New EU Liability Proposals on Products and AI (EU)

On 28 September, the European Commission proposed 2 new instruments –

(1) A Directive to update existing rules on the strict liability of manufacturers for defective products (replacing the existing Product Liability Directive dating from 1985).

(2) A new Directive to harmonise national liability rules for artificial intelligence ( AI).

Further information on both instruments is here.

The new Product Liability Directive (PLD) aims (amongst other objectives) to ensure there is always a business in the EU that can be held liable for defective products bought directly from manufacturers outside the EU.

If the new PLD proposal is ratified, the proposal is that Member States would need to bring forward the necessary legislation to transpose and comply with this Directive within twelve months of it coming into force.

New General Product Safety Regulation (EU)

Agreement has been reached (between the European Council and the European Parliament) on the EU’s proposed General Product Safety Regulation (GPSR). The GPSR will replace the 2001 General Product Safety Directive.

Information on the GPSR is here. The GPSR proposal (COM(2021) 346 final) is here.

The new rules will oblige economic operators to designate a responsible person for products sold online and offline, whether they originate from the EU or from a third country.

The responsible person will be in charge of checking that technical documentation exists for the products that they are responsible for offered by the economic operator and that products are accompanied by instructions and safety information.

Following the formal adoption of the regulation and its entry into force, EU member states will have 18 months to apply the new rules on general product safety.

The GPSR will be added to Cardinal Environment EHS Legislation Registers & Checklists, where subscribers had the GPSD (the Directive), and it will also be supplied to subscribers in Britain (for look-up) purposes, again where the GPSD is already in the look-up list.

EU Water Standards (EU)

(1) On 26 October 2022, the EU adopted a proposal to amend the Water Framework Directive, the Groundwater Directive and the Environmental Quality Standards Directive. This proposal is here.

24 substances are proposed for addition to the list of priority substances in surface waters, as well as a standard for total pesticides. They include PFAS, a range of pesticides, bisphenol A, and a number of pharmaceuticals.

The proposal also includes making certain standards stricter for substances already on the list, such as some metals and industrial chemicals.

Four other existing priority substances are proposed for removal from the list, and another for integration into the new PFAS group, and eight already-regulated “other pollutants” have been re-designated as priority substances, resulting in a total of 73.

A Q&A on this proposal is here.

(2) On the 26th October 2022, the EU adopted a proposal to revise the Urban Wastewater Treatment Directive. This proposal is here.

A Q&A on this proposal is here.

The revised directive will introduce extended producer responsibility. This means certain industries will be asked to pay for the treatment of the harmful pollutants that are released from the use of their products. Currently the pharmaceuticals and the cosmetics sectors are jointly responsible for 92% of the toxic load in wastewaters. For both sectors, there is sufficient evidence on the existence of micropollutants from these products in wastewater and there are treatments to remove their harmful residues. In the long term, the European Commission will assess if other sectors can be added to the extended producer responsibility scheme.

Budget Statement (UK)

Yesterday 17 November 2022 saw the UK Government make a budget statement. The following are announcements of interest –

(1) Deletion of Retained EU Law (REUL) – a bill is in progress to delete a significant body of law off the statute books by the end of 2023 (I have blog posted about this a number of times already).

The Budget Statement asserts “the government is committed to reforming retained EU law”. The Statement states 5 areas will be reviewed over the next year, comprising “life sciences”, “green industries”, and “ advanced manufacturing” (along with “financial services”, and “digital technology”).

In addition, the government will task Sir Patrick Vallance to advise on how to regulate “emerging technologies”.

(2) Climate Change Levy (CCL) – the rates will be rebalanced, the CCL rate on gas will be raised, and the CCL rate on electricity will be frozen. These steps will take effect in the Finance Bill 2023. The percentage discount on the CCL main rates available through the Climate Change Agreement Scheme will be fixed at 92% for electricity and 77% for LPG. The discounts for gas and solid fuels will be adjusted to 89%.

(3) Carbon Price Support (CPS) – CPS rates in Britain will be kept at a level equivalent to £18 per tonne of carbon dioxide in 2024-2025.

EU Commission Work Programme (EU)

On 18 October 2022, the European Commission adopted its 2023 work programme (CWP), entitled ‘A Union Standing Firm and United’. It outlines the Commission’s policy initiatives for 2023, and how it would achieve the headline ambitions in Commission President von der Leyen’s Political Guidelines as set out at the start of her mandate.

The 2023 CWP frames the EU’s headline ambitions within the context of global challenges: in Ukraine, on energy, on the environment, and the fall-out of these developments on the global economy.

The 2023 CWP contains 43 new policy initiatives, eight suggestions to simplify regulation, and 116 pending “priority proposals” for legislation.

Re European Green Deal – the core Fit for 55 package from the 2021 CWP continues, added to this is a new planned revision of EU REACH and a call for binding targets to restore degraded ecosystems.

Note as part of EU Fit for 55, the European Parliament and Council already agreed on stricter regulation of greenhouse gas emissions in member states including less flexibility and more transparency – here.

Also, the Carbon Border Adjustment Mechanism (CBAM) is a key element of EU Fit for 55 – here.

Note re UK REACH – the UK’s Defra department is exploring An Alternative Transitional Registration Model which would apply to Britain. Presently EU REACH applies to Northern Ireland.

The EU continues to exchange views on chemicals regulatory developments with the UK, including through the Specialised Committee on Technical Barriers to Trade set up under the Trade and Cooperation Agreement that was agreed with the UK.

Medical Devices Regulation Delay (Britain)

On 26 June 2022, the MHRA published the government response to the public consultation it had held on the future regulation of medical devices in the UK.

In a decision published 25 October 2022, the UK government has stated it will introduce a 12 month extension to the implementation of the future Medical Device Regulations, with the aim to bring the new regulations into force by July 2024.

The UK government has previously stated it intends to bring in new Medical Devices Regulations as a substantial reform of the current framework in Britain.

On the EU side, EU MDR (European Regulation 2017/745) came into force on 26 May 2021 after the UK had exited the EU. The EU MDR is significantly longer and more rigorous than the MDD (European Directive 93/42/EEC) it replaced. EU MDR does not apply in Britain. EU MDR does apply in Northern Ireland from 26 May 2021. Similarly, the related EU IVDR (in vitro Diagnostic Medical Device Regulations) has applied in Northern Ireland from 26 May 2022.

On the UK side, the current Medical Device Regulations 2002 (UK MDR 2002) which implemented the pre 31 Dec 2020 EU MDD, as amended by Brexit law following the UK’s exit from the EU, states that the acceptance of CE marked devices in Britain ends on 30 June 2023.

The UK government intends to introduce new legislation by Spring 2023. Manufacturers will be able to place CE marked devices on the British market after 1 July 2023. From July 2024, transitional arrangements will apply for CE and UKCA marked devices placed on the British market.

The current guidance “Regulating Medical Devices in the UK” which is listed in the Brexit Guidance List on Cardinal Environment Limited EHS Registers and Checklists will be updated.

UKCA Marking Further Delay (Britain)

On 14th November the BEIS department of the UK Government laid before Parliament a further draft Statutory Instrument “Product Safety and Metrology (Amendment and Transitional Provisions) Regulations 2022. The earlier draft instrument (I reported on by Email Alert a while back) is not proceeded.

The main purposes of this new instrument are to:

(1) extend acceptance of certain products meeting EU requirements and markings on the market in Britain for a further 2 years, until 31 December 2024, and

(2) as previously announced on 20 June 2022 (see my earlier blog post), but with updated timelines –

* provide that where manufacturers, or other relevant persons, have acted under EU conformity assessment procedures by 31 December 2024, that action will be treated as having been taken under the UK conformity assessment procedures until the expiry of the certificate, or until 31 December 2027, whichever is sooner

* extend existing labelling provisions for UKCA marking, importer information and responsible persons’ information until 31 December 2027.

There are different rules for medical devices, construction products, cableways, transportable pressure equipment, unmanned aircraft systems, rail products, cosmetics, and marine equipment.

There are different rules for Northern Ireland.

I will update Cardinal Environment Limited EHS Registers and Checklists. This matter will also be in the next Email Alert.

EU Law Revocation (Britain) Update

The Financial Times is reporting this morning that a further large number of EU laws has been located by the National Archives. The report is that the end 2023 deadline for revocation of REUL (retained EU law) is now likely to slip, as the scale of the work challenge to replace or reform each instrument builds.

The Bill is currently in Committee stage, as currently drafted Ministers could delay until June 2026, but both dates of December 2023 and June 2026 could now change.

We will nonetheless, list the instruments that will be affected, and load this onto Cardinal Environment Limited EHS Legislation Registers & Checklists in January 2023. We will track the changes to this list and the development of replacement or reformed instruments by using the traffic light system, the same approach we used for the Brexit Consolidated Law project (which is concluded).

I will write further Updates (Blog posts) as more information becomes available on the revocation of REUL.

Statutory Environmental Targets (UK)

The Environment Act 2021 introduced a system of environmental governance based on statutory environmental principles and long-term environmental targets, and an Environmental Improvement Plan, all supported by an independent Office for Environmental Protection (operating in England and separately in Northern Ireland). Scotland does not have an OEP, it has set up a separate body under different legislation. Wales has no OEP.

Statutory targets were due (by law) by 31st October, but this deadline has been missed. The first review of the Environmental Improvement Plan is required by 31 Jan 2023. The current Environmental Improvement Plan is dated 2018 and the latest annual report on it is here. Annual reports are required by section 9 of the Environment Act 2021. Environment targets are governed by sections 1 to 7 of the Act. Section 10 stipulates reviews of the Environmental Improvement Plan.

In March 2022, the government announced a consultation on the targets. It closed on 27th June. The outcome of this consultation is not announced, nor are the statutory targets.

DEFRA responded to the OEP that it is committed to the target of halting species decline by 2030 which is included on the face of the Environment Act, and to bring forward the wider suite of targets specified under the Act.

The OEP is pressing for publication of the targets – here is their latest letter to DEFRA.

Included in the OEP’s letter to DEFRA is a non-exhaustive list of other statutory deadlines which appear to have been missed.