We're regulated by the EU & the FDA.
Nara Organics is made in Germany to meet both U.S. and EU food safety standards. Even our facility is inspected by the EU and the FDA. When it comes to your baby’s safety, more is more.
The Nara Safety Standard
We’ve chosen to go beyond required standards to create a one-of-a-kind safety program. Here's our approach.
Nara has a comprehensive safety program that goes beyond regulatory requirements for infant formula. Wherever the stricter standard exists (U.S. or EU), that’s the regulation we follow. Where regulations don’t exist, we’ve set voluntary limits for our formula. We’ve also run a panel of non-required bacterial testing from Day One.
Raw ingredient testing: We test every ingredient before production and verify their Certificates of Analysis to ensure safety, purity, and nutrition. Testing at the ingredient level allows us to catch potential problems before they even start.
In-process testing: We do extensive testing of our formula powder before it’s put in our cans. We test for 13 different microorganism parameters (only 2 are mandated by the FDA), across 135+ microbiological tests per batch. We also test for 29+ nutrients verified against tight specifications and conduct a complete fatty acid profile. Also evaluated: physical parameters (i.e. moisture, pH, residual oxygen, powder density), purity testing, and sensory evaluation.
Science-based monitoring during the process ensures that critical parameters are maintained and that the manufacturing process is performed according to our strict specifications.
Finished formula testing: Once our formula powder is in our blue cans, we test again. We run the same tests as we did during the manufacturing process, as well as a slew of additional tests for chemical contaminants. We also test the physical properties of the can and the powder, making sure they’re properly sealed in an extremely oxygen-reduced environment to protect product freshness, nutrient content, and integrity.
Finished product testing is a double-verification that the formula meets our strict quality requirements before it’s ready to ship to the U.S.
EU-specific contaminant testing: The EU has some of the strictest regulations on chemical contaminants in infant formula in the world. They have specified limits on various chemical contaminants for infant formula which other countries have not yet placed limits on.
We’ve built a comprehensive testing regimen — from the raw materials to the finished product — to ensure that our product remains safe and compliant until it reaches your hands.
Our team traveled the world (literally) to find the best place to make Nara Organics. We found a renowned formula manufacturer that has been making top European formulas for 70+ years and has an impeccable track record.
By working closely with our European partners, we’ve created a system of checks and balances that enhances our safety procedures — two teams of scientists, invested in safety.
Restricted access: No one except for manufacturing and science experts are allowed onto the floor when formula processing is taking place. This is for cleanliness, safety, and most importantly, to prevent any incidental contamination during production.
High-hygiene zone entry requirements: Entry into an infant formula facility in general requires special precautions (wearing special clean suiting and shoes, hand washing and sanitizing, hair netting and eye protection); however, entry into the most restrictive areas of the facility is a step further. This involves restrictions such as new separate shoes and protective clothing which are dedicated to that area only and going through a special transition area with “air showers” which blast high pressure air to remove any dust or other particles prior to entry into the critical area.
Environmental swabbing: As part of our facility’s comprehensive quality and safety program, extensive microbiological swabbing is conducted in the manufacturing environment to ensure cleanliness and hygiene monitoring of the plant before, during, and after production.
UV light disinfection: Our empty cans and lids pass through a UV light sterilizer to ensure they are sanitary prior to use in canning. This is a step that contributes to our high quality.
Industry leading oxygen reduction: Our cans have some of the lowest residual oxygen content in the industry (routinely <1%). This is important because it protects freshness and prevents oxidation of certain nutrients, preserving the nutrient activity through shelf life of the product.
High hygiene zone overpressure: In areas where our infant formula powder is being processed, such as during canning, the area is configured with over-pressured, HEPA-filtered airflow. This creates positive pressure and prevents outside air from entering the room, reducing the chance of contamination.
Exceptional in-process testing: Because of the scale and expertise of our manufacturer, they have equipment capable of testing parameters on site which usually require sending samples to outside laboratories (using analytical techniques such as near infrared and laser diffraction). This allows our team to react more quickly during production and ensure everything is on track.
Independent food safety audit: In addition to being inspected by the FDA and EU regulators, our partner facility is also inspected by BRCGS (Brand Reputation through Compliance Global Standards), which is one of the most widely used food safety certifiers in the world, and was the first standard to be GFSI (Global Food Safety Initiative) benchmarked. As part of this certification, unannounced audits occur yearly. Each unannounced audit is spread across multiple days involving teams of inspectors covering all aspects of the facility’s production and quality systems. Our partner facility has an excellent track record in these audits, typically receiving “A+” audit grades.
Nara is the only American, USDA organic whole milk formula available today that has successfully completed a clinical trial. Unlike other American whole milk formulas that use a mix of whole and skim milk, Nara doesn't rely on past clinical trials of a skim milk formulation.
Our clinical trial was a randomized, double-blind study study conducted over 12+ months with the careful oversight of scientists and pediatricians. Before we could launch, the results of the trial had to be fully reviewed by the FDA to ensure the results met regulatory requirements. The trial proved that Nara Organics formula supports healthy growth for babies ages 0-12 months.
Every ingredient in our formula is chosen for high quality, wholesome nutrition. At Nara, we control every single ingredient, allowing us to create the very first USDA organic whole milk formula with no skim milk.
USDA Organic: Our formula is USDA organic certified, and we source organic ingredients from the U.S. and the EU. We have extremely high standards for working with a supplier, and conduct full evaluations of every ingredient partner prior to working with them.
Clean Label Certified: We won the Purity Award and the Pesticide-free Award from the Clean Label Project after they independently tested our formula for 300+ chemicals of concern, including heavy metals, glyphosate, BPA, pesticides, and phthalates.
Rigorous testing: Every ingredient goes through extensive testing protocols before it becomes part of our formula. Excellent, safe ingredients are the bedrock of our recipe.
