legislation-obligation

Substance Regulatory Obligations

OBL

Benzyl butyl phthalate

EC number: 201-622-7

CAS number: 85-68-7

Last updated: 11/10/2020
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

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

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
BBP; benzyl butyl phthalate e
85-68-7
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
1152
Benzyl butyl phthalate
201-622-7
85-68-7
All cosmetic products
0 %
Details
EU Ecolabel Regulation

EU Ecolabels - Restrictions for Hazardous Substances/Mixtures

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  
BBP
benzyl butyl phthalate e
85-68-7
yes
yes
Details
Plastic Materials and Articles Regulation

FCM and Articles Regulation, Annex I - Authorised Substances

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, benzyl butyl ester
85-68-7
159
74560
yes
no
no
30 mg/kg
Only to be used as: (a)plasticiser in repeated use materials and articles;(b)plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae as defined by Directive 2006/141/EC or processed cereal-based foods and baby foods for infants and young children as defined by Directive 2006/125/EC;(c)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, benzyl butyl ester
85-68-7
159
74560
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;(b)plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae as defined by Directive 2006/141/EC or processed cereal-based foods and baby foods for infants and young children as defined by Directive 2006/125/EC;(c)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

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

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  
BBP; benzyl butyl phthalate e
85-68-7
Repr. 1B
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 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  
BBP; benzyl butyl phthalate e
85-68-7
Repr. 1B
Details
RoHS - Restriction of Hazardous Substances in Electrical & Electronic Equipment Directive

ROHS Directive - Restricted Substances as per Art. 4(1), Annex II

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
Butyl benzyl phthalate (BBP)
85-68-7
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

Workplace Signs - minimum requirements & signs on containers and pipes

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  
BBP; benzyl butyl phthalate e
201-622-7
85-68-7
607-430-00-3
Health hazard
Details
WFD - Waste Framework Directive

Waste Framework Directive, Annex III - Waste - Hazardous Properties

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
BBP; benzyl butyl phthalate e
201-622-7
85-68-7
Repr. 1B
Aquatic Acute 1
Aquatic Chronic 1
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.
HP14 Ecotoxic: waste which presents or may present immediate or delayed risks for one or more sectors of the environment.
607-430-00-3

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