Guidance

Non-Automatic Weighing Instruments Regulations 2016: Great Britain

Updated 5 December 2024

Guidance on the regulations as they apply to non-automatic weighing instruments being supplied in or into Great Britain.

This guidance has been amended to reflect the announcements on 1 August 2023 and 24 January 2024 that the Government is extending recognition of certain goods that meet EU requirements (including the CE marking), indefinitely, beyond 2024 for many products. The Product Safety and Metrology etc. (Amendment) Regulations 2024 give effect to this and came into force on 1 October 2024.

December 2024

1. Introduction

This Guide is for businesses placing non-automatic weighing instruments on the market in Great Britain (“GB”). ^{[footnote 1]} If you are placing non-automatic weighing instruments on the market in Northern Ireland (“NI”), you should read separate guidance.

Read guidance on the regulations in NI.

This Guide is designed to help you comply with the Non-Automatic Weighing Instruments Regulations 2016, as they apply in GB (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 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 GB.

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 GB only, and not to NI, 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), 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 NI 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) gave 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 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.
• On 1 August 2023 and 24 January 2024, the UK Government announced it would extend recognition of goods that meet EU requirements (including the CE marking), indefinitely, beyond 2024 for many products. This means that certain goods that meet EU requirements can be placed on the GB market beyond 31 December 2024. The Product Safety and Metrology etc. (Amendment) Regulations 2024 give effect to this and came into force on 1 October 2024. The legislation also provides for a ‘Fast-Track’ UKCA scheme, whereby steps taken towards CE marking will count towards UKCA marking, while UK product safety regulations remain aligned with EU product safety law.

Read guidance on the regulations in NI.

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) ^{[footnote 2]} 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 UKCA/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 or modified, and markets those weighing instruments under their name or trademark.

The obligations of manufacturers in relation to regulated weighing instruments include:

1) 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.

2) 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 relevant conformity assessment marking (see section 9 (or section 10 for Qualifying NI Goods)) and the M marking visibly, legibly and indelibly to the instrument or its data plate.

3) 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.

4) The manufacturer must 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).

5) The manufacturer must 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).

6) The manufacturer must ensure that procedures are in place for series production to remain in conformity with the essential requirements.

7) 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.

8) 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.

9) The manufacturer must also cooperate with and provide information to competent authorities following any requests.

10) 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 or distributor who: (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 wishing to place goods on the NI market should follow the Regulation as it applies to NI. Qualifying NI goods can be placed on the GB market without any additional approvals, although additional information as to the UK based importer may be required, if the goods have an importer based in the EU/EEA. See further detail in Section 10 on Qualifying NI 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:

1) keeping the declaration of conformity and the technical documentation at the disposal of the national MSAs for 10 years beginning with the day after the day on which the regulated non-automatic weighing instrument was on the GB market

2) 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

3) 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 NI, 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 NI or EEA markets. Therefore, a GB manufacturer selling products to the EEA or into NI, 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 NI 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 a UK business which acted as a ‘distributor’ before 1 January 2021 is now legally an ‘importer’ if they place products from an EEA country or Switzerland on the GB market and therefore must comply with the importer duties under GB legislation.

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 10 on Qualifying NI 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 ^{[footnote 3]} 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 NI goods. For further detail on qualifying NI goods, please see Section 10 on Qualifying NI 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 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:

1) Before placing a regulated non-automatic weighing instrument on the GB market the importer must ensure that:

a) 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.

b) the manufacturer has drawn up technical documentation

c) the instrument bears the relevant conformity assessment marking (see section 9 (or section 10 for Qualifying NI Goods)) and the M marking

d) the instrument is accompanied by the required instructions and information in clear, legible and easily understandable English

2) 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.

3) 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.

4) 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 MSAs on request.

5) 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.

6) 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 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.

7) The importer must also cooperate with and provide information to a competent authority following any reasoned requests.

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:

1) 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.

2) Before making a regulated non-automatic weighing instrument available on the GB market the distributor must verify that:

a) the instrument bears the relevant conformity assessment marking (see section 9 (or section 10 for Qualifying NI Goods)) and the M marking

b) the instrument is accompanied by instructions and information in a manner easily understood by end users

c) the manufacturer and importer have complied with the marking requirements to allow for identification of the instrument and of the manufacturer and importer

3) 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.

4) 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 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.

5) The distributor must also cooperate with and provide information to a competent authority following any reasoned requests.

9. Conformity assessment and marking before placing non-automatic weighing instruments on the GB market

As set out in section 5 above, before placing an instrument on the GB market or using it for their own purposes, the manufacturer must:

a) design and manufacture the instrument in accordance with the essential safety requirements

b) determine the conformity procedure that applies, carry out the relevant conformity assessment procedure, (or have it carried out by an independent third party, depending on the category the product falls into), and draw up the relevant technical documentation

The product should then be marked with the applicable conformity assessment marking, provided it meets the essential requirements, and the relevant conformity assessment procedure has been carried out and/or a certificate has been issued by the relevant body.

What conformity assessment marking should the product have and when?

In line with the Government’s announcements on 1 August 2023 and 24 January 2024 about extended recognition of CE marking for products intended for the GB market, the Product Safety and Metrology etc. (Amendment) Regulations 2024 were made on 23 May 2024, and came into force on 1 October 2024.

These regulations extend recognition of CE marking indefinitely in GB. This allows businesses to use either CE or UKCA markings when placing goods on the GB market beyond 31 December 2024.

However, if GB based businesses wish to place products on the EEA market, they will continue to require a CE marking before the product is placed on the EEA market, including NI.

Self-declaration

Manufacturers placing equipment and protective systems on the GB market on the basis of self-declaration of conformity (where the Regulations permit) can affix either the UKCA marking or the CE marking before placing equipment on the GB market.

It is possible to affix both the UKCA marking and the CE marking to the same equipment, where conformity procedures are based on self-declaration, as long as the EU and GB requirements remain the same. When selling to the EU or supplying to NI, the CE marking remains mandatory.

Where independent third-party conformity assessment is required

Placing on the market in GB	Conditions to be met	Timeframe
Can be CE marked	If the product was conformity assessed by an EU Notified Body (but not a UK Approved Body), and meets all the essential safety requirements	Since 31/12/20
Must be UKCA marked	If the product has been conformity assessed by a UK Approved Body, and meets all the essential safety requirements	Since 31/12/20
Can be UKCA marked, but not CE marked	If the product is intended for placing on the GB market after 1 October 2024, and conformity assessment steps have been begun by an EU Notified Body and completed by a UK Approved Body, and has met all the essential safety requirements	New, since 1 October 2024

Placing on the market in NI	Conditions to be met	Timeframe
Must be CE marked	If the product was conformity assessed by an EU Notified Body and meets all the essential safety requirements	Since 31/12/20
Must be CE + UKNI marked	If the product has been conformity assessed by a UK Approved Body, and meets all the essential safety requirements	Since 31/12/20

Placing on the market in EEA	Conditions to be met	Timeframe
Must be CE marked	If the product was conformity assessed by an EU Notified Body (but not a UK Approved Body), and meets all the essential safety requirements	Since 31/12/20

Can a product be dual marked CE and UKCA?

Yes, but only, and before placing on market:

a) where an EU Notified Body has completed conformity assessment procedures for CE marking, and

b) where a UK Approved Body has completed conformity assessment procedures for UKCA marking, and it meets all the essential safety requirements

OR from 1 October 2024:

c) where an EU Notified Body has completed conformity assessment procedures for CE marking and it meets all the essential safety requirements, the product can also be UKCA marked, or

d) where an EU Notified Body has begun conformity assessment procedures for CE marking, and these have then been completed by a UK Approved Body for UKCA marking and it meets all the essential safety requirements, the product can be UKCA marked

Can a CE marked product already on the market, subsequently be UKCA marked?

A product already on the market, marked with a CE marking, cannot subsequently be UKCA marked, unless it has undergone full conformity assessment by a UK Approved Body and meets all the essential requirements.

The M Marking is still required when either the UKCA marking or the CE marking is used.

Any queries about CE marking or UKCA marking policy should be directed to Goods.Regulation@businessandtrade.gov.uk.

Where do I affix the conformity assessment marking?

The conformity assessment marking should be affixed visibly, legibly and indelibly to the instrument. Where it is not possible or not warranted on account of the nature of the instrument to affix the conformity assessment marking directly on the instrument (or its data plate), then it can be affixed to the packaging and accompanying documents.

Until 31 December 2027, the UKCA marking may be affixed to a label affixed to the instrument or a document accompanying the instrument, rather than being affixed to the instrument itself (even where it is otherwise possible to affix it to the instrument itself) ^{[footnote 4]}.

Placing on the market

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

10. Qualifying Northern Ireland Goods

The Government committed to providing unfettered access for qualifying NI goods to the rest of the UK market after 1 January 2021. Products that can be placed on the market in NI in accordance with the legislation, as it applies to NI, can be sold in the rest of the UK without any additional approvals.

This means that products that are qualifying NI 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.

Read guidance on UKNI marking.

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 NI goods.

11. Approved Bodies

The UK established a new framework for UK based bodies to assess products against GB rules. Existing UK notified bodies were 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.

12. Enforcement

In GB 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 GB).

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 MSA 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 MSAs 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.

Read the Regulators’ Code.

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 MSA are liable to civil penalties enforced by the Secretary of State.

13. 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.
• CE marking – the conformity assessment marking used by the European Union. Certain goods (including simple pressure vessels) can be placed on the GB market bearing the CE marking. Where third party conformity assessment is required before the CE marking can be affixed, the assessment must be carried out by a Notified Body, not a UK Approved Body.
• Competent Authority – In GB local trading standards authorities are the competent authority responsible for enforcing the 2016 Regulations.

• 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.

• Economic Operator - means a manufacturer, authorised representative, importer or distributor

• Importer – A person established in the UK who places a 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) is now 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 UK Conformity Assessed UKCA) marking is the new UK conformity marking used for certain goods (including non-automatic weighing instruments being placed on the GB market.
• 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 NI 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 NI goods.

14. Footnotes

1. GB comprises England, Scotland and Wales. It does not include the Isle of Man or the Channel Islands. ↩

2. 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. ↩

3. 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. ↩

4. 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. ↩