By Dr. Annelie Struessmann
Although most countries around the world have cosmetics legislation in place; some regulatory frameworks have only been implemented or amended in recent years. These laws are designed to safeguard consumers and ensure the use of cosmetic products do not carry a risk of harm. This often includes prohibiting or restricting certain ingredients with toxicological effects for humans, such as allergenic, carcinogenic, or irritating properties, etc.
While local authorities are implementing such laws, manufacturers are also responsible for ensuring pre-market requirements are fulfilled from product safety assessments and suitable labeling to GMP production and notification. Usually, competent local authorities will follow up on each products’ compliance, ensuring only authorised products are available to consumers. As such, a very good safety standard for users of cosmetics has so far been achieved.
However, the cosmetics regulatory frameworks are still not consistently addressing the environmental impact of cosmetic products. Cosmetic ingredients after use are often discharged into the sewage system where they are hopefully, captured in sewage treatment plants; but research shows they can be found in the environment, in aquatic systems like lakes, oceans, rivers as well as in soil. The potential risk of such contamination may include toxicity to aquatic organisms, flora and fauna, e.g. endocrine disrupting activities, as well as bioaccumulation, etc. Cosmetics packaging also contributes to microplastics and packaging waste in the oceans, which can cause serious and fatal effects for the aquatic life and for sea birds.
In Europe, cosmetic ingredients are falling under the scope of the chemicals legislation, Regulation (EC) No 1907/2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). REACH addresses human and environmental hazards and the risks of chemicals, substance by substance, while recognising that the total exposure to a single chemical can result from different sources. During the registration process under REACH, information on intrinsic properties and uses of substances are gathered as well as exposure criteria and potential risks to humans and the environment. When a substance has been proven to possess hazardous properties, further evaluation may lead to additional authorisation requirements or to a product restriction to protect humans and the environment from unacceptable risks posed by chemicals. For cosmetics, only the environmental concerns for ingredients are considered under this regulation.
Recently, the European Chemicals Agency restricted, for the first time, two substances for use as cosmetic ingredient. The restriction applies to Octamethylcyclotetrasiloxane (D4) and to Decamethylcyclopentasiloxane (D5) in wash-off personal care products in the EU. All wash-off products are not allowed to contain more than 0.1% of D4 or more than 0.1% of D5. The reason for the restriction is that D4 meets the criteria for identification as a persistent, bioaccumulative and toxic (PBT) and very persistent bioaccumulative (vPvB) substance and D5 meets the criteria for a vPvB substance. The restriction of this substance in Europe demonstrates the importance of the environmental safety of cosmetics ingredients . Here, important legislation is in place, which addresses the environmental properties of cosmetic ingredients systematically while human safety is addressed under the EU’s cosmetics regulation. The REACH regulations also provides a list of chemicals restricted in cosmetic products for environmental reasons. The next step will see this list combined with existing annexes to enhance the cosmetic products regulation, which looks to control substances based on human health concerns.
Dr. Annelie Struessmann will host a presentation at in-cosmetics Asia on Regulatory updates from ASEAN, China and EU, on 31st October, 15.55-17.55. Register online for free entry.