The evaluation of substances plays a key part not only within the framework of compliance checks by ECHA, but also for substances which fall under the Community Rolling Action Plan (CoRAP).
Substances included in the Community Rolling Action Plan (CoRAP) are subject to substance evaluation (SEv) by Competent Authorities of the Member States. The CoRAP list, which is updated every year, specifies substances to be evaluated over a period of three years. The evaluation aims to clarify the initial concern that the manufacture and/or use of these substances could pose a risk to human health or the environment. In many cases, these initial concerns are related to potential persistency, bioaccumulation and toxicity (PBT), endocrine disruption, or carcinogenicity, mutagenicity and toxicity to reproduction (CMR); in combination with wide dispersive use or consumer uses. The substance evaluation process assesses all registration dossiers from all registrants specific to the same substance, i.e. in order to take into account the combined exposure. Substances listed in the first year of the three-year CoRAP plan are evaluated first. The evaluation starts for these first-year substances on the date of publication of the final CoRAP update every spring (usually around March). The designated Member States have 12 months to evaluate substances starting from the date of publication of this CoRAP update. If necessary, Member States will prepare a draft decision for requesting any relevant further information to clarify the suspected risks. In principle, the evaluation addresses the concerns originally identified in the justification documents for CoRAP listing. However, the Member States may also identify additional concerns during their evaluation, and propose to request further information to clarify any potential risk of the substance.
Any registration dossier can be subject to compliance checks by ECHA. With this process ECHA aims to verify if the information submitted by registrants is compliant with the legal requirements. Compliance checks evaluate the substance identity description and the safety information in the dossier including the chemical safety report or specific parts of the dossier, for example the information related to the protection of human health. According to REACH, ECHA must check at least 5% of the registration dossiers of each tonnage band. Dossier selection for compliance check is either random or concern based (targeted).
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