Europe and Spain debate on the freamers regulatorios of biopesticidas of botanic origin and MDF
The sector of the agriculture is living a moment of big changes, where the field of the Maximum Limits of Waste (LMR) in the crops purchases each greater day leadership. From here the importance to regulate, so much to national level like European, the use and the criteria that define so much to the Means of Phytosanitary ware Defence (MDF) as to the botanic extracts, since both have established in the last years like an alternative to the use of pesticidas chemical.
The publication of this preliminary draft has caused an internal debate between the companies of the sector, together with the Ministry of Agriculture, Feeding and Environingingment (Magrama), on the criteria that would have to prevail to guarantee the maximum quality and efficiency of these products. In this context have established the need to show through the necessary studies for such end, criteria like his efficiency, hygiene (do not have to present risk for the health) and stability (components have to be analytically trazables). In this way they would pose three areas of evaluation: efficiency, toxicology and analytical. The following escollo in the leaf of route to the set up of the legislation that will define the Royal decree, poses in how show the efficiency, toxicology and analytical of the MDF.
The fault of a normative national frame sufficiently clear in the past and the bad praxis and ineficacia of some of the actors involved in the Means of Phytosanitary ware Defence (MDF), have given place to that at present they exist in the Spanish market references of these means of defence that do not offer the sufficient guarantees. From here the importance of the publication of the preliminary draft of Royal decree that will regulate the commercialisation of the Means of Phytosanitary ware Defence (MDF), and will derogate the Order APA/1470/2007 that until the moment defined the frame regulatorio of the same.
On this point the company bets by prestigiar to the maximum the MDF, "since they fulfil an important paper in the vegetal production, in the frame of the sustainable use of the phytosanitary ware products, as well as in the field of the ecological agriculture", as it explains his president, Pedro Peleato. In this line the company pleads for the establishment of professional criteria that would include essays of efficiency, toxicology, ecotoxicología and evaluation of the formulated (so much to level of composition as of stability, so that it guarantee to the agriculturalist that the use of the same will be viable along the useful life of the product). "Inside the exigencias exposed by the ministry we bet for establishing some exhaustive criteria of evaluation, establishing the maximum guarantees of quality, that show to the Administration and to the consumers that the MDF are viable products, effective and insurance", underlines Peleato.
Seipasa Participates in the European debate on the frame regulatorio of biopesticidas to ensure the health in the agricultural fields.
The European legislation on botanic extracts
The Regulation (CE) number 1107/2009 of the European Parliament and of the Council regulates the commercialisation of phytosanitary ware products to European level. In relation to the same, recently, has published the Regulation 283/2013 that establishes the requirements on applicable data to the active substances, of compliance therefore with the Regulation (CE) number 1107/2009, opening the door to the use of the botanic extracts like active substances, allowing a different approximation, regarding the characterisation, identification and purity, of these in front of the active substances of synthesis. In this sense is debating acutely the document of recent publication, Sanco/11470/2012 of 8 May of the 2013, like draft of the requirements to establish for the definition of an active substance of botanic origin, understanding like such the resultant of the process/s to which has been subjected a drug of vegetal origin for the obtaining of an active substance in the sense of the regulation of the Regulation 1107/ 2009.
On the quoted draft, the distinct associations of the sector already are debating. From Seipasa, ensures Pedro Peleato: "we Are working together with distinct associations to European level to help to establish the mechanisms that define to these substances, together with authorities and laboratories". The final aim of all these reglamentaciones is to obtain a frame regulatorio that establish the distinct applicable requirements to the botanic extracts, used like active substances in the manufacture of phytosanitary ware of low risk, such like criteria of identification, characterisation and analysis, as well as of the processes extractivos, the establishment of waste, the criteria toxicológicos and ecotoxicológicos, among others.
On the same line of legislative development, has published the document of work Sanco 10363, of 3 April 2013, whereby pretends develop the article 23 of the European Regulation 1107/2009, concerning basic substances. This new concept defines like an element that in spite of not being considered phytosanitary ware product can present beneficial effects for the crops, and that it has to commercialise without substantial modifications in the prime matter, improving the weight of the agriculturalist in the manufacturing of insumos agricultural.
The present document fulfils his purpose to expand the information about the new concept of 'basic substances' that defines in the quoted European Regulation, at the same time that opens a process of public queries that has like purpose receive contributions that allow limar the definitions, conditions and procedures presented in the document of work published by the European General Steering of Health and Protection to the Consumer (DG Sanco), of face to reach a result consensuado that can satisfy the pretences of all the parts involved. The concept of basic substances still does not find totally clear-cut, therefore, in the document Sanco 10069/2013 on 14 January, published a list of substances considered by part of the States Members, as well as by consultores skilled, as possible candidates to be cataloged like basic substances.
Like example of the indefinición legal in which we find us at present in this field, realised a pilot project to develop an application of register of one of the substances proposed by the document Sanco 10069/2013 like basic substance; however, after the evaluation of the application of register, Efsa published a document in which it established that it was not possible to llevar this register, since the characteristics of some of these substances did not fulfil the requirements established in the article 23 of the European Regulation 1107/2009 to be considered basic substance.
