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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 12 lipnja 2024. Database contains 4821 unique substances/entries.
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A complex residuum from the distillation of the products from a steam-cracking process. It consists predominantly of aromatic and unsaturated hydrocarbons having carbon numbers greater than C7 and boiling in the range of approximately 101°C to 555°C (214°F to 1030°F).
271-013-9
68513-69-9
Carc. 1B
A complex combination of hydrocarbons obtained by the distillation of the products of steam cracking or similar processes after taking off the very light products resulting in a residue starting with hydrocarbons having carbon numbers greater than C5. It consists predominantly of aromatic hydrocarbons having carbon numbers greater than C5 and boiling above approximately 40°C (104°F).
310-057-6
102110-55-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained as residue from the distillation of steam cracked heat soaked naphtha and boiling in the range of approximately 150°C to 350°C (302°F to 662°F).
297-905-8
93763-85-0
Carc. 1B
A complex combination of hydrocarbons obtained as a residual fraction from the distillation of hydrotreated steam-cracked naphtha. It consists predominantly of hydrocarbons boiling in the range of approximately 200°C to 350°C (32°F to 662°F).
295-514-7
92062-00-5
Carc. 1B
A complex combination of hydrocarbons obtained by treating an atmospheric tower residuum with hydrogen in the presence of a catalyst under conditions primarily to remove organic sulfur compounds. 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.
265-181-2
64742-78-5
Carc. 1B
A complex combination of hydrocarbons produced as the residual fraction from distillation of the products of a hydrocracking process. It consists of hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350°C (662°F).
265-076-1
64741-75-9
Carc. 1B
A complex combination of hydrocarbons produced as the residual fraction from the distillation of heavy coker gas oil and light vacuum gas oil. It consists predominantly of hydrocarbons having carbon numbers predominantly greater than C13 and boiling above approximately 230°C(446°F).
270-983-0
68512-61-8
Carc. 1B
A complex combination of hydrocarbons produced as the residual fraction from distillation of the product from a catalytic reforming process. It consists of predominantly aromatic hydrocarbons having carbon numbers predominantly in the range of C10 through C25 and boiling in the range of approximately 160°C to 400°C (320°F to 725°F). This stream is likely to contain 5 wt. % or more of 4- or 6-membered condensed ring aromatic hydrocarbons.
265-069-3
64741-67-9
Carc. 1B
A complex residuum from the distillation of catalytic reformer fractionator residue. It boils approximately above 399°C (750°F).
270-792-2
68478-13-7
Carc. 1B
A complex combination of hydrocarbons produced as the residual fraction from the distillation of the products from a catalytic cracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly greater than C11 and boiling above approximately 200°C (392°F).
295-511-0
92061-97-7
Carc. 1B
A complex residuum from the catalytic reforming of C6-8 feed. It consists of hydrocarbons having carbon numbers predominantly in the range of C2 through C6.
270-794-3
68478-15-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex residuum from the distillation of butane stream. It consists of aliphatic hydrocarbons having carbon numbers predominantly in the range of C4 through C6.
270-791-7
68478-12-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex residuum from atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly greater than C11 and boiling above approximately 200°C (392°F). This stream is likely to contain 5 wt.% or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
269-777-3
68333-22-2
Carc. 1B
A complex residuum from the atmospheric distillation of crude oil. 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.
265-045-2
64741-45-3
Carc. 1B
A complex residuum from the distillation of streams from various refinery operations. It consists of hydrocarbons having carbon numbers in the range of C4 through C5, predominantly butane and boiling in the range of approximately -11.7°C to 27.8°C (11°F to 82°F).
271-010-2
68513-66-6
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A cohesive powder composed of coal mineral matter and undissolved coal remaining after extraction of coal by a liquid solvent.
302-681-2
94114-46-2
Carc. 1B
Residue from the fractional distillation of pitch distillate boiling in the range of approximately 400°C to 470°C (752°F to 846°F). Composed primarily of polynuclear aromatic hydrocarbons, and heterocyclic compounds.
295-507-9
92061-94-4
Carc. 1B
The residue from the fractional distillation of wash oil boiling in the approximate range of 270°C to 330°C (518°F to 626°F). It consists predominantly of dinuclear aromatic and heterocyclic hydrocarbons.
295-506-3
92061-93-3
Carc. 1B
The residue from the fraction distillation of crude anthracene boiling in the approximate range of 340°C to 400°C (644°F to 752°F). It consists predominantly of tri- and polynuclear aromatic and heterocyclic hydrocarbons.
295-505-8
92061-92-2
Carc. 1B; Muta. 1B
A complex combination of hydrocarbons obtained as the solvent insoluble fraction from solvent refining of a residuum using a polar organic solvent such as phenol or furfural. It consists of hydrocarbons having carbon numbers predominantly higher than C25 and boiling above approximately 400°C (752°F).
265-101-6
64742-01-4
Carc. 1B
A complex combination of hydrocarbons, sulfur compounds and metal-containing organic compounds obtained as the residue from refinery fractionation cracking processes. It produces a finished oil with a viscosity above 2cSt. at 100°C.
298-754-0
93821-66-0
Carc. 1B
A complex combination of hydrocarbons obtained by removal of long, branched chain hydrocarbons from a residual oil by solvent crystallization. It consists of hydrocarbons having carbon numbers predominantly greater than C25 and boiling above approximately 400°C (752°F).
265-166-0
64742-62-7
Carc. 1B
A complex combination of hydrocarbons obtained as the solvent soluble fraction from C3 - C4 solvent deasphalting of a residuum. It consists of hydrocarbons having carbon numbers predominantly higher than C25 and boiling above approximately 400°C (752°F).
265-096-0
64741-95-3
Carc. 1B
A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists of hydrocarbons having carbon numbers predominantly greater than C25 and boiling above approximately 400°C (752°F).
265-160-8
64742-57-0
Carc. 1B
292-656-1
90669-74-2
Carc. 1B
A complex combination of hydrocarbons produced by solvent removal of paraffins from the residue of the distillation of acid-treated, hydrocracked heavy paraffins and boiling approximately above 380°C (716°F).
295-499-7
92061-86-4
Carc. 1B
A complex residuum from the atmospheric distillation of the butane-butylene stream. It consists of aliphatic hydrocarbons having carbon numbers predominantly in the range of C4 through C6.
270-795-9
68478-16-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained by treatment of a residual oil with a natural or modified clay in either a contacting or percolation process to remove the trace amounts of polar compounds and impurities present. It consists of hydrocarbons having carbon numbers predominantly higher than C25 and boiling above approximately 400°C (752°F).
265-143-5
64742-41-2
Carc. 1B
A complex combination of hydrocarbons obtained by treatment of solvent-dewaxed petroleum residual oils with bleaching earth for the removal of trace polar constituents and impurities.
309-711-3
100684-38-6
Carc. 1B
294-843-3
91770-57-9
Carc. 1B
A complex combination of hydrocarbons obtained by the treatment of solvent-dewaxed petroleum residual oils with activated charcoal for the removal of trace polar constituents and impurities.
309-710-8
100684-37-5
Carc. 1B
232-645-0
9001-98-3
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
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Glass, oxide, chemicals
This category encompasses the various chemical substances manufactured in the production of inorganic glasses. For purposes of this category, 'glass' is defined as an amorfous, inorganic, transparent, translucent or opaque material traditionally formed by fusion of sources of silica with a flux, such as an alkali-metal carbonate, boron oxide, etc. and a stabilizer, into a mass which is cooled to a rigid condition without crystallization in the case of transparent or liquid-phase separated glass or with controlled crystallization in the case of glass-ceramics. The category consists of the various chemical substances, other than by-products or impurities, which are formed during the production of various glasses and concurrently incorporated into a glass mixture. All glasses contain one or more of these substances, but few, if any, contain all of them. The elements listed below are principally present as components of oxide systems but some may also be present as halides or chalcogenides, in multiple oxidation states, or in more complex compounds. Trace amounts of other oxides or chemical compounds may be present. Oxides of the first seven elements listed* comprise more than 95 percent, by weight, of the glass produced. @Aluminium*@Lead@Boron*@Lithium@Calcium*@Manganese@Magnesium*@Molybdenum@Potassium*@Neodymium@Silicon*@Nickel@Sodium*@Niobium@Antimony@Nitrogen@Arsenic@Phosphorus@Barium@Praseodymium@Bismuth@Rubidium@Cadmium@Selenium@Carbon@Silver@Cerium@Strontium@Cesium@Sulfur@Chromium@Tellurium@Cobalt@Tin@Copper@Titanium@Germanium@Tungsten@Gold@Uranium@Holmium@Vanadium@Iron@Zinc@Lanthanum@Zirconium
EC / List no: 266-046-0 | CAS no: 65997-17-3
Zirconia Aluminosilicate Refractory Ceramic Fibres
are fibres covered by index number 650-017-00-8 in Annex VI, part 3, table 3.1 of Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, and fulfil the three following conditions: a) oxides of aluminium, silicon and zirconium are the main components present (in the fibres) within variable concentration ranges b) fibres have a length weighted geometric mean diameter less two standard geometric errors of 6 or less micrometres (µm). c) alkaline oxide and alkali earth oxide (Na2O+K2O+CaO+MgO+BaO) content less or equal to 18% by weight
EC / List no: - | CAS no: -
Aluminosilicate Refractory Ceramic Fibres
are fibres covered by index number 650-017-00-8 in Annex VI, part 3, table 3.1 of Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, and fulfil the three following conditions: a) oxides of aluminium and silicon are the main components present (in the fibres) within variable concentration ranges b) fibres have a length weighted geometric mean diameter less two standard geometric errors of 6 or less micrometres (µm) c) alkaline oxide and alkali earth oxide (Na2O+K2O+CaO+MgO+BaO) content less or equal to 18% by weight
EC / List no: - | CAS no: -
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Carc. 1B
231-768-7
7723-14-0
Flam. Sol. 1
FCC 963
410-880-1
147170-38-5
Acute Tox. 4; Skin Corr. 1B
MP-2000; MP-2000X
406-620-1
129217-90-9
Skin Sens. 1
ORGANOTUNGSTEN COMPOUND CONCENTRATE
408-250-6
121754-49-2
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
-
-
Carc. 1B; Muta. 2; Acute Tox. 4; STOT RE 2; Skin Corr. 1C; Eye Dam. 1; Skin Sens. 1A
-
-
Carc. 1B; Muta. 2; Acute Tox. 4; Acute Tox. 3; STOT RE 2; Skin Corr. 1B; Eye Dam. 1; Skin Sens. 1A
432-440-8
220444-73-5
Carc. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
426-860-0
191877-09-5
Eye Dam. 1
939-460-0
1471311-26-8
yes
500-033-5
25068-38-6
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
428-630-5
-
Skin Sens. 1
PDN 2287
417-450-2
-
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
PRODUKT 1245
420-980-7
-
Eye Dam. 1
424-510-1
-
Eye Dam. 1
PES-SOLID
420-070-1
-
Org. Perox. D; Acute Tox. 4; Skin Corr. 1A
R633
406-230-1
224635-63-6
Flam. Liq. 3; Carc. 2; Skin Corr. 1B; Acute Tox. 4; Skin Sens. 1
E-101
420-310-3
-
Acute Tox. 4
YELLOW MGI 1301
424-250-9
-
Eye Dam. 1
TYZOR ZEC
417-110-3
1379678-99-5
Flam. Liq. 2; Skin Irrit. 2; Eye Dam. 1
SHC 3000
401-530-9
-
Flam. Sol. 1; STOT SE 1; Acute Tox. 4
431-120-5
-
Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
439-540-0
-
Skin Irrit. 2; Skin Sens. 1
432-200-2
1379679-02-3
STOT SE 3; Skin Irrit. 2; Eye Dam. 1
ADDITIV 104
412-780-3
1380226-46-9
Skin Irrit. 2; Skin Sens. 1
-
-
yes
ORANGE LEP 2471
421-290-9
-
STOT RE 2
435-180-3
-
Asp. Tox. 1; Skin Irrit. 2
GA161895; GLUCAMIDE
411-130-6
-
Eye Dam. 1
P2-800; P2-935LV
415-870-0
-
Skin Sens. 1
NOIR SANDODERM HH 1050; SANDODERM BLACK HH 1050; SANDODERM BLACK R; SANDODERM BLACK R CONC.; SANDODERM SCHWARZ R; SANDODERM SCHWARZ R KONZ.
402-850-1
-
Eye Dam. 1
RED MDO 358
414-620-8
-
Eye Dam. 1; Skin Sens. 1
444-050-5
-
Eye Dam. 1
428-400-4
-
Eye Dam. 1
REACTIVE RED 180 (HYDROLYSED)
423-200-3
98114-32-0
Eye Dam. 1; Skin Sens. 1
428-260-4
-
Eye Dam. 1
BROWN 1619246
406-870-1
115100-55-5
Skin Sens. 1
C.I. DIRECT BLACK 184; C.I. DIRECT NOIR 184
406-000-0
173939-66-7
Eye Dam. 1
DUASYN DIREKTSCHWARZ HEF-SF VP 332
411-890-9
108936-08-9
Acute Tox. 4; Eye Dam. 1
ARQUAD 3.16
405-620-9
-
Eye Dam. 1
438-310-7
-
Self-react. C; Repr. 2; Acute Tox. 4; STOT RE 2
432-230-6
-
STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
429-620-3
110028-14-3
Skin Irrit. 2; Skin Sens. 1
CLARYCET
412-450-9
131766-73-9
Skin Sens. 1
2-ISOPROPYL-5-CARBOXY-1,3-DIOXANE
418-170-3
116193-72-7
Eye Dam. 1
ACETOXYACID
411-660-8
147027-04-1
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
CYRACURE PHOTOINITIATOR UVI-6990; CYRACURE PHOTOINITIATOR UVI-6992
403-490-8
104558-95-4
Eye Irrit. 2; Skin Sens. 1
BDS-HEXAFLUOROPHOSPHATE; BDS-HEXAFLUORPHOSPHAT; ESACURE 1004
404-986-7
74227-35-3
Eye Dam. 1
EBO
417-540-1
-
Eye Dam. 1
ITC 288/S
410-800-5
-
Skin Sens. 1
PROCION YELLOW PX-R; S154357; SUBSTANCE S154357
412-940-2
148878-18-6
Skin Sens. 1
429-440-5
-
Eye Dam. 1
PRICARE
411-910-6
-
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
PRIAZUL MYRISTOYL LACTYLATE; PRICARE MYRISTYL LACTYLATE (1:1.5)
412-580-6
174591-51-6
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
432-790-1
847871-03-8
Acute Tox. 4; Skin Corr. 1B; STOT SE 2
ACID RED HT 3728; ERIONYL RED HT 3728
410-070-8
141880-36-6
Skin Sens. 1
DRIMAREN NAVY R-GRL; NAVY 14 08 723
407-100-7
-
Skin Sens. 1
C.I. DIRECT VIOLET 107; PRO-JET FAST MAGENTA 2 COLOUR; S161629
413-180-4
187285-15-0
Eye Dam. 1
427-740-0
-
Eye Dam. 1; Skin Sens. 1
426-470-0
214897-29-7
Skin Sens. 1
TASP
411-250-9
-
Skin Sens. 1
EVAPORATED ELEMINOL JS-2 MATERIAL
410-230-7
-
Skin Corr. 1B; Skin Sens. 1
T-271
417-980-4
157321-59-0
Self-react. C; Carc. 2
433-860-4
-
Eye Irrit. 2; Skin Sens. 1
422-500-1
-
STOT RE 2
COLUMBIADUNKELBLAU R
415-350-3
-
Eye Dam. 1
MARINE REN 600
424-320-9
180778-23-8
Eye Dam. 1
445-280-9
371921-40-3
Eye Dam. 1; Skin Sens. 1

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