Requirements for composition, physicochemical characteristics, agronomic efficacy, safety, and analytical methods

Editorial note: Regulatory requirements can change. Confirm the current official texts and ONSSA instructions before filing or making a compliance decision.

Pour In order to obtain a marketing authorization (AMM) or certificate, a product must undergo rigorous scientific and technical evaluations to ensure its agronomic utility and health safety..

Composition requirements

The composition must be transparent and exhaustive to enable precise conformity control.

• Product Identity: Trade name, origin (natural or industrial), and precise designation of all raw materials used.
• Integral formula: A complete and detailed composition sheet balanced to 100% and signed and stamped by the formulator.
• Expression of Nutrients (Fertilizers): The contents must be expressed exclusively in terms of the weight of elemental nitrogen (Az), anhydrous phosphoric acid (P₂O₅), and anhydrous potash (K₂O) contained in 100 kg of goods.
• The terms "nitrogen," "phosphoric acid," and "potash" must be written in full.
• Secondary and trace elements: Detailed content information for calcium (Ca), magnesium (Mg), sodium (Na), and sulfur (S), as well as boron (B), cobalt (Co), copper (Cu), iron (Fe), manganese (Mn), molybdenum (Mo), zinc (Zn), and silicon (Si).
• Purity and Contaminants: The certificate of analysis must demonstrate the absence of harmful impurities and compliance with thresholds for heavy metals, such as lead and arsenic, as well as cadmium in phosphate fertilizers.

Physico-chemical characteristics and requirements

These data ensure product stability and quality of application.

• Physical properties: Evaluation of particle size (i.e., fineness of grind for powdered products), density, pH, solubility;
• Storage stability: providing data on product stability at different temperatures ensures the absence of chemical degradation or unacceptable physical changes during its shelf life.

Agronomic efficacy requirements

The dossier must provide scientific proof that the product fulfills its nutritional or soil-improvement functions without harming crops.

• Proof of Efficacy: The product must demonstrate its effectiveness under normal usage conditions for its intended purposes.
• Summary of Trials: The marketing authorization (AMM) application must include a summary of efficacy trials conducted on target crops that prove the benefits for plant nutrition or soil improvement.
• Selectivity and Phytotoxicity: Trials must confirm the absence of unacceptable phytotoxic effects on plants or plant products.
• GEP protocols: Experiments must be conducted by approved bodies (personne morale) that apply Good Experimental Practice (GEP) protocols. Only results validated by these providers are recognized when examining the AMM dossier.

Safety and health security

The fundamental criterion is that the material must not have any unacceptable effects on human or animal health or the environment.

• Risk Assessment: The dossier must include toxicological and ecotoxicological data that assesses exposure risks for users and applicators.
• Environmental Impact: Establish that the product, its metabolites, and its residues do not adversely affect human or animal health or the environment, paying particular attention to protecting groundwater.
• Chemical Safety and Contaminants: The product must comply with regulatory standards for harmful impurities and heavy metals, such as lead and arsenic. Strict vigilance is applied to cadmium content in phosphate fertilizers.
• Safety Data Sheets (SDS): Detailed SDSs for the finished product and each co-formulant in its composition must be mandatorily provided.
• Microorganisms Case: For biological products, the applicant must specify the scientific name and complete taxonomic group (family, genus, species, etc.) of each microorganism.

Analytical methods and compliance control

The ONSSA requires total transparency regarding the methods used to verify product compliance.

• Exhaustive Composition: The applicant must provide a comprehensive composition sheet that is balanced to 100% and signed by the formulator.
• Method Validation: The analytical methods used to monitor compliance and product purity must be described in the dossier.
• ISO/IEC 17025 Accreditation: Analysis reports must come from ISO/IEC 17025-accredited laboratories. A copy of the accreditation certificate specifying the scope and validity of the tests must accompany each report.
• Expertise for Non-Analyzable Products: If a product is deemed non-analyzeable in Morocco, the original analysis report must be from an accredited foreign laboratory on the ILAC list.
• Batch Traceability: Submitted analyses must relate to the same batch of the product, and the analysis date must be no older than one year at the time of filing.