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印度尼西亞關(guān)于化妝品標(biāo)準(zhǔn)和通報(bào)程序的規(guī)定

嘉峪檢測(cè)網(wǎng)        2015-09-13 07:50

通報(bào)號(hào): G/TBT/N/IDN/91
ICS號(hào): 71.100.70
發(fā)布日期: 2015-01-08
截至日期: 2015-03-09
通報(bào)成員: 印度尼西亞
目標(biāo)和理由: 質(zhì)量要求
內(nèi)容概述: 本NADFC主席條例RINo.HK.03.1.23.12.10.11983/2010規(guī)定了化妝品一般原則、標(biāo)準(zhǔn)和通報(bào)程序。在印尼分銷的化妝品必須向NADFC主席通報(bào)且必須符合標(biāo)準(zhǔn):1.在正?;蚝侠砜深A(yù)見的使用條件下,化妝品成分和最終產(chǎn)品不對(duì)人類健康產(chǎn)生傷害的安全性評(píng)估;2.從正確的預(yù)定用途和列出的聲明中獲益;3.質(zhì)量評(píng)估,履行生產(chǎn)管理規(guī)范要求?;瘖y品通報(bào)基于以下程序:1.申請(qǐng)人在申請(qǐng)電子通報(bào)之前應(yīng)通過網(wǎng)站http://www.pom.go.id注冊(cè)以獲得編號(hào)和密碼;2.申請(qǐng)通過填寫模板提交,模板從網(wǎng)站http://www.pom.go.id下載;3.完成的通報(bào)模板可保存和通過電子方式提交;4.提交通報(bào)模板的申請(qǐng)人將通過申請(qǐng)人電子信箱收到電子付款單。申請(qǐng)人打印付款單并通過指定銀行付款;5.付款后10天內(nèi),申請(qǐng)人必須向NADFC或NADFC地區(qū)辦公室提交原始付款收據(jù);6.如果付款后10天內(nèi),NADFC或NADFC地區(qū)辦公室未收到原始付款收據(jù),通報(bào)申請(qǐng)被視為拒絕;7.NADFC或NADFC地區(qū)辦公室收到的原始付款收據(jù)將被核實(shí)。如果原始付款收據(jù)正確,申請(qǐng)人將收到產(chǎn)品編碼(產(chǎn)品ID)作為提交通報(bào)的收據(jù);8.如果提交通報(bào)得到收據(jù)后14天內(nèi),NADFC未發(fā)出拒絕信,通報(bào)的化妝品被視為批準(zhǔn)可以在印尼分銷。通報(bào)有效期3年。此后,可在有效期到期前至少1個(gè)月再次提交通報(bào),依照上述通報(bào)程序。本條例有4個(gè)附錄:1.附錄I:化妝品類型2.附錄II:申請(qǐng)人通報(bào)模板3.附錄III:申請(qǐng)人類型數(shù)據(jù)變更4.附錄IV:通報(bào)模板。本條例代替NADFC主席條例No.HK.00.05.4.1745/2003化妝品。
正文: 
世界貿(mào)易組織
G/TBT/N/IDN/91
2015-01-08
15-0109
 
技術(shù)性貿(mào)易壁壘
原文:英語
 
通 報(bào)


以下通報(bào)根據(jù)TBT協(xié)定第10.6條分發(fā)

1.
通報(bào)成員: 印度尼西亞
如可能,列出涉及的地方政府名稱 ( 3.2條和7.2 條):
2.
負(fù)責(zé)機(jī)構(gòu):印尼國(guó)家藥品食品管理局(NADFC)
3.
通報(bào)依據(jù)條款:2.9.2,5.6.2
4.
覆蓋的產(chǎn)品: 化妝品
HS編碼:33   ICS編碼:71.100.70
5.
通報(bào)標(biāo)題: NADFC主席條例RINo.HK.03.1.23.12.10.11983/2010關(guān)于化妝品標(biāo)準(zhǔn)和通報(bào)程序

語言:印尼語 頁(yè)數(shù):24 鏈接網(wǎng)址:
 
6.
內(nèi)容簡(jiǎn)述:

本NADFC主席條例RI No. HK.03.1.23.12.10.11983/2010規(guī)定了化妝品一般原則、標(biāo)準(zhǔn)和通報(bào)程序。

在印尼分銷的化妝品必須向NADFC主席通報(bào)且必須符合標(biāo)準(zhǔn):

1.在正常或合理可預(yù)見的使用條件下,化妝品成分和最終產(chǎn)品不對(duì)人類健康產(chǎn)生傷害 的安全性評(píng)估

2.從正確的預(yù)定用途和列出的聲明中獲益;

3.質(zhì)量評(píng)估,履行生產(chǎn)管理規(guī)范要求。

化妝品通報(bào)基于以下程序:

1.申請(qǐng)人在申請(qǐng)電子通報(bào)之前應(yīng)通過網(wǎng)站http://www.pom.go.id注冊(cè)以獲得編號(hào)和密碼;

2.申請(qǐng)通過填寫模板提交,模板從網(wǎng)站http://www.pom.go.id下載;

3.完成的通報(bào)模板可保存和通過電子方式提交;

4.提交通報(bào)模板的申請(qǐng)人將通過申請(qǐng)人電子信箱收到電子付款單。申請(qǐng)人打印付款單并通過指定銀行付款;

5.付款后10天內(nèi),申請(qǐng)人必須向NADFCNADFC地區(qū)辦公室提交原始付款收據(jù);

6.如果付款后10天內(nèi),NADFCNADFC地區(qū)辦公室未收到原始付款收據(jù),通報(bào)申請(qǐng)被視為拒絕;

7.NADFCNADFC地區(qū)辦公室收到的原始付款收據(jù)將被核實(shí)。如果原始付款收據(jù)正確,申請(qǐng)人將收到產(chǎn)品編碼(產(chǎn)品ID)作為提交通報(bào)的收據(jù);

8.如果提交通報(bào)得到收據(jù)后14天內(nèi),NADFC未發(fā)出拒絕信,通報(bào)的化妝品被視為批準(zhǔn)可以在印尼分銷。

通報(bào)有效期3年。此后,可在有效期到期前至少1個(gè)月再次提交通報(bào),依照上述通報(bào)程序。

本條例有4個(gè)附錄:

1.附錄I:化妝品類型

2.附錄II:申請(qǐng)人通報(bào)模板

3.附錄III:申請(qǐng)人類型數(shù)據(jù)變更

4.附錄IV:通報(bào)模板。

本條例代替NADFC主席條例No. HK.00.05.4.1745/2003化妝品。
7.
目標(biāo)與理由:1.防止群眾使用不符合安全和質(zhì)量要求的化妝品; 2.作為化妝品通報(bào)的指導(dǎo)原則。
8.
相關(guān)文件: NADFC主席條例RINo.HK.03.1.23.12.10.11983/2010關(guān)于化妝品標(biāo)準(zhǔn)和通報(bào)程序
9.
擬批準(zhǔn)日期:公布之后
擬生效日期:公布之后
10.
意見反饋截止日期: 通報(bào)之后60天
11.
文本可從以下機(jī)構(gòu)得到:

正文(英): 

NOTIFICATION

The following notification is being circulated in accordance with Article 10.6

 

1.

Notifying Member: Indonesia

If applicable, name of local government involved (Article 3.2 and 7.2):  

2.

Agency responsible: National Agency of Drug and Food Control (NADFC) RI

Name and address (including telephone and fax numbers, email and website addresses, if available) of agency or authority designated to handle comments regarding the notification shall be indicated if different from above:

Bureau for Law and Public Relation

National Agency of Drug and Food Control (NADFC) Republic of Indonesia

Jl. Percetakan Negara No. 23

Jakarta 10560 - Indonesia

Telephone: +(62-21) 4263333

Facsimile: +(62-21) 4209221

Email: humas_bpom@yahoo.com / ulpk@pom.go.id

Website: http://www.pom.go.id

Bureau for International Cooperation

National Agency of Drug and Food Control (NADFC) Republic of Indonesia

Jl. Percetakan Negara No. 23

Jakarta 10560 - Indonesia

Telephone: +(62-21) 42875379

Facsimile: +(62-21) 42875379

Email: kerjasamaln_bpom@yahoo.co.id

Website: http://www.pom.go.id

Center for Cooperation on Standardization

National Standardization Agency of Indonesia (BSN)

BPPT I Building, 12th Floor

Jl. M.H. Thamrin No.8

Jakarta - Indonesia 10340

Telephone:  +62 21 3927434 ext. 127

Facsimile:  +62 21 3927527

E-mail: tbt.indonesia@gmail.com / tbt.indonesia@bsn.go.id

Website: http://bsn.go.id/

3.

Notified under Article 2.9.2 [ X ], 2.10.1 [   ], 5.6.2 [ X ], 5.7.1 [   ], other:

4.

Products covered (HS or CCCN where applicable, otherwise national tariff heading. ICS numbers may be provided in addition, where applicable): Cosmetic products

5.

Title, number of pages and language(s) of the notified document: Regulation of the Chairman of NADFC RI No. HK.03.1.23.12.10.11983 Year 2010, on the Criteria and Notification Procedures of Cosmetics (24 pages, in Indonesian)

6.

Description of content: This regulation of the Chairman of NADFC RI No. HK.03.1.23.12.10.11983 Year 2010 established the general principle, criteria, and notification procedures of cosmetic.

Cosmetics that will be distributed in Indonesia must be notifyed to the Chairman of NADFC and meet the criteria:

1.          Safety is assessed from cosmetic's ingredient and final productdo not cause damage to human health, both under normal or reasonably foreseable conditions of use;

2.          Benefit that appropriate with the intended use and claims listed;

3.         Quality is assessed from fulfilment of good manufacturing practice requirements.

Notification of cosmetics based on the following procedures, i.e.:

1.         The applicant should register through website http://www.pom.go.id/ to obtain ID and password before applying Electronic Notification;

2.         The application filed by filling out a template which can be downloaded from the website http://www.pom.go.id/;

3.         Notification templates that have been completed can be saved and submit electronically;

4.         Applicants who have submitted notification template will receive a payment order letter electronically via applicant's emails. Applicant printed payment order and makes payments through the designated bank;

5.         Maximum of 10 (ten) days after the date of pay order, the applicant must submit the original receipt of payment to NADFC or NADFC provincial office;

6.         If within 10 (ten) days after the date of pay order, NADFC or NADFC provincial office has not received the original receipt of payment, notification application is deemed rejected;

7.         The original receipt of payment received by NADFC or NADFC provincial office will be verified truth. If the original receipt of payment is received correctly, the applicant receives the product identification (product ID) as a receipt of notification submission;

8.         If within 14 (fourteen) days after the receipt of notification submission obtained, NADFC has not issued a rejection letter, the cosmetics are notified shall be deemed approved and may be distributed in Indonesia.

The Notifications is valid for a period of 3 (three) years. Hereinafter, re-notification may submit no later than 1 month before the period of validity expired, in accordance with the notification procedure as mentioned above.

There are 4 (four) annexes in this regulation:

1.         Annex I: The Type of Cosmetics

2.         Annex II: Applicant Notification Template

3.         Annex III: Type of Applicant Data Changes

4.         Annex IV: Notification Template

This regulation replaces the Chairman of NADFC's Regulation No. HK.00.05.4.1745 Year 2003 on Cosmetics.

7.

Objective and rationale, including the nature of urgent problems where applicable:

1.         To protect people from cosmetics which do not meet safety and quality requirements;

2.         As guidelines for cosmetic's notification.

8.

Relevant documents: Regulation of the Chairman of NADFC RI No. HK.03.1.23.12.10.11983 Year 2010 on the Criteria aand Notification Procedures of Cosmetics

9.

Proposed date of adoption:   After the date of publication

Proposed date of entry into force:   After the date of publication

10.

Final date for comments: 60 days after notification

11.

Texts available from: National enquiry point [X] or address, telephone and fax numbers and email and website addresses, if available, of other body:

Center for Cooperation on Standardization

National Standardization Agency of Indonesia (BSN)

BPPT I Building, 12th Floor

Jl. M.H. Thamrin No.8

Jakarta - Indonesia 10340

https://members.wto.org/crnattachments/2015/TBT/IDN/15_0069_00_x.pdf

 

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