Regulatory ESSENTIAL



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

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

layoutpicture
Scope: 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

Stakeholders: Manufacturer, Importer
Legislation in force: 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 General Criteria and Classification of Materials for Packaging and Equipment in Contact with Foods Subchapter: General criteria for adhesives used in the manufacturing of packaging and equiment intended to come in direct contact with food. 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 Metal packaging (2): Sanitary requirements applicable to packaging, coatings, utensils, lids and metallic equipment intended to come into contact with food. Implements GMC/MERCOSUL Regulations: - GMC Resolution No. 46, of June 24, 2006; - GMC Resolution No. 16, of December 17, 2020; It is - GMC Resolution No. 48, of December 5, 2023. Art. 5 This Resolution comes into force on 02-MAY-2024, transition period: 180 days. The following resolutions are repealed: RDC No 20 of 2007:2007-03-22 RDC No 498 of 2021:2021-05-20

Application national: Brazil, Food Contact Materials, Packaging Materials, ANVISA Rules

Countries: Image for BR Brazil,  
Comment on the comparability to EU legislation: 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 2024-05-27 by Anette Dunkel-Reinboth: Which documents are required by an approval body?, Food contact materials
ROGER WILLCO ID: #2i6n
Price 30 day license for 89.00 € NET net

ANY QUESTIONS?

essentials@globalnorm.de

+49 30 3229027-50




Buy a 30 day license for 89.00 € net now ...




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

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 license)

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 license)

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 license)

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 license)

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, 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






GLOBALNORM COMPLIANCE
GLOBALNORM ACADEMY
GLOBALNORM GmbH

Keep abreast of new and changed requirements and thus act proactively.
Our ACADEMY offers training in a format to suit you – for a direct knowledge transfer from our experts to your company.
Minimize risk, conserve resources, and grow successfully with an understanding of standards and market approval requirements.




Top of the page

© 2024 Globalnorm GmbH