EU-IN_VITRO_MEDICAL_DEVICE_REG-ART_5_2_ANX_1

In Vitro Diagnostic Medical Devices Regulation - Hazardous Substances

EU. Hazardous Substances for Purposes of Art. 5(2) and Annex I of Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices, 5 May 2017, as corrected 27 December 2019

This list contains a non-exhaustive inventory of hazardous substances for purposes of Regulation (EU) 2017/746, including Chap. 2 (Placing on the market and putting into service) and Annex I (General Safety and Performance Requirements). 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).

Last updated 26 april 2024. Database contains 4917 unique substances/entries.
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F Fungi
Details
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
Details
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
Details
619-396-7
99129-21-2
Acute Tox. 4; Skin Sens. 1
Details
600-662-6
105512-06-9
Acute Tox. 4; STOT RE 2; Skin Sens. 1
Details
617-258-0
81777-89-1
Acute Tox. 4
Details
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P Parasites
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P Parasites
Details
216-935-4
1702-17-6
Eye Dam. 1
Details
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
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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
Details
433-460-1
210880-92-5
Repr. 2; Acute Tox. 4; STOT SE 1
Details
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
Details
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
Details
231-158-0
7440-48-4
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
Details
208-169-4
513-79-1
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
C Carcinogenic (article 57a)
R Toxic for reproduction (article 57c)
Details
200-755-8
71-48-7
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
C Carcinogenic (article 57a)
R Toxic for reproduction (article 57c)
Details
231-589-4
7646-79-9
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1
C Carcinogenic (article 57a)
R Toxic for reproduction (article 57c)
Details
268-169-5
68016-03-5
Carc. 1A; STOT RE 1; Skin Sens. 1
Details
233-402-1
10141-05-6
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
C Carcinogenic (article 57a)
R Toxic for reproduction (article 57c)
Details
442-750-5
113066-89-0
Carc. 1A; Acute Tox. 2; STOT RE 1; Skin Sens. 1
Details
261-346-8
58591-45-0
Carc. 1A; STOT RE 1; Skin Sens. 1
Details
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
Details
620-395-9
12737-30-3
Carc. 1A; STOT RE 1; Skin Sens. 1
Details
215-154-6
1307-96-6
Acute Tox. 4; Skin Sens. 1
Details
233-334-2
10124-43-3
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1
C Carcinogenic (article 57a)
R Toxic for reproduction (article 57c)
Details
215-273-3
1317-42-6
Skin Sens. 1
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F Fungi
Details
200-598-5
64-86-8
Muta. 1B; Acute Tox. 2
Details
200-673-2
67-97-0
Acute Tox. 2; STOT RE 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.
Details
SUBSTANCE S171393
427-390-9
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Skin Sens. 1
Details
INDULIN MQK-1M
413-770-1
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Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
Details
ALLYL SUCROSE
419-640-0
68784-14-5
Acute Tox. 4
Details
231-842-9
7758-89-6
Acute Tox. 4
Details
243-815-9
20427-59-2
Acute Tox. 2; Acute Tox. 4; Eye Dam. 1
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Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2
Details
231-847-6
7758-98-7
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
Details
616-477-9
7758-99-8
Acute Tox. 4; Eye Dam. 1
Details
235-113-6
12069-69-1
Acute Tox. 4; Eye Irrit. 2
Details
KUPFER-II-METHANSULFONAT; KUPFERMETHANSULFONAT
405-400-2
54253-62-2
Acute Tox. 4; Eye Dam. 1
Details
204-810-7
126-90-9
Skin Sens. 1B
Details
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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.
Details
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B Bacteria and similar species
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B Bacteria and similar species
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68583-16-4
B Bacteria and similar species
Details
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B Bacteria and similar species
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