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美國關(guān)于雜貨制造商協(xié)會:食品添加劑申請文件的申請通知

嘉峪檢測網(wǎng)        2015-11-15 23:58

通報(bào)號: G/SPS/N/USA/2791
ICS號: 67
發(fā)布日期: 2015-10-30
截至日期: 2015-10-30
通報(bào)成員: 美國
目標(biāo)和理由: 保障食品安全
內(nèi)容概述: 食品藥物管理局歸檔了一份雜貨制造商協(xié)會提交的申請。該申請建議修改食品添加劑法規(guī),規(guī)定在不同食品內(nèi)安全使用部分氫化植物油(PHOs)。
通報(bào)熱點(diǎn):食品和飼料添加劑問題
正文: 

世界貿(mào)易組織
G/SPS/N/USA/2791
2015-10-30
15-5762
 
衛(wèi)生及植物衛(wèi)生措施委員會
原文:英文
 
通 報(bào)


1.
通報(bào)成員: 美國
2.
負(fù)責(zé)機(jī)構(gòu):美國食品藥物管理局
3.
覆蓋的產(chǎn)品: HS代碼:15;ICS代碼:67
4.
可能受影響的地區(qū)或國家:
[X] 所有貿(mào)易伙伴
[ ] 特定地區(qū)或國家
5.
通報(bào)標(biāo)題: 雜貨制造商協(xié)會:食品添加劑申請文件:申請通知
語言:英文 頁數(shù):2頁 鏈接網(wǎng)址:
6.
內(nèi)容簡述:食品藥物管理局歸檔了一份雜貨制造商協(xié)會提交的申請。該申請建議修改食品添加劑法規(guī),規(guī)定在不同食品內(nèi)安全使用部分氫化植物油(PHOs)。
7.
目標(biāo)與理由:
[X] 食品安全
[ ] 動物健康
[ ] 植物保護(hù)
[ ] 保護(hù)國家免受有害生物的其它危害
[ ] 保護(hù)人類免受動/植物有害生物的危害
保護(hù)國家免受有害生物的其它危害:
8.
是否有相關(guān)國際標(biāo)準(zhǔn)?如有,指出標(biāo)準(zhǔn):
[ ] 食品法典委員會(例如:食品法典委員會標(biāo)準(zhǔn)或相關(guān)文件的名稱或序號)

[ ] 世界動物衛(wèi)生組織(OIE)(例如:陸生或水生動物衛(wèi)生法典,章節(jié)號)

[ ] 國際植物保護(hù)公約(例如:ISPM N°)

[X] 無
該法規(guī)草案是否符合相關(guān)國際標(biāo)準(zhǔn): [ ] 是 [ ]否
9.
可提供的相關(guān)文件及文件語種:
10.
擬批準(zhǔn)日期:不適用
擬公布日期:不適用
11.
擬生效日期:
[ ] 通報(bào)日后6個月,及/或(年月日): 不適用
[ ] 貿(mào)易促進(jìn)措施
12.
意見反饋截止日期:
[ ] 通報(bào)發(fā)布日起60天,及/或(年/月/日): 歸檔通知公布后隨時受理評議;但是,如頒布了一項(xiàng)最終法規(guī),則僅受理最終法規(guī)公布前收到的評議。
13.
負(fù)責(zé)處理反饋意見的機(jī)構(gòu):
[ ] 國家通報(bào)機(jī)構(gòu)
[ ] 國家咨詢點(diǎn),或其他機(jī)構(gòu)的聯(lián)系地址、傳真及電子郵件地址(如能提供):
請您按以下方式提交評議: 電子版評議:請按以下方式會提交電子版評議: 聯(lián)邦電子決策門戶網(wǎng)站: http://www.regulations.gov. 按指示要求提交評議。向http://www.regulations.gov提交的電子版評議,包括附件將原文不變地粘貼在文檔內(nèi)。由于您的評議將予以公開,您要負(fù)責(zé)保證您的評議不含您或第三方不想公開粘貼的任何保密性信息,如:醫(yī)療信息、您或任何其它社會安全密碼,或保密商業(yè)信息,如:制造工藝。請注意,如您的評議包括了您的個人姓名、聯(lián)系方式或其它可識別您所在單位的信息,這些信息將粘貼于:http://www.regulations.gov.  如您打算提交的評議包含您不愿公布的保密信息,請用書面/紙文件方式提交,詳細(xì)方法見("書面/紙文件"及"指示")。書面/紙文件提交:請按以下方式提交書面/紙文件評議: 信郵/當(dāng)面提交/快遞(書面/紙文件評議): DivisionofDocketsManagement(HFA-305),(文檔管理處) FoodandDrugAdministration,(食品藥物管理局) 5630FishersLane,Rm.1061,Rockville, MD20852.(馬里蘭州) 對于提交到文檔管理處的書面/紙文件評議,除按“提示”詳述方式提交的,注明及指定為保密信息外,食品藥物管理局將把您的評議及任何附件粘貼在網(wǎng)上。提示:所有獲悉評議必須包括文檔號:FDA-2015-F-3663——“雜貨制造商協(xié)會(GroceryManufacturersAssociation);食品添加劑歸檔文件”。除作為“保密評議”提交的外,所獲評議將置于文檔內(nèi),公布于:http://www.regulations.gov,或可到文檔管理處查看。開放時間:周一~周五,上午9:00~下午4:00。保密評議:要提交一份您不愿公布的保密信息,您只能采用書面/紙文件形式提交。您需要提交一式兩份。一份包括用標(biāo)題或在封面上標(biāo)明“此文件含保密內(nèi)容”的信息。食品藥物管理局將在考慮評議時,審閱此份件,包括聲明的保密信息。另一份將保密信息修改/涂黑后公布于眾,粘貼在:http://www.regulations.gov。請向文檔管理處提交兩份文件。如您不想公開自己的姓名和聯(lián)系方式,不要自評議內(nèi)容中注明,而要在封頁說明次信息“保密”。除根據(jù)21CFR10.20及其它適用披露法規(guī)定外,任何標(biāo)有“保密”字樣的信息不予泄露。有關(guān)食品藥物管理局在公開文檔內(nèi)粘貼評議的詳細(xì)信息,請見80FR56469,2015年9月18日或信息訪問鏈接: http://www.fda.gov/regulatoryinformation/dockets/default.htm  
14.
文本可從以下機(jī)構(gòu)得到:
[X] 國家通報(bào)機(jī)構(gòu)
[ ] 國家咨詢點(diǎn),或其他機(jī)構(gòu)的聯(lián)系地址、傳真及電子郵件地址(如能提供):
UnitedStatesSPSNationalNotificationAuthority(美國SPS國家通報(bào)機(jī)構(gòu)), USDAForeignAgriculturalService(美國農(nóng)業(yè)部農(nóng)產(chǎn)品外銷局), InternationalRegulationsandStandardsDivision(IRSD—國際法規(guī)和標(biāo)準(zhǔn)處), Stop1014,WashingtonD.C.20250;(華盛頓) Tel:+(1202)7201301; Fax:+(1202)7200433; E-mail:us.spsenquirypoint@fas.usda.gov 全文另可查詢聯(lián)邦紀(jì)事,80側(cè),208號,65978頁或網(wǎng)址: http://www.gpo.gov/fdsys/pkg/FR-2015-10-28/pdf/2015-27277.pdf.  

正文(英): 

NOTIFICATION

1.

Notifying Member: United States of America

If applicable, name of local government involved:  

2.

Agency responsible: United States Food and Drug Administration

3.

Products covered (provide tariff item number(s) as specified in national schedules deposited with the WTO; ICS numbers should be provided in addition, where applicable): HS Code(s): 15; ICS Code(s): 67

4.

Regions or countries likely to be affected, to the extent relevant or practicable:

[X]    All trading partners  

[ ]      Specific regions or countries:  

5.

Title of the notified document: Grocery Manufacturers Association; Filing of Food Additive Petition; Notice of Petition  Language(s): English  Number of pages: 2

http://members.wto.org/crnattachments/2015/SPS/USA/15_4409_00_e.pdf

6.

Description of content: The Food and Drug Administration has filed a petition, submitted by the Grocery Manufacturers Association, proposing that the food additive regulations be amended to provide for the safe use of partially hydrogenated vegetable oils (PHOs) in various food applications.

7.

Objective and rationale: [X] food safety, [ ] animal health, [ ] plant protection, [ ] protect humans from animal/plant pest or disease, [ ] protect territory from other damage from pests.  

8.

Is there a relevant international standard? If so, identify the standard:

[ ]        Codex Alimentarius Commission (e.g. title or serial number of Codex standard or related text)  

[ ]        World Organization for Animal Health (OIE) (e.g. Terrestrial or Aquatic Animal Health Code, chapter number)  

[ ]        International Plant Protection Convention (e.g. ISPM number)  

[X]      None

Does this proposed regulation conform to the relevant international standard? 

[ ] Yes   [ ] No

If no, describe, whenever possible, how and why it deviates from the international standard:  

9.

Other relevant documents and language(s) in which these are available:    

10.

Proposed date of adoption (dd/mm/yy): Not applicable

Proposed date of publication (dd/mm/yy): Not applicable

11.

Proposed date of entry into force: [ ] Six months from date of publication, and/or (dd/mm/yy): Not applicable

[ ]      Trade facilitating measure  

12.

Final date for comments: [ ] Sixty days from the date of circulation of the notification and/or (dd/mm/yy): Comments will be accepted at any time after publication of the notice of filing; however, if a final rule is promulgated, it will address only those comments that were received prior to publication of the final rule.

Agency or authority designated to handle comments: [ ] National Notification Authority, [ ] National Enquiry Point. Address, fax number and e?mail address (if available) of other body:

You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:

Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see "Written/Paper Submissions" and "Instructions").

Written/Paper Submissions

Submit written/paper submissions as follows:

Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in "Instructions."

Instructions: All submissions received must include the Docket No. FDA-2015-F-3663 for "Grocery Manufacturers Association; Filing of Food Additive Petition". Received comments will be placed in the docket and, except for those submitted as "Confidential Submissions," publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Confidential Submissions: To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states "THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION". FDA will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as "confidential." Any information marked as "confidential" will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, 18 September 2015, or access the information at:

http://www.fda.gov/regulatoryinformation/dockets/default.htm.

13.

Text(s) available from: [X] National Notification Authority, [ ] National Enquiry Point. Address, fax number and e?mail address (if available) of other body:

United States SPS National Notification Authority, USDA Foreign Agricultural
Service, International Regulations and Standards Division (IRSD), Stop 1014, Washington D.C. 20250; Tel: +(1 202) 720 1301; Fax: +(1 202) 720 0433; E-mail: us.spsenquirypoint@fas.usda.gov

Text can also be found in the Federal Register, Vol. 80, No. 208, page 65978 or on the internet at: http://www.gpo.gov/fdsys/pkg/FR-2015-10-28/pdf/2015-27277.pdf.

 


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