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Resource center Editor

Saura Sahu
Center for Food Safety and Applied Nutrition
College Park, MD, USA
Saura Sahu reports no conflicts of interest with the content of this Resource Center.

About this resource center

The Research Institute for Fragrance Materials (RIFM) has partnered with Elsevier on the Food and Chemical Toxicology Fragrance Material Safety Assessment Center to provide open access to RIFM’s peer-reviewed Safety Assessments and related papers and research.

RIFM Safety Assessments are written according to the guidelines outlined in the Criteria for the Research Institute for Fragrance Materials (the “Criteria Document”) safety evaluation process for fragrance ingredients. The Criteria Document provides guidance on conducting safety assessments and is designed to incorporate the best science to appropriately evaluate fragrance ingredients using the latest testing strategies and methods.

The assessments may be found by using the search feature above. Group Studies and Background Studies that predate the Criteria Document may be found in the Historical Data section below.

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For more information on RIFM, visit www.rifm.org.

Webinars

New Webinar

The RIFM approach to evaluating Natural Complex Substances (NCS)

  • Learn how RIFM uses a 4-step approach to provide a comprehensive Safety Assessment of NCS used as a fragrance ingredient.
  • Featuring a team of RIFM Scientists lead by Anne Marie Api and Danielle Botelho
  • Moderated by Saura Sahu

The Creme RIFM Aggregate Exposure ModelEvolution and Innovation in Fragrance Safety Assessment: RIFM at 50

Learn about 50 years of innovation in the safety assessment of raw fragrance matials, the role of RIFM’s Expert Panel, and the latest method of calculating aggregate exposure in consumers.

Assessing the Safety of Fragrance Materials: What are the Criteria?

Join a panel of experts as they detail the latest updates to the criteria used to evaluate the safety of fragrance ingredients.

Criteria Documents

Criteria for the Research Institute for Fragrance Materials, Inc. (RIFM) Safety Evaluation Process for Fragrance Ingredients

Api AM, Belsito D, Bruze M, et al

This Criteria Document details recent updates to the RIFM safety assessment process, reflecting advances in approaches in risk assessment and new and classical toxicological methodologies employed by RIFM over the past 10 years.

These changes include incorporating:
  • New scientific information including a framework for choosing structural analogs
  • Consideration of the Threshold of Toxicological Concern (TTC)
  • Quantitative Risk Assessment (QRA) for dermal contact sensitization
  • Respiratory route of exposure
  • Aggregate exposure assessment methodology
  • Latest methodology and approaches to risk assessments
  • Latest alternatives to animal testing methodology
  • Environmental risk assessment
The RIFM approach to evaluating Natural Complex Substances (NCS)

Api AM, Belsito D, Botelho D, et al

RIFM has evaluated safety data for fragrance materials for 55 years. The safety assessment of Natural Complex Substances (NCS) is similar to that of discrete fragrance materials; all of the same endpoints are evaluated. A series of decision trees follows a tiered approach for each endpoint using a 4-step process with testing only as a last resort. This process aims to provide a comprehensive Safety Assessment of NCS used as a fragrance ingredient.

  • Using the foundation of the 2015 Criteria II Document, published in 2015, RIFM employs a multi-step process to evaluates NCS.
  • A series of decision trees follows a tiered approach for each endpoint.
  • Learn how RIFM's 4-step process is used to provide a comprehensive Safety Assessment of NCS used as a fragrance ingredient.

Feature Articles

Clustering a Chemical Inventory for Safety Assessment of Fragrance Ingredients: Identifying Read-Across Analogs to Address Data Gaps

Date MS, O’Brien D, Botelho DJ, et al

A valuable approach to chemical safety assessment is the use of read-across chemicals to provide safety data to support the assessment of structurally similar chemicals.
Bolstering the Existing Database Supporting the Non-Cancer Threshold of Toxicological Concern Values with Toxicity Data on Fragrance-Related Materials

Patel A, Joshi K, Rose J, et al

The use of threshold of toxicological concern (TTC) supports the safety assessment of exposure to low levels of chemicals when toxicity data are limited. A major goal for the RIFM safety assessment program is to invest in alternative methods to animal testing for use in assessment of fragrance materials.
Application of the Dermal Sensitization Threshold Concept to Chemicals Classified as High Potency Category for Skin Sensitization Assessment of Ingredients for Consumer Products

Nishijo T, Api AM, Gerberick GF, et al

Skin sensitization evaluation is a key part of the safety assessment of ingredients in consumer products, which may have skin sensitizing potential.
Updating Exposure Assessment for Skin Sensitization Quantitative Risk Assessment for Fragrance Materials

Api AM, Basketter D, Bridges J, et al

This revision of the Quantitative Risk Assessment 1 (QRA1), termed QRA2, provides an improved method for establishing safe levels for sensitizing fragrance materials in multiple products to limit the risk of induction of contact allergy.
Fragrance Skin Sensitization Evaluation and Human Testing: 30-Year Experience

Fragrance Skin Sensitization Evaluation and Human Testing: 30-Year Experience

The human repeated insult patch test (HRIPT) has a history of use in the fragrance industry as a component of safety evaluation, exclusively to confirm the absence of skin sensitization at a defined dose. The aim of the study was to document the accumulated experience from more than 30 years of conducting HRIPTs.
Dermal Sensitization Quantitative Risk Assessment (QRA) for Fragrance Ingredients

Api AM, Basketter DA, Cadby PA, et al

Based on chemical, cellular, and molecular understanding of dermal sensitization, an exposure-based quantitative risk assessment (QRA) can be conducted to determine safe use levels of fragrance ingredients in different consumer product types.
Implementation of the Dermal Sensitization Quantitative Risk Assessment (QRA) for Fragrance Ingredients

Api AM, Vey M

Significant developments have recently been incorporated in the way dermal sensitization risk assessments are conducted for fragrance ingredients.
The Research Institute for Fragrance Materials’ Human Repeated Insult Patch Test Protocol

Politano VT, Api AM

With implementation of the dermal sensitization QRA approach for fragrance ingredients, IFRA/RIFM are recommending use of the RIFM standard human repeated insult patch test (HRIPT) protocol for generation of confirmatory human data for the induction of dermal sensitization in a normal human population.
Use of an Aggregate Exposure Model to Estimate Consumer Exposure to Fragrance Ingredients in Personal Care and Cosmetic Products

Safford B, Api AM, Barratt C, et al

Ensuring the toxicological safety of fragrance ingredients used in personal care and cosmetic products is essential in product development and design, as well as in the regulatory compliance of the products.
Extension of the Dermal Sensitisation Threshold (DST) Approach to Incorporate Chemicals Classified as Reactive

Safford RJ, Api AM, Roberts DW, Lalko JF

The evaluation of chemicals for their skin sensitising potential is an essential step in ensuring the safety of ingredients in consumer products.
Principles for identification of High Potency Category Chemicals for Which the Dermal Sensitisation Threshold (DST) Approach Should Not be Applied

Roberts DW, Api AM, Safford RJ, Lalko JF

An essential step in ensuring the toxicological safety of chemicals used in consumer products is the evaluation of their skin sensitising potential.
Integrating Habits and Practices Data for Soaps, Cosmetics and Air Care Products into an Existing Aggregate Exposure Model

Comiskey D, Api AM, Barrett C, et al

In order to accurately assess aggregate exposure to a fragrance material in consumers, data are needed on consumer habits and practices, as well as the concentration of the fragrance material in those products.
Application of the Expanded Creme RIFM Consumer Exposure Model to Fragrance Ingredients in Cosmetic, Personal Care and Air Care Products

Safford B, Api AM, Barrett C, et al

As part of a joint project between the Research Institute for Fragrance Materials (RIFM) and Crème Global, a Monte Carlo model (here named the Creme RIFM model) has been developed to estimate consumer exposure to ingredients in personal care products.
Novel Database for Exposure to Fragrance Ingredients in Cosmetics and Personal Care Products

Comiskey D, Api AM, Barratt C, et al

Exposure of fragrance ingredients in cosmetics and personal care products to the population can be determined by way of a detailed and robust survey.
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Historic Data

Group Summaries
Monographs Prior to 2003, RIFM produced over 1,000 safety assessment monographs. Click here for a listing of these publications.
Background Studies
The Safety Assessment of Fragrance Materials

Bickers DR, Calow P, Greim HA, et al

Safety evaluation of the large number of diverse chemicals used as fragrance ingredients follows a systematic prioritization of data generation and analysis, consideration of exposure and critical analysis of the quality of the available information.

Criteria for Development of a Database for Safety Evaluation of Fragrance Ingredients

Ford RA, Domeyer B, Easterday O, et al

Over 2000 different ingredients are used in the manufacture of fragrances. The majority of these ingredients have been used for many decades.

Consumer Exposure to Fragrance Ingredients: Providing Estimates for Safety Evaluation

Peter A. Cadby, William R. Troy, Matthias G. H. Vey

To fully apply already published procedures for the safety evaluation of fragrance ingredients, it is necessary to estimate exposure through different routes and leading to different potential endpoints.

About RIFM Safety Assessments

Information for reviewers image description

Introduction to RIFM Safety Assessments

RIFM evaluates available data and sponsors studies for relevant toxicological endpoints for local and systemic human health effects, including genotoxicity, repeated dose and reproductive toxicity, skin sensitization, photoirritation/photoallergenicity, and local respiratory toxicity. RIFM also sponsors testing and academic research on the fate and effects of fragrance materials in water, soil, sediments, and air, working closely with international research organizations to assess the behavior and risk of chemicals in the environment.

RIFM compiles its findings, along with other relevant data, into Safety Assessments for each material currently in use by the fragrance industry. The Expert Panel for Fragrance Safety, an independent, international team of researchers and academics with no ties to the fragrance industry, reviews and must approve all of RIFM’s Safety Assessments before RIFM submits them for peer-reviewed publication.

RIFM Safety Assessments are dynamic, “living” documents, and RIFM reevaluates materials on a rolling five-year basis to help ensure safe conditions of use. When a Safety Assessment is updated and published, only the most up-to-date version will be available on this resource center. (Previous versions of the safety assessments will always be available on the Food and Chemical Toxicology site or from Science Direct.) A list of RIFM safety assessments that have been reviewed with no changes will also appear on this resource center.

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