Notification of studies
Article 26
1. Business operators shall notify to the Database of Study Notifications referred to in Article 9 of this Regulation, without delay, any studies that generate chemicals data and that they commission to support an application, notification or regulatory dossier notified or submitted to an Authority, as well as any studies on chemicals on their own or in products that business operators commission as part of a risk or safety assessment under the Union legal acts listed in Annex I, Part 1, to this Regulation. However, business operators shall not notify to the Database of Study Notifications referred to in Article 9 of this Regulation studies that are to be notified under Article 32b of Regulation (EC) No 178/2002. 2. For the purposes of paragraph 1, business operators shall notify to the Database of Study Notifications referred to in Article 9 of this Regulation the identity of the chemicals concerned, title and scope of the study, the laboratory or testing facility carrying out the study, the intended starting and planned completion dates, and, where relevant, whether the study is commissioned to comply with a decision of the ECHA pursuant to Articles 40, 41 or 46 of Regulation (EC) No 1907/2006. At the time a study is commissioned, business operators shall inform the laboratory or testing facility in which the study is carried out whether the study is subject to the notification obligation under this Article. 3. Laboratories and testing facilities shall, without delay, notify to the Database of Study Notifications referred to in Article 9 of this Regulation any information as referred to in paragraph 2 of this Article related to studies commissioned by business operators to support an application, notification or regulatory dossier notified or submitted to an Authority, as well as any studies on chemicals on their own or in products that they commission as part of a risk or safety assessment under the Union legal acts listed in Annex I, Part 1, to this Regulation. However, laboratories and testing facilities shall not notify to the Database of Study Notifications referred to in Article 9 of this Regulation studies that are to be notified under Article 32b of Regulation (EC) No 178/2002. 4. For the purposes of paragraph 3 of this Article, for each study, laboratories and testing facilities shall notify to the Database of Study Notifications referred to in Article 9 the identity of the chemicals concerned, the title and scope of the study, the intended start and completion date and the name of the business operator that commissioned the study. 5. Paragraphs 3 and 4 shall apply, mutatis mutandis , to laboratories and testing facilities located in third countries, insofar as set out in relevant agreements with those third countries. 6. The obligations laid down in paragraphs 1 to 5 shall apply from 2 November 2027. 7. Member States may provide for exemptions from the obligations laid down in paragraphs 1 to 5 of for studies conducted in the interests of defence. Where a Union legal act listed in Annex I, Part 1, provides that Member States may provide for exemptions from the obligations of that legal act in the interests of national security, Member States may provide for exemptions from the obligations laid down in paragraphs 1 to 5. 8. The ECHA, in close cooperation with the EFSA and in consultation with stakeholders, shall lay down the practical arrangements for implementing this Article.