Commission Delegated Directive (EU) 2021/1978 of 11 August 2021 amending, for the purposes of adapting to scientific and technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for the use of bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP) in spare parts recovered from and used for the repair or refurbishment of medical devices
Proposed act with possible EEA relevance
Act under scrutiny by EEA EFTA
Draft Joint Committee Decision (JCD) under consideration
Entry into force of Joint Committee Decision (JCD) pending
Incorporated into the EEA Agreement and in force
Incorporated into the EEA Agreement but no longer in force
Legal status
EU legal act incorporated into the EEA Agreement by a Joint Committee Decision (JCD) Area (EEA Agreement)
II Technical Regulations, Standards, Testing and Certification
II.XV Dangerous Substances
Joint committee decision (JCD)
121/2022 In force in the EEA
Yes Legal documents
Commission Delegated Directive (EU) 2021/1978 of 11 August 2021 amending, for the purposes of adapting to scientific and technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for the use of bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP) in spare parts recovered from and used for the repair or refurbishment of medical devices
Framseld tilskipun framkvæmdastjórnarinnar (ESB) 2021/1978 frá 11. ágúst 2021 um breytingu á IV. viðauka við tilskipun Evrópuþingsins og ráðsins 2011/65/ESB, að því er varðar undanþágu fyrir notkun bis(2-etýlhexýl)þalats (DEHP), bútýlbensýlþalats (BBP), díbútýlþalats (DBP) og díísóbútýlþalats (DIBP) í varahlutum sem eru endurheimtir úr lækningatækjum og notaðir til viðgerða eða endurbóta á þeim, í því skyni að laga viðaukann að framförum á sviði vísinda og tækni
Delegierte Richtlinie (EU) 2021/1978 der Kommission vom 11. August 2021 zur Änderung — zwecks Anpassung an den wissenschaftlichen und technischen Fortschritt — des Anhangs IV der Richtlinie 2011/65/EU des Europäischen Parlaments und des Rates hinsichtlich einer Ausnahme für die Verwendung von Diethylhexylphthalat (DEHP), Benzylbutylphthalat (BBP), Dibutylphthalat (DBP) und Diisobutylphthalat (DIBP) in aus medizinischen Geräten ausgebauten und für die Reparatur und Wiederinstandsetzung medizinischer Geräte verwendeten Ersatzteilen
History
30.04.2022
Adopted JCD confirmed entry into force date
30.04.2022
Compliance date in the EEA
29.04.2022
Adoption of Joint Commitee Decision (JCD) incorporating the act into the EEA Agreement
12.01.2022
Draft Joint Commitee Decision (JCD) incorporating the act into the EEA Agreement sent to Commission
11.08.2021
Adoption date in the EU
15.11.2021
Compliance date in the EU
Disclaimer: EEA-Lex is provided for information purposes only. The information is not guaranteed or promised to be current or complete and is not intended to replace any applicable legal sources.