Regulation on the licensing and placing on the market of plant protection products.

This Regulation sets out the procedures and principles regarding licensing, classification, packaging, labeling, placing on the market of plant protection products and the obligations of license applicants and license holders, in order to ensure effective control over the negative effects they may have on human and animal health and the environment. The purpose of this Regulation is to protect plants or plant products from all kinds of diseases, pests and weeds and/or preventing the effects of such organisms. Article 9 lists the preparations falling within the definition of plant protection products which are subject to registration, such as: pesticides, insecticides, and biological control agents.
This Regulation provides rules for the licensing of plant protection products, plant protection products containing a new active substance, plant protection products containing different ratios and/or formulations of the licensed active substance, mixed plant protection products containing more than one active ingredient, biotechnical control products, biological control agents, microbial pesticides, and plant extracts. Furthermore, it lays down provisions on the issuance, transfer, suspension, cancellation and extension of validity of licenses; expansion of the content of licenses; utilization and placing on the market of licensed plant protection products; temporary use permit for emergencies; classification, packaging and labeling of plant protection products; introductory, usage and protection information that are mandatory to be included on the label; information that must be included on the outer packaging to be used during transport and shipping; license-based biological activity, residue, side effects, initial toxicity and resistance testing of plant protection products; and the duties and working procedures and principles of the Plant Protection Products License Evaluation Commission.
This Regulation addresses the standards of EU, FAO, WHO and OECD, such as Maximum Residue Limits and contaminant values in microbial pesticides. The transactions and procedures relating to the licensing, classification, packaging, labeling, manufacturing, import, sale and control of plant protection products shall be carried out by the General Directorate of Food and Control.