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Newsletter on Brexit

Territory affected by Brexit

What we call the United Kingdom (UK) consisted mainly of England, Scotland, Whales and Northern Ireland. Following Brexit we make a distinction between Great Brittan (GB) and Northern Ireland as the latter remains in the EU market. This means basically that the EU BPR rules still apply in Northern Ireland but no longer in GB!

Harmonization and continuity of the BPR in Great Britain and Northern Ireland

To make it not too difficult, GB took over the BPR but with its own administrative approach. This means that the dossiers to be submitted to the GB HSE (Health and Safety Executive, the competent authority) have the same format as under the EU.

There are of course a number of important aspects we cannot forget! Let’s address them using geraniol and geraniol based products for PT 18 and 19 as examples.

GB made its own article 95 list of accepted active substance (and product) suppliers by simply copying the ECHA article 95 list of 31 December 2020 with the requirement to have an entity in GB replacing the EU based entity before the end of 2022.  Also, by the same deadline the data (and/or LoA) supporting this listing have to be submitted to GB HSE.

TerpeneTech has been able to adapt to these changes

TerpeneTech will handle this and, where before the Brexit became effective the former TerpeneTech UK on the EU article 95 list was replaced by TerpeneTech Eire, as the EU requires a legal entity in the EU, now, to comply with GB BPR, the current entry of TerpeneTech Eire in the GB article 95 list will be replaced by TerpeneTech UK. TerpeneTech will keep you informed.

The TerpeneTech Source maintained throughout the EU and BREXIT territory.

Biocidal products using geraniol as active substance and marketed as insecticides or insect repellents are currently under the national law “Control of Pesticides Regulations” or COPR.

Once geraniol will be approved under GB BPR, the products under COPR will be re-evaluated under the rules of GB BPR. Therefore, as in the EU, an application for product authorisation has to be submitted by the approval date of the active substance (or the approval date of the last active substance if more than 1 are combined in the product).

The complex system to submit pending applications for product authorisation in the EU to GB do not apply to geraniol-based products as this active substance is not yet approved in the EU.

How to maintain your products or enter the BREXIT market in a transitional phase.

In case you want to sell your geraniol-based product in GB you will have to apply under COPR and not under the GB BPR! For detailed information we can refer to the excellent HSE website:

How to maintain your products or enter the BREXIT market after the Geraniol evaluation

In a previous newsletter we elaborated on the timing expected in relation to the approval of geraniol. How will this be dealt with in GB?

For active substances not yet approved in the EU, the dossier submitted within the scope of the EU Review Programme needs to be submitted before 29 June 2021 to GB HSE! This is what the Geraniol Task Force has to do.

From the GB HSE factsheet:

“HSE will conduct its own full evaluation, separate from any EU evaluation.” And

“Once all relevant resubmission deadlines have passed, HSE will consider the totality of the evaluations required under the GB Review Programme. Once determined, further information will be made available regarding the scheduling of those evaluations as appropriate.”

And from a reply from the HSE helpdesk”(underline added):

“In order to maintain access to the GB market it is necessary to resubmit to GB the data dossier that has been submitted to the EU so that we are able to carry out our own review of the active substance; we will charge for this activity.

What can we conclude in terms of implementation deadlines?

GB HSE will receive hundreds of active substance and biocidal product dossiers. GB will establish its own Review Programme based on the totality of dossiers and if we can assume some similarity with the EU Review Programme, we are going for a long-lasting programme – there are no 27 member states to divide the work, it all needs to be done by one agency!

It looks like GB will keep kind of status quo with its COPR law and slowly (re-)evaluate according to their GB BPR. Once companies have made the necessary resubmissions, it will take years before decisions will be made and until than, business as usual??

The GB HSE Factsheet