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Trade Barrier NFR?

Underutilized Species under the European Union’s

Novel Food Regulation

commissioned by Deutsche Gesellschaft für

Technische Zusammenarbeit (GTZ) GmbH Global Facilitation Unit for Underutilized Species

October 2003

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Contents

Page Abbreviations and Acronyms 2

Summary 3

1 Introduction 4

2 Case Studies 5

2.1 Notification/Rejection Procedures 5

2.2 Applications for Marketing Novel Foods 6

2.3 Rejections of Non-notified Products 7

3 International Regulatory Framework 9

3.1 National Regulations of Third Countries 9

3.2 International Conventions 12

3.3 Conclusion Drawn from the Comparison of Different Regulations 13

4 Positions on NFR 13

5 Proposals for Modification of the NFR 17

5.1 Separate Regulations for GMO and Non-GMO Foods 17

5.2 Introduction of a Separate Category for Exotic Traditional Foods 18

5.3 Simplified Notification Procedure 18

5.4 Generic Admission of Exotic Traditional Foods 19

5.5 Closing Remarks 19

6 Sources of Information 19 Annex I Terms of Reference

Annex II Contacts

Annex III Instruction Sheet from Switzerland

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Abbreviations and Acronyms AESGP Association of the European Self-Medication Industry

BDIH Bundesverband Deutscher Industrie- und Handelsunternehmen für Arzneimittel, Reformwaren, Nahrungsergänzungsmittel und Körperpflegemittel - Federal Association of German Industry and Commercial Companies for Pharmaceuticals, Health Products, Dietary Supplements and Personal Hygiene Products

BfR Bundesinstitut für Risikobewertung – German Federal Institute for Risk Assessment

BMVEL Bundesministerium für Verbraucherschutz, Ernährung und Landwirtschaft - German Federal Ministry of Consumer Protection, Food and Agriculture

CIP Centro Internacional de la Papa

EFSA European Food Safety Authority

EHIA European Herbal Infusions Association

EHPM European Federation of Associations of Health Product Manufacturers

EU European Union

FAO Food and Agriculture Organization of the United Nations

FDA Food and Drugs Administration

GATT General Agreement on Tariffs and Trade

GmbH Gesellschaft mit beschränkter Haftung –Limited Liability Company

GMO Genetically Modified Organism(s)

NFR Novel Food Regulation

SPS Sanitary and Phytosanitary Measures

TBT Technical Barriers to Trade

UNCTAD United Nations Conference on Trade and Development

USA United States of America

WHO World Health Organization

WTO World Trade Organization

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Summary Imports into the European Union (EU) of foods derived from underutilized plant and animal species may fall under the Novel Food Regulation (NFR), if they have not been used in the EU to a significant degree for human consumption prior to May 15, 1997. The European market has, for example, repeatedly rejected traditional exotic foods such as maca, chontaduro, and borojo originating from Andean countries. This practice constitutes an obstacle to efforts by technical cooperation to promote exports of underutilized plant and animal species for food purposes and to thus generate income and reduce poverty in rural areas of developing countries. The objective of this study is to collect and analyze information about rejected food derived from underutilized species and to provide arguments for improving the NFR during the ongoing revision process as launched by the EU discussion paper in July 2002. Any revision in this connection ought to take account of the special requirements pertaining to the promotion of and trade with underutilized plant and animal species. A comparison of the EU’s NFR with similar regulations by other countries shows that third countries do use somewhat different approaches in part. While definitions of novel food and the requirements for notification seem to be partly identical with the EU approach, practical implementation is, in some cases, more pragmatic and less obstructive to international food trade. There are no international conventions on novel food issues. The positions of the various parties affected by the NFR, as voiced in response to the EU discussion paper, indicate that most of them share similar concerns about the consequences of the NFR on trade with traditional exotic foods. The modification proposals given as part of the responses mainly deal with the need for a clarification of terms and for simpler procedures, but also call for the complete exemption of traditional exotic foods from NFR jurisdiction. Having analysed the different national regulations valid in third countries and the positions of the parties concerned, the study proposes that the following modifications be made to the ongoing NFR: 1 Introduction of a separate category under the NFR for exotic traditional foods to

facilitate imports

2 Simplification of the notification procedure for foods in this category, in particular with regard to the assessment of food safety

3 Generic instead of applicant-specific admission of exotic traditional foods to avoid creating a monopoly for the first applicant

These proposals have been developed, with a view to introducing simple, readily enforceable stipulations and procedures for imports of exotic traditional foods into the EU. These procedures are designed to serve the interests of both the producers and traders in developing countries whilst concomitantly meeting EU consumer-health objectives.

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1 Introduction Importing food from underutilized plant and animal species into the European Union (EU) may be subject to the Novel Food Regulation (NFR – EC No. 258/97), if these food items have not been used to a significant degree for human consumption in the EU before May 15, 1997. Article 1 (2 (e)) of the NFR stipulates that foods produced according to traditional procedures are excluded from the Regulation provided that they have a history of safe food use. The respective text says:

Article 1

(…)

2. This Regulation shall apply to the placing on the market within the Community of foods and food ingredients which have not hitherto been used for human consumption to a significant degree within the Community and which fall under the following categories:

(…)

(e) foods and food ingredients consisting of or isolated from plants and food ingredients isolated from animals, except for foods and food ingredients obtained by traditional propagating or breeding practices and having a history of safe food use;

(…). In practice, however, the EU has repeatedly rejected traditional exotic foods. The critical issue in Article 1 (2 (e)) is the term “history of safe food use“ which is not clearly defined in the NFR. On the one hand, it can be interpreted as a well-documented history that follows scientific criteria. This implies, in practice, written documentation that includes various data on toxicity, allergenic potential and other safety issues. On the other hand, it can be understood to refer to (oral) traditions based on consumption of the respective food throughout centuries or even millennia without observable damage or risks. As notification has been denied in the past to two products (stevia and nangai nuts) obtained by traditional propagating and breeding processes on the basis of insufficient information on food safety, it can be concluded that the scientific approach to NFR implementation is preferable. It is worthwhile mentioning here that Commission Recommendation 97/618/EC on the scientific information and safety assessment reports required for applications classifies novel foods exclusively along the lines of “history of food use in the Community”. Apart from this, a number of other legal terms are used in the NFR which are not clear and therefore complicate its implementation considerably. Some of the questions arising from this lack of clarity are:

Which food is “novel”? There are huge practical difficulties in determining the extent to which food items have been imported into the EU before 15 May 1997 owing to the lack or incomplete nature of relevant statistical data.

What is meant by “consumption to a significant degree”? This expression is not quantified in terms of period of consumption, quantities consumed, number of consumers, area of distribution, etc., thus rendering the indicator of little practical value.

What does “equivalent“ or “different” in comparison with a conventional food or food ingredient mean in practice? Because of the nature of food products, i.e. an extremely complex chemical structure, every assessment of equivalence has a considerable subjective component and cannot really withstand objective criteria.

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Since the EU introduced the NFR , access to the EU market has been denied to several food products derived from underutilized plant species with reference to Article 1 (2 (e)). Some of these cases are described in Chapter 2 of this paper. And similar cases can be expected in future. This practice is an obstacle to technical cooperation efforts funded by EU Member State governments, other nations and private initiatives to promote the commercialization of underutilized plant and animal species for food purposes, with a view to generating income and reducing poverty in rural areas of developing countries. As a consequence, some of the limited funds being made available to assist developing countries may be going into activities which are doomed to failure from the very beginning. The objective of this study is to collect and analyze information about rejected foods derived from underutilized species and to then provide arguments in favour of improving the NFR within the scope of the current revision process as launched by the EU discussion paper in July 2002. The revision process should take into account the special requirements involved in the promotion of and trade with underutilized plant and animal species. The following issues may serve as points of departure for proposals to modify the text that is currently in force:

Examples of similar regulations from other countries outside the EU and their experiences with implementation (see Chapter 3) and

Positions and proposals of governmental organizations in the exporting countries involved, their trade organizations and other concerned parties (see Chapter 4).

2 Case Studies 2.1 Notification/Rejection Procedures A company intending to import novel food into the EU is requested to submit an application for notification to the relevant authority in the country of entry. If the evidence provided with regard to consumer safety is considered insufficient, the product will be rejected. In this case, basic information on the decision and its circumstances becomes available shortly afterwards on the EU website. Novel food items may also be rejected by the EU if an attempt is made to import them without previous notification. It is difficult to access detailed information on rejections of this kind, because there is no systematic, centralized register of decisions in Member States. A preliminary list of national decisions relating to products presumably falling under the NFR has been compiled by the EU Commission. Given the objections of some Member States, this list has not been made public and therefore could not be used in this study. However, a final version of this list may be made available to the public by the end of the year 2003. German food control authorities at the sub-federal, i.e. state or “Land”, level decide autonomously on rejection or authorization of novel foods originating from outside the EU at the point of entry to their respective state. Consequently, information on decisions concerning the entry or rejection of exotic food is only available at the point of entry. The respective state authorities may ask advice from the federal authority responsible for consumer health protection (Bundesinstitut für Risikobewertung - BfR). However, neither the BfR nor any other federal authority keeps a centralized register of decisions. Technically, information on rejections should also be available from associations of exporters and importers as well as from trade companies. And yet enquiries made to export associations in Colombia, Honduras and Peru and to import associations located in

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Germany, the Netherlands and Switzerland as well as private companies in several exporting and importing countries proved negative in most cases. With the exception of one exporter of maca (Lepidium meyinii) from Peru, all companies contacted successfully stated that they had never encountered problems in connection with the rejection of food products under the NFR. Further background information on the maca case can be obtained from UNCTAD (United Nations Conference on Trade and Development); details are given in Section 2.3 of this paper. 2.2 Applications for Marketing Novel Foods To date, the EU Commission has published three decisions on novel food items derived from underutilized crops. Stevia (Stevia rebaudiana – family: Compositae) and nangai nuts (Canarium indicum – family Burseraceae) have been officially rejected by the Scientific Committee for Food after a standard application had been made. In both cases, the Committee deemed the information on safety to be too insufficient as to justify placing these products on the market. Noni juice (Morinda citrifolia – family: Rubiaceae) from Tahiti is the only product derived from an underutilized crop that was granted notification in 2003. Stevia Stevia is a plant originating from Paraguay. Its leaves contain the natural sweetener stevioside which is many times sweeter than sugar from sugarcane or turnips. The application by the Laboratory of Plant Physiology at the Catholic University of Leuven, Belgium, to have stevia plants and leaves notified as a commercial, novel food in November 1997, was rejected in September 2000. The Committee based its rejection on insufficient proof of the product’s conformity with Article 3.1 of the NFR. In other words, the applicants were unable to convince the Committee that Stevia, or more specifically its ingredients such as glycoside stevioside and its derivatives steviol and steviol epoxide, all of which are new to the EU, did not pose a risk to the consumer. The status of stevia as a food or dietary supplement differs widely the world over. Stevia plays an important role as a sweetener in countries such as Paraguay, Brazil, South Korea, China and, in particular, Japan. In the United States of America (USA), it cannot be commercialized as a sweetener. Indeed, having already been labelled “an unsafe food additive” in the mid-1980s, imports were subsequently banned by the Food and Drugs Administration (FDA) in 1991. However, as of 1994, its import and use as a dietary supplement (but not as a sweetener) have been legalized again under the US Dietary Supplement Health and Education Act. Nangai Nuts The application made by the Pacific Nuts Company in December 1998 concerning nangai or kenari nuts was also rejected on similar grounds in December 2000. In particular, the Commission was not convinced that the data provided on toxicology and allergenic potential were sufficient, as other nuts from the same botanical family can cause contact dermatitis and allergies.

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Noni The US American Company Morinda obtained permission to market noni juice in the EU as a functional food. A request by the German company Pharmos Naturkosmetik und Heilmittel GmbH for permission to market noni capsules based on their equivalence with the juice product was rejected, however, on the grounds that a separate application procedure, including a complete set of data, would be required. Noni grows in Polynesia and other parts of Southeast Asia. The ripe fruits from which the juice is pressed have an offensive smell and a foul taste. Promoters claim that noni constitutes a centuries-old, traditional folk medicine in Polynesia, whereas others report that the local population does not appreciate it very much. Taste and smell do not seem to be the primary reasons for noni consumption, but rather a strong belief in its functional and medicinal virtues. Most of the presumed medicinal effects of noni (including a positive effect on the healing of wounds and abscesses, diabetes and venereal diseases) are not proven according to current scientific standards. 2.3 Rejections of Non-notified Products In a letter dated October 2002, the coordinator of the BIOTRADE initiative at UNCTAD informed the EC’s Director General for Health and Consumer Protection that a number of Andean countries were concerned about the EU’s NFR “becoming a technical barrier to trade for products derived from biodiversity”. This concern was related to recent prohibitions of imports under the NFR of maca from Peru as well as chontaduro (Bactris gasipaes) and borojo (Borojoa patinoi) from Colombia into Germany, Denmark, Portugal, Spain and the Netherlands. During the intensive research conducted as part of this study, it was only possible to shed further light on the maca case using information provided by UNCTAD and an exporter from Peru. No further information on the rejections of chontaduro and borojo could be traced. At least in one case, a shipment of maca was intercepted by Dutch authorities (Keuringsdienst van Waren) at Schiphol Airport in the Netherlands in June, 2002, on the grounds that it constituted a novel food according to the NFR. In the German Federal State of Bavaria, a company was prohibited from importing and commercializing maca plants and products derived from them, also in keeping with the NFR and due to the absence of notification. No detailed information could be obtained concerning rejections in Denmark, apart from the fact that it placed maca on a list of prohibited medicinal plants. Spain and Portugal do not seem to apply the NFR to maca, since they consider it to be a medicinal plant. Switzerland has approved maca as a food. There was a hint from BfR that some rejections of various underutilized crops were based on the fact that these products had been advertised for their medicinal properties or that attempts had been made to market them as pharmaceutical products. Practices such as these are not in compliance with German food legislation. And it would appear that, in such a scenario, the NFR does not come into play at all; instead regulations for pharmaceutical products would be applicable. The information obtained shows that there is a lot of confusion about the legal status of products derived from underutilized species. A certain item may be considered as a food, a dietary supplement or a pharmaceutical product. This confusion, and the partly dubious image that some of these products have, is certainly due to a lack of knowledge and to the way in which most of them are advertised. Internet-based research using a commercial search engine and the key word “maca”, for example, results in hundreds of hits. About 90 % of them are commercial websites and at least half of these place catchwords in the foreground such as “aphrodisiac”, “sexual desire”, “virility”, “natural viagra”, and “powerful

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sexual enhancer”. The fact that “sex sells” is well known in the advertising business, but it would seem doubtful whether sex would also facilitate administrative procedures! Like other underutilized species, the products maca, chontaduro and borojo are not very familiar to most European consumers, administrative officials and food scientists. Therefore, a brief description is given below. Maca Maca (Lepidium meyinii), also known as mace, is a root crop belonging to the family Brassicaceae to which cabbages and mustard belong, too. It is only grown in a very restricted part of Peru and has a comparatively high nutritional value. Maca contains a rather high percentage of proteins (about 10 % of dry weight) and a large number of essential amino acids and minerals such as iron and calcium. According to local belief, it is considered to be an aphrodisiac for both sexes and to increase fertility. Nowadays, maca is processed into products supposed to increase energy, to overcome depressions and to heal a variety of disorders and diseases such as anemia, leukemia, AIDS, cancer and alcoholism which are difficult to control. Labels typically attributed to this type of product are “Peru’s natural viagra” or “Peruvian ginseng”. Chontaduro Chontaduro (Bactris gasipaes – family Arecaceae: palm trees) is also known as peach-palm. It constituted a major crop of the pre-Columbian Amerindians and is widespread in humid regions. The fruit is used for consumption in a variety of ways and surpasses maize in nutritional value. Flour made from peach-palm has many uses. Chontaduro is also said to positively influence sexual function and fertility, although any possible medicinal uses have yet to be explored. Borojo Borojo (Borojoa patinoi) is a shrub from the Rubiaceae family growing in the Colombian Chocó region. It produces a huge fruit rich in minerals such as phosphorous, iron and calcium as well as essential amino acids. Borojo fruits are used for human consumption in a variety of ways. Numerous, as yet unproven, functional and medicinal benefits are attributed to borojo, including an increase in general well-being and sexual desire. Brief Comment on the Possible Benefits of Rejected Products Information available on the products listed above indicate that they have above-average nutritional value, appealing taste and probably some desirable functional properties which would seem to make them attractive additions to the European food basket. In their countries of origin, some are consumed in a rather restricted geographical zone (e.g. maca and borojo), and others in wider areas (e.g. chontaduro). Their commercial importance is generally rather insignificant. All of them are primarily considered to be food items, but local populations that consume them also believe they have functional and medicinal properties. However, traditional and modern folklore concerning any purported medicinal and/or functional virtues should be regarded skeptically, especially since such claims may be partly responsible for rejections under the NFR or other EU regulations, particularly if their derivatives are advertised as drugs.

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3 International Regulatory Framework 3.1 National Regulations in Third Countries As the NFR states in its preamble, its main aim is to protect public health and, in the case of genetically modified organisms (GMO), to protect the environment. A number of other countries have also implemented regulations on novel food which serve similar purposes. These countries use partly differing approaches to achieve their objectives. However, a large number of countries do not have any regulations of this kind at all. Indeed, besides the EU, most countries with regulations on novel food are industrialized ones (e.g. Australia, Canada, New Zealand, Switzerland and the USA). In the Tables below, these countries’ respective national regulations on novel food are presented and compared to the NFR in force in the EU, the aim being to identify possibilities for NFR alignment with practical requirements. Australia and New Zealand have a common unified regulation on novel food. Canada has a NFR that is based on definitions similar to the EU’s. Switzerland has no special novel food regulation; all registered foods are described in the Swiss Food Regulation. It has only one instruction sheet (“Merkblatt” – see Annex III) for the registration of new products (called “Neuprodukte”) that do not comply with one of the descriptions in the Food Regulation. The USA do not seem to have a regulation comparable to the NFR either. As in Switzerland, general food regulations provide the framework for dealing with novel foods. The following Tables provide definitions, name the authorities involved, elucidate the application procedures and state the information required for notification. Synoptic Comparison of Novel Food Definitions and Notification Procedures under Different Novel Food Regulations Definition of “Novel Food” (Definitions are quoted from the respective legal texts. However, only those parts of the definitions are given that are relevant to the thematic focus of this study)

Australia and New Zealand

“a food which does not have a history of significant human consumption by the broad community in Australia or New Zealand”

Canada “a substance, including a micro-organism, that does not have a history of safe use as a food“

Switzerland No definition could be found. Foods that are not described in the Swiss Food Regulation are considered to be new or novel.

USA No definition could be found; the Food and Drugs Administration (FDA) considers food ingredients as novel ”that have not previously been used as food ingredients“.

EU “foods and food ingredients which have not hitherto (until May 15, 1997) been used for human consumption to a significant degree within the Community and which fall under the following categories: (…) (e) foods and food ingredients consisting of or isolated from plants and food ingredients isolated from animals, except for foods and food ingredients obtained by traditional propagating or breeding practices and having a history of safe food use“

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Application procedures and information required

Australia and New Zealand

Novel foods require pre-market clearance under the Food Standards Code. Food importers are required to supply Food Standards Australia New Zealand (FSANZ) with scientific information that satisfies the specifications outlined in Standard 1.5.1, taking into account the composition or structure of the product, levels of undesirable substances in the product, known potential for adverse effects in humans, traditional preparation and cooking methods, and patterns and levels of consumption of the product. This information is examined by FSANZ scientists and supplemented by information derived from the scientific literature and external experts. The safety assessment will be performed in accordance with the Authority’s safety assessment guidelines. Once a novel food regulated under Standard 1.5.1 has completed the safety assessment process, a report is released for public comment. The food is added to the relevant standard and allowed for sale once approved by the food standards ministerial council.

Canada Importers of novel foods have to notify the Food Director of Health Canada of their intention. Notification has to include, amongst other indications, the common name under which the novel food is to be sold and the description of the novel food, together with information on its development, details of the method by which it is manufactured, prepared, preserved, packaged and stored, details of major changes, if any, its intended use and directions for its preparation, its history of use as a food in a country other than Canada, if applicable, and the information relied on to establish that the novel food is safe for consumption. Information concerning the estimated levels of consumption by consumers of the novel food is also required. The Director reviews this information within 45 days after receiving a notification. S/he then notifies the importer that the information is sufficient, if the information establishes that the novel food is safe. Otherwise s/he requests additional information of a scientific nature in order to assess the safety of the novel food. Within 90 days after receiving the additional information, the Director assesses it and, if s/he establishes that the novel food is safe for consumption, notifies the importer that the information is sufficient.

Switzerland All foods that are not described in the Swiss Food Regulation require authorization by the Federal Heath Authority (Bundesamt für Gesundheit – BAG) before being placed on the market. Fruits are exempt from this stipulation. After notification of a new food, BAG assesses its composition, intended use and declaration, and issues an admission number that must be indicated on the label. If a substance is novel, the absence of health risks must be proven in scientific studies (no further details on the number and type of studies requested are provided in the instruction sheet). Information on the contents and processes used in production is compulsory. In the case of products imported from other countries, an official statement on the food’s legal status in the country of origin must be provided. The product is not allowed to have a chiefly pharmaceutical rather than a nutritional effect.

USA Before being allowed to enter the market, novel food is examined by the FDA according to the same criteria as conventional food in terms of nutritional value, digestibility and “substantial equivalence” of the ingredients with common substances. On the basis of this examination, a food item will be approved or prohibited for consumption. This means that the inherent characteristics of a product are the basis for approval rather than categories such as novelty or use of recent biotechnology, including genetic engineering. With the exception of most meat and poultry, all food as defined in the Federal Food, Drug, and Cosmetic Act and related laws, is subject to examination by the FDA when being imported into the USA. Imported foods must be pure, wholesome, safe to eat, and produced under sanitary conditions. Importers must file an entry notice with the US Customs Service (Customs) and acquire a bond to cover their goods’ release. The FDA is notified by Customs of the entry and makes a decision as to the articles’ admissibility. If FDA does not wish to examine the entry, the product is allowed to proceed into the United States. If the FDA samples an entry and analysis shows that the product is in compliance, the shipment is released onto the US market.

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Application procedures and information required (continued from the previous page)

EU Companies wishing to market a novel food in the EU need to submit a request to the Member State in which the product is to be placed on the market for the first time. At the same time, they forward a copy of the request to the Commission. An initial assessment is carried out. The Member State that received the application informs the applicant without delay about the decision (either authorization to place the food on the market or the need for an authorization decision). The periods of time involved are three months for drawing up the initial assessment report and another two months for comments by Member States or the Commission. Where an additional assessment is required or an objection is raised, an authorization decision is taken. This decision defines the scope of the authorization and establishes, where appropriate, the conditions of use of the food, its designation, its specification and specific labelling requirements.

Information to be provided by the applicant includes specification of the novel food, history of the organism used as the source of the novel food, anticipated intake/extent of use, information from previous human exposure to the novel food or its source, nutritional and toxicological information.

Novel foods may follow a simplified procedure merely requiring notification by the company, if a national food assessment body considers these foods to be "substantially equivalent" to existing foods (in terms of their composition, nutritional value, metabolism, intended use and the level of undesirable substances contained therein).

Observations and Conclusion Two basic attitudes prevail as far as definitions of novel food are concerned: Switzerland and the USA do not make a particular distinction between conventional and novel food by definition. This implies that introducing a novel food to the market does not constitute a problem in itself, because the necessary procedures follow schedules established for any type of food. The remaining countries have definitions which are based either exclusively on the history of consumption in the respective countries (Australia and New Zealand), the history of safe use as a food (Canada) or both criteria at the same time (the EU). As the EU approach combines both aspects, it is the most exacting one and also the one that produces the highest number of novel foods by definition. Apart from this, none of these definitions is particularly precise in the use of terms such as “significant”, “broad community”, and “history of safe use”. As a consequence, the respective regulations leave a lot of room for interpretation and implementation. The description of the legal procedures involved in marketing a novel food in the countries analyzed in this study does not necessarily provide a clear indication of the practical implications involved. Most of the regulations involved are short and comparatively clear (e.g. the ones from Australia and New Zealand, Canada and Switzerland) as compared to the EU regulation. In some cases, implementation of the regulations is biased more in favour of the applicants than the EU procedure is. In Australia and New Zealand, Canada and Switzerland, information on safe food use from third countries is taken into consideration, whereas the EU does not follow this approach. Australia and New Zealand seem to have adopted the principle of generic admission of novel foods in their regulations. The Swiss regulation is not precise on the topic of generic

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admission, and practical application calls for every importer to make an individual application for authorization. Generic admission is, however, particularly appropriate for traditional exotic foods which, by their very nature, cannot be considered the property of a single company or other legal person. Furthermore, the first applicant does not have the chance to establish a monopoly for this product, as is the case with the European Union’s NFR. This is of particular importance for smaller companies that cannot afford costly admission procedures for marketing purposes. If all these observations are taken into account, it can be concluded that the regulations and procedures of all the countries included in this comparison appear to constitute less of a barrier to imports of exotic traditional foods than does the EU’s NFR. At the same time, there is no indication that the health of the consumers in these countries is subject to higher risks owing to novel food consumption than that of consumers in the EU. 3.2 International Conventions There is no International Convention that specifically regulates novel food issues. Codex Alimentarius of FAO (Food and Agriculture Organization of the United Nations), WHO (World Health Organization) plus the WTO (World Trade Organization) Agreements are relevant to novel issues in a general sense. As far as WTO is concerned, the SPS (Sanitary and Phytosanitary Measures) Agreement and the Agreement on Technical Barriers to Trade (TBT) cover novel food issues. Codex Alimentarius The Codex Alimentarius Commission was created to develop food standards, guidelines and related texts (e.g. codes of practice) under the joint FAO/WHO Food Standards Program. The main purposes of this program are to protect consumer health and to ensure fair food-trade practices, as well as to promote coordination of work on food standards by international organizations. There is, however, no official Codex standard on non-GMO novel food. Likewise, there is no Committee or Task Force in charge of this topic. Article 4.1 of the Code of Ethics for International Trade in Food of the Codex Alimentarius Commission includes a general principle that touches on the novel food issue:

4.1 International trade in food should be conducted on the principle that all consumers are entitled to safe, sound and wholesome food and to protection from unfair trade practices.

According to this principle, it can be concluded that trade with novel food should be subject to the same consumer-health protection standards as trade with conventional foodstuffs. Further stipulations with regard to novel foods do not exist at the Codex Alimentarius level. SPS and TBT Agreements The WTO Agreements establish rules of trade between nations, their basic goal being to facilitate free trade. WTO is based on the GATT Agreement of 1947 (General Agreement on Tariffs and Trade). Article 20 of GATT contains general exceptions to free trade and allows

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governments to act on trade in order to protect human life or health (and a series of other values), provided they do not discriminate or use this as disguised protectionism. There are two specific WTO agreements on food safety (as well as animal and plant health and safety) and product standards. The SPS Agreement deals with food safety and plant and animal health. It does not impose any quantitative and legally-binding schedules of concessions, but is rather a set of rules and principles to ensure, among other things, that sanitary and phytosanitary trade measures and food safety are scientifically justified and do not constitute disguised restrictions on international trade. The SPS Agreement allows countries to set their own standards and says that regulations must be based on scientific risk analysis. The SPS Agreement complements the TBT Agreement which seeks to ensure that technical regulations and standards, including packaging, marking and labeling requirements, as well as analytical procedures for assessing conformity with technical regulations and standards do not create unnecessary obstacles to trade. Before the SPS Agreement was negotiated, many food safety regulations came under the TBT Agreement. With regard to the NFR, it is worth mentioning that the SPS Agreement gives members the opportunity to apply the “precautionary principle”, a kind of “safety first” approach to dealing with scientific uncertainty. However, it does not specifically mention novel food. After the WTO Secretariat had been notified of the NFR in line with the stipulations of the SPS Agreement, the Secretariat forwarded it to all WTO members to give them an opportunity to comment on the measures taken. A survey of the protocols of the SPS Committee meetings from the beginning of 1996 onwards showed that obstacles to trade caused by the NFR have never been raised as a concern in the Committee. 3.3 Conclusion from the Comparison of Different Regulations From the analysis of the Codex Alimentarius and WTO texts, it can be concluded that there is no specific common ground for novel food regulations at the international level. The texts mentioned above only touch on novel food issues in general terms and are therefore not of much practical importance. National regulations vary in concept from rather liberal and pragmatic regulations, such as those in Switzerland and the USA, to rather strict ones such as the NFR in the EU (cf. Tables with summaries of the relevant regulations in Section 3.1). Whereas liberal legislation does not constitute a specific trade barrier, the NFR in force in the EU counts, at least, as a potential non-tariff trade barrier.

4 Positions on NFR This section deals with the different positions of the various parties concerned about (possible) obstacles to trade in underutilized species owing to the NFR. These positions have mainly been taken from the responses to the EU discussion paper. Most of the numerous attempts to obtain additional information during the preparation of this study failed. In particular, the SPS Enquiry Points did not give any feedback on the issue. None of the fruit importers contacted during this study showed any concern with regard to the NFR; indeed, none of them had ever made an application. A number of telephone interviews gave the impression that most of the exotic traditional food imported into the EU is not considered to be subject to the NFR by the relevant authorities. The obvious lack of

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complaints from exporters and importers and their organizations indicates that the NFR has not been a real trade barrier in practice, but that rejections may rather have something to do with the import of products of a more or less pharmaceutical nature. It appears that the NFR provides a legal basis for rejecting functional foods with uncertain characteristics with regard to their action and safety. Proposals made by M. Hermann of the International Potato Institute (CIP) in an unpublished paper of August 2003 entitled “The amendment of the EU Novel Food Regulation: Opportunity for recognizing the special status of exotic traditional foods“ have also been taken into consideration in this section. Position of Comunidad Andina Comunidad Andina represents the countries Bolivia, Colombia, Ecuador, Peru and Venezuela and constitutes an important representative of countries cultivating or breeding underutilized species that are being or may be exported to Europe. Complaints concerning rejections raised in the afore-mentioned UNCTAD letter relate to Comunidad Andina members in particular. In its response to the EU discussion paper, the General Secretariat of Comunidad Andina underlines the fact that its member countries host about one quarter of the planet’s biodiversity and that both the utilization of and trade in these resources are growing, especially in “green markets”. The response consists of three major observations and conclusions derived from them. The first observation points out that food products having a proven safety record and that are derived from the biodiversity of the Andean-Amazon region cannot and indeed should not be associated with GM-derived foods, but are nevertheless being given the same treatment. The General Secretariat disagrees with the stipulation that the foods given in the different categories of Article (1) of the NFR should be subject to the same notification procedures. Hence the request to exclude traditional Andean-Amazon food items from the NFR. The second observation deals with the procedural inadequacy (including analytical and bureaucratic procedures) besetting notification of traditional foods. The procedures in use were actually designed for foods produced with novel biotechnologies, a practice judged to be contradictory to WTO Agreements. At the same time, EU requirements are considered to be insufficiently clear or explicit. The lack of clarity of terms such as “consumed to a significant degree within the Community” is a good example here. The third observation contains comments on the type of legal instrument and person initiating the procedure. The General Secretariat clearly opts for regulations with a general effect instead of individual decisions to avoid duplication. However, any assessment of food from the Andean-Amazon region should relate to the food product itself, regardless of the person making the application, as the product is always basically identical, irrespective of its presentation (e.g. natural, packaged, dried etc.). The conclusions made in this response summarize these points and propose that

a health certificate issued by the exporting country should suffice as a basis for approval;

in line with WTO Agreements, the NFR should not apply to:

(i) foods and food ingredients which form part of the traditional diet in third countries, are well known and have a history of safe food use in these countries;

(ii) traditional, exotic and “ethnic” foods and food ingredients which have been marketed in any way within the European Union before 15 May 1997.

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Position of Peru Peru submitted four comments on the discussion paper. The first expresses the opinion that the NFR should exempt plants and animals used for human consumption which have a history of safe food use, without territorial limitation to any part of the planet. The second postulates that authorizations must be generally applicable, i.e. they should be granted to the product and not to the importer. The third comment disagrees with the stipulation that requests must be made by a person who has a legal representative in the EU. Peru proposes applications be allowed by any interested party, irrespective of the existence of a legal representative in the EU. The fourth comment requests the immediate suspension of the NFR for indigenous food products with a history of safe use in third countries as acknowledged by the health authorities of the country of origin. Position of Australia Australia’s comments on the NFR discussion paper underline the fact that the approach taken by both Australia and New Zealand does not depart from physical or technological food properties, but defines novel food in terms of the level of knowledge and understanding available on the food’s potential public health risk. Such an approach provides the opportunity to limit scientific risk assessment to those foods for which risks are unknown or uncertain. Both countries are in favour of taking regulations and experiences of third countries into account in order to make informed decisions. However, they do not provide further details on the implementation of their proposal. Position of UNCTAD Through its Biotrade Initiative, UNCTAD, along with other institutions, is attempting to promote efforts by developing countries to promote trade and investment in biological resources. However, the trade-barrier issue described in Section 2.3 of this study remains. The following recommendations are thus intended to halt current interpretation of the NFR resulting in trade barriers:

Exact definition and interpretation of the products covered by the NFR

Ways and means of facilitating and simplifying procedures, including an evaluation of decisions geared to individuals as opposed to regulations with general application

Support to developing countries to help them build up the technical and institutional capacities required to implement the NFR.

Positions of Private Companies and their Associations For the purpose of this paper, the focus has been only on the positions of medium-sized and small companies and their associations in the underutilized species sector. This is because the two responses from big international companies refer to products produced with modern biotechnology and do not relate to matters dealt with here. Responses by the following associations were also taken into consideration (i.e. only those arguments relevant to the purpose of this paper):

Association of the European Self-Medication Industry (AESGP)

Federal Association of German Industry and Commercial Companies for Pharmaceuticals, Health Products, Dietary Supplements and Personal Hygiene Products (Bundesverband Deutscher Industrie- und Handelsunternehmen für

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Arzneimittel, Reformwaren, Nahrungsergänzungsmittel und Körperpflegemittel – (BDIH))

European Herbal Infusions Association (EHIA)

European Federation of Associations of Health Product Manufacturers (EHPM) These four associations are all involved in the import and processing of herbs. AESGP expressed concern about the complexity of the current NFR procedures and their failure to protect the functioning of the internal EU market. BDIH remarks that, in practice, exemptions under Article 1 (2 (e) are not being applied as intended. Specific comments and proposals for amendments of the NFR include:

Plant material used traditionally as food in third countries is felt to fulfill the requirements of the NFR with regard to customer protection and should be excluded from the scope of the NFR.

The idea of a separate category for exotic traditional foods is supported.

Simplified procedures should be introduced that take account of the history of safe use in third countries.

A notification procedure which does not require marketing authorization is considered to be sufficient.

The fact that foods had been available in pharmacies exclusively and not in food stores or supermarkets is not considered to be a criterion for determining significance in terms of consumption, since the distribution of dietary supplements is not harmonized in the EU either.

Logically, GM food should be regulated differently to non-GM foods.

All approvals for novel foods should be documented in a register, thus enabling all companies to market a registered food.

Memorandum of “Kleiner Rechtsanwälte” This memorandum has been elaborated by the German Society of Lawyers, “Kleiner Rechtsanwälte”, and highlights some important legal issues. It states that initially the NFR focused on GMO products and has been extended to non-modified products during the course of the political discussion. The NFR is deemed to be essentially at odds with WTO regulations and national food laws which consider food to be safe as long as there is no specific reason to halt imports and distribution. The standards and criteria set by the NFR are too extreme and not justified when applied to traditional products. In particular, the standards with regard to toxicity are far too extensive. Also, there is a lack of precision with regard to the term “history of safe food use”. Another problem raised here is the monopoly resulting from the notification procedure by individual applicants. “Kleiner Rechtsanwälte” therefore proposes the following:

a) No application of the NFR to natural food products.

b) As an alternative, a simple reporting obligation could be introduced.

c) The third option would be to improve definitions of the terms used.

d) Irrespective of these three alternatives, the first person or company to apply for notification of a given product must not be able to establish a monopoly for this item.

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This memorandum is particularly useful, as it has been prepared by a legal specialist in this sphere and takes into account the needs and interests of exporting countries. Proposals by M. Hermann, CIP (International Potato Center) M. Hermann has submitted a discussion paper on the issue of underutilized species under the NFR to the German Federal Ministry of Consumer Protection and Agriculture (BMVEL). (Cf. Section 6). After discussing income opportunities for poor countries through trade with exotic traditional foods and describing the adverse impact of the NFR on trade, Hermann proposes the following amendments to the NFR:

1. Recognition of exotic traditional foods as a separate novel food category

2. Simplification of safety evaluation of exotic traditional foods

3. Regulations with general applicability for exotic traditional foods instead of applicant-specific notification

4. Admittance of public-sector applicants

5. Generic admission of exotic traditional foods

6. Food safety dossiers To a great extent, these proposals have been integrated into the formulation of the recommendations in the following section.

5 Proposals for NFR Modification The positions presented in the previous section show that most of the parties that have been quoted here share similar concerns about the consequences of NFR on trade with food derived from underutilized species. Some of the observations quoted above were already made in the EU discussion paper. In the author’s view, most of the concerns raised in connection with the discussion paper are fully justified and necessitate the revision of NFR provisions. The proposals for modifications made by the different parties are, of course, not uniform and in some parts are not even compatible. However, they serve as a good indicator of the exporters’ and importers’ practical needs and provide a basis for the proposals made by the author of this paper. In keeping with legal requirements and based on the technical information available on exotic food, its history of safe use as food in third countries and the legitimate interests of exporting countries, this study suggests the following amendments be made to the NFR. 5.1 Separate Regulations for GMO and Non-GMO Foods A central argument that was brought forward repeatedly states that GMO food should be regulated separately from non-GMO food. The author strongly supports this view. As a new GM Food and Feed Regulation will be issued by the EU in the near future, it does not appear necessary to make any proposals in this regard here, as the topic has obviously already been taken into account.

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5.2 Introduction of a Separate Category for Exotic Traditional Foods Exotic traditional foods, including foods derived from underutilized species, do not have much in common with other categories of food regulated under the NFR. In particular, many of them have been consumed by populations in countries outside the EU for long periods of time (sometimes even for thousands of years) without any tangible adverse effects on human health. On the contrary, there are indications that some exotic traditional foods actually enhance the well-being of the consumer. This is why it would appear justified to place exotic traditional foods in a separate category under the NFR to which the simplified notification procedure outlined below should apply. Any description of this category should not fail to mention the fact that it comprises products that do not have a primarily pharmaceutical effect (cf. the Food Regulation of Switzerland). This statement would help clearly separate (novel) foods from products which obviously come under different regulations. On these grounds, importers who declare their products as aphrodisiacs etc. could easily be referred to pharmaceutical product regulations, a move that would definitely help put an end to the current confusion with products such as maca. 5.3 Simplified Notification Procedure The obvious need to simplify the notification procedure has already been recognized by the EU. Thus, in future, applications for notification of a novel food will not be addressed to national authorities any more, but passed on directly to the European Food Safety Authority (EFSA). Simple notification instead of a request for authorization to import a product would appear adequate, if an appropriate period of delay between notification and intended import (e.g. 60 days) is upheld to give the authority the chance to make any justified objections. Evidence concerning the product’s history of safe use in third countries must be taken into account by the EU. A simple official statement on types of use (food, beverage, etc.), preparation, period of safe use, geographic area where the product is used, estimated population consuming the food, frequency of consumption, etc. should be sufficient. Request for scientific data on toxicology, etc. appears exaggerated, as long as there is no particular reason to doubt the product’s safety. If, however, doubts prevail with regard to consumer safety, a simplified risk assessment procedure is proposed which follows the format of the food-safety dossier to be included in the revised NFR. M. Hermann made the following proposal in this regard: ”Issues that need to be addressed include history of use (origins, domestication, cultivation), composition and compositional changes due to post-harvest conditions and processing, evidence for the presence of functional nutrients, evidence for the presence or absence of anti-nutritional or toxic factors, nutritional assessments (food intake) for both human and animal use. The NFR should make clear indications as to the acceptable format and methods of such information.“ If the dossier provided by an applicant is still considered to be insufficient, scientific tests are justified and necessary. In order to minimize health hazards, the simplified risk assessment procedure may be accompanied by post-marketing surveillance under conditions that have to be determined.

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5.4 Generic Admission of Exotic Traditional Foods If the EU Commission decides it is unable to implement the proposal to replace the current notification procedure for exotic traditional foods with a simplified scheme as outlined above, then another suggestion involves making authorization to market a product in the EU species or at least product specific (this means it should be generic), instead of applicant specific. This approach could be used as long as the product is obtained from the same species using standard and widespread food-processing techniques. This proposal is based on the fact that a traditional food product cannot constitute an intellectual property and should therefore stay in the public domain. Current NFR practice has resulted in a monopoly for a USA-based company marketing noni juice, while an established competitor selling noni capsules has been excluded. The author of the study is, however, aware of the possibility of legal difficulties arising through this recommendation, because food is not generally subject to a registration procedure, as is the case with pharmaceutical products, for example. Possible legal complications with this option thus constitute yet another good argument for introducing a simplified notification procedure as proposed above. 5.5 Closing Remarks The above-mentioned proposals have been developed by the author of this study, with a view to introducing simple stipulations and procedures with which to regulate imports of exotic traditional foods into the EU. The proposed amendments will result in regulations that are easy to implement and which serve the interests of producers and traders in developing countries whilst also meeting EU consumer-health requirements. The package of proposals made in Sections 5.1, 5.2 and 5.3 is considered to be sufficient to achieve the purposes of the NFR as far as exotic traditional foods and, in particular, foods that are derived form underutilized species are concerned. BMZ and GTZ should support participation in stakeholder meetings by representatives of countries affected by the problem described in this paper. In addition, it is recommended that BMVEL, BMZ and GTZ lobby for an NFR which is biased more in favour of producers and exporters of exotic traditional foods in developing countries. Proposal 5.4 is intended as an additional option in case proposal 5.3 does not prove to be feasible. It is not favored by the author, as it would constitute a precedence for pre-market food registration procedures, something which is not in line with current global principles and practices which consider food to be safe as long as there is no specific reason to doubt its safety.

6 Sources of Information Books and Brochures GTZ (2002): Protection by Utilization. Economic Potential of Neglected Breeds and Crops in

Rural Development. 14 pages Hermann, M. & J. Heller, editors. (1997): Andean roots and tubers: Ahipa, arracacha, maca

and yacon. Promoting the conservation and use of underutilized and neglected crops.

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21. Institute of Plant Genetics and Crop Plant Research, Gatersleben / International Plant Genetic Resources Institute, Rome Italy, 256 pages

Hernández Bemejo, J.E. & J. León (1994): Neglected Crops - 1494 from a different

perspective. FAO Plant Production and Protection Series, no.26. 341 pages. Studies Hermann, M. (2003): The amendment of the EU Novel Food Regulation: Opportunity for

recognizing the special status of exotic traditional foods. Discussion paper for presentation at BMVEL, Bonn, 6 August 2003 (unpublished).

Mück, O. (2003): Underutilized Plant and Animal Species and the EU Novel Food Regulation

- An Overview of Potentials and Constraints (unpublished) Information on Conventions and Regulations in the Internet Codex Alimentarius: www.codexalimentarius.net Novel Food Regulation of the European Union: http://europa.eu.int/comm/food/fs/novel_food/nf_index_en.html http://europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc&lg=EN&numdoc=31997R0258&model=guichett SPS and TBT Agreements: http://www.wto.org/english/tratop_e/sps_e/sps_e.htm; http://www.wto.org/english/tratop_e/tbt_e/tbt_e.htm National Novel Food Regulations and Other Legal Texts: Australia and New Zealand http://www.foodstandards.gov.au Canada http://www.hc-sc.gc.ca/food-aliment/mh-dm/ofb-bba/nfi-ani/e_novel_foods_and_ingredient.html Switzerland

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http://www.bag.admin.ch/verbrau/lebensmi/d/index.htm; http://www.bag.admin.ch/verbrau/lebensmi/lmrecht/d/d_Merkblatt_Neuprodukte%2018.10.02.pdf United States of America http://www.cfsan.fda.gov/ Other Web Sites Deutsche Gesellschaft für Technische Zusammenarbeit (GTZ) GmbH http://www.gtz.de/agrobiodiv/ The GTZ-assisted project "Managing Agrobiodiversity in Rural Areas" maintains a website that gives an overview of the project’s objectives and activities, including several useful documents on underutilized species in full text. European Union (EU) http://europa.eu.int/comm/food/fs/novel_food/nf_index_en.html Information on novel food and the European Union’s NFR is available on the European Union’s website. It also includes information on applications, decisions, the discussion paper "Implementation of Regulation (EC) No. 258/97 of the European Parliament and that of the Council of 27 January 1997 concerning Novel Foods and Novel Food Ingredients” as well as comments related to this discussion paper. Global Facilitation Unit for Underutilized Species (GFU) http:// www.underutilized-species.org/ The website of the Global Facilitation Unit for Underutilized Species (GFU), an initiative of the Global Forum on Agricultural Research (GFAR) and funded by BMZ, aspires to be a portal to all sources of information about underutilized species available through the Internet. The kind of information on the site ranges from details of specific crops to databases of experts. It also gives access to searchable databases of publications. As well as making knowledge available for download, the site also intends to offer a platform for communication among interested parties. International Plant Genetic Resources Institute (IPGRI) http://www.ipgri.cgiar.org/nus/home.htm The IPGRI website is a rich source of information on neglected crops and underutilized species. It includes 24 full-text monographs that can be downloaded free of charge. World Trade Organization (WTO):

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http://www.wto.org/ This website contains extensive information on international trade issues, but does not include any specific information on novel food topics.

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Annex I: Terms of Reference Tasks The expert shall implement the following tasks:

1. Establish contacts with exporters, development organizations/projects, state institutions in the commercial sector in developing countries (see below) to collect and process case studies of countries and products for which the NFR has constituted a trade barrier, either in the past or present (for traditional exotic foods, i.e. exclusively for Novel Foods that do not consist of genetically modified organisms (GMO))

2. Research the Novel Food Regulations (i.e. relating to non-GMO) in force in Switzerland, New Zealand, Australia, Canada and the USA: In what way do they differ from the regulation in the European Union? Which aspects have been resolved more favourably from the point of view of developing countries? What has hands-on implementation of these regulations revealed and what changes do developing nations feel ought to be made on the basis of this experience? To what extent have the proposals given in the discussion paper by M. Hermann been incorporated into these regulations?

3. Review the Codex Alimentarius in terms of statements relating to Novel Food (non-GMO)

4. Research official documents on the WTO website (notification and comments on the

notification of Novel Food regulations). Establish contacts with the agencies in developing countries responsible for WTO notification (see below) and with the Sanitary and Phytosanitary Enquiry Points in these countries, enquire about their stance on the NFR (non-GMO) and systematize the results (backstopping by D. Guenther, GTZ)

5. Present these positions, including these countries’ proposals for NRF amendment in keeping with their needs, and specify the support inputs they will require in order to assert their position in the NFR revision process.

6. List the most important sources of literature and other information.

7. Write a 2-page thematic paper in German on the EU’s NFR (max. 2000 words, structure the text in line with the format used in existing thematic documents) and submit electronically as a computer file.

Research should focus on the following countries/regions: Argentina, Bolivia, Brazil, Columbia, Ecuador, Paraguay, Peru, Polynesia, Venezuela, West and Eastern Africa. Reports in connection with items 1-6 above are to be written in English and submitted electronically as a computer file.

Period of work September/October 2003 Submission date 31st October, 2003

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Annex II: Contacts The following persons and institutions were contacted in the course of the study. The author would like to take this opportunity to thank all those who contributed in any way through useful information or further contacts. Contact Person Institution Coordinates H. Baber Food Standards Australia New

Zealand hugh.baber@foodstandards.govt.nz

A. Barros Natuzon Brazil info@natuzon.com.br a.barros@natuzon.com.br

A. Büren Proexport Hamburg directorofcom@t-online.de

J. Cock CIAT j.cock@cgiar.org

M. da Costa Austrian embassy Colombia marianne.dacosta@bmaa.gv.at

J. Geuns Cath. University Leuven jan.geuns@bio.kuleuven.ac.be

D. Günther GTZ doris.guenther@gtz.de

N. Gutierrez Frutierrez Colombia frutierr@cable.net.co

nestorg@cable.net.co

K. Hecht CIM Colombia klaushecht@hotmail.com

Mr. Heuer Heuer Hamburg Tel.: +49 40 7887660

A. Klepsch EU Tel.: +32 2 2953210 andreas.klepsch@cec.eu.int

RK. Lojenga UNCTAD Geneva Tel.: +41 22 9175607

M. Lundy CIAT m.lundy@cgiar.org

Ms. Noble BMVEL Tel.: +49 1888 5294665

T. Oberthur CIAT t.oberthur@cgiar.org

J. Pohlan ECOSUR University Mexico drjpohlan@excite.com

Mr. Reimer FTK Netherlands Tel.: +31 1052 41700

M. Schauzu BfR Berlin Tel.: +49 1888 4123758

F. Staubli SIPPO Switzerland fstaubli@sippo.ch

Mr. Tamm Trofi Hamburg Tel.: +49 40 3070960

M. Valdivia MG Investements SRL Peru mvaldivia@mgnatura.com mvaldivia@mginvestments.net

Z. Wiegand DFHV Hamburg Tel.: +49 40 3232550 zuzana.wiegand@dfhv.de

H. Wirth BUG Hamburg Tel.: +49 40 428414016 harald.wirth@bug.hamburg.de

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Contact Person Institution Coordinates Agro Biofloresta Brazil bioflorestal@bioflorestal.com.br

Ansesuyo SRL Peru andesuyo2002@terra.com

CBI Netherlands cbi@cbi.nl

CINEXPORT Traders Colombia nexport1@yahoo.com

Corporación Colombia Internacional cci@cable.net.co

EHM Productora Ecuador buda@interactive.net.ec

Fondación Hondureña de Investigación Agrícola

fhia@fhia.org.hn

Food and Drugs Administration USA http://www.cfsan.fda.gov/

Food Standards Australia New Zealand

info@foodstandards.gov.au

Health Canada food-aliment@hc-sc.gc.ca

Proexport Bogotá info@proexport.com.co

Productos Alimenticios Castipan Colombia

castipan@epm.net.co

Prompex Peru sae@prompex.gob.pe

STI Trading, Argentina fernando@stitrading.net List of contacted SPS Enquiry Points: Bolivia, Brazil, Chile, Côte d’Ivoire, Colombia, Maldives, Peru, Solomon Islands List of SPS Enquiry Points where attempts to contact failed because the coordinates given in the WTO website are invalid: Argentina, Ecuador, Fiji, Ghana, Cameroon, Kenya, Papua New Guinea, Paraguay, Senegal, Tanzania, Venezuela

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Annex III: Translation of Instruction Sheet on the Registration of a New Product Pursuant to Article 3, Section ff of the Swiss Food Regulations (LMV) Preliminary Remarks Foods that are not described in the food regulations require authorization by the Swiss Federal Health Office (Bundesamt für Gesundheit (BGA)). The article in question may be a new food for general consumption or a special, novel food. The BAG examines its composition, its intended use and labelling, specifies the product’s title and grants an authorization number which has to be printed on the package, i.e. label. Authorization can only be granted to people or companies personally or commercially domiciled in Switzerland. Foreign applicants must appoint a representative in Switzerland who shall assume responsibility for ensuring adherence to the regulations. Please refer to the section on legal basis below for the relevant regulations. Requirements In principle, the provisions given in the food regulations are to be adhered to; this applies

in particular to the provisions relating to additives, contaminants and ingredients as well as to the hygiene provisions (ZuV, FIV, HyV).

Labelling is to be based primarily on Articles 19-37a of the food regulations (LMV) and on the provisions given in the regulation on nutritional value (NwV).

The products must differ clearly from products that have already been described. If new, as yet unknown additives or substances are used, pertinent scientific data has to

be submitted proving that the respective additive or substance is not harmful in terms of health, is suitable for use in food and does not have a primarily pharmacological effect.

Evidence must be submitted proving that the product has an appropriate composition and possesses the properties it is claimed to have, if necessary as validated by a scientific report (Art. 3. Section 4 LMV).

The product is not permitted to bear any information whatsoever attributing to it properties capable of preventing, treating or healing human illnesses or of promoting weight loss or which give rise to the impression that such properties are on hand (Art. 19 LMV).

Documents to be submitted The following written documents must be submitted by post, whereby the right is reserved to request further, specific documentation if necessary. Completed application form for authorization to market a foodstuff (Bewilligungsgesuch

zum Inverkehrbringen eines Lebensmittels) to be obtained from BAG, Sektion Lebensmittel, Postfach, 3003 Bern or downloaded from the Internet at the following address: http://www.admin.ch/bag/verbrau/lebensmi/lmrecht/d/index.htm

Precise formulation with exact quantities and manufacturer’s specifications on the ingredients used, if necessary together with the manufacturing procedure.

Samples of goods, as far as possible in the original packaging. Draft label which complies with the requirements given in the law on food production and

distribution. If vitamins, minerals or other nutritional ingredients are claimed to be contained in the

product, pertinent analytical proof is required. Furthermore, official certification of its status under food law in the country of origin, if the

product is a foreign one (free sale certificate). Scientific studies, should it be claimed the food has specific properties (Art. 167 LMV).

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Legal Basis Swiss Food Law (LMG) SR 817.0 Swiss Food Regulation (LMV) SR 817.02 Swiss Regulation on Additives (ZuV) SR 817.021.22 Swiss Regulation on Nutritional Value (NwV) SR 817.021.55 Regulation on Contaminants and Ingredients (FIV) SR 817.021.23 Hygiene Regulation (HyV) SR 817.05

Source of reference: BBL, Vertrieb Publikationen, CH-3003 Bern http://www.admin.ch/ch/d/sr/81.htm#817