legislation-obligation

Substance Regulatory Obligations

OBL

Sodium fluoride

EC number: 231-667-8

CAS number: 7681-49-4

Last updated: 28/08/2021
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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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
sodium fluoride
7681-49-4
Acute Tox. 3; Eye Irrit. 2; Skin Irrit. 2
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
sodium fluoride
7681-49-4
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)
sodium fluoride
7681-49-4
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
sodium fluoride
7681-49-4
Cosmetic Products Regulation

Cosmetic Products Regulation, Annex III - Restricted Substances

This list contains substances whose use in cosmetic products in the European Union is banned, except under certain conditions as indicated in Annex III. The list specifies the field of application or use, maximum allowable concentration limits in finished products, and any additional limitations.

Ref No. Substance Identification Restrictions Warning Label Notes  
Name EC Number CAS Product type, body parts Function(s) Maximum Threshold Minimum Threshold Restriction(s) Qualifier(s) Expressed As
31
Sodium fluoride
231-667-8
7681-49-4
Oral products
0.15 %
When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0.15 %
As F
Contains sodium fluoride. For any toothpaste with compounds containing fluorine in a concentration of 0.1 to 0.15 % calculated as F unless it is already labelled as contraindicated for children (e.g. 'for adult use only') the following labelling is obligatory: 'Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.' case of intake of fluoride from other sources consult a dentist or doctor.'
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)
sodium fluoride
7681-49-4
Acute Tox. 3
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  
sodium fluoride
7681-49-4
yes
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
sodium fluoride
7681-49-4
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
sodium fluoride
7681-49-4
Acute Tox. 3; Eye Irrit. 2; Skin Irrit. 2
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). The specific CAS linked as members on this list are representative examples, but not exhaustive.

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
SODIUM FLUORIDE SOLUTION
7681-49-4
6.1
6.1
III
MP19
P001
IBC03
LP01
R001
3415
L4BH
TU15
TE19
T4
60
E1
5 l
AT
T4
TP1
CV13
CV28
S9
(E)
2
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). The specific CAS linked as members on this list are representative examples, but not exhaustive.

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
SODIUM FLUORIDE SOLUTION
7681-49-4
6.1
6.1
III
3415
T4
CE8
60
L4BH
TU15
E1
5 l
P001
IBC03
LP01
R001
MP19
TP1
T4
2
CW13
CW28
CW31
W12
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). The specific CAS linked as members on this list are representative examples, but not exhaustive.

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)
SODIUM FLUORIDE SOLUTION
7681-49-4
6.1
6.1
III
3415
T4
PP
EP
TOX
A
E1
5 l
0
VE02
802
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
sodium fluoride
7681-49-4
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
sodium fluoride
7681-49-4
Acute Tox. 3; Eye Irrit. 2; Skin Irrit. 2
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  
sodium fluoride
7681-49-4
Acute Tox. 3
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
sodium fluoride
7681-49-4
Acute Tox. 3; Eye Irrit. 2; Skin Irrit. 2
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  
sodium fluoride
231-667-8
7681-49-4
009-004-00-7
Skull and crossbones
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
sodium fluoride
231-667-8
7681-49-4
Acute Tox. 3
Skin Irrit. 2
EUH032
HP6 Acute Toxicity: waste which can cause acute toxic effects following oral or dermal administration, or inhalation exposure.
HP4 Irritant — skin irritation and eye damage: waste which on application can cause skin irritation or damage to the eye.
HP12 Release of an acute toxic gas: waste which releases acute toxic gases (Acute Tox. 1, 2 or 3) in contact with water or an acid.
009-004-00-7