CTFA Annual Report 2019

The South African delegation raised concerns around trade barriers created by the current system of East African Community (EAC) standards, and proposed that the International Organisation's standards be adapted to individual local requirements. South Africa has over the years created a library of standards that are mostly aligned with international best practice to enable international trade of safe and efficacious products. WTO Regulatory Alerts CTFA receives notifications from the World Trade Organisation (WTO) on a regular basis, and shares the relevant alerts with members that could impact business operations and international trade. In 2019, a number of such notifications prompted CTFA to submit comments to the relevant authorities. 1. National Medical Products Administration in China- Draft regulation for notification of non-special cosmetics On 13 June 2019, CTFA submitted comments to the Draft Regulations for Notification of “Non-Special Purpose Cosmetics Recordation Administration Measures” issued on 27 May. In the letter to the National Medical Products Administration in China, CTFA stated its’ support for China’s move towards international convergence of cosmetic regulation in terms of recognition of safety assessments. In supporting this move, CTFA noted that not all countries are able to issue quality management certificates. In light of national differences, the following alternatives were suggested: • Regulatory certificates issued by any level of administration (state, provincial, municipal, etc.) • Certificates issued by organisations, such as trade associations, that are recognized or authorized by regulators • Certificates issued by organizations that are recognized by relevant international standards organizations such as International Standards Organization. • Requirement of Quality management certificate issued by the health authority of importing country • Safety-assessment based exemption from toxicology testing The Draft Regulation excludes products for children or infants and products with new ingredients from the possibility of waiving animal testing requirements. Since there is no scientific justification to exclude these products from a safety assessment approach, CTFA reiterated that it is international best practice to include the safety assessments of baby products. 2. United States of America Food and Drug Administration (FDA)- Proposed Rule Announcement on Sunscreen Products 21 CFR Parts 201, 310, 347 and 352 On 26 June 2019, CTFA submitted comments to the US Food and Drug Administration regarding the Proposed Rule on Sunscreen Products 21 CFR Parts 201, 310, 347 and 352. It was important to convey the need for the South African sunscreen regulatory regimen to be flexible and accommodating yet assure adequate access to safe and efficacious sunscreen products for the public. - FDA Proposal 1: Proposed GRASE status of Active Ingredients in the stayed 1999 Final Monograph: It was stated that there are “12 ingredients for which there are insufficient safety data to make a positive GRASE determination at this time. To address these 12 ingredients, the FDA is asking industry and other interested parties for additional data”. CTFA commented that the designation of Benzophenone-6 and Methyl Anthranilate are no longer listed as permitted UV filters in the South African market. Therefore, their designation as “Not GRASE” will not affect South Africa negatively. COSMETIC TOILETRY AND FRAGRANCE ASSOCIATION OF SOUTH AFRICA 10