reachFactsheet

ECHA-11-FS-03-EN

Substance Evaluation
The REACH Regulation contains
a specific process for substanceevaluation. Its aim is to clarify whether
the manufacture or uses of a chemical
substance poses a risk to human health or
the environment.
Substance evaluation is one of the three types ofevaluation processes under REACH. The other two
are testing proposal examinations and compliancechecks, which together are also known as dossier
evaluation.
WHAT ARE THE SPECIFIC FEATURES OFSUBSTANCE EVALUATION?
There are four major differences between substanceevaluation and dossier evaluation:
1. The substance evaluation process is triggered
as a result of risk-based concerns. Underdossier evaluation all testing proposals must beexamined, whereas for compliance checks any
registration dossier can be selected.
2. If it turns out in a dossier evaluation that aregistration dossier does not fulfil the standard
information requirements of the REACH
Regulation for its relevant tonnage band, theEuropean Chemicals Agency (ECHA) can take adecision requiring the registrant to provide thismissing information; under substance evaluationsuch requests can go beyond these standard
REACH information requirements.
3. Substance evaluation involves an assessmentof all registration dossiers from all registrants
specific to the same substance as well as an
assessment of any other sources of information
available, while dossier evaluation involves theassessment of a specific registration dossier.
4. Substance evaluation is carried out by theMember States, while ECHA evaluates dossiers
under dossier evaluation. ECHA has a coordinatingrole in the substance evaluation process andremunerates the Member States for the task.
WHICH SUBSTANCES WILL BE EVALUATED?
For substances for which the registration or otherdata is already sufficient to conclude that a risk doesor does not exist, substance evaluation is not needed.
Substance evaluation can be useful for substancesthat trigger initial concerns for human health or theenvironment. Such substances will be prioritisedfor substance evaluation if it is expected that byrequesting and receiving further information theinitial concern will be confirmed, or eliminated sothat a conclusion can be drawn as to whether furtheraction is necessary.

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The selection and eventual prioritisation ofsubstances for evaluation is made according to riskbased criteria, which include:• Hazard information (for instance structuralsimilarity of the substance to known substancesof concern or to substances that are persistentand liable to bio-accumulate),• Exposure information regarding people and theenvironment,• Tonnage, including the aggregated tonnage ofthe registrations submitted by several registrants.
These criteria are further refined in collaboration
with the Member States and published by ECHA.
Member States can also propose substances basedon other specific risk-based concerns that they findappropriate and necessary.
Prioritised substances are then listed in aCommunity Rolling Action Plan (CoRAP).
WHAT IS INCLUDED IN THE COMMUNITY ROLLINGACTION PLAN??
The first CoRAP was adopted by ECHA on 29February 2012. It covers a period of three years(2012-2014) and includes:

HOW WILL THE PLAN BE UPDATED?
The CoRAP list will be updated annually following
the same procedure as for its first establishment.
This consists of several steps:
5. Identification of possible CoRAP candidate
substances from the pool of registeredsubstances by ECHA and the Member States;
6. Preliminary draft CoRAP - prioritised list ofcandidate CoRAP substances, which is the resultof screening the identified substances;
7. Draft CoRAP, following comments andconfirmation/expression of interest by Member
States to evaluate a substance;
8. Consultation with the Member States and opinionof the Member State Committee on the draft
CoRAP. As a result of this consultation process,substances may be added or removed from thelist. ECHA also publishes the draft CoRAP on
its website to inform the stakeholders of theprogress made.
9. Adoption and publication of the CoRAP by ECHA.

• An indication of the initial concern about thesubstances

REACH requires ECHA to submit a draft of theupdate to the Member States by 28 February eachyear. However, ECHA always plans to adopt theupdated CoRAP by the end of February and thus thedraft for it will be submitted already in October/
November of the previous year. The first update will
be adopted in 2013.

• Names of the Member States responsible forthe evaluation of each substance

WHAT IF MY SUBSTANCE IS INCLUDED IN THE
COMMUNITY ROLLING ACTION PLAN?

• The year of evaluation

The inclusion of a substance in the CoRAP list does
not in itself have any immediate legal impact on
the registrant and does not necessarily mean thatthe substance causes risks to human health or theenvironment.

• Names of the substances to be evaluated

The rolling nature of the plan means that the listof prioritised substances included for evaluation
during the second and the third year may change
when the plan is annually updated. In the update ofthe previous CoRAP, the second year’s list becomesthe list of the first year and a new list of substances
for the third year is added. The evaluations on theoriginal first year substances are either concluded
or continued later when the new information isavailable.

The evaluating Member State will assess whether
it is necessary to require further information inorder to clarify the potential risk. If it concludes so,a legally binding request for further information,
which is addressed to the registrants of that
substance will be issued. In case the evaluating

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Member States can already conclude on thesuspected risk on the basis of the available
information, there is no need to request any further
information from the registrants.

• After the adoption of the decision, theregistrants shall, within the timelines specified in
the decision, submit the requested information by
updating their registration dossiers.

In accordance with the legislation, and similar to
dossier evaluation, registrants that are directlyaffected by a substance evaluation procedure areformally consulted at the stage of a draft decisionprior to a final decision being taken.

The responsible Member State will examine any
new information in the updated registration and,if needed, draft a further appropriate decision
within another 12 months of the information being
submitted.

WHAT IS THE SUBSTANCE EVALUATION PROCESS?

If the evaluation is finalised without a draft decision(i.e. meaning that no further information is needed
after all), the evaluating Member State also needs to
notify ECHA of that outcome within 12 months.

From the date of publication of the CoRAP list, theevaluating Member State has, for those substances
to be evaluated in that year, 12 months to consider
the need for further information to clarify theconcern and to prepare the request in the form of adraft decision.
As all the Member States will be preparing draft
decisions, ECHA will monitor the draft decisions
to ensure a harmonised approach for all evaluation
cases.
The decision-making process is essentially the same
as for dossier evaluation:• First the draft decision is sent to theregistrant(s) for comments.
• Then the draft decision is sent to theother Member States and ECHA for possible
amendments.
• In cases where Member States and ECHA do
not propose any amendments, ECHA takes thedecision as notified to the Member States without
the involvement of the Member State Committee.
• In cases where proposals for amendment
are made to the draft decision, ECHA forwards
the draft decision to the Committee and to theregistrants for comments.
• If the Committee reaches a unanimousagreement, ECHA takes the decision accordingly.
• If a unanimous agreement cannot be reachedin the Committee, the European Commission isresponsible for taking the decision.

WHAT HAPPENS AFTER SUBSTANCEEVALUATION?
In many cases, substance evaluation is expected toresult in a request for further information from theregistrants of the substance. The registrants must
submit the required information within the deadline
specified in the final decision.
Once the newly-provided information has beenassessed, the responsible Member State completes
the evaluation and considers whether and how to
use the information obtained for the purposes ofCommunity level risk management measures. The
conclusion can also be that the risks are sufficiently
under control with the measures already in place.
ECHA informs the Commission, the registrants andthe other Member States about the conclusions.
The decisions on requests for further informationand the evaluation reports of the Member States will
be published on the ECHA website.
As a further follow-up of the substance evaluation,
Member States may decide to:• Propose EU-wide risk management measures(e.g. EU-wide restriction, EU-wide authorisation,
EU-harmonised classification and labelling,
occupational exposure limits, measures for theprotection of the environment under the Water
Framework Directive) or• Impose national actions.

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Inclusion of a substance in the CoRAP does notdirectly lead to risk management actions. Thus, any
proposed Community-wide actions will be subject
to a separate regulatory process. For authorisation,restriction and/or harmonised classification under
the REACH and the Classification, Labelling andPackaging Regulations, stakeholders are consulted
at all relevant stages of the process and decisions
are taken by the European Commission on the basisof the opinions adopted by the ECHA Committees.

For further information:
Visit the evaluation section of the ECHA website:
http://echa.europa.eu/evaluation
The REACH Regulation EC (No) 1907/2006:
http://echa.europa.eu/regulations/reach/legislation© European Chemicals Agency, 2012annankatu 18 , p.o. box 400, fi - 00121 helsinki, finland | echa.europa.eu