To comply with The Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012 (RoHS 2012), e-cigarette manufacturers must follow a structured approach involving material selection, testing, documentation, and certification.
Steps to Achieve RoHS Compliance
Step 1: Identify Restricted Substances in Components
E-cigarettes contain multiple electronic components (e.g., batteries, circuit boards, heating elements) that may have lead, mercury, cadmium, or other restricted substances. Manufacturers should work with suppliers to source RoHS-compliant materials for lithium-ion batteries, circuit boards, soldering materials, heating coils, metal parts, and casings, ensuring they avoid restricted substances.
Step 2: Conduct Material Testing and Analysis
Manufacturers must conduct material testing to confirm RoHS compliance using approved methods like X-ray fluorescence (XRF) screening, Inductively Coupled Plasma Mass Spectrometry (ICP-MS) and Gas Chromatography-Mass Spectrometry (GC-MS). These tests can be carried out by accredited third-party laboratories that issue RoHS compliance certificates.
Step 3: Maintain Technical Documentation
Manufacturers must maintain comprehensive technical documentation to demonstrate RoHS compliance, including material declarations from suppliers, test reports from certified laboratories, a Bill of Materials (BoM) listing all components, risk assessment reports, a Declaration of Conformity (DoC), and UKCA/CE marking records, which are necessary for selling in the UK and EU. These records ensure ongoing compliance and transparency in the manufacturing process.
Step 4: Apply UKCA/CE Marking and RoHS Labelling
Upon confirming compliance with the RoHS Directive, manufacturers are required to affix the UKCA or CE marking to their products. These markings serve as the sole indicators of conformity with RoHS requirements. The use of additional symbols such as the “RoHS Tick,” “RoHS Compliant,” or similar markings is prohibited.
- Products sold in Great Britain (GB) must carry the UKCA marking instead of CE.
- Products sold in Northern Ireland (NI) must still comply with EU RoHS and carry the CE mark.
- Manufacturers may need dual certification (UKCA + CE) if selling in both GB and the EU.
- The UKCA/CE mark should be placed on the product itself. However, if this is not possible due to the product’s size or shape, it can appear on the packaging or in the product documentation.
- The UKCA mark must be at least 5mm in height. Larger sizes are acceptable as long as the proportions are maintained.
- The mark should be easily visible, legible, and permanently attached to the product or its packaging.
Step 5: Regular Audits and Supply Chain Monitoring
Manufacturers should conduct regular supplier audits to ensure that materials consistently meet RoHS requirements and periodically re-test products, particularly when switching suppliers or materials, to maintain ongoing compliance.
Restriction of Hazardous Substances (RoHS) labelling requirements:
These labelling requirements ensure that products meet UK/EU standards for safety, health, and environmental protection, as outlined in the UKCA/CE marking regulations.
| Manufacturer’s labelling obligations | |
| 1. CE (or UKCA) Marking: | a) The CE (or UKCA) mark must be visible on the product to indicate that the product conforms to the essential health and safety requirements of relevant European (CE) or UK regulations (UKCA). |
| b) The mark should typically be at least 5mm in height. If the product size doesn’t permit this (e.g., very small products), a size exclusion might apply, allowing for a smaller mark. However, this must still be legible and identifiable. | |
| 2. RoHS Status Indication: | The CE and UKCA marks are the sole indicators of a product’s conformity with the RoHS Directive. Affixing additional symbols such as the “RoHS Tick,” “RoHS Compliant,” or similar markings is prohibited. |
| 3. Marking Coverage: | The CE or UKCA mark must be on the product itself, but if it is not feasible due to the product’s size or shape, it can appear on the packaging or in the product documentation. Additional markings (e.g., safety certifications, compliance symbols) can also appear alongside the CE/UKCA mark, but they should not obscure it. |
| 4. Product Identification: | There should be a clear and visible identifier like a model number, batch number, or serial number to help with product traceability. |
| 5. Manufacturer’s Information: | The manufacturer’s name, trademark, or trade name must be clearly displayed. |
| 6. Manufacturer’s Address: | The manufacturer’s postal address should be provided, which helps authorities or consumers contact the manufacturer in case of issues with the product. |
| 7. Address Location: | The manufacturer’s address should be within the relevant regulatory jurisdiction, whether the UK or the EU, to ensure compliance with local laws. For UKCA, it should be a UK address, and for CE marking, it could be within the EU or European Economic Area (EEA). |
| Importer’s Labelling Obligations (Applicable if the manufacturer is based outside the UK) | |
| 8. Importer’s Information: | The importer’s name, trademark, or trade name should also appear on the product, especially if the product is imported into the UK from a non-UK manufacturer. This ensures traceability for imported products. |
| 9. Importer’s Address: | The importer’s address must be included. This helps authorities track and reach out to the importer for compliance purposes. |
| Indelibility (Only applicable if the CE mark is present on the product) | |
| 10. Mark Durability: | The CE mark must be durable and should not be easily removed, ensuring that it stays legible throughout the product’s lifespan. |
| 11. Mark Resistance: | The CE mark should be resistant to gentle rubbing or wiping. It should remain intact, even when cleaned, to avoid the risk of the mark becoming unreadable. |
Waste Electrical and Electronic Equipment (WEEE) labelling requirements:
These labelling requirements are mandated by the Waste Electrical and Electronic Equipment (WEEE) Directive to ensure proper disposal and recycling of electronic products. Compliance with these obligations helps protect the environment and promotes the sustainable management of electronic waste
| Manufacturer’s Labelling Obligations under the WEEE Directive | |
| 1. Affixing the WEEE Symbol: | The crossed-out wheeled bin symbol must be clearly displayed on each item of electrical or electronic equipment. This symbol indicates that the product must not be disposed of in regular household waste and should be separately collected for recycling or disposal. |
| 2. Symbol Visibility and Durability: | The WEEE symbol must be clearly visible, legible, and indelible on the product. It should remain intact throughout the product’s lifetime and should be durable enough not to fade or be easily removed by normal handling or cleaning. |
| 3. Symbol on Packaging and Documentation: | The crossed-out wheeled bin symbol should also appear on the packaging, user instructions, and any warranty documents associated with the product. |
| 4. Exceptions Due to Product Size or Function: | In cases where the product is too small or if the function of the product makes it difficult to display the symbol directly on the product, the WEEE symbol can be placed on the packaging, user instructions, or warranty documents instead. |
| 5. Date of Manufacture or Market Release: | The date of manufacture or market release of the product should be indicated on the product. If the date cannot be directly marked on the product due to space limitations, a black bar beneath the WEEE symbol may be used to indicate that the product was placed on the market after the implementation of the WEEE Directive. |
| 6. Durability of Date Mark: | The date mark on the product must be durable to ensure it remains visible and accurate throughout the product’s lifecycle. |