6 Amendments of Billy KELLEHER related to 2023/0453(COD)
Amendment 503 #
Proposal for a regulation
Article 22 – paragraph 1
Article 22 – paragraph 1
1. Business operators shall notify to the Database of Study Notifications referred to in Article 9, without undue delay, any studies on chemicals 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 they commission as part of a risk or safety assessment , prior to placing on the market, under the Union acts listed in Annex I. However, business operators, laboratories and testing facilities shall not notify to the Database of Study Notifications referred to in Article 9 studies that are to be notified under Article 32b of Regulation (EC) No 178/2002.,
Amendment 504 #
Proposal for a regulation
Article 22 – paragraph 1 – point a (new)
Article 22 – paragraph 1 – point a (new)
(a) in case of studies that are to be notified under Article 32b of Regulation (EC) No 178/2002;
Amendment 505 #
Proposal for a regulation
Article 22 – paragraph 1 – point b (new)
Article 22 – paragraph 1 – point b (new)
(b) when a valid justification for late or non-notification is provided by business operators. The assessment of the validity of justifications for non- notifications shall be done by ECHA. [For research in and development of medicinal products,] studies conducted in the context of Scientific Research and Development (SR&D) or Product and Process Orientated Research and Development (PPORD), each as defined in Regulation (EC) No 1907/2006 (REACH), are sensitive data and commercially confidential by nature and shall be considered a valid justification for non-notification; or,
Amendment 506 #
Proposal for a regulation
Article 22 – paragraph 1 – point c (new)
Article 22 – paragraph 1 – point c (new)
(c) in case of studies under Articles 40, 41 and 46 of Regulation (EC) No 1907/2006 (REACH). They shall be excluded from the notification requirement, given that such studies are carried out in response to a request from the authority.
Amendment 507 #
Proposal for a regulation
Article 22 – paragraph 1 a (new)
Article 22 – paragraph 1 a (new)
1 a. For the purpose of paragraphs 1 and 2, business operators, laboratories and testing facilities may claim all or part of the information in paragraph 2 is confidential in accordance with the provisions on confidentiality under the originating Union act.
Amendment 525 #
Proposal for a regulation
Article 22 – paragraph 7 a (new)
Article 22 – paragraph 7 a (new)
7 a. This article shall not apply to substances manufactured, imported or used in Scientific Research and Development (SR&D) and Product and Process Orientated Research and Development (PPORD), each as defined in Regulation (EC) No 1907/2006 (REACH), when used in or for research in and development of medicinal products.