CTFA Annual Report 2022

REGULATORY AFFAIRS & POLICY ANALYSIS NAD I A RASH I D | R EGU L ATORY AF FA I R S MANAGE R CAR I NA DEWAR | R EGU L ATORY AF FA I R S OF F I CE R NATIONAL DEPARTMENT OF HEALTH (NDOH) In March 2022, the National Department of Health published a Hazardous Substances Act, 1973 (Act no. 157 of 1973) Group I, Category A, Hazardous Substances: Declaration. In terms of section 2(1) (a) of the Hazardous Substances Act, the Minister of Health, declared the substances mentioned in the schedule and mixtures containing such substances, products or materials to be Group I, Category A Hazardous Substances. In April, 2022, the National Department of Health published a Hazardous Substances Act, 1973 (Act no. 157 of 1973) Group II, Hazardous Substances: Declaration. The Minister of Health, intent, in terms of section 2(1) (a) of the Hazardous Substances Act, to declare the substances mentioned in the schedule and mixtures containing such substances, products or materials to be Group II hazardous substances. More details can be found in the CTFA Compendium. DEPARTMENT OF FORESTRY, FISHERIES AND ENVIRONMENT (DFFE) South African Biotrade Standard The DFFE is in the process of developing a framework for a South African Biotrade Standard in compliance with the Nagoya Protocol on Access and Benefit-Sharing. Work on this is ongoing and will continue next year. Rotterdam Convention on the Prior Informed Consent (PIC) procedure Due to concerns surrounding the porous nature of the border which allowed unregulated substances entering the country, the South African Government chose to domesticate the requirements of the Rotterdam Convention on the Prior Informed Consent procedure for certain Hazardous Chemicals and Pesticides in international trade to be compliant with them being a party to the Convention. Chemicals Allied Industries Association (CAIA) offered their support to indicate that Chapter 3 of the National Environmental Management Act was mentioned for the purposes of domesticating multilateral environmental agreements. One year was given to finalise the Draft regulation with an extension of a further 120 days without taking into consideration further comments. Cabinet protocol was not followed, thus industry requested a bilateral meeting considering stakeholder comments. The meeting is scheduled for early 2023. Multi-stakeholder Committee on Chemical Management (MCCM) In 2022, DFFE circulated a proposed draft regulation, which qualifies the Minamata Convention on Mercury. As a signatory, South Africa is obliged to enact legislation to enforce the convention. Annex II of the Minamata Convention refers to the restriction of mercury in cosmetics. Mercuric compounds used in the preservation of eye care products are exempt from this convention. The regulation should be published in 2023. SOUTH AFRICAN BUREAU OF STANDARDS (SABS) SABS is a statutory body that was established in terms of the Standards Act, 1945 (Act No. 24 of 1945) and continues to operate in terms of the latest edition of the Standards Act, 2008 (Act No. 8 of 2008) as the national standardisation institution in South Africa. CTFA is part of the SABS Technical Committee TC 217. The South African Bureau of Standards published the following updated standards, these are available on the CTFA’s website for members: • SANS 289:2022 – Labelling requirements for prepackaged products (prepackages) and general requirements for the sale of goods subject to legal metrology control. • SANS 10393:2022 - Hair care products — General requirements • SANS 18415:2022 - Cosmetics —Microbiology — Detection of specified and non-specified microorganisms SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY (SAHPRA) In 2022, SAHPRA shared a guideline for Borderline Products. The intention of the document is to provide guidance to applicants on borderline products and outline the process for product designation requests by applicants. It represents the South African Health Products Regulatory Authority’s current thinking on the safety, quality and efficacy of medicines and the safety, quality and performance of medical devices. D uring the year under review CTFA’s regulatory footprint grew exponentially, and remained the core of the industry association, with local stakeholder engagement gaining momentum. LOCAL ENGAGEMENT COSMETIC TOILETRY AND FRAGRANCE ASSOCIATION OF SOUTH AFRICA 08