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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 24 lipnja 2024. Database contains 4821 unique substances/entries.
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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.
200-673-2
67-97-0
Acute Tox. 2; STOT RE 1
200-598-5
64-86-8
Muta. 1B; Acute Tox. 2
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F Fungi
215-273-3
1317-42-6
Skin Sens. 1
233-334-2
10124-43-3
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1
yes
215-154-6
1307-96-6
Acute Tox. 4; Skin Sens. 1
620-395-9
12737-30-3
Carc. 1A; STOT RE 1; Skin Sens. 1
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77332.
269-051-6
68186-89-0
Carc. 1A; STOT RE 1; Skin Sens. 1
261-346-8
58591-45-0
Carc. 1A; STOT RE 1; Skin Sens. 1
442-750-5
113066-89-0
Carc. 1A; Acute Tox. 2; STOT RE 1; Skin Sens. 1
233-402-1
10141-05-6
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
268-169-5
68016-03-5
Carc. 1A; STOT RE 1; Skin Sens. 1
231-589-4
7646-79-9
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 4; 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
208-169-4
513-79-1
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
231-158-0
7440-48-4
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
The product obtained by filtration of coal mineral matter and undissolved coal from coal extract solution produced by digesting coal in a liquid solvent. A black, viscous, highly complex liquid combination composed primarily of aromatic and partly hydrogenated aromatic hydrocarbons, aromatic nitrogen compounds, aromatic sulfur compounds, phenolic and other aromatic oxygen compounds and their alkyl derivatives.
302-682-8
94114-47-3
Carc. 1B
The substantially solvent-free product obtained by the distillation of the solvent from filtered coal extract solution produced by digesting coal in a liquid solvent. A black semi-solid, composed primarily of a complex combination of condensed-ring aromatic hydrocarbons, aromatic nitrogen compounds, aromatic sulfur compounds, phenolic compounds and other aromatic oxygen compounds, and their alkyl derivatives.
302-683-3
94114-48-4
Carc. 1B
433-460-1
210880-92-5
Acute Tox. 4
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
204-385-8
120-32-1
Carc. 2; Repr. 2; Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1; Eye Dam. 1; STOT RE 2
216-935-4
1702-17-6
Eye Dam. 1
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P Parasites
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P Parasites
617-258-0
81777-89-1
Acute Tox. 4
600-662-6
105512-06-9
Acute Tox. 4; STOT RE 2; Skin Sens. 1
619-396-7
99129-21-2
Acute Tox. 4; Skin Sens. 1
A complex combination of hydrocarbons obtained by treating catalytic cracked clarified oil with hydrogen to convert organic sulfur to hydrogen sulfide which is removed. It consists of hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350°C (662°F). This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
269-782-0
68333-26-6
Carc. 1B
A complex combination of hydrocarbons produced as the residual fraction from distillation of the products from a catalytic cracking process. It consists of hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350°C (662°F). This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
265-064-6
64741-62-4
Carc. 1B
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F Fungi
245-119-0
22605-92-1
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
242-161-1
18283-82-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
201-069-1
77-92-9
Eye Irrit. 2; STOT SE 3
226-394-6
5392-40-5
Skin Irrit. 2; Skin Sens. 1
205-859-7
156-59-2
Flam. Liq. 2; Acute Tox. 4
236-086-3
13149-00-3
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
231-187-9
7443-70-1
Acute Tox. 4
422-660-2
7480-35-5
Eye Dam. 1; Skin Sens. 1
PD 133602-2
417-430-3
63645-17-0
Acute Tox. 3; STOT RE 2; Skin Sens. 1
426-020-3
51229-78-8
Flam. Sol. 2; Repr. 2; Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
425-080-8
104860-26-6
Acute Tox. 4; STOT RE 2; Eye Dam. 1
213-308-7
935-79-5
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
216-906-6
1694-82-2
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
ARGOLD; CINMETHYLIN; WL 95481
402-410-9
87818-31-3
Acute Tox. 4
604-318-6
142891-20-1
Carc. 2; Skin Sens. 1
204-454-2
121-20-0
Acute Tox. 4
246-948-0
25402-06-6
Acute Tox. 4
232-671-2
9004-07-3
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
207-803-7
495-54-5
Muta. 2; Acute Tox. 4; Skin Irrit. 2
264-409-8
63681-54-9
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
282-432-1
84196-22-5
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
208-545-8
532-82-1
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
278-290-5
75660-25-2
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
281-549-5
83968-67-6
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
304-236-8
94247-67-3
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
286-946-7
85407-90-5
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
279-116-0
79234-33-6
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
205-923-4
218-01-9
Carc. 1B; Muta. 2
yes
239-056-8
14977-61-8
Ox. Liq. 1; Carc. 1B; Muta. 1B; Skin Corr. 1A; Skin Sens. 1
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
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Carc. 1B; Skin Sens. 1
231-801-5
7738-94-5
yes
282-714-4
84332-86-5
Carc. 2
244-663-6
21923-23-9
Acute Tox. 2; Acute Tox. 3
207-902-5
500-28-7
Acute Tox. 4
217-637-7
1918-13-4
Acute Tox. 4
227-011-5
5598-13-0
Skin Sens. 1
220-864-4
2921-88-2
Acute Tox. 3
202-925-7
101-21-3
Carc. 2; STOT RE 2
204-105-4
115-78-6
Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
215-316-6
1321-23-9
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
221-437-5
3091-32-5
Acute Tox. 4
239-592-2
15545-48-9
Carc. 2; Repr. 2
246-698-2
25168-05-2
Acute Tox. 4
217-588-1
1897-45-6
Carc. 2; Acute Tox. 2; STOT SE 3; Eye Dam. 1; Skin Sens. 1
232-234-6
7790-94-5
Skin Corr. 1A; STOT SE 3
204-818-0
126-99-8
Flam. Liq. 2; Carc. 1B; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
246-691-4
25167-80-0
Acute Tox. 4
223-003-0
3691-35-8
Repr. 1B; Acute Tox. 1; STOT RE 1
show/hide
2-chloro-6-nitroaniline EC / List no: 212-204-9 | CAS no: 769-11-9
2-chloro-5-nitroaniline EC / List no: 228-498-7 | CAS no: 6283-25-6
5-chloro-2-nitroaniline EC / List no: 216-661-5 | CAS no: 1635-61-6
3-chloro-4-nitroaniline EC / List no: 642-644-0 | CAS no: 825-41-2
Benzenamine, chloronitro- EC / List no: - | CAS no: 41587-36-4
Benzenamine, 2-chloro-3-nitro- EC / List no: - | CAS no: 3970-41-0
4-chloro-3-nitroaniline EC / List no: 211-231-3 | CAS no: 635-22-3
3-chloro-2-nitroaniline EC / List no: 261-782-9 | CAS no: 59483-54-4
2-chloro-4-nitroaniline EC / List no: 204-502-2 | CAS no: 121-87-9
4-chloro-2-nitroaniline EC / List no: 201-925-4 | CAS no: 89-63-4
Benzenamine, 4-chloro-N-nitro- EC / List no: - | CAS no: 69732-97-4
Benzenamine, 3-chloro-5-nitro- EC / List no: - | CAS no: 5344-44-5
N-chloro-2-nitroaniline EC / List no: - | CAS no: 59483-60-2
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Acute Tox. 2; Acute Tox. 1; STOT RE 2
200-817-4
74-87-3
Flam. Gas 1; Press. Gas; Carc. 2; STOT RE 2
200-663-8
67-66-3
Carc. 2; Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 1; Eye Irrit. 2; Skin Irrit. 2
200-830-5
75-00-3
Flam. Gas 1; Press. Gas; Carc. 2
247-109-1
25567-67-3
Acute Tox. 3; STOT RE 2
200-431-6
59-50-7
Acute Tox. 4; Skin Corr. 1C; Eye Dam. 1; STOT SE 3; Skin Sens. 1B
208-110-2
510-15-6
Acute Tox. 4
203-628-5
108-90-7
Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2
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Acute Tox. 3; STOT RE 2
201-171-6
79-04-9
Acute Tox. 3; STOT RE 1; Skin Corr. 1A
203-467-0
107-14-2
Acute Tox. 3
201-178-4
79-11-8
Acute Tox. 3; Skin Corr. 1B
203-472-8
107-20-0
Carc. 2; Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B
SEL DE VILSMEIER-HAACK
425-970-6
3724-43-4
Repr. 1B; Acute Tox. 4; Skin Corr. 1A
444-950-8
99464-83-2
Muta. 2; Skin Sens. 1
SILAN MCS
410-270-5
770722-46-8
Skin Corr. 1A
203-480-1
107-30-2
Flam. Liq. 2; Carc. 1A; Acute Tox. 4

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