Fragrances are ingredients used in a wide variety of cosmetics and personal care products to make the products more pleasant and to make them recognizable to the users. Fine fragrances, or perfumes, are used specifically to provide a pleasant and attractive odor for the user, while functional fragrances are added to products that serve some function such as cleaning or moisturizing.
According to the U.S. Food and Drug Regulation, the term “fragrance” on a product label signifies "any natural or synthetic substance or substances used solely to impart an odor to a cosmetic product.” In Europe, the labeling name for Fragance is Parfum.
Fragrances encompass a wide variety of natural and synthetic materials that are used alone or in combinations to produce a unique fragrance in products. Studies have shown that users associate a pleasant fragrance with a clean environment. In other words, consumers know an area is clean because of the pleasant smell that remains following cleaning. It’s impossible to know if a product without fragrance has been applied; without fragrance there is no perceived effectiveness.
The safety of fragrance ingredients is assessed by a comprehensive program operated by the International Fragrance Association (IFRA). This comprehensive program, in operation since 1973, includes a Code of Practice (the Code) that provides recommendations for good operating practice and guidelines on fragrance ingredient safety assessment, and includes fragrance safety Standards which limit or ban the usage of certain fragrance materials. IFRA oversees the gathering of information about the safety of individual fragrance ingredients and reviews this information to determine the safety under conditions of use. The conclusions of the IFRA safety review are published in the IFRA “Code of Practice” which provides critical guidance to fragrance formulators and users to ensure that their products are safe.
Scientific review of fragrance ingredients is conducted by the Research Institute for Fragrance Materials (RIFM). RIFM is the scientific arm of IFRA and is a non-profit scientific institute, founded in 1966 for the purpose of generating and evaluating safety data on fragrance ingredients. The scientific foundation of RIFM is built around its independent Expert Panel (REXPAN), made up of toxicologists, pharmacologists, dermatologists and environmental scientists, none of whom has any other connection to the fragrance industry, and whose work involves the safety evaluation of fragrance ingredients under conditions of intended use.
The results of the RIFM Expert Panel evaluations are published in peer-reviewed scientific journals, and their decisions regarding restrictions of use are published in the IFRA Standards. RIFM evaluates and distributes scientific data on the safety assessment of fragrance raw materials found in perfumes, cosmetics, shampoos, creams, detergents, air fresheners, candles and other personal and household products. RIFM's Database of Fragrance and Flavor Materials is the most comprehensive source worldwide for toxicology data, literature and information on the safety evaluation of fragrance and flavor materials.
The Cosmetic Ingredient Review (CIR) defers review of individual fragrance ingredients to the IFRA/RIFM program unless the ingredient has significant uses other than as a fragrance. In this case, the ingredient may be assessed by both the CIR Expert Panel and REXPAN.
Link to the Web Site for the International Fragrance Association:
http://www.ifraorg.org/
Link to the IFRA fragrance standards and code of practive:
http://www.ifraorg.org/GuideLines.aspThe Research Institute for Fragrance Materials (RIFM) supports a rigorous safety review program that systematically assesses the safety of fragrance ingredients. Safety data for all fragrance ingredients that are commercially available and offered for sale by a RIFM member must be submitted by the ingredient manufacturer to RIFM for inclusion in the Fragrance and Flavor Ingredient Database. Under this program, manufacturers must provide all available information on specifications, use and use levels as well as copies of test reports and other safety related information for examination by the REXPAN. In particular, when fragrance manufacturers have evidence that warrants creation or modification of a Standard, they must inform IFRA and supply the data to RIFM.
In evaluating a fragrance ingredient, consideration should be given to possible effects on the skin, including skin irritation and sensitization, with special attention paid to the effect of sunlight, should the ingredient absorb ultra-violet radiation. Systemic toxicity should be considered in relation to the quantities of fragrance material used and likelihood of entry into the body. The safety evaluation of the ingredients requires the review of consumer exposure information and supporting safety data. An important component in establishing priorities, essential to a thorough safety assessment, is a survey of the total usage of individual fragrance ingredients. IFRA generally carries out a worldwide survey of fragrance ingredient usage every three to five years. This survey is conducted by requests made to all suppliers or compounders of fragrance materials on record, whether members of IFRA member associations or not.
Also critical to a thorough safety assessment of individual fragrance ingredients are data on levels, and routes of exposure of consumers, to individual fragrance ingredients. These data are determined from a collaborative effort of IFRA and various cosmetic companies or trade associations, with the data being analyzed and summarized in documents prepared by IFRA. All data collected as described above are communicated routinely to RIFM, for consideration by REXPAN – the independent expert review panel that operates under the management of RIFM. If there are inadequate data from the sources mentioned above, a toxicological program will be designed, which includes dermatological and systemic endpoints as described in the RIFM “Criteria Document” (see below). Possible environmental effects should be considered in the assessment of substances’ use.
As a result of safety assessments, the usage of certain fragrance ingredients has been restricted and these restrictions are set forth in IFRA Standards. Standards that impose a quantitative limit on the use of fragrance materials are expressed as a maximum concentration of fragrance material in the consumer product. It is therefore essential that fragrance suppliers inform manufacturers of consumer products, who use or intend to use a fragrance compound, that due to the presence of a restricted ingredient, the compound should only be used up to a specified maximum concentration or in well-defined applications.
Fragrance ingredients that deviate from generally accepted quality standards or that are not covered in the IFRA Code of Practice (section 4.2) should be used only after satisfactory evaluation according to the requirements described in annex 4 of the IFRA Code of Practice. The IFRA Scientific Committee collects data about the safety of a fragrance ingredient and provides this information to RIFM for the safety evaluation of fragrance ingredients including volume of use, ingredient use level in fragrance compositions and results of testing programs made available by the originators of such programs. This is in addition to the data collection and generation efforts of RIFM by consistent review of the scientific literature, submission of member company studies and RIFM sponsored research and testing.
To help ensure that the standards are followed, IFRA has implemented a compliance policy.
Find out more about the IFRA Compliance Policy at the following link:
Insert info on IFRA Compliance Program
http://www.ifraorg.org/Enclosures/News/Compliance%20policy%2...
Link for the IFRA Standards for Fragrance Ingredients:
http://www.ifraorg.org/GuideLines.asp
