New Raw Materials - KKT Expert Talk (Part Three)

Environmental aspects of cosmetic UV filters in
sunscreens

Cosmetic UV filters are the active ingredients of sunscreens and protect people from skin damage and ageing. Several UVA, UVB or broadband UV filters of organic or inorganic origin are usually used to cover the required UV spectrum and sun protection factor (SPF). In this context, functional properties, i.e. certain physico-chemical properties, trigger possible critical environmental properties (e.g. bioaccumulation, chronic aquatic toxicity, biodegradability), which in turn require additional investigations in the relevant areas. As UV filters can be directly introduced into water bodies through various recreational activities such as swimming, snorkelling or diving, they are often caught between the benefits to humans and possible environmental effects. In Europe, UV filters as cosmetic ingredients must be evaluated for consumer safety by the Scientific Committee on Consumer Safety (SCCS). The occupational and environmental safety assessment is carried out under the EU REACH legislation. The amount of data required depends on the tonnage and increases with the annual production volume. At the end of this assessment, if a hazardous property (“hazard”) of the substance is present, a risk assessment is performed, comparing derived effect limits based on standard tests with expected/measured environmental concentrations. Specifically for cosmetic UV filters, BASF has developed the EcoSun Pass, an assessment tool that combines environmental properties with functional aspects (absorption efficiency) to enable product selection towards more environmentally friendly UV filters in sunscreens. To better assess the potential impact of UV filters on corals, raw material producers, cosmetic product manufacturers and other scientists, such as universities, are working together to develop standardised test methods. The aim is to initiate a transparent regulatory process, which is currently lacking due to a lack of methods and measurement data. 

Legal requirements for a 
new raw material

According to the European Cosmetics Regulation (EC) 1223/2009, cosmetic products must be safe when used as intended and in a reasonably foreseeable manner. For this reason, by law, a safety assessment must be carried out for each cosmetic product before it can be placed on the market. This also includes the safety assessment of cosmetic raw materials.

In addition, cosmetic raw materials are also subject to chemical regulations, such as REACH, which must be fulfilled.

Especially in toxicological and regulatory raw material assessment, the differences between (chemical) substances, INCI components and raw materials have to be taken into account. While substances are clearly defined by their intrinsic physico-chemical and toxicological properties, apparently identical INCI components or raw materials can sometimes differ significantly in their properties. This may be due to differences in the origin of the raw materials, the manufacturing process, the purification or the composition of the raw materials. In contrast to substances, INCI components and raw materials must therefore be checked and evaluated very carefully with regards to their origin, their degree of purity and, consequently, their impurities.

In particular, impurities in cosmetic raw materials are often prohibited substances such as heavy metals, polycyclic aromatic hydrocarbon compounds or intermediates from the manufacturing process, which, according to Article 17 of the EU Cosmetics Regulation, may only be present in cosmetic products in trace amounts if they can be 

shown to be technically unavoidable and safe. However, a large number of non-prohibited substances, such as unregulated CMRs, mycotoxins, pesticides, monomers or botanical ingredients, can also have a lasting effect on, or in some cases determine, the toxicological properties of INCI ingredients and cosmetic raw materials. 

Manufacturers of cosmetic raw materials are therefore faced with the challenge of producing suitable raw materials for cosmetic products that meet both the chemical-legal requirements and the specifications of the EU Cosmetics Regulation. The task of the safety assessor is to check whether the cosmetic raw materials comply with the legal requirements for cosmetics with regard to their composition (their ingredients, INCI components, substances) and their purity and whether their use in cosmetic products is toxicologically safe and harmless for human health.