legislation-obligation

Substance Regulatory Obligations

OBL

Tetrafluoroethylene

EC number: 204-126-9

CAS number: 116-14-3

Last updated: 17/03/2023
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, 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
tetrafluoroethylene
116-14-3
CMD - Carcinogens and Mutagens Directive

Carc and Muta Directive, Annex I - Substances, Mixtures & Processes

This list contains a non-exhaustive inventory of substances based on Art. 2 carcinogen, mutagen and reprotoxin (CMR) definitions and Annex I of the Carcinogens, Mutagens and Reprotoxins Directive (CMRD). Category 1A and 1B CMRs are derived from the CLP Regulation's Table 3 of Annex VI (1272/2008/EC). Employers are obligated to minimize worker exposure to these agents as far as possible, and must arrange for medical surveillance of workers exposed to these substances.

Name CAS Restriction(s) Physical form Substance Description Notes  
tetrafluoroethylene
116-14-3
Details
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)
tetrafluoroethylene
116-14-3
yes
Annex 17 Appendix 2

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
tetrafluoroethylene
116-14-3
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
1681
Tetrafluoroethylene
204-126-9
116-14-3
All cosmetic products
0 %
Applies from 17 December 2022
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)
tetrafluoroethylene
116-14-3
Carc. 1B
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  
tetrafluoroethylene
116-14-3
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
tetrafluoroethylene
116-14-3
602-110-00-X
204-126-9
Carc. 1B
Food Contact Recycled Plastic Materials and Articles Regulation-repealed

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  
tetrafluoroethylene
116-14-3
281
25120
no
yes
no
0.05 mg/kg
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
tetrafluoroethylene
116-14-3
yes
Annex 17 Appendix 2
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
tetrafluoroethylene
116-14-3
Carc. 1B
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  
Carc. 1B
Details
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). Any specific CAS linked as members for substances where the list refers to finished material/article/compound/component 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
TETRAFLUOROETHYLENE, STABILIZED
116-14-3
2
2.1
MP9
P200
1081
PxBN(M)
TU40
TA4
TT9
2F
239
E0
FL
(M)
386
662
CV9
CV10
CV36
S2
S4
S20
(B/D)
2
1 Not permitted to be carried in limited quantities
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). Any specific CAS linked as members for substances where the list refers to finished material/article/compound/component 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
TETRAFLUOROETHYLENE, STABILIZED
116-14-3
2
2.1
1081
2F
CE3
239
PxBN(M)
TU38
TU40
TE22
TA4
TT9
E0
P200
MP9
(M)
2
CW9
CW10
CW36
386
662
1 Not permitted to be carried in limited quantities
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). Any specific CAS linked as members for substances where the list refers to finished material/article/compound/component 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)
TETRAFLUOROETHYLENE, STABILIZED
116-14-3
2
2.1
1081
2F
PP
EX
A
E0
1
VE01
386
662
1 Not permitted to be carried in limited quantities
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
tetrafluoroethylene
116-14-3
yes
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  
Carc. 1B
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 Expressed As  
tetrafluoroethylene
116-14-3
281
25120
no
yes
no
0.05 mg/kg
Details
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  
tetrafluoroethylene
116-14-3
Carc. 1B
yes
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  
tetrafluoroethylene
116-14-3
Carc. 1B
Details
Recycled Plastic Food Contact Materials

Recycled Plastic FCMs - Regulation (EU) 2022/1616

The list contains the Union list of authorised substances for the purposes of compositional requirements related to recycled plastic FCMs. The list is taken from Annex I to Commission Regulation (EU) No 10/2011. Recycled plastic FCMs shall comply with the requirements set out in Regulation (EU) No 10/2011. In addition, plastic waste inputs shall originate only from plastic materials and articles manufactured in accordance with Regulation (EU) No 10/2011.

Additive or PPA Expressed As FCM No FRF applicable  
no
281
no
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
tetrafluoroethylene
116-14-3
Carc. 1B
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  
tetrafluoroethylene
204-126-9
116-14-3
602-110-00-X
Health hazard
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
tetrafluoroethylene
204-126-9
116-14-3
Carc. 1B
HP7 Carcinogenic: waste which induces cancer or increases its incidence.
602-110-00-X