Sometime tomorrow, 20 February, a new Delegated Act will be published.
amending Regulation (EC) No 1272/2008 as regards hazard classes and criteria for the classification, labelling and packaging of substances and mixtures
I will add the final text tomorrow.
I thought I’d take a quiet Sunday to try and recreate the key dates from my memory (if there are any errors, please let me know) and draw some broader lessons about working on secondary legislation.
You can track the political scrutiny of a delegated act via the Commission’s Portal (link).
The debate on the extension of the hazard classes has been going on for a long time. See the timeline below.
What’s New
The new delegated act adds new hazard classes to the CLP Regulation:
(i) endocrine disruptors;
(ii) PBT (persistent, bioaccumulative,toxic) and vPvB (very persistent, very bioaccumulative);
(iii) PMT (persistent, mobile, toxic) and vPvM (very persistent, very mobile).
This change did not come out of the blue.
Key Dates
- 12 March 203: Entry into Force 20 days from publication in the Official Journal of the EU .
- 20 February 2023: Published in OJ
- 8 February: COREPER recommends non-objection
- 6 February 2023: Council Working Group discuss and agree on – no majority for extension or objection
- 31 January 2023: Deadline for Council objection
- 19 January 2023: Internal deadline for objection to be raised
- 7 January 2023: Sent to MEPs on the lead Environment Committee via the Comitology Newsletter
- 19 December 2022: Adopted and transmitted to the Council and European Parliament
- 29 November 2022: CARACAL meet
- 22 November 2022: Deadline for comments to the WTO
- 15 November 2022: Public Consultation ends (link)
- 11 November 2022: Revised Draft Regulation
- 18 October 2022: Deadline for Comments to the public consultation
- 30 October 2022: Impact Assessment to support the CLP DA proposal published by mistake and withdrawn
- 10 October: CARACAL discuss the feedback on the draft delegated act
- 20 September 2022: Launch of Public Consultation on Draft Delegated Act (link)
- 13 September 2022: CARACAL sub-group meet
- 5 July 2022: CARACAL
- 13 May 2022: RSB Positive Opinion on Impact Assessment
- 11 May 2022 RSB meet
- 13 April 2022: Impact Assessment transmitted to RSB
- 22 February 2022: CARACAL subgroup meets
- 14 December 2021: CARACAL meet
- 30 Septmber 2021 CARACAL meet
- 9 August 2021: Launch Public Consultation (link)
- 28 June 2021: ECHA’s PBT Expert Group
- 28 May 2021: ECHA’s PBT Expert Group
- 4 May 2021: Launch of Inception Impact Assessment
- 22 March 2021: The commission presents a draft proposal on endocrine disruptors to the CARACAL’s sub-group on endocrine disruptors
- 19 October 2020: CARACAL sub-group meet
- 14 October 2020: Commission Communication, Chemicals Strategy for Sustainability. see action mentioned in box, page 13
- 2 July 2020: CARACAL sub-group meet
- 7 February 2020: CARACAL sub-group meet
- 19 May 2020: Framework Contract to support scientific and technical assistance for the reform of REACH, CLP, PIC and POP published
- 11 December 2019: Fitness Check of the EU legislation with regard to Endocrine Disruptors
- 6 November 2019: CARACAL discuss mandate on sub-group on endocrine disruptors
- 7 November 2018: Communication ‘Towards a comprehensive European Union framework on endocrine disruptors’, adopted on
Some Lessons Learned
These are some broad and specific lessons I draw from this file:
- You need to be vigilant every step of the way and have allies in the Member States and the EP ready to stand up for you.
- During the drafting phase, if influential Member States ask the Commission to change the Commission’s draft, and other countries don’t clearly object, the Commission will change its text.
- Timing is everything. The Commission is not meant to transmit delegated acts from 22 December until 6 January. The Commission did it on 19 December. They bought themselves 21 days.The Environment Committee knew about the file on 7 January via the Comtitology Newsletter and set an internal deadline for objections for 19 January. You need to bring your data to the table early, at the latest 5 weeks before the impact assessment is sent to the RSB, end of February 2021.
- You need a simple majority to ask for an extension in the Council. Only 8 Member States called for an extension: Germany, Poland, Finland, Bulgaria, Slovenia, Slovakia, Spain and Portugal.
- Only 2 countries – Finland and Slovakia – objected to the proposal. You need 20 Member States (or 353 MEPs) to block a delegated act. It is not easy to get this done. The best way to secure this is to have pre-discussed a challenge with a large block of Member States to get activated on day 1 and/or a cross-party group of MEPs.
- The legal concerns about the essential elements that had been voiced throughout the adoption process, nor the political debate about delegated acts, were enough to override support for introducing the new hazard classes. Politics trumps legal reservations 9 times out of 10.
- Nearly all decision-makers see CLP as a purely technical file. There is little to no interest in getting involved in the nitty gritty, let alone looking at chemical issues.
- The only way to change the contents of a delegated act is to get the issues re-opened in ordinary legislation.
- You need to have the resources, expertise, and resilience to work on a file over many years and be trusted by key decision makers in the Commission and the Member States at both the political, regulatory and technical levels.
- Finally, when the policy train starts (e.g.) back in 2018, it is hard to stop it. Change is historically inevitable, but it is hard to stop when it is on the Commission’s agenda.
- I don’t think WTO submissions influence the Commission or most of the EU Member States. The Commission listens to the Member States.
I assume the first two dates on the list should read 2023 rather than 2022, and the CARACAL meetings on 30 September and 14 December were 2021, not 2022.
thank you