EU Regulation1107/2009 established the plant protection industry. Plant protection products (PPPs) in the European Union under Regulation (EC) No 1107/2009 Data requirements have increased, and risk assessment schemes have become more complex. The European Food Safety Authority (EFSA) is constantly developing new guidance documents.
Authorties
EU Regulation1107/2009 established the plant protection industry. Plant protection products (PPPs) in the European Union under Regulation (EC) No 1107/2009 Data requirements have increased, and risk assessment schemes have become more complex. The European Food Safety Authority (EFSA) is constantly developing new guidance documents.
Overview
Plant protection products (PPPs) are placed on the market in the European Union under Regulation (EC) No 1107/2009. Pesticides are products that are delivered to the consumer in the form of active chemicals, safeners, or synergists, and are designed for one of the following purposes:
unless the main objective of these goods is deemed to be for reasons of hygiene rather than for the protection of plants or plant products (e.g., fungicides, insecticides), protecting plants or plant products against all hazardous organisms or stopping the action of such organisms.
other than as a nutrient, impacting plant life processes, such as plant growth regulators and rooting hormones.
preserving plant goods, to the extent that such substances or products are not subject to special Community preservative rules (for example, extending the life of cut flowers).
destroying unwanted plants or parts of plants, except algae, unless the products are applied to soil or water to protect plants (e.g., herbicides/weedkillers to kill actively growing weeds); checking or preventing undesired plant growth, except algae, unless the products are applied to soil or water to protect plants (e.g., herbicides/weedkillers to prevent weed growth).
Dossier preparation, submission, and post submission
The data requirements are set out in Regulation (EU) No. 283/2013 for the active substance and in Regulation (EU) No. 284/2013 for the product formulation along with national requirements which are specific to each Member State. However, writing EU regulatory dossiers is one of the most important tasks. Data must be provided in a draft Registration Report dRR. The report consists of core assessment for zone and national addenda as per Member State (MS) requirement. Below are required procedures:
Compilation and preparation of dossier
Authority comment’s reply with scientific justification
Communication with authorities
Task Force identification and management
Management of the entire authorization process
Data requirements for active substance authorization
The current data requirements for the EU dossier of an active substance are set out in. Regulation (EU) 283/2013. These data facilitate an in-depth assessment of the active substance. The data are sub divided into various sections:
Physical and chemical properties
Information regarding use
Methods of analysis
Efficacy
Toxicology and metabolism
Residues in food and feed
Fate and behavior in the environment and
Ecotoxicology
Classification, Labelling and Packaging (CLP Regulation)
CLP regulation came into force on 20 January 2009. It gives harmonized requirements for the classification, packaging and labelling of the articles and chemical substances. CLP regulation is based on the United Nations’ Globally Harmonized System (GHS) and purpose to ensure high level of protection environment and human health.
1. The CLP regulation requires manufacturers, importers, and other downstream users to do correct classification, labelling and packaging of the substances according to the guidelines before they reach the market.
2. After the classification of substance, it must communicate to the supply chain with its hazard’s information.
3. The labelling of hazard is done to classify the level with labels and SDS which must be communicated to the supply chain till the consumers along with the management and precautionary statements associated with the risks.