EU RoHS Exemptions List: Annex III and Annex IV

Under EU RoHS, some applications are exempted from the general thresholds of restricted hazardous substances, under certain conditions. They are RoHS exemptions.

Enviropass maintains the updated RoHS exemption lists on this Europe RoHS page.

EU RoHS Exemptions List: Annex III and Annex IV

Under the EU RoHS Directive 2011/65/EU, electrical and electronic equipment must comply with restrictions on hazardous substances such as lead, mercury, cadmium, hexavalent chromium, PBB, PBDE, DEHP, BBP, DBP, and DIBP. However, some specific applications may temporarily use restricted substances when substitution is not technically or scientifically feasible. These are called RoHS exemptions.

This page summarizes the EU RoHS exemptions listed in Annex III and Annex IV, including their scope, application, and expiry dates where applicable.

Annex III includes general RoHS exemptions that may apply to different categories of electrical and electronic equipment.

Annex IV includes exemptions specific to medical devices and monitoring and control instruments.

The New List of General EU RoHS Exemptions (Annex III)*

The New RoHS Exemption List Exclusively to Medical Devices and Monitoring and Control Instruments (Annex IV)*

* Note: These are simplified lists. Enviropass Expertise Inc. does not warrant the accuracy or completeness of these documents. The opinion expressed in this document is only that of the Enviropass Expertise Inc and does not constitute legal advice. Technical and compliance specifications and any other materials or information provided are subject to change without notice and reliance on its contents shall be at your sole risk.

What is a RoHS Exemption?

A RoHS exemption is not the same as being outside the RoHS scope. If a product is excluded from RoHS, the Directive does not apply to it. If a product is within scope, a specific material, component, or application may still benefit from an exemption if it meets the exact wording and conditions of Annex III or Annex IV.

Examples of Common RoHS exemptions

Common RoHS exemptions include lead in certain copper alloys, aluminum alloys, steel alloys, solders, glass, ceramics, and high-reliability electronic applications. These exemptions are not blanket permissions: the exact material, product category, concentration, and expiry date must match the Annex wording.

RoHS Exemption 6: Lead in Steel, Aluminum, and Copper Alloys

RoHS exemption 6 covers specific uses of lead as an alloying element in certain metals. This exemption is especially relevant for electronic equipment containing machined metal parts, terminals, connectors, fasteners, housings, heat sinks, brackets, and other metallic components.

In practice, exemption 6 is divided into several sub-exemptions, depending on the alloy type and lead concentration.

Exemption	Application	Maximum lead concentration
6(a)	Lead as an alloying element in steel for machining purposes and in galvanized steel	Up to 0.35% lead by weight
6(a)-I	Lead as an alloying element in steel for machining purposes	Up to 0.35% lead by weight
6(b)	Lead as an alloying element in aluminum	Up to 0.4% lead by weight
6(b)-I	Lead as an alloying element in aluminum from lead-bearing aluminum scrap recycling	Up to 0.4% lead by weight
6(b)-II	Lead as an alloying element in aluminum for machining purposes	Up to 0.4% lead by weight
6(c)	Copper alloy containing lead	Up to 4% lead by weight

These exemptions are commonly used when lead improves machinability, mechanical performance, or manufacturing reliability. However, they are not blanket exemptions for all metal parts containing lead. The material must match the exact exemption wording, the lead concentration must remain within the authorized limit, and the exemption must still be valid for the applicable product category.

For RoHS technical documentation, manufacturers should keep evidence such as supplier declarations, material specifications, alloy grades, full material declarations, test reports, or certificates of conformity. The technical file should clearly identify the applicable exemption, affected parts, material composition, and product category.

RoHS Exemptions Differ from a Product Category to Another

As you can see in the tables above, the RoHS exemption scope differs depending on the electrical or electronic equipment category. Here is a table with the different product categories per Annex I of EU RoHS:

Category #	Products Scope
1	Large household appliances
2	Small household appliances
3	IT and telecommunications equipment
4	Consumer equipment
5	Lighting equipment
6	Electrical and electronic tools
7	Toys, leisure and sports equipment
8	Medical devices
9	Monitoring and control instruments including industrial monitoring and control instruments
10	Automatic dispensers
11	Other EEE not covered by any of the categories above

The RoHS exemption scope can apply only to a portion product category, like in vitro diagnostic medical devices (part of category 8) or industrial monitoring and control instruments (part of category 9).

Annex III of Directive 2011/65/EU RoHS lists general RoHS exemptions. Product categories 1 to 7 and 10 typically share the same RoHS exemptions.

Some particular exemptions rule apply to categories 8 and 9, and 11. Even within category 8, in-vitro medical devices benefit from some special provisions. In category 9, industrial monitoring and control instruments also have extensions or more access to exemptions.

Additionally, Annex IV of Directive 2011/65/EU gives RoHS exemptions to categories 8 and 9.

RoHS Scope vs. Exemption

Is the product excluded from RoHS?

RoHS may not apply to the product at all.

Is the product in scope but using a restricted substance?

A RoHS exemption may be needed.

Is the exemption still valid for the product category?

The expiry date and category must be checked.

Is the exemption documented?

The technical file should justify and document the exemption.

Why a RoHS Exemption?

RoHS is an EU Directive that restricts the use of certain hazardous substances in electrical and electronic equipment. For technical reasons, some applications benefit from exemptions to the general restriction limits. However, as technology improvements tend to reduce environmental impacts, several RoHS exemptions will eventually vanish.

To push improvements from the industry, article 5 of the Directive 2011/65/EU requires the European Union to revise the Annex III list of exemptions at least every five years, from July 2011. As a result, on July 22nd, 2021, the European Union updated the entire Annex III RoHS exemption list.

A RoHS exemption was either:

Renewed and maintained when there is no viable technological alternative on the market;
Modified, typically with additional constraints; or
Removed.

Expired RoHS Exemptions on July 21st, 2021

Several RoHS exemptions have expired on July 21st, 2021.

For example:

General exemptions 21a, b, and c for particular cadmium and lead applications in printing inks;
Specific lead exemption 34 in the fluorescent powder of discharge lamps in some medical devices, monitoring and control instruments

Manufacturers or Electrical or electronic products can no longer claim these exemptions. Instead, they must revise their technical file and eventually the parts lists to avoid parts using expired exemptions.

Maintained RoHS Exemptions

The European Commission maintained most exemptions for another period validity of 5 years. It is the case for example of these common exemptions in electronic products:

Exemption 6A1 applicable to lead in certain steel alloys;
Exemptions 7C1 and 7C2 for lead in some galls or ceramic applications.

It is important to note that many exemptions apply to fewer product categories than before. For instance, some only apply to products categories 8, 9, and 11.

How RoHS Exemptions are Reviewed

RoHS exemptions are temporary and are regularly reassessed. The European Commission considers the availability and reliability of substitutes, environmental and health impacts, socioeconomic impacts, and effects on innovation. Renewal applications must generally be submitted no later than 18 months before an exemption expires. Existing exemptions under renewal may remain valid until the Commission makes a decision.

How Delegated Directives Update RoHS Exemptions

RoHS exemptions are not static. The European Commission may update Annex III and Annex IV of the RoHS Directive through delegated directives. These legal acts are used to add, renew, amend, or remove exemptions based on technical and scientific assessments.

A delegated directive may:

Action	Meaning
Add a new exemption	A new specific use of a restricted substance is temporarily allowed.
Renew an existing exemption	An exemption remains available for a defined period.
Amend an exemption	The wording, scope, expiry date, or product categories may change.
Delete an exemption	The exemption is no longer available after the applicable transition period.

Before an exemption is renewed or modified, the European Commission evaluates whether substitution is technically and scientifically practicable. The assessment may also consider reliability, environmental impacts, health impacts, socioeconomic factors, and the availability of alternatives.

For manufacturers, delegated directives are important because they can directly affect product compliance. A product that relied on a valid RoHS exemption in the past may need to be reassessed if the exemption wording, expiry date, or applicable product categories change.

As a good compliance practice, companies should periodically review the current versions of Annex III and Annex IV, update their supplier declarations, and make sure their IEC 63000 technical documentation reflects the latest exemption status.

What to do to Comply with the Current RoHS Exemption list?

Manufacturers should update their technical files and see what parts in the product’s bills of materials (BOMs) no longer comply. Then, they must find valid alternatives on the market with RoHS exemptions. Maintaining the RoHS technical file is essential. An internal procedure should detail how to do it.

To audit your suppliers, you can use the free Enviropass Product Environmental Compliance (EPEC) form. The EPEC form keeps up with the valid RoHS exemptions.

RoHS Exemption FAQ

What is a RoHS exemption?

A RoHS exemption allows a restricted substance to be used in a specific application when substitution is not technically or scientifically feasible.

Are RoHS exemptions permanent?

No. RoHS exemptions are time-limited and regularly reviewed by the European Commission.

What is the difference between Annex III and Annex IV?

Annex III contains general exemptions. Annex IV contains exemptions for medical devices and monitoring and control instruments.

Can a manufacturer request a new RoHS exemption?

Yes, but the process requires a strong technical and scientific dossier. The European Commission states that a decision currently takes about 18 to 24 months from the application date.

What happens if a RoHS exemption expires?

If no valid renewal or transition applies, the product must comply without relying on that exemption.

Need help confirming a RoHS exemption? Enviropass can review your bill of materials, supplier declarations, test reports, and technical documentation to confirm whether a RoHS exemption applies. We can also help prepare IEC 63000 technical files, supplier questionnaires, and RoHS compliance certificates.

Ask an Enviropass specialist!

EU RoHS Exemptions List: Annex III and Annex IV