To ensure that the UK has a functioning statute book after Brexit, many thousands of changes are being made by statutory instrument, with limited scrutiny from Parliament. The government has given assurances that this is essentially a technical process which will not involve the erosion of existing rights or protections – but a recent controversy over pesticides legislation indicates that the position is not quite as straightforward as these statements would suggest.
Pesticides legislation? Why should I care?
Pesticides regulation may sound highly technical but it governs matters which affect us all, such as the acceptable level of chemical residues in food. Without it, that supposedly healthy and nutritious salad that you ate at lunchtime might turn out to be rather less beneficial than you had hoped. And the issues which have arisen recently with pesticides legislation provide a compelling illustration of the problems of attempting to "import" EU legislation into the UK statue book, whilst at the same time de-coupling the UK from the wider EU regulatory framework. Quite apart from any intentional divergence from the EU on matters of principle, it demonstrates the rather more basic risk of significant errors arising in the transposition of complex EU legislation, with the potential for damaging consequences.
EU pesticides regulation
Pesticides, and in particular the sub-set designed to protect crops etc (known as 'plant protection products' or "PPP"), are substances which prevent, destroy, or control a harmful organism or disease, or protects plants or plant products during production, storage and transport. They are tightly regulated at the EU level. Two key EU Regulations govern: (i) the placing of PPPs on the market – requiring EU-wide assessment and approval of the active substances within the PPPs; and (ii) Maximum Residue Levels ("MRL") permitted to remain in marketed foods.
The government recently published 3 statutory instruments (the "Pesticide SIs"). As we have generally seen with the Brexit statutory instruments to date, these largely make technical amendments to these EU Regulations to bring them into UK law - for example changing references from 'Member State' to the UK. However there are a number of more notable changes that were made.
Error in Transposition of Endocrine Disruptor Ban
Amongst other things, the EU's PPP Regulations ban the use of 'endocrine disruptors' in plant protection products. These are chemicals which can interfere with hormone systems at certain doses, potentially leading to cancerous tumours, birth defects, and other developmental disorders. The original form of the Pesticide SIs deleted certain paragraphs in the technical schedules of the EU legislation which provided for this prohibition. Various other provisions of the Pesticide SIs did continue to allude to restrictions on endocrine disruptors and other related matters, suggesting that this was (as one would hope) an error rather than an intentional change. Nevertheless, an outcry rightly followed, legal action was threatened, and the government hastily published amendments to the Pesticide SIs to correct the error. However the issue remains a rather ominous reminder of the risks that can arise in trying to transpose a huge amount of very complex (and important) EU legislation in a very short amount of time.
Weakened requirement for independent assessment of applications
Whilst the above issue was an error which was subsequently corrected, the Pesticide SIs do make a number of other (intentional) changes to EU legislation which may be significant, including in particular to the process for approving MRLs or active substances within a new PPP.
The EU legislation requires not only that the relevant Member State undertake an assessment of any such application, but also that (in all cases for MRLs, and in certain circumstances for a new PPP approval) the European Food Safety Authority ("EFSA") give a reasoned opinion on the application, which may then be considered by the Commission in making its decision. In contrast the UK transposition (as to be effected by the Pesticide SIs) simply provides that the 'competent authority' (the Secretary of State) shall assess the application, prepare the reasoned opinion and shall also decide on the MRL to set. Unlike the EU regime, there will be no requirement in the transposed UK legislation to consult expert scientific advice from a body which is independent of the decision maker (although the legislation does note that the 'competent authority' may choose to do so where appropriate).
In practice, it is expected that independent advice will be sought by the Secretary of State in assessing applications. The UK has an Expert Committee on Pesticides, which acts for DEFRA pursuant to a published code of practice. Health and Safety Executive (the main regulator with remit over PPPs) guidance indicates that this committee will continue to be involved in decision-making. However the lack of any commitment at law to consulting with that body – and the concentration within the Secretary of State of responsibility for both preparing the opinion on PPP approvals / MRLs, and for then issuing an approval / setting the MRL - is nevertheless striking when compared to the EU regime.
Practical challenges following implementation
In terms of future market access, some good news for companies supplying or reliant on pesticides, is that existing authorisations will continue to be valid following Brexit – even in the event of a no-deal. Unlike other environmental, product and chemical regimes (such as REACH or medical devices) there is no requirement for the holder of the authorisation to be based in the EU.
The greater challenge is for new products coming to market. The arguable weakening in requirements for scrutiny (discussed above) that arises in the transposition is linked to the wider challenge that Brexit poses in areas where environmental laws meet product laws. Regulation in these areas tends to rely on the physical fabric of the EU regime – the centralised IT systems, processes, institutions (such as the EFSA) and sharing of responsibilities which to date has operated the regime at the EU level. The legal text can be transposed, but replicating a physical infrastructure is far more difficult – and may explain the government's reluctance in the Pesticide SIs to commit to anything in this respect. Although, as those on the pro-Brexit side of the debate will highlight, challenges can bring opportunities – the HSE has stated that it intends that changes in approach to assessment of PPP/MRL applications (to review applications in parallel rather than sequentially) will reduce the typical authorisation timeline from 5 years to 2 years.
Future market access
And then there is the need for manufacturers to obtain approval for new PPPs in both the UK and the EU, post-Brexit (unless the UK and EU reach some form of mutual recognition agreement – which seems unlikely, or at least some way off, in the present climate). In theory, in a 'No Deal' scenario, the UK will be able to make its own decision as to what is (for example) an acceptable MRL for new active substances. But will it really wish to set either: (i) a less restrictive limit than the EU, and risk accusations of exposing the UK population to dangerous chemicals, and penalising UK businesses exporting to the EU who will still need to manufacture to the higher standards; or (ii) a more restrictive limit than the EU – and risk foreclosing incoming trade which UK agriculture may be relying on? Also, the requirements of any future agreement and/or backstop scenario may also tie the UK's hands here – for example, the previous 'Political Declaration' on the future relationship agreed with the EU by Theresa May's administration referred to the need to maintain a 'level playing field' including in respect of environmental matters – would a less restrictive MRL in the UK be regarded by the EU as an uneven playing field? The Pesticide SIs do not offer any clarity on issues such as this. Indeed, they serve as a reminder of how much uncertainty remains over the post-Brexit status of pesticide regulation in the UK.
The Pesticide SIs present a subtle (but possibly telling) potential weakening of the EU regime in the transposition, notwithstanding recent government statements that there would be no erosion in the laws or their enforcement as a result of Brexit. They highlight not only the fundamental risk of damaging errors arising in the comparatively simple act of copying legal standards and requirements into UK law, but also the challenges that arise in the more complex process of replicating the fabric of EU institutions, bodies and processes.
In a briefing published shortly after the referendum (see here) we highlighted this as an issue that would arise in the transposition process in the interlinked area of environmental, product and chemical laws – particularly where (as with pesticides) EU Regulations are involved. As the Pesticide SIs demonstrate, two and a half years later, many of the issues and challenges highlighted there remain unchanged or unanswered, notwithstanding subsequent political developments.
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