible for placing products on the EU market a Novel Food Catalogue had been created, and a document indicating how interested operators may establish whether a food or food ingredient had a history of consumption in the European Union. The European Union remained committed to work with concerned partners towards an amicable solution of this matter.

In March 2013, Peru reiterated its previously raised concern with regard to EU Regulation 258/97 on Novel Foods whose application restricted access to the EU market for products which were not marketed in the European Union before May 1997 (G/SPS/GEN/1137). Peru considered the Regulation to be an unjustified trade barrier for Peruvian traditional products derived from biodiversity, due to the high costs of the application required to access the market and to the time required for market access approval. The EU measure was contradictory to international co-operation and technical assistance efforts for market development and for capacitation of small and medium producers. For example, camu camu (Myrciaria dubia), a sylvan fruit native to the western Amazon basin, was traded in countries like Japan and the United States and was listed in the Codex Classification of Foods and Feeds, but banned in the European Union. Peru requested information on the status of the new EU legislative proposal on Novel Foods and asked the European Union to reconsider those traditional products arising from biodiversity with a history of safe consumption outside the EU market.
Chile, Colombia, Ecuador and Paraguay echoed Peru's concern and looked forward to the EU legislative proposal to revise the regulation. Colombia and Paraguay urged the European Union to take into account the history of safe consumption of such products.
The European Union stated that the new legislative proposal was still taking shape and was due later that year. Specific measures for traditional foods from third countries to ease their access to EU markets would be proposed. The overall purpose of the proposal was to streamline the approval procedure and provide for a centralized system of authorization. The new draft, once finalised, would be sent to all EU trading partners via notification under both the SPS and the TBT Agreements to allow any comments and concerns to be taken into account. The European Union remained open to discuss the matter in more detail.

In October 2013, Peru reiterated its concern over the EU Regulation on Novel Foods, as it restricted the access of traditional biodiversity-based products into the European market. Peru had previously shown the negative effects of this measure on exporters. The <>proposed amendment of Regulation No. 258/97 would exclude from its scope traditional biodiversity-based products which had previously been safely consumed in their country of origin. The aim of this was to facilitate the export of these products from developing countries. Peru requested information on the status of the proposed amendment to Regulation No. 258/97, which would be an important step to access the European market.
Chile, Colombia, Costa Rica, Cuba and El Salvador expressed their support for Peru's concerns.
The European Union confirmed that the European Commission intended to present a new Novel Food proposal by the end of 2013. This would take into account the overarching agreement reached by the EU co-legislators on future measures applicable to Novel Foods, including those which were traditional in third countries. The proposal would streamline the approval process and provide specific measures for traditional foods from third countries, intended to ease their access to EU markets for the benefit of consumers whilst ensuring their safety. The draft proposal would be circulated to all Members through notifications under the SPS and TBT Agreements to allow for any comments and concerns to be well taken into account.

In March 2014, Peru reiterated its concern over the EU Regulation on Novel Foods and requested information on the status of the proposed amendment to Regulation No. 258/97.
Ecuador noted that the revised legislation, 2013/894, still posed barriers to products of biodiversity and sought assurances that it was compliant with Articles 2.2 and 5.6 of the SPS Agreement. The regulation created a disadvantage to small producers because the EU regulations required that the marketing history of traditional biodiversity-based products be disclosed, and this information was rarely available in developing countries. Ecuador suggested that the European Union: (i) replace the existing process with a simplified risk-based authorization procedure; (ii) define clearly the factors to be used to evaluate safety; and (iii) clarify the international standards and procedures on which EFSA would base its decisions and carry out the risk assessments.
Costa Rica, El Salvador and Nicaragua also expressed support for Peru's concerns.
The European Union announced that in December 2013, the Commission adopted a proposal for a new regulation on novel foods, accompanied by a further proposal on cloning. The proposed new regulation for novel foods focused on easing market access for traditional foods, including those produced by small producers. The objective was to simplify and streamline approval procedures while ensuring food safety. The proposal was notified to WTO in December 2013 (G/SPS/N/EU/64) and an exceptionally long comment period (120 days) had been given. No comments had been received to date and interested Members were encouraged to submit their comments by the 20 April 2014 deadline. The European Union encouraged Ecuador to submit their comments in writing so that they could be considered as part of the notification process.

In July 2014, Peru reiterated its concern over the proposed amendment of Regulation No. 258/97 (documents G/SPS/N/EU/64, G/SPS/N/EU/64/Add.1 and G/SPS/N/EU/64/Add.2) and referred to its comments on how to facilitate access to the EU market for biodiversity products from developing countries (G/SPS/GEN/1329). Peru highlighted its concerns on the proposed definitions of: (1) "novel food" - and requested the risk assessment that established 15 May 1997 as the reference date; (2) "traditional food from third country", given that the majority of potentially exportable traditional foods derived from primary production; and (3) "history of safe food use in a third country"- proposing a period of five years without any indication of risk to human health for demonstrating safe use, instead of the 25 year time-period envisaged by the European Union. Peru requested that the European Union revise these definitions to establish criteria that would allow traditional biodiversity products from developing countries real and timely access to the EU market.
Colombia, Costa Rica and Ecuador expressed their support for Peru's concerns.
The European Union recalled that in December 2013 it notified the proposal for a new regulation on novel foods, and an exceptionally long comment period (150 days in total) had been given to facilitate interested Members to dialogue with the European Union. The deadline to submit comments had been extended to 20 May 2014, and comments had been received from Canada, China, Costa Rica, Ecuador, Peru and the United States. EU experts were examining the comments and written replies would be provided soon. The European Union explained that the reference date of 15 May 1997 was already applied by the existing Regulation No. 258/97/EC, and as the new proposal did not change the scope of the EU legislation, this date remained unchanged. A guidance document had been elaborated to explain how to establish the use of a food to "a significant degree". On the definition of "traditional food from third country", this only referred to primary production. Sacha inchi oil could be placed on the EU market, whereas camu camu or rumberry were only known in the European Union to be used in food supplements. The 25 years history of safe use reflected experience gained by one generation of population consuming the food in question, and no toxicological data were required, only compositional data. The new proposals aimed to streamline the pre-market authorization procedure, in particular by faster and more proportionate safety assessments for traditional foods from third countries with a history of safe use. Detailed guidance on all information to be presented as part of the application would be provided. Recommendation 97/618/EC would be replaced by a new scientific guidance elaborated by EFSA by 31 October 2015, and would be subject to public consultation.


In October 2014, Peru restated its concerns over the proposed amendment of EU Regulation No. 258/97 (G/SPS/GEN/1361), again requesting the review of several definitions. Furthermore, Peru addressed Article 9 of the proposed amendment, which sets forth the procedure for authorizing the placement of novel food on the EU market, requiring the exporter to present scientific evidence demonstrating the safety of the novel food in question. Peru challenged the consistency of EU's proposed Regulation with Articles 2.2 and 5 of the SPS Agreement, which require the importing Member to adopt the least trade-restrictive measure, based on a risk assessment, and requested the European Union to provide the underpinning scientific basis.
Colombia and Guatemala expressed their support for Peru's concerns.
The European Union informed the Committee that Members' comments on the new proposed Regulation were being transmitted to the European Parliament and European Council for consideration before its final adoption. Regarding Peru's comments on Article 9, the European Union recalled that one of the main objectives of the proposed Regulation was to facilitate and streamline the authorization of novel foods from third countries. European Commission Recommendation 97/618/EC reflected the scientific considerations underpinning the draft legislation. As it was not possible to anticipate the potential risks associated with novel foods production processes, the European Union noted that a high level of food safety could only be achieved by putting in place a pre-market approval system, compatible with Article 8 and Annex C of the SPS Agreement. The European Union expressed its confidence that the proposed Regulation was consistent with the SPS Agreement since it provided unified, simplified and shortened authorization procedures. The European Union reiterated its commitment <>to work closely with all Members to address their concerns and to provide detailed guidance to applicants regarding the authorization and notification procedures.

In March 2015, Peru reiterated its concerns over the proposed amendment of EU Regulation No. 258/97 (G/SPS/GEN/1383). Peru challenged the consistency of the EU proposed regulation with Articles 2.2 and 5 of the SPS Agreement, which require the importing Member to adopt the least trade-restrictive measure, based on a risk assessment, and requested the European Union to provide the underpinning scientific basis. Peru noted how trade statistics for kaniwa (or caƱihua) exports showed the detrimental effects of the EU's Regulation on Novel Foods on Peru's traditional products derived from biodiversity. While Peru's global exports of kaniwa had increased by more than 317% in 2013 and about 206% in 2014, going to markets such as Australia, Canada and the United States, the marketing of this food in the European market was restricted and its real potential was therefore reduced. Peru also requested the European Union to clarify the scope of the phrase "a large part of the population of a third country", contained in Article 2.2(c). The definition did not specify the percentage or number of people required for this part of the population to be considered "large", nor did it specify whether the population in question should constitute a representative sample of the country's population as a whole or whether it may concern specific areas.
The Plurinational State of Bolivia, Colombia, Costa Rica, Dominican Republic, Ecuador and Guatemala expressed their support for Peru's concerns.
The European Union recalled that the new proposal did not change the definition of novel food or the scope of the regulation, which covered foods, production processes and production methods new to the European Union for various reasons. This was in line with article 5.2 of the SPS Agreement. The European Union noted that in some cases safe consumption might require preparation or consumption habits only known to the consumers of the country producing the food in question. It was therefore not possible to anticipate the potential risk associated with such novel foods, production processes or production methods and to address them in an all-encompassing risk assessment. As a result, the high level of food safety pursued in the European Union could only be achieved on a case by case basis within the framework of a pre-market approval system. The EU scheme for Novel Food was in line with the SPS Agreement, as it was a pre-market approval based on scientific risk assessment, in line with Articles 5, 8 and Annex C. The European Union also reiterated its commitment to provide detailed guidance to applicants regarding the authorization and notification procedures and noted that products such as kaniwa should particularly benefit from the new Novel Food Regulation, as they were likely to qualify for the simplified and shortened procedure for authorization of traditional foods from third countries. The European Union finally recalled that the discussion by the EU Parliament and the Council had not yet concluded; therefore no final text was available. The European Union would be in a position to provide a definitive answer to the questions and concerns raised by WTO Members only when the final text was available.

In July 2015, Peru reiterated its concerns over the EU proposal for a regulation repealing Regulation (EC) No. 258/98 on novel foods notified in G/SPS/N/EU/64. Peru's traditional biodiversity products with high export potential were being affected by the European Union's current regulation on novel foods, to the detriment of small- and medium sized Peruvian producers and exporters. Peru gave the example of "huito", the marketing of which is restricted in the European Union, as described in document G/SPS/GEN/1422. Peru requested that the European Union indicate the scientific basis for its regulation on novel foods and take into consideration the points raised by Peru at different meetings.
Colombia, Ecuador, the Dominican Republic, Nicaragua, Guatemala, Costa Rica and Brazil supported Peru's statement, and highlighted the measures potential adverse effects on trade that the measure. They stated that the EU measure was not based on scientific principles and requested more information on its current status.
The European Union announced that the definitive text of the new regulation was not yet available, although some progress had been made by the co-legislators. It was not possible to anticipate the potential risk associated with all novel foods, production processes and methods, and to address them in an all-encompassing risk assessment. The high level of food safety pursued by the European Union could only be achieved on a case-by-case basis within the framework of a pre-market approval system, in accordance with Article 8 and Annex C of the SPS Agreement. Regarding "huito", there had been no application for its authorization as novel food. Since the current novel food regulation had been in place since 1997, but there had been substantial imports of "huito" into the European Union in 2008, there seemed to be no causal relationship between the regulation and the trade of this product into the European Union. Like all other traditional biodiversity foods, "huito" should particularly benefit from the new novel food regulation, since it was likely to qualify for the simplified, shorter procedure for such traditional foods. The European Union announced that once the regulation was adopted, guidance on all the information to be presented by applicants would be made available for public consultation and an information session would be organized. The European Union remained committed to cooperating on this matter with all interested WTO Members.

In October 2015, Peru reiterated its concerns on the EU proposed novel foods regulation, as notified in G/SPS/N/EU/64. Peru asserted that the proposed regulation was not compatible with Articles 5.1, 5.2 and 2.2 of the SPS Agreement, since the ban on the marketing of traditional biodiversity products was not justified by scientific evidence (G/SPS/GEN/1444). Peru observed that there was no scientific justification to require exporters to demonstrate safety of each product they wished to export to the European market and emphasized that Peru's traditional biodiversity products with high export potential were being affected by the European Union's current regulation. Peru gave the example of ornamental fish, which were of high importance for vulnerable regions of Peru and exported to over 80 countries, but would be subject to restrictions in the EU market due to this regulation. The proposed regulation did not take into account the needs of developing countries regarding access for biodiversity products and generated high barriers to trade in the European market. Peru requested that the European Union respond to the questions it had submitted. Peru invited the European Union to provide information on the upcoming vote by the European Parliament on this regulation, as well as details on the content of the project, and future steps.
Brazil, Chile, Colombia, Costa Rica, the Dominican Republic and Guatemala supported the concern and requested additional information on the scientific justification of the regulation. They also requested information on the discussions and voting process in the European Parliament, and on its adoption.
The European Union recalled that the co-legislators, European Parliament and Council, had made progress in the negotiations on the regulation and expressed hope that the novel foods legislation could be adopted in the current year. The European Union confirmed that it would hold a special information session to present the new regulation once finalized. After its adoption, a document containing detailed guidance for applicants on the information to be presented would be prepared and subject to public consultation. In responding to the specific queries raised, the European Union indicated that it was not possible to anticipate the potential risks associated with all novel foods, production processes and methods and to address them in an all-encompassing risk assessment. The high level of food safety pursued in the European Union could only be achieved on a case-by-case basis within the framework of a pre-market approval system, in accordance with Article 8 and Annex C of the SPS Agreement. The European Union noted that the proposed regulation was in line with the SPS Agreement as it was based on scientific risk assessment. In addition, the regulation complied with Article 10 on special and differential treatment because it introduced a simplified procedure for the placement of traditional biodiversity foods on the EU market, once their history of safe use in third countries had been demonstrated if no safety concerns based on scientific evidence had been raised. The European Union queried Peru's example of ornamental fish, which was not considered food in the European Union. In addition, the European Union highlighted that Peru currently exported ornamental fish to the European Union on a regular basis.
Peru commented that the regulation would limit its exports to the European Union and requested that Peru be informed ex-ante and not ex-post on this issue. The European Union indicated that information would be provided on the final text and on the practicalities of the regulation, once available. The European Union underscored the objective of the regulation which was to shorten and simplify the current process, especially for traditional foods.

In March 2016, Peru raised its concerns over the new EU Regulation No. 2015/2283 on novel foods, which, like its predecessor Regulation No. 258/97, restricted the entry into the European market of certain foods and food ingredients qualified as "new foods" for not being marketed in the European Union before 15 May 1997. Peru expressed its appreciation for the seminar organized by the European Union on the margins of the current SPS Committee meeting, but noted that once again there was no scientific basis to justify the 25-year history period of safe food use. Peru also highlighted the potential adverse impacts the regulations may have on SMEs in developing countries. Peru invited Members to review the examples of products affected by such regulations from previous submissions and cited in G/SPS/GEN/1477. Peru urged the European Union to address its concerns regarding the new regulation, in particular to provide the necessary scientific justification for the regulation.
Colombia noted that some of its concerns on the new legislation had been addressed in the seminar organized by the European Union, particularly on documentation requirements. However, Colombia remained concerned that the definition of a novel food remained a product not consumed in the EU market before 1997, and about the burden small producers in developing countries would face in complying with the regulation.
Guatemala also shared the concern, reaffirming that the measure needed a scientific basis and urging the European Union to take into account the implications for small-scale, rural producers.
The European Union had already informed the Committee under a previous agenda item that the new Regulation No. 2015/2283 had been adopted in November 2015 and would apply from 1 January 2018. Preparations for implementing the new rules were ongoing, including guidance from EFSA for applicants seeking authorization. The European Union noted that the proposed regulation was consistent with the SPS Agreement. As it was not possible to the address potential risks associated with novel foods in an all-encompassing<><><> risk assessment, the high level of food safety pursued in the European Union could only be achieved on a case-by-case basis within the framework of a pre-market approval system, in accordance with Article 8 and Annex C of the SPS Agreement. The pre-market approval system foreseen in the regulation was based on scientific risk assessment in line with Articles 5, 8, and Annex C. Concerning the 25-year period of consumption, although there was no consensus on an exact period, most experts and regulators considered the period should cover one to several generations; 25 years translated to roughly one generation, which was in the lower-end of this spectrum. In addition, the regulation complied with Article 10 on special and differential treatment because it introduced a simplified procedure for the placement of traditional biodiversity foods on the EU market, once their history of safe use in third countries had been demonstrated, and if no safety concerns based on scientific evidence had been raised. The European Union was confident that the new regulation was fully consistent with the provisions of the SPS Agreement and remained committed to cooperating with all interested Members.

In October 2016, Peru recalled its concern regarding the new EU Regulation No. 2015/2283 on novel foods, which like its predecessor Regulation (EC) No. 258/97, restricted the entry into the European market of traditional biodiversity products not marketed in the European Union before 15 May 1997. Peru considered both regulations not to be based on scientific evidence and a risk assessment and therefore to be inconsistent with Articles 2, 5.1 and 5.2 of the SPS Agreement. As an example, Peru invited Members to review the case of products of stevia, a species native to the tropical region of South America used as a sweetener, described in G/SPS/GEN/1526. In particular, Peru urged the European Union to consider its comments on the implications of implementing its regulation, which constituted an unjustified barrier to trade with negative impacts on small farmers and producers.
Colombia recognized the European Union's right to protect its population, but highlighted the burden and high costs its small producers would face in complying with the regulation. Colombia urged the European Union to take into account the concerns raised. Costa Rica highlighted that novel foods were a tool for fostering rural development and SMEs growth in countries largely depending on trade of biodiversity products. Guatemala also shared the concerns, and noted that this type of measures discouraged trade of biodiversity products. The measure jeopardized Guatemala's free trade agreements negotiated with the purpose of diversifying its exports. Ecuador requested that the European Union provide the necessary scientific justification for the regulation. Ecuador also highlighted the need to consider special and differential treatment as well as technical cooperation activities.
The European Union recalled that the new regulation had been adopted and would apply from January 2018. Implementation rules on administrative and scientific requirements for applicants would be finalized by the end of 2017 and duly notified under the SPS Agreement. In addition, two European Food Safety Authority guidance documents for applicants seeking authorisation and for notifications of traditional foods would be published in November. The guidance documents had been subject to public consultation and had been discussed with stakeholders, including non-EU countries, in April 2016. Technical reports on the outcome of these consultations would be published. The European Union was confident that the new regulation was consistent with the SPS Agreement. As it was not possible to anticipate potential risks associated with novel foods or processing methods in one comprehensive risk assessment, the high-level of food safety pursued in the European Union could only be achieved through a pre-market approval scheme, in accordance with Article 8 and Annex C of the SPS Agreement. The European Union considered the new regulation to be in line with special and differential treatment, as it provided for a simplified and faster procedure for traditional biodiversity products, including stevia. The European Union indicated that Peru's application on stevia had not been approved due to lack of information. Concerning the 25-year period of consumption, it translated to roughly one generation, which was on the lower end of the recommended spectrum. The European Union remained committed to continue working with Members and addressing their concerns on this issue.

In March 2017, Peru referred to its previously raised concern regarding the EU Regulation on novel foods which restricted the entry into the European market of traditional biodiversity products not marketed in the European Union before 15 May 1997. This concern had previously been raised in several SPS Committee meetings. Peru outlined that although the European Union had notified the modifications to the regulation, through bilateral channels, as well as through EFSA, to date no information had been circulated regarding the conformity of these regulations to the SPS Agreement. Peru argued that implementation of this regulation constituted an unjustified barrier to the Peruvian food trade and urged the European Union to provide the scientific justification underpinning the regulation, as well as to align its regulation with the SPS Agreement. Peru reserved the right to include this concern on the agenda of the next Committee meeting.