Experiences and Statistical Evaluation of Serious Undesirable Effects of Cosmetic Products in the EU

Abstract

The Council of Europe created an outline for a vigilant system of undesirable effects of cosmetic products in 2006. In 2013, some of those aspects were included in the European Cosmetics Regulation (EC) 1223/2009. Since then, serious undesirable effects (SUEs), which are the tip of the iceberg of all undesirable effects of cosmetic products, have to be reported to competent authorities. Neglecting the first phase of establishing the system, we have about two years of experience regarding the notification of SUEs. This notification system is based on a huge amount of cases that allow us to identify occurring problems at an early stage through a signal of increased reported cases for a certain product. It has already been shown that the system is able to identify products that have the potential to cause health risks even if they seem to comply with the legal requirements and the safeguard clause was applied. Until May 2016, 680 cases of SUEs were shared in the EU. The statistics of SUEs indicate that hair dyes and skin care products are the product types that cause the most SUEs. Almost 80% of all SUEs occurred in the head area, especially the skin of the face was affected.

Contact allergy to hair-colouring products: a cosmetovigilance follow-up study by four companies in Europe from 2014 to 2017

“…Since 2013, cosmetic companies are obliged to notify all reported SUEs, except those with causality assessment "excluded" to the competent Authorities. The first statistical analysis of SUEs reported in the European Union (2014-2015) showed that hair-colouring and skin-care products stand out regarding the number of cases and the seriousness criterion leading to hospitalization [16].…”

Why is there a need for cosmetics safety risk assessment?

“…u frizerskom salonu. U 74% svih slučajeva povezanost između izlaganja kozmetičkom proizvodu i pojave ozbiljnih neželjenih efekata se pokazala "verovatnom" ili "vrlo verovatnom" [15]. U najvećem broju slučajeva posledice su bile privremena sprečenost za rad, u 26% slučajeva bila je neophodna hospitalizacija, npr.…”

“…Registrovana su dva smrtna slučaja, po jedan nakon primene farbe za kosu i proizvoda za negu kože. U pogledu identifikovanih SUEs većinom su bili prijavljeni kontaktni alergijski dermatitisi (34,4%) ili iritacija kože (3,8%), dok se u 6,3% slučajeva radilo o sistemskom efektu i pojavi anafilaktičkog šoka [15]. Autori ističu da je malo ovih reakcija potvrđeno od strane medicinskog osoblja, te je moguća prijava i lažnih reakcija.…”

“…Međutim, smrtni ishod nije isključen, budući da se nakon primene kozmetičkog proizvoda može javiti anafilaktički šok, koji neposredno ugrožava život i može uzrokovati letalitet. Potvrda ozbiljnog neželjenog efekta za neki kozmetički proizvod ne znači nužno ozbiljan rizik [15]. U nekim slučajevima, kompanije su na dobrovoljnoj osnovi preduzele mere za zamenu supstance u proizvodu, npr.…”

Cosmetovigilance in a tertiary care hospital: A prospective observational study

“…The statistics also found that hair dyes skin care products were most commonly implicated in SUEs. 9 In retrospective study conducted over a period of 5 years in the Netherlands reported itching (70.9%), burning sensation (50%), and dryness of skin (63.3%) as the most common adverse events. 10 Dermatitis caused by kumkum and hair dye is prevalent in India.…”