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Related Information requirements Practical guide for SME managers and REACH coordinators - How to fulfil your information requirements at tonnages 1-10 and 10-100 tonnes per year Guidance on...
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21/12/21
../file-system/small/txt ../file-system/small/txt Registration - related documents
Related CLP Legislation Commission Regulation amending REACH annexes VII to XI Implementing legislation on dossier updates IT screening campaigns on dossiers REACH Legislation Upcoming changes to...
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14/12/21
Dissemination and Confidentiality under REACH Regulation Dissemination and Confidentiality under REACH Regulation manual_dissemination_en.pdf (1.5 MBk)
Dissemination and Confidentiality under REACH Regulation
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16/11/21
How to prepare an inquiry dossier How to prepare an inquiry dossier manual_inquiry_en.pdf (1.7 MBk)
How to prepare an inquiry dossier
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27/10/21
How to prepare registration and PPORD dossiers How to prepare registration and PPORD dossiers manual_regis_and_ppord_en.pdf (3.5 MBk)
How to prepare registration and PPORD dossiers
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27/10/21
Implementing Legislation Regulation on the duties placed on registrants to update their registrations under Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the...
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27/10/21
Please note: The ‘Substance has nanoform’ search filter returns all factsheets containing any data related to nanomaterials. NB: This does not mean that a registration covering nanoforms has been...
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14/10/21
Guidance on Registration Guidance on Registration registration_en.pdf (1.4 MBk)
Guidance on Registration
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17/08/21
../file-system/small/txt ../file-system/small/txt Legislation - REACH Regulation
REACH Legislation
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09/06/21
../file-system/small/txt ../file-system/small/txt Homepage subscribe
Follow us Read ECHA Weekly news Subscribe to our news
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22/04/21
../file-system/small/txt ../file-system/small/txt Content pages - Subscribe
Follow us Read ECHA Weekly news Subscribe to our news
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08/04/21
Manufacturers, importers and downstream users based in the EU can submit a request for the use of an alternative chemical name to ECHA. It is not possible to appoint a ‘Third Party...
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08/03/21
../file-system/small/txt ../file-system/small/txt PPORD
If your substance is subject to product and process orientated research and development (PPORD), you can submit a PPORD notification to ECHA in order to be exempted from the obligation to register.
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04/03/21
../file-system/small/txt ../file-system/small/txt Registration - support
See also under the Support section Registration Questions and Answers on Registration
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25/02/21
Related Substance evaluation – CoRAP table Substance evaluation Evaluation process Practical guide on how to act in substance evaluation Community rolling action plan
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22/02/21
Related Understanding CLP C&L Inventory How to submit and update your C&L notification Implementing Regulation (EU) 2020/1435
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22/02/21
Related Substance identification process under REACH Substance identification – get started Guidance on substance identification How to prepare registrations for nanomaterials [PDF]
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22/02/21
Related Public activities coordination tool Substances of potential concern Examination of testing proposals Strategy for gathering your data Adaptations Good Laboratory Practice Dossier evaluation...
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22/02/21
../file-system/small/txt ../file-system/small/txt Recommendations - cnl box
Classification and labelling
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22/02/21
../file-system/small/txt ../file-system/small/txt Recommendations - adaptions box
Adaptations
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22/02/21
Keep your registrations up to date and take actions to proactively improve your registration data by following these general recommendations. Monitor changes and update by relevant deadlines You...
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22/02/21
../file-system/small/txt ../file-system/small/txt Recommendations - substance id
Companies need to clearly identify the substances they manufacture or import. This makes it possible for companies to register the same substance jointly, following the ‘one substance, one...
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22/02/21
../file-system/small/txt ../file-system/small/txt Recommendations - registration
If your company manufactures or imports substances in quantities of more than one tonne per year, you are responsible for compiling and submitting a registration dossier to ECHA. The following...
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22/02/21
You need to carry out exposure assessment and risk characterisation for substances registered at or above 10 tonnes per year, if they are classified as dangerous or as having persistent,...
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22/02/21
In dossier evaluation, ECHA checks if the information that you have submitted in your registration meets the requirements set in REACH for your substance and tonnage band. If your dossier does not...
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22/02/21
../file-system/small/txt ../file-system/small/txt Recommendations - cnl
Classification and labelling is the starting point for hazard communication and important elements in making sure that human health and the environment are protected from harmful chemicals....
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22/02/21
../file-system/small/txt ../file-system/small/txt Recommendations - adaptions panels
An adaptation to a standard information requirement means that instead of performing a test, you provide a justification. Your justification has to either be based on general rules as explained in...
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22/02/21
Substance evaluation is carried out by the EU Member States. It aims to clarify potential risks related to the safe use of a substance. The evaluating competent authority may request information...
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22/02/21
../file-system/small/txt ../file-system/small/txt Annex III modification
Please note that Annex III has been modified by Regulation 2018/1881, modifying provisions in case of nanomaterials (Commission Regulation (EU) 2018/1881 of 3 December 2018 amending Regulation (EC)...
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08/02/21
../file-system/small/txt ../file-system/small/txt Recommendations - introduction
All REACH registrants must proactively review and update the information in their registration dossiers and are encouraged to improve the quality and relevance of the included data. The following...
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01/02/21
In this table, you will find all public data submitted to ECHA in REACH registration dossiers by substance manufacturers, importers, or their representatives, as laid out by the REACH Regulation...
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08/12/20
Further information Registered substances information How to determine what will be published (Data Submission Manual 15) Understanding REACH Regulation Q&A on registered substances What is an...
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08/12/20
Webinar related to dossier quality Content Date Substance identity issues covered in the screening campaign Concentration ranges Compositions with no constituents No analytical information Low...
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14/07/20
../file-system/small/txt ../file-system/small/txt What information you need to submit
As a registrant of a substance, you need to compile all the required information in a registration dossier, which has two main components: A technical dossier is always required for all substances...
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10/06/20
If you have prepared your registration dossier in IUCLID, you need to submit it to ECHA through REACH-IT. REACH-IT is the central IT system for companies to securely submit, process and manage...
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10/06/20
There are four steps in the process of data gathering before registering a substance. Agree with your co-registrants how to divide the work or whether to outsource some, or all of it. 1. Collect...
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10/06/20
Typically, tests are contracted out as a package. This has the advantage of being performed by experts in the most time-efficient manner and according to the required quality standards and legal...
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10/06/20
../file-system/small/txt ../file-system/small/txt In vitro methods main
A test performed in vitro ("in the glass") means that it is done outside of a living organism and it usually involves isolated tissues, organs or cells. You can use in vitro data to fully or partly...
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10/06/20
If you manufacture or import a substance in amounts less than one tonne a year, you do not need to register the substance. If you reach or exceed this threshold, your tonnage band will determine...
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10/06/20
../file-system/small/txt ../file-system/small/txt inforeq 10 to 100 main
To register a substance in the 10 to 100 tonnage band, you need to provide information specified in Column 1 of REACH Annexes VII and VIII, comprising certain physicochemical data, toxicological...
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10/06/20
../file-system/small/txt ../file-system/small/txt inforeq 1 to 10 tonnes main
To register a substance in the 1 to 10 tonnage band, you need to provide information specified in Column 1 of REACH Annex VII, including certain physicochemical data, toxicological information and...
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10/06/20
If you only have a few substances to manage, you can take advantage of the IUCLID Cloud to create your dossiers in the IUCLID format. To use the service, you will need an ECHA account and to...
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10/06/20
Under REACH, testing on vertebrate animals (e.g. rats, other mammals or fish) can only be used as a last resort to fulfil information requirements for registration. There are multiple ways to avoid...
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10/06/20
../file-system/small/txt ../file-system/small/txt From submission to decision
ECHA assigns a submission number to each received dossier. This number is used as a reference in all correspondence relating to this registration until a registration number is assigned. Dossier...
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10/06/20
../file-system/small/txt ../file-system/small/txt Finding your co-registrants
You will need to share data and register your substance jointly with other companies. In practice, this means that you need to: Submit an inquiry via REACH-IT to ask ECHA if you have...
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10/06/20
Claiming an “adaptation” means that it is possible to omit a test based on certain general rules or specific rules that apply for just one information requirement. General rules for adaptations can...
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10/06/20
../file-system/small/txt ../file-system/small/txt Collecting information on uses main
In your registration dossier you also have to report / provide information on how your substance is used in your supply chain. To retrieve such information you can use many sources, for example:...
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10/06/20
../file-system/small/txt ../file-system/small/txt Creating your registration dossier
After you have compiled all the information on your substance necessary for fulfilling the REACH requirements, you need to document your findings in a registration dossier. The file that you submit...
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10/06/20
../file-system/small/txt ../file-system/small/txt what info you need top text
To be ready for registration, you first need to understand what information you have to collect to demonstrate the safe use of your substance. You then report this information in your registration...
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10/06/20
Demonstrating the safe use of your substance in a registration dossier requires a significant investment of time, money and expertise. You will need to have dialogue and, normally, contractual...
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10/06/20