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https://food.ec.europa.eu/system/files_en?file=2016-10/novel-food_guidance_human-consumption_en.pdf 2 1. Criteria to be considered when establishing whether a food has been used for human consumption to a significant degree 1.1 Information In addition to general information about the composition of the product, at least the following information is needed in order to ensure that the available documentation about the use of the food prior to 15 May 1997 relates to the product in question. The enquirer should therefore provide at least the following information for: organisms (plants, micro-organisms, fungi, algae, animals etc.) and ingredients produced from organisms: 1) taxonomic name of the organism (full Latin name with author name), also other names, synonyms etc, where applicable 2) specification of which part of the organism the use before 15 May 1997 refers to 3) the form and/or concentration of the product (fluid, extract etc.), and 4) if ingredient in a food supplement, possible indication of the quantity/amount chemical substances: 5) CAS 1 name according to IUPAC2 , also other product names (e. g. trade name, com- mon name), where applicable, and specification about purity 6) description/specification of production process, and 7) if ingredient in a food supplement, possible indication of the quantity/amount. The main points that have to be taken into account, when considering the novel food status are described below. Whilst there may be occasions when a history of consumption to a signifi- cant degree for a product is unequivocal (e.g. by provision of extensive sales data), given the timescales since the entry into force of Regulation (EC) No 258/97, it should be emphasised that as it is as such evidence would now be 12-15 years old this will not always be the case and the “whole picture” needs to be examined. This document therefore also details possible alternative sources of information which could be used to determine “consumption to a sig- nificant degree”. 1 CAS = Chemical Abstracts Service 2 IUPAC = International Union of Pure and Applied Chemistry 2 1. Criteria to be considered when establishing whether a food has been used for human consumption to a significant degree 1.1 Information In addition to general information about the composition of the product, at least the following information is needed in order to ensure that the available documentation about the use of the food prior to 15 May 1997 relates to the product in question. The enquirer should therefore provide at least the following information for: organisms (plants, micro-organisms, fungi, algae, animals etc.) and ingredients produced from organisms: 1) taxonomic name of the organism (full Latin name with author name), also other names, synonyms etc, where applicable 2) specification of which part of the organism the use before 15 May 1997 refers to 3) the form and/or concentration of the product (fluid, extract etc.), and 4) if ingredient in a food supplement, possible indication of the quantity/amount chemical substances: 5) CAS 1 name according to IUPAC2 , also other product names (e. g. trade name, com- mon name), where applicable, and specification about purity 6) description/specification of production process, and 7) if ingredient in a food supplement, possible indication of the quantity/amount. The main points that have to be taken into account, when considering the novel food status are described below. Whilst there may be occasions when a history of consumption to a signifi- cant degree for a product is unequivocal (e.g. by provision of extensive sales data), given the timescales since the entry into force of Regulation (EC) No 258/97, it should be emphasised that as it is as such evidence would now be 12-15 years old this will not always be the case and the “whole picture” needs to be examined. This document therefore also details possible alternative sources of information which could be used to determine “consumption to a sig- nificant degree”. 1 CAS = Chemical Abstracts Service 2 IUPAC = International Union of Pure and Applied Chemistry
IUPAC = 國際純粹與應用化學聯合會 3 1.2 Documentation The fact finding process whether a food has already been used for human consumption to a significant degree within the European Union before 15 May 1997 should be based on robust, reliable information and data taken from referenced sources and relate to foods which have been legally on the Community market. It is recognised that individual pieces of information provided may not, in isolation, reliably indicate that a product was on the market to a significant degree in the EU before 15 May 1997. For example import or distribution lists may not accurately describe the purpose for which the specific product has been sold/imported (food, cosmetics, medicinal products, ani- mal feed…). It is therefore reasonable that all available data and information should be taken into account in establishing whether the food in question falls within the scope of Regulation (EC) No 258/97. These could include for example, invoices, recipes, cookbooks, catalogues etc. Relevant national and Community legislation also needs to be taken into account to determine whether a food would fall under the scope of Regulation (EC) No 258/97. For instance, cer- tain fruit may be used for the production of fruit nectar is listed in Annex IV of Council Di- rective 2001/112/EC of 20 December 2001 relating to fruit juices and certain similar products intended for human consumption (and were already listed in the previous Directive 93/77/EWG). In such cases, Regulation (EC) No 258/97 would not be applicable, unless the food/food ingredient in question does not correspond to the form or type of food/food ingredi- ent covered by the legislation in question (e. g. a new extract from a fruit). 1.3 Geographical aspects Foodstuffs commonly used and known in different EU Member States and in specific regions of some Member States, vary greatly. Therefore the first step is to provide information whether a specific food was used for human consumption to a significant degree before 15 May 1997 widely and commonly within an EU country or whether the use as food was only on local or regional scale. However, food use on local or regional scale does not necessarily mean that such a food re- quires authorisation under Regulation (EC) No 258/97. The respective Member State's au- thorities have to see in each case whether such local use could be considered as “significant degree” or not. The authorities will take into account criteria as, whether operators were con- 3 1.2 Documentation The fact finding process whether a food has already been used for human consumption to a significant degree within the European Union before 15 May 1997 should be based on robust, reliable information and data taken from referenced sources and relate to foods which have been legally on the Community market. It is recognised that individual pieces of information provided may not, in isolation, reliably indicate that a product was on the market to a significant degree in the EU before 15 May 1997. For example import or distribution lists may not accurately describe the purpose for which the specific product has been sold/imported (food, cosmetics, medicinal products, ani- mal feed…). It is therefore reasonable that all available data and information should be taken into account in establishing whether the food in question falls within the scope of Regulation (EC) No 258/97. These could include for example, invoices, recipes, cookbooks, catalogues etc. Relevant national and Community legislation also needs to be taken into account to determine whether a food would fall under the scope of Regulation (EC) No 258/97. For instance, cer- tain fruit may be used for the production of fruit nectar is listed in Annex IV of Council Di- rective 2001/112/EC of 20 December 2001 relating to fruit juices and certain similar products intended for human consumption (and were already listed in the previous Directive 93/77/EWG). In such cases, Regulation (EC) No 258/97 would not be applicable, unless the food/food ingredient in question does not correspond to the form or type of food/food ingredi- ent covered by the legislation in question (e. g. a new extract from a fruit). 1.3 Geographical aspects Foodstuffs commonly used and known in different EU Member States and in specific regions of some Member States, vary greatly. Therefore the first step is to provide information whether a specific food was used for human consumption to a significant degree before 15 May 1997 widely and commonly within an EU country or whether the use as food was only on local or regional scale. However, food use on local or regional scale does not necessarily mean that such a food re- quires authorisation under Regulation (EC) No 258/97. The respective Member State's au- thorities have to see in each case whether such local use could be considered as “significant degree” or not. The authorities will take into account criteria as, whether operators were con-
然而，在當地或區域範圍內使用食品並不一定意味著此類食品需要根據法規 （EC） No 258/97 獲得授權。在每種情況下，各成員國的當局必須查看這種本地使用是否可以被視為“重大程度”。當局將考慮以下標準：運營商是否 4 tinuously on the market, whether the use of the food is linked to local or regional traditions etc. An established history of food use to a significant degree in at least one EU Member State is sufficient to exclude the food from the scope of Regulation (EC) No 258/97. The deadline 15 May 1997 is applicable to all Member States, irrespective from the date of accession to the EU. A use of a food in third countries only is not acceptable to demonstrate a history of food use according to Regulation (EC) No 258/97. 1.4 Quantity of use Generally, the more a food has been used the easier it should be to demonstrate a significant degree. However, the quantities consumed may vary significantly dependent on the type of food, e. g. spices, herbs or some berries may be used in smaller amounts than bread, cereals or flour. The assessment as to whether a food has been used for human consumption to a signifi- cant degree before May 1997 should therefore be based on typical levels of consumption for specific product categories. In addition to the information about quantities (weight) consumed also the number of units (packages) sold, the availability on the market (only in a very limited number of shops or widely available) and the nature of these “shops” (if they were only home-sales or sales to a limited group of consumers) are sometimes important (see also the section “Availability”). In certain cases, Member States have to determine for a food that was used in apparently small quantities, whether such a food requires authorisation under the Novel Food Regulation. 1.5 Intended purpose Regulation (EC) No 258/97 exclusively covers foods and food ingredients. Therefore, only food uses can be taken into account in establishing whether a specific product has been used for human consumption to a significant degree within the Community before 15 May 1997 or not. Furthermore, the demonstrated use should relate to the specific food in question. Products that have been used for their medicinal effects/as a drug or as cosmetics (for exam- ple, traditional restorative remedies, plant based medicinal products, traditional Chinese med- icine, toothpaste) do not indicate that this product was used as food. It should be kept in mind that the classification of products as medicinal product or a food may differ across the EU and 4 tinuously on the market, whether the use of the food is linked to local or regional traditions etc. An established history of food use to a significant degree in at least one EU Member State is sufficient to exclude the food from the scope of Regulation (EC) No 258/97. The deadline 15 May 1997 is applicable to all Member States, irrespective from the date of accession to the EU. A use of a food in third countries only is not acceptable to demonstrate a history of food use according to Regulation (EC) No 258/97. 1.4 Quantity of use Generally, the more a food has been used the easier it should be to demonstrate a significant degree. However, the quantities consumed may vary significantly dependent on the type of food, e. g. spices, herbs or some berries may be used in smaller amounts than bread, cereals or flour. The assessment as to whether a food has been used for human consumption to a signifi- cant degree before May 1997 should therefore be based on typical levels of consumption for specific product categories. In addition to the information about quantities (weight) consumed also the number of units (packages) sold, the availability on the market (only in a very limited number of shops or widely available) and the nature of these “shops” (if they were only home-sales or sales to a limited group of consumers) are sometimes important (see also the section “Availability”). In certain cases, Member States have to determine for a food that was used in apparently small quantities, whether such a food requires authorisation under the Novel Food Regulation. 1.5 Intended purpose Regulation (EC) No 258/97 exclusively covers foods and food ingredients. Therefore, only food uses can be taken into account in establishing whether a specific product has been used for human consumption to a significant degree within the Community before 15 May 1997 or not. Furthermore, the demonstrated use should relate to the specific food in question. Products that have been used for their medicinal effects/as a drug or as cosmetics (for exam- ple, traditional restorative remedies, plant based medicinal products, traditional Chinese med- icine, toothpaste) do not indicate that this product was used as food. It should be kept in mind that the classification of products as medicinal product or a food may differ across the EU and
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當局必須在每種情況下查看這種本地使用是否可以被視為在市場上持續使用，食品的使用是否與當地或區域傳統有關等。在至少一個歐盟成員國有相當程度的食品使用歷史，足以將該食品排除在法規 （EC） No 258/97 的範圍之外。
已用於藥用作用/作為藥物或化妝品的產品（例如，傳統修復療法、植物性藥物、中藥、牙膏）並不表明該產品被用作食品。應該記住，產品作為醫藥產品或食品的分類在歐盟和 5 independent of the classification under Regulation (EC) No 258/97, a product might be classi- fied as a medicinal product in one or several Member States. Furthermore, the placing on the market of a product might be restricted by other specific national legislation. When a food has been exclusively used as food belonging to one of the categories mentioned in Article 2.1 of Regulation (EC) No 258/97 (food additives, flavourings, extraction solvents), such a use cannot be taken into account as "food use" in the sense of Regulation (EC) No 258/97. 1.6 Specific population groups/context of use The assessment whether a specific food has been used for human consumption to a significant degree before 15 May 1997 should also take into consideration if the product in question is part of a normal diet by the average population or has been used by specific population groups only, or whether it is used in a specific and limited food category only. The Standing Committee on the Food Chain and Animal Health agreed in its meeting of 14 February 2005, that a use exclusively in food supplements before 15 May 1997 would not be considered as “human consumption to a significant degree” according to Article 1 of Regula- tion (EC) No 258/97. Therefore, authorisation under Regulation (EC) No 258/97 would be necessary if the food/food ingredient should be used in other foodstuffs than food supple- ments. Food used at specific occasions like particular ceremonies, festivities etc., might be significant use in the sense of the Novel Food regulation. However, products on the market only in emer- gency situations, but not regularly and in a commercially sustainable way, could require an authorisation under the Novel Food Regulation. 1.7 Use of other forms/parts of a food/new technologies It is also important to note that the use to a significant degree within the EU before 15 May 1997 of a particular food or food ingredient does not automatically apply if the product in question has been subject to additional processing. If this processing alters the composition of the food, or the food is produced from a new source material or by a new production process (Article 1(2)(f)) then the resultant product could fall under the scope of Regulation (EC) No 258/97. For example, specific selective extracts of a plant, fungus, algae or microorganism could fall within the scope of Regulation (EC) No 258/97 if they have not been used for human con- 5 independent of the classification under Regulation (EC) No 258/97, a product might be classi- fied as a medicinal product in one or several Member States. Furthermore, the placing on the market of a product might be restricted by other specific national legislation. When a food has been exclusively used as food belonging to one of the categories mentioned in Article 2.1 of Regulation (EC) No 258/97 (food additives, flavourings, extraction solvents), such a use cannot be taken into account as "food use" in the sense of Regulation (EC) No 258/97. 1.6 Specific population groups/context of use The assessment whether a specific food has been used for human consumption to a significant degree before 15 May 1997 should also take into consideration if the product in question is part of a normal diet by the average population or has been used by specific population groups only, or whether it is used in a specific and limited food category only. The Standing Committee on the Food Chain and Animal Health agreed in its meeting of 14 February 2005, that a use exclusively in food supplements before 15 May 1997 would not be considered as “human consumption to a significant degree” according to Article 1 of Regula- tion (EC) No 258/97. Therefore, authorisation under Regulation (EC) No 258/97 would be necessary if the food/food ingredient should be used in other foodstuffs than food supple- ments. Food used at specific occasions like particular ceremonies, festivities etc., might be significant use in the sense of the Novel Food regulation. However, products on the market only in emer- gency situations, but not regularly and in a commercially sustainable way, could require an authorisation under the Novel Food Regulation. 1.7 Use of other forms/parts of a food/new technologies It is also important to note that the use to a significant degree within the EU before 15 May 1997 of a particular food or food ingredient does not automatically apply if the product in question has been subject to additional processing. If this processing alters the composition of the food, or the food is produced from a new source material or by a new production process (Article 1(2)(f)) then the resultant product could fall under the scope of Regulation (EC) No 258/97. For example, specific selective extracts of a plant, fungus, algae or microorganism could fall within the scope of Regulation (EC) No 258/97 if they have not been used for human con-
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植物基醫藥產品 獨立於法規 （EC） No 258/97 的分類，產品可能在一個或多個成員國被歸類為醫藥產品。此外，產品投放市場可能受到其他具體國家立法的限制。
當食品被專門用作屬於法規 （EC） No 258/97 第 2.1 條中提到的類別之一（食品添加劑、調味劑、萃取溶劑）的食品時，此類用途不能被視為法規 （EC） No 258/97 意義上的“食品用途”。
例如，植物、真菌、藻類或微生物的特定選擇性提取物如果未用於人類控制，則可能屬於法規 （EC） No 258/97 的範圍。 6 sumption as such and this may be the case even if the source material is widely consumed. Consideration should also be given to the type of the extracts. For instance, an aqueous extract might be classified quite differently from an extract obtained by using another solvent. In such cases the safety of the particular product needs to be demonstrated due to a lack of experience with and knowledge about the safe use of such ingredients an authorisation under Regulation (EC) No 258/97 would be required. In this context the following aspects should be considered what are the normal quantities consumed, whether the new purpose would correspond to such quantities or would lead to significantly higher intakes or whether the amounts that are in- tended to be used would deviate extensively to those normally consumed with common food. This also applies to other parts of a plant that have so far not been used for human consump- tion. A specific part of a plant, e.g. a fruit may be an established food, but if the leaves, bark or the rind have not been consumed as food, authorisation under Regulation (EC) No 258/97 would be required. The use of new technologies in food production might in some cases also lead to a signifi- cantly different product with new desirable and/or also undesirable properties. In such cases a safety assessment under Regulation (EC) would be required since knowledge about the safety of the commonly produced product cannot be applied equally to the product produced by a new production process, e. g. food ingredients used in significantly different forms than commonly known, like nano-particles. Consequently, the conclusion that a specific form or part of a food has been used to a signifi- cant degree should not be applied to all other forms/parts of that particular food in general. In fact, applicability of Regulation (EC) No 258/97 should be carefully checked on a case by case basis. 1.8 Availability a) Locality Another criterion for consideration whether a food has been used to a significant degree is the question how and where the food has been available. Only foods that have legally been placed on the respective Member State’s market can be taken into account. If a product has only limited availability e.g. in pharmacies, health shops or specific restau- rants, a significant use could be questionable. However, if a food has been widely available to consumers in common food stores/supermarkets a significant use could normally be assumed. 6 sumption as such and this may be the case even if the source material is widely consumed. Consideration should also be given to the type of the extracts. For instance, an aqueous extract might be classified quite differently from an extract obtained by using another solvent. In such cases the safety of the particular product needs to be demonstrated due to a lack of experience with and knowledge about the safe use of such ingredients an authorisation under Regulation (EC) No 258/97 would be required. In this context the following aspects should be considered what are the normal quantities consumed, whether the new purpose would correspond to such quantities or would lead to significantly higher intakes or whether the amounts that are in- tended to be used would deviate extensively to those normally consumed with common food. This also applies to other parts of a plant that have so far not been used for human consump- tion. A specific part of a plant, e.g. a fruit may be an established food, but if the leaves, bark or the rind have not been consumed as food, authorisation under Regulation (EC) No 258/97 would be required. The use of new technologies in food production might in some cases also lead to a signifi- cantly different product with new desirable and/or also undesirable properties. In such cases a safety assessment under Regulation (EC) would be required since knowledge about the safety of the commonly produced product cannot be applied equally to the product produced by a new production process, e. g. food ingredients used in significantly different forms than commonly known, like nano-particles. Consequently, the conclusion that a specific form or part of a food has been used to a signifi- cant degree should not be applied to all other forms/parts of that particular food in general. In fact, applicability of Regulation (EC) No 258/97 should be carefully checked on a case by case basis. 1.8 Availability a) Locality Another criterion for consideration whether a food has been used to a significant degree is the question how and where the food has been available. Only foods that have legally been placed on the respective Member State’s market can be taken into account. If a product has only limited availability e.g. in pharmacies, health shops or specific restau- rants, a significant use could be questionable. However, if a food has been widely available to consumers in common food stores/supermarkets a significant use could normally be assumed.
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sumtion 本身，即使源材料被廣泛消費，情況也可能如此。還應考慮提取物的類型。例如，水性提取物的分類可能與使用另一種溶劑獲得的提取物完全不同。在這種情況下，由於缺乏安全使用此類成分的經驗和知識，需要證明特定產品的安全性，因此需要根據法規 （EC） No 258/97 獲得授權。在這種情況下，應考慮以下幾個方面：正常消費量是多少，新用途是否與這些數量相對應，或者會導致攝入量顯著增加，或者傾向於使用的量是否會與通常與普通食物一起消費的量有很大偏差。
這也適用於迄今為止尚未用於人類食用的植物的其他部分。植物的特定部分，例如水果，可能是一種既定的食物，但如果葉子、樹皮或果皮沒有作為食物食用，則需要根據法規 （EC） No 258/97 獲得授權。
如果一種產品在藥店、保健品商店或特定餐館的供應有限，那麼重要的用途可能是值得懷疑的。然而，如果一種食品在普通食品店/超市中被消費者廣泛使用，通常可以假設其用途很大。 7 In the context of Regulation (EC) No 258/97, foods that have been commercially placed on the market of at least one EU Member State have to be taken into account rather than a use in the private domain only (e. g. mushrooms that have only been used as food by some people, berries that have been picked from the forest by individuals). However, such foods may be on the market in certain geographical areas, e.g. in local farmers markets. Therefore they may be included e.g. in official and qualified Member States documentation for edible mush- rooms/berries/herbs, and may be regarded by the Member States authorities as consumed to a significant degree, even if the commercial value is limited. b) Timeframe The availability over the years should also be considered. It is of interest, whether the food has been available regularly e.g. for dozens of years, or only once in a while. For instance, if a product had only been presented once at a trade fair before 15 May 1997, this does not dem- onstrate significant use. Also foods that were used a long time/many years ago only but not in recent times a history of food use relevant for the Novel Food Regulation has not been estab- lished. 2. Decision tree/Questionnaire In order to assist interested parties to assess the novel food status of a particular product and, if necessary, to ensure that all relevant information is made available to Competent Authori- ties the attached decision tree and questionnaire should be followed. The use of the decision tree and questionnaire should also indicate to interested parties when the evidence that they have available is unlikely to be sufficient to demonstrate that the produce has been consumed to a significant degree prior to 15 May 1997. The decision tree is intended as a guidance and to give an initial indication whether or not a product in question would fall within the scope of Regulation (EC) No 258/97. Due to the diversity of possible novel foods, it may in many cases not be possible to determine whether a certain food was on the market on simple "yes or no" answers. Therefore, several sub-criteria need to be considered. In view of this the questionnaire, which requires the provision of more detailed information, will facilitate the answer. 7 In the context of Regulation (EC) No 258/97, foods that have been commercially placed on the market of at least one EU Member State have to be taken into account rather than a use in the private domain only (e. g. mushrooms that have only been used as food by some people, berries that have been picked from the forest by individuals). However, such foods may be on the market in certain geographical areas, e.g. in local farmers markets. Therefore they may be included e.g. in official and qualified Member States documentation for edible mush- rooms/berries/herbs, and may be regarded by the Member States authorities as consumed to a significant degree, even if the commercial value is limited. b) Timeframe The availability over the years should also be considered. It is of interest, whether the food has been available regularly e.g. for dozens of years, or only once in a while. For instance, if a product had only been presented once at a trade fair before 15 May 1997, this does not dem- onstrate significant use. Also foods that were used a long time/many years ago only but not in recent times a history of food use relevant for the Novel Food Regulation has not been estab- lished. 2. Decision tree/Questionnaire In order to assist interested parties to assess the novel food status of a particular product and, if necessary, to ensure that all relevant information is made available to Competent Authori- ties the attached decision tree and questionnaire should be followed. The use of the decision tree and questionnaire should also indicate to interested parties when the evidence that they have available is unlikely to be sufficient to demonstrate that the produce has been consumed to a significant degree prior to 15 May 1997. The decision tree is intended as a guidance and to give an initial indication whether or not a product in question would fall within the scope of Regulation (EC) No 258/97. Due to the diversity of possible novel foods, it may in many cases not be possible to determine whether a certain food was on the market on simple "yes or no" answers. Therefore, several sub-criteria need to be considered. In view of this the questionnaire, which requires the provision of more detailed information, will facilitate the answer.
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日本原生種百合有三種 ~~~ (甲)(1) Lilium auratum, 1862, 山百合, (2) Lilium auratum var. auratum, 山百合變種, (3) Lilium auratum var. platyphyllum, 1880, 作百合,
