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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).
ECHA releases the shortlist of substances of potential concern in early January and Member States have until mid-Februuary to select substances for manual screening.
The manual screening can take from a few days to several weeks, depending on the complexity of the case. The deadline for screening is end May but for larger and more complex groups, there is some flexibility. However, if MSCAs wish to place the substance on the draft CoRAP list for next year, it is important that the deadline of end May is respected.
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
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:
- Candidate for compliance check (CCH): standard information requirements are not fulfilled: if the outcome is CCH and the substance is considered a priority for ECHA, then the substance would appear in the list of substances potentially subject to CCH: http://echa.europa.eu/regulations/reach/evaluation/compliance-checks
- Candidate for substance evaluation (CoRAP substance): in October each year, the draft CoRAP is published on ECHA’s website: http://echa.europa.eu/ information-on-chemicals/evaluation/community-rolling-action-plan.
If the outcome of the manual screening is as a candidate for substance evaluation, then the substance would appear in the draft CoRAP.
- Candidate for further regulatory risk management:
- Risk management option analysis (RMOA): if the outcome of the manual screening is RMOA, then the substance will appear on the Public Activities Coordination Tool (PACT) available at: http://echa.europa.eu/pact
- Proposal for harmonised classification and labelling (CLH) at EU level: if the outcome is a CLH proposal, then once the Member States are ready to prepare the dossier, the intention to do so will be available at: http://echa.europa.eu/registry-current-classification-and-labelling-intentions
- Need for further assessment before the SVHC properties are confirmed and further regulatory risk management can be decided (e.g. the substance needs to be further assessed and discussed by the PBT or ED expert groups): if the outcome is further assessment and the need is to investigate PBT/ED properties, then this information will be available on: http://echa.europa.eu/pact
- 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
MSCAs make their own selection of the substances from the shortlist and not all substances are necessarily selected. In the case of large groups of substances, two or more MSCAs can collaborate during the manual screening. We don’t publish 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.
We check to see whether there are any ongoing activities with the substance or similar substances before shortlisting. For individual substances, depending on the nature of the process and the concern examined in these ongoing processes, we may exclude them from the shortlist. If a substance with an ongoing RFEACH/CLP regulatory process belongs to a group of substances that merits to be manually screened together by the same Member State, that substance will appear as a group member. ECHA informs the evaluating MSCA of the ongoing process for that substance.
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.
Yes, the CSR will be examined during the manual screening.
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 to go straight to the CoRAP, RMOA (PACT listing) or regulatory risk management without manual screening. 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.
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.
During IT screening, ECHA invites Member State Competent Authorities to propose substances meeting their national priorities to be added on the shortlist. Such substances can be identified based on many issues but are usually not found by IT screening as being substances of potential concern.
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
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
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.
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.
A substance is not excluded from screening just because it has been evaluated under the old ESR process. but aAny conclusions reached during this evaluation should however be taken into account during manual verificationscreening. 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.
If a REACH registration is ceased, the related registration dossier is not taken into consideration for creating the shortlisting. However, if the cease of manufacture occurs after the shortlisting the possible follow-up processes will consider the new status of the registration.
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.
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.
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/screening.
Common screening uses a wide range of QSAR models to detect likely endocrine disrupting properties. Moreover, substances confirmed to be endocrine disruptors are used as “seeds” to identify structurally similar substance that may exert similar properties. Finally, common screening uses external (external means data outside IUCLID registration dossiers) databases with confirmed/suggested endocrine disruptors and external databases with in vivo and in vitro data related to endocrine disruption.
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).
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. This version of IUCLID includes 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 submitted test material information in IUCLID 5. 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
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”.
For substances shortlisted as part of a group, the group members were included in the letter sent to registrants (as separate annex). If no group was indicated, your substance was shortlisted as an individual substance.
If a substance is already included in a group it will be manually screened by the Member States. Registrants cannot influence grouping based on structural similarity. However, they may be able to influence grouping based on read-across or categories by strengthening the read-across argumentation to explain the similarities or dissimilarities between substances. Read-across approaches can also be removed and testing may be proposed instead to fulfil the information requirements.
Yes, groups are based on read-across linkages for the most relevant endpoints even if the substances are structurally different. Of course during manual screening the validity of RA/structural differences will be further scrutinized.
No this is not made available to registrants, however in the letter sent to registrants information on shortlist substances that are part of the same group is given. For structural similarities search the OECD QSAR toolbox can be used.
It is a reasonable initial assumption that similar substances might show similar toxicological properties. The presence of similar functional groups should be picked up by our similarity assessment. Further scrutiny on how structural differences impact toxicological profile are made during the manual screening. Generally, screening uses quite tight structural similarity criteria.
No, groups formed based on algorithms are not fixed. In the first instance the whole group will be subject to manual screening as a whole. However, based on the conclusion of the manual screening it may be that the group is found invalid, or it needs to be split into smaller groups containing substances with likely similar (eco)toxicological modes of action. With regard to any detected information requirements that are not met, it is possible that one (or some) of the substances in the groups may be selected for testing, typically the substance expected to represent worst case.
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.
ECHA is aware of the short time between the receipt of the letters and the start of the manual screening work by the MSCAs
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.
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.
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.
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.
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.
Registration updates are valuable also if received after the manual screening. In such case, the dossier update will be looked at if the substance is selected for further regulatory processes as a result of this manual screening. Please note that ECHA provides the MSCAs with a report with all the updates submitted for the shortlisted substances on a monthly basis.
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/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 widespread (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.
It is important to ensure that the uses reported in your registration dossiers are up-to-date and reflect uses that are on the market.
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.
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.
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/screening.
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.
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/screening.
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 checked by MSCAs during manual screening. 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.
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/screening.
It is advisable to consult this document if you have received a letter pointing to an external source or QSARs.
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.
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.
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.
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.
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.