Placing Manufactured Goods on EU market (UK)

The UK is churning out updated Brexit Guidance, we will be updating today (Christmas Day) the Brexit Guidance List on Cardinal Environment EHS Legislation Registers & Checklists – please look later today or tomorrow morning.

Re CE marked manufactured goods – the instructions confirm – From 1 January 2021 any mandatory conformity assessment will need to be carried out by an EU-recognised conformity assessment body. This includes both EU based bodies and bodies in countries with which the EU has concluded a mutual recognition agreement (this is not the UK).

UK conformity assessment bodies will no longer be able to carry out mandatory conformity assessment for products being placed on the EU market.

The legal text for the EU-UK trade and cooperation agreement is not yet published, documents issued so far by the EU and the UK indicate only medicinal products are covered by mutual recognition. Medicinal products are not CE marked goods.

If you have an EU based distributor they will become an ‘importer’ from 1 January 2021.

They will need to make sure:

• goods are labelled with their address and either your details or your EU, EEA or Norther Ireland-based authorised representative’s details (including your company’s name and a contact address or registered trademark)

• the correct conformity assessment procedures have been carried out and that goods have the correct conformity markings

• you, as the manufacturer, have drawn up the correct technical documentation and complied with the labelling requirements

• they maintain a copy of the declaration of conformity for a period of 10 years

• goods conform with the relevant essential requirements.

Details are here.

EU-UK Trade and Cooperation Agreement (2) (EU & UK)

We await the legal text. In the meantime, the UK has published a 34 page summary explainer – here.

A couple of things to notice –

Part 2 Heading 1

(1) a specific Annex on medicinal products (page 9) – This Annex aims to facilitate availability of medicines, promote public health and protect high levels of consumer and environmental protection in respect of medicinal products. It provides for mutual recognition of Good Manufacturing Practice (GMP) inspections and certificates, meaning that manufacturing facilities do not need to undergo separate UK and EU inspections, as well as ongoing co-operation.

(2) a specific Annex on chemicals (page 9) – The Annex seeks to facilitate trade in chemicals, ensure high levels of environmental and health protection and provides for cooperation between authorities. It includes joint commitments to comprehensive implementation of international classification and labelling rules as well as commitments to ongoing cooperation and information exchange.

(3) unsurprisingly, the agreement has a chapter on SPS (pages 9 and 10 summarise) – The Chapter includes bespoke arrangements for the UK and the EU to hold regular, joint reviews of their respective SPS border controls. The aim of these reviews is to see if each Party can further facilitate trade without compromising biosecurity.

(4) Title II Chapter 4 sets out commitments for business mobility – for example (page 12) – The Parties have also agreed commitments on length of stay that broadly reflect the outcome reached in the EU-Japan Economic Partnership Agreement. This includes the ability for UK short-term business visitors to travel to the EU for 90 days in any 180-day month period. The Parties have also agreed not to impose work permits on business visitors for establishment purposes.

(5) Title II Chapter 5 Regulatory Framework – Section 2 (page 13) – The UK and the EU have agreed a framework for the recognition of qualifications between the Parties which is based on the EU’s recent FTA agreements. It makes improvements on those agreements, which are designed to make the system more flexible and easier for regulatory authorities to use.

This approach will allow the UK and its regulators to maintain standards of professional competence. From early 2021, the government will provide help and guidance to UK regulatory authorities and professional bodies to help them benefit from these provisions as well as other recognition paths.

The Agreement clarifies that the provisions on professional qualifications are without prejudice to alternative arrangements that the UK may agree with the EU, allowing for improved mechanisms to be agreed in future. Agreements will be negotiated on a profession-by-profession basis.

Note – the EU has made it clear they rejected mutual recognition of professional qualifications.

(6) Title II Chapter 5 – Section 7 Legal Services (page 14) – The Agreement includes ground-breaking provisions on legal services that go beyond what the EU has included in any other FTA to date. These measures will improve the clarity and certainty of market access for UK lawyers. The Agreement will give UK solicitors, barristers and advocates the right to advise their clients across the EU on UK and public international law using their home professional titles, except where EU Member States have placed specific limits on this activity.

(7) Title XI Chapter 6 Labour and social standards (page 19) – The Agreement includes reciprocal commitments not to reduce the level of protection for workers or fail to enforce employment rights in a manner that has an effect on trade. This is very much in line with similar “non-regression” clauses in other FTAs and with international norms. The provisions are clear that both Parties have the freedom and ability to make their own decisions on how they regulate – meaning that retained EU law will not have a special place on the UK’s statute books. This Chapter is not subject to the Agreement’s main dispute resolution mechanism but will instead be governed by a bespoke Panel of Experts procedure.

(8) Title XI Chapter 7 Environment and Climate (pages 19 and 20) – In a similar way, the Agreement includes reciprocal commitments not to reduce the level of environmental or climate protection or fail to enforce its laws in a manner that has an effect on trade. This includes reciprocal commitments to cross-economy greenhouse gas emission reduction targets. The Agreement gives both Parties the freedom to set their own climate and environmental policies in the way most appropriate to achieve our world- leading domestic aims. The domestic supervisory bodies of the UK and EU will cooperate to ensure effective enforcement of their respective environmental and climate laws. Once again, this chapter is not subject to the Agreement’s main dispute resolution mechanism but will instead be governed by a bespoke Panel of Experts procedure.

The Agreement makes clear both parties will have their own effective systems of carbon pricing in place to help fulfil our respective climate goals. The Parties have agreed to cooperate on carbon pricing in future and consider linking their respective systems, although they are not under any obligation to do so.

Part 2 Heading Three Road Transport

(9) Title I (page 22) – The Agreement also sets out the standards to which operators must adhere when undertaking international journeys between the UK and the EU. These standards only apply to international journeys and do not affect the UK’s ability to regulate the domestic market. These standards for the international carriage of goods broadly reflect the standards to which UK operators are already subject when operating internationally, with some bespoke standards aimed at ensuring greater road safety and effective regulation. These standards include restrictions on driver hours, requirements about professional qualifications and tachographs and vehicle weight and dimension limits. There is a tailored mechanism to manage differences in national regulations in these areas in the unlikely event that they emerge. The ultimate safeguard in the case of real difficulties is that either side may terminate this Heading.

EU-UK Trade and Cooperation Agreement (EU & UK)

The EU has begun publishing documents – here. (scroll down)

A couple of items from the EU overview –

(1) Common definition of international standards and possibility to self-declare conformity of low-risk products make it easier for producers to cater to both markets.

(2) Specific facilitation arrangements for wine, organics, automotive, pharmaceuticals and chemicals.

(3) Service suppliers or investors from the EU are treated no less favourably than UK operators in the UK, and vice-versa.

(4) Facilitations for short-term business trips and temporary secondments of highly-skilled employees.

(5) Offshore energy cooperation in the North Sea.

(6) Enforceable commitments towards the Paris Climate Agreement and non-regression on climate change and carbon pricing, with possibility of linking EU and UK carbon pricing regimes.

(7) Unlimited point-to-point access for hauliers carrying loads between the EU and the UK + full transit rights across each other’s territories.

(8) Provisions on working conditions, road safety and fair competition, on top of horizontal level playing eld clauses on environment, social issues and competition.

(9) UK participates in 5 EU programmes open to third-country participation (subject to its nancial contribution), namely:

• Horizon Europe (research and innovation)

• Euratom Research and Training programme

• ITER (fusion test facility)

• Copernicus (Earth monitoring system)

• Access to EU satellite surveillance & tracking (SST) services

Energy White Paper (UK)

I Blog posted this morning re the UK ETS. Publication of the UK ETS (which was already provided for in Law) is contained in the Energy White Paper (published today).

The Energy White Paper (CP 337) “Powering our Net Zero Future” is here.

It is a long document (170 pages) with many promises for consultations and targets.

A few I have singled out –

(1) significant strengthening of the Energy Performance Certificates system with an EPC target of C for domestic buildings by 2035 (and B for rented non-domestic buildings by 2030). Since most domestic properties are D or below, this is huge and will necessitate new law. Involvement of mortgage lenders is also being consulted on.

(2) re the UK ETS no further detail is given (other than is set out in my blog post this morning)

(3) an Industrial Decarbonisation Strategy to be published in Spring 2021

(4) targeting 40GW offshore wind by 2030, including 1GW floating wind, plus growing the installation of electric heat pumps from 30,000 per year to 600,000 per year by 2028

(5) commitment to make the UK continental shelf a net zero basin by 2050. This will necessitate a new legal approach

(6) commitment to join the UK to the World Bank’s ‘Zero Routine Flaring by 2030’

(7) a new strategy for the Oil & Gas Authority by end of 2020

(8) review of the Offshore Petroleum Regulator for Environment and Decommissioning

UK Emissions Trading System (Britain from 1st Jan)

I Email Alerted to customers carbon trading in the EU ETS system. This morning, the UK government publishes Britain will set up its own UK ETS (it had the law already in place and in force to set up the UK ETS from 1st Jan). Britain will not operate a carbon tax. Northern Ireland will continue inside the EU ETS.

The Legislation for the UK ETS is in the Brexit Consolidated Law List (see the Email Alert I issued – look in your inboxes). UK ETS law is in force, and will be included in the EHS Registers & Law Checklists from 1st Jan 2021. Existing Brexit Transition Registers also have the Carbon Tax provision, it is marked “not in force” and there is no Summary and it is not in Law Checklists.

Despite this morning’s announcement, there are still few details for UK ETS.

The announcement this morning is of the Energy White Paper – here.

The details so far (from this announcement) –

The UK ETS will be the world’s first net zero carbon cap and trade market, and a crucial step towards achieving the UK’s target for net zero carbon emissions by 2050.

The scheme is more ambitious than the EU system it replaces – from day one the cap on emissions allowed within the system will be reduced by 5%, and we will consult in due course on how to align with net zero.

I will issue a new Email Alert shortly.

This UK ETS, adds to the list of standalone UK/GB systems –

(1) UK REACH

(2) GB CLP

(3) UKCA

(4) UK ETS

GB Designated Standards (Britain)

European harmonised standards are used to provide a presumption of conformity with the relevant EU laws. On 1st Jan 2021, the essential legal requirements that businesses must meet will be the same as they are now. All harmonised standards that give a presumption of conformity to EU law at the end of the transition period will become ‘designated standards’ by the references being published on GOV.UK. Businesses will be able to use designated standards to provide presumption of conformity with GB law.

European harmonised standards will remain the relevant standards for placing goods on the Northern Ireland market where EU rules will continue to apply.

A designated standard is a standard, developed by consensus, which may be recognised by government in part or in full by publishing the reference on GOV.UK. Depending on the product, it can be a standard published by any of the following recognised standardisation bodies:

• British Standards Institution (BSI)

• European Committee for Standardisation (CEN)

• European Committee for Electrotechnical Standardisation (Cenelec)

• European Telecommunications Standards Institute (ETSI)

• International Organization for Standardization (ISO)

• International Electrotechnical Commission (IEC)

• International Telecommunication Union (ITU)

The content of the standard is the responsibility of the recognised standardisation bodies, with BSI as the UK’s National Standards Body representing the interests of UK stakeholders. From 1 January 2021, when deciding if a standard is appropriate for designation, the government will check how far the standard covers the various essential requirements set out in the relevant legislation. The government may decide not to designate or to designate with restriction. Any such restrictions will be described on the GOV.UK pages.

The UK government will, for 28 days, make publicly available a notice of proposal to publish references to standards. Interested parties may object to the publication within the 28-day timeframe. The references to the standards will be published for the purposes of designation of the standards on the 29th day unless the notice is withdrawn or amended before that date.

This link collates existing publications of GB Designated Standards – here (scroll down).

Post-Transition Borders Preparedness (UK)

On 10th Dec, the Chair of the EU Goods Sub-Committee wrote to the UK CDL Michael Gove with questions. The EU Goods Sub-Committee is a Lords Sub-Committee of the European Union Select Committee.

This letter is found here. The questions are identified in bold.

In November 2020 the Committee held five evidence sessions on preparedness for the end of transition, and the arrangements for the import and export of goods after the transition period.

The letter presents to the Government the key findings of the inquiries, asks urgent questions and makes recommendations.

Key Findings

• Crucial IT systems to deal with customs declarations and accessing Kent are still in testing and may not be ready for the end of transition.

• Small businesses will struggle to access these IT systems, or the services of the customs intermediary sector which appears to be under-resourced.

• The traffic management plan is vulnerable to closures, and the plan splits traffic well before drivers would normally make the decision on which route to take.

• Facilities for drivers are inadequate and will have serious welfare, safety and legal implications for those stuck in what may be delayed queues. Comfort breaks and sustenance have not been adequately considered or provided for.

• Animal welfare issues may arise for vehicles carrying livestock if they are stuck in queues for a long time.

• There is widespread uncertainty and the guidance provided by the Government has been complicated and unclear.

Separately (also in the week to 10th Dec), nine organisations involved in the supply of goods to the UK wrote to the UK transport minister Grant Schapps to warn that the current levels of congestion at the country’s leading container ports could continue for some time to come.

This report is here.

In response to pressures on local and national supply chains, the UK Department for Transport, pursuant to Article 14(2) of Regulation (EC) No 561/2006, introduced a temporary and limited urgent relaxation of the enforcement of EU drivers’ hours rules in England, Scotland and Wales.

These temporary relaxations apply from 12:01am on 10 December 2020 until 11:59pm on 30 December 2020, subject to review.

This notice is here.

EU REACH and UK REACH (UK from 1st Jan)

Like CLP (see my blog post on CLP), the key principles of the European Union (EU) REACH Regulation are retained. This document is included (separated into four line entries) in our Brexit Consolidated Law project (the coloured list in Cardinal Environment EHS Legislation Registers & Checklists).

From 1 January 2021, UK REACH and EU REACH will operate independently from each other. Companies that are supplying and purchasing substances, mixtures or articles to and from the EU/EEA/Northern Ireland and Britain (England, Scotland and Wales) will need to ensure that the relevant duties are met under both systems.

EU REACH will apply to Northern Ireland from 1st Jan, while UK REACH will regulate the access of substances to the GB market.

GB- based Businesses holding EU REACH Registrations (in ECHA)

The EU REACH registration will be (and must be) legally recognised (grandfathered) in the UK REACH system after 31st Dec, but information will be supplied to the HSE (the UK REACH regulator) via an account (the holder sets up) on the new UK REACH IT system.

* initial information on the existing EU REACH registration within 120 days of 31st Dec.

* technical information (required under UK REACH) within 300 days plus either 2, 4 or 6 years of 31st Dec. The deadline depends on the tonnage and/or hazard profile of substances.

Grandfathering will be available (and will be required) for all registrations (including intermediates) held by GB-based entities, including importers and Only Representatives (ORs) based in Britain, and to sole, lead or joint registrants.

All GB-based registrations that exist on 31st Dec, and all registrations held by GB entities at any point since 29 March 2017 will be grandfathered. This means that if a GB registration was transferred to an EU/EEA/NI-based entity in the run-up to 31st Dec, it will still be grandfathered into UK REACH.

Grandfathering will not apply to registrations held by entities established outside of Britain, regardless of whether they are part of a group of companies which also has a presence in Britain. Those registrations will not be grandfathered, unless they have been transferred to a GB entity before 31st Dec.

Before transferring any registrations, the HSE asks you to consider how this would affect your operations in the EU/EEA and Northern Ireland, and your ability to access the EU/EEA and NI markets in future.

The HSE says any ECHA decisions relevant to a registration(s) will remain valid.

Access to the technical information used for EU REACH registration may require renegotiating commercial contracts/letters of access which were originally put in place for EU REACH under a Substance Information Exchange Forum (SIEF).

UK REACH will not require GB companies to form a Substance Information Exchange Forum (SIEF) to submit registration data, including under the grandfathering provisions. UK REACH will include a similar Article 26 substance inquiry system to EU REACH to facilitate the principle of ‘one substance, one registration’ which will be retained under UK REACH.

This link gives access to HSE details of the information that must be submitted (scroll down)

Separate Rules apply for GB- based businesses that are downstream users and distributors if they continue to be supplied from the EU/EEA – read here.

GB- based businesses importing non EU/EEA substances Businesses that act only as importers of substances will not be able to appoint an Only Representative (OR) under EU REACH (only a manufacturer, formulator or producer of articles can do so). This means that, as a GB-based importer, you will not have the option to transfer your EU REACH registrations to an EU-based entity OR to continue selling into the EU/EEA or Northern Ireland.

To sell chemicals to EU/EEA or NI customers you should:

* help your EU/EEA and NI-based customers to register with ECHA as importers

or

* work with the non-EU/EEA or NI-based manufacturer who supplies you to encourage them to appoint an OR based in Northern Ireland or an EU/EEA country, who can register the substance with ECHA. The HSE advises you will need to consider in each case whether this registration will be sufficient to allow you to export the substance into the EU/EEA or Northern Ireland.

For mixtures to be placed on the EU/EEA or NI markets you should ensure that each substance at one-tonne or over is registered with ECHA in accordance with EU REACH directly by someone EU-based in your supply chain (again see above re OR).

GB- based Businesses holding EU REACH Authorisations (in ECHA)

Again, these will be grandfathered. The deadline here is 60 days from 31st Dec for information supply to HSE –

* the information included in the application for the authorisation

* any other information provided to ECHA by the applicant for the authorisation which was material to the formation of ECHA’s opinion

* any information required to be submitted or recorded before 31st Dec under any condition under which the authorisation is granted.

Separate Rules apply for GB- based businesses that are downstream users and distributors if they continue to be supplied by anyone with an EU REACH authorisation – read here.

Link to HSE information for GB- based Businesses bringing to GB NI- registered goods under EU REACH (qualifying Northern Ireland goods – QNIGs) – here.

Link to HSE information for NI- based businesses trading QNIGs – here.

Note : see above re GB holders of EU REACH registrations.

LINK to HSE for further scenarios.

EU CLP and GB CLP (UK from 1st Jan)

I mentioned GB CLP yesterday in my blog about publication of the new rules for Northern Ireland.

From 1 January 2021, the European Union (EU) CLP Regulation will be replaced in Britain by retained EU law – the GB CLP Regulation. The GB CLP Regulation will be added to Cardinal Environment EHS Legislation Registers & Checklists, and is included in our Brexit Consolidated Law project (the coloured list).

Businesses based in Britain (England, Scotland and Wales) that place chemicals (substances and mixtures) on the GB market will comply with the GB CLP Regulation (not the EU CLP Regulation) from 1st January.

GB CLP Agency

GB-based businesses supplying the GB market with chemicals (substances and mixtures) will deal with the Health and Safety Executive (HSE) as the GB CLP Agency instead of the European Chemicals Agency (ECHA).

GB Notification

GB-based businesses will notify the GB CLP Agency (not ECHA) of the classification and labelling of the substances they place on the GB market, whether on their own or in mixtures, where they meet the criteria for notification (please check that notification is not required if the substance is subject to UK REACH registration).

GB mandatory classification and labelling (GB MCL)

GB-based businesses will classify and label their substances, where required, in accordance with GB MCL and with the entries in the GB MCL list hosted and managed by the GB CLP Agency.

Downstream users and distributors supplied from the EU/ European Economic Area (EEA)

GB-based downstream users or distributors supplied from the EU/EEA will be importers after 31st December if these supply arrangements continue. 

Exporting to the EU/EEA

Responsibility for the classification, labelling and packaging of chemicals exported to the EU/EEA from Britain will rest with the EU/EEA-based importer.

Unchanged from 1st Jan 2021 –

The main duties on GB-based businesses i.e. manufacturers, importers, downstream users and distributors (“suppliers”) to classify, label and package the chemicals (substances and mixtures) they place on the market under the GB CLP Regulation will stay the same.

Classification

From January 2021, GB-based manufacturers, importers and downstream users will still classify substances and mixtures) i.e. identify any hazardous properties, before they place them on the GB market.

Labelling

Manufacturers, importers, downstream users and distributors based in Britain will still label substances and mixtures to reflect their hazard classification before they place them on the GB market.

There are no changes to requirements for when GB CLP Regulation labelling appears alongside those for transport (dangerous good transport).

Packaging

There are no changes to packaging requirements. Substances and mixtures placed on the GB market must still be safely and securely packaged. Requirements for child resistant closures and tactile warning devices will remain in place.

Responsibility to identify health, environmental and physical hazards 

All suppliers based in Britain will continue to be responsible for identifying, examining and evaluating available scientific and information on substances and mixtures relating to possible physical, health or environmental hazardous properties of chemicals. This is to ensure all the requirements of classification, labelling and packaging are fulfilled.

Testing arrangements 

Testing arrangements for chemicals, including a ban on testing on humans or primates for the purposes of the GB CLP Regulation, will still apply.

Relationship with UN GHS

The GB CLP Regulation, as retained EU law, will continue to adopt changes to the United Nations Globally Harmonized System of classification and labelling of chemicals (UN GHS) in a similar way to the EU CLP Regulation.

Northern Ireland- based Businesses

The EU CLP Regulation will apply in Northern Ireland. This will mean that:

* chemicals (substances or mixtures) placed on the market in Northern Ireland will comply with the EU CLP Regulation (not the GB CLP Regulation)

* Northern Ireland- based businesses will notify ECHA (not the HSE) of the hazard classification and labelling of the substances they place on the NI market, for inclusion in the EU Classification and Labelling Inventory, whether on their own or in mixtures, where they meet the criteria for notification (notification is not required if the substance is subject to EU REACH registration)

* Northern Ireland-based downstream users and distributors who are currently supplied by businesses in the EU/EEA will not face any new EU CLP Regulation requirements if these supply arrangements continue (GB businesses will be importers – see above)

Responsibility for the classification, labelling and packaging of chemicals traded from Britain to Northern Ireland will rest with the Northern Ireland based business who places the chemical on the Northern Ireland market even if it is currently a downstream user or distributor.

NI- based businesses placing goods on the GB market must study the new Rules for Northern Ireland published yesterday. Please note the relevant clauses of the Internal Market Bill are dropped (and the HSE Guidance is not yet updated).

Link to HSE.