What companies should expect post transition period?
Prepare for after the transition period- Biocides
The UK has left the EU but remains strongly committed to the effective and safe management of chemicals. The transition period governing the UK’s exit from the EU is scheduled to end on 31 December 2020.
The Withdrawal Agreement states that the UK cannot act as the lead in any EU level business such as risk assessments, examinations or authorisations, from the point at which it entered into force on 31 January 2020.
As a result, the UK has enacted legislation covering BPR but also the Classification, Labelling and Packaging Regulation (CLP) and the Export and Import of Hazardous Chemicals (Prior Informed Consent (PIC) Regulation, under. It also implements the Government’s commitment for Northern Ireland based businesses to have ‘Unfettered Access’ to Great Britain (GB) for these regimes.
There has been a change in the terms used by HSE, from UK to Great Britain (GB) to accommodate the Northern Ireland Protocol.
Things we know now!
Northern Ireland Protocol- At the end of the transition period, the Northern Ireland Protocol will take effect. The Protocol is a practical solution to avoid a hard border with Ireland whilst ensuring the UK, including Northern Ireland, leaves the EU, enabling the entire UK to benefit from future Free Trade Agreements. NI will still have access to the EU market after the transition period. Companies established in NI can hold EU BPR biocidal product authorisations and be listed on EU BPR Article 95. Similarly, a biocidal product produced in NI and shipped to the EU will not be classified as an ‘imported product’. However, products shipped from GB to NI will have to follow the relevant import Regulation.
Article 95- Great Britain will have its own separate Article 95 list, for access to the Great Britain market, companies must be on this list. The list will mirror the EU list from 1st. Jan 2021 and will operate in the same way as the EU Article 95. The current Article 95 listings will be grandfathered into the GB list for two years, after which data will need to be resubmitted to remain on the UK Article 95 list.
What do to if your business is already on the EU list?
Your business will be included in the Great Britain list from 1st. Jan 2021. To stay on the Great Britain list, you will need to submit supporting information to HSE. This is the same information you submitted to ECHA, for example, an active substance dossier or a letter of access to data held by HSE. You will also have to ensure that your business is established in the UK. You will have 2 years to meet these requirements.
Regarding BPR, GB companies can be represented on the EU Article 95 list by an EU representative, and this needs to be in place by the end of this year.
C4C can act as your business GB representative on the GB Article 95 list.
Interested in learning more? Get in touch info@connect4compliance.com
Active substances- Existing active substance approvals will be grandfathered into UK law with the same renewal date, i.e. they will remain valid until the existing expiry date. Pending active substance applications in the review programme, including renewals, will be maintained in the UK regime and redistributed to a new eCA. There is then the requirement for resubmission to the UK within 90 days (if UK was the eCA) or within 180 days (if UK was not the eCA) after the end of the transition period on 31 December 2020
Biocidal products- Existing approvals under BPR will be ‘lifted and shifted’ from EU BPR to UK BPR. Thus, product authorisations valid in the EU before the transition end date will remain valid in the UK. However, a company will need to be established in the UK within 365 days. HSE might also request additional data such as scientific and authorisation data which will need to be provided within 60 days of the request being made. Existing non-UK biocidal product authorisation ‘assets’ held by UK legal entities will also need to be transferred by the end of 2020 to an EU legal entity. Ongoing applications for national authorisation, mutual recognition, Union authorisation, renewals and simplified authorisation, including changes to these, will be maintained in the UK if they are resubmitted to the UK, within 90 (where UK active) or 180 days (where UK passive), after the end of the transition period on 31 December 2020, depending on the situation. Companies will also need to be established in the UK within 365 days.
Interested in learning more? Get in touch info@connect4compliance.com