Safety of cosmetic products: Regulatory aspects

Modern cosmetic products must meet quality standards and expectations for the cosmetic effects, but above all must be safe for use. Regulation (EC) 1223/2009 on cosmetics, which with some articles entered into force on January 2010, has set as a condition for placing cosmetic products on the market, evidence of its safety for consumers, when applied under normal and foreseeable conditions of use. When applying cosmetics products may cause a penetration of product ingredients through the skin and the occurrence of undesired side effects. For certain individuals, these products may cause local adverse reactions after (during) application (irritation, allergy or hypersensitivity skin, phototoxity), and the safety assessment of cosmetic products prior to marketing, is very important part in premarketing stages of product development, which is particularly emphasized in Annex I to Regulation (EC) 1223/2009 on cosmetics. Safety Assessment of cosmetic products in the EU is based on an assessment of safety of each ingredient individually, primarily on assessment of toxicological profiles of raw (materials) and finished cosmetic products, and should be performed by qualified person. Until recently, the safety assessment was based mainly on animal testing, but the current legislation in the EU limit this type of testing. Therefore, alternative methods are used in the toxicity of cosmetic raw materials and products, all of which have their opinions validated alternative methods. It is alleged that the cosmetic industry should promote the use and implementation of alternative methods, in all areas in which they offer the same level of consumer protection, as the application of animal testing, in accordance with paragraph 40 of the Regulation. In Article 16 of Regulation (EC) 1223/2009, there are requirements regarding the application of nanomaterials in cosmetic products, and time limits for the period from 2010 by 2018 related to nanomaterials in cosmetic products. Article 18 of Regulation 1223/2009 states the necessity of toxicity testing of substances profiles that are included in the composition of cosmetic products. Special emphasis is placed on local toxicity evaluation (skin and eye irritation), skin sensitization, and fotoinduced toxicity. This paper presents recent data, taken up from the relevant sources related to the safety assessment of cosmetic raw materials, such as hair dyes, UV filters, perfumes, preservatives, surfactants, vegetable raw materials and antiperspirants.