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The IFRA 42nd Amendment
Posted: March 30, 2007
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In brief, the key steps of the dermal sensitization QRA process for fragrance ingredients are:
- determination of benchmarks (no expected sensitization induction level, or NESIL);
- application of sensitization assessment factors (SAF) and
- calculation of consumer exposure (CEL) through product use.
Using these parameters, an acceptable exposure level (AEL) can be calculated and compared with the consumer exposure level (CEL). The ratio of the AEL to CEL must be favorable to support the safe use of the skin sensitizer. This ratio must be calculated for each fragrance ingredient identified as a potential skin sensitizer in each product type. (For more details, see the paper on the RIFM or IFRA websites written by the QRA Expert Group, Dermal Sensitization Quantitative Risk Assessment (QRA) for Fragrance Ingredients, Technical Dossier, March 15, 2006, www.rifm.org/pub/publications.asp and www.ifraorg.org/news.asp).1). The principles and practical applications of this new methodology for fragrance ingredients continue to be presented at both fragrance and consumer product industry meetings as well as at toxicology and dermatology scientific meetings.2,3,4
Based on the RIFM Expert Panel’s recommendation, RIFM and IFRA have formally adopted the QRA approach, refined for fragrance ingredients identified as contact allergens, as the core strategy for primary prevention of dermal sensitization to these materials in consumer products. This methodology will be used to determine global fragrance industry product management practices (IFRA Standards) for potentially sensitizing fragrance ingredients, the first of which was implemented in May 2006 with the 40th Amendment to the IFRA Code of Practice. It contained the first four IFRA Standards based on the QRA and limited the use of the material for the 11 individual product categories. (For IFRA/RIFM information, see reference 5.)
The implementation of the QRA approach will continue with the publication of the 42nd Amendment to the IFRA Code of Practice. The 42nd Amendment will include all modifications to the existing Standards based on dermal sensitization for which there are adequate data to allow QRA review (approximately 20 Standards, covering about 30 materials). In addition, approximately 15 new IFRA Standards (covering about 20 materials) will be introduced, which cover most of the fragrance ingredients that require “allergen labeling” in Europe. As with previous Amendments, some of these new IFRA Standards restrict fragrance ingredients that can be found in other sources such as essential oils, so this needs to be taken into account.