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Chemical Registration in South Africa - Overview
Cleaning and disinfectant products are called, identified, and regulated differently across countries and regions, making it very challenging for the industry to place these products in different markets.
In South Africa, disinfectants and germicides used on inanimate surfaces in low-risk areas within houses, public venues (schools and restaurants), health institutions, health professional consulting rooms, and clinics are controlled under the ambit of the FCD Act and fall within the mandate of the Directorate: Environmental Health within the Department of Health. These products must comply with the requirements of the “Compulsory specification for chemical disinfectants VC8054” as set out by the National Regulator for Compulsory Specifications (NRCS), the Trade Metrology Act, 1973 (Act 77 of 1973) as well as all relevant SANS standards. Along with disinfectants and chemicals, detergent/cleaning products are regulated under different acts and regulations that enforce manufacturers to comply with certain standards and acts to ensure product safety
Table 1: Chemical Regulations in South Africa - Overview
Categories | Biocide/Disinfectant | Detergents/Cleaning Products | General Consumer Products | Chemicals |
Regulations |
|
|
|
|
Registration/Notification Requirement | Yes | No | No | Yes |
Process Brief | A dossier application is to be compiled as per CM FM 8054-2 (Technical file requirement) and to be submitted to NRCS by a local entity acting as an applicant. | Only product compliance is required to ensure the safety and quality of the product. | Only product compliance is required to ensure the safety and quality of the product. | Chemicals under Group I and III toxic/hazardous substances require licensing. |
Local Representative | Yes | NA | NA | NA |
Key Data Requirements |
| NA | NA | NA
|
Global Harmonized System (GHS) is applicable in South Africa for the classification and labeling of chemicals and chemical products under the Hazardous chemical agents regulations.
Freyr Expertise
- Product Classification and Regulatory Guidance.
- Regulatory Strategies for Market Access/Product Launch.
- Product Notification/Registration Strategies/Product Registration South Africa NRCS.
- Regulatory Applicability Review and Interpretation.
- Technical Data Files (Specification, MSDS, etc.), including Registration/Notification Dossiers.
- Application Preparation and Submission for Relevant Introductions and Renewals.
- Sustainability and Packaging Solutions.
- Regulatory Intelligence (RI) Services.
Freyr Advantages
- Local presence in the market with relevant expertise and experience.
- End-to-end Regulatory consultation for product registration with South Africa NRCS.
- Easily navigate the complexities of Regulatory authorities.
- Support for region-specific Regulatory complexities.
- A structured and cost-effective approach to ensure compliance in multi-market scenarios.
- Quick turnarounds and faster time-to-market.