Non-Automatic Weighing Instruments Regulations 2016: Great Britain
Updated 7 November 2023
Guidance on the regulations as they apply to non-automatic weighing instruments being supplied in or into Great Britain.
This guidance has not yet been amended to reflect the announcements on 1 August 2023 and 24 January 2024 that the Government intends to introduce legislation to extend recognition of certain goods that meet EU requirements (including the CE marking), indefinitely, beyond 2024 for many products. When that legislation is passed, certain goods that meet EU requirements will be able to be placed on the GB market.
January 2024
1. Introduction
This Guide is for businesses placing non-automatic weighing instruments on the market in Great Britain. See footnote 1 If you are placing non-automatic weighing instruments on the market in Northern Ireland, you should read separate guidance.
Read guidance on the regulations in Northern Ireland
This Guide is designed to help you comply with The Non-Automatic Weighing Instruments Regulations 2016, as they apply in Great Britain (referred to in this document as “The 2016 Regulations”). The 2016 Regulations set out the requirements that must be met before regulated non-automatic weighing instruments can be placed on the GB market. The purpose of the legislation is to ensure the accuracy and performance of non-automatic weighing instruments to deliver confidence in measurement and transactions for businesses and consumers by requiring manufacturers to show how their instruments meet the ‘essential requirements’.
2. Legislative Background
The Regulations implemented Directive 2014/31/EU on non-automatic weighing instruments. The EU Withdrawal Act 2018 preserved the Regulations and enabled them to be amended so as to continue to function effectively now the UK has left the EU. Accordingly, the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 see footnote 2 fixed any deficiencies that arose from the UK leaving the EU (such as references to EU institutions) and made specific provision for the GB market.
There is therefore one set of UK 2016 Regulations, but some of the provisions apply differently in NI under the terms of the Windsor Framework. References to the 2016 Regulations in this guide are references to those Regulations as they apply in Great Britain.
Read guidance on the regulations in Northern Ireland
3. Scope
The 2016 Regulations define a non-automatic weighing instrument as a weighing instrument that: (a) serves to determine the mass of a body by using the action of gravity on that body and which may also serve to determine other mass-related magnitudes, quantities, parameters and characteristics; and (b) requires the intervention of an operator during weighing.
The 2016 Regulations distinguish between non-automatic weighing instruments intended to be used to perform one of the functions listed at (a) to (f) below (regulated non-automatic weighing instruments), and non-automatic weighing instruments used for any other purpose (non-regulated non-automatic weighing instruments).
a) “the determination of mass for commercial transactions”, which deals with trading transactions where the goods are bought or sold by mass. The cost therefore is directly proportional to the mass of the product. For example: weighing of fruit in a supermarket or using a weighbridge to weigh a load of timber.
b) “the determination of mass for the calculation of a toll, tariff, tax, bonus, penalty, remuneration, indemnity or similar type of payment”, this category of use not only includes situations where the payment is directly proportional to the mass, e.g. remuneration (money paid for work or service), tax, but also situations where the mass value determines the cost of the service, e.g. post office use, laundry or airport baggage tariff, charge for transporting goods, disposal of waste.
c) “the determination of mass for the application of laws or regulations or for an expert opinion given in court proceedings”, which covers the activities where an instrument is used by a person who is not an expert in metrology but is giving evidence based on weighing results. Instruments used for the same purposes by experts from metrological laboratories are therefore excluded on the condition that such laboratories keep their instruments properly maintained, calibrated and adjusted.
This might however include, for instance: the weighing of aircraft in connection with statutory requirements, or the weighing of vehicles in connection with statutory weight restrictions.
d) “the determination of mass in the practice of medicine for weighing patients for the purposes of monitoring, diagnosis and medical treatment”, which covers those activities where medical staff are responsible for the weighing of patients. Examples are the use of weighing instruments in hospitals, health centres or taken into the community for medical purposes. Medical staff includes all persons that lawfully carry out the medical weighing tasks. Medical weighing tasks might include, for example, bed-weighers and baby-weighers.
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”, where medical laboratories are laboratories that carry out analyses at the request of medical practitioners and pharmaceutical laboratories are quality control laboratories of manufacturers of medicinal products for human use. Pharmaceutical laboratories do not include the research and development laboratories of manufacturers of these medicinal products.
f) “the determination of price on the basis of mass for the purposes of direct sales to the public and the making up of pre-packages”. The former case covers the use of instruments with price calculation, in particular price-calculating retail scales, and the latter refers to scales used to make up pre-weighed non-predetermined quantities.
4. Requirements
Most of the obligations in the 2016 Regulations, including the obligation for the instrument to conform to essential requirements, apply to regulated non-automatic weighing instruments. For example, all regulated non-automatic weighing instruments must undergo a conformity assessment procedure in accordance with regulation 36 (referring to Schedule 7 see footnote 3) to demonstrate compliance with the essential requirements applicable to the regulated non-automatic weighing instrument in question (or that class of instrument) specified in Schedule 6 to the 2016 Regulations.
Essential requirements do not apply to non-regulated non-automatic weighing instruments and such instruments are not conformity assessed nor CE and M marked but are required to be marked with the manufacturer’s name, registered trade name or registered trademark and address at which the manufacturer can be contacted (indicating a single point of contact) and maximum capacity as set out in Part 4 of the 2016 Regulations. Furthermore, importers of non-regulated non-automatic weighing instruments must ensure such information has been marked on the instrument and must indicate their own name or registered trade mark and the postal address at which they can be contacted, either by marking the instrument, or, where that would require the packaging to be opened, by providing that information on the packaging and in a document accompanying the instrument. Distributors must verify that both the manufacturer and importer have provided the required information in the manner required before making any non-regulated non-automatic weighing instrument available on the market.
Non-regulated non-automatic weighing instruments are used for such purposes as domestic use (kitchen, bathroom etc), goods inwards inspection and medical practice except for the monitoring of patients for the purposes of diagnosis and medical treatment.
5. Obligations of manufacturers
A manufacturer is a person who manufactures non-automatic weighing instruments, or has weighing instruments designed or manufactured, and markets those weighing instruments under their name or trademark.
The obligations of manufacturers in relation to regulated weighing instruments include:
- Before placing a regulated non-automatic weighing instrument on the GB market, the manufacturer must ensure that it has been designed and manufactured in accordance with the essential requirements. The 2016 Regulations set these out in Schedule 6. They must also have carried out the appropriate conformity assessment procedures referred to in Schedule 7 and have technical documentation drawn up.
- Once this has been done a manufacturer must draw up a declaration of conformity, the format of which is found in Schedule 9 and affix the UKCA marking see footnote 4 and the M marking visibly, legibly and indelibly to the instrument or its data plate.
- Until 31 December 2027 see footnote 5, the UKCA marking may be affixed to a label affixed to, or a document accompanying, the weighing instrument.
- Qualifying Northern Ireland goods can be placed on the GB market with the CE and CE UKNI conformity markings, see further detail in Section 11 on Qualifying Northern Ireland Goods.
- The manufacturer must keep the declaration of conformity up to date and must keep it and the technical documentation for 10 years beginning with the day after the day on which the regulated non-automatic weighing instrument was placed on the market.
- The manufacturer must ensure that procedures are in place for series production to remain in conformity with the essential requirements. They must also label regulated non-automatic weighing instruments with the type and serial or batch identification, the manufacturer’s name, registered trade name or registered trade mark and postal address (also indicating a single point at which the manufacturer can be contacted) and ensure that they are accompanied by instructions and information on the operation of the instrument which is easily understood by end-users and is in clear, legible and easily understandable English (see also Schedule 1 to the 2016 Regulations for further information to be marked on regulated non-automatic weighing instruments).
- The manufacturer, when appropriate with regard to the use of a regulated non-automatic weighing instrument, carry out sample testing of instruments and investigate any complaints and, if necessary, keep records of these complaints, any non-conforming instruments and instrument recalls, and keep distributors informed of any such monitoring.
- The manufacturer must take action where they have reason to believe that the regulated non-automatic weighing instruments they have placed on the GB market is not in conformity with the legal requirements of the 2016 Regulations by bringing the instrument into conformity, withdrawing the instrument or recalling the instrument. Where the regulated non-automatic weighing instruments presents a risk, the manufacturer must immediately inform the market surveillance authority (MSA), giving details of how the instrument is not in conformity and any corrective measures taken. Read more information on how to notify the MSA.
- The manufacturer must also cooperate with and provide information to competent authorities following any requests.
- The manufacturer must mark non-regulated non-automatic weighing instruments with the manufacturer’s name, registered trade name or registered trademark and address and maximum capacity as set out in Part 4 of the 2016 Regulations.
In addition, an importer see below or distributor which: (a) places a regulated non-automatic weighing instrument on the GB market under the name or trade mark of that importer or distributor; or (b) modifies a regulated non-automatic weighing instrument already placed on the market in such a way that compliance with the 2016 Regulations may be affected; will be treated as the manufacturer and accordingly subject to the manufacturer’s obligations.
Manufacturers based in Northern Ireland can follow the legislation as it applies to Northern Ireland and place qualifying Northern Ireland goods on the GB market without any additional approvals. See further detail in Section 11 on Qualifying Northern Ireland Goods.
6. Obligations of authorised representatives
Manufacturers are able to appoint authorised representatives to perform certain tasks on their behalf under a written mandate.
The mandate shall at least allow the authorised representative to perform the following tasks:
- keeping the declaration of conformity and the technical documentation at the disposal of the national market surveillance authorities for 10 years beginning with the day after the day on which the regulated non-automatic weighing instrument was on the GB market
- further to a reasoned request from a competent national authority, providing that authority with all the information and documentation necessary to demonstrate the conformity of the regulated non-automatic weighing instrument
- cooperating with the competent national authorities, at their request, on any action taken to eliminate the risks posed by the regulated non-automatic weighing instrument covered by the mandate
An authorised representative must comply with all the duties, imposed on the manufacturer under the 2016 Regulations, that they are appointed for and mandated by the manufacturer to perform. The manufacturer remains responsible for the proper performance of any obligations the authorised representative performs on their behalf.
Mandated authorised representatives for the GB market can be based in GB or Northern Ireland, but cannot be based outside the UK. A manufacturer can only mandate an authorised representative established in the UK, under the Regulations as they apply in GB.
No GB-based authorised representatives are recognised under EU law. This means GB-based authorised representatives cannot carry out tasks on the manufacturer’s behalf for products being placed on the Northern Ireland or EEA markets. Therefore, a GB manufacturer selling products to the EEA or into Northern Ireland, who wishes to appoint an authorised representative to carry out tasks for them in respect of those products, must appoint an authorised representative based in Northern Ireland or the EEA.
7. Obligations of importers
An importer is a person or business based in the UK who places non-automatic weighing instruments on the GB market from a country outside the UK. This means that UK businesses which used to act as a ‘distributor’ before 1 January 2021 legally become an ‘importer’ if they place products from an EEA country on the GB market.
This includes non-automatic weighing instruments that are supplied to NI businesses from the EEA and then placed on the GB market. In this instance the NI business will take on importer obligations for EEA-supplied goods that are placed on the GB market (see also Section 11 on Qualifying Northern Ireland Goods).
Importers have additional legal obligations which go beyond those of distributors, such as checking that manufacturers have carried out the right conformity assessment procedures and including their (the importer’s) name, registered trade name or mark and a postal address on the regulated non-automatic weighing instrument or, where this would require the packaging to be opened, on its packaging and in accompanying documentation.
To assist with the transition, the UK is applying a transitional period ending 31 December 2027 see footnote 6 to allow GB distributors of goods from the EEA or Switzerland (who from 1 January 2021 are importers into the GB market) to provide their details on the accompanying documentation as an alternative to placing them on the product itself. This applies to goods that are not qualifying Northern Ireland goods. For further detail on qualifying Northern Ireland goods, please see Section 11 on Qualifying Northern Ireland Goods.
Can you be contacted easily if there is a problem?
A key principle underpinning legal metrology, for the benefit of consumers and regulators, is traceability of an instrument back to its source.
In recognition that under the new regulatory regime you may have the new status of an importer when placing regulated weighing instruments from an EEA state or Switzerland on the GB market, you are temporarily permitted when placing such instruments on the market (until 31 December 2027) to indicate your name, registered trade name or trademark and a postal address in a document accompanying the instrument, instead of on the instrument itself. As set out above, this is usually only permitted where an importer would have to open an instrument’s packaging in order to indicate the specified information on the instrument itself. This additional temporary easement is permitted until 31 December 2027.
We understand that there may be a period of adjustment to the new arrangements for importer documentation for the GB market, and it may be difficult to provide your details on documentation accompanying each and every individual instrument.
You may therefore use an alternative method where, for example, your contact information is on a document accompanying a batch of instruments. This document would then follow each batch of instruments through the distribution chain. Your contact details must follow each instrument through the distribution chain, but not necessarily by one document per instrument. Ultimately, the end user, each distributor (and a regulator) must be able to access the information.
Methods which enable traceability of the instrument after the initial batch has been broken up could include:
- The importer address is present in shipping documents.
- The importer address is present on the invoice to the GB customer.
- The importer address is present on the label that is on the outer packaging (“shipper”) in which a number of finished goods is packed (normally customers will receive shippers unless the order is very small so that the shipper has to be opened and split).
- The importer address is included on the EU Declaration of Conformity and/or UK Declaration of Conformity (whichever is relevant for the product in question).
You should work with your distributors to ensure physical documentation does accompany batches of instruments as far as possible, and in all cases that there are measures in place to ensure end users are able to identify the UK importer.
Alongside that, but not as an alternative, you can use your company website to provide more information, access to product details and contact points for retailers, consumers and enforcement bodies.
These options are for a time limited period only and may not be used after 31 December 2027. You are encouraged to put in place measures to ensure that individual items do carry the importer’s address where required ahead of this date.
The EU does not have any such transitional provision. In the absence of this, non-automatic weighing machines being sold from GB to NI or the EU must be labelled with the NI or EU-based importer’s address.
Read guidance on the regulations in the UK
The obligations of importers in relation to regulated non-automatic weighing instruments include:
- Before placing a regulated non-automatic weighing instrument on the GB market the importer must ensure that the appropriate conformity assessment procedures referred to in Schedule 7 have been carried out by the manufacturer. This means that the instrument must comply with the essential requirements set out in Schedule 6. They must ensure that the manufacturer has drawn up technical documentation; the instrument bears the UKCA marking see footnote 4 and the M marking and is accompanied by the required instructions and information in clear, legible and easily understandable English. Until 31 December 2027, the UKCA marking may be affixed to a label affixed to, or a document accompanying, the measuring instrument.
- When deemed appropriate with regard to the performance of a regulated non-automatic weighing instrument the importer must carry out sample testing of instruments made available on the GB market by the importer, keep a register of complaints, non-conforming instruments and recalls of instruments, and keep distributors informed of any such monitoring.
- The importer must indicate their name, registered trade name or trademark and a postal address in clear, legible and easily understandable English. Where this would require the packaging to be opened, the information may instead be set out on the packaging and in a document accompanying the instrument, or where the importer has imported the instrument from an EEA state or Switzerland and places it on the GB market before 31 December 2027, it may be provided in an accompanying document.
- The importer must keep a copy of the declaration of conformity and technical documentation for a period of 10 years beginning with the day after the day on which the regulated non-automatic weighing instrument has been placed on the GB market and ensure that the technical documentation can be made available to market surveillance authorities on request.
- The importer must ensure that regulated non-automatic weighing instruments under their responsibility are stored and transported in such a way that does not jeopardise conformity with the essential requirements.
- The importer must take action where they have reason to believe that the regulated non-automatic weighing instruments they have placed on the GB market is not in conformity with the legal requirements of the 2016 Regulations by bringing the instrument into conformity, withdrawing the instrument or recalling the instrument. Where the regulated non-automatic weighing instruments presents a risk, the importer must immediately inform the market surveillance authority, giving details of how the instrument is not in conformity and any corrective measures taken. Read more information on how to notify the MSA.
- The importer must also cooperate with and provide information to a competent authority following any reasoned requests.
Qualifying Northern Ireland goods complying with the legislation as it applies in Northern Ireland, including affixing the CE marking, may also be placed on the GB market. See further detail in Section 11 on Qualifying Northern Ireland Goods.
8. Obligations of distributors
UK businesses which were distributors of goods within the EU single market should now consider whether they are importers from the EU single market and therefore what additional requirements they might face – see section 7 above. The same applies to distributors of goods from the EEA and Switzerland.
A distributor is any person, other than the manufacturer or importer, who makes non-automatic weighing instruments available on the GB market.
The obligations of distributors include:
- Before making a regulated non-automatic weighing instrument available on the GB market the distributor must take due care to ensure that it is in conformity with the 2016 Regulations.
- Before making a regulated non-automatic weighing instrument available on the GB market the distributor must verify that it bears the UKCA marking see footnote 4 and the M marking, and that it is accompanied by instructions and information in a manner easily understood by end users, and that the manufacturer and importer have complied with the marking requirements to allow for identification of the instrument and of the manufacturer and importer. Until 31 December 2027, the UKCA marking may be affixed to a label affixed to, or a document accompanying, the measuring instrument.
- The distributor must ensure that the regulated non-automatic weighing instruments under their responsibility are stored and transported in such a way that does not jeopardise their conformity with the essential requirements.
- The distributor must take action where they have reason to believe that the regulated non-automatic weighing instruments they have placed on the GB market is not in conformity with the legal requirements of the 2016 Regulations by bringing the instrument into conformity, withdrawing the instrument or recalling the instrument. Where the regulated non-automatic weighing instruments presents a risk, the distributor must immediately inform the market surveillance authority, giving details of how the instrument is not in conformity and any corrective measures taken. Read more information on how to notify the MSA.
- The distributor must also cooperate with and provide information to a competent authority following any reasoned requests.
9. Conformity assessment and marking – non-automatic weighing instruments placed on the GB market before 11pm 31 December 2024
If you place an individual fully manufactured instrument on the EEA or the UK market (either in Northern Ireland or Great Britain) before 11pm 31 December 2024, you do not need to do anything new. These individual goods can continue to circulate on either market until they reach their end user and do not need to comply with the changes that take effect from 11pm 31 December 2024.
A fully manufactured good is ‘placed on the market’ when there is a written or verbal agreement (or offer of an agreement) to transfer ownership or possession or other rights in the product. This does not require physical transfer of the good.
You can usually provide proof of placing on the market on the basis of any relevant document ordinarily used in business transactions, including:
- contracts of sale concerning goods which have already been manufactured and meet the legal requirements
- invoices
- documents concerning the shipping of goods for distribution
The relevant economic operator (whether manufacturer, importer or distributor) bears the burden of proof for demonstrating that the good was placed on the EEA or UK market before 11pm 31 December 2024.
Spares
Non-automatic weighing instruments which are repaired, refurbished or exchanged without changing their original performance, purpose, or type, are not considered ‘new’ and therefore do not need to be recertified and remarked.
This includes if the instrument is temporarily exported for repair (as the instrument is not being placed on the GB market for the first time when re-imported).
If the instrument has been subject to important changes, substantially changing its original performance, purpose, or type, it will be considered as a ‘new’ instrument. Therefore, the modified instrument must comply with GB regulatory requirements, including the requirement for UKCA marking from 11pm 31 December 2024.
Repair, replacement and maintenance operations are often carried out using other products which are spare parts. Spare parts are considered to have been placed on the market at the time at which the original instrument they are ultimately intended to repair, replace or maintain was placed on the market.
This means that spare parts can comply with the same conformity assessment requirements that were in place at the time the original instrument they are ultimately intended to repair, replace or maintain was placed on the market.
The definition of a spare part will vary depending on the commercial context, butit is broadly determined by a product’s ultimate intended usage. Whether a product is ultimately intended to be used as a spare part should be evidenced by any document demonstrating this intended use, which should be produced when requested by market surveillance authorities.
10. Conformity assessment and marking – non-automatic weighing instruments placed on the GB market from 11pm 31 December 2024
From 11pm 31 December 2024, non-automatic weighing instruments intended for the GB market should be conformity assessed by a UK approved body and UKCA marked, not CE marked. See footnote 5
Qualifying Northern Ireland goods complying with the legislation as it applies in Northern Ireland, including affixing the CE marking, may be placed on the GB market after 11pm 31 December 2024. See further detail in Section 11 on Qualifying Northern Ireland Goods.
Rules around physically affixing the new UKCA conformity marking mirror those which currently apply for the application of the CE marking, although until 31 December 2027, the UKCA marking may be affixed to a label affixed to the non-automatic weighing instrument or a document accompanying the non-automatic weighing instrument, rather than being affixed to the non-automatic weighing instrument (or its data plate) itself (even where it is otherwise possible to affix it to the instrument itself).
Self-declaration
Manufacturers selling goods on the GB market can affix the new UKCA marking before placing a non-automatic weighing instrument on the GB market. CE marking based on self-declaration of conformity by the manufacturer is still possible in the same circumstances as during the transition period, until 11pm 31 December 2024.
It will also be possible to affix both the UKCA marking and the CE marking to the same instrument on the basis of self-declaration, as long as the EU and GB requirements remain the same. When exporting to the EU or placing regulated non-automatic weighing instruments on the market in Northern Ireland, the CE marking remains mandatory.
Reducing re-certification/re-testing costs for UKCA marking
The Government has introduced legislation to allow conformity assessment activities undertaken by EU-recognised Conformity Assessment Bodies (CABs), for CE certification before 11pm 31 December 2024, to be used by manufacturers, and other relevant persons, to declare existing product types as compliant with UKCA requirements. Products must still bear the UKCA marking and will need to undergo conformity assessment with a UK Approved Body at the expiry of the certificate or after 31 December 2027, whichever is sooner. For ongoing production, they will need to undergo conformity assessment with a UK Approved Body once any of the relevant CE certification has expired, or after 31 December 2027, whichever is sooner.
Before 11pm 31 December 2024, if an EU-recognised CAB has completed the relevant conformity assessment activities applying to a product intended for placing on the market after 11pm 31 December 2024, this would allow manufacturers to apply the UKCA mark without the need for any UK Approved Body involvement. They could continue to place their goods on the market on the basis of their existing CE certification following the end of 2024, for the lifetime of the certificate issued, or until 31 December 2027 (whichever is sooner).
Where manufacturers are using conformity assessment under existing CE certification before 11pm 31 December 2024 as the basis to demonstrate compliance with UKCA requirements for their products, it is recommended they include in the UK Declaration of Conformity the list of relevant UK designated standards and equivalent EU harmonised standards that apply to their product, as well as details of the EU-recognised CAB (or CAB recognised under an EU Mutual Recognition Agreement with a third country) which carried out the conformity assessment procedures.
This measure applies across all relevant module types.
The M Marking is still required when either the UKCA marking or the CE marking is used.
11. Qualifying Northern Ireland Goods
The government committed to providing unfettered access for qualifying Northern Ireland goods to the rest of the UK market after 1 January 2021. Products that can be placed on the market in Northern Ireland in accordance with the legislation, as it applies to Northern Ireland, can be sold in the rest of the UK without any additional approvals.
This means that products that are qualifying Northern Ireland goods can be sold in the rest of the UK if any of the following apply:
- the CE marking is lawfully applied to the good on the basis of self-declaration
- any mandatory third-party conformity assessment was carried out by an EU-recognised notified body (including a body in a country with which the EU has a relevant mutual recognition agreement) and a CE marking is affixed
- the certificate of conformity previously held by a UK approved body has been transferred to an EU-recognised notified body and a CE marking has been affixed, or
- any mandatory third-party conformity assessment was carried out by a UK-based body, and the good is therefore marked with the CE marking and with the new UKNI marking
This will be the case even if there are changes between the EU rules apply in NI under the terms of the Windsor Framework and the GB rules.
NI businesses that are importing products from the EEA and placing them on the GB market must ensure that the relevant conformity assessment procedure has been carried out, that the technical documentation has been drawn up and that the non-automatic weighing machines bear the CE marking. They will also have to comply with the importer labelling duties (see Section 7 on obligations of importers).
Read guidance on qualifying Northern Ireland goods
12. Approved Bodies
The UK has established a new framework for UK based bodies to assess products against GB rules. Existing UK notified bodies have been granted new UK ‘approved body’ status and are listed on a new UK database.
Approved bodies are conformity assessment bodies which have been approved by the Secretary of State to carry out the procedures for conformity assessment and certification as set out in the 2016 Regulations.
These approved bodies retain their 4-digit identification number. New approved bodies will be assigned a number by the Office for Product Safety and Standards.
UK approved bodies can assess products for the GB market against GB essential requirements (which are, as yet, the same as EU essential requirements).
Approved bodies must be established in the UK and be independent of the manufacturer. Approved bodies must examine the technical documentation and supporting evidence in respect of a regulated non-automatic weighing to assess the adequacy of the technical design.
Where an approved body finds that essential requirements have not been met by a manufacturer, they must not issue a certificate of conformity and they must require the manufacturer to take corrective measures.
Access the list of UK Approved Bodies
The register also contains details of bodies in other countries such as Australia, New Zealand, Canada, Japan, and the United States of America, which the UK is designating as Approved Bodies through Mutual Recognition Agreements.
13. Enforcement
In Great Britain the Office for Product Safety and Standards (OPSS) on behalf of the Secretary of State has responsibility for market surveillance. OPSS and Local trading standards authorities have a duty to enforce the 2016 Regulations RAMS (Regulation (EC 765/2008, as amended by the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019, which sets out requirements for market surveillance of products in Great Britain).
The 2016 Regulations provide the power to OPSS to take action against economic operators for products that are not in conformity with the 2016 Regulations, and for products which are in conformity but present a risk. There are requirements on economic operators to co-operate with the enforcement authority as appropriate on request.
The GB market surveillance authority will take all appropriate measures to withdraw from the GB market or to prohibit and restrict the supply of regulated non-automatic weighing instruments which present a risk in relation to any regulated purpose.
Regulators’ Code
Local authorities and market surveillance authorities must continue to have regard to the Regulators’ Code when developing the policies and operational procedures that guide their regulatory activities in this area. They should carry out their activities in a way that supports those they regulate to comply and grow, including choosing proportionate approaches that reflect risk.
In responding to non-compliance that they identify, regulators should clearly explain what the non-compliant item or activity is, the advice being given, actions required, or decisions taken, and the reasons for these. Unless immediate action is needed to prevent a serious breach, regulators should provide an opportunity for dialogue in relation to the advice, requirements or decisions, with a view to ensuring that they are acting in a way that is proportionate and consistent. The Secretary of State takes account of the provisions of both the Regulators’ Code and the Growth Duty in exercising his regulatory functions.
Penalties
An economic operator or persons committing an offence in relation to an ‘event of default’ under the 2016 Regulations may be liable to a criminal penalty. An economic operator or approved body committing an offence in relation to activities associated with the market surveillance authority are liable to civil penalties enforced by the Secretary of State.
14. Glossary
- Approved Body – A conformity assessment body which has been approved by the Secretary of State.
- Authorised Representative – A person appointed in writing by a manufacturer to perform specific tasks for the manufacturer. Authorised representatives for the GB market must be based in the UK. Manufacturers remain ultimately responsible for ensuring these tasks are carried out properly.
- Competent Authority – In Great Britain local trading standards authorities are the competent authority responsible for enforcing the 2016 Regulations.
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Declaration of conformity – A document prepared by the manufacturer which must detail, among other things, the following:
- the specific regulated non-automatic weighing instrument to which the declaration is referring
- the name and address of the manufacturer and, where applicable, their authorised representative
This must be kept by the manufacturer for a period of ten years from the date on which the regulated non-automatic weighing instrument was placed on the GB market. This declaration must be made available to the enforcing authority upon request.
- Distributor – Any person in the GB supply chain, other than the manufacturer or the importer, who makes a regulated measuring instrument available on the GB market.
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Economic Operator - means a manufacturer, authorised representative, importer or distributor
- Importer – A person established in the UK who places a regulated non-automatic weighing instrument from a country outside of the UK on the GB market. A person who before 1 January 2021 (under EU Rules) distributed non-automatic weighing instruments within the EU (including the UK, and including Switzerland) will now be an importer if they are bringing regulated non-automatic weighing instruments into GB from another country (including EEA States or Switzerland). This includes a person based in NI who has been supplied with the product from an EEA country, who would, under NI law, be a distributor.
- Manufacturer – A person who manufactures a regulated non-automatic weighing instrument or has a regulated non-automatic weighing instrument designed or manufactured and markets that instrument under their name or trademark.
- UKCA Marking – The UKCA (UK Conformity Assessed) marking is the new UK conformity marking used for certain goods (including non-automatic weighing instruments being placed on the GB market, in place of the CE marking which is the conformity marking used in Northern Ireland and the European Union.
- UKNI Marking (also known as the UK(NI) indication) – The UKNI marking is a new marking applied in addition to the CE marking, where a good requiring mandatory third-party conformity assessment has been tested against EU requirements by a UK body. The UKNI marking applies when placing such products on the Northern Ireland market. Under the Government’s unfettered access commitments, products lawfully marked with the UKNI marking can also be placed on the GB market if they are also qualifying Northern Ireland goods.
15. Footnotes
1: Great Britain comprises England, Scotland and Wales. It does not include the Isle of Man or the Channel Islands.
2: The following legislative amendments and Government announcements apply:
- The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 were amended by the Product Safety and Metrology etc. (Amendment to Extent and Meaning of Market) (EU Exit) Regulations 2020 to apply to Great Britain only, and not to Northern Ireland, in support of implementing The Protocol of Ireland and Northern Ireland (“The Northern Ireland Protocol”) and now the Windsor Framework.
- The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 were further amended by the Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations 2020 to provide for a 24 month transition period for importer labelling (for goods from the EEA), and UKCA marking, to amend the definition of “authorised representative” as well as introducing an end (in 12 months from the end of the Transition Period) to the recognition of goods meeting EU requirements, as well as introducing provisions for qualifying Northern Ireland goods.
- On 24 August 2021 the Government announced the transition period for UKCA marking would be extended until 31 December 2022. The Product Safety and Metrology etc (Amendment) Regulations 2021 gave effect to this. On 14 November 2022 the Government announced it would be extending this until 31 December 2024. The Product Safety and Metrology (Amendment and Transitional Provisions) Regulations 2022 (SI 2022/1393) give effect to this.
- On 20 June 2022, the Government announced the provisions for UKCA labelling and importer labelling would be extended until 31 December 2025. On 14 November 2022 the Government announced it would be extending this until 31 December 2027. The Product Safety and Metrology (Amendment and Transitional Provisions) Regulations 2022 (SI 2022/1393) give effect to this.
3: Schedules 6 and 7 of the 2016 Regulations were added by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 and essentially incorporate with the relevant deficient terms corrected Annexes I and II of the Measuring Instruments Directive 2014/32/EU.
4: Until 11pm 31 December 2024, non-automatic weighing instruments conforming to EU rules, including the CE marking, may be placed on the market of Great Britain – see below; qualifying Northern Ireland goods complying with NI rules, including the CE marking, may also be placed on the GB market – see below.
5: On 24 August 2021 the Government announced the transition periods for UKCA marking and UKCA labelling would each be extended until 31 December 2022 and 31 December 2023 respectively. The Product Safety and Metrology etc (Amendment) Regulations 2021 gave effect to this. On 20 June 2022, the Government announced the provisions for UKCA labelling would be extended until 31 December 2025. On 14 November 2022 the Government announced it would be extending the transition period for UKCA marking until 31 December 2024 and the provisions for UKCA labelling and importer labelling until 31 December 2027. The Product Safety and Metrology (Amendment and Transitional Provisions) Regulations 2022 (SI 2022/1393) give effect to this.
6: On 20 June 2022, the Government announced the provisions for importer labelling would be extended until 31 December 2025. On 14 November 2022 the Government announced it would be extending the provisions for importer labelling until 31 December 2027. The Product Safety and Metrology (Amendment and Transitional Provisions) Regulations 2022 (SI 2022/1393) give effect to this.