Most countries worldwide nowadays have cosmetics legislation in place; some regulatory frameworks were implemented or amended only recently.
The laws are addressing the safety of the consumers in use of the products. Legal tools applied include prohibiting or restricting certain ingredients with toxicological effects for humans, such as allergenic, carcinogenic, or irritating properties, etc. Further pre-market requirements to be performed by the manufacturers are product safety assessments, labeling, GMP production, notification, etc. Usually, competent authorities in the countries follow up on products’ compliance with the laws by performing in-market control of products on the shelves. As such, a very good safety standard for users of cosmetics was achieved.
Yet, the cosmetics regulatory frameworks are not looking into the environmental aspects of cosmetic products. Obviously, the cosmetic ingredients after use are discharged into the sewage system and ideally are captured in sewage treatment plants; but they can also be found in the environment, in the aquatic systems like lakes, oceans, rivers and in the soil. Potential risks may include toxicity to aquatic organisms, flora and fauna, e.g. endocrine disrupting activities, as well as bioaccumulation, etc. Cosmetics packaging contributes to microplastics and packaging waste in the oceans, which causes serious or 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 risks of chemicals, substance by substance, while recognizing that the total exposure to a single chemical can result from different sources. During the registration step 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 proved to possess hazardous properties, further evaluation may lead to authorization requirements or to a restriction, so to protect humans and the environment from unacceptable risks posed by chemicals. Restrictions are normally leading to limitation or banning the manufacture, the marketing or the use of a substance. For cosmetic, 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 very bioaccumulative (vPvB) substance and D5 meets the criteria for a vPvB substance. In consequence, in Europe environmental safety of cosmetics ingredients is not only a goal for the industry, but legislation is in place, which addresses the environmental properties of cosmetic ingredients systematically and similarly as human safety is addressed under the EU’s cosmetics regulation. And the REACH regulation provides now for a list of chemicals restricted in cosmetic products for environmental reasons. This list is to be applied similarly to those lists contained as annexes to the cosmetic products regulation, which regulate substances based on human health concerns.
Dr. Annelie Struessmann will host a presentation on Regulatory updates from ASEAN, China and EU, on 31st October, 15.55-17.55, Visit in-cosmetics Asia for more information
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