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)?

Scope of legislation

This ESSENTIAL describes the legal obligations for manufacturers and the regulatory requirements for other than consumer products (b2b-products) as specified in the Proposition 65. Section 25249.6 of the Act No person in the course of doing business shall knowingly and intentionally expose any individual to a chemical known to the state to cause cancer or reproductive toxicity without first giving clear and reasonable warning to such individual. Section 25102 of the Regulations (i) “Expose” means to cause to ingest, inhale, contact via body surfaces or otherwise come into contact with a listed chemical. An individual may come into contact with a listed chemical through water, air, food, consumer products and any other environmental exposure as well as occupational exposures. (k) “In the course of doing business” means any act or omission, whether or not for profit, or any act or omission of any employee which furthers the purpose or operation of the business, or which is expressly or implicitly authorized within the meaning of Section 25249.6 of the Act to a listed chemical'

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

Authority

Here you will get textual information Name of the authority for approval, registration, market surveillance and/or enforcement

Link/Reference to other reference document(s)

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

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 textual information Registration requirements for substances in articles

Registration obligations for articles

Here you will get textual information

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 textual information what are the criteria for these substances? (e.g. Art. 57 REACH)

Substances of very high concern (SVHC)

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

Hints

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

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

Required information to communicate

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, Continent	USA-CA,
Economic Area
Official Language	English
Standard Institute
HS Codemember