Are you planning to manufacture or import sex toys to the European Union? In this guide, we introduce sex toy safety standards and regulations, including the world’s first sex toy standard – ISO 3533. This guide also covers the General Product Safety Directive (GPSD), REACH, and other regulations.
Content Overview
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ISO 3533 – Sex toys – Design and safety requirements for products in direct contact with genitalia, the anus, or both
ISO 3533 is the world’s first international standard for sex toys. This standard was first published in 2021 and concerns the design and safety requirements for products in direct contact with the genitalia, the anus, or both.
ISO 3533 specifies the design, materials, construction, and user information requirements regarding products that are intended for sexual use. As explained by the Swedish Institute for Standards (SIS), which developed the standard with the help of several stakeholders, in the past manufacturers and importers were forced to either use self-developed standards, or standards that apply to products with similar material and design.
Product scope
ISO 3533 applies to sex toys that are intended for sexual stimulation or to enhance sexual pleasure, and that is designed to be in direct contact with the genitals and or the anus.
The standard excludes items that are classified as medical devices or assistive products, such as the following:
- Lubricants
- Massage oil
- Intimate gels/sprays
Electrical safety requirements
ISO 3533 specifies the electrical safety requirements for sex toys covered by this standard. It requires manufacturers to consider the electrical safety of the product during usage and charging conditions. The electrical safety requirements also cover the product charger.
Mechanical safety requirements
ISO 3533 specifies the mechanical safety requirements for sex toys covered by this standard. The requirements concern the safety of sex toys from the following aspects:
- Prevention of retention
- Products for genital enclosure
- Moving and removable parts
It provides instructions on the dimensions and design features from an ergonomic standpoint so that it does not harm the users.
Labeling requirements
The standard provides the labeling instructions for sex toys manufacturers. It states that the product and/or the packaging should contain information such as:
- Product description
- Product traceability (e.g. batch number)
- Company information
- Symbols and markings, if relevant
- User instructions
General Product Safety Directive (GPSD)
The General Product Safety Directive (GPSD) concerns the safety of consumer products placed in the EU market. Products that are deemed unsafe by the relevant authorities might be denied entry to the EU, or be subject to a recall.
Sex toys, just like other regular consumer products, are covered by the requirements of the GPSD.
Safety standards
The GPSD does not specify standards for each type of product, including sex toys. When harmonized standards do not exist, national or international standards can be used to assess the conformity of the product with relevant technical requirements.
For instance, importers or manufacturers of sex toys could refer to the following standards to assess the conformity of their products:
a. ISO 3533 – Sex toys – Design and safety requirements for products in direct contact with genitalia, the anus, or both
b. EN 61959 – Secondary cells and batteries containing alkaline or other non-acid electrolytes – Mechanical tests for sealed portable secondary cells and batteries
Requirements
The GPSD requires importers and manufacturers to ensure that the products are safe for the users before placing them on the EU market. Importers’ and manufacturers’ responsibilities cover:
- Product safety (e.g. risk and conformity assessment, testing)
- Promotion (e.g. Product instruction information, marketing information)
- Market supervision (e.g. Communicate and report to the authority, recall, withdrawal)
Specifically, importers or manufacturers should prepare documents such as the following:
- Risk assessment report
- User manual
- Technical file
- Test reports
- Product traceability labeling
REACH
REACH addresses the use of unsafe chemical substances in consumer products. It set up rules to restrict the concentration level of toxic chemicals under REACH Annex XVII and the SVHC List. REACH covers most consumer products, including sex toys.
Restricted substances
Sex toys can be made from various types of materials, such as silicone, plastic, and rubber. These materials might contain or treated with substances restricted or prohibited by REACH. Below we list materials that might contain REACH-restricted substances:
- Silicone (might contain phthalates)
- PVC Plastic (might contain phthalates, or BPA)
- Thermoplastic rubber (might contain BPA)
- Metal (might contain lead, cadmium, or chromium)
- Ceramic (might contain lead, cadmium, or chromium)
The substances that we listed as examples are restricted by either the REACH Substance of Very High Concern (SVHC) List or the REACH Annex XVII.
Products that contain substances listed in Annex XVII in an amount greater than the allowed one are deemed non-compliant. Conversely, products that contain more than 0.1% by weight of substances listed in the SVHC list can still be placed in the EU market, although the notification is necessary.
Electronic Sex Toys
Additional regulations apply to electronic products, including electronic sex toys such as vibrators. Here is an overview:
- RoHS Directive (Heavy metals and chemicals restrictions)
- EMC Directive
- Low Voltage Directive (e.g. AC adapters for sex toys)
- Radio Equipment Directive
- Ecodesign Directive
CE Marking
Products that fall within the regulations listed above must be CE marked. In addition, electronics must also comply with a set of documentation and labeling requirements:
- CE mark
- Importer/manufacturer label information
- Product and traceability label information
- Declaration of Conformity (DoC)
- Technical file
- User instructions
- Lab test reports
Waste Electrical and Electronic Equipment (WEEE) Directive
Electronic sex toys, such as vibrators, should comply with the Waste Electrical and Electronic Equipment (WEEE) Directive, which sets requirements for the labeling, disposal, collecting, and recycling of electrical and electronic equipment.
The purpose of this directive is to promote the sustainable production and consumption of electronic and electrical products.
Requirements
The WEEE Directive requires that importers or manufacturers of electronic and electrical products, including electronic sex toys, should:
a. Apply the separate collection symbol on the product or its packaging
b. Register and report to the national organization on their products and business information, such as product parameters and manufacturer’s contact details
Battery Directive
The Battery Directive establishes rules for batteries and accumulators regarding hazardous substance limits, labeling, waste collection, and disposal.
Electronic sex toys that are operated with batteries such as button-cell batteries, alkaline batteries or other types of batteries should comply with the requirements of the Battery Directive.
Restricted substances
The Battery Directive restricts the content of mercury, cadmium, and lead in covered batteries. The restriction limit for each substance is as follow:
- Mercury < 0.0005% by weight
- Cadmium < 0.002% by weight
- Lead (any battery that contains more than 0.004% of lead must display the symbol “Pb” on the product label)
Requirements
The Battery Directive requires that importers or manufacturers of batteries and accumulators must register their products with the relevant national authorities.
In addition, all the batteries and accumulators must bear the separate collection symbol, which is an icon of a crossed-out wheeled bin.
Lab Testing
Importers or manufacturers of sex toys must make sure that their products comply with relevant regulations in the destined markets. Oftentimes, the only way to assess compliance is to arrange lab testing, such as substance testing, mechanical testing, electrical safety testing, or other tests.
For sex toys, this might include substance testing, mechanical and electrical safety testing, and more.
Here a shortlist of companies that offer testing services for sex toys:
- SGS Polymer Solutions Incorporated (PSI)
- TÜV Rheinland
- Picked Testing Services
