Regulatory Requirements for Safety of Cosmetics
 Both the United State FDA and the European Union require that cosmetics be safe for intended use prior to marketing and both mandate that proof of cosmetic safety is the responsibility of the manufacturer and/or the distributor. In addition, where as both agree that Risk Assessment is part of safety evaluation process, under European Union Directive safety assessor’s report is a key part of the Product Information Package (PIP) or technical file.
The cosmetics legislation in European Union is based on Council Directive 76/768/EEC (1976). This directive requires that manufacturers maintain “Product Information Packages” (PIP) for their cosmetics products. Safety Assessments is one of the important components of PIP and is therefore required by the Council Directive.
The United State FDA requires that cosmetics must be safe for their intended use. Safety Assessments conducted through literature search can be considered a tool for establishing safety of cosmetics. Moreover, this method can be considered as a reasonable alternative to animal testing.
What is Safety Assessment of Cosmetics?
Info. Tox. International, Inc. believes that safety assessment is an interdisciplinary approach that focuses on the intended use of the product, toxicity characteristics of individual as well as the combined effects of ingredients, exposure characteristics of the products when used as intended and ultimately the risks associated with the product.
According to the Danish Environmental Protection Agency, the safety assessment of a cosmetic product to a considerable extent depends on its route of application. The route of application of the product has an influence on how much of the product - and in this connection - how much of each ingredient can be ingested, inhaled or absorbed through skin and mucous membranes. Further, the amount of each ingredient in the individual product has an influence on the safety assessment.
Before a safety assessment and a risk assessment of a cosmetic product can be initiated, the degree and route of application must be described thoroughly. An evaluation of whether the application of a cosmetic product can be considered safe for especially vulnerable groups such as children, must as a principal rule form part of the risk assessment and the factors in the risk assessment must be considered before weighting the individual ingredients. For additional information you may visit:
http://www.mst.dk/default.asp?Sub=http://www.mst.dk/udgiv/publications/2000/87-7944-336-2/html/helepubl_eng.htm.
Professionals at Info. Tox. International, Inc.
Professionals at Info. Tox. International, Inc. who take part in the Toxicological Risk Assessment (TRA) or Safety Evaluation process include EUROTOX registered Toxicologists, Board Certified toxicologist, Board Certified Industrial Hygienist, and Certified Safety Assessor for cosmetics under the EU Directive.
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