COP26: lead up

EU Environment Ministers, Environment Council of 6 October 2021, approved conclusions setting out the EU’s position for the United Nations climate change summit (COP26) in Glasgow, UK – here.

ECOFIN (5th October 2021) conclusions on climate finance are here.

COP26 aims to bring countries together to accelerate action towards the goals of the Paris Agreement. The Paris Agreement (PA) was adopted in 2015 at the UN Climate Change Conference (COP 21) and entered into force on 4 November 2016.

It counts to date 191 countries and the European Union, and sets two main goals –

(1) limiting the global average temperature increase to well below 2°C above pre-industrial levels, and pursuing efforts to limit it to 1.5°C,

(2) adapting to the unavoidable impacts of climate change while making finance flows consistent with climate-resilient development.

The main goals of COP26 are to encourage parties to come forward with ambitious Nationally Determined Contributions (NDCs) that establish their emission reduction targets for 2030, to discuss adaptation measures, to increase climate finance and to finalise the Paris Rulebook (the detailed rules that make the Paris Agreement operational).

The state of NDCs is collated in the interim NDC Registry, the latest NDC Synthesis Report is 17th September 2021 (NDCs submitted and recorded to 30 July 2021). NDCs contain information on targets, and policies and measures for reducing national emissions and on adapting to climate change impacts.  NDCs also contain information on either the needs for, or the provision of, finance, technologies and capacity building for these actions. Countries communicate new or updated NDCs to the interim NDC Registry every five years starting in 2020. The interim NDC Registry is here.

The state of domestic mitigation measures (not country specified) is here.

An update of the key findings of the NDC Synthesis Report, which will cover updated or new NDCs submitted between 31 July and 12 October 2021, will be published on 25 October. This is to ensure that the most updated information is made available to COP26.

The September 2021 NDC Synthesis Report identified an urgent need for either –

* a significant increase in the level of ambition of NDCs between now and 2030, or

* a significant overachievement of the latest NDCs,

* or a combination of both,

in order to attain cost-optimal emission levels suggested in many of the scenarios considered by the IPCC for keeping warming well below 2 °C or limiting it to 1.5 °C.

If emissions are not reduced by 2030, they will need to be substantially reduced thereafter to compensate for the slow start on the path to net zero emissions. Net zero CO2 emissions are a prerequisite for halting warming at any level.

At COP26, parties also need to agree on the details of the so-called Art.6 that lays down rules for international carbon markets, enabling parties to trade emission reductions. In addition, parties will seek to establish a common time frame for their NDCs. Discussions at global level revolve around setting a five-year or a ten-year common time frame.

The UK (COP26 host) is making announcements currently about its domestic measures, I will blog post separately when the strategy documents are published.

EU NIP announcements (Northern Ireland)

On 13 October, the EU announced its October 2021 package of proposed measures to amend the Northern Ireland Protocol (to the UK-EU Withdrawal Agreement). This October 2021 package is here. (scroll down)

The October 2021 package is a series of “non papers”, these are not binding. The UK has it’s similar not binding “command paper” issued July – here. Both sets of documents contain a certain amount of spin.

UKG (UK Government) and the EU will discuss the documents over the next weeks. In the meantime, UKG had already extended indefinitely existing NIP grace periods and this is reflected in UKG Brexit Guidance (instructions) found collated in Cardinal Environment EHS Legislation Registers and Checklists.

The Northern Ireland Protocol regulates Northern Ireland’s access to the EU single market, but also affects it’s arrangements with the rest of the UK. This has since 1 Jan 2021 impacted on goods movements from Britain (GB) to Northern Ireland (UKG itself relaxed NIP rules for movement from Northern Ireland to GB); and it’s state aid rules.

Governance of the Northern Ireland Protocol arrangements is currently by the ECJ or CJEU as the court is known as in the EU. It is also an ask of UKG that this governance be altered and the role of the ECJ removed. This was a UKG ask at the time of negotiation of the Withdrawal Agreement.

In the event that agreement is not reached between the parties (UKG unilateral extension of grace periods is itself not agreed), it is open to one or the other to take unilateral action.

Further announcements are awaited.

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.

Transportable Pressure Equipment (UK)

UPDATE : recognition of EU Pi-marked TPE will end on 1st Jan 2023.

I posted earlier that the government started a consultation on ending the circulation (in Britain) of EU Pi-marked Transportable Pressure Equipment (TPE) post Brexit. This consultation concluded and the government response is here.

The government response states the Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations 2009 (as amended) will be further amended to end recognition of EU Pi-marked TPE. The purpose of the consultation was to establish whether this amendment should come into force by 1 January 2022 or by 1 January 2023. But there is no consensus on the date, and the government response gives no date.

Answering questions raised, the government response states –

* UK Rho conformity marking was introduced in the Carriage of Dangerous Goods and Use of Transportable Pressure Equipment (EU Exit) (Amendment) Regulations 2020 (amending the 2009 Regulations). Until the regulations are further amended Rho marking remains optional. When the amendment is made, the government response states TPE placed on the market in Britain must be Rho-marked by a GB-appointed body or Pi-marked by a Northern Ireland notified body and accompanied by the UK(NI) indication.

* Under the existing 2009 regulations, TPE can be carried between Great Britain and an EU member state as long as it complies with ADR/RID, even if it is not Rho-marked. Similarly, the European Dangerous Goods Directive 2008/68/EC and the European Transportable Pressure Equipment Directive 2010/35/EU permit the carriage of TPE between a member state and a non-EU country if it complies with ADR/RID, even if it is not Pi-marked.

* Under the Northern Ireland Protocol, Northern Ireland follows the requirements of the European Transportable Pressure Equipment Directive 2010/35/EU (the TPED). EU Pi-marked TPE is accepted in both Northern Ireland and the European Union, so a further conformity assessment would not be necessary to access the market in Northern Ireland. To access both the GB and EU/NI markets the government response states dual conformity assessments would be required.

* There are no plans to amend the regulations for smaller items of TPE. Under the already amended regulations, the minimum height of the Rho marking is reduced to 2.5 millimetres for smaller cylinders with a diameter less than or equal to 140 millimetres.

* As Northern Ireland continues to follow the requirements of TPED, TPE being placed on the market must be Pi-marked by a notified body established in the EU or Northern Ireland and Rho marked TPE will not be accepted onto the NI market. Periodic inspections of Pi-marked TPE also need to be compliant with TPED in NI and conducted by EU notified bodies.

* Periodic inspections of Rho-marked TPE will need to be undertaken by a GB-appointed body. As Britain is continuing to accept TPE which has been conformity assessed by bodies established in Northern Ireland, such bodies will be able to undertake periodic inspections on TPE accepted onto the GB market. The government response states multiple conformity marks are permitted.

The (2009 Regulations) law supplied in Cardinal Environment EHS Legislation Registers and Checklists already has the 2020 amendment included.

Live Animal Exports Ban (Britain)

Being able to ban live animal exports is considered a Brexit win (although note EU Animal Health rules also moved on since 31st Dec 2020). Animal welfare is a devolved policy area. The UK and Welsh governments consulted on the matter, and the Scottish government consulted separately. The UK and Welsh governments now publish their consultation response, and this is in line with proposals by the Scottish government – here.

The proposals will not apply to journeys under 65km. The proposals are –

* A ban on the export of livestock (cattle, sheep, goats and pigs) and horses from England, Wales and Scotland for slaughter and fattening. Exports for slaughter and fattening from England, Wales and Scotland will be prohibited whether the animals originate from or are travelling through England, Wales and Scotland.

The ban will apply to all exports of livestock and horses where an animal is exported to the place of destination in order to be fattened for subsequent slaughter.

The ban will be achieved via the Animal Welfare (Kept Animals) Bill (Clause 42) – here.

The proposals also cover maximum journey times, temperature and comfort during travel and other matters. These proposals could be achieved via Statutory Instruments or guidance, or both.

Hydrogen Strategy (UK)

UPDATE (18th August) : the 121 page UK Hydrogen Strategy is here.

Four consultations are started –

(1) the business model – here,

(2) a NetZero Fund – here,

(3) a UK low carbon hydrogen standard – here,

(4) facilitating a grid conversion hydrogen heating trial – here.

The current intention is that low carbon hydrogen producers seeking government support, through a Net Zero Hydrogen Fund, and/or the Hydrogen Business Model would be required to comply with a UK low carbon hydrogen standard in order to secure support.

The standard could also be developed into a certification scheme.

The design elements of a UK low carbon hydrogen standard are expected to be finalised by early 2022, while work continues on delivery and administration considerations.

The approach in the UK will involve a mix of hydrogen production methods, including large scale gas reforming with carbon capture, utilisation, and storage (CCUS) (blue hydrogen with CCUS) and electrolytic hydrogen from low carbon electricity (green hydrogen).

Note the following are out of scope for the purpose of developing a UK low carbon hydrogen standard (and are addressed by separate BEIS work streams that are not yet reporting) –

* End use safety / quality standards e.g., regulations for use of hydrogen in transport, or regulations on hydrogen boilers,

* Gas Safety (Management) Regulations and entry standards for blending hydrogen into the gas grid,

* Standards for other (non-hydrogen) decarbonised gases,

* Wider environmental standards and regulations (e.g., water consumption, air quality) although later work on these areas is not excluded. Hydrogen producers will, in any event, need to comply with current and future regulations on air pollutants including nitrogen oxides (NOx),

* Gas quality – e.g., the Wobbe Index.

—————————–

The UK government issued this morning a press release – here – signalling its published Hydrogen Strategy which it is consulting on – but (once again as is typical of these press releases) the strategy document itself is not published (even though the press release is written using the past tense that the document is already in the public domain) nor the consultation questions.

I will update this post on the blog itself (that won’t be a second email notification, so check the blog post) when the strategy document is finally available, with a link to that document, and some comments on its content.

Here is the link to government consultations.

Here is the New Scientist take on the strategy – its link to the strategy itself sends to a 404 page not found.

UKCA and UKNI marks (UK)

The European CE mark is being phased out in the UK. Various deadlines apply to the situation where no CE marked good may be imported into the UK market unless it has been re-marked as UKCA.

A special situation exists in Northern Ireland – the Ireland/Northern Ireland Protocol allows European CE marking to continue to be used in Northern Ireland. The alternative UK mark to be used in Northern Ireland is UKNI, not UKCA.

A vast number of CE marked goods are in regular use in the UK. All businesses and individuals operating in the UK must assess their future requirements for CE marked goods and take steps to ensure their timely delivery before deadlines kick in.

Please check with suppliers and BEIS (the government department) on the current availability of already imported CE marked goods, and the deadline for a particular CE marked good.

Not all local assessment processes are set up, and deadlines may change. Further information is likely – please pay close attention to Email Alerts and Blog posts in the autumn.

[Not all European goods use the CE mark, I posted earlier about consultation underway on the timings for the phaseout of European marked Transportable Pressure Equipment – TPE – European sourced TPE has a different European mark]

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]