Cosmetics Europe

A prevalidation study carried out by Cosmetics Europe on this optimized protocol showed that the SkinEthic HCE method consistently discriminated UN GHS classified from non-classified test substances within and between laboratories [47]. A combination of the two exposure times in a testing strategy that allocates test substances to the short or long exposure time depending on their intrinsic chemical reactivity increased the overall accuracy under GHS. The chemical reactivity, i.e., electrophilic potential to react with cysteine- or lysine-containing peptides, was measured by the direct peptide reactivity assay (DPRA) [48]. Reactive substances (peptide depletion is >5.95 % relative to the control) were allocated to the short exposure time, whereas non-reactive substances (depletion <5.95 %) are allocated to the long exposure time. 

However, recent analyses of several in vivo eye irritation databases carried out under a collaboration agreement between EURL ECVAM and Cosmetics Europe revealed the importance of conjunctiva effects in the classification of GHS Cat. 2 eye irritants [21], This indicates the usefulness of in vitro methods that can identify conjunctiva effects, and especially conjunctiva redness, to fully replace the in vivo Draize eye test. Since the HET-CAM (described under Sections 4.1.4 and 4.2.2) and similar methods like CAMVA have been proposed to provide information on conjunctiva effects in vivo due to the similarity of the CAM to the conjunctiva, it might be helpful to reconsider the usefulness of these methods for inclusion in an in vitro eye irritation testing strategy to eventually for example identify GHS Cat. 2 eye irritants. 

Pfannenbecker U, Bessou-Touya S, Faller C, Harbell J, Jacob T, Raabe H, Tailhardat M, Alepee N, De Smedt A, De Wever B, Jones P, Kaluzhny Y, Le Varlet B, McNamee P, Marrec-Fairley M, Van Goethem F (2013) Cosmetics Europe multi-laboratory pre-validation of the EpiOcular reconstituted human tissue test method for the prediction of eye irritation. Toxicol In Vitro 27 619-626... 

Regulatory FDA 21CFR 172.515 FEMA GRAS prohibited in cosmetics (Europe)... 

The colorant is prepared by leaching the annatto seeds with an extractant prepared from one or more approved, food-grade materials taken from a hst that includes various solvents, edible vegetable oils and fats, and alkaline aqueous and alcohoHc solutions (46,47). Depending on the use intended, the alkaline extracts are often treated with food-grade acids to precipitate the annatto pigments, which ia turn may or may not be further purified by recrystallization from an approved solvent. Annatto extract is one of the oldest known dyes, used siace antiquity for the coloring of food, textiles, and cosmetics. It has been used ia the United States and Europe for over 100 years as a color additive for butter and cheese (48—50). 

SAN is also used for pharmaceutical and cosmetic packaging. Usage breakdown for Western Europe in the early 1990s has been estimated at 28% for household products, 21% for domestic electrical applications, 8% for battery casings, 12% for pharmaceutical/cosmetic packaging and a large figure of 31% for other applications. 

Association of Petrochemicals Producers in Europe (APPE), See European Chemical hidustry Comicil (CEFIC), 256 Association of Plastics Manufacturers in Europe (APME), 256 Association of Polish Producers of Paints Lacquers, 263 Association of Producers for Cosmetics and Household Chemicals, 263... 

However, this request of more animal testing faces several issues. There is an ethical concern on the millions of animals used every year for experiments. These tests are also those more expensive, and thus this poses questions about the costs for these experiments and the resources to cover them. Many of these tests, especially the chronic ones, require long times, years in some cases. The number of available laboratories in Europe to cover this potential request is insufficient. For all these reasons, some European regulations foresee the use of methods alternative to animal tests, such as the REACH legislation, and actually the cosmetics directive foresees the complete ban of animal tests for cosmetics by 2013. 

As long as it complies with certain purity requirements, the pigment is approved as a colorant for food and cosmetics in the USA under FD C Yellow 5 and in Europe under E102. 

Dosing substances to the eye is a technique performed since the start of civilization. First eye cosmetics have been described around 1550 bc by the ancient Egyptians. Later, eye preparations for women (e.g., containing belladonna extracts) have been described during the Baroque period of Europe. Major importance for eye medications was gained through the discovery of alkaloids in the nineteenth century. Since then, eye medications always played a major role in therapeutics. 

In addition, in the USA ether sulfates are used on a large scale in laundry detergents. For that reason, their market share in the USA is even larger than in Europe (3), At present, alkyl ether sulfates are primarily useH in the form of their Na salts. In the past, however, cosmetic preparations containing ammonium and Mg salts have also been quite common (4). 

The example of the textile chain demonstrates (i) how much the techni-cal/aesthetic quality of products and chemicals-related product security are interdependent and (ii) what requirements exist for a quality management system beyond the supply chain level. Only the major brands can take this initiative on a global scale. For cosmetic, medical devices and food products, as well as technical products with high safety requirements (such as aircraft), management systems beyond supply chain level have now become a matter of survival. The same holds true for products that are subject to special waste and design regulations in Europe (such as automotive vehicles and electronic equipment). 

In Europe, the developmental toxicity testing (including teratogenicity) of new cosmetic ingredients is performed according to the Cosmetics Directive 76/768/EEC only alternatives leading to full replacement of animal experiments should be used. This chapter presents the three scientifically validated animal alternative methods for the assessment of embryotoxicity the embryonic stem cell test (EST), the micromass (MM) assay, and the whole embryo culture (WEC) assay. 

In Europe, the Cosmetics Directive of the European Union (EU) has implemented a ban on animal testing of finished cosmetic... 

Students came from all parts of Europe to live at his boarding school, and the rooms of the quarter were filled with half-pensioners, who wished at least to eat at his home. His pharmaceutical preparations had a large sale, and the profits from his bismuth magistery, a cosmetic, were sufficient for all the expenses of his household. In 1675 he published his famous Cours de Chymie, which, unlike most scientific books, sold out edition after edition like a work of romance or satire. ... 

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