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.

Scales; automatic weighing instruments; non automatic weighing instruments; Measuring Instruments; Type approval; Pattern approval; legal metrology, metrology mark; WELMEC; OIML; gravity zone; verification
Scope: This ESSENTIAL describes the UK regulations on REGULATED NAWI, based on - the Non-automatic Weighing Instruments Regulations 2016 - the The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 - BREXIT Guidance dokuments published by the UK government (see: Link/Reference to other reference documents) In UK, NAWI are classified into 2 sections (for a better understanding the words REGULATED and NON-REGULATED are typed in capitals in this CRF) 1.) REGULATED weighing instruments, see Part 2 of SI 2016 No.1152(corresponding to 2014/31/EU, Article 1, (a) - (f)) These Regulations apply to an instrument (referred to in these Regulations as a “REGULATED non-automatic weighing instrument”) for use for any of the following purposes: (a) the determination of mass for commercial transactions; (b) the determination of mass for the calculation of a toll, tariff, tax, bonus, penalty, remuneration, indemnity or similar type of payment; (c) the determination of mass for the application of laws or regulations or for an expert opinion given in court proceedings; (d) the determination of mass in the practice of medicine for weighing patients for the purposes of monitoring, diagnosis and medical treatment; (e) the determination of mass for making up medicines on prescription in a pharmacy and determination of mass in analyses carried out in medical and pharmaceutical laboratories; (f) the determination of price on the basis of mass for the purposes of direct sales to the public and the making up of prepackages. 2.) NON-REGULATED weighing instruments, see Part 4 of SI 2016 No.1152 (corresponding to 2014/31/EU, Article 1, (g))

Stakeholders: Manufacturer, Importer
Legislation in force: The Non-automatic Weighing Instruments Regulations 2016 (transposition of 2014/31/EU into the national law of the United Kingdom) Schedule 26 (Amendment of the Non-automatic Weighing Instruments Regulations) describes changes to SI 2016 No.1152, post-BREXIT legislation Moves date of mandatory UKCA marking of products from 01-JAN-2022 to 01-JAN-2023 Purpose of the instrument The main objective of this instrument is to provide businesses with additional time to transition to the post-exit independent UK conformity assessment marking (UKCA) regime requirements, in order to legally place products on the market in Great Britain (England and Wales and Scotland).

Application national: United Kingdom, Legal Metrology, Non-Automated Weighing Instruments/NAWI - Post-BREXIT regulation (2021 status)

Countries: Image for GB United Kingdom,  
Comment on the comparability to EU legislation: This SI 2016 No.1152 (Statutory Instrument) is being made in order to implement the provisions of the NAWI (Non-automatic Weighing Instruments Directive) 2014/31/EU of the European Union....
Status: Published 2021-04-23 by Anette Dunkel-Reinboth and Michael Loerzer
Last change 2024-07-17 by Anette Dunkel-Reinboth: Hints, Metrology and legal metrology
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Scope of this ESSENTIAL
This ESSENTIAL describes the UK regulations on REGULATED NAWI, based on
- the Non-automatic Weighing Instruments Regulations 2016
- the The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019
- BREXIT Guidance dokuments published by the UK government (see: Link/Reference to other reference documents)

In UK, NAWI are classified into 2 sections (for a better understanding the words REGULATED and NON-REGULATED are typed in capitals in this CRF)
1.) REGULATED weighing instruments, see Part 2 of SI 2016 No.1152(corresponding to 2014/31/EU, Article 1, (a) - (f))
These Regulations apply to an instrument (referred to in these Regulations as a “REGULATED non-automatic weighing instrument”) for use for any of the following purposes:
(a) the determination of mass for commercial transactions;
(b) the determination of mass for the calculation of a toll, tariff, tax, bonus, penalty, remuneration, indemnity or similar type of payment;
(c) the determination of mass for the application of laws or regulations or for an expert opinion given in court proceedings;
(d) the determination of mass in the practice of medicine for weighing patients for the purposes of monitoring, diagnosis and medical treatment;
(e) the determination of mass for making up medicines on prescription in a pharmacy and determination of mass in analyses carried out in medical and pharmaceutical laboratories;
(f) the determination of price on the basis of mass for the purposes of direct sales to the public and the making up of prepackages.

2.) NON-REGULATED weighing instruments, see Part 4 of SI 2016 No.1152 (corresponding to 2014/31/EU, Article 1, (g))'

Hints
Here you will get textual information

Specific recommendations, information or most common mistakes

Analysis of regulatory requirements

Measuring Device Type
Here you will get textual information

e. g. NAWI, AWI

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)?

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 related hyperlink(s)

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

Market surveillance authority
Here you will get textual information

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

Abbrevations
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]

Member of International Metrology Organizations
Here you will get textual information

e.g. OIML

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 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 textual information

If a important voluntary certification schemes exists, one link will be given. Important voluntary schemes are for example: UL, CSA, VCCI (Japan)

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"

Source for standards for conformity assessment
Here you will get related hyperlink(s)

OIML Recommendations adopted?
Here you will get textual information

OIML is publishing international standards. IEC and ISO are not relevant for this theme.

National Standardisation Organisation
Here you will get related hyperlink(s)

Link to organisation

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

Acceptance of foreign test reports
Here you will get textual information

Country gravity zones
Here you will get related hyperlink(s)

Verification Regulation
Here you will get related hyperlink(s)

DE: Eichwesen

Regulatory labelling, markings and user information

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

e. g. product label

Specific Metrology Marking(s)
Here you will get a image or chart

Regulatory e-labelling allowed?
Here you will get related hyperlink(s)

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

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

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

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

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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