Constraints/Criteria

Constraints

• The design must not affect the downstream process

• The design must not change the already existing lipid yield

• The design must increase profitability by recovering high-value proteins

• The design must follow environmental and safety regulations

• The design must be scalable to fit the existing plant

Criteria

• Must reach a protein purity of 95%

• Reach profitability in 5 years

• Must maintain 85% lipid retention

Standards and Specifications

• FDA Regulations:

  • Generally Recognized as Safe (GRAS) notice - organism safety and biotoxicity

  • Title 21 of the United States Code of Federal Regulations -Medium, solvents, and additives

  • Food Chemicals Codex grade - mediums solvents, and additives

• European Standards applicable to Microalgae:

  • Regulation EC 178/2002 – general food safety regulations

  • Regulation EC 258/1997 – novel food ingredients safety

  • Regulation EC 396/2005 – maximum residue levels from pesticides, feed, or organism

  • Regulation EC 1881/2006 – maximum contamination levels (extensive list of toxins and hazards)

References

TK Biohealth. GRAS Determination for the Use of Algal Oil from Schizochytrium limacinum. (2021, May 7). Retrieved October 13, 2022, from https://www.fda.gov/media/156122/download 

Garcia-Vaquero, M. (2020, November 20). Food applications. Retrieved November 7, 2022, from https://doi.org/10.1016/B978-0-12-821218-9.00008-6