Responsibilities, control, and market surveillance

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

The MFSC framework is based on increased accountability of economic operators and extensive administrative control powers to ensure health and safety, as well as fair transactions.

Responsibilities of economic operators

• Mandatory Prior Approval: Activities such as manufacturing, packaging, repackaging, importing, or wholesale distribution of MFSC require an approval issued by ONSSA. This approval is strictly personal and non-transferable. It is valid for ten years and can be renewed (Articles 29 and 31).
• Product Conformity: Only products with a marketing authorization (AMM) or that comply with a mandatory standard may be marketed or used (Article 6). Operators are responsible for ensuring their products comply with the technical specifications validated during the authorization process.
• Information and Withdrawal Obligation: The holder of an AMM or the owner of a product that complies with a standard must immediately inform the ONSSA if they have reason to believe that a product poses a risk to human or animal health or the environment (Article 52).
• Waste Management: In the event of an AMM withdrawal due to health or environmental concerns, the holder must promptly initiate a market recall and dispose of the products as waste at their own expense and risk (Article 15).
• Record Keeping: Approval holders, retail distributors, and approved experimenters must maintain and update a chronological register of all operations related to their activity, including an electronic copy (Articles 31 and 41).
• Advertising Integrity: Direct or indirect claims of plant protection product properties are strictly prohibited for MFSC, except for duly authorized mixed products (Article 47).

Control and market surveillance procedures

• Authorized Agents: Judicial police officers and ONSSA agents who are specifically authorized and sworn in for this purpose carry out the investigation and recording of violations (Article 53).
• Investigative Powers: To perform their duties, these agents have the right to access professional premises and means of transport. They may consult and copy any relevant documents and demand the opening of any container during transport or delivery (Article 54).
• Sampling and Interim Measures: Agents may take samples for conformity analysis purposes (Article 54, paragraph 6). Pending the results, they may order the seizure of the products.
• Official Reports: Any recorded violation is subject to an official report (PV), which is considered authentic until proven otherwise (Article 61).