[expand title=”Are there any significant changes to my health, safety and environmental duties that I should be aware of?” tag=”h4″]
In short, not much.
There are no changes in the way you need to manage the health and safety of your employees or anybody else affected by your business. Similarly, there are no changes in the environmental standards to which you must manage your business.
There are however some procedural changes concerning registration and import or export of certain products, in particular in relation to CE marking, and concerning registration and authorisation of various chemical products (for which see below).
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[expand title=”Why are there two versions of EU legislation (an EU version and a new GB version)?” tag=”h4″]
In order to avoid a sudden and dramatic change in regulation for businesses in Great Britain, the European Union (Withdrawal) Act 2018 provides that all EU Regulations previously enforceable in the UK up to the end of the Brexit implementation period, are copied into law in Great Britain (England, Scotland and Wales). This means that from 1st January 2021 there will be two versions of EU Regulations:
- The original EU version which is unchanged;
- The new GB version which applies the Regulation solely within GB.
The new GB versions of EU Regulations are referred to as ‘retained EU law’.
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[expand title=”What is the difference between ‘exit day’ and the ‘IP completion day’?” tag=”h4″]
The European Union (Withdrawal) Act 2018 originally provided for EU law to be copied into UK law on ‘exit day’ which was 31st January 2020. However, many EU Regulations contain references to EU terminology and delegate certain powers and responsibilities to EU institutions such as the European Commission, or the European Chemicals Agency. In order to ensure that the GB versions of the EU Regulations operate correctly (i.e. that they make sense in a GB context), multiple amendment regulations have been passed to revise the GB versions of the EU Regulations so that they contain UK terminology and confer powers on UK institutions. The GB versions of the EU Regulations, together with the various amendments to make them GB specific, were originally due to come into force on ‘exit day’.
The UK and EU then signed the Withdrawal Agreement which led to a transition period (known as the ‘implementation period’). During the implementation period, the UK continued to apply EU Regulations in full (i.e. rather than the GB versions and amendments). The date when the new GB versions of EU Regulations come into force, together with the various amendments needed to make those GB Regulations work, was postponed until ‘IP completion day’ (11pm on 31st December 2020, i.e. the end of the implementation period).
Therefore, where Brexit amendments to legislation were due to come into effect on ‘exit day’, the European Union (Withdrawal Agreement) Act 2020 overrides this and replaced ‘exit day’ with ‘IP completion day’.
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[expand title=”How is Northern Ireland affected by these Brexit changes and is it different from what’s happening in Great Britain?” tag=”h4″]
Under the terms of the Northern Ireland Protocol, which forms part of the Withdrawal Agreement, Northern Ireland is treated as though it remains part of the EU (though technically it has left the EU along with the rest of the UK). This means that EU Regulations continue to be directly enforceable in Northern Ireland. (In Great Britain, the EU Regulations will not be directly enforceable, but the new GB versions of the EU Regulations will be directly enforceable).
Therefore, if you are based in Northern Ireland, you continue to comply with the EU version of EU Regulations. The GB versions of the EU Regulations do not apply to you.
If you are based in Northern Ireland but trading with the rest of the UK, you will probably also need to be aware of the new GB versions of the EU Regulations. The GB versions of the EU Regulations contain special simplified provisions in relation to ‘qualifying Northern Ireland goods’ (in summary, these are goods made in or in some way closely connected with Northern Ireland). Generally, there will be a much-simplified process for export of qualifying Northern Ireland goods to Great Britain. The purpose of this is to protect Northern Ireland business as much as possible by making the trade of goods between Northern Ireland and Great Britain as frictionless as possible.
Non-qualifying Northern Ireland goods (e.g. goods which are not connected with Northern Ireland and have simply been imported into Northern Ireland for onward trade to Great Britain) will be subject to the same restrictions as goods from elsewhere in the world entering GB.
If you are based in Great Britain but trading with Northern Ireland, those goods which are exported to Northern Ireland will need to comply with EU rules.
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[expand title=”Do EU Regulations still apply to me?” tag=”h4″]
Brexit does not remove EU Regulations from UK law. There are several reasons why EU Regulations may continue to apply to you:
- If you continue to trade with businesses in the EU, then you will probably still need to be familiar with relevant EU Regulations which apply to the products you are trading in.
- Even though Northern Ireland has left the EU, Northern Ireland will continue to apply EU Regulations directly. If you are moving goods between Great Britain and Northern Ireland, you will need to be aware of relevant EU Regulations.
- Following the end of the Brexit implementation period, EU Regulations are ‘copied’ into law in Great Britain, so that there are two versions of EU Regulations (the EU version and a GB version). Even if you only trade within Great Britain, the GB versions of the EU Regulations may apply to you.
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[expand title=”Are the EU and the GB versions of the EU Regulations identical?” tag=”h4″]
The new GB versions of EU Regulations are not identical.
The GB versions implement the same standards as the EU versions (for example, chemicals must be labelled and packaged in the same way, products must comply with the same essential safety requirements etc). However, the implementation and regulation of the GB versions differ from the EU versions.
For example, GB organisations will no longer be able to register chemicals with the European Chemicals Agency and therefore the UK* version of REACH delegates the HSE as the new UK REACH regulatory body. The GB versions of the EU Regulations also set out transitional arrangements detailing what happens to registrations and authorisations held by GB organisations with European bodies such as the European Chemicals Agency. The GB versions also change various definitions and references from EU to GB terminology and restrict the scope of the Regulations to GB.
*Confusingly, the Government and the HSE have adopted the term ‘UK REACH’ even though it only applies to GB. We have therefore adopted the same term. In relation to other Regulations, the Government has adopted the term ‘GB Regulation’ rather than ‘UK Regulation’.
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[expand title=”Which version (EU version or GB version) of EU Regulations do I need?” tag=”h4″]
If you continue to trade with the EU or with Northern Ireland, you will probably need to keep the EU versions of EU Regulations.
If you trade solely within Great Britain i.e. you are not importing or exporting any raw materials or finished products outside Great Britain, then you probably only need the GB versions of relevant EU Regulations.
If you do both, then you will need both the EU and the GB versions.
(N.b. if you are based solely in the Republic of Ireland and have not ticked any UK jurisdiction in your set up, you should not have any of the new GB versions of the EU Regulations).
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[expand title=”What is divergence?” tag=”h4″]
On 1st January 2021, the new GB versions of the EU Regulations implement the same standards as the EU versions of those Regulations. The implementation and regulation of those standards may differ (see above), but the standards themselves remain the same in the EU and the UK for the time being.
The EU frequently amends and updates EU Regulations in order to reflect amended and updated standards. In the past, those amendments applied automatically in the UK. From 1st January 2021, any new amendments to the EU versions of Regulations will not automatically apply in GB. It is likely that UK legislators will choose to update the GB versions of Regulations so that they continue to mirror the same standards as the EU. However, the UK Government will no longer be bound to do so, and for that reason, it is possible that the UK Government will choose to diverge from some EU standards. In this manner, over time, GB versions of EU Regulations may diverge from the EU versions.
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[expand title=”I make and/or distribute chemical products. What has changed?” tag=”h4″]
If you simply use chemicals (but you aren’t making or selling them to others) there is unlikely to be any change you need to be aware of.
If you do make or sell chemicals, you will probably already be aware of the following:
- The REACH Regulation concerning the registration of all chemicals and the authorisation or restriction of specified hazardous chemicals
- The CLP Regulation concerning requirements for labelling and packaging of hazardous chemical products
- The Biocidal Products Regulation concerning the approval of ‘active substances’ and the authorisation of biocidal products
The underlying requirements in these Regulations concerning the standard to which chemicals are made, packaged, labelled, etc are not changed. However, if you are placing chemical products on the market in GB (either by making them or by importing them), or if you are based in GB and placing products on the market in the EU/ Northern Ireland, there are significant changes in the procedure for registration and authorisation of various products. Note that these changes also apply to you where you are an organisation which has sites in GB and you also have ‘sister’ sites in the EU and you are importing chemicals from any of your EU sites to your GB sites (or vice versa). You will need to consult the relevant pages (i.e. the ones listed above) in LUS concerning the changes to those Regulations.
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[expand title=”I make and/or distribute CE marked products. What has changed?” tag=”h4″]
There is no change in relation to existing CE marked stock which has already been ‘placed on the market’ before 1st January 2021.
The changes below apply to placing goods on the market for the first time on or after 1st January 2021. The procedure for carrying out conformity assessment and marking of goods in the UK will change, but the standard to which goods must conform is not planned to diverge from existing EU standards (at least for the time being).
The rules are different depending on whether you are based in Great Britain or Northern Ireland. Depending on where you are based, be careful to read the right section below.
Businesses based in Great Britain
Goods placed on the market in Great Britain
Manufacturers, importers, etc placing goods on the market in Great Britain will need to UKCA mark goods from 1st January 2022 (i.e. in 12 months’ time). Most new CE marked goods can continue to be placed on the market in GB until that date after which time they must be UKCA marked.
However, if the goods are of a type that must be assessed by an independent ‘notified body’, and the notified body which carried out the assessment is based in the UK, the goods must be UKCA marked from 1st January 2021 unless the assessment files have already been transferred to an EU based notified body.
Goods placed on the market in the EU
Goods placed on the market in the EU will continue to need to be CE marked (the EU will not recognise UKCA marking).
If the goods are assessed by the manufacturer, they will continue to be accepted in the EU (in the same way that manufacturers in any other part of the world can legitimately apply the CE mark provided that they have correctly followed the relevant procedures).
Where the goods are conformity assessed by an independent notified body, it must be a notified body that is recognised in the EU. If the notified body is a GB based notified body, the CE marking will not be accepted in the EU after 1st January 2021. GB organisations can avoid this problem by transferring the conformity assessment files from their GB based notified bodies to EU based notified bodies.
Goods placed on the market in Northern Ireland
Businesses in Great Britain who wish to place goods on the market in Northern Ireland must ensure that they have been correctly CE or UK NI marked (see below). UKCA marked goods cannot be placed on the market in Northern Ireland.
Mandatory third-party assessment
Under the EU system, goods are sometimes conformity assessed and CE marked by the manufacturer, and sometimes by an independent notified body (which is a third-party assessment body recognised across the EU).
From 1st January 2021, UK recognised notified bodies will no longer be recognised in the EU, but they will automatically become ‘approved bodies’ which can carry out third-party conformity assessments in the UK. For UKCA marking, where third party assessment is required the conformity assessment must be carried out by a UK recognised approved body.
CE marked goods which were conformity assessed by a UK recognised notified body will no longer be accepted in the EU. The conformity assessment files must therefore be transferred to an EU based notified body.
This means that in time, GB manufacturers may need to both CE and UKCA mark their goods.
Businesses based in Northern Ireland
Northern Ireland will continue to apply EU rules directly. Goods manufactured in Northern Ireland to be placed on the market in the EU must be CE marked.
Where conformity assessment is completed by the manufacturer, there is no change.
Where third party conformity assessment is required the conformity assessment must be carried out by an EU recognised notified body in order for the CE mark to be applied and the goods accepted in the EU.
If the manufacturer plans to arrange for the conformity assessment to be carried out by a UK recognised body rather than an EU body, the goods must be ‘UK NI marked’. ‘UK NI marking’ means that a UK NI mark is applied in addition to the CE mark (the UK NI mark is not applied on its own). The standard for UK NI marking is therefore the same standard as for CE marking, the only difference being that the conformity assessment is completed by a UK rather than EU recognised body.
UK NI marked goods can only be marketed in Northern Ireland and Great Britain – they will not be accepted in the EU (even though they will have a CE mark next to the UK NI mark).
This is particularly complex and we recommend that you review the Government’s own guidance here and here
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[expand title=”What’s the difference between a Regulation and a Directive?” tag=”h4″]
An EU Regulation is directly enforceable against individuals and organisations in all EU Member States (and in the UK until the end of the Brexit implementation period). A business which breaches an EU Regulation can be prosecuted by state prosecutors.
EU Directives are instructions from the European Union to EU Member State governments to enact national legislation to implement requirements in the Directive. The Directives have never been directly enforceable against individuals or businesses in EU Member States (or the UK).
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[expand title=”Do EU Directives still apply?” tag=”h4″]
EU Directives are instructions from the European Union to EU Member State governments to enact national legislation to implement requirements in the Directive.
Directives frequently contain annexes which set out standards or criteria which are then enacted by national legislation. For example, Directives set out the standards to which machinery must comply in order to be safe prior to being CE marked. Legislation in the UK often refers to the annexes in Directives and will continue to do so even after the end of the Brexit implementation period. For that reason, Directives may continue to be relevant to your business even though they do not create duties which apply directly to you.
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