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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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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KLOBENPROP
426-350-8
138666-92-9
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
AZYLACID-POTASSIUMSALT
401-630-2
96566-70-0
Acute Tox. 4; Eye Irrit. 2; STOT SE 3
233-002-7
10007-85-9
Eye Irrit. 2
426-300-5
-
Eye Dam. 1
V67282
406-500-9
174393-75-0
Skin Sens. 1
426-620-5
619297-89-1
Eye Dam. 1
232-156-2
7789-29-9
Acute Tox. 3; Skin Corr. 1B
CHEMICAL CHELATING AGENT #2
411-640-9
153352-59-1
Acute Tox. 4
231-829-8
7758-01-2
Ox. Sol. 1; Carc. 1B; Acute Tox. 3
223-289-7
3811-04-9
Ox. Sol. 1; Acute Tox. 4
209-676-3
590-28-3
Acute Tox. 4
213-029-0
917-58-8
Self-heat. 1; Skin Corr. 1B
430-010-4
12160-44-0
Skin Corr. 1B; Skin Sens. 1
232-151-5
7789-23-3
Acute Tox. 3
231-594-1
7646-93-7
Skin Corr. 1B; STOT SE 3
215-181-3
1310-58-3
Acute Tox. 4; Skin Corr. 1A
FEKPDTA; KFEPDTA
405-680-6
148434-01-9
Self-heat. 2
212-736-1
865-33-8
Self-heat. 1; Skin Corr. 1B
EURELYT
400-040-2
12091-08-6
Flam. Sol. 1; Water-react. 1; Skin Corr. 1A; Acute Tox. 4
D(-) VALINE DANE SALT
427-240-2
134841-35-3
Skin Sens. 1
POTASSIUM N-(4-FLUOROPHENYL)GLYCINATE
415-710-1
184637-63-6
STOT RE 2; Eye Dam. 1; Skin Sens. 1
POTASSIUM-P-TOLYLSULFIMIDE
406-650-5
97888-41-0
Eye Dam. 1
231-832-4
7758-09-0
Ox. Sol. 2; Acute Tox. 3
231-911-3
7778-73-6
Carc. 2; Acute Tox. 2; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
231-912-9
7778-74-7
Ox. Sol. 1; Acute Tox. 4
220-527-1
2795-39-3
Carc. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Lact.
231-760-3
7722-64-7
Ox. Sol. 2; Repr. 2; Acute Tox. 4
253-390-1
37199-66-9
Skin Corr. 1B
-
5787-96-2
Acute Tox. 3; STOT RE 2
C.I. REACTIVE YELLOW 138:1
403-810-6
140876-13-7
Eye Dam. 1
REAKTIVROT 2713
412-490-7
-
Skin Sens. 1
C.I. REACTIVE RED 231
402-150-6
-
Eye Irrit. 2; Skin Sens. 1
SUMIFIX BRILLIANTBLAU GL KONZENTRAT
414-100-0
154336-20-6
Eye Dam. 1
425-830-4
-
Eye Dam. 1
432-240-0
12056-51-8
Carc. 2
ORANGE DER 8068
422-980-2
187026-95-5
Eye Dam. 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.
245-387-9
23031-36-9
Acute Tox. 3; Acute Tox. 4
-
-
B Bacteria and similar species
266-994-5
67747-09-5
Acute Tox. 4
BROWN JR 547
419-260-5
-
Eye Dam. 1
425-740-5
-
Eye Dam. 1
255-255-2
41198-08-7
Acute Tox. 4
247-656-6
26399-36-0
Eye Irrit. 2
604-105-8
139001-49-3
Carc. 2; Repr. 2; Skin Sens. 1
220-113-0
2631-37-0
Acute Tox. 3
203-471-2
107-19-7
Flam. Liq. 3; Acute Tox. 3; Skin Corr. 1B
217-638-2
1918-16-7
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
200-746-9
71-23-8
Flam. Liq. 2; Eye Dam. 1; STOT SE 3
200-661-7
67-63-0
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
204-623-0
123-38-6
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
200-827-9
74-98-6
Flam. Gas 1; Press. Gas
211-914-6
709-98-8
Acute Tox. 4
219-006-1
2312-35-8
Carc. 2; Acute Tox. 3; Skin Irrit. 2; Eye Dam. 1
205-359-9
139-40-2
Carc. 2
204-062-1
115-07-1
Flam. Gas 1; Press. Gas
262-104-4
60207-90-1
Repr. 1B; Acute Tox. 4; Skin Sens. 1
620-365-5
9016-72-2
Acute Tox. 4; STOT RE 2; Skin Sens. 1
201-176-3
79-09-4
Skin Corr. 1B
204-638-2
123-62-6
Skin Corr. 1B
201-170-0
79-03-8
Flam. Liq. 2; Skin Corr. 1B
204-043-8
114-26-1
Acute Tox. 3
204-498-2
121-79-9
Acute Tox. 4; Skin Sens. 1
203-686-1
109-60-4
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
203-687-7
109-61-5
Flam. Liq. 2; Acute Tox. 3; Skin Corr. 1B
203-798-0
110-74-7
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
203-389-7
106-36-5
Flam. Liq. 3; Acute Tox. 4
203-132-9
103-65-1
Flam. Liq. 3; Asp. Tox. 1; STOT SE 3
203-572-1
108-32-7
Eye Irrit. 2
201-155-9
78-90-0
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1A
620-432-9
2122-19-2
Repr. 2; Acute Tox. 4
245-951-4
23950-58-5
Carc. 2
606-168-7
189278-12-4
Carc. 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.
PROSULFOCARB
401-730-6
52888-80-9
Acute Tox. 4; Skin Sens. 1
619-000-2
94125-34-5
Acute Tox. 4
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Proteinase, Myxobacter AL-1, II EC / List no: 276-716-4 | CAS no: 72561-05-8
Proteinase, Bacillus subtilis, sutilain EC / List no: 235-390-3 | CAS no: 12211-28-8
Proteinase, serine (Tritirachium album) EC / List no: 686-165-5 | CAS no: 102925-54-2
Proteinase, submandibular gland serine, A EC / List no: 279-893-6 | CAS no: 82047-85-6
Proteinase, Streptomyces griseus EC / List no: 232-909-5 | CAS no: 9036-06-0
Proteinase, microbial neutral EC / List no: 232-966-6 | CAS no: 9068-59-1
Proteinase, Bothrops atrox serine EC / List no: 232-918-4 | CAS no: 9039-61-6
Proteinase, Bacillus subtilis metallo- EC / List no: 232-991-2 | CAS no: 9080-56-2
Proteinase, Bacillus subtilis serine EC / List no: 266-557-9 | CAS no: 67051-83-6
Proteinase, Bacillus subtilis EC / List no: 257-520-8 | CAS no: 51931-23-8
Proteinase, bacterial E 30 serine EC / List no: - | CAS no: 39369-34-1
Aspergillin M EC / List no: - | CAS no: 42615-60-1
Proteinase, Aspergillus acid EC / List no: 232-796-2 | CAS no: 9025-49-4
Proteinase, microbial alkaline EC / List no: 256-863-0 | CAS no: 50936-53-3
Proteinase, Bacillus polymyxa neutral EC / List no: 255-914-4 | CAS no: 42613-33-2
Amylase, mixed with proteinase, Bacillus cereus-fermented EC / List no: - | CAS no: 68909-35-3
Proteinase, rhizopus acid EC / List no: 812-486-9 | CAS no: 9074-09-3
Proteinase, Aspergillus alkaline EC / List no: 232-977-6 | CAS no: 9074-07-1
Proteinase, Aspergillus oryzae neutral EC / List no: 232-990-7 | CAS no: 9080-55-1
Bacillus megaterium protease fermentation product EC / List no: - | CAS no: 68909-17-1
Bacteria, complex with amylase and proteinase EC / List no: - | CAS no: 68920-42-3
Proteinase, Aspergillus niger neutral EC / List no: 254-422-7 | CAS no: 39346-39-9
Proteinase, Agkistrodon serine EC / List no: 232-933-6 | CAS no: 9046-56-4
Amylase, mixture with proteinase EC / List no: 685-079-5 | CAS no: 9001-11-0
Proteinase, aspartic EC / List no: 278-856-1 | CAS no: 78169-47-8
Proteinase, oryzin EC / List no: 232-992-8 | CAS no: 9081-30-5
Thrombin EC / List no: 232-648-7 | CAS no: 9002-04-4
Proteinase, Aspergillus neutral EC / List no: 278-588-5 | CAS no: 77000-13-6
Proteinase, Staphylococcus aureus serine EC / List no: 259-611-8 | CAS no: 55354-32-0
Myxobacteralphalyticproteinase EC / List no: - | CAS no: 12585-31-8
Proteinase, microbial acid EC / List no: 256-862-5 | CAS no: 50936-52-2
Proteinase, serine EC / List no: 253-431-3 | CAS no: 37259-58-8
Proteinase, Bacillus alkaline EC / List no: 232-972-9 | CAS no: 9073-77-2
Proteinase, Aspergillus parasiticus neutral EC / List no: 254-418-5 | CAS no: 39335-09-6
Proteinase, Tritirachium album serine EC / List no: 254-457-8 | CAS no: 39450-01-6
Proteinase, Bacillus neutral EC / List no: 278-547-1 | CAS no: 76774-43-1
Proteinase, Mucor aspartic EC / List no: 232-975-5 | CAS no: 9073-79-4
Proteinase, Serratia extracellular EC / List no: 253-457-5 | CAS no: 37312-62-2
Proteinase, Endothia aspartic EC / List no: 253-395-9 | CAS no: 37205-60-0
Proteinase, Myxobacter α-lytic EC / List no: 253-448-6 | CAS no: 37288-76-9
Proteinase, Aspergillus melleus, semialkaline EC / List no: - | CAS no: 76106-83-7
Proteinase, pancreatic EC / List no: 232-626-7 | CAS no: 9001-72-3
Proteinase, Bacillus alcalophilus serine EC / List no: 306-090-0 | CAS no: 95979-76-3
Proteinase, Bacillus licheniformis serine EC / List no: 279-361-3 | CAS no: 79986-26-8
934-013-6
39450-01-6
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
232-966-6
9068-59-1
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
218-893-2
2275-18-5
Acute Tox. 1; Acute Tox. 2
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
205-443-5
140-93-2
Acute Tox. 4; Skin Irrit. 2
-
68583-29-9
B Bacteria and similar species
-
-
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.
602-927-1
123312-89-0
Carc. 2; Repr. 2
605-747-1
175013-18-0
Acute Tox. 3; Skin Irrit. 2
429-520-1
4023-02-3
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
236-656-1
13457-18-6
Acute Tox. 4
-
108-34-9
Acute Tox. 2; Acute Tox. 1
-
-
Acute Tox. 4
PYRIDABEN
405-700-3
96489-71-3
Acute Tox. 3
259-686-7
55512-33-9
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
203-809-9
110-86-1
Flam. Liq. 2; Acute Tox. 4
The complex combination of polyalkylated pyridines derived from coal tar distillation or as high-boiling distillates approximately above 150°C (302°F) from the reaction of ammonia with acetaldehyde, formaldehyde or paraformaldehyde.
269-929-9
68391-11-7
Carc. 1B; Muta. 1B
236-671-3
13463-41-7
Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Eye Dam. 1
201-762-9
87-66-1
Muta. 2; Acute Tox. 4

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