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.

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.

UK relations with EU (UK)

The UK government has brought back Lord (David) Frost, its EU-UK Trade and Cooperation Agreement (TCA) negotiator, to lead UK relations with the EU as a Cabinet Minister (scrutinised by Lords select committee). He will be the UK lead (co-chair with the EU) of the two key committees (replacing Michael Gove CDL) –

(1) The Joint Committee of the 2020 EU-UK Withdrawal Agreement (WA) – a key workload is the IRL/NI Protocol functioning

(2) The Partnership Council set up under the 2020 TCA

These two images depict the TCA work ongoing. The various committees and sub-committees of the Partnership Council are not yet announced.

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.

Northern Ireland (& separately CLP) (from 1 Jan 2021)

The UK government tonight published its details for the new arrangements that will apply in Northern Ireland re NI goods trade with Britain and with the EU – here.

This has also clarified some issues re trade across the UK and the EU, including re the new GB CLP that will replace the European Union (EU) CLP Regulation in Britain. Note, British mandatory classification and labelling (GB MCL) will replace the EU harmonised classification and labelling system in Britain (not Northern Ireland. Also, references to the Internal Market Bill on the HSE web pages (on both GB and NI CLP) are now out of date.

The EU CLP will continue to apply in Northern Ireland.

We will update the Brexit Consolidated Law List, to add the GB CLP in the middle section. This will show Orange as a work in progress. Those of you who have asked for CLP to be included in the Brexit Consolidated Law List, will receive an email.

We will update the Brexit Guidance List, to add and update the links for the new NI Guidance applying from 1 Jan 2021, some of this exists as date updates to existing NI links in this List.

These Lists are found in Cardinal Environment EHS Legislation Registers & Checklist, and are talked about in the monthly Email Alerts.

We strongly advise getting to grips with the guidance links in the Brexit Guidance List.

Trader Support Service (Northern Ireland)

HMRC today advises the Trader Support Service is now available to be signed up to.

The Trader Support Service is established to assist persons moving goods between GB and Northern Ireland.

The Sign Up is here (on the Trader Support Service website).

The HMRC announcement is here.

UK implementation of Ireland/Northern Ireland Protocol (Northern Ireland)

The UK government has today published its approach to implementing the Ireland-Northern Ireland Protocol of the Withdrawal Agreement that was signed with the European Union.

The Protocol sets up special arrangements that stem from the Withdrawal Agreement and apply in Northern Ireland from 1st January 2021, until at least 2024, when the first four-year consent vote process contained in the Protocol is initiated.

The Protocol covers a range of areas: human rights, the Common Travel Area, customs and trade, regulation of manufactured goods, the Single Electricity Market, some limited state aid provisions, and VAT and excise. The paper published today sets out the UK’s thinking in all of these areas. But the core of the Protocol is the provisions on customs and trade. It is these areas which are covered in most detail in the document.

It is the responsibility of the UK Government and UK authorities to give effect to the Protocol in Northern Ireland. The Protocol has as Annex 2, a list of EU law that will continue to apply in Northern Ireland – at least 2021 to 2024.

The UK approach is set out in a Cabinet Office Command Paper – here.

The paper sets out four key commitments that will underpin the UK Government’s approach to implementing the Protocol:

• There will be unfettered access for Northern Ireland’s producers to the whole of the UK market and this will be delivered through legislation by the end of the year.

• No tariffs will be paid on goods that move and remain within the UK customs territory

• Implementation of the Protocol will not involve new customs infrastructure – with any processes on goods moving from Great Britain to Northern Ireland kept to an absolute minimum so that the integrity and smooth functioning of the UK internal market is protected.

• Northern Ireland’s businesses will benefit from the lower tariffs delivered through our new Free Trade Agreements with countries like the United States, Australia, New Zealand and Japan – ensuring Northern Ireland firms will be able to enjoy the full benefits of the unique access they have to the GB and EU markets.

Today’s publication also sets out plans to establish a new business engagement forum, which will meet regularly to allow Northern Ireland’s businesses to put forward proposals and provide feedback on how to maximise the free flow of trade. The Northern Ireland Executive will be invited to join the forum.

The Withdrawal Agreement is administered by a Joint EU-UK Committee set up under the Agreement, and both the Agreement and the Protocol have dispute mechanisms.

More detail is expected, and accordingly I will write more Blog posts.

COVID-19 New State Guidance (Northern Ireland)

England yesterday issued new state guidance, and Ireland (the Republic) issued a Roadmap some days ago (see recent posts about these).

Northern Ireland has now issued new state guidance – here.

Unlike England and the Republic, Northern Ireland is not proposing specific target dates.

Apart from garden centres reopening, no changes to workplace restrictions are proposed. The next review is 28 May.

Withdrawal Agreement Ireland/Northern Ireland Protocol (Northern Ireland)

I posted earlier about the first meeting of the EU-UK Withdrawal Agreement Joint Committee. The first meeting of the Specialised Committee that deals with the Ireland/Northern Ireland Protocol has also been held. Note, this Specialised Committee will also have a specific advisory group report to it.

The Ireland/Northern Ireland Protocol is a particularly tricky aspect of the EU-UK Withdrawal Agreement that was signed late in 2019. It requires new arrangements to be set up for Northern Ireland. I have posted about this before.

The EU issued (and published) on 30 April a Technical Note on the implementation of the Protocol – here.

At various points, EU Technical Note reminds that from the end of the transition period, the UK has committed to apply in Northern Ireland the provisions of EU law listed in Annex 2 to the Protocol relating to sanitary and phytosanitary (SPS), products, and goods requirements.

The altered Cardinal Environment EHS Legislation Registers and Checklists for Northern Ireland will have these Annex 2 EU Law identified at the head of the Registers. We are working to the 31st December 2020 deadline for these alterations.