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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 16 travnja 2024. Database contains 4821 unique substances/entries.
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200-751-6
71-36-3
Flam. Liq. 3; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
203-448-7
106-97-8
Flam. Gas 1; Press. Gas; Carc. 1A; Muta. 1B
203-448-7
106-97-8
Flam. Gas 1; Press. Gas
202-496-6
96-29-7
Carc. 1B; Acute Tox. 4; Acute Tox. 3; STOT SE 3; STOT SE 1; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
201-159-0
78-93-3
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
203-452-9
107-01-7
Flam. Gas 1; Press. Gas
252-139-3
34681-10-2
Flam. Liq. 3; Acute Tox. 3; Eye Irrit. 2
BUTROXYDIM; ICIA0500
414-790-3
138164-12-2
Repr. 2; Acute Tox. 4; Skin Irrit. 2
TILCOM CA35; TILCOM IA10; TYTAN AP 100; TYTAN CA 100; TYTAN CX 35; TYZOR IAM
401-100-0
109037-78-7
Flam. Liq. 2; Eye Irrit. 2
202-318-7
94-26-8
yes
203-656-8
109-21-7
Flam. Liq. 3
209-750-5
592-34-7
Flam. Liq. 3; Acute Tox. 3; Skin Corr. 1B
209-772-5
592-84-7
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
219-376-4
2426-08-6
Flam. Liq. 3; Carc. 2; Muta. 2; Acute Tox. 4; STOT SE 3; Skin Sens. 1
208-862-1
544-16-1
Flam. Liq. 2; Acute Tox. 3
203-699-2
109-73-9
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1A
230-358-5
7067-44-9
Acute Tox. 4
204-646-6
123-72-8
Flam. Liq. 2
203-792-8
110-69-0
Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2
203-532-3
107-92-6
Skin Corr. 1B
205-498-5
141-75-3
Flam. Liq. 2; Skin Corr. 1B
204-650-8
123-77-3
Resp. Sens. 1
yes
208-953-6
548-62-9
yes
208-953-6
548-62-9
Carc. 2; Acute Tox. 4; Eye Dam. 1
208-953-6
548-62-9
Carc. 1B; Acute Tox. 4; Eye Dam. 1
220-600-8
2832-40-8
Carc. 2; Skin Sens. 1
212-668-2
842-07-9
Carc. 2; Muta. 2; Skin Sens. 1
ORASOL BLAU 761B
414-110-5
1379678-96-2
Eye Dam. 1
CD 23-404
404-750-3
119415-07-5
Acute Tox. 4; Skin Corr. 1B
417-360-3
1379678-84-8
Acute Tox. 4; Skin Irrit. 2
INTERSEPT
404-690-8
68132-19-4
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
208-168-9
513-78-0
Carc. 1B; Muta. 1B; Acute Tox. 4; STOT RE 1
yes
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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
-
-
Acute Tox. 4
208-829-1
542-83-6
Acute Tox. 2; Acute Tox. 1; Carc. 2; STOT RE 2
224-729-0
4464-23-7
Acute Tox. 3; Carc. 2; STOT RE 2
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
232-223-6
7790-80-9
Acute Tox. 3; Carc. 2; STOT RE 2
-
-
yes
233-710-6
10325-94-7
Carc. 1B; Muta. 1B; Acute Tox. 4; STOT RE 1
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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
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Sulfuric acid, cadmium salt (1:1), hydrate EC / List no: 626-360-4 | CAS no: 15244-35-6
Sulfuric acid, cadmium salt, hydrate (3:3:8) EC / List no: 616-572-5 | CAS no: 7790-84-3
233-331-6
10124-36-4;31119-53-6
yes
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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
231-152-8
7440-43-9
Pyr. Sol. 1; Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 2; STOT RE 1
231-152-8
7440-43-9
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 2; STOT RE 1
241-084-0
17010-21-8
Acute Tox. 3; Carc. 2; STOT RE 2
200-362-1
58-08-2
Acute Tox. 4
231-179-5
7440-70-2
Water-react. 2
Z-28
421-670-4
1379765-16-8
Skin Irrit. 2
PIGMENTGELB 82 897
400-710-4
94612-72-3
Acute Tox. 4
231-904-5
7778-44-1
yes
200-848-3
75-20-7
Water-react. 1
233-140-8
10043-52-4
Eye Irrit. 2
237-366-8
13765-19-0
Carc. 1B; Acute Tox. 4
205-861-8
156-62-7
Acute Tox. 4; STOT SE 3; Eye Dam. 1
209-740-0
592-01-8
Acute Tox. 2
232-189-2
7789-78-8
Water-react. 1
231-908-7
7778-54-3
Ox. Sol. 2; Acute Tox. 4; Skin Corr. 1B
-
-
Expl.
Z 7
402-040-8
148262-93-5
Skin Corr. 1B
215-142-0
1305-99-3
Water-react. 1; Acute Tox. 2; Acute Tox. 3; Acute Tox. 1; Eye Dam. 1
215-709-2
1344-81-6
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
243-873-5
20548-54-3
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
-
-
V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
232-283-3
8001-35-2
Carc. 2; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Skin Irrit. 2
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
F Fungi
-
-
F Fungi
-
-
P Parasites
-
-
P Parasites
219-363-3
2425-06-1
Carc. 1B; Skin Sens. 1
205-087-0
133-06-2
Carc. 2; Acute Tox. 3; Eye Dam. 1; Skin Sens. 1
229-879-0
6804-07-5
Flam. Sol. 1; Carc. 1B; Acute Tox. 4
200-555-0
63-25-2
Carc. 2; Acute Tox. 4
234-232-0
10605-21-7
Muta. 1B; Repr. 1B; Skin Sens. 1
240-286-6
16118-49-3
Carc. 2; Repr. 1B; Acute Tox. 4
216-353-0
1563-66-2
Acute Tox. 2
200-843-6
75-15-0
Flam. Liq. 2; Repr. 2; STOT RE 1; Eye Irrit. 2; Skin Irrit. 2
211-128-3
630-08-0
Flam. Gas 1; Press. Gas; Repr. 1A; Acute Tox. 3; STOT RE 1
200-262-8
56-23-5
Carc. 2; Acute Tox. 3; STOT RE 1
240-408-8
16337-84-1
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
212-324-1
786-19-6
Acute Tox. 3
259-565-9
55285-14-8
Acute Tox. 2; Acute Tox. 3; Skin Sens. 1
226-031-1
5234-68-4
STOT RE 2; Skin Sens. 1
-
-
B Bacteria and similar species
239-309-2
15263-52-2
Acute Tox. 4
202-759-5
99-49-0
Skin Sens. 1
253-465-9
37329-65-0
Resp. Sens. 1
232-734-4
9012-54-8
Resp. Sens. 1
-
-
Resp. Sens. 1
618-392-2
9004-70-0
Expl. 1.1
-
-
V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
-
-
V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
-
-
B Bacteria and similar species

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