Regulation (EC) No 1107/2009 - plant protection products
This Regulation lays down rules for the authorisation, placing on the market, use and control of plant protection products
- in order to ensure a high level protection of both human health and the environment, and
- to improve the functioning of the internal market and agricultural production through the harmonisation of these rules.
Working life and workers are also concerned by this Regulation, however, it focuses on the entire population.
The Regulation specifies its scope concerning plant protection products and their active substances, safeners, synergists, co-formulants and adjuvants.
Definitions are given for the following terms: residues, substances, preparations, substance of concern, plants, plant products, harmful organisms, non-chemical methods, placing on the market, authorisation of a plant protection product, producer, letter of access, environment, vulnerable groups, micro-organisms, genetically modified organisms, zone, good plant protection practice, good laboratory practice, good experimental practice, data protection, rapporteur Member State, tests and studies, authorisation holder, professional user, minor use, greenhouse, post-harvest treatment, biodiversity, competent authority, advertisement, metabolite, impurity.
The Regulation also sets the approval criteria for active substances by specifying the approval procedure as the producer of the active substance submits the dossier to the rapporteur Member State for assessment. Besides efficacy, the assessment is based on properties like mutagenicity, carcinogenity, reprotoxicity, endocrine disrupting properties, persistency and bioaccumulation. Mutual recognition of authorisations is possible.
The authorisation clearly states the accepted uses of the substances and sets the necessary requirements thereof.
Packaging and labelling should comply with the provisions of Directive 1999/45/EC.
Producers, suppliers, distributors, importers and exporters shall keep records of the plant protection products they produce, while Member States shall carry out monitoring and controls. Member States shall keep an up-to-date inventory of any authorised and withdrawn plant protection products in a publicly available database.
Definition of zones for the authorisation of plant protection products
Procedure and criteria for the approval of active substances, safeners and synergists
List of co-formulants which are not accepted for inclusion in plant protection products
Repealed Directives and their successive amendments
This legal act is a regulation thus applying directly in the Member States - no national implementing measures are required.