in force 2021-02-22
02019R1021-20200907 → 02019R1021-20210222
Amended by Regulation (EU) 2021/115 32021R0115
detected 2026-09-04
1 provision touched — 1 substantive, 0 date-only, 1 disputed · every change carries an explanation that passed its citation check
Emendrix checks every change against three independent sources. Where they disagree it says so rather than picking a winner.
MODIFIED +390 −22 Annex I ANNEX I§
applies from: unknown (the text changed beyond its dates, so no date that moved can be read as the application date)
dates added to the text: 2023-02-22
Sources disagree — the text comparison and the EU's own amendment metadata found this change; the amending act's instructions do not mention it. All are shown; none is overruled.
In point 3 of the PFOA entry, the earlier text referred to fluorochemicals with a carbon chain equal to or shorter than 6 atoms, while the later text specifies a perfluoro carbon chain equal to or shorter than 6 atoms.
In point 4 of the PFOA entry, the earlier text limited the ionising irradiation process for producing PTFE micropowders to up to 400 kilograys, whereas the later text removes that dose limit and simply refers to ionising irradiation.
The later text adds a new point 10 to the PFOA entry, setting a concentration threshold of 2 mg/kg for PFOA, its salts and/or PFOA-related compounds in medical devices other than invasive and implantable devices, and stating that this exemption shall be reviewed and assessed by the Commission no later than 22 February 2023.
Cited: Annex I, v1 · Annex I, v2
text before / after
02019R1021-20200907 → 02019R1021-20210222
ANNEX I
Part A
Substances listed in the Convention and in the Protocol as well as substances listed only in the Convention
Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of … 2,828 unchanged words … a transported isolated intermediate within the meaning of Article 3 point 15(c) of Regulation (EC) No 1907/2006 and fulfilling the strictly controlled conditions set out in Article 18(4)(a) to (f) of that Regulation for the production of fluorochemicals with a perfluoro carbon chain equal to or shorter than 6 atoms. This exemption shall be reviewed and assessed by the Commission no later than 5.7.2022.
4. For the purposes of this entry, point (b) of Article 4(1) shall apply to concentrations of PFOA and its salts equal to or below 1 mg/kg (0,0001 % by weight) where they are present in polytetrafluoroethylene (PTFE) micropowders produced by ionising irradiation of up to 400 kilograys or by thermal degradation as well as in mixtures and articles for industrial and professional uses containing PTFE micropowders. All emissions of PFOA during the manufacture and use of PTFE micropowders shall be avoided and, if not possible, reduced as … 377 unchanged words … the market and use of PFOA, its salts and PFOA-related compounds shall be allowed until 3 December 2020 for the following purposes:
(a) medical devices other than implantable ones, within the scope of Regulation (EU) 2017/745
;
(b) latex printing inks;
(c) plasma nano-coatings.
10. For the purposes of this entry, point (b) of Article 4(1) shall apply to concentrations of PFOA and its salts and/or PFOA-related compounds equal to or below 2 mg/kg (0,0002 % by weight) where they are present in medical devices other than invasive devices and implantable devices. This exemption shall be reviewed and assessed by the Commission no later than 22 February 2023.
Dicofol 115-32-2 204-082-0 None
Part B
Substances listed only in the Protocol
Substance CAS No EC No Specific exemption on intermediate use or other specification
The full entry, with the citation mapping v1 = 02019R1021-20200907, v2 = 02019R1021-20210222, is committed at eu/32019R1021/CHANGELOG.md.