legislation-obligation

Substance Regulatory Obligations

OBL

Hexan-2-one

EC number: 209-731-1

CAS number: 591-78-6

Last updated: 20/12/2022
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Active Implantable Medical Devices Directive-repealed

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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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
hexan-2-one; methyl butyl ketone; butyl methyl ketone; methyl-n-butyl ketone
591-78-6
Flam. Liq. 3; Repr. 2; STOT RE 1; STOT SE 3
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
hexan-2-one; methyl butyl ketone; butyl methyl ketone; methyl-n-butyl ketone
591-78-6
606-030-00-6
209-731-1
Flam. Liq. 3
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
hexan-2-one; methyl butyl ketone; butyl methyl ketone; methyl-n-butyl ketone
591-78-6
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)
hexan-2-one; methyl butyl ketone; butyl methyl ketone; methyl-n-butyl ketone
591-78-6
yes

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
hexan-2-one; methyl butyl ketone; butyl methyl ketone; methyl-n-butyl ketone
591-78-6
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
1074
Hexan-2-one
209-731-1
591-78-6
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)
hexan-2-one; methyl butyl ketone; butyl methyl ketone; methyl-n-butyl ketone
591-78-6
Flam. Liq. 3; Repr. 2; STOT RE 1
EU Ecolabel Regulation

Ecolabel - 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  
hexan-2-one; methyl butyl ketone; butyl methyl ketone; methyl-n-butyl ketone
591-78-6
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
hexan-2-one; methyl butyl ketone; butyl methyl ketone; methyl-n-butyl ketone
591-78-6
606-030-00-6
209-731-1
Repr. 2
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
hexan-2-one; methyl butyl ketone; butyl methyl ketone; methyl-n-butyl ketone
591-78-6
yes
In Vitro Diagnostic Medical Devices Directive-repealed

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). 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.

Name CAS EU CLP (1272/2008) EU_BA Directive 2000/54/EC EU REACH: List of SVHC
hexan-2-one; methyl butyl ketone; butyl methyl ketone; methyl-n-butyl ketone
591-78-6
Flam. Liq. 3; Repr. 2; STOT RE 1; STOT SE 3
In Vitro Diagnostic Medical Devices Regulation

In Vitro Diagnostic Medical Devices Regulation - Hazardous Substances

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).

EU CLP (1272/2008) EU_BA Directive 2000/54/EC EU REACH: List of SVHC  
Flam. Liq. 3; Repr. 2; STOT RE 1; STOT SE 3
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
hexan-2-one; methyl butyl ketone; butyl methyl ketone; methyl-n-butyl ketone
591-78-6
yes
Medical Devices Directive-repealed

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
hexan-2-one; methyl butyl ketone; butyl methyl ketone; methyl-n-butyl ketone
591-78-6
Flam. Liq. 3; Repr. 2; STOT RE 1; STOT SE 3
Medical Devices Regulation

Medical Devices Regulation - Hazardous Substances

This list contains hazardous substances for purposes of the Medical Devices Regulation (MDR), based on the legislation's Annex I general safety and performance requirements, including for chemical, physical and biological properties. 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).

EU CLP (1272/2008) EU REACH: List of SVHC EU_BA Directive 2000/54/EC  
Flam. Liq. 3; Repr. 2; STOT RE 1; STOT SE 3
Details
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
hexan-2-one; methyl butyl ketone; butyl methyl ketone; methyl-n-butyl ketone
591-78-6
606-030-00-6
209-731-1
Flam. Liq. 3
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  
hexan-2-one; methyl butyl ketone; butyl methyl ketone; methyl-n-butyl ketone
591-78-6
Repr. 2
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  
hexan-2-one; methyl butyl ketone; butyl methyl ketone; methyl-n-butyl ketone
591-78-6
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
hexan-2-one; methyl butyl ketone; butyl methyl ketone; methyl-n-butyl ketone
591-78-6
Flam. Liq. 3; Repr. 2; STOT RE 1; STOT SE 3
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  
hexan-2-one; methyl butyl ketone; butyl methyl ketone; methyl-n-butyl ketone
209-731-1
591-78-6
606-030-00-6
Flame
Health hazard
Exclamation mark
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
hexan-2-one; methyl butyl ketone; butyl methyl ketone; methyl-n-butyl ketone
209-731-1
591-78-6
Flam. Liq. 3
Repr. 2
STOT RE 1
STOT SE 3
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.
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.
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.
606-030-00-6