PRESERVATIVES
The end of the road for
free-from claims
Preservatives are essential to ensure an adequate shelf-life for cosmetic products as well as product and consumer safety during use. Yet these ingredients have in recent times faced scrutiny by consumer advocacy groups worldwide based on the belief of their potential safety risks that they pose to the consumer. Dershana Jackison explores compliance in the local context when it comes to formulating with preservatives.
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cientific studies have been undertaken internationally to determine the safety and use levels of preservatives. Based on these studies, regulators around the globe have devised annexes of permitted preservatives to cosmetic regulations
preservatives allowed for use in cosmetics, appearing in the regulation, is complied with to ensure product and consumer safety. This annex provides permitted preservatives as well as their specific maximum use levels for different product applications. Referencing
been proactively preparing the industry for the imminent changes to promote alignment with international best practice.
including the South African National Department of Health’s draft Regulations relating to labelling, advertising and composition of cosmetics, R. 1469, 22 December 2017. For local product compliance, it is imperative that the Annex IV List of
and complying with this list will ensure compliance to the draft regulations and the development of safe cosmetic products from a preservative ingredient perspective.
by CTFA to include new and/or amended entries in the Journal of the European Union. These updates are included in the CTFA Cosmetic Compendium and are accompanied by a transition period to allow industry a reasonable time period to comply to the imminent regulatory updates. It is important to note that these updates are also informed to the national regulator in an effort to keep the local draft regulations aligned to the EU regulations, which continue to form the premise for local regulations. In addition to complying with Annex IV of the draft regulations, it is the responsibility of the brand owner or manufacturer to ensure that the preservative used is efficacious in protecting the product from contamination during use and throughout it’s shelf life. This is established through a preservative efficacy test or a challenge test, as it is better known. Only products that pass this test qualify to be placed on the market. These test results may be included in the product information file to support the safety assessment report requirement of the draft regulations.
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AVOID NON-CONTENT CLAIMS
As a result of the scrutiny mentioned, advertising campaigns have jumped onto the ‘free-from’ Protect your movement. Such formulations claims are not with permitted in many cosmetic parts of the world, preservatives especially where from the safety and level of use of such ISCA UK, preservatives has proudly been scientifically distributed in substantiated. This South Africa type of advertising is by Chempack also denigrating and Industries. is not permitted in South Africa by virtue of the Advertising Regulatory Board’s (ARB) Advertising Code of Practice. In 2021, the cosmetic industry can anticipate specific updates within the ARB’s Appendix B- Cosmetic code to address local Chempack Industries | Contact: Linda Thieme | guidelines on free600 0167 / 064 610 2736 | Email: linda@cpack.co.za | from claims. CTFA Website: www.cpack.co.za has for the last year,
FEBRUARY 2021 // WWW.PHARMACOS.CO.ZA
DO THE NECESSARY TESTING On an annual basis the Annexes are updated
GET THE INCI RIGHT In terms of the ingredient listing of preservatives, this is to follow the requirements as stipulated in the local regulations guided by the South African National Standard, SANS 98: 2012 Ingredient labelling of cosmetic products. This standard is available on the CTFA website for members or can be purchased from the South African Bureau of Standards (SABS). • CTFA – www.ctfa.co.za
