bonus欧盟-保健宣称 REGULATION (EC) No 1924-2006中文翻译

應與同樣數量的食物的功效

2. Comparative nutrition claims shall compare the composition of the

food in question with a range of foods of the same category, which do

not have a composition which allows them to bear a claim, including

foods of other brands

考慮一定範圍相同類別食物間，組成份所造成的營養差異比較。

也可以採用不同品牌食物，也不需要只有一種成分組合來確認此功效。

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CHAPTER IV

HEALTH CLAIMS

健康說明

Article 10

Specific conditions

特殊情形

1. Health claims shall be prohibited unless they comply with the

general requirements in Chapter II and the specific requirements in

this Chapter and are authorised in accordance with this Regulation

and included in the lists of authorised claims provided for in

Articles 13 and 14.

健康功效如要通過，要到

Chapter II

裡面及這章節裡面的特殊情況已經做到，

而且已經依此法規通過批准，包含在

Articles 13 and 14

的審查要求。

2. Health claims shall only be permitted if the following information

is included in the labelling, or if no such labelling exists, in the presentation

and advertising:

保健聲稱，如果只允許下列資料

包括在標籤，或者如果沒有這樣的標籤存在，在演示文稿

和廣告

(a) a statement indicating the importance of a varied and balanced diet

and a healthy lifestyle;

關於不同及均衡的飲食和健康的生活方式說明

(b) the quantity of the food and pattern of consumption required to

obtain the claimed beneficial effect;

此功效對食物數量與飲食習慣所帶來的好處

(c) where appropriate, a statement addressed to persons who should

avoid using the food; and

同時說明人們要避免些食物

(d) an appropriate warning for products that are likely to present a

health risk if consumed to excess.

如食用過量會有健康風險的警示語

3. Reference to general, non-specific benefits of the nutrient or food

for overall good health or health-related well-being may only be made if

accompanied by a specific health claim included in the lists provided for

in Article 13 or 14.

Article 13 or 14

在

一個特定的健康聲明中伴隨出。

4. Where appropriate, guidelines on the implementation of this

Article shall be adopted in accordance with the procedure referred to

in Article 25(2) and, if necessary, in consultation with interested parties,

in particular food business operators and consumer groups.

依執行程序

Article 25(2)

來執行。如需要

請教各方，特別是食品企業負責人及消費團體。

Article 11

National associations of medical, nutrition or dietetic professionals

and health-related charities

國家藥物食品機構或食品專家及慈善醫療團體

Article 12

Restrictions on the use of certain health claims

特定健康宣稱的使用規範

Article 13

Health claims other than those referring to the reduction of disease

risk and to children's development and health

關於健康宣稱外，減低疾病風險及兒童發育健康的影響

Article 14

Reduction of disease risk claims and claims referring to children's

development and health

關於減低疾病風險及兒童發育健康的影響

Article 15

Application for authorization

申請批准

1. When reference is made to this Article, an application for authorisation

shall be submitted in accordance with the following paragraphs.

申請此產品時申請批准需依以下執行

2. The application shall be sent to the

national competent authority

of

a Member State.

申請書應送交會員國的國家主管機關的

(a) The national competent authority shall:

國家主管機關應

(i) acknowledge receipt of an application in writing within 14

days of its receipt. The acknowledgement shall state the date

of receipt of the application;

確認收到書面申請後

14

天內

發出回單。回單上應當註明收到的申請日期。

(ii) inform without delay the Authority; and

立即告知管理局而且

(iii) make the application and any supplementary information

supplied by the applicant available to the Authority;

將申請人提供的申請資料和任何補充資料

給管理局

(b) The Authority shall:

管理局需

(i) inform without delay the other Member States and the

Commission of the application and shall make the application

and any supplementary information supplied by the applicant

available to them;

立刻通知其他會員及申請委員會。同時將申請資料提供給他們

(ii) make the summary of the application referred to in paragraph 3(g) available to the public

將申請資料依第三段

(g)

做成節錄提供給大眾

.

3. The application shall include the following:

申請者須

(a) the name and address of the applicant;

申請表上有姓名住址

(b) the nutrient or other substance, or the food or the category of food,

in respect of which the health claim is to be made and its particular

characteristics;

營養物或其他物質、食物、食物種類及健康功能和特殊性質

(c) a copy of the studies, including, where available, independent, peer reviewed

studies, which have been carried out with regard to the

health claim and any other material which is available to demonstrate

that the health claim complies with the criteria provided for in

this Regulatio n;

一份研究；裡面包含已經存在、獨立、同儕回顧報告，可以關於健康效果證明。

和其他材料依此文件能提供其健康功效的判斷。

(d) where appropriate, an indication of the information which should be

regarded as proprietary accompanied by verifiable justification;

適當時，顯示的信息應

被視為審查的判斷。

(e) a copy of other scientific studies which are relevant to that health

claim;

其他科學研究相關於健康效果

(f) a proposal for the wording of the health claim for which authorization

is sought including, as the case may be, specific conditions

for use;

一份有關健康功能提案可以讓批准活動可以參考

,

內容如下

,

使用特殊情形

(g) a summary of the application.

一份申請節錄

4. The Commission, having first consulted the Authority, shall

establish in accordance with the procedure referred to in Article 25(2)

implementing rules for the application of this Article, including rules

concerning the preparation and presentation of the application.

該委員會在第一次諮詢委員會，應

按 照建立的程序中提到的第

25

（

2

）

實施規則中的應用這條，包括規則

關於編制及呈列的應用

5. The Commission, in close cooperation with the Authority, shall

make available appropriate technical guidance and tools to assist food

business operators, in particular SMEs, in the preparation and presentation

of the application for scientific assessment.

該委員會在與管理局密切合作，應

提供適當的技術指導和工具，以幫助食物

企業經營者，尤其是中小型企業，在編制及呈報

應用程序進行科學評估

Article 16

Opinion of the Authority

主管單位意見

1. In giving its opinion, the Authority shall respect a time limit of

five months from the date of receipt of a valid application. Whenever

the Authority seeks supplementary information from the applicant as

provided for in paragraph 2, such time limit shall be extended by up

to two months following the date of receipt of the requested information

submitted by the applicant.

在有效申請時程中，從申請日開始

5< /p>

個月內，管理局需提出意見。

無論何時 ，管理局需要申請者補充資料。如段落

2

，

2

個月內申請者要提出回應。

2. The Authority or a national competent authority through the

Authority may, where appropriate, request the applicant to supplement

the particulars accompanying the application within a specified time

limit.

管理局或國家主管單位在審查時，要求增加文件時程要有限制。

3. In order to prepare its opinion, the Authority shall verify: