legislation-obligation

Substance Regulatory Obligations

OBL

Bis(2-ethylhexyl) phthalate

EC number: 204-211-0

CAS number: 117-81-7

Last updated: 11/03/2020
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.

CAD - Chemical Agents Directive

EU. Worker Protection-Hazardous (98/24)

This list represents a calculated inventory of substances based on the list of harmonized substances contained in Table 3 of Annex VI to the CLP Regulation (1272/2008/EC). Note that this list is not exhaustive. While the harmonized list covers many hazardous substances, other ones not listed may also meet the classification criteria in accordance with the CLP.

Name CAS
bis(2-ethylhexyl) phthalate; di-(2-ethylhexyl) phthalate; DEHP
117-81-7
Cosmetic Products Regulation

EU. Cosmetics 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
677
bis(2-Ethylhexyl) phthalate
204-211-0
117-81-7
All cosmetic products
0 %
Details
EU Ecolabel Regulation

EU. Dangerous Substances - Eco-Labels

This database contains: (1) the list of hazardous substances harmonized for classification and labeling in EU (i.e. Table 3 of Annex VI to CLP Regulation); and (2) the Candidate List of substances of very high concern (SVHC). The EU Ecolabel may not be awarded to substances or mixtures classified as such. Note that this list is not exhaustive. While the harmonized list covers many hazardous substances, other ones not listed may also meet the classification criteria in accordance with the CLP.

Name CAS Restriction(s) Expressed As Table 3 of Annex VI to CLP EU REACH: List of SVHC Physical form Substance Description  
di-(2-ethylhexyl) phthalate
bis(2-ethylhexyl) phthalate
DEHP
117-81-7
yes
Details
Industrial Emissions Directive

EU. Integrated Pollution Prevention & Control

This database contains the list of polluting substances for which emission limit values are assigned under Directive 2010/75/EU on Industrial Emissions (Integrated Pollution Prevention and Control - IPPC) . Member states must permit all qualifying facilities in order to ensure that they minimize impact on the environment. The permit issued must provide emission limit values for pollutants on this list.

Name CAS Air Water Annex X of Dir 2000/60/EC
Di(2-ethylhexyl)phthalate; DEHP
117-81-7
yes
yes
Plastic Materials and Articles Regulation

EU. Com. Reg. No 10/2011 on plastic materials in contact with food

Also referred to as the Plastics Implementation Measure (PIM), this Regulation provides the Union List of monomers and other substances authorized in the manufacture of food contact plastics.

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  
phthalic acid, bis(2-ethylhexyl) ester
117-81-7
283
74640
yes
no
no
1.5 mg/kg
Only to be used as: (a)plasticiser in repeated use materials and articles contacting non-fatty foods;(b)technical support agent in concentrations up to 0,1 % in the final product.
V7 If testing in food is performed, Annex V 1.4 shall be taken into account.
Details
phthalic acid, bis(2-ethylhexyl) ester
117-81-7
283
74640
yes
no
no
G32 Group Restriction No. 32 corresponds to FCM substance No. 8,72,73,138,140,157,159,207,242,283,532,670,728,729,775,783,797,798,810,815. Group restriction specification is expressed as the sum of the substances.
8,72,73,138,140,157,159,207,242,283,532,670,728,729,775,783,797,798,810,815
60 mg/kg
Only to be used as: (a)plasticiser in repeated use materials and articles contacting non-fatty foods;(b)technical support agent in concentrations up to 0,1 % in the final product.
V7 If testing in food is performed, Annex V 1.4 shall be taken into account.
As the sum of the substances
Details
Protection of Pregnant and Breastfeeding Workers Directive

EU. Pregnant Women Protection (92/85)

This list contains substances to which pregnant workers and workers who have recently given birth or are breastfeeding may not be exposed. This is only a partial list; employers are obliged to prevent the exposure of these workers to any agents that may cause adverse health effect for either mother or child. This list is generated from hazardous substances listed in Directive 92/85/EEC and from table 3.2 of Annex VI of the CLP.

Name CAS CLP (1272/2008) CMRs ECCAR Directive 2004/37/EC EU_BA PREGW Notes  
bis(2-ethylhexyl) phthalate; di-(2-ethylhexyl) phthalate; DEHP
117-81-7
Repr. 1B
Details
Protection of Young People Directive

EU. Young People at Work (94/33)

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 database represents a non-exhaustive list 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  
bis(2-ethylhexyl) phthalate; di-(2-ethylhexyl) phthalate; DEHP
117-81-7
Repr. 1B
Details
RoHS - Restriction of Hazardous Substances in Electrical & Electronic Equipment Directive

EU. Exemptions from Art. 4(1) Restrictions (Annexes III & IV) (RoHS)

This database contains the application exemptions listed in Annexes III and IV to RoHS (2011/65/EU). Annex III contains applications exempted from the restriction in Article 4(1), while Annex IV lists applications exempted from the restriction in Article 4(1) specific to medical devices and monitoring and control instruments.

Name CAS Annex Application Begin date Cut-off Expiration Date Expressed As Part Reference Restriction(s) Note(s)  
Bis(2-ethylhexyl) phthalate
117-81-7
III
In rubber components in engine systems, designed for use in equipment that is not intended solely for consumer use and provided that no plasticised material comes into contact with human mucous membranes or into prolonged contact with human skin and the concentration value of bis(2-ethylhexyl) phthalate does not exceed: (a) 30 % by weight of the rubber for (i) gasket coatings, (ii) solid-rubber gaskets, or (iii) rubber components included in assemblies of at least three components using electrical, mechanical or hydraulic energy to do work, and attached to the engine. (b) 10 % by weight of the rubber for rubber-containing components not referred to in point (a)
07/21/2024
43
Applies to category 11
For the purposes of this entry, “prolonged contact with human skin” means continuous contact of more than 10 minutes duration or intermittent contact over a period of 30 minutes, per day.
Details

EU. Restricted Substances Referred to in Art. 4(1) (Annex II) (ROHS)

This database contains the substances listed in Annex II to the Directive on the restriction of hazardous substances in electrical and electronic equipment (ROHS - 2011/65/EU). Restricted pursuant to Art. 4(1) of ROHS, each listed substance includes a maximum concentration value tolerated by weight in homogeneous materials.

Name CAS Max Conc % wt Notes
Bis(2-ethylhexyl) phthalate (DEHP)
117-81-7
0.1 %wt
2 The restriction of DEHP, BBP, DBP and DIBP shall apply to medical devices, including in vitro medical devices, and monitoring and control instruments, including industrial monitoring and control instruments, from 22 July 2021.
3 The restriction of DEHP, BBP, DBP and DIBP shall not apply to cables or spare parts for the repair, the reuse, the updating of functionalities or upgrading of capacity of EEE placed on the market before 22 July 2019, and of medical devices, including in vitro medical devices, and monitoring and control instruments, including industrial monitoring and control instruments, placed on the market before 22 July 2021.
4 The restriction of DEHP, BBP and DBP shall not apply to toys which are already subject to the restriction of DEHP, BBP and DBP through entry 51 of Annex XVII to Regulation (EC) No 1907/2006.
Safety and/or Health Signs at Work Directive

EU. Workplace Signs

This directive requires employers to ensure proper signage is posted in areas where hazards cannot be avoided or reduced. The annexes to this directive provide detailed information about the minimum requirements for all safety and health signs. According to the annexes to the directive, storage areas and containers containing chemical substances or mixtures that are classified as hazardous according to the CLP Regulation (1272/2008/EC) must be marked and/or labeled.

Name EC Number CAS Index Sustance Description Danger Symbols Restriction Physical form  
bis(2-ethylhexyl) phthalate; di-(2-ethylhexyl) phthalate; DEHP
204-211-0
117-81-7
607-317-00-9
Health hazard
Details
Water Environmental Quality Standards Directive

EU. Environmental Quality Standards, Annex I, Part A (2008/105/EC)

This list contains environmental quality standards (EQS), including annual averages and maximum allowable concentrations, for priority substances and certain other pollutants as provided for in Article 16 of Directive 2000/60/EC.

Name CAS NO AA-EQS Inland AA-EQS Other MAC-EQS Inland MAC-EQS Other EQS Biota Calculation Basis Notes  
Di(2-ethylhexyl)phthalate
DEHP
117-81-7
12
1.3 µg/l
1.3 µg/l
5 Where the MAC-EQS are not applicable, the AA-EQS values are considered protective against short-term pollution peaks in continuous discharges since they are significantly lower than the values derived on the basis of acute toxicity.
12 Unless otherwise specified, the EQS parameter expressed as an annual average value (AA-EQS) applies to the total concentration of all isomers.
Details
Water Framework Directive

EU. Directive 2000/60/EC, Annex X, Priority Substances, Water Policy

This list contains substances identified as priority substances that are targeted for reduction and eventual removal from waste water discharge. The list includes 'priority hazardous substances' which are subject to special restrictions.

Name EC Number CAS Priority Group Notes  
Di(2-ethylhexyl)phthalate
DEHP
204-211-0
117-81-7
yes
Details
WFD - Waste Framework Directive

EU. Hazardous Waste Properties: Annex III (2008/98/EC)

This database contains substances that have been assigned hazard property (HP) waste codes 1-15, as defined in terms of the hazard class & 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 database are based on their harmonized 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
bis(2-ethylhexyl) phthalate; di-(2-ethylhexyl) phthalate; DEHP
204-211-0
117-81-7
Repr. 1B
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.
607-317-00-9

Categories Display