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.

COVID status data and GDPR (England)

The European REGULATION (EU) 2016/679 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 April 2016 (on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) known as the GDPR – applies in the UK (UK GDPR).

UK GDPR applies to certain ‘processing’ of personal data. The ICO (the Information Commissioner’s Office) says –

If you are only conducting a visual check of COVID Passes (either a hard-copy document or a pass held on a digital device) and do not retain any personal data from it, this would not constitute ‘processing’. The activity would therefore fall outside of the UK GDPR’s scope.

However, if you are conducting checks digitally (for example, by scanning the QR code displayed on the pass), this would constitute processing of personal data – even if you do not keep a record of it. The UK GDPR would therefore apply.

If you make a record of any personal data, whether you conduct visual or digital checks, then you would be processing personal data and the UK GDPR would apply.

Article 9(1) of GDPR does not permit an employer to be in possession of employees’ personal and medical data. Article 9(2) sets out situations where the employer might have Covid status data.

The ICO says –

A person’s COVID status is health data, which has the protected status of ‘special category data’ under data protection law. This means it requires extra protection. You must also identify an Article 9 condition for processing. The two you could consider are:

• the employment condition; or

• the public health condition.

If you intend to rely on the public health condition, you must ensure that either a health professional carries out the processing, or that you tell people you are treating their COVID status as confidential and would only disclose it in clearly defined circumstances.

Consent is rarely appropriate in an employment setting given the imbalance of power between the employer and employee. Similarly, consent is unlikely to be appropriate where checking a COVID pass is a condition of entry to your premises. This is because you cannot consider consent to be ‘freely given’ in these circumstances.

This generally means that COVID status data cannot be held.

The ICO provides detailed information on the steps to be gone through if COVID status information is to be asked for, and held – here.

Framework for Better Regulation (UK)

The government yesterday initiated a consultation on its plans to reform its Framework for Better Regulation. The consultation is here.

Better Regulation is a principles-led process of evaluating legislation before it’s proposed and enacted, and then after it is enacted. Better Regulation also exists at EU level.

In the UK, (per the explanation in the document) –

Better Regulation is designed to ensure that government regulation is proportionate and is only used where alternative non-regulatory approaches would not achieve the desired policy outcomes. The framework enables ministerial decisions to be based on robust analysis of the costs and benefits of different options, including the direct costs on businesses, and means that decision making is clear and transparent. The framework helps ensure that new burdens are only imposed where there is clear evidence they will generate sufficient benefits for society, and that measures are implemented and enforced in a way that is easier for businesses to deal with.

The revisions propose increasing the outcomes orientation of regulation –

(1) delegating more power and discretion to the UK’s regulatory bodies, removing many of the detailed rules in the existing statutory frameworks to make them less prescriptive (replacing them with outcomes to be achieved), and allowing the regulatory regime to be shaped more by case law.

(2) Parliament should set out only what is prohibited or the outcomes to be achieved, in plain English, and set out any parameters within which regulators would need to operate to meet these outcomes, but then giving regulators appropriate powers and discretion over how to do so, rather than legislation setting out all of the rules that businesses have to comply with in detail.

(3) regulators would still set out some detail in rules and guidance but would have flexibility to change these without having to petition the Government to introduce further legislation. This would give regulators the freedom to regulate based on whether the outcomes set by Parliament are being achieved rather than whether a particular rule has been followed. Where regulators provide for detailed rules or processes, they would also be able to provide for exemptions and waivers to reach the outcomes set out by Parliament in the most sensible way.

The Government wants to identify areas where the envisaged benefits of a move to a less codified, more common law focused approach are likely to be the greatest, and areas where the Government should be more cautious about adopting such an approach.

The government is also seeking responses on its proposals to replace the Precautionary Principle with a Principle of Proportionality. Pages 21 and 22 in the consultation document set this out. This would be a major departure.

Please read the other sections of the document for further questions.

Consultation ends 1st October 2021.

[if the focus changes to a more outcomes-led Regulation in the UK (Britain) in this manner, then we would, in Cardinal Environment, need to start analysing and reporting on case law (i.e. the common law as this document puts it) in this jurisdiction]

New Energy Performance Bill (UK)

A new private members’ bill is starting in the House of Lords on 21st July. The bill is titled ‘Minimum Energy Performance of Buildings Bill’. The Bill document is here.

In its policy statements, the Government has said –

• Homes should be Energy Performance Certificate (EPC) band C by 2035 where practicable, cost-effective and affordable

• All Private Rented Sector (PRS) homes should be EPC band C by 2028

• Mortgage lenders should ensure an EPC band C average for their portfolios by 2030

• The Secretary of State to take reasonable steps to assist owner occupiers to achieve EPC band C

• Non-domestic commercial lettings are to achieve EPC band B by 2030

The Bill aims to set these into law.

For a Private Members’ Bill to become law, the government has to support it (in effect take it over).

I will post again if this happens.

A Private Members’ Bill of similar title is also started in the House of Commons (text not available).

PPE Duty amendment (Britain)

The HSE has today (19th July) launched a consultation here, on proposed changes to the Personal Protective Equipment at Work Regulations 1992 (PPER). Consultation closes on 15th August.

Currently, employers have a duty to their ‘employees’ in respect to PPE – changes to the PPER will ensure this duty also extends to ‘limb (b) workers’, and will apply in England, Scotland and Wales.

In the PPER, PPE is defined as “all equipment (including clothing affording protection against the weather) which is intended to be worn or held by a person at work and which protects the person against one or more risks to that person’s health or safety, and any addition or accessory designed to meet that objective.”

This Blog does not extend to employment law, but note in Britain there are two main employment statuses for employment rights: ‘employee’ and ‘worker’. Employees are defined as limb (a) and workers are defined as limb (b) in the Employment Rights Act 1996 s.230: [we do not supply the ERA or advise on it]

..an individual who has entered into or works under– (a) a contract of employment; or (b) any other contract, whether express or implied and (if it is express) whether oral or in writing, whereby the individual undertakes to do or perform personally any work or services for another party to the contract whose status is not by virtue of the contract that of a client or customer or any profession or business undertaking carried on by the individual. [my bold]

According to the HSE consultation document – Generally, limb (b) workers:

• carry out casual or irregular work for one or a number of organisation(s),

• receive holiday pay, but not other employment rights such as the minimum period of statutory notice, after one month of continuous service

• only carry out work if they choose to

• have a contract or other arrangement to do work or services personally for a reward (the contract doesn’t have to be written) and they only have a limited right to send someone else to do the work, for example, swapping shifts with someone on a pre-approved list (subcontract)

• are not in business for themselves (they do not advertise services directly to customers who can then also book their services directly)

Specific PPE required and provided for in the below health and safety regulations is not part of this HSE consultation – PPE required in relation to:

• lead exposure – Control of lead at work

• ionising radiation – Work with ionising radiation    

• asbestos – Managing and working with asbestos   

• substances hazardous to health in the workplace (for example: chemicals, fumes, dusts, non-water vapours, non-water mists, nanotechnology, and/or gases) – Control of substances hazardous to health

• noise – Controlling noise at work

FTA UK & Iceland, Liechtenstein, Norway (UK)

Thursday 8th July, trade ministers from Iceland, Liechtenstein and Norway signed a free trade agreement (FTA) with the UK. Conclusion of negotiations on an FTA had been announced on 4th June, and Norway had published the text (English language starts at page 105).

The UK trade minister made a statement to Parliament (8th July) – here.

Norway’s minister of trade and industry remarks at 4th June press conference on the matter – here, Norway’s press release (4th June) here.

The signed legal text will be published in the UK shortly, along with the Explanatory Memorandum that is a statutory requirement under the Constitutional Reform and Governance (CRaG) Act.

The Explanatory Memorandum provides the context, explaining what the new treaty is meant to achieve, what legislation (if any) will be needed to implement it, when it will take effect, the financial implications, and the territorial application of the agreement.

I will blog post again when the further documents are published.

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.