On July 24th, 2023, the European Commission published the Directive (EU) 2023/1526 in its official gazette, aiming at amending the 41a exemption for lead in polyvinyl chloride (PVC) in Annex IV of the EU RoHS Directive, which came into effect on the 20th day after its publication.

The substitution of lead in specific sensors in medical equipment has not been completed, and the current lead substitutes are not accurate and reliable for all parameters (such as creatinine and urea nitrogen), so it is impossible to ensure the provision of substitutes for these specific equipment. In order to avoid negative impact on medical services, it is assessed that this clause meets the relevant exemption conditions of EU RoHS Directive 2011/65/EU, so the following items are added to Annex IV of the Directive:

Relevant rules on EU RoHS directive exemption

Rule for the longest period of exemption -2011/65/EU Article 5(2)

For the exemptions listed in Annex III on July 21st, 2011, the longest exemption period is 5 years for products in categories 1-7, 10 and 11 in Annex I, and 7 years for products in categories 8 and 9, unless a shorter period is specified.

For the exemption listed in Annex IV on July 21, 2011, the longest exemption period is 7 years, unless a shorter period is specified.

Application Rules for Extension of Exemption -2011/65/EU Article 5(5)

The application for renewal shall be submitted 18 months before the expiration of the exemption period. Before the update decision is issued, the existing exemption will remain valid.

Exemption from revocation of transitional rules -2011/65/EU Article 5(6)

When an exemption application is rejected or an exemption is revoked, the validity of the exemption expires within 12 months at the earliest and 18 months at the latest from the date of making the decision.

Warm tips

Annex IV of EU RoHS Directive is the exemption content for Category 8 (medical devices, including in-vitro diagnostic medical devices) and Category 9 (monitoring and control equipment, including industrial monitoring and control equipment). Since the formulation of EU RoHS Directive, Annex IV has been constantly updated, and the validity of EU RoHS exemption clauses has a great impact on the compliance of enterprise products with RoHS Directive. ZRLK advises relevant enterprises to pay close attention to the update trends of RoHS exemption clauses at all times, and make reasonable arrangements for production plans and material substitution to avoid products exported to Europe. Our company has a professional technical team and rich experience in controlling harmful substances, which can help you easily know whether the products are safe and compliant. If you need it, please feel free to contact us, and our engineers will serve you as soon as possible!