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EU RoHS Directive PVC Exemption Clause Update!


Time:

2023-07-24

The European Commission has issued Directive (EU) 2023/1526, adding Article 41a on the exemption of lead in polyvinyl chloride (PVC) to Annex IV of the EU RoHS Directive.

On July 24, 2023, the European Commission issued Directive (EU) 2023/1526, adding Article 41a on the exemption of lead in polyvinyl chloride (PVC) to Annex IV of the EU RoHS Directive, which takes effect on the 20th day after its publication.

 

The replacement of lead in specific sensors in medical equipment has not yet been completed. The current lead substitutes are not accurate and reliable for all parameters (such as creatinine and Blood urea nitrogen), which cannot ensure the provision of substitutes for these specific equipment. In order to avoid negative impact on medical services, the article is evaluated to comply with the relevant conditions of EU RoHS Directive 2011/65/EU exemption. Therefore, the following items are added to Annex IV of the Directive:



 

Terms

Content

Scope and validity period

Annex IV, 41a

 

Lead as heat stabilizer in polyvinyl chloride (PVC) substrate for current, potential and conductivity sensors in in vitro diagnostic medical equipment used for analysis of whole blood creatinine and Blood urea nitrogen

 

Applicable to Class 8 products, expiring on December 31, 2023

 

 

EU RoHS Directive Exemption Rules

 

Maximum Exemption Period Rule -2011/65/EU Article 5 (2)

For the exemptions listed in Annex III on July 21, 2011, the maximum 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 specifically specified.

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

 

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

The application for renewal should be submitted 18 months before the expiration of the exemption period. The existing exemptions will remain valid until the updated decision is made.

 

Exemption from Revocation Transition Period Rules -2011/65/EU Article 5 (6)

When an exemption application is refused or an exemption is revoked, the validity period of the exemption shall expire at the earliest within 12 months from the date of the decision, and at the latest within 18 months from the date of the decision.

 

 

 

 

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