General recommendations

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 are responsible for keeping your registration up to date.
  • Submit an update to ECHA if any of the following information changes:
    • your role (manufacturer, importer or a producer of articles), identity (company name) or contact details;
    • the composition of your substance;
    • the annual or total production volume, or import volume, of your substance decreases or increases the tonnage indicated in your registration must correspond with your actual manufactured or imported tonnage;
    • there are new identified uses or new uses advised against for your substance;
    • you become aware of new information on the hazards or risks of your substance to human health or the environment that affects the safety data sheet or the chemical safety report;
    • the classification and labelling of your substance;
    • you identify a data gap for any endpoint listed in Annexes IX and X; in this case you must submit a testing proposal;
    • there is a change in the access granted to information in the registration.
  • The European Commission has clarified the concept of ‘without undue delay’ and set the following deadlines for updates:
    • three months for administrative updates, including change in registrants’ status or identity,
    • three months for reporting a change in substance composition,
    • three months in case of change of tonnage band, including cease of manufacture or import.
    • Six, nine or 12 months for more complex updates, including change of classification and labelling of a substance without a harmonised classification, changes in the chemical safety report or guidance on safe use.
    Make sure that you have monitoring systems in place to easily identify the changes that require updates in your registration.
  • Keep records of your updates, so you can show your national enforcement authorities that the necessary updates were done in time for all your substances.

 

Follow up the regulatory status of your substance
  • Monitor the regulatory status of your substance continuously. Depending on the adopted regulatory risk management actions, the use of your substance may be restricted or you may need to apply for an authorisation to continue its use. Your substance may also be included in Annex VI of CLP for harmonised classification and labelling, which would mean new obligations to you.
  • Public activities coordination tool (PACT) provides an overview of authorities’ activities under REACH and CLP on specific substances. Use the tool to keep yourself up to date on the status of your substance.

 

Inform ECHA about cease of manufacture or import
  • When you decide to cease the manufacture or import of your substance, you must notify ECHA in REACH-IT within three months of the date of cessation.
  • Cease of manufacture during decision making: 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 will no longer be valid. Consequently, you will not receive the adopted decision, while the decision-making process will continue for other addressees of the draft decision (where applicable). However, any other decisions adopted before the cease of manufacture are still valid.
  • Cease of manufacture after a decision is adopted: 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, adaptations 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:
    • submit a testing proposal for a given endpoint 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,
    • include your considerations for alternative methods in case testing on vertebrate animals is proposed,
    • 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 and the study design you propose to follow for the test you need to conduct.
    Provide comprehensive, scientifically sound and transparent justification if you propose to conduct a test with another substance than the registered one. 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. Provide this test material information either in the testing proposal justification document (if applicable) or in the endpoint study record in IUCLID.
  • Ensure that the test material composition is within the boundaries of the substance identity profile reported in the lead registrant dossier, and relevant to all members of the Joint Submission.
  • Correct any substance identification mistakes proactively.

 

Use and report good laboratory practice
  • All new toxicological and eco-toxicological tests must be carried out following 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.
  • For results of a toxicological or an ecotoxicological 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, specify 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 existing experiments not carried out according to GLP to fulfil your information requirements.

 

Use appropriate test guidelines
  • You need to conduct all tests in accordance with recognised test methods, following either the EU Test Method Regulation or the OECD test guidelines. Choose the most recently published test guideline.
  • Regarding in vitro tests, to assess properties of your substance you may use the positive results obtained through test methods that have not been formally validated yet but meet the pre-validation criteria (as outlined in Annex XI, 1.4).

 

Be accurate about the reported data
  • Prepare a robust study summary including sufficient information for ECHA to conduct an independent assessment.
  • If you want to adapt standard testing or replace the experimental value with a prediction, you need to provide the legal basis for the adaptation and the information used to fulfil the information requirement, e.g. a justification document and relevant studies.

 

Report nanoforms of substances
  • Use the available ECHA guidance to learn how to address nanoforms when generating or collecting information.
  • Document the nanoforms of the substance you intend to register and the nanoforms of the substance your data refers to in the reporting fields available in the composition records of IUCLID.
  • If you register a set of similar nanoforms, you need to provide:
    • clearly defined boundaries for the parameters specified in the REACH Annex VI points 2.4.2 to 2.4.5; and
    • a justification that hazard, exposure and risk assessment of the nanoforms in the set can be performed jointly, using a text template available in Section 1.2 of IUCLID.

 

Check REACH-IT regularly and communicate
  • Set up an email alert to receive a notification each time you get a new message in your REACH-IT account.
  • Log into your REACH-IT account regularly to check the message box.
  • Identify who in your company is 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.