7 Amendments of Laurent CASTILLO related to 2023/0453(COD)
Amendment 107 #
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. Union agencies are required to make every effort to protect the data they hold, in particular where there is a cybersecurity risk.
Amendment 127 #
Proposal for a regulation
Recital 9
Recital 9
(9) These data should also be limited to data submitted to the EMA in the context of the relevant procedures that are finalised or submitted after the entry into force of this Regulation. At a later stage, it should also be possible to include in the common data platform, where relevant, dData the EMA holds on procedures concluded before the entry into force of this Regulation will be entered as and when sufficient human and financial resources are available.
Amendment 135 #
Proposal for a regulation
Recital 12
Recital 12
(12) In order to respond to the needs of the digital economy and to ensure a high level of protection of the environment and human health, it is necessary to lay down a harmonised framework specifying who is entitled to access and use the chemicals data contained in the common data platform, under which conditions, on what basis, and for which purposes. The Authorities that are entrusted with regulatory tasks related to chemicals should be allowed and encouraged to use the chemicals data and information contained in the common data platform to effectively fulfil their regulatory duties and tasks, in order to improve the effectiveness, efficiency, and coherence of chemicals- related assessments as well as the development of Union chemicals policies. The Authorities should give limited access to personal data in accordance with the purposes for which the data is used.
Amendment 308 #
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 publicconfidential or not under the originating Union act.
Amendment 478 #
Proposal for a regulation
Article 21 – paragraph 5
Article 21 – paragraph 5
5. The ECHA shall commission these scientific studies in an open and transparent manner and shall open a public consultation to stakeholders affected by them.
Amendment 481 #
Proposal for a regulation
Article 21 – paragraph 5 a (new)
Article 21 – paragraph 5 a (new)
5a. When a study is commissioned, the ECHA shall publish electronically the subject of the study, the reasons for it, details of the funding arrangements and the protocol to follow for its implementation.
Amendment 501 #
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 delayin three months, 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 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.