Regulatory ESSENTIAL
China - REACH

Analysis of regulatory requirements

Legislation in force for this PCT

here you will get a linked document in ROGER WILLCO (only reachable with additional ROGER WILLCO licence) Are legal provisions regulates the product compliance topic? If yes, what is the reference (title, number)?

Scope of legislation

This ESSENTIAL descibes the legal obligations for manufacturers of articles (users) and the regulatory requirements for substances in articles. China MEE No. 12 requires that manufacturers and importers submit new substance notifications or registrations and obtain approvals from the Department of Solid Wastes and Chemicals of China MEE prior to production or importation. The notification requirement applies to new substance on its own, in preparation or articles intended to be released. Article 2: The articles which are designed to intentionally release contained new chemical substances in their normal use shall be governed by these Measures. Article 3: The term “new chemical substances” as mentioned in these Measures refers to chemical substances that are not listed in the Inventory of Existing Chemical Substances in China. Note: The requirements of MEE No. 12 are similar to former MEP No. 7 apart from registration obligations (see chapter "Obligations of producers, suppliers and users of articles" below).'

Responsible actors

here you will get textual information Which actor(s) are responsible for compliance with the legal provisions: e. g. - economic operators (manufacturer, importer, distributor, fulfilment service provider), - user (commercial/industrial/professional), - user (private, consumer)?

Regulatory market access conditions for the actor(s)

here you will get textual information What are the main regulatory requirements (e. g. conformity assessment fulfilment of essential requirements of Annex I 2006/42/EC) prior placing on the market, importation and putting into service (brief description)

Exemption clauses

here you will get textual information Exempted devices/products or industry sectors.

Sub-federal legislation of states/counties

here you will get textual information E. g. by 2019 an Inter-Governmental Agreement (IGA) on governance of the Electrical Equipment Safety System (EESS) has been signed by Queensland, Victoria, Western Australia and Tasmania.

FTA/MRA status with EU

here you will get textual information Has the country signed a Free Trade Agreement (FTA) or a Mutual recognition agreement (MRA) with EU?

Authority

here you will get related hyperlink(s) Name of the authority for approval, registration, market surveillance and/or enforcement

Link/Reference to other reference document(s)

here you will get related hyperlink(s)

Hints

here you will get textual information Specific recommendations, information or most common mistakes

Route to compliance

Formal and administrative requirements

Registration at related authority required?

here you will get textual information Product registration? Manufacturer registration? Importer / Representative registration? if required.

Local representative legally required?

here you will get textual information [Yes/No]

Hints

here you will get textual information Specific recommendations, information or most common mistakes

Obligations of producers, suppliers and users of articles Producers, suppliers and users of articles can have information and notification obligations as well as the obligation to register substances in certain circumstances.

Registration obligations for substances

here you will get a image or chart Registration requirements for substances in articles

Hints

here you will get textual information

Registration obligations for articles

here you will get textual information

Obligations for substances of very high concern (SVHC) Obligations (notification, information) in relation to substances of very high concern (SVHC) or other special substances

Obligations for substances of very high concern (SVHC)

here you will get a linked document in ROGER WILLCO (only reachable with additional ROGER WILLCO licence) Obligations (notification, information) in relation to substances of very high concern (SVHC) or other special substances

Hints

here you will get textual information Specific recommendations, information or most common mistakes

Obligations for substances of very high concern (SVHC)

here you will get a image or chart Obligations (notification, information) in relation to substances of very high concern (SVHC) or other special substances

Substances of very high concern (SVHC)

here you will get a linked document in ROGER WILLCO (only reachable with additional ROGER WILLCO licence) what are the criteria for these substances? (e.g. Art. 57 REACH)

Notification obligations

here you will get textual information e.g. Art. 7 (2) REACH Notification to ECHA if SVHC is present in those articles above a concentration of 0,1 % weight by weight (w/w).

Required information for notification

here you will get textual information Which information shall be submitted?

Deadline for the notification

here you will get textual information

Duty to communicate information on substances in articles

here you will get textual information

Required information to communicate

here you will get textual information

Deadline for the information

here you will get textual information

Hints

here you will get a image or chart

Code, Continent	CHN, Asia
Economic Area	APEC (Asia-Pacific Economic Cooperation)
Official Language	Chinese (Mandarin) - Law of the People's Republic of China on the Standard Spoken and Written Chinese Language | http://www.npc.gov.cn/zgrdw/englishnpc/Law/2007-12/11/content_1383540.htm
Standard Institute	Standardization Administration of China (SAC) | https://www.sac.gov.cn/
HS Codemember	Yes