Counting GB divergence from EU law (Britain)

To date (end Feb 2021) divergence (this is not a definitive list) :

(1) international waste shipment – divergent waste transshipment law – EU bans plastics to non-OECD, Britain has enhanced pre-notification

(2) lead shot in fishing/hunting – EU Reach ban in/around wetlands from Feb 2023 (no announcement in Britain)

(3) carcinogen OELs – EU has further 2021 OELs (EH40 unchanged thus far)

(4) medicines licensing – Britain has ILAP launched 1st Jan – further information is here

(5) safety data sheets – EU has new Reach Annex II, one year grace (UK Reach unchanged so far)

There are other minor divergences

Additionally, and off topic, GB will not implement the latest proposed update to the EU motor insurance directive.

EU-UK Trade and cooperation agreement (2) (UK & EU)

I updated my post this morning with the link to the UK published legal text (1,246 pages – it’s the same text in the individual sections and chapters). Look back on the blog itself.

I also updated my post this morning (online) with the link to the EU document now loaded on a dedicated website, this also includes an EU Q&A – here.

A couple of points (identified in the Q&A) –

(1) Trading under ‘FTA’ (free trade agreement) terms from 1st Jan will differ substantively to trading in EU’s Customs Union and Single Market.

In particular:

• rules of origin will apply to goods in order to qualify for preferential trade terms under the agreement;

• all imports will be subject to customs formalities and will need to comply with the rules of the importing party;

• all imports into the EU must meet all EU standards and will be subject to regulatory checks and controls for safety, health and other public policy purposes.

(2) Traders will account not only for the origin of materials used, but also if their processing took place in the territory of one of the Parties. This is called ‘full cumulation’. Exporters will be able to self-certify the origin of the goods, and will have additional flexibility in collecting documentary evidence to prove origin during the first year.

(3) The Parties will recognise each other’s ‘Authorised Economic Operators’ programmes, enabling trusted traders with this status to use certain simplifications and/or facilitations relating to security and safety in their customs operations with the customs authorities of the other Party. But there is no waiver on security and safety declarations, as this requires alignment between the Parties on security standards.

(4) From 1st Jan, the EU and the UK will be two separate regulatory and legal spaces. This means that all products exported from the EU to the UK will need to comply with UK technical regulations and will be subject to any applicable regulatory compliance checks and controls. Similarly, all products imported from the UK to the EU will need to comply with EU technical regulations and will be subject to all applicable regulatory compliance obligations, checks and controls for safety, health and other public policy purposes.

(5) Both Parties agreed on a definition of international standards that identifies the relevant international standard-setting bodies. This is intended to ensure that both sides’ domestic product standards and technical regulations are based on the same international references and are therefore compatible to the extent possible.

(6) In the field of conformity assessment, the Parties agreed to maintain simplified access to each other’s markets through, in particular, the continued use of self-certification of conformity by the manufacturer where this is currently applied in both the EU and the UK. This covers a very large share of bilateral trade.

(7) Re Automotive Products – the Parties agreed that regulatory convergence will be based on the use of the international technical standards set at UNECE (United Nations Economic Commission for Europe) level. Both Parties will accept, in their respective markets, products that are covered by a valid UN type-approval certificate.

(8) Re Medicinal Products – the Parties agreed to recognise the results of inspections carried out by the authorities of the other Party in manufacturing facilities located in the territory of the issuing authority. This will avoid unnecessary duplication of inspections of manufacturers of medicinal products to assess their compliance with Good Manufacturing Practice requirements.

(9) Re Chemicals – the Parties agreed to cooperate, while respecting each Party’s right to regulate, both bilaterally and in relevant international fora, on the assessment of hazards and risks of chemicals and the formats for documenting the results of such assessment. The Parties already implement the UN GHS and this will continue. The Parties agreed to use transparent procedures for the classification of substances and possibly to exchange non-confidential information.

(10) Re Organic Products – the Parties agreed reciprocal recognition of equivalence of the current EU and UK organic legislation and control system, for all categories of organic products. Organic products complying with EU law and certified by control bodies recognised by the EU will be accepted on the UK market and vice-versa. In view of new EU rules for organic products applying as of 1.1.2022, equivalence will be reassessed by end-2023.

(11) Re SPS – there will be no changes to EU food safety standards. UK agri-food exporters will need to meet all EU SPS import requirements and be subject to official controls carried out by Member States’ authorities at Border Control Posts. Where required, these controls will include the verification of health certificates in line with international standards. Similarly, EU agri-food exporters will need to meet all UK SPS import requirements.

The Agreement allows for either party to unilaterally decide to reduce the frequency of certain types of border import controls, taking into account the extent to which their SPS rules converge.

It also ensures a simplified process for the approval of imports, where relevant by drawing up lists of establishments that are eligible to export to the other party, based on guarantees provided by the authorities of the exporting Party.

(12) Re Northern Ireland – the EU acquis, including the Union Customs Code, legislation on goods, sanitary rules for veterinary controls (“SPS rules”), rules on agricultural production/marketing, or VAT and excise in respect of goods, will apply to all goods entering Nortern Ireland.

As a result, from 1 January, goods entering Northern Ireland from Great Britain will constitute “imports”.  This means that such goods will need to comply with EU product rules and be subject to checks and controls for safety, health and other public policy purposes, including all necessary SPS controls applicable between the EU and the UK.

An agreement in principle (under the separate Withdrawal Agreement) has been found in the following areas, amongst others: export declarations, the supply of medicines, the supply of certain chilled meats and other food products to supermarkets, and a clarification on the application of State aid under the terms of the Protocol. There are some facilitations –

For example, certain chilled meat, for which imports in the Union market are normally prohibited, will be accepted for delivery to supermarkets in Northern Ireland during a limited period of 6 months:

• Minced meat of poultry, frozen or chilled. Chilled minced meat from animals other than poultry (e.g. minced beef.

• Chilled meat preparations (e.g. sausages, meatballs, pork pies)..

• Any fresh meat, including minced meat and meat preparations, produced from triangular trade (e.g. EU meat exported to Great Britain, cut or minced in Great Britain and re-exported to Northern Ireland).

Another example is that, during a limited period of 3 months, the goods coming from Great Britain and destined for supermarkets located in Northern Ireland will be accompanied with a simplified, collective certificate covering all the goods transported in the same truck, instead of individual certificates.

During this period of time, the UK shall maintain its current EU SPS legislation for the products concerned.

The scope is limited to a restricted number of food suppliers for supermarkets which are approved by the UK authorities after demonstrating that they meet a range of trust criteria. This list of members will be established by the United Kingdom in cooperation with the European Commission before 31 December 2020 and cannot be extended after that date.

(13) Re Business Persons Mobility – the temporary movement of natural persons for business purposes (often refered to as ‘mode 4‘), the EU and the UK have agreed on a broad range of reciprocal commitments facilitating the ability of companies located in a Party to transfer certain employees, as intra-corporate transferees, to work in an associated company located in the other Party. As intra-corporate transferees constitute temporary migration, the maximum duration of such transfers is capped at three years. With respect to UK nationals transferred to the EU, this duration includes periods of mobility between Member States. This is in line with current EU practice with other third countries.

The EU-UK Agreement also facilitates the movement of “contractual service suppliers” or “independent professionals” to supply services under certain conditions. Business visitors not providing services will also be allowed short-term entry in order to carry out certain activities.

(14) Re Legal Services – the EU and its Member States, and the UK will allow lawyers from the other Party to provide legal services relating specifically to the practice of international law and the law of the country where they are authorised under their “home” title.

However, it should be noted that EU law is not considered to be international law, but instead the law of the Member State in which EU lawyers are established or hold their “home title”.

(15) Re Energy – the UK will leave the EU’s internal energy market on 1st Jan, Northern Ireland will maintain the Single Electricity Market with Ireland (Republic of Ireland) (under the separate Withdrawal Agreement). The EU and the UK have agreed to establish a new framework for their future cooperation in the energy field. The UK Energy (Electricity) Guidance was updated on Dec 24th (see the Brexit Guidance List on Cardinal Environment Registers & Checklists).

The UK also leaves the EU ETS (see the Brexit Guidance List) and Euratom.

The UK will define its own climate change targets and policies and the UK committed to implementing a system of carbon pricing as of 1 January 2021. The Parties agreed a framework for cooperation in the fight against climate change, and their ambition to achieve economy-wide climate neutrality by 2050. The Parties will give serious consideration to linking their respective carbon pricing systems in a way that preserves the integrity of these systems and provides for the possibility to increase their effectiveness, for instance by adding further sectors, such as buildings. This would be subject to an agreement to be negotiated separately in the future.

There are also agreed provisions for cooperation in the development of offshore energy, with a focus on the North Sea.

(16) Re Euratom – the Agreement contains a separate agreement between Euratom and the UK on the safe and peaceful uses of nuclear energy.

This Agreement enables:

• the supply and transfer of nuclear material, non-nuclear material, technology and equipment;

• trade and commercial cooperation relating to the nuclear fuel cycle;

• cooperation in the safe management of spent fuel and radioactive waste;

• nuclear safety and radiation protection;

• use of radioisotopes and radiation in agriculture, industry and medicine;

• geological and geophysical exploration;

• development, production, further processing and use of uranium resources.

(17) Re Rebalancing (Level Playing Field, includes OHS and ENV Standards) – the Agreement provides the possibility to apply unilateral rebalancing measures in the case of significant divergences in the areas of labour and social, environment or climate protection, or of subsidy control, where such divergences materially impact trade or investment between the Parties.

This might be relevant, for example in a situation where one Party would significantly increase its levels of protection related to labour or social standards, the environment or climate above the levels of the other Party. This may entail an increase in the costs of production and hence a competitive disadvantage.

Another example would be a situation where one Party would have a system of subsidy control that would systemically fail to prevent the adoption of trade distorting subsidies, which would provide a competitive advantage for that Party.

In such cases, a Party would be able to adopt measures to rebalance the competitive advantage of the other Party.

Each Party could also, at regular intervals and if rebalancing measures have been taken frequently or for more than 12 months, seek a review of the trade and other economic parts of the Agreeent to ensure an appropriate balance between the commitments in the Agreement on a durable basis. In this case, the Parties could negotiate and amend relevant parts of the Agreement. Any trade or economic part of the Agreement, including aviation, that would remain in place or be renegotiated would retain appropriate level playing field commitments.

(18) Re OHS and ENV – the EU and the UK agreed to uphold levels of protection in the areas reated to labour and social standards, and environment and climate.

Labour and social levels of protection cover the following areas:

• fundamental rights at work;

• occupational health and safety standards;

• fair working conditions and employment standards;

• information and consultation rights at company level; or

• restructuring of undertakings.

Environmental levels of protection include the following areas:

• industrial emissions;

• air emissions and air quality;

• nature and biodiversity conservation;

• waste management;

• the protection and preservation of the aquatic environment;

• the protection and preservation of the marine environment;

• the prevention, reduction and elimination of risks to human health or the environment arising from the production, use, release or disposal of chemical substances; or

• the management of impacts on the environment from agricultural or food production, notably through the use of antibiotics and decontaminants.

The climate level of protection applies to:

• emissions and removals of greenhouse gases covering EU’s and the UK’s respective 2030 economy-wide targets including their systems of carbon pricing; and

• the phasing-out of ozone depleting substances.

(19) Re Further OHS and ENV Provisions – the Agreement contains several guarantees in terms of environmental protection, over and above the non-regression provisions applying to environment, climate and labour and social protection. These include:

• A recognition of the shared biosphere;

• Coverage of future targets that are now in the laws of the parties – the 2030 waste recycling targets, the 2027 water targets and the 2030 air pollution ceilings;

• Full inclusion of the key environment principles, including precautionary principle, polluter pays, and integration principle;

• Full inclusion of the principles of the Aarhus Convention with modernised text, including access to justice, access to information and public participation;

• Effective co-operation mechanism foreseen between the supervisory body or bodies in the UK in terms of protection of the environment, and the Commission;

• The recognition of the relevance of procedures for evaluating the likely impact of a proposed activity on the environment, such as an environmental impact assessment or a strategic environmental assessment.

(20) Re Health/Sanitary Quality in Agri/Foods – the broad scope of the commitment on the environment refers to agricultural and food production. In addition, it specifies two important areas for the level playing field with regards to agriculture and food production, namely the use of antibiotics and decontaminants.

(21) Re Aviation – UK carriers will be able to fly across the territory of the EU without landing; make technical stops in the territory of the EU for non-traffic purposes; and carry passengers and/or cargo on any routes between a given point in the UK and a point in the EU. Also, the Agreement will permit Member States and the UK to bilaterally exchange onward travel (termed 5th freedom) rights for extra-EU all-cargo operations only (e.g. Paris-London-New York).

The Agreement defines new arrangements for the recognition of future design and environmental certificates, as well as for production organisation oversight. Existing design certificates issued under EU rules before 1 Jan will remain valid.

(22) Re Road Transport – the Agreement provides for quota-free point-to-point access for operators transporting goods by road between the EU and the UK. This means UK lorries would be able to reach the EU and return from the EU, including when not loaded. The same rights are conferred to EU hauliers travelling from any point in the EU to the UK, and back from the UK to anywhere in the UK.

UK and EU trucks will also be able to perform up to two additional operations in the other party’s territory, once they have crossed the border.

This will allow EU hauliers that carry a load to the UK to perform two cabotage operations in the UK, thus limiting the risk of having to travel back to the EU without a load. 

For UK hauliers, these additional operations can be composed of two cross-trade operations (i.e. transport operations between two Member States) or one cross-trade and one “cabotage” operation (i.e. a transport operation within two points of a single Member State). Special provisions are made in the case of Ireland, as Northern Irish hauliers will be able to perform two cabotage operations in Ireland.

ECMT holders will be able to do 3 cabotage operations.

Medical Supplies (UK from 1st Jan 2021)

Healthcare is devolved in the UK, but contingency planning covers all 4 nations of the UK as well as the Crown Dependencies. Yesterday, the Department of Health & Social Care (DHSC) wrote to medical suppliers. The letter is here.

Re-routing away from the short straits

A large percentage of medical supplies come from the EU or have a supply touchpoint at the short straits (between Calais/Dunkirk/Coquelles and Dover/Folkestone). The DHSC letter asserts the first priority of any contingency should be to maintain replenishment rates at necessary levels by securing capacity to reroute freight away from the short straits potential disruption points. Companies are encouraged to review their own logistics arrangements and consider making plans for avoiding the short straits as a matter of priority.

In 2019, the Department for Transport (DfT) put in place a 4-year procurement framework for freight capacity for ‘Category 1’ goods , which includes all health supplies. This framework is still in place. DHSC is seeking to secure capacity on the government secured freight capacity (GSFC) to support the health and social care sector. More information will be provided when possible, including updates on the procurement timescales and when companies can expect to be able to register and access the service.

In addition, DHSC has retained its express freight service arrangements with 3 specialist logistics providers to support the urgent movement of medicines and medical products to care providers and patients if other measures experience difficulties. This service will be in place for deployment from 1 Jan 2021 as required.

Buffer stocks where possible

We encourage companies to make stockpiling a key part of contingency plans, and ask industry, where possible, to stockpile to a target level of 6 weeks’ total stock on UK soil. DHSC stands ready to support companies with their plans if required and understands that a flexible approach to preparedness may be required that considers a mixture of stockpiling and rerouting plans as necessary.

Centralised stock build

In the run-up to EU Exit, DHSC, working with NHS Supply Chain, built up a centralised stock build (CSB) of fast-moving medical devices and clinical consumables. Some of this stock remains and accounting for likely demand trends for the time of year, the DHSC plans to build these levels back up to a target level of 6 weeks’ total stock. The devolved nations of the UK may, in addition, choose to build their own stockpiles.

The UK Government also updated its guidance (for 1 Jan 2021) to healthcare providers – here.

And updated its Government contact details for medical supply businesses – here.

COVID-19 Medicines (UK)

1st April, the UK medicines regulator has issued guidance for industry on regulatory flexibilities that apply to the production of medicines in the UK.

The Link is here (this link also links to other relevant guidance)

The regulatory flexibilities are too lengthy and complex to summarise here in this Blog. The reader is asked to use the Link and read the relevant sections.

The Chancellor has also waived import duties and VAT on medical imports – here.

EU Readiness Notices (EU Brexit)

The UK is exiting the transition period on 31st December.

The European Commission is reviewing – and where necessary updating – the over 100 sector-specific stakeholder preparedness notices it published during the Article 50 negotiations with the UK.

The documents (updated so far) are published as ‘notices for readiness’ for 1st January 2021 –

(1) Air Transport – here

(2) Aviation safety – here

(3) Consumer protection and passenger rights – here

(4) Cosmetic products – here

(5) Animal feed – here

(6) Food law – here

(7) Industrial products – here

(8) Medicinal products for human use and veterinary medical products – here

(9) Movements of live animals – here

(10) Online sale of goods with subsequent parcel delivery – here

(11) Plant health – here

The transition period ends on 31st December, unless it is extended by agreement.

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.

EU Law in UK 2021 (UK Brexit)

Exit day is 31st January (end of this month)

Implementation period completion day is 31st December (this is the end of the transition period)

The Chancellor speaking to the Financial Times, confirms there will be no dynamic alignment with EU Law after 2020.

I am not yet clear which laws will diverge, but please note the Brexit laws allow divergence, for example the Brexit Agriculture Bill provides for England, Wales and Northern Ireland to create their own marketing standards (Scotland will need to enact its own Brexit Agriculture Bill).

The EU Exit regulations (statutory instruments) we (Cardinal Environment) are consolidating into domestic law only deal with the pre-Brexit period to end Dec 2020.

It is the FT front page today (Saturday 18th January) and the lead on BBC online.

EU Law per se will not apply anyway. Note, there may be some long tail implementation left over from pre-Brexit that will be implemented.

We (Cardinal Environment) are already consolidating the EU Exit regulations into domestic law, and creating the Retained EU Law (EU Regulations, not Directives, that are adopted). Progress in this project can be seen by clicking the Brexit Consolidated Law List on the top right hand side of EHS Legislation Registers & Checklists homepages (both ENV and OHS).

We are working to the deadline of 31st December 2020 for completion of this project.

In addition, EHS Legislation Registers & Checklists will see the home page choice of ENV or OHS have additional Post-Brexit choices, and the existing links relabelled Pre-Brexit.

The Post-Brexit links will direct to shadow Registers & Checklists that will run from the end of Q1 to hit the end Dec 2020 deadline, for switch over to Post-Brexit.

Post-Brexit shadow Registers & Checklists running in 2020 will have Brexit Consolidated Law loaded (accessibility will stay from the main Brexit Consolidated Law list), and will display a changed Register layout.

Post-Brexit EHS Legislation Registers layout – EU Law will be moved from the top to below Guidance. We will still supply up to date EU Law to UK customers, but this is where it will be found. Retained EU Law will be displayed at the top of the Register.

Medical Devices Notified Bodies (UK Brexit)

Exit day is 31st October (this date is in a Statutory Instrument)

Yesterday (8th October) the MHRA updated its instructions on Notified Bodies.

Here

This link updates on notified bodies: UL International (UK) Ltd address, contact details and EC link updated, BSI Healthcare EC link added, SGS named contact updated and LRQA was removed from the list.

The link also has the published guidance on how medical devices will be regulated.

Medicines and MHRA Instructions (UK Brexit)

Exit day is 31st October.

The MHRA today updated its instructions for the regulation of medicines, medical devices and clinical trials after Exit.

Here.

Please see the link on this page to other MHRA instructions issued,

Please check for situations where this comes within the scope of the Brexit Law being consolidated by Cardinal into base law and supplied to subscribers to Cardinal Environment EHS Legislation Registers & Checklists.

UK Brexit Preparedness – Medicines (UK Brexit)

Exit day is 31st October (127 days)

Today, 26th June, sees the following :

(1) Ministerial Statement – here

(2) Letter to Suppliers re Medicines – here

Ministerial Statement – extracts

Guaranteeing the supply of critical ‘category 1’ goods, including medicines, medical products, veterinary medicines and chemicals remains an essential element of the Government’s No Deal contingency planning. The Government is therefore undertaking steps to secure freight capacity for suppliers of these goods in a No Deal scenario.

The Department of Health and Social Care is starting the process of setting up an express freight contingency arrangement to support continuity of supply of medicines and medical products. This will be an urgent contingency measure for products requiring urgent delivery, within a 24-48 hour timeframe, if the UK leaves the EU without a deal. This express freight contingency arrangement forms part of the Department’s multi-layered approach, which includes rerouting medical supplies from the short strait crossings, extra warehouse space, stockpiling, buffer stocks, clarifying regulatory requirements, supporting traders to have all necessary paperwork in place at the border, and strengthening the processes used to deal with shortages to ensure that patients have uninterrupted access to medicines and medical products if the UK leaves the EU without a deal. Government will only pay for capacity as and when it is needed and used. This will be designed to cover all of the UK. The Department will be writing to industry to set out further details of these preparations.

The Department for Transport is putting in place a freight capacity framework agreement that will provide government departments with the ability to secure freight capacity for our critical supply chains as and when required. This framework does not commit the Government to purchasing or reserving any freight capacity, but it does provide a flexible list of operators and options for the provision of the capacity that can be drawn upon if needed.

In the coming months, the Government will make further announcements on its preparations for a possible No Deal Exit on 31 October, including on trade continuity agreements to limit disruption to our trade with third countries after we leave the EU.

Letter to Suppliers re Medicines – extracts

All no-deal preparedness plans should contain a mix of the following, depending on each company’s specific situation:

–  Secured capacity for rerouting freight away from the short straits after no-deal exit day, in order to avoid the worst restrictions on flow outlined above.

–  Stockpiling product above and beyond business-as-usual inventory levels; as a default, this is recommended as six weeks’ stock above business as usual inventory, the same as last time.

–  Assurance on the readiness of a company’s logistics and supply chains to meet the new customs and border requirements for both import and export (sometimes referred to as “trader readiness”).

Where companies have not yet done so [made a plan] the Government asks that they build a plan which includes a stockpile of an additional six weeks’ supply in the UK, on top of operational buffer stocks, in addition to developing a robust re-routing plan away from the short straits. As before, for products with a short shelf life or where production constraints mean stockpiling is not possible, for example, medical radioisotopes, we ask for alternative air freight plans to be made.

In the coming days, companies will be asked to provide information at product level, focused on the minimum key data set necessary for assurance of the programme. This will build on information from the 29th March exercise, including stock levels expected to be held on 31st October and plans for re-routing away from the short straits.