RoHS (CE) Certification

The RoHS Directive (2011/65/EU) restricts the use of certain hazardous substances in electrical and electronic equipment. Ten substances are currently restricted: lead, mercury, cadmium, hexavalent chromium, PBB, PBDE and four phthalates (DEHP, BBP, DBP, DIBP). The limits are set per homogeneous material — calculated not across the whole product but for each material that can be mechanically separated from the others. This distinction is the source of the most common mistake in practice.

• Manufacturers of every kind of electrical and electronic equipment
• Suppliers of cables, connectors, boards and components
• Importers and distributors of electrical equipment
• Firms selling electronic products under their own brand

Mandatory for equipment within scope, with no provision for notified-body involvement; conformity assessment is carried out through internal production control (Module A). RoHS is listed separately in the declaration of conformity. Time-limited exemptions for specific applications are defined in Annexes III and IV; if an exemption is relied on, this must be shown in the technical file.

• Scope: 11 equipment categories and excluded products
• Restricted substances and the maximum concentration values by weight in a homogeneous material
• The concept of a homogeneous material and the disassembly logic
• The Annex III and Annex IV exemptions; their being time-limited
• The conformity-assessment procedure: technical documentation under EN IEC 63000
• Supply-chain information gathering and material declarations
• Obligations of the manufacturer, authorised representative, importer and distributor
• Marking and stating RoHS in the EU Declaration of Conformity

1. 1Determining the LegislationIt is determined which EU legislation applies to the product. A product can fall within scope of more than one piece of legislation at the same time; all of them must be met.
2. 2Selecting the Conformity Assessment ModuleThe legislation determines the module to follow according to the product's risk class. The manufacturer self-declares under some modules, while a notified body is involved under others.
3. 3Testing Against Harmonised StandardsConformity with harmonised standards published in the EU Official Journal is demonstrated through testing; this provides a presumption of conformity with the legislation.
4. 4Risk Analysis and the Technical FileThe risk assessment, design calculations, test reports, instructions for use and sample labels are compiled in the technical file.
5. 5The EU Declaration of ConformityThe manufacturer or its EU-based authorised representative signs the declaration of conformity. Responsibility rests with the signatory of the declaration.
6. 6Affixing the CE MarkThe mark is affixed to the product in the form and size the legislation prescribes; the notified body's identification number is added if one is involved.
7. 7Retaining the Technical FileThe technical file is retained for the period the legislation sets from the product's placing on the market (10 years under most legislation) and presented to the competent authority on request.

The CE mark is not a certificate but the manufacturer's declaration of conformity, and it has no expiry. However, the declaration remains valid as long as the product and the legislation do not change: the technical file must be updated if the legislation or the harmonised standard is updated. Notified-body certificates (e.g. an EU Type-Examination Certificate) are subject to a validity period.

• The product description, model list and technical drawings
• Risk assessment
• The list of harmonised standards applied
• Test reports
• Instructions for use and warning labels (in the target market's language)
• A draft EU Declaration of Conformity
• The bill of materials (BOM) and the homogeneous-material breakdown
• Supplier RoHS declarations of conformity and material declarations
• Analysis reports for critical materials (XRF screening and wet chemistry where needed)
• The list of exemptions relied on and their justification
• Technical documentation drawn up under EN IEC 63000

There is no fixed list price; the cost is calculated based on the following variables and provided in writing in the quote.

• The number of pieces of legislation applicable to the product
• The conformity-assessment module — whether a notified body is involved
• The required test scope and number of samples
• The current state of the technical file
• Translation and documentation needs

A Notified Body under CE is registered in the European Commission's NANDO database for the relevant EU regulation and carries a four-digit identification number. Notified body authority is based on legislation and product scope; The authority granted for one regulation does not extend to another. Testing is within the scope of ISO/IEC 17025, product certification is within the scope of ISO/IEC 17065.

The scope under which this scheme can be offered varies according to your product and activity; it is confirmed in writing at the quote stage.

• CEEcodesign
• CEMachinery Safety
• CELVD
• CEEMC
• CERED
• CEMDR
• CEIVDR
• CEPED