Electrical appliances

RoHS – Hazardous substances in electrical and electronic appliances

The use of certain metals, plasticising agents and flame retardants in electrical appliances is subject to restrictions. The purpose of RoHS (Restriction of Hazardous Substances) legislation is to protect human health and the environment and reduce the harmfulness of waste.

Restrictions apply to the use of following substances in EEE, their cables and spare parts:

• cadmium, Cd
• lead, Pb
• mercury, Hg
• hexavalent chromium, Cr6+
• polybrominated biphenyls, PBB
• polybrominated diphenyl ethers, PBDE
• bis (2-ethylhexyl) phthalate, DEHP
• butyl benzyl phthalate, BBP
• dibutyl phthalate, DBP
• di-isobutyl phthalate, DIBP

The maximum allowed concentrations in homogeneous material are:

• cadmium, 0.01 % by weight
• all other substances, 0.1 % by weight

For phthalate restrictions, you should note that they do not apply to toys, as the phthalate restrictions for toys are laid down in annex XVII, item 51, of the REACH regulation.

Homogeneous material is either uniform material or material consisting of a combination of materials that cannot be separated by mechanical means. Twisting, cutting, crushing, grinding and rubbing are examples of mechanical means. Electrical and electronic equipment consist of a variety of homogeneous materials, which must not contain restricted substances above the maximum concentration. Plastic case of display monitors, copper wire in a cable and the soldering material on a soldered joint are examples of homogeneous materials. In certain situations, the maximum concentrations can be exceeded (see chapter RoHS exemptions).

Scope

The scope of the RoHS Directive is open, which means that all appliances that meet the RoHS definition of electrical and electronic equipment is covered unless specifically excluded.

Electrical or electronic equipment

• needs electric currents or electromagnetic fields to fulfil at least one intended function or
• generates, transfers or measures such currents or fields and
• has a voltage rating not exceeding 1,000 volts for alternating current and 1,500 volts for direct current.

Electrical and electronic products include household appliances, consumer electronics, power tools, electric toys, watches, battery-powered scales and smoke detectors. In accordance with the definition of electrical appliances, it is sufficient that the product needs electricity for one of its uses. This means that products that are not traditionally considered electrical products are electrical products. For example, ties with sound, sneakers with flashing lights and lawnmowers with internal combustion engines are electrical products according to the RoHS Directive.

The scope of the RoHS Directive excludes:

• equipment which is necessary for the protection of essential security interests or for military purposes
• equipment designed to be sent into space
• large-scale stationary industrial tools
• large-scale fixed installations
• means of transport for persons or goods, excluding electric two-wheel vehicles which are not type-approved
• non-road mobile machinery made available exclusively for professional use
• active implantable medical devices
• photovoltaic panels designed, assembled and installed by professionals
• equipment designed for the purposes of research and development and made available on a business-to-business basis
• pipe organs
• equipment which is specifically designed to be installed as part of another type of equipment mentioned above.

Some of the excluded products such as vehicles are covered by the existing special legislation restricting the use of certain substances.

It is the responsibility of the manufacturer and the importer to assess whether the appliance falls outside the scope of the RoHS Directive. Sometimes, the buyer might also require that the equipment e complies with the RoHS Directive, even if legislation do not require it.

Examples of large fixed industrial tools: CNC lathes, newspaper presses and cranes. The mere bolting of a tool to the floor structure does not make the tool a large fixed industrial tool. Large fixed installations include various production lines, belt conveyor systems and lifts.

If the product can be used for a variety of purposes covered or excluded from the scope, the product must comply with the RoHS Directive. For example, if the same refrigerator is sold for use in hotel rooms and motorhomes, the refrigerator must meet RoHS requirements.

Exemptions

The RoHS exemptions allow the use of restricted substances for specific purposes. In general, exemptions are strictly defined for a specific use, but there are also some concerning materials such as copper alloys.

The European Commission grants, renews and withdraws exemptions. The application is submitted to the Commission, which will use a consultant to assess the application. The application summary and the report of the Commission’s consultant are public documents.  Before issuing a delegated directive, the Commission hears the Member States and stakeholders, including various organisations.

The exemption is granted based on the criteria laid down in the Directive. An exemption can be granted if:

• the restricted substances cannot technically or scientifically be replaced, or
• the reliability of substituting agents cannot be ensured, or
• the overall harm to the environment, health and consumer safety are greater than the overall benefits of compensation

The delegated directive announces the exemptions granted and their period of validity. For medical, monitoring and surveillance appliances, the exemptions are valid for a maximum of seven years. For other appliances, the validity period is shorter, up to a maximum of five years.

An application for renewal of an exemption must be submitted no later than 18 months before the expiry date. The exemption is valid after submitting the renewal application until a delegated directive is issued on the matter. If the exemption is terminated, it will be valid for 12–18 months from the date of the delegated directive.

Once the exception is in force, it can be used by all businesses, and not just by the party applying for the exemption.

Standards

Standard EN IEC 63000:2018 on technical documentation has been harmonised under the RoHS Directive. The standard determines what kind of information is required in the technical documentation to demonstrate compliance with the RoHS Directive.

The IEC 62321 or SFS-EN 62321 series of standards are commonly used in RoHS analyses. The standards define the procedures for the pre-treatment of samples and the analytical steps for the different analysis methods.

Demonstration of conformity

For the RoHS Directive, the manufacturer can use internal production control in accordance with Module A of Annex II to Decision No 768/2008/EC establishing a common framework for the marketing of products and repealing Decision 93/465/EEC as the conformity assessment procedure for electrical appliances. The documents and test reports in accordance with the conformity assessment procedure are attached to the technical documentation.

Internal production control is a conformity assessment procedure in which the manufacturer fulfils certain obligations and assures responsibility for ensuring that the products in question meet the requirements of the legal provisions that apply to them.

The manufacturer must draw up technical documentation that can be used to assess whether the product complies with its essential requirements. The technical documentation must also include an appropriate analysis and assessment of the risks. The manufacturer must also ensure that the appliance complies with the technical documentation and the regulations relating to the appliance. The manufacturer affixes the CE marking and other required markings to the product and prepares an EU declaration of conformity.

Read more about RoHS:

Hazardous substances in electrical and electronic equipment – RoHS on the Tukes website

RoHS Directive 2011/65/EU

European Commission’s RoHS website, in English

Commission’s website on exemptions, in English

Fimea’s website, the market surveillance authority for medical devices with regard to RoHS

Exemptions, Ökö-Institut