Why is there a need for cosmetics safety risk assessment?

• Main Authors: Đukić-Ćosić Danijela, Antonijević Biljana
• Format: Article
• Language: srp
• Published: Pharmaceutical Association of Serbia, Belgrade, Serbia 2018-01-01
• Series: Arhiv za farmaciju
• Subjects: cosmetic product; safety assessment; human health risk assessment; regulation (ec) 1223/2009
• Online Access: https://scindeks-clanci.ceon.rs/data/pdf/0004-1963/2018/0004-19631805971D.pdf

Bearing in mind that cosmetic products are applied throughout the lifetime and that they can contain potentially harmful and toxic substances, valid EU regulation in this area has set strict requirements regarding their safety. Manufacturers are required to provide a cosmetic product safety report containing a toxicological assessment made by experts. Toxicological assessment is based on existing in vivo toxicological data, and in particular in silico and in vitro, since EU regulations in the field of cosmetic products prohibit new animal studies. Although sporadic cases of serious poisoning after the application of cosmetic products have been recorded, adverse effects after normal and reasonably foreseeable use of cosmetic products are usually mild (allergic reactions and skin irritation) and completely reversible. EU regulations require mandatory reporting of serious adverse effects (functional incapacity, hospitalization, disability, etc.) in order to detect ingredients of cosmetic products that potentially endanger human health and prevent similar effects from recurred. The paper describes the procedure of toxicological risk assessment for cosmetic ingredients because the assessment of the safety of the cosmetic product is based on the assessment of the safety of its ingredients.