|
Entry Nr
|
Substance
|
Intrinsic property(ies) referred to in Article 57
|
Transitional arrangements
|
Exempted (categories of) uses
|
Review periods
|
|
Latest application date (1)
|
Sunset date (2)
|
|
1.
|
5-tert-butyl-2,4,6-trinitro-m-xylene
(Musk xylene)
EC No: 201-329-4
CAS No: 81-15-2
|
vPvB
|
21 February 2013
|
21 August 2014
|
—
|
—
|
|
2.
|
4,4’-Diaminodiphenylmethane
(MDA)
EC No: 202-974-4
CAS No: 101-77-9
|
Carcinogenic
(category 1B)
|
21 February 2013
|
21 August 2014
|
—
|
—
|
|
3.
|
Hexabromocyclododecane
(HBCDD) EC No: 221-695-9,
247-148-4, CAS No: 3194-55-6
25637-99-4
alpha-hexabromocyclododecane
CAS No: 134237-50-6,
beta-hexabromocyclododecane
CAS No: 134237-51-7
gamma-hexabromocyclododecane
CAS No: 134237-52-8
|
PBT
|
21 February 2014
|
21 August 2015
|
—
|
—
|
|
▼M68
|
|
4.
|
Bis(2-ethylhexyl) phthalate
(DEHP)
EC No: 204-211-0
CAS No: 117-81-7
|
Toxic for reproduction (category 1B)
Endocrine disrupting properties (Article 57(f) – human health)
Endocrine disrupting properties (Article 57(f) – environment)
|
(a) 21 August 2013 (*)
(b) By way of derogation from point (a):
14 June 2023 for uses in:
— food contact materials within the scope of Regulation (EC) No 1935/2004;
— immediate packaging of medicinal products covered under Regulation (EC) No 726/2004, Directive 2001/82/EC, and/or Directive 2001/83/EC;
— mixtures containing DEHP at or above 0,1 % and below 0,3 % weight by weight;
►M76
(c) by way of derogation from point (a):
1 January 2029 for uses in medical devices within the scope of Regulations (EU) 2017/745 and (EU) 2017/746.
◄
|
(a) 21 February 2015 (**)
(b) By way of derogation from point (a):
14 December 2024 for uses in:
— food contact materials within the scope of Regulation (EC) No 1935/2004;
— immediate packaging of medicinal products covered under Regulation (EC) No 726/2004, Directive 2001/82/EC, and/or Directive 2001/83/EC;
— mixtures containing DEHP at or above 0,1 % and below 0,3 % weight by weight;
►M76
(c) by way of derogation from point (a):
1 July 2030 for uses in medical devices within the scope of Regulations (EU) 2017/745 and (EU) 2017/746.
◄
|
-
|
-
|
|
5.
|
Benzyl butyl phthalate
(BBP)
EC No: 201-622-7
CAS No: 85-68-7
|
Toxic for reproduction (category 1B)
Endocrine disrupting properties (Article 57(f) – human health)
|
(a) 21 August 2013 (*)
(b) By way of derogation from point (a):
14 June 2023 for uses in:
— immediate packaging of medicinal products covered under Regulation (EC) No 726/2004, Directive 2001/82/EC, and/or Directive 2001/83/EC;
— mixtures containing BBP at or above 0,1 % and below 0,3 % weight by weight.
|
(a) 21 February 2015 (**)
(b) By way of derogation from point (a):
14 December 2024 for uses in:
— immediate packaging of medicinal products covered under Regulation (EC) No 726/2004, Directive 2001/82/EC, and/or Directive 2001/83/EC;
— mixtures containing BBP at or above 0,1 % and below 0,3 % weight by weight.
|
-
|
-
|
|
6.
|
Dibutyl phthalate
(DBP)
EC No: 201-557-4
CAS No: 84-74-2
|
Toxic for reproduction
(category 1B)
Endocrine disrupting properties (Article 57(f) – human health)
|
(a) 21 August 2013 (*)
(b) By way of derogation from point (a):
14 June 2023 for uses in:
— immediate packaging of medicinal products covered under Regulation (EC) No 726/2004, Directive 2001/82/EC, and/or Directive 2001/83/EC;
— mixtures containing DBP at or above 0,1 % and below 0,3 % weight by weight.
|
(a) 21 February 2015 (**)
(b) By way of derogation from point (a):
14 December 2024 for uses in:
— immediate packaging of medicinal products covered under Regulation (EC) No 726/2004, Directive 2001/82/EC, and/or Directive 2001/83/EC;
— mixtures containing DBP at or above 0,1 % and below 0,3 % weight by weight.
|
-
|
-
|
|
7.
|
Diisobutyl phthalate
(DIBP)
EC No: 201-553-2
CAS No: 84-69-5
|
Toxic for reproduction
(category 1B)
Endocrine disrupting properties (Article 57(f) – human health)
|
(a) 21 August 2013 (*)
(b) By way of derogation from point (a):
14 June 2023 for uses in mixtures containing DIBP at or above 0,1 % and below 0,3 % weight by weight.
|
(a) 21 February 2015 (**)
(b) By way of derogation from point (a):
14 December 2024 for uses in mixtures containing DIBP at or above 0,1 % and below 0,3 % weight by weight.
|
-
|
-
|
|
▼M15
|
|
8.
|
Diarsenic trioxide
EC No: 215-481-4
CAS No: 1327-53-3
|
Carcinogenic
(category 1A)
|
21 November 2013
|
21 May 2015
|
—
|
—
|
|
9.
|
Diarsenic pentaoxide
EC No: 215-116-9
CAS No: 1303-28-2
|
Carcinogenic
(category 1A)
|
21 November 2013
|
21 May 2015
|
—
|
—
|
|
10.
|
Lead chromate
EC No: 231-846-0
CAS No: 7758-97-6
|
Carcinogenic
(category 1B)
Toxic for reproduction
(category 1A)
|
21 November 2013
►M43
(*1)
◄
|
21 May 2015
►M43
(*2)
◄
|
—
|
—
|
|
11.
|
Lead sulfochromate yellow
(C.I. Pigment Yellow 34)
EC No: 215-693-7
CAS No: 1344-37-2
|
Carcinogenic
(category 1B)
Toxic for reproduction
(category 1A)
|
21 November 2013
►M43
(*1)
◄
|
21 May 2015
►M43
(*2)
◄
|
—
|
—
|
|
12.
|
Lead chromate molybdate sulphate red
(C.I. Pigment Red 104)
EC No: 235-759-9
CAS No: 12656-85-8
|
Carcinogenic
(category 1B)
Toxic for reproduction
(category 1A)
|
21 November 2013
►M43
(*1)
◄
|
21 May 2015
►M43
(*2)
◄
|
|
|
|
13.
|
Tris (2-chloroethyl) phosphate
(TCEP)
EC No: 204-118-5
CAS No: 115-96-8
|
Toxic for reproduction
(category 1B)
|
21 February 2014
|
21 August 2015
|
|
|
|
14.
|
2,4-Dinitrotoluene (2,4-DNT)
EC No: 204-450-0
CAS No: 121-14-2
|
Carcinogenic
(category 1B)
|
21 February 2014
►M43
(*1)
◄
|
21 August 2015
►M43
(*2)
◄
|
|
|
|
▼M22
|
|
15.
|
Trichloroethylene
EC No: 201-167-4
CAS No: 79-01-6
|
Carcinogenic
(category 1B)
|
21 October 2014
►M43
(*1)
◄
|
21 April 2016
►M43
(*2)
◄
|
—
|
—
|
|
16.
|
Chromium trioxide
EC No: 215-607-8
CAS No: 1333-82-0
|
Carcinogenic
(category 1A)
|
21 March 2016
►M43
(*1)
◄
|
21 September 2017
►M43
(*2)
◄
|
—
|
—
|
|
17.
|
Acids generated from chromium trioxide and their oligomers
Group containing:
Chromic acid
EC No: 231-801-5
CAS No: 7738-94-5
Dichromic acid
EC No: 236-881-5
CAS No: 13530-68-2
Oligomers of chromic acid and dichromic acid
EC No: not yet assigned
CAS No: not yet assigned
|
Carcinogenic
(category 1B)
|
21 March 2016
►M43
(*1)
◄
|
21 September 2017
►M43
(*2)
◄
|
—
|
—
|
|
18.
|
Sodium dichromate
EC No: 234-190-3
CAS No: 7789-12-0
10588-01-9
|
Carcinogenic
(category 1B)
Toxic for reproduction
(category 1B)
|
21 March 2016
►M43
(*1)
◄
|
21 September 2017
►M43
(*2)
◄
|
—
|
—
|
|
19.
|
Potassium dichromate
EC No: 231-906-6
CAS No: 7778-50-9
|
Carcinogenic
(category 1B)
Toxic for reproduction
(category 1B)
|
21 March 2016
►M43
(*1)
◄
|
21 September 2017
►M43
(*2)
◄
|
—
|
—
|
|
20.
|
Ammonium dichromate
EC No: 232-143-1
CAS No: 7789-09-5
|
Carcinogenic
(category 1B)
Toxic for reproduction
(category 1B)
|
21 March 2016
►M43
(*1)
◄
|
21 September 2017
►M43
(*2)
◄
|
|
|
|
21.
|
Potassium chromate
EC No: 232-140-5
CAS No: 7789-00-6
|
Carcinogenic
(category 1B)
|
21 March 2016
►M43
(*1)
◄
|
21 September 2017
►M43
(*2)
◄
|
|
|
|
22.
|
Sodium chromate
EC No: 231-889-5
CAS No: 7775-11-3
|
Carcinogenic
(category 1B)
Toxic for reproduction
(category 1B)
|
21 March 2016
►M43
(*1)
◄
|
21 September 2017
►M43
(*2)
◄
|
|
|
|
▼M28
|
|
23.
|
Formaldehyde, oligomeric reaction products with aniline (technical MDA)
EC No: 500-036-1
CAS No: 25214-70-4
|
Carcinogenic
(category 1B)
|
22 February 2016
►M43
(*1)
◄
|
22 August 2017
►M43
(*2)
◄
|
—
|
—
|
|
24.
|
Arsenic acid
EC No: 231-901-9
CAS No: 7778-39-4
|
Carcinogenic
(category 1A)
|
22 February 2016
|
22 August 2017
|
—
|
—
|
|
25.
|
Bis(2-methoxyethyl) ether (diglyme)
EC No: 203-924-4
CAS No: 111-96-6
|
Toxic for reproduction
(category 1B)
|
22 February 2016
►M43
(*1)
◄
|
22 August 2017
►M43
(*2)
◄
|
—
|
—
|
|
26.
|
1,2-dichloroethane (EDC)
EC No: 203-458-1
CAS No: 107-06-2
|
Carcinogenic
(category 1B)
|
22 May 2016
|
22 November 2017
|
—
|
—
|
|
27.
|
2,2′-dichloro-4,4′-methylenedianiline (MOCA)
EC No: 202-918-9
CAS No: 101-14-4
|
Carcinogenic
(category 1B)
|
22 May 2016
►M43
(*1)
◄
|
22 November 2017
►M43
(*2)
◄
|
—
|
—
|
|
28.
|
Dichromium tris(chromate)
EC No: 246-356-2
CAS No: 24613-89-6
|
Carcinogenic
(category 1B)
|
22 July 2017
►M43
(*1)
◄
|
22 January 2019
►M43
(*2)
◄
|
—
|
—
|
|
29.
|
Strontium chromate
EC No: 232-142-6
CAS No: 7789-06-2
|
Carcinogenic
(category 1B)
|
22 July 2017
►M43
(*1)
◄
|
22 January 2019
►M43
(*2)
◄
|
—
|
—
|
|
30.
|
Potassium hydroxyoctaoxodizincatedichromate
EC No: 234-329-8
CAS No: 11103-86-9
|
Carcinogenic
(category 1A)
|
22 July 2017
►M43
(*1)
◄
|
22 January 2019
►M43
(*2)
◄
|
—
|
—
|
|
31.
|
Pentazinc chromate octahydroxide
EC No: 256-418-0
CAS No: 49663-84-5
|
Carcinogenic
(category 1A)
|
22 July 2017
►M43
(*1)
◄
|
22 January 2019
►M43
(*2)
◄
|
—
|
—
|
|
▼M43
|
|
32.
|
1-Bromopropane (n-propyl bromide)
EC No: 203-445-0
CAS No: 106-94-5
|
Toxic for reproduction
(category 1B)
|
4 January 2019
►M56
(*1)
◄
|
4 July 2020
►M56
(*2)
◄
|
—
|
—
|
|
33.
|
Diisopentylphthalate
EC No: 210-088-4
CAS No: 605-50-5
|
Toxic for reproduction
(category 1B)
|
4 January 2019
►M56
(*1)
◄
|
4 July 2020
►M56
(*2)
◄
|
—
|
—
|
|
34.
|
1,2-Benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7 rich
EC No: 276-158-1
CAS No: 71888-89-6
|
Toxic for reproduction
(category 1B)
|
4 January 2019
►M56
(*1)
◄
|
4 July 2020
►M56
(*2)
◄
|
—
|
—
|
|
35.
|
1,2-Benzenedicarboxylic acid, di-C7-11-branched and linear alkyl esters
EC No: 271-084-6
CAS No: 68515-42-4
|
Toxic for reproduction
(category 1B)
|
4 January 2019
►M56
(*1)
◄
|
4 July 2020
►M56
(*2)
◄
|
—
|
—
|
|
36.
|
1,2-Benzenedicarboxylic acid, dipentylester, branched and linear
EC No: 284-032-2
CAS No: 84777-06-0
|
Toxic for reproduction
(category 1B)
|
4 January 2019
►M56
(*1)
◄
|
4 July 2020
►M56
(*2)
◄
|
—
|
—
|
|
37.
|
Bis(2-methoxyethyl) phthalate
EC No: 204-212-6
CAS No: 117-82-8
|
Toxic for reproduction
(category 1B)
|
4 January 2019
►M56
(*1)
◄
|
4 July 2020
►M56
(*2)
◄
|
—
|
—
|
|
38.
|
Dipentylphthalate
EC No: 205-017-9
CAS No: 131-18-0
|
Toxic for reproduction
(category 1B)
|
4 January 2019
►M56
(*1)
◄
|
4 July 2020
►M56
(*2)
◄
|
—
|
—
|
|
39.
|
N-pentyl-isopentylphthalate
EC No: —
CAS No: 776297-69-9
|
Toxic for reproduction
(category 1B)
|
4 January 2019
►M56
(*1)
◄
|
4 July 2020
►M56
(*2)
◄
|
—
|
—
|
|
40.
|
Anthracene oil
EC No: 292-602-7
CAS No: 90640-80-5
|
Carcinogenic
(category 1B) (*3), PBT, vPvB
|
4 April 2019
►M56
(*1)
◄
|
4 October 2020
►M56
(*2)
◄
|
—
|
—
|
|
41.
|
Pitch, coal tar, high temp.
EC No: 266-028-2
CAS No: 65996-93-2
|
Carcinogenic
(category 1B), PBT, vPvB
|
4 April 2019
►M56
(*1)
◄
|
4 October 2020
►M56
(*2)
◄
|
—
|
—
|
|
42.
|
4-(1,1,3,3-Tetramethylbutyl)phenol, ethoxylated
(covering well-defined substances and UVCB substances, polymers and homologues)
EC No: —
CAS No: —
|
Endocrine disrupting properties (Article 57(f) — environment)
|
►M62
(a) 4 July 2019 (*1);
(b) by way of derogation from point (a), 22 June 2022 for uses as follows:
— for the research, development and production of medicinal products falling within the scope of Directive 2001/83/EC or medical devices or accessories to medical devices falling within the scope of Directive 93/42/EEC, Regulation (EU) 2017/745, Directive 98/79/EC or Regulation (EU) 2017/746 of the European Parliament and of the Council (*4), in view of their use for the diagnosis, treatment or prevention of the coronavirus disease (COVID-19),
— in medical devices or accessories to medical devices falling within the scope of Directive 93/42/EEC, Regulation (EU) 2017/745, Directive 98/79/EC or Regulation (EU) 2017/746, for the diagnosis, treatment or prevention of COVID-19.
◄
|
►M62
(a) 4 January 2021 (*2);
(b) by way of derogation from point (a), 22 December 2023 for uses as follows:
— for the research, development and production of medicinal products falling within the scope of Directive 2001/83/EC or medical devices or accessories to medical devices falling within the scope of Directive 93/42/EEC, Regulation (EU) 2017/745, Directive 98/79/EC or Regulation (EU) 2017/746, in view of their use for the diagnosis, treatment or prevention of COVID-19,
— in medical devices or accessories to medical devices falling within the scope of Directive 93/42/EEC, Regulation (EU) 2017/745, Directive 98/79/EC or Regulation (EU) 2017/746, for the diagnosis, treatment or prevention of COVID-19.
◄
|
—
|
—
|
|
43.
|
4-Nonylphenol, branched and linear, ethoxylated
(substances with a linear and/or branched alkyl chain with a carbon number of 9 covalently bound in position 4 to phenol, ethoxylated covering UVCB- and well-defined substances, polymers and homologues, which include any of the individual isomers and/or combinations thereof)
EC No: —
CAS No: —
|
Endocrine disrupting properties (Article 57(f) — environment)
|
4 July 2019
►M56
(*1)
◄
|
4 January 2021
►M56
(*2)
◄
|
—
|
—
|
|
▼C8
|
|
44.
|
1,2-Benzenedicarboxylic acid, dihexyl ester, branched and linear
EC No: 271-093-5
CAS No: 68515-50-4
|
Toxic for reproduction (category 1B)
|
27 August 2021 (*1)
|
27 February 2023 (*2)
|
—
|
—
|
|
45.
|
Dihexyl phthalate
EC No: 201-559-5
CAS No: 84-75-3
|
Toxic for reproduction (category 1B)
|
27 August 2021 (*1)
|
27 February 2023 (*2)
|
—
|
—
|
|
46.
|
1,2-benzenedicarboxylic acid, di-C6-10-alkyl esters; 1,2-benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters with ≥ 0,3 % of dihexyl phthalate (EC No 201-559-5)
EC No: 271-094-0; 272-013-1
CAS No: 68515-51-5; 68648-93-1
|
Toxic for reproduction (category 1B)
|
27 August 2021 (*1)
|
27 February 2023 (*2)
|
—
|
—
|
|
47.
|
Trixylyl phosphate
EC No: 246-677-8
CAS No: 25155-23-1
|
Toxic for reproduction (category 1B)
|
27 November 2021
|
27 May 2023
|
—
|
—
|
|
48.
|
Sodium perborate; perboric acid, sodium salt
EC No: 239-172-9; 234-390-0
CAS No: -
|
Toxic for reproduction (category 1B)
|
27 November 2021
|
27 May 2023
|
—
|
—
|
|
49.
|
Sodium peroxometaborate
EC No: 231-556-4
CAS No: 7632-04-4
|
Toxic for reproduction (category 1B)
|
27 November 2021
|
27 May 2023
|
—
|
—
|
|
50.
|
5-sec-butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [1], 5-sec-butyl-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [2] [covering any of the individual stereoisomers of [1] and [2] or any combination thereof]
EC No: -
CAS No: -
|
vPvB
|
27 February 2022
|
27 August 2023
|
—
|
—
|
|
51.
|
2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol (UV-328)
EC No: 247-384-8
CAS No: 25973-55-1
|
PBT, vPvB
|
27 May 2022
|
27 November 2023
|
—
|
—
|
|
52.
|
2,4-di-tert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol (UV-327)
EC No: 223-383-8
CAS No: 3864-99-1
|
vPvB
|
27 May 2022
|
27 November 2023
|
—
|
—
|
|
53.
|
2-(2H-benzotriazol-2-yl)-4-(tert-butyl)-6-(sec-butyl)phenol (UV-350)
EC No: 253-037-1
CAS No: 36437-37-3
|
vPvB
|
27 May 2022
|
27 November 2023
|
—
|
—
|
|
54.
|
2-benzotriazol-2-yl-4,6-di-tert-butylphenol (UV-320)
EC No: 223-346-6
CAS No: 3846-71-7
|
PBT, vPvB
|
27 May 2022
|
27 November 2023
|
—
|
—
|
|
▼M71
|
|
55.
|
Tetraethyllead
EC No: 201-075-4
CAS No: 78-00-2
|
Toxic for reproduction (category 1A)
|
1 November 2023
|
1 May 2025
|
-
|
-
|
|
56.
|
4,4'-bis(dimethylamino)-4"-(methylamino)trityl alcohol (with ≥ 0,1 % of Michler’s ketone (EC No 202-027-5) or Michler’s base (EC No 202-959-2))
EC No: 209-218-2
CAS No: 561-41-1
|
Carcinogenic (category 1B)
|
1 November 2023
|
1 May 2025
|
-
|
-
|
|
57.
|
Reaction products of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and 4-heptylphenol, branched and linear (RP-HP) (with ≥ 0,1 % w/w 4-heptylphenol, branched and linear)
EC No: -
CAS No: -
|
Endocrine disrupting properties (Article 57, point (f) – environment)
|
1 November 2023
|
1 May 2025
|
-
|
-
|
|
58.
|
2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (DOTE)
EC No: 239-622-4
CAS No: 15571-58-1
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Toxic for reproduction (category 1B)
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1 November 2023
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1 May 2025
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-
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-
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59.
|
Reaction mass of 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate and 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (reaction mass of DOTE and MOTE)
EC No: -
CAS No: -
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Toxic for reproduction (category 1B)
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1 November 2023
|
1 May 2025
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-
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-
|
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▼C1
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(1)
Date referred to in Article 58(1)(c)(ii) of Regulation (EC) No 1907/2006.
(2)
Date referred to in Article 58(1)(c)(i) of Regulation (EC) No 1907/2006.
(*1)
►M56
1 September 2021 for the use of the substance in the production of spare parts as articles or as complex products for the repair of articles or complex products, the production of which ceased or will have ceased before the sunset date indicated in the entry for that substance, where that substance was used in the production of those articles or complex products and these cannot function as intended without that spare part and the spare part cannot be produced without that substance, and for the use of the substance (on its own or in a mixture) for the repair of such articles or complex products where that substance on its own or in a mixture was used in the production of those articles or complex products and they cannot be repaired otherwise than by using that substance.
(*2)
1 March 2023 for the use of the substance in the production of spare parts as articles or as complex products for the repair of articles or complex products the production of which ceased or will have ceased before the sunset date indicated in the entry for that substance, where that substance was used in the production of those articles or complex products and these cannot function as intended without those spare parts and the spare part cannot be produced without that substance, and for the use of the substance (on its own or in a mixture) for the repair of such articles or complex products, where that substance on its own or in a mixture was used in the production of those articles or complex products and they cannot be repaired otherwise than by using that substance.
(*3)
Does not meet the criteria for identification as a carcinogen if it contains < 0,005 % (w/w) benzo[a]pyrene (Einecs No 200-028-5). ◄
(*4)
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176).
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