End of EU Pi-marked TPE in GB (Britain)

The UK government has today commenced consultation on the ending of recognition of EU Pi-marked TPE (transportable pressure equipment) in Britain.

The proposal is to amend the 2009 Carriage of Dangerous Goods and Transportable Pressure Equipment Regulations to require that, in future, TPE being placed on the GB market is conformity-assessed by:

• a GB-appointed body and affixed with a Rho marking

or

• a notified body established in Northern Ireland, affixed with a Pi marking plus the indication ‘UK(NI)’.

This would effectively end recognition of EU Pi-marked TPE in GB, although TPE already on the GB market before this amendment comes into force may remain in circulation.

The proposal is that this change will come into effect between 1 January 2022 and 1 January 2023.

The consultation invites comments on the impact of ending recognition of EU Pi-marked TPE in GB. The findings from this consultation will be used to inform a decision on when the amendment should come into effect.

The consultation is here. It is a short consultation that will run until 30 June.

Equal Pay Proposal (EU)

On 4th March, the European Commission presented a proposal on pay transparency – here.

The legislative proposal focuses on two core elements of equal pay:

(1) measures to ensure pay transparency for workers and employers, and

(2) better access to justice for victims of pay discrimination.

Further information is here.

NB: this Blog does not focus on Employment Law issues.

UK-EU Future Dealings (UK)

The parameters of economic and internal security co-operation between the UK and EU are defined by three key documents:

* the Trade and Cooperation Agreement (TCA – the ‘deal’ signed on Christmas Eve 2020);

* the Withdrawal Agreement (WA), which lays out the future relationship for trade in goods between Northern Ireland, Britain and the EU; and

* the UK Internal Market Act, supplemented by ‘common frameworks’, which set out how the UK proposes to maintain internal coherence between the four nations of the UK after the loss of the EU framework within which devolution was originally conceived.

A new unit is established in No.10, under Lord Frost (the 2019-2020 Brexit negotiator). This unit has a strategic role, both on the approach to Europe and the EU as well as wider international policy.

The TCA establishes a complex governance model – at the top political level, the TCA will be overseen by a new Partnership Council. Not dissimilar to the Joint Committee established in the Withdrawal Agreement, it will be co-chaired by a representative from the European Commission (recently confirmed to be Maroš Šefčovič, also co-chair of the Joint Committee) and a minister from the UK government (yet to be announced). Its role includes:

• Oversight: The Partnership Council will be responsible for overseeing the application and implementation of the TCA. As part of this responsibility, it will be able to set up or disband specialised committees, delegating powers where necessary.

• Amendment: For the next four years, the Partnership Council will be able to amend the TCA, or supplement agreements, to correct errors or address omissions. But
the power goes beyond just a tidying up function and has the potential to be quite wide-ranging. For example, the Partnership Council will be able to decide to amend some parts of the agreement by mutual agreement, including parts of the chapters and annexes on rules of origin, customs and energy.

• Dispute settlement: For most parts of the TCA, the first step in the dispute resolution process is for the two sides to enter into ‘consultations’, which can take place either in one of the specialised committees or the Partnership Council. If a dispute cannot be resolved through consultation at the political level, the complaining party will have the option of requesting an arbitration tribunal and go through the resolution process.

NB : This process will not apply to all parts of the TCA. There are separate dispute arrangements in areas such as law enforcement and judicial co-operation, fisheries, and parts of the level playing field (LPF), including subsidies, labour and social standards, and environment and climate standards. Other parts do not have a formal dispute arrangement, including competition, tax, SMEs and cultural property.

The TCA also establishes the Trade Partnership Committee to oversee the trade
part of the agreement, with 10 trade-specialised committees, which will oversee specific aspects of the trading provisions, including on sanitary and phytosanitary (SPS), regulatory co-operation, and the LPF. There will be a further eight specialised committees to oversee other aspects of the TCA, including on social security co-ordination and law enforcement, and judicial co-operation. Together, these amount to nearly double the number of committees included in the EU–Canada Comprehensive Economic and Trade Agreement (CETA).

Four working groups are also established in the TCA to support the work of specific specialised committees. These are on organic products, motor vehicles and parts, medicinal products (supervised by the trade specialised committee on technical barriers to trade) and social security co-ordination (supervised by the Specialised Committee on Social Security Coordination). These groups have been set up where it is already clear that greater co-ordination or discussion will be needed.

The structure is not fixed. The Trade Partnership Committee and eight specialised committees can establish and dissolve working groups where they agree it is necessary to support the functioning of the agreement.

The TCA also allows the EU and UK parliaments to set up a new ‘parliamentary partnership assembly’ to exchange and request information on the implementation of the agreement from the Partnership Council as well as to make recommendations. The two sides will also establish a civil society forum and are expected to set up domestic advisory groups.

The Cabinet Office confirmed this morning (in questions to it, in Parliament) that the Partnership Council and various committees will be stood up next month, June.

Medical Devices Regulation (EU)

The new EU Medical Devices Regulation 2017/745 (MDR) applies from (yesterday) 26 May, after a year’s postponement. The MDR is here.

The MDR tightens controls on high-risk devices such as implants and requires the consultation of a pool of EU level experts before placing medical devices on the market. Clinical evaluations, investigations and the notified bodies that approve the certification of medical devices will be subject to tighter controls.

The new European database of medical devices (EUDAMED) will contain information about each medical device on the market, including economic operators and certificates issued by notified bodies. Each device will have a unique device identifier so that it can be found in EUDAMED. Labelling will be more detailed and electronic manuals will increase user-friendliness. Implant patients will receive an implant card with all the essential information.

Once devices are available on the market, manufacturers will have to collect data about the devices’ performance. EU countries will closely coordinate their vigilance and market surveillance.

The MDR is complemented by the Regulation on in vitro diagnostic medical devices (2017/746/EU) which applies a year later on 26 May 2022.

Q&A about the MDR is here.

Environment Bill (announced additions) (UK)

The long awaited and highly significant Environment Bill is revived in the current Parliament session. I Blog posted earlier that it would be.

The UK government has made 3 announcements in May –

(1) new legal duties on water companies and the government will be inserted to reduce sewage discharged into waterways – announcement is here

(2) a new additional legally binding target for species abundance for 2030 will be inserted – George Eustice Speech is here

Environmental targets in the Bill are summarised in the October 2020 updated August 2020 policy paper – here.

(3) a new power will be taken to refocus the Habitats Regulations – see George Eustice Speech

[The George Eustice Speech also makes further announcements on consultation and strategy publication in the areas of Nature, Peat and Trees.]

The Bill, as we see it now, was originally revived from the previous May Government after the 2019 general election.

In 2020, the majority of the 2019-2020 Bill provisions were substantially the same as its predecessor, although a number of minor technical changes had been made to the drafting. The substantive additions to the Bill (at the start of 2020) were :

• a requirement on Ministers to make a statement to Parliament setting out the effect of new primary environmental legislation on existing levels of environmental protection (Clause 19); and

• a requirement on the Secretary of State to conduct a two-yearly review of the significant developments in international legislation on the environment, and to publish a report on their findings every two years (Clause 20).

The Commons Library analysed the Environment Bill in March 2020 – here.

Most of the Bill extends to England and Wales and applies in England. There are some parts that extend to the whole of the UK or apply to specific UK nations. For example, there are specific provisions on environmental governance, managing waste and water quality that extend and apply to Northern Ireland only. Provisions on waste including producer responsibility, resource efficiency and exporting waste extend and apply to the whole of the UK, as do the provisions on environmental recall of motor vehicles, and the provisions on the regulation of chemicals.

Note – DEFRA has current consultations relating to the Environment Bill –

(1) Consultation on the Draft Policy Statement on Environmental Principles – here.

(2) Consultation on Introducing a Deposit Return Scheme in England, Wales and Northern Ireland (a Deposit Return Scheme is already legislated for in Scotland) – here.

Plastic Bag Charge in law (England)

The legislation increasing the plastic bag charge in England was enacted yesterday 20 May, and comes into force today 21 May – this legislation is here. [I blog posted about this before]

It will be added to those Cardinal Environment EHS Legislation Registers & Checklists that monitor the Plastic Bag Charges. It amends the existing 2015 Order (the Carrier Bags Order).

[Separate legislation in Scotland, already added, has already increased the charge in Scotland.]

Article 3 amends the Carrier Bags Order by omitting the expiry date of 5th October 2022 in article 1(d), by which that Order would have ceased to have effect. Articles 6, 7, 10 and 11 make amendments to the Carrier Bags Order consequential on the omission of the expiry date.

Articles 4 and 8 amend the Carrier Bags Order in order to substitute a new definition of “seller”. This brings all sellers of goods under the obligation to charge in article 3 of the Carrier Bags Order and restricts the obligation relating to records in article 4 of, and Schedule 3 to, that Order to sellers within the meaning given in Schedule 1.

Article 5 amends the Carrier Bags Order in order to increase the minimum charge for each single use carrier bag (SUCB) supplied in a reporting year from 5 pence to 10 pence.

Article 9 amends the definition of SUCB in Schedule 2 to the Carrier Bags Order by amending the list of “excluded bags” in the table.

The effect of this is –

(1) The single-use carrier bag charge is increased to 10 pence and extended to all retailers in England from today (21 May). This includes small, medium and micro retailers (including airport retailers).

(2) An extra 10 pence is not chargeable if a charge of 10 pence or more is already charged for bags.

(3) Biodegradable bags are not exempt from the charge.

(4) Carrier bag use records or reports do not need to be made if the company employs fewer than 250 staff.

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.