{"id":3060,"date":"2017-09-07T12:19:42","date_gmt":"2017-09-07T11:19:42","guid":{"rendered":"https:\/\/mcamps.com\/?p=3060"},"modified":"2017-09-14T10:49:11","modified_gmt":"2017-09-14T09:49:11","slug":"estudios-en-humanos-producto-cosmetico","status":"publish","type":"post","link":"https:\/\/mcamps.com\/eng\/estudios-en-humanos-producto-cosmetico\/","title":{"rendered":"Can I market 1 cosmetic without conducting human studies?"},"content":{"rendered":"

HUMAN STUDIES<\/strong>- The answer is yes, it is possible to market a cosmetic product without human studies. But only under certain circumstances, related to the knowledge of the cosmetic product.<\/p>\n

On the one hand, we know that one of the objectives of the Regulation 1223\/2009<\/a> on cosmetic products is to achieve a high level of safety. Therefore, in its Annex I, the necessary information is requested to ensure that this is achieved. On the other hand, conducting studies on humans, which are subjected to certain risks in order to obtain already known results, is questionable. A duality therefore arises between the safety of use and the risk of testing. Where the safety of the cosmetic product is very clear, human studies could be dispensed with.<\/p>\n

This would be the case, for example, for cosmetic products that are derived from a minor variation - with a detoxifying profile - of another product for which safety has already been established. In these cases, if appropriate, the omission of human studies requires a clear and robust justification by the assessor.<\/p>\n

More information on human studies on cosmetic products: what does the Regulation say?\u00a0<\/strong><\/h4>\n

There are 10 sections of Annex I, which indicate the minimum content of the cosmetic product safety report. The first eight contain the data on which the high level of human health protection sought by the Regulation will be based. But this information is only an assumption of safety. And it must be corroborated, before being placed on the market, by human testing of the cosmetic product.<\/p>\n

For example: for a facial moisturiser, information can be provided showing a formula that does not contain unauthorised products or concentrations of them, or toxic impurities. It is also useful to provide information on a pH compatible with the skin and a viscosity suitable for the product to remain at the application site. Or data on chemical and microbiological stability over time of use, and ocular tolerance in in vitro models.<\/p>\n

In this way, each and every one of the requirements of the first eight sections could be fulfilled. The problem lies in the fact that all this background, even if it constitutes a very solid basis, does not guarantee the safety of use of the cosmetic product. Therefore, there must be human verification, through appropriate testing. Measure potential risks according to the product profile. The information requested in this respect is indicated in sections 9 and 10.<\/p>\n

Paragraphs 9 and 10 of Annex I of the Regulation<\/strong><\/h4>\n

Paragraph 9 states that they shall provide \u00aball available data on undesirable effects and serious undesirable effects of the cosmetic product. This description shall include statistical data\u00bb. This refers primarily to data that we obtain through market monitoring and corroboration of its safety. This data is updated in the safety dossier.<\/p>\n

But this paragraph also states: \u00abwhere appropriate, results from other cosmetic products\u00bb. This means that data obtained from equivalent products can support the safety of a cosmetic product that we want to market. In this sense, we understand as equivalent those products with qualitatively equal formulations. And in which the substances that may present a risk are in lower concentration.<\/p>\n

Let's look at some case studies<\/strong><\/h4>\n

Let's take the example of the above-mentioned facial moisturiser. Let's suppose that we start from the same formula and develop a moisturising cream for legs. The concentration of the emulsion has been reduced to make it more fluid and easier to apply. And we replace the perfume with one that has a less irritating profile and is free of allergens.<\/p>\n

If the reference product has been studied in humans with satisfactory results, it may be reasonable not to perform safety testing in humans. If, in addition, results are available showing the absence of undesirable effects during the monitoring of the reference product on the market, this omission of testing may be more justified. It is important that the impurity profile of the substances and mixtures in the new product is the same as that of the reference product.<\/p>\n

Equivalent cases could be found, for example, in a reformulation of a product in which the concentration of preservatives has been reduced. Either to be presented in a tamper-proof container or in sterilised single doses. Or by the replacement of a colouring agent or perfume with a more innocuous one. Or simply a change of intended function with application to less sensitive skin areas.<\/p>\n

The other side of the coin: when the toxicity of a cosmetic product is known<\/strong><\/h4>\n

At the other end of the spectrum from the products we have just given as examples, there are all those cosmetics whose toxicity is known, and which are directly related to their intended function. This toxic potential could entail certain risks for the subjects undergoing the safety study.<\/p>\n

Examples include hair dyes, or certain depilatory creams. In this type of product, rather than testing on humans, it should be checked that the labelling clearly states the warnings or instructions for use. Once again, we must consider that the Regulation is aimed at a high level of safety in use. And not the intrinsic safety of cosmetic products.<\/p>\n

Final conclusions<\/strong><\/p>\n

In any case, the assumptions we have raised in this commentary must be interpreted as very special. And they require a very reasoned analysis, either by the assessor or by an expert assessor. The general rule is that the safety of use of a cosmetic product before it is marketed shall be verified by human testing. What kind of testing should be done for each cosmetic is a complex issue. It depends on many factors that we can discuss in further comments.<\/p>\n

Do you need more information on human studies for the safety of a cosmetic product? Do not hesitate to contact us<\/a>\u00a0to seek expert advice.\u00a0Our proposal? Solutions!<\/strong><\/p>\n

\n
    \n
  • The\u00a0Expert opinion<\/strong>\u00a0was written in 2012 for the former GTF M. Camps website. And it coincided with a context of doubts regarding the interpretation of Regulation (EC) No 1223\/2009 on cosmetic products. Today, these issues are still of great relevance for the cosmetics sector.<\/li>\n<\/ul>\n

     <\/p>","protected":false},"excerpt":{"rendered":"

    ESTUDIOS EN HUMANOS– La respuesta es s\u00ed, es posible comercializar un cosm\u00e9ticos sin realizar estudios en humanos. Pero s\u00f3lo cuando concurran determinadas circunstancias, relacionadas con los conocimientos que se tengan del producto cosm\u00e9tico. Por un lado, sabemos que uno de los objetivos del Reglamento 1223\/2009 sobre productos cosm\u00e9ticos es alcanzar un elevado nivel de seguridad. […]<\/p>\n","protected":false},"author":1,"featured_media":3061,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","inline_featured_image":false,"footnotes":""},"categories":[714,99],"tags":[103,195,772,724,760,273],"class_list":["post-3060","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-opinion-del-experto","category-cosmeticos","tag-cosmeticos","tag-cosmetovigilancia","tag-estudios-en-humanos","tag-productos-cosmeticos","tag-reglamento-12232009","tag-seguridad"],"_links":{"self":[{"href":"https:\/\/mcamps.com\/eng\/wp-json\/wp\/v2\/posts\/3060","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mcamps.com\/eng\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/mcamps.com\/eng\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/mcamps.com\/eng\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/mcamps.com\/eng\/wp-json\/wp\/v2\/comments?post=3060"}],"version-history":[{"count":0,"href":"https:\/\/mcamps.com\/eng\/wp-json\/wp\/v2\/posts\/3060\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/mcamps.com\/eng\/wp-json\/wp\/v2\/media\/3061"}],"wp:attachment":[{"href":"https:\/\/mcamps.com\/eng\/wp-json\/wp\/v2\/media?parent=3060"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/mcamps.com\/eng\/wp-json\/wp\/v2\/categories?post=3060"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/mcamps.com\/eng\/wp-json\/wp\/v2\/tags?post=3060"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}