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印度尼西亚关于化妆品标准和通报程序的规定

嘉峪检测网        2015-09-13 07:50

通报号: G/TBT/N/IDN/91
ICS号: 71.100.70
发布日期: 2015-01-08
截至日期: 2015-03-09
通报成员: 印度尼西亚
目标和理由: 质量要求
内容概述: 本NADFC主席条例RINo.HK.03.1.23.12.10.11983/2010规定了化妆品一般原则、标准和通报程序。在印尼分销的化妆品必须向NADFC主席通报且必须符合标准:1.在正常或合理可预见的使用条件下,化妆品成分和最终产品不对人类健康产生伤害的安全性评估;2.从正确的预定用途和列出的声明中获益;3.质量评估,履行生产管理规范要求。化妆品通报基于以下程序:1.申请人在申请电子通报之前应通过网站http://www.pom.go.id注册以获得编号和密码;2.申请通过填写模板提交,模板从网站http://www.pom.go.id下载;3.完成的通报模板可保存和通过电子方式提交;4.提交通报模板的申请人将通过申请人电子信箱收到电子付款单。申请人打印付款单并通过指定银行付款;5.付款后10天内,申请人必须向NADFC或NADFC地区办公室提交原始付款收据;6.如果付款后10天内,NADFC或NADFC地区办公室未收到原始付款收据,通报申请被视为拒绝;7.NADFC或NADFC地区办公室收到的原始付款收据将被核实。如果原始付款收据正确,申请人将收到产品编码(产品ID)作为提交通报的收据;8.如果提交通报得到收据后14天内,NADFC未发出拒绝信,通报的化妆品被视为批准可以在印尼分销。通报有效期3年。此后,可在有效期到期前至少1个月再次提交通报,依照上述通报程序。本条例有4个附录:1.附录I:化妆品类型2.附录II:申请人通报模板3.附录III:申请人类型数据变更4.附录IV:通报模板。本条例代替NADFC主席条例No.HK.00.05.4.1745/2003化妆品。
正文: 
世界贸易组织
G/TBT/N/IDN/91
2015-01-08
15-0109
 
技术性贸易壁垒
原文:英语
 
通 报


以下通报根据TBT协定第10.6条分发

1.
通报成员: 印度尼西亚
如可能,列出涉及的地方政府名称 ( 3.2条和7.2 条):
2.
负责机构:印尼国家药品食品管理局(NADFC)
3.
通报依据条款:2.9.2,5.6.2
4.
覆盖的产品: 化妆品
HS编码:33   ICS编码:71.100.70
5.
通报标题: NADFC主席条例RINo.HK.03.1.23.12.10.11983/2010关于化妆品标准和通报程序

语言:印尼语 页数:24 链接网址:
 
6.
内容简述:

本NADFC主席条例RI No. HK.03.1.23.12.10.11983/2010规定了化妆品一般原则、标准和通报程序。

在印尼分销的化妆品必须向NADFC主席通报且必须符合标准:

1.在正常或合理可预见的使用条件下,化妆品成分和最终产品不对人类健康产生伤害 的安全性评估

2.从正确的预定用途和列出的声明中获益;

3.质量评估,履行生产管理规范要求。

化妆品通报基于以下程序:

1.申请人在申请电子通报之前应通过网站http://www.pom.go.id注册以获得编号和密码;

2.申请通过填写模板提交,模板从网站http://www.pom.go.id下载;

3.完成的通报模板可保存和通过电子方式提交;

4.提交通报模板的申请人将通过申请人电子信箱收到电子付款单。申请人打印付款单并通过指定银行付款;

5.付款后10天内,申请人必须向NADFCNADFC地区办公室提交原始付款收据;

6.如果付款后10天内,NADFCNADFC地区办公室未收到原始付款收据,通报申请被视为拒绝;

7.NADFCNADFC地区办公室收到的原始付款收据将被核实。如果原始付款收据正确,申请人将收到产品编码(产品ID)作为提交通报的收据;

8.如果提交通报得到收据后14天内,NADFC未发出拒绝信,通报的化妆品被视为批准可以在印尼分销。

通报有效期3年。此后,可在有效期到期前至少1个月再次提交通报,依照上述通报程序。

本条例有4个附录:

1.附录I:化妆品类型

2.附录II:申请人通报模板

3.附录III:申请人类型数据变更

4.附录IV:通报模板。

本条例代替NADFC主席条例No. HK.00.05.4.1745/2003化妆品。
7.
目标与理由:1.防止群众使用不符合安全和质量要求的化妆品; 2.作为化妆品通报的指导原则。
8.
相关文件: NADFC主席条例RINo.HK.03.1.23.12.10.11983/2010关于化妆品标准和通报程序
9.
拟批准日期:公布之后
拟生效日期:公布之后
10.
意见反馈截止日期: 通报之后60天
11.
文本可从以下机构得到:

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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