I am a senior inspector in the pesticide control service of the Department of Agriculture and Food. My Department is responsible for the formulation and implementation of the regulatory framework for the marketing and use of plant protection products. Council Directive 91/414/EEC, concerning the placing of plant protection products on the market, which was transposed into Irish law by means of SI 83/2003, as amended, established the regulatory framework under which my Department currently operates in respect of plant protection products.
I am joined by Mr. Gordon Rennick, agricultural inspector in the regulatory and enforcement unit of the pesticide control service, who has been and is directly involved in the negotiations on these proposals. I am also joined by Mr. Aodh O'Gallchoir, assistant principal in the crop production and safety division of the Department, who provides administrative support to the pesticide control service.
As this is the first time, to my knowledge, that this committee has considered issues relating to the regulation of plant protection products, it might be useful to place the documents being scrutinised by the committee in context. With its permission I will start with an outline of the regulatory system currently in place as provided for by EU Directive 91/414/EEC concerning the placing of plant protection products on the market. I will then deal with the proposal for a regulation to update the existing regulatory framework. I would then like to deal with the proposals concerning eight individual substances that are the active components of certain plant protection products. I will also update the committee on developments since the publication of these proposals by the Commission.
Plant protection products can be chemical or biological in nature. They are used to prevent damage caused by harmful organisms such as weeds, insects, plant pathogens, etc. EU Directive 91/414/EEC, concerning the placing of plant protection products on the market, introduced a two-stage process for the regulation of these products. Reflecting the principle of subsidiarity, active substances are approved centrally by the Commission while the products containing them are authorised by the member states by applying uniform principles for evaluation and decision-making. The regime in place establishes a high level of protection for man, animals and the environment and also serves to facilitate free trade. A review programme for existing active substances, undertaken to ensure that the same standards are applied to existing and new active substances, is at an advanced stage, being approximately 60% complete.
Proposal No. 11755/06, AGRILEG 127 ENV 411 CODEC 773, for a regulation of the European Parliament and of the Council concerning the placing of plant protection products on the market, will, on adoption, replace EU Directive 91/414/EEC and will also repeal Council Directive 79/117/EEC prohibiting the placing on the market and use of plant protection products containing specified active substances. It was developed following extensive consultation and is designed to update the existing regulatory framework for plant protection products.
Key features of the proposal were stressed by the Commission in presenting its proposal to the 2,750th meeting of the Council on 18 September 2006. It provides for the continued maintenance of a high level of protection for human health and the environment. It reflects the Lisbon strategy as the proposed procedures provide more certainty and enhance competitiveness. It provides for better regulation and simplification of the legislation and it is linked to the Commission communication on the thematic strategy on the sustainable use of pesticides and the Commission proposal for a directive establishing a framework for community action to achieve a sustainable use of pesticides. With those initiatives it forms a cohesive package of measures to deal with pesticides.
The Commission highlighted its consistency with other measures concerning the regulation of chemicals, existing or proposed, the introduction of comparative assessment, the substitution principle for plant protection products, a simplification of the rules on data protection and the strengthening of control measures.
During the initial discussions, which commenced on 18 September, Ireland welcomed the proposal as being progressive, balanced and well constructed. We also welcomed the intention to continue ensuring a high level of protection for man, animals and the environment. Ireland raised issues of concern which will be pursued during the detailed examination of the proposals. These include the need for the reintroduction of arrangements for authorisation of plant protection products containing active substances for provisional periods, to ensure that farmers and growers have early access to improved means to protect crops and to prevent a reduction in the competitiveness of Irish and European agriculture. We also feel there is a need to change the rules on the protection afforded to proprietary data and to extend the procedures to deal with intercompany disputes to avoid restricting the availability of required technology to Irish and European agriculture and to ensure that plant protection products are available to Irish farmers and growers at competitive prices.
The next points we felt needed to be dealt with were as follows: the need to insert explicit procedural rules to facilitate efficiency and predictability in the elaboration of conclusions prepared by the European Food Safety Authority, EFSA, on active substances; to ensure the continued competitiveness of Irish and European agriculture; the need to adjust the procedures proposed for mutual recognition of authorisations by other member states; to ensure that products authorised for use in Ireland are appropriate for local conditions; and to prevent progress achieved in recent years in minimising the risks associated with use of plant protection products being reversed. This is the element relating to proposals for a new regulation. The remaining section relates to the eight proposals for the specified or named active substances listed at the beginning of this document.
In accordance with the procedures specified for the evaluation of existing active substances, each of the active substances was evaluated by a member state acting as rapporteur for the Commission. The evaluation produces an assessment or a monograph which is prepared and peer reviewed by all member states. As part of this process, Ireland was rapporteur for the active substance flusilazole, which is one of the eight molecules being discussed. Active substances can be approved and be included in Annexe I of the EU Directive 91/414 if it is established for a representative use that a plant protection product containing the active substance can be used safely.
Proposals for the approval and inclusion of the eight active substances in Annexe I under restricted conditions were submitted to the relevant regulatory committee, the standing committee on the food chain and animal health, on 3 March 2006. That committee failed to deliver an opinion on any of the proposals. There was neither a qualified majority for nor against their approval and inclusion in Annexe I.
In accordance with the provisions of Article 19 of Directive 91/414/EEC and Article 5 of Council Decision 1999/468/EC, the Commission was then required to submit proposals to Council on the measures to be taken. If agreement is not attained at Commission level, the issue must go to the Council to get agreement.
On 18 September 2006, the Council rejected by qualified majority the proposed approval and inclusion of vinclozolin and of azinphos methyl into annexe I. The outcome is that the Commission indicated no further action will be taken with respect to these two active substances. Accordingly, member states will be required to revoke all authorisations associated with these compounds present in plant protection products from the end of December 2006. This is provided for in Commission Regulation 1335/2005. In effect, those two pesticides are now gone from the market and member states will take action to ensure this.
With regard to the other six active substances, the proposal made by the Commission did not get a qualified majority for or against inclusion in annexe I when Council considered the matter on 25 September this year. In accordance with the provisions of Article 19 of Directive 91/414/EEC and Article 5 of Council Decision 1999/468/EC, the Commission will adopt and publish the measures submitted to Council. As there is no agreement for or against in Council, the proposal made by the Commission will be adopted.
The Commission's proposals for the eight active substances were felt by the Department of Agriculture and Food to interfere directly with a member state's competence to authorise at national level a product in accordance with the uniform principles set out in annexe VI to Council Directive 91/414/EEC. Thus, we felt the principle of subsidiarity is affected. There is a situation in place where if there is a safe use under existing conditions, these active substances should be listed in annexe I of Council Directive 91/414/EEC. The Commission put restrictions in place, which has not been the case up to now.
This approach was seen to exacerbate existing problems in the area of availability of plant protection products for use on "minor" crops. It was also seen as a departure from the normal procedure and, as such, a retrograde step. It transfers responsibility from the member states to the Commission or Council, as appropriate. Article 4 of Directive 91/414/EEC provides for member state competence in authorising plant protection products containing active substances included in annexe I for particular uses. Evaluations conducted by member states in authorising plant protection products for particular uses are carried out using the most up-to-date scientifically valid risk assessment techniques.
As safe uses for products containing each of the active substances had been identified, Ireland favoured their inclusion without restriction as to the crops for which member states could authorise use. When these individual pesticides were being discussed, the Irish position was abstention for all eight compounds in both the standing committee and subsequently in Council, as we were not satisfied with the Commission approach. This was basically a matter of principle rather than a specific issue. As can be seen in the table on the last page of the circulated document, not all these pesticides are approved for use in Ireland. It was an issue we had with the Commission approach.
My colleagues and I will endeavour to assist the committee in responding to any questions members may have. If we do not have the specific answers today, we will communicate further information as required.
