Pesticides (UK from 1st Jan 2021)

From 1 January 2021, in Great Britain (England, Scotland and Wales) a new independent pesticides regulatory regime will operate. Great Britain (GB) will take responsibility for its own decisions using its own rules.

Great Britain will have no formal role in EU decision-making processes and new decisions taken under the EU regime will not apply in GB. This includes active substance and Maximum Residue Level (MRL) decisions and any new EU Plant Protection Product (PPP) legislation.

The Health and Safety Executive (HSE) will remain the national regulator for the whole of the UK, on behalf of the UK government and the devolved administrations.

Under the terms of the Withdrawal Agreement and Northern Ireland Protocol, the EU pesticides regime will continue to apply in Northern Ireland after the end of the transition period, in the same way as during the transition period.

Existing approvals, authorisations and MRLs

All existing active substance approvals, PPP authorisations and MRLs will continue to be valid in GB.

Existing PPP authorisations remain valid until their current expiry date.

Active substance approvals due to expire before December 2023 will be extended for 3 years to allow time for the necessary evaluation work.

After the end of the transition period Great Britain will set MRLs based on its own assessments but all existing MRLs will remain valid until they are amended.

Applicants will need to continue to meet any existing conditions under the new GB pesticide regime.

New applications

To gain access to both GB and EU markets new applications will need to be submitted under both the GB and EU regimes. This may be a common application where there is no divergence between the two regimes.

Mutual recognition

HSE will no longer accept new applications for mutual recognition of authorisations in EU Member States but will process any existing applications to a conclusion under the national GB regime.

The HSE will continue to make use of other regulators’ assessments where possible and appropriate to support GB decisions.

Parallel trade permits

HSE will no longer accept new applications for parallel trade permits in GB. Existing parallel trade permits will continue until their current expiry date or until 31 December 2022, whichever is the sooner.

The above is not a full list, further information is here.

Pesticides (EU)

Regulation (EC) No 1107/2009 is the governing EU Law on the placing of plant protection products (pesticides and herbicides) on the European market – the PPP Regulation.

This is a useful Q&A document (2015) about the PPP Regulation – here.

A zonal system of authorisation operates in the EU to enable a harmonised and efficient system to operate.

The EU is divided into 3 zones; North, Central and South. EU countries assess applications on behalf of other countries in their zone and sometimes on behalf of all zones.

The PPP Regulation sets out the requirements, procedure and timeframes for authorisation of Plant Protection Products (PPPs).

Applicants, EU countries, the European Commission and the European Food Safety Authority (EFSA) can be involved in the process of authorisation.

There are different types of application that can be submitted depending on the intended use of the PPP, the Member State(s) for which the PPP is required and the regulatory status of any existing authorisations.

Authorisations usually are time-limited and therefore come up again for review. The relevant EU body for the whole EU is the Standing Committee on Plants, Animals, Food and Feed (SCoPAFF).

In March 2019, the non-renewal of the fungicide active substance chlorothalonil came up for review at SCoPAFF, and the decision was not to renew.

In December 2019, the non-renewal of two organophosphate active substances chlorpyrifos and chlorpyrifos-methyl came up for review at SCoPAFF, and the decision is not to renew (this decision is not yet published).

This means products containing the above active substances may not circulate in the European market, stocks may be used up for a short time, determined by the EU authorisation document that is issued for the active substance.

Brexit : as an EU Regulation, the PPP Regulation is adopted in the UK as Retained EU Law. Enacted Brexit Law (in force from Exit day) makes changes to the PPP Regulation to enable it to stand alone within the UK statute base.

DEFRA has made no announcements re reversing EU bans.

New Plant Health Regulation (EU)

Regulation (EU) 2016/2031 is a new European Plant Health Regulation, which entered into force on 13th December 2016, and is a major overhaul of the EU’s Plant Health legislation that has been in place since 1977. It will repeal and replace seven Council Directives on harmful organisms and will become fully applicable on 13 December 2019. The new Regulation is here

It focuses particularly on the prevention of entry or spread of plant pests within the EU territory, and sets out detailed rules for the early detection and eradication of Union quarantine pests if found present in the EU territory. These rules establish obligations for the notification of outbreaks by professional operators, surveys and multiannual survey programmes, demarcation of areas for the purpose of eradication, as well as enhanced requirements for the priority pests as described above.

Under the new Regulation, all Member States will have to immediately proceed with the eradication of a Union quarantine pest if found present in an area where it was not known to be present. This means that they will no longer be allowed to proceed unilaterally with containment, namely to skip the eradication step and simply take measures to restrict the presence of the pests in a particular area.

Details

Plant pests currently fall under different legal acts depending on their quarantine status or whether they affect the quality of plant reproductive material. The new Regulation will list all pests together, under three main categories:

Union quarantine pests: Not present at all in the EU territory or, if present, just locally and under official control (examples include Citrus black spot, which is not present in the EU, and Xylella which is present in a few specific locations only). Strict measures must be taken to prevent their entry or further spread within the EU due to their increased risk for plant health. These pests have to be eradicated immediately if detected.

Protected zone quarantine pests: Present in most parts of the Union, but still known to be absent in certain demarcated areas called ‘protected zones’ (for example grape phylloxera, which is present in the territory of the EU but not in Cyprus which is designated as protected zone for this pest). These pests are thus not allowed to enter and spread within these protected zones. Measures are taken (such as prohibition or restriction of movement of commodities, surveys, etc.) to avoid the introduction of these pests into the protected zones or to ensure their eradication if found present in these zones.

Regulated non-quarantine pests: Widely present in the EU territory but, since they have an impact on the quality of the plants, plant reproductive material on the market should be guaranteed free or almost free from the pest (for example, the fungus Verticillium albo-atrum is known to be harmful to the apple production in the EU, therefore certified apple trees are not allowed to enter the EU market if more than 2% of the examined quantity is contaminated with the fungus). This way the starting quality and economic value of many agricultural crops as well as forestry and fruit plants can be ensured.

The new Regulation introduces the concept of “priority pests“. These are the Union quarantine pests with the most severe potential impacts on the economy, environment and/or society of the EU. They will be subject to enhanced measures concerning surveys, action plans for their eradication, contingency plans and simulation exercises. 

The list of these priority pests will be adopted through a delegated act, as close as possible to the date of application of this Regulation (end of 2019). It will be based on the criteria fixed by the Regulation and the assessments of the severity of the impacts of those pests.

The import of most plants and plant products from non-EU countries will in principle be allowed, subject to certain conditions. Some will be prohibited or subject to very strict requirements if a risk assessment indicates that this is necessary due to the pests they might host. The new Regulation sets out more precise rules about the risk assessment and risk management supporting such measures.

Under the new Regulation, the Commission is further required to adopt within two years a list of so-called high risk plants or plant products. The import of these commodities will be prohibited as long as no detailed risk assessment has been carried out to determine if such imports should be acceptable and, if yes, under which conditions.

All living plant material (namely entire plants, fruits, vegetables, cut flowers, seeds, etc.) will only be imported into the EU if accompanied by a phytosanitary certificate confirming their compliance with the EU legislation. The Commission will adopt within two years a list of plant materials to be exempted from that certification if they are deemed safe for the EU territory.

Finally, for specific cases where there is little experience with trade of certain plants or plant products and where related pest risks are still unknown, the new Regulation sets out the possibility to introduce temporarily phytosanitary import restrictions or even a prohibition until more scientific information becomes available. 

Imports by Passengers

In principle, passengers will no longer be allowed to introduce into the EU plants/plant products from non-EU countries if they are not accompanied by a phytosanitary certificate. However, harmonised exemptions to this general rule might be granted through a Commission implementing act, setting out the maximum quantity of plant material that might be allowed to be introduced by the passengers into the EU without phytosanitary certificate.

Plant Passports

Plant passports are the documents that accompany plants and certain plant products while moving within the Union and certify their phytosanitary health status. Under the new Regulation, all plant passports will be issued using a common format, thus facilitating their visibility and making them more easily recognisable throughout the EU.

Plant passports will now be required for the movement of all plants for planting, (under the current legislation, plant passports are required only for certain plants for planting). However, in order to avoid disproportionate administrative burdens, no plant passports will be required when the plants are transferred to non-professional consumers (e.g. in places like flower shops or other retail shops).

Professional Operators

Professional operators will have to notify any quarantine pest they find in the areas of their control. For the purpose of more efficient controls, the professional operators will have to be registered by the competent authorities. The professional operators will also have to ensure the traceability of the regulated plants/plant products they receive from and submit to other professional operators.

Professional operators will be allowed to issue plant passports, under the supervision of the competent authorities. To that purpose they will have to be authorised specifically by the authorities, subject to specific conditions.

National Authorities

Member States’ competent authorities will play a key role in the implementation of these rules. They will be responsible for activities such as surveys, eradication of outbreaks, contingency plans, simulation exercises, notification of pest occurrences, controls of imports, registration of professional operators, authorisation of professional operators to issue plant passports and other attestations.

In this respect, the new Regulation will be complemented, in the coming months, by the Regulation on Official Controls which will set out the obligations of Member States with regards to official controls and other official activities.

Why will the Regulation be applicable only in three years’ time?

To replace the existing legislation, it was decided that an EU Regulation was the right instrument, since it is directly and universally applicable throughout the EU. During the next three years, a string of delegated and implementing acts needs to be adopted. This period will also be used by competent authorities and professional operators to adjust to the new common rules.

Neonicotinoids (UK/EU)

UPDATE : the DEFRA statement is here

UK DEFRA has confirmed an article in this morning’s Guardian online – the UK will back a total EU ban on neonicotinoids. This newspaper article is here

“A total ban on insect-harming pesticides in fields across Europe will be backed by the UK, environment secretary Michael Gove has revealed. The decision reverses the government’s previous position and is justified by recent new evidence showing neonicotinoids have contaminated the whole landscape and cause damage to colonies of bees. It also follows the revelation that 75% of all flying insects have disappeared in Germany and probably much further afield, a discovery Gove said had shocked him.”

In 2013, three neonicotinoids were restricted by the EU.

Per The Guardian : “The European Commission now wants a total ban on their use outside of greenhouses, with a vote expected in December, and the UK’s new position makes it very likely to pass.”

The European Commission’s information on its regulatory activities in this area is here

UK exits the EU (Notices to Business Operators)

I posted earlier re Medicines. The European Commission has now issued Notices to Business Operators in the following areas :

(1) GMOs – the Notice is here (this post will be updated when the Q&A is available). 

(2) Biocides – the Notice is here and the Q&A is here

(3) Pesticides and Plant Protection Products – the Notice is here and the Q&A is here.

Please pay close attention as the requirements differ with each legal instrument (topic). 

Glyphosate (UK) Regulatory Query

UPDATE (November 2017) : The European Commission has approved glyphosate for a further five years. This approval will be adopted before 15th December 2017 (when the current approval runs out).

The details are here.

UPDATE (June 2016) : The European Commission has adopted an eighteen month extension of its current approval. 

Press Release is here.

The legal position (set out below) in the UK is unchanged. Please note : some Local Authorities may trial alternatives for use in parks and gardens (eg Bristol).

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Glyophosate is regulated in the UK as a pesticide. Under European Union (EU) rules, pesticides are only approved for use if a scientific assessment has identified no unacceptable risks to people or the environment. The EU current approval of glyphosate expires on 31st December 2015.

The matter of health risks being created by use of glyphosate was raised in a recent assessment by the World Health Organisation’s latest review of cancer risks of this chemical (a main ingredient of the popular herbicide Roundup).

UK Department of Environment, Food and Rural Affairs (DEFRA) responded on 29th April 2015 as follows to a Freedom of Request:

“As part of the review of glyphosate, the regulatory authority responsible for pesticides in Germany (BfR) has assessed the relevant data to see if EU approval can continue from 2016. BfR’s assessment has been circulated to the European Food Safety Authority (EFSA) and to all EU Member States for critical review. EFSA published the assessment on its website in March 2014 for a two month public consultation and has co-ordinated a peer review, conducted in February 2015. This involved all Member States’ pesticides regulatory authorities, European Food Safety Authority, EFSA, and it’s expert advisors.

EFSA is in the process of drawing up its findings in a formal conclusion, which will be sent to the Commission for consideration. In light of this conclusion, a decision will be taken either to renew the approval of glyphosate or not. If approval is renewed, products which contain the active substance will be separately re-assessed at Member State level, to confirm that they too continue to meet the required standards of safety.

If approval is not renewed, glyphosate products will be withdrawn from the market.

In the work carried out so far under the EU review, glyphosate has been judged not to show an ability to cause cancer in humans. In addition, predicted exposures from authorised uses of glyphosate were found to be within acceptable limits for all aspects of human health.”

The full text is here.

Neonicotinoids (EU)

European Regulation (EU) No 485/2013 which restricts the use of 3 pesticides belonging to the neonicotinoids family (clothianidin, imidacloprid and thiametoxam) for a period of 2 years, is effective from 1st December 2013.

The EU Regulation is a response to the European Food Safety Authority’s (EFSA) scientific report which identified “high acute risks” for bees as regards exposure to dust in several crops such as maize, cereals and sunflower, to residue in pollen and nectar in crops like oilseed rape and sunflower and to guttation in maize.