Guidance on the regulations as they apply to products being supplied in or into Northern Ireland.
This Guide is for businesses placing non-automatic weighing instruments on the market in Northern Ireland.
While the Northern Ireland Protocol see footnote 1 (‘the Protocol’) is in force see footnote 2, Northern Ireland (“NI”) is aligning with relevant EU rules relating to the placing on the market of manufactured goods. Non-automatic weighing instruments placed on the NI market must therefore follow UK law as it applies to NI. The relevant law is The Non-Automatic Weighing Instruments Regulations 2016, which apply across the UK but some of their provisions apply differently in NI so that they continue to implement in NI Directive 2014/31/EU on non-automatic weighing instruments pursuant to the Protocol.
This Guide is designed to help you comply with The Non-Automatic Weighing Instruments Regulations 2016, as they apply in NI. References to “The 2016 Regulations” in this document are therefore references to The Non-Automatic Weighing Instruments Regulations 2016, as they apply in NI.
The 2016 Regulations set out the essential requirements which must be met before non-automatic weighing instruments can be placed on the NI market. The purpose of the legislation is to protect business and consumers from inaccurate non-automatic weighing instruments by requiring manufacturers to show how their instruments meet the ‘essential requirements’.
Since 16 July 2021, the EU Regulation on Market Surveillance 2019/1020 (referred to as “MSC” in this document) has replaced the market surveillance provisions in the Regulation on Accreditation and Market Surveillance 765/2008. For the duration of the Protocol, EU rules on goods apply in Northern Ireland, including MSC, which will be directly applicable in NI and applies in addition to the 2016 Regulations. MSC does not apply in Great Britain.
Article 4 of MSC requires that an economic operator responsible for compliance must be based in the EU (or NI) in order to lawfully place certain products on the market, including non-automatic weighing instruments. This responsible economic operator must fulfil certain compliance tasks. This Guide summarises key requirements of Article 4, but detailed guidance is available.
Read guidance on placing certain products on the Northern Ireland market
Non-automatic weighing instruments placed on the Great Britain (“GB”) market (GB comprises England, Scotland and Wales) must follow the separate rules for the GB market. If you are placing non-automatic weighing instruments on the GB market, you should read the relevant separate guidance.
Read guidance on the regulations in Great Britain
The government committed to providing unfettered access for qualifying NI goods to the rest of the UK market after 1 January 2021. Non-automatic weighing instruments that can be placed on the market in NI in accordance with the 2016 Regulations, as they apply in NI, can be sold in the rest of the UK without any additional approvals. The arrangements here are explained in detail in the separate guidance for placing non-automatic weighing instruments on the market in GB.
Directive 2014/31/EU on non-automatic weighing instruments was implemented into UK law with effect from 28 December 2016 by way of The Non-Automatic Weighing Instruments Regulations 2016. As such the Regulations apply to the whole of the UK.
The Directive will continue to apply in respect of NI, for as long as the Protocol on Ireland/ Northern Ireland is in force. However, the 2016 Regulations (as they apply in NI) also implement parts of the Protocol which have particular provisions in them, recognising that the UK has left the EU.
There is therefore one set of UK 2016 Regulations, but some of the provisions apply differently in NI and GB. References to the 2016 Regulations in this guidance are references to those Regulations as they apply NI.
The 2016 Regulations were amended by the Product Safety and Metrology etc. (Amendment) (Northern Ireland) (EU Exit) Regulations 2020 and the Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations 2020 to give effect to the Protocol as it relates to the placing on the NI market of non-automatic weighing instruments. See footnote 3
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 greengrocer’s 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.
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 Annex II to Directive 2014/31/EU) to demonstrate compliance with the essential requirements applicable to the regulated non-automatic weighing instrument in question (or that class of instrument) specified in Annex I to Directive 2014/31/EU.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.
If a non-automatic weighing instrument is offered for sale or supply to NI (or EU) consumers, it is considered to be placed on the EEA market. Article 4 requires that a responsible economic operator must be based in NI (or the EU) to carry out certain compliance tasks in respect of that instrument. This can be the manufacturer, an importer, a manufacturer’s authorised representative, or a fulfilment service. They must carry out the compliance tasks in Article 4 and their contact details must be indicated on the product or on its packaging, the parcel or an accompanying document.
Read guidance on placing certain products on the Northern Ireland market
5.Obligations of manufacturers
A manufacturer is a person who manufactures non-automatic weighing instruments, or has non-automatic weighing instruments designed or manufactured, and markets those non-automatic weighing instruments under their name or trademark.
The obligations of manufacturers in relation to regulated non-automatic weighing instruments include:
In addition, an importer (see below) or distributor which: (a) places a regulated non-automatic weighing instrument on the relevant 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.
If a non-automatic weighing instrument is offered for sale or supply to NI (or EU) consumers, it is considered to be placed on the EEA market. Article 4 requires that a responsible economic operator must be based in NI (or the EU) to carry out certain compliance tasks in respect of that instrument. This can be the manufacturer, the importer, a manufacturer’s authorised representative, or a fulfilment service. The responsible economic operator must:
The contact details of the responsible economic operator must be indicated on the product or on its packaging, the parcel or an accompanying document.
6.Obligations of authorised representatives
Manufacturers are able to appoint authorised representatives to perform certain tasks on their behalf under a written mandate.
An authorised representative appointed by a manufacturer to represent them in either the NI or EEA markets cannot be based in GB. This means that GB based authorised representatives cannot carry out tasks on the manufacturer’s behalf for products being placed on the NI or EEA markets.
An authorised representative based in NI can, under the 2016 Regulations as they apply in NI, carry out tasks on the manufacturer’s behalf for products placed on the NI or EEA markets.
An authorised representative must comply with all the duties imposed on the manufacturer under the 2016 Regulations that they are appointed by the manufacturer to perform. There are some duties that a manufacturer cannot mandate an authorised representative to perform (e.g. conformity assessment) and some that must form part of the authorised representatives mandate (e.g. retention of technical documentation).
The written mandate shall at least allow the authorised representative to perform the following tasks:
A manufacturer remains responsible for the proper performance of any obligations the authorised representative performs on their behalf.
Any references in the 2016 Regulations to the manufacturer are to be taken to include a reference to the authorised representative including in relation to penalties for failure to comply with those duties.
7.Obligations of importers
For the purposes of the 2016 Regulations as they apply in NI (pursuant to the Protocol), an importer is a business or person established in NI or the EEA who places non-automatic weighing instruments from outside of the EEA or NI on the NI or EEA market. Therefore, a business or person based in NI who is supplied with a product from GB will be an importer under the 2016 Regulations, if they then sell that product on the NI (or EEA) markets.
The obligations of importers in relation to regulated non-automatic weighing instruments include:
8.Obligations of distributors
A distributor is any person, other than the manufacturer or importer, who makes non-automatic weighing instruments available on the NI and EEA markets.
NI businesses which were distributors of non-automatic weighing instruments supplied to them from GB should now consider whether they are classified as importers under the 2016 Regulations and therefore what additional requirements they need to comply with – see section 7 above. An NI business placing a product from GB on the NI market does so as an importer, not as a distributor under the 2016 Regulations.
The obligations of distributors include:
If you placed an individual fully manufactured product on the EEA or the UK market (either in NI or GB) before 1 January 2021, you do not need to take any additional action. 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 took effect from 1 January 2021.
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:
The relevant economic operator (whether manufacturer, importer or distributor) bears the burden of proof for demonstrating that the good was placed on the market before 1 January 2021.
Where a non-automatic weighing instrument is being placed on the NI market, and the manufacturer chooses to have it conformity assessed by an EU recognised body, the marking for the NI and EEA markets continues to be the CE marking.
The CE marking can continue to be used for the GB market until 31 December 2022 see footnote 6, as long as all the other rules have been met. From 1 January 2023, the UKCA marking must be used for the GB market, but there are special rules under unfettered access that apply for qualifying NI goods.
For qualifying Northern Ireland goods, non-automatic weighing instruments meeting NI rules (the 2016 Regulations as they apply in NI), which are CE or both CE and UKNI marked, can be placed on the GB market from 1 January 2021 and on an ongoing basis thereafter (there is further information on the reasons for this below and this arrangement is explained further in the separate guide to placing non-automatic weighing instruments on the GB market).
An instrument that does not fall within the definition of qualifying NI goods will need to meet the GB rules, including being UKCA marked, if placed on the GB market after 31 December 2022.
From 1 January 2021, where the manufacturer chooses to have the non-automatic weighing instrument conformity assessed by a UK notified body, the CE marking must be accompanied by the UKNI marking. Products with the UKNI marking cannot be placed on the EEA market.
There is separate guidance on when and how to use the UKNI marking.
Read guidance on UKNI marking
Notified Bodies are independent organisations notified to the European Commission to carry out the procedures for conformity assessment and certification set out in the 2016 Regulations.
From 1 January 2021, all UK Notified Bodies will remain Notified Bodies for the purpose of CE marking products for the NI market. When these UK bodies are used for mandatory conformity assessment activity, then the manufacturer will need to affix both the CE and the UKNI markings. A product with both the CE and the UKNI markings cannot then be placed on the EEA market.
There is separate guidance on when and how to use the UKNI marking.
Read guidance on UKNI marking
A list of EU Notified Bodies can be found on the NANDO website. If a manufacturer uses a Notified Body from this list, then they apply only the CE marking to their product (not the CE UKNI marking).
Access the list of UK Notified Bodies
12.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. Non-automatic weighing instruments that can be placed on the market in NI in accordance with the 2016 Regulations, as it applies in NI, can be sold in the rest of the UK without any additional approvals. The guide to placing non-automatic weighing instruments on the GB market has further details on these arrangements.
Read guidance on the regulations in Northern Ireland
The UK market surveillance authority for regulated non-automatic weighing instruments is the Secretary of State with enforcement action carried out by the Office for Product Safety and Standards (OPSS). The 2016 Regulations provide the power to the market surveillance authority to take action against economic operators for products that are not in conformity with the Regulations. There are requirements on economic operators to co-operate with the competent authority as appropriate on request.
The UK market surveillance authority will take all appropriate measures to withdraw from the market or to prohibit and restrict the supply of regulated non-automatic weighing instruments which present a risk in relation to any regulated purpose.
In NI the Department for the Economy has a duty to enforce the 2016 Regulations (other than Part 7).
The 2016 Regulations also provide powers to the UK market surveillance authority to enforce the Regulations and RAMS (Regulation (EC 765/2008, which sets out requirements for market surveillance of products).
Enforcement authorities are required under the 2016 Regulations to take all appropriate measures to withdraw or recall from the NI market or to prohibit, and restrict the supply of products bearing CE Marking which may endanger the health and safety of persons, property or the environment if the relevant economic operator does not take adequate corrective action within a reasonable period. Under the safeguard procedure, the UK must inform the European Commission and EU Member States immediately of any enforcement action taken indicating the reasons justifying the action. This will enable Member States to take action against similar products placed on the market on their territories. Similarly, if an EEA State initiates the procedure with respect to action taken on their territories, certain actions are required of the UK market surveillance authority. The European Commission will determine whether the action taken is justified; if so the UK market surveillance authority must take necessary measures to ensure the non-automatic weighing instrument is withdrawn from the market without delay.
OPSS 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
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 notified 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.Where to find out more about Directive 2014/31/EU
Access guidance from the European Commission
The European Commission’s ‘Blue Guide’ aims to give a better understanding of EU product rules and to their application across different sectors and throughout the EU single market.
Access the Blue Guide from the European Commission
This must be kept by the manufacturer for a period of ten years from day after the day on which the product was placed on the NI market. This declaration must be made available to the enforcing authority upon request.
1: The Protocol on Ireland/Northern Ireland (also known as ‘The Northern Ireland Protocol’ and referred to in this document as ‘the Protocol’.
2: It should be noted that the Government is seeking to find a new balance in operating the Protocol, in order to place it on a more sustainable footing. These proposals are set out in the Government’s July 2021 Command Paper (Northern Ireland Protocol: the way forward). This guidance will be updated to account for any changes.
3: In 2019, the 2016 Regulations were amended by the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 to fix any deficiencies that would arise from the UK leaving the EU (such as references to EU institutions) and to make specific provision for the UK market. The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 were then 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 (with the exception of those that amend the Hallmarking Act 1973 and those that amend or revoke retained direct EU legislation), in support of implementing the Protocol.
4: The form of the UK(NI) indication is set out in Schedule 1 to the Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations 2020.
5: When conformity assessment has been carried out by a UK notified body, the UKNI marking (also known as the UK(NI) indication) must also be affixed.
6: On 24 August 2021 the Government announced the transition period for UKCA marking would be extended until 31 December 2022. Legislation will be placed before Parliament in the autumn to give effect to this.
7: Fulfilment service is defined in Article 3 of MSC and for the purposes of MSC only is considered an economic operator. There are no specific obligations on fulfilment services under the 2016 Regulations.