8 Amendments of Kristoffer STORM related to 2023/0453(COD)
Amendment 105 #
Proposal for a regulation
Recital 6
Recital 6
(6) Business operators and Members States’ competent authorities are required by various Union acts to submit data and information to a multitude of Union agencies, as well as to the Commission in specific cases. This generates a fragmentation of data and information on chemicals, which are held under various data sharing and use conditions and in different formats. Such fragmentation prevents public authorities, as well as the general public, from having a clear overview of what information is available on individual chemicals or groups of chemicals, of where and how information can be accessed and whether it can be used. This increases the likelihood of inconsistency between various assessments of the same chemical required by various Union acts on chemicals and of damaging the general public’s trust in the scientific grounds for Union decisions on chemicals. In order to ensure that data on chemicals is easily findable, accessible, interoperable and usable, the ECHA should establish a common data platform on chemicals. The common data platform on chemicals should serve as a single point of reference and as a broadened and shared evidence base to enable the efficient delivery of coherent hazard and risk assessments of chemicals across various Union acts on chemicals, as well as to enable the timely identification of emerging chemical risks and the drivers and impact of chemical pollution. Authorities should take the necessary measures to protect the confidentiality of data, including, where relevant, by means of physical and cybersecurity measures.
Amendment 121 #
Proposal for a regulation
Recital 8 a (new)
Recital 8 a (new)
(8 a) Chemicals contained in medicinal products are covered by Annex II to this Regulation, as well as Annex I since chemicals in medicinal products are also subject to regulatory procedures under the majority of other Union legislation listed under Annex I. In order to protect the confidentiality of certain data and to prevent any conflicts between legislative acts, the provisions from Directive 2001/83/EC of the European Parliament and the Council and Regulation (EC) 726/2004 of the European Parliament and the Council should always take precedence over this Regulation. This covers future implementation through delegating and/or implementing acts.
Amendment 303 #
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
2. Where the Commission or the Agencies hold data or information referred to in Article 3(2), they shall make that data available to the ECHA, in a standard format, where available, together with the relevant context data as referred to in Article 4(4), point (c). The Commission and the Agencies shall indicate whether that data or information is made available to the public or they are deemed confidential in accordance with the provisions on confidentiality under the originating Union act.
Amendment 419 #
Proposal for a regulation
Article 16 – paragraph 2
Article 16 – paragraph 2
2. The Authorities shall take the necessary measures, including security measures, to ensure that information contained in the common data platform marked as confidential in accordance with Article 5(2), is not made publicavailable to the public in accordance with the provisions on confidentiality under the originating Union act.
Amendment 490 #
Proposal for a regulation
Article 21 – paragraph 7 a (new)
Article 21 – paragraph 7 a (new)
7 a. In alignment with the REACH regulation and the CLP regulation, the obligations put forward in article 22 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).
Amendment 508 #
Proposal for a regulation
Article 22 – paragraph 2
Article 22 – paragraph 2
2. For the purposes of paragraph 1, information to be notified by business operators shall notify to the Database of Study Notifications referred to in Article 9 shall be limited to the title, scope, 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. For medicinal products, notification is only required after the market authorisation application has been submitted.
Amendment 512 #
Proposal for a regulation
Article 22 – paragraph 2 a (new)
Article 22 – paragraph 2 a (new)
2 a. For the purpose of paragraphs 1 and 2, business operators may claim part of the information in paragraph 2 is confidential in accordance with the provisions on confidentiality under the originating Union act.
Amendment 514 #
Proposal for a regulation
Article 22 – paragraph 3
Article 22 – paragraph 3
3. Laboratories and testing facilities shall also, without undue delay, notify any study commissioned by business operators to support a regulatory dossier on which an Agency is required to provide a scientific output, including a scientific opinion, under the Union acts listed in Annex I. However, 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. The confidentiality of information on laboratories and testing facilities shall be respected.