ZeroPM Regulatory Watch Update January 2024

Agreement on the revision of the CLP Regulation aims to accelerate the adoption of harmonised classification and gives priority to group classifications

The European Parliament and the Council adopted the provisional agreement on the revision of the CLP Regulation on 20 December 2023. To accelerate the adoption of harmonised classifications, the revised Regulation gives the possibility to the Commission to request ECHA and EFSA to prepare a harmonised classification proposal, which previously was only provided to Member States competent authorities and manufacturers, importers and downstream users. In addition, ECHA and EFSA are enabled to provide, on their own initiative, scientific advice to the Commission and Member States on which substances or group of substances should have harmonised classification. As proposed by the European Parliament, the revised Regulation explicitly calls for the prioritisation of groups of substances over individual substances in proposals for harmonised classification and labelling whenever feasible.

The revised Regulation provides a mandate for the Commission to promote at UN level the harmonisation of the criteria for classification and labelling of endocrine disruptors, PBT, vPvB, PMT, vPvM, the adaptation of criteria for alternative approaches, in particular non-animal test methods, and the assessment of the need for new criteria for immunotoxic and neurotoxic substances. New provisions also aim to speed up the integration into CLP of alternative approaches for the classification of substances and mixtures, in particular non-animal test methods, preferably no later than 18 months after non-animal data are included in harmonised criteria at UN level.

Agreement on the Regulation establishing the Industrial Emissions Portal requires the reporting of emissions of PFOA and PFHxS to air, water and soil

The European Parliament and the Council adopted the provisional agreement on the Industrial Emissions Portal (replacing the European Pollutant Release and Transfer Register (E-PRTR)) on 29 November 2023. The Regulation requires certain industries (installations subject to IED, mining, UWWTPs, aquaculture, shipbuilding) to report their releases of certain pollutants (listed in Annex II) to air, water and soil, when they are above a certain threshold. The addition of PFOA and its salt and PFHxS and its salts to the list of pollutants which have to be reported, with thresholds set at 1kg/year released to air, water and land, has been maintained in the final text of the Regulation. The Regulation will enter into force in 2028.

Agreement on the Industrial Emissions Directive tightens permit conditions for industrial installations but fails to harmonise rules for setting emissions limits

The European Parliament and the Council adopted the provisional agreement on the revision of the Industrial Emissions Directive on 29 November 2023. The main points of the new Directive are summarised below.

Permit conditions

The New Directive requires that permits contain emission limit values for polluting substances listed in Annex II to the Industrial Emissions Portal Regulation which are likely to be emitted from the installations. Compared to the previous Directive, the list of substances concerned is more specific and can be amended more easily. A requirement to assess the need to prevent or reduce the emissions of SVHCs and substances addressed in REACH restrictions; measures to protect drinking water abstraction points; and appropriate requirements for the periodic monitoring of soil, surface and groundwater in relation to relevant hazardous substances likely to be found on site are new elements that should be included in the permit.

Environmental management system (EMS)

The new Directive introduces an obligation for operators to implement an environmental management system, which must contain a chemicals inventory of the hazardous substances present in or emitted from the installation, a risk assessment of the impacts of these substances on human health and the environment, and an assessment of the possibilities to substitute them with safer alternatives.

Setting emission limit values

The proposal from the Commission that competent authorities should set the emission limit values at the lowest end of the relevant BAT-AEL range, which aimed to harmonised the emission limit values across Member States, was not maintained in the final text. Instead, competent authorities should set ‘the strictest achievable emission limit values by applying BAT in the installation, considering the entire range of the emission levels associated with the best available techniques (BAT-AELs)’.

Stricter conditions to meet EQS

The general principle that where an environmental quality standard requires stricter conditions than those achievable by the use of the BAT, additional measures shall be included in the permit, is maintained in the final agreement. The requirement for the operator of the installation, when stricter conditions have been included in the permit, to monitor the concentration of relevant pollutants in the receiving environment is removed and replaced by a requirement for the competent authority to assess the impact of the stricter conditions on the concentration of the pollutants concerned in the receiving environment. In addition, ‘where the load of pollutants emitted by the installation has a quantifiable or measurable effect on the environment, Member States shall ensure that the concentration of the pollutants concerned in the receiving environment is monitored’. The results of the monitoring should be transmitted to the competent authority.

Transitional periods

The Directive provides for transitional periods for competent authorities and operators to comply with the new provisions of the Directive: 12 years for existing activities and 10 years for new activities.

Agreement on the Ecodesign for Sustainable Products Regulation (ESPR) paves the way for performance and information requirements on substances of concern in products

The European Parliament and the Council adopted the provisional agreement on the new Ecodesign Regulation on 19 December 2023. The Regulation establishes the general framework allowing the Commission to establish ecodesign requirements (performance and information requirements) for products through subsequent regulations specific to product groups. Performance requirements may be adopted to restrict the use of substances of concern during the manufacturing process of a product and/or the presence of such substances in the final product, primarily if these substances impede the reuse or recycling of the product. Information requirements may be adopted to enable the tracking of all substances of concern throughout the life cycle of products; the required information will be provided either on the product or be accessible through the digital product passport.

The Regulation defines substances of concern as: 1) substances identified as SVHCs under REACH, 2) substances with certain CLP classifications (including CMR 1 & 2; endocrine disruptors 1 & 2; PBT, vPvB; PMT, vPvM) and substances regulated under the POPs Regulation and 3) substances that negatively affects the re-use and recycling of materials in the product in which it is present. The Commission will be tasked to determine, for each product group, which substances fall under this definition before eco-design requirements can be adopted.

The purpose of performance and information requirements related to substances of concern is primarily to increase product circularity and recyclability. The Regulation specifies that performance requirements ‘shall not restrict the presence of substances in products for reasons relating primarily to chemical safety’, which is regulated by the REACH Regulation. It however raises questions as to how this distinction will be made consistently. Information requirements aim to ensure that information on hazardous chemicals present in the product is still accessible at the time the product is reused or recycled. Possible overlaps with reporting requirements under the Waste Framework Directive (SCIP database) for SVHCs will also likely come up as an issue in the adoption of information requirements under the ESPR.

The Regulation establishes a work programme for the adoption of ecodesign criteria, which prioritises product groups. The first programme should focus on iron, steel, aluminium, textiles, furniture, tyres, detergents, paints, lubricants, chemicals, energy related products, ICT products and other electronics.

Upcoming consultation deadlines:

  • Deadline to provide feedback on the draft Regulation amending Regulation (EC) No 440/2008 as regards the test methods, to adapt them to technical progress: 9 January 2024.
  • Deadline to provide feedback on the draft Regulation establishing a common data platform on chemicals: 4 March 2024
  • Deadline to provide feedback on the draft Regulation on the re-attribution of scientific and technical tasks and improving cooperation among Union agencies in the area of chemicals: 4 March 2024
  • Deadline to provide feedback on the draft Directive on the re-attribution of scientific and technical tasks to the European Chemicals Agency: 4 March 2024

More information 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 roll out, continuously updated spreadsheet and more information, please visit