Scope of this ESSENTIAL

This ESSENTIAL describes the Canadian food and consumer products regulations, based on the - Food and Drugs Act - Food and Drug Regulations - Canada Consumer Product Safety Act - Health Canada information and guidelines'

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)?

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)

Penalty by this legislation

Here you will get textual information What are the possible penalties (e. g. sales ban, fines) in the case of non-compliance?

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 related hyperlink(s) Has the country signed a Free Trade Agreement (FTA) or a Mutual recognition agreement (MRA) with EU?

Authority

Here you will get textual information 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)

Abbreviations

Here you will get a table Important abbreviations which are special for this legislation or theme.

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

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]

Equipment authorization (approval process)

Approval process (conformity assessment procedure)

Here you will get textual information Means each legally required approval process prior placing on the market, importation or putting into service

Approval process (conformity assessment procedure)

Here you will get a image or chart Means each legally required approval process prior placing on the market, importation or putting into service

Conformance document(s) to show compliance to the authority

Here you will get textual information e. g. SDoC, technical documentation (for 10 years), filled-in approval forms (e. g. ACMA in AUT)

Conformance document validity and renewal

Here you will get textual information Validity for Conformance document name mentioned. For mandatory certification validity is important.

Which documents are required by an approval body?

Here you will get textual information e .g. formal application

Is a factory inspection legally required

Here you will get textual information

Hint to voluntary certification scheme

Here you will get related hyperlink(s) If a important voluntary certification schemes exists, one link will be given. Important voluntary schemes are for example: UL, CSA, VCCI (Japan)

Testing & Standards

Specific requirements for testing

Here you will get textual information e. g. is an accredited test lab. mandatory, limits, test samples, product description

Regulatory labelling, markings and user information

Regulatory label (mandatory)

Here you will get textual information e. g. product label

Regulatory e-labelling allowed?

Here you will get textual information e. g. put the regulatory information and labels in a software menu

Required information on the product and/or packaging

Here you will get textual information e. g. address of the manufacturer/importer, serial number

User instructions language(s)

Here you will get textual information Regulated by the legal provisions

Warnings, symbols

Here you will get textual information e. g. ANSI Z 535.4

Hints

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

National Standardisation Organisation

Here you will get related hyperlink(s) Link to organisation

Code, Continent	CAN, America
Economic Area	APEC
Official Language	English; French - Official Languages Act (R.S.C., 1985, c. 31 (4th Supp.)) | https://laws-lois.justice.gc.ca/eng/acts/o-3.01/fulltext.html
Standard Institute	Standards Council of Canada (SCC) | https://www.scc.ca/ Canadian Standards Association (CSA) |https://www.csagroup.org/
HS Codemember	Yes