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Rozporządzenie REACH ma na celu poprawę ochrony zdrowia ludzkiego i środowiska przed zagrożeniami ze strony chemikaliów.
Rozporządzenie CLP zapewnia przekazywanie pracownikom i konsumentom w Unii Europejskiej informacji na temat zagrożeń związanych z chemikaliami w sposób jasny poprzez klasyfikację i oznakowanie substancji chemicznych.
Wykaz klasyfikacji i oznakowania
Celem rozporządzenia w sprawie produktów biobójczych jest usprawnienie funkcjonowania rynku produktów biobójczych w UE, przy jednoczesnym zapewnieniu wysokiego poziomu ochrony ludzi i środowiska naturalnego.
zatwierdzenie substancji czynnych
Udzielanie pozwoleń na produkty biobójcze
Wytyczne i narzędzia informatyczne
Rozporządzenie w sprawie zgody po uprzednim poinformowaniu (PIC) reguluje przywóz i wywóz niektórych niebezpiecznych chemikaliów i nakłada obowiązki na przedsiębiorstwa, które chcą wywozić te substancje chemiczne do krajów spoza UE.
Lista chemikaliów objętych zgodą po uprzednim poinformowaniu
Rozporządzenie dotyczące TZO zakazuje lub surowo ogranicza produkcję i stosowanie trwałych zanieczyszczeń organicznych w Unii Europejskiej.
Dopuszczalne stężenia w środowisku pracy pochodzą z dwóch ram prawnych stanowiących integralną część unijnego mechanizmu ochrony zdrowia pracowników.
The Waste Framework Directive aims to protect the environment and human health from the generation and management of waste and to improve efficient use of resources.
Zmieniona dyrektywa w sprawie wody pitnej ma na celu ochronę ludzi i środowiska przed szkodliwymi skutkami zanieczyszczenia wody pitnej oraz poprawę dostępu do takiej wody.
Dyrektywa w sprawie wody pitnej
ECHA organizuje konsultacje w celu otrzymania uwag od wszystkich zainteresowanych stron i zgromadzenia jak najwięcej informacji naukowych do procesów regulacyjnych.
Jest to unikalne źródło informacji nt. chemikaliów produkowanych w Europie i do niej przywożonych. Obejmuje niebezpieczne właściwości, klasyfikację i oznakowanie substancji oraz informacje na temat ich bezpiecznego stosowania.
Zgoda po uprzednim poinformowaniu
opinie i porozumienia
W sekcji „Wsparcie” znajdują się narzędzia i praktyczne porady dla firm mających obowiązki na mocy prawodawstwa UE dotyczącego substancji chemicznych.
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.
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.
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.
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.
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.:
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.
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:
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.
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.
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.
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.
There is no harmonised classification and there are no notified hazards by manufacturers, importers or downstream users for this substance.
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:
The following properties of concern are calculated:
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.
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 (*).
This section highlights four regulatory activities or outcomes under REACH – Registration, Evaluation, Authorisation and Restriction of Chemicals – Regulation (EC) No 1907/2006:
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.
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.
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):
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.
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.
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.
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.
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.
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.
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).
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.
This substance has been identified as member of the following groups of substances:
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