Chemical approvals could take half the time if no deal

Photo : fginsight

 

Should there be no agreed deal on Brexit by the end of next March, the UK would have an operable chemicals regime, including agrochemicals.

That was the promise of David Bench, director, EU exit, chemicals, Health and Safety Executive (HSE). “While a deal is the preferred position, we are planning for no deal. If there is no deal by March 29 we will take the body of EU law and put it into UK law.

“In the chemicals area there are many complex, EU level interactions, agencies and lots of collective decision making. We need to make it work so the UK can take decisions on its own. This would be done by a raft of secondary legislation – Statutory Instruments – all the chemical ones will go into parliament over the next few months.”

Existing active substance approvals or product authorisations in the UK would remain until their existing expiry date with companies able to plan regulatory processes on existing timelines, said Mr Bench. “All data requirements will still exist, EU guidance documents will exist – any changes would come in the future, not at the point of exit.”

With the UK no longer involved in the European agrochemicals approvals system, future applications for registration of pesticides would need to be made to the HSE. “The companies will have to duplicate if they want to register the product in the UK and EU,” he said.

“Post Brexit the UK must not be at a disadvantage compared with Europe. We want clear, credible, science-based risk assessment and to see faster, pragmatic decision making.”


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Quicker decisions

However, decisions from HSE would be quicker and more predictable than via the EU system, said Mr Bench. “Registration of actives and MRLs would not involve individual pieces of legislation, as on an EU basis. If a new active was approved or there were new MRLs, they would just be updated on an online register.”

He estimated that HSE would be able to approve actives in half the time or less than it currently takes. There would also be extension of authorisations if necessary, to allow the UK process to adapt, said Mr Bench. “With no deal we won’t fall off a cliff edge. It is not that there will be no change, it just means we are smoothing the change.”

A Brexit deal, if based on the White Paper – ‘The future relationship between the UK and EU’ published last July – with close alignment to the EU on trade of goods, which includes chemicals, would mean operating in a way not dissimilar to the way the system operates now, said Mr Bench. “We could be working exactly the way we operate now but just not having a final decision in the [EC] standing committee as there is no way that will be on the table in any kind of deal.”

In a deal scenario, NFU senior regulatory affairs adviser Dr Chris Hartfield said while there would be no regulatory changes to the chemicals regime in the short term, he wanted to see changes happen as soon as possible. “How long will the alignment continue, where will we see changes and when will we realise the Brexit dividend?” he said.

Source :

Fginsight

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