CTFA Annual Report 2019

However, regarding the remaining 10 ingredients, CTFA proposed a five-year deferment period from the final rule for the ingredients to remain on the market, as the additional data is generated to demonstrate that they are GRASE based on the specific criterion per the FDA with regular updates to the regulatory agency. Furthermore, it was proposed that the FDA expands its list of UV filters to harmonize with the EU and other countries to above the 12 proposed Category III as GRASE on its sunscreen monograph. - FDA Proposal 2: Proposed Requirements Related to Dosage Forms: It was stated that “powders are proposed to be eligible for inclusion in the monograph. Additional data in the form of particle size restrictions if found to be GRASE are requested before powders can be included in the monograph”. To this, CTFA commented that in South Africa, powders are included as a form of sunscreen that is GRASE (for example make-up products). The exclusion of powders will prevent South African sunscreen products from being exported to the USA. Therefore, it was proposed that powders be included as a GRASE sunscreen form irrespective of particle size as they play an important role in make-up products which serve to protect the consumer from the harmful UV rays in a different product category, which adds to product innovation and efficacy aimed at consumer safety benefits. - FDA Proposal 3: Proposed Maximum Sun Protection Factor and Bro ad-Spectrum Requirements: The proposal was to “raise the maximum proposed SPF value on sunscreen labels from SPF 50+ to SPF 60+. CTFA commented that products with SPF limits higher than 50+ will not be permitted on the South African market. Therefore, CTFA proposed that the FDA align with the EU’s capping limit of 50+, in order to avoid a potential barrier to trade for US labelled sunscreens. - FDA Proposal 4: Proposed Principal Display (PDP) Labelling Requirements: It was proposed that “new sunscreen product label requirements to assist consumers in more easily identifying key information, including the addition of the active ingredients on the front of the packaging. To bring sunscreen in line with other OTC drugs; a notification on the front label for consumers to read the skin cancer/ skin aging alert for sunscreens that have not been shown to help prevent skin cancer; and revised formats for SPF, broad spectrum and water resistance statements”. CTFA commented that phrases such as “Drug Facts” and “Active Ingredients” are misleading and often causes issues at the South African ports of entry. The Port authorities regard such products imported from the US labelled as “medicines”, although they may be cosmetics. This causes delays in the availability of the product, and thus loss in revenue. - FDA Proposal 5: Proposed Requirements Related to Final Formulation Testing Processes and Recordkeeping: The proposal was to “clarify FDA’s expectations for testing and record keeping by entities that conduct sunscreen testing to ensure that the FDA can assess industry compliance with regulations. CTFA commented that inferred FDA test site registration would not be advised as an option as this may have the unintended consequence of systematically excluding test sites outside the regulatory jurisdiction of the FDA. COSMETIC TOILETRY AND FRAGRANCE ASSOCIATION OF SOUTH AFRICA 11