In brief
A modification of the current fertiliser products regulation (Royal Decree 529/2023) has been published. This new Royal Decree 529/2023 improves the alignment of national regulations with Regulation (EU) 2019/1009 on EU fertiliser products to avoid tensions between these two regimes. The new regulation introduces provisions on certain mixtures of micronutrients, inorganic fertilisers based on ammonium nitrate and the criteria that sub-products must meet in order to be classified as such.
In more detail
Last July, the Royal Decree 529/2023 (“Royal Decree“), which amends the former Royal Decree 506/2013, of 28 June, on fertiliser products (RDPF), was published in the Official State Gazette. This regulation introduces minor amendments to improve the adaptation of national legislation to Regulation (EU) 2019/1009, laying down rules on the making available on the market of EU fertilising products (“Regulation“).
The Regulation provides for partial harmonisation of fertiliser products, allowing non-harmonised fertilisers to be placed on the internal market in accordance with national legislation and without having to bear the CE marking. As a result, the purpose of the new Royal Decree is to clarify the applicability of the current legislative framework on the national market for these products.
Among the various amendments introduced by the Royal Decree, the most relevant one is the update of Annex I of RDPF, by including certain mixtures of micronutrients, in order to correct the error made by Order APA/104/2022, of 11 February, amending Annexes I, II, III and VI of Royal Decree 506/2013 (“Order“), which excluded certain types of inorganic fertilisers, preventing them from being placed on the market. In this sense, the Order left out solid and simple inorganic fertilisers, based on ammonium nitrate, with high nitrogen content. This product category is now also included in Annex I of the RDPF, with the intention of ensuring its safety in line with the Regulation. In addition, the Royal Decree also provides that tests for inorganic ammonium nitrate fertilisers may be carried out by accredited bodies, without the need to qualify as notified bodies.
Finally, the Royal Decree details the safety and agronomic efficiency criteria that sub-products used for the production of EU fertiliser products must meet, based on the technical proposals drawn up by the European Commission’s Joint Research Centre. In this way, materials that meet these criteria will be considered as sub-products in accordance with Law 7/2022, of 8 April, on waste and contaminated soils for a circular economy.
For more information, you can access the full text of the Royal Decree by clicking on this link. You can also contact our expert team in case you require individual advice for your business.
Author
Montserrat Llopart
Montserrat has extensive experience in pharmaceutical and health law, as well as in compliance, contract law, licensing, competition law and acquisitions in the pharmaceutical sector. She is the coordinator of the healthcare practice in the Barcelona office.
She assists healthcare companies throughout the life cycle of healthcare products (drugs, IVD and medical devices, combination products, cosmetics and food supplements), from R&D to commercialization and more specifically in the areas of clinical trials (agreements, regulatory procedures, processing of personal data), market access (pricing and reimbursement), products and companies regulations (MA/CE-marking, vigilances, required licenses, product classification, labelling), commercial relations between healthcare industries (distribution, (co)promotion, manufacturing, supply, licensing, partnership agreements), relations with healthcare professionals and/or patients including compliance (anti-gift and transparency laws); communication and advertising, e-health (connected devices, telemedicine, hosting of health data) and product liability. Her practice encompasses both advisory and litigation matters.
She also has considerable experience in the drafting of codes of professional ethics and conducting compliance audits, and advising on advertising and promotion of medicines and medical devices, including via the internet, online advertising and social media. Montserrat advises on a wide range of agreements related to the pharmaceutical industry, such as license and distribution agreements, clinical trial agreements, and supply and manufacturing agreements.
Author
Elisabet Cots
Elisabet is a Senior Associate experienced Public Law/ Regulatory lawyer in Baker McKenzie's Barcelona office. She has more than 10 years' experience advising heavyweight companies on public law and regulatory issues.
Elisabet advises both national and multinational companies on public procurement, administrative compliance, license schemes, environmental, ESG, regulatory, and products-related matters (circular economy and sustainability requirements, green claims, consumer protection issues, etc), including assistance before regulators, authorities, and courts. In addition, she regularly advises private companies on regulatory issues related to business expansion and the opening of new plants/premises. She also advises on litigation and trials related to the areas of specialization. She has extensive experience in the consumer & goods and life sciences sectors.
Regarding the life sciences sector, she offers advice to Spanish and foreign life sciences companies and represent them before authorities and courts regarding public procurement issues, price & reimbursement procedures, authorization and registration, promotion and advertising of medicines, and other regulatory issues related to medicinal products, medical devices, cosmetics, food supplements and other foods for particular nutritional uses.
She also professor at Pompeu Fabra University, UPF Barcelona School of Management and ESADE Law School in the field of Public Law. She regularly participates in publications and articles related to her specialty.
