| Category: |
| flavor and fragrance agents |
| RIFM Fragrance Material Safety Assessment: Search |
| IFRA Code of Practice Notification of the 49th Amendment to the IFRA Code of Practice |
| IFRA Critical Effect: |
| Phototoxicity |
| IFRA fragrance material specification: |
| Where the bergapten (5-methoxypsoralen) content of all relevant oils present in a compound has been determined, it is recommended that for applications on areas of skin exposed to sunshine, excluding bath preparations, soaps and other products which are washed off the skin, the total level of bergapten in the consumer products should not exceed 0.0015% (15 ppm). This is equivalent to 0.0075% (75 ppm) in a fragrance compound used at 20% in the consumer product. Where the level of bergapten has not been determined by appropriate methods, the limits specified in the guidelines on individual oils should apply. In those cases, where such oils are used in combination with other phototoxic ingredients, the additive effect has to be taken into consideration and the use levels have to be reduced accordingly. The sum of the concentrations of all phototoxic fragrance ingredients, expressed in % of their recommended maximum level in the consumer product, shall not exceed 100. exceed 0.0015% (15 ppm). This is equivalent to 0.0075% (75 ppm) in a fragrance compound used at 20% in the consumer product. Where the level of bergapten has not been determined by appropriate methods, the limits specified in the guidelines on individual oils should apply. In those cases, where such oils are used in combination with other phototoxic ingredients, the additive effect has to be taken into consideration and the use levels have to be reduced accordingly. The sum of the concentrations of all phototoxic fragrance ingredients, expressed in % of their recommended maximum level in the consumer product, shall not exceed 100. |
| contains the following IFRA (Annex) restricted components: (non-analysis max. level reference only) |
| citral | Max. Found: 0.7 % and Reason: Sensitization |
| geraniol | Max. Found: 0.1 % and Reason: Sensitization |
| 7-methoxycoumarin | Max. Found: 0.01 % and Reason: Sensitization, photosensitization |
| View the IFRA Standard |
| View IFRA Standards Library for complete information. |
| Please review Amendment 49 IFRA documentation for complete information. |
| IFRA RESTRICTION LIMITS IN THE FINISHED PRODUCT (%): |
| Category 1: Products applied to the lips |
| 0.40 % |
| Category 2: Products applied to the axillae |
| 0.40 % |
| Category 3: Products applied to the face/body using fingertips |
| 0.40 % |
| Category 4: Products related to fine fragrance |
| 0.40 % |
| Category 5: Products applied to the face and body using the hands (palms), primarily leave-on |
| Category 5A: Body lotion products applied to the body using the hands (palms), primarily leave-on |
| 0.40 % |
| Category 5B: Face moisturizer products applied to the face using the hands (palms), primarily leave-on |
| 0.40 % |
| Category 5C: Hand cream products applied to the hands using the hands (palms), primarily leave-on |
| 0.40 % |
| Category 5D: Baby Creams, baby Oils and baby talc |
| 0.40 % |
| Category 6: Products with oral and lip exposure |
| 0.40 % |
| Category 7: Products applied to the hair with some hand contact |
| Category 7A: Rinse-off products applied to the hair with some hand contact |
| No Restriction % |
| Category 7B: Leave-on products applied to the hair with some hand contact |
| 0.40 % |
| Category 8: Products with significant anogenital exposure |
| 0.40 % |
| Category 9: Products with body and hand exposure, primarily rinse off |
| No Restriction % |
| Category 10: Household care products with mostly hand contact |
| Category 10A: Household care excluding aerosol products (excluding aerosol/spray products) |
| No Restriction % |
| Category 10B: Household aerosol/spray products |
| 0.40 % |
| Category 11: Products with intended skin contact but minimal transfer of fragrance to skin from inert substrate |
| Category 11A: Products with intended skin contact but minimal transfer of fragrance to skin from inert substrate without UV exposure |
| No Restriction % |
| Category 11B: Products with intended skin contact but minimal transfer of fragrance to skin from inert substrate with potential UV exposure |
| 0.40 % |
| Category 12: Products not intended for direct skin contact, minimal or insignificant transfer to skin |
| No Restriction |
| Notes: |
| IFRA FLAVOR REQUIREMENTS: |
Due to the possible ingestion of small amounts of fragrance ingredients from their use in products in Categories 1 and 6, materials must not only comply with IFRA Standards but must also be recognized as safe as a flavoring ingredient as defined by the IOFI Code of Practice (www.iofi.org). For more details see chapter 1 of the Guidance for the use of IFRA Standards. |
|
| Use levels for FEMA GRAS flavoring substances on which the FEMA Expert Panel based its judgments that the substances are generally recognized as safe (GRAS). |
| The Expert Panel also publishes separate extensive reviews of scientific information on all FEMA GRAS flavoring substances and can be found at FEMA Flavor Ingredient Library |
| publication number: 3 |
| Click here to view publication 3 |
| average usual ppm | average maximum ppm |
| baked goods: | - | 29.00000 |
| beverages(nonalcoholic): | - | 8.90000 |
| beverages(alcoholic): | - | - |
| breakfast cereal: | - | - |
| cheese: | - | - |
| chewing gum: | - | 43.00000 |
| condiments / relishes: | - | - |
| confectionery froastings: | 1.00000 | 130.00000 |
| egg products: | - | - |
| fats / oils: | - | - |
| fish products: | - | - |
| frozen dairy: | - | 7.90000 |
| fruit ices: | - | 7.90000 |
| gelatins / puddings: | 5.30000 | 90.00000 |
| granulated sugar: | - | - |
| gravies: | - | - |
| hard candy: | - | 27.00000 |
| imitation dairy: | - | - |
| instant coffee / tea: | - | - |
| jams / jellies: | - | - |
| meat products: | - | - |
| milk products: | - | - |
| nut products: | - | - |
| other grains: | - | - |
| poultry: | - | - |
| processed fruits: | - | - |
| processed vegetables: | - | - |
| reconstituted vegetables: | - | - |
| seasonings / flavors: | - | - |
| snack foods: | - | - |
| soft candy: | - | - |
| soups: | - | - |
| sugar substitutes: | - | - |
| sweet sauces: | - | - |