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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 22 svibnja 2024. Database contains 4821 unique substances/entries.
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282-714-4
84332-86-5
Carc. 2
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
239-056-8
14977-61-8
Ox. Liq. 1; Carc. 1B; Muta. 1B; Skin Corr. 1A; Skin Sens. 1
205-923-4
218-01-9
Carc. 1B; Muta. 2
yes
279-116-0
79234-33-6
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
281-549-5
83968-67-6
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
208-545-8
532-82-1
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
264-409-8
63681-54-9
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
207-803-7
495-54-5
Muta. 2; Acute Tox. 4; Skin Irrit. 2
232-671-2
9004-07-3
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
246-948-0
25402-06-6
Acute Tox. 4
204-454-2
121-20-0
Acute Tox. 4
216-906-6
1694-82-2
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
213-308-7
935-79-5
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
231-187-9
7443-70-1
Acute Tox. 4
236-086-3
13149-00-3
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
205-859-7
156-59-2
Flam. Liq. 2; Acute Tox. 4
226-394-6
5392-40-5
Skin Irrit. 2; Skin Sens. 1
201-069-1
77-92-9
Eye Irrit. 2; STOT SE 3
242-161-1
18283-82-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
245-119-0
22605-92-1
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
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
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
216-935-4
1702-17-6
Eye Dam. 1
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
231-158-0
7440-48-4
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
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
268-169-5
68016-03-5
Carc. 1A; 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
261-346-8
58591-45-0
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
215-154-6
1307-96-6
Acute Tox. 4; 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
215-273-3
1317-42-6
Skin Sens. 1
200-598-5
64-86-8
Muta. 1B; Acute Tox. 2
200-673-2
67-97-0
Acute Tox. 2; STOT RE 1
231-842-9
7758-89-6
Acute Tox. 4
243-815-9
20427-59-2
Acute Tox. 2; Acute Tox. 4; Eye Dam. 1
231-159-6
7440-50-8
Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2
231-847-6
7758-98-7
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
235-113-6
12069-69-1
Acute Tox. 4; Eye Irrit. 2
204-810-7
126-90-9
Skin Sens. 1B
201-378-1
81-82-3
STOT RE 2
204-195-5
117-52-2
Acute Tox. 3; STOT RE 1

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