Safety in 3D Printing
3D printing opens the door to creating functional, customized parts, but it also introduces important safety considerations. Material choice is only one part of the equation. The printing process itself, including temperature, hardware, and design, can directly impact whether a finished object is safe for its intended use. This section provides a high-level overview of key safety topics to keep in mind when working with 3D printed parts.
Food Safety
Some raw materials may meet food contact standards in their base form, and certain certifications exist in regions like the EU. However, in the United States, the FDA does not certify raw filament materials. Instead, certification applies to the final manufactured object. With 3D printing, factors like layer lines, surface porosity, print settings, and even the nozzle material can introduce contamination risks. As a result, a filament that may be considered food safe in its raw state can produce a printed object that is not food safe.
Child and Toy Safety
Material compliance standards such as EN 71-3 and CPSIA-style documentation can be achieved for specific products, and efforts are ongoing to expand certified material options. That said, safety is not determined by material alone. Print quality plays a major role. Poor layer adhesion, sharp edges, small detachable parts, or brittle prints can all create hazards. A material that meets toy safety standards can still result in an unsafe object depending on how it is printed and finished.
Polymaker EN 71-3 CertificationsMore on Child Toy Safety
Skin Contact Safety
Certain materials can be evaluated for biocompatibility using standards such as ISO 10993, which includes tests for cytotoxicity, irritation, sensitization, and systemic toxicity. PolyFlex TPU90 is an example of a material that has passed multiple ISO 10993 tests, and additional materials are being evaluated.
Then REACH and RoHS declarations are useful because they show whether restricted substances and certain hazardous materials are intentionally avoided or kept below limits.
Even with tested materials, print conditions, post-processing, and cleanliness can influence how suitable a printed part is for prolonged skin contact.
Indoor Air Quality
3D printing can release ultrafine particles and volatile organic compounds during the printing process. Some materials may also produce noticeable odors when heated. These emissions vary depending on the material and print settings. It is recommended to operate all 3D printers in a well-ventilated area, regardless of material type, including commonly used filaments like PLA. Research into emissions and air quality impacts is ongoing.
Other Certifications and Declarations
In addition to application-specific safety considerations, material-level compliance and chemical safety declarations are also important. These may include statements regarding restricted substances, environmental regulations, and chemical composition. Examples include compliance with regulations such as REACH, RoHS, TSCA, and declarations covering PFAS, BPA, PAHs, and other substance groups. These documents help provide transparency into material composition, but they do not replace the need to evaluate the safety of the final printed object.
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