7 Amendments of Radan KANEV related to 2023/0453(COD)
Amendment 131 #
Proposal for a regulation
Recital 10
Recital 10
(10) Due to the sensitivity of the information on the exact chemical composition of mixtures placed on the market and classified as hazardous on the basis of their health or physical effects, submitted to the bodies appointed by the Member States under Article 45 of Regulation (EC) No 1272/2008 of the European Parliament and the Council6 , that information should not be included in the common data platform. Likewise, due to the commercial sensitiveness of data and information on final cosmetic products, the information related to cosmetic products notified to the Cosmetic Product Notification Portal under Article 13 of Regulation (EC) No 1223/20097 of the European Parliament and of the Council should not be included in the common data platform either. However, chemicals data and information on individual chemical ingredients of cosmetic products should be included in the common data platform. To preserve innovation, this Regulation should not undermine the exemptions for Scientific Research and Development (SR&D) and Product and Process- Oriented Research and Development (PPORD) as established under REACH8a and CLP, ensuring that such data remains appropriately protected. _________________ 6 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1). 7 Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59). 8a Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC
Amendment 137 #
Proposal for a regulation
Recital 13
Recital 13
(13) Chemicals data and information generated as a result of obligations set by Union acts on chemicals may be protected by confidentiality claims on confidential business information. The public dissemination of such data may affect the commercial interest of private parties. To ensure legal certainty for duty holders and to protect their legitimate expectations, as well as to ensure industry’s competitiveness on the internal market, the ECHA, as a manager of the common data platform, should grant differentiated access rights to the data and information contained in the common data platform. To this end, the Authorities should have full access to all chemicals data and information contained in the common data platform, including access to confidential information, while business operators and the general public should have restricted access to that data and information, which does not include access to confidential information. Where Union law requires that commercial or industrial information be kept confidential to protect a legitimate economic interest, that confidentiality should be safeguarded.
Amendment 301 #
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 Commconfidentiality provissions and the Agencies shall indicate whether that data or information is made available to the public underpplicable under Union acts listed in Annex I shall remain in force and prevail over this Regulation in case of any conflict. All data deemed confidential under originating Union acts shall be treated accordingly in the common data platform.Confidential business information submitted by business operators, including trade secrets as defined under Directive (EU) 2016/943, shall not be disclosed unless explicitly required by the originating Union act.
Amendment 415 #
Proposal for a regulation
Article 16 – paragraph 1
Article 16 – paragraph 1
1. The Authorities shall have access to all the chemicals data contained in the common data platform, including data which is deemed to be confidential under Article 5(2), second sentence. Access to confidential data shall be limited to authorised entities performing regulatory tasks, with clear audit trails to monitor access and prevent misuse.
Amendment 417 #
Proposal for a regulation
Article 16 – paragraph 2
Article 16 – paragraph 2
2. The Authorities shall take the necessary measures to ensure that information contained in the common data platform marked as confidential in accordance with Article 5(2) is not made public. In the event of a conflict between confidentiality protections under this Regulation and sector-specific legislation, the latter shall prevail.
Amendment 421 #
Proposal for a regulation
Article 16 – paragraph 3
Article 16 – paragraph 3
3. The general public shall have access to all the chemicals data contained in the common data platform and considered as available to the public in accordance with the Union act under which the data was generated or submitted. The designation of data as public shall respect existing confidentiality safeguards under Union acts, including protections for trade secrets as defined in Directive (EU) 2016/943.
Amendment 496 #
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 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. Studies conducted as part of Scientific Research and Development (SR&D) or Product and Process-Oriented Research and Development (PPORD), as defined under REACH (Article 9) and CLP, are exempt from this notification requirement unless explicitly mandated by the corresponding regulatory act. Notifications for SR&D and PPORD activities shall be limited to high-level summaries ensuring no disclosure of proprietary data, including detailed chemical identification or testing plans, which could compromise competitive interests or future intellectual property rights.