Fish Oil

Many species are used in the production of fish oils. However, the majority are derived from fatty fish and the liver of lean fish. The commonly used raw materials include, but are not limited to, menhaden, sardines, anchovies, herring, capelin, mackerel, salmon, tuna and cod liver. In addition to bony fish, some fish oil and fish liver oil can be obtained from cartilaginous fish, such as sharks. Shark and cod are the two main fish whose livers are extracted for oil. While sharks are specifically targeted for their livers, cod livers are taken as a by-product along with the roe. Fish oil intended for human consumption must comply with the requirements for fishery products. The difference between fish oil and other oils is mainly the unique variety of fatty acids. Marine oils are excellent sources of polyunsaturated fatty acids (PUFAs), mainly longchain omega-3 fatty acids, also sometimes referred to as n-3 fatty acids. The amount and variety of the fatty acids in fish oil varies from one fish species to another with the biological stage, food availability, fishing location, ocean temperature, nutritional and spawning state. The major omega-3 fatty acids present in fish oils are eicosapentaenoic acid (C20/5 omega-3, commonly called EPA) and the docosahexaenoic acid (C22/6 omega-3, commonly entitled DHA).

Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API). This monograph also contains the acceptable daily exposure (ADE) value.

Please note: Due to the complexity and amount of studies regarding this compound—a Natural Health Product—increased cost is charged.

Fish Oil

CAS Registry Number:
Natural Health Product:
$1,399 USD


Why do you need this OEL Fastrac monograph?

OEL Fastrac monographs are a cost-effective and convenient way to meet the requirements for PDEs (ADEs) contained in the EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/169430/2012), as well as PIC/S and ANVISA requirements, and to obtain the following information:

  • The numerical OEL and control band assignment needed to determine the level of required engineering controls and personal protective equipment
  • A listing of all cited references utilized in the derivation of the OEL and ADE
  • An expert review and discussion with respect to the critical endpoints of concern, the rationale for the choice of endpoints, and dose that is to be used in the derivation of the ADE (PDE), as required by the EMA's Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

Benefits of OEL Fastrac monographs

  • Fully documented. Over 20 pages in length, with calculations and cited references.
  • Save time! Unsurpassed delivery with instant download.
  • Save money. Similar documents cost 5-12 times as much.
  • Stay current. Automatic notification of revisions.

How to order

To order an OEL/ADE monograph for Fish Oil, just click the ADD TO CART button.


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Affygility Solutions’ OEL Fastrac service is an user-friendly system that enables us to make confident decisions and focus on moving the compound safely through our facility. We can quickly access the database to determine if a new drug is within the OEL Fastrac library, and if so, immediately download a detailed OEL banding report. The OEL Fastrac system has been a helpful tool in our overall EH&S program.
  • K. Rosenthal
  • Director of Manufacturing