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
Substance Infocard
4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane
Substance identity
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.: 500-033-5
CAS no.: 25068-38-6
Mol. formula:
Hazard classification and labelling
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.
Warning! According to the harmonised classification and labelling (CLP00) approved by the European Union, this substance is toxic to aquatic life with long lasting effects, causes serious eye irritation, causes skin irritation and may cause an allergic skin reaction.
About this substance
This section provides an overview of the calculated volume at which the substance is manufactured or imported to the European Economic Area (EU28 + Iceland, Liechtenstein and Norway). Additionally, if available, information on the use of the substance and how consumers and workers are likely to be exposed to it can also be displayed here.
The use information is displayed per substance life cycle stage (consumer use, in articles, by professional workers (widespread uses), in formulation or re-packing, at industrial sites or in manufacturing). The information is aggregated from the data coming from REACH substance registrations provided by industry.
For a detailed overview on identified uses and environmental releases, please consult the registered substance factsheet.
Use descriptors are adapted from ECHA guidance to improve readability and may not correspond textually to descriptor codes described in Chapter R.12: Use Descriptor system of ECHA Guidance on information requirements and chemical safety assessment.
The examples provided are generic examples and may not apply to the specific substance you are viewing. A substance may have its use restricted to certain articles or products and therefore not all the examples may apply to the specific substance. Furthermore, some substances can be found in an article, but with unlikely exposure (e.g. inside a watch) or with very low concentrations considered not to pose risks to human health or the environment.
Please note:
For readability purpose, only non-confidential use descriptors occurring in more than 5% of total occurrences are displayed.
The described Product category (i.e. the products in which the substance may be used) may refer to uses as intermediate and under controlled conditions, for which there is no consumer exposure.
More help is available here.
This substance is registered under the REACH Regulation but is not currently being manufactured in and / or imported to the European Economic Area.
This substance is used by consumers, in articles, by professional workers (widespread uses), in formulation or re-packing, at industrial sites and in manufacturing.
Consumer Uses
This substance is used in the following products:
adhesives and sealants,
coating products and
fillers, putties, plasters, modelling clay.
Other release to the environment of this substance is likely to occur from:
indoor use and
outdoor use resulting in inclusion into or onto a materials (e.g. binding agent in paints and coatings or adhesives).
Article service life
Release to the environment of this substance can occur from industrial use:
as an intermediate step in further manufacturing of another substance (use of intermediates),
in the production of articles,
formulation of mixtures and
manufacturing of the substance.
Other release to the environment of this substance is likely to occur from:
indoor use and
outdoor use resulting in inclusion into or onto a materials (e.g. binding agent in paints and coatings or adhesives).
This substance can be found in complex articles, with no release intended:
machinery, mechanical appliances and electrical/electronic products (e.g. computers, cameras, lamps, refrigerators, washing machines) and
vehicles.
This substance can be found in products with material based on:
metal (e.g. cutlery, pots, toys, jewellery),
plastic (e.g. food packaging and storage, toys, mobile phones),
stone, plaster, cement, glass or ceramic (e.g. dishes, pots/pans, food storage containers, construction and isolation material),
paper (e.g. tissues, feminine hygiene products, nappies, books, magazines, wallpaper) and
wood (e.g. floors, furniture, toys).
Widespread uses by professional workers
This substance is used in the following products:
polymers,
adhesives and sealants,
coating products,
fillers, putties, plasters, modelling clay and
semiconductors.
This substance has
an industrial use resulting in manufacture of another substance (use of intermediates).
This substance is used in the following areas:
building & construction work and
formulation of mixtures and/or re-packaging.
This substance is used for the manufacture of:
plastic products,
electrical, electronic and optical equipment and
machinery and vehicles.
Release to the environment of this substance can occur from industrial use:
as an intermediate step in further manufacturing of another substance (use of intermediates),
in the production of articles and
formulation of mixtures.
Other release to the environment of this substance is likely to occur from:
indoor use (e.g. machine wash liquids/detergents, automotive care products, paints and coating or adhesives, fragrances and air fresheners) and
outdoor use.
Formulation or re-packing
This substance is used in the following products:
polymers,
adhesives and sealants,
coating products and
fillers, putties, plasters, modelling clay.
This substance has
an industrial use resulting in manufacture of another substance (use of intermediates).
Release to the environment of this substance can occur from industrial use:
formulation of mixtures,
as an intermediate step in further manufacturing of another substance (use of intermediates) and
formulation in materials.
Uses at industrial sites
This substance is used in the following products:
polymers,
adhesives and sealants and
coating products.
This substance has
an industrial use resulting in manufacture of another substance (use of intermediates).
This substance is used in the following areas:
formulation of mixtures and/or re-packaging and
building & construction work.
This substance is used for the manufacture of:
machinery and vehicles,
plastic products,
electrical, electronic and optical equipment and
chemicals.
Release to the environment of this substance can occur from industrial use:
in the production of articles,
as an intermediate step in further manufacturing of another substance (use of intermediates),
in processing aids at industrial sites and
formulation of mixtures.
Other release to the environment of this substance is likely to occur from:
indoor use.
Manufacture
Release to the environment of this substance can occur from industrial use:
manufacturing of the substance.
Properties of concern
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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Skin sensitising |
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Skin sensitising |
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How to use it safely
This section provides links to the list of precautions (precautionary statements) and to the guidance on safe use, if they have been provided in REACH registration dossiers.
- Precautionary statements - describe recommended measures to minimise or prevent adverse effects resulting from exposure to a hazardous product or improper storage or handling of a hazardous product.
- Guidance on safe use - recommendations by substance registrant on the proper use of the substance in various situations. Examples include recommended measures on fire-fighting, transport and recycling and disposal.
Please note: Precautionary measures and guidance on safe use concern the use and handling of the specific substance as such, not of the presence of the substance in other articles or mixtures. The precautionary measures and guidance on safe use are as submitted to ECHA by registrants under the REACH Regulation. Information on precautionary measures and the safe use is submitted by the registrant of a substance and the registrant is solely responsible for its accuracy and completeness.
More help available here.
- Precautionary measures suggested by manufacturers and importers of this substance.
- Guidance on the safe use of the substance provided by manufacturers and importers of this substance.
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.
HELP
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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Substances assessed for potential regulatory needs.
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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 which have been registered and can be placed on the EEA market by those companies with a valid registration.
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Harmonized C&LCLP Regulation Annex VISubstances for which an agreed set of classification and labelling data has been agreed at EU level by Member States.
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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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Seveso Annex ISeveso III Directive Annex ISubstances for which industrial accident prevention and reporting requirements have been established.
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Substances listed in the EINECS, ELINCS, or NLP inventories.
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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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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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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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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 - 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)
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.
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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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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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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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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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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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