Anwendungsbereich des Regulatory Essentials
This ESSENTIAL descibes the regulatory requirements for manufacturers of articles (users) and the regulatory requirements for substances in articles.
User, B2C products, B2B products
Geltende Rechtsvorschriften:
MEE Order No. 12
Decree No. 591
SAWS Order No. 57
Nationale Anwendungsebene:
China
Kommentar bezüglich der Vergleichbarkeit mit der EU-Gesetzgebung:
The objectives of EU REACH and MEE Order No. 12 are similar. There are however key differences (i.e., regarding which substances require registration; hazard or novelty approach)....
Published 2020-05-25 by Linda Kritzler and Inken Green
Last change 2025-05-12 by Linda Kritzler: Comment on the comparability to EU legislation , Chemical requirements (general) (REACh)
Inhalt des Regulatory Essentials
| Hints |
Hier erhalten Sie textbasierte Informationen
Specific recommendations, information or most common mistakes
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| Scope of legislation |
MEE Order 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 People's Republic of China (PRC) 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 the PRC.
Note: The requirements of MEE Order No. 12 are similar to former MEP No. 7 apart from registration obligations (see chapter "Obligations of producers, suppliers and users of articles" below).'
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| Responsible actors |
Hier erhalten sie eine Tabelle
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)?
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| Regulatory market access conditions for the actor(s) |
Hier erhalten sie eine Tabelle
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)
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| Penalty by this legislation |
Hier erhalten Sie textbasierte Informationen
What are the possible penalties (e. g. sales ban, fines) in the case of non-compliance?
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| Exemption clauses |
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Exempted devices/products or industry sectors.
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| Sub-federal legislation of states/counties |
Hier erhalten Sie zugehörige weiterführende Links
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.
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| FTA/MRA status with EU |
Hier erhalten Sie zugehörige weiterführende Links
Has the country signed a Free Trade Agreement (FTA) or a Mutual recognition agreement (MRA) with EU?
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| Authority |
Hier erhalten Sie zugehörige weiterführende Links
Name of the authority for approval, registration, market surveillance and/or enforcement
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| Market surveillance authority |
Hier erhalten Sie zugehörige weiterführende Links
Name of the authority for market surveillance and/or enforcement
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| Link/Reference to other reference document(s) |
Hier erhalten Sie zugehörige weiterführende Links
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| Comment on the comparability to EU legislation |
Hier erhalten Sie textbasierte Informationen
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Formal and administrative requirements
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| Registration at related authority required? |
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Product registration?
Manufacturer registration?
Importer / Representative registration?
if required.
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| Local representative legally required? |
Hier erhalten Sie textbasierte Informationen
[Yes/No]
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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.
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| Registration obligations for substances |
Hier erhalten sie eine Tabelle
Registration requirements for substances in articles
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| Hints |
Hier erhalten Sie textbasierte Informationen
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| Registration obligations for articles |
Hier erhalten Sie textbasierte Informationen
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Obligations for substances of very high concern (SVHC)
Obligations (notification, information) in relation to substances of very high concern (SVHC) or other special substances
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| Obligations for substances of very high concern (SVHC) |
Hier erhalten Sie textbasierte Informationen
Obligations (notification, information) in relation to substances of very high concern (SVHC) or other special substances
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| Hints |
Hier erhalten Sie textbasierte Informationen
Specific recommendations, information or most common mistakes
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| Obligations for substances of very high concern (SVHC) |
Hier erhalten Sie ein Foto oder Diagram
Obligations (notification, information) in relation to substances of very high concern (SVHC) or other special substances
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| Obligations for substances of very high concern (SVHC) |
Hier finden Sie ein thematisch passendes Dokument in ATERIOS
(Zugang nur mit erweiterter ATERIOS Lizenz)
Obligations (notification, information) in relation to substances of very high concern (SVHC) or other special substances
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| Substances of very high concern (SVHC) |
Hier finden Sie ein thematisch passendes Dokument in ATERIOS
(Zugang nur mit erweiterter ATERIOS Lizenz)
what are the criteria for these substances? (e.g. Art. 57 REACH)
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| Notification obligations |
Hier erhalten Sie textbasierte Informationen
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).
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| Required information for notification |
Hier erhalten Sie textbasierte Informationen
Which information shall be submitted?
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| Deadline for the notification |
Hier erhalten Sie textbasierte Informationen
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| Duty to communicate information on substances in articles |
Hier erhalten Sie textbasierte Informationen
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| Required information to communicate |
Hier erhalten Sie textbasierte Informationen
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| Deadline for the information |
Hier erhalten Sie textbasierte Informationen
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| Hints |
Hier erhalten sie eine Tabelle
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Allgemeine Informationen
China
Code, Kontinent, Wirtschaftsraum
APEC (Asia-Pacific Economic Cooperation)
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
Standardization Administration of China (SAC) | https://www.sac.gov.cn/
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