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Summary of 'Deal or No Deal' Scenarios for Chemical Regulations

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Summary of 'Deal or No Deal' Scenarios for Chemical Regulations

By 31 October 2019 EU leaders insist that the UK must either ratify the Withdrawal Agreement (and allow a transition period), leave the EU without a deal or cancel Brexit.

The two most likely options are:

  1. DEAL SCENARIO

  2. NO DEAL SCENARIO

WITH A DEAL:

The UK will no longer be a member of the EU State during the potential trade deal transition period, but access to the market will continue as normal until the transition period ends, which is expected to be two years.

This means that products which complied with the applicable chemical regulatory laws and harmonised standards when placed on the EU or British market before 31 December 2020, can continue to be re-distributed and used within the EU or the UK.

However:

  1. During this transition period, the UK cannot act as the leading authority for risk assessments, examinations, approvals or authorizations (Article 128(6)).

  2. All risk assessments, approvals and authorization procedures led by the UK must be transferred (Art. 44).

  3. The EU regulatory bodies will retain competence on compliance and harmonization with EU law after Brexit for products on the market before the Withdrawal date.

  4. The Court of Justice of the European Union will retain its competence during the transition period.

 

KEY DIFFERENCES BETWEEN ‘DEAL OR NO DEAL’ FOR REACH, BIOCIDES, PESTICIDES AND CLP

Below is a short summary of the key differences between a ‘Deal or No Deal’ scenario for REACH, biocides and pesticides.

REACH (EC No.1907/2006) WITH A DEAL

REACH (EC No 1907/2006) WITH NO DEAL

* REACH will continue to apply to the UK.

 

* Current registrations, approvals and authorisations will remain valid.

 

* The process for registering new chemicals under REACH will be the same - UK companies will still need to register with ECHA.

 

* The UK will recognize all new registrations, approvals, authorisations and classifications granted by the EU. However it is unlikely that the HSE will be able to act as a ‘leading authority’ to conduct certain assessments under REACH.

 

* UK-based businesses will have the same rights as EU-based businesses to have their cases accepted and processed by ‘leading authorities’ based in other Member States.

* REACH as it currently stands will become part of UK law via the European Union (Withdrawal) Act 2018.

 

* Current registrations will need to be transferred to an EU/EEA-based organization, or EU/EEA-based importers could become the registrant.

 

* UK-based companies with EU REACH registrations will have their registrations legally recognized under 'UK REACH'. Grandfathered registrations will need to be validated.

 

* UK will have its own REACH IT system in operation, and initial registration information will need to be provided within 120 days of the UK leaving the EU, and full dossier information will need to be provided within 2 years of the UK leaving the EU.

 

* Importers will need to open a REACH IT account and provide initial information on their registration within 180 days of the UK leaving the EU, and provide full technical information on their registration within 2 years of the UK leaving the EU (see data sharing issues below).

 

* Downstream users and distributors must ensure that a valid UK REACH registration is held by someone in the supply chain.

 

REACH DATA SHARING WITH A DEAL

REACH DATA SHARING WITH NO DEAL

* Chemical companies may not have to pay for data if a data-sharing agreement with ECHA can be reached.

 

* Companies can also defer decisions relating to data purchase during the transition period.

* Companies operating in the UK will need to register under a new UK REACH system at an estimated cost of approximately £70,000 per substance (based on admin costs, and access to existing data etc).

 

* Current LoAs may not cover submissions to the HSE, depending on how they were originally drafted. Companies should review LoAs currently held and assess what may be needed with regards to data access in future.

 

* Companies should review their rights to access data required for UK REACH. There may be the need for renegotiation of these access rights required for UK-REACH.

 

 

BIOCIDES (EC No. 528/2012) WITH A DEAL

BIOCIDES (EC No. 528/2012) WITH NO DEAL

* The BPR will continue to apply in the UK.

 

* Existing active substance approvals and biocidal product authorisations will continue to be valid.

 

* The UK will be able to mutually recognise biocidal product authorisations granted by an EU Member State and Union authorisations will apply in the UK.

 

* The HSE will no longer be able to act as the evaluating Competent Authority/reference Member State for active substance approval, Union authorisation or mutual recognition BPR applications.

 

* Companies will still be able to comply with the requirement of being ‘established in the Union’ if they are established in the UK.

 

* UK-based businesses will also have the same rights as EU-based businesses to have their cases accepted and evaluated by Competent Authorities based in EU Member States.

 

* HSE will continue to process BPR applications.

 

* Biocidal product applications being processed by HSE on exit day will still be evaluated, but a resubmission to the HSE will be required.

 

* For ongoing applications for mutual recognition with the UK as a concerned Member State or Union authorisations that include the UK but the UK is not the lead evaluating competent authority, these applications would need to be resubmitted to the UK as new national authorisations.

 

* If the UK is the lead evaluating competent authority for ongoing Union authorisations and national authorisations with associated concerned Member States for mutual recognitions, the applications will need to be resubmitted to a new EU lead evaluating competent authority.

 

* A UK version of the Article 95 list would be established. Companies already on the EU Article 95 list on exit day will automatically be included on the UK list but resubmission of information for UK and EU companies to remain on the UK list will be required and normal EU expiry dates will apply in the UK to active substance approvals.

 

* Functions such as technical equivalence assessments would be handled by the HSE and not ECHA and the UK would develop its own IT system for application handling, equivalent to ECHA’s Register for Biocidal Products (R4BP).

 

* UK biocidal product authorisation holders will need to be established in the UK.

 

* HSE will not have access to all data relevant to the application of the BPR which is currently held by ECHA, including all data provided for active substance approval, product authorisation and Article 95 listings and so companies may have to supply data to the HSE, as the UK’s independent biocides regime is established.

 

* BPR rules on data sharing will not apply. Therefore, there will be no legal obligation on data owners to share their data for companies looking to submit data under the UK’s biocides regime.

 

 

 

PESTICIDES (EC 1107/2009) WITH A DEAL

PESTICIDES (EC 1107/2009) WITH NO DEAL

* Existing active substance approvals and MRLs will remain valid.

 

* New EU active substance approval decisions and MRL decisions will also apply to the UK.

 

* The HSE will not be able to act as a zonal Rapporteur Member State (zRMS) but will continue to recognize ‘Central Zone’ PPP authorisations by EU Member States

 

* Any active substance approval applications still being processed by the HSE on exit day will be transferred to another Member State by the European Commission.

 

* Existing parallel trading permits for plant protection products will remain valid after exit day.

 

* EU law will no longer apply - new laws will be similar to existing laws.

 

* Products placed on the UK market will require authorisation under the new rules.

 

* Current product authorisations and MRLs will be valid immediately after EU exit.

 

* The HSE will continue to act as UK regulator.

 

 

Classification, packaging and labelling (CLP) in ‘No Deal’ scenario

The UK would have to establish an independent standalone chemicals regime; however the UK would adopt the United Nations Globally Harmonised System (UN GHS) in the same way as the EU.

  • The UK classification and labelling regime would be based on the existing EU regulatory regime to provide continuity for businesses.

  • Most provisions of CLP would continue to be applied in the UK, so the main duties and obligations on UK manufacturers, importers and downstream users to classify, label and package the substances and mixtures they place on the UK market will remain.

All labelling requirements would remain in place including the principles of precedence for the different labelling elements, the location of the label on packaging, and exemptions where available. Packaging requirements would remain the same.

  • The HSE would act as the competent authority for the UK – the HSE would establish a dedicated IT system.

  • Future UK decisions on classification may diverge from those taken by the EU.

If you have any questions regarding a ‘Deal or No Deal’ scenario, please contact Peter Godfrey (Peter.Godfrey@cea-res.co.uk) or Sarah Henly (Sarah.Henly@cea-res.co.uk).

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