EXPLANATORY MEMORANDUM TO
THE PRODUCT SAFETY AND METROLOGY ETC. (AMENDMENT)
REGULATIONS 2021
2021 No. [XXXX]
1. Introduction
1.1 This explanatory memorandum has been prepared by the Department for Business, Energy and Industrial Strategy (the Department) and is laid before Parliament by Act. 1.2 This memorandum contains information for the Sifting Committees.
2. Purpose of the instrument
2.1 There are two objectives of this statutory instrument (SI): firstly, it makes provisions to ensure businesses have sufficient time to comply with new UK conformity assessment marking (UKCA) requirements in order to legally place products on the market in Great Britain (England and Wales and Scotland). Secondly, this instrument makes necessary technical amendments to certain product safety and metrology legislation so that it works fully as intended. 2.2 To this end this instrument: i. Extends the UK’s acceptance of certain products meeting EU requirements and markings until 31 December 2022 for products placed on the market in Great Britain; ii. Extends existing easements allowing businesses to affix the UKCA marking using a label or accompanying document until 31 December 2023; and iii. Amends some provisions of specific product safety and metrology legislation, which have previously been amended following the European Union (Withdrawal) Act 2018, to ensure those provisions work fully as intended.
3. Matters of special interest to Parliament
Matters of special interest to the Sifting Committees 3.1 This instrument is being laid for sifting by the Sifting Committees. It is being laid under the negative procedure because the amendments it makes are technical in nature or simply extend transitory periods for provisions that have already been agreed. The amendments are limited to extending acceptance of certain products meeting EU requirements and markings, extending existing labelling easements, and ensuring product safety and metrology regulations operate fully as intended (as detailed in section 2 and section 7 of this Memorandum).
4. Extent and Territorial Application
4.1 The territorial extent of this instrument varies between provisions. 4.2 The provisions to extend acceptance of certain products meeting EU requirements and markings on the market in Great Britain until 31 December 2022, and the
2
CO/EM/2021.2
provisions extending the period of existing easements allowing businesses to affix the UKCA marking using a label or accompanying document unit 31 December 2023, extend to England, Wales, and Scotland only. 4.3 The amendments to specific product safety and metrology legislation vary between provisions. In part they extend to: i. England, Wales and Scotland only; ii. England and Wales and Scotland and Northern Ireland; and iii. Northern Ireland only. 4.4 The territorial application of this instrument is the same as its extent.
5. European Convention on Human Rights
5.1 As this instrument is subject to negative resolution procedure and does not amend primary legislation, no statement is required.
6. Legislative Context
6.1 The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 SI No. 696 (the 2019 Regulations) amended a number of pieces of legislation, including provisions to end mutual recognition of EU notified bodies carrying out conformity assessment, and goods meeting EU requirements (such as the CE marking) in Great Britain. They set out a new system whereby only approved bodies established in the UK could test and certify products for the market in Great Britain, where third-party conformity assessment is required. They also introduced the new UKCA marking to replace the CE marking for goods to be placed on the market in Great Britain. 6.2 To support businesses in transitioning to the new regime and mitigate potential disruption to the supply of certain goods on the market in Great Britain following the UK’s withdrawal from the EU, the Regulations 2019 introduced a transitional arrangement allowing for the UK’s continued acceptance of certain products meeting EU requirements and markings for 12 months from the Implementation Period (IP) completion day, until 11pm on 31 December 2021, which applied to most goods covered by the new UKCA marking regime. Additionally, they provided easements whereby UKCA marking could be affixed using a label or accompanying document for a 12-month period after the UK’s acceptance of certain products meeting EU requirements and markings ended, until 31 December 2022, ensuring businesses had sufficient time to fully comply with the new UKCA requirements. 6.3 They also corrected other deficiencies and introduced provision ensuring access to the market in Great Britain of qualifying Northern Ireland goods. To introduce some of these changes, the Regulations 2019 were themselves amended by other statutory instruments before it came into force, including by S.I. 2020/1460 (see, in particular Schedule 3) (the 2020 Regulations).
7. Policy background
What is being done and why? 7.1 This instrument extends the UK’s acceptance of certain products meeting EU requirements and markings for products placed on the market in Great
3
CO/EM/2021.2
Britain until 31 December 2022, and extends existing easements allowing businesses to affix the UKCA marking using a label or accompanying document until 31 December 2023. It also amends specific product safety and metrology legislation, previously amended following the EU Withdrawal Act, to ensure those provisions work fully as intended. 7.2 The extension provisions of this instrument, contained in Part 3, regulations 7 and 8 and Schedules 1 and 2, are being introduced as a one-off measure to take account of the unexpected challenges businesses have faced due to the COVID-19 pandemic, which have affected readiness to transition to the new UKCA regime. This instrument will give effect to the Government’s announcement made on 24 August 2021, providing businesses with an additional year to start using the new UKCA marking. Ongoing engagement with businesses (as outlined in section 10 of this memorandum) also indicates that additional product testing capacity is needed in some sectors to meet market demand. 7.3 Without these amendments the acceptance of certain products meeting EU requirements and markings would end on 31 December 2021, as is currently set out in legislation. This could have public health and safety implications due to businesses placing non-compliant, but otherwise safe, goods on the market in Great Britain, in turn creating challenges for market surveillance. It could also cause potential disruption to supply chains for a wide range of sectors, including personal protective equipment used by the health service, as businesses would not legally be able to place these products on the market in Great Britain. Therefore, these provisions ensure there is sufficient time for businesses and manufacturers to transition to the new UKCA marking requirements and mitigate the potential economic impacts of disruption, given the challenging and unexpected circumstances of the past year. 7.4 Additionally, this instrument makes necessary technical amendments to some product safety and metrology regulations (which require products to meet certain essential safety and accuracy requirements so that only safe and accurate products are on the market). These amendments, which are detailed below, make technical amendments to earlier EU Exit legislation, ensuring the regulations work as fully intended and providing business with the necessary clarity. 7.5 The Non-automatic Weighing Instruments Regulations 2016 and the Measuring Instruments Regulations 2016 ensure that only accurate instruments are placed on the market and when they are used to measure for regulated purposes, that they remain accurate in use. These Regulations are being amended to clarify procedure for instruments that were lawfully placed on the market by meeting EU requirements (whether before or after the IP completion day), and no longer meet requirements, to ensure that their accuracy is maintained once they have been put into service. For weighing and measuring instruments used for regulated purposes, such as trade use, there is an established procedure of disqualification and requalification already set out in the Regulations as an alternative to taking formal enforcement action where the instruments are found to be non-compliant. This Instrument ensures that the processes of disqualification and re-qualification will continue smoothly for instruments both in Northern Ireland and in Great Britain, given the changes arising out of the UK’s exit from the EU. 7.6 It also sets out the disqualification and re-qualification markings in legislation for transparency, and introduces information that must accompany the markings. These changes are necessary because without amendment, the provisions
4
CO/EM/2021.2
do not take into account the change from notified bodies to approved bodies for the market in Great Britain and do not distinguish between requalification for the market of Great Britain and the market of Northern Ireland. 7.7 This instrument also includes a couple of very minor reference updates (see regulations 9 and 10) related to the UK’s withdrawal from the EU. In the Supply of Machinery (Safety) Regulations 2008, it removes a reference to texts published in the Official Journal of the EU as this is no longer required. Similar references in the Pressure Equipment (Safety) Regulations 2016, are also changed from ‘Notified Body’ to ‘Approved Body’. 7.8 It amends the Radio Equipment Regulations 2017 and related retained legislation as they apply in Great Britain to clarify what information must be included and where in relation to authorisations or restrictions of use in Great Britain (see regulation 13). The 2017 Regulations are also amended as they apply in Northern Ireland to clarify that an authorised representative can draw up the EU declaration of conformity and affix the CE marking, for products placed on the NI market, in line with the provisions of the relevant EU legislation (see regulation 16).
Explanations
What did any law do before the changes to be made by this instrument? 7.9 The UK’s legislative framework for product safety and legal metrology operates via regulations covering specific product sectors (such as toys, electrical equipment or weighing and measuring instruments) or general safety regulations which apply where there is no product-specific product regulation. These regulations are there to provide protection for UK consumers and other end users, and to ensure only safe or accurate products are placed on the market. They also make provisions to correct or remove unsafe or inaccurate products from the market so that consumers and other end users have reassurance about the safety and accuracy of products. 7.10 To prepare for leaving the EU and the end of the Implementation Period (IP), the Department introduced a package of legislation, with the aim of ensuring the continuation of an effective and functioning domestic regulatory framework for product safety and legal metrology, as well as compliance with the Withdrawal Agreement and the Protocol on Ireland/Northern Ireland in the Withdrawal Agreement. The 2019 Regulations were a significant element of this package of legislation, amending the UK’s product safety and legal metrology regulations as they apply to Great Britain, in addition to other retained EU law, to achieve these objectives. 7.11 Subsequently, the 2020 Regulations implemented changes to earlier EU Exit legislation (including the 2019 Regulations) and directly to the UK’s product safety and metrology regulations. The 2020 Regulations included provisions which set a date to end continued acceptance of certain products meeting EU requirements and markings to 12 months from end of the IP, until 31 December 2021, and labelling easements to 12 months beyond that date, until 31 December 2022. They also made changes required to support implementation of the Withdrawal Agreement. In particular, the 2020 Regulations made provision implementing the Protocol on Ireland/Northern Ireland, which provides that Northern Ireland continues to follow some EU law, including product safety and metrology legislation. With regard to the Radio Equipment Regulations 2017, these were made under section 2(2) of the
5
CO/EM/2021.2
European Communities Act 1972. They have been amended by the 2019 Regulations, which included inserting regulation 18C, which is a power to amend regulation 14.
Why is it being changed? 7.12 The extension provisions of this instrument are being introduced to ensure businesses have sufficient time to comply with new UKCA marking requirements, recognising the impact of the COVID-19 pandemic on readiness to transition to the new regime. There is no change in policy as acceptance of products meeting EU requirements remains time-limited, however, additional time is needed in view of the unexpected challenges to businesses caused by COVID-19 preventing them from adapting to the new requirements of the UKCA regime. 7.13 The technical amendments to some product safety and metrology regulations are being made to ensure those regulations operate fully as intended for the end of the IP.
What will it now do? 7.14 This instrument provides sufficient time for businesses to comply with UKCA marking requirements by extending acceptance of certain products meeting EU requirements and markings by 12 months until 31 December 2022, and easements allowing businesses to affix the UKCA marking on a label or accompanying document by 12 months until 31 December 2023. 7.15 Additionally, technical amendments being made to the underlying regulations will provide the necessary clarity and certainty for business, where references or provisions made by earlier EU Exit legislation did not deliver this or work fully as intended.
8. European Union Withdrawal and Future Relationship
8.1 This instrument is partly being made using the power in section 8 of the European Union (Withdrawal) Act 2018 in order to address failures of retained EU law to operate effectively or other deficiencies arising from the withdrawal of the UK from the EU. The instrument is also partly made under the power in section 8C of and in paragraph 21 of Schedule 7 to that Act. In accordance with the requirements of that Act, the Minister has made the relevant statements as detailed in Part 2 of the Annex to this Explanatory Memorandum. 8.2 Alongside the EU (Withdrawal) Act 2018 powers the instrument is also being made under regulation 18C of the Radio Equipment Regulations 2017. In accordance with the requirements of the European Union (Withdrawal) Act 2018 the Minister has made a statement setting out the good reasons for making these changes.
9. Consolidation
9.1 There are no plans to consolidate the legislation amended by this instrument.
10. Consultation outcome
10.1 A formal consultation has not been completed for this instrument. The Department chose not to undertake a public consultation given that its provisions are limited to extending existing transitional arrangements each by a further 12 months. Additionally, it makes only necessary technical amendments to product safety and metrology legislation to address failures in retained EU and UK law, ensuring it
6
CO/EM/2021.2
operates effectively as a result of EU Exit and implements the requirements of the Withdrawal Agreement, including the Protocol on Ireland/Northern Ireland. 10.2 The Department has, however, undertaken extensive engagement with a variety of stakeholders, including manufacturers and Trade Associations, and UK approved bodies across a range of sectors to monitor business readiness and product testing capacity in the UK, which has and continues to inform policy development.
11. Guidance
11.1 Following the Government’s announcement on 24 August 2021 to extend transitional arrangements each by 12 months, the Department updated guidance on 24 August 2021 regarding how to use the UKCA marking for businesses placing products on the market in Great Britain on the ‘Brexit: business guidance’ section of GOV.UK (https://www.gov.uk/guidance/using-the-ukca-marking). 11.2 There is guidance on the UK’s product safety and metrology framework, provided to support businesses, enforcement agencies and consumers, which can be found on the Office for Product Safety and Standards section of GOV.UK (https://www.gov.uk/government/organisations/office-for-product-safety-and-standards).
12. Impact
12.1 There is no, or no significant, impact on business, charities or voluntary bodies.
12.2 There is no, or no significant, impact on the public sector. 12.3 A full Impact Assessment has not been prepared for this instrument because the annual net costs will be de-minimis. 12.4 The impact of the 2020 Regulations, which in part amended the 2019 Regulations to set an end date for continued acceptance of certain products meeting EU requirements and markings (where there was previously no time limit) and introduced the provision for labelling easements, was classified as de-minimis. 12.5 This instrument is making a relatively smaller change than the earlier amendments to the 2020 Regulations (i.e. an additional 12-month period vs setting a 12-month period from an undefined time-limited period). The measure will impact a subset of the original business population in scope of the 2020 Regulations as some businesses will have already implemented the changes. Therefore, the annual net costs for this instrument are also assessed to be de-minimis. 12.6 The counterfactual in our assessment, is that businesses will have to comply with new UKCA requirements associated with ending acceptance of certain products meeting EU requirements and markings on the market in Great Britain by the end of 2021. However, because of unexpected challenges businesses have faced due to COVID-19, this has affected readiness to transition to the UK’s new regime. Our engagement with stakeholders suggests that some businesses have not complied with the changes yet. Because of their lack of readiness, and product testing capacity in some sectors, they may not be ready to do so for the end of the year, which could cause some potential market disruption with wider public health, safety, and economic impacts. 12.7 Similarly to the de-minimis impact assessment for the 2020 Regulations, three key components feature in the assessment of this instrument: acquiring conformity assessment certificates from UK bodies if they are currently with non-UK bodies (i.e.,
7
CO/EM/2021.2
transferring certificates to UK bodies); changes to product safety marking and labelling; and costs associated with businesses familiarising themselves with the changes in legislation. 12.8 For conformity assessment certification transfers, this will be a net benefit to businesses because businesses who still hold conformity assessment certificates with EU conformity assessment bodies will have an additional 12 months to transfer them to UK bodies carrying out conformity assessment. For product marking and labelling changes, there will also be a net benefit to businesses. This is because some businesses will have their normal product development cycle in 2022, meaning that they will not incur additional costs of adding the marking changes outside of their normal cycle. Also, manufacturers can make use of removable marking and labelling for an additional year to the end of 2023. Finally, for familiarisation costs, this will be a net cost to businesses. Overall, the combination of the impact of these three components results in annual net costs that are de-minimis. 12.9 Without this instrument, there may also be impacts and costs for businesses associated with possible market disruption, for example being unable to place goods on the market and the wider impacts this can have, like reduced product availability and/or higher prices. Despite significant engagement with businesses and other stakeholders it has not be possible to quantify these impacts due to uncertainties over the scale of products affected and the extent to which sales would be forgone rather than delayed.
13. Regulating small business
13.1 The legislation applies to activities that are undertaken by small businesses. 13.2 No specific action is proposed to minimise the regulatory burdens on small businesses. 13.3 The legal requirements on the industry do not differentiate between business in terms of their size and they are dependent on the type and nature of products being manufactured and placed on the market. Therefore, we are unable to take any mitigating actions to reduce burdens on small business.
14. Monitoring & review
14.1 The Department does not intend to monitor this instrument.
14.2 As this instrument is made under the European Union (Withdrawal) Act 2018, no review clause is required. The Radio Equipment Regulations 2017 already include a review clause in regulation 76 and therefore section 28 of the Small Business Enterprise and Employment Act 2015 do not apply (see s. 28(3)(e)).
15. Contact
15.1 Matthew Ireland at the Department for Business, Energy and Industrial Strategy Telephone: 07786432748 or email: OPSSlegislation@beis.gov.uk can be contacted with any queries regarding this instrument. 15.2 Rosanna Wong, Deputy Director Trade and Investment Negotiations (Goods), at the Department for Business, Energy and Industrial Strategy can confirm that this Explanatory Memorandum meets the required standard. 15.3 Paul Scully MP, Parliamentary Under Secretary of State (Minister for Small Business, Consumers and Labour Markets) at the Department for Business, Energy and
8
CO/EM/2021.2
Industrial Strategy can confirm that this Explanatory Memorandum meets the required standard.
9
CO/EM/2021.2
Annex
Statements under the European Union (Withdrawal) Act 2018 and the European Union (Future Relationship) Act 2020
Part 1A
Table of Statements under the 2018 Act
This table sets out the statements that may be required under the 2018 Act.
Statement
Where the requirement sits
To whom it applies
What it requires
Sifting
Paragraphs 3(3), 3(7) and 17(3) and 17(7) of Schedule 7
Ministers of the Crown exercising sections 8(1) or 23(1) to make a Negative SI
Explain why the instrument should be subject to the negative procedure and, if applicable, why they disagree with the recommendation(s) of the SLSC/Sifting Committees
Appropriate-
ness
Sub-paragraph (2) of paragraph 28, Schedule 7
Ministers of the Crown exercising sections 8(1) or 23(1) or jointly exercising powers in Schedule 2
A statement that the SI does no more than is appropriate.
Good Reasons
Sub-paragraph (3) of paragraph 28, Schedule 7
Ministers of the Crown exercising sections 8(1) or 23(1) or jointly exercising powers in Schedule 2
Explain the good reasons for making the instrument and that what is being done is a reasonable course of action.
Equalities
Sub-paragraphs (4) and (5) of paragraph 28, Schedule 7
Ministers of the Crown exercising sections 8(1) or 23(1) or jointly exercising powers in Schedule 2
Explain what, if any, amendment, repeals or revocations are being made to the Equalities Acts 2006 and 2010 and legislation made under them.
State that the Minister has had due regard to the need to eliminate discrimination and other conduct prohibited under the Equality Act 2010.
Explanations
Sub-paragraph (6) of paragraph 28, Schedule 7
Ministers of the Crown exercising sections 8(1) or 23(1) or jointly exercising powers in Schedule 2
In addition to the statutory obligation the Government has made a political commitment to include these statements alongside all EUWA SIs
Explain the instrument, identify the relevant law before IP completion day, explain the instrument’s effect on retained EU law and give information about the purpose of the instrument, e.g., whether minor or technical changes only are intended to the EU retained law.
Criminal offences
Sub-paragraphs (3) and (7) of paragraph 28, Schedule 7
Ministers of the Crown exercising sections 8(1) or
Set out