EU-IN_VITRO_MEDICAL_DEVICES-ART_3_ANX_1

In Vitro Diagnostic Medical Devices Directive - Hazardous Substances

EU. Hazardous Substances for Purposes of Article 3 & Annex I (Essential Requirements), Directive 98/79/EC on In Vitro Diagnostic Medical Devices, 7 December 1998

This list contains a non-exhaustive inventory of hazardous substances for purposes of essential requirements (Article 3 and Annex I) for general safety, design, manufacture and hazard communication of in vitro diagnostic medical devices. It is derived from: Table 3 of Annex VI to CLP, REACH Candidate List of SVHCs, and Directive 2000/54/EC's Annex III (Biological Agents list). Note that Regulation 2017/746/EU on in vitro diagnostic medical devices was published in the EU Official Journal on 5 May 2017. With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.

Last updated 29 svibnja 2024. Database contains 4821 unique substances/entries.
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Any of the volatile predominately terpenic fractions or distillates resulting from the solvent extraction of, gum collection from, or pulping of softwoods. Composed primarily of the C10H16 terpene hydrocarbons: α-pinene, β-pinene, limonene, 3-carene, camphene. May contain other acyclic, monocyclic, or bicyclic terpenes, oxygenated terpenes, and anethole. Exact composition varies with refining methods and the age, location, and species of the softwood source.
232-350-7
8006-64-2
Flam. Liq. 3; Acute Tox. 4; Asp. Tox. 1; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
232-650-8
9002-07-7
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
610-700-3
51580-86-0
Acute Tox. 4; Eye Irrit. 2; STOT SE 3
220-767-7
2893-78-9
Ox. Sol. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
218-828-8
2244-21-5
Ox. Sol. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
215-244-5
1314-84-7
Water-react. 1; Acute Tox. 2
246-677-8
25155-23-1
Repr. 1B
yes
604-291-0
142469-14-5
Skin Sens. 1
-
138182-18-0
Repr. 2; STOT RE 2
REACTIVE BLUE 245
407-580-8
130201-51-3
Eye Dam. 1
238-253-6
14312-40-4
yes
225-768-6
5064-31-3
Carc. 2; Acute Tox. 4; Eye Irrit. 2
422-090-4
172737-80-3
Eye Dam. 1
TRILON(R) ES 9851
414-070-9
129050-62-0
Skin Corr. 1B
TRILON(R) ES 9910
414-130-4
119710-96-2
Acute Tox. 4
239-148-8
15096-52-3
STOT RE 1; Acute Tox. 4
237-410-6
13775-53-6
STOT RE 1; Acute Tox. 4
RED JB 747
418-220-4
-
Skin Sens. 1
BI 3277; NOIR CORSE SANODAL H3LW CONC.; SANODAL DEEP BLACK H-3LW CONC.; SANODAL TIEFSCHWARZ H-3LW; SANODAL TIEFSCHWARZ H-3LW KONZ.
400-810-8
106084-79-1
Muta. 2
ACID BLUE 349; AZO-METALCOMPLEX-BLUE AP 1149; BLEU ACIDE 349; C.I. ACID BLUE 349; SELLASET BLEU H; SELLASET BLUE H
402-870-0
93952-24-0
Eye Dam. 1
SOLAMINLICHTBLAU VGRL 133
413-590-3
164058-22-4
Carc. 1B
TURQUOISE 10 40 518
411-430-7
-
Eye Dam. 1; Skin Sens. 1
423-100-1
-
Eye Dam. 1
C.I. REACTIVE YELLOW 174; GIALLO REATTIVO 174; JAUNE REACTIF 174; REAKTIV GELB 174
402-170-5
106359-91-5
Skin Sens. 1
440-480-2
341026-59-3
Eye Dam. 1; Skin Sens. 1
430-280-3
844491-96-9
Skin Sens. 1
BLEU REACTIF CAC 10; DIOXAZINE MONCHLORTRIAZINE; FAT NO. 40 407; REACTIVE BLUE CAC 10
410-130-3
136248-03-8
Skin Sens. 1
429-240-8
212652-59-0
Eye Dam. 1
427-710-7
215612-56-9
Eye Dam. 1; Skin Sens. 1
BLUE TZ 4312
423-770-3
-
Eye Dam. 1
SCARLET 12 04 262
406-820-9
159317-41-6
Eye Irrit. 2
SÄUREBLAU 82 226
402-500-8
104105-46-6
Eye Dam. 1
BROWN 1612969
407-110-1
480445-87-2
Eye Dam. 1; Skin Sens. 1
237-159-2
13674-87-8
Carc. 2
LEXMARK YELLOW DYE 415; PRISM YELLOW
406-073-9
131013-81-5
Acute Tox. 3
PIGMENTBLAU 1755
403-210-4
108300-90-9
Eye Dam. 1
247-759-6
26523-78-4
Skin Sens. 1
yes
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Phenol, p-sec-nonyl-, phosphite EC / List no: - | CAS no: 106599-06-8
Phenol, p-isononyl-, phosphite (3:1) EC / List no: - | CAS no: 31631-13-7
tris(4-nonylphenyl, branched) phosphite EC / List no: 701-028-2 | CAS no: -
Tris(nonylphenyl) phosphite EC / List no: 247-759-6 | CAS no: 26523-78-4
Phenol, 4-nonyl-, phosphite (3:1) EC / List no: 608-492-4 | CAS no: 3050-88-2
799-976-5
-
yes
213-934-0
1067-53-4
Repr. 1B
yes
204-118-5
115-96-8
Carc. 2; Repr. 1B; Acute Tox. 4
yes
ACETOACETYLORTHOSINIC ACID, A6-SALT
403-760-5
68030-79-5
Skin Sens. 1
-
7276-58-6
Acute Tox. 4
-
-
Acute Tox. 3
TRYPROPYLAMMONIUM DIHYDROGENPHOSPHAT
433-700-3
35687-90-2
Acute Tox. 4
-
-
Acute Tox. 3
442-960-7
332350-93-3
Acute Tox. 3; Eye Dam. 1
202-908-4
101-02-0
Eye Irrit. 2; Skin Irrit. 2
-
-
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
TZ 02508
413-320-4
869-59-0
STOT RE 1; Skin Irrit. 2
-
12137-12-1
Carc. 1A; STOT RE 1; Skin Sens. 1

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