Climate legislation (Ireland)

On 23 March, Ireland published its Climate Action and Low Carbon Development (Amendment) Bill 2021.

This Bill, when enacted, will amend the Climate Action and Low Carbon Development Act 2015 – to –

(1) set an objective of climate neutrality by 2050,

(2) set an interim target of a 51% reduction in GHG emissions by 2030 relative to a baseline of 2018,

(3) provide a framework for the development of enabling plans and strategies to reach the 2030 and 2050 targets as follows:

* annual climate action plans

* five-yearly long-term climate action strategies

* five-yearly climate budgets

* sectoral emissions ceilings

* a national adaption framework,

(4) make changes to the Climate Change Advisory Council including to its functions and its membership,

(5) oblige all local authorities to make individual local climate action plans,

(6) oblige climate reporting by a Minister to the Joint Oireachtas Committee,

The Bill does not propose a ban on the sale of new, and importation of, petrol and diesel vehicles by 2030 (which was included in the 2019 General Scheme of the Bill) or a ban on the importation of fracked gas and on liquified natural gas (LNG) terminals.

The Bill is here.

We will add this legislation to Cardinal Environment EHS Legislation Registers & Checklists (Ireland), when it is enacted.

First Project Orbis Cancer Treatment Authorisation (UK)

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

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

It involves the regulatory authorities of:

• Australia (TGA)

• Canada (Health Canada)

• United Kingdom (MHRA)

• Singapore (HSA)

• Switzerland (Swissmedic)

• Brazil (ANVISA)

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

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

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

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

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

Titanium Dioxide E171 Conclusion (EU)

The European Food Safety Authority (EFSA) has concluded –

“Taking into account all available scientific studies and data, the Panel concluded that titanium dioxide can no longer be considered safe as a food additive. A critical element in reaching this conclusion is that we could not exclude genotoxicity concerns after consumption of titanium dioxide particles. After oral ingestion, the absorption of titanium dioxide particles is low, however they can accumulate in the body”. (Prof Maged Younes, Chair of EFSA’s expert Panel on Food Additives and Flavourings (FAF)

The press release is here.

Titanium dioxide (E 171) is authorised as a food additive in the EU according to Annex II of Regulation (EC) No 1333/2008.  

Titanium dioxide is used a food colour (E171) and, as with all food colours, its technological function is to make food more visually appealing, to give colour to food that would otherwise be colourless, or to restore the original appearance of food. Titanium dioxide is also present in cosmetics, paints, and medicines.

EFSA’s scientific advice will be used by risk managers (the European Commission, Member States) to inform any decisions they take on possible regulatory actions.

Plastic Bag Charge (England)

The UK government has just announced that the single-use carrier bag charge will be increased from 5p to 10p and extended to all businesses in England from 21 May.

The announcement is here. The guidance was updated on 30 April here – note the exceptions.

Scotland already raised the plastic bag charge, effective from 1st April 2021. This was reported in our March Email Alert. Note, plastic bag charges are temporarily suspended (Scotland) for certain types of delivery until 31 May.

Queen’s Speech 2021 (UK)

The State Opening of Parliament is scheduled to take place on 11 May 2021. Parliament was prorogued on Thursday 29 April 2021, bringing the 2019-21 Session to an end.

The House of Commons Library has a Research Briefing that identifies issues and bills that may appear in the Queen’s Speech on 11 May or that may require legislation in the forthcoming parliamentary session. This Briefing is here.

A number of items to note :

(1) some bills have been subject to carry-over motions, notably –

* the Environment Bill (again)

On 26 January 2021, special arrangements were made to carry-over the Environment Bill 2019-21. Normally bills that are carried over must complete their passage through both Houses in 12 months. The Environment Bill 2019-21 was re-introduced on 30 January 2020 (as a reinstatement of the previous administration’s Environment Bill with some additions, and some deletions). The motion to carry-over the January 2020 bill allowed two years instead of the one year provided for in Standing Orders for the completion of the passage of the Bill. The motion was agreed without a division.

Progress of the Environment Bill can be seen here.

* the Finance (formerly Finance No. 2)) Bill (this contains the landfill tax rates from 1st April 2021 – England and Northern Ireland, the CCL uprating from 1st April 2022, abolition of the carbon emissions tax provision, and provision for the packaging tax from 1st April 2022)

* the Draft Building Safety Bill (published in the 2019-2021 session)

(2) a number of issues are identified as potential subjects for legislation, notably –

* Planning reform in England

The August 2020 White Paper said that the proposed changes would require primary and secondary legislation, as well as updating the National Planning Policy Framework. In response to a parliamentary question in September 2020, the Government said it would “set out any decisions and any associated proposed implementation” in “due course.” A newsletter from MHCLG’s chief planner in December 2020 said that the Government would “publish a response in the Spring setting out its decisions on the proposed way forward including preparing for legislation, should the government so decide, in the Autumn.”

No further detail has been announced.

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.

Fire Safety Bill (England and Wales)

I posted before about the Fire Safety Bill. The current version is here.

The Queen’s Speech included a commitment to bring forward a Fire Safety Bill, its purpose being to clarify that the Regulatory Reform (Fire Safety) Order 2005 (the Fire Safety Order) applies to external walls (including cladding, balconies and windows) and individual flat entrance doors in multi-occupied residential buildings.

This is relevant to building owners, leaseholders or managers of multi-occupied residential buildings who are likely to be the responsible persons and who need to ensure that they have assessed the fire safety risks of the premises for which they are responsible, and have taken the necessary fire precautions as a result of that assessment.

The Fire Safety Bill also affirms Fire and Rescue Authorities have the relevant enforcement powers to hold owners or managers to account.

It complements existing powers local authorities have to take enforcement action against building owners and managers under the housing health and safety rating system (HHSRS) provided for in the Housing Act 2004 and the Building (Amendment) Regulations 2018 (SI 2018/1230) which came into force on 21 December 2018 and banned the use of combustible materials within the external walls, and certain attachments to the external walls, of any new building at least 18 metres in height where:

* the building contains at least one dwelling;

* the building contains certain residential accommodation for the treatment, care or maintenance of persons; and

* the building contains certain rooms used for residential purposes, including student accommodation and school dormitories.

Including such a building created by a material change of use.

The Fire Safety Bill supports the Government’s intended action to introduce secondary legislation to implement the specific recommendations made in the Grenfell Tower Inquiry Phase One Report. The recommendations called for new legal duties on “building owners or managers of high-rise buildings” in relation to inspection and information sharing with the local Fire and Rescue Service. This includes the requirement for building owners or managers to share information with their local Fire and Rescue Service about the design of its external walls and details of the materials from which they are constructed and to undertake regular inspections of individual flat entrance doors.

The Fire Safety Bill is now ready for Royal Assent today 29 April.

When published, it will be consolidated into the existing 2005 Fire Safety Order and added to Cardinal Environment EHS Legislation Registers & Checklists (England, Wales, and England & Wales).

The secondary legislation is likely to be of interest.

Trade Deals status (UK)

The UK is entering into bi-lateral trade arrangements following its exit from the European Union. The current status is here. Note the conformity assessment arrangements in MRAs.

The UK and Australia announced a few days ago, a trade deal would be agreed shortly, likely June.

The UK Department for International Trade gave an update on the UK-Australia FTA on 15 March – here.

I will issue a new blog post when the UK-Australia FTA text is published.

European Climate Law (EU)

I blog posted before (in December) about the EU’s proposal for a European Climate Law. On 21 April, the EU’s co-legislators reached provisional agreement on the matter.

The European Climate Law will contain the EU’s commitment to reaching climate neutrality by 2050 and the intermediate target of reducing net greenhouse gas emissions by at least 55% by 2030, compared to 1990 levels.

Once this provisional agreement is formally approved by Parliament and Council, the European Climate Law will be published in the Official Journal of the Union and will enter into force.

Further information is here.

SPS Export Health Certificates from April 21 (EU)

I posted before about the new EU Animal Health Law (Regulation (EU) 2016/429) that comes into force on April 21. This document is here.

The new EU Animal Health Law (AHR) is a large and complex Regulation designed to consolidate, update and replace a number of existing Regulations.

The main change is the new model export health certificates (EHCs) in use from April 21. EHCs are required for third country import into the EU.

AT THE SAME TIME, April 21 is the date for new rules for entry into the EU of composite products.

Including those for composites, a total of five new EHCs are needed from 21 April. These include three new products of animal origin (POAO) EHCs, two new composite EHCs and a private attestation document for composites exempt from certification. In the UK, private attestations do not need to be signed by an Official Veterinarian (OV) or Food Competent Certifying Officer (FCCO).

The three new POAO EHCs include meat of certain wild game and farmed large game and mechanically separated pork meat.

The two new composite product EHCs are –

a. Entry into the EU (or Northern Ireland) of not shelf-stable composite products and shelf stable composite products, containing any quantity of meat products (except gelatine, collagen and highly refined products) and intended for human consumption; and,

b. Transit through the EU to a third country either by immediate transit or after storage in the Union of not shelf-stable composite products and shelf-stable composite products containing any quantity of meat products and intended for human consumption.

Article 12 of Commission Delegated Regulation (EU) No 2019/625 (delegated rules to a DIFFERENT Regulation (EU) No 2017/625, the Official Controls Regulation) establishes three categories of composite products (applicable from April 21):

(1) non shelf-stable composite products,

(2) shelf-stable composite products that contain any quantity of meat products, except gelatine, collagen and highly refined products, and

(3) shelf-stable composite products that do not contain meat products, except gelatine, collagen and highly refined products.

Note: the EU Official Controls Regulation itself has applied since 14 December 2019.

With a view to smoothen the transition, Article 35 of Commission Implementing Regulation (EU) No 2020/2235 introduces a period of six months (to 20 October 2021) for the imports of composite products during which the old certificate will be accepted to enter the Union. Where no certificate was required prior to 21 April 2021, then the new relevant certificate or private attestation must be provided.

What is not a composite product?

The addition of a product of plant origin during the processing defined in Article 2(1)(m) of Regulation (EC) No 852/2004 of an animal product does not automatically mean that the resulting food falls within the definition of composite products. If such addition does not modify the main characteristics of the final product, the latter is not a composite product. It can be to add special characteristics or necessary for the manufacture of the product of animal origin (Article 2(1)(o) of Regulation (EC) No 852/2004).

For instance, a cheese to which herbs are added or a yogurt to which fruit is added remain dairy products. Similarly, canned tuna to which vegetable oil is added remains a fishery product. These foodstuffs must be produced in approved establishments in accordance with Regulation (EC) No 853/2004.

What percentage of a processed product of animal origin makes a food subject to the rules applicable to composite products?

What makes foodstuff subject to the rules applicable to the composite products is the fact that it is made by both products of vegetable origin and processed products of animal origin. The percentage of processed product of animal origin included in the composite product is irrelevant.

The above is taken from the EU Q&A on composite products – here.

These changes create a high impact on food trade between the UK and the EU.

From April 21, any composite product containing meat products (except gelatine, collagen and highly refined products) is subject to EU Border Control Post (BCP) (or Points of Entry (PoE) for Northern Ireland) checks and requires an EHC.

Chilled/frozen composite products containing processed dairy/egg/fish require EU BCP/PoE checks and an EHC.

Shelf stable composite products containing processed dairy/egg/fish (where the dairy or egg components meet certain heat treatment requirements) require a private attestation and EU BCP/PoE checks unless they are on the EU’s list of lower risk products.

The UK has updated its composites products guidance – here.

APHA (a DEFRA agency) has produced guidance on the April 21 changes – here.

It will be noted that guidance in the EU and the UK is not yet updated in all areas.

The EU is yet to publish the final EHCs for live animals and germinal products that will be used under the AHR. All EU EHCs and Notes for Guidance are being updated to reflect the new rules by August 2021. Only those needed for use by traders from 21 April will be available from April on EHC Online (EHCO), with the remainder uploaded and available by August 2021.