The issue of Brexit is undoubtedly somewhat complex, one consequence of which has been creating uncertainty among economic operators. With the transition period coming to an end on 1 January 2021, and with the recent conclusion of the Trade and Cooperation Agreement of 24 December 2020 (PDF), we will now examine some of the future regulations governing CE/UKCA marks, as well as relevant dates arising from UK legislation concerning withdrawal from the EU.
In addition to the “European Union (Withdrawal) Act” of 2018 and 2020, the relevant statutes are, above all, the “Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations” of 2019 and 2020.
We should begin by pointing out that, in general, directly applicable EU legislation is to be implemented into national law and national legislation based on EU law is to remain in effect as amended “immediately before exit day” (cf. the section on “Retention of existing EU law” in the European Union (Withdrawal) Act 2018). The “EU Exit Web Archive” was created in order to preserve the relevant status of each statute.
Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019
Schedule 12 relates e.g. to amendments to the “Supply of Machinery (Safety) Regulations” 2008 and Paragraph 9 of this Schedule introduces a new clause, Regulation 12A, Paragraph 1 of which makes reference to the EU Machinery Directive, Directive 2006/42/EC.
In accordance with Regulation 12A(3), machinery which meets the EU requirements in accordance with Regulation 12A(2) is to be treated as meeting the UK requirements in effect at the time.
But an exception to this rule applies, in accordance with Regulation 12A(2) in conjunction with Regulation 12A(6), for machinery listed in Annex IV to the EU Machinery Directive for which no “designated standards” exist corresponding to the relevant EU harmonized standards. In short, this category is comprised of machinery which is currently subject to the EU type examination procedure and therefore requires the involvement of a “notified body” in the conformity assessment procedure. In accordance with Regulation 12A(7), however, this machinery is to be treated as specified in Regulation 12A(2) once the EU type examination is concluded.
The national requirements in the UK apply for all other machinery. This means, in particular, that the UKCA mark must be affixed, a UK declaration of conformity must be issued and, if necessary, a UK type examination must be conducted. Also see Schedule 12, beginning with Paragraph 6, in which Regulation 7 and subsequent Regulations of the “Supply of Machinery (Safety) Regulations” 2008 are amended accordingly.
Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2020
In accordance with Schedule 3 Paragraph 7(5), a new Regulation 12B is to be added to the “Supply of Machinery (Safety) Regulations” 2008 providing that Regulation 12A will cease to have effect 12 months after “IP completion day.”
In accordance with Section 39(19) of the “European Union (Withdrawal) Act” of 2020, “IP completion day” means 11 PM on 31 December 2020, which in turn means that the aforementioned Regulation 12A will expire at 11 PM on 31 December 2021, after which all the requirements of the amended “Supply of Machinery (Safety) Regulations” will take effect.
Conclusion
Based on the above, if the product is covered by a relevant statute, the following general system will be adhered to: for the period between 1 January 2021 and 31 December 2021, the CE mark may continue to be used in the UK if
- there is no need for a notified body to be involved in the conformity assessment procedure or
- the conformity assessment procedure prescribes the involvement of a notified body and a EU-notified body is used for the procedure.
However, if the involvement of a notified body is necessary in the conformity assessment procedure and a UK-notified body is used for this purpose, a UKCA mark generally has to be used as of 1 January 2021. This is also the case if the relevant legislation is amended after 1 January 2021, resulting in substantive deviations between the requirements in the EU and the UK.
Use of the UKCA mark will be mandatory in the UK after 31 December 2021: from that point on, CE marks will no longer have any relevance in the UK. UKCA marks may be used in the UK as of 1 January 2021, although these marks are not recognized in the EU.
We would also point out that special regulations apply with regard to Northern Ireland, but these regulations will not be examined at this point.