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Authorisation of Plant Protection Products
The EU’s policy on the authorisation of plant protection products (PPPs) is governed by Regulation (EC) No 1107/2009, which sets the legal framework for placing these products on the market in the European Union. Plant protection products are the products supplied to users that contain one or more approved active substances, and may also contain safeners or synergists. They are used to protect plants and plant products against harmful organisms, influence plant life processes, preserve plant products, destroy unwanted plants, or control unwanted plant growth.
A basic feature of the system is that a plant protection product cannot be marketed or used unless it has first been authorised in the EU country concerned. This means the EU works with a two-level model: the key substances are approved under the EU framework, but the final authorisation of the product as marketed is granted at national level under the rules and procedures laid down by Regulation (EC) No 1107/2009. Plant protection products must contain at least one approved active substance, which may include micro-organisms, pheromones or botanical extracts.
The policy also gives Member States responsibility for the control of use and placing on the market of plant protection products. This includes oversight of how products are authorised and used domestically, and it also extends to concerns about illegal and counterfeit pesticides, which are treated as part of the broader enforcement context.
Under Emergency authorisation of plant protection products, the system allows a limited derogation from the normal authorisation process. Under Article 53 of Regulation (EC) No 1107/2009, Member States may authorise the placing on the market of a plant protection product for a period of up to 120 days, for limited and controlled use, where this is necessary because of a danger that cannot be contained by any other reasonable means. Emergency authorisation is therefore an exception mechanism for special circumstances rather than a parallel ordinary route.
Information on emergency authorisations is made available through the EU Pesticides Database, but the legal responsibility remains with the Member States. They are fully responsible for granting those emergency authorisations, and questions on specific cases must therefore be addressed to the relevant Member State competent authority. Applications for emergency authorisations are submitted through the ESFC system, which is also taking over functions previously handled by PPPAMS.
Under Further information, the framework is complemented by operational tools and procedures. The ESFC and PPPAMS systems support dossier submission for authorisation procedures, while the Procedure to apply for authorisation of a PPP reflects the EU’s zonal system of authorisation, under which the Union is divided into three zones to support a more harmonised and efficient approach.
The framework is also linked to the assessment of plant protection products, where the Commission, EFSA and Member State authorities work on improving the transparency and efficiency of product assessment.
A basic feature of the system is that a plant protection product cannot be marketed or used unless it has first been authorised in the EU country concerned. This means the EU works with a two-level model: the key substances are approved under the EU framework, but the final authorisation of the product as marketed is granted at national level under the rules and procedures laid down by Regulation (EC) No 1107/2009. Plant protection products must contain at least one approved active substance, which may include micro-organisms, pheromones or botanical extracts.
The policy also gives Member States responsibility for the control of use and placing on the market of plant protection products. This includes oversight of how products are authorised and used domestically, and it also extends to concerns about illegal and counterfeit pesticides, which are treated as part of the broader enforcement context.
Under Emergency authorisation of plant protection products, the system allows a limited derogation from the normal authorisation process. Under Article 53 of Regulation (EC) No 1107/2009, Member States may authorise the placing on the market of a plant protection product for a period of up to 120 days, for limited and controlled use, where this is necessary because of a danger that cannot be contained by any other reasonable means. Emergency authorisation is therefore an exception mechanism for special circumstances rather than a parallel ordinary route.
Information on emergency authorisations is made available through the EU Pesticides Database, but the legal responsibility remains with the Member States. They are fully responsible for granting those emergency authorisations, and questions on specific cases must therefore be addressed to the relevant Member State competent authority. Applications for emergency authorisations are submitted through the ESFC system, which is also taking over functions previously handled by PPPAMS.
Under Further information, the framework is complemented by operational tools and procedures. The ESFC and PPPAMS systems support dossier submission for authorisation procedures, while the Procedure to apply for authorisation of a PPP reflects the EU’s zonal system of authorisation, under which the Union is divided into three zones to support a more harmonised and efficient approach.
The framework is also linked to the assessment of plant protection products, where the Commission, EFSA and Member State authorities work on improving the transparency and efficiency of product assessment.
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