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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 20 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.
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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.
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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.
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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.
211-139-3
630-60-4
Acute Tox. 3; STOT RE 2
254-637-6
39807-15-3
Repr. 2; STOT RE 2
205-634-3
144-62-7
Acute Tox. 4
202-464-1
95-92-1
Acute Tox. 4; Eye Irrit. 2
243-867-2
20543-06-0
Carc. 1A; STOT RE 1; Skin Sens. 1
207-306-5
460-19-5
Press. Gas; Flam. Gas 1; Acute Tox. 3
245-445-3
23135-22-0
Acute Tox. 2; Acute Tox. 4
604-430-5
144651-06-9
STOT RE 2
271-846-8
68609-97-2
Skin Irrit. 2; Skin Sens. 1
DAISO CCS-1S-E; S-GLYTO
417-210-7
70987-78-9
Carc. 1B; Muta. 2; Eye Dam. 1; Skin Sens. 1
LUCHEM HA-R 100; LUPERSOL HA-R 100
413-230-5
122035-71-6
Eye Dam. 1; Skin Sens. 1
226-066-2
5259-88-1
Acute Tox. 4
206-110-7
301-12-2
Acute Tox. 3
203-430-9
106-75-2
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
211-745-8
693-21-0
Expl. 1.1; Acute Tox. 2; Acute Tox. 1; STOT RE 2
211-745-8
693-21-0
Unst. Expl.; Acute Tox. 2; Acute Tox. 1; STOT RE 2
219-679-1
2497-07-6
Acute Tox. 2; Acute Tox. 3
231-956-9
7782-44-7
Ox. Gas 1; Press. Gas
203-254-2
104-94-9
Acute Tox. 2; Acute Tox. 1; STOT RE 2
203-405-2
106-51-4
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
203-398-6
106-44-5
Acute Tox. 3; Skin Corr. 1B
202-795-1
99-86-5
Flam. Liq. 3; Acute Tox. 4; Skin Sens. 1; Asp. Tox. 1
202-810-1
100-01-6
Acute Tox. 3; STOT RE 2
203-404-7
106-50-3
Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
203-180-0
104-15-4
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
203-180-0
104-15-4
Skin Corr. 1B
203-403-1
106-49-0
Carc. 2; Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
UP 565
411-530-0
15024-10-9
Skin Sens. 1
203-396-5
106-42-3
Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2
616-379-6
76738-62-0
Repr. 2; Acute Tox. 4; Eye Irrit. 2
232-627-2
9001-73-4
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
200-397-2
58-74-2
Acute Tox. 4
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F Fungi
A complex combination of hydrocarbons obtained from a catalytic dewaxing process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity of at least 100 SUS at 100°F (19cSt at 40°C).
265-174-4
64742-70-7
Carc. 1B
A complex combination of hydrocarbons obtained from a catalytic dewaxing process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity of less than 100 SUS at 100°F (19cSt at 40°C).
265-176-5
64742-71-8
Carc. 1B
A complex combination of hydrocarbons obtained from sulfur-containing paraffinic crude oil. It consists predominantly of a solvent refined deparaffinated lubricating oil with a viscosity of 65cSt at 50°C.
295-810-6
92129-09-4
Carc. 1B
A complex combination of hydrocarbons obtained by the treatment of lignite carbonization tar with bentonite for removal of trace constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
308-297-1
97926-77-7
Carc. 1B
A complex combination of hydrocarbons obtained by the treatment of lignite carbonization tar with silicic acid for removal of trace constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
308-298-7
97926-78-8
Carc. 1B
A complex combination of hydrocarbons obtained by the treatment of lignite carbonization tar with activated carbon for removal of trace constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
308-296-6
97926-76-6
Carc. 1B
A complex combination of hydrocarbons obtained from liqnite carbonization tar by solvent crystallisation (solvent deoiling), by sweating or an adducting process treated with hydrogen in the presence of a catalyst. It consists predominantly of straight and branched chain saturated hydrocarbons having carbon numbers predominantly greater than C12.
295-455-7
92045-72-2
Carc. 1B
A complex combination of hydrocarbons obtained from liqnite carbonization tar by solvent crystallisation (solvent deoiling), by sweating or an adducting process. It consists predominantly of straight and branched chain saturated hydrocarbons having carbon numbers predominantly greater than C12.
295-454-1
92045-71-1
Carc. 1B
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P Parasites
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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.
217-615-7
1910-42-5
Acute Tox. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
218-196-3
2074-50-2
Acute Tox. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
200-271-7
56-38-2
Acute Tox. 2; Acute Tox. 3; STOT RE 1
206-050-1
298-00-0
Flam. Liq. 3; Acute Tox. 2; Acute Tox. 3; STOT RE 2
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B Bacteria and similar species
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B Bacteria and similar species
214-215-4
1114-71-2
Acute Tox. 4
266-275-6
66246-88-6
Repr. 2; Acute Tox. 4
254-938-2
40487-42-1
Skin Sens. 1
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F Fungi
210-172-0
608-93-5
Flam. Sol. 1; Acute Tox. 4
200-925-1
76-01-7
Carc. 2; STOT RE 1
201-778-6
87-86-5
Carc. 2; Acute Tox. 2; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
225-644-1
4986-89-4
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
201-084-3
78-11-5
Unst. Expl.
201-084-3
78-11-5
Expl. 1.1
222-540-8
3524-68-3
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
426-590-3
187412-41-5
Skin Sens. 1
202-490-3
96-22-0
Flam. Liq. 2; STOT SE 3
203-692-4
109-66-0
Flam. Liq. 2; Asp. Tox. 1; STOT SE 3
204-634-0
123-54-6
Flam. Liq. 3; Acute Tox. 4
250-378-8
30899-19-5
Flam. Liq. 3; Acute Tox. 4; STOT SE 3
404-290-3
7216-95-7
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
418-270-7
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Skin Sens. 1
205-391-3
140-01-2
Acute Tox. 4; STOT RE 2
REACTIVE NAVY BLUE 9411; SUMIFIX SUPRA MARINE BNF GRANULES
423-790-2
1379676-74-0
Eye Dam. 1; Skin Sens. 1
301-312-2
93983-23-4
Eye Irrit. 2
436-920-8
172399-10-9
Eye Dam. 1
OLIVE-GREEN JB 1170
419-210-2
178452-71-6
Eye Dam. 1
414-910-4
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Eye Dam. 1; Skin Sens. 1
442-030-0
321912-47-4
Eye Dam. 1
215-320-8
1321-64-8
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
211-047-3
628-63-7
Flam. Liq. 3
211-340-6
638-49-3
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
207-332-7
463-04-7
Flam. Liq. 2; Acute Tox. 4
210-852-7
624-54-4
Flam. Liq. 3
232-629-3
9001-75-6
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
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B Bacteria and similar species
201-186-8
79-21-0
Flam. Liq. 3; Org. Perox. D; Acute Tox. 4; Skin Corr. 1A
603-902-8
13517-20-9
Repr. 1B; STOT SE 3; Eye Dam. 1
603-902-8
13517-20-9
Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
600-611-8
10486-00-7
Repr. 1B; STOT SE 3; Eye Dam. 1
600-611-8
10486-00-7
Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
600-419-4
10332-33-9
Ox. Sol. 3; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Eye Dam. 1
600-419-4
10332-33-9
Ox. Sol. 3; Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
234-390-0
11138-47-9;12040-72-1;37244-98-7
Ox. Sol. 3; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Eye Dam. 1
234-390-0
11138-47-9;12040-72-1;37244-98-7
Ox. Sol. 3; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Eye Dam. 1
234-390-0
11138-47-9;12040-72-1;37244-98-7
Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
234-390-0
11138-47-9;12040-72-1;37244-98-7
Ox. Sol. 3; Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
234-390-0
11138-47-9;12040-72-1;37244-98-7
Ox. Sol. 3; Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
234-390-0
11138-47-9;12040-72-1;37244-98-7
Repr. 1B; STOT SE 3; Eye Dam. 1
231-512-4
7601-90-3
Ox. Liq. 1; Skin Corr. 1A
253-718-3
37924-13-3
Acute Tox. 4; Eye Irrit. 2

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