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
Scope: This ESSENTIAL describes conformity procedures for food contact materials (FCM), based on the Brazilian INMETRO ordinances. For product groups not listed in this ESSENTIAL, please see: ESSENTIAL ESS BRA Food Contact Materials/ANVISA.

Stakeholders: Manufacturer, Importer
Legislation in force: Dummies/Pacifiers -The conformity assessment of Pacifiers, through the certification mechanism, must be carried out by a Product Certification Body - OCP, established in Brazil and accredited by Inmetro. -The National Health Surveillance Agency - ANVISA is responsible for defining, through its own normative act, as to the mandatory certification of pacifiers. - Compliance Identification Seal: INMETRO Segurança Compulsorio Disposable plastic cups - Suppliers (both national manufacturers and importers) of disposable plastic cups must fully comply with the provisions of these Regulations. - Disposable plastic cups, manufactured, imported, distributed and marketed in national territory, free of charge or for consideration, must be subject to conformity assessment. Baby bottles and teats/nipples - The conformity assessment of Baby Bottles and Baby Bottle Nozzles, through the certification mechanism, must be carried out by a Product Certification Body - OCP, established in Brazil and accredited by Inmetro. - The National Health Surveillance Agency - Anvisa - is responsible for defining, through its own normative act, as to the mandatory certification of bottles and bottle nipples. - warning statements are defined in the Portaria/Ordinance, i.e.: "Attention: This product contains natural rubber latex. Its use can cause allergic reactions in people sensitive to latex" - Compliance Identification Seal: INMETRO Segurança Compulsorio § 1 This Regulation applies to Metal Cookware: I - for use in an oven, with a base or diagonal diameter of up to and including 75 cm, including baking trays, molds, trays and toaster ovens, or other utensil with a similar function; II - for use on stoves, with a volumetric capacity of up to and including 17 l, including bain-marie, casseroles, cauldrons, steamers, couscous dishes, spaghetti dishes, kettles, lunch boxes, paejeiras, pans, paprika, popcorn makers, pudinzeiras, pots, woks, teapots, mugs, coffee makers, kettles, fryers, milk jugs, lunchboxes and saucers, or other utensil with a similar function; III - for use on stoves, with a base or diagonal diameter of up to and including 40 cm, including steak makers, steak makers, barbecue grills, pancake makers, closed pizza molds, molds for direct heat sources, frying pans, omelettes, pancake makers, sandwich makers and tapioca makers , or other utensil with a similar function, and IV - PRESSURE COOKERS, with a volumetric capacity of up to 30 l.

Application national: Brazil, Specific Products in Contact with Food, INMETRO Certification needed for: party items, dummies/pacifiers, baby bottles and teats, disposable plastic cups, packaging for alcoholic beverages, water plumbing devices, drinking water reservoirs, metallic cookware

Countries: Image for BR Brazil,  
Comment on the comparability to EU legislation: The INMETRO Ordinances regarding food contact materials (product-specific) are not comparable with the general EU legislation (material-specific)....
Status: Published 2021-11-10 by Anette Dunkel-Reinboth and Michael Loerzer
Last change 2024-05-27 by Anette Dunkel-Reinboth: Abbreviations, Food contact materials
ROGER WILLCO ID: #di6k
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Scope of this ESSENTIAL
This ESSENTIAL describes conformity procedures for food contact materials (FCM), based on the Brazilian INMETRO ordinances.

For product groups not listed in this ESSENTIAL, please see: ESSENTIAL ESS BRA Food Contact Materials/ANVISA.
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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 a table

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.

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

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)

Hints
Here you will get related hyperlink(s)

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

General information to the application of standards
Here you will get textual information

e. g. China: GB standards are mandatory, EU: harmonized standards shall be published in the OJEU with respect to "presumption of conformity"

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

Is in-country testing legally required?
Here you will get textual information

Regulatory labelling, markings and user information

Regulatory label (mandatory)
Here you will get a image or chart

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

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


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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