Chemical Regulatory Services 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.

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.

Summary Table

Categories

Biocide/Disinfectant

Detergents/Cleaning Products

General Consumer Products

Chemicals

Regulations

  1. Standards set by the NSRC, established by the National Regulator for Compulsory Specifications Act, 2008 (Act 5 of 2008)
  2. Foodstuffs, Cosmetics, and Disinfectants Act, 1972 (Act 54 of 1972)
  3. Medicines and related Substances Act, 1965 (Act 101 of 1965)
  4. The Fertilizers, Farm Feeds, Agricultural Remedies, and Stock
  5. Remedies Act, 1947 (Act 36 of 1947)
  1. Regulations for hazardous chemical agents, 2021
  2. South Africa Bureau Standards (SABS)
  3. Consumer Protection Act, No. 68 of 2008
  1. Consumer Protection Act, No. 68 of 2008
  2. Regulations for Hazardous Chemical Agents, 2021
  1. National Environmental Management Act, 1998 (Act No. 107 of 1998)
  2. Hazardous Substances Act 15 of 1973

     

  3. Occupational Health and Safety Act No. 85 of 1993.

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

  1. Application form (Completed and signed NRCS form No. CMM FM 8054-3)
  2. Manufacturing plants and warehouses
  3. List of raw materials
  4. SDS that shall satisfy the requirements of paragraphs 5, A.2, A.4, A.5, A.8, A.9, A.10, A.11, and A.12 of the latest edition of SANS 11014
  5. Product label (A product label for the chemical disinfectant formulation as required by paragraph 5 of VC8054:2017)
  6. Proof of compliance [Copies of test reports – test reports only from a Conformity Assessment Body (CAB) that has been accredited in accordance with the latest edition of SANS 17025 by a signatory to the International Laboratory Accreditation Co-Operation's Mutual Recognition Agreement shall be accepted as proof of compliance]
  7. Conformity of production and routine tests
  8. Completed NRCS form No. CMM FM 8054-6

NA

NA

NA

 

Global Harmonized System (GHS) is applicable in South Africa for the classification and labeling of chemicals and chemical products under the Regulation for Hazardous Chemical Agents, 2021.

Expertise

Freyr Expertise

  • Product Classification and Regulatory Guidance
  • Regulatory Strategies for Market Access/Product Launch
  • Product Notification/Registration Strategies
  • 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)
Freyr Advantages
Advantages

Freyr Advantages

  • Local presence in the market with relevant expertise and experience
  • End-to-end Regulatory consultation
  • Easily navigate the complexities of Regulatory authorities
  • Support for region-specific Regulatory complexities
  • A structured and cost-effective approach to ensure compliance in the multi-market scenario
  • Quick turnarounds and faster time-to-market