Pesticides (UK from 1st Jan 2021)

From 1 January 2021, in Great Britain (England, Scotland and Wales) a new independent pesticides regulatory regime will operate. Great Britain (GB) will take responsibility for its own decisions using its own rules.

Great Britain will have no formal role in EU decision-making processes and new decisions taken under the EU regime will not apply in GB. This includes active substance and Maximum Residue Level (MRL) decisions and any new EU Plant Protection Product (PPP) legislation.

The Health and Safety Executive (HSE) will remain the national regulator for the whole of the UK, on behalf of the UK government and the devolved administrations.

Under the terms of the Withdrawal Agreement and Northern Ireland Protocol, the EU pesticides regime will continue to apply in Northern Ireland after the end of the transition period, in the same way as during the transition period.

Existing approvals, authorisations and MRLs

All existing active substance approvals, PPP authorisations and MRLs will continue to be valid in GB.

Existing PPP authorisations remain valid until their current expiry date.

Active substance approvals due to expire before December 2023 will be extended for 3 years to allow time for the necessary evaluation work.

After the end of the transition period Great Britain will set MRLs based on its own assessments but all existing MRLs will remain valid until they are amended.

Applicants will need to continue to meet any existing conditions under the new GB pesticide regime.

New applications

To gain access to both GB and EU markets new applications will need to be submitted under both the GB and EU regimes. This may be a common application where there is no divergence between the two regimes.

Mutual recognition

HSE will no longer accept new applications for mutual recognition of authorisations in EU Member States but will process any existing applications to a conclusion under the national GB regime.

The HSE will continue to make use of other regulators’ assessments where possible and appropriate to support GB decisions.

Parallel trade permits

HSE will no longer accept new applications for parallel trade permits in GB. Existing parallel trade permits will continue until their current expiry date or until 31 December 2022, whichever is the sooner.

The above is not a full list, further information is here.

REACH Chemical Legislation (UK Brexit)

On 1 September, DEFRA updated its existing webpage guidance for – How to comply with the EU’s REACH chemical regulations when using, making, selling or importing chemicals in the EU, and how to prepare for 1 January 2021 – here.

Per the webpage –

UK REACH, the UK’s independent chemicals regulatory framework, starts on 1 January 2021. Anyone making, selling or distributing chemicals in the UK and the EU needs to follow UK REACH and EU REACH rules.

UK REACH will maintain EU REACH’s aims and principles. These include:

• the “no data, no market” principle

• the “last resort” principle on animal testing

• access to information for workers

• the precautionary principle

The government intends to extend the deadlines for submitting data under UK REACH transitional provisions subject to scrutiny by parliament and the devolved administrations. This guidance includes these extension dates rather than those currently provided in UK REACH legislation.

Please note the new deadlines in the DEFRA updated webpage.

GB-based companies currently registered with EU REACH will no longer be able to sell into the EEA market without transferring their registrations to an EU/EEA-based organisation. This registration transfer stipulation is set out in the EU instruction notice – here.

Registration transfer to an EU/EEA-based Organisation will not apply in Northern Ireland. We await confirmation on the application of UK REACH in Northern Ireland.

Per the webpage –

Under the Northern Ireland Protocol, the process for Northern Ireland businesses moving goods to and from the European Union under EU REACH will not change from 1 January 2021. Further guidance will be published for NI businesses moving goods into the GB market.

EU REACH registrations held by UK-based companies will carry across directly into UK REACH, legally ‘grandfathering’ the registrations into the new regime.

UK-based holders of existing EU REACH registrations may continue the ‘grandfathering’ process by providing basic information to the Health and Safety Executive (HSE) by 30 April 2021.

Holders must complete the grandfathering process within 2, 4 or 6 years of 28 October 2021, depending on their Tonnage Band Deadlines.

Per the webpage –

The information UK-based holders need to provide will be the same or very close to what holders previously provided. Defra will publish any changes to the information needed in September 2020.

Businesses importing chemicals from the EU currently relying on a registration held by an EU/EEA-based company can continue importing substances as they do now on 1 January 2021. They will need to take subsequent actions to ensure that the chemical is registered for UK REACH purposes.

These UK downstream users must notify the HSE using a Downstream User Import Notification (DUIN) of their intention to continue importing substances from the EU/EEA by 27 October 2021.

A new registration must then be submitted to the HSE within 2, 4 or 6 years of 28 October 2021. Alternatively, UK downstream users can encourage their EU/EEA supplier to appoint a UK-based Only Representative (OR), or change their source to a UK registered supplier.

It’s possible to submit DUINs if a chemical is covered by a registration held by an EU/EEA-based OR and then sold into the UK.

The online service ‘Comply with UK REACH’ will go live on 1 January 2021. Businesses can use the service to:

• validate existing UK-held EU registrations (‘Grandfathering’)

• submit downstream user import notifications (DUIN)

• submit new substance registrations

• submit new product and process orientated research and development (PPORD) notifications

Businesses will need to coontact the HSE to ensure that they:

• validate existing UK-held product and process orientated research and development (PPORDs), known as ‘grandfathering’

• provide information on any authorisation matter,including new authorisation application, grandfathering of existing authorisations, and downstream user notifications of authorised uses

The above is NOT a full list of the stipulations in the updated webpage. Please read all parts of the webpage for all instructions.

EU-UK Readiness post 1st Jan 2021 (EU 1st Jan 2021)

The European Commission published a Communication “Getting Ready for Changes. Communication on readiness at the end of the transition period between the European Union and the United Kingdom” today 9th July. This document is here.

The Communication is posted on the European Commission’s End of Transition Period Readiness Page here, where other notices, with various publication dates, are posted.

Key points in the 35 page Communication (this is not a full list):

(1) As of 1 January 2021, the European Union and the United Kingdom will be two separate regulatory and legal spaces.

(2) As of 1 January 2021, licences issued to railway undertakings by the United Kingdom will no longer be valid in the European Union, and certificates or licences issued in the United Kingdom to train drivers will no longer be valid for the operation of locomotives and trains on the EU’s railway system.

[I Blog posted recently specifically re Railways]

(3) As of 1 January 2021, air carriers holding operating licences granted by the UK licensing authority for the commercial carrying by air of passengers, mail and/or cargo, will no longer be able to provide air transport services within the European Union. EU air carriers and holders of aviation safety certificates will need to ensure, and uphold compliance with European Union requirements, including airlines’ requirements on principal place of business and EU majority ownership and control, as well as the European Union aviation safety acquis.

(4) As of 1 January 2021, road transport operators that are established in the United Kingdom will no longer hold a European Community licence. In the absence of a reciprocal access agreement, the limited quotas already available under the mechanism of the European Conference of Ministers of Transport (ECMT) will be available for EU operators to conduct journeys to the United Kingdom, and for UK operators to conduct journeys to the EU.

[I Blog posted in 2019 about this topic]

(5) As of 1 January 2021, EU REACH registrations held by manufacturers and producers established in the United Kingdom will no longer be valid in the European Union. These entities will have to ensure that their substances are registered with a manufacturer or importer in the European Union or appoint an ‘Only Representative’ in the European Union as registrant for the substance.

[A UK REACH will operate in the UK, I Blog posted about this in 2019]

(6) As of 1 January 2021, downstream users in the EU will have to check whether chemical substances they use are registered by a registrant established in the European Union. Where this is not the case, they should:

* check whether the UK registrant they deal with plans to appoint an ‘Only Representative’ in the European Union; or

* register the substance in the capacity of importer.

Re Northern Ireland specifics (this is not a full list)

(1) Checks and controls will take place on goods entering Northern Ireland from the rest of the United Kingdom, for example on food products and live animals to ensure adherence to sanitary and phytosanitary (‘SPS’) requirements. Goods leaving Northern Ireland to enter the EU must comply with EU standards and rules.

(2) EU customs duties will apply to goods entering Northern Ireland unless the Joint Committee (set up under the Ireland/Northern Ireland Protocol) sets out a framework of conditions under which these goods are considered not to be at risk of entering the EU’s Single Market. Based on such a framework, no customs duties will be payable if it can be demonstrated that goods entering Northern Ireland from the rest of the UK are not at risk of entering the EU’s Single Market.

Sanitary and Phytosanitary Notification (UK WTO)

The UK is a member of the World Trade Organisation (WTO). The WTO members operate amongst themselves an Agreement on the Application of Sanitary and Phytosanitary (SPS) Measures.

The UK submitted (13 March) information (for circulation to WTO Members) to answer the matter of the ongoing implementation of the United Kingdom’s obligations under this WTO SPS Agreement during the transition period following the United Kingdom’s withdrawal from the European Union, and to set out the UK’s own SPS Regulatory System.

The UK ceased to be a member State of the European Union on 31 January 2020. The UK and the EU agreed a Withdrawal Agreement which provides for a time-limited transition period until 1 January 2021 during which European Union law, as implemented through the Withdrawal Agreement, will continue to apply to and in the United Kingdom.

This means that the European Union SPS regime continues to apply in the United Kingdom during the transition period and, following that, the United Kingdom will apply its own SPS regime.

The United Kingdom Parliament legislated to repeal the European Communities Act 1972 by means of the European Union (Withdrawal) Act 2018. The 2018 Act preserves, and incorporates into domestic law, those elements of European Union law which will apply in the United Kingdom at the end of the transition period.

The European Union (Withdrawal Agreement) Act 2020 in turn implements the Withdrawal Agreement (which provides for the transition period) including by amending the European Union (Withdrawal) Act 2018 to reflect the terms of the Withdrawal Agreement.

The UK SPS Regulatory System is set out in the Notice – here

The UK Government is responsible for matters pertaining to the SPS Agreement and international trade. However, powers to implement, regulate and assure food safety, animal and plant health including matters relating to import and export, are devolved by the UK Parliament to the respective administrations in Scotland, Wales and Northern Ireland (collectively referred to as the Devolved Administrations).

Explosives Precursors from 1 Jan (UK Brexit)

The UK has not confirmed that it’s explosives precursors regulation system will continue in its current form after 1 January 2021. No notice is yet issued.

The matter is presently addressed (for the EU27) by a 98/2013 EU Marketing and Use Regulation, that will be replaced on 1st February 2021 by a 2019/1148 EU Explosives Precursors Regulation.

In the UK, this 2013 EU Regulation is retained as Retained EU Law, and a 2019 enacted Brexit EU Exit instrument makes the Retained EU document operate in the UK (see the Brexit Consolidated Law List in Subscribers systems). There is also domestic law.

The current UK explosive precursors regulation system is explained (2018) here.

The 2019 EU Regulation tightens controls (for the EU27 from 1st Feb 2021) on “explosives precursors”—chemical substances that have a legitimate purpose but can also can be used in home-made explosives—to keep pace with the evolving security threat.

The changes will further restrict access to explosives precursors and clarify the rights and obligations of those involved in the supply chain. It will distinguish between ordinary members of the public, who would require a licence to purchase restricted explosives precursors above a specified concentration limit, “professional users” who need the substances for their own trade, business or profession, and “economic operators” who trade in them. Professional users will not require a licence but will have to explain the purpose for which restricted explosives precursors were to be used. This information will then be available to EU27 national law enforcement and inspection authorities.

Until a UK notice is issued on the matter, subscribers to Cardinal Environment EHS Legislation Registers and Checklists – UK systems – that have explosives precursors included in their systems – will have the 2013 EU Regulation (repealed in EU27 on 1 Feb 2021) in the Retained EU Law section of the Registers. The 2019 EU Regulation (applicable in the EU27) will appear below Guidance, with other supplied EU Law (applicable in EU27). They will also have the domestic law.

Persistent Organic Pollutants from 1st Jan (UK Brexit)

The UK has confirmed that it’s persistent organic pollutants (POPs) regulation system will continue in its current form after 1 January 2021.

The matter is presently addressed (for the EU27) by a 2019/1021 recast EU POPs Regulation that came into force in 2019. In the UK, this 2019 EU Regulation is retained as Retained EU Law, and a 2019 enacted Brexit EU Exit instrument makes the Retained EU document operate in the UK (see the Brexit Consolidated Law List in Subscribers systems).

The UK confirmation is here.

The UK notice confirms all existing obligation and protections will continue because the UK is a signatory to both the Stockholm Convention and the Convention on Long-Range Transboundary Air Pollution. These Conventions are UNECE Conventions. The UK did not leave the UNECE (UN Economic Commission for Europe).

There is no change to the UK competent authorities.

Future updates will reflect Stockholm Convention decisions and agreed scientific and technical progress, and not necessarily changes to the EU POPs Regulation if it diverges.

Accordingly, subscribers to Cardinal Environment EHS Legislation Registers and Checklists – UK systems – will have both conventions added, where POPs are included in their UK systems. This is in addition to the necessary Retained EU Law.

The list of restricted, banned and monitored substances, with the exemptions, set out in the annexes to the current EU POPs Regulation will be amended this year (2020) to reflect decisions made at the last Stockholm Convention conference.

The Environment Agency is accordingly addressing changes pertinent to Perfluorooctane sulfonate (PFOS). The EA document is here.

These changes can be expected in amendments to existing domestic law.

The UK notice confirms identification of potential new POPs substances, with the exception of pesticides, will be managed initially through the UK chemicals regulatory regime that will replace EU REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) in the UK.

The UK notice confirms if all the characteristics of a POP emerge from the evidence gathering, the UK will develop a dossier for the Stockholm Convention’s POP Review Committee to assess.

Now that the UK has left the EU, this UK POPs notice confirms further changes to UK regulation of POPs will result from the review processes set up under UNECE Conventions.

Environment Bill (England & UK, Brexit)

Exit day is tomorrow, the transition period will last until 31st December.

The Environment Bill (from the previous session) is being brought back today and given its First Reading in the UK Parliament.

I Blog posted already about the earlier Environment Bill (various sections). When the Bill is published I will reprise those areas that are changed, and Blog post as well on the further sections I had not covered.

To remind – the Environment Bill is an important Bill setting up the Office for Environmental Protection (England) and making further changes to UK REACH to enable it to function from 1st Jan 2021, and additionally setting out other measures (England, and some provisions for Scotland, Wales and Northern Ireland).

The government announcement last night signals :

(1) A ban on the export of plastic waste (which was in the Conservative manifesto), additional to the waste provisions in the previous Bill. Note, the waste provisions as signalled do not align with the 2019 EU Single-Use Plastics Directive.

(2) A bi-annual review of international developments in environmental law that it says will inform domestic law making.

Please look out for further Blog posts on the matter, when the Bill is published.

EU Law in UK 2021 (UK Brexit)

Exit day is 31st January (end of this month)

Implementation period completion day is 31st December (this is the end of the transition period)

The Chancellor speaking to the Financial Times, confirms there will be no dynamic alignment with EU Law after 2020.

I am not yet clear which laws will diverge, but please note the Brexit laws allow divergence, for example the Brexit Agriculture Bill provides for England, Wales and Northern Ireland to create their own marketing standards (Scotland will need to enact its own Brexit Agriculture Bill).

The EU Exit regulations (statutory instruments) we (Cardinal Environment) are consolidating into domestic law only deal with the pre-Brexit period to end Dec 2020.

It is the FT front page today (Saturday 18th January) and the lead on BBC online.

EU Law per se will not apply anyway. Note, there may be some long tail implementation left over from pre-Brexit that will be implemented.

We (Cardinal Environment) are already consolidating the EU Exit regulations into domestic law, and creating the Retained EU Law (EU Regulations, not Directives, that are adopted). Progress in this project can be seen by clicking the Brexit Consolidated Law List on the top right hand side of EHS Legislation Registers & Checklists homepages (both ENV and OHS).

We are working to the deadline of 31st December 2020 for completion of this project.

In addition, EHS Legislation Registers & Checklists will see the home page choice of ENV or OHS have additional Post-Brexit choices, and the existing links relabelled Pre-Brexit.

The Post-Brexit links will direct to shadow Registers & Checklists that will run from the end of Q1 to hit the end Dec 2020 deadline, for switch over to Post-Brexit.

Post-Brexit shadow Registers & Checklists running in 2020 will have Brexit Consolidated Law loaded (accessibility will stay from the main Brexit Consolidated Law list), and will display a changed Register layout.

Post-Brexit EHS Legislation Registers layout – EU Law will be moved from the top to below Guidance. We will still supply up to date EU Law to UK customers, but this is where it will be found. Retained EU Law will be displayed at the top of the Register.

EU Law in UK 2020 (UK Brexit)

UPDATE (24th Jan) : UK Policy is NOT to implement beyond the Implementation period completion day

Exit day is 31st January (end of this month)

Implementation period completion day is 31st December (this is the end of the transition period)

The Withdrawal Agreement agreed between the UK and the EU in November 2019 will be ratified in the UK and the EU imminently. This will bring about an ordered UK exit from the EU, and initiate a Transition Period.

The Transition Period will operate for 2020. During the Transition Period EU law enacted and in force by 31st December 2020 will be implemented in the UK, even if it has implementation deadlines after 31st December.

UPDATE (24th Jan) : For our purposes, this means the 2018 EU Circular Waste Economy Package will be implemented in the UK. The 2019 EU Single-Use Plastics Directive would not be implemented.

In addition, EU laws already implemented in the UK but with long tail deadlines for e.g. product bans (e.g. menthol cigarettes) that apply after Exit day or after Implementation period completion day, will still apply in the UK.

The envisaged purpose of the Transition Period is for the UK and the EU to agree alternative arrangements for trade in goods, primarily, that will subsist from 1st January 2021.

For our purposes, this means the new UK chemicals regime, the new UK medicines regime, the new UK equipment label (UKCA Mark), and UK issued certificates of all kinds, will need to be in place by end of 2020. Expect unilateral arrangements for EU goods and chemicals etc circulation in the UK for a limited period after 31st December 2020. I Blog posted a few days ago about hops and the later date available for circulation of EU hops in the UK.

There could also be unilateral arrangements on the EU side for limited time-length goods circulation in the EU.

A key issue is acceptance on both sides of certificates issued, and the matter of double testing for chemicals, medicines etc.

Pesticides (EU)

Regulation (EC) No 1107/2009 is the governing EU Law on the placing of plant protection products (pesticides and herbicides) on the European market – the PPP Regulation.

This is a useful Q&A document (2015) about the PPP Regulation – here.

A zonal system of authorisation operates in the EU to enable a harmonised and efficient system to operate.

The EU is divided into 3 zones; North, Central and South. EU countries assess applications on behalf of other countries in their zone and sometimes on behalf of all zones.

The PPP Regulation sets out the requirements, procedure and timeframes for authorisation of Plant Protection Products (PPPs).

Applicants, EU countries, the European Commission and the European Food Safety Authority (EFSA) can be involved in the process of authorisation.

There are different types of application that can be submitted depending on the intended use of the PPP, the Member State(s) for which the PPP is required and the regulatory status of any existing authorisations.

Authorisations usually are time-limited and therefore come up again for review. The relevant EU body for the whole EU is the Standing Committee on Plants, Animals, Food and Feed (SCoPAFF).

In March 2019, the non-renewal of the fungicide active substance chlorothalonil came up for review at SCoPAFF, and the decision was not to renew.

In December 2019, the non-renewal of two organophosphate active substances chlorpyrifos and chlorpyrifos-methyl came up for review at SCoPAFF, and the decision is not to renew (this decision is not yet published).

This means products containing the above active substances may not circulate in the European market, stocks may be used up for a short time, determined by the EU authorisation document that is issued for the active substance.

Brexit : as an EU Regulation, the PPP Regulation is adopted in the UK as Retained EU Law. Enacted Brexit Law (in force from Exit day) makes changes to the PPP Regulation to enable it to stand alone within the UK statute base.

DEFRA has made no announcements re reversing EU bans.