11 minute read
All you need to know about cruelty-free testing, microplastics and cannabis in cosmetics
Regulations are implemented to ensure fair business practices and to protect consumers and the environment. In the South African cosmetics industry, business has been self-regulated for over 26 years premised on the EU regulations, EC 1223/2009. The past two years have seen some significant developments in terms of cosmetic ingredient safety information, product testing and the use of cannabis as an ingredient in cosmetics. Dershana Jackison, CTFA’s head of policy and regulatory affairs, unpacks these developments from a local perspective.
Several common ingredients or groups of chemicals are under review by the European Chemicals Agency (ECHA) via REACH, including cyclic siloxanes D4/D5/D6. Cyclic volatile methyl siloxane (cVMS) includes the cyclosiloxanes octamethylcyclotetrasiloxane (D4), decamethylcyclopentasiloxane (D5), and dodecamethylcyclohexasiloxane (D6) which have four, five and six siloxane groups, respectively. D5 and D6 function as emollients, hair and skin conditioning ingredients and solvents in cosmetics. They find application in rinse-off (hair conditioner) and leave-on products (skin care, personal deodorants and colour cosmetics).
In the EU, the cosmetic Regulation (EC) No. 1223/2009 include restrictions for the use of D4 and D5 in rinse-off applications. This restriction entered into force on 30 January 2018 and applied to all products placed on the EU market from 31 January 2020.
The new proposed restriction will apply to all leave-on applications and will extend the rinse-off restriction to D6 as well.
How does this affect local products exported to the EU? The proposed transition period is five years from publication of the amending regulation to allow brand owners and manufacturers to reformulate their products and avoid the cost of writing off raw ingredient and packaging inventory. It is important to note that these cVMS may be present in cosmetic products as impurities of silicone polymers, which must be considered during the review of existing cosmetic formulations in order to comply.¹
Within the self-regulated framework, the Cosmetic Toiletry & Fragrance Association of South Africa (CTFA) will include the EU updates in its next annual update of the Cosmetic Compendium in 2022. This amendment will have an associated transition period to be confirmed at the time of the update.
MICROPLASTICS
The WWF describes the problem of microplastics being everywhere – in our oceans, on land, in rivers, wetlands and soil, and in the air. The NGO also suggests that it will take a concerted effort from various stakeholders including governments, businesses, scientists and individuals to fix this pervasive problem.
In a WWF Plastic File article posted online, the NGO states: “As with larger pieces of plastic, there is evidence of damage to marine animals from microplastics, particularly by filter feeders such as zooplankton that ingest them. This is of major concern because plankton is critical for marine food chains and help to remove carbon dioxide from Earth’s atmosphere. Research has found that at least 220 marine species have been known to ingest microplastics, most often because they are mistaken for food. While some animals can excrete the plastics, a number of them can’t. Once ingested, these small nonnutritious plastic bits fill up the stomachs of marine mammals and sea birds, which can cause death by starvation through damage or obstruction to the gut.”²
According to ECHA, microplastics accumulate in animals, including fish and shellfish, and are consequently also consumed as food by humans. Microplastics have been found in marine, freshwater and terrestrial ecosystems as well as in food and drinking water. Their continued release contributes to permanent pollution of our ecosystems and food chains. Exposure to microplastics in laboratory studies has been linked to a range of negative (eco)toxic and physical effects on living organisms.³
A WORLD VIEW
Many countries across the globe have implemented a ban on microplastics. These include Canada, France, New Zealand, Sweden, Taiwan, the United Kingdom, and the United States. Some countries have already started drafting legislation to ban microplastics. Several EU member states have already enacted or proposed national bans on the intentional use of microplastics in consumer products. The bans concern mainly uses of microbeads in rinse-off cosmetics, where the microplastics are used as exfoliating agents. Microplastics are also used as glitters or in makeup.
Prompted by these concerns, in 2017 the European Commission requested ECHA to assess scientific evidence and prepare a restriction dossier under the REACH Regulation targeting the intentional addition of microplastics in products such as cosmetics. One of the many reasons why the agency concluded it necessary to restrict microplastic ingredients under REACH, is because microplastics accumulate and persist in the environment. Following ECHA’s opinion, the EC has proposed the amendment of the list of substances under Annex XVII of REACH. This proposal is due to be submitted to a vote by the EU member states in the REACH Committee. Member state governments will vote in 2021 and a final law is expected to come into force in early 2022.⁴
WHAT IS SOUTH AFRICA’S POSITION?
In November 2019, the Department of Forestry, Fishery and Environment (DFFE) hosted the Plastics Colloquium where Minister Barbara Creecy addressed the forum. Creecy mentioned that microplastics are of major concern in SA and described them as “examples of where end-of-life considerations did not influence product design resulting in the regulator needing to exercise regulatory powers to phase out or restrict the use of the material. The South African Health Products Regulatory Authority is considering the revision of the cosmetics regulations; meanwhile SABS and DTI are working on standards.”⁵
Being a proponent of environmental safety, since 2018 CTFA has recommended to all its members to discontinue the use of plastic microbeads in wash-off products by 2020. This was initiated even though the potential contribution of microbeads from exfoliating rinse-off products to overall environmental microplastic pollution is minute.
CTFA has also been collaborating with the DFFE by providing input on impact assessment studies and engaging with the cosmetic regulator on the matter. This involved industry surveys carried out in 2018 and 2019 to assess the reduction in use of microbeads by the South African cosmetics industry. This bears testament to the initiative taken by individual companies and underlines the industry’s voluntary action to transition to microplasticfree cosmetic products. Through CTFA’s continued engagement with the relevant regulators, the industry can expect legislation which will prohibit the use of microplastics in the near future, with specific timelines for the phase-out.
CRUELTY-FREE TESTING AN IMMINENT REALITY
In recent years, advocacy campaigns for nonanimal methods to test cosmetic products have gained traction, drawing the attention of consumers, industry players, regulators and industry associations to the significance of the matter.
All affected stakeholders have a distinct and defined role to play in this evolving trend. Consumers create and drive market trends such as natural cosmetics, clean label, environmental and animal considerations, and veganism etc. Regulatory authorities around the globe are waking up to the anticipation and compulsion from consumers and advocacy groups to include a total ban on animal testing for cosmetic ingredients and products. Reforms in emergent regulatory jurisdictions are predicated on international regulatory trends and best practices.
Traditionally, animal testing was the accepted primary and sole means of assessing the safety of ingredients. Over the years, data has been collated for reference by regulators as a precursor to developing regulations that will ensure product and consumer safety. With the advent of greater technological advances in testing capabilities and scientific advancement, experts are continuously researching and developing alternative methods to assess the safety of cosmetic ingredients and products.
Progressive regulatory reform around non-animal testing in regions like the European Union, the US and Canada, have laid the premise for a global paradigm shift in safety assessments. These countries have made reasonable transitions that will enable continued innovation within the cosmetics industry as well as eliminate the need for animal testing to assess the safety of products. For example, the European Commission (EC) specifically established a testing ban which placed a prohibition on testing finished cosmetic products and cosmetic ingredients on animals and a marketing ban which placed a prohibition on marketing finished cosmetic products and ingredients in the EU which were tested on animals. The testing ban on finished cosmetic products came into effect on 11 September 2004. The testing ban on ingredients or a combination of ingredients came into effect on 11 March 2009. The marketing ban applied since 11 March 2009 for all human health effects with the exception of repeated-dose toxicity, reproductive toxicity, and toxicokinetics. For these specific health effects, the marketing ban applied since 11 March 2013, irrespective of the availability of alternative non-animal test methods.⁶
This approach was informed through an impact assessment carried out by the EC as well as targeted stakeholder engagements. The resultant transition period considered that in order to comply, industry members would require time to exhaust their current raw ingredient stock and packaging inventory and to redesign their product formulations. Most importantly, this approach ensured a continued supply of many essential cosmetics for consumers.
Regulators, scientists and industry members continue to collaborate to make alternative cruelty-free assessment methods available to facilitate continued growth and innovation within the cosmetics industry. Some methods have already been internationally validated and have found application in countries across the globe, enabling and enhancing international trade.
LOCAL DEVELOPMENTS
In South Africa, the Department of Land Reform and Rural Development is the custodian of the Animal Protection Act, 1962. An amendment to this act was proposed in 2017 by the publishing of the Animal Protection Amendment Bill, in Notice 942 of 2017 and then again in Government Gazette No. 43702 of 11 September 2020.
As the industry association representing more than 80% of the industry, CTFA fully supports the proposed ban and has made submissions to the department, highlighting industry concerns for consideration on the proposed amendments:
• the non-adherence to the national parliamentary process in the approach of the proposal to the amendment of the said Act
• the National Department of Health is the regulator of the cosmetics industry and as such should be consulted prior to considering amendments which will directly impact the regulatory oversight of the cosmetics industry
• the regulations should be reflected in the appropriate legislation relevant to the cosmetics industry
• in line with international regulatory practice, a similar, reasonable approach to the institution of the ban is advised which will ensure that an already economically strained industry is given a transition period to comply.
The Parliamentary Committee is due to meet on the matter in Q3 of 2021. CTFA is keeping a close eye on this development and will be publishing communications in this regard.
CANNABIS IN COSMETICS
The trend of cannabis-based consumer products is growing even in the cosmetics industry. In recent years, the National Department of Health published legislation with the objective to improve regulations on the use of cannabis in medicines, complementary medicines and processed products (food and cosmetic products).
On 23 May 2019, the Minister of Health excluded cannabidiol (CBD) from the Schedules of the Medicines and Related Substances Act, 1965 (Act no. 101 of 1965), for a period of 12 months, under restricted conditions, in the exclusion notice R.756 published in Government Gazette No.42477. Since the expiry of this exemption notice, on 22 May 2020 the Minister of Health issued the amended schedules under restricted conditions in Government Notice No. 586 in the Government Gazette No. 43347, as follows:
1. previous entries for cannabis, dronabinol and tetrahydrocannabinol in Schedule 7 have been deleted
2. CBD is listed in Schedule 4, except:
• processed products made from cannabis raw plant material intended for ingestion containing 0.0075% or less of CBD where only the naturally occurring quantity of cannabinoids found in the source material are contained in the product. Those products that meet the listed conditions will instead be regulated as Schedule 0
3. (-)-transdelta-9-tetrahydrocannabinol (THC) is listed in Schedule 6, except processed products made from cannabis containing 0.001% or less of tetrahydrocannabinol.⁷
WHAT DOES THIS MEAN FOR COSMETICS?
CBD-containing processed products intended for ingestion or for use as cosmetics, which make no pharmacological or medicinal claim and is approved for use in terms of the relevant legislation, is excluded from having to be registered as a medicine provided it is approved for such use.
Cannabis cosmetics that are permitted contain the cannabis raw plant material with naturally occurring trace elements of CBD up to a maximum concentration of 0.0075% and less than 0.001% of THC. Cold-pressed hemp seed oil has been cited as an example of a source of the material that is permissible.
In addition, the regulator will require that the levels of CBD and THC be verified in the final product. Furthermore, manufacturers and importers of CBD-containing processed products that respect the above requirement and do not make any medicinal claims do not require a license to manufacture or import in terms of Section 22c of the Medicines and Related Substances Act, 1965 (Act no. 101 of 1965). •
CTFA – www.ctfa.co.za
REFERENCES:
1. Exponent.com 2. www.wwf.org.za/plastic_files/?26141/plastic-file-03 3. echa.europe.eu 4. https://echa.europa.eu/hot-topics/microplastics 5. www.environment.gov.za 6. https://ec.europa.eu/ 7. THC and CBD Information, SAHPRA, 2021
