Q&As

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REACH

Screening of substances of potential concern

(Manual) screening process and timelines

Does ECHA manually check the results of the IT screening?

ECHA validates and quality checks the IT algorithms but does not examine all individual findings one-by-one. The IT results for a selected substance are checked and validated by the Member State competent authorities (MSCAs) during the manual verification phase (manual screening).

What is the timeline for manual screening?

ECHA releases the shortlist of substances of potential concern in late January and Member States have until mid-March to select substances for manual verification.

The manual verification can take from a few days to several weeks, depending on the complexity of the case. There are two deadlines for the Member States to finish their screening.

If they wish to place the substance on the draft CoRAP list for next year, they need to submit their screening results by the end of May 2017.

For all other substances, they need to submit their screening results by the end of July 2017.

For more information on the screening process and timelines, please see the Common Screening Approach document: https://echa.europa.eu/documents/10162/19126370/common_screening_approach_en.pdf

How is the outcome of the manual screening communicated to registrants? Will the registrant be informed if there is no action? How do Member States decide on the follow up actions?

We recommend monitoring the ECHA dissemination on a regular basis to see if some further actions have been started on your substance: http://echa.europa.eu/information-on-chemicals

The manual screening can result in the following outcome options:

  • Need for other action (e.g. enforcement or action under other regulations);
  • No need for further action.

If the outcome of the manual screening would be no action, the substance would not appear in any follow up action. However, this information is not made publicly available and is not communicated to registrants. Manual screening cannot be completely comprehensive and even though the MSCA considers that no action is needed at present, the substance may be selected for manual screening again at a later date. New information or new uses may change the outcome of the screening.  

Please note that it is up to the Member States to decide on the outcome of the manual screening.

In general if there is enough information to conclude that there is a concern, then the immediate follow up would be RMOA or CLH. If there is a need first to generate additional information, then either compliance check or substance evaluation would be selected by Member States. Registrants can influence the outcome of manual screening by timely updating their dossiers with any additional information/clarification

Do MSCAs select substances from the shortlist or are they allocated? Can we know which MSCAs manually verify our substances? Is it possible for the registrants to have a face to face meeting with the evaluating authority to clarify some question the evaluating MS may have before they render their opinion on the substance?

MSCAs select their own substances from the shortlist and not all substances are necessarily selected. We don’t publish the outcome of the screening or the evaluating MSCA but whenever a regulatory activity is initiated on a substance, the Member State or authority initiating the activity is published on our website, along with their contact details. When a regulatory action is started on a substance, a face-to-face meeting might be possible if initiated by the MSCA but no such interaction is foreseen during manual screening. 

Does ECHA consider other on-going REACH/CLP processes before shortlisting a substance for manual screening? Are substances with ongoing processes removed from the shortlist?

We check to see whether there are any ongoing activities with the substance or similar substances before shortlisting. Depending on the nature of the process and the concern examined in these ongoing processes, we may exclude the substance from the shortlisting or inform the evaluating MSCA of the ongoing process.

What is the difference between the shortlist for manual screening of substances of potential concern and the list of substances for potential compliance check (CCH)?

The shortlist for manual screening is only released to MSCAs once a year and aims to identify candidates for several REACH and CLP processes. Member State competent authorities perform the manual screening. Compliance check can be an outcome of this manual screening. However, substances may be selected for Complicance Check by other means.

The list of potential candidates for CCH is updated several times a year, published on ECHA’s website and aims to identify candidates with specific data gaps that can be addressed with CCH. 

There are additional explanations provided in the CSR, which are not noted in IUCLID. Will the CSR be carefully reviewed during the manual verification?

Yes, the CSR will be examined during the manual verification of the IT-screening.

How is manual screening linked with other processes under REACH or CLP? Can a substance enter one regulatory process (e.g. CoRAP, SVHC) without being screened (e.g. a substance with a harmonised classification and labelling, SVHC substance)?

During manual screening, MSCAs determine whether regulatory action is needed for a substance and if so, which is the most appropriate action.  It is therefore the first step for most substances entering the other processes under REACH or CLP. However, Member States can propose a substance for the CoRAP or initiate regulatory action on any substance at any time so it is possible for a substance not to go by screening and go straight to the CoRAP, RMOA (PACT listing) or regulatory risk management. MSCAs may select substances based on their prioritisation schemes, although every effort is made so that all MSCAs and ECHA collaborate in common screening.

Note though that there is a general agreement among Member States to have a RMOA done first before proposing a substance for being identified as an SVHC or to go through the restriction process.

Can registrants propose to delete one substance from the shortlist?

It is not up to the registrant to decide whether one substance should be deleted or not from the shortlist. For a substance considered as not being hazardous and/or for which there is no need to go for further action based on uses and exposure information, the outcome of the manual screening done by the Member States will most probably be no need for further action for the time being.

How can registrants know if their substance has been manually screened?
If a substance is shortlisted for potential manual screening, a letter will be sent to the registrants through REACH-IT. The letter will be in the form of an Annotation to your latest submission of your substance. If you have many registered substances, please note that REACH-IT will send you an alert to your email whenever an Annotation is created for any of your submissions. Registrants may also be contacted via a letter to explain that their substance is being assessed as part of a substance group.
Why is the list of substances not published? Isn't it ECHA's aim to be more transparent?
ECHA does not publish the shortlist as it is based on an unverified IT selection of substances. Publishing it might result in unwarranted blacklisting of substances. The statistics from each round are published annually in the SVHC Roadmap annual report.
General questions

Where can I find an explanation for all the abbreviations used in substance screening?

­An "ECHA-term" page is available from the front page of ECHA’s website. Acronyms mentioned during the webinar presentation may not all be found there. We recommend you first to consult the document entitled "a common screening approach for REACH and CLP processes".­

The document can be found at: https://echa.europa.eu/documents/10162/19126370/common_screening_approach_en.pdf

What are the differences between manual screening in this process and manual verification done during the completeness check after the submission of a registration dossier?

They are of very different nature. The manual screening process aims at identifying substances of potential concern for regulatory action. The manual verification done in conjunction with the automated completeness check aims at verifying certain elements of the registration dossier that cannot be checked automatically, to ascertain that all the information required by the legislation has been included in a REACH registration. Further explanation of manual verification at completeness check is given here: https://echa.europa.eu/documents/10162/13652/manual_completeness_check_en.pdf

How are UVCB substance treated in the manual screening procedure?

There is in principle no differentiation made between the different substance types (well-defined vs UVCB). Our screening algorithms are applied to registered substances regardless of the substance type (mono-constituent, multi-constituent or UVCB). A potential concern can be identified based on their individual constituents. It is important that the compositional information of UVCBs is properly documented­ in the REACH registrations.

When prioritising substances for possible screening, do you take into account whether a substance was evaluated under the old Existing Substances Regulation (ESR, Council Regulation (EEC) No 793/93) process?

A substance is not excluded from screening just because it has been evaluated under the old ESR process but any conclusions reached during this evaluation should be taken into account during manual verification. ECHA is using a range of internal and external regulatory sources to ensure that previous or on going actions on the same or similar substances are identified and are made available to the MSCAs so that their relevance for the newly identified concerns are fully addressed.

Screening for endocrine disruptors

What are the criteria for endocrine disruptors?

The European Commission announced last June scientific criteria to determine what is an endocrine disruptor under the pesticides and biocides regulations. Although there are no criteria for identifying endocrine disruptors under REACH, at the moment they are identified case-by-case based on the WHO/IPCS definition.

According to the recommendation of the EU Commission's Endocrine Disruptor Expert Advisory Group (ED EAG), factors such as severity, irreversibility, lead toxicity and potency can be considered to characterise the hazard potential of an endocrine-disrupting substance, e.g. when assessing the relevance of a substance for consideration in regulatory terms.

Therefore, on the basis of the WHO/IPCS definition, it is possible to search for indications that a substance may be endocrine active and/or elicit adverse effects that are (potentially) mediated by endocrine modes of action and the lack of criteria under REACH is not a reason to postpone screening activities.

For the purposes of screening, it is sufficient if algorithms identify endocrine active substances although some scenarios provide suspicion of adverse effects potentially caused due to an ED mode of action. The substances will then be manually screened and any ED activity and/or adverse effects will be scrutinised.

­Please refer to the screening definition document for more details on our current approach in identifying potential ED substances in common screening algorithms.­

ECHA’s letter indicates that the registered substance (or an impurity in it) may be an endocrine disruptor. How should this endpoint be addressed in the dossier, as it is not one of the standard endpoints?

Endocrine disruption may manifest itself in toxicological and ecotoxicological standard (in REACH Annexes) tests. As explained above, and in more detail in our definition document, common screening is looking for such evidence. ­Therefore, if there is a concern for ED properties based on the dossier, or external data, registrants might perform or propose further specialised in vitro or in vivo ED tests as necessary. In case such test results are available they should be included in the registration dossier, even if they do not constitute standard information requirements.

The OECD Conceptual Framework for Testing and Assessment of Endocrine Disrupters lists the OECD Test Guidelines and standardised test methods available, under development or proposed that can be used to evaluate substances for endocrine disruption and could provide a guide to the tests for endocrine disrupters’ assessment.

When considering a substance as a potential endocrine disruptor, which external lists does ECHA consult? There are a number of publications claiming endocrine disruptor effects that use unvalidated assays or poor quality data.

For the IT-screening, we use external lists of suspected ED such as the Commission, WHO, TEDX and SIN lists. Further evaluation steps during the manual-screening conducted by the MSCAs will assess the reliability of the available evidence on a case by case basis. However, the listing of a substance in an “ED-list” is never used as stand-alone criterion to suspect a substance as potential ED but always in combination with other information. The different sources of information and how these are used are described in the definition document that is updated annually at: http://echa.europa.eu/addressing-chemicals-of-concern/substances-of-potential-concern/screening

Substance grouping

Is substance grouping information being published?
ECHA is carrying out substance grouping to support all REACH and CLP regulatory activities. The results of this exercise, that involve both computational and manual verification steps, are not made publicly available but only shared with MSCAs. However, for some substance groups ECHA and MSCAs may approach registrants indicating that their substances are to be assessed in a group. Registrants may receive separate communication to indicate this. The communication policy may change in the future.
If in a given group of registrants, there are two very similar substances (same tonnage band, same hazard profile and the same registered uses) and one of them was shortlisted and the other one was not, what could be the reason for that?
­ECHA is trying to identify relationships among substances and construct substance groups that are to be evaluated together and at the same time, by the same Member State. However, it is possible that two similar substances are indeed evaluated at different times, if for example for one of the substances there are on-going regulatory actions that prevent evaluation at the moment, such as awaiting the outcome of a test or the conclusion of a risk management option analysis. It is also possible that our substance grouping algorithms failed to identify certain structural relationships, especially for not well-defined substances.
Is ECHA sending letters to registrants for all substances in a substance group?
ECHA sends letters to all registrants of full registrations that have been shortlisted using the screening scenarios as described in the definition document. However, if additional substances have been identified that are related (via structural similarity or read-across/category) to these substances, but have not themselves triggered shortlisting, ECHA is not sending information letters. However, for some substance groups all registrants may receive separate communication indicating that the substances will be assessed in a group. 
When are substance groups formed?
ECHA forms groups as part of the short list compilcation. The groups are manually verified before the short list is provided to MSCAs, but without examining in detail whether any differences in structures are toxiclogically important. This is done during manual screening by MSCAs, which means that the group boundaries may be altered after the short list is finalised. On some occasions, the grouping may only hold for some endpoints and not for for others. Finally, it is possible that ECHA and MSCAs carry out a second, more precise screening for additional substances that may have the same hazardous properties if based on the manual screening there is a need to do so and the accumumlated knowledge and increased understanding indicates that a more precise grouping approach is warranted. 
How comprehensive is ECHA’s grouping?
ECHA utilises all available information for grouping substances. The algorithms use all available identifiers in all registrations, compositions and reference substances in IUCLID dossiers. Hence, it is quite likely that all structurally related substances are identified, to the extent the submitted information allows to do so. However, for certain substances, such as inorganic UVCBs, substance grouping may be less accurate and may require additional manual effort for fine tuning the approach and manually verifying the accuracy of the results.
Does ECHA use mode of action information for forming groups?
At the level of manual screening, grouping is mostly chemistry based with limited consideration on the specific mode of action. This is partially due to complexity but also because prior to manual screening we are not certain that all hazards have been identified. Additional grouping may be carried during manual screening if needed and requested by the MSCAs, in which case available information on likely mode of action will be taken into account to design a grouping approach that reflects this knowledge.
How robust is substance grouping?
Substance grouping at the level of short listing is designed to be inclusive rather than robust. It is indeed true, that small differences in molecular structure that are considered insignificant for grouping are toxicologically relevant. Such considerations will be made during manual screening, in which case it is possible that the group will be split in smaller subgroups, or the substances will be assessed individually. Hence, the robustness of the group depends at the process/stage we are at and at the level of certainty this stage requires.
Can substances handled by one consortium be under regulatory scrutiny because of related substances not handled by the same consortium?
Substance grouping does not take into account who is the registrant or the consortium to which the registrant belongs. Hence, in principle it is possible that substances handled by different consortia are grouped together if this justified by their structural similarity and expectation of similar toxicological profiles. In case grouping was based on read-across or categories the chances are that the substances are handled by the same consortium though.
How are UVCBs and impurities handed in the grouping approach?
Generally ECHA is using all substance identity information in registration dossiers for generating structures and for executing the screening scenarios. However, when it comes to substance grouping impurities and minor constituents are not considered. In other words, structural similarity only considers consituents above a given concentration threshold. However, the presence of the impurities may be a reason to short list the substance because of their hazardous properties. With regard to the grouping of UVCBs, they are handled like well defined substances if they can be structurally represented with a representative structure or possibly a set of representative structures. Moreover, grouping based on read-across or categories is not affected by the substance composition.
Can information on similar substances influence the outcome of manual screening for substances that have their own dataset?

When substances are grouped because there is evidence that similar hazards are to be expected, then the datasets of all substances are considered together in manual screening. This approach may, to some extent, alleviate issues with information deficiencies for one or more of the substances in the group that in principle could not be assessed on their own without generating further information. However, if there are reliable experimental data on the same substance and these prove that the suspectd concern does not hold then these data will overrule any conflicting evidence from similar substances (and even question the robustness of the grouping).

Does the grouping approach consider read-across endpoint study records that have been automatically migrated to IUCLID 6?

The grouping algorithms consider all information in registration dossiers, including migrated read-across endpoint study records. However, the clarity of such information is significantly reduced compared with a dossier that has been submitted to benefit from the additional features provided by IUCLID 6, that include a much clearer presentation of read-across information using two separate endpoint study records for the source and target substances. Moreover, the automatic migration may have introduced artefacts in the test material identifiers due to initially poorly subsmitted test material information in IUCLID 5.x. In such case the grouping algorithm may be less accurate. In the interest of efficiency, registrants are advised to consider updating their registration dossiers so that they can manually examine the correctness of the migration and use the new features of IUCLID 6

My substance has been shortlisted because it is structurally similar to a substance in the Candidate List. The entry in the Candidate List does not refer to a specific substance but is a group entry. How can I find out the substances covered by the candidate list entry?

Some entries in the Candidate List of SVHCs are indeed group entries covering several substances. To find out the substances covered by such entries, please consult first the support document which defines in more details the substances belonging to the entry. The document is accessible by clicking the last column of the relevant Candidate List entry. ECHA also normally publishes a non-hexaustive list of substance identifiers on the same webpage in a separate document entitled “Non-exhaustive list of Substance identifiers”.

Update of registration dossiers

How does ECHA decide whether to inform a registrant of the shortlisting of a substance they registered? As a recipient of the letter informing of the shortlisting of my substance, should I update my registration?

For transparency, ECHA informs all the registrants of the shortlisting of a substance they registered. No differentiation is made between lead registrants, member registrants or individual registrants. No differentiation is also made between registrants at the level of the information they submitted separately. However, letters are typically only sent to registrants who have submitted full registrations according to REACH Article 10.

You are not formally required to update your registration. However, if you consider that the information in your own registration is not up-to-date, or that you have additional data that may assist with the assessment of your substance, ECHA recommends updating your dossier by the deadline specified in the letter you received. If the information to be updated is submitted jointly, the lead registrant can update the registration they submitted on behalf of the co-registrants. The updated information will be taken into account during the manual screening carried out by the MSCAs or during any potential follow up regulatory action.

The time between receiving the letter and the date to update the dossier is quite short (ca. 1 and a half months). This time is too short to understand why the substance has been selected (especially if it comes from external sources), review the full dossier and define the update to do with experts and co-registrants, particularly if more than one substance is implicated. Can the period between the letter and update deadline be increased?

ECHA is aware of the short time between the receipt of the letters (end of January 2017) and the start of the manual screening work by the MSCAs (mid-March 2017).

On a monthly basis, ECHA provides the MSCAs with a report with all the updates submitted for the shortlisted substances. Therefore, if a substance is selected for manual screening, MSCAs will be informed about dossier updates, in case these updates cannot be submitted before the start of the manual screening work.

Please note that dossier updates not considered during the manual screening will be valuable if the substance is selected for further regulatory processes as a result of this manual verification. Unfortunately, we cannot send the letters earlier than January because this is when the shortlist is finalised.

If a registrant or group of registrants come to the conclusion that the dossiers are up-to-date and the concerned raised is sufficiently disproved, do they still need to update the dossier or communicate with ECHA? Is it possible to send a clarification letter with a document (i.e. peer reviewed papers

The aim of the letter campaign for shortlisted substances is to inform registrants about the shortlisting and to invite them to review the related registration dossiers and consider to update them in particular for information on uses and tonnage per use and possibly on the potential hazard properties, as indicated in the letters, before the manual screening starts.

However, if the registrants are confident that the information in the dossiers is up-to-date, then no action is needed. Registrants can also attach a clarification document/peer reviewed papers in an updated dossier if they wish so. 

The lead registrant updates the dossier for all registrants of the substance and indicates that they confirm the data of the dossier. In this case, should this confirmation be filled in a remark field of the IUCLID dossier? Or should each registrant update its own dossier? Or should each registrant answer to ECHA’s letter?

Registration updates are only relevant if new/revised information is to be included. If the information in your registration is correct, you do not need to update your dossier or respond to the letter you received.

If relevant new/revised information is to be included in a dossier submitted jointly, an update by the lead registrant is sufficient if this new/revised information is valid for all registrants. However, if the new/revised information to be included in a dossier updated is members’ specific (e.g. information on substance composition or on specific uses) then it could be that only certain members need to update their dossiers.

What provision is made for problems with ECHA's IT systems hindering meeting a deadline outlined in a letter? I ask this because of recent problems with REACH-IT and other ECHA websites.

The deadline set in the letter for shortlisted substances is the date when MSCAs may start the manual screening. It is important to clarify that these are informative letters, so there is no legal obligation to update registration dossiers. However, it is in the registrant’s own interest to review their dossiers and ensure that information on potential hazard properties and uses is up-to-date. REACH-IT is not foreseen to be non-operational over a significant period so please consider updating your dossier, if relevant, as soon as possible.

Why is the timing for updating the dossiers in relation to common screening overlapping with the timing for updating the dossiers for potential CCH? This is causing resources constraints for registrants.
­To use resources efficiently, candidates for potential CCH are screened continuously during the year but shortlisting is done only once per year in late January. Therefore, only the current batch of potential CCH candidates overlaps with the shortlisted substances. Future batches of potential CCH candidates will be published later in the year and will not overlap with the actions on shortlisted substances.
If in a given group of registrants, there are two very similar substances (same tonnage band, same hazard profile and the same registered uses) and one of them was shortlisted and the other one was not, what could be the reason for that?
­ECHA is trying to identify relationships among substances and construct substance groups that are to be evaluated together and at the same time, by the same Member State. However, it is possible that two similar substances are indeed evaluated at different times, if for example for one of the substances there are on-going regulatory actions that prevent evaluation at the moment, such as awaiting the outcome of a test or the conclusion of a risk management option analysis. It is also possible that our substance grouping algorithms failed to identify certain structural relationships, especially for not well-defined substances.
In the letters, the reason for shortlisting is quite wide. Could ECHA give more detailed information to the registrant on why the substance was selected for the shortlist (e.g. QSAR tool used, which external list etc.)?

ECHA makes every effort to include as much information as possible in the letters.

However, due to the high number of letters and complexity, ECHA is not in the position to list all technical information that led to shortlisting in the communication letters, such as the entry in the particular external list that was matched against a constituent, impurity or additive in the registration dossier.

Further details are provided in the definition document updated annually at: 
https://echa.europa.eu/addressing-chemicals-of-concern/substances-of-potential-concern/screening

­It is advisable to consult this document if you have received a letter pointing to an external source or QSARs.­

Will companies that do not have registration obligations be also informed if their substance is shortlisted? E.g. based on their CLP notification? If new registrants join the registration after the letter campaign, will they receive a letter?
Only REACH registrants with full registrations are included in the letter campaign and the letters are only sent to those individual registrants and registrants that are part of the joint submission at the time of the letter campaign. For other registrants joining later, they will have to rely on the communication in their SIEFs.
What are the benefits for the registrant to update the dossier and more generally to learn about the early phases of the common screening approach? Should this be considered in the communication/planning

One of the aims of the letter campaign and interaction with Registrants in the early phases of common screening is to increase transparency of authorities' work in the early stages of substance selection and to give Registrants the possibility to clarify the potential hazard and use profile of their substances. The improved quality of the registration dossiers will in turn provide authorities a more solid basis for deciding on the need for further actions.

Therefore, if we have in registration dossiers the right information on hazard and uses this will impact the way substances are selected for further processes. Which means, for example, that if a substance is mainly handled under rigorous containment the authorities do not want to spend time on screening it. It is in fact in the interest of both authorities and industry that we focus on substances that matter and for which uses are of relevance from a regulatory risk management perspective. 

Use and exposure-related screening criteria

Can ECHA clarify the information used in the common screening when it comes to prioritisation based on uses and exposure information?

The detailed description of the uses and exposure related screening criteria used to prioritise substances is available in the screening definition document updated annually at: http://echa.europa.eu/addressing-chemicals-of-concern/substances-of-potential-concern/screening. Priority is given to those substances having a high tonnage in uses considered as being wide dispersive.

Note that IUCLID6 has been further enhanced from a use and exposure perspective also taking into account the needs from the screening by authorities. Registration information is the main source of information for screening and it is therefore important that this information is up to date. We are also using external sources of information as listed in the screening definition document to support registration information.

The aim of the screening is to prioritise those substances that matter and for which the need for regulatory action is expected in order to best use the resources of both authorities and industry. For instance a substance registered at 100 tonnes per year for which 99 tonnes goes to intermediate uses and only 1 tonne to wide dispersive uses would be of lower priority compared to a substance with the same tonnage but for which 99 tonnes would go to wide dispersive uses.

This highlights the fact that the following information are needed to best assign priorities to substances:

  • Information on the scope of the regulatory status of the uses (e.g. intermediate use, biocide);
  • Tonnage per use;
  • Whether the use is under rigorous containment to decide whether the substance has wide dispersive use or not.

Authorities are interested in substances where the uses can be regulated by REACH. For each REACH process, exemptions are available and documented both in the REACH Regulation but also in the screening definition document. It is also important to note that this information is used to set priorities among substances.

The screening has so far considered those substances with wide dispersive uses (i.e. professional, consumer and/or article service with potential for exposure to human or release to the environment) as a high priority. However, industrial uses can also be considered wide dispersive and may be prioritised later on as described in the screening definition document. 

If professional, consumer uses and article service life are considered by default as being widesrpread (many users and/or many sites) this is not the case for industrial uses for which it is up to each registrant to indicate whether they believe their uses only take place for instance at few sites and to justify it in IUCLID6.

Substances that have no widespread uses are considered of lower priority for the time being and will not be included in the short list for manual screening by Member States except if they are indications that such substance can be used as a substitute for a structurally similar substances already under regulatory scrutiny. 

How can I gather the information on uses and tonnages in the supply chain? What are the duties of registrants and downstream users?

The screening is done at the level of the substance and therefore considers information on uses coming from all registration dossiers for that substance.

As a consequence, it is in the interest of all registrants to have up to date uses reflected in the registration dossier.

We are aware that it may be difficult to gather information on uses and tonnages per uses from downstream users in the supply chain. However, it should be clear to all that if some uses are relevant for further regulatory action, the Member State will consider the substance for further action even though it may only be present in one member dossier.

It may be difficult and time consuming at the level of the manual screening to gather such information however if the substance is moved to further action then there will be more time and more possibilities for exchange with the Member States and this information can still influence the outcome of the action envisaged for that substance.  

If it is difficult to communicate with your downstream users, we would encourage you to try to explain those considerations. For confidentiality, it will potentially be easier for the downstream user to provide such information directly to the Member State in charge, for instance, of substance evaluation or RMOA. However, it should be kept in mind that providing clarification on the uses as early as possible is in the interest of registrants, downstream users and authorities.

In addition, in ECHA's view downstream users would not disclose confidential business information (CBI) if they break down the tonnage received from their supplier into generic type of use (possibly making reference to the cumulative tonnage fields in IUCLID 6:

  • consumer uses;
  • widespread professional workers;
  • industrial use;
  • service life.

Both lead registrants and co-registrants are responsible for updating the information in their registration dossiers.

Use and relevance of lists, external sources and C&L Inventory

Which sources of information is ECHA using in addition to the data in the registration dossiers?

The primary input to the common screening algorithms come from REACH registration dossiers. With regard to submitted data, common screening also uses the data in the C&L inventory, although more weight is usually given to classifications that are underpinned by test data in the registration dossiers. In addition to the submitted data in REACH dossiers and C&L notifications, the algorithms use external tools and databases to derive molecular structures from the chemical names and numerical identifiers, such as the CAS number and the EC number, when a structure cannot be directly derived from the SMILES and InChI information provided in the registration dossier.

These structures are used to run predictions for fate and (eco)toxicological properties using models. Finally, the algorithms use external lists, such as the SIN list: (http://chemsec.org/what-we-do/sin-list), and the assessments from other regulatory regimes, such as the IMAP programme: (http://www.nicnas.gov.au/chemical-information/imap-assessments/imap-assessments) in Australia. ECHA is also using datasets used for QSAR model development in case the screened substance is identical or similar to one of the tested substances in the training sets.

The different sources of information and how these are used are described in the definition document that is updated annually at: https://echa.europa.eu/addressing-chemicals-of-concern/substances-of-potential-concern/screening.

Is ECHA examining all external sources of information for their validity and regulatory relevance?

The external sources used are carefully selected based on the available information, which includes discussion with the data providers, e.g. other regulatory authorities and non-governmental organisations. Nevertheless, ECHA is not in position to assess every individual entry in the external lists.

ECHA provides all algorithm results to Member States that enables the Member State experts to verify the relevance of all findings before deciding on any required regulatory actions.

If ECHA possesses additional information, such as toxicological assessment accompanying non-governmental substance priority lists, this information is provided to Member States. 

Are the external lists used in common screening referenced in the communication letters sent to industry?

ECHA is making every effort to provide as much information as possible in the communication letters. However, due to the high number of letters and complexity, ECHA is not in the position to list all technical information that led to shortlisting in the communication letters, such as the entry in the particular external list that was matched against a constituent, impurity or additive in the registration dossier.

The external sources are listed in the definition document, which can be consulted for more information. It is available at: http://echa.europa.eu/addressing-chemicals-of-concern/substances-of-potential-concern/screening.

Why is the C&L Inventory used as part of the selection criteria in the IT screening when it is filled with unverified classification data? How do you decide when the classification differs between notifications and REACH registrations?

The C&L Inventory is one of the sources used to identify substances of potential concern as it represents an overview of how the substance is classified on the EU market. We take into account the number of notifiers behind each classification and the consistency of the notifications. Diverging classifications in the C&L Inventory can reveal disagreements among manufacturers and importers on how to classify the substance, which might require regulatory action such as harmonised classification and labelling. The IT screening findings are manually checked by MSCAs during manual verification. In general, we place a higher emphasis on classifications coming from REACH registrations but those coming from notifiers often provide valuable insights into the substance in question.

In the letters, the reason for shortlisting is quite wide. Could ECHA give more detailed information to the registrant on why the substance was selected for the shortlist (e.g. QSAR tool used, which external list etc.)?

ECHA makes every effort to include as much information as possible in the letters.

However, due to the high number of letters and complexity, ECHA is not in the position to list all technical information that led to shortlisting in the communication letters, such as the entry in the particular external list that was matched against a constituent, impurity or additive in the registration dossier.

Further details are provided in the definition document updated annually at: http://echa.europa.eu/addressing-chemicals-of-concern/substances-of-potential-concern/screening.

­It is advisable to consult this document if you have received a letter pointing to an external source or QSARs.­

Use of in silico methods for the screening

Which predictive tools are used for screening?

­We use a variety of commercial and public predictive tools, such as the public tools OECD QSAR Toolbox (http://www.qsartoolbox.org/) and EPISUITE (http://www.epa.gov/tsca-screening-tools/epi-suitetm-estimation-program-interface). The tools are of various kinds, including classical QSAR models and predictive methods based on structural alerts.

ECHA is not in a position to publish the full set of tools used for screening, especially if they are commercial. We try to cover all major REACH endpoints, often with more than one tool, so that the tools can be used in combination to assess the consistency of the predictions.

For certain endpoints, the model predictions are only used as supporting information to other hazard evidence, such as the listing of the substance in priority lists of non-governmental organisations.

Is the quality of the predictions used in screening assessed?

The algorithms use applicability domain considerations when appropriate. Moreover, multiple models are often used in combination to be able to check their consistency. For models where the expected error may be larger, predictions are only used as supporting information to other findings, such as weak/inconclusive evidence of hazard in experimental studies reported in the registration dossiers. The validity and relevance of all findings, including the model predictions are assessed by Member States during manual screening.

Does ECHA carry out its own predictions or are you using the QSAR estimations in registration dossiers?

ECHA is independently running a suite of predictive tools but is also using the model results found in registration dossiers. The screening algorithms use all endpoint study records in the registration dossiers, but they give different weights depending on the reliability of the information provided. This is to ensure that good quality experimental studies have more weight compared with predicted results, although contradicting results are also identified for further investigation.

Which structures does ECHA use to run predictions on?

Common screening uses an extended set of tools to generate molecular structures from the identifiers provided in registration dossiers and C&L notifications. The algorithms consider all registrations/notifications, all compositions and all reference substances in ECHA’s databases.

For each reference substance, we use all identifiers provided, such as the CAS number, CAS name, IUPAC name, SMILES, InChI and synonyms. In this way, we can ensure that the algorithms are run on the broadest possible set of chemical structures associated with the registered substance.

This means that the algorithms also generate predictions for minor constituents, impurities and additives, but their concentration and frequency of occurrence in the joint submission are used as criteria for shortlisting.

ECHA is currently expanding its algorithms to better structurally represent UVCB substances. During manual screening, Member States examine the validity of the predictions, which on some occasions may be compromised due to the generation of erroneous structural information, e.g. when a registrant provides a synonym that points to a molecular structure other than the constituent, impurity or additive indented to be included in the registration.

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