ChemRegs Newsletter – August 2018

HSE EU Exit Chemicals Workshop, Liverpool

As mentioned in our July Newsletter, ChemRegs attended the HSE Chemicals EU Exit Workshop in Liverpool and the following is our summary of the day.

HSE’s Chemicals Regulation Division (CRD) announced in July that they were holding a one-day stakeholder ‘HSE EU Exit Chemicals Workshop’ at the Hilton Hotel in Liverpool City Centre on Wednesday 1st August 2018.

ChemRegs registered for a place straight away as we were eager to see what the HSE had planned with regards to chemical legislation following Brexit.

The workshop was to cover the EU Exit and its impact on the BPR and CLP regulations as part of planning for a contingency scenario (‘no deal’). However, it was made clear during the various sessions that the Government’s preferred outcome is an agreement with the EU.

If an agreement with the EU is concluded, then the implementation period will start on 30 March 2019 and last until 31 December 2020. During this implementation period the UK will no longer be a Member State of the EU, but market access and trade will be able to continue on the same terms as now up until the end of 2020.

The European Union (Withdrawal) Act 2018 has received Royal Assent and is now on the statute books. The effect of the Act is to cut and paste, or ‘lift and shift’ to use the Civil Service lingo, existing EU law into UK law. This will take effect from ‘exit day’ on 29 March 2019. In other words, all EU-derived domestic legislation, as it has effect in domestic law immediately before exit day, will continue to have effect in domestic law on and after exit day.

If there are deficiencies in the law arising from withdrawal, then Section 8 of the Act (‘Dealing with deficiencies arising from withdrawal’) gives power to fix and remedy them. It is these ‘deficiencies’ and ‘fixes’ that the HSE wanted to discuss with stakeholders as part of the workshop.

The welcome speech was given by Matt Penrose, Head of Chemicals EU Exit Unit, who outlined the day’s Agenda. The morning session would include presentations to give an oversight of the preparations being made for EU Exit in general, and in relation to the chemicals regimes that HSE has policy responsibility for. During the afternoon, breakout sessions would provide an opportunity to discuss the impact of EU Exit on the BPR and CLP regulations in more detail.

Dave Bench, Director of Chemicals EU Exit Unit, then gave a presentation on “Setting the scene”. He revealed that within hours of the EU referendum result, preparations were being initiated for a ‘no deal’ outcome and the Chemicals EU Exit Unit was set up including the HSE and the Department for Environment, Food and Rural Affairs (DEFRA).

The HSE lead is the CLP, PIC (Prior Informed Consent), BPR, PPP (Pant Protection Products fees and charges) regulations. DEFRA lead is REACH, PPP, MRL (Maximum Residue Levels), Detergents, POP (Persistent Organic Pollutants) and Mercury regulations.

Dave Bench explained that the HSE have a transition programme to ensure that the Chemicals Regulation Division (CRD) remains fully operational regardless of the scenario and to ensure that IT and administrative processes are in place to allow the HSE to continue to act as regulator for chemical legislation. He revealed that permission was only granted in July for the HSE to talk about a ‘no deal’ scenario that was the main purpose of the day’s workshop.

If an implementation period is agreed, then HSE will no longer be able to act as a ‘lead authority’ and would have limited participation in EU institutions, agencies and bodies during this period.

The White Paper on Legislating for the Withdrawal Agreement between the United Kingdom and the European Union sets out a close alignment for legislation following the implementation period, with a future economic partnership to start from 2021. There will be a common rulebook for goods and alignment with EU Rules is expected. Participation in EU Agencies, including ECHA, EASA and the EU Medicines Agency is also anticipated.

Leo McDaid, Team Leader, Policy & Whitehall Engagement Team, Chemicals EU Exit Unit, then took the floor for a presentation on ‘HSE Chemical regimes – EU Exit preparations’. This covered the effect of the EU exit on the CLP, BPR and PIC regulations.

The European Union (Withdrawal) Act will convert all directly acting EU Regulations into domestic law e.g. CLP will becomes retained UK law. The HSE is currently preparing contingency Statutory Instruments (SIs) to ensure that these laws will be operable outside of the EU. Legislative clearance starts in early Autumn with the aim of the SIs to be made and laid before parliament by the end of December 2018/early January 2019, with them coming into effect on ‘exit day’, 29 March 2019.

The HSE are working on various ‘fixes’ to cover some ‘deficiencies’ they have identified in converting the EU law. Some of these are simple fixes e.g. references to the EU or Member States and superseded EU legislation. These would be replaced with references to UK law.

Others are more complicated.

The EU Commission currently acts as the decision making body and this role will be given to the relevant Secretary of State in the event of a ‘no deal’. The devolved administrations i.e. Scottish Parliament, National Assembly for Wales and the Northern Ireland Assembly, will also have to be taken into account and ongoing discussions are in place.

The current competent authority arrangements will not change.  ECHA currently has certain roles and functions given to it by EU legislation and the HSE would take over these in a ‘no deal’ scenario. However, the UK would no longer have access to R4BP3 and ePIC and the HSE is working with Defra to develop new IT systems for registrations/notifications etc.

Main changes in a no deal scenario – BPR

The UK would no longer play a part in the EU system of approving active substances and authorising biocidal products. Separate applications would be needed to the UK and EU. As the UK would no longer work with ECHA, it would lose access to the IT systems and would use its own systems for receiving and processing applications. The UK would also lose access to the data held on the EU (ECHA) systems and data held in these databases may need to be resubmitted to HSE e.g. by letters of access etc.

A UK Article 95 list would be established and companies already on the EU Article 95 list will be transferred to the UK list but would need to re-submit information to the UK. A transitional period will be provided.

All active substance approvals or product authorisations valid in the UK on ‘exit day’ would remain valid until their normal expiry date. However, applications being processed on ‘exit day’ would need to be resubmitted if the UK loses access to R4BP3.

A UK base would be needed for UK authorisation and likewise an EU base would be needed for EU authorisation.

The CLP regulation will become a separate UK system but would adopt the GHS system in the same way as CLP. Companies would have to comply with both the UK system and EU CLP to export chemicals to the EU.

Main changes in a no deal scenario – CLP

The UK is to establish its own independent chemicals regime and the HSE is to act as the UK Competent Authority. The HSE will also act as the agency for alternative names, notifications database and mandatory (harmonised) classifications.

Distributors and downstream users of chemicals in the UK will become importers of chemicals from the EU.

All existing notifications will be recognised and companies will interact with HSE for new notifications using a UK IT system.

Existing harmonised classifications will remain valid and become UK ‘mandatory classifications’. New arrangements will be made for updating the UK mandatory classification and labelling list.

Fees and charges will be adopted to reflect UK cost levels.

Companies will use new UK tools such websites, guidance, IT systems etc.

Main changes in a no deal scenario – PIC

The HSE would continue to act as the Designated National Authority (DNA) and the appropriate Secretary of State and NI Minister would take on decision making responsibility.

The UK will need to develop an alternative to ePIC, but may this would not have the same degree of IT functionality.

Exporters would need to notify via HSE any exports of PIC-listed chemicals to EU member states.

Fees and Cost Recovery

The UK currently uses EU provisions for cost recovery and the HSE would continue to use and adapt these provisions for UK work.

The UK provisions would be included in the new SIs as an hourly charge.

What ‘no deal’ means for Industry

• On Day 1, similar requirements as are now in place would continue to apply i.e. there would not be any policy changes.
• The Government is to publish a series of technical notices for the contigency ‘no deal’ scenario in August/September.
• All existing REACH registrations, approvals, authorisations and classifications in place on the day of exit would continue to be valid in the UK but may not be valid in EU.
• Distributors and downstream users of chemicals will become importers of chemicals from the EU.
• UK based companies would need to find an EU based importer to place substances/products on the market in the EU as the “only representative’ route does not apply for BPR and CLP, only for REACH imports.
• Functions carried out by the EU Commission or ECHA would mainly be performed by the HSE.
• As far as possible, rules and requirements would stay the same at the point of leaving the EU on 29 March 2019.

A Q & A session was then open to the floor and various ‘hot topics’ were asked including questions on letters of access, a common rule book for frictionless trade at the border (no divergence), HSE extra funding, expertise and staffing for the CRD, how the UK CLP will mirror the GHS and how would it be updated etc.

A welcome lunch break was then taken.

After lunch, Matt Penrose introduced the afternoon sessions. He explained that our name badges each had a coloured circle and that these colours would form small groups for breakout sessions in order to discuss the impact of EU Exit on the BPR and CLP regulations in more detail.

We dutifully filed out of the room and found our respective groups. Each group then sub-divided into smaller groups and given a flip chart and a series of questions to brain storm on CLP and BPR.

Points for discussion were:

• Are there any immediate concerns or difficulties with this approach that come to mind?
• What would the impacts of our approach be and what are the practical consequences?
• What kinds of preparations are companies making for a ‘no deal’ scenario?

An hour or so of heated debate was then had!

Following the breakout sessions, we went back to hear the closing session given by Dave Bench, who gave a summary of the day and said that more workshops and sessions were planned.

Although we weren’t allowed a copy of the slides on the day, the questions and answers raised would be consolidated and published on the HSE website at some point in the future.

For more information on anything in this Newsletter, please contact us at info@chemregs.co.uk