Standards and EU Exit

The UK left the European Union on 31 January 2020. We are close to end of the EU exit transition period, on 31 December 2020, after which point the UK, with exceptions in Northern Ireland, will no longer automatically align with EU rules or obligations.  The UK government is currently negotiating a trade agreement with the EU which will set out our future relationship.

BSI works closely with government departments to advise them about the way standards can support regulations. In addition to our regular engagement, BSI advises government on standards in trade negotiations. Scott Steedman, BSI’s Director of Standards, sits on the Strategic Trade Advisory Group, the government’s stakeholder forum on trade as the representative for standards and consumer protection. More information on our trade policy activity can be found through the link at the bottom of this page.


Product regulation in the UK from the end of the EU exit transition period: UKCA marking

This page is provided as information and should not be regarded as legal advice. The position may change should the UK and EU agree a future relationship deal by the end of 2020.

This page provides information on issues concerning standards. Should you require advice on regulatory issues, for example product marking, you may wish to approach government, a notified/approved body, or an enforcement body, like a local authority trading standards department, the Health and Safety Executive or the Office for Product Safety and Standards. If you are a BSI customer looking for advice on conformity assessment, you should visit the BSI product certification or medical device web pages.

Product regulation in the UK from 1/1/21: UKCA marking and designated standards 

From the end of the EU exit transition period, new regulations will apply for the UK market that update EU CE marking and similar legislation, including general product safety regulation. The government has made new laws to amend existing product regulations – see ‘Further information' for links to the government website.

The new product regulations split the UK territory into two parts: Great Britain (England, Scotland and Wales) and Northern Ireland. The approach to trade within the UK and devolution is set out in the UK Internal Market Bill.  

Product regulation in Great Britain: UKCA marking

Products placed on the market in Great Britain that are covered by relevant UK product regulatory requirements will need to bear the UKCA marking from the end of 2020: the UKCA marking will replace the CE marking.

As an exception to the UKCA marking rules, products legitimately bearing the CE marking will continue to be accepted in the UK until the end of 2021 (with some specific exceptions, such as 30 June 2023 for medical devices), provided neither UK nor EU legislation changes in the meantime.

Designated standards in Great Britain

UK regulation that applies in Great Britain from 1 January 2021 permits the relevant Secretary of State to ‘designate’ standards for regulatory conformity purposes. As part of the new UK product regulation model, this replaces the European Commission’s citation of harmonised European standards in the Official Journal of the European Union. Where government designates standards, their use will confer on the product a legal advantage, usually a presumption of conformity with relevant aspects of UKCA marking regulation.

UK has stated that it will designate for relevant UK regulations all harmonised European standards that are currently cited in the OJEU from 1 January. Government has published the details of designated standards through a listing here.

BSI is working with government to provide the information necessary for the development and management of a system for the designation of standards. For example, BSI will help government to update the list of designated standards when new or revised European harmonised standards are agreed.

Content of designated standards

Government will designate several thousand standards from the end of this year and users of these standards need to understand their new relationship to UK laws. While new/revised standards for designation will in due course contain information about the new UK regulations for Great Britain and for Northern Ireland within the national foreword, this will not be the case immediately.

The table below shows how text in the European foreword and annexes, or similar text, should be read by users seeking to understand how a standard relates to UK regulations, where there is no additional information in the national foreword.

Users should always check the UK government website to see if a standard is designated.

 

Informative text in the European standard

 

Relevance for UKCA marking in the Great Britain market from 1/1/21*

 

Relevance for Northern Ireland market from 1/1/21**

European foreword

 

“This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU directive XXX.

 

For relationship with EU Directive XXX, see informative Annex ZA, which is an integral part of this European Standard.”

 

This text in the European foreword of the standard indicates that this is a harmonised European standard. It may therefore be a designated standard for UK conformity purposes. Please check the table of regulations to see whether standards are designated under the named regulation (see section Relationship between UK and EU regulation’) and then visit the gov.uk website  to see if this particular standard is designated (BSI will provide the link when it is available).

 

No change from the relationship before the end of the transition period. 

           

European standard annex ZA or ZZ

“Clauses of this European Standard addressing essential requirements or other provisions of EU Directives.

 

This European standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements

of the New Approach Directive XXX.

 

Once this European Standard is cited in the Official Journal of the European Union under that Directive compliance with the clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this European Standard, a presumption of conformity with the corresponding Essential

Requirements of that Directive and associated EFTA regulations.

 

Table ZA.1 — Relationship between this European Standard and the Essential Requirements of EU Directive XXX

 

UK government has not amended the essential requirements of the legislation, therefore the table in this annex should be read in the same way for UK law as prior to the end of the transition period. Please refer to the UK implementing regulations (see section ‘Relationship between UK and EU regulation’) and how they bring the EU directive into UK law to understand this relationship (i.e. compare the references of the clauses of EU directive to the UK regulations).

 

If the EU legislation is a regulation rather than a directive (ie directly applicable on Member States) there is no UK implementing measure for the essential requirements and the references in the annex will therefore be the same as in the table.

 

 

No change from the relationship before the end of the transition period. 

           

Text in a European standard referencing EU regulation

Some European standards contain text that refers to EU regulation. Examples could be, “According to Directive XXX the following safety requirements apply regarding…”; “The modification was introduced after it had been requested that the standard should reflect the exact wording of Directive XXX which includes the words…”; “Directive XXX includes additional specific safety requirements for…”.

 

 

When the harmonized European standard references EU regulation, this should be read as referring to the appropriate UK legislation, in line with the section Relationship between UK and EU regulation’.

 

No change from the relationship before the end of the transition period. 

*Note: CE marking is accepted in Great Britain until 31/12/2020, longer for certain legislation 

**Note: this refers to regulation referenced in the Northern Ireland Protocol, where the UK will continue to apply EU law in Northern Ireland after the end of the EU exit transition period.

Product regulation in Northern Ireland

Unlike Great Britain, Northern Ireland will continue to follow EU single market rules in 2021 and beyond for certain regulations including CE marking and general product safety, subject to periodic consent from the Northern Ireland Assembly. 

Products placed on the market in NI will still therefore have to bear the CE marking. A new combined marking, the CE marking and the UKNI marking together, will be used if UK conformity assessment bodies have been used as part of the conformity process. The combined marking will allow products to access the market of Northern Ireland, not to the European Union. 

Harmonised European standards that are cited in the OJEU will therefore also continue to be used for regulatory conformity in Northern Ireland. See ‘further information’ for links to those standards.

The references in the European foreword of standards and in the Annex ZA or ZZ to EU law should therefore continue to be read as prior to the end of the transition period.  

‘Qualifying goods’ placed on the NI market will benefit from ‘unfettered access’ to the Great Britain market – see government advice in ‘further information’.

Relationship between EU and UK regulation 

This table links EU legislation to the UK regulations that bring them into UK law where BSI expects government to designate standards. UK government has amended these UK regulations to bring in the changes required to ensure that they can operate as needed after the end of the transition period, in the light of the new regulatory positions in the different parts of the UK. These new provisions include the power for the Secretary of State to designate standards for conformity purposes. See ‘further information’ for more details about the amendments to these laws on government web pages.

EU

 

 

UK

General product safety directive

 2001/95/EC

 

 

General Product Safety Regulations 2005

2005 No. 1803

Machinery directive

2006/42/EC

 

 

Supply of Machinery (Safety) Regulations 2008

2008 No. 1597

Toy safety directive

2009/48/EC

 

 

Toys (Safety) Regulations 2011

2011 No. 1881

Pyrotechnics directive

2013/29/EU

 

 

Pyrotechnic Articles (Safety) Regulations 2015

2015 No. 1553

Electromagnetic compatibility directive

2014/30/EU

 

 

Electromagnetic Compatibility Regulations 2016

2016 No. 1091

Lifts directive

2014/33/EU

 

 

Lifts Regulations 2016

2016 No. 1093

Low voltage electrical equipment directive

2014/35/EU

 

 

Electrical Equipment (Safety) Regulations 2016

2016 No. 1101

Non-automatic weighing instruments directive

2014/31/EU

 

 

Non-automatic Weighing Instruments Regulations 2016

2016 No. 1152

Measuring instruments directive

2014/32/EU

 

 

The Measuring Instruments Regulations 2016

2016 No. 1153

Recreational craft directive

2013/53/EU

 

 

Recreational Craft Regulations 2017

2017 No. 737

Radio equipment directive

2014/53/EU

 

 

Radio Equipment Regulations 2017

2017 No. 1206

Simple pressure vessels directive

2014/29/EU

 

 

Simple Pressure Vessels (Safety) Regulations 2016

2016 No. 1092

Pressure equipment directive

2014/68/EU

 

 

Pressure Equipment (Safety) Regulations 2016

2016 No. 1105

Medical devices directive

93/42/EEC

 

 

The Medical Devices Regulations 2002

2002 No. 618

 

In-vitro diagnostic devices directive

98/79/EC

 

 

The Medical Devices Regulations 2002

2002 No. 618

Active implantable medical devices directive

90/385/EEC

 

 

The Medical Devices Regulations 2002

2002 No. 618

Construction products regulation

305/2011

 

 

Regulation (EU) 305/2011 on construction products (as it has effect in domestic law)

PPE regulation

2016/425

 

 

Regulation (EU) 2016/425 on personal protective equipment (as it has effect in domestic law)

Gas appliances regulation

2016/426

 

Regulation (EU) 2016/426 on appliances burning gaseous fuels (as it has effect in domestic law)

Product labelling and marking other than UKCA

The end of the EU exit transition period will amend legislation that requires product marking and labelling beyond the UKCA marking regime. This will impact both businesses and consumers. There may be new requirements that cover the whole of the UK, Great Britain and Northern Ireland separately or the constituent nations of the UK individually. 

Businesses and consumers should check the relevant parts of the government website for more information. Businesses can also contact their trade association or relevant enforcement body as appropriate. Consumers can seek advice through trusted consumer organizations.  

In some instances, standards may be used to show conformity with regulations. The regulations should be clear about which standards are relevant and their role in demonstrating conformity. Government or enforcement bodies can offer more advice about compliance with regulation. If you have specific questions about the role of standards, contact us using the email address below.

The role of National Standards Body post transition period

Under the direction of UK stakeholders including government, BSI has for many years sought wherever possible to develop international standards first, with UK leadership or influence.

We will continue to promote and enable UK stakeholder leadership in international and European regional standardization. BSI will work with government on the role of standards as an enabler of trade and international competitiveness. We will optimize the participation of UK stakeholders through BSI’s membership of ISO, IEC, CEN, CENELEC and ETSI and our support for UK government in the ITU, always recognizing the need for flexibility where standards are used to support compliance with national regulation.

CEN and CENELEC membership

BSI's membership of CEN and CENELEC continues beyond the end of the EU exit transition period. The General Assemblies of CEN and CENLELEC have set a timeframe to update the organizations’ statutes in response to the UK’s departure from the EU. This will run until the end of 2021, enabling the UK’s continued influence over standards produced in CEN and CENELEC, providing stability and certainty for our stakeholders. BSI is confident its membership will continue beyond that time and we are working with the other CEN and CENELEC members to ensure the best outcome for the UK.

CEN and CENELEC voting procedure

From 1 July 2020, BSI has been classed as a non-EEA member of CEN and CENELEC. This affects a few specific voting situations. In the types of vote listed in subclause 6.1.4 of CEN/CENELEC internal regulations part 2 (e.g. new or amended European standards), weighted voting is applied. In the first stage, votes from all members are counted and the proposal is adopted if the weighted voting criteria are met. There are no changes to the UK in this stage; our weighting remains the same. However, if the proposal is not adopted in the first stage the votes of only the EEA countries are counted separately. In this situation, the UK’s vote would not be counted.

Therefore, if the proposal passes stage 1, all members are obliged to implement it, including BSI. If the proposal fails stage 1 but passes stage 2, all EEA members are obliged to implement it, along with any non-EEA members that voted positively. This means that if BSI voted negatively, it would not be obliged to implement the decision. If BSI voted positively, we would be obliged to implement the decision. If the proposal fails stage 2, there is no further action.

Other standards organizations

BSI’s membership of ETSI continues and will not undergo a statute review as membership arrangements are unaffected by the UK’s exit from the EU. BSI’s voting on ETSI ENs has also moved to the non-EEA category.

BSI’s membership of the international standards organisations ISO and IEC is unaffected by the UK’s exit from the EU. BSI does not manage UK activity with ITU, which is the responsibility of UK government.