Regulatory ESSENTIAL
Brazil - Food Contact Materials/ANVISA

Scope of this ESSENTIAL

This ESSENTIAL describes conformity procedures for food contact materials (FCM), based on the Brazilian ANVISA ordinances. For specific products in contact with food under INMETRO conformity regulation, please see ESSENTIAL BRA Food Contact Materials - INMETRO'

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)?

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 a linked document in ROGER WILLCO (only reachable with additional ROGER WILLCO licence) 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 a linked document in ROGER WILLCO (only reachable with additional ROGER WILLCO licence) 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

Comment on the comparability to EU legislation

here you will get textual information

Abbreviations

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

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 related hyperlink(s) Specific recommendations, information or most common mistakes

Equipment authorization (approval process)

Approval process (conformity assessment procedure)

here you will get a linked document in ROGER WILLCO (only reachable with additional ROGER WILLCO licence) 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)

Which documents are required by an approval body?

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

Hint to voluntary certification scheme

here you will get textual information If a important voluntary certification schemes exists, one link will be given. Important voluntary schemes are for example: UL, CSA, VCCI (Japan)

Hints

here you will get a linked document in ROGER WILLCO (only reachable with additional ROGER WILLCO licence) Specific recommendations, information or most common mistakes

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

National Standardisation Organisation

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

Are national standards based on IEC/ISO standards?

here you will get textual information Undetailed information

Acceptance of foreign test reports

here you will get textual information

Hints

here you will get a linked document in ROGER WILLCO (only reachable with additional ROGER WILLCO licence) Specific recommendations, information or most common mistakes

Regulatory labelling, markings and user information

Required information on the product and/or packaging

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

Warnings, symbols

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

Code, Continent	BRA, South America
Economic Area	MERCOSUR/MERCOSUL
Official Language	Portugese - Constitution of 1988, Article 13 | https://www.jusbrasil.com.br/topicos/10640315/artigo-13-da-constituicao-federal-de-1988
Standard Institute	ABNT (Associação Brasileira de Normas Técnicas) | https://www.abnt.org.br/
HS Codemember	Yes, since 1981