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REACH

Preparing a registration dossier in IUCLID

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.

When is the description of article service life expected and why?
REACH requires that all the life-cycle stages of a substance are addressed in the registration dossier. This includes also the life-cycle stages subsequent to the use of the substance as such or in mixture. Substances having been processed into or onto an article may be released during the service life or at end of service life of this article, leading to exposure of humans or the environment. This exposure may even be higher than the exposure occurring during the production of the article in industry or the application of coatings to article surfaces by professionals. Examples for significant release potential during or after service life include migration to skin and washout from textiles, migration of substances from plastic articles or leaching from surfaces due to water contact.  
 
An article service life is to be reported in section 3.5.6 of IUCLID when the substance (or its reaction products) is expected to be present in an article. This applies for example for the following substance functions:
  • Substance is meant to present in the material matrix forming an article. Typical technical functions include plasticisers, fillers, flame retardants, pigments or stabilisers in plastic articles; dyes, finishing or sizing agents in textile, paper and leather; or alloying elements in metal articles.
  • Substance is meant to be present in the surface layer protecting an article or delivering a certain appearance. Typical technical functions include binders (film formers), driers, pigments, plasticisers, stabilisers in the coatings for metal articles or wooden/mineral elements in building and construction. 
  • Substance is meant to be present on the article surface to promote or prevent adhesion to other surfaces. Typical technical functions include adhesion promoters, binders in adhesives, antiadhesives, release agents remaining on surfaces of mineral construction elements.    
  • Substance is meant to be present on article surface during longer periods of article service life, such as polishing, waxing or impregnation agents.   
  • Substance is a component in printing inks applied to packages or print media. Typical technical functions include binder, pigment, dyes. 
  • Substance is meant to be present in a plastic compound (or master-batch) in order protect the material against degradation by heat during processing (heat stabiliser).  
While the technical functions listed above mostly imply that the substance is included in articles, in some cases functions such as dye or stabiliser are also delivered in products not leading to article service life (for example lubricants, fuels, cleaning products). For such uses, it is compatible with the technical function that no article service life is reported.
 
An article service life should not be reported in section 3.5.6 of IUCLID when the substance (or its reaction products) is not expected to be present in the article after use. This applies typically to substances which are meant to remove material from solid surfaces, substances which are part of functional fluids and fuels, or substances that are meant to evaporate during their application to the article surface. Examples include:
  • Anti-freeze agents and de-icers
  • Cleaning and chelating agents
  • Etching agents
  • Flocculation or floatation agents
  • Fuels and fuel additives
  • Agents in hydraulic fluids, heat transfer fluids or other functional fluids
  • Lubricating agents
  • Solvents 
When describing the substance functions in section 3.5 of IUCLID, the information should also be consistent with other elements of the use description.
  • Within a use, report the technical functions that relate to the product(s) relevant for the use described. 
  • Functions excluding each other (e.g. flame retardant and fuel) should not be included in the same use.
  • The technical function should be consistent with the selected environmental release categories (ERC), which systematically distinguish between inclusion and no-inclusion into/onto articles
  • It should be also compatible with the indication in field ‘Subsequent service life relevant for this use’ of IUCLID.
More practical considerations and examples on how to report uses of substances becoming part of articles, can be found in ECHA’s Practical Guide for Industry: Describing uses of additives in plastic material for articles and estimating related exposure. Although focussed on additives in plastic, the core principles explained are there also applicable for substances in other materials for articles.
What is needed in the CSR when a service life use is reported in IUCLID?

If you report one or more uses in Section 3.5.6: Service Life of IUCLID, and the sub-stance you register meets the criteria of Article 14(4) of REACH for classification as haz-ardous (or considered PBT/vPvB), then your CSR must contain the corresponding expo-sure scenario(s). The exposure scenario(s) for service life are expected to address the conditions driving the release/ exposure. This usually includes the concentration of the substance in the material forming the article, the type of activity (associated with PROC) with the article and the related conditions of use for workers, or the type of article (asso-ciated with AC*) and related conditions of use for consumers.

*Note that for consumer activities, the use descriptors Article Category (AC) 1,2 and 3 refer to multi-material complex objects, which cannot be assessed as such in a contrib-uting scenario without further information on the type of material in which the substance occurs. Registrants are therefore advised to refer their contributing activities by consum-ers and their assessment to the material-based Article categories AC 4 to AC 13.

Each contributing scenario usually requires an estimate of the releases from the article and a corresponding exposure estimate and risk characterisation. Tools are available to help with this: ECHA's practical guide Describing uses of additives in plastic material for articles and estimating related exposure provides an overview on methods and tools that contains useful information also for other materials.

When considering how to complete your CSR to assess one or more uses (Service Life) reported in section 3.5.6 of IUCLID there may be situations that justify the absence of quantitative exposure assessment if relevant explanation is provided. The expected ex-planation depends on the situation you encounter:

  1. The substance is contained in concentration in the article material below the cut-off values as laid down in Regulation 1272/2008 (CLP) in relation to the mixture classification (using by analogy Article 14(2) of REACH, as a benchmark). If so, your dossier must contain explanation on the points listed under section A below.
  2. The substance reacts on use, and hence is not available for exposure anymore during service life. If so, your dossier must contain explanation on the points listed under section B below.

In contrast, simply stating that a substance is expected to be released from the article only in very small [negligible] amounts is not considered a valid argument to justify the absence of a quantitative assessment. The extent of exposure during handling or pro-cessing of articles depends on the conditions of use (e.g. abrasive processes, elevated temperature, intensity of dermal contact), the concentration of the substance in the arti-cle material and the interaction between the substance and the article material. In addi-tion, the hazard of the substance plays a role when determining whether the release is sufficiently low to guarantee control of risk. If situation A/B do not apply, you are there-fore expected to quantify the release, exposure and risk resulting from the service life use. If you don’t expect any reasonably quantifiable release on one or more routes, you may set the relevant release estimate(s) to zero and describe the related conditions of use in the contributing scenario. These conditions of use may, for example, include:

  • no dermal contact, because the substance is embedded in the internal parts of the article, or the substance cannot migrate through a shielding surface layer.
  • no oral contact during service life, because mouthing of the material by consumers or food contact not foreseen.
  • no water contact during service life because the material is not foreseen to be used in articles for outdoor use, in pipes or similar articles, and also cleaning with water is not foreseen (e.g. as for flooring material).

A) Justification related to low concentration

To justify the absence of quantitative exposure assessment for certain service life uses due to the low concentration of your substance in the article material, your reasoning must include: the concentration of the substance in the article material and the following information:

  • If the concentration is below 0.1% (this corresponds to the lowest concentration in table below), no further reasoning is expected at TCC, unless a specific con-centration limit (below 0.1%) for mixture classification is applicable to the sub-stance (in which case such cut off should be used). In addition, for substances classified for the environment as ‘Acute Category 1’ or ‘Chronic Category 1’, 0.1% is to be divided by the M-Factor to determine the substance-specific cut-off.
  • If the concentration is above 0.1%, you must provide the hazard category(ies) and class(es) of your substance and the corresponding cut-off(s) from CLP, indi-cating the concentration above which your substance must be taken into account for the purposes of mixture classification. Based on this, you can demonstrate that the concentration in the article material is below the lowest cut-off relevant to your substance.

Such justification must be provided for each exposure scenario to which it applies.

B) Justification related to reaction on use

If a hazardous substance reacts on use, such reaction may be fast and complete (no re-sidual parent substance available for exposure) or some parent substance may remain, and the reaction product may be more hazardous or less hazardous compared to the parent substance. Therefore, the “disappearance” of the parent substance alone is not a sufficient argument for the absence of the exposure assessment.

To justify the absence of quantitative exposure assessment for certain service life uses you must quantify the residual concentration of the parent substance, and you must pro-vide information on the chemical nature and the known/expected hazard of the transfor-mation products. Your reasoning must include the following elements:

  • To justify the absence of assessment of your substance:
    • Provide an explanation how the substance transforms (including the reaction mecha-nism and the identity of the transformation products) and quantify the remaining re-sidual concentration of the substance in the article material (under the conditions of use of the service life).
    • Compare the concentration of the substance in the article material with the cut-off concentration from the mixture classification rules (see table below) and provide the information as specified in point A above
  •  To justify the absence of assessment for the transformation product(s):
    • Explain the available evidence that the transformation product(s) do(es) not meet the criteria for being considered hazardous.

Such justification should be provided for each exposure scenario to which it applies.