Key SDS Compliance Mandates in Rwanda

1. Format and GHS System

• Mandatory Format: The SDS must be prepared in the universally recognized 16-Section GHS Format. Rwanda FDA guidelines (for laboratory chemicals and pesticides) specifically require comprehensive scientific data that align with the content of a GHS SDS.

• Regulatory Basis: Compliance for many regulated chemicals (e.g., laboratory chemicals, pesticides, household chemicals) is managed via Rwanda FDA guidelines, which draw heavily from the European Union's REACH Regulation (EC) No 1907/2006 regarding data requirements.

• GHS Classification: The chemical classification, labeling, signal words, and hazard/precautionary statements (found in Section 2) must be GHS-compliant to meet safety and environmental risk assessment needs of both the Rwanda FDA and REMA.

• Transport Compliance: Transport of hazardous materials must comply with local laws and international requirements, including the UN Model Regulations (Section 14).

2. Language Requirement

• Official Languages: Rwanda has four official languages: Kinyarwanda, English, French, and Swahili.

• SDS Language: The official guidelines for importation and exportation of regulated products state that the products' labeling and supporting information should be in any of the official languages used in Rwanda.

• Best Practice: For technical documentation, providing the SDS in English is mandatory and accepted for technical review. Providing it in both English and French offers the highest level of regulatory assurance, given the use of French in some official documentation and its status as an official language.

3. Regulatory and Documentation Focus

• Market Authorization/Registration (Rwanda FDA): For regulated products (like laboratory and household chemicals, and pesticides), the SDS is the core document required for the registration dossier. Registration is mandatory before the product can be manufactured, imported, or placed on the Rwandan market.

  • Specific Exclusions: Waste, substances under customs supervision (in-transit), and radioactive substances are generally exempted from these specific chemical registration guidelines.

• Import/Export Authorization (REMA): The Rwanda Environment Management Authority (REMA) requires authorization for the import or export of chemicals and hazardous wastes to ensure compliance with international conventions. The SDS is vital for this process.

• International Conventions: Rwanda is a party to the Basel, Rotterdam (PIC), and Stockholm (POPs) Conventions. The SDS must confirm the product's compliance status with any restrictions or prior informed consent procedures (Section 15).

• Local Representative (LTR): Manufacturers not residing in Rwanda must appoint a Local Technical Representative (LTR)/Agent in Rwanda to deal with their products, and this information should be included in the SDS (Section 1).