Pesticides have been in the news a lot recently, with very many active substances being assessed for re-authorisation at EU level. We in Ireland have been very much affected by some of these decisions, with specific examples of recent withdrawals being the removal of chlorpyrifos and the loss of Aphox (pirimicarb) for use on cereals.
The withdrawal of chlorpyrifos leaves a complete gap in the ability of farmers to control pests such as leather-jackets. This is particularly important given the insistence of the use of rotations at farm level under the auspices of greening and the suggestion that grass is seen as a particularly environmentally friendly land use. But one of the potential downsides of trying to incorporate grass into a tillage rotation is the risk of problems with leather-jackets, which could threaten partial or total crop loss.
Of significance also is the loss of Aphox for use on spring barley where no other product is cleared for aphid control late in the season. This is also important given the risk of further resistance development in aphids to the commonly used pryethroid group of insecticides.
Of concern also is the risk of loss of very many other actives due to their potential hazard as an endocrine disruptor. A decision on what an endocrine disruptor will be defined as is due to be made shortly and this will have significant implication for a whole range of actives, most notably in Ireland’s case, the triazole fungicides.
Loss of some or all of the triazoles would be hugely significant for us in terms of the tools we would have for the containment of resistance in wet weather disease.
Management of resistance development against the few remaining groups of actives becomes an increasingly big challenge when fewer actives are available. This is most obvious in the case of septoria control and the SDHIs on wheat in Ireland.
A report on the neonicotinoids is due out early next year according to a Commission spokesperson.
The lifecycle of a plant protection product
One could be forgiven for thinking that all these changes are due to the indifference or perhaps excessive influence of green politics in Europe. This is unquestionably true to some degree, but it is not the whole story.
We have plenty evidence of the tail wagging the dog within the EU processes and last week I attended a briefing by DG SANTE in Brussels which outlined the procedure for chemical registration in the EU and, not surprisingly, it had a particular emphasis on the current situation with glyphosate.
In the EU, plant protection products are legislated for under three different phases:
Production phase.Use phase.Consumption phase.The law governing the production phase sets out what can be authorised for sale in member states. This is governed by Regulation (EC) No 1107/2009 on placing of PPP on the market. This is an update on previous legislation and it governs what an active substance must comply with in order to be placed on the market.
This legislation significantly changed previous rules which assessed products as to their risk in the plant protection chain to a hazard-based system, and this introduced the endocrine disruptor assessment.
The laws governing the production phase set out the controls which apply to users and the application of plant protection products. Three separate bits of legislation apply here:
Directive 2009/128/EC on Sustainable Use of Pesticides.Regulation on Pesticide Statistics.Amended Machinery Directive.These introduced changes such as the introduction of integrated pest management (IPM), the registration of pesticide advisers and professional users, the testing of sprayers and records requirement, among other things. The legislation governing the consumption phase is guided by:
Regulation (EC) No 396/2005 on MRLs of pesticides.Legislation on Chemicals (chemical waste).MRLs are the maximum residue level set for individual active substances in food products and are influenced by the timing of application of products and the crops on which they are allowed or not allowed to be used. MRL legislation supersedes product registration and this allows products to enter the EU treated with actives that are prohibited for use internally.
Two authorisation systems
In the EU, the registration process operates at two different levels. This involves the assessment of potential new and existing active substances at EU level. This process examines the safety issues of a product for users and consumers and its potential environmental impact. This is based on the most up-to-date science available at the time as it pertains within the legislation, which is frequently updated.
This assessment on each active substance is conducted on behalf of the EU by one member state. This is called the Rapporteur country and its scientific findings, in conjunction with the European Food Safety Authority (EFSA) report on each active, are then discussed and evaluated by expert representatives from all member states.
Pending the assessment results, and the deliberations of all the member states, an active substance is then authorised to be placed on the market or not. The authorisation applies to all member states, ie one decision for all member states.
The second phase is then back to each individual member state. A plant protection product (PPP) can be sold as an individual active substance or as a mixture of different actives depending on the requirements of that specific market. So, after the active substance is authorised, each member state has the power to govern how, or if, it is placed on the market in its territory.
However, a member state must provide proof of problems or issues for an active substance if it does not want to allow its sale in that jurisdiction.
One of the requirements of a PPP is that it be effective and able to deliver its claims. This can only be adjudicated upon at member state level as complications like resistance can alter efficacy on a member state basis. And specific problems are not necessarily common to all member states.
Definitions
It is important to be aware of the definitions of the terms that apply here.
A “pesticide” is something that prevents, destroys, or controls a harmful target organism (“pest”) or disease, or protects plants or plant products during production, storage and transport. The term pesticide includes herbicides, fungicides, insecticides, acaricides, nematicides, molluscicides, growth regulators, repellents, rodenticides and biocides.
Plant protection products are “pesticides” that are used to protect crops or desirable or useful plants. They are primarily used in the agricultural sector but also in forestry, horticulture, amenity areas and in home gardens.
PPPs contain at least one active substance and have one of the following functions:
Protect plants or plant products against pests/diseases, before or after harvest.Influence the life processes of plants (such as substances influencing their growth – excluding nutrients).Preserve plant products.Destroy or prevent growth of undesired plants or parts of plants.PPPs may also contain other components including safeners, synergists and adjuvants.
EU countries authorise the use of plant protection products on their territory and ensure compliance with EU rules. This process can be referred to as risk management for the individual authorised active substances.
An active substance is any chemical, plant extract, pheromone or micro-organism (including viruses), that has action against ‘pests’ or on plants, parts of plants or plant products. The European Commission authorises the active substance to be sold.
The authorisation process requires that active substances undergo an intensive evaluation and peer review by member states and the European Food Safety Authority before a decision can be made on approval. This process is really about risk assessment for an individual substance.
Active substances are then marketed as plant protection products in the member states. While it is common to refer to a pesticide as a plant protection product, a pesticide is a broader term that also covers non-plant/crop uses, for example biocides.
The politicisation
of authorisation
In the normal course of events, the issues relating to the authorisation of active substances at EU level is conducted by scientists who evaluate facts within the legal framework. However, when it comes to the final decision on a substance, all member states have a say. Nowadays, the fact that so many governments in the EU are dependent on support from small parties with extreme views on a range of issues leave this political phase vulnerable.
Decisions in the EU are normally executed by a process known as a qualified majority. Such decisions depend on having at least 65% support from an EU population perspective plus at least 55% of the member states in favour.
This sounds like a reasonable criterion, but it is open to abuse to stifle decisions on controversial issues. This has been the case with regard to GMO licensing for decades, where the lack of a qualified majority slows due process and ultimately forces the final decision back on to the Commission. So politicians can wash their hands of the decision while laying the blame for the decision on the Commission. This is done by abstaining in votes to block a qualified majority decision either way on an issue. It basically says the member state does not care about the specific issue.
The renewal of the glyphosate registration is now caught in the same quagmire. The green element of a number of governments is forcing member states who normally operate with a level of accountability to abstain on specific votes to prevent progress. In the case of glyphosate these member states hope that if a non-conclusive vote can be prolonged, the deadline for reregistration will pass and the product will have to be withdrawn because it would not be authorised for sale. This would not be a case of the EU banning the active but rather a case of the political establishments not being willing to make a decision.
The reregistration of glyphosate began as far back as 2012 and the 40-year-old herbicide was given the all-clear by the Rapporteur member state – Germany. This was all based on a scientific process and this information was sent to be reviewed by EFSA. In the meantime, a WHO report suggested that glyphosate could be carcinogenic and this gave rise to valid questions regarding its safety. Then in October 2015 the existing glyphosate authorisation was extended for six months to allow a further EFSA expert review on the carcinogenicity risk posed. This latter work is continuing.
Initially the Commission proposed that the active be reauthorised for a normal further 15 years. This was not accepted. Then came the proposal to limit this to seven to nine years – not accepted either. Most recently, the Commission proposed to roll over the existing authorisation for a further 18 months – not accepted. The final vote was on the above plus other restrictions outlined below – not accepted either. While the justification for abstention in these votes was the WHO (IARC) report, an official EU report presented an opposite view and another international report indicated no carcinogenicity issue.
Indeed, a previous report by IARC suggested that processed meat was potentially carcinogenic. However, the same could possibly be said for the majority of substances on earth. But political organisations choose to pay no heed to those facts and to hide behind what appears to be a questionable WHO report.
Whether it was the WHO announcement which has driven this indifference, or the fact that glyphosate is primarily a Monsanto active, is a matter for conjecture. What is obvious is that registration was initially delayed to allow for an internal EU examination of the facts and that initial report was dogmatic that glyphosate was not carcinogenic.
What now for glyphosate?
As things stand now, a number of proposals on the reregistration of glyphosate have either been accepted or rejected by a qualified majority. Indeed, 27 member states accepted the Rapporteur report.
Germany was the Rapporteur country for the file but now its representatives are abstaining in the votes to block a qualified majority. In the vote last week, 51% of the population vote favoured the proposal, but this requires 65% for a qualified majority, plus 55% of member states.
The absence of a qualified majority either way points to two things. One must be the lack of willingness of member state governments to govern and the second is the consequence for glyphosate. When standing committees declined to provide a decision either way on the proposal, this left the Commission with two alternatives.
One was to put forward an alternative proposal, but this looked to be futile given that a move to address the original concerns did not result in a decision.
The second option was to put the same proposal in front of the EU Appeals Committee. This committee is made up of more senior member state representatives who are usually the permanent representatives to the Commission. While the Commission will now seek to influence how these people vote, there is little to suggest that they will not continue to vote along party or government lines.
The appeals committee is to meet around 23/24 June. If no decision is forthcoming from this meeting, then the Commission has the power to adopt its current proposal. The basis of the most recent proposal put forward by Commissionner Andriukaitis to member states on 6 June included:
An extension of the current authorisation period for an additional 18 months to allow for the completion of the European Chemicals Agency report.To ban the co-formulant POE-tallow-amine from glyphosate based products.To minimise its use in public parks, public playgrounds and gardens.To minimise the pre-harvest use of glyphosate.If the Appeals Committee does not provide a qualified majority either for or against then the decision falls back to the Commission. But while the Commission is in favour of glyphosate authorisation, there is no guarantee as to what its final decision will be. But many farmers on this island will note the proposal to limit or minimise its use pre-harvest.
Pesticides have been in the news a lot recently, with very many active substances being assessed for re-authorisation at EU level. We in Ireland have been very much affected by some of these decisions, with specific examples of recent withdrawals being the removal of chlorpyrifos and the loss of Aphox (pirimicarb) for use on cereals.
The withdrawal of chlorpyrifos leaves a complete gap in the ability of farmers to control pests such as leather-jackets. This is particularly important given the insistence of the use of rotations at farm level under the auspices of greening and the suggestion that grass is seen as a particularly environmentally friendly land use. But one of the potential downsides of trying to incorporate grass into a tillage rotation is the risk of problems with leather-jackets, which could threaten partial or total crop loss.
Of significance also is the loss of Aphox for use on spring barley where no other product is cleared for aphid control late in the season. This is also important given the risk of further resistance development in aphids to the commonly used pryethroid group of insecticides.
Of concern also is the risk of loss of very many other actives due to their potential hazard as an endocrine disruptor. A decision on what an endocrine disruptor will be defined as is due to be made shortly and this will have significant implication for a whole range of actives, most notably in Ireland’s case, the triazole fungicides.
Loss of some or all of the triazoles would be hugely significant for us in terms of the tools we would have for the containment of resistance in wet weather disease.
Management of resistance development against the few remaining groups of actives becomes an increasingly big challenge when fewer actives are available. This is most obvious in the case of septoria control and the SDHIs on wheat in Ireland.
A report on the neonicotinoids is due out early next year according to a Commission spokesperson.
The lifecycle of a plant protection product
One could be forgiven for thinking that all these changes are due to the indifference or perhaps excessive influence of green politics in Europe. This is unquestionably true to some degree, but it is not the whole story.
We have plenty evidence of the tail wagging the dog within the EU processes and last week I attended a briefing by DG SANTE in Brussels which outlined the procedure for chemical registration in the EU and, not surprisingly, it had a particular emphasis on the current situation with glyphosate.
In the EU, plant protection products are legislated for under three different phases:
Production phase.Use phase.Consumption phase.The law governing the production phase sets out what can be authorised for sale in member states. This is governed by Regulation (EC) No 1107/2009 on placing of PPP on the market. This is an update on previous legislation and it governs what an active substance must comply with in order to be placed on the market.
This legislation significantly changed previous rules which assessed products as to their risk in the plant protection chain to a hazard-based system, and this introduced the endocrine disruptor assessment.
The laws governing the production phase set out the controls which apply to users and the application of plant protection products. Three separate bits of legislation apply here:
Directive 2009/128/EC on Sustainable Use of Pesticides.Regulation on Pesticide Statistics.Amended Machinery Directive.These introduced changes such as the introduction of integrated pest management (IPM), the registration of pesticide advisers and professional users, the testing of sprayers and records requirement, among other things. The legislation governing the consumption phase is guided by:
Regulation (EC) No 396/2005 on MRLs of pesticides.Legislation on Chemicals (chemical waste).MRLs are the maximum residue level set for individual active substances in food products and are influenced by the timing of application of products and the crops on which they are allowed or not allowed to be used. MRL legislation supersedes product registration and this allows products to enter the EU treated with actives that are prohibited for use internally.
Two authorisation systems
In the EU, the registration process operates at two different levels. This involves the assessment of potential new and existing active substances at EU level. This process examines the safety issues of a product for users and consumers and its potential environmental impact. This is based on the most up-to-date science available at the time as it pertains within the legislation, which is frequently updated.
This assessment on each active substance is conducted on behalf of the EU by one member state. This is called the Rapporteur country and its scientific findings, in conjunction with the European Food Safety Authority (EFSA) report on each active, are then discussed and evaluated by expert representatives from all member states.
Pending the assessment results, and the deliberations of all the member states, an active substance is then authorised to be placed on the market or not. The authorisation applies to all member states, ie one decision for all member states.
The second phase is then back to each individual member state. A plant protection product (PPP) can be sold as an individual active substance or as a mixture of different actives depending on the requirements of that specific market. So, after the active substance is authorised, each member state has the power to govern how, or if, it is placed on the market in its territory.
However, a member state must provide proof of problems or issues for an active substance if it does not want to allow its sale in that jurisdiction.
One of the requirements of a PPP is that it be effective and able to deliver its claims. This can only be adjudicated upon at member state level as complications like resistance can alter efficacy on a member state basis. And specific problems are not necessarily common to all member states.
Definitions
It is important to be aware of the definitions of the terms that apply here.
A “pesticide” is something that prevents, destroys, or controls a harmful target organism (“pest”) or disease, or protects plants or plant products during production, storage and transport. The term pesticide includes herbicides, fungicides, insecticides, acaricides, nematicides, molluscicides, growth regulators, repellents, rodenticides and biocides.
Plant protection products are “pesticides” that are used to protect crops or desirable or useful plants. They are primarily used in the agricultural sector but also in forestry, horticulture, amenity areas and in home gardens.
PPPs contain at least one active substance and have one of the following functions:
Protect plants or plant products against pests/diseases, before or after harvest.Influence the life processes of plants (such as substances influencing their growth – excluding nutrients).Preserve plant products.Destroy or prevent growth of undesired plants or parts of plants.PPPs may also contain other components including safeners, synergists and adjuvants.
EU countries authorise the use of plant protection products on their territory and ensure compliance with EU rules. This process can be referred to as risk management for the individual authorised active substances.
An active substance is any chemical, plant extract, pheromone or micro-organism (including viruses), that has action against ‘pests’ or on plants, parts of plants or plant products. The European Commission authorises the active substance to be sold.
The authorisation process requires that active substances undergo an intensive evaluation and peer review by member states and the European Food Safety Authority before a decision can be made on approval. This process is really about risk assessment for an individual substance.
Active substances are then marketed as plant protection products in the member states. While it is common to refer to a pesticide as a plant protection product, a pesticide is a broader term that also covers non-plant/crop uses, for example biocides.
The politicisation
of authorisation
In the normal course of events, the issues relating to the authorisation of active substances at EU level is conducted by scientists who evaluate facts within the legal framework. However, when it comes to the final decision on a substance, all member states have a say. Nowadays, the fact that so many governments in the EU are dependent on support from small parties with extreme views on a range of issues leave this political phase vulnerable.
Decisions in the EU are normally executed by a process known as a qualified majority. Such decisions depend on having at least 65% support from an EU population perspective plus at least 55% of the member states in favour.
This sounds like a reasonable criterion, but it is open to abuse to stifle decisions on controversial issues. This has been the case with regard to GMO licensing for decades, where the lack of a qualified majority slows due process and ultimately forces the final decision back on to the Commission. So politicians can wash their hands of the decision while laying the blame for the decision on the Commission. This is done by abstaining in votes to block a qualified majority decision either way on an issue. It basically says the member state does not care about the specific issue.
The renewal of the glyphosate registration is now caught in the same quagmire. The green element of a number of governments is forcing member states who normally operate with a level of accountability to abstain on specific votes to prevent progress. In the case of glyphosate these member states hope that if a non-conclusive vote can be prolonged, the deadline for reregistration will pass and the product will have to be withdrawn because it would not be authorised for sale. This would not be a case of the EU banning the active but rather a case of the political establishments not being willing to make a decision.
The reregistration of glyphosate began as far back as 2012 and the 40-year-old herbicide was given the all-clear by the Rapporteur member state – Germany. This was all based on a scientific process and this information was sent to be reviewed by EFSA. In the meantime, a WHO report suggested that glyphosate could be carcinogenic and this gave rise to valid questions regarding its safety. Then in October 2015 the existing glyphosate authorisation was extended for six months to allow a further EFSA expert review on the carcinogenicity risk posed. This latter work is continuing.
Initially the Commission proposed that the active be reauthorised for a normal further 15 years. This was not accepted. Then came the proposal to limit this to seven to nine years – not accepted either. Most recently, the Commission proposed to roll over the existing authorisation for a further 18 months – not accepted. The final vote was on the above plus other restrictions outlined below – not accepted either. While the justification for abstention in these votes was the WHO (IARC) report, an official EU report presented an opposite view and another international report indicated no carcinogenicity issue.
Indeed, a previous report by IARC suggested that processed meat was potentially carcinogenic. However, the same could possibly be said for the majority of substances on earth. But political organisations choose to pay no heed to those facts and to hide behind what appears to be a questionable WHO report.
Whether it was the WHO announcement which has driven this indifference, or the fact that glyphosate is primarily a Monsanto active, is a matter for conjecture. What is obvious is that registration was initially delayed to allow for an internal EU examination of the facts and that initial report was dogmatic that glyphosate was not carcinogenic.
What now for glyphosate?
As things stand now, a number of proposals on the reregistration of glyphosate have either been accepted or rejected by a qualified majority. Indeed, 27 member states accepted the Rapporteur report.
Germany was the Rapporteur country for the file but now its representatives are abstaining in the votes to block a qualified majority. In the vote last week, 51% of the population vote favoured the proposal, but this requires 65% for a qualified majority, plus 55% of member states.
The absence of a qualified majority either way points to two things. One must be the lack of willingness of member state governments to govern and the second is the consequence for glyphosate. When standing committees declined to provide a decision either way on the proposal, this left the Commission with two alternatives.
One was to put forward an alternative proposal, but this looked to be futile given that a move to address the original concerns did not result in a decision.
The second option was to put the same proposal in front of the EU Appeals Committee. This committee is made up of more senior member state representatives who are usually the permanent representatives to the Commission. While the Commission will now seek to influence how these people vote, there is little to suggest that they will not continue to vote along party or government lines.
The appeals committee is to meet around 23/24 June. If no decision is forthcoming from this meeting, then the Commission has the power to adopt its current proposal. The basis of the most recent proposal put forward by Commissionner Andriukaitis to member states on 6 June included:
An extension of the current authorisation period for an additional 18 months to allow for the completion of the European Chemicals Agency report.To ban the co-formulant POE-tallow-amine from glyphosate based products.To minimise its use in public parks, public playgrounds and gardens.To minimise the pre-harvest use of glyphosate.If the Appeals Committee does not provide a qualified majority either for or against then the decision falls back to the Commission. But while the Commission is in favour of glyphosate authorisation, there is no guarantee as to what its final decision will be. But many farmers on this island will note the proposal to limit or minimise its use pre-harvest.
This is a subscriber-only article
SHARING OPTIONS: