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Spray November 2015

IFRA Releases the 48th Amendment to the Code of Practice Lori H. Parker 20 Spray November 2015 Regulatory Affairs Manager Arylessence, Inc. Continuing the bi-annual program to keep the science and art of fragrance creation updated with new guidance on ingredient safety The global fragrance industry self regulatory compliance program, known as the International Fragrance Association (IFRA) Code of Practice, has established a program of amendment updates that comes out every two years. In August, the 48th amendment was released to the industry. IFRA updates are the backbone of an ongoing global safety program providing assurance to the manufacturers of personal care, home care and industrial and institutional products, and all of the consumers and users of these products, that when used correctly in proper concentrations, the fragrance ingredients used within the scents we love are safe as well as effective. The objective of the IFRA code of practice is soundly based in conservative science. It is designed to prevent not only the reoccurrence of fragrance sensitivity, but also the development of fragrance sensitivity in the first place. The IFRA Code of Practice uses data that is independently developed by the Research Institute for Fragrance Materials (RIFM) to set safe usage levels for fragrance materials that are subsequently used in the thousands of fragrance blends that are developed by the industry each year. Membership in IFRA mandates manufacturers’ adherence to these safe usage levels in their creations. This allows the fragrance developer to issue a Certificate of Conformity for the fragrance blends they create for their clients. New & updated standards in the 48th Amendment The 48th amendment has given the industry three new use level standards based on dermal sensitization, three revised standards for use level, two new standards prohibiting ingredient use and a revised policy on four phototoxic ingredients. Three standards have been expanded to cover new molecules based on their Chemical Abstracts Service (CAS) numbers and several standards have been clarified. In addition, the Quantitative Risk Assessment (QRA) guidance has been updated. • The new use level standards are for DPMI, commonly called Cashmeran, Trimofix and m-BMHCA, often known as Lilial or Lysmeral. These new standards were developed using new data in the context of the QRA for dermal sensitization. • p-BMHCA (Lilial) has a revised standard for pragmatic use level. Also, the category 9 use level for p-BMHCA was reevaluated and revised. Methyl Eugenol and Estragole standards have had the usage level reduced for non-skin application products in order to be more consistent with the restricted levels in other categories. • Newly-prohibited ingredients are Hexadienol, commonly known as Sorbic Alcohol, and 2,4-Dodecadien-1-ol. Their prohibition is due to a lack of data available to RIFM to do a complete safety assessment on long term toxicity effects. • The policy on combined use of phototoxic ingredients has been revised for four materials that are not likely to induce phototoxicity by a common mechanism. These materials are AHMI—also known as Phantolid,


Spray November 2015
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