Materials and Safety

This page is for outlining the different materials that toys are generally made out of and defining whether or not they are "body safe" using citations from the US FDA and EU equivalents.

Defining Body Safe

The term "Body Safe" is not defined by the US FDA or any EU regulator. This is a term coined by manufacturers and used by makers to simplify the terminology used in government regulations, laws and data sheets. When a maker or manufacturer says something is "Body Safe" they are saying that the materials used meet the standards set by their country's rules for food-safe materials, medical grade materials, or both.

The United States of America Code of Federal Regulations (CFR) pertaining to food and drug is referred to as Title 21. It defines the regulations set forth by the Food and Drug Administration (FDA) and is separated into numbered parts and sections connected by a decimal point. The USA FDA defines the requirements for rubber materials to be considered food safe in CFR 177.2600. It defines what rubber polymers and rubber additives are considered safe to use in manufacturing products that will come into regular contact with food items. While there are no parts of title 21 that pertain to the recreational insertion of materials into human orifices, some useful information can be pulled from the sections on specific medical devices. The inference is that if a material is rated as safe for permanent implantation under the skin or inside the body cavity, then it should also be safe for temporary insertion in less sensitive areas or external use. As an example, certain types of stainless steel are used for artificial joints. Since these materials are exposed to constant moisture and biological agents inside the human body they are modified to be more resistant to corrosion and less bio-reactive than stainless steel selected decoration or jewelry. This material, often referred to as 'surgical steel', would meet all the requirements of the FDA regulations to be considered medical grade, and in turn the industry title of body safe. However, this specialized variety of stainless steel is expensive and unlikely to be used for making toys as a result. Instead, a toy is more likely to be made of the same material as stainless steel piercings, a cheaper variety but still produced with the idea of being in contact with human skin for extended periods of time. While not medical grade, this material would still be considered body safe by the industry.

Most material suppliers and manufacturers will want to show that they are compliant with the various regulatory bodies in the countries they sell their products in. Since these manufacturers are typically geared toward producing a product and not lab testing they will typically outsource this task to existing third party groups to do the testing for them. This is where certifications come in. Smooth-On produces a number of 'Skin-Safe' materials

That being said, the promise of what a product is made of is only as valuable as the trust you place in that maker.

Body Safe Materials

Platinum Cure Silicone

Smooth-On Skin Safe Materials are OECD TG 439 certificatied.