BRASÍLIA, Brazil—Humane World for Animals welcomes the National Council for the Control of Animal Experimentation’s publication of a rule that recognizes recombinant Factor C (rFC), a non-animal test, as the official method to detect contamination of medical products. This is a milestone in the effort to modernize pharmaceutical quality control and reduce reliance on the traditional horseshoe crab blood-derived test.
The newly implemented rule, Resolution No. 77/2026, acknowledges rFC as an internationally validated method, and marks the beginning of a five-year transition period in which it will replace the horseshoe crab blood-derived test, except in cases where there is a scientifically demonstrated incongruity with the product being tested.
“We commend CONCEA [National Council for the Control of Animal Experimentation] and the government for recognizing rFC as a scientifically robust replacement for the horseshoe crab blood-derived test. This decision aligns Brazil with international regulatory practice, giving laboratories and manufacturers a clear pathway to adopt a method that is accurate, reproducible, sustainable and more humane,” says Bianca Marigliani, senior principal for regulatory science at Humane World for Animals and current coordinator of CONCEA’s Permanent Chamber of Alternative Methods. “Humane World for Animals has worked in Brazil and around the world to support the transition from animal-derived tests to advanced non-animal technologies. This resolution is an important milestone for animal protection and environmental preservation.”
Humane World for Animals has actively supported the transition to rFC and other recombinant technologies in Europe, Brazil, the US, South Korea, India and Indonesia by working with policymakers, regulators, pharmaceutical companies, biopharmaceutical manufacturers and reagent suppliers. In Brazil, the organization has collaborated with leading biopharmaceutical companies, regulators and rFC kit suppliers to create a working group for exchanging technical experience, identifying implementation challenges and supporting regulatory acceptance of the method.
Key provisions in the new resolution include:
- Recognition of rFC as an official method, making recombinant Factor C the official, preferred method for the detection of bacterial endotoxins, rather than an “alternative” option.
- International validation and acceptance, with an acknowledgment that the method has been validated through international studies and achieved international regulatory acceptance.
- Transition from the horseshoe crab blood-derived test, with a period of up to five years for mandatory replacement by rFC..
- Product-specific flexibility, allowing other methods to be considered only in exceptional cases of incompatibility with the product, when technically justified and supported by scientific evidence.
- Alignment with ethical science, centering on the replacement, reduction and refinement of animal use and the adoption of more sustainable quality control technologies.
Moving to the rFC method can help reduce dependence on wild horseshoe crab populations, protect marine ecosystems, strengthen supply chain resilience for endotoxin testing reagents and advance more consistent quality control for medical products. Humane World for Animals will continue working with regulators, industry and scientific partners to accelerate the global adoption of animal-free and animal-sparing technologies that deliver better outcomes for animals, people and the environment.
Humane World for Animals works around the globe to replace cruel, outdated animal experiments with innovative methods that don’t use animals. The teams in Australia, Brazil, Canada, the European Union, India, South Africa, South Korea, the United States and other key economies help change laws, regulations and scientific practices to end testing and research on animals and promote the development, acceptance and use of advanced non-animal methods. Humane World for Animals leads the Animal-Free Safety Assessment Collaboration as well as the Biomedical Research for the 21st Century Collaboration, multi-sector, multi-country partnerships advancing animal-free science as the gold standard.
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Note to editors:
- Endotoxin testing is an essential quality control step for injectable medicines, vaccines and other parenteral products because endotoxins can cause fever and severe adverse reactions if they contaminate products intended for medical use. For decades, the Limulus Amebocyte Lysate (LAL) test has been used to detect and quantify endotoxins, but the key reagent is obtained from horseshoe crab hemolymph, often referred to as “blue blood.” The collection process can harm the animals and contributes to pressure on wild horseshoe crab populations and the coastal ecosystems that depend on them.
- Recombinant Factor C was developed to address scientific, ethical and environmental limitations associated with LAL. The method uses recombinant DNA technology to produce Factor C, a key endotoxin-sensitive protein involved in the horseshoe crab coagulation cascade, without relying on animal-derived blood products. Evidence reviewed by CONCEA’s Permanent Chamber of Alternative Methods found that rFC is relevant, reliable and reproducible, with international validation and regulatory acceptance supporting its use for bacterial endotoxin detection.
- The recognition of rFC in Brazil is part of a broader international movement to replace outdated animal-based and animal-derived safety tests with modern methods that improve predictability, consistency and sustainability. The rFC method has already been accepted by major international regulatory authorities and pharmacopoeias, including the U.S. Food and Drug Administration and the European Pharmacopoeia, and is being incorporated or considered in other major pharmacopoeial systems.