2021/2125(DEC) | [ParlTrack]

Draft opinion
Paragraph 1

1. Observes that the European Chemicals Agency ('the Agency') is the driving force among regulatory authorities in implementing the Union's chemicals legislation for the benefit of human health and the environment, as well as for innovation and competitiveness; notes that the Agency provides information on chemicals, helps companies comply with legislation and promotes the safe use of chemicals; underlines that Regulation (EC) No 1907/2006 of the European Parliament and of the Council1a ("REACH Regulation") specifies that this should be done in a way that ensures that animal testing is only ever a last resort and that the use of non-animal methods is promoted; _________________ 1aRegulation (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 (OJ L 396, 30.12.2006, p. 1).

Amendment 10 #

Draft opinion
Paragraph 6 b (new)

6b. Calls on the Commission to immediately recognise and restrict substances on the Agency's Candidate List of Substances of Very High Concern (SVHCs) by including them in Annex XIV of the REACH Regulation, the so-called 'Authorisation List'; expresses serious concern at the slow progression of SVHCs to the Authorisation List;

Amendment 11 #

Draft opinion
Paragraph 6 c (new)

6c. Reiterates its calls1a to the Agency to step up its efforts to reduce the reliance on animal testing methods, deeply regrets the lack of action following its calls, urges the Agency again to undertake significant additional efforts to protect animal welfare and promote and facilitate the use of non-animal testing methods; _________________ 1a European Parliament resolution of 10 July 2020 on the Chemicals Strategy for Sustainability (OJ C 371, 15.9.2021, p. 75) and Decision (EU, Euratom) 2021/1622 of the European Parliament of 28 April 2021 on discharge in respect of the implementation of the budget of the European Chemicals Agency for the financial year 2019 (OJ L 340, 24.9.2021, p. 353).

Amendment 12 #

Draft opinion
Paragraph 6 d (new)

6d. Underlines the need to foster a positive attitude towards phasing out the use of animal testing throughout the entire Agency, including in the attitude and mind-set of its Executive Director;

Amendment 13 #

Alexandr VONDRA

Draft opinion
Paragraph 8

8. Notes that the Agency collaborates closely with other Union agencies, such as the European Food Safety Authority, the European Centre for Disease Prevention and Control and the European Medicines Agency, by means of memoranda of understanding to strengthen exchanges of information, better mutual understanding and, where appropriate, joint projects; underlines the importance of such an approach, in order to ensure that the work of each agency is consistent with that of the other agencies and to meet the requirements of sound financial management; welcomes the sharing of services and encourages cooperation among the Union agencies where and when possible;

Amendment 14 #

Martin HOJSÍK

Draft opinion
Paragraph 8

8. Notes that the Agency collaborates closely with other Union agencies, such as the European Food Safety Authority, the European Centre for Disease Prevention and Control and the European Medicines Agency, by means of memoranda of understanding; underlines the importance of such an approach, in order to ensure that the work of each agency is consistent with that of the other agencies and to meet the requirements of sound financial management; welcomes the sharing of services, such as sharing the Internal Audit Capability (IAC) with the EU Agency for the Space Programme (EUSPA), and encourages cooperation among the Union agencies where and when possible;

Amendment 15 #

Draft opinion
Paragraph 8 a (new)

8a. Stresses the need to allocate budget to pursue closer cooperation to consolidate a unique EU chemical database with its sister agencies under the one substance one assessment principle1a in particular by incorporating NAMs entries into IUCLID.1b _________________ 1a https://echa.europa.eu/documents/10162/ 21877836/efsa-echa-position-paper- osoa_en.pdf/74b1ae31-290b-a608-85e9- 05b340840b34#:~:text=We%20propose% 20that%20%E2%80%9Cone%20substanc e,built%20around%20three%20main%20 principles%3A&text=%2D%20Better%20 coordination%20on%20or%20distributio n,uses%20of%20the%20same%20chemic al. 1b https://echa.europa.eu/documents/10162/ 29387629/annual_report_2020_en.pdf/09 d078c5-ff40-6737-3e4c- 41dea91a7738#:~:text=We%20note%20th at%20the%20Agency's,final%20impleme ntation%20rate%20of%2098.5%20%25. P63

Amendment 16 #

Draft opinion
Paragraph 8 a (new)

8a. Welcomes the fact that, in spite of the difficult working conditions in connection with the COVID-19 pandemic, the Agency completed 194 of 210 planned outputs; respects the fact that, in view of these external circumstances, in the case of compliance checks, 271 substances were checked out of a planned 300 outputs;

Amendment 17 #

Draft opinion
Paragraph 8 b (new)

8b. Highlights the Agency’s role in tackling the COVID-19 pandemic, including by working with the Commission and the Member States to speed up supplies of disinfectant to the EU market;

Amendment 18 #

Draft opinion
Paragraph 8 c (new)

8c. Welcomes the Agency’s cooperation with UK-based companies on the end of the post-Brexit transition period, thus helping to prevent significant disruption to the Union market;

Amendment 19 #

Draft opinion
Paragraph 8 d (new)

8d. Is pleased that the occupancy of posts for temporary and contract staff reached 98% of the plan, which enabled the Agency to perform its tasks in a highly professional manner and to the extent planned;

Amendment 2 #

Monika BEŇOVÁ

Draft opinion
Paragraph 5

5. Stresses the need to ensure that the Agency is able to fulfil its mandate in the long term; calls, in this regard, for the lack of predictability of the Agency’s budget income to be addressed; while recognizing the positive developments in the governance and financing structure of the agency, notes the declining trend in fee income and believes that a new stable financing model should be developed and introduced without unnecessary delays; highlights that despite previously declared observations from the Parliament and the Court of Auditors, an unforeseen and significant drop of EUR 7,0 million in fee income under the REACH Regulation was reported by the Agency in 2020;

Amendment 20 #

Draft opinion
Paragraph 8 e (new)

8e. Emphasises that one of the Agency’s fundamental tasks for the period ahead will continue to be implementation of the Chemicals Strategy for Sustainability adopted by the Commission on 14 October 2020;

Amendment 21 #

Draft opinion
Paragraph 8 f (new)

8f. Welcomes the Agency’s decision to become climate-neutral in line with the Union’s 2030 climate target and its ambition to extend environmental certification to the EU’s eco-management and audit scheme (EMAS);

Amendment 22 #

Draft opinion
Paragraph 8 g (new)

8g. Welcomes the Agency’s efforts to strengthen, clarify and speed up the process for approving and reviewing active substances with biocidal effect under the Active Substances Action Plan (ASAP);

Amendment 23 #

Draft opinion
Paragraph 8 h (new)

8h. Notes and welcomes the fact that 271 full compliance checks covering 258 substances and 76 targeted checks concerning 44 substances were carried out in 2020;

Amendment 24 #

Draft opinion
Paragraph 8 i (new)

8i. Notes that the Agency currently maintains the largest database on chemicals, which makes it possible to provide transparent information on chemicals used within the Union; welcomes the Agency’s efforts to increase the transparency of this database by providing more detailed information to its users and the general public;

Amendment 25 #

Draft opinion
Paragraph 8 j (new)

8j. Takes note of the conclusions of the analysis carried out by ECHA, the Commission and the Exchange Network on Exposure Scenarios (ENES) as part of the third review of REACH, according to which further efforts are needed, in particular by industry;

Amendment 26 #

Draft opinion
Paragraph 8 k (new)

8k. Acknowledges that ECHA continued to support the Union’s efforts to reduce and replace animal tests by publishing new tools and expanding access to information, which aids the transition to alternatives that do not involve animal testing;

Amendment 27 #

Draft opinion
Paragraph 8 l (new)

8l. Welcomes the ECHA’s analysis of the issue of microplastics and their unintentional release into the environment; agrees with the conclusion that a Union-wide ban under REACH on products containing deliberately added microplastics, which are released into the environment on use, is an appropriate approach to resolving this issue;

Amendment 3 #

Alexandr VONDRA

Draft opinion
Paragraph 5

5. Stresses the need to ensure that the Agency is able to fulfil its mandate in the long term; calls, in this regard, for the lack of predictability of the Agency’s budget income to be addressed; notes the declining trend in fee income and believes that a new stable financing model should be developed and introduced without ~~unnecessary~~ delays;

Amendment 4 #

Draft opinion
Paragraph 5 a (new)

5a. Recommends fees as a new source of income for providing scientific advice for applicants, with fee reductions available for small and medium-sized enterprises, on the most appropriate way to generate robust evidence on chemicals’ hazard and risks using New Approach Methodologies (NAM).

Amendment 5 #

Monika BEŇOVÁ

Draft opinion
Paragraph 6

6. Underlines the necessity of ensuring adequate staffing reflecting the needs of the European Green Deal and the Union Chemical Strategy for Sustainability, Circular Economy Action Plan and zero pollution ambition in particular; notes the positive work undertaken on Directive 2008/98/EC of the European Parliament and of the Council1a and recognises the need for continued efforts towards establishing a fully sustainable financing model; _________________ 1aDirective 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives (OJ L 312, 22.11.2008, p. 3).

Amendment 6 #

Alexandr VONDRA

Draft opinion
Paragraph 6

6. Underlines the necessity of ensuring adequate staffing reflecting, in particular, the needs of the ~~European Green Deal and the Union~~ Chemicals Strategy for Sustainability, the Circular Economy Action Plan, the delivery of a toxic-free environment, and zero -pollution ambition ~~in particular;~~and the eighth Environmental Action Programme.

Amendment 7 #

Draft opinion
Paragraph 6

6. Underlines the necessity of ensuring adequate staffing reflecting the needs of the implementation of the European Green Deal and the Union Chemical Strategy for Sustainability, Circular Economy Action Plan and zero pollution ambition in particular;

Amendment 8 #

Draft opinion
Paragraph 6 a (new)

6a. Calls on the Agency to enforce more strictly the removal from the market of chemicals with incomplete registration dossiers in accordance with the REACH Regulation principal of ‘no data, no market’; welcomes the Agency’s commitment to reviewing all registration dossiers by 2027 and its publication in December 2019 of a list of more than 21 000 registered substances mapped in its chemical universe, to which the Agency added in 2020; acknowledges the enormity of this mapping task and recognises that fully and strictly enforcing the ‘no data, no market’ principle would require a full review of all dossiers and therefore significantly increase the programme’s costs; notes that the majority of REACH-registered substances have not yet been assigned to one of the regulatory action pools in this chemical universe, meaning they have not gone through any evaluation or prioritisation procedure to decide on the need for further regulatory action;

Amendment 9 #