Substance Information
Substance Information
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REACH Registration data can be found in the new ECHA CHEM database. The old ‘Registered substance factsheets’ will be available on this web site during the transition period but have not been updated since 19 May 2023. More
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Substance Infocard
Fatty acids, tallow, hydrogenated, lead salts
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The ‘Substance identity’ section is calculated from substance identification information from all ECHA databases. The substance identifiers displayed in the InfoCard are the best available substance name, EC number, CAS number and/or the molecular and structural formulas.
Some substance identifiers may have been claimed confidential, or may not have been provided, and therefore not be displayed.
EC (European Community) Number
The EC Number is the numerical identifier for substances in the EC Inventory. The EC Inventory is a combination of three independent European lists of substances from the previous EU chemicals regulatory frameworks (EINECS, ELINCS and the NLP-list). More information about the EC Inventory can be found here.
If the substance was not covered by the EC Inventory, ECHA attributes a list number in the same format, starting with the numbers 6, 7, 8 or 9.
The EC or list number is the primary substance identifier used by ECHA.
CAS (Chemical Abstract Service) registry number
The CAS number is the substance numerical identifier assigned by the Chemical Abstracts Service, a division of the American Chemical Society, to substances registered in the CAS registry database. A substance identified primarily by an EC or list number may be linked with more than one CAS number, or with CAS numbers that have been deleted. More information about CAS and the CAS registry can be found here.
Molecular formula
The molecular formula identifies each type of element by its chemical symbol and identifies the number of atoms of each element found in one discrete molecule of the substance. This information is only displayed if the substance is well–defined, its identity is not claimed confidential and there is sufficient information available in ECHA’s databases for ECHA’s algorithms to generate a molecular structure.
Molecular structure
The molecular structure is based on structures generated from information available in ECHA’s databases. If generated, an InChI string will also be generated and made available for searching. This information is only displayed if the substance is well-defined, its identity is not claimed confidential and there is sufficient information available in ECHA’s databases for ECHA’s algorithms to generate a molecular structure.
More help available here.
EC / List no.: 271-722-3
CAS no.: 68605-98-1
Mol. formula:
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The ‘Hazard classification and labelling’ section shows the hazards of a substance based on the standardised system of statements and pictograms established under the CLP (Classification Labelling and Packaging) Regulation. The CLP Regulation makes sure that the hazards presented by chemicals are clearly communicated to workers and consumers in the European Union. The CLP Regulation uses the UN Global Harmonised System (GHS) and European Union Specific Hazard Statements (EUH).
This section is based on three sources for information (harmonised classification and labelling (CLH), REACH registrations and CLP notifications). The source of the information is mentioned in the introductory sentence of the hazard statements. When information is available in all sources, the first two are displayed as a priority.
Please note:
The purpose of the information provided under this section is to highlight the substance hazardousness in a readable format. It does not represent a new labelling, classification or hazard statement, neither reflect other factors that affect the susceptibility of the effects described, such as duration of exposure or substance concentration (e.g. in case of consumer and professional uses). Other relevant information includes the following:
- Substances may have impurities and additives that lead to different classifications. If at least one company has indicated that the substance classification is affected by impurities or additives, this will be indicated by an informative sentence. However, substance notifications in the InfoCard are aggregated independently of the impurities and additives.
- Hazard statements were adapted to improve readability and may not correspond textually to the hazard statements codes description in the European Union Specific Hazard Statements (EUH) or the UN Global Harmonised System (GHS).
To see the full list of notified classifications and to get more information on impurities and additives relevant to classification please consult the C&L Inventory.
More information about Classification and Labelling is available in the Regulations section of ECHA website.
More help available here.
Harmonised classification and labelling (CLH)
Harmonised classification and labelling is a legally binding classification and labelling for a substance, agreed at European Community level. Harmonisation is based on the substance’s physical, toxicological and eco-toxicological hazard assessment.
The ‘Hazard classification’ and labelling section uses the signal word, pictogram(s) and hazard statements of the substance under the harmonised classification and labelling (CLH) as its primary source of information.
If the substance is covered by more than one CLH entry (e.g. disodium tetraborate EC no. 215–540–4, is covered by three harmonisations: 005–011–00–4; 005–011–01–1 and 005–011–02–9), CLH information cannot be displayed in the InfoCard as the difference between the CLH classifications requires manual interpretation or verification. If a substance is classified under multiple CLH entries, a link to the C&L Inventory is provided to allow users to view CLH information associated with the substance and no text is automatically generated for the InfoCard.
It is possible that a harmonisation is introduced through an amendment to the CLP Regulation. In that case, the ATP (Adaptation to Technical Progress) number is displayed.
More info on CLH can be found here.
Classification and labelling under REACH
If available, additional information on classification and labelling (C&L) is derived from REACH registration dossiers submitted by industry. This information has not been reviewed or verified by ECHA, and may change without prior notice. REACH registration dossiers have greater data requirements (such as supporting studies) than do notifications under CLP.
Notifications under the Classification Labelling and Packaging (CLP) Regulation
If no EU harmonised classification and labelling exists and the substance was not registered under REACH, information derived from classification and labelling (C&L) notifications to ECHA under CLP Regulation is displayed under this section. These notifications can be provided by manufacturers, importers and downstream users. ECHA maintains the C&L Inventory, but does not review or verify the accuracy of the information.
Note that for readability purposes, only the pictograms, signal words and hazard statements referred in more than 5% of the notifications under CLP are displayed.
![GHS08: Serious Health Hazard](https://echa.europa.eu/o/echa-revamp-theme/images/cnl/pictograms/GHS08.png)
![GHS07: Health hazard](https://echa.europa.eu/o/echa-revamp-theme/images/cnl/pictograms/GHS07.png)
![GHS09: Hazardous to the Environment](https://echa.europa.eu/o/echa-revamp-theme/images/cnl/pictograms/GHS09.png)
Danger! According to the harmonised classification and labelling (CLP00) approved by the European Union, this substance may damage the unborn child and is suspected of damaging fertility, is very toxic to aquatic life, is very toxic to aquatic life with long lasting effects, is harmful if swallowed, is harmful if inhaled and may cause damage to organs through prolonged or repeated exposure.
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The ‘Properties of concern’ section shows ECHA-assigned graphical indicators for certain substance properties that are regarded as being of relevance or importance to human health and/or the environment based on the information provided to the Agency.
Properties of concern are calculated at four "levels" of certainty:
- "Recognised" - meaning that the concern is indicated in an official source. Recognised concerns are illustrated with a dark red icon. Sources for these are either a Harmonised C&L (CLP Regulation Annex VI) or in the Candidate list of substances of very high concern for authorisation (REACH).
- "Potential" - again comes from official sources only. Potential concerns are illustrated with a light red icon. For (C), (M), and (R) it means that the concern is suspected in a Harmonised C&L (CLP Regulation Annex VI), as Carc. 2, Muta. 2, or Repr. 2. For (PBT) and (ED) Potential means that the concern is under assessment in the PBT or ED assessment list, and the outcome indicates a potential ED. There are no potential (Ss) or (Sr)s.
- "Broad agreement" - comes from data submitted by industry to ECHA, and indicates that the data submitted is aligned, with >= 50% of the data submitters providing the same concern. Broad agreement concerns are illustrated with a solid outlined circle icon.
- "Minority position" - comes from data submitted by industry to ECHA, and indicates that the data submitted is not aligned. > 5% and < 50% of the data submitters have provided the concerns indicated at this "level". Minority position concerns are illustrated with a greyed out circle icon.
The following properties of concern are calculated:
- Carcinogenic (C) – Recognised carcinogen: comes from a harmonised C&L classifying the substance as Carc. 1A or 1B and/or an entry in the Candidate list. Potential carcinogen: comes from a harmonised C&L classifying the substance as a suspected carcinogen Carc.2. Broad agreement: comes from industry data where a majority of data submitters agree the substance is carcinogenic. Minority position: comes from industry data where a minority of data submitters indicate the substance is carcinogenic. More information about carcinogenicity here.
- Mutagenic (M) – Recognised mutagen: comes from a harmonised C&L classifying the substance as Muta. 1A or 1B and/or an entry in the Candidate list. Potential mutagen: comes from a harmonised C&L classifying the substance as a suspected mutagen Muta. 2. Broad agreement: comes from industry data where a majority of data submitters agree the substance is mutagenic. Minority position: comes from industry data where a minority of data submitters indicate the substance is mutagenic. More information about mutagenicity here.
- Toxic to Reproduction (R) – Recognised as toxic to reproduction: comes from a harmonised C&L classifying the substance as Carc. 1A or 1B and/or an entry in the Candidate list. Potentially toxic to reproduction: comes from a harmonised C&L classifying the substance as suspected toxic to reproduction Repr. 2. Broad agreement: comes from industry data where a majority of data submitters agree the substance is toxic to reproduction. Minority position: comes from industry data where a minority of data submitters indicate the substance is toxic to reproduction. More information about reproductive toxicity here.
- Skin sensitising (Ss) – Recognised skin sensitiser: comes from a harmonised C&L classifying the substance as Skin Sens. 1, 1A, or 1B. Broad agreement: comes from industry data where a majority of data submitters agree the substance is a skin sensitiser. Minority position: comes from industry data where a minority of data submitters indicate the substance is skin sensitising. More information about skin sensitiser here.
- Respiratory sensitising (Sr) – Recognised respiratory sensitiser: comes from a harmonised C&L classifying the substance as Resp. Sens. 1, 1A, or 1B and/or an entry in the Candidate list. Broad agreement: comes from industry data where a majority of data submitters agree the substance is a respiratory sensitiser. Minority position: comes from industry data where a minority of data submitters indicate the substance is a respiratory sensitiser. More information about respiratory sensitiser here.
- PBT – Recognised Persistent, bioaccumulative and toxic (PBT) (or vPvB): comes from an entry in the Candidate list. Potential PBT: is shown for substances under assessment, and comes from an entry in the PBT assessment list. Broad agreement: comes from industry data where a majority of data submitters agree the substance is PBT. Minority position: comes from industry data where a minority of data submitters indicate the substance is PBT. More information about persistent, bioaccumulative and toxic substances here.
- ED – Recognised Endocrine Disruptor (ED): comes from an entry in the Candidate list. Potential ED: is shown for substances under assessment, and comes from an entry in the ED assessment list, if the outcome is not final and “Not ED”. At this time there is no industry submitted data taken into account to display an ED property of concern. More information about endocrine disrupting substances here.
- POP – Recognised Persistent Organic Pollutant (POP): comes from an entry in the Annex I, II or III to the POPs Regulation and/or an entry in the Annex A, B or C to the Stockholm Convention. Under assessment as Persistent Organic Pollutant: is shown for substances that have been proposed for their inclusion in the Stockholm Convention and are under assessment, or for which a proposal is under preparation in the European Union. Note that proposals that have been set aside, either before their submission by the EU to the Convention, or by the POP Review Committee are still indicated as "Under assessment as POP".
The substance properties displayed in this section are derived from Harmonised classification and labelling (CLH) data, entries in the Candidate list of substances of very high concern for authorisation, the PBT assessment list, the ED assessment list, REACH registered dossier data and from notifications made under CLP. A prioritisation hierarchy means that data is taken from harmonised C&L data and regulatory lists first, then REACH registrations and finally from CLP notifications. By clicking on the "More details" button you can see the exact origin(s) of each Property of Concern.
Impurities or additives: When a specific critical property is calculated from industry data and where the majority of data submitters have indicated that the property relates to cases containing impurities and/or additives, then the respective critical property icon is modified with an asterisk (*).
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Toxic to Reproduction |
Properties of concern | Source(s) | |
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Toxic to Reproduction |
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This section highlights four regulatory activities or outcomes under REACH – Registration, Evaluation, Authorisation and Restriction of Chemicals – Regulation (EC) No 1907/2006:
- Community rolling action plan - indicates if the substance is or was included in the Community rolling action plan (CoRAP). The CoRAP list includes substances that could pose a risk to human health or the environment and whose (potentially hazardous) properties are to be evaluated by the Member States in the next three years. After evaluation, proposals may be made for further regulatory action regarding the substance.
- Candidate List - indicates if the substance is included in the candidate list of substances of very high concern (SVHCs). The Candidate List includes substances that are subject to additional protocols and reporting obligations and which may eventually be included in the Authorisation List, further limiting their use.
- Authorisation list (Annex XIV to REACH) - indicates if the substance is included in the Authorisation list. These substances cannot be placed on the market or used after a given date, unless an authorisation is granted for their specific use, or the use is exempted from authorisation.
- Restriction list (Annex XVII to REACH) - indicates if the substance is included in the Restriction List. The Restriction List describes the conditions for the manufacture, placing on the market or use of certain substances, either on their own or in mixtures or articles.
Please note: The identification of relevant regulatory activities and outcomes is done automatically and without manual verification. Substances may be grouped together under a specific regulatory activity for more efficient risk management and legislative processing (e.g. restriction on "Lead and its compounds"). In these cases, Infocards may not identify all substances in the group.Therefore it does not represent official and legally–binding information. To confirm if a substance is covered by a specific regulatory action the official publication, e.g. the electronic edition of the Official Journal of the European Union should be consulted.
More help available here.
- Some uses of this substance are restricted under Annex XVII of REACH.
The InfoCard summarises the non-confidential data of a substance held in the databases of the European Chemicals Agency (ECHA). InfoCards are generated automatically based on the data available at the time of generation.
The quality and correctness of the information submitted to ECHA remains the responsibility of the data submitter. The type of uses and classifications may vary between different submissions to ECHA and for a full understanding it is recommended to consult the source data. Information on applicable regulatory frameworks is also automatically generated and may not be complete or up to date. It is the responsibility of the substance manufacturers and importers to consult official publications, e.g. the electronic edition of the Official Journal of the European Union.
InfoCards are updated when new information is available. The date of the last update corresponds to the publication date of the InfoCard and not necessarily to the date in which the update occurred in the source data.
More help available here.
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Regulatory context
Here you can find all of the regulations and regulatory lists in which this substance appears, according to the data available to ECHA. This substance has been found in the following regulatory activities (directly, or inheriting the regulatory context of a parent substance):
- ECHA Legislations
- Occupational Exposure limits (OELs)
- Emission Limit Values (ELVs)
- Other chemical legislations
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PACT - Public activities Co-ordination ToolPublic (risk management) activities co-ordination tableTool showing an overview of substances in various key regulatory processes that authorities are working on.
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Substances indicated, in 2009, as being intended to be registered by at least one company in the EEA.
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Substances for which classification and labeling data have been submitted to ECHA in a registration under REACH or notified by manufacturers or importers under CLP. Such notifications are required for hazardous substances, as such or in mixtures, as well as for all substances subject to registration, regardless of their hazard.
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Substances listed in the EINECS, ELINCS, or NLP inventories.
Region | Legislation | Emission medium | Process/equipment | Maximum emissions | Average emissions | Notes | |||
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Maximum limit | Maximum sampling duration | Average limit | Average sampling duration | ||||||
European Union | Industrial Emissions Directive | Waste gases | Combustion plants co-incinerating waste | 0.5 mg/Nm3 | 8.0 h | These average values cover also the gaseous and the vapour forms of the relevant heavy metal emissions as well as their compounds Emission limit value defined as total emission limit for the total sum of antimony arsenic lead chromium cobalt copper manganese nickel and vanadium expressed as average value over the sampling period All emission limit values shall be calculated at a temperature of 27315 K a pressure of 1013 kPa and after correcting for the water vapour content of the waste gases O2 content 6% for solid fuels and 3% for liquid fuels For technical provisions regarding 'Monitoring of emissions' see Part 6 (Annex VI). For 'Formula to calculate the emission concentration at the standard percentage oxygen concentration' see Part 7 (Annex VI). For 'Assessment of compliance with emission limit values' see Part 8 (Annex VI) Directive 2010/75/EU | |||
European Union | Industrial Emissions Directive | Waste gases | Cement kilns co-incinerating waste | 0.5 mg/Nm3 | 8.0 h | These average values cover also the gaseous and the vapour forms of the relevant heavy metal emissions as well as their compounds Emission limit value defined as total emission limit for the total sum of antimony arsenic lead chromium cobalt copper manganese nickel and vanadium expressed as average value over the sampling period All values are standardised at 10 % oxygen All emission limit values shall be calculated at a temperature of 27315 K a pressure of 1013 kPa and after correcting for the water vapour content of the waste gases For technical provisions regarding 'Monitoring of emissions' see Part 6 (Annex VI). For 'Formula to calculate the emission concentration at the standard percentage oxygen concentration' see Part 7 (Annex VI). For 'Assessment of compliance with emission limit values' see Part 8 (Annex VI) Directive 2010/75/EU | |||
European Union | Industrial Emissions Directive | Waste gases | Waste incineration plants | 0.5 mg/Nm3 | 8.0 h | All emission limit values shall be calculated at a temperature of 27315 K a pressure of 1013 kPa and after correcting for the water vapour content of the waste gases.They are standardised at 11 % oxygen in waste gas except in case of incineration of mineral waste oil as defined in point 3 of Article 3 of Directive 2008/98/EC when they are standardised at 3 % oxygen and in the cases referred to in Point 2.7 of Part 6 These average values cover also the gaseous and the vapour forms of the relevant heavy metal emissions as well as their compounds Emission limit value defined as total emission limit for the total sum of antimony arsenic lead chromium cobalt copper manganese nickel and vanadium expressed as average value over the sampling period For technical provisions regarding 'Monitoring of emissions' see Part 6 (Annex VI). For 'Formula to calculate the emission concentration at the standard percentage oxygen concentration' see Part 7 (Annex VI). For 'Assessment of compliance with emission limit values' see Part 8 (Annex VI) Directive 2010/75/EU | |||
European Union | Industrial Emissions Directive | Waste water from the cleaning of waste gases | Waste incineration plants and waste co-incineration plants | 0.2 mg/l | |||||
European Union | Water Environmental Quality Standards Directive | Inland surface waters | 14.0 µg/l | 1.2 µg/l | 1.0 yr | Unless otherwise specified the EQS parameter expressed as an annual average value (AA-EQS) applies to the total concentration of all isomers. Inland surface waters encompass rivers and lakes and related artificial or heavily modified water bodies. These EQS refer to bioavailable concentrations of the substances. | |||
European Union | Water Environmental Quality Standards Directive | Surface waters other than inland surface waters | 14.0 µg/l | 1.3 µg/l | 1.0 yr | Unless otherwise specified the EQS parameter expressed as an annual average value (AA-EQS) applies to the total concentration of all isomers. Inland surface waters encompass rivers and lakes and related artificial or heavily modified water bodies. These EQS refer to bioavailable concentrations of the substances. |
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Active Implantable Medical Devices Directive - Hazardous SubstancesEU. Hazardous Substances for Purposes of Directive 90/385/EEC on Active Implantable Medical Devices, 20 July 1990, amended by Directive 2007/47/EC, 21 September 2007
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.
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Batteries Directive - Prohibitions & LabellingEU. Prohibited Substances (Article 4) & Labelling Requirements (Article 21(3)), Directive 2006/66/EC on Batteries and Accumulators, 26 September 2006, as amended by Directive 2018/849/EU, 14 June 2018
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Batteries Regulation - Prohibitions and LabellingEU. Prohibited Substances (Annex I) & Labeling Requirements (Art. 13(5) and Annex VI) for batteries, Regulation (EU) 2023/1542, OJ L 191, 28 July 2023
This database contains: 1/use prohibitions of mercury, cadmium, and lead in batteries; and 2/ labeling requirements for cadmium and lead, other hazardous substances (non-exhaustive list derived from CLP Regulation (EC) No 1272/2008, Annex VI, Table 3) and critical raw materials (derived from 4th List of Critical Raw Materials, 2020) in batteries. The list is based on the new Batteries Regulation (EU) 2023/1542 which became enforceable on 18 February 2024, with some transitional periods.
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CAD - Chemical Agents Directive, Annex II - Binding BLVsEU. Directive 98/24/EC, Annex II, Binding Biological Limit Values and Health Surveillance Measures, as amended by Directive (EU) 2024/869, OJ L of 19 March 2024
This list contains substances assigned a binding biological exposure limit (BEL) by the European Union. National BELs for these substances may not deviate from the limits in the Directive. Annex II contains the binding BEL for lead which will be deleted from CAD, Annex II and, starting 9 April 2026, will be regulated only in the CMR Directive, Annex IIIa.
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CAD - Chemical Agents Directive, Article 2(b)(i) - Hazardous AgentsEU. Hazardous Substances - Article 2(b)(i), Directive 98/24/EC on Protection of Workers from Chemical Agent-related Risks, 5 May 1998 (Table 3 of Annex VI to CLP, as amended)
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.
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CMRD - Carcinogens, Mutagens, Reprotoxins Directive, Annex IIIa - BLVsEU. BLVs for Certain Hazardous Substances: Annex IIIa, Directive (EC) 2004/37 (CMRD), as amended by Directive (EU) 2024/869, OJ L of 19 March 2024
This list contains substances assigned a binding occupational exposure limit value (OELV) by the European Union. National OELVs for these substances may not deviate from the limits in the Directive. Annex I contains the binding OELV for lead which will be deleted from CAD, Annex I and, starting 9 April 2026, will be regulated only in the CMR Directive, Annex III.
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Carc and Muta Directive, Annex I - Substances, Mixtures & ProcessesEU. Substances, Mixtures, Related Processes: Annex I & Art. 2, Dir 2004/37/EC (CMRD), as amended by Dir (EU) 2022/431, 16 March 2022
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.
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Construction Product Regulation - Annex I (3) - Hazardous SubstancesEU. Hazardous Substances for Purposes of Annex I (3) (Requirements for Construction Works), Regulation 305/2011/EU on Marketing of Construction Products, amended by Regulation 574/2014/EU, 28 May 2014
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.
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Construction Product Regulation - Article 6(5) - SDS and DeclarationEU. Hazardous Substances Subject to Declaration (Article 6(5)), Regulation 305/2011/EU on Marketing of Construction Products, amended by Regulation 574/2014/EU, 28 May 2014
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.
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Cosmetic Products Regulation, Annex II - Prohibited SubstancesEU. Prohibited Substances: Annex II, Regulation 1223/2009/EC on Cosmetic Products, as amended by Regulation (EU) 2024/996, OJ L of 4 April 2024
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Ecolabel - Restrictions for Hazardous Substances/MixturesEU. Hazardous Substances which may Preclude Goods from the Ecolabel Award as per Article 6(6) of Regulation 66/2010/EC, L 27/1, 30 January 2010
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.
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End-of-Life Vehicles Directive - General Use ExemptionsEU. General Use Exemptions from Article 4(2)(a) (Annex II), Directive 2000/53/EC on End-of-Life Vehicles, as amended by Directive 2020/363/EU, 5 March 2020
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End-of-Life Vehicles Directive - Hazardous SubstancesEU. Hazardous Substances per Article 2(11) of End-of-Life Vehicles Directive 2000/53/EC, 21 October 2000, amended by Directive 2020/363/EU, 5 March 2020 (based on Table 3/Annex VI of CLP)
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End-of-Life Vehicles Directive - Specific Use ExemptionsEU. Specific Use Exemptions from Article 4(2)(a) (Annex II), Directive 2000/53/EC on End-of-Life Vehicles, as amended by Commission Delegated Directive (EU) 2023/544, OJ L 73, 10 March 2023
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Active and Intelligent Materials - CMR Substances not allowed for useEU. Carcinogens, Mutagens and Reproductive substances Not Allowed for Use in Components of Active and Intelligent Materials and Articles (Article 5(2)(c)(i)), Regulation 450/2009/EC, 30 May 2009
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).
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General Product Safety Directive - Hazardous SubstancesEU. Hazardous Substances for Purposes of General Product Safety Directive (2001/95/EC), 15 January 2002, amended by Reg 596/2009/EC, 18 July 2009
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.
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In Vitro Diagnostic Medical Devices Directive - Hazardous SubstancesEU. Hazardous Substances for Purposes of Article 3 & Annex I (Essential Requirements), Directive 98/79/EC on In Vitro Diagnostic Medical Devices, 7 December 1998
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.
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In Vitro Diagnostic Medical Devices Regulation - Hazardous SubstancesEU. Hazardous Substances for Purposes of Art. 5(2) and Annex I of Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices, 5 May 2017, as corrected 27 December 2019
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).
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IPPC - Industrial Emissions Directive, Annex II - Polluting SubstancesEU. Polluting Substances: Annex II, Directive 2010/75/EU on Industrial Emissions (IPPC), 17 December 2010
This list contains the 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.
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IPPC, Annexes V, VI, VIII - Provisions relating to industrial plantsEU. Emission Limit Values: Annexes V (combustion plants), VI (waste incineration/co-incineration plants), VIII (TiO2 installations), Dir. 2010/75/EU on Industrial Emissions (IPPC), 17 December 2010
This list contains emission limit values for polluting substances in waste gases and waste water, assigned according to facility type (i.e., combustion plants (Annex V), waste incineration/co-incineration plants (Annex VI), and installations producing titanium dioxide (Annex VIII)), under Directive 2010/75/EU on Industrial Emissions (Integrated Pollution Prevention and Control - IPPC). For this list, if a substance presents 2 values in the ''Average sampling duration'' field, these indicate minimum and maximum average sampling period.
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Marine Environmental Policy Framework Directive - Hazardous SubstancesEU. Hazardous Substances for Purposes of Directive 2008/56/EC (Marine Strategy Framework Directive), 25 June 2008, amended by Directive 2017/845/EU, 18 May 2017
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).
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Medical Devices Directive - Hazardous SubstancesEU. Hazardous Substances for Purposes of Medical Devices Directive 93/42/EEC, 12 July 1993, amended by Directive 2007/47/EC, 21 September 2007
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.
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Medical Devices Regulation - Hazardous SubstancesEU. Hazardous Substances for Purposes of Medical Devices Regulation 2017/745/EU, 5 May 2017, as amended by Regulation 2020/561/EU, 24 April 2020
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).
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Protection of Pregnant and Breastfeeding Workers Directive, Annex I+IIEU. Chemical Agents: Annexes I & II, Directive 92/85/EEC on Pregnant Workers, 28 November 1992 (updated by table 3 of Annex VI to CLP, 5 October 2018)
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.
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Physical, Biological and Chemical Agents & Processes and WorkEU. Non-Exhaustive List of Banned Substances, Directive 94/33/EC on Young People at Work, 20 August 1994, as amended by Dir 2014/27/EU, March 5, 2014 (Based on Table 3 of Annex VI to CLP, inter alia)
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.
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ROHS - Exemptions from Article 4(1) Restrictions, Annexes III & IVEU. Exemptions from Art. 4(1) Restrictions (Annexes III & IV), Directive 2011/65/EU (RoHS), as amended by Commission Delegated Directive (EU) 2024/1416, OJ L of 21 May 2024
This list 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.
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ROHS Directive - Restricted Substances as per Article 4(1), Annex IIEU. Restricted Substances Referred to in Article 4(1) (Annex II), Directive 2011/65/EU (RoHS), as amended by Directive 2015/863/EU, 4 June 2015
This list 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 per Art. 4(1) of RoHS, each listed substance includes a maximum concentration value tolerated by weight in homogeneous materials.
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Safety and Health of Workers at Work Directive - Hazardous SubstancesEU. Hazardous Substances for Purposes of Directive 89/391/EEC, 29 June 1989, amended by Regulation 1137/2008/EC, 21 November 2008 (Table 3/Annex VI, CLP; Annex III, 2000/54/EC)
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.
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Workplace Signs - minimum requirements & signs on containers and pipesEU. Workplace Signage: Annexes I and III, Directive 92/58/EEC, last amended by Directive 2014/27/EU, 5 March 2014
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.
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Toy Safety Directive - Substances Restricted in ToysEU. Substances Restricted in Toys, Directive 2009/48/EC, OJ L 170/1, 30 June 2009, last amended by Directive (EU) 2021/903, 4 June 2021
This list contains substances whose use in toys is restricted in the European Union in accordance with points 8 and 13, Part III, and Appendices A and C of Annex II (Particular Safety Requirements) to Directive 2009/48/EC on toy safety. List entries include substance name, CAS number, limit values for certain product types and, where applicable, notes on restrictions.
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Waste Framework Directive, Annex III - Waste - Hazardous PropertiesEU. Substances according to Hazardous Waste Properties: Annex III, Directive 2008/98/EC, 22 November 2008, amended by Directive 2018/851/EU, 14 June 2018
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.
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Annex I, Part A - Priority Substances & Pollutants in waterEU. Environmental Quality Standards (EQS) for Priority Substances: Annex I, Part A, Directive 2008/105/EC, 24 December 2008, amended by Directive 2013/39/EU, 24 August 2013
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 establishing a framework for Community action in the field of water policy.
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Water Framework Directive, Annex X - Priority SubstancesEU. Annex X to Directive 2000/60/EC, Priority Substances in the Field of Water Policy, as amended by Directive 2013/39/EU, OJ L 226/1, 24 August 2013
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Substance names and other identifiers
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This substance has been identified as member of the following groups of substances:
Name | EC / List no. | CAS no. | Association |
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lead compounds with the exception of those specified elsewhere in this Annex | - | - | Expert judgement |
Lead and its compounds | - | - | Expert judgement |