Response to the letter to the editor by Rasmussen and Mech, 2014 Better understanding of the EU regulatory frameworks for cosmetic products (original) (raw)
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Skin cancers including malignant melanoma which are due to UV radiation constitute a serious public health problem. Recent studies have confirmed the importance of UVA radiation in the pathogenesis of skin cancer, as well as the protective effects of broad-spectrum sunscreen use. Barriers for effective protection of the US public include the lack of effective UV filters, especially in the UVA spectrum. The major reason for the paucity of UVA-effective filters in the US is due primarily to the FDA's reluctance to approve agents which have already been on the market in Europe and elsewhere in the world for more than a decade. The underlying reasons for these discrepancies in new sunscreen approval success between the US and abroad are complex, and include factors such as that the FDA considers UV filters as drugs, whereas they are regulated as cosmetics elsewhere. FDA has not as yet developed a consistent approach for the approval of new UV filters. We provide a paradigm for both non-clinical testing and human safety testing which includes parameters for a human maximum use test (MUsT) that is based upon both ethical and scientific concepts. These suggestions could form the basis of future regulatory guidelines for rational testing thus allowing us to reach the consensus goal of more efficient and timely approval of much-needed UV filters to provide protection for the US public.
Cosmetics
Attention to environmental issues has become increasingly important in recent years and also massively affects the cosmetics sector. In this context, sunscreens are questioned due to the proven or believed ecotoxicity of organic ultraviolet (UV) filters. This has pushed developers increasingly towards the use of inorganic filters, which can prove difficult to spread with low compliance. We faced the problem by proposing a rational approach based on the evaluation of the morphology of the inorganic material, as the real dimension does not often correspond to the characteristics declared by the producers because the material itself tends to aggregate. A combination of a specially selected inorganic filter is required to formulate Cosmetic Products with a Natural and Sustainable Connotation (CPCNS) standards.
Analytical and bioanalytical chemistry, 2018
The cosmetic industry currently focuses on products with magnified or exaggerated effects or extremely long-lasting characteristics. There are also a number of related commercial products for which the regulatory framework is far from clear; they are called 'borderline', and the European authorities only recommend which regulations they need to comply with. In any case, all these products must be safe under reasonable conditions of use in accordance with the applicable laws in force in the European Union (EU) framework. In this context, adequate analytical methodology is needed to evaluate the degree of compliance. Ultrasound Assisted Extraction (UAE) procedures for the analysis of 70 cosmetic ingredients have therefore been developed in this work. Moreover, for cosmetics with plastic applicators, a Supported-UAE (Sup-UAE) method was also opportunely optimized to check if a partial transfer of plasticizers to the cosmetics-and thereby to the consumers-could happen. In a surv...
UV filters in sunscreen products - a survey
Contact Dermatitis, 2002
The contents of 18 permitted chemical UV filters in 75 sunscreen products have been determined to check the compliance of these products with the EU Cosmetic Directive, as well as to generate data for quantitative exposure assessments. 81% of the products were found to contain 14 of the target chemical UV filters. The remaining products contained only the physical UV-filters titanium oxide and zinc oxide, which were not determined in the present study. Maximum content (29.3%) of chemical UV filters was found in a product that contained 6 of the target UV filters. Octyl methoxycinnamate (1.4-4.7%) and butyl methoxydibenzoylmethane (0.4-4.8%) were the most frequently used UV filters, present, respectively, in 49% and 44% of the investigated products. Correlation between declared sun protection factor (SPF) and the contents of chemical UV filters in the respective products was not significant (correlation coefficient 0.5362). The content of UV filters in all products complied with the maximum allowed concentration of these according to EU Cosmetic Directive.
Regulatory framework of cosmetic in the European Union
Cosmetics that are personal or personalized are now becoming extremely prevalent. While compliance is mandated by European Union (EU) Cosmetics Directive 1223/2009, there seem to be no strict guidelines for maintaining obedience. Cosmetics must meet a number of conditions in order to be sold in the European Single Market; however, the focus of this article is on the Cosmetics Regulation 1223/2009. Regulations are examined for certain elements and several solutions are presented that allow for careful use of individually cloaked cosmetics that are available on the market. Metallic nanoparticles (NMs) have been proposed for usage as active ingredients/excipient in a number of cosmetics products. Due to fast-paced businesses in the cosmetic industry, cosmetology tends to focus on its distinctive characteristics to bring value to a diverse array of products, but due to the small size of nanometers, NMs may not always follow the very same handling guidelines as their conventional material. As a result, a nano-specific framework for regulating the use of nanomaterials & creation of nano-improved cosmetics is becoming increasingly prevalent. Scientific and industrial perspective into the NMs presently used for the marketplace, with an emphasis on metallic NMs, and also an evaluation of the regulatory requirements and Scientific Commission on Consumer Safety (SCCS) Opinions. Considering the fact that the original Cosmetic products Directive (EU Legislation No 1223/2009) has precise restrictions on NMs, beauty materials containing unlawful NMs have already been supplied in the EU on numerous times. Researchers examine the risk evaluation indicated in Article 16 of the Cosmetology Code acts as a framework for the potential expansion to enhance nano-items, considering the long-term risks of nanomaterials if mistreated. The nation's attention is on synchronizing efforts to integrate metallic NMs into cosmetic products but to the restricted fusion of metallic NMs with numerous non-metallic nanoparticles. Although Directive 76/768/EEC on the beauty items is an upright division of amendment that requires the European market for every cosmetic product placed to meet its exigencies would be irrational that it is for believings a stand-alone part of regulations is unaffected by other legal texts. In reality, Directive 76/768/EEC takes the form part of complicated legal action that began 40 years ago that ensure the free passage of goods throughout the EU while also European individuals' and their environment's safety. The ongoing chapter outlines the most important aspects of the Directive Cosmetic Products along with the latest guidelines 2022 prepared by the COS law Team of what happened in the EU cosmetics regulatory framework between January and March, which serves as the book's foundation. The trend of personal skincare seems to be high among clients.
EU legislations affecting safety data availability of cosmetic ingredients
Regulatory Toxicology and Pharmacology, 2007
, imposing a testing and marketing ban on cosmetic products tested on animals, the retrieval of toxicological data on individual ingredients became of greater need. Since the majority of cosmetic ingredients are used for many other purposes than their cosmetic function, they fall under the scope of more than one EU Directive. An overview is given of EU legislation that could potentially affect the availability and interpretation of cosmetic safety data. It will become clear that, although cosmetics are regulated by a specific so-called ''vertical'' legislation, ''horizontal'' influences from other products' legislations play a role since they determine the type and amount of data that theoretically could be found on the specific substances they regulate. This knowledge is necessary while performing extended searches in databases and becomes indispensable when initiating negotiations with manufacturers or suppliers for obtaining the safety data required.
Archives of Toxicology
The EU Directive 2010/63/EU on the protection of animals used for scientific purposes and other EU regulations, such as REACH and the Cosmetic Products Regulation advocate for a change in the way toxicity testing is conducted. Whilst the Cosmetic Products Regulation bans animal testing altogether, REACH aims for a progressive shift from in vivo testing towards quantitative in vitro and computational approaches. Several endpoints can already be addressed using non-animal approaches including skin corrosion and irritation, serious eye damage and irritation, skin sensitisation, and mutagenicity and genotoxicity. However, for systemic effects such as acute toxicity, repeated dose toxicity and reproductive and developmental toxicity, evaluation of chemicals under REACH still heavily relies on animal tests. Here we summarise current EU regulatory requirements for the human health assessment of chemicals under REACH and the Cosmetic Products Regulation, considering the more critical endp...