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Brazil
ESS BRA Food Contact Materials/ANVISA
Food contact materials; food contact substances; food processing machinery; hygienic design of food processing machinery; hygienic design; hygienic sanitary design; product contact surfaces; cleaning; disinfection; dead spaces; bakery machines; grocery machines; meat; diary

89.00 € NET

30-Tages-Lizenz

Anwendungsbereich des Regulatory Essentials

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

Stakeholder:

Manufacturer, Importer

Geltende Rechtsvorschriften:

General Law: It defines the National Health Surveillance System, creates the National Health Surveillance Agency, and provides other measures. ANVISA Responsibility: In accordance with Article 8 of Law No. 9782/99, Anvisa is given the power to regulate, control and supervise products and services involving a risk to public health, including food packaging, as well as physical facilities and technologies involved in the production process. Packaging regulations include packaging and materials that come into direct contact with food and are intended to contain them, from their manufacture to their delivery to the consumer, for the purpose of protecting them from external agents, alterations and contaminations, as well as tampering. They also include food equipment used during the preparation, fractionation, storage, marketing and consumption of food. Included in this definition are: containers, machines, conveyor belts, pipes, fittings, valves, utensils and the like. The sanitary legislation of packaging is organized by type of material, i.e.: plastic, cellulosic, metallic, glass, textile and elastomeric materials Metal packaging (1): Prohibits the use of industrial welded metal packaging with lead and tin alloy for packaging foodstuff, except for dry and dried products List of ANVISA RDCs (Resolutions) and Ordinance regarding food contact materials.

Nationale Anwendungsebene:

Brazil, Food Contact Materials, Packaging Materials, ANVISA Rules

Länder:

 

Brazil

Kommentar bezüglich der Vergleichbarkeit mit der EU-Gesetzgebung:

EU Directives and FDA legislation (USA) regarding food contact materials have been adopted....

Status:

Published 2021-11-10 by Anette Dunkel-Reinboth and Michael Loerzer
Last change 2025-02-26 by Anette Dunkel-Reinboth: Hints, Food contact materials

ID:

#2i6n


Inhalt des Regulatory Essentials

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

Exemption clauses
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Exempted devices/products or industry sectors.

Sub-federal legislation of states/counties
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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
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Has the country signed a Free Trade Agreement (FTA) or a Mutual recognition agreement (MRA) with EU?

Authority
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Name of the authority for approval, registration, market surveillance and/or enforcement

Market surveillance authority
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Name of the authority for market surveillance and/or enforcement

Link/Reference to other reference document(s)
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Comment on the comparability to EU legislation
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Abbreviations
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Important abbreviations which are special for this legislation or theme.

Hints
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Specific recommendations, information or most common mistakes

Route to compliance

Formal and administrative requirements

Registration at related authority required?
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Product registration? Manufacturer registration? Importer / Representative registration? if required.

Local representative legally required?
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[Yes/No]

Hints
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Specific recommendations, information or most common mistakes

Equipment authorization (approval process)

Approval process (conformity assessment procedure)
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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
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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?
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e .g. formal application

Hint to voluntary certification scheme
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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
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e. g. is an accredited test lab. mandatory, limits, test samples, product description

National Standardisation Organisation
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Link to organisation

Are national standards based on IEC/ISO standards?
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Undetailed information

Acceptance of foreign test reports
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Hints
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Specific recommendations, information or most common mistakes

Regulatory labelling, markings and user information

Required information on the product and/or packaging
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e. g. address of the manufacturer/importer, serial number

Warnings, symbols
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e. g. ANSI Z 535.4


Allgemeine Informationen

   
Brazil

Code, Kontinent, Wirtschaftsraum

BRA, South America

Wirtschaftsraum

MERCOSUR/MERCOSUL

Offizielle Amtssprache

Portugese - Constitution of 1988, Article 13 | https://www.jusbrasil.com.br/topicos/10640315/artigo-13-da-constituicao-federal-de-1988

Normen Institut

ABNT (Associação Brasileira de Normas Técnicas) | https://www.abnt.org.br/

HS Codemitglied

Yes, since 1981

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