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

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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 The Supply of Machinery (Safety) Regulations, plus additional guidelines (Food Standards agency). For all matters related to The Supply of Machinery (Safety) Regulations, please see: ESSENTIAL GBR Machine Safety Product Cat.1 post-BREXIT. For other aspects of food contact (e.g.: materials, migration limits, see: ESSENTIAL GBR Food Contact Materials.

Stakeholders: Manufacturer, Importer
Legislation in force: The Food Safety Act 1990 (as amended) provides the framework for all food legislation in the England, Wales and Scotland. SCHEDULE 1 - Provisions of Regulations under Section 16(1) - Food safety and consumer protection. Food hygiene 5(1) Provision for imposing requirements as to— (a) the construction, maintenance, cleanliness and use of food premises, including any parts of such premises in which equipment and utensils are cleaned, or in which refuse is disposed of or stored; (b) the provision, maintenance and cleanliness of sanitary and washing facilities in connection with such premises; and (c) the disposal of refuse from such premises. (2) Provision for imposing requirements as to— (a) the maintenance and cleanliness of equipment or utensils used for the purposes of a food business; and (b) the use, for the cleaning of equipment used for milking, of cleaning agents approved by or under the regulations. (3) Provision for requiring persons who are or intend to become involved in food businesses, whether as proprietors or employees or otherwise, to undergo such food hygiene training as may be specified in the regulations. Transposition of the European Union Machinery Directive 2006/42/EC into the national law of the United Kingdom. 2. SUPPLEMENTARY ESSENTIAL HEALTH AND SAFETY REQUIREMENTS FOR CERTAIN CATEGORIES OF MACHINERY 2.1. FOODSTUFFS MACHINERY AND MACHINERY FOR COSMETICS OR PHARMACEUTICAL PRODUCTS 2.1.1. General Machinery intended for use with foodstuffs or with cosmetics or pharmaceutical products must be designed and constructed in such a way as to avoid any risk of infection, sickness or contagion. The following requirements must be observed: (a) materials in contact with, or intended to come into contact with, foodstuffs or cosmetics or pharmaceutical products must satisfy the conditions set down in the relevant enactments.The machinery must be designed and constructed in such a way that these materials can be cleaned before each use. Where this is not possible disposable parts must be used; (b) all surfaces in contact with foodstuffs or cosmetics or pharmaceutical products, other than surfaces of disposable parts, must: — be smooth and have neither ridges nor crevices which could harbour organic materials. The same applies to their joinings, — be designed and constructed in such a way as to reduce the projections, edges and recesses of assemblies to a minimum, — be easily cleaned and disinfected, where necessary after removing easily dismantled parts; the inside surfaces must have curves with a radius sufficient to allow thorough cleaning; (c) it must be possible for liquids, gases and aerosols deriving from foodstuffs, cosmetics or pharmaceutical products as well as from cleaning, disinfecting and rinsing fluids to be completely discharged from the machinery (if possible, in a “cleaning” position); (d) machinery must be designed and constructed in such a way as to prevent any substances or living creatures, in particular insects, from entering, or any organic matter from accumulating in, areas that cannot be cleaned; (e) machinery must be designed and constructed in such a way that no ancillary substances hazardous to health, including the lubricants used, can come into contact with foodstuffs, cosmetics or pharmaceutical products. Where necessary, machinery must be designed and constructed in such a way that continuing compliance with this requirement can be checked. The Food Safety and Hygiene (England) Regulations 2013 ( SI 2013 No. 2996 - amended) Enforces and executes Regulation (EC) 178/2002 and the EU food hygiene Regulations and provides national rules for: • Temperature control at retail; • Sales of raw cows’ drinking milk • Bulk transport of oils, fats and raw sugar at sea. • Direct supply of small quantities of meat of poultry & lagomorphs (dt.: Hasenartige) slaughtered on farm There are parallel instruments in force in Northern Ireland, Scotland, Wales. For an overview, please see the "Food Standards Agency Food and Feed Law Guide - 2020" The Statutory Instrument (SI) will come into force on 01-OCT-2024 and has two main objectives: - To revoke the expiry date of the recognition of certain European Union (EU) requirements relating to goods, which is due to end on 31-DEC-2024 and to remove the associated transitional provisions which are no longer required. This will allow continued recognition of EU requirements for the product regulations within scope for goods placed on the market in Great Britain (GB); and - To replace the expiry provision and the associated transitional provisions, with a provision that recognises EU testing or conformity assessment procedures. This will mean that, where manufacturers have undertaken conformity assessment procedures with EU recognised bodies, the United Kingdom Conformity Assessed (UKCA) marking may be used, instead of the relevant EU conformity marking.

Application national: Manufacturer, Importer UK, Hygienic Design of food processing machinery

Countries: Image for GB United Kingdom,  
Comment on the comparability to EU legislation: The Supply of Machinery (Safety) Regulations and The Food Safety and Hygiene Regulations are adopted EU Directives. ...
Status: Published 2023-01-26 by Anette Dunkel-Reinboth and Michael Loerzer
Last change 2024-07-19 by Anette Dunkel-Reinboth: Hints, Food contact materials
ROGER WILLCO ID: #766g
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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 The Supply of Machinery (Safety) Regulations, plus additional guidelines (Food Standards agency).

For all matters related to The Supply of Machinery (Safety) Regulations, please see: ESSENTIAL GBR Machine Safety Product Cat.1 post-BREXIT.
For other aspects of food contact (e.g.: materials, migration limits, see: ESSENTIAL GBR Food Contact Materials.'

Hints
Here you will get textual information

Specific recommendations, information or most common mistakes

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)?

Legislation in force for this PCT
Here you will get a table

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 related hyperlink(s)

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

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

Comment on the comparability to EU legislation
Here you will get textual information

Route to compliance

Formal and administrative requirements

Local representative legally required?
Here you will get related hyperlink(s)

[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

Testing & Standards

General information to the application of standards
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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
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Link to organisation

Are national standards based on IEC/ISO standards?
Here you will get textual information

Undetailed information

Hints
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Specific recommendations, information or most common mistakes

Regulatory labelling, markings and user information

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

e. g. product label

Digital user documentation allowed?
Here you will get textual information

User instructions allowed by QR-Code/internet or digital medium or integrated in device with display? Safety instruction allowed by QR-Code or digital medium?

User instruction requirements and specific compliance notes
Here you will get textual information

Form, sentence inside, simple text. E. g. FCC/ISED compliance information, SAR information, battery, environmental information like waste


Code, ContinentGBR, Europe
Economic Area
Official LanguageEnglish (plus 6 regional official languages) De facto official language of the United Kingdom is English. Welsh, an official language in Wales, and the only de jure official language in any part of the UK and Scots
Standard InstituteBSI - British Standards Institution | https://www.bsigroup.com/en-US/Standards/
HS CodememberYes, since 1952






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