Sittings · Document

REPORT (COM(2023)0783 – C90447/2023 – 2023/0455(COD)) 2025-02-25

On the proposal for a regulation of the European Parliament and of the Council amending Regulations (EC) No 178/2002, (EC) No 401/2009, (EU) 2017/745 and (EU) No 2019/1021 of the European Parliament and of the Council as regards the re-attribution of scientific and technical tasks and improving cooperation among Union agencies in the area of chemicals

Committee on the Environment, Climate and Food Safety · Rapporteur: Dimitris Tsiodras

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* Consultation procedure

*** Consent procedure

***I Ordinary legislative procedure (first reading)

***II Ordinary legislative procedure (second reading)

***III Ordinary legislative procedure (third reading)

(The type of procedure depends on the legal basis proposed by the draft act.)

Amendments to a draft act

Amendments by Parliament set out in two columns

Deletions are indicated in bold italics in the left-hand column. Replacements are indicated in bold italics in both columns. New text is indicated in bold italics in the right-hand column.

The first and second lines of the header of each amendment identify the relevant part of the draft act under consideration. If an amendment pertains to an existing act that the draft act is seeking to amend, the amendment heading includes a third line identifying the existing act and a fourth line identifying the provision in that act that Parliament wishes to amend.

Amendments by Parliament in the form of a consolidated text

New text is highlighted in bold italics. Deletions are indicated using either the ▌symbol or strikeout. Replacements are indicated by highlighting the new text in bold italics and by deleting or striking out the text that has been replaced.

By way of exception, purely technical changes made by the drafting departments in preparing the final text are not highlighted.

DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

on the proposal for a regulation of the European Parliament and of the Council amending Regulations (EC) No 178/2002, (EC) No 401/2009, (EU) 2017/745 and (EU) No 2019/1021 as regards the re-attribution of scientific and technical tasks and improving cooperation among Union agencies in the area of chemicals

(COM(2023)0783 – C90447/2023 – 2023/0455(COD))

(Ordinary legislative procedure: first reading)

– having regard to the Commission proposal to Parliament and the Council (COM(2023)0783),

– having regard to Article 294(2) and Article 114 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C90447/2023),

– having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

– having regard to the opinion of the European Economic and Social Committee of 20 March 2024,

– having regard to Rules 60 of its Rules of Procedure,

– having regard to the report of the Committee on the Environment, Climate and Food Safety (A10-0020/2025),

1. Adopts its position at first reading hereinafter set out;

2. Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

3. Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Amendment 1

Proposal for a regulation

Recital 8

Text proposed by the Commission

Amendment

(8) Correspondingly, this Regulation aims to address the eventual divergence between scientific opinions of the European Food Safety Authority and those of other Union agencies. Regulation (EC) No 178/2002 of the European Parliament and Council already contains provisions establishing a procedure to solve divergent scientific opinions. Those resolution procedures should be reinforced, in that the European Food Safety Authority and the other dissenting agency should be bound to make their best effort to resolve the divergence on general scientific issues, and only when they are not able to resolve the divergence, should they refer to risk managers.

(8) Correspondingly, this Regulation aims to address the eventual divergence between scientific opinions of the European Food Safety Authority and those of other Union agencies. Regulation (EC) No 178/2002 of the European Parliament and Council already contains provisions establishing a procedure to solve divergent scientific opinions. Those resolution procedures should be reinforced, in that the European Food Safety Authority and the other dissenting agency should be bound to make their best effort to resolve the divergence on general scientific issues. Differences in assessment methodologies resulting in divergent opinions, particularly with regard to the protection of vulnerable groups, should be duly justified. In such instances, priority should be given to the most protective opinion to safeguard vulnerable groups. Only when they are not able to resolve the divergence, should they refer to risk managers.

Amendment 2

Proposal for a regulation

Recital 9

Text proposed by the Commission

Amendment

(9) In the more specific case of scientific divergence pertaining to the hazard identification of chemical substances, a new procedure enabling the resolution of the divergence should be established. This procedure should enable the Commission to request the European Chemicals Agency, as the Union agency most equipped with expertise and capacity in hazard assessment, as well as long-standing experience with the harmonised classification and labelling process, to develop a proposal for harmonised classification and labelling, in accordance the Regulation (EC) No 1272/2008 of the European Parliament and Council, moving closer to the ‘one substance, one assessment’ vision as regards uniformity of hazard assessments of chemicals across the Union. This possibility should be reflected in the relevant provision providing for the resolution of diverging scientific opinions laid down in Regulation (EC) No 178/2002.

(9) In the more specific case of scientific divergence pertaining to the hazard identification of chemical substances, a new procedure enabling the resolution of the divergence should be established. This procedure should enable the Commission to request the European Chemicals Agency, as the Union agency most equipped with expertise and capacity in hazard assessment, as well as long-standing experience with the harmonised classification and labelling process, to develop a proposal for harmonised classification and labelling, in accordance with Regulation (EC) No 1272/2008 of the European Parliament and Council, moving closer to the ‘one substance, one assessment’ vision as regards uniformity of hazard assessments of chemicals across the Union, enhancing the protection of health and the environment. This possibility should be reflected in the relevant provision providing for the resolution of diverging scientific opinions laid down in Regulation (EC) No 178/2002.

Amendment 3

Proposal for a regulation

Recital 14 a (new)

Text proposed by the Commission

Amendment

(14a) This Regulation expands the tasks, workload and remit of the scientific committees of the European Chemicals Agency. In order to provide adequate expertise, support and thorough scientific evaluations, appropriate and stable resources, capacity and governance of the scientific committees should be ensured. In this respect, the European Commission should regularly monitor the needs of the European Chemicals Agency stemming from this Regulation, and provide the Agency with sufficient and stable resources.

Amendment 4

Proposal for a regulation

Article 1 – paragraph 1 – point 2

Regulation (EC) No 178/2002

Article 30 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

Where the Authority identifies a potential source of divergence, it shall contact the body concerned in order to ensure that all relevant scientific or technical information is shared and in order to identify the potentially contentious scientific or technical issues. Differences in assessment methodologies resulting in divergent opinions shall be duly justified, especially regarding the protection of vulnerable groups.

Amendment 5

Proposal for a regulation

Article 1 – paragraph 1 – point 2

Regulation (EC) No 178/2002

Article 30 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

The Authority and the body concerned shall cooperate to resolve the divergence. If the Authority and the body concerned are not able to resolve the divergence, they shall draw up a joint report. The report shall clearly outline the contentious scientific issues and identify the relevant uncertainties in the data and be made publicly available.

The Authority and the body concerned shall cooperate to resolve the divergence, with the aim of ensuring the highest level of protection of health and the environment. Priority shall be given to the opinion that affords the highest level of protection in order to safeguard the most vulnerable groups. If the Authority and the body concerned are not able to resolve the divergence, they shall draw up a joint report. The report shall clearly outline the contentious scientific issues, identify the relevant uncertainties in the data and the possible causes for the diverging opinions, including on methodological differences, and be made publicly available.

Amendment 6

Proposal for a regulation

Article 1 – paragraph 1 – point 2

Regulation (EC) No 178/2002

Article 30 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3a. Where a substantive divergence over scientific issues has been identified and the body in question is a Member State body, the Authority and the national body shall be obliged to cooperate with a view to either resolving the divergence or preparing a joint document clarifying the contentious scientific issues and identifying the relevant uncertainties in the data. That document shall be made public.

Amendment 7

Proposal for a regulation

Article 1 – paragraph 1 – point 2

Regulation (EC) No 178/2002

Article 3 – paragraph 3 b (new)

Text proposed by the Commission

Amendment

3b. In cases where a divergence is identified, and the Authority requests additional information from the other Union or Member State authority, the period within which the relevant authorities are required to adopt their respective output, or the joint output referred to in paragraph 2, may be extended. After consulting the body concerned, the Authority shall lay down a period within which that information is to be provided and shall inform the Commission of the additional period needed. The Commission shall inform the business operators and the Member States concerned of the extension.

Amendment 8

Proposal for a regulation

Article 3 – paragraph 1 – point 1

Regulation (EU) 2017/745

Annex I – Section 10.4.1 – point b

Text proposed by the Commission

Amendment

(b) substances which are identified as endocrine disruptors for human health, of Category 1, in accordance with Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council12 and substances having endocrine-disrupting properties for which there is scientific evidence of probable serious effects to human health and which are identified in accordance with the procedure set out in Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council or substances having endocrine disrupting properties relevant to human health identified in accordance with Regulation (EU) No 528/2012.

(b) substances which are classified as endocrine disruptors for human health, of Category 1, in accordance with Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council12 and substances having endocrine-disrupting properties for which there is scientific evidence of probable serious effects to human health and which are identified in accordance with the procedure set out in Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council or substances having endocrine disrupting properties relevant to human health identified in accordance with Regulation (EU) No 528/2012.

__________________

12 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 ).

Amendment 9

Proposal for a regulation

Article 4 – paragraph 1 – point 2

Regulation (EU) 2019/1021

Article 8 – paragraph 1a – subparagraph 1 – point a

Text proposed by the Commission

Amendment

(a) as appropriate, information on human health and environmental impacts of waste consisting of, containing or contaminated with POPs, including impacts on waste management;

(a) information on human health and environmental impacts of waste consisting of, containing or contaminated with POPs, including impacts on waste management;

Amendment 10

Proposal for a regulation

Article 4 – paragraph 1 – point 2

Regulation (EU) 2019/1021

Article 8 – paragraph 1a – subparagraph 2

Text proposed by the Commission

Amendment

The Agency shall, as soon as it receives the request referred to in the first subparagraph, point (i), publish on its website a notice that a report on a possible amendment of Annex IV or V will be prepared inviting all interested parties, including waste operators and users of recycled materials, to submit comments within 8 weeks. The Agency shall publish those comments on its website.

The Agency shall, as soon as it receives the request referred to in Article 8(1), point (i), publish on its website a notice that a report on a possible amendment of Annex IV or V will be prepared inviting all interested parties, including waste operators and users of recycled materials, to submit comments within 8 weeks. The Agency shall publish those comments on its website.

Amendment 11

Proposal for a regulation

Article 4 – paragraph 1 – point 2

Regulation (EU) 2019/1021

Article 8 – paragraph 1a – subparagraph 3

Text proposed by the Commission

Amendment

At the latest 9 months following the submission of that report, the Committee for Socio-economic Analysis of the Agency, set up pursuant to Article 76(1), point (d), of Regulation (EC) No 1907/2006 shall adopt an opinion on the report and on the concentration limit values proposed therein. For the purpose of adopting an opinion on the report, Article 87 of Regulation (EC) No 1907/2006 shall apply mutatis mutandis.

At the latest 9 months following the submission of the report referred to in Article 8(1), point (i), the Committee for Socio-economic Analysis of the Agency, set up pursuant to Article 76(1), point (d), of Regulation (EC) No 1907/2006 shall adopt an opinion on the report and on the concentration limit values proposed therein. For the purpose of adopting an opinion on the report, Article 87 of Regulation (EC) No 1907/2006 shall apply mutatis mutandis.

Amendment 12

Proposal for a regulation

Article 4 – paragraph 1 – point 4

Regulation (EU) 2019/1021

Article 15 – paragraph 2

Text proposed by the Commission

Amendment

2. The Commission is empowered to adopt delegated acts in accordance with Article 18, to amend Annexes IV and V to adapt them to the changes to the list of substances set out in the Annexes to the Convention or the Protocol or to adapt them to scientific and technical progress.

2. The Commission is empowered to adopt delegated acts in accordance with Article 18, to amend Annexes IV and V to adapt them to the changes to the list of substances set out in Annexes I, II or III to Regulation (EU) 2019/1021, or the Annexes to the Convention or the Protocol or to adapt them to scientific and technical progress.

Amendment 13

Proposal for a regulation

Article 4 – paragraph 1 – point 4 a (new)

Regulation (EU) 2019/1021

Article 16 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

(4a) In Article 16, the following paragraph is added:

"2a. The Commission shall monitor the situation regarding the resources of the European Chemicals Agency and tasks, workload and remit of the scientific committees of the European Chemicals Agency and present, where necessary, a legislative proposal to reflect any needs of the European Chemicals Agency stemming from tasks introduced by this Regulation and to improve the governance of its scientific committees."

Amendment 14

Proposal for a regulation

Article 4 – paragraph 1 – point 5 – point c

Regulation (EU) 2019/1021

Article 18 – paragraph 6

Text proposed by the Commission

Amendment

6. A delegated act adopted pursuant to Articles 4(3), 10(2) and 15 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object..

Amendment 15

Proposal for a regulation

Article 4 – paragraph 1 – point 5 – point c a (new)

Regulation (EU) 2019/1021

Annex IV – Table 1 – Row 5

Present text

Alkanes C10-C13, chloro (short-chain chlorinated paraffins) (SCCPs)

85535-84-8

287-476-5

1 500 mg/kg

The Commission shall review that concentration limit and shall, where appropriate, adopt a legislative proposal to lower that value no later than 30 December 2027.

Amendment

(ca) in Annex IV, table 1, row 5 is replaced by the following:

Alkanes C10-C13, chloro (short-chain chlorinated paraffins) (SCCPs)

85535-84-8

287-476-5

1 500 mg/kg

By 30 December 2027, the Commission shall review that concentration limit and shall, where appropriate, adopt a delegated act in accordance with Article 15(2) to lower that value.

Amendment 16

Proposal for a regulation

Article 4 – paragraph 1 – point 5 – point c b (new)

Regulation (EU) 2019/1021

Annex IV – Table 1 – Row 12

Present text

Polychlorinated dibenzo-p-dioxins and dibenzofurans (PCDD/PCDF) and dioxin-like polychlorinated biphenyls (dl-PCBs)

5 μg/kg

The Commission shall review that concentration limit and shall, where appropriate, adopt a legislative proposal to lower that value, where such lowering is feasible in accordance with scientific and technical progress, no later than 30 December 2027.

Amendment

(cb) in Annex IV, table 1, row 12 is replaced by the following:

Polychlorinated dibenzo-p-dioxins and dibenzofurans (PCDD/PCDF) and dioxin-like polychlorinated biphenyls (dl-PCBs)

5 μg/kg

By 30 December 2027, the Commission shall review that concentration limit and shall, where appropriate, adopt a delegated act in accordance with Article 15(2) to lower that value.

Amendment 17

Proposal for a regulation

Article 4 – paragraph 1 – point 5 – point c c (new)

Regulation (EU) 2019/1021

Annex IV – Table 1 – Row 27

Present text

Hexabromocyclododecane

25637-99-4, 3194-55-6, 134237-50-6, 134237-51-7, 134237-52-8

247-148-4 221-695-9

500 mg/kg

The Commission shall review that concentration limit and shall, where appropriate, adopt a legislative proposal to lower that value to not higher than 200 mg/kg no later than 30 December 2027.

(4) For the purpose of emission inventories, the following four compound indicators shall be used: benzo(a)pyrene, benzo(b) fluoranthene, benzo(k)fluoranthene and indeno(1,2,3-cd)pyrene

Amendment

(cc) in Annex IV, table 1, row 27 is replaced by the following:

Hexabromocyclododecane

25637-99-4, 3194-55-6, 134237-50-6, 134237-51-7, 134237-52-8

247-148-4 221-695-9

500 mg/kg

By 30 December 2027, the Commission shall review that concentration limit and shall, where appropriate, adopt a delegated act in accordance with Article 15(2) to lower that value to not higher than 200 mg/kg.

(4) For the purpose of emission inventories, the following four compound indicators shall be used: benzo(a)pyrene, benzo(b) fluoranthene, benzo(k)fluoranthene and indeno(1,2,3-cd)pyrene

Amendment 18

Proposal for a regulation

Article 4 – paragraph 1 – point 5 – point c d (new)

Regulation (EU) 2019/1021

Annex IV – Table 1 – Row 30

Present text

Perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds, as set out in Annex I

335-67-1 and others

206-397-9 and others

1 mg/kg

(PFOA and its salts),

40 mg/kg

(sum of PFOA-related compounds)

Amendment

(cd) in Annex IV, table 1, row 30 is replaced by the following:

Perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds, as set out in Annex I

335-67-1 and others

206-397-9 and others

1 mg/kg

(PFOA and its salts),

40 mg/kg

(sum of PFOA-related compounds)

By 30 December 2027, the Commission shall review that concentration limit and shall, where appropriate, adopt a delegated act in accordance with Article 15(2) to lower that value.

Amendment 19

Proposal for a regulation

Article 4 – paragraph 1 – point 5 – point c e (new)

Regulation (EU) 2019/1021

Annex IV – Table 1 – Row 31

Present text

Perfluorohexane sulfonic acid (PFHxS), its salts and PFHxS-related compounds

355-46-4 and others

206-587-1 and others

1 mg/kg

(PFHxS and its salts), 40 mg/kg

(sum of PFHxS-related compounds)

Amendment

(ce) in Annex IV, table 1, row 31 is replaced by the following:

Perfluorohexane sulfonic acid (PFHxS), its salts and PFHxS-related compounds

355-46-4 and others

206-587-1 and others

1 mg/kg

(PFHxS and its salts), 40 mg/kg

(sum of PFHxS-related compounds)

By 30 December 2027, the Commission shall review that concentration limit and shall, where appropriate, adopt a delegated act in accordance with Article 15(2) to lower that value.

EXPLANATORY STATEMENT

The Rapporteur considers that strengthening the knowledge base on chemicals, facilitates the exchange of data between regulatory bodies as well as their communication and coordination on regulatory action, while streamlining the assessment of chemicals, and ensuring early detection and action on emerging chemical risks.

The Rapporteur welcomes the Commission’s proposal and the proposed harmonisation of assessments, with the caveat that each of the agencies work under their individual mandates, and full harmonisation is not possible without alignment of the regulations. He considers that streamlining is needed, and data harmonisation could work for the benefit of EU citizens and industry.

The reassignment of scientific and technical tasks should not lead to all tasks being centralised primarily in one agency (e.g. ECHA). When it comes to the hazard assessment of substances, it would be understandable that ECHA would be more involved. However, the risk assessment of chemicals – especially in the context of specific applications or product groups – should still be carried out by the agencies that have already gained extensive experience in this field.

In the case of substantive divergence over scientific issues, the Rapporteur considers that all the bodies involved in the process should work either resolving the divergence or preparing a joint document clarifying the contentious scientific issues.

ANNEX: ENTITIES OR PERSONS FROM WHOM THE RAPPORTEUR HAS RECEIVED INPUT

Pursuant to Article 8 of Annex I to the Rules of Procedure, the rapporteur declares that he received input from the following entities or persons in the preparation of the report, prior to the adoption thereof in committee:

Entity and/or person

CEFIC

COSMETICS EUROPE

EFPIA

SFEE (Hellenic Association of Pharmaceutical Companies)

BASF

EFEO

ECHA

L'Oréal group in Europe

AnimalhealthEurope

ClientEarth

European Environmental Bureau (EEB)

FuelsEurope

EFSA

EEA

EMA

Croplife Europe

DOW

AESPG

AISE

SMEunited

DUCC (Downstream Users of Chemicals Co-ordination group)

SEVAS (Association of the Greek Industry of Detergents and Soaps)

Eurometaux

Eurocolour

The list above is drawn up under the exclusive responsibility of the rapporteur.

Where natural persons are identified in the list by their name, by their function or by both, the rapporteur declares that he has submitted to the concerned natural persons the European Parliament's Data Protection Notice No 484 (https://www.europarl.europa.eu/data-protect/index.do), which sets out the conditions applicable to the processing of their personal data and the rights linked to that processing.

PROCEDURE – COMMITTEE RESPONSIBLE

Title

Re-attribution of scientific and technical tasks and improving cooperation among Union agencies in the area of chemicals

References

COM(2023)0783 – C9-0447/2023 – 2023/0455(COD)

Date submitted to Parliament

7.12.2023

Committee(s) responsible

ENVI

Committees asked for opinions

Date announced in plenary

AGRI

29.2.2024

Not delivering opinions

Date of decision

AGRI

12.2.2025

Rapporteurs

Date appointed

Dimitris Tsiodras

7.8.2024

Discussed in committee

25.11.2024

Date adopted

18.2.2025

BUDG

Result of final vote

–:

Members present for the final vote

Grégory Allione, Vytenis Povilas Andriukaitis, Pascal Arimont, Bartosz Arłukowicz, Sakis Arnaoutoglou, Anja Arndt, Thomas Bajada, Barbara Bonte, Stine Bosse, Lynn Boylan, Delara Burkhardt, Pascal Canfin, Annalisa Corrado, Antonio Decaro, Ondřej Dostál, Pietro Fiocchi, Emma Fourreau, Anne-Sophie Frigout, Heléne Fritzon, Gerben-Jan Gerbrandy, Andreas Glück, Hanna Gronkiewicz-Waltz, Anja Hazekamp, Esther Herranz García, Martin Hojsík, Pär Holmgren, Romana Jerković, Radan Kanev, Stefan Köhler, Ewa Kopacz, András Tivadar Kulja, Katri Kulmuni, Peter Liese, Javi López, César Luena, Elżbieta Katarzyna Łukacijewska, Ignazio Roberto Marino, Tilly Metz, Dolors Montserrat, Dan-Ştefan Motreanu, Jana Nagyová, Rasmus Nordqvist, Jacek Ozdoba, Jutta Paulus, Carola Rackete, Massimiliano Salini, Silvia Sardone, Majdouline Sbai, Lena Schilling, Jonas Sjöstedt, Sander Smit, Claudiu-Richard Târziu, Ingeborg Ter Laak, Beatrice Timgren, Dimitris Tsiodras, Filip Turek, Ana Vasconcelos, Aurelijus Veryga, Kristian Vigenin, Alexandr Vondra, Emma Wiesner, Michal Wiezik, Milan Zver

Substitutes present for the final vote

Stefano Cavedagna, Per Clausen, Valérie Deloge, Gabriella Gerzsenyi, Jens Gieseke, Sunčana Glavak, Nicolás González Casares, Michalis Hadjipantela, Matteo Ricci, Chloé Ridel, André Rodrigues, Bruno Tobback, Raffaele Topo, Laurence Trochu

Members under Rule 216(7) present for the final vote

Salvatore De Meo, Nora Junco García, Alexander Jungbluth, Julien Leonardelli

PROCEDURE – COMMITTEE RESPONSIBLE

Title

Re-attribution of scientific and technical tasks and improving cooperation among Union agencies in the area of chemicals

References

COM(2023)0783 – C9-0447/2023 – 2023/0455(COD)

Date submitted to Parliament

7.12.2023

Committee(s) responsible

ENVI

Committees asked for opinions

Date announced in plenary

AGRI

29.2.2024

Not delivering opinions

Date of decision

AGRI

12.2.2025

Rapporteurs

Date appointed

Dimitris Tsiodras

7.8.2024

Discussed in committee

25.11.2024

Date adopted

18.2.2025

BUDG

Result of final vote

–:

Members present for the final vote

Substitutes present for the final vote

Members under Rule 216(7) present for the final vote

Salvatore De Meo, Nora Junco García, Alexander Jungbluth, Julien Leonardelli

Date tabled

25.2.2025

INAL VOTE BY ROLL CALL BY THE COMMITTEE RESPONSIBLE

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