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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 26 April 2024. Database contains 4821 unique substances/entries.
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95342-41-9
yes
-
852541-21-0
yes
-
741687-98-9
yes
-
135821-03-3
yes
-
135821-74-8
yes
-
852541-30-1
yes
-
852541-25-4
yes
-
75166-31-3
yes
-
75166-30-2
yes
701-394-3
1782069-81-1
yes
253-242-6
36861-47-9
yes
202-486-1
96-18-4
Carc. 1B; Repr. 1B; Acute Tox. 4
yes
221-695-9
3194-55-6
Repr. 2; Lact.
yes
271-094-0
68515-51-5
yes
271-093-5
68515-50-4
Repr. 1B
yes
284-032-2
84777-06-0
Repr. 1B
yes
272-013-1
68648-93-1
yes
276-158-1
71888-89-6
Repr. 1B
yes
271-084-6
68515-42-4
Repr. 1B
yes
203-977-3
112-49-2
Repr. 1B
yes
203-458-1
107-06-2
Flam. Liq. 2; Carc. 1B; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
yes
211-076-1
629-14-1
Flam. Liq. 2; Repr. 1A; Eye Irrit. 2
yes
203-794-9
110-71-4
Flam. Liq. 2; Repr. 1B; Acute Tox. 4
yes
219-514-3
2451-62-9
Muta. 1B; Acute Tox. 3; STOT RE 2; Eye Dam. 1; Skin Sens. 1
yes
TEPIC-H
423-400-0
59653-74-6
Muta. 1B; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
yes
214-317-9
1120-71-4
Carc. 1B; Acute Tox. 4
yes
204-661-8
123-91-1
Flam. Liq. 2; Carc. 1B; Eye Irrit. 2; STOT SE 3
yes
236-948-9
13560-89-9
yes
-
-
yes
239-139-9
15087-24-8
yes
203-445-0
106-94-5
Flam. Liq. 2; Repr. 1B; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
yes
214-012-0
1072-63-5
Repr. 1B
yes
202-918-9
101-14-4
Carc. 1B; Acute Tox. 4
yes
221-967-7
3296-90-0
Carc. 1B; Muta. 1B
yes
253-057-0
36483-57-5
yes
236-236-8
13252-13-6
yes
218-173-8
2062-98-8
yes
202-480-9
96-13-9
Carc. 1B; Repr. 2; Acute Tox. 3; Acute Tox. 4
yes
223-383-8
3864-99-1
yes
204-450-0
121-14-2
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
yes
247-384-8
25973-55-1
yes
253-037-1
36437-37-3
yes
201-289-8
80-54-6
Repr. 1B
yes
show/hide
2-(4-tert-butylbenzyl)propionaldehyde EC / List no: 201-289-8 | CAS no: 80-54-6
(2S)-3-(4-tert-butylphenyl)-2-methylpropanal EC / List no: - | CAS no: 75166-30-2
(2R)-3-(4-tert-butylphenyl)-2-methylpropanal EC / List no: - | CAS no: 75166-31-3
799-970-2
-
yes
243-816-4
20427-84-3
yes
230-770-5
7311-27-5
yes
618-344-0
9002-93-1
yes
687-832-3
1119449-37-4
yes
223-346-6
3846-71-7
yes
CG 25-369; IRGACURE 369; TK 11-319
404-360-3
119313-12-1
Repr. 1B
yes
203-804-1
110-80-5
Flam. Liq. 3; Repr. 1B; Acute Tox. 3; Acute Tox. 4
yes
203-839-2
111-15-9
Flam. Liq. 3; Repr. 1B; Acute Tox. 4
yes
239-622-4
15571-58-1
Repr. 1B; STOT RE 1
yes
201-963-1
90-04-0
Carc. 1B; Muta. 2; Acute Tox. 3
yes
203-713-7
109-86-4
Flam. Liq. 3; Repr. 1B; Acute Tox. 4
yes
203-772-9
110-49-6
Repr. 1B; Acute Tox. 4
yes
ACETOCURE 97; GENOCURE*PMP; IGM 4817; IRGACURE 907; SPEEDCURE 97
400-600-6
71868-10-5
Repr. 1B; Acute Tox. 4
yes
211-765-7
693-98-1
Repr. 1B
yes
687-833-9
1119449-38-5
yes
248-743-1
27942-27-4
yes
219-682-8
2497-59-8
yes
604-395-6
14409-72-4
yes
247-816-5
26571-11-9
yes
622-370-8
1522-92-5
yes
ZOLDINE MS-PLUS
421-150-7
143860-04-2
Repr. 1B; Skin Corr. 1B
yes
201-025-1
77-40-7
yes
209-218-2
561-41-1
yes
202-027-5
90-94-8
Carc. 1B; Muta. 2; Eye Dam. 1
yes
202-974-4
101-77-9
Carc. 1B; Muta. 2; STOT SE 1; STOT RE 2; Skin Sens. 1
yes
212-658-8
838-88-0
Carc. 1B; Acute Tox. 4; Skin Sens. 1
yes
-
-
Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 3
yes
202-977-0
101-80-4
Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 3
yes
AP-5
401-720-1
6807-17-6
Repr. 1B; Eye Irrit. 2
yes
-
-
yes
621-341-7
2315-61-9
yes
205-426-2
140-66-9
Skin Irrit. 2; Eye Dam. 1
yes
257-907-1
52427-13-1
yes
635-388-6
521947-27-3
yes
-
-
yes
272-233-8
68784-25-8
yes
635-389-1
186825-36-5
yes
635-391-2
142731-63-3
yes
635-696-0
186825-39-8
yes
200-453-6
60-09-3
Carc. 1B
yes
217-862-0
1987-50-4
yes
-
-
yes
608-055-8
27147-75-7;27459-10-5
yes
608-055-8
27147-75-7;27459-10-5
yes
202-453-1
95-80-7
yes
284-325-5
84852-15-3
Repr. 2; Acute Tox. 4; Skin Corr. 1B
yes
-
-
yes
-
-
yes
1 - 2.5 moles ethoxylated
500-315-8
127087-87-0
yes
1 - 2.5 moles ethoxylated
500-045-0
26027-38-3
yes
202-591-2
97-56-3
Carc. 1B; Skin Sens. 1
yes
202-679-0
98-54-4
Repr. 2; Skin Irrit. 2; Eye Dam. 1
yes
621-345-9
2315-67-5
yes
-
-
yes
-
-
yes
-
-
yes
204-327-1
119-47-1
Repr. 1B
yes
204-419-1
120-71-8
Carc. 1B; Acute Tox. 4
yes
219-943-6
2580-56-5
yes
273-688-5
69011-06-9
yes
257-175-3
51404-69-4
yes
201-173-7
79-06-1
Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 3; STOT RE 1; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
yes
-
-
yes
287-476-5
85535-84-8
Carc. 2
yes
281-985-6
84082-38-2
yes
307-451-5
97659-46-6
yes
283-930-1
84776-06-7
yes
287-504-6
85536-22-7
yes
701-376-5
1372804-76-6
yes
287-477-0
85535-85-9
Lact.
yes
283-931-7
84776-07-8
yes
285-195-2
85049-26-9
yes
272-924-4
68920-70-7
yes
263-004-3
61788-76-9
yes
603-801-9
134237-50-6
yes
604-314-4
142844-00-6
yes
700-242-3
62037-80-3
yes
232-143-1
7789-09-5
Ox. Sol. 2; Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
221-470-5
3108-42-7
Carc. 2; Repr. 1B; Lact.
yes
269-511-6
68259-08-5
yes
-
4149-60-4
Carc. 2; Repr. 1B; Lact.; Acute Tox. 4; STOT RE 1; Eye Dam. 1
yes
223-320-4
3825-26-1
Carc. 2; Repr. 1B; Lact.; Acute Tox. 4; STOT RE 1; Eye Dam. 1
yes
204-371-1
120-12-7
yes
A complex combination of hydrocarbons from the distillation of anthracene obtained by the crystallization of anthracene oil from bituminous high temperature tar and boiling in the range of 330°C to 350°C (626°F to 662°F). It contains chiefly anthracene, carbazole and phenanthrene.
295-275-9
91995-15-2
Carc. 1B; Muta. 1B
yes
A complex combination of hydrocarbons from the distillation of anthracene obtained by crystallization of anthracene oil from bituminous high temperature tar and boiling in the range of approximately 290°C to 340°C (554°F to 644°F). It contains chiefly trinuclear aromatics and their dihydro derivatives.
295-278-5
91995-17-4
Carc. 1B; Muta. 1B
yes
The anthracene-rich solid obtained by the crystallization and centrifuging of anthracene oil. It is composed primarily of anthracene, carbazole and phenanthrene.
292-603-2
90640-81-6
Carc. 1B; Muta. 1B
yes
The oil remaining after the removal, by a crystallization process, of an anthracene-rich solid (anthracene paste) from anthracene oil. It is composed primarily of two, three and four membered aromatic compounds.
292-604-8
90640-82-7
Carc. 1B; Muta. 1B
yes
A complex combination of polycyclic aromatic hydrocarbons obtained from coal tar having an approximate distillation range of 300°C to 400°C (572°F to 752°F). Composed primarily of phenanthrene, anthracene and carbazole
292-602-7
90640-80-5
Carc. 1B
yes
231-901-9
7778-39-4
Carc. 1A; Acute Tox. 3
yes
201-622-7
85-68-7
Repr. 1B
yes
200-280-6
56-55-3
Carc. 1B
yes
209-008-0
552-30-7
STOT SE 3; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
200-028-5
50-32-8
Carc. 1B; Muta. 1B; Repr. 1B; Skin Sens. 1
yes
205-883-8
191-24-2
yes
205-916-6
207-08-9
Carc. 1B
yes
603-802-4
134237-51-7
yes
202-177-1
92-67-1
Carc. 1A; Acute Tox. 4
yes
205-594-7
143-24-8
Repr. 1B
yes
204-211-0
117-81-7
Repr. 1B
yes
203-924-4
111-96-6
Flam. Liq. 3; Repr. 1B
yes
204-212-6
117-82-8
Repr. 1B
yes
214-604-9
1163-19-5
yes
200-268-0
56-35-9
yes
201-245-8
80-05-7
Repr. 1B; STOT SE 3; Eye Dam. 1; Skin Sens. 1
yes
-
90568-23-3
yes
-
125022-34-6
yes
233-139-2
10043-35-3
Repr. 1B
yes
234-343-4
11113-50-1
Repr. 1B
yes
-
22454-04-2
yes
-
14890-53-0
yes
-
25747-83-5
yes
215-604-1
1333-73-9
yes
202-318-7
94-26-8
yes
204-650-8
123-77-3
Resp. Sens. 1
yes
208-953-6
548-62-9
yes
208-168-9
513-78-0
Carc. 1B; Muta. 1B; Acute Tox. 4; STOT RE 1
yes
show/hide
cadmium chloride (CdCl2), hydrate (2:5) EC / List no: 640-998-0 | CAS no: 7790-78-5
233-296-7
10108-64-2
Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1
yes
640-998-0
7790-78-5
yes
232-222-0
7790-79-6
Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1
yes
244-168-5
21041-95-2
Carc. 1B; Muta. 1B; Acute Tox. 4; STOT RE 1
yes
-
-
yes
show/hide
Monteponite (CdO) EC / List no: - | CAS no: 12139-21-8
215-146-2
1306-19-0
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 2; STOT RE 1
yes
show/hide
Sulfuric acid, cadmium salt, hydrate (3:3:8) EC / List no: 616-572-5 | CAS no: 7790-84-3
Sulfuric acid, cadmium salt (1:1), hydrate EC / List no: 626-360-4 | CAS no: 15244-35-6
233-331-6
10124-36-4;31119-53-6
yes
show/hide
Sulfuric acid, cadmium salt, hydrate (3:3:8) EC / List no: 616-572-5 | CAS no: 7790-84-3
Sulfuric acid, cadmium salt (1:1), hydrate EC / List no: 626-360-4 | CAS no: 15244-35-6
233-331-6
10124-36-4;31119-53-6
Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1
yes
215-147-8
1306-23-6
Carc. 1B; Muta. 2; Repr. 2; STOT RE 1; Acute Tox. 4
yes
231-152-8
7440-43-9
yes
231-904-5
7778-44-1
yes
231-801-5
7738-94-5
yes
215-607-8
1333-82-0
Ox. Sol. 1; Carc. 1A; Muta. 1B; Repr. 2; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Skin Corr. 1A; Resp. Sens. 1; Skin Sens. 1
yes
205-923-4
218-01-9
Carc. 1B; Muta. 2
yes
236-086-3
13149-00-3
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
208-169-4
513-79-1
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
200-755-8
71-48-7
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
231-589-4
7646-79-9
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1
yes
233-402-1
10141-05-6
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
233-334-2
10124-43-3
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1
yes
201-604-9
85-42-7
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
208-764-9
541-02-6
yes
950-299-5
-
yes
205-017-9
131-18-0
Repr. 1B
yes
215-116-9
1303-28-2
Carc. 1A; Acute Tox. 3
yes
215-481-4
1327-53-3
Carc. 1A; Acute Tox. 2; Skin Corr. 1B
yes
215-125-8
1303-86-2
Repr. 1B
yes
201-557-4
84-74-2
Repr. 1B
yes
245-152-0
22673-19-4
Repr. 1B; STOT RE 1
yes
211-670-0
683-18-1
Muta. 2; Repr. 1B; Acute Tox. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Corr. 1B
yes
236-881-5
13530-68-2
yes
246-356-2
24613-89-6
Ox. Sol. 1; Carc. 1B; Skin Corr. 1A; Skin Sens. 1
yes
201-545-9
84-61-7
Repr. 1B; Skin Sens. 1
yes
200-589-6
64-67-5
Carc. 1B; Muta. 1B; Acute Tox. 4; Skin Corr. 1B
yes
201-559-5
84-75-3
Repr. 1B
yes
201-553-2
84-69-5
Repr. 1B
yes
276-090-2
71850-09-4
Repr. 1B
yes
210-088-4
605-50-5
Repr. 1B
yes
201-058-1
77-78-1
Carc. 1B; Muta. 2; Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
yes
201-861-7
88-85-7
Repr. 1B; Acute Tox. 3; Eye Irrit. 2
yes

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