On November 15, 2021, the European Commission issued amendments to Annex IV of RoHS Directive (2011/65/EU) - (EU) 2021/1978, (EU) 2021/1979 and (EU) 2021/1980 in the Official Gazette, adding three new exemptions for phthalates, namely 45, 46 and 47.

According to the amendment, the following three exemptions were added to Annex IV of the RoHS Directive:

The main contents of the new exemption clauses are as follows:

Term of validity:

45 DEHP in Ion Selective Electrode for Analysis of Human Body Fluid and/or Dialysate 21 July 2028

46 DEHP in plastic assembly of magnetic resonance imaging (MRI) inspection coil January 1, 2024

47 DEHP, BBP, DBP, DIBP in the parts and components recovered from medical equipment (including in vitro diagnostic medical devices and their accessories) and used for repair or refurbishment, provided that the reuse process is carried out in an auditable B2B closed-loop system, and the consumers shall be informed of the reused parts July 21, 2028

Note: The exemption list of RoHS2.0 Directive is listed in Annex III and IV of 2011/65/EU respectively;

Annex IV is the exemption clause for the application of medical and monitoring control equipment;

Annex III is an exemption clause for all electronic and electrical equipment.

The new exemption clauses have come into force since the date of publication in the official gazette.

In July 2021, the European Union notified the WTO of a number of revised drafts of the exemption provisions for mercury in Appendix III of the RoHS Directive, which are expected to be updated in the near future. The relevant provisions mainly cover the exemption requirements for mercury in lamps.

Maximum Exemption Validity Rules - 2011/65/EUArticle5 (2)

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

For the exemption 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 shall be submitted 18 months before the expiration of the exemption.

The existing exemptions remain valid until the update decision is issued.

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

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

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