Q&As

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REACH

I have existing data to support the waiving of a study. How should I report this in my IUCLID dossier?

If you are adapting the information requirement based on existing data according to REACH Annex XI section 1, you should provide the applicable data (e.g. read-across study, Q(SAR)) as an endpoint study record, marked with the appropriate ‘Adequacy of study’ and ‘Type of information’. You should not report existing data as a data waiving record.

If you are waiving (omitting) the information requirement based on the provisions of Column 2 of the relevant requirement, or Sections 2 or 3 of Annex XI, you should include a data waiving record clearly documenting the justification for the waiving. Any available data that support this justification (e.g. a property of the substance, classification) should be reported in the relevant IUCLID section. For transparency, you may wish to link this information in the data waiving record using the ‘Cross-reference’ field.

For further information on how to complete endpoint study records in IUCLID, please refer to chapter 9.7 of the manual How to prepare registration and PPORD dossiers available on the ECHA website.

I am preparing a data waiving record in IUCLID. When inserting the justification in the field ‘Justification for data waiving’ I noticed there is a character limit in the text field next to the option 'other'. For complex discussions on waivers this character limit is often inadequate. How can I ensure all necessary information is included to support my waiving justification?

A: If the character limit in the free text field next to the value ‘other:’ does not allow you to provide sufficient information to justify the waiving, you can use the following IUCLID fields in the Administrative data part:

  • ‘Remarks’ field below the picklist value ‘other:’
  • ‘Justification for type of information’ – this field has a higher character limit and allows for a longer argumentation.

In addition, should you need to provide further information in the form of a report or schematic, you can use the field ‘Attached justification’ to attach the supporting document. To refer to information provided elsewhere in the dossier, you can also use the field ‘Cross-reference’.

However, it is important to note that the main argumentation for the data waiving has to be included in the fields ‘Other’, ‘Remarks’ or the field ‘Justification for type of information’ of the relevant endpoint study record. Only referring to somewhere else in the dossier (e.g. another section, an endpoint summary) or to an attachment is not a valid approach to justify the data waiving and such a record will not pass the completeness check.

I am preparing a registration dossier for a substance with a tonnage above 1000 t/y. I want to wait for the results of another test to finalise the study design of the extended one-generation reproductive toxicity study (EOGRTS). How should I report this in IUCLID?

At Annex X, the EOGRTS is the standard information requirement to address reproductive toxicity. If you would like to wait for the results of another test (e.g. results from a 90-day study or from a prenatal developmental toxicity study) before starting the EOGRTS, you should indicate this in IUCLID section 7.8.1 with an endpoint study record flagged as testing proposal.

To indicate an endpoint study record as a testing proposal for EOGRTS, set the field ‘Type of information’ to ‘experimental study planned’ and choose in the field ‘Endpoint’ one of the picklist values referring to the EOGRTS. In the testing proposal record you can explain the sequential testing and the test guideline(s) that you intend to follow. ECHA will evaluate this testing proposal and may set a timeline to allow this sequential testing.

I am preparing a registration dossier for a substance with a tonnage between 100 to 1000 t/y. I want to wait for the results of another test to know if I need to perform the extended one-generation reproductive toxicity study (EOGRTS). How should I report this in IUCLID?

At Annex IX, it is indicated in Column 1 of 8.7.3 that the extended one-generation reproductive toxicity study (EOGRTS) must be performed “if the available repeated dose toxicity studies (e.g. 28-day or 90-day studies, OECD 421 or 422 screening studies) indicate adverse effects on reproductive organs or tissues or reveal other concerns in relation with reproductive toxicity”. Therefore, the EOGRTS is not an automatic requirement at Annex IX, but relies on the indication of adverse effects from other tests.

If you are awaiting the results of such test(s) to determine if you need to conduct the EOGRTS, you can indicate this in an endpoint study record flagged as data waiving in IUCLID section 7.8.1. To indicate an endpoint study record as a data waiving for EOGRTS pending the outcome of another study, set the field ‘Data waiving’ to ‘study not scientifically necessary’ and choose in the field ‘Endpoint’ one of the picklist values referring to the EOGRTS. In the data waiving record, select under ‘Justification for data waiving’ the value ‘other:’ and explain that you are awaiting the outcome of another study. Be explicit on which study/studies you refer to, preferably by indicating the relevant section(s) in the field ‘Cross-reference’. If you have any ECHA/authority decision on the test, also include the decision number in the data waiving justification.

By following this approach, you do not need to submit a testing proposal for the EOGRTS at Annex IX, before you know if this study is needed. Once the repeated dose toxicity study is finalised, you should without delay submit an update of the registration, and in addition to reporting the results of the finalised test, in section 7.8.1 either (i) amend the data waiving record to explain that no adverse effects in line with Column 1 of 8.7.3 were observed in the test; or (ii) replace the data waiving record with a testing proposal for the EOGRTS.

I am preparing to update my registration dossier for a substance with a tonnage above 1000 t/y. I have previously submitted a testing proposal to ECHA for the pre-natal developmental toxicity (PNDT) study and have received the decision to carry out the test in two different species. I have started the testing in the first species, but I would like to wait for the results of this test before starting the test in the second species. If I need to submit an update of the registration in the meantime, how should I report this in IUCLID?

REACH Annex X requires registrants to provide two pre-natal developmental toxicity studies in different species. For each of the two species, you need to provide an endpoint study record in IUCLID section 7.8.2 indicated as key study, weight of evidence, data waiving, or testing proposal.

In the situation you refer to, you have received the decision to carry out the PNDT test in two species, and you have started the testing in the first species. However, you would like to wait for the results of the PNDT test in the first species before initiating the second species study. In this situation, you should include in IUCLID section 7.8.2 the following endpoint study records:

First species record:

  • You should indicate the endpoint study record for the ongoing first species PNDT test as a data waiving. Set the field ‘Data waiving’ to ‘other justification’. Under ‘Justification for data waiving’ select the value ‘other:’ and type the following sentence in the adjacent text field: “This information will be submitted later based on ECHA decision number TPE-F-xxxxxxxxxx-xx-xx”, where you replace the “x”-characters with the decision number issued to you by ECHA.

Second species record:

  • You should indicate the endpoint study record for the second species PNDT test as a data waiving. Set the field ‘Data waiving’ to ‘other justification’. Under ‘Justification for data waiving’ select the value ‘other:’ and type the following sentence in the adjacent text field: “The second species PNDT test may be performed sequentially once the first species test results are available. This information will be submitted later based on ECHA decision number TPE-F-xxxxxxxxxx-xx-xx”, where you replace the “x”-characters with the decision number issued to you by ECHA.

Once a study is finalised, you must without delay submit an update of the registration, and report the results of the finalised test in IUCLID section 7.8.2.

Note that the only reasons for why the testing in the second species could be permanently waived based on the results of the first species study are listed in REACH Annex X, section 8.7.2, column 2.

For further information on the information requirements for the PNDT studies, please read the Newsletter, issued on October 2014.

I am preparing a registration dossier for a substance with a tonnage above 1000 t/y. I am planning to address the information requirement for the pre-natal developmental toxicity (PNDT) study with a testing proposal. However, I would like to wait for the results of the test in the first species before starting the test in the second species. How should I report this in IUCLID?

REACH Annex X requires registrants to provide two pre-natal developmental toxicity studies in different species. For each of the two species, you need to provide an endpoint study record in IUCLID section 7.8.2 indicated as key study, weight of evidence, data waiving, or testing proposal. Before carrying out a test in vertebrate animals to fulfil information requirements for REACH Annexes IX and X, you need to first submit a testing proposal to ECHA and receive the decision to carry out the test.

In the situation you refer to, you are about to submit a testing proposal for the PNDT study at Annex X. You should therefore include in IUCLID section 7.8.2 the following endpoint study records:

First and second species records:

  • You should create separate endpoint study records for the first and second species and indicate each of them as a testing proposal by setting the field ’Type of information’ to ‘experimental study planned’. Provide information on the ‘Guideline’, ‘Test material information’ and ‘Species’ of the planned test.
  • In addition, ensure to include in the field ‘Justification for type of information’ of both records the considerations for why the adaptation possibilities offered by the REACH Regulation cannot be used to address the information requirement and animal testing is necessary.
  • Finally, include in at least one of the records in the field ‘Attached justification’ the clarification of that you propose to carry out the testing of the two species in a sequential manner (depending on the results of the PNDT study in the first species).

Once a study is finalised, you must without delay submit an update of the registration, and report the results of the finalised test in IUCLID section 7.8.2.

Note that the only reasons for why the testing in the second species could be permanently waived based on the results of the first species study are listed in REACH Annex X, section 8.7.2, column 2.

For further information on the information requirements for the PNDT studies, please read the Newsletter, issued on October 2014.

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