legislation-obligation

Substance Regulatory Obligations

OBL

Benzoic acid

EC number: 200-618-2

CAS number: 65-85-0

Last updated: 25/05/2022
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Active Implantable Medical Devices Directive-repealed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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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
benzoic acid
65-85-0
STOT RE 1; Skin Irrit. 2; Eye Dam. 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
benzoic acid
65-85-0
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)
benzoic acid
65-85-0
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
benzoic acid
65-85-0
Cosmetic Products Regulation

Cosmetic Products Regulation, Annex V - Allowed Preservatives

This list contains substances designated as preservatives which cosmetic products marketed in the European Union may contain. The list contains maximum concentration limits and other restrictions. It also contains special labelling requirements, which outline conditions of use and warnings.

Ref No. Substance Identification Conditions Warning Label Notes  
Name EC Number CAS Product type, body parts Function(s) Restriction(s) Maximum Threshold Qualifier(s) Expressed As
1
Benzoic acid
200-618-2
65-85-0
Rinse-off products excluding oral products
Preservative
Maximum concentration value is given for 'Benzoic acid and its sodium salt'
2.5 %
As acid
Details
1
Benzoic acid
200-618-2
65-85-0
Oral products
Preservative
Maximum concentration value is given for 'Benzoic acid and its sodium salt'
1.7 %
As acid
Details
1
Benzoic acid
200-618-2
65-85-0
Leave-on products
Preservative
Maximum concentration value is given for 'Benzoic acid and its sodium salt'
0.5 %
As acid
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)
benzoic acid
65-85-0
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  
benzoic acid
65-85-0
yes
Details
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  
benzoic acid
65-85-0
116
13090, 37600
yes
yes
no
Details
Food Contact Regenerated Cellulose Directive

Food Contact Regenerated Cellulose Directive - Authorised Substances

This list contains the substances and substance groups authorised by the EU in the manufacture of regenerated cellulose film intended to come into contact with foodstuffs. Representing Annex II of Directive 2007/42/EC, the list is divided into first and second parts, for uncoated and coated regenerated cellulose film, respectively. For some entries, the list includes functional classes, maximum and minimum limit values, and other restrictions.

CAS Restrictions Denominations Part 1 Part 2 Notes  
Restriction(s) Qualifier(s) Maximum Thres(T) Minimun Threshold SML SML(T) QM QM(T) QM(T)2 Expressed as (1) Expressed as (2) Expressed as (3) Expressed as (4) Expressed as (5) Application Name Function
65-85-0
In the uncoated regenerated cellulose film
1 %w/w
2 mg/dm2
As the sum of all Additives other than Softeners
As the sum of Benzoic acid and Sodium benzoate
Uncoated regenerated cellulose film
Additives other than Softeners: First Class
Yes
3 The total quantity of the substances listed in Additives other than Softeners shall not be more than 1 % (w/w), calculated in relation to the quantity of anhydrous uncoated regenerated cellulose film.
Details
65-85-0
In the uncoated regenerated cellulose film, inclusive of the coating on the side in contact with foodstuffs
1 %w/w
2 mg/dm2
6 mg/dm2
As the sum of all Additives other than Softeners
As the sum of Benzoic acid and Sodium benzoate
As the sum of all Coating: Other additives (specific and not specific for coating)
Coated regenerated cellulose film
Additives other than Softeners: First Class
Coating: Other additives not specific for coating other than Softeners - First class
Yes
3 The total quantity of the substances listed in Additives other than Softeners shall not be more than 1 % (w/w), calculated in relation to the quantity of anhydrous uncoated regenerated cellulose film.
10 The total quantity of Coating: Other additives (specific and not specific for coating) may not exceed 6 mg/dm2 in the uncoated regenerated cellulose film, inclusive of the coating on the side in contact with foodstuffs.
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
benzoic acid
65-85-0
yes
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). 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
benzoic acid
65-85-0
STOT RE 1; Skin Irrit. 2; Eye Dam. 1
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
benzoic acid
65-85-0
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
benzoic acid
65-85-0
STOT RE 1; Skin Irrit. 2; Eye Dam. 1
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  
STOT RE 1; Skin Irrit. 2; Eye Dam. 1
Details
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  
Benzoic acid
65-85-0
Annex IV
All Products
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  
benzoic acid
65-85-0
116
37600
13090
yes
yes
no
Details
PPPR - Plant Protection Products Regulation

Annex of Approved Active Substances for Plant Protection Products

This list contains the active substances approved under Regulation 1107/2009/EC, as listed in Regulation 540/2011/EU. The list is separated into five parts: Part A (deemed to have been approved under 1107/2009/EC); Part B (approved under 1107/2009/EC); Part C (basic substances); Part D (low-risk active substances); and Part E (candidates for substitution). Entries include common & IUPAC names, identifiers (e.g., CAS, CIPAC), purity information, and approval and approval expiration dates.

Name CAS Ref No. CIPAC No. Purity Qualifier Expressed As Date of approval Expiration of approval Part Use Notes  
Benzoic acid
65-85-0
115
622
990 g/kg
1 September 2017
31 August 2032
B Active substances approved under Regulation (EC) No 1107/2009
1 Please refer to the original source document (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32011R0540) and subsequent amendments for applicable additional specific provisions.
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  
benzoic acid
65-85-0
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
benzoic acid
65-85-0
STOT RE 1; Skin Irrit. 2; 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  
benzoic acid
200-618-2
65-85-0
607-705-00-8
Health hazard
Corrosion
Details
Statistics on Pesticides Regulation

Statistics on Pesticides Regulation - Annex III Harmonised C&L

This list contains Annex III of Regulation 1185/2009/EC. It provides the substances with harmonised classifications to be covered to produce European statistics on the sales and use of pesticides.

Name CAS Chemical Class Group Category Code CIPAC Note(s)
Benzoic acid
65-85-0
UNCLASSIFIED FUNGICIDES
Fungicides and bactericides
Other fungicides and bactericides
F99_99_05
622
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
benzoic acid
200-618-2
65-85-0
STOT RE 1
Skin Irrit. 2
Eye Dam. 1
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.
607-705-00-8