CICLOPIROX OLAMINE

Name / description

Ciclopirox Olamine; 6-Cyclohexyl-1-hydroxy-4-methylpyridin-2(1H)-one, Compound with 2-Aminoethanol (1:1)

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Function(s) of this ingredient in cosmetic products

ANTI-SEBORRHEIC

Prevents seborrhea and / or seborrheic dermatitis or relieves their symptoms; and / or acts against dandruff

ANTIMICROBIAL

Helps control the growth of micro-organisms (eg bacteria and fungi)

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Origin

synthetic

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Information on safe use

This substance is expressly approved and / or subject to a restriction as a result of an entry in Annex III of the EC Cosmetics Regulation after an assessment by the Scientific Committee on Consumer Safety of the EU Commission (SCCS). Restrictions can relate eg to purity criteria, a maximum concentration or the restriction to certain product categories. Subject to the conditions possibly imposed in Annex III, the use of this substance in cosmetic products is safe.

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Why are we talking about it?

Annex III of the European Cosmetic Products Regulation sets maximum limits for the level of nitrosamines in mono- and trialkylamines and -alkanolamines and in fatty acid dialkylamines and dialkanolamides. Formation of relevant nitrosamines can occur by the reaction of secondary amino compounds contained as impurities in such ingredients with nitrosating agents (with nitrites; nitrosation reaction). Nitrosamines, which are potentially carcinogenic components, may therefore appear as unavoidable traces in the cosmetic product after its manufacture. The facts: There is a global strategy against the formation of nitrosamines, relying on cosmetic regulations and the recommendations of professional bodies (1 and 2). This strategy covers the raw materials (whose purity is controlled to limit impurities), the manufacturing process, storage and the finished product. Choosing ingredients with low potential for nitrosation is also critical (2). In order to guarantee the effectiveness of these measures, nitrosamines levels are measured in the raw materials and in the finished product. To limit the formation of nitrosamines, it is also possible to add ingredients to the formula which will prevent this reaction. Cosmetic formulation is a rigorous science with many constraints, which the issue of nitrosamine management perfectly illustrates. Key points to take away: The formation of nitrosamines is a very well regulated issue in the manufacture of cosmetic products, from raw materials to finished products. All precautions are taken to avoid their formation. Sources: (1) Opinion of the European Scientific Committee on Consumer Safety (SCCS): SCCS/1458/11 - Opinion on Nitrosamines and Secondary Amines in Cosmetic Products: https://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_090.pdf (2) COSMETICS EUROPE: Technical guidance document on minimising and determining nitrosamines in cosmetics, 2009: https://cosmeticseurope.eu/download/TjBjaHR5ekxhQ0Vxbkc1eEtKU2NTdz09

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Belongs to the following substance groups

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Regulating cosmetics

Cosmetics Ingredients are subject to regulation. Please note, different regulations may apply to cosmetic ingredients outside the EU.