The registration of plant protection products is an essential process to ensure the safety and efficacy of these substances dedicated to crop protection. It is a procedure ruled by strict regulations to ensure that plant protection products do not pose a risk to human or animal health, nor the environment.
What is registration of plant protection products?
Registering plant protection products is a procedure by which the selling and use of crop protection products is evaluated and authorised. This registration ensures that the products comply with the safety and efficacy requirements established by the legislation in force.
As in other European countries, in Spain it is compulsory to register any phytosanitary product, whether it is an active substance of chemical synthesis or of natural origin. For registration, it is necessary to present a series of studies and documents demonstrating that the product is safe for health and environment, and effective for the control of pests and diseases in crops.
How are phytosanitary products regulated?
The regulation of plant protection products in Spain lies within the scope of the European Union norms, exactly under Regulation (EC) No 1107/2009, which establishes 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, in Spanish), through the General Directorate of Agricultural Production Health; however, there are also other institutions involved in the process such as the Ministries of Health and Environment, or the INIA-CSIC (Spanish National Research Council).
How is a plant protection product registered?
In order to register a plant protection product, the applicant must submit a formal application to MAPA accompanied by a complete dossier with all required studies and data, including detailed information on the composition of the product, toxicology, operation way, biological efficacy and safety profile.
The evaluation process can be long and complex, since it involves a thorough review by INIA-CSIC of the data submitted and, in some cases, additional studies if requested by authorities. However, the registration of a phytosanitary product is necessary to legalise it in the country of destination, as well as in third countries that are part of the OECD. Once the evaluation has been passed, the product is entered in the Official Register of Plant Protection Products and is granted a marketing authorisation.
In order to facilitate the procedures for applications to the Register of Plant Protection Products, there is also the option of using the online platform FITOCERES, which use is voluntary but can help to ensure that the products to be registered comply with all regulations.
How long is the product registration valid?
The validity of the registration of a plant protection product is limited and depends on several factors. In any case, 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 new scientific studies. Before the end of this period, in order to continue marketing the product, it is necessary to apply for renewal of the registration by submitting new documents and data demonstrating that it continues to meet the safety and efficacy standards. To do so, it is necessary to wait until the active substance (s) contained in the product has/have been renewed. However,it is common for the renewal of plant protection active substances to be postponed, and the validity of the product registration to be extended.
The importance of RETO in phytosanitary products
In order to maintain greater control over phytosanitary products, the MAPA has created RETO (Electronic Register of Transactions and Operations with Phytosanitary Products, or Registro Electrónico de Transacciones y Operaciones con Productos Fitosanitarios in Spanish). This is a computer app that registers online all transactions of these products. To register in this application it is necessary to be registered in the Official Register of Producers and Operators of Phytosanitary Products (ROPO) of the corresponding Autonomous Community.
The RETO app for phytosanitary products provides the authorities with traceability and control of the movements of these products, from their manufacture to their final use, allowing real-time monitoring of compliance with regulations, and also detecting possible irregularities in the marketing and use of phytosanitary substances. It is, therefore, a crucial tool in the management and control of phytosanitary products in Spain.
How can Kaeltia help you to register a plant protection product?
At Kaeltia we know that the process of registering a phytosanitary product can be complex and hard. That is why our team of experts in regulatory affairs offers you a comprehensive advisory and management service for the registration of your products. We accompany and advise you throughout the entire process: from preparation and presentation of the dossier to contact with authorities, ensuring that you comply with all the regulations and procedures required. We offer this service both in Spain and in other countries.
At Kaeltia we have been helping all types of companies to market their products and to ensure that they comply with current regulations for more than 15 years. Trust our experts for the registration of plant protection products, and make sure they reach the market in compliance with all guarantees and regulations. Contact us: we know how to do things right.
