14 Nov 2018 Withdrawal Agreement (EU-UK Brexit)

I posted yesterday (Brexit Status) that Withdrawal Agreement text had been agreed between EU and UK negotiators. This text was agreed last night at a meeting of the UK Cabinet, and then published – here. Alongside the 14 Nov 2018 Withdrawal Agreement text, a starter for the Outline Political Declaration on the Future Relationship was also published, and a Joint Statement (in that link).

Alongside this, DExEU also published and Explainer and Explanatory Notes – here.

The EU also published a Fact Sheet on the Withdrawal Agreement (WA) text – here, and a Fact Sheet on the Protocol on Ireland and Northern Ireland (one of the 3 Protocols to the WA) – here.

The 14 Nov 2018 Withdrawal Agreement has 185 Articles, 3 Protocols, and a series of Annexes.

The objective of the Withdrawal Agreement (WA) is to put in place an orderly exit of the UK from the EU on 12 midnight CET (11pm GMT) 29 March 2019 – dealing with matters such as citizen rights, money, and a series of separation technicalities. The WA (if ratified as a Treaty) also puts in place a Transition Period (in the UK, this is termed an Implementation Phase) lasting until 31 December 2020, during which EU Law will continue to apply and trade will be unchanged.

Note :

(1) the WA text must pass through a series of gates before ratification as a Treaty. When a Treaty, it will be given effect by the EU (Withdrawal and Implementation) Bill in the UK, which itself must be created and enacted. And this new Bill will necessarily amend and rewrite parts of the already enacted EU (Withdrawal) Act 2018. It is hoped, but by no means certain, these gates can be crossed by the exit date of 29 March 2019.

(2) during the transition to 31 Dec 2020, EU Law would continue to apply to and within the UK and override domestic law. But, as the UK will be a third country, this means it will have only minimal influence on the creation and enactment of EU law in that phase.

(3) a single extension for an (at present unspecified) length of time is permitted to the Transition Phase, this extension to be agreed by 1 July 2020. A firm end date will need to be negotiated by the European Council on 25th Nov (if it takes place).

(4) a specific Protocol for handling the border between Ireland and Northern Ireland is the first of 3 Protocols in the 14 Nov 2018 WA text. This Protocol includes a detailed “backstop” to be used if the Future Relationship is not in place by the end of the transition period.

(5) the UK is a Third Country on exit on 29 March 2019, the transition period gives a further short period for transition to this Third Country status (relationship with the EU).

(6) the objective is to transition from the current EU member state status direct to the Future Relationship (Trade Agreement) status, via the Transition Period (which could be extended).

Further work is ongoing, and the WA text must pass a series of gates.

It is essential that Brexit Preparedness planning continues, and that the current Brexit Preparedness and Brexit Contingency EU and the UK Notices are read and understood. I have posted these. Please keep following this Blog for updates.

No Deal Contingency Action Plan (EU Brexit Contingency Measures)

The Commission has issued a Press Release updating on its No Deal Contingency Action Plan. The Press Release with links is here.

Note – the new Travel Notice (linked from the Press Release).

Note – the new 13 November Communication (linked from the Press Release)

Additionally two November 2018 PDF documents summarise the situation. Here and Here. The second PDF is reproduced as two images.

Persistent Organic Pollutants (EU)

The EU Regulation on Persistent Organic Pollutants will be reissued (recast). Consultation responses are here. The proposal is here.

Detail

The European Commission is recasting the Persistent Organic Pollutants Regulation (EC) No 850/2004 (the current POPs regulation) which implements the commitments of the EU under the Stockholm Convention on POPs, and also takes account of the 1998 protocol to the 1979 Convention on Long-Range Transboundary Air Pollution on POPs (protocol). Most EU countries, including the UK, are party to the Stockholm Convention and the protocol in their own right and as a member of the EU.

Persistent Organic Pollutants (POPs) are substances that remain intact in the environment for long periods, become widely distributed geographically, accumulate in the fatty tissue of humans and wildlife, and have harmful impacts on human health or on the environment. Examples of POPs include polychlorinated biphenyls (PCBs) and pesticides such as DDT.

The reasons for this recast are:

i. The EU Council Directive which provides the legal basis for the comitology committee for this regulation has been revoked and the committee ceased to exist on 1 June 2015.

ii. The regulation needs to take into account updated procedural changes introduced by the ‘Lisbon treaty’, in particular, which rules are subject to implementing acts and which conditions apply to the adoption of delegated acts.

The Commission proposes a recast of the Regulation with three objectives:

(1) to align the provisions for adoption of detailed implementing rules with changes introduced under the Lisbon Treaty—and, in particular, to stipulate which rules are subject to implementing acts and which to delegated acts; (see above)

(2) to involve the European Chemicals Agency (ECHA) in supporting the scientific, technical and reporting aspects of the Regulation—this includes providing advice on substances that are being considered by the Stockholm Convention for bans and restrictions and compiling, registering and disseminating information provided by Member States on the implementation of the agreement; and

(3) to simplify the reporting provisions.

Nonetheless there are changes, see the consultation responses.

BREXIT : It is possible that the recast Regulation will enter into force prior to the end of the post-Brexit implementation period on 31 December 2020. As a result, the Regulation could be directly applicable in the UK until the end of that period.

The UK relevant ministry (DEFRA) indicates possible concerns regarding the introduction of delegated acts and the ability for Member States to scrutinise and participate in decision making on the setting of thresholds and the nomination of POPs under the Stockholm Convention. It is not clear exactly, says the Minister, how the Commission will manage the approval of use of POPs in closed site systems nor how they will set waste thresholds for POPs in products. She believes that clarification over the ECHA’s role will be key. This includes whether there will be a requirement to use committees such as the Risk Assessment Committee and the Committee for Socio Economic Analysis to set maximum limits for POPs content within an article. The POPs element of the article above the maximum limit must be destroyed, usually at high temperature. The Government will therefore seek this clarification regarding the application of delegated acts during the negotiations.

The Minister welcomes the use of ECHA to assist in the implementation of the regulation as it brings the POPs regime into alignment with the REACH Regulation. This, she says, will help prevent conflicting decisions for the same substances and align timelines at the international and EU level. The UK is supportive of strengthening the role of the ECHA, and will be seeking further clarification regarding its role in relation to the POPs Review Committee (POPRC) and reporting to ensure there are no additional resource impacts.

The UK also supports streamlining reporting, digitalisation, and encouraging the use of the Information Platform for Chemical Monitoring (IPCheM). While there is no longer a requirement for triennial reports, a requirement is proposed to keep up to date data uploaded on the IPCHeM platform, allowing the ECHA to provide six-monthly reports to the Commission. The IPCHeM brings together chemical monitoring data under a new platform, established in 2015. It also brings the general EU reporting in line with the requirements under the Stockholm Convention, including requests for information for POPRC and the reporting for the convention under Article 13. The UK will seek clarification regarding the information and reporting requirements and standards which will be set by the ECHA going forward to align with the portal. Until the UK clarifies its relationship with the EU and the ECHA the precise impact of these changes once the UK has left the EU remains unclear.

Life Science Sector (UK Brexit Preparedness)

UPDATE : further information on the Clinical Trials Regulation (issued 6th August) is here.

Today (6th August) the Department of Health & Social Care, the Medicines & Healthcare products Regulatory Agency and the Veterinary Medicines Directorate, together, issued Guidance.

The guidance is “What the implementation period means for the life science sector’. This document is here. NB – the implementation period is the UK term for the EU transition period.

The guidance states (and note, this is subject to EU-UK agreement of the Withdrawal Agreement) :

During the implementation period:

• pharmaceutical firms will be able to continue UK batch release testing and Qualified Person certification in the UK, with this being recognised by the EU and vice versa

• marketing authorisation holders and qualified persons for pharmacovigilance will continue to be able to be based in the UK and access EU markets. There will be continued mutual recognition of manufacturing and distribution licences, as well as associated inspections such as good manufacturing practice (GMP)

• firms based in the UK will be able to continue to apply for marketing authorisations via either the centralised or decentralised procedures

• for medical devices, CE marking will continue to be used and recognised for both the UK and EU markets, and UK-based industry will not require an authorised representative established in the EU. UK notified bodies will continue to conduct third-party conformity assessment in the UK and the results of these tests will continue to be used and recognised for both the UK and EU markets.

The document also states the UK reached agreement with the EU at March European Council that the UK is to be treated as a Member State for the purposes of international agreements, including Mutual Recognition Agreements, for the duration of the implementation period. The EU will notify other parties of this approach.

This means that there will be no disruption to existing relationships underpinned by international agreements as we move into the implementation period.

A vital issue is EU legislation enacted during this implementation/transition period, or enacted beforehand with forward enforcement dates in the period, or enacted after the period – below is illustrative (from this document, and applicable to this subject)

(1) The new Clinical Trials Regulation (CTR) is expected to be implemented during 2020 and would therefore apply to the UK under the terms of the time-limited implementation period.

If the new regulation does not come into force during the implementation period, the government has confirmed that UK law will remain aligned with parts of the EU’s CTR legislation that are within the UK’s control, so that researchers conducting clinical trials can plan with greater certainty.

Regardless of the outcome of the negotiations, the UK is committed to offering a competitive service for clinical trial assessment. This covers regulatory approval from MHRA as well as services from HRA, ethics services, NIHR and the NHS. (This is not applicable to the veterinary sector.)

(2) The EU Medical Devices Regulation will fully apply from May 2020. As this falls during the implementation period the government will fully implement the legislation.

(3) The new EU Regulation on in vitro diagnostic (IVD) medical devices will not apply until May 2022, which is outside of the implementation period. However, elements of both new devices regulations have applied directly in UK law since May 2017, meaning medical devices, including IVDs, can now be legally placed on the UK market if they are in conformity with the new regulations, invoking all relevant requirements. (This is not applicable to the veterinary sector.)

National Emission Ceilings Directive (EU)

In 2011-2013 the Commission conducted a review of the EU air policy which resulted in the adoption of the Clean Air Policy Package. As part of the package, the Commission proposed a Clean Air Programme for Europe, updating the 2005 Thematic Strategy on Air Pollution in order to set new objectives for EU air policy for 2020 and 2030.

The main legislative instrument to achieve the 2030 objectives of the Clean Air Programme is new Directive 2016/2284/EU on the reduction of national emissions of certain atmospheric pollutants which entered into force on 31 December 2016. This Directive sets national reduction commitments for the five pollutants (sulphur dioxide, nitrogen oxides, volatile organic compounds, ammonia and fine particulate matter) responsible for acidification, eutrophication and ground-level ozone pollution which leads to significant negative impacts on human health and the environment.

The new Directive repeals and replaces Directive 2001/81/EC, the National Emission Ceilings Directive (NEC Directive) from the date of its transposition (30 June 2018) ensuring that the emission ceilings for 2010 set in that Directive shall apply until 2020. Directive 2016/2284 also transposes the reduction commitments for 2020 taken by the EU and its Member States under the revised Gothenburg Protocol and sets more ambitious reduction commitments for 2030 so as to cut the health impacts of air pollution by half compared with 2005.

Directive 2016/2284/EU is here. A Q&A about the Directive is here.

Some customers have already requested this Directive or have the Directive already. The national implementing regulations will be inserted into the ENV Air Register. Email Alerts will be sent out. If you need this Directive (and it’s local implementing regulations), please email me direct.

The role of the Member States in coordinating and implementing the Directive at national level is very important. Member States must transpose the Directive into national legislation by 30 June 2018 and produce a National Air Pollution Control Programme by 2019 setting out measures to ensure that emissions of the five main air pollutants are reduced by the percentages agreed by 2020 and 2030.  They must also coordinate with plans in fields such as transport, agriculture, energy and climate.

The Commission will work with Member States to ensure sound implementation, for example by setting up a new Clean Air Forum by autumn 2017. This will bring together stakeholders to exchange experience and good practice. The Commission will also facilitate access to EU funding instruments.

BREXIT : the UK has enacted implementing regulations (in force 1st July 2018) – here

The obligations rest with national implementing authorities, the new National Emission Ceilings Directive does not create direct obligations for facility managers or owners.

UK exits the EU (EU Brexit Preparedness)

You notice I have been posting about EU Notices and my last post is entitled Brexit Preparedness, and this post identifies the EU is also publishing Brexit Preparedness legislative proposals.

The European Commission has now re-organised the EU Notice site online, and retitled it as Brexit Preparedness.

Today they also show the state of play of planned legislative proposals (at 12 June 2018) as a link from the Legislative initiatives tab on the Brexit Preparedness site. That state of play is here. But you can find for yourself on the site where this document is.

Note : the EU Notices are retitled Preparedness Notices, and are identified by European Commission department. This makes them easier to locate, but at moment they are not sortable by date of issue.

Note : the Notices issued by the EU regulators (described as EU decentralised agencies) are found on the original page – this is linked behind the words “Read more on EU Brexit Preparedness Notices”. Here

The reorganised EU Brexit Preparedness online site is here.