Category: Regulatory Watch

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ZeroPM Regulatory Watch Update March 2023

REACH restriction on C9-C14 PFCAs enters into force

REACH restriction on perfluorocarboxylic acids containing 9 to 14 carbon atoms in the chain (C9-C14 PFCAs), their salts and C9-C14 PFCA-related substances (Annex XVII, entry 68), adopted in August 2021 entered into force on 25 February 2023. A proposal for listing Long-chain PFCAs their salts and related compounds in Annexes to the Stockholm Convention is also under review.

Amendment to Annex I to POPs Regulation – PFOA

An amendment to Annex I to the POPs regulation adopted on 24 February 2023 restricts the unintentional trace contaminant (UTC) limit of PFOA in polytetrafluoroethylene (PTFE) micropowders to 0,025 milligrams per kilogram (compared to the previous limit of 1 mg/kg).

European Parliament’s ENVI Committee adopted its position on the revision of the F-gas Regulation

The ENVI Committee’s position, adopted on 1 March, increases the ambitions of the Commission legislative proposal by accelerating HFC phase down and introducing the objective a complete HFC production and consumption phase out in the EU by 2050. The Committee report adds prohibitions on the use of F-gases for sectors where it is technologically and economically feasible to switch to F-gases free alternatives, such as refrigeration, air conditioning, heat pumps and electrical switchgear.

Revision of the Groundwater Directive and EQS Directive – Draft report from European Parliament’s Rapporteur proposes quality standard for ‘PFAS total’

The European Parliament’s Rapporteur for the revision of the EQS and Groundwater Directives proposed in its draft report published on 20 February to set a two-year deadline for the Commission to establish technical guidelines regarding methods for monitoring all PFAS in ground and surface water in order to establish an EQS and a groundwater quality standard for ‘PFAS Total’ (in addition to the EQS and groundwater standard set for the sum of 24 PFAS).

The Rapporteur also proposed to reintroduce the deadline for Member States to phase out priority hazardous substances no later than 20 years after they are listed in the EQS Directive, remove the maximum numbers of new and emerging substances that can be contained in the EU watch lists for surface (10 substances) and groundwater (5 substances) at the same time, to introduce provisions to ensure faster deployment of effect-based monitoring methods to combined effects of priority substances, and to introduce an extended producer responsibility scheme for funding ground and surface water monitoring programmes. The draft report will be discussed at the end of March, with a Committee vote planned for the end of May.

European Parliament’s ENVI Committee members express strong concerns on the timing of the revision of REACH

On 1 March the ENVI Committee of the European Parliament organised an exchange of views with the Commission (DG Environment and DG GROW) on the upcoming Commission proposal for the revision of REACH. Members of the ENVI Committee expressed strong concerns about the timing of the publication of the legislative proposal as a publication in Q4 of 2023, as announced by the Commission, is likely to delay the legislative process to after the European elections in 2024. Several Committee members called for an earlier publication of the Commission proposal in June 2023 to increase health and environment protection and give the industry more legal clarity for their investment decisions. The Commission reiterated the commitment to publish the proposal within the set timeline (Q4 2023) and, if possible, before, without taking further commitment on an earlier publication. The Commission confirmed that the generic approach to risk management, the essential use concept, the inclusion of polymers, combination effects and the introduction of a mixture assessment factor, and provisions to improve implementation and enforcement of the Regulation would be part of the legislative proposal.

Upcoming consultation deadlines:

Upcoming consultations

The public consultation on the PFAS restriction will start on 22 March 2023 and will be open until 22 September 2023

Gantt Chart and Detailed Spreadsheet and more info of upcoming actions related to persistent and mobile substances

For more information of regulations under the regulatory watch, as well as a Gantt Chart of the rollout, continuously updated spreadsheet and more information, please visit https://zeropm.eu/regulatory-watch/

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ZeroPM Regulatory Watch Update February 2023

PFAS restriction

The proposal to restrict PFAS under REACH, drafted by the national authorities of Denmark, Germany, the Netherlands, Norway and Sweden, has been submitted to ECHA in January. The proposal was published on 7 February.

The restriction concerns all PFAS falling under the 2021 OECD definition, with the exception of ‘a few fully degradable PFAS subgroups’. The proposed restriction option provides for a ban on the manufacture, placing on the market and use of PFAS as substances on their own and bans the presence, in substances, mixtures or articles, of any non-polymeric PFAS above 25 parts per billion, while a limit for the sum of non-polymeric PFAS is set at 250 parts per billion. For polymeric PFAS, the limit would be set at 50 parts per million. An 18-month transition period is proposed before the entry into force of the restriction.

The restriction option excludes PFAS used as active substances in plant protection products, biocidal products, and human and veterinary medicinal products, which are covered by other regulations. It also provides for use-specific time-limited derogations (18-month transition period + 5- or 12-year derogation period depending on whether possible alternatives to the PFAS use have already been identified or not) for a wide range of products. 8 uses would benefit from a 5-year derogation and 16 from a 12-year derogation. A number of tentative derogations are included in the proposal and will be reconsidered after the public consultation.

The six-month public consultation will start on 22 March 2023 (until 22 September 2023). An online information session will be organised by ECHA on 5 April.

Candidate list

Following Member States Committee decisions in November and December, ECHA has added Melamine and Perfluoroheptanoic acid and its salts to the Candidate list on 17 January 2023.

Revision of food contact materials legislation delayed

The Commission has announced that the proposal for the revision of the food contact material legislation would not be published in the second quarter of 2023 as initially planned. According to a recent Commission presentation, the impact assessment will be carried out in 2023-2024 and the work on the legislative proposal will take place in ‘2024 and beyond’, suggesting that the legislative procedure will be carried out under the next Commission. According to the same presentation, the generic approach to assessing chemical risk, based on hazard classifications, will be part of the proposal, although it does not specifically mention PMT/vPvM.

Chemical industry transition pathway

The updated EU 2021 industrial strategy set the objective of developing actions plans for achieving the ‘green and digital transition’ for selected industries. These action plans or ‘pathways’ are developed jointly by the Commission, EU Member States and stakeholders (industry, social partners, NGOs and academia). The Transition pathway for the chemical industry has been published in January 2023. It lists a series of actions to be taken by chemical companies, the EU and Member States, and a timeline for their implementation. Among environmental objectives, the transition pathway reiterates the objectives of the Chemicals Strategy for Sustainability to ‘establish safe and sustainable chemicals as an EU global benchmark’ and to ban ‘most harmful substances in consumer products unless they are essential for society’. The implementation of the transition pathway will start in the second quarter of 2023.

Swedish presidency support to REACH revision

During an exchange of views with the Environment Committee of the European Parliament, Romina Pourmokhtari, Minister for Climate and Environment of Sweden, gave an overview of the priorities of the Swedish presidency on climate and environment policy. She recalled the Presidency’s aim to adopt Council mandates on many files including the Industrial Emissions Directive, the Ecodesign for sustainable products Regulation, to continue the legislative work on water, urban wastewater treatment and air legislation and start the work on the packaging and packaging waste Directive. She also stressed that the revision of REACH was a priority for Sweden and that the Presidency is ready to start the negotiations as soon as there is a proposal from the Commission. She recalled the full support of the Council to an ambitious REACH Revision, which was expressed in the Council conclusions of March 2021.

Upcoming consultation deadlines:

  • Deadline to comment on the draft Delegated act amending Annex I to the POPs Regulation to include PFHxS, its salts and PFHxS-related compounds (following inclusion in Annex A to the Stockholm Convention): 9 March 2023.
  • Deadline to comment on the draft Commission Proposal revising the lists of surface and groundwater pollutants: 14 March 2023.
  • Deadline to comment on the draft Commission Proposal revising the Urban Waste Water Treatment Directive: 14 March 2023.
  • Deadline to comment on the draft Commission Proposal revising the Ambient Air Quality Directive: 14 March 2023.
  • Deadline to comment on the draft Commission Proposal amending the CLP Regulation: 30 March 2023.
  • Deadline to comment on the draft Commission Proposal for a Regulation on Packaging and Packaging Waste: 04 April 2023.

New consultation:

The Commission’s recent proposal on an Ecodesign for Sustainable Products Regulation (ESPR), currently undergoing legislative procedure, should be completed with a work plan, prioritising product groups and measures for the establishment of ecodesign requirements. The Commission seeks views on the categories of new products and measures to address first.

Gantt Chart of upcoming actions related to persistent and mobile substances

Click here to find Gantt chart of upcoming actions related to regulations that could impact the use and management of persistent and mobile substances in Europe.

For more information of regulations under the regulatory watch, visit https://zeropm.eu/regulatory-watch/

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ZeroPM Regulatory Watch Update January 2023

Adoption of new CLP hazard classes

The Delegated Regulation setting out new regards hazard classes and criteria, including for PMT / vPvM substances has been adopted on 19 December 2022. The Regulation will enter into force early this year (mid-February), after scrutiny by the European Parliament and Council.

CLP revision

Together with the adopted delegated act, the Commission published on 19 December 2022 a proposal for the revision of the CLP Regulation. The proposed revision adds the new hazard classes to the hazards that are normally subject to harmonised classification and labelling (amendments to Article 36 of the CLP Regulation). The proposal introduces the possibility for the Commission to initiate the harmonised classification and labelling procedure by requesting ECHA or EFSA to prepare a CLH proposal for a substance (amendments to Article 37 of the CLP Regulation). This possibility was so far only provided to Member States competent authorities and manufacturers, importers and downstream users. The possibility to initiate harmonised classification and labelling proposals for several substances at once is also added to the Regulation. The consultation on the draft Commission proposal is open until 28 February 2023.

Melamine

The Member States Committee identified Melamine as SVHC in December 2022.

Regulation on maximum levels of PFAS in certain foodstuffs

The Commission Regulation amending Regulation (EC) No 1881/2006 as regards maximum levels of perfluoroalkyl substances in certain foodstuffs has been adopted on 7 December 2022. Addressing the presence of PFAS in food by introducing limits in the legislation on food contaminants was in the action plan of the Chemicals Strategy for Sustainability. Commission Regulation (EC) No 1881/2006 sets maximum levels for certain contaminants in foodstuffs listed in Annex to the Regulation. The amending Regulation sets maximum levels in food (eggs, fish, crustaceans and meat) for PFOS, PFOA, PFNA, and PFHxS. The limit values have been adopted based on EFSA’s opinion of 9 July 2020 on the risk to human health related to the presence of perfluoroalkyl substances in food. The Regulation entered into force on 1 January 2023.

Zero pollution monitoring and outlook

The European Environmental Agency presented their first Zero pollution monitoring assessment and the Commission Joint Research Center the Zero pollution outlook 2022 at the Zero Pollution Stakeholder Conference on 14 December 2022. The presentations from the conference are available here.

The Zero pollution monitoring assessment assesses progress towards the six targets set out for 2030 in the Zero Pollution Action Plan of 2021. The EEA concluded that the two targets to ‘reduce the use and risk of chemical pesticides by 50 %’ and to ‘reduce the use of the more hazardous chemical pesticides by 50 ’. EEA’s report is available here (most relevant chapters are the ‘production’ section and the health chapter) and the Commission’s Zero pollution monitoring and outlook report here.

The JRC’s Zero pollution outlook 2022 presents modelling and foresight results which provide a broader perspective on whether the EU is on track with regard to the objectives of the EU zero pollution ambitions and associated EU legislation. The JRC’s report is available here.

Swedish presidency of the Council

Sweden has taken up the presidency of the Council for the next six months, until end of June 2023. The Presidency’s work programme prioritises, in the Environment Council, the revision of the Industrial Emissions Directive, the revision of the Ambient Air Quality Directives, and aims to advance the work on the revision of the Packaging Directive and on circular-economy related matters, in particular on ‘EU regulatory frameworks that promote non-toxic material cycles, increased use of high-quality recycled materials in products, and other business models that promote a circular economy’.

Upcoming consultation deadlines:

Upcoming regulatory milestones:

  • Transposition of the Drinking water Directive (Directive (EU) 2020/2184) in all 27 Member States is due on 12 January 2023.
  • PFAS Restriction: The restriction proposal on the manufacture, placing on the market and use of PFAS, prepared by Germany, Denmark, the Netherlands, Norway and Sweden, is expected to be submitted on 13 January 2023.

Gantt Chart of upcoming actions related to persistent and mobile substances

Click here to find Gantt chart of upcoming actions related to regulations that could impact the use and management of persistent and mobile substances in Europe.

For more information of regulations under the regulatory watch, visit https://zeropm.eu/regulatory-watch/