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.

UK updates to the TCA (Britain)

A little while ago, the Government announced (unilateral) new dates for the grace periods applying to GB goods movement to Northern Ireland under the IRl/NI Protocol. The Brexit Guidance was then updated.

The Government has now announced (unilateral) new dates for the grace periods applying to EU imports into Britain under the TCA (the UK-EU FTA). The Brexit Guidance will be updated.

We are announcing today a clear revised timetable for the introduction of controls, as follows:

• Pre-notification requirements for Products of Animal Origin (POAO), certain animal by-products (ABP), and High Risk Food Not Of Animal Origin (HRFNAO) will not be required until 1 October 2021. Export Health Certificate requirements for POAO and certain ABP will come into force on the same date.

• Customs import declarations will still be required, but the option to use the deferred declaration scheme, including submitting supplementary declarations up to six months after the goods have been imported, has been extended to 1 January 2022.

• Safety and Security Declarations for imports will not be required until 1 January 2022.

• Physical SPS checks for POAO, certain ABP, and HRFNAO will not be required until 1 January 2022. At that point they will take place at Border Control Posts.

• Physical SPS checks on high risk plants will take place at Border Control Posts, rather than at the place of destination as now, from 1 January 2022.

• Pre-notification requirements and documentary checks, including phytosanitary certificates will be required for low risk plants and plant products, and will be introduced from 1 January 2022.

• From March 2022, checks at Border Control Posts will take place on live animals and low risk plants and plant products.

Traders moving controlled goods into Great Britain will continue to be ineligible for the deferred customs declaration approach. They will therefore be required to complete a full customs declaration when the goods enter Great Britain.

Controls and checks on Sanitary and Phytosanitary goods are of course a devolved matter and we continue to work closely with the Devolved Administrations on their implementation, in particular with the Welsh Government on their timetable for completing supporting Border Control Post infrastructure in Wales.

The written statement is here.

GB goods movement to the EU is unaffected, i.e. the TCA applies in full.

New Animal Health Law (EU)

From 21st April 2021, the EU will operate a new single, comprehensive regulatory framework for animal health, replacing a miscellany of complex law. The instrument (amended in 2017) is here. It’s a 2016 dated EU Regulation 2016/429, and applies to terrestrial and aquatic animals, animal products, and pets. It does not directly deal with animal welfare.

Q&A on the EU Animal Health Law is here.

The EU Animal Health Law sets out requirements for:

• disease prevention and preparation (e.g. biosecurity measures) for eventual outbreaks, such as the use of diagnostic tools, vaccination and medical treatments;

• the identification and registration of animals and the certification and tracing of their consignments, as well as those of certain animal products (e.g. semen, ova, embryos);

• the entry of animals and animal products into the EU and movement within;

• disease control and eradication, including emergency measures such as restrictions on the movement of animals, killing and vaccination.

The EU’s Animal Health Law is supplemented in the following aspects:

• the approval of germinal product establishments and the traceability and animal health requirements for movements within the EU of germinal products of certain kept terrestrial animals;

• prevention and control of certain diseases;

• animal health requirements for the movements within the EU of terrestrial animals and hatching eggs;

• surveillance, eradication and disease free status for certain diseases;

• rules for aquaculture establishments and transporters of aquatic animals;

• rules for entry into the EU, and the movement and handling after entry of consignments of certain animals, germinal products and products of animal origin; and

• rules for establishments keeping terrestrial animals and hatcheries, and the traceability of certain kept terrestrial animals and hatching eggs;

• diseases subject to union surveillance programmes, its geographical scope and diseases for which disease-free status of compartments may be established.

A series of delegated Regulations and an implementing Regulation supplement the EU Animal Health Law.

Export Health Certificates (UK from 1st Jan 2021)

From 1 January 2021, an export health certificate (EHC) will be required to export products of animal origin from Great Britain (England, Scotland and Wales) to the EU or to move them to Northern Ireland.

The Animal and Plant Health Agency has issued information – here.

If located in Northern Ireland, an EHC is NOT required to export to the EU. Contact DAERA on 02877 442 060 to find out the stipulations.

GB to EU exports or GB to NI movements that are planned for 1 January 2021 onwards should be prepared for by registering to use the new EHC service and drafting applications for EHCs from 13 October 2020.

The official vet or inspector who will certify the EHC should be contacted before any applications are submitted to the EHC service.

The application process for the new EHC service is contained in this link – here.

In England, Scotland and Wales, call APHA on 03000 200 301.

Importing Animal Products etc from 1st Jan 2021 (UK Brexit)

The UK is in the Brexit Transition Period. From 1st January 2021, (it is expected) access is denied to the EU’s import system TRACES (Trade Control and Expert System).

Importers from non-EU should use the UK’s new Import of Products, Animals, Food and Feed System (IPAFFS) for imports of:

• live animals

• products of animal origin (POAO) subject to veterinary checks

• high-risk food and feed not of non-animal origin

• germplasm (also called germinal products)

• animal by-products not intended for human consumption (ABP) subject to veterinary checks

(non-EU) Health certificates and other documentation currently used for imports will be accepted by the UK for 6 months from 1 January 2021. Importers will then need to use a new UK health certificate.

(non-EU) Imports of high-risk food or feed of non-animal origin into the UK must continue to be made through a border control post (BCP), previously called a border inspection post (BIP) or designated point of entry (DPE).

(non-EU) Live animals, germplasm, POAOs and ABP that are subject to vet checks must continue into the UK through a UK border control post (BCP).

Further information is here. Note the IV66 form. This is to be used initially for imports from the EU, because the IPAFFS will not be used initially.

Products of animal origin (POAO) arriving in the UK from the EU will not need to notify using IV66 unless the consignment is coming from an EU member state with disease outbreak safeguard measures in place.

Imports from the EU of POAO will not need to be accompanied by a health certificate, unless a health certificate was required on the commodity before 31 January 2020.

The process for importing feed and food from the EU to the UK won’t change from 1 January 2021. There will be no additional controls or checks – if you did not use TRACES, you will not need to use IPAFFS or IV66.

Please read the attached information here, this Blog post is not a complete summary.

The UK also updated its list of Border Control Posts – here.

The UK also updated its guidance on trade agreements with non-EU countries (this is important for imports from non-EU) – here.

Animals and Animal Products Update (UK Brexit)

The Exit day is 12th April (day after tomorrow) – the Exit time is 12.00 (midnight) CET

(1) The EU has now listed the UK as a ‘third country’. This means the EU has accepted that the UK meets the health requirements for trade with the EU. It ensures that exports of animals and animal products can continue from the UK to the EU if the UK leaves the EU without a deal. This is following a meeting yesterday.

(2) The European Commission has confirmed that the current list of UK animal byproduct-registered or approved premises will be accepted. These premises will continue to be listed with the EU for the purpose of exporting animal byproducts to the EU.

The Department for Environment, Food and Rural Affairs (Defra) is preparing to confirm the list of these establishments with the EU.

(3) Defra is preparing to submit a list of establishments that want to export commodities other than animal byproducts to the EU.

Establishments can provide information and ask to be listed by emailing eulistings@food.gov.uk.

(4) The government will seek to bring into force UK-third country agreements from Exit day, or as soon as possible afterwards. But few are currently in force.

These new agreements will replicate existing EU agreements as far as possible. Where replacement trade agreements are not agreed, trade would take place on World Trade Organisation (WTO) terms with that country. Details of each agreement will be shared with parliament and the public when they have been agreed.

(5) At the moment there is no Border Inspection Post (BIP) in Calais. BIPs are under construction that had the intention of the French authorities to be operational by the end of March.

(6) UK access to TRACES after Exit day is not confirmed.

[the Exit day may change, please continue to follow this Blog]

Animal Products Import from the UK (Ireland Brexit)

The Exit day is 12th April (this Friday) – the Exit time is 12.00 CET (midnight)

UPDATE (10th April) : The EU has now listed the UK as a ‘third country’. This means the EU has accepted that the UK meets the health requirements for trade with the EU. It ensures that exports of animals and animal products can continue from the UK to the EU if the UK leaves the EU without a deal.

The Irish Department of Agriculture, Food and the Marine has published its Information Note on Animal Products Import (from the UK) – here.

It’s part of the DAFM series of Brexit Related Trader Notices and Information Notes – here.

The DAFM Animal Product Information Note repeats – when the United Kingdom (UK) will leave the European Union (EU), it will become a Third Country (i.e. a non EU member State).

Given that the UK will exit the Single Market on that date, there will be a requirement for EU Member States (including Ireland) to apply sanitary and phytosanitary (SPS) checks on all imports of animal products from the UK into the EU.

It continues – my comments in [ ]

This will mean that the importation of animal products from the UK into Ireland will have to meet certain requirements, including:

(1) The UK will have to be listed by the European Commission as a country approved to export the relevant products of animal origin to the EU.

[Presently, it is not. Third Country listing is expected to be granted by 12th April. – see UPDATE]

(2) The UK will have to be listed as having a residue plan approved in accordance with EU legislation.

(3) The establishment in the UK from where the animal product is dispatched must be listed as an EU approved establishment for that category of animal product in the EU’s TRACES system.

[The UK access to this is not confirmed after Exit. The status of EU approval of individual establishments is not published. Queries should be addressed to UK DEFRA.]

(4) Each consignment of animal products must be accompanied by an original health certificate, drawn up in conformity with the model under EU law for the particular product, completed and signed on behalf of the competent authorities of the UK.

[The status of health certification is not published, Queries should be addressed to UK DEFRA.]

(5) The consignment may only enter Ireland through an approved Border Inspection Post (BIP).

[Current Ireland BIPs are at Dublin Airport, Dublin Port and Shannon – here.]

[So far there is no indication where the BIP checks will be made for trade across the Irish Border (from Northern Ireland to Ireland).]

(6) At least 24 hours before the physical arrival of the consignment in Ireland, the person responsible for the load must complete Part 1 of the Common Veterinary Entry Document (CVED) in the EU TRAde Control and Expert System (TRACES).

[Note, UK access to TRACES is not confirmed.]

(7) The consignment must be presented to the BIP where it will be subjected to official controls. These official controls will include documentary checks and identity checks, and may include physical checks, including the taking of samples for laboratory testing.

(8) In addition, a declaration to Customs must be made of the intention to bring a consignment of products/animals into Ireland. The consignment must be declared to Customs using the Single Administrative Document (SAD) before the official controls at the BIP can be completed.

(9) Upon satisfactory completion of the required checks, the decision is entered in Part 2 of the CVED which must accompany the consignment to the first place of destination referred to in the CVED.

[In addition, animal products imported from the UK into Ireland will face tariffs.]

[the Exit day may change, please continue to follow this Blog]