The term appears on shampoo bottles, cream tubes and make-up jars: “dermatologically tested”. Also other designations such as “clinically tested” or “tested for harmful substances” often lead to the assumption that the product is safe for sensitive people. But the term “dermatologically tested” initially only says that the product was tested in the presence of a dermatologist – but nothing about the testing procedure, the independence of the testers or the scientific recording of the tests.
Strict self-monitoring
Of course, “dermatologically tested” is not just wastepaper. On the contrary, established manufacturers and pharmaceutical producers subject their products to the most stringent testing at all stages of development. This includes the scientifically based design of the test arrangement, the documentation as well as the exact and traceable test itself. Test series with patients are carried out at university skin clinics.
Test series in several test centers and under the supervision of different dermatologists help to compensate for any country-specific differences. Many pharmaceutical companies have their own ethics committees that deal with the development of tests, the scientific conduct of the tests and even the development of equipment for these tests. At the same time, hardly any tests are performed on animals. Numerous dermatological tests are performed on skin cells in the reagent glass.
Monitoring guidelines for the manufacturing process
Meanwhile, there are several so-called GMP guidelines for the entire European area. GMP is the abbreviation for “Good Manufacturing Practice”. Within this regulation, the production of active ingredients is also regulated worldwide.
If an active ingredient is to be manufactured or used for a drug product, it should be manufactured in accordance with these guidelines. The guideline specifies requirements for personnel, quality management, packaging and labeling, storage and distribution, and distributors. However, there is currently no applicable regulation for monitoring active ingredient manufacturers in Europe, so compliance with this directive is largely voluntary.
Ingredients must be labeled
The labeling of ingredients themselves is determined by EU directives, which are intended to provide greater clarity for consumers when purchasing cosmetics. All ingredients are labeled with so-called INCI numbers. The “International Nomenclature of Cosmetic Ingredients” (INCI) has brought about a standardization of terms throughout Europe.
So if you buy your makeup in France, you can identify colorants, for example, by their INCI number. Although deciphering the numbers still remains complicated enough for the layman, this regulation is particularly important for allergy sufferers.
Risk assessment through labeling
Dermatologists and dermatology clinics track allergy cases very closely. If a substance stands out because of increased allergy incidence, it is closely examined. Many cosmetic dyes are included in the so-called Blue List, which contains a total of four allergy classifications. The numbers 0-4 indicate whether and how frequently allergic reactions have occurred. This classification is assigned to the individual substances with their INCI numbers.
The dye CI 40 800, for example, is beta-carotene, the orange dye from the carrot. Its allergy class is 0: allergies are therefore unknown or extremely rare. This makes it easy to determine whether a particular dye carries a higher allergy risk than another. Allergy sufferers should therefore have the corresponding INCI numbers entered in their allergy passport.
Anyone who wants to know exactly what is behind the term “dermatologically tested” on their shampoo bottle should contact the manufacturer and ask for proof. If this request is refused, it may be worth calling the consumer advice center. One should refrain from buying dermatological products at the door: Even if they are offered as particularly inexpensive natural products, one usually learns little about ingredients and test methods.
