End of EU Pi-marked TPE in GB (Britain)

The UK government has today commenced consultation on the ending of recognition of EU Pi-marked TPE (transportable pressure equipment) in Britain.

The proposal is to amend the 2009 Carriage of Dangerous Goods and Transportable Pressure Equipment Regulations to require that, in future, TPE being placed on the GB market is conformity-assessed by:

• a GB-appointed body and affixed with a Rho marking

or

• a notified body established in Northern Ireland, affixed with a Pi marking plus the indication ‘UK(NI)’.

This would effectively end recognition of EU Pi-marked TPE in GB, although TPE already on the GB market before this amendment comes into force may remain in circulation.

The proposal is that this change will come into effect between 1 January 2022 and 1 January 2023.

The consultation invites comments on the impact of ending recognition of EU Pi-marked TPE in GB. The findings from this consultation will be used to inform a decision on when the amendment should come into effect.

The consultation is here. It is a short consultation that will run until 30 June.

UK Emissions Trading System (Britain from 1st Jan)

I Email Alerted to customers carbon trading in the EU ETS system. This morning, the UK government publishes Britain will set up its own UK ETS (it had the law already in place and in force to set up the UK ETS from 1st Jan). Britain will not operate a carbon tax. Northern Ireland will continue inside the EU ETS.

The Legislation for the UK ETS is in the Brexit Consolidated Law List (see the Email Alert I issued – look in your inboxes). UK ETS law is in force, and will be included in the EHS Registers & Law Checklists from 1st Jan 2021. Existing Brexit Transition Registers also have the Carbon Tax provision, it is marked “not in force” and there is no Summary and it is not in Law Checklists.

Despite this morning’s announcement, there are still few details for UK ETS.

The announcement this morning is of the Energy White Paper – here.

The details so far (from this announcement) –

The UK ETS will be the world’s first net zero carbon cap and trade market, and a crucial step towards achieving the UK’s target for net zero carbon emissions by 2050.

The scheme is more ambitious than the EU system it replaces – from day one the cap on emissions allowed within the system will be reduced by 5%, and we will consult in due course on how to align with net zero.

I will issue a new Email Alert shortly.

This UK ETS, adds to the list of standalone UK/GB systems –

(1) UK REACH

(2) GB CLP

(3) UKCA

(4) UK ETS

EU REACH and UK REACH (UK from 1st Jan)

Like CLP (see my blog post on CLP), the key principles of the European Union (EU) REACH Regulation are retained. This document is included (separated into four line entries) in our Brexit Consolidated Law project (the coloured list in Cardinal Environment EHS Legislation Registers & Checklists).

From 1 January 2021, UK REACH and EU REACH will operate independently from each other. Companies that are supplying and purchasing substances, mixtures or articles to and from the EU/EEA/Northern Ireland and Britain (England, Scotland and Wales) will need to ensure that the relevant duties are met under both systems.

EU REACH will apply to Northern Ireland from 1st Jan, while UK REACH will regulate the access of substances to the GB market.

GB- based Businesses holding EU REACH Registrations (in ECHA)

The EU REACH registration will be (and must be) legally recognised (grandfathered) in the UK REACH system after 31st Dec, but information will be supplied to the HSE (the UK REACH regulator) via an account (the holder sets up) on the new UK REACH IT system.

* initial information on the existing EU REACH registration within 120 days of 31st Dec.

* technical information (required under UK REACH) within 300 days plus either 2, 4 or 6 years of 31st Dec. The deadline depends on the tonnage and/or hazard profile of substances.

Grandfathering will be available (and will be required) for all registrations (including intermediates) held by GB-based entities, including importers and Only Representatives (ORs) based in Britain, and to sole, lead or joint registrants.

All GB-based registrations that exist on 31st Dec, and all registrations held by GB entities at any point since 29 March 2017 will be grandfathered. This means that if a GB registration was transferred to an EU/EEA/NI-based entity in the run-up to 31st Dec, it will still be grandfathered into UK REACH.

Grandfathering will not apply to registrations held by entities established outside of Britain, regardless of whether they are part of a group of companies which also has a presence in Britain. Those registrations will not be grandfathered, unless they have been transferred to a GB entity before 31st Dec.

Before transferring any registrations, the HSE asks you to consider how this would affect your operations in the EU/EEA and Northern Ireland, and your ability to access the EU/EEA and NI markets in future.

The HSE says any ECHA decisions relevant to a registration(s) will remain valid.

Access to the technical information used for EU REACH registration may require renegotiating commercial contracts/letters of access which were originally put in place for EU REACH under a Substance Information Exchange Forum (SIEF).

UK REACH will not require GB companies to form a Substance Information Exchange Forum (SIEF) to submit registration data, including under the grandfathering provisions. UK REACH will include a similar Article 26 substance inquiry system to EU REACH to facilitate the principle of ‘one substance, one registration’ which will be retained under UK REACH.

This link gives access to HSE details of the information that must be submitted (scroll down)

Separate Rules apply for GB- based businesses that are downstream users and distributors if they continue to be supplied from the EU/EEA – read here.

GB- based businesses importing non EU/EEA substances Businesses that act only as importers of substances will not be able to appoint an Only Representative (OR) under EU REACH (only a manufacturer, formulator or producer of articles can do so). This means that, as a GB-based importer, you will not have the option to transfer your EU REACH registrations to an EU-based entity OR to continue selling into the EU/EEA or Northern Ireland.

To sell chemicals to EU/EEA or NI customers you should:

* help your EU/EEA and NI-based customers to register with ECHA as importers

or

* work with the non-EU/EEA or NI-based manufacturer who supplies you to encourage them to appoint an OR based in Northern Ireland or an EU/EEA country, who can register the substance with ECHA. The HSE advises you will need to consider in each case whether this registration will be sufficient to allow you to export the substance into the EU/EEA or Northern Ireland.

For mixtures to be placed on the EU/EEA or NI markets you should ensure that each substance at one-tonne or over is registered with ECHA in accordance with EU REACH directly by someone EU-based in your supply chain (again see above re OR).

GB- based Businesses holding EU REACH Authorisations (in ECHA)

Again, these will be grandfathered. The deadline here is 60 days from 31st Dec for information supply to HSE –

* the information included in the application for the authorisation

* any other information provided to ECHA by the applicant for the authorisation which was material to the formation of ECHA’s opinion

* any information required to be submitted or recorded before 31st Dec under any condition under which the authorisation is granted.

Separate Rules apply for GB- based businesses that are downstream users and distributors if they continue to be supplied by anyone with an EU REACH authorisation – read here.

Link to HSE information for GB- based Businesses bringing to GB NI- registered goods under EU REACH (qualifying Northern Ireland goods – QNIGs) – here.

Link to HSE information for NI- based businesses trading QNIGs – here.

Note : see above re GB holders of EU REACH registrations.

LINK to HSE for further scenarios.

EU CLP and GB CLP (UK from 1st Jan)

I mentioned GB CLP yesterday in my blog about publication of the new rules for Northern Ireland.

From 1 January 2021, the European Union (EU) CLP Regulation will be replaced in Britain by retained EU law – the GB CLP Regulation. The GB CLP Regulation will be added to Cardinal Environment EHS Legislation Registers & Checklists, and is included in our Brexit Consolidated Law project (the coloured list).

Businesses based in Britain (England, Scotland and Wales) that place chemicals (substances and mixtures) on the GB market will comply with the GB CLP Regulation (not the EU CLP Regulation) from 1st January.

GB CLP Agency

GB-based businesses supplying the GB market with chemicals (substances and mixtures) will deal with the Health and Safety Executive (HSE) as the GB CLP Agency instead of the European Chemicals Agency (ECHA).

GB Notification

GB-based businesses will notify the GB CLP Agency (not ECHA) of the classification and labelling of the substances they place on the GB market, whether on their own or in mixtures, where they meet the criteria for notification (please check that notification is not required if the substance is subject to UK REACH registration).

GB mandatory classification and labelling (GB MCL)

GB-based businesses will classify and label their substances, where required, in accordance with GB MCL and with the entries in the GB MCL list hosted and managed by the GB CLP Agency.

Downstream users and distributors supplied from the EU/ European Economic Area (EEA)

GB-based downstream users or distributors supplied from the EU/EEA will be importers after 31st December if these supply arrangements continue. 

Exporting to the EU/EEA

Responsibility for the classification, labelling and packaging of chemicals exported to the EU/EEA from Britain will rest with the EU/EEA-based importer.

Unchanged from 1st Jan 2021 –

The main duties on GB-based businesses i.e. manufacturers, importers, downstream users and distributors (“suppliers”) to classify, label and package the chemicals (substances and mixtures) they place on the market under the GB CLP Regulation will stay the same.

Classification

From January 2021, GB-based manufacturers, importers and downstream users will still classify substances and mixtures) i.e. identify any hazardous properties, before they place them on the GB market.

Labelling

Manufacturers, importers, downstream users and distributors based in Britain will still label substances and mixtures to reflect their hazard classification before they place them on the GB market.

There are no changes to requirements for when GB CLP Regulation labelling appears alongside those for transport (dangerous good transport).

Packaging

There are no changes to packaging requirements. Substances and mixtures placed on the GB market must still be safely and securely packaged. Requirements for child resistant closures and tactile warning devices will remain in place.

Responsibility to identify health, environmental and physical hazards 

All suppliers based in Britain will continue to be responsible for identifying, examining and evaluating available scientific and information on substances and mixtures relating to possible physical, health or environmental hazardous properties of chemicals. This is to ensure all the requirements of classification, labelling and packaging are fulfilled.

Testing arrangements 

Testing arrangements for chemicals, including a ban on testing on humans or primates for the purposes of the GB CLP Regulation, will still apply.

Relationship with UN GHS

The GB CLP Regulation, as retained EU law, will continue to adopt changes to the United Nations Globally Harmonized System of classification and labelling of chemicals (UN GHS) in a similar way to the EU CLP Regulation.

Northern Ireland- based Businesses

The EU CLP Regulation will apply in Northern Ireland. This will mean that:

* chemicals (substances or mixtures) placed on the market in Northern Ireland will comply with the EU CLP Regulation (not the GB CLP Regulation)

* Northern Ireland- based businesses will notify ECHA (not the HSE) of the hazard classification and labelling of the substances they place on the NI market, for inclusion in the EU Classification and Labelling Inventory, whether on their own or in mixtures, where they meet the criteria for notification (notification is not required if the substance is subject to EU REACH registration)

* Northern Ireland-based downstream users and distributors who are currently supplied by businesses in the EU/EEA will not face any new EU CLP Regulation requirements if these supply arrangements continue (GB businesses will be importers – see above)

Responsibility for the classification, labelling and packaging of chemicals traded from Britain to Northern Ireland will rest with the Northern Ireland based business who places the chemical on the Northern Ireland market even if it is currently a downstream user or distributor.

NI- based businesses placing goods on the GB market must study the new Rules for Northern Ireland published yesterday. Please note the relevant clauses of the Internal Market Bill are dropped (and the HSE Guidance is not yet updated).

Link to HSE.

Office for Product Safety and Standards (UK from 1st Jan)

The Office for Product Safety and Standards (OPSS) has published guidance for businesses in Great Britain (GB) and separately in Northern Ireland (NI).

The guidance is issued separately (for GB and NI) – here – for the following –

(1) General Product Safety

(2) ATEX

(3) Cosmetics

(4) Electrics and electronics

(5) Gas appliances

(6) Lifts

(7) Machinery

(8) Metrology (weights and measures)

(9) Outdoor equipment

(10) Pressure equipment

(11) Recreational craft

(13) Toys

Guidance (Brexit) in these areas was issued in earlier years, but these documents are a fresh issue, and will be added imminently to the Brexit Guidance List in subscribers’ EHS Legislation Registers & Checklists online.

The Implementation or Transition Period officially ends at 11pm on 31 December 2020; therefore references to 1 January 2021 should be read as meaning 11pm on 31st December 2020.

Great Britain

The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019, and other Brexit Law, that are being consolidated into domestic law – the Brexit Consolidated Law List in subscribers’ EHS Legislation Registers & Checklists) are also amended by the Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations 2020 – which are not yet approved by Parliament.

This (as yet not approved amendment) provides for a 24 month transition period for importer labelling (for goods from the EEA), and the UKCA marking. It also amends the definition of “authorised representative” as well as introduces an end (in 12 months from the end of the Transition Period) to the recognition of goods meeting EU requirements, as well as introduces provisions for qualifying Northern Ireland goods.

Northern Ireland

Only a few of these guides are yet published.

UK Internal Market Bill (Scotland 1st Jan 2021)

The UK Internal Market Bill is not yet published. Accounts of it suggest it’s purpose is to put into law the common approaches that subsist across the UK and the Devolved Governments to food, environment and animal welfare, in the context of international trade agreements.

Presently, a concept of ‘common frameworks’ is agreed between the UK and the Devolved Governments to enable the functioning of the UK internal market (in areas that are currently governed by the European Union) from the 1st January 2021, while acknowledging policy divergence.

The Finance and Constitutional Committee (FCC) of the Scottish Parliament has been consulting on views about how the UK Internal Market might operate from 1st January 2021. This consultation closed 28th February 2020.

More details are here.

Further Blog posts will be issued in the event that the UK Internal Market Bill is progressed.

Scotland EU Continuity Bill (Scotland 1st Jan 2021)

On 18 June 2020, the Scottish Government introduced the UK Withdrawal from the European Union (Continuity) (Scotland) Bill. Details are here.

The purpose of the Bill is to:

a. enable the Scottish Ministers to make provision in secondary legislation to allow Scots law to be able to ‘keep pace’ with EU law in devolved areas, where appropriate;

b. ensure that there continue to be guiding principles on the environment in Scotland;

c. establish an environmental governance body, Environmental Standards Scotland;

[The UK Environment Bill at Westminster seeks to establish, amongst other matters, an environmental governance body, the Office for Environmental Protection, in England]

d. continue the role and functions of the European institutions in ensuring the complete and effective implementation of environmental law.

Environment is a devolved area.

In the Scottish Parliament, the Finance and Constitution Committee (FCC) is the lead Committee for considering this Bill and focuses on the constitutional aspects of the Bill. 

The Environment, Climate Change and Land Reform Committee (ECCLRC) is a secondary committee and focuses on the environmental policy aspects of the Bill. 

The FCC is currently conducting a consultation (ends 7th August 2020). This seeks views on questions – including –

The policy memorandum states that “the Scottish Government considers it necessary to give Scottish Ministers the power to ensure that Scotland’s laws may keep pace with changes to EU law, where appropriate and practicable.”

The Committee would welcome your views on how wide-ranging this power is likely to be given the following statutory and non-statutory constraints –

* Compliance with UK international obligations including future trade deals and other international agreements;

* Statutory and non-statutory common frameworks;

* The functioning of a UK internal market;

* The replacement of EU funding.

More details are here.

The ECCLR has its own consultation (ends 31st July 2020). This seeks views on questions – including –

• The extent to which the proposals will address the governance issues arising from EU exit

• The limit of the obligations of ‘public authorities’ and the exclusions

• How the proposed model will align with that proposed for functions in the rest of the UK, and for reserved matters in Scotland, through the UK Environment Bill and any potential for gaps in the oversight arrangements; and the ability to co-operate and share data

More details are here.

Rail Transport (UK from 1st January 2021)

Rules change from 1st January 2021 (as a result of Brexit).

The UK Department for Transport issued on 1st July, text applicable to Rail Transport from 1st January 2021. This text is here.

The UK text also refers the reader to the already existing European Commission Notice, updated 28 April, here.

Note the following (this is not an exhaustive list, please read the text behind the links).

Note the deadlines – 1st January 2021 and 1st January 2022. Note the different rules in Northern Ireland.

(1) EU-based operators must apply to the Office of Rail and Road (ORR) for documentation to run services in Britain – the necessary documentation is required by 31 January 2022.

For Northern Ireland, the UK text says “non-UK operators are currently not subject to a time-limited period”. This flows from the Ireland/Northern Ireland Protocol of the EU-UK Withdrawal Agreement.

(2) The UK text says “It is likely that certificates and licences issued in the UK will not be valid in the EU from 1 January 2021”.

If this is the case, operators of cross-border services will be subject to the recognition implications set out in both UK and EU rules.

(3) The UK will continue to recognise certain EU-issued documents until 31 January 2022 for services in Britain. These are operator licences, safety certificates, and train driving licences.

For Northern Ireland, the UK text says “The 2-year time limit from 31 January 2020 on recognition of these categories of EU-issued documents does not currently apply to Northern Ireland.” Again, this flows from the Ireland/Northern Ireland Protocol of the EU-UK Withdrawal Agreement.

Any future arrangements with France are expected to deal with the Channel Tunnel itself but not with the routes into continental Europe (beyond Calais-Fréthun). UK operators and train drivers will need to obtain additional licences and safety certificates to operate or work in the EU.

(4) The UK’s formal participation in the EU Agency for Railways (ERA) ended on 31 January 2020 and the UK is not seeking membership of ERA. The UK text says “The UK intends to put in place appropriate arrangements for regulatory co-operation with ERA where this is necessary to secure the safety of international rail services.”

(5) After 31 January 2022, operators with an EU operating licence will need to hold an ORR-issued licence to operate in Britain. Establishment in the UK is not necessary, but the UK ORR licence will need to have been applied for and obtained by 31 January 2022 to continue operating after that date.

Operators holding an ORR-issued licence that run domestic services in the EU will need to re-apply for an operator licence in an EU member state, consulting the relevant guidance and following the requirements from the EU or the relevant member state. The licence must be in place by 1 January 2021.

This is also the case for UK-based operators seeking to run new domestic services in an EU member state.

Operators of cross-border services between the UK and the EU holding an ORR-issued licence will need to re-apply for an operator licence in an EU member state. The licence must be in place by 1 January 2021.

(6) ORR-issued Part A and Part B safety certificates will be valid for UK-based domestic operators operating in Britain until their normal expiry.

EU established operators running a domestic-only service in Britain, with a Part A safety certificate issued in the EU before 31 January 2020, will be able to use these certificates until 31 January 2022 or until they expire – whichever is earlier.

Proposed changes to UK regulations will allow EU established operators running a domestic-only service in Britain with a Part A safety certificate issued in the EU before 31 January 2022 to run services in Britain until 31 January 2022. These changes are to be made in the Railways (Miscellaneous Amendments, Revocations and Transitional Provisions) (EU Exit) Regulations 2020. Subject to Parliamentary process, it is expected they will come into force on 31 December 2020.

This will also apply to operators running services with a single safety certificate issued under Directive (EU) 2016/798, which will be deemed equivalent to a UK Part A safety certificate during the period between 31 December 2020 (subject to the changes to regulations coming into force) and 31 January 2022.

If trains are operated in Britain on the basis of an EU-issued safety certificate, the relevant safety certification issued by the ORR is required by 31 January 2022 at the latest. An ORR-issued Part B certificate associated with an EU-issued Part A safety certificate or a Single Safety Certificate will expire alongside the parent certificate. An operator obtaining new safety certification will also be required to apply for and obtain a new Part B safety certificate.

Establishment in the UK is not required to obtain relevant safety certification issued by the ORR, but a UK address must be supplied in the application.

For Northern Ireland – the UK text says – “non-UK based operators running a domestic-only service with a Part A safety certificate issued in the EU are not currently subject to a time-limited recognition period.” Again, this flows from the Ireland/Northern Ireland Protocol of the EU-UK Withdrawal Agreement.

Any EU operator seeking to run domestic services in Britain based on an EU-issued Single Safety Certificate, issued under Directive (EU) 2016/798 until 31 January 2022, will also have to obtain a Part B safety certificate from the ORR before it can do so.

UK-based operators running domestic services in the EU who hold an ORR-issued, or Northern Ireland-issued, Part A safety certificate need to obtain an EU safety certificate by 1 January 2021. This also applies to UK-based operators seeking to run new domestic services in an EU country.

Operators established in the UK who operate cross-border services and hold an ORR-issued Part A safety certificate will need to obtain EU safety certification by 1 January 2021.

(7) Entities in charge of maintenance (ECM) that maintain vehicles in the EU on the basis of an ECM certificate issued in the UK by the ORR or an accredited certification body need to apply for and obtain a new ECM certificate from a certification body in an EU country.

Vehicles used in international traffic between the UK and the EU also have the option of obtaining a certificate according to the legal framework of the Convention concerning International Carriage by Rail (COTIF). The validity of ECM certificates issued in the UK by the ORR or an accredited certification body will be unchanged for freight wagons running purely on the UK mainline railway. ECMs that hold a certificate issued in accordance with COTIF can continue using these certificates in the UK for operations involved in international traffic. ECMs may also rely on certificates issued in the EU in accordance with Commission Regulation 445/2011 to maintain freight wagons for use in domestic operations.

Proposed changes to regulations will allow ECMs to rely on certificates issued in the EU in accordance with the new Commission Implementing Regulation (EU) 2019/779 to maintain freight wagons for use in domestic operations. These changes are included in the Railways (Miscellaneous Amendments, Revocations and Transitional Provisions) (EU Exit) Regulations 2020. Subject to Parliamentary process, it is expected they will come into force on 31 December 2020.

(8) Drivers working on services in Britain, including cross-border services, and using licences and certificates issued in the EU up to the 31 January 2020, are able to drive trains on the basis of those licences until 31 January 2022 or until they expire – whichever is earlier.

Proposed changes to regulations will allow train drivers working on services in Britain, including cross-border services, and using licences and certificates issued in the EU up to the 31 January 2022, to use this documentation until the 31 January 2022. These changes are included in the Railways (Miscellaneous Amendments, Revocations and Transitional Provisions) (EU Exit) Regulations 2020. Subject to Parliamentary process, it is expected they will come into force on 31 December 2020.

From 31 January 2022, train drivers working in Britain will need to have obtained a UK train driving licence from the ORR to continue operating. The validity of train driving certificates is unaffected. However, operators must ensure that certificates held by newly re-licensed drivers (and their registers of those certificates) refer to the correct licence.

This means that, UK train driving licences are required by 31 January 2022.

Train drivers operating international services or driving domestic services in an EU member state on the basis of an ORR-issued train driving licence will need to re-apply for a train driving licence in an EU country. The new licence will need to be in place by 1 January 2021. Train drivers should apply for and obtain this as soon as possible, where they have not already done so.

(9) From 1 January 2021, the placing of interoperability constituents on the UK market will be based on a UK conformity assessment process, requiring compliance with applicable UK National Technical Specification Notices (NTSNs).

For Northern Ireland, the UK text says “Further updates may be provided in relation to Northern Ireland due to a review of obligations under the Northern Ireland Protocol.” This is the Ireland/Northern Ireland Protocol of the EU-UK Withdrawal Agreement.

The UK text says “It is currently expected that an interoperability constituent placed on the EU market up to 31 December 2020 with a certificate of conformity from a UK notified body will be able to be used within the EU for the period of validity of that certificate in subsystems or vehicles authorised before 1 January 2021.”

(10) Vehicles first authorised in the UK from 1 January 2021 will need to be authorised in the EU as well before they can be used in the EU. Vehicle authorisations issued in the EU up to 31 December 2020 will remain valid in the UK if the vehicle is already in use here prior to that date.

From 1 January 2021 vehicles first authorised outside the UK will require an additional authorisation before they are first used in the UK. This system will be operated in accordance with the UK’s COTIF international obligations.

Immigration Bill (UK Brexit)

The Immigration and Social Security Co-ordination (EU Withdrawal) Bill (a Brexit Bill) was introduced in the House of Commons today (5 March 2020). This Blog does not focus on immigration or social security policy or law, and this post will be the only one on this matter.

The purpose of the Bill is to end free movement of persons in UK law and make nationals from the European Union (EU), the European Economic Area (EEA) and Switzerland, and their family members, subject to UK immigration control.

The Government’s intention is at the end of the transition period, 31 December 2020, citizens of the EU, the EEA EFTA states of Iceland, Norway and Liechtenstein, and of Switzerland, and their family members, will require permission to enter and remain in the UK under the Immigration Act 1971.

The Bill protects the immigration status of Irish citizens once free movement ends.

It also contains provision for the Government (and/or, where appropriate, a devolved authority) to amend retained direct EU legislation relating to the social security co-ordination regime, which is retained in UK law by the EUWA 2018.

The Bill was first introduced in the Commons in the previous Parliament where, in the 2017-2019 session, it reached Report stage after completing a Public Bill Committee. The Bill fell when Parliament was prorogued before the December 2019 General Election. I posted about it at the time.

There have been no substantial changes to the content of the Bill since it was previously considered in the last Parliament. The only changes made are minor drafting clarifications in places, and updates to the list of retained EU law to be repealed to avoid duplication of changes already made through the Immigration, Nationality and Asylum (EU Exit) Regulations 2019 (2019/745) which come into force on 31 December 2020.

The Government has legislated to protect resident EEA citizens and their family members through the EUWAA 2020, which protects the residence rights of EEA citizens and their family members who are resident in the UK by the end of the transition period.

The Government fully opened the EU Settlement Scheme (EUSS) to all EEA citizens and their family members on 30 March 2019. The Scheme is set out in the Immigration Rules to enable EEA citizens and their family members to apply for UK immigration status, so their current rights continue, and their status is clear when the new global points-based immigration system begins.

The Immigration (Citizens’ Rights Appeals) (EU Exit) Regulations 2020 made under the EUWAA 2020, provide individuals who apply under the EUSS or for an EUSS family permit or travel permit, after 31 January 2020, with a right of appeal against decisions affecting their entitlement to enter and remain in the UK under the EUSS, and against decisions in relation to applications for EUSS family permits or travel permits.

Those individuals who have a right to apply under the EUSS will have until 30 June 2021 to do so, provided they arrived in the UK by the end of 2020.

This period of six months between the end of the transition period (31 December 2020) and 30 June 2021 is referred to as ‘the grace period’ and is a requirement of Articles 18(1)(b) and 18(2) of the UK-EU Withdrawal Agreement (and equivalent provisions in the EEA EFTA and Swiss citizens’ rights agreements). Statutory instruments to be made under the powers in the EUWAA 2020 will protect EEA citizens and their family members’ existing rights of residence, entry and exit until then. These savings will also extend to those with pending applications to the scheme and those with unresolved appeals.

The Government will also bring forward a statutory instrument to ensure individuals who are in the UK as frontier workers by the end of the transition period can continue working from January 2021 onwards. Frontier workers are individuals who are resident outside the UK, but employed or self-employed in the UK.

Further information may be obtained from these Bill Explanatory Notes – here.

Medicines and Medical Devices Bill (UK Brexit)

The (Brexit) Medicines and Medical Devices Bill 2019-20 was announced in the Queen’s Speech on 19 December 2019. The second reading is taking place today.

A large proportion of the legal framework for medicines and medical devices in the UK derives from EU Directives and has been implemented into domestic legislation through section 2(2) of the European Communities Act 1972 (ECA). This enables EU Directives to be transposed into UK law through secondary legislation and has been used to create a body of regulations that include the:

• Human Medicines Regulations 2012

• Medicines for Human Use (Clinical Trials) Regulations 2004

• Veterinary Medicines Regulations 2013

• Medical Devices Regulations 2002.

At the end of the Transition Period, the European Union (Withdrawal) Act 2018 (see the Brexit Law List in subscribers’ systems) will have preserved these frameworks as “retained EU Law”. Since the ECA is now no longer available (due to the Act that implemented the Withdrawal Agreement), there is no other ‘general power’ for updating these regulations from 1st January 2021, except through the introduction of new primary legislation.

The Medicines and Medical Devices Bill seeks to address this regulatory gap through introducing regulation-making, delegated powers covering the fields of

* human medicines,

* clinical trials of human medicines,

* veterinary medicines, and

* medical devices.

Its purpose is to enable the existing regulatory frameworks to be updated at the end of the Transition Period.

The Bill has been drawn to create ‘targeted’ delegated powers which can only be exercised in relation to a restricted number of matters. The Government states in the Explanatory Notes to the Bill that it intends to use these powers to keep the existing regulatory frameworks updated, while also consolidating the enforcement regime for medical devices. In addition, the Bill will provide the Secretary of State with the ability to impose civil sanctions – as an alternative to criminal prosecution – for breaches of the medical device regime.

Further details are set out in this Commons Briefing – here.