EU Law Revocation (Northern Ireland)

I had earlier written that the REUL Bill does not apply to Northern Ireland. This is incorrect. As currently drafted, the Bill applies to Northern Ireland, and so it’s accommodation of the pre-existing Northern Ireland Protocol is not presently understood.

The Bill is back in Parliament today for its Third Reading in the House of Commons.

I will commence compiling the list of laws pertaining to Northern Ireland affected by the Bill. This will load onto subscribers Northern Ireland systems shortly, and updates included in the monthly Email Alerts. This list will also identify those of the cohort also listed in the Northern Ireland Protocol. If a document is listed in the Northern Ireland Protocol, it also applies in Northern Ireland, even if identified for deletion under the Bill.

Note: the list pertaining to Britain and the devolved administrations in Britain (Scotland and Wales) is already loaded onto subscribers systems for these jurisdictions.

I will Blog post again, if the Government accepts any amendments arising from the Report stage, being debated later today.

The later stages in the Lords (of enactment of this Bill) could also make amendments, that may or may not be accepted by the Government. Further Blogs on the matter can be expected.

SPS Border Posts Construction (Northern Ireland)

The UK Government has enacted The Official Controls (Northern Ireland) Regulations 2023, in force on 2nd February 2023.

These Regulations make provision allowing the Secretary of State to implement specific elements of Article 64 of European Regulation (EU) 2017/625 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, in Northern Ireland.

The EU document applies in Northern Ireland by virtue of the Withdrawal Agreement.

Regulation 3 provides that the Secretary of State may do anything that the Secretary of State considers appropriate in connection with the construction of facilities for the purpose of performing official controls.

It also makes provision for the Secretary of State to direct the competent authority in Northern Ireland to recruit and employ staff to implement Article 64 in Northern Ireland.

As a result, border post construction for the purposes of SPS checks on goods likely to cross the border into the EU (on the island of Ireland) can be expected to commence.

EU-UK Withdrawal Agreement Joint Committee (Northern Ireland)

The EU-UK Withdrawal Agreement (an international agreement) is overseen by a Joint Committee of the parties. This Joint Committee holds regular meetings, the last meeting was in June 2021. Specialised Committees operate under the auspices of the Joint Committee, these also meet regularly. The last meeting of the Specialised Committee for the Withdrawal Agreement Ireland/Northern Ireland Protocol was in September 2021. The EU tracks these meetings here. The UK tracks these meetings here. You will notice that the statements made re the Ireland/Northern Ireland Protocol are not Joint Statements. This is the case also re Gibraltar.

The next meeting of the Joint Committee is next week, but the agenda is not published.

Meanwhile, the Northern Ireland Executive is not operating (this has happened before). An executive order to stop checks on goods moving from Britain to Northern Ireland is stayed by the Northern Ireland High Court pending a decision of a Judicial Review of that order due early March (in 2021 the Northern Ireland High Court quashed a similar order). Also May is a month in which elections to the Northern Ireland Assembly are scheduled.

In advance of the Joint Committee meeting next week, Irish and EU representatives are discussing matters with Northern Ireland political parties, business and civil society representatives. Checks on goods moving between Britain and Northern Ireland are continuing. In the absence of a Northern Ireland Executive, civil servants will attend the Joint Committee.

The Joint Committee may also consider other matters (the Withdrawal Agreement has other protocols, and five Specialised Committees). The agenda will give more information.

I will update this post (on the blog platform) after the Joint Committee meeting.

Further Border Control Delays (UK)

The UK government recently announced that movement of goods from GB to Northern Ireland (occurring under the grace arrangements in the Northern Ireland Protocol – NIP) would continue in the current manner indefinitely.

The UK government also recently announced that CE marked goods would continue to circulate in GB for the entire 2022. CE marked goods circulate in Northern Ireland by virtue of the NIP. This was included in the August Email Alert.

This morning, the UK government confirmed – here

• The requirement for pre-notification of agri-food imports will be introduced on 1 January 2022 as opposed to 1 October 2021.

• The new requirements for Export Health Certificates, which were due to be introduced on 1 October 2021, will now be introduced on 1 July 2022.

• Phytosanitary Certificates and physical checks on SPS goods at Border Control Posts, due to be introduced on 1 January 2022, will now be introduced on 1 July 2022.

• The requirement for Safety and Security declarations on imports will be introduced as of 1 July 2022 as opposed to 1 January 2022.

The timetable for the removal of the current easements in relation to full customs controls and the introduction of customs checks remains unchanged from the planned 1 January 2022.

EU further detail re NI Protocol (Northern Ireland)

The EU issued (a few days ago) a set of non-papers that give further detail on its proposals for changes to its Single Market rules to ease movements between NI and GB under the Ireland/Northern Ireland Protocol (a schedule to the UK-EU Withdrawal Agreement).

The first set deals with sanitary and phytosanitary (SPS) – here.

(1) re guide dogs (assistance dogs) – European Commission’s services had clarified (some time ago) that assistance dogs accompanying their owner when entering the EU territory and Northern Ireland, may benefit from the flexibility offered by Article 32 of Regulation (EU) No 576/2013 on the non- commercial movement of pet animals.

The above was recalled in the technical meetings the EU held with the UK Cabinet Office and the British DEFRA ministry, especially those held on 27 April and 12 May 2021, where the UK side confirmed that the Northern Ireland ministry DAERA would propose an operating procedure for the practical implementation of Article 32.

DAERA updated its guidance on 2 June 2021 – here.

(2) re identification and re-identification of cattle, sheep and goats – the document points out that EU rules on traceability of terrestrial animals require that certain species (bovines, ovines, caprines, camelids and cervids) shall be individually identified on the establishment where they are born. The same requirement applies to animals of those species when they enter into the Union from a non-EU country; those animals have to be individually identified at the establishment of arrival.

Under the EU animal health legislation (Delegated Regulation (EU) 2019/2035), bovine, ovine and caprine animals need to be identified with an eartag bearing a code as laid down in Implementing Regulation (EU) 2021/520 so that the first element of the identification code is the country code of the Member State where the means of identification was first applied to. The country code can be either a two-letter code (mirroring ISO standard 3166-1 alpha-2) or a three-digit country code (ISO standard 3166-1 numeric).

The EU has now issued Implementing Regulation (EU) 2021/1064 to provide that ‘XI’ is the two-letter code to be used in United Kingdom in respect of Northern Ireland and the three-digit code assigned is ‘899’.

–  New-born animals in NI after 01/07/21 should bear the “XI or “899” code in their eartags;

–  Animals introduced from third countries (or GB) into NI after 01/07/21 and identified not in accordance with EU rules (e.g. bearing a UK code) should be re-identified with eartags bearing “XI” or “899” establishments of the first arrival;

–  Animals introduced from third countries (or GB) into NI already identified in accordance with EU rules (e.g. bearing a XI code) do not need to be re-identified.

It must be remembered that EU Animal Health Law already moved on since 31st Dec 2020.

(3) re re-entry of animals for exhibitions/events – the document points out that EU animal health legislation (Delegated Regulation (EU) 2020/692) stipulates ungulate animals (except racing horses) to be introduced into the EU have to fulfil all the requirements and respect a residency period of 6 months in an authorised third country of origin for such imports.

To enable the participation of EU animals in events, exhibitions or shows, the Commission has drafted an amendment to Delegated Regulation (EU) 2020/692 to set up for certain species of ungulates (bovine, ovine and caprine animals) :

* a derogation from certain general requirements, including from the 6 months residency in the “guest” country;

* minimum specific animal health requirements for the re-entry into the Union of those animals:

–  they are moved for a period not exceeding 15 days to participate in events, exhibitions;

–  the third country is listed for the entry into the EU of cattle, sheep, goats;

–  the establishment complies with the requirements for assembly operations of ungulates;

–  the transport is direct and in appropriate vehicles;

–  the animals do not have contact with animals of a lower health status during the stay in the third country.

In addition, the Commission has drafted a new legal text (amending Implementing Regulation (EU) 2021/403 as regards the new model certificate and amending Regulation (EU) 2021/404 as regards the list of third countries authorised) to lay down:

–  a specific model certificate for entry into the EU of those animals reflecting the requirements described above;

–  the list of third countries authorised for this special re-entry into the EU of animals which took part to such events.

(4) re animal products that originate in the Union and move to a third country and then move back again after unloading, storage and reloading in that third country

The document states that animal health policy for entry into the EU of products of animal origin does not allow third countries to certify for import into the EU products which have been imported in that third country, including products of EU origin.

Therefore, the EU’s Implementing Regulation (EU) 2020/2235, which establishes the model certificates for entry into the EU of products of animal origin, does not include any model certificate to cover the entry into the Union of products of animal origin which originate in the EU and which are moved to a third country or territory, and are then moved back to the Union from that third country or territory after unloading, storage and reloading.

The lack of such certificate model would prohibit EU products of animal origin to re-enter the EU after being stored in a third country.

The Commission has drafted a new Implementing Regulation amending Implementing Regulation (EU) 2020/2235 to add a model certificate for that purpose. This will allow re-entry into the EU of products of EU origin which are packaged and stored under the control of the competent authority of the third country.

The change will also amend Annex XXII to Implementing Regulation (EU) 2021/404 to establish a list of third countries that are authorised to use that certificate (including GB and the Crown Dependencies).

A separate non-paper addresses medicines – here.

This document points out that medicines placed on the market in Northern Ireland (NI) must be covered by a valid marketing authorisation issued by the Commission (EU-wide authorisations) or the UK for NI in applying the Union legislation for medicinal products listed in Section 20 of Annex 2 to the Ireland/Northern Ireland Protocol (UK national authorisations).

The Protocol provides for two possible UK national authorisation routes: purely UK national authorisations (“NI-only authorisations”), which concern medicines that are made available in NI only, and UK national authorisations granted via the Mutual Recognition or Decentralised Procedures (MRP/DCP), which is mandatory.

European Commission Notice of 25 January 20212 provides for a grace period of one year (until end-December 2021) for maintaining batch testing and manufacturing / logistics in Great Britain (GB) to ensure undisrupted supply of medicines to NI and those EU Member States (Cyprus, Ireland and Malta) that have been historically dependent on medicines supply from or through GB.

Bear in mind that medicines supply in Northern Ireland is the responsibility of the UK authorities, not the EU.

The EU is now proposing that regulatory compliance functions may exceptionally be located in UK (GB) in respect of medicines covered by any national authorisations issued by the UK authorities in respect of NI, provided that the following conditions are met:

a. the UK fully applies the relevant Union legislation on medicines: on quality, safety, efficacy, pharmacovigilance and batch testing and release when issuing national marketing authorisations in respect to NI;

b. the marketing authorisation contains a legal prohibition of sale (resale) outside its geographical scope: medicines with an authorisation for UK(NI) cannot be legally sold anywhere else in the EU and the specific authorisation code for NI is stamped on each pack;

c. the safety features required under applicable Union law are placed on each pack ensuring that medicines can only be sold in conformity with a valid marketing authorisation in NI;

d. the UK ensures and demonstrates the correct implementation/application of the Falsified Medicines Directive in respect of NI. The EU end-to-end verification system must generate an alert if a medicine specifically authorised for NI is scanned elsewhere in the EU Internal Market;

e. enforcement and supervision by the UK competent authorities on economic operators and regulatory compliance activities located in GB are carried out in accordance with applicable Union law.

The document sets out additional requirements.

Information on the EU’s controls on medicines for human use is – here.

Bear in mind that the UK has signed up to the separate (non-EU) Project ORBIS and the MHRA has issued its first authorisation here. I wrote a blog post about this at the time.

Bear in mind that the BGMA has issued a press release about withdrawal of medicines a few days ago – reported by the BBC – here. The BGMA press release is – here.

EU announcements re NI Protocol (Northern Ireland)

The Protocol on Ireland and Northern Ireland (often referred to in the UK as the Northern Ireland Protocol), as an integral part of the EU-UK Withdrawal Agreement, was agreed jointly and ratified by both the EU and the UK. It has been in force since 1 February 2020 and has legal effects under international law.

The EU has announced the following re Northern Ireland (as respects the NI Protocol):

(1) the EU extends the non-application of third country rules (grace period) for meat products to 30th September (1st October is the date when the UK will apply its own ban on chilled meat imports) – the EU declaration is here – the UK declaration is here.

This will mean that meat products can continue to move from Britain (a third country in EU terms) to Northern Ireland (a part of the UK subject to the NI Protocol).

This temporary solution is subject to strict conditions. For example, the meat products that are subject to the channelling procedure referred to in the United Kingdom’s unilateral declaration must remain under the control of the Northern Ireland competent authorities at all stages of that procedure. These meat products must be accompanied by official health certificates issued by the UK competent authorities, can exclusively be sold to end consumers in supermarkets located in Northern Ireland, and must be packed and labelled accordingly. (EU declaration)

(2) the EU will change its own rules so that regulatory compliance functions for medicines authorised by the UK for the Northern Ireland market, in accordance with the NI Protocol, may be located in Britain, subject to specific conditions ensuring that the medicines concerned are not further distributed in the EU Internal Market – the European Commission will put forward a legislative proposal in the early autumn (the grace period runs out at the end of 2021)

(3) the EU will facilitate the movements of guide dogs accompanying persons travelling from Britain to Northern Ireland – this is communicated to the UK authorities and it is for the Northern Irish competent authorities to define the details for its implementation on the ground

(4) the EU waives the obligation to show the motor insurance Green Card for drivers from the UK – applicable for Northern Irish motorists crossing the border into Ireland (not for British motorists travelling to Ireland)

(5) the EU has removed the need for re-tagging when animals move multiple times between Britain and Northern Ireland during their life – the European Commission adopted an implementing act to that effect on 29 June 2021 (Commission Implementing Regulation (EU) 2021/1064).

The EU also announces the European Commission is working on a regulatory solution to facilitate the swift return of livestock to Northern Ireland from exhibitions or trade fairs in Britain, so that the animals concerned will not have to wait for a minimum residency period in Britain – the relevant delegated and implementing acts will be adopted in October 2021.

The EU also announces work is ongoing on a solution regarding the risk control of scrapie, to facilitate the movement of sheep and goats between Britain and Northern Ireland.

EU Eco-design & labelling rules (Britain)

The UK government has decided to introduce EU Ecodesign and Energy labelling rules for lighting products in Britain in 2021 (if there is parliamentary time).

The UK government decision is set out here, and here.

In the EU from 1 September 2021, the existing rules under Regulation (EU) No 874/2012 will be repealed and replaced by new energy labelling requirements for light sources under Regulation on energy labelling for light sources (EU) 2019/2015

The new EU rules will use a scale from A (most efficient) to G (least efficient), the new labels will give information on the energy consumption, expressed in kWh per 1000 hours and have a QR-code that links to more information in an online database.

In the EU, with the new regulation, most halogen lamps and the traditional fluorescent tube lighting, which are common in offices, will be phased-out from September 2023 onwards.

Note : the UK government earlier decided to rescale the energy labels for some energy-related products from 1 March 2021, following the EU. The legislation is not yet adjusted. The Office for Product Safety and Standards (OPSS) issued technical notices, and the UK government updated the information on gov.uk and responded to email queries from businesses. I blog posted at the time about this change. The updated guidance is found in the Brexit Guidance List on subscribers’ Cardinal Environment Limited EHS Legislation Registers & Checklists.

Note (2) : the EU rules will apply in Northern Ireland by virtue of the Northern Ireland Protocol.

First Project Orbis Cancer Treatment Authorisation (UK)

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has just announced its first authorisation (of a post-surgery lung cancer treatment) under Project Orbis.

Project Orbis is a programme coordinated by the US Food and Drug Administration (FDA) to review and approve promising cancer treatments.

It involves the regulatory authorities of:

• Australia (TGA)

• Canada (Health Canada)

• United Kingdom (MHRA)

• Singapore (HSA)

• Switzerland (Swissmedic)

• Brazil (ANVISA)

The UK joined Project Orbis on 1 January 2021 following its departure from the EU (and the European Medicines Agency with the ending of the Brexit transition period on 31 Dec 2020). While the FDA serves as the primary coordinator for application selection and review, Project Orbis Partners (POPs) may propose products for inclusion in the scheme. Each country remains fully independent on their final regulatory decision. Applications submitted to the MHRA within a Project Orbis procedure are national (Great Britain only) marketing authorisation applications and variations.

Per the MHRA press release – Osimertinib (Tagrisso), a medicine made by AstraZeneca, is a licensed treatment for patients with mid and later stage non-small cell lung cancer (NSCLC) who test positive for a specific gene mutation called EGFR. EGFR mutations occur in approximately 12% of lung cancer patients. The licence has now been extended to include a new population of patients in early-stage disease. The extended licence offers a novel treatment option for these patients, after their cancer has been surgically removed, in an area of significant unmet need.

NHS England, NICE (the National Institute for Health and Care Excellence) and AstraZeneca have reached an agreement to enable early access to osimertinib for early-stage lung cancer patients in England on a budget-neutral basis to the NHS while NICE undertakes its appraisal.

The MHRA press release is here. The press release sets out further detail.

Please note different Medicines supply stipulations apply in Northern Ireland from 1 Jan 2021 – here.

Northern Ireland 100 Years (Northern Ireland)

Today (3rd May 2021) is the centenary of the political entity known as “Northern Ireland”, and 100 years from the date of connected customs and other border controls.

The UK House of Commons Library published today a briefing paper on the origins and development of the Northern Ireland borders. This paper is here.

Key points are set out below –

(1) Claims by England over the island of Ireland and its peoples date from the 12C.

(2) The Government of Ireland Act 1920 (UK) – Royal Assent on 23 December 1920, created devolved parliaments in “Northern Ireland” and “Southern Ireland”. An administrative boundary was to divide the two.

(3) The separate parliaments of Northern and Southern Ireland were given legal basis (UK) by Order in Council under the 1920 Act on 3 May 1921 (hence 100 years as respects Northern Ireland).

(4) The Anglo-Irish Treaty signed 6 December 1921, allowed Northern Ireland to “opt out” of coming under the jurisdiction of the declared Irish Free State (Ireland), which it did on 7 December 1922. This triggered a Boundary Commission, which was to revise the boundary between NI and the Free State.

(5) In the interim, a customs frontier was erected along the Northern Ireland/Free State border on 1 April 1923. This “hardened” the boundary for the first time. Cross-border roads were identified as “approved” or “unapproved”; duties were payable on many commercial goods.

(6) The Tripartite Boundary Agreement of 3 December 1925 confirms the existing border.

(7) The 1937 Constitution (Ireland) formally renames the ‘Southern Ireland’ state Ireland.

(8) 26 counties of Ireland explicitly become a Republic under the terms of the Republic of Ireland Act 1948 (Ireland), definitively ending membership of the British Commonwealth on 18 April 1949, further strengthening the border as an international frontier. The Ireland Act 1949 (UK) subsequently confirms that the “consent” of the NI Parliament is required to end or alter partition.

(9) When the IRA launch “Operation Harvest” in 1956, the border is “securitised” for the first time, with “unapproved” routes cratered or spiked. This happens again in August 1970 as a response to “The Troubles”:

(10) Both Ireland and the UK accede to the then European Economic Community on 1 January 1973. As a result, the border between the two becomes softer, but customs checks remain in place, as does the Common Travel Area (that exists between the UK and Ireland).

(11) Following the Single European Act of 1986, customs checks cease at what the UK HM Customs & Excise call the “Northern Ireland Land Boundary” at midnight on 31 December 1992. Only the border’s security aspects remain.

(12) The Belfast/Good Friday Agreement is endorsed in a referendum (Northern Ireland) on 22 May 1998. A referendum is also held on the same day in Ireland. Although the Belfast/Good Friday Agreement does not explicitly rule out a “hard” border in Ireland, it does commit the UK Government to removing security installations.

(13) On 1 January 2021 the Northern Ireland Protocol (under the EU-UK Withdrawal Agreement) comes into effect. This avoids “customs and regulatory checks or controls and related physical infrastructure at the border between Ireland and Northern Ireland” by creating an “Irish Sea border”.

Under the Protocol, Northern Ireland remains aligned to a number of European Union rules, as set out in the Protocol’s Annexes. These include the Union Customs Code and the Official Controls Regulation on food and animal products. As a result, traders moving most commercial goods from Britain to Northern Ireland (but not from Northern Ireland to Britain) are required to meet certain customs requirements and – in the case of products of plant or animal origin – various Sanitary and Phytosanitary (SPS) requirements.

To do this, traders are required to make customs declarations, and in some cases pay tariffs. Traders must also provide Export Health Certificates (EHCs) for agri-food goods. These documents, and the goods themselves, may also be subject to checks. The UK-EU Joint Committee (provided for by the EU-UK Withdrawal Agreement) has (to date) agreed a number of exceptions whereby these requirements could be reduced for certain authorised traders: for example, the so- called “grace periods” during which supermarkets and their suppliers are permitted to move food products into Northern Ireland without an EHC, provided certain other conditions are met.

Under the terms of the EU-UK Withdrawal Agreement, the 90 members of the Northern Ireland Assembly have the periodic power (after 31 December 2024) to decide whether to terminate or continue the Protocol arrangements. If the former, then the Joint Committee is obliged to make alternative proposals to the UK and EU in order to avoid a hard border on the island of Ireland.

UK updates to Northern Ireland Protocol (Northern Ireland)

The Secretary of State for Northern Ireland announced (unilateral) via written ministerial statement today the following –

For supermarkets and their suppliers, as part of the operational plan the UK committed to at the UK-EU Joint Committee on 24 February, the current Scheme for Temporary Agri-food Movements to Northern Ireland (STAMNI) will continue until 1 October. Certification requirements will then be introduced in phases alongside the roll out of the Digital Assistance Scheme.

In addition, further guidance will be provided later this week on parcel movements from Great Britain to Northern Ireland to provide necessary additional time for traders beyond 1 April. Guidance will also be set out to help address practical problems on soil attached to the movement of plants, seeds, bulbs, vegetables and agricultural machinery. And the Government will write to the Northern Ireland Executive to confirm that flexibilities within the Official Controls Regulation 2017/625 are such that no charging regime is required for agri-food goods.

The ministerial statement is here.