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: Hygienic Design is defined as: Design and engineering (materials and fabrication) of equipment and premises which are easily cleanable assuring the food is safe and suitable for human consumption. This ESSENTIAL decribes hygienic design requirements on the basis of - Brazilian laws/decrees - ANVISA Resolutions - Brazilian NRs (Normas Regulamentadoras) for work safety regarding food machinery and equipment For other aspects of food contact (e.g.: materials, migration limits, see: ESSENTIAL BRA Food Contact Materials.

Stakeholders: Manufacturer, Importer, Operator
Legislation in force: Art. 1 This code establishes norms for the protection and defense of consumers, public order and social interest. SECTION I - Health and Safety Protection Art.8.2: The supplier must clean the equipment and utensils used in the supply of products or services, or made available to the consumer, and inform, in an ostensive and adequate manner, when applicable, about the risk of contamination. NR-12 Annex VI - Bakery and Confectionary Machines This annex sets out specific saftey requirements for the bakery and confectionary machines, e.g., kneaders, mixers, rollers, moulders, sheeters, bread slicers and breadcrumb mills. NR-12 Annex VII - Grocery and Butcher Machines This annex sets out specific safety requirements for new, used or imported butcher and grocery machines, namely: band saw, meat slicer, meat tenderizer, meat grinder and cold cut slicer. Decree 9013 - Regulation of the industrial and sanitary inspection of animal products (amended by Decree No.10.468 of 2020) TITLE IV- GENERAL CONDITIONS FOR ESTABLISHMENTS CHAPTER I - BUILDING FACILITIES AND EQUIPMENT Article 42. Animal product establishments must possess the following basic and shared conditions, taking into consideration applicable technical specificities, without prejudice to other criteria established in supplementary norms: ... XVII - corrosion-resistant equipment and utensils that are easy-to-clean, non-toxic and do not allow the accumulation of residues; XVIII - equipment and instruments to monitor the manufacturing process, calibrated and externally checked, considered needful for technical and sanitary control of production; XIX - an area for the cleaning of containers used in moving raw material and products CHAPTER II - HYGIENE CONDITIONS Article 54. Establishments' built facilities, equipment and utensils must be kept in good hygiene conditions before, during and after the performance of the industrial activities. Single paragraph. Cleaning procedures must be carried out regularly and whenever necessary, taking into consideration the specificities of each industrial sector, so as to avoid the contamination of animal product Article 72. In spaces where there is an immediate risk of contamination of utensils and equipment, there must be devices or mechanisms for sanitizing using water at a minimum of 82.2º C (eighty-two point two degrees Celsius) or some other equivalent method recognized by the Department of Inspection of Animal Products. TITLE V - INDUSTRIAL AND SANITARY INSPECTION CHAPTER I - INDUSTRIAL AND SANITARY INSPECTION OF MEAT AND PRODUCTS CHAPTER IA - INDUSTRIAL AND SANITARY INSPECTION OF FISH AND DERIVATIVES CHAPTER II - INDUSTRIAL AND SANITARY INSPECTION OF EGGS AND EGG DERIVATIVES CHAPTER III - INDUSTRIAL AND SANITARY INSPECTION OF MILK AND DAIRY PRODUCTS CHAPTER IV - INDUSTRIAL AND SANITARY INSPECTION OF BEE PRODUCTS AND DERIVATIVES CHAPTER IV - INSPECTION STAMPS Art. 463. The inspection stamp represents the official SIF mark and constitutes the guarantee that the product comes from an establishment inspected and supervised by the Ministry of Agriculture, Livestock and Supply. NR-36 – Health and Safety at Work in Slaughter Houses and Processing Meat and Derivatives Chapters: 36.7 Machines 36.7.1 The machinery and equipment used in slaughter and meat and meat products processing companies must comply with the provisions of NR12 (Safety at Work in Machinery and Equipment) 36.8 Equipment and Tools

Application national: Brazil, Food Processing Machinery, Hygienic Design

Countries: Image for BR Brazil,  
Status: Published 2023-05-25 by Anette Dunkel-Reinboth and (Marius Galka)
Last change 2024-04-24 by Anette Dunkel-Reinboth: Legislation in force for this PCT, Food contact materials
ROGER WILLCO ID: #no65
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Scope of this ESSENTIAL
Hygienic Design is defined as: Design and engineering (materials and fabrication) of equipment and premises which are easily cleanable assuring the food is safe and suitable for human consumption.
This ESSENTIAL decribes hygienic design requirements on the basis of
- Brazilian laws/decrees
- ANVISA Resolutions
- Brazilian NRs (Normas Regulamentadoras) for work safety regarding food machinery and equipment

For other aspects of food contact (e.g.: materials, migration limits, see: ESSENTIAL BRA Food Contact 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 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)?

Penalty by this legislation
Here you will get textual information

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

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

Link/Reference to other reference document(s)
Here you will get related hyperlink(s)

Hints
Here you will get textual information

Specific recommendations, information or most common mistakes

Route to compliance

Formal and administrative requirements

Hints
Here you will get textual information

Specific recommendations, information or most common mistakes

Equipment authorization (approval process)

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)

Testing & Standards

Specific requirements for testing
Here you will get a table

e. g. is an accredited test lab. mandatory, limits, test samples, product description

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

Regulatory labelling, markings and user information

Regulatory label (mandatory)
Here you will get textual information

e. g. product label


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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