Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Sunscreen products - drug or cosmetics? A Comparison of the legal requirements for sunscreen products in Europe, Australia and United States ***

Claudia Engeler-Plischka (Abschlußjahr: 2014)

Summary
Sunscreen products have a long history, dating back to era of the Egypt’s. Sun protection was already important at that time. Since then, sunscreen products have been further developed, while the scientific knowledge about the different UV rays and its effects on the skin has also been investigated. Sun exposure can lead to sunburn, skin ageing and skin cancer. Sunscreen products and other factors play an important role in the prevention of skin cancer. How are sunscreen products regulated in Europe, Australia and Unites States? Is it a cosmetic or a drug?
In Europe, sunscreen products are regulated as cosmetic products. Therefore, a notification is required before a cosmetic product can be put on the market. In Australia, sunscreen products are regulated as therapeutic sunscreen products and cosmetic sunscreen products, the former of which are divided into primary, secondary and exempt sunscreen products and must be listed or registered by the TGA. The Therapeutic Goods Administration (TGA) is responsible for therapeutic sunscreen products and the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) is responsible for the cosmetic products. All the chemical ingredients of the cosmetic sunscreen product have to be registered by NICNAS. The Australian Competition & Consumer Commission (ACCC) is responsible for the labelling of all cosmetic products. The cosmetic sunscreen products are divided into make-up and skin care products and are also called “excluded sunscreen products”. In the United States, sunscreen products are regulated as Over-The-Counter (OTC) sunscreen products without an approved application and the FDA is the responsible authority. Before an OTC sunscreen product can be put on the market, a registration or listing is required. At present, an OTC monograph for sunscreen products is available, although it has not come into force since it was first published. The reason for this is that FDA is collecting further information, which should be included into the OTC monograph in the future. In the meantime, the current enforcement policy will be continued until the OTC monograph becomes effective.
The three different frameworks of Europe, Australia and the United States show a conformity within the principal requirements. The testing procedures of SPF, water resistant, broad spectrum, stability are similar or identical, based upon the international harmonisation of the testing procedures. Australia is the only country with a Sunscreen Standard, citing all testing procedures and labelling claims.
The use of nanoparticles is also very common in sunscreen products. Not only is the safety of therapeutic sunscreen products or OTC sunscreen products evaluated accurately, but also the safety of cosmetic sunscreen products. The reporting of adverse events or serious adverse events is mandatory for both cosmetic sunscreen products and therapeutic or OTC sunscreen products. The quality of sunscreen products also has to be assured, which guaranteed by the GMP requirements for cosmetic sunscreen products, therapeutic sunscreen products and OTC sunscreen products. The requirements for cosmetics are quite high and thus there is not a significant difference with the GMP requirements for therapeutic sunscreen products and OTC sunscreen products.
The most differences can be found in the labelling of the sunscreen products. The protection level of the SPF is the same for all three regions: low, medium, high, very high. In all three regions, the highest value for SPF claims is SPF 50+. In Europe, the labelling of UVA/UVB is common, whereas in Australia and the United States the term broad spectrum is used. In Europe, the claims water resistant and very water resistant are used, whereas the claims in Australia are water resistant up to two hours and water resistant up to four hours. In the United States, the term water resistant (40 minutes) or water resistant (80 minutes) are common.
Finally, sunscreen products are regulated differently in Europe, Australia and United States, although the commonalties outweigh the differences. Cosmetic sunscreen products are comparable with therapeutic sunscreen products or OTC sunscreen products.