[ParlTrack]

Proposal for a regulation
Recital 28

(28) In order to increase transparency, as well as to enable Authorities to have complete prior knowledge of studies commissioned by business operators, irrespective of whether such studies are carried out by the business operator itself or are outsourced, business operators and laboratories should notify to a database of study notifications established and managed by the ECHA the studies on chemicals they commission for compliance with regulatory requirements under the Union acts listed in Annex I. For this purpose, the ECHA should establish and manage a database of study notifications, as a dedicated service of the common data platform, to store the information related to those studies. In order to allow business operators and laboratories sufficient time to prepare the notifications of studies, the obligation to notify studies should only start to apply two years after the date of entry into force of this Regulation.deleted

2024/12/05
Committee: ENVI

Dennis RADTKE

Proposal for a regulation
Recital 29

(29) Under Regulation (EC) No 178/2002 of the European Parliament and of the Council, business operators and laboratories are obliged to notify to the database of study notifications established and managed by the EFSA the studies they commission to support an application or notification in relation to which Union law contains provisions for the EFSA to provide a scientific output. To avoid overburdening business operators and laboratories, they should therefore not be required to also notify those studies to the database of study notifications established and managed by the ECHA under this Regulation.deleted

2024/12/05
Committee: ENVI

Dennis RADTKE

Proposal for a regulation
Recital 30

(30) To ensure the coherence between those two study notification mechanisms, as well as to ensure certainty for business operators submitting notifications, the rules on the public dissemination of study notifications should, where relevant, correspond in that the notifications should only be made available through the common data platform once a corresponding registration, application, notification or other relevant regulatory dossier was submitted to the relevant Union or national institution and a decision on the confidentiality of the data contained in that regulatory dossier was taken by that Union or national institution. In addition, in order to facilitate compliance with the requirement to notify a study, the ECHA and the EFSA should cooperate to ensure a common approach for the identification of notified information in order to facilitate the traceability of studies notified to their respective databases.deleted

2024/12/05
Committee: ENVI

Dennis RADTKE

Proposal for a regulation
Recital 31

(31) While the study notification obligation established in this Regulation should apply in the context of all the Union acts on chemicals listed in Annex I, the various relevant data collection and safety assessment processes under those acts may vary widely procedurally. The overarching aim of the database of study notifications established under this Regulation should be to bring together information on studies on chemicals being commissioned by business operators, such as to enable a centralised and complete overview of the studies being performed to support regulatory compliance under Union acts on chemicals as listed in Annex I. On the basis of this objective and considering the fact that assessment procedures under Union acts on chemicals in Annex I may vary widely, it would be beyond the scope and aim of this Regulation to amend existing assessment processes set under those Union acts listed in Annex I by imposing additional conditions leading to potential market access consequences not foreseen in those Union acts. Consequently, it is not appropriate to introduce in this Regulation the consequences associated non-compliance with the study notification obligation as laid out in Article 32b of Regulation (EC) No 178/2002 of the European Parliament and of the Council.deleted

2024/12/05
Committee: ENVI

Dennis RADTKE

Proposal for a regulation
Recital 32

(32) Nevertheless, to ensure compliance with the study notification obligation laid down in this Regulation, and to cater to the specificities of individual assessment processes, where existing, Member States should lay down rules on penalties applicable to the infringement of that obligation and take all necessary measures to ensure that those rules are complied with. Those penalties should be effective, proportionate, and dissuasive, since non- compliance with this Regulation could result in less robust chemicals risk assessments, creating potential risks and consequently adverse effects on human health and the environment.deleted

2024/12/05
Committee: ENVI

Dennis RADTKE

Proposal for a regulation
Recital 33

(33) In order to facilitate enforcement by Member States, the Agencies responsible for assessing and providing scientific output, including scientific opinions, on regulatory dossiers containing studies subject to notification to ECHA should, where relevant, cooperate and exchange information with the Member State enforcement authorities on the compliance with the obligations laid out in Article 22.deleted

2024/12/05
Committee: ENVI

Dennis RADTKE

Proposal for a regulation
Recital 34

(34) While Regulation (EC) No 178/2002 of the European Parliament and of the Council also requires the consultation of stakeholders and the public following the notification to the EFSA of studies commissioned for the purposes of the renewal of an authorisation or approval, a similar requirement under this Regulation would lay a disproportionate administrative burden on the ECHA, given the wide scope of the studies that is to be notified under this Regulation.deleted

2024/12/05
Committee: ENVI

Dennis RADTKE

Proposal for a regulation
Recital 35

(35) A mechanism related to study notifications exists in Regulation (EC) No 1907/2006 of the European Parliament and of the Council. Where registrants are required to perform studies to generate data in accordance with requirements in Annexes IX and X to that Regulation, they must first submit a testing proposal to the ECHA in order to receive a decision requiring them to perform a study. Such decision may also be issued as an outcome of compliance check or substance evaluation under that Regulation. In order to facilitate the transparency, traceability, and effective monitoring of studies commissioned or carried out pursuant to a decision of the ECHA in accordance with Articles 40, 41 or 46 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council, business operators should specify in their notifications of studies under this Regulation that those studies are being commissioned or carried out in compliance with those decisions.deleted

2024/12/05
Committee: ENVI

Dennis RADTKE

Proposal for a regulation
Article 4 – paragraph 4

4. The Commission shall adopt and publish the governance scheme referred to in paragraph 3 and any revision thereof by means of an implementing decision after consulting stakeholders, when appropriate.

2024/12/05
Committee: ENVI

Dennis RADTKE

Proposal for a regulation
Article 14 – paragraph 6

6. The Commission and the Agencies shall cooperate when setting standard formats to ensure coherence with other formats and the interoperability of the standard formats with the common data platform and with existing data submission approaches. When appropriate, they shall also consult stakeholders.

2024/12/05
Committee: ENVI

Dennis RADTKE

Proposal for a regulation
Article 15 – paragraph 6

6. The Commission and the Agencies shall cooperate with each other in setting the controlled vocabularies and shall consult stakeholders.

2024/12/05
Committee: ENVI

Dennis RADTKE

Proposal for a regulation
Article 22

Article 22 Notification of studies 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 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. 2. For the purposes of paragraph 1, business operators shall notify to the Database of Study Notifications referred to in Article 9 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. 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. 4. For the purposes of paragraph 3, laboratories and testing facilities shall notify to the Database of Study Notifications referred to in Article 9 the title, scope, intended starting and planned completion dates of any test they carry out, as well as the name of the business operator who commissioned the test. 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 set under this article shall apply from [OP please insert date: 24 months after the date of entry into force of this Regulation]. 7. The ECHA shall lay down the practical arrangements for implementing the provisions of this Article.deleted

2024/12/05
Committee: ENVI

12 Amendments of Dennis RADTKE related to 2023/0453(COD)

ParlTrack - 2011-2024