Regulatory Requirements
Agricultural chemicals are chemical substances used in agriculture to increase crop yields and protect plants, such as fertilizers and plant protection products, conventional, biological or innovative new substances. They are a central component of integrated modern agricultural procedures.
In the European Union, the authorization of plant protection products and their active substances is governed by a comprehensive regulatory framework to ensure human and environmental safety.
To be placed on the market, active substances, basic substances, safeners and synergists must be approved on EU level before the respective Plant protection products, including biopesticide products, are authorized at national level.
The regulatory framework is set by Regulation (EC) No. 1107/2009, governing the approval of active substances, safeners, synergists and co-formulants used in plant protections products at EU-level, the authorization of plant protection products at member state level, renewal and withdawal procedures, the provisions for low-risk and basic substances, comparative assessment for candidates for substitution, etc.
Detailed data requirements are specified by Commission Regulation (EU) No. 283/2013 for active substances, evaluation of toxicology, residues, fate and behaviour in the environment and ecotoxicology, and Commission Regulation (EU) No. 284/2013 for products, covering product efficacy, operator and user exposure, residues and environmental risk.
Commission implementing Regulation (EU) No 540/2011 provides a list of actice substances that are approved under Regulation (EC) No 1107/2009.
The uniform principles are defined in Regulation (EU) No 546/2011.
Regulation (EU) No. 2020/1740 sets out the provisions necessary for the implementation of the renewal procedure for active substances (AIR), ensuring that substances continue to meet safety standards over time.
Regulation (EC) No 396/2005 sets harmonised rules for Maximum Residue Levels (MRL) in food and feed as well as for enforcement and compliance controls.
Plant protection products must be classified, labelled and packaged in compliance with the CLP Regulation (EC) No. 1272/2008.
Member states of the EU have mandatory national regulatory laws for the authorisation of plant protection products defining competent authorities, national administrative rules (fees, submission procedure, language and timelines), national post-authorisation obligations, national risk mitigation measures and rules for sales and distribution, user requirements, advertising, integrated pest management, etc.
States that are not part of the EU but associated, such as the EEA EFTA states Norway, Iceland and Liechtenstein, Switzerland and Great Britain have partly aligned rules to the EU but are not part of the harmonised system and specific national rules must be considered.
Compliance with these regulations requires a thorough understanding of the legal requirements, scientific data generation and risk assessment procedures associated with the authorization process.
