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Regulatory ESSENTIAL
Brazil - Food Contact Materials/ANVISA

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

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Stakeholders:      Manufacturer, Importer     
Application: Brazil, Food Contact Materials, Packaging Materials, ANVISA Rules
Countries: Image for BR Brazil,  
#2i6n  
Status: Published 2021-11-10 by Anette Dunkel-Reinboth and Michael Loerzer
Last change 2023-09-25 by Anette Dunkel-Reinboth: Abbrevations, Food contact materials
   
Price 365 day licence for 695.00 € net         Buy this REGULATORY ESSENTIAL >>

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Subject Areas of this Essential:


Food contact materials

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

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'

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)

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

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 textual information

Means each legally required approval process prior placing on the market, importation or putting into service

Hints
here you will get textual information

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

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

General Information:

   Brazil

Code, ContinentBRA, South America
Economic AreaMERCOSUR/MERCOSUL
Official LanguagePortugese - Constitution of 1988, Article 13 | https://www.jusbrasil.com.br/topicos/10640315/artigo-13-da-constituicao-federal-de-1988
Standard InstituteABNT (Associação Brasileira de Normas Técnicas) | https://www.abnt.org.br/
HS CodememberYes, since 1981

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