Proposal on the Revision of EU Directive 91/414 and its Impact on Resistance
Management and hence Sustainable Crop Production in Europe

The views expressed here and the accompanying recommendations are endorsed by the following
bodies:

European Herbicide Resistance Workgroup (HRAC)

Efficient and sustainable crop production in Europe depends on the effective management of a broad range of pathogens, weeds and pest insects. European agriculture and horticulture is thus dependent on a variety of inputs including a diverse range of readily available, safe and highly efficacious pesticidal crop protection products. Their responsible and effective use has led to Europe becoming one of the most efficient areas of crop production in the world.

The two most important features of an available portfolio of crop protection products are firstly that the active ingredients provide the degree of control required and secondly that the same actives show diversity in terms of the way that they act in the target organism. In reality, these two requisites cannot be taken individually; they must be considered together as crucial to sustainable crop protection.

Effective resistance management requires the portfolio to contain a range of available ‘modes of action’ such that each has a different target site within the target organism, and the grower does not have to rely on a single mode of action. We know from over half a century of experience that the repeated use of crop protection products with just one mode of action can readily lead to resistance to those products in the target pathogens, weeds or pests.

It is for this reason that resistance management strategies using a broad range of diverse modes of action are commonplace; they avoid the possibility of target site cross-resistance, reduce the commercial impact should resistance to a major mode of action arise and they are part of effective product stewardship and sustainability. Moreover, effective resistance management using chemical diversity is recognized by the EU Parliament and the Commission in its regulatory framework as indicated below.

It is particularly worrying that the most successful molecules are generally considered to be at the most risk from resistance development. For fungicides and herbicides, safeguarding their future is commonly achieved by incorporating lower risk molecules into the control programme, either as mixture components or as alternating applications. Should either component be lost due to resistance or regulatory procedures, control would have to rely on potentially less satisfactory crop protection agents and crop production would suffer accordingly. For insecticides, the availability and use of alternative modes of action in resistance management programmes is essential to reduce selection pressures from key favoured products.

The crop protection products portfolio in Europe has already been very seriously impacted by the ongoing EU re-registration process under Directive 91/414. Of the 952 existing crop protection products that existed previously, 589 have already been eliminated. Of the remaining 268 list 3 and 4 compounds, it is possible that a significant proportion may fail to achieve Annex I

Inclusion, and for those which do, many uses will no longer be supportable under today’s regulatory environment. The revision of the Directive, and especially the use of hazard based cut-off criteria as proposed by the EU Parliament, is likely to lead to further and significant attrition of the remaining crop protection products portfolio.

Based on ECPA member company detailed evaluations of 210 dossiers, currently proposed cutoff criteria would impact the currently registered active substances thus:

• 65% (poss.85%) trigger one of the non-inclusion criteria
  • Of the remaining 15%, 40% could be ‘candidates for substitution’
• 80% (poss.95%) of insecticides trigger either
  • Neurotoxicity = 50% (developmental?)
  • Bee toxicity = 65%
• 70% (poss.85%) of fungicides trigger one of the criteria
• 50% (poss.80%) of herbicides trigger one of the criteria

Further use of comparative assessment and substitution will further jeopardise the remaining pest management tool box.

It is already clear that the supply of new compounds entering the market cannot be relied upon to fill the gaps. This is especially so given the ever-increasing cost and difficulty of discovering new active ingredients with novel modes of action that not only circumvent existing resistance problems but that also pass increasingly stringent regulatory hurdles. It is also quite clear from history that new molecules entering the market tend to be at risk from resistance development. Effective resistance management is thus required to safeguard their future and the R&D programmes that produced them.

The RACs fully and strongly support the Commission’s repeated references to avoid using products in a way that would create or increase the risk of resistance. Annex IV, point 1, subparagraph 3 (a) page 74 of the Commission’s original text COM(2006) 388 final, indicates that:

“substitution shall be applied only where the chemical diversity of the active substances is sufficient to minimize the occurrence of resistance in the target organism.“

In addition, the objective to avoid the risk of resistances is highlighted in Art 48, paragraph 1 (c) which reads:

“(c) the chemical diversity of active substances is adequate to minimise the occurrence ofresistance in the target organism.”

The European Parliament has supported these references in 1st reading and also Council emphasises the importance of an adequate resistance management in its current discussions to reach a Common position.

In these and further examples it is recognized that chemical diversity is a crucial element in effective resistance management for Europe’s pesticide portfolio.

1. Sustainable resistance management is based on effective disease/pest/weed management. To permit the implementation of an effective, sustainable resistance management strategy for any crop and pathogen/weed/pest situation, no less than three pesticidal modes of action should be considered for a particular crop and target pest in individual geographies, of which one should ideally be from an accepted low risk category. Four or more modes of action are desirable. Current knowledge does not predict future needs.

2. Especially in crops where season long control requires a higher number of crop protection applications, the use of less than four modes of action to control a crop and pathogen and pest situation is considered extremely risky and therefore unsustainable from an effective disease and pest management perspective and as well as from a resistance management perspective. Five or more modes of action are desirable.

3. The value to the crop protection industry of diversity in available modes of action including genuinely multisite active substances is very high and must not be underestimated. This importance should also be factored into the decision making process and means sought to maintain this valuable resource.

4. Hazard-based cut-off criteria and substitution should not be indiscriminately applied in such a way that the minimum level of chemical diversity, as defined above, is not available to achieve effective disease/pest/weed management and resistance management and thus jeopardise future food production in Europe.