The European Union (EU) is currently reviewing its Restriction on Hazardous Substances (RoHS) directive for the upcoming year. The most notable change is a proposed revision that would encompass the entire RoHS directive. While the revision proposal has been delayed until Q2 of 2023, there are many other changes for which manufacturers must be prepared. Continue reading to learn more about what to expect from EU RoHS compliance in 2023.
What are the latest revisions to the EU RoHS Directive?
Several revisions to the EU RoHS directive are being proposed in 2023, including the addition of two new restricted substances, multiple proposed exemptions, and exemption expirations. Our team of experts compiled the most important updates to help you prepare for what’s coming this year.
Proposed Substance Additions
The European Commission has proposed adding two new substances to the restricted substance list: tetrabromobisphenol A (TBBPA) and medium-chain chlorinated paraffins (MCCPs). Adding TBBPA and MCCPs would increase the number of restricted substances under EU RoHS from 10 to 12.
- TBBPA is a flame retardant commonly used to reduce the flammability of plastics and synthetic resins in consumer products, including electrical and electronic equipment parts. It is being considered as an addition to the restricted substances list due to its potential to harm human health, as it is a known carcinogen.
- MCCPs are industrial chemicals often used as flame retardants or plasticizers in plastics, rubber, adhesives, paints, and more. They are also used in metal operations as lubricants or coolants. MCCPs are being considered as an addition to the restricted substances list because they are expected to be bio-accumulative and are considered toxic to the environment by some agencies.
Exemption Expirations
Multiple exemptions contained in Annex III and Annex IV are set to expire in 2023 and are no longer renewable. Most of the exemptions apply to RoHS category 8.
Exemption Renewals
Several exemptions, also within Annex III and Annex IV, are currently under review for renewal. It is expected that some exemptions will be replaced by a new exemption with a narrower scope. Commonly used exemptions are included in the requested renewals, such as:
- 6(a)-I, 6(b)-I, 6(b)-II, and 6(c)
- 7(a)
- 7(c)-I and 7(c)-II
Exemption Updates
Annex IV
Annex IV of the EU RoHS Directive, which applies to medical devices and monitoring and control instruments, has been updated with a new exemption:
Exemption 48 - Lead in bismuth strontium calcium copper oxide (BSCCO) superconductor cables and wires and lead in electrical connections to these wires. This exemption expires on June 30th, 2027.
Exemption 27 has also been amended to include the following:
(c) MRI non-integrated coils, for which the Declaration of Conformity of this model is issued for the first time before September 23rd, 2022, or
(d) MRI devices that include integrated coils, which are used in magnetic fields within the sphere of 1 m radius around the isocenter of the magnet in medical magnetic resonance imaging equipment, for which the Declaration of Conformity is issued for the first time before June 30th, 2024.
Exemption 27 expires on June 30th, 2027.
EU Member States must apply the provisions of both exemptions beginning on March 1st, 2023.
Annex III
Following the evaluation of an exemption request, a new exemption has been added to Annex III:
9(a)-III - Up to 0.7 % hexavalent chromium by weight, used as an anticorrosion agent in the working fluid of the carbon steel sealed circuit of gas absorption heat pumps for space and water heating.
The exemption applies to Category 1 and expires on December 31st, 2026.
EU Member States must apply the provisions beginning on September 1st, 2023.
Exemption Proposals
Proposed Exemption 49
The EU Commission is expected to adopt a draft delegated directive that would exempt certain rheometers from the requirement to meet mercury restrictions. The proposal follows an evaluation that substitution of mercury in melt pressure transducers for capillary rheometers at temperatures over 300°C (572°F) and pressures over 1000 bar are currently scientifically and technically impracticable.
If adopted as planned, exemption 49 would be added to Annex IV of the RoHS Directive as follows:
Mercury in melt pressure transducers for capillary rheometers at temperatures over 300°C (572°F) and pressures over 1000 bar.
The exemption, which is planned for commission adoption in Q1 of 2023, would apply to Category 9 and expire on December 31st, 2024, unless it becomes subject to renewal.
Proposed Exemption 41a
The EU Commission is expected to adopt a draft delegated directive that would exempt certain sensors from the requirement to meet lead restrictions. The proposal follows an evaluation that substitution of lead in sensor cards analyzing the parameter creatinine and blood urea nitrogen is not sufficiently progressed but is expected to be finalized by the end of 2023.
If adopted as planned, exemption 41a would be added to Annex IV of the RoHS Directive as follows:
Lead as a thermal stabilizer in polyvinyl chloride (PVC) used as a base material in amperometric, potentiometric, and conductometric electrochemical sensors, which are used in in-vitro diagnostic medical devices for the analysis of creatinine and blood urea nitrogen in whole blood.
Exemption 41a would apply to Category 8 and expire on December 31st, 2023, unless it becomes subject to renewal.
Preparing for Changes to EU RoHS in 2023
Looking for more information to help you prepare for the upcoming changes to EU RoHS this year? Watch our recent webinar where our experts covered the main regulatory changes expected to impact product compliance in 2023, including those applicable to EU RoHS, and how your business can remain compliant.
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