Food Safety Substance
Arachidonic acid
Arachidonic acid is a food additive with Not novel food (present in foods) in the EU, Notice does not provide a basis for a GRAS determination in the US, and data from 6 regulatory sources.
Substance Identity
Resolved identifiers used to render this food-safety record.
Multi-Jurisdiction Comparison
Side-by-side status rows for the same resolved substance across public food regulators.
| Jurisdiction | Authority | Status | Evidence |
|---|---|---|---|
| European Union | EU Commission | Not novel food (present in foods) | - |
| United States | FDA | Notice does not provide a basis for a GRAS determination | GRAS notice |
FDA GRAS Status
US FDA GRAS notice evidence from enriched and notice tables.
| Jurisdiction | GRN | Substance | FDA response | Intended use | Basis | Notifier |
|---|---|---|---|---|---|---|
| United States | 7 | ARASCO (arachidonic acid-rich single-cell oil) and DHASCO (docosahexaenoic acid-rich single-cell oil) as sources of the fatty acids ARA (arachidonic acid) and DHA (docosahexaenoic acid) | Notice does not provide a basis for a GRAS determination | ARASCO as a source of ARA and DHASCO as a source of DHA in infant formula | Scientific procedures | Wyeth Nutritionals International |
| United States | 41 | DHASCO (docosahexaenoic acid-rich single-cell oil) and ARASCO (arachidonic acid-rich single-cell oil) | FDA has no questions | Provide DHASCO (as a source of docosahexaenoic acid) and ARASCO (as a source of arachidonic acid) in term infant formula, at a maximum level of 1.25 percent each of the total... | Scientific procedures | Martek Biosciences Corporation |
| United States | 80 | ARASCO (arachidonic acid-rich single-cell oil) | FDA has no questions | Provide ARASCO (as a source of arachidonic acid) in term infant formula, at a maximum level of 1.88 percent of total dietary fat when used in combination with DHASCO... | Scientific procedures | Mead Johnson Nutritionals |
| United States | 94 | Docosahexaenoic acid-rich oil from tuna (DHA-rich tuna oil) and arachidonic acid-rich oil from Mortierella alpina (AA-rich fungal oil) | FDA has no questions | Provide arachidonic acid (AA) at a mean level of 0.4 percent of total fatty acids and docosahexaenoic acid (DHA) at a mean level of 0.25 percent of total fatty acids in preterm... | Scientific procedures | Ross Products Division, Abbott Laboratories |
| United States | 326 | Arachidonic acid rich oil from M. alpina strain I49-N18 | FDA has no questions | Provide arachidonic acid (ARA), at mean concentrations of 0.75 grams (g) per 100 g total fat for term infants and 0.40 g per 100 g total fat for preterm infants, when used in... | Scientific procedures | Cargill, Inc. |
| United States | 958 | Fungal oil (≥40% arachidonic acid) from Mortierella alpina strain AF | At the notifier's request, FDA ceased to evaluate this notice | Intended for use as an ingredient in cow milk- and soy-based, non-exempt infant formula for term infants and exempt infant formula for pre-term infants at levels of 0.75 g/100 g... | Scientific procedures | Hubei Fuxing Biotechnology Co., Ltd. |
| United States | 963 | Fungal oil (≥40% arachidonic acid) from Mortierella alpina | FDA has no questions | Intended for use as an ingredient in cow milk-and soy-based non-exempt infant formulas for term infants at levels providing up to 0.75% of fat as arachidonic acid (ARA) and in... | Scientific procedures | BASF Corporation |
| United States | 1115 | Fungal oil (≥40% arachidonic acid (ARA)) from Mortierella alpina strain AF | FDA has no questions; some uses may require a color additive listing | Intended for use as an ingredient in cow milk- and soy-based, non-exempt infant formula for term infants at levels providing up to 0.75% of fat as ARA and in exempt infant formula... | Scientific procedures | Hubei Fuxing Biotechnology Co., Ltd. |
| United States | 1162 | Fungal oil (≥38% arachidonic acid (ARA)) from Mortierella alpina FJRK-MA01 | At the notifier's request, FDA ceased to evaluate this notice | Intended for use as an ingredient in cow milk-, goat milk-, soy-, amino acid-, and extensively hydrolyzed protein-based, non-exempt infant formula for term infants and exempt... | Scientific procedures | Runke Bioengineering (Fujian) Co., Ltd. |
| United States | 1186 | Fungal oil (≥38% arachidonic acid (ARA)) from Mortierella alpina "FJRK-MA01" | Notice does not provide a basis for a GRAS determination | Intended for use as an ingredient in cow milk-, goat milk-, soy-, amino acid-, and extensively hydrolyzed protein-based, non-exempt infant formula for term infants and exempt... | Scientific procedures | Runke Bioengineering (Fujian) Co., Ltd. |
| United States | 1259 | Fungal oil (≥40% arachidonic acid (ARA)) from Mortierella alpina strain TKA-1 | FDA has no questions | Intended for use as an ingredient in cow milk- and soy-based, non-exempt infant formula for term infants at levels providing up to 0.75% of fatty acids as ARA and in exempt infant... | Scientific procedures | ATK Biotech Co., Ltd. |
| United States | 7 | ARASCO (arachidonic acid-rich single-cell oil) and DHASCO (docosahexaenoic acid-rich single-cell oil) as sources of the fatty acids ARA (arachidonic acid) and DHA (docosahexaenoic acid) | Notice does not provide a basis for a GRAS determination | ARASCO as a source of ARA and DHASCO as a source of DHA in infant formula | Scientific procedures | Wyeth Nutritionals International |
| United States | 41 | DHASCO (docosahexaenoic acid-rich single-cell oil) and ARASCO (arachidonic acid-rich single-cell oil) | FDA has no questions | Provide DHASCO (as a source of docosahexaenoic acid) and ARASCO (as a source of arachidonic acid) in term infant formula, at a maximum level of 1.25 percent each of the total... | Scientific procedures | Martek Biosciences Corporation |
| United States | 80 | ARASCO (arachidonic acid-rich single-cell oil) | FDA has no questions | Provide ARASCO (as a source of arachidonic acid) in term infant formula, at a maximum level of 1.88 percent of total dietary fat when used in combination with DHASCO... | Scientific procedures | Mead Johnson Nutritionals |
| United States | 94 | Docosahexaenoic acid-rich oil from tuna (DHA-rich tuna oil) and arachidonic acid-rich oil from <i>Mortierella alpina<i> (AA-rich fungal oil) | FDA has no questions | Provide arachidonic acid (AA) at a mean level of 0.4 percent of total fatty acids and docosahexaenoic acid (DHA) at a mean level of 0.25 percent of total fatty acids in preterm... | Scientific procedures | Ross Products Division, Abbott Laboratories |
| United States | 326 | Arachidonic acid rich oil from <i>M. alpina </i>strain I<sub><small>49</small></sub>-N<sub><small>18</small></sub> | FDA has no questions | Provide arachidonic acid (ARA), at mean concentrations of 0.75 grams (g) per 100 g total fat for term infants and 0.40 g per 100 g total fat for preterm infants, when used in... | Scientific procedures | Cargill, Inc. |
| United States | 958 | Fungal oil (≥40% arachidonic acid) from <i>Mortierella alpina</i> strain AF | At the notifier's request, FDA ceased to evaluate this notice (in PDF) | Intended for use as an ingredient in cow milk- and soy-based, non-exempt infant formula for term infants and exempt infant formula for pre-term infants at levels of 0.75 g/100 g... | Scientific procedures | Hubei Fuxing Biotechnology Co., Ltd. |
| United States | 963 | Fungal oil (≥40% arachidonic acid) from <i>Mortierella alpina</i> | FDA has no questions (in PDF) | Intended for use as an ingredient in cow milk-and soy-based non-exempt infant formulas for term infants at levels providing up to 0.75% of fat as arachidonic acid (ARA) and in... | Scientific procedures | BASF Corporation |
| United States | 1115 | Fungal oil (≥40% arachidonic acid (ARA)) from <i>Mortierella alpina</i> strain AF | FDA has no questions; some uses may require a color additive listing (in PDF) | Intended for use as an ingredient in cow milk- and soy-based, non-exempt infant formula for term infants at levels providing up to 0.75% of fat as ARA and in exempt infant formula... | Scientific procedures | Hubei Fuxing Biotechnology Co., Ltd. |
| United States | 1162 | Fungal oil (≥38% arachidonic acid (ARA)) from <i>Mortierella alpina</i> FJRK-MA01 | At the notifier's request, FDA ceased to evaluate this notice (in PDF) | Intended for use as an ingredient in cow milk-, goat milk-, soy-, amino acid-, and extensively hydrolyzed protein-based, non-exempt infant formula for term infants and exempt... | Scientific procedures | Runke Bioengineering (Fujian) Co., Ltd. |
| United States | 1186 | Fungal oil (≥38% arachidonic acid (ARA)) from <i>Mortierella alpina</i> FJRK-MA01 | Notice does not provide a basis for a GRAS determination (in PDF) | Intended for use as an ingredient in cow milk-, goat milk-, soy-, amino acid-, and extensively hydrolyzed protein-based, non-exempt infant formula for term infants and exempt... | Scientific procedures | Runke Bioengineering (Fujian) Co., Ltd. |
| United States | 1259 | Fungal oil (≥40% arachidonic acid (ARA)) from <i>Mortierella alpina</i> strain TKA-1 | FDA has no questions (in PDF) | Intended for use as an ingredient in cow milk- and soy-based, non-exempt infant formula for term infants at levels providing up to 0.75% of fatty acids as ARA and in exempt infant... | Scientific procedures | ATK Biotech Co., Ltd. |
EU FCM Substances
EU food-contact material rows and migration-limit fields.
| Jurisdiction | FCM no. | Ref no. | Substance | Use | SML | Regulation |
|---|---|---|---|---|---|---|
| European Union | 518 | 35845 | arachidonic acid | additive/PPA | - | Regulation (EU) No 10/2011, Annex I |
Cross-Reference to Cosmetics / Chemicals / Pharma
Same-CAS public rows from adjacent Roots verticals where available.
Cross-Vertical Regulatory Divergence
This substance has different regulatory treatment across food, cosmetics, and industrial use.
Frequently Asked Questions
Food-use, safety, ADI, and cross-vertical answers mirrored into FAQPage JSON-LD.
What is Arachidonic acid used for in food?
Arachidonic acid appears in food-use rows as: other.
Is Arachidonic acid safe?
This page does not assign a standalone safety verdict; it renders public regulatory evidence. EU status evidence: Not novel food (present in foods). US/FDA evidence: Notice does not provide a basis for a GRAS determination.
What is the ADI for Arachidonic acid?
No ADI row was found for Arachidonic acid in the rendered EFSA, food_substances, food_additives, or JECFA tables.
Is Arachidonic acid also used in cosmetics?
Arachidonic acid has a same-CAS cosmetics cross-reference: ARACHIDONIC ACID, EU status permitted.