CoRAP and Substance Evaluation

When a substance is included in the CoRAP, are there any mechanisms by which a registrant can challenge the inclusion or provide input into the evaluation process?

Registrants cannot challenge the inclusion of a substance into the CoRAP (Community Rolling Action Plan).

However, registrant(s) may provide input into the evaluation process. Registrant(s) of a substance in the CoRAP, particularly those substances on the current year of the CoRAP are encouraged to contact the evaluating Member State Competent Authority (eMSCA) early on in the evaluation process. The contact details for the eMSCA are published in the CoRAP. If the dialogue has not already started, the eMSCA will usually contact the lead registrant when the evaluation starts and offer the opportunity to meet to discuss technical issues related to substance evaluation. The registrants should consider nominating a representative for interacting with the eMSCA. The interaction between registrant(s) and the eMSCA at this phase of the evaluation is informal.

When the outcome of a substance evaluation is that an information request to clarify the suspected concern is deemed necessary (i.e. the evaluating MSCA prepares a draft decision on substance evaluation), the registrant(s) will get the opportunity to formally comment within 30 calendar days on any draft decision as part of the decision making process (Articles 50-52 of the REACH Regulation). The evaluating MSCA shall take the comments of the registrant(s) into account and decide whether the draft decision needs to be amended on the basis of the comments/additional information provided by the registrant(s) (Article 50(1) of REACH).

ECHA communicates to the registrant(s) the draft decision as notified to the other MSCAs and ECHA and the received proposals for amendment. At this stage, the registrant(s) will have the opportunity to comment on the proposals for amendment (Article 51(5) of REACH). Registrants are reminded of their obligation to always keep their registration dossier up to date, cf article 22(1).

What is substance evaluation?

Substance Evaluation is an integral part of the REACH implementation. It aims to clarify whether a substance, which has been identified as being of potential concern, poses an actual risk to human health and/or the environment. To clarify the risks, the registrants may be asked for more information on the substance. Substance evaluation shall be carried out by the Member States, whilst ECHA coordinates the procedure. The substances to be evaluated annually are listed in the CoRAP (Community Rolling Action Plan).

Which Member States will evaluate the listed substances?

Member States may volunteer to evaluate a substance. Two Member States may also decide to make a joint evaluation. However, in all cases only one Member State will be designated as the responsible Member State for the evaluation. Final allocation of the substances to the Member States is decided with the adoption of the CoRAP by ECHA, based on the opinion of the Member State Committee (MSC) on the draft CoRAP. Thus, the CoRAP will include for each substance on the list the Member State responsible for the evaluation. The contact information of the responsible competent authority will also be reported for the substances to be evaluated in the first year, to inform the stakeholders about the body handling each substance.

In case of joint evaluations by two Member States, the co-evaluating Member State is also indicated in the CoRAP.

What happens after the CoRAP is adopted?

From the publication of the CoRAP, the respective Member States have one year to evaluate substances listed for the first year (n) and, where regarded as necessary, to prepare a draft decision for requesting further information to clarify the suspected risks. The evaluation of the substances listed for the second and third year starts only after the publication of the CoRAP update in year n+1 and year n+2 respectively.

What is the difference between dossier evaluation and substance evaluation under REACH?

Dossier evaluation comprises the examination of testing proposals and compliance check of registration dossiers. Testing proposals are triggered by the REACH information requirements and all testing proposals submitted by the registrants must be examined by ECHA. The aim of this examination is to decide on the most appropriate testing in order to fulfil the REACH information requirements. ECHA can perform a compliance check on any registration dossier to verify whether the REACH information requirements are met. Dossiers can be chosen for compliance check based on random selection or prioritised based on a specific concern.

The substance evaluation process is triggered as a result of risk-based concerns and aims to clarify whether a substance poses a risk for human health or the environment. Substance evaluation is targeted at substances (including aggregated tonnages, all uses, etc.). Under substance evaluation any information (beyond the REACH requirements) can be requested provided that it is considered necessary for the purposes of risk assessment of the substance.

Substance evaluation is carried out by the Member States, while ECHA is responsible for dossier evaluation.

The decision making process is essentially the same for both processes.

What is the added value of substance evaluation?

Substance Evaluation may identify risks that could otherwise be missed. This process can further create additional value in respect of:

  • Concerns that go beyond the control of the individual registrant, like regional risks or the potential additional risk caused by aggregated exposures of a (sub)population or releases into the environment.
  • The assessment of groups of similar substances to predict cumulative effects and potentially increased risk levels from exposures to the different substances in the group. 
  • If considered scientifically necessary and proportionate, the request for additional information can go beyond the standard information requirements in REACH.
Why is a substance on the CoRAP list? Which criteria have been used?

The REACH Regulation Article 44(1) provides the general criteria for substances to be selected for substance evaluation. The legal text defines that prioritisation shall be on a risk-based approach. According to Article 44(1): "(...) the criteria shall consider:

hazard information, for instance structural similarity of the substance with known substances of concern or with substances which are persistent and liable to bio-accumulate, suggesting that the substance or one or more of its transformation products has properties of concern or is persistent and liable to bio-accumulate;

exposure information; tonnage, including aggregated tonnage from the registrations submitted by several registrants".

The criteria have been refined by ECHA in cooperation with the Member States and are published on ECHA's website: Selection criteria to prioritise substances for Substance Evaluation (2011 CoRAP selection criteria) http://echa.europa.eu/documents/10162/13628/background_doc_criteria_ed_32_2011_en.pdf.

These criteria are applied in the initial step of the identification of substances with potential concerns. A further screening and selection process takes into consideration whether the substances are already subject to regulatory measures and the effectiveness of the substance evaluation to clarify the concern by requesting further information on the substance. Thus, meeting the risk-based criteria alone does not automatically mean an inclusion of the substance in the CoRAP.

According to Article 45(5) of the REACH Regulation, a Member State may notify ECHA of a substance, whenever it is in possession of information suggesting that the substance is a priority for evaluation. Thus, the CoRAP may also contain substances that have been included based on notifications from Member States.

Both hazard and exposure information (or a lack of it) is taken into consideration upon prioritising the substances. In the first CoRAP with many substances, the initial concerns are generally related to potential PBT-properties, suspected endocrine disruption, or carcinogenic, mutagenic and reprotoxic properties in combination with wide dispersive or consumer use(s) and/or high tonnages. In general, the uses of these substances cover various areas and do not focus on any particular industrial, professional or consumer uses.

The final published CoRAP also contains a general indication of the reasons why the substance was prioritised and selected for substance evaluation (grounds for concern). Before inclusion in the CoRAP, the substances have not been evaluated and thus the indicated grounds for concern are just an indication of the possible areas of risk, based on the selection criteria. The initial grounds for concern should not be taken as a statement on a known risk or as a statement on what the evaluation will cover. During the evaluation, other areas of concern may be identified and investigated further. Only after the substance evaluation is completed, risks can be defined and communicated. The Member States have agreed that from the first update of the CoRAP in 2013, more detailed justification documents regarding selection of each substance will be prepared and published.

What does a known or suspected property mean in the grounds for concern in the CoRAP?
For example, the difference between known and suspected CMR-property is the following: "Known" means that the substance has either a harmonised classification and labelling or a self-classification chosen by the registrant(s) for one or more of the CMR-properties. "Suspected" means that e.g. non-conclusive information on intrinsic properties or results of structural prediction models indicate that the substance could have CMR-properties.
(CMR = carcinogenic, mutagenic, toxic to reproduction)
When was the first CoRAP adopted?
ECHA submitted a draft CoRAP to the Member State Competent Authorities and the ECHA Member State Committee in October 2011. The draft CoRAP was also published on the ECHA website to inform the stakeholders. The Committee gave its opinion on the draft CoRAP in February 2012. On the basis of the Committee's opinion, ECHA adopted the first CoRAP on 29 February 2012.
Is the CoRAP a new "black list" of chemicals?
The CoRAP list is neither a black list nor a sunset list, i.e. it will not cause a substance to be taken off the market. Instead, substance evaluation is a mechanism to evaluate and get more information on the substances listed therein, when there are concerns that the substances may pose a risk to human health or the environment. The evaluation can result in the conclusion that the concern is resolved and thus no further action is needed. If the initial concern is confirmed in substance evaluation, the Member State may consider further risk management options such as harmonised classification and labelling, restriction or authorisation to control that risk for a respective substance. However, that would be subject to a separate process.
What is the impact of substance evaluation on my business?

The listing of a substance on the CoRAP does not in itself have any legal impact on the registrant and thus does not require any further action by the registrants. When the CoRAP is adopted/updated, the registrants of substances listed for the first year of the CoRAP may expect to receive a draft decision requesting further information after the evaluation period of 12 months. At that point of time, the registrants will be given an opportunity to comment before any final decision to request further information is taken. The final decision will contain a deadline by which the additional information must be submitted.

On the other hand, if the evaluating Member State comes to the conclusion that no further information is necessary to clarify the risk, the substance evaluation process is concluded without a decision to request further information.

Inclusion of a substance in the CoRAP does not automatically mean that the substance poses a risk to human health or the environment, but rather that there is a concern that it may pose a risk, which needs to be clarified (confirmed or dismissed). It also does not automatically trigger, for example, the restriction or authorisation process. However, the Member State responsible for the evaluation of a substance may consider these options once the evaluation is finished, if the risk is confirmed.

Once adopted, is CoRAP fixed?
The CoRAP list will cover a period of three years. The first CoRAP thus includes substances planned for evaluation in the years 2012, 2013 and 2014. The plan should be annually updated. ECHA will make a proposal for the annual update at the latest by 28 February each year. However, currently ECHA plans that the updated CoRAP could already be adopted by the end of February and thus the draft for the CoRAP would be prepared and communicated already in October/November of the previous year. Thus, the first update is expected in February 2013. The rolling nature of the plan means that the list of prioritised substances included for evaluation during the second and third year may change when the plan is updated (e.g. a substance may be dropped or new ones introduced) and that each year a new subsequent year is added.
Is there any interaction between the evaluating Member State and the registrants/stakeholders?

The REACH Regulation does not foresee any formal interaction during the 12 month evaluation process i.e. before the possible draft decision is prepared. Once the draft decision is issued, the registrants will be contacted via REACH-IT. During the decision making procedure registrants will be consulted on any prepared draft decision and proposals made to amend this draft decision. The registrants may submit comments that will be taken into account in the decision making of the evaluating Member State and by the Member State Committee, if the draft decision is referred to the Committee.

The possibility for registrants/stakeholders to interact with the evaluating Member State during the evaluation phase may differ between Member States and substances that are evaluated. However, interaction between the registrants / stakeholders and the evaluating Member State is appreciated in general under substance evaluation. Thus, all relevant information available to the registrants of the substances should be included in the registration dossiers by the start of evaluation (i.e. March each year).

What is the outcome of substance evaluation?

If the evaluating Member State considers that further information is necessary to clarify a potential risk caused by the substance, it may draft a decision specifying the additional data requests. The initially identified concern in the CoRAP does not limit the evaluation made by the Member States and thus the potential request can address any property or exposure scenario of the substance. The registrants of that substance will have an opportunity to provide comments on the draft decision. Such a draft decision will be reviewed and agreed by the other Member States and ECHA, and in the case of proposals for amendment also by the Member State Committee. After this procedure, ECHA will take the final decision in line with the agreement in the Member State Committee. If no unanimous agreement is reached by the Member State Committee, the decision will be taken by the European Commission. The decision will contain a deadline by which the registrants must submit the requested information. It may also be that no request for information is needed because the risks can be clarified with the information already available.  In such cases, the substance evaluation is considered to be completed.

Once the registrants submit the requested information, the responsible Member State has another 12 months to assess this information and decide whether a further request for information is necessary or whether the evaluation can be concluded. In this latter case, the responsible Member State should consider whether and how to use the information obtained for the purposes of Community level risk management measures. The Member States may conclude:

  • EU-wide risk management measures are necessary (e.g. EU wide restriction, EU-wide authorisation, EU-harmonised classification and labelling, occupational exposure limits, measures for the protection of the environment under the Water Framework Directive) or
  • Actions at national level should be taken.

The conclusion can also be that the risks are sufficiently under control with the measures already in place. ECHA informs the European Commission, the registrant and the other Member States about the conclusions.

The decisions on data requests and evaluation reports will be made publicly available once finalised. It should be noted that as the production of the information requested may, in some cases, take several years (e.g. in the case of long term studies and annual environmental monitoring) finishing a final evaluation report may also take several years from the adoption of the CoRAP.

After adoption of the CoRAP, when can a possible first decision requiring further information on a substance be expected? If further information is requested, when would this become available?

From the publication of the CoRAP (March each year), the Member States have 12 months to prepare a draft decision for a substance included for evaluation during the first year, i.e. by end of February of the following year. After that, the decision making process may take approximately four to eight months depending on whether the Member State Committee is involved or not. Thus under favourable conditions, first decisions are likely to be taken between the middle and end of the following year after CoRAP inclusion. The registrants will have the opportunity to comment on the draft decision before the final decision is taken.

The decision will define the deadline by which the registrant(s) must provide the necessary information. Depending on the type of information, the deadline may be between some months and several years.

What is the follow up of substance evaluation?

"Follow up" under substance evaluation means: once the requested information is available and evaluated by the Member State, it will consider whether and how to use the information obtained for the purposes of Community level risk management measures.  The follow up can either be no action or recommendation to take further actions, such as to propose EU wide risk management measures.

A follow up conclusion under substance evaluation is not directly initiating further risk management measures. Any proposed Community-wide actions will be subject to a separate decision making process and Member States need to file a notification for this purpose. For authorisation, restriction and/or harmonised classification under the REACH and the CLP Regulations, stakeholders are consulted at all relevant stages of the process and decisions are taken on the basis of the opinions adopted by the ECHA Committees.

Are substances in the (draft) CoRAP going to be included in the authorisation/restriction processes?
There is no direct link between the CoRAP and the authorisation/restriction processes. While inclusion in the CoRAP means that a substance is going to be evaluated by a Member State to clarify whether there is a potential risk by asking further information, the restriction or authorisation processes aim to control known risks, which cannot be managed by other risk reduction measures. Thus, a follow-up to substance evaluation may be that a Member State wishes to start an authorisation or restriction process.
Where can I get more information on the CoRAP substances?

Information on the substances is available on the ECHA website. This website contains non-confidential information on the properties and uses of the substances that have been retrieved from the registrations for each substance.

Decisions on requests of further information and substance evaluation reports prepared by the Member States will also be published on the ECHA website, when they are available.
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