New Packaging and Packaging Waste Regulation (EU)

The European Commission is proposing new EU-wide rules on packaging, in the form of an EU Regulation, replacing the existing Directive.

The new Regulation has three main objectives:

(1) to prevent the generation of packaging waste: reduce it in quantity, restrict unnecessary packaging and promote reusable and refillable packaging solutions.

(2) to boost high quality (‘closed loop’) recycling: make all packaging on the EU market recyclable in an economically viable way by 2030.

(3) to reduce the need for primary natural resources and create a well-functioning market for secondary raw materials, increasing the use of recycled plastics in packaging through mandatory targets.

The proposal on packaging and packaging waste will now be considered by the European Parliament and the Council.

The proposal is here. The Q&A is here.

New Batteries Regulation (EU)

Provisional political agreement is reached between the European Parliament and the Council on a new Batteries Regulation. The proposed Regulation is here. It will replace the existing Batteries Directive.

Once the new law enters into force, sustainability requirements on carbon footprint, recycled content and performance and durability will be introduced gradually from 2024 onwards. A more comprehensive regulatory framework on Extended Producer Responsibility will start applying by mid-2025, with higher collection targets being introduced over time. For portable batteries the targets will be 63% in 2027 and 73% in 2030, while for batteries from light means of transport, the target will be 51% in 2028 and 61% in 2031. All collected batteries will have to be recycled and high levels of recovery will have to be achieved, in particular of valuable materials such as copper, cobalt, lithium, nickel and lead.

Extensive more detailed secondary legislation will be adopted from 2024 to 2028 to enable the new regime to be fully operational.

Companies placing batteries on the EU internal market will have to demonstrate that the materials used for their manufacturing were sourced responsibly. This means that social and environmental risks associated with the extraction, processing and trading of the raw materials used for the battery manufacturing will have to be identified and mitigated.

The new Batteries Regulation will enter into force once it’s adopted by the European Parliament and the Council. It will then be added to Cardinal Environment Tailored EHS Legislation Registers & Checklists.

Carbon Border Adjustment Mechanism (EU )

Agreement was reached on Tuesday on the EU’s Carbon Border Adjustment Mechanism. (CBAM). The agreement needs to be confirmed by ambassadors of the EU member states, and by the European Parliament, and adopted by both institutions before it is final.

This provisional agreement is dependent on some aspects which are relevant for CBAM but need to be spelled out in other pieces of legislation on which negotiations are still ongoing. The Council presidency considers that the CBAM regulation can be formally adopted only once the elements relevant for CBAM are resolved in other related dossiers.

Concerning the products and sectors which fall within the scope of the new rules, CBAM will initially cover a number of specific products in some of the most carbon-intensive sectors: iron and steel, cement, fertilisers, aluminium, electricity and hydrogen, as well as some precursors and a limited number of downstream products. Indirect emissions would also be included in the regulation.

Under the provisional agreement, CBAM will begin to operate from October 2023 onwards. Initially, a simplified CBAM would apply essentially with reporting obligations only. The aim is to collect data. From then onwards, the full CBAM will kick in. It would be phased in gradually, in parallel to a phasing out of the free allowances, once it begins under the revised EU emissions trading system (ETS) for the sectors concerned.

CBAM addresses greenhouse gas emissions embedded in certain goods listed in Annex I of the proposal, upon their importation into the customs territory of the Union, in order to prevent the risk of carbon leakage.

CBAM targets imports of products in carbon-intensive industries. The objective of CBAM is to prevent the greenhouse gas emissions reduction efforts of the EU being offset by increasing emissions outside its borders through relocation of production to non-EU countries (where policies applied to fight climate change are less ambitious than those of the EU) or increased imports of carbon-intensive products.

CBAM is designed to function in parallel with the EU’s Emissions Trading System (EU ETS), to mirror and complement its functioning on imported goods. It will gradually replace the existing EU mechanisms to address the risk of carbon leakage, in particular the free allocation of EU ETS allowances.

It is essentially a Carbon Border tax. Importers will have to buy permits for their carbon emissions at the same price as domestic producers under the EU’s emissions trading system.

Some issues are still outstanding (set to be discussed over this weekend) . These include energy rebates, and the free greenhouse gas allowances currently received by some EU companies.

CBAM is designed to protect against “carbon leakage” – the risk that EU industries could outsource manufacture of goods for the domestic market to regions with lower environmental standards.

Note: the US has introduced its own Inflation Reduction Act of 2022 – a 700 billion US dollar climate, health and tax bill. Information is here.

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.

Access to EU Law REMINDER (Britain)

I am reminding you – Cardinal Environment Limited EHS Legislation Registers & Checklists applicable in Britain, and the variants of Britain (England, Wales and Scotland), still have access to EU Law.

Up to date EU Law (as applies in France and Ireland) is found on the top left hand side as a look up List. In both OHS and ENV.

As Retained EU Law is removed from the statute book in Britain, manufacturers and distributors will be operating the two systems – the British system and the EU system. So we will keep Access to EU Law on going on British Registers & Checklists.

Any questions, and you are a current subscriber to Cardinal Environment EHS Legislation Registers and Checklists, please email them to me.

Obviously, subscribers to Registers and Checklists in Ireland, France and other EU and EEA (for example Norway) have EU Law inserted into the Registers and Checklists as standard, and not simply a look up list.

I will continue to post about changes and developments to EU Law on this Blog. So followers of Blog will have this heads-up.

EU Law developments will not appear in British Email Alerts, however. They will appear in Email Alerts for Ireland, France etc.

If anything is unclear, and you are a subscriber to our Registers & Checklists, email me. Replies to this Blog itself will not be addressed, and most likely won’t be published.

Corporate Sustainability Reporting Directive (EU)

The EU Corporate Sustainability Reporting Directive (CSRD) will amend the 2014 EU non-financial reporting directive. It will introduce more detailed reporting requirements and ensure that large companies are required to report on sustainability issues such as environmental rights, social rights, human rights and governance factors.

The CSRD will also introduce a certification requirement for sustainability reporting as well as improved accessibility of information, by requiring its publication in a dedicated section of company management reports.

The European Financial Reporting Advisory Group (EFRAG) will be responsible for establishing European standards, following technical advice from a number of European agencies.

EU rules on non-financial information apply to all large companies and all companies listed on regulated markets. These companies are also responsible for assessing the information at the level of their subsidiaries.

The rules also apply to listed SMEs, taking into account their specific characteristics. An opt-out will be possible for SMEs during a transitional period, meaning that they will be exempted from the application of the CSRD until 2028.

For non-European companies, the requirement to provide a sustainability report applies to all companies generating a net turnover of €150 million in the EU and which have at least one subsidiary or branch in the EU. These companies must provide a report on their ESG impacts, namely on environmental, social and governance impacts, as defined in this directive.

Application will take place in three stages:

• 1 January 2024 for companies already subject to the non-financial reporting directive

• 1 January 2025 for large companies that are not presently subject to the non-financial reporting directive

• 1 January 2026 for listed SMEs, small and non-complex credit institutions and captive insurance undertakings.

Further information is here, including the link to the CSRD itself.

Changes to EU Industrial Emissions Directive (EU)

The European Commission has announced today (5 April 2022) major changes (proposed) to the EU Industrial Emissions Directive (the IED).

Pollution prevention and control will continue to be based on the ‘Best Available Techniques’ (BAT) IED permitting process, but the framework will be enhanced by measures to boost effectiveness:

• Member State permitting authorities will be required to use tighter pollutant emission limit values when revising permits or setting new permit conditions. Currently, about 80% of permits stick to the lowest legally allowed values.

• Extending the IED’s coverage to additional livestock farming and industrial activities: new sectors with significant potential for high resource use or pollution will need to curb environmental damage at source by applying Best Available Techniques.

• Increased focus on energy, water and material resource efficiency and reuse, as well as promoting the use of safer and less toxic, or non-toxic chemicals in industrial processes.

The new sectors proposed for IED coverage include especially:

–   Extractive industry installations (mines), covering metals, rare earth metals and industrial minerals. Energy minerals, such as coal, and aggregate quarries are excluded.

–   ‘Giga-factories’ for electro-mobility batteries: a growth sector, relevant for the industrial transformation, and complementing the Batteries Regulation, for larger-scale plants.

The new rules will preserve the effective mechanism used to date to decide what Best Available Techniques are for the various industrial sectors, known as the Sevilla process. The Sevilla process is a participatory, transparent, science-based information exchange involving all industry, national and European Commission experts, and civil society to set mandatory emission limits of pollutants emitted by large agro-industrial installations. Environmental norms defined through the Sevilla process are published for each industrial sector in the Best Available Techniques Reference Documents – BREFs.

BREFs then become BATC documents, when agreed and published.

Details are here.

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.