legislation-obligation

Substance Regulatory Obligations

OBL

Ethylene oxide

EC number: 200-849-9

CAS number: 75-21-8

Last updated: 12/08/2021
ECHA Legislation Regulatory Obligations

Regulatory obligations may exist for this substance under the legislations under ECHA’s remit or for which ECHA has delegated tasks (i.e. REACH, CLP, BPR, PIC, CAD / CMD, WFD, and POPs). Please check the substance Infocard.

Active Implantable Medical Devices Directive

Active Implantable Medical Devices Directive - Hazardous Substances

This list contains hazardous substances for purposes of Directive 90/385/EEC on active implantable medical devices, particularly as regards Article 3 and Annex I (Essential Requirements). This non-exhaustive database 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). Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021. Nevertheless, Article 120 of the Regulation provides for a transitional period allowing medical devices, under specified conditions (e.g., placed on the market prior to 26 May 2021), to continue to comply with the Directive. In accordance with the fourth paragraph of Article 120, this period ends 26 May 2025.

Name CAS EU CLP (1272/2008) EU_BA Directive 2000/54/EC EU REACH: List of SVHC
ethylene oxide; oxirane
75-21-8
Press. Gas; Flam. Gas 1; Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 3; STOT SE 3; STOT RE 1; Skin Corr. 1; Eye Dam. 1
Aerosol Dispensers Directive

Aerosols Directive - Flammable Contents - Labelling Requirements

This list contains a subset of Table 3-listed substances in Annex VI to the CLP Regulation (1272/2008/EC). The non-exhaustive list is based on: (1) the flammable content, and (2) flammable aerosol definitions in sections 1.8 and 1.9, and (3) the labelling requirements given in section 2.2, of the Annex to the Aerosol Dispensers Directive 75/324/EEC.

Name CAS Index EC Number Substance Description Expressed As Physical form Restriction(s) Classifications
ethylene oxide; oxirane
75-21-8
603-023-00-X
200-849-9
Flam. Gas 1
CAD - Chemical Agents Directive

CAD - Chemical Agents Directive, Article 2(b)(i) - Hazardous Agents

This list contains a non-exhaustive inventory based on the list of substances with harmonised classification and labelling (i.e., Table 3 of Annex VI to the CLP Regulation 1272/2008/EC). While the harmonised list covers many hazardous substances, others not listed may also meet the classification criteria in accordance with the CLP Regulation.

Name CAS
ethylene oxide; oxirane
75-21-8
CMD - Carcinogens and Mutagens Directive

CMD - Carcinogens and Mutagens Directive, Annex III - OELVs

This list contains occupational exposure limit values (OELs) for carcinogens and mutagens pursuant to Annex III of Directive 2004/37/EC (CMD). Employers are obligated to minimize worker exposure to these agents in so far as possible, and must arrange for medical surveillance of workers exposed to these substances.

Name of Agent EC Number CAS Long-term Exposure Limit (LTEL) Values Short-term Exposure Limit (STEL) Values Expressed As Carcinogen Category Physical form Dermal Sensitisation Respiratory Sensitisation Skin Designation Effective Date Expiration Date Work Sector Miscellaneous Notes  
Name f/ml mg/m3 ppm mg/m3 ppm
Ethylene oxide
200-849-9
75-21-8
1.8 mg/m3
1 ppm
1B Category 1B, presumed to have carcinogenic potential for humans, classification is largely based on animal evidence.
yes
Details

Carc and Muta Directive, Annex I - Substances, Mixtures & Processes

This list contains a non-exhaustive inventory of substances based on Art. 2 carcinogen and mutagen (CM) definitions and Annex I of the Carcinogens and Mutagens Directive. Category 1A and 1B carcinogens and mutagens are derived from the CLP Regulation's Table 3 of Annex VI (1272/2008/EC). Employers are obligated to minimize worker exposure to these agents as far as possible, and must arrange for medical surveillance of workers exposed to these substances.

Name CAS Restriction(s) Physical form Substance Description Notes  
ethylene oxide; oxirane
75-21-8
Details
Construction Products Regulation

Construction Product Regulation - Annex I (3) - Hazardous Substances

This list contains a non-exhaustive inventory of substances taken from: (1) Table 3 of Annex VI to CLP; (2) the Candidate List of SVHCs; (3) Annex XIV of REACH (Authorisation List); (4) Annex XVII of REACH (Restrictions List); (5) F-gases subject to emission limits/reporting per Regulation 517/2014/EU; and (6) volatile organic compounds (VOCs) listed in the Ambient Air Directive 2008/50/EC. The basis of the list is Annex I(3) of the Construction Products Regulation 305/2011/EC, which stipulates that construction works must not have a high impact on human health or the environment as a result of: giving off toxic gas; emissions of dangerous substances, volatile organic compounds (VOC), greenhouse gases or dangerous particles into indoor or outdoor air; release of dangerous substances into drinking water, ground water, marine waters, surface waters or soil.

Name CAS EU CLP (1272/2008) EU REACH: Annex XIV EU REACH: List of SVHC EU REACH: Annex XVII EU FGG (517/2014) EU VOC (2008/50)
ethylene oxide; oxirane
75-21-8
yes
Annex 17 Appendix 2; Annex 17 Appendix 4; Annex 17 Appendix 6

Construction Product Regulation - Article 6(5) - SDS and Declaration

This list contains a non-exhaustive inventory of substances originating from: (1) Table 3 of Annex VI to CLP (i.e., the list of harmonised substances); (2) the Candidate List of Substances of Very High Concern (SVHCs); and REACH Annex XIV (Authorisation List). This list is compiled on the basis of Article 6(5) of Regulation 305/2011/EC on Marketing of Construction Products. This provision requires SDSs and information on hazardous substances (i.e., SVHCs) contained in construction products be provided with the declaration of performance.

Name CAS EU REACH: Annex XIV EU REACH: List of SVHC
ethylene oxide; oxirane
75-21-8
Cosmetic Products Regulation

Cosmetic Products Regulation, Annex II - Prohibited Substances

This list contains substances which are banned from use in any cosmetic products marketed for sale or use in the European Union.

Ref No. Substance Identification Expressed As Product type, body parts Maximum Threshold Restriction(s) Notes  
Name EC Number CAS Molecular formula
182
Ethylene oxide
200-849-9
75-21-8
All cosmetic products
0 %
Details
End-of-Life Vehicles Directive

End-of-Life Vehicles Directive - Hazardous Substances

This list contains a non-exhaustive inventory of hazardous substances as defined by Article 2(11) of the End-of-Life Vehicles Directive 2000/53/EC. It is based on the relevant subset of substances with harmonised classification listed in Table 3 of Annex VI to the CLP Regulation 1272/2008/EC.

Name CAS EU CLP (1272/2008)
ethylene oxide; oxirane
75-21-8
Carc. 1B; Repr. 1B; Acute Tox. 3; STOT RE 1
EU Ecolabel Regulation

Ecolabels - Restrictions for Hazardous Substances/Mixtures

This list contains a non-exhaustive inventory of substances based on the list of hazardous substances with harmonised classification and labelling (i.e. Table 3 of Annex VI to the CLP Regulation), and the Candidate List of substances of very high concern (SVHCs). Pursuant to Article 6(6) of the EU Ecolabel Regulation, the ecolabel must not be awarded to goods containing substances or mixtures classified according to the CLP as toxic; hazardous to the environment; and carcinogenic, mutagenic, or toxic for reproduction (CMRs). Nor are products allowed the ecolabel award when they contain SVHCs (per Article 57 of REACH). While the CLP's harmonised list contains many such substances, other ones not listed in Table 3 may also meet the criteria specified for classification under the CLP.

Name CAS Restriction(s) Expressed As Table 3 of Annex VI to CLP EU REACH: List of SVHC Physical form Substance Description  
ethylene oxide; oxirane
75-21-8
yes
Details
Food Contact Active and Intelligent Materials and Articles Regulation

Active and Intelligent Materials - CMR Substances not allowed for use

This list contains a non-exhaustive list of Carcinogens, Mutagens and Reproductive substances (CMRs) that are not allowed for use in components of active and intelligent materials and articles per Art. 5(2)(c)(i) of Regulation 450/2009/EC. The list is derived from a subset of substances on Table 3 of Annex VI to the CLP Regulation (1272/2008/EC).

Name CAS Index EC Number Substance Description Expressed As Physical form Restriction(s) Classifications
ethylene oxide; oxirane
75-21-8
603-023-00-X
200-849-9
Carc. 1B; Muta. 1B; Repr. 1B
Food Contact Recycled Plastic Materials and Articles Regulation

FCMs Recycled Plastic & Articles Regulation - Annex I - Authorised Use

This list contains the Annex I Plastic Food Contact Materials (FCMs) authorised for use in the European Union under Regulation 10/2011/EU. Pursuant to Art. 4(b) of Directive 282/2008/EC on recycled plastic FCMs, plastic recycling processes can only be authorised if input originates from plastic materials and articles manufactured in accordance with EU legislation on plastic food contact materials and articles.

Name CAS Physical form FCM No Ref No. Additive or PPA Use as monomer/macromolecule FRF applicable SML (mg/kg) SML(T) Group Restriction No SML(T) Group FCM substances SML(T) (mg/kg) Restriction(s) Notes on verification Notes  
ethylene oxide
75-21-8
129
17020
no
yes
no
0.01 mg/kg
1 mg/kg in final product.
V10 Verification of compliance by residual content per food contact surface area (QMA) in case of reaction with food or simulant.
ND The specific migration limit is non-detectable (ND). A detection limit of 0.01mg substance per kg food is applicable unless specified differently for an individual substance.
Details
General Product Safety Directive

General Product Safety Directive - Hazardous Substances

This list contains a non-exhaustive inventory of substances that fall within the European Union's hazardous substance definitions, as provided on: (1) Table 3 of Annex VI to the CLP Regulation 1272/2008/EC; (2) Annex III of Directive 2000/54/EC (Biological Agents); Candidate List of SVHCs; and REACH Annexes XIV and XVII (Authorisation and Restriction lists). They can be considered hazardous for purposes of the General Product Safety Directive 2001/95/EC.

Name CAS EU CLP (1272/2008) EU REACH: Annex XIV EU REACH: List of SVHC EU REACH: Annex XVII EU_BA Directive 2000/54/EC
ethylene oxide; oxirane
75-21-8
yes
Annex 17 Appendix 2; Annex 17 Appendix 4; Annex 17 Appendix 6
In Vitro Diagnostic Medical Devices Directive

In Vitro Diagnostic Medical Devices Directive - Hazardous Substances

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).

Name CAS EU CLP (1272/2008) EU_BA Directive 2000/54/EC EU REACH: List of SVHC
ethylene oxide; oxirane
75-21-8
Press. Gas; Flam. Gas 1; Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 3; STOT SE 3; STOT RE 1; Skin Corr. 1; Eye Dam. 1
Inland Transport of Dangerous Goods Directive

Inland Transport of Dangerous Goods Directive, Annex I - ADR

This list contains the ADR Dangerous Goods List, as implemented by the European Union's Directive 2008/68/EC. This Directive applies the European Agreements on the international transport of dangerous goods by road (ADR) and inland waterways (ADN), and the regulations concerning the international carriage of dangerous goods by rail (RID).

Name CAS Class Labels Packing Group Packaging UN No. ADR tank Classification code Hazard identification no. Limited and excepted quantities Vehicle for tank carriage Portable tank and bulk containers Special provisions Special provisions for carriage Transport category (Tunnel restriction code) Notes  
Mixed packing provisions Special packing provisions Packing instructions Tank code Special provisions Excepted quantities Limited quantities Unit Instructions Special provisions bulk Loading, unloading & handling Operation Packages Tunnel restriction code Transport category
ETHYLENE OXIDE
75-21-8
2
2.3+2.1
MP9
P200
1040
2TF
263
E0
FL
(M)
342
CV9
CV10
CV36
S2
S14
(B/D)
1
1 Not permitted to be carried in limited quantities
Details
ETHYLENE OXIDE WITH NITROGEN up to a total pressure of 1 MPa (10 bar) at 50 °C
75-21-8
2
2.3+2.1
MP9
P200
1040
PxBH(M)
TA4
TT9
2TF
263
E0
FL
(M)
T50
TP20
342
CV9
CV10
CV36
S2
S14
(B/D)
1
1 Not permitted to be carried in limited quantities
Details

Inland Transport of Dangerous Goods Directive, Annex II - RID

This list contains the RID Dangerous Goods List, as implemented by the European Union's Directive 2008/68/EC. This Directive applies the European Agreements on the international transport of dangerous goods by road (ADR) and inland waterways (ADN), and the regulations concerning the international carriage of dangerous goods by rail (RID).

Name CAS Class Labels Packing Group UN No. Classification code Express parcels Hazard identification number RID Tanks Limited and excepted quantities Packaging Portable tanks and bulk containers Transport category Special provisions for carriage Special provisions Notes  
Tank code Special provisions Excepted quantities Units Limited quantities Special packaging provisions Packaging instructions Mixed packing provisions Special provisions Instructions Loading, unloading & handling bulk Packages
ETHYLENE OXIDE
75-21-8
2
2.3+2.1
1040
2TF
263
E0
P200
MP9
(M)
1
CW9
CW10
CW36
342
1 Not permitted to be carried in limited quantities
Details
ETHYLENE OXIDE WITH NITROGEN up to a total pressure of 1 MPa (10 bar) at 50 °C
75-21-8
2
2.3+2.1(+13)
1040
2TF
263
PxBH(M)
TU38
TE22
TE25
TA4
TT9
TM6
E0
P200
MP9
TP20
T50
(M)
1
CW9
CW10
CW36
342
1 Not permitted to be carried in limited quantities
Details

Inland Transport of Dangerous Goods Directive, Annex III - ADN

This list contains the ADN Dangerous Goods List, as implemented by the European Union's Directive 2008/68/EC. This Directive establishes rules for the safe transport of dangerous goods between EU countries by road (ADR) and inland waterways (ADN), and the regulations concerning the international carriage of dangerous goods by rail (RID).

Name CAS Class Labels Packing Group UN No. or ID no. Carriage permitted Classification code Equipment required Limited and excepted quantities Number of blue cones/lights Provisions concerning loading, unloading and carriage Ventilation Remarks Special provisions Notes  
Excepted quantities Limited quantities Units Column (11c) Column (11b) Column (11a)
ETHYLENE OXIDE
75-21-8
2
2.3+2.1
1040
2TF
PP
EP
EX
TOX
A
E0
2
VE01
VE02
342
1 Not permitted to be carried in limited quantities
Details
ETHYLENE OXIDE WITH NITROGEN up to a total pressure of 1 MPa (10 bar) at 50 °C
75-21-8
2
2.3+2.1
1040
T
2TF
PP
EP
EX
TOX
A
E0
2
VE01
VE02
342
1 Not permitted to be carried in limited quantities
Details
Marine Environmental Policy Framework Directive

Marine Environmental Policy Framework Directive - Hazardous Substances

This list contains a non-exhaustive inventory of hazardous substances for purposes of the Marine Strategy Framework Directive, especially as it concerns Art. 3(8), and Annexes I and III. The listed substances meet the European Union's definitions as hazardous, as provided on: (1) Table 3 of Annex VI to the CLP Regulation (1272/2008/EC); (2) Annex III of Directive 2000/54/EC (Biological Agents); Candidate List of SVHCs; and REACH Annex XIV (Authorisation List).

Name CAS EU CLP (1272/2008) EU REACH: List of SVHC EU_BA Directive 2000/54/EC EU REACH: Annex XIV
ethylene oxide; oxirane
75-21-8
yes
Medical Devices Directive

Medical Devices Directive - Hazardous Substances

This list contains hazardous substances in accordance with the Medical Devices Directive's (MDD) design and construction requirements pursuant to Annex I, Part II (7) & (8) (i.e., chemical, physical and biological properties; and infection and microbial contamination). Specifically, the non-exhaustive database 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). Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 93/42/EEC and begun to apply from 26 May 2021. Nevertheless, Article 120 of the Regulation provides for a transitional period allowing medical devices, under specified conditions (e.g., placed on the market prior to 26 May 2021), to continue to comply with the Directive. In accordance with the fourth paragraph of Article 120, this period ends 26 May 2025.

Name CAS EU CLP (1272/2008) EU_BA Directive 2000/54/EC EU REACH: List of SVHC
ethylene oxide; oxirane
75-21-8
Press. Gas; Flam. Gas 1; Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 3; STOT SE 3; STOT RE 1; Skin Corr. 1; Eye Dam. 1
Pesticide Residues Regulation

Annexes II, III, IV, VII - Defined & Temporary Maximum Residue Levels

This list contains the maximum residue level (MRLs) entries as listed in the following annexes of Regulation (EC) No 396/2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC: (1) Annex II: Maximum Residue Levels; (2) Annex III: Temporary MRLs; (3) Annex IV: Active Substances for Which No MRLs Are Required; and (4) Annex VII: Active Substance/Product Combinations.

Name CAS Annex No. Product Name Category CodeNumber Category Group/SubGroup CodeNumber Group/SubGroup MRL  
Ethylene oxide
75-21-8
Annex V
Garlic (Twistedleaf garlic)
Onions
Other bulb vegetables
Shallots
Spring onions/green onions and Welsh onions
0200000
Vegetables, fresh or frozen
0220000
Bulb vegetables
0.02 mg/kg
Details
Ethylene oxide
75-21-8
Annex V
Beans (Species listed with code numbers 0260010-xxx, dried seeds, except soyabeans/edamame)
Lentils
Lupins/lupini beans
Other pulses
Peas
0300000
Pulses
0.02 mg/kg
Details
Ethylene oxide
75-21-8
Annex V
Cinnamon
Other bark spices
0800000
Spices
0830000
Bark spices
0.1 mg/kg
Details
Ethylene oxide
75-21-8
Annex V
Anise/aniseed
Black caraway/black cumin (Nigella)
Celery (Angelica, Lovage)
Coriander
Cumin
Dill
Fennel
Fenugreek
Nutmeg
Other seed spices
0800000
Spices
0810000
Seed spices
0.1 mg/kg
Details
Ethylene oxide
75-21-8
Annex V
Apricots
Cherries (sweet)
Other stone fruits
Peaches
Plums
0100000
Fruits, fresh or frozen and Tree nuts
0140000
Stone fruits
0.02 mg/kg
Details
Ethylene oxide
75-21-8
Annex V
Baby leaf crops (including brassica species)
Basil and edible flowers
Celery leaves
Chards/beet leaves
Chervil
Chives
Cresses and other sprouts and shoots
Escaroles/broad-leaved endives
Lamb's lettuces/corn salads
Land cresses
Laurel/bay leaves
Lettuces
Other herbs and edible flowers
Other lettuces and salad plants
Other spinaches and similar leaves
Parsley (Root parsley leaves)
Purslanes
Red mustards
Roman rocket/rucola (Wall rocket)
Rosemary
Sage
Spinaches
Tarragon
Thyme
0200000
Vegetables, fresh or frozen
0250000
Leaf vegetables, herbs and edible flowers
0.01 mg/kg
Details
Ethylene oxide
75-21-8
Annex V
Ginger
Liquorice
Other root and rhizome spices
Turmeric/curcuma
0800000
Spices
0840000
Root and rhizome spices
0.1 mg/kg
Details
Ethylene oxide
75-21-8
Annex V
Chicory roots
Other sugar plants
Sugar beet roots
Sugar canes
0900000
Sugar plants
0.02 mg/kg
Details
Ethylene oxide
75-21-8
Annex V
grape leaves and similar species
lettuces and salad plants
spinaches and similar leaves
watercresses
witloofs/Belgian endives
0200000
Vegetables, fresh or frozen
0250000
Leaf vegetables, herbs and edible flowers
0.02 mg/kg
Details
Ethylene oxide
75-21-8
Annex V
Beans (with pods)
Beans (without pods)
Lentils
Other legume vegetables
Peas (with pods)
Peas (without pods)
0200000
Vegetables, fresh or frozen
0260000
Legume vegetables
0.02 mg/kg
Details
Ethylene oxide
75-21-8
Annex V
Capers
Cloves
Other bud spices
0800000
Spices
0850000
Bud spices
0.1 mg/kg
Details
Ethylene oxide
75-21-8
Annex V
Asparagus (Hop sprouts)
Bamboo shoots
Cardoons (Borage stems)
Celeries
Florence fennels
Globe artichokes
Leeks
Other stem vegetables
Palm hearts
Rhubarbs
0200000
Vegetables, fresh or frozen
0270000
Stem vegetables
0.02 mg/kg
Details
Ethylene oxide
75-21-8
Annex V
Allspice/pimento
Caraway (Ajowan)
Cardamom (Marjoram, Star anise)
Juniper berry
Other fruit spices
Peppercorn
Sichuan pepper
Tamarind
Vanilla
0800000
Spices
0820000
Fruit spices
0.1 mg/kg
Details
Ethylene oxide
75-21-8
Annex V
Apples
Loquats/Japanese medlars
Medlars
Other pome fruits
Pears
Quinces
0100000
Fruits, fresh or frozen and Tree nuts
0130000
Pome fruits
0.02 mg/kg
Details
Ethylene oxide
75-21-8
Annex V
Aubergines/eggplants
Courgettes
Cucumbers
cucurbits with edible peel
cucurbits with inedible peel
Gherkins (Bur gherkins)
Melons
Okra/lady's fingers
Other cucurbits with edible peel
Other cucurbits with inedible peel
other fruiting vegetables
Other solanaceae and malvaceae
Pumpkins
Solanaceae and Malvaceae
sweet corn (Baby corn)
Sweet peppers/bell peppers
Tomatoes
Watermelons
0200000
Vegetables, fresh or frozen
0230000
Fruiting vegetables
0.02 mg/kg
Details
Ethylene oxide
75-21-8
Annex V
Chamomile
flowers
Ginseng (Siberian ginseng)
Herbal infusions from parts of the plant not explicitly defined
Hibiscus/roselle
Jasmine
leaves and herbs
Lime/linden
Mate/maté
Other Herbal infusions from flowers
Other Herbal infusions from leaves and herbs
Other Herbal infusions from roots
Rooibos
roots
Rose
Strawberry
Valerian
0600000
Teas, Coffee, Herbal Infusions, Cocoa and Carobs
0630000
Herbal infusions from
0.1 mg/kg
Details
Ethylene oxide
75-21-8
Annex V
herbs and edible flowers
0200000
Vegetables, fresh or frozen
0250000
Leaf vegetables, herbs and edible flowers
0.05 mg/kg
Details
Ethylene oxide
75-21-8
Annex V
American persimmons/Virginia kaki
Avocados
Bananas
Breadfruits
Carambolas
Cherimoyas
Dates
Durians
edible peel
Figs
Granate apples/pomegranates
Guavas
inedible peel, large
inedible peel, small
Jambuls/jambolans
Kaki/Japanese persimmons
Kiwi fruits (green, red, yellow)
Kumquats
Litchis/lychees
Mangoes
Other edible peel
Other inedible peel, large
Other inedible peel, small
Papayas
Passionfruits/maracujas
Pineapples
Prickly pears/cactus fruits
Soursops/guanabanas
Star apples/cainitos
Table olives
0100000
Fruits, fresh or frozen and Tree nuts
0160000
Miscellaneous fruits
0.02 mg/kg
Details
Ethylene oxide
75-21-8
Annex V
Grapefruits
Lemons
Limes
Mandarins
Oranges
Other citrus fruits
0100000
Fruits, fresh or frozen and Tree nuts
0110000
Citrus fruits
0.02 mg/kg
Details
Ethylene oxide
75-21-8
Annex V
Almonds
Brazil nuts
Cashew nuts
Chestnuts
Coconuts
Hazelnuts/cobnuts
Macadamias
Other tree nuts
Pecans
Pine nut kernels
Pistachios
Walnuts
0100000
Fruits, fresh or frozen and Tree nuts
0120000
Tree nuts
0.05 mg/kg
Details
Ethylene oxide
75-21-8
Annex V
Cultivated fungi
Mosses and lichens
Wild fungi
0200000
Vegetables, fresh or frozen
0280000
Fungi, mosses and lichens
0.02 mg/kg
Details
Ethylene oxide
75-21-8
Annex V
Mace
Other aril spices
0800000
Spices
0870000
Aril spices
0.1 mg/kg
Details
Ethylene oxide
75-21-8
Annex V
Broccoli
Brussels sprouts
Cauliflowers
Chinese cabbages/pe-tsai
flowering brassica
head brassica
Head cabbages
Kales
kohlrabies
leafy brassica
Other flowering brassica
Other head brassica
Other leafy brassica
0200000
Vegetables, fresh or frozen
0240000
Brassica vegetables (excluding brassica roots and brassica baby leaf crops)
0.02 mg/kg
Details
Ethylene oxide
75-21-8
Annex V
Other flower pistil spices
Saffron
0800000
Spices
0860000
Flower pistil spices
0.1 mg/kg
Details
Ethylene oxide
75-21-8
Annex V
Borage seeds
Castor beans
Cotton seeds
Gold of pleasure seeds
Hemp seeds
Kapok
Linseeds
Mustard seeds
Oil fruits
Oil palms fruits
Oil palms kernels
Oilseeds
Olives for oil production
Other oil fruits
Other oilseeds
Peanuts/groundnuts
Poppy seeds
Pumpkin seeds
Rapeseeds/canola seeds
Safflower seeds
Sesame seeds
Soyabeans
Sunflower seeds
0400000
Oilseeds and oil fruits
0.05 mg/kg
Details
Ethylene oxide
75-21-8
Annex V
Azaroles/Mediterranean medlars
Blackberries
Blueberries
cane fruits
Cranberries
Currants (black, red and white)
Dewberries
Elderberries
Gooseberries (green, red and yellow)
grapes
Mulberries (black and white)
Other cane fruits
other small fruits and berries
Raspberries (red and yellow)
Rose hips
strawberries
Table grapes
Wine grapes
0100000
Fruits, fresh or frozen and Tree nuts
0150000
Berries and small fruits
0.02 mg/kg
Details
Ethylene oxide
75-21-8
Annex V
Arrowroots
Beetroots
Carrots
Cassava roots/manioc
Celeriacs/turnip rooted celeries
Horseradishes
Jerusalem artichokes
other root and tuber vegetables except sugar beets
Other tropical root and tuber vegetables
Parsley roots/Hamburg roots parsley
Parsnips
potatoes (Andigena)
Radishes
Salsifies
Swedes/rutabagas
Sweet potatoes
tropical root and tuber vegetables
Turnips )
Yams
0200000
Vegetables, fresh or frozen
0210000
Root and tuber vegetables
0.02 mg/kg
Details
Ethylene oxide
75-21-8
Annex V
Barley
Buckwheat and other pseudocereals
Common millet/proso millet
Maize/corn
Oat
Other cereals
Rice
Rye
Sorghum
Wheat
0500000
Cereals
0.02 mg/kg
Details
Ethylene oxide
75-21-8
Annex V
Cattle
Goat
Horse
Other milk
Sheep (Mouflon (farmed))
1000000
Products of animal origin - Terrestrial animals
1020000
Milk
0.02 mg/kg
Details
Ethylene oxide
75-21-8
Annex V
Horseradish
0800000
Spices
0840000
Root and rhizome spices
0.01 mg/kg
Details
Ethylene oxide
75-21-8
Annex V
bovine
Edible offals (other than liver and kidney)
equine
Fat
Goat
Kidney
Liver
Muscle
Other commodities from bovine
Other commodities from equine
Other commodities from goat
Other commodities from other farmed terrestrial animals
Other commodities from poultry
Other commodities from sheep
Other commodities from swine
other farmed terrestrial animals
poultry
Sheep (Mouflon (farmed))
swine (Wild boar (farmed))
1000000
Products of animal origin - Terrestrial animals
1010000
Commodities
0.02 mg/kg
Details
Ethylene oxide
75-21-8
Annex V
Chicken
Duck
Geese
Other birds eggs
Quail
1000000
Products of animal origin - Terrestrial animals
1030000
Birds eggs
0.02 mg/kg
Details
Plastic Materials and Articles Regulation

FCM and Articles Regulation, Annex I - Authorised Substances

This list contains the Union list of authorised monomers, other starting substances, macromolecules obtained from microbial fermentation, additives and polymer production aids. It is taken from Annex I of the Commission Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food.

Name CAS FCM No Ref No. Additive or PPA Use as monomer/macromolecule FRF applicable SML (mg/kg) SML(T) Group Restriction No SML(T) Group FCM substances SML(T) (mg/kg) Restriction(s) Notes on verification Notes Physical form Group name Expressed As  
ethylene oxide
75-21-8
129
17020
no
yes
no
0.01 mg/kg
1 mg/kg in final product.
V10 Verification of compliance by residual content per food contact surface area (QMA) in case of reaction with food or simulant.
ND The specific migration limit is non-detectable (ND). A detection limit of 0.01mg substance per kg food is applicable unless specified differently for an individual substance.
Details
PPPR - Plant Protection Products Regulation

Annex of co-formulants not accepted for inclusion in PPPs

This list contains the PPPR's Annex III co-formulants that are not accepted for inclusion in plant protection products (PPPs), as referred to in Article 27 of Regulation 1107/2009/EC (PPPR). Authorisations granted for PPPs containing co-formulants listed in Annex III shall be amended or withdrawn from the EU market no later than 24 March 2023.

Ref No. Notes
41
1 The limit for the acceptable presence of the substances listed in the table as unintentional impurity in the finished product is 0,1 % (weight by weight (w/w)) except where stated otherwise in this Annex
3 From recital 14 in Regulation 2021/383/EU: The individual concentration of the unacceptable co-formulants in the finished plant protection product or adjuvant should be less than 0,1 % weight by weight (w/w) or less than a specific concentration limit related to CMR properties (carcinogenic, mutagenic and reprotoxic), when established in Annex VI to Regulation (EC) No 1272/2008 for the unacceptable co-formulant at a level lower than 0,1 % weight by weight (w/w), in order to be considered as...
Pressure Equipment Directive

Pressure Equipment Directive - Group 1 Fluids Hazardous Substances

This list contains a non-exhaustive inventory of hazardous substances based on Article 13(1)(a) of Directive 2014/68/EU, defining Group 1 fluids for purposes of classifying pressure equipment in accordance with the Directive. The list is derived from a subset of the substances with harmonised classifications, as listed on Table 3 of Annex VI to the CLP Regulation 1272/2008/EC.

Name CAS Substance Description Expressed As Physical form Restriction(s) Index EC Number Classifications
ethylene oxide; oxirane
75-21-8
603-023-00-X
200-849-9
Flam. Gas 1; Acute Tox. 3 (Inhalation)
Protection of Pregnant and Breastfeeding Workers Directive

Protection of Pregnant and Breastfeeding Workers Directive, Annex I+II

This list contains a non-exhaustive inventory of substances to which pregnant workers and workers who have recently given birth or are breastfeeding may not be exposed. Employers are obligated to prevent the exposure of these workers to any agents that may have adverse health effects on either mother or child. The inventory originates from Table 3 of Annex VI to the CLP.

Name CAS CLP (1272/2008) CMRs ECCAR Directive 2004/37/EC EU_BA PREGW Notes  
ethylene oxide; oxirane
75-21-8
Carc. 1B; Muta. 1B; Repr. 1B
yes
Details
Protection of Young People Directive

Physical, Biological and Chemical Agents & Processes and Work

This list contains biological and chemical agents, in accordance with Art. 7 and points 2 and 3 of the Annex to Directive 94/33/EC, to which young persons (under 18 years of age) may not be exposed at the workplace. The list is a non-exhaustive inventory of such substances based on: 1) agents of risk groups 3 and 4 under Directive 2000/54/EC; 2) Table 3 of Annex VI to the CLP Regulation; 3) and Annex I of Directive 2004/37/EC.

Name CAS EC_YOUNG ECCAR Directive 2004/37/EC EU CLP (1272/2008) EU_BA Directive 2000/54/EC Notes  
ethylene oxide; oxirane
75-21-8
Flam. Gas 1; Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 3; STOT RE 1
Details
Safety and Health of Workers at Work Directive

Safety and Health of Workers at Work Directive - Hazardous Substances

This list contains a non-exhaustive inventory of substances that fall within the scope of the European Union's definition of hazardous chemical and biological substances, as provided on: (1) Table 3 of Annex VI to the CLP Regulation 1272/2008/EC; and (2) Annex III of Directive 2000/54/EC (Biological Agents). The EU's Occupational Safety and Health (OSH) Framework Directive 89/391/EEC applies to risks arising from chemical, physical and biological agents at the workplace.

Name CAS EU CLP (1272/2008) EU_BA Directive 2000/54/EC
ethylene oxide; oxirane
75-21-8
Press. Gas; Flam. Gas 1; Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 3; STOT SE 3; STOT RE 1; Skin Corr. 1; Eye Dam. 1
Safety and/or Health Signs at Work Directive

Workplace Signs - minimum requirements & signs on containers and pipes

This list contains hazardous substances based on Table 3 of Annex VI to the CLP Regulation 1272/2008/EC. According to the annexes to Directive 92/58/EEC, storage areas and containers containing chemical substances or mixtures that are classified as hazardous according to the CLP Regulation must be duly marked and/or labeled. Directive 92/58/EEC requires employers to ensure proper signage is posted in areas where hazards cannot be avoided or reduced.

Name EC Number CAS Index Sustance Description Danger Symbols Restriction Physical form  
ethylene oxide; oxirane
200-849-9
75-21-8
603-023-00-X
Flame
Gas cylinder
Skull and crossbones
Health hazard
Corrosion
Details
WFD - Waste Framework Directive

Waste Framework Directive, Annex III - Waste - Hazardous Properties

This list contains substances that have been assigned hazard property (HP) waste codes 1-15, as defined in terms of the hazard class and category, hazard (H) statement, and/or concentration limits provided in Annex III of the Waste Framework Directive 2008/98/EC. The classifications of the substances listed in the list are based on their harmonised classifications per Table 3 of Annex VI to the CLP Regulation 1272/2008/EC.

Name EC Number CAS EU CLP (1272/2008) HP Code Index
ethylene oxide; oxirane
200-849-9
75-21-8
Flam. Gas 1
Carc. 1B
Muta. 1B
Repr. 1B
Acute Tox. 3
STOT SE 3
STOT RE 1
Eye Dam. 1
HP3 Flammable Waste (FW): (a)liq FW with flash pt <60°C or FW gas, diesel and light heating oils with flash pt >55°C and ≤75°C (b)pyrophoric liq/solid FW liable to ignite within 5 min after air contact (c)solid FW readily combustible or which may cause/contribute to fire by friction (d)gas FW which is F in air at 20°C and 101.3 kPa (e)water reactive FW which, in contact with water, emits F gases in dangerous quantities (f)other: aerosols, self-heating, organic peroxides and self-reactive FWs.
HP7 Carcinogenic: waste which induces cancer or increases its incidence.
HP11 Mutagenic: waste which may cause a mutation, that is a permanent change in the amount or structure of the genetic material in a cell.
HP10 Toxic for reproduction: waste which has adverse effects on sexual function and fertility in adult males and females, as well as developmental toxicity in the offspring.
HP6 Acute Toxicity: waste which can cause acute toxic effects following oral or dermal administration, or inhalation exposure.
HP5 Specific Target Organ Toxicity (STOT)/Aspiration Toxicity: waste which can cause specific target organ toxicity either from a single or repeated exposure, or which cause acute toxic effects following aspiration.
HP4 Irritant — skin irritation and eye damage: waste which on application can cause skin irritation or damage to the eye.
603-023-00-X