P10_TA(2025)0047 – Re-attribution of scientific and technical tasks and improving cooperation among Union agencies in the area of chemicals – Amendments adopted by the European Parliament on 1 April 2025 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) 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 (COM(2023)0783 – C9-0447/2023 – 2023/0455(COD)) (Ordinary legislative procedure: first reading)
Date: 2025-04-01
Institutions: Committee on Agriculture and Rural Development, Committee on Budgets, Committee on Industry, Research and Energy, Committee on the Environment, Climate and Food Safety, European Parliament
Subjects: European Agency for Safety and Health at Work, European Chemicals Agency, European Environment Agency, European Food Safety Authority, European Medicines Agency, chemical product, chemicals legislation, exchange of information, interinstitutional cooperation (EU), scientific report








C_202504378EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2025/4378


9.9.2025






P10_TA(2025)0047

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


Amendments adopted by the European Parliament on 1 April 2025 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) 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 (COM(2023)0783 – C9-0447/2023 – 2023/0455(COD))
             (1)


(Ordinary legislative procedure: first reading)

(C/2025/4378)


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.


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 Council (12) 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 Council (12) 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.













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..












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. 
That period may be extended by two months at the initiative of the European Parliament or of the Council’
.









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 (2)



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
.




 


 


 


 
















Amendment













(cc)






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










Hexabromocyclododecane (3)



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.




 


 


 


 





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)


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













(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)


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













(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.






(1)  The matter was referred back for interinstitutional negotiations to the committee responsible, pursuant to Rule 60(4), fourth subparagraph (A10-0020/2025).

(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 ).

(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).

(2)  
            ‘Hexabromocyclododecane’ means hexabromocyclododecane, 1,2,5,6,9,10-hexabromocyclododecane and its main diastereoisomers: alpha-hexabromocyclododecane, beta-hexabromocyclododecane and gamma-hexabromocyclododecane.

(3)  
            ‘Hexabromocyclododecane’ means hexabromocyclododecane, 1,2,5,6,9,10-hexabromocyclododecane and its main diastereoisomers: alpha-hexabromocyclododecane, beta-hexabromocyclododecane and gamma-hexabromocyclododecane.


ELI: http://data.europa.eu/eli/C/2025/4378/oj
ISSN 1977-091X (electronic edition)