A Group Summary on Cyclic and Non-Cyclic Terpene Alcohols and Related Fragrance Material Reviews (FMRs)

RIFM has published, in the November 2008 issue of Food and Chemical Toxicology, Volume 46, Supplement 11S, it’s Group Summary on Cyclic and Non-Cyclic Terpene Alcohols and their related Fragrance Material Reviews (FMRs). The group consists of 68 materials, including d,l-Citronellol, Geraniol, Linalool, and Tetrahydrolinalool, andmany that are among the high priority list of fragrance materials selected for review. The data show that, at the current levels of use, these materials are practically non-irritating, have a generally low sensitization potential, and show no grounds for environmental concern.

A Special Issue: Dermal Sensitization Quantitative Risk Assessment for Fragrance Ingredients

This Special Issue on the Quantitative Risk Assessment (QRA) for Fragrance Ingredients is published in Regulatory Toxicology and Pharmacology, (Vol. 52, No. 1, October 2008), the official peer-reviewed scientific journal of the International Society of Regulatory Toxicology and Pharmacology.

The QRA is now the basis for IFRA Standards on ingredients exhibiting a potential for dermal sensitization and has led to the Standards having individual restrictions for 11 product categories. The categories were achieved by grouping consumer product types according to key parameters identified within the QRA approach. These parameters are Sensitization Assessment Factors (SAFs) and consumer product exposure, which when combined, lead to acceptable use levels of a fragrance ingredient. This is the most current and comprehensive publication on the QRA.

A Toxicological and Dermatological Assessment of Cyclic Acetates When Used as Fragrance Ingredients

This RIFM Group Summary, A Toxicological and Dermatological Assessment of Cyclic Acetates When Used as Fragrance Ingredients, is published in the December 2008 special issue of Food and Chemical Toxicology, Volume 46, Supplement 12S. 

These esters are used in decorative cosmetics, fine fragrances, shampoos, toilet soaps and other toiletries as well in non-cosmetic products such as household cleaners and detergents. This group summary of cyclic acetates contains 25 substances which include 15 esters of monocylic alcohols, three of bicyclic alcohols, and seven of tricyclic alcohols.

The Expert Panel is of the opinion that there are no safety concerns regarding cyclic acetates under the present declared levels of use and exposure.

Chemical respiratory allergy and occupational asthma: what are the key areas of uncertainty?

In July 2006 RIFM held a ground-breaking workshop in London that brought together an international panel of scientific experts in chemical respiratory allergy and occupational asthma. The goal of the 2-day workshop was to develop a path towards solving the most pressing issues in this area, mainly methodology and models to identify and characterize the materials that have the potential to induce chemical respiratory allergy, occupational asthma and other related health effects. The review of this workshop Chemical respiratory allergy and occupational asthma: what are the key areas of uncertainty? by Daniel Isola, Ian Kimber, Katherine Sarlo, Jon Lalko and I. Glenn Sipes was published in the April 2008 issue of the Journal of Applied Toxicology.

Evaluating inhalation safety of fragrances

Fragrances are intended to be enjoyed through the sense of smell. Therefore, one primary route of exposure to fragrance materials is inhalation. The Research Institute for Fragrance Materials (RIFM) has an active scientific program to verify the inhalation safety of fragrance materials. With a multi-faceted approach, RIFM has established projects to identify parameters of sensitization, estimate potential physiological fate and effects using a computational fluid dynamics model, and calculate air concentrations to determine potential inhalation exposure based on human ventilation. Within this comprehensive program, RIFM has also taken the initiative to develop alternative research methods. The Respiratory Sciences Program at RIFM is designed to further support the safe use of fragrances.

Fragrance and Cosmetics - Sharing Strategies
Read this interview with Dr. Ladd W. Smith, President of RIFM, from the article, Fragrance and Cosmetics - Sharing Strategies that appeared in the January 2006 Cosmetics & Toiletries magazine, Vol. 121, No.1, p.84 Read More >

Fragrance materials and the environment - is there a risk?
Written by Daniel Salvito, RIFM; Ronald Senna, IFF and Colin McIntosh, Firmenich, this article appeared in the Learned Discourses section of the October 2006 SETAC Globe. Read More >

More recent studies on fragrances (Letter)
Published in Environmental Health Perspectives, Vol. 112:15:A865, November 2004. This is a rebuttal to an earlier letter from Curtis, L., 2004, Toxicity of fragrances, published in Environmental Health Perspectives in June, 112:A461. Read More >

Quantitative Risk Assessment (QRA) DATA FORM FOR CATEGORIZATION OF PRODUCT TYPES

The introduction of the QRA as the basis for IFRA Standards on ingredients exhibiting a potential for dermal sensitisation led to the Standards having individual restrictions for 11 product categories. The categories were achieved by grouping consumer product types according to key parameters identified within the QRA approach. These parameters are Sensitization Assessment Factors (SAFs) and consumer product exposure, which when combined, lead to similar acceptable use levels of a fragrance ingredient. In cases, where a product is not currently categorized and where the likely consumer product exposure is clearly different or where the matrix may indicate a higher degree of potential penetration or irritation, then it is incumbent on the fragrance supplier to contact the IFRA secretariat (secretariat@ifraorg.org) for advice on appropriate product categorization. This would lead to a modification of the IFRA/RIFM Information Booklet and the IFRA membership and stakeholders would be adequately informed about the change(s).

There is critical information that is necessary to classify new product applications, so far not included in the system, or to reclassify existing entries. RIFM and IFRA have developed a form to help those who would like to have a new product type classified.

Information should either be sent to Anne Marie Api at RIFM (amapi@rifm.org) or Matthias Vey at IFRA (mvey@ifraorg.org). Requests for (re)-categorization should reach either IFRA or RIFM before the end of October each year so they can be included in the update of the QRA-Information booklet that will be issued with the next IFRA Amendment the following spring.

In the absence of sufficient information, product types will be categorized using a conservative approach.

To download the form, click on the link here.

Quantitative Risk Assessment (QRA) Information Booklet July 2009

Based on the Expert Panel’s recommendation, RIFM and IFRA formally agreed to adopt 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 is used to determine global fragrance industry product management practices (IFRA Standards) for potentially sensitizing fragrance ingredients, the first of which was implemented in April 2006.

Given the impact of this major change, it is important that global fragrance suppliers and users are fully informed about the changes and the implementation of this approach. It affects them in terms of the identification of acceptable levels of fragrance ingredients in different product types and how to manage this on a practical basis through grouping of certain product types into product categories.

The purpose of this booklet is to provide basic guidance on the implementation of the QRA approach to fragrance suppliers and users.  It will specifically provide information on:

• how new IFRA Standards will be set
• how existing IFRA Standards will be handled
• what should be expected in future IFRA Amendments to the Code of Practice
• definition of the IFRA categories
• relevant product types included in each category

This booklet is a dynamic document that will change and require periodic updating.  As such, it will be important to check that any printed copy has an issue date (located at the bottom of each page of this booklet) that agrees with the issue date published on either the RIFM or IFRA web site to be sure you have the most current issue. The current issue date is July 2009.

Quantitative Risk Assessment (QRA) Technical Dossier Rev 2006 06 22

This QRA Technical Dossier is the latest revision from the expert group that was convened by the COLIPA Toxicology Advisory Group and the Joint COLIPA/AISE/EFFA/IFRA Perfume Safety Group to address dermal sensitization risk assessment for fragrance ingredients.  Read about their work and recommendations for using an exposure-based Quantitative Risk Assessment (QRA) methodology for fragrance ingredients.

RIFM/IFRA: watching the back of the fragrance industry
The fragrance industry's self-regulation through the coordinated activities of RIFM and IFRA is profiled in this article from the February 28, 2005 issue of Cosmetic World Read More >

Roles in the safe use of fragrance materials
This article appeared in the Jan/Feb 2005 issue of Perfumer & Flavorist. Read More >

Toxicologic and Dermatologic Assessments for Three Groups of Fragrance Ingredients: 1) Related Esters and Alcohols of Cinnamic Acid and Cinnamic Alcohol; 2) Ionones; 3) Salicylates

RIFM has released three more Group Summaries and their related Fragrance Material Reviews (FMRs) for publication in a Special Supplement of Food and Chemical Toxicology, Volume 45, Supplement 1, 2007. These materials were among the high priority list of fragrance materials selected for review and will serve as the basis for the dermatological and toxicological evaluation for the group.

The three Group Summaries and 70 FMRs were authored by RIFM’s Expert Panel (REXPAN) and RIFM staff, respectively.  The group assessment approach is based on structural relationship that enables consistency in predicting metabolism and toxicity. It also conserves resources by reducing duplicate testing. These publications provide the scientific and regulatory communities with all the toxicological data available to RIFM on these fragrance ingredients. And, they provide the RIFM Expert Panel’s safety assessment of these groups of fragrance ingredients. The Group Summaries and related FMR’s also continue to be the supporting structure of RIFM’s safety assurance program and a key part of the RIFM proactive program. They also will be usd by industry to meet REACH requirements.