Europe moves to phase out old products 

The principle of comparative assessment (CA) already exists in European legislation – for biocides. Regulator Canice Nolan gives an overview of its application to pesticides, and the potential for substituting least hazardous products, at the European level.

Canice Nolan, Peter Bergvist (see p. 14), and Sue Popple (see p. 11). Photo: Billy Ridgers

Various pieces of European legislation include substitution requirements. However, with the exception of the Biocides Directive there is no stringent legal concept at the European Union (EU) level. Substitution can be seen as one of the available management tools to prevent or minimise risks. It could be applied either as an explicit strategy in chemicals policy, and/or a duty of companies in general. Substitution should include a prior comparison of alternatives, covering all three perspectives of sustainability, namely: a high level of protection of the environment and health; the social impact; and economical feasibility (holistic perspective).
    Applied to plant protection products (PPPs), the comparative assessment can be defined as a procedure to find out whether there are alternative active substances, products or techniques intended for the same purpose that:

• present significantly less risk to health or the environment
• can be used for sufficient and effective control of the target organism(s)
• can be used without significant economic or practical disadvantages for the user

Comparative assessment essentially aims to compare similar PPP active substances and products and to rank them according to acceptability. The least acceptable ones could then be substituted for example, withdrawn from the market.
    An important element for the practical implementation of this concept is the availability of comparable data on uses. The wide range of potential uses of any given substance can, according to some, make comparative assessment very difficult because of the amount of work that it could represent. The implementation of such a principle can, on the one hand, be considered as a major improvement for risk management but it is not without its complications.
    Therefore, there is a need to further examine not only the decision criteria but also the timing and the level at which the decision has to be taken, including such questions as where and by whom.

Experience with biocides
In the context of the Biocides Directive, a guidance document (Technical Notes for Guidance on Annex I inclusion) was adopted based on the experiences that have been gained in Sweden and Denmark where the principle of comparative assessment has already been implemented for biocides and pesticides.
    According to the definition of article 10(5(i)) of Directive 98/85/EEC, candidates for comparative assessment are active substances which, despite acceptable risks under normal conditions of use still give rise to concern. Those active substances can be included in Annex I of the Biocides Directive (list of authorised active substances). However, the Biocides Directive foresees also that there may be specific restrictive safety conditions. Such substances are candidates for comparative assessment.
    The same article 10(5(i)) further stipulates that when a withdrawal or refusal of an Annex I inclusion in favour of an alternative substance is considered, the alternative must show significantly lower risk to health and the environment. An assessment of the alternative substance shall take place to demonstrate whether it can be used with similar effect on the target organism and without significant economic and practical disadvantages to the user or not. These are defined as the quantifiable major impairment of working practices or business activity leading to an inability to maintain sufficient control of the target organism.
    Article 10(5(ii)) establishes as further conditions:

• maintenance of chemical diversity in order to minimise the occurrence of resistance in the target organism
• the similarity of products to be compared
• the possibility to delay the application of the substitution in order to acquire experiences from the practice, when it is not already available
• the completeness of data to be provided before comparative assessment

If the outcome of the comparative assessment is that no alternative substance is available, the substance shall be included in Annex I but shall remain a candidate for comparative assessment and substitution.

Stakeholder discussions
At the request of the Council and the Parliament, the Commission organised a conference in Corfu to give indications for drafting a proposal to amend the Agricultural Pesticides Directive 91/414/EEC. The workshop mainly addressed points that were identified as being relevant for a better functioning of the Directive but also for improving risk assessment of new and existing active substances. For the purpose of comparative assessment and substitution principle, the participants of the conference were invited to examine several thought-starter documents that had been prepared in advance by some Member States. This was done with the aim at responding to the views expressed by the Council and supported by the Parliament on the possible integration of those principles in the body of a proposal for a new Directive to be presented in 2003. Copies of the report of the conference are available on request.The participants were invited to reflect on: 

• the level at which comparative assessment should better operate
• the timing and the manner according to which new provisions could be operated under the new Directive
• the outcome for substituted compounds/products

From the discussions raised during the conference, there appears to be most support for comparative assessment/substitution at the product level.
    Starting from a comparison with the Biocides Directive, participants established rationales explaining the reasons why the comparative assessment seems to be applicable only with great difficulty at the level of Annex I inclusion for PPP: 

• parallels with biocides are not obvious and the approach seems not practical. Biocides have similar uses but typically PPP substances have very wide range of different uses
• Annex I listing relates to limited uses while wider uses are still unknown at EU level during the inclusion process
• even if uses are the same, the target pest may be different

Sustainable use of pesticides
The objective of the stakeholders’ conference organised by the Commission on 4 November 2002 was to exchange views and experiences among stakeholders (industry, environmental NGOs, farmers and consumers’ organisations, workers, and others) about the future Thematic Strategy on the Sustainable Use of Pesticides (see box). 
    One of the tracks proposed with the adopted 6th Environmental Action Plan (EAP) refers to the full implementation and further revision of existing legislation, in particular Directive 91/414/EEC. In practice, this would entail systematic evaluation of the possible substitution of a particular active substance for which certain concerns persist, either by another substance (on the basis of the inventory of active substances, when an alternative is available for a specific purpose) or by a pesticide-free alternative. 
    The conclusions of the stakeholders’ conference and the first consultation organised at the Council and Economic and Social Committee revealed that:

• the thematic strategy is considered as a necessary complement to existing regulations
• the objectives of the substitution principle highlighted by the Commission are relevant
• as far as ICM/IPM is concerned, substitution has to be preferably maintained at farm level in order to offer a broader choice and avoid the emergence of resistant strains among the targeted pests

Conclusions
The substitution principle could be applied and could be practical, feasible and economically viable at various stages of the authorisation process. The principle could even be applied after authorisation, taking account of resistance management and of the results of the current review process for old active ingredients, without excluding all potential alternatives (be they substances, products or methods) on a case-by-case (crop-by-crop) basis.
    Further guidance, technical or otherwise will need to be developed on how to compare risks (e.g. can a potentially ecotoxic product be compared meaningfully with another that could potentially harm users), and on how to balance the economic, social and agronomic aspects of this issue. Based on the results of the various ongoing and possible future consultations, the Commission will explore the possibility to:

• Define the concept and the most suitable way of implementation in the revised PPP Directive, and 
• Define the concept and guiding principles in the future thematic strategy on the sustainable use of PPP.

Both instruments should be used in a complementary way in order to ensure a maximal reduction in the risks relating to pesticide use. This could include the application of this principle and thereby respond positively to the requests and recommendations expressed by the Council and the Parliament in different contexts.

Conclusions from stakeholder conference on review of the Pesticide Directive

At what level should comparative assessment operate?

Active substance level before inclusion in Annex I Very little support was registered from participants. But several Member States think the possibility should remain open for some active substances.

Product level in Member States It was recognised that this can prevent the mutual recognition of products in some cases when applied by individual Member States.

• in relation to products, some support was observed from Member States and PAN for comarative assessment which includes the substitution principle
• some support was observed from Member States and industry for comparative assessment but not substitution at regulatory level
• participants concluded that the application at use level has to be considered in the future sustainable use thematic strategy. Several stakeholders (farmers, industry) considered that this level might be the most appropriate

How should comparisons be made?

The following principles were identified by participants: 

• there should be clear differences in risks between products with similar use
• the alternative should be sufficiently effective
• the substitution has no major economic or practical disadvantages

The rules to define ‘a candidate for comparative assessment’ were also examined and participants came to the following conclusions:

• criteria should be those used for inclusion but at a broader level
• risk/benefit analysis needs to be incorporated

When to introduce comparative assessments?

Different aspects have to be taken into account:

• for practical reasons, it is reasonable to think that it will be easier to apply it after 2008 (end of the evaluation of all active ingredients); in other words, a lot of active substances will disappear after the review process (establish the baseline for comparison) and data would have been provided to compare the risks
• for political reasons and if a wait until after 2008 is unacceptable, then post-2005 might be a compromise for the Council and the Parliament because it corresponds to the end of review period for the most problematic substances i.e. those in stages 1 and 2 of the review programme
• but if introduced at use level it could be done more quickly

What happens to substituted products?

Participants considered that:

• substituted products should have a longer phase-out period than products considered ‘unacceptable’ according to the Uniform Principles, in order to avoid discouragement or uncertainties for notifiers who will be reluctant to invest in a dossier for a the product that might be ‘vulnerable’ to replacement
• the same should apply for active substances

The general feeling of the participants at this conference was that comparative assessments need not necessarily lead to substitution. Also advice to farmers and/or the development of Integrated Crop Management (ICM) solutions may be directed by comparative assessments. 
A few Member States considered that it will be difficult to accept the substitution principle after 2008, when the review programme is finished. A comparative assessment is still possible at this stage, but may form a basis to define ICM or advice to farmers rather than lead to substitutions of uses, which are acceptable in principle.

Edited presentation to the Pesticide Challenge conference, November 2003, Canice Nolan, European Commission, Health & Consumer Directorate, Canice.Nolan@cec.eu.int

[This article first appeared in Pesticides News No. 58, December 2002, pages 12-13]