The REACH regulation has the objective to provide more transparency about chemicals. At the same time, the regulation recognizes registrants’ interests of keeping data confidential.
Article 118 REACH refers to sensitive information that is not automatically published, e.g. details of a preparation, tonnage or information about the supply chain. In a case of an emergency, e.g., the agency is allowed to publish this information in order to protect human health, security or the environment.
According to Article 119 REACH, there is the possibility to claim confidentiality for a few additional parts of the technical dossier.
If so, ECHA requires a justification that a publication would be harmful for the registrant’s or any other concerned party’s commercial interests. Just stating that the data is a “company secret” is not accepted by the Agency. The justification has to be detailed and plausible.
Confidentiality causes extra fees up to 4.500 € per criteria for the registrant. Rebates for Joint registrations and SMEs are granted.
If confidentiality is claimed for data in the joint part of a lead dossier, each member of the joint submission has to submit his own justification for the confidentiality claim and has to pay the reduced fee for joint submissions.
For further information, please view ECHA’s guidance document for making data confidential: