{"id":2952,"date":"2017-07-06T09:48:43","date_gmt":"2017-07-06T08:48:43","guid":{"rendered":"https:\/\/mcamps.com\/?p=2952"},"modified":"2017-07-11T12:16:43","modified_gmt":"2017-07-11T11:16:43","slug":"dosier-de-seguridad-evaluacion","status":"publish","type":"post","link":"https:\/\/mcamps.com\/eng\/dosier-de-seguridad-evaluacion\/","title":{"rendered":"Does a change of composition require a reassessment of the Security Dossier?"},"content":{"rendered":"

Cosmetic Product Safety Dossier<\/strong> - The toxic potential of a cosmetic product<\/strong> depends fundamentally on its composition, i.e. on the toxicological profile<\/strong> characteristic of each of the substances or mixtures of which it is composed. And, obviously, of the quantity present of each of them.<\/p>\n

When carrying out the assessment of the safety documentation of a cosmetic product, the composition is based on the composition indicated in Annex I, Part A, Section 1. Directly or indirectly, the information in the other sections is conditional on this section.<\/p>\n

That is why, strictly speaking, any change in composition should be considered as another cosmetic product<\/strong>. The extent of the changes will give a measure of the complexity of the new assessment. In any case, all change in composition<\/strong>, however small, requires the an evaluator's analysis.\u00a0<\/strong>\u00a0I will be in charge of measuring the impact of the changes introduced on the safety of use of the cosmetic product.<\/p>\n

\"dosier<\/a><\/p>\n

More information on the Security Dossier<\/strong><\/h2>\n

In its Article 2, the Regulation 1223\/2009 on cosmetic products<\/a> <\/strong>defines \u00abcosmetic product\u00bb as: \u00abany substance or mixture intended to be placed in contact with the superficial parts of the human body (epidermis, hair and capillary system, nails, lips and external genital organs) or with the teeth and oral mucous membranes, for the sole or principal purpose of cleansing, perfuming, modifying their appearance, protecting, maintaining them in good condition or correcting body odours\u201d.<\/p>\n

Therefore, we can consider that a cosmetic product<\/strong> is defined by its composition<\/strong> (substance or mixture), by the place of application<\/strong> and for its function<\/strong>. Of these three parameters, the Composition is the main determinant of the safety profile.<\/strong> of a cosmetic.<\/p>\n

When considering the development of a cosmetic product, the starting point is the function for which it is intended. For example, it could be a nourishing cream for the eye contour, a deodorant for the feet, a toothpaste, etc. This function will determine the reasonably foreseeable conditions of use and exposure, the place of application, the area of the surface applied, the amount of product applied or the duration and frequency of use<\/strong>. These parameters alone do not determine the safety of a cosmetic product.<\/p>\n

On the one hand, in order for a cosmetic product to perform a specific function, we must establish a composition that is not only effective but also safe. On the other hand, to establish this composition we have a large number of substances and mixtures that we can use. In most cases, in quite wide concentration ranges. Thus, we can state that the product safety<\/strong> The cosmetic depends primarily on:<\/p>\n