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

Before reading any further, accept that no one knows everything. A material that is considered safe today could be found to be toxic tomorrow. Asbestos was used for thousands of years, considered a wonder material for its insulating effects and being fire proof until exposure to asbestos was linked to Mesothelioma, a cancer of the membrane that covers our organs. Government approval, material certifications or any other promises that a material is safe should be taken as a lack of evidence that a material will hurt you, not proof that it won't.

First and foremost, the term Body Safe is a marketing term. It is not regulated or defined by any government agency and no one can enforce any one definition of the term as a result. It also comes in other varieties such as Skin Safe. The only terms directly regulated by government bodies are Food Safe and Medical Grade. Anything else is an advertising buzz word designed to comfort and attract potential buyers and assure them that their products are safe to use. This isn't entirely false, and some manufacturers have gone out of their way to prove that they're living up to consumer expectations of products that bear these labels. Regardless, the term has been adopted by consumers and toy makers alike. Colloquially the term has come to mean that a given material itself won't harm the user if inserted into the body.

Old Below

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 ranging from silicone to pigments and glues. Smooth-On outsourced their testing to a third party lab and received OECD TG 439 certification. This certification, provided by the Organization for Economic Co-operation and Development (OECD), means that the lab tests found the provided materials did not cause unacceptable levels of irritation to living skin cells when exposed for long periods of time. Certifications like this one can be used as evidence for whether a material is body safe.

That being said, the promise of what a product is made of is only as valuable as the trust you place in that maker. Anyone can make a website and make it say what ever they want. It's up to you, the buyer, to determine if a particular seller can be trusted, that their products are made from what they say they are, and that they're being honest when they say no harmful additives were used in production. Do you trust the seller? Is the seller in a country with the same or better regulations than your own? Do they have a history of doing business with customers who report problems with their purchases? Do you care about any of that? Ultimately, only you can decide if a purchase is worth the risk.

Finally, some common sense and observation is required. Even a known safe material can become dangerous if exposed to another material that causes a reaction. Stainless steel is corrosion resistant, not corrosion proof. If your toy is rusty, has sharp edges or burs, or appears partially melted then it's probably not safe to insert it into your body. Tempered glass can become chipped, stainless steel can rust or develop burs when scratched, and platinum cure silicone can degrade to the point of being unusable if not cared for properly. Keep this in mind if you decide to buy a toy second hand.

Materials Considered Body Safe

The below list of materials are generally considered Body Safe. They're either medical grade materials or considered inert, meaning that they have little to no bio-reactivity.

Platinum Cure Silicone

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

Materials Considered Unsafe or Potentially Harmful

The below list of materials are generally not considered to be Body Safe for one reason or another. They might be structurally unsafe or leak chemical additives. See each material for the stated reason that specific material is considered potentially unsafe.

Polyvinyl Chloride (PVC) Rubber

PVC plastic is turned into PVC rubber by adding pthalates. Pthalates are a group of chemicals used to soften plastics and make them stretchy. According to the US Center for Disease Control some Pthalates have been shown to cause reproductive issues in animals, but there is insufficient research to determine if there is any effect in humans. Web MD agrees that there is not enough research to know for sure, but leans toward Pthalates being hazardous to the very young and the very old. Other groups attribute endocrin disruption to Pthalates, meaning that the chemicals interrupt the natural process the human body uses to control and signal tissues within the human body to do certain tasks. However, Pthalates are also used in cosmetics and have not yet been banned or otherwise flagged as harmful by the US FDA.

In addition to the above concerns, some people are more sensitive to Pthalates and report that they experience a 'warming' or 'burning' sensation when using toys or lubricants that contain them. This appears to be specific to the individual, though, as many users do not report experiencing this sensation. There does not appear to be any research into this topic at this time.

For the above reasons and concerns, PVC rubber toys are generally not considered to be body safe. The lack of Pthalates in other materials is often touted as a feature and selling point.

PVC rubber toys can be identified by their sheen and chemical scent. They are usually black with a high gloss surface, but can also be given a surface coat of pigment to be more appealing to the eye. Most PVC rubber toys are labelled as such. If in doubt, ask the seller.