- Background
Ecoflora is a Colombian company developing natural color solutions from biodiversity, including Jagua Blue, a natural blue colorant derived from the jagua fruit. As part of its growth strategy, Ecoflora is pursuing regulatory approval for the use of Jagua Blue in new applications and markets, including its proposed use in pet foods in the United States.
The proposed use of Jagua Blue in pet foods in the United States is subject to the regulatory process of the U.S. Food and Drug Administration (FDA) under Color Additive Petition (CAP) 6C0341, concerning the proposed use of jagua (genipin-glycine) blue as a color additive in pet foods.
Through the IDH reVive Hub, Ecoflora is receiving technical assistance to strengthen its market readiness and address key regulatory and technical requirements associated with the expansion of Jagua Blue into new markets. As part of this support, additional scientific information is required as part of the FDA regulatory process, including an animal feeding study to support the proposed use of Jagua Blue in pet foods.
This Terms of Reference is intended to support Ecoflora in identifying a qualified laboratory to design, conduct and report the animal feeding study, including preparation of the study protocol, support during the regulatory review process, study implementation, data analysis and preparation of the final study report.
- Objective
The objective of this assignment is to design, conduct and report an animal feeding study to generate the scientific evidence required to support Ecoflora’s regulatory process for the proposed use of Jagua Blue in pet foods under FDA Color Additive Petition (CAP) 6C0341.
The selected entity will be expected to propose and implement a scientifically sound study design that is appropriate for the intended regulatory purpose and consistent with the study parameters outlined in these Terms of Reference.
- Scope of Services
The assignment is expected to cover the development, regulatory review, implementation and reporting of an animal feeding study in support of Ecoflora’s regulatory process.
- Study design and protocol development:
The selected entity will be responsible for developing the detailed study protocol based on the study parameters outlined in these Terms of Reference and the information provided by Ecoflora.
The study design and protocol should address, at a minimum, the following parameters:
- Species: The study may be conducted in both dogs and cats. A study in cats only is also acceptable.
- Number of animals: Each experimental animal group should include a minimum of twelve animals.
- Age and sex: There is no age range requirement, and an equal split between the sexes is not required.
- Test food: Wet pet food with Jagua Blue incorporated should be used as the test food.
- Test food formulation: The test food may consist of formulated wet pet food with Jagua Blue incorporated at the proposed inclusion levels, or commercial wet pet food that does not contain other color additives, with Jagua Blue incorporated at the proposed inclusion levels.
- Nutritional requirements: The test food should meet the applicable minimum nutrient requirements established by the Association of American Feed Control Officials (AAFCO).
- Jagua Blue inclusion levels: The test food should incorporate Jagua Blue at the proposed maximum use level, and the study should include at least two different inclusion levels.
- Control food: There should be no variability between the control food and the test food other than the incorporation of Jagua Blue.
- Study design: The feeding study may follow either a two-arm design or a crossover design. If a crossover design is used, the study should include a washout period of at least two weeks.
- Feeding period: The feeding period should be a minimum of two weeks.
- Monitoring: Urine color and feces color should be monitored daily throughout the feeding study.
- Serum bilirubin: Serum bilirubin levels should be assessed at baseline and at the end of the study.
The quotation should describe the entity’s proposed approach to developing the study design and protocol.
- Regulatory protocol review
The selected entity will prepare the study protocol and support Ecoflora in submitting it for regulatory review prior to commencement of the feeding study.
The selected entity will also support Ecoflora in addressing comments received through the review process and incorporating any necessary revisions to the protocol.
FDA indicated that its review of feeding study protocols typically takes approximately 45 days. This period should be incorporated into the proposed timeline as a separate stage before commencement of the feeding study.
- Study Implementation
Following completion of the applicable protocol review and Ecoflora’s authorization to proceed, the selected entity will conduct the feeding study in accordance with the final agreed protocol.
The study will include the parameters described in Section 3.1, including the agreed test and control foods, Jagua Blue inclusion levels, feeding period, daily monitoring of urine and feces color, and serum bilirubin assessments at baseline and at the end of the study.
- Data analysis and final study report
The selected entity will analyze and report the data generated through the study, including the serum bilirubin measurements and daily urine and feces color observations.
The final study report should document the study design, methodology, implementation, results and interpretation and provide the scientific information generated through the study for Ecoflora’s regulatory process.
- Proposal / Quotation Requirements
The quotation should include:
- A brief description of the proposed approach and study design;
- The estimated timeline for the protocol development, regulatory review, study implementation and final report;
- A brief description of the entity’s relevant experience and capabilities; and
- A detailed cost estimate for the proposed services.
The quotation should clearly identify any assumptions or relevant exclusions.
- Required Experience and Capabilities
The entity should demonstrate:
- Relevant experience in designing and conducting animal feeding studies;
- Experience with dogs and/or cats, as applicable to the proposed study design;
- Appropriate facilities and technical capabilities to conduct the proposed study; and
- Experience preparing scientific or technical reports for regulatory purposes.
The entity should also have the personnel, facilities and any applicable certifications, accreditations or regulatory authorizations required to conduct the proposed study.
- Confidentiality, Data and Contracting
The selected entity will be contracted directly by Ecoflora.
All information provided by Ecoflora in connection with the assignment, as well as data and documentation generated through the study, shall be treated as confidential and used solely for the purposes of the assignment and the related regulatory process.
The final agreement will define the applicable terms regarding scope of services, deliverables, fees, confidentiality, data, intellectual property and other contractual matters.
- Procurement and Compliance
The procurement and contracting process will be conducted in accordance with Ecoflora’s applicable procurement procedures and any requirements applicable to the use of IDH reVive and CI-GEF funding.
Where applicable, the selected entity will be required to comply with relevant contractual and CI-GEF requirements, including provisions relating to legal and sanctions screening, record keeping, confidentiality and data protection, intellectual property, audit and access to records, and other applicable compliance requirements.
- Submission of Proposals and Contact Information
Interested entities are invited to submit their quotations by 16/10/2026
For questions and clarifications:
Laura Alzate Blandón / Technical Manager
desarrollos@ecofloracares.com
Submission of quotations:
desarrollos@ecofloracares.com
Please include “Animal Feeding Study – CAP 6C0341” in the subject line of the email.
Questions may be submitted until 09/10/2026
Submission deadline: 16/10/2026