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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 17 svibnja 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.
(R)-EPICHLOROHYDRIN
424-280-2
51594-55-9
Flam. Liq. 3; Carc. 1B; Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
SCH.19927 DIBENZOYLTARTRATE
404-390-7
88976-55-0
Flam. Sol. 1; Skin Sens. 1
PANTERA; QUIZALOFOP-P-TEFURYL
414-200-4
119738-06-6
Carc. 2; Repr. 2; Acute Tox. 4; STOT RE 2
201-435-0
82-68-8
Skin Sens. 1
602-997-3
124495-18-7
Skin Sens. 1
219-455-3
2439-01-2
Repr. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Sens. 1
202-051-6
91-22-5
Carc. 1B; Muta. 2; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
205-711-1
148-24-3
Repr. 1B; Acute Tox. 3; Eye Dam. 1; Skin Sens. 1
BAS 514 H
402-780-1
84087-01-4
Skin Sens. 1
237-031-6
13593-03-8
Acute Tox. 3; Acute Tox. 4
264-151-6
63449-41-2
Acute Tox. 4; Skin Corr. 1B
610-007-6
422556-08-9
Skin Sens. 1
611-516-6
57369-32-1
Acute Tox. 4
201-762-9
87-66-1
Muta. 2; Acute Tox. 4
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77588.
232-382-1
8012-00-8
yes
236-671-3
13463-41-7
Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Eye Dam. 1
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
203-809-9
110-86-1
Flam. Liq. 2; Acute Tox. 4
259-686-7
55512-33-9
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
PYRIDABEN
405-700-3
96489-71-3
Acute Tox. 3
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Acute Tox. 4
204-927-3
129-00-0
yes
-
108-34-9
Acute Tox. 2; Acute Tox. 1
236-656-1
13457-18-6
Acute Tox. 4
429-520-1
4023-02-3
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
605-747-1
175013-18-0
Acute Tox. 3; Skin Irrit. 2
602-927-1
123312-89-0
Carc. 2; Repr. 2
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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.
-
68583-29-9
B Bacteria and similar species
205-443-5
140-93-2
Acute Tox. 4; Skin Irrit. 2
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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
218-893-2
2275-18-5
Acute Tox. 1; Acute Tox. 2
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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
232-966-6
9068-59-1
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
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Proteinase, microbial alkaline EC / List no: 256-863-0 | CAS no: 50936-53-3
Bacillus megaterium protease fermentation product EC / List no: - | CAS no: 68909-17-1
Aspergillin M EC / List no: - | CAS no: 42615-60-1
Proteinase, Aspergillus neutral EC / List no: 278-588-5 | CAS no: 77000-13-6
Proteinase, serine EC / List no: 253-431-3 | CAS no: 37259-58-8
Proteinase, Bacillus alcalophilus serine EC / List no: 306-090-0 | CAS no: 95979-76-3
Proteinase, Bacillus subtilis EC / List no: 257-520-8 | CAS no: 51931-23-8
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
Amylase, mixed with proteinase, Bacillus cereus-fermented EC / List no: - | CAS no: 68909-35-3
Proteinase, Aspergillus acid EC / List no: 232-796-2 | CAS no: 9025-49-4
Proteinase, Bacillus subtilis metallo- EC / List no: 232-991-2 | CAS no: 9080-56-2
Proteinase, bacterial E 30 serine EC / List no: - | CAS no: 39369-34-1
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
Bacteria, complex with amylase and proteinase EC / List no: - | CAS no: 68920-42-3
Proteinase, Mucor aspartic EC / List no: 232-975-5 | CAS no: 9073-79-4
Proteinase, serine (Tritirachium album) EC / List no: 686-165-5 | CAS no: 102925-54-2
Proteinase, Bacillus alkaline EC / List no: 232-972-9 | CAS no: 9073-77-2
Thrombin EC / List no: 232-648-7 | CAS no: 9002-04-4
Proteinase, Myxobacter AL-1, II EC / List no: 276-716-4 | CAS no: 72561-05-8
Proteinase, pancreatic EC / List no: 232-626-7 | CAS no: 9001-72-3
Proteinase, Aspergillus alkaline EC / List no: 232-977-6 | CAS no: 9074-07-1
Proteinase, Agkistrodon serine EC / List no: 232-933-6 | CAS no: 9046-56-4
Proteinase, oryzin EC / List no: 232-992-8 | CAS no: 9081-30-5
Proteinase, Bothrops atrox serine EC / List no: 232-918-4 | CAS no: 9039-61-6
Amylase, mixture with proteinase EC / List no: 685-079-5 | CAS no: 9001-11-0
Proteinase, submandibular gland serine, A EC / List no: 279-893-6 | CAS no: 82047-85-6
Proteinase, Bacillus subtilis serine EC / List no: 266-557-9 | CAS no: 67051-83-6
Myxobacteralphalyticproteinase EC / List no: - | CAS no: 12585-31-8
Proteinase, rhizopus acid EC / List no: 812-486-9 | CAS no: 9074-09-3
Proteinase, aspartic EC / List no: 278-856-1 | CAS no: 78169-47-8
Proteinase, microbial acid EC / List no: 256-862-5 | CAS no: 50936-52-2
Proteinase, Endothia aspartic EC / List no: 253-395-9 | CAS no: 37205-60-0
Proteinase, Staphylococcus aureus serine EC / List no: 259-611-8 | CAS no: 55354-32-0
Proteinase, Bacillus polymyxa neutral EC / List no: 255-914-4 | CAS no: 42613-33-2
Proteinase, Serratia extracellular EC / List no: 253-457-5 | CAS no: 37312-62-2
Proteinase, Bacillus neutral EC / List no: 278-547-1 | CAS no: 76774-43-1
Proteinase, Aspergillus parasiticus neutral EC / List no: 254-418-5 | CAS no: 39335-09-6
Proteinase, Aspergillus oryzae neutral EC / List no: 232-990-7 | CAS no: 9080-55-1
Proteinase, Tritirachium album serine EC / List no: 254-457-8 | CAS no: 39450-01-6
Proteinase, Bacillus licheniformis serine EC / List no: 279-361-3 | CAS no: 79986-26-8
Proteinase, Bacillus subtilis, sutilain EC / List no: 235-390-3 | CAS no: 12211-28-8
Proteinase, Aspergillus niger neutral EC / List no: 254-422-7 | CAS no: 39346-39-9
934-013-6
39450-01-6
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
619-000-2
94125-34-5
Acute Tox. 4
PROSULFOCARB
401-730-6
52888-80-9
Acute Tox. 4; Skin Sens. 1
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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.
606-168-7
189278-12-4
Carc. 2
245-951-4
23950-58-5
Carc. 2
620-432-9
2122-19-2
Repr. 2; Acute Tox. 4
201-155-9
78-90-0
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1A
200-879-2
75-56-9
Flam. Liq. 1; Carc. 1B; Muta. 1B; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
yes
203-572-1
108-32-7
Eye Irrit. 2
203-132-9
103-65-1
Flam. Liq. 3; Asp. Tox. 1; STOT SE 3

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