Plant Protection Products directive

Substances notified under the DSD (392) are considered as having been registered. Similarly, substances used only as active substances for plant protection products, which are covered by the Plant Protection Products Directive (a. 13), or for biocidal products, which are covered by the Biocidal Products Directive (a. 14) are counted as registered under REACH. 

Within the EU, experimental human toxicity smdies must not be conducted specifically for the purpose of hazard assessment of biocides according to the EU Biocidal Product Directive (EC 1998), or pesticides according to the EU Plant Protection Product Directive (EC 1991). 

EEC Directive amending Directive 91/414/EEC on plant protection products... 

Decision on the Convention on the Transboundary Effects of Industrial Accidents Decision concerning the non-mclusion of DNOC m Annex I of Directive 91/414/EEC on plant protection products... 

Decision on the possible inclusion of oxasulfuron in Annex I to Council Directive 91/414/EEC concerning the placing of plant-protection products on the market... 

In order to set up a harmonized framework for the regulation of plant protection products in the EC, Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market was adopted and implemented in all Member States. Six annexes were established within this Directive, providing the basis for the harmonization of registration procedures and regulatory decisions (Table 1). 

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). ... 

Annex VI to Directive 91/414/EEC concerning the placing of plant protection products on the market. The section concerning residue analytical methods was not fully finalized when the Directive was first adopted. There were no provisions for methods to determine residues from a.i. and relevant metabolites in soil, water, and air. The criteria for foodstuffs partly proved to be not helpful for the practice of assessment (e.g., with regard to reproducibility, ISO 5725 requires validation in at least eight independent laboratories). 

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