Interview with Sara Tormo, Regulatory Affairs Director at Tradecorp, to get an insight on the regulatory implications of IsliFe 8.2
Date:09-25-2018
With the launch of IsliFe 8.2, an innovative iron chelate with progressive biodegradability, Tradecorp is firmly committed to innovation and sustainability. However, the use of a completely new chelating agent not only grabs the attention of the market, it also involves extensive and complicated registration processes, which can considerably delay (and even block) the entry of the product into the market.
To learn more about the situation of IsliFe 8.2 at the regulatory level, we spoke with Sara Tormo, Regulatory Affairs Director at Tradecorp.
Question - Tradecorp has made a very strong commitment in launching this new biodegradable chelating agent. Considering that this is completely new for the market, registration must be complicated, and entail a long and laborious process. Where does Tradecorp stand regarding the launch of this product?
Answer.- We are making steady progress in registering IsliFe 8.2 within the different markets. Registration requirements as well as times vary from one country to another. As a consequence, in some countries - like Australia - we could launch immediately, while in others - like Mexico - the process could take up to two years. In any case, we are optimistic and the entire Regulatory department is committed and excited about the launch of IsliFe 8.2. We believe that it is a truly innovative product and we hope that it will soon be accessible in many markets.
Q.- Tradecorp is a Spanish company and its factories are located in Europe, which is, in fact, one of your biggest markets. At what stage is the IsliFe 8.2 registration for the European market?
A.- Given that the chelate is manufactured in Europe, the first step is to register the substance in accordance with the REACH Regulation, whose main objective is to guarantee high levels of protection for human health as well as the environment. The fact that IsliFe 8.2 is manufactured in Europe is a differentiating factor compared to products made in other regions. This is because, in order for it to be placed on the market, we had to previously carry out a series of identification, toxicological and ecotoxicological trials, which guarantee its safety in the conditions of use referred to in the safety data sheet of the product.
On the other hand, Europe is one of the markets in which the registration of IsliFe 8.2 as a fertilizer is more complex, because we have to request the amendment of the legislation by requesting the inclusion of a new type of fertilizer. We expect the approval from the Spanish Authorities for the inclusion of this new iron chelate in the Royal Decree 506/2013 by the end of this year. With this approval, we will begin mutual recognition procedures for other countries of the European Union.
Q.- IsliFe 8.2 is directed towards a very specific niche, the growing market for sustainable products. In our interview with José Nolasco, he commented that one of the main differentiating features of IsliFe 8.2. is its "progressive biodegradability", which is undoubtedly an indicator that the product is sustainable. However, an important issue when talking about sustainable products is their use in Organic Farming. In the case of a product as innovative as IsliFe 8.2, which brings a new chelating agent to the agricultural market, its consideration within the legislation of Organic Farming must be uncertain. What is the current status of this product with respect to the Organic Farming legislation?
A. - To date, the European Organic Agriculture Regulation only accepts inorganic micronutrients that are listed in Part E of Annex I of Regulation (EC) No. 2003/2003. In other words, in Organic Farming, it is only possible to use those chelated micronutrients whose chelating agent is included in section E.3.1. of the Regulation. IsliFe 8.2 is a truly innovative product, so it could be included in Organic Farming only after the new chelating agent is approved for inclusion in Regulation 2003/2003. This is a slow and complex process and is undoubtedly a clear sign that Europe needs a Regulation for fertilizers according to the needs of the industry and the population, a regulation that truly encourages innovation. For this reason, we hope that the European Parliament will favorably consider the industry’s proposals and approves a Regulation that favors sustainable development of European agriculture during this term.
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