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UK – BREXIT: Last information from HSE

The HSE (Health and Safety Executive) has published on its website information concerning Brexit whose transition period soon expires on 31 December 2020.

Thus from 01.01.2021, a new independent pesticides regulatory regime will operate in Great Britain with national decisions based on national rules. In Northern Ireland, the EU pesticides regime will continue to apply after the end of the transition period, in the same way as during the transition period.

The HSE will remain the sole national regulator for the whole UK.

Firms are informed on how to prepare different kind of dossiers in Great Britain:

– For active substance approvals: For the existing ones, they will continue to be valid in Great Britain until their current expiry date which will nevertheless be extended for 3 years for substances that expire before December 2023. For new active substances, Great Britain and the HSE will make their own decisions. A statutory register for approved active substances will be published on the HSE website from 01.01.2021. A specific program is actually in development for the review of the safety of active substances.

– For PPP authorisations: For the existing ones, they will continue to be valid until their current expiry date. For new applications, same data requirements and same formats as actual will be required by HSE. Active substance must be first approved in Great Britain to be used in a PPP.

– For MRLs: Great Britain will set MRLs based on their assessments but all existing MRLs will remain valid until they are amended.

– For mutual recognition: New applications for mutual recognition of authorisations in European Member States will no longer be accepted, except for existing applications for which a conclusion will be raised under the national British regime.

– For parallel trade permits: New applications for parallel trade permits in Great Britain will no longer be accepted. Existing permits will be valid until their current expiry date or until 31.12.2022 for permits with a later expiry date.

 

See also our previous articles: 

France – ANSES: Brexit impact on mutual recognitions and parallel trade permits

 

Lynxee consulting’s team is at your disposal to answer your questions.

Contact us! http://lynxee.consulting/en/contact/

 

France – ANSES: Brexit impact on mutual recognitions and parallel trade permits

On 31 January 2020 at midnight, the UK left the European Union. The European rules will continue to apply during a transition period that will end on 31 December 2020. This transition period could be extended to end of 2021 or 2022 if such a decision is taken by 1st July 2020.

During this transition period, the provisions remain the same for mutual recognitions (article 40 of Reg. (EC) 1107/2009) and parallel trade permits (article 52 of Reg. (EC) 1107/2009).

After this transition period, any application for mutual recognition or parallel trade permit under administrative completeness check will be rejected. Moreover, any application under scientific evaluation or decision process will result in a refusal.

The authorisations granted by mutual recognition before the date of withdrawal of the UK will not be affected by the Brexit.

However, after the transition period, a parallel trade permit  with a UK origin will not be valid anymore. No grace period will be granted for sales and distribution. A 12-month period will be granted for storage and use of products.

 

To download: 

Anses paper as regards « Brexit » impact on mutual recognitions and parallel trade permits (in French)

Lynxee consulting’s team is at your disposal to answer your questions.

Contact us! http://lynxee.consulting/en/contact/

UK – Brexit: scenarios in case of no-deal

The Health and Safety Executive (HSE) have issued technical notices detailing what will happen if the UK leaves the EU without an agreement (‘no deal’).

Regarding PPPs, in a no deal scenario, the UK would establish an independent standalone PPP regime, with all decision making repatriated from the EU to the UK. HSE would continue to operate as the national regulator.

All current active substance approvals, PPP authorisations, and Maximum Residue Levels (MRLs) in place on 29 March 2019 would remain valid in the UK after the Brexit, so businesses could continue to trade and products would continue to be available.

After the Brexit, all applications for products to be authorised in the UK, and all active substances and MRLs would be considered under the national regime. The format of applications and basic data requirements would remain the same as under the current regime. Applications for EU approvals would need to be submitted separately to the EU for their consideration.

To ensure that processes run smoothly, there would be an extension of three years to active substance approvals which are due to expire in the three years after the Brexit. This would provide time for establishment of national renewal arrangements.

Applications which are being considered by the UK at the point of exit will be progressed to completion under the national regime.

At medium or long-term, HSE envisage developing a UK legislation divergent from the EU legislation.

Action for business:

  • No immediate action is required in respect of current active substance approvals, PPP authorisations, and MRLs. These will all remain valid in the UK and EU after exit day as now.
  • Start to consider what new applications businesses might wish to make under both the UK and EU regimes in the period after EU exit, and to plan ahead for any applications under each regime relating to renewals of existing approvals and authorisations as they expire over time.
  • Keep in touch with HSE as the regulator with respect to any current applications.

To download:

Plant Protection Products (PPP) regulation – ‘Regulating pesticides if there’s no Brexit deal’

Classification, Labelling and Packaging (CLP) regulation – ‘Classifying, labelling and packaging chemicals if there’s no Brexit deal’

Biocidal Products Regulation (BPR) – ‘Regulating biocidal products if there’s no Brexit deal’

Prior Informed Consent (PIC) regulation – ‘Export and import of hazardous chemicals if there’s no Brexit deal’

Regulation on mercury – ‘Control on mercury if there’s no Brexit deal’

Regulating Persistent Organic Pollutants (POPs) – ‘Control on Persistent Organic Pollutants if there’s no Brexit deal’

Registration, Evaluation, Authorisation and restriction of Chemicals (REACH) regulation – ‘Regulating chemicals (REACH) if there’s no Brexit deal’

 

See also our previous article:

UK: Notice on the BREXIT impact for applicants

 

Lynxee consulting’s team is at your disposal to answer your questions.

Contact us! http://lynxee.consulting/en/contact/

UK: Notice on the BREXIT impact for applicants

This Notice from DG SANTE reminds applicants that, unless the withdrawal agreement (‘Brexit’) establishes another date or the period is extended by the European Council, all Union primary and secondary law ceases to apply to the United Kingdom from 30 March 2019 (‘the withdrawal date’). The United Kingdom will then become a ‘third country’.

In view of the considerable uncertainties, in particular concerning the content of a possible withdrawal agreement, all applicants for an active substance or plant protection product are reminded of certain legal repercussions.

In particular, applicants should consider that, according to Union law, UK as a third country will not be able to act as rapporteur Member State, zonal rapporteur Member State or evaluating Member State for MRLs anymore.

As regards submissions of new applications, applicants should take into account the expected timelines of different regulatory procedures in which the UK would be acting and should consider taking the relevant actions. For example, where there is a risk that those procedures are not concluded by the date when the UK will leave the Union, applicants may choose by preference another Member State to carry out the evaluation or assessment.

Concerning those on-going procedures for which the UK is currently carrying out an assessment or evaluation, applicants  should carefully monitor their progress. Where there are clear indications that the procedure will not be concluded by the withdrawal date, taking account of the uncertainties as well as the regulatory framework, applicants  should consider taking the necessary actions. For example, a change of the rapporteur or evaluating Member State may be required.

The Commission Services are working with Member States and EEA countries in order to establish a coordinated way forward for a timely communication, agreement and technical transfer of the file in case that change is needed. This will be particularly relevant for the review programme of existing active substances, for which the UK was assigned by law (Commission Implementing Regulation (EU) 686/2012) as rapporteur and co-rapporteur Member State.

The Commission Services stand ready to provide further clarification and will provide a series of Questions & Answers (Q&A) in relation to Regulation (EC) No 1107/2009 and Regulation (EC) No 396/2005. They will be made publicly available on a dedicated page of the Directorate-General for Health and Food Safety: http://ec.europa.eu/food/plant/pesticides/approval_active_substances_en

This page will be updated with further practical information and relevant Q&A pairs, and will be subsequently expanded, where necessary.

 

To download:  

Notice to business operators in the field of regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market and regulation (EC) No 396/2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin

Questions and Answers related to the United Kingdom’s withdrawal from the European Union with regard to plant protection products and pesticides residues

 

Lynxee consulting’s team is at your disposal to answer your questions.

Contact us! http://lynxee.consulting/en/contact/