EN Official Journal of the European Union CE 84/676

(2004/C 84 E/0763)

WRITTEN QUESTION E-0812/04

by María Sornosa Martínez (PSE) to the Commission

(15 March 2004)

Subject: Infringement of European legislation on phyto sanitary products in the ‘Abac’ case (Valencia)

It was recently reported in Valencia that the Spanish Ministry of Agriculture was allegedly involved in the ‘Fabra’ case, in which the president of the Castellón regional government apparently asked the Ministry that the insecticide ‘Abac’ (based on abamectin), marketed by the company Naranjax, be granted marketing authorisation without having passed the relevant toxicity tests. It emerges that this phytosanitary product had been refused authorisation three times before the intervention of the president of the regional government. In actual fact other products with exactly the same composition manufactured under other names have never obtained authorisation from the Ministry because they exceed the toxicity limits. Furthermore, according to information revealed by the judicial process, it appears that ‘Abac’ began to be sold before it had even received the disputed authorisation, which constitutes a twofold irregularity, since the product was on sale for a certain period of time without a licence and without the relevant tests being carried out.

If this really proves to be the case, it may constitute a serious hazard for public health and the environment, an infringement of the principles of at least Directive 2002/79/EC (1) (even the earlier versions) amending the Annexes as regards the fixing of maximum levels for certain pesticide residues. According to the Directive the maximum pesticide residue level for abamectin, the main ingredient of ‘Abac’, should be 0,01 mg/kg.

Quite apart from the legal proceedings and bearing in mind that the Ministry of Agriculture has not yet publicly revealed either the actual composition of ‘Abac’, the abamectin content or its reasons for approving the conformity of the product, can the Commission say:

— whether it does not consider that the Spanish Ministry of Agriculture, in view of its concealment of information, may have committed a serious infringement of at least Community legislation on limit values for phytosanitary products;

— what steps it intends to take in response to this case?

Answer given by Mr Byrne on behalf of the Commission

(15 April 2004)

Council Directive 91/414/EEC of 15 July 1991 on the placing of plant protection products on the market (2) provides that active substances may only be used in plant protection where it has been demonstrated that the use has no unacceptable effects on human health or the environment. Pending Community evaluations and Commission Decisions on individual substances that were already on the market in July 1993, the Directive permitted national rules to stay in place on a temporary basis. Abamectin is on the third priority list of substances established by the Commission under the Directive. Under Commission Regulation (EC) No 451/2000 of 28 February 2000 laying down the detailed rules for the implementation of the second and third stages of the work programme referred to in Article 8(2) of Council Directive 91/414/EEC (3), industry indicated its interest in supporting the substance in the review process. Dossiers had to be submitted to the rapporteur Member State, the Netherlands, by 25 November 2003. The rapporteur will examine the dossier and send its draft assessment report to the European Food Safety Authority (EFSA). The Commission will decide on the acceptability of the use of abamectin in plant protection on the basis of an evaluation of that report by the EFSA.

The Commission is aware that in Spain several plant protection products containing abamectin are authorized. For all these products, including the product ‘Abac’, Spain can only grant authorizations if the use of the product does not leave residues on the treated crops exceeding the maximum residue limit for the crops involved. The maximum residue limits for abamectin are established in Commission Directive 2002/79/EC of 2 October 2002 amending the Annexes to Council Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC as regards the fixing of maximum levels for certain pesticide residues in and on cereals, foodstuffs of animal origin and certain products of plant origin, including fruit and vegetables, and are varying between 0,1 and 0,005 milligrams per kilogram (mg/kg) depending on the crop or foodstuff.

It cannot be excluded that certain plant protection products containing abamectine would not have been authorized. In fact in such cases, insufficient information may have been provided to the authorities or the information submitted may have shown that there are particular problems related to the specific product.

The Commission is not aware that there would be any particular safety problem with products containing abamectin requiring immediate action before the review process in the framework of the Directive would be finalised.

(1) OJ L 291, 28.10.2002, p. 1.

(2) OJ L 230, 19.8.1991.

(3) OJ L 55, 29.2.2000.