General recommendations

These general recommendations highlight ECHA’s key messages for keeping your registration data in order and improving it proactively.

 

Update regularly
  • You are responsible for keeping your registration up to date. Submit an update to ECHA if:
    • your role (manufacturer, importer or a producer of articles), identity (company name) or contact details change;
    • the composition of your substance is refined;
    • the annual or total production or import volume of your substance significantly decreases or increases, or if the quantities of substances present in articles manufactured or imported change: such updates correct any mismatch between the actual tonnage and the tonnage band you registered for, and must also be made if you cease manufacture or import;
    • there are new identified uses or new uses advised against for your substance;
    • you learn something new about the risks of the substance to human health or the environment that affect the safety data sheet or the chemical safety report;
    • the classification and labelling of the substance has changed;
    • you need to submit a testing proposal to ECHA before performing a new test for any property listed in Annexes IX and X;
    • there is a change in your access rights to the information in your registration (e.g. due to a change related to the letter of access).

 

Inform ECHA immediately about cease of manufacture or import
  • Mark in REACH-IT the cease of manufacture or import of your substance.
  • If you inform ECHA of a cease of manufacture or import after receiving a draft evaluation decision but before the decision is adopted, your registration will be revoked and no longer be valid. The ongoing decision-making procedure will be terminated and no further information will be requested. However, any other decisions adopted before the cease of manufacture will still apply.
  • If you inform ECHA of a cease of manufacture or import after an evaluation decision has been adopted, you still have to fulfil all requests in the decision.

 

Consider whether a testing proposal is needed before testing
  • Generate new data with care - explore all the possibilities of using existing information and alternative methods to meet the information requirements.
  • If you need to perform a new test to fulfil standard information requirements listed in Annexes IX or X to REACH, you need to first submit a testing proposal:
    • The testing proposal for a given property has to be submitted in the relevant IUCLID section of the lead or opt-out dossier.
    • Record the testing proposal properly: under the relevant endpoint study record in IUCLID, select ‘Experimental study planned’ from the ‘Type of information’ drop-down list.
    • When testing involves vertebrate animals, you must include your considerations for alternative methods.
    • Identify and select the test material carefully and ensure that it is representative also for all the other members of the joint submission.
    • Include the OECD/EU method you propose to follow for the test you need to conduct.
  • If you propose to conduct a test with a substance other than the registered substance, you must provide a comprehensive, scientifically sound and transparent justification. You also need to explain why you are applying this category or read-across approach to the registered substance and the endpoint in question.

 

Demonstrate the relevance of your test material
  • Report the constituent identities and their concentration values for each test material used to generate your data, providing this test material information either in the testing proposal or in the endpoint study record in IUCLID.
  • Ensure that the test material composition is within the boundaries of the substance identity profile (SIP) reported in the lead registrant dossier.
  • Correct any substance identification mistakes proactively on your own initiative.

 

Use and report good laboratory practice
  • All new toxicological and eco-toxicological tests must be carried out in compliance with the principles of good laboratory practice (GLP).
  • For physicochemical testing, it is recommended but not mandatory to have tests performed according to the GLP standard.
  • When you report the results of a toxicological or an eco-toxicological study, identify the test facility by providing the complete name and address of the facility.
  • If parts of a study were not conducted in line with the GLP principles, indicate this in the GLP compliance section in IUCLID.
  • Check Annex XI, Section 1.1.2 to REACH to see under which conditions you can use experiments not carried out according to GLP to fulfil your information requirements.

 

Use appropriate test guidelines
  • Under REACH, you need to conduct all tests in accordance with recognised test methods, adhering to the EU Test Method Regulation or to the OECD test guidelines (whichever is newer).

 

Be accurate about the reported data
  • Prepare a robust study summary.
  • Report as many details on the set-up of the study as possible.
  • If you want to adapt standard testing or replace the experimental value with a prediction, you need to create two separate endpoint study records in IUCLID: in one of them you mention the legal basis for the adaptation, in the other you provide the actual information.

 

Report nanoforms of substances
  • Read the available ECHA guidance on how to address nanomaterials when generating or collecting information.
  • Make use of the reporting fields available in the composition records of IUCLID to document the form of the substance you intend to register and the form of the substance your data refers to.

 

Check REACH-IT regularly and communicate
  • Log in to your REACH-IT account regularly to check the message box.
  • Identify the person(s) in your company in charge of making these regular checks and keep their contact details up to date.
  • Outside of REACH-IT, keep in touch and communicate with your co-registrants, your supply chain, and your industry sector associations.

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