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 Article 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 article 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.

Body Safe Materials

Platinum Cure Silicone

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