| | 1. 應該是沒開放吧!
https://web.customs.gov.tw/singlehtml/1205?cntId=cus1_112173_1205
稅則稅率下載專區
海關進口稅則資料(xls檔案)
貨品分類號列中文貨名輸入規定輸出規定
06011000109一葉蘭球莖，休眠中者B01
06011000207鬱金香鱗莖，休眠中者B01
06011000305水仙鱗莖，休眠中者B01
06011000403葉蘭匍匐莖，休眠中者B01
06011000500黃根節蘭，休眠中者B01 MW0
06011000617唐菖蒲球莖，休眠中者B01 MW0
06011000626百合鱗莖，休眠中者B01 MW0
06011000635風信子鱗莖，休眠中者B01
06011000644海芋塊莖，休眠中者B01 MW0
06011000653金花石蒜鱗莖，休眠中者B01 MW0
06011000662晚香玉鱗莖，休眠中者B01 MW0
06011000671孤挺花鱗莖，休眠中者B01 MW0
06011000902其他鱗莖、塊莖、塊根、球莖、冠芽及匍匐莖，休眠中者B01 MW0
06012010105一葉蘭球莖，生長中者B01 MW0
06012010203鬱金香鱗莖，生長中者B01
06012010301水仙鱗莖，生長中者B01
06012010409葉蘭匍匐莖，生長中者B01
06012010506黃根節蘭，生長中者B01
06012010613唐菖蒲球莖，生長中者B01 MW0
06012010622百合鱗莖，生長中者B01 MW0
06012010631風信子鱗莖，生長中者B01
06012010640海芋塊莖，生長中者B01 MW0
06012010659金花石蒜鱗莖，生長中者B01 MW0
06012010668晚香玉鱗莖，生長中者B01 MW0
06012010677孤挺花鱗莖，生長中者B01 MW0
06012010686鳳梨冠芽，生長中者B01 MW0 441
06012010702香蕉，球莖B01 MW0 441
06012010908其他鱗莖、塊莖、塊根、球莖、冠芽及匍匐莖，生長中B01 MW0
06012020103一葉蘭球莖，開花中者B01 MW0
06012020201鬱金香鱗莖，開花中者B01
06012020309水仙鱗莖，開花中者B01
06012020407葉蘭匍匐莖，開花中者B01
06012020504黃根節蘭，開花中者B01
06012020611唐菖蒲球莖，開花中者B01 MW0
06012020620百合鱗莖，開花中者B01 MW0
06012020639風信子鱗莖，開花中者B01
06012020648海芋塊莖，開花中者B01 MW0
06012020657金花石蒜鱗莖，開花中者B01 MW0
06012020666晚香玉鱗莖，開花中者B01 MW0
06012020675孤挺花鱗莖，開花中者B01 MW0
06012020906其他鱗莖、塊莖、塊根、球莖、冠芽及匍匐莖，開花中B01 MW0 |
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https://fbfh.trade.gov.tw/fh/ap/downLoadListf.do
輸入規定代號(下載請逕自點選超連結)
輸入規定代號規定中文說明規定英文說明規定生效日資料筆數
MW0大陸物品不准輸入。Importation of Mainland China products is prohibited.08804202629 |
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2.如果就歐盟1997Novel food的定義來看，如果特有於人類很晚抵達的，包含多數島嶼區跟遠洋區的物種，可能，都比有人類的大陸塊上的物種，更缺乏人類食用歷史? 比如說日本特有的山百合?
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
2
1. 確定食品是否在很大程度上被人類食用時要考慮的標準
1.1 資訊
除了有關產品成分的一般資訊外，至少還需要以下資訊，以確保有關 1997 年 5 月 15 日之前使用該食品的現有檔與有關產品有關。
因此，查詢人應至少提供以下資料：
生物體（植物、微生物、真菌、藻類、動物等）和生物體產生的成分：
1)
生物體的分類名稱（帶有作者姓名的全拉丁名稱），以及其他名稱、同義詞等（如適用）
2)
1997 年 5 月 15 日之前使用的生物體的哪個部分的說明
3)
產品（液體、提取物等）的形式和/或濃度，以及
4)
如果是食品補充劑中的成分，則可能標明數量/數量
化學物質：
5)
根據 IUPAC 的 CAS 名稱，以及其他產品名稱（例如商品名、通用名稱）（如適用）以及純度規範
6)
生產過程的描述/規範，以及
7)
如果是食品補充劑中的成分，則可能標明數量/數量。
下面描述了在考慮新型食品狀況時必須考慮的要點。雖然在某些情況下，某種產品的消費歷史可能很明確（例如通過提供廣泛的銷售數據），但考慮到自第 258/97 號法規生效以來的時間尺度，應該強調的是，由於證據現在已有 12-15 年的歷史，情況並非總是如此，需要檢查“全貌”。因此，本檔還詳細說明瞭可用於確定“在很大程度上消費”的可能替代資訊來源。
1
CAS = 化學文摘服務
2
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-
3
1.2 文件
在 1997 年 5 月 15 日之前，一種食品是否在歐洲聯盟境內已經在相當程度上被用於人類消費的事實調查過程，應以可靠、可靠的資料和數據為基礎，這些資料和數據來自參考來源，並與共同體市場上合法銷售的食品有關。
我們認識到，所提供的個別資訊可能不能單獨可靠地表明某產品在 1997 年 5 月 15 日之前在歐盟市場上有相當大的程度。例如，進口或分銷清單可能無法準確描述特定產品的銷售/進口目的（食品、化妝品、醫藥產品、動物飼料......因此，在確定相關食品是否屬於第 258/97 號法規 （EC） 的範圍時，應考慮所有可用數據和資訊是合理的。例如，這些可能包括發票、食譜、食譜、目錄等。
還需要考慮相關的國家和共同體立法，以確定食品是否屬於第 258/97 號條例 （EC） 的範圍。例如，某些水果可用於生產水果花蜜，列於 2001 年 12 月 20 日理事會指令 2001/112/EC 的附件四中，該指令涉及果汁和某些供人類消費的類似產品（並且已經列在以前的指令 93/77/EWG 中）。在這種情況下，法規 （EC） No 258/97 將不適用，除非相關食品/食品成分與相關立法所涵蓋的食品/食品成分的形式或類型不符（例如，從水果中提取的新提取物）。
1.3 地理方面
不同歐盟成員國和某些成員國特定地區常用和已知的食品差異很大。
因此，第一步是提供資料，說明某種特定食品在 1997 年 5 月 15 日之前是否在歐盟國家內廣泛和普遍地被大量用於人類消費，或者是否僅在地方或區域範圍內用作食品。
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
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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
4
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。
1997 年 5 月 15 日的最後期限適用於所有成員國，無論從加入歐盟之日起。
根據法規 （EC） No 258/97，僅在第三國使用食品不能證明食品使用歷史。
1.4 使用數量
一般來說，一種食物使用的次數越多，就越容易證明出顯著的程度。然而，食用量可能會因食物類型而有很大差異，例如香料、香草或一些漿果的使用量可能比麵包、穀物或麵粉少。因此，評估一種食品在 1997 年 5 月之前是否在相當程度上被人類消費，應以特定產品類別的典型消費水準為依據。
除了有關消耗數量（重量）的資訊外，還包括銷售的單位（包裝）數量，市場上的可用性（僅在極少數商店或廣泛可用）和這些“商店”的性質（如果它們只是房屋銷售或向有限的消費者群體銷售）有時很重要（另見“可用性”部分）。
在某些情況下，會員國必須確定使用量明顯很少的食品是否需要根據《新型食品條例》獲得授權。
1.5 預期用途
法規 （EC） No 258/97 僅涵蓋食品和食品成分。因此，在確定某種特定產品在 1997 年 5 月 15 日之前是否在共同體內被大量用於人類消費時，只能考慮食品用途。此外，證明的用途應與相關特定食品有關。
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
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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-
5
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”。
1.6 具體人群/使用環境
在評估某種特定食品在 1997 年 5 月 15 日之前是否已大量供人類食用時，還應考慮到有關產品是普通人口的正常飲食的一部分，還是僅供特定人群使用，或者是否僅用於特定和有限的食品類別。
食物鏈和動物衛生常設委員會在 2005 年 2 月 14 日的會議上同意，根據第 258/97 號條例（EC）第 1 條，1997 年 5 月 15 日之前僅用於食品補充劑將不被視為“在很大程度上人類消費”。因此，如果食品/食品成分應用於食品補充劑以外的其他食品中，則需要根據法規 （EC） No 258/97 獲得授權。
在特定場合（如特定儀式、慶祝活動等）使用的食物，在《新型食品條例》的意義上可能是重要用途。然而，僅在緊急情況下上市的產品，而不是定期以商業可持續的方式上市的產品，可能需要根據《新型食品法規》獲得授權。
1.7 使用食品的其他形式/部分/新技術
同樣重要的是要注意，如果相關產品經過額外加工，則在 1997 年 5 月 15 日之前在歐盟境內大量使用特定食品或食品成分並不自動適用。如果這種加工改變了食品的成分，或者食品是由新的原料或新的生產工藝生產的（第 1（2）（f） 條），則所得產品可能屬於法規 （EC） No 258/97 的範圍。
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.
6
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。
在某些情況下，在食品生產中使用新技術還可能導致具有新理想和/或不良特性的顯著不同產品。在這種情況下，需要根據法規 （EC） 進行安全評估，因為有關常用生產產品的安全性的知識不能平等地應用於由新生產工藝生產的產品，例如以與通常已知的形式明顯不同的食品成分，例如納米顆粒。
因此，食物的特定形式或部分已被大量使用的結論不應一般適用於該特定食物的所有其他形式/部分。事實上，應根據具體情況仔細檢查法規 （EC） No 258/97 的適用性。
1.8 可用性
a） 地點
考慮食品是否已得到大量使用的另一個標準是食物如何以及在何處可用的問題。只有合法投放在相應成員國市場上的食品才能被考慮在內。
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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