Scientific regulatory affairs
Regulatory support for biostimulants
It has been long awaited, the update of the European Fertiliser Regulation 2003/2003 to eventually include biostimulants !The good news is: it now includes biostimulants. The bad news: it only comes into application on 16 July 2022. Until then, national legislation applies (together with EC Regulation 2003/2003).So, what does it bear, the brand-new Fertiliser Regulation 2019/2009 ?For starters, its scope has been extended to include now products such as soil improvers, biostimulants and organo-mineral fertilisers and it replaces the 2003/2003 regulation. While its scope has been extended, the plant protection products regulation will be amended to reflect the new scope of the fertiliser regulation, whereas “biostimulants” will be defined as:“Products stimulating plant nutrition processes independently of the product’s nutrient content with the sole aim of improving one or more of the following characteristics of the plant or the plant rhizosphere:
There we are!There is another particularity: As opposed to most other European Union laws aiming at harmonising a market, the Fertiliser Regulation 2019/1009 does not prevent non-harmonised fertilisers (hereafter called “national fertilisers”) from being sold on individual national markets in accordance with the respective national law.In contrast to national fertilizers, an EU fertiliser product complying with the regulation should be allowed to move freely one the European internal market and EU Member States are not supposed to hinder the free movement of any compliant EU fertilizer on their market. However, “a Member States, which, on 14 July 2019 benefits from a derogation from Article 5 of Regulation (EC) 2003/2003 in relation to cadmium content in fertilisers granted in accordance with Article 114(4) TFEU may continue to apply its national limit values for cadmium content.” Any cadmium content of a fertiliser product, as well as the knowledge of national limit in contaminants is therefore critical.The new EU fertiliser regulation 2019/1009 (hereafter called the new fertiliser regulation) has divided EU fertilisers into different product function categories (PFCs). Each category is subject to specific quality and safety requirements. Annex I contains the list of these product function categories.Likewise, specific requirements in terms of components and other requirements have been set for biostimulants, soil improvers, and inhibitors.Raw materials that can be used for the manufacture of fertilisers are set out in Annex II of the new Fertiliser Regulation.Label requirements are set out in annex III of the new Fertiliser regulation 2019/2009.One of the "hot topics" during the discussions on how to amend the Fertiliser Regulation were phosphonates. These, as specified in the new Fertiliser Regulation, "may not be intentionally added to any EU fertilisers. Unintended presence of this substance may not exceed 0,5%."Interested in the detailed summary of the new EU Fertiliser Regulation? It should be available soon. If you don't want to miss its publication, just subscribe to the updates.
English summary of Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003.
This summary focuses on biostimulants, soil improvers and inhibitors. It aims at extracting and presenting all relevant information as regards to these product categories. For details on other product categories, please check on the original legislation., soil improvers and inhibitors. It aims at extracting and presenting all relevant information as regards to these product categories. For details on other product categories, please check on the original legislation.
Number of pages: 15Date of publication: 09 August 2020
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