What does RIFM cover in its safety assessments?
Using up-to-date, cutting-edge science, the Research Institute for Fragrance Materials (RIFM) evaluates six areas (or endpoints) of human health plus environmental impact in its comprehensive safety assessments. Following the protocol of the peer-reviewed RIFM Criteria Document and NCS Criteria Document, RIFM considers the following endpoints to ensure the safe use of fragrance ingredients:
- Genotoxicity refers to an ingredient’s potential to alter or damage the genetic material (DNA, or deoxyribonucleic acid) in the body’s cells. This change in genetic material can occur through mutations in DNA (mutagenicity) or damage to chromosomes (clastogenicity). In the rare event that a fragrance ingredient is shown to have genotoxic potential, it will be banned from use in fragranced products.
- The repeated dose toxicity endpoint evaluates the potential of a fragrance ingredient to cause systemic (i.e., throughout the whole body) adverse effects due to prolonged usage and exposure. In addition to using robust scientific data from existing studies, RIFM uses the Threshold of Toxicological Concern, or TTC, to evaluate repeated dose toxicity. The TTC is a level of exposure beneath which there are no concerns for adverse effects.
- Reproductive toxicity refers to the potential of an ingredient to cause adverse effects on pre-natal (before birth) and post-natal (after birth) development in infants and children (collectively known as developmental toxicity) or on the sexual function in adults (fertility). Like the repeated dose toxicity endpoint, RIFM scientists use existing studies and TTC to evaluate an ingredient’s safe use.
- Skin sensitization refers to the potential of an ingredient to cause a rare allergic reaction on the skin. Using existing study data and real-world exposure levels, RIFM determines a fragrance ingredient’s potential for sensitization. If an ingredient is found to be a potential skin sensitizer, RIFM calculates the Maximum Acceptable Concentration (MAC) values for consumer products and these MAC values are included in the published safety assessment. The International Fragrance Association (IFRA) then sets the IFRA Standards based on these MAC values. The Standards may ban, limit, or set criteria for using certain ingredients based on scientific evidence. Like the repeated dose toxicity and reproduction endpoints, RIFM scientists use existing studies and the Dermal Sensitization Threshold (DST), which is similar to the TTC, to evaluate an ingredient’s safe use.
- The photoirritation/photoallergenicity endpoint evaluates the potential of an ingredient to cause a light-induced skin irritation reaction (photoirritation) or allergic reaction (photoallergenicity). If a fragrance ingredient causes a photoirritation reaction, RIFM calculates the Maximum Acceptable Concentration (MAC) values for all consumer products. The International Fragrance Association (IFRA) then sets the IFRA Standards based on these MAC values. If a fragrance ingredient causes a photoallergic reaction, then it will be banned from use in fragranced products.
- Local Respiratory toxicity refers to an ingredient’s potential to cause adverse effects in the organs of the respiratory system (such as the lungs). Data have shown that 99% of all fragrance ingredients fall below the most conservative TTC and present no risk of adverse effects. Additionally, there are no known respiratory-sensitizing fragrance ingredients.
- Environmental toxicity refers to the potential impact of an ingredient on aquatic environment. RIFM evaluates both environmental risk and hazard. Risk is evaluated following the 2002 RIFM framework, whereas hazard evaluation follows the EU REACH criteria for Persistent, Bioaccumulative, or Toxic (PBT). Both assessments are conducted using a combination of the volume of use of each ingredient (IFRA VoU survey, conducted every four years), its physical-chemical properties, in silico (“in a computer”) models, and existing studies.
To further enhance our understanding of these endpoints, RIFM is active in collaborative projects with scientists worldwide to develop new and reliable ways to assess the safety of fragrance ingredients. These “New Approach Methodologies” (NAMs) are being developed as animal-alternative testing strategies.
Danielle Botelho, PhD, is Safety Assessment Manager for the Research Institute for Fragrance Materials (RIFM).