Plant protection products authorization

EC Decision on the withdrawal of authorizations of plant protection products containing monolmuron... 

EEC concerning the placing of plant-protection products on the market 2000/233/EC Decision on the withdrawal of authorizations for plant-protection products containing pyrazophos... 

Through the adoption of Directive 91/414/EEC, a decision-making regime for determining the acceptability of a.i., which are denoted as active substances (a.s.) in the EU s legislation, was established. Authorization of plant protection products was still to be undertaken at national level by the individual Member States. 

These annexes set out the requirements for the dossier to be submitted by applicants either for inclusion of an a.i. in Annex I or for authorization of a plant protection product. Active ingredients are listed in Annex I if their use and their residues, resulting from applications consistent with good plant protection practice [or Good Agricultural Practice (GAP)] do not have harmful effects on human and animal health, or on ground water or any unacceptable influence on the environment (Article 5 of the Directive). 

Annex I listing is the prerequisite for the mutual recognition of authorizations between Member States, whereby one Member State is obliged to accept the evaluation and authorization prepared by another Member State in situations where the agricultural, plant health, and environmental (including climatic) conditions relevant to the use of the plant protection product are comparable in the regions concerned (Article 10 of the Directive). ... 

Requirements of the dossier to be submitted for the authorization of a plant protection product... 

In addition to the evaluation at Community level, Member States have to evaluate the data submitted by applicants, because the authorization of plant protection products... 

Article 4 of Council Directive 91/414 EEC requests Member States to ensure that a plant protection product is not authorized unless its residues, resulting from authorized uses, which are of toxicological or environmental significance, can be determined... 

Any possible risk to users while spraying plant-protection products must be evaluated before its authorization. When it is necessary for workers to reenter crops shortly after their treatment, they may be exposed to the plant-protection product through contact with the spray deposit therefore, this possible means of exposure must be evaluated when a plant-protection product is to be used. This chapter discusses the procedure for and some examples of the assessment of re-entry exposure and provides instructions for placing protective measures on product labels if dermal and inhalative exposure is relevant. 

The basic idea of the CLH process is the transfer of responsibility for classification and labeling from industrial companies to authorities on a European Community level. In case of active substances in biocidal or plant protection products, all intrinsic properties including physicochemical properties, human health hazards, and environmental hazards are subject to the harmonization. By contrast, in the case of chemicals which are used in other application fields only some specific hazard classes are considered in the CLH procedure. According to Article 36 of the CLP Regulation, these are respiratory sensitization, carcinogenicity, germ cell mutagenicity, and reproductive toxicity. Consequently, these provisions have... 

Pesticide regulation is another area where Sweden wants to avoid direct confrontation with the EU Commission, while trying to evade EU regulations. Annex VI to the EU s uniform principles for evaluation and authorization of plant protection products (iCouncil Directive on the Placing of Plant Protection Products on the Market, (91/414/EEC) requires that exposure assessments be... 

Brock TCM. 2001. Risk assessment and mitigation measures for pesticides are all patches of freshwater habitat equal In Streloke M, editor. Workshop on risk assessment and risk mitigation measures in the context of the authorization of plant protection products (WORMM). Volume 383. Berlin (Germany) Mitteilungen aus der Biologischen Bundesanstalt fur Land- und Forstwirtschaft, p 68-72. 

European Food Safety Authority. 2006. Opinion of the scientific panel on plant protection products and their residues on a request from EFSA on the final report of the FOCUS Working Group on Landscape and Mitigation Factors in Ecological Risk Assessment. EFSA J 437 1-30. http //www.efsa.europa.eu/EFSA/efsa locale-1178620753812 home.htm (accessed December 28, 2007). 

Coordinate the overall arrangements for authorization of plant protection products within the European Union. Whereas it is intended to coordinate the process for considering the safety of particular substances at the Community level, individual Member States have responsibility for product authorization. 

Member States can authorize the sale and use of plant protection products only if they are listed in Annex I. 

Even if the use of synthetic plant protection products is required by the authorities (compulsory phytosanitary measures, e.g. in cases of fire blight), the product shall not be labelled as organically produced. 

EC 16 Aug 1999 The chemical is banned. It is prohibited to place on the market or use plant protection products containing DNOC. DNOC is not included as an active ingredient in Annex I to Directive 91/414/EEC. The authorizations for plant protection products containing DNOC were withdrawn within a period of 6 months from the date of notification of the Commission Decision 1999/164/EC. From the date of the notification, no authorization for plant protection products containing DNOC will be granted or renewed. 

It is prohibited to place on the market or use plant protection products containing nitrofen. The authorizations for plant protection products containing nitrofen had to be withdrawn from the 1st of January 1988 according to Council Directive 87/181/EEC of 9 March 1987. There is sufficient evidence to provide a strong presumption that human exposure to nitrofen may result in the development of cancer. Hazard to non-target organisms. (Reference (EPS) UNEP/FAO - PIC Circulars XIV. XV, XVI, XVII - 12/2001,6/2002, 12/2002,6/2003., )... 

According to the principles of decision making defined in EU Directive 91/414 EEC, Annex VIC 2.5.22 (European Commission 2002a), a plant protection product (PPP) failing the acceptability criteria in a standard risk assessment will not be authorized unless it is clearly established through an appropriate risk assessment that... 

As in many countries and federations the registration or authorization of agrochemicals (plant protection products (PPPs)) is an active process of carrying out risk assessments for this type of substances that involves several aspects and a lot of data to be taken into account. In the European Union (EU) it is the same of course. It needs for example an active positive decision on the marketing of PPPs from the European Commission considering human health, worker exposure, agricultural efficacy and environmental criteria. (EU, 1991) In this presentation an overview will be given of the environmental aspects taken into consideration and the way... 

Safety Authority will take responsibility in this area. How this will work out has to be seen in the near future. Nevertheless, the straightforwardness of the approach does not hide the relatively complex methods that are used or have to be used. The models applied in the determination of the PEC are far from simple they contain the current state-of-the-art of the scientific description of chemical, physical and microbiological processes in the environment. The methods will be kept update and communications with the research institutes and the users of the models will continue. The main aim is to keep having available a system of methods to carry out risk assessments for plant protection products. 

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