Regulatory ESSENTIAL



Regulatory ESSENTIALS - modular information package with all the essential information for compliant products in your target market. Conveniently read online at Product-Compliance-Portal ROGER WILLCO.

Chemical; material compliance; substance; substance of very high concern; SVHC; REACH

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Scope: This CRF describes the legal obligations for downstream users and manufacturers of articles and the regulatory requirements for substances of very high concern in articles.

Stakeholders: User, B2C products, B2B products
Legislation in force: REACH

Application national: SCIP

Countries: Image for EEA European Economic Area (EU + Iceland, Lichtenstein, Norway),  
Status: Published 2020-05-12 by Linda Kritzler and Inken Green
Last change 2024-07-18 by Linda Kritzler: Authority, Chemical requirements (general) (REACH)
ROGER WILLCO ID: #v86o
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Scope of this ESSENTIAL
This ESSENTIAL describes the legal obligations for downstream users and manufacturers of articles and the regulatory requirements for substances of very high concern in articles. '

Abbreviations
Here you will get a table

Important abbreviations which are special for this legislation or theme.

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 license)

Are legal provisions regulates the product compliance topic? If yes, what is the reference (title, number)?

Hints
Here you will get textual information

Specific recommendations, information or most common mistakes

Scope of legislation
Article 1:
2. This Regulation lays down provisions on substances and mixtures within the meaning of Article 3. These provisions shall apply to the manufacture, placing on the market or use of such substances on their own, in mixtures or in articles and to the placing on the market of mixtures.
3. This Regulation is based on the principle that it is for manufacturers, importers and downstream users to ensure that they manufacture, place on the market or use such substances that do not adversely affect human health or the environment.'

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)

Hints
Here you will get a linked document in ROGER WILLCO
(only reachable with additional ROGER WILLCO license)

Specific recommendations, information or most common mistakes

Penalty by this legislation
Here you will get a table

What are the possible penalties (e. g. sales ban, fines) in the case of non-compliance?

Exemption clauses
Here you will get a table

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

Market surveillance authority
Here you will get related hyperlink(s)

Name of the authority for market surveillance and/or enforcement

Link/Reference to other reference document(s)
Here you will get related hyperlink(s)

Link/Reference to other reference document(s)
Here you will get a linked document in ROGER WILLCO
(only reachable with additional ROGER WILLCO license)

Hints
Here you will get a table

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.

Obligations of producers, suppliers and users of articles
Here you will get a image or chart

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 textual information

Registration requirements for substances in articles

Registration obligations for articles
Here you will get a linked document in ROGER WILLCO
(only reachable with additional ROGER WILLCO license)


Hints
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

Substances of very high concern (SVHC)
Here you will get related hyperlink(s)

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


Duty to communicate information on substances in articles 2
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

Hints
Here you will get textual information

Hints 2
Here you will get textual information

Specific recommendations, information or most common mistakes


Code, ContinentEEA,
Economic Area
Official Language24 official languages
Standard Institute
HS Codemember






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