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RoHS, an abbreviation for "Restriction of Hazardous Substances" was initiated in 2003 within the European Union, intending to reduce the adverse environmental and health effects related to electronic devices. Its primary goal is to accomplish this objective.

The intention of the RoHS directive is to prohibit the utilization of certain dangerous materials in Electrical and Electronic Equipment (EEE) for the subsequent reasons:

• Protect human health and the environment from the detrimental effects of these substances.
• Simplify the retrieval and recycling of materials from Waste Electrical and Electronic Equipment (WEEE).
• Discover and develop safer alternatives to hazardous substances.
• Increase competitiveness by introducing innovative solutions that prioritize health and environmental considerations.
• Support and strengthen the internal market within the European Union.

The RoHS 2 directive (2011/65/EU) is a progression of the primary directive 2002/95/EU, and it was enacted on 21st July 2011, with implementation commencing on 2nd January 2013.

Since RoHS 2, the presence of the CE mark on a product signifies its compliance with the EU RoHS requirements. As a consequence, specific documents related to compliance are mandatory, including:

1. Large Household Appliances: Laundry Machines, Cookers, Fridges, Air Conditioners
2. Small Household Appliances: Dust busters, Bread Warmers, Coffee Makers
3. IT and Telecommunications: PCs, Data Centers, Mobile Phones, Printing Devices
4. Consumer Equipment: Televisions, Stringed Instruments, Camcorders
5. Lighting Equipment: Lighting Fixtures, Mobile Stadium Lights, Handheld Torches
6. Electrical and Electronic Tools: Power Drills, Tailoring Machines, Cutting Tools, Fusion Tools
7. Toys, Leisure, and Sports Equipment: Gaming Consoles, Exercise Machines, Gambling Devices
8. Medical Devices: Heart Care, In Vitro Diagnostics, Kidney Treatment, Blood Analysis
9. Monitoring & Controlling Instruments: Flow Gauges, Temperature Regulators, Fire Detectors, Warning Systems
10. Automatic Dispensers: Cash Machines, Drink Dispensers
11. Other EEE Not Covered by Other Categories: Wires, Miscellaneous Undefined Products
12. Industrial Processes

EU RoHS Key Definitions

Electrical and electronic equipment or (EEE):

A device that is included in Annex (1) of the resolution. The device operates using electrical power or electromagnetic field and is          designed to function with a maximum voltage of (1000) volts for alternating current and (1500) volts for direct current.

Cables: 

They are used to connect electrical and electronic equipment (EEE) to a power outlet or to connect two or more EEEs to each other. The cables must have a rated voltage of less than 250 volts.

A homogeneous material can be defined in two ways:

1. A substance that has a consistent composition throughout.
2. A substance that is made up of a blend of materials that cannot be separated into individual components by physical methods like grinding, crushing, cutting, unscrewing, or abrasive processes.

EU RoHS – Restricted Substances

RoHS – Exempted Categories

1. Equipment that is deemed crucial for safeguarding the fundamental security interests of Member States. Such equipment may include arms, ammunition, and military-related materials designed for specific military applications.
   
2. Equipment that is specifically engineered and built to be launched into outer space for various purposes such as scientific exploration, communication, navigation, or military operations.
   
   
3. Equipment that is designed to be installed as an integral part of another type of equipment that is either excluded from, or does not fall under the scope of, the Directive. This specialized equipment can only perform its intended function if it is integrated into that particular equipment, and it can only be replaced by an identical piece of specifically designed equipment.
   
   
4. Stationary industrial equipment that is large in size and scale, intended for use in manufacturing, production, or other industrial processes, and is not easily portable or movable.
   
   
5. Installations that are large in size and scale, intended to remain in a fixed location, and are not easily movable. These installations can include things such as power plants, refineries, telecommunication towers, or other infrastructure that is vital to a particular area or region.
   
   
6. Vehicles that are used for transporting people or goods and can include cars, trucks, buses, trains, ships, and airplanes, among others. However, it excludes electric two-wheel vehicles that are not type-approved, meaning they have not been certified or approved for use on public roads.
   
   
7. Mobile machinery that is not designed for use on public roads, and is only intended for professional or commercial use. Examples of such machinery can include construction equipment, agricultural machinery, mining equipment, and industrial forklifts, among others
   
   
8. Active implantable medical devices refer to devices that are intended to be surgically implanted into the body of a patient and are designed to perform an active function such as monitoring, supporting, or substituting a physiological function. These devices are powered by a source other than the body's own energy and are intended to remain in the body for an extended period of time. Examples of such devices can include pacemakers, implantable defibrillators, neurostimulators, and implantable drug delivery systems.
   
   
9. Photovoltaic panels are solar panels that are designed to convert sunlight into electricity. When these panels are intended to be used as part of a system that is installed by professionals for permanent use at a fixed location to produce energy from solar light for public, commercial, industrial, and residential applications, they are considered as photovoltaic panels for such use. Such systems may include solar power plants, rooftop solar installations, and other large-scale solar projects designed to provide energy to homes, businesses, or the public grid.
   
   
10. Equipment that is designed exclusively for use in research and development activities and is only made available for purchase on a business-to-business basis. Such equipment may include laboratory instruments, testing equipment, and specialized machinery that are designed to aid in the research and development of new products, processes, or technologies. These items are typically not intended for general commercial use and are only available to businesses or organizations that require them for R&D purposes.

Large-scale fixed installations

A collection of various types of  equipment and other devices are put together by professionals for permanent use in a particular location. It is a large-scale installation that requires assembly, installation, and removal by professionals.

Examples of Large-scale fixed installations (benefiting from an exclusion):

• Production and processing lines, including robots and machine tools (industrial, food print media etc.); Passenger lifts;
• Conveyor transport systems
• Automated storage systems
• Electrical distribution systems such as generatos;
• Railway signaling infrastructure;
• Fixed installed cooling, air conditioning  and refrigeration systems or heating systems designed exclusively for non-residential use.

How to determine whether equipment is considered a Large-Scale Fixed Installation (LSFI) and thereby excluded from certain regulatory scopes:

 

Specific conditions under which combined equipment is considered to be part of a Large-Scale Fixed Installation (LSFI) and therefore out of scope for certain regulations:

1-Combined Equipment Definition for LSFI

Combined equipment is defined as b2b (business-to-business) and the installation is considered large-scale if it at least meets one of the following criteria occurs:

• When installing or de-installing the installation, it is too large to be moved in an ISO 20-foot container because the total sum of its parts transformed is larger than 5.7m x 2.35m x 2.39m (more than 32.07 m³).
• The maximum weight of any road truck is 44 tons. Thus, when installing or de-installing the installation, if it's too heavy to be moved by a 4-axle road truck, because the total sum of its parts as transported weighs more than the truck's load capacity.

2-Requirement for Special Skills

Specially skilled and trained staff is necessary to:

• Combine/put together the various equipment.
• Integrate it into a building or structure at a predefined and dedicated location.
• The de-installation process dismantles the LSFI from the building or structure where it was installed – also requiring the same specially skilled and trained staff that assembled and installed it.

3-Permanent Use Within a Building or Structure

To be part of requires integration of the equipment into the building or structure:

• Permanently used a part means that the LSFI will not change location in its entire life. This is the case when it is intended to be used at one single location. Although the equipment itself may have some mobility. For example, on rails located within the building/structure.
• If the installation is intended to be used on different sites during its life it is not considered as permanent.

4-Design Specificity for LSFI

Only specifically designed equipment can be part of a LSFI, This means:

• Specifically designed equipment means that it must be tailor made (unique) for the installation. This is the case, if it is specifically designed, dimensioned and customized, according to the specific needs of the installation.
• Standardized, not tailer-made products can be combines in a LSFI but they are not excluded as LSFI or part of another type of equipment that is excluded.

Large-scale stationary industrial tools

A large-scale collection of A large-scale collection of machines, equipment, and/or components that work together for a particular purpose, which is permanently installed and removed by professionals at a specific location.

How to determine whether a particular type of Electrical and Electronic Equipment (EEE) falls within the scope of a specific regulatory framework or is excluded as Large-Scale Stationary Industrial Tools (LSSIT):

 

Tools refer to machines that can be either standalone or assembled, and usually consist of moving parts. They are utilized in various applications, such as the treatment or manufacturing of materials and workpieces. In addition to traditional tools, electrical pumps, power generators, and compressors are also considered as tools. Generally, tools are sold as individual units and are not custom-made.

Equipment is generally created to be used in a fixed location and is not meant to be relocated over time. Although certain types of equipment may have some mobility, like being attached to rails within a plant or site, any installation or removal should be done within an industrial manufacturing or research and development facility. Therefore, the LSSIT is specifically designed for use in a professional setting within a business-to-business (B2B) context as it falls under the category of equipment.

The weight of the item should be greater than 2 tons and it should have a minimum volume of 15,625 cubic meters, which could be achieved with dimensions such as 2.5 meters by 2.5 meters by 2.5 meters.

Annex III & IV RoHS – Exemptions :

Annex III contains a list of exceptions that are applicable to all equipment categories, while Annex IV comprises a list of exceptions that apply exclusively to medical devices and monitoring / control equipment.

Duration of the Exemptions :

• 5 years for Categories 1-7, 10 and 11
• 7 years for Categories 8 and 9

The applicant should submit the application for renewal of exemption 18 months prior to its expiration. The Commission will decide on the renewal no later than 6 months before the expiration date. If the application for renewal is rejected or the exemption is revoked, the decision will not take effect until at least 12 months, but no later than 18 months after the Commission's decision

Last status :

• During a conversation with the EU Commission representative in charge of ROHS, I received the following details:
• Exemptions that have had renewal requests submitted for them will continue to be valid until a decision is made by the commission. We are currently anticipating a decision to be made by the end of this year.

There are two expected scenarios :

• The exemptions may expire permanently, and if this is the case, they will remain valid for at least 12 months but no longer than 18 months from the date of publication of the decision.
• The exemptions may be extended, and if this happens, the minimum extension period will be 18 months from the date of publication of the decision. This will enable us to apply for an extension of the exemptions if it becomes necessary.

Two new substances are expected to be added to RoHS:

1. Tetrabromobisphenol-A (TBBP-A)
2. Medium Chain Chlorinated Paraffins (MCCPs), have been approved for inclusion.

These two substances expected to be added to the RoHS are already under REACH Substances of Very High Concern (SVHC).

ComplyMarket will organize a joint extension application for the RoHS exemptions, once the new decision of the EU parliament is known

Joint extension applications will have more power and save 90% of the costs

 

RoHS Key Elements Applicable Standards – Testing Standards

 

Ahmed Sakr

Product Compliance Consultant 

ComplyMarket UG (haftungsbeschraenkt)