In this article, we set out some legislative background and context to the 2022 Regulations, highlight the key changes introduced by the 2022 Regulations and also touch on the procedural aspects surrounding this draft legislation – in particular the “sifting” process and “negative procedure”.
As set out in an Explanatory Memorandum to the 2022 Regulations, the main purpose of this secondary legislation is to provide businesses with additional time to transition to the post-Brexit UK conformity assessment marking (“UKCA”) regime requirements, in order to legally place products on the market in Great Britain. The 2022 Regulations also aim to correct other minor deficiencies in individual product regulations.
Although the UK Government announced guidance in June earlier this year that it intended to introduce an easement to UKCA labelling requirements, the publication of draft legislation in the form of the 2022 Regulations should hopefully provide more comfort and clarity to businesses that they now have more time to adjust to the new labelling regime.
Background – the 2019 Regulations
Upon Brexit, the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I 2019/696) (the “2019 Regulations”) came into effect, bringing an end to mutual recognition which previously allowed bodies established in the EU to undertake conformity assessment for products being placed anywhere on the EU market, including in Great Britain.
The 2019 Regulations brought in an independent UK system, establishing that any third-party conformity assessment must be carried out by a UK Approved Body, a UKCA marking is to replace the CE marking in demonstrating that a product is in conformity with UK requirements, and that an importer must be established in the UK to commercially supply a product on the Great Britain market.
Transitional arrangements were also included in the 2019 Regulations to support businesses with the post-Brexit transition:
Until 31 December 2022: businesses can continue placing goods that meet EU requirements on the Great Britain market.
Until 31 December 2022: “new” UK importers (who, prior to Brexit, had only been considered as distributors when supplying goods from the EU to the Great Britain market) are permitted to place their name and contact details on a label affixed to the product or an accompanying document, instead of the product itself.
Until 31 December 2023: the UKCA marking can be affixed using a label or accompanying document, instead of on the product itself.
In spite of these initial transitional periods, a number of concerns were raised amongst industry that many businesses would still struggle to comply with the new labelling requirements in time. It is in light of this industry feedback, as well as the continued impact of the COVID-19 pandemic on businesses, that BEIS has published the 2022 Regulations.
Key changes for businesses – the 2022 Regulations
The main changes brought about by the 2022 Regulations which businesses should be aware of are as follows:
Where a manufacturer has undertaken any steps under EU conformity assessment procedures in the period during which goods that meet EU requirements are recognised, but where those goods have not yet been placed on the Great Britain market, those steps will be taken to have been done under the equivalent UK conformity assessment procedures. This applies for as long as any certificate issued pursuant to the applicable conformity assessment procedure is valid, or until 31 December 2027, whichever is sooner.
Echoing previous UK government guidance, the 2022 Regulations also introduce further labelling easements:
Until 31 December 2025: businesses are permitted to affix the UKCA marking, and to include importer information for products imported from EEA countries (and in some cases Switzerland) on a label affixed to the product or an accompanying document, instead of on the product itself.
Until 31 December 2025: for cosmetic products, businesses are permitted to include details of an EU responsible person, instead of a UK responsible person.
It is hoped that these changes will reduce burdens and prevent cost increases for businesses transitioning to using the UKCA regime, and also reduce temporary and short-term market and supply chain disruption that could occur at the start of 2023 when CE-marked products are no longer recognised in Great Britain.
The 2022 Regulations have been laid in draft before each House of Parliament, and are currently undergoing a “sifting” process. This is a new procedure for negative statutory instruments relating to Brexit, and involves scrutinization by committees in each of the House of Commons and House of Lords as to whether or not the proposed negative statutory instrument requires active approval by Parliament (i.e. via the “affirmative procedure”) before passing into law. Each sifting committee has a ten-sitting-day scrutiny period to determine whether or not the statutory instrument should be “upgraded” to the affirmative procedure.
If by the end of its sitting period, neither sifting committee has made a recommendation for affirmative procedure, the statutory instrument will be formally laid before Parliament under the “negative procedure”. The 2022 Regulations will therefore automatically come into effect as law on the date set out in the statutory instrument, unless a motion to reject (or “annul”) it is agreed by either House within a set period (usually 40 sitting days).
Despite these procedural formalities, about 80% of statutory instruments are laid under the negative procedure, and a successful motion to annul a statutory instrument is rare. It is therefore expected that the 2022 Regulations will pass into law without annulment, particularly given that the key focus is to extend transitional periods for businesses post-Brexit.