Plant Bio-stimulant & Fertilizer Registration Services

The EU Fertilizing Products Regulation (FPR), under Regulation 2019/1009, is an integral part of the EU's circular economy initiative, overseeing the standards for fertilizers.

Within this framework, biostimulants are recognized as a distinct 'Product Function Category' (PFC), a classification that has been in effect since July 2019. The FPR meticulously outlines robust guidelines to ensure the safety of products, thereby protecting people, animals, and the environment, and provides a uniform definition for plant-related products.

Under this regulation, a fertilizer is described as a product that supplies essential nutrients to plants. A biostimulant is defined as a product that enhances plant nutrition processes, independent of its nutrient content, with the primary goal of improving one or more of the following aspects for the plant or its rhizosphere:

(a) Efficiency in nutrient usage

(b) Resilience to abiotic stress

(d) Accessibility of restricted nutrients in the soil or rhizosphere.

PFCs and CMCs under the EU Fertilizer Products Regulation

PFCs (Product Function Categories) and CMCs (Component Material Categories) are classifications that define the types of products and their components:

PFCs (Product Function Categories): Product Function Categories (PFCs) are designated to categorize fertilizing products according to their specific roles. For instance, PFCs encompass a variety of products such as fertilizers, soil conditioners, liming materials, and plant biostimulants.
CMCs (Component Material Categories): Component Material Categories (CMCs) serve to categorize the various elements that constitute fertilizing products. To be incorporated into EU fertilizing products, each component must adhere to certain established criteria. CMCs cover a range of materials, including various substances and mixtures, botanical parts or extracts, compost, as well as by-products derived from the food processing industry.

How to register Bio-stimulant in EU

To align with the European Union’s regulatory standards, the registration process for bio stimulants must be conducted in accordance with Regulation (EU) 2019/1009. This regulation provides a definitive framework for bio stimulants, detailing the criteria for their introduction into the EU market. Applicants are required to present their bio stimulant products to the appropriate national authority for a thorough conformity assessment, ensuring adherence to the established fertilizer product and raw material categories. Securing a CE mark is a prerequisite for marketing bio stimulants within the EU.

Moreover, it is essential to verify that all raw materials utilized in fertilizer production are duly registered under REACH. Additionally, the product specifications should conform to the stipulated Product Function Categories (PFCs) and Component Material Categories (CMCs) as per Regulation (EC) No 2019/1009. Should you need further assistance, our regulatory experts are available for consultation.

Key Services Provided by Auxilife for Biostimulant & Fertilizer registration

Strategic advice and guidance

Auxilife is equipped to provide valuable assistance in formulating a detailed strategy that outlines the steps necessary to enter national or EU-wide markets, considering mutual recognition where relevant. We are committed to keeping our clients well-informed about any changes or updates in the regulatory landscape that may affect the registration of their products.

Data gap analysis

We provide a comprehensive strategic assessment that delineates the necessary studies, associated costs, and projected timelines for the registration of biostimulants and fertilizers, in line with the EU Fertilizing Products Regulation (FPR).

Data generation and study monitoring

We diligently oversee the execution of all essential studies to guarantee adherence to EU regulatory standards. Our role includes meticulous planning and coordination of studies to gather the requisite data for registration purposes. We also provide vigilant oversight to ensure that Contract Research Organizations (CROs) conduct these studies in strict compliance with legal mandates, established protocols, and regulatory guidelines. Furthermore, we meticulously review the outcomes of these studies to confirm that they meet the necessary criteria for supporting product claims and the registration process.

Risk assessment

Auxilife is committed to the responsible identification of potential environmental, human health, and ecological risks associated with the use of bio stimulants and fertilizers. We conduct thorough risk assessments to evaluate the likelihood and impact of any adverse effects under standard usage conditions, ensuring full compliance with the EU Fertilizing Products Regulation (FPR) and all relevant guidelines.

Dossier preparation, submission, and post submission

We are at your service to facilitate the demonstration of compliance with the EU Fertilizing Products Regulation (FPR). Our assistance extends to the meticulous preparation, compilation, and submission of detailed dossiers that encompass technical information, safety evaluations, efficacy research, and other relevant data. Additionally, Auxilife is prepared to provide support with any inquiries that may arise from the evaluating body following submission.

Classification, Labelling & Packaging (CLP)

The Classification, Labelling, and Packaging (CLP) process plays a pivotal role in confirming that bio stimulant registrations are accurately categorized and labelled, reflecting their potential hazards. Our expertise extends to aiding in the classification and labelling of bio stimulants, ensuring they meet safety and efficacy standards, adhering to rigorous safety guidelines, and securing independent confirmation of the claims made on labels throughout the conformity assessment process.