ECHA Issues New Substance Evaluation Criteria for REACH Chemical Assessments

The European Chemicals Agency (ECHA) has issued "selection criteria" for substance evaluation under the REACH program.  These criteria will be used by ECHA and the Members States to identify candidate substances for the first Community Rolling Action Plan (now called CoRAP after someone pointed out the inadequacy of its original acronym, CRAP).

According to ECHA:

Substance evaluation aims to clarify whether a given substance constitutes a risk to human health or the environment in cases where insufficient information is available. Substance evaluation will be conducted only in relation to a selected number of substances which will be chosen according to risk-based criteria. The prioritisation criteria cover hazard information, exposure information and tonnage of substances including the aggregated tonnage from the registrations submitted by several registrants. The first set of criteria is adopted by ECHA according to Executive Director's decision taken on 26 May 2011. ECHA and the Member States are using these criteria to identify possible substances that may be listed on the CoRAP and evaluated by Member States. In addition to this the Member States can also propose substances to be prioritised at any time on other risk-based grounds too. In the future, this first set of criteria will be further refined by ECHA in cooperation with the Member States.

The criteria identified by ECHA include the following:

Hazard related selection criteria:

• Suspected PBTs, vPvBs, and PBT-like substances
• Known PBTs/vPvBs
• Suspected endocrine disruptors
• Suspected CMRs
• Known CMRs
• Suspected sensitizers
• Known sensitizers

Exposure related selection criteria:

• Wide dispersive use
• Number of sites of use
• Pattern and amount of releases/exposure
• Number and type of reported uses and exposure scenarios
• Incorporation into mixtures or articles used by the public
• Potential size of the exposed population
• Number of using sites if emission is due to industrial use
• Consumer use and exposure of sensitive subpopulations such as children
• Aggregated tonnage

Risk related selection criteria:

• The risk assessment in the chemical safety report shows the risk characterization ratio is not well below 1 for human and/or environmental exposure
• Cumulative exposure from related substances with critical hazardous properties

More information on the criteria can be downloaded as a PDF file here.

European Chemicals Agency Publishes Evaluation of REACH Chemical Registrations

By now readers should know that REACH is the EU's chemical control law, the Registration Evaluation Authorization (and Restriction) of Chemicals regulation.  November 30, 2010 was the deadline for manufacturers and importers to register their hazardous or high production volume chemicals.  And now the European Chemicals Agency (ECHA) has released a report evaluating registration dossiers, as well as substance evaluations.  The goal is to summarize progress to date and provide useful feedback to future REACH dossier submitters.

There are actually three different evaluation processes. One is the "compliance check," in which ECHA "examines the quality and adequacy of data provided by the registrant." The second is examination of "testing proposals," in which ECHA "decides whether testing is necessary and may then provide permission for the tests to be performed." The third is "substance evaluation," in which the Member States prepare a dossier on chemicals they believe "there is a suspicion that certain uses of a substance may cause harm to human health or the environment."


The Evaluation report concludes that there were "quality problems in a considerable proportion of dossiers in 2010," though ECHA is still in the early stages of review. In an effort to improve future submissions, the gives specific recommendations for registrants, including:

• The identity of the registered substance needs to be clearly described;
• Any adaptation to the standard testing regime must meet the conditions set out in Annexes VII to XI of the REACH Regulation, and a clear justification for any adaptation must be provided;
• The robust study summaries should contain enough detail to allow an independent assessment of the information provided;
• Classification and labelling should be in line with the hazards identified or with the harmonized classification and labelling of the substance;
• A proposal to do testing must be submitted first (for tests under Annex IX and X) before the test is done. Doing a test before getting ECHA's decision may lead to legal action;
• Registrants have an obligation to share data resulting from animal tests and to share the costs before submitting the dossier.

The full Evaluation progress report for 2010 can be downloaded as a PDF file here.