Compliance Guide
What Certifications Are Needed for EU and US Adult Wellness Product Sales?
Direct Answer
For EU sales: CE Marking (EMC + LVD directives), RoHS compliance, and WEEE registration are mandatory for electronic adult wellness products. Rechargeable batteries require IEC 62133. For US sales: FDA 21 CFR 177.2600 material safety compliance is required for body-contact silicone products; FCC ID is required for Bluetooth devices. Evokomoribi pre-certifies all standard SKUs β buyers receive a complete compliance documentation package with every order.
EU Market: Required Certifications
All electronic adult wellness products sold in EU/EEA member states must comply with the following directives.
| Certification | Directive / Standard | Status at Evokomoribi |
|---|---|---|
| CE Marking | EMC Directive 2014/30/EU + LVD Directive 2014/35/EU Electromagnetic compatibility and electrical safety | Full CE DoC provided with every order |
| RoHS Compliance | RoHS Directive 2011/65/EU (amended 2015/863/EU) Restricts 10 hazardous substances (lead, mercury, cadmium, etc.) | RoHS statement + test report included |
| REACH Regulation | EC 1907/2006 Chemical safety in materials β silicone, ABS, coatings | REACH SVHC declaration on request |
| WEEE Marking | WEEE Directive 2012/19/EU End-of-life recycling responsibility and registration | WEEE symbol applied on packaging per buyer's registration number |
| IPX5 Waterproof | IEC 60529 Β§14.2.5 12.5 L/min at 1 m for 3 min β tested per production batch | Batch test report available on request |
| IEC 62133 (Battery) | IEC 62133-2:2017 Lithium battery safety under normal and abused conditions | IEC 62133 certificate included for all rechargeable SKUs |
US Market: Required Certifications
The US has no single unified standard for adult wellness products, but several regulations apply depending on distribution channel and product type.
| Certification | When Required | Evokomoribi Status |
|---|---|---|
| FDA Material Safety (21 CFR 177.2600) | Required for body-contact products marketed in the US | FDA material compliance declaration included |
| FCC ID (Part 15) | Required for any wireless device (BLE/RF) sold in the US | FCC ID issued for all BLE models (FCC-certified firmware) |
| CPSC / CA Prop 65 | Required for California sales; advised for all US retail | Material safety data supports Prop 65 analysis β consult your US counsel |
| UN 38.3 (Lithium Battery Transport) | Required by IATA/ICAO for air freight of lithium battery products | UN 38.3 test report included for all rechargeable SKUs |
| ASTM F963 (Toy-adjacent products) | If product may be classified as a toy or novelty by US customs | Available on request for applicable SKUs |
What Compliance Documents Does Evokomoribi Provide?
Every production order ships with a complete compliance documentation package. Documents can be issued under your brand name for private label orders.
CE Declaration of Conformity (DoC)
RoHS Compliance Statement
FDA 21 CFR 177.2600 Material Safety Declaration
IEC 62133 Battery Safety Certificate
UN 38.3 Battery Transport Test Report
IPX5 Waterproof Test Report (per batch)
FCC ID Certificate (BLE models)
REACH SVHC Declaration (on request)
MSDS / Safety Data Sheet
Packing List and Commercial Invoice
Need a third-party inspection? View our full quality assurance program β
Certification FAQ
What certifications are required to sell adult wellness products in the EU?
For the EU market, the mandatory certifications are: CE Marking (covering EMC Directive 2014/30/EU and LVD Directive 2014/35/EU), RoHS Compliance (Directive 2011/65/EU), and WEEE registration (for electronic products). Rechargeable battery products must also meet IEC 62133 battery safety standards. Waterproof marketing claims require IPX test documentation per IEC 60529.
What certifications are required to sell adult wellness products in the US?
For the US market: FDA 21 CFR 177.2600 material safety compliance is required for body-contact silicone products. FCC ID certification is mandatory for any Bluetooth or wireless device. UN 38.3 battery certification is needed for air freight. California Proposition 65 compliance is required for California retail sales. There is no federal requirement for a specific 'adult toy certification' in the US β FDA material safety and FCC (if applicable) are the primary compliance needs.
Does CE certification cover the UK after Brexit?
No. Since January 1, 2021, products sold in Great Britain (England, Scotland, Wales) require UKCA (UK Conformity Assessed) marking instead of CE marking. Northern Ireland continues to accept CE marking. Evokomoribi can provide UKCA documentation β contact us for details. Many manufacturers continue to pursue both CE and UKCA in parallel to cover both markets.
Who is responsible for obtaining CE certification β the manufacturer or the importer?
For products manufactured in China, the EU importer (or the authorized representative in the EU) is legally responsible for CE compliance when the manufacturer is outside the EU/EEA. Evokomoribi provides a complete technical file and Declaration of Conformity (DoC) that you as the importer can use as the basis for your CE compliance. The DoC is issued on your behalf with Evokomoribi's technical documentation.
Are all Evokomoribi products pre-certified?
Yes. All standard catalog SKUs are pre-certified with CE DoC, RoHS, FDA material compliance, IEC 62133, and UN 38.3. FCC ID is issued for all BLE-enabled models. This means your private label order receives a complete compliance documentation package with no additional certification cost. For custom mold projects, certification costs and timelines are quoted separately.
Can you provide white-label compliance documents for my brand name?
Yes. We can reissue compliance documents with your company name and brand as the responsible party. This is standard for private label B2B orders where you will be selling under your own brand identity. The technical basis and test results remain Evokomoribi's β the declaration identifies your company as the EU importer or brand owner.
Related Resources
Certifications & Quality β
Full CE, RoHS, FDA certification details
Compliance Documents β
Request the full documentation package
Private Label Services β
White-label production with pre-certified products
OEM/ODM Services β
Custom product development + certification support
Product Catalog β
All SKUs ship with full compliance docs
Contact Sales β
Ask about documentation for your market
Get the Full Compliance Documentation Package
Every Evokomoribi order ships with CE, RoHS, FDA, and battery compliance documents. Request a quote and we will confirm which certifications apply to your target market.