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: This ESSENTIAL describes conformity procedures for food contact materials (FCM), based on UK and retained EU Regulations. Food Contact Materials (FCMs) are materials and articles that come into contact with food during its production, processing, storage, preparation or serving. Examples of FCMs include: - containers for the transportation of food - packaging materials - kitchenware - tableware There are four categories of food contact materials which are subject to specific regulations: - plastic monomers and additives - active/intelligent materials (‘AIMs’) - recycled plastic processes - regenerated cellulose film (RCF)

Stakeholders: Manufacturer, Importer, B2C products, B2B products
Legislation in force: The Food Safety Act 1990 The Food Safety Act 1990 (as amended) provides the framework for all food legislation in the England, Wales and Scotland. The main responsibilities for all food businesses under the Act are to ensure that: - businesses do not include anything in food, remove anything from food or treat food in any way which means it would be damaging to the health of people eating it - the food businesses serve or sell is of the nature, substance or quality which consumers would expect - the food is labelled, advertised and presented in a way that is not false or misleading Adopts Regulation (EU)1935/2004, (EU) No. 10/2011, and other EU food contact materials regulations Amends SI 2012 No. 2619 in the EU Exit context. Defines requirements for - Recycled plastic materials - Bisphenol A - Animal feed and adopts several EC regulations into the English law.

Application national: UK (England, Scotland, Wales) Food Contact Materials, FSA (Food Standards Agency)

Countries: Image for GB United Kingdom,  
Status: Published 2021-12-14 by Anette Dunkel-Reinboth and Michael Loerzer
Last change 2024-03-01 by Torsten Sahm: Hints, Food contact materials
ROGER WILLCO ID: #gi6x
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Scope of this ESSENTIAL
This ESSENTIAL describes conformity procedures for food contact materials (FCM), based on UK and retained EU Regulations.

Food Contact Materials (FCMs) are materials and articles that come into contact with food during its production, processing, storage, preparation or serving. Examples of FCMs include:
- containers for the transportation of food
- packaging materials
- kitchenware
- tableware

There are four categories of food contact materials which are subject to specific regulations:
- plastic monomers and additives
- active/intelligent materials (‘AIMs’)
- recycled plastic processes
- regenerated cellulose film (RCF)'

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 textual information

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

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

Link/Reference to other reference document(s)
Here you will get a linked document in ROGER WILLCO
(only reachable with additional ROGER WILLCO license)

Abbreviations
Here you will get textual information

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 related hyperlink(s)

[Yes/No]

Hints
Here you will get textual information

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

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 related hyperlink(s)

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

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

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"

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

Acceptance of foreign test reports
Here you will get textual information

Hints
Here you will get related hyperlink(s)

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

Regulatory e-labelling allowed?
Here you will get textual information

e. g. put the regulatory information and labels in a software menu

Required information on the product and/or packaging
Here you will get related hyperlink(s)

e. g. address of the manufacturer/importer, serial number

Required information on the product and/or packaging
Here you will get textual information

e. g. address of the manufacturer/importer, serial number

User instructions language(s)
Here you will get textual information

Regulated by the legal provisions

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?

Hints
Here you will get textual information

Specific recommendations, information or most common mistakes


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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