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The registration of plant protection products is an essential process for ensuring the safety and efficacy of products used to protect crops. It is a procedure governed by strict regulations to guarantee that plant protection products do not pose a risk to human or animal health or to the environment.
What Does the Registration of Plant Protection Products Involve?
The registration of plant protection products is a procedure through which the marketing and use of products intended to protect crops is assessed and authorised. This registration ensures that products meet the safety and efficacy requirements set by current legislation.
As in other European countries, in Spain every plant protection product must be registered, whether it is an active substance of chemical synthesis or of natural origin. For registration, a series of studies and documentation must be submitted to show that the product is safe for health and the environment and effective in controlling pests and diseases in crops.
How Are Plant Protection Products Regulated?
The regulation of plant protection products in Spain falls within the framework of the European Union, under Regulation (EC) No 1107/2009, which sets out the rules for the authorisation, marketing and use of these products. In Spain, the competent authority for the registration of plant protection products is the Ministry of Agriculture, Fisheries and Food (MAPA), through the Directorate-General for Agricultural Production Health; however, other institutions also take part in the process, such as the Ministries of Health and Environment, and INIA-CSIC.
How Is a Plant Protection Product Registered?
To register a plant protection product, the applicant must submit a formal application to MAPA together with a complete dossier containing all the required studies and data, including detailed information on the composition of the product, its toxicology, its mode of action, its biological efficacy and its safety profile.
The evaluation process can be long and complex, as it involves a thorough review by INIA-CSIC of the documentation submitted and, in some cases, additional studies if requested by the authorities. Even so, completing the registration of a plant protection product is necessary in order to legalise it in the destination country, as well as in third countries that are members of the OECD. Once the evaluation has been passed, the product is entered in the Official Register of Plant Protection Products and granted a marketing authorisation.
To make applications to the Register of Plant Protection Products easier, there is also the option of using the online platform FITOCERES, which is voluntary but can help ensure that the products to be registered comply with all regulations.
How Long Is a Product Registration Valid?
The validity of the registration of a plant protection product is limited and depends on several factors. In any case, the authorisation is granted for a maximum period of 10 years, although this may vary depending on risk assessments and the appearance of new data or scientific studies. Before this period ends, in order to keep marketing the product, a renewal of the registration must be requested by submitting new documentation showing that it still meets the safety and efficacy requirements.
To do so, it is necessary to wait until the active substances contained in the product have been renewed. It is common for the renewal of active substances in plant protection products to be postponed and for the validity of the product registration to be extended.
The Importance of RETO for Plant Protection Products
In order to maintain greater control over plant protection products, MAPA has created RETO (Electronic Register of Transactions and Operations with Plant Protection Products). It is a computer application that electronically records all transactions involving these products. To register in this application, it is necessary to be entered in the Official Register of Producers and Operators of Plant Protection Products (ROPO) of the corresponding Autonomous Community.
The RETO application for plant protection products gives the authorities traceability and control of the movement of these products from manufacture to final use, making it possible to monitor in real time compliance with regulations and to detect possible irregularities in the marketing and use of plant protection substances. It is therefore a crucial tool for the management and control of plant protection products in Spain.
How Can Kaeltia Help You Register a Plant Protection Product?
At Kaeltia we know that the registration process for a plant protection product can be complex and tedious. That is why our team of regulatory affairs experts offers you a comprehensive service of advice and management for the registration of your products. We support and advise you throughout the whole process: from preparing and submitting the dossier to liaising with the authorities, making sure that you comply with all regulations and required procedures. We offer this service both in Spain and in other countries.
At Kaeltia we have spent more than 15 years helping companies of all kinds to market their products and to make sure they comply with current regulations. Trust our experts to register your plant protection products and make sure they reach the market with all the necessary guarantees and in compliance with the rules.
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