News

Another substantial update on the roll out of the Chemicals Strategy for Sustainability as it relates to persistent and mobile substances.

New CLP hazard classes have entered into force, ECHA updates relevant guidance and tools

The new CLP hazard classes entered into force on 20 April 2023. New requirements will apply to new substances from 1 May 2025 (and from 1 November 2026 for substances placed on the market before 1 May 2025). For new mixtures placed on the market, requirement will apply from 1 May 2026 (1 May 2028 for mixtures placed on the market before 1 May 2026). ECHA is currently updating all guidance and tools to include the new hazard classes: the harmonised classification and labelling (CLH) proposal template is already updated; new hazard classes will be included in the IT tool IUCLID in spring 2024 so that companies can submit information related to the new hazard classes; and the guidance on applying the CLP criteria is expected to be updated by mid-2024.

Commission proposal revising the pharmaceutical legislation strengthens provisions on environmental risk assessment of medicinal products

The Commission published on 26 April 2023 a proposal for a new Directive and a new Regulation revising the general pharmaceutical legislation. The proposal strengthens the environmental risk assessment (ERA) of pharmaceuticals and requires that the ERA indicates whether the pharmaceutical product contains PBT, vPvB, PMT, vPvM, or endocrine active agents. The ERA must also include risk mitigation measures to avoid or limit emissions to air, water and soil of pollutants listed in the Water Framework Directive, the Groundwater Directive, the Environmental Quality Standard Directive and the Industrial Emissions Directive. Under the new legal framework, the fact that the ERA does not provide enough evidence that environmental risks have been adequately evaluated and addressed through risk management measures becomes a ground for refusing the market authorisation, which was not the case in the previous legislation.

The new Directive also provides that a medicinal product must be subject to medical prescription if it contains an active substance that is a PBT, vPvB, PMT or vPvM, for which medical prescription is required as an environmental risk minimisation measure, unless the use of the medicinal product and the patient safety require otherwise (Article 51).

The consultation on the Commission proposal is open until the end of June. More details on the proposed revision can be found in the excel sheet.

Denmark, Germany, the Netherlands and Czech Republic call for lowering maximum levels of PFAS in food and establishing maximum levels for additional foodstuffs

In December 2022, the European Commission introduced maximum levels for certain PFAS (PFOS, PFOA, PFNA, and PFHxS) in certain foodstuffs of animal origin (eggs, meat, fish, fishery product and mussels). These maximum levels were based on EFSA’s opinion of 9 July 2020 on the risk to human health related to the presence of perfluoroalkyl substances in food. Delegations from Denmark, Germany, the Netherlands and Czech Republic submitted a note that was debated at the Agriculture and Fisheries Council on 25 April 2023, recommending to regularly review and lower existing maximum levels for PFAS in foodstuffs, and to set new maximum levels in additional foodstuffs based on occurrence data in food. To achieve this, the note encourages all Member States to submit monitoring data to EFSA as requested by Commission Recommendation (EU) 2022/1431. The Recommendation requests that Member States to monitor annually until 2025 levels of PFOS, PFOA, PFNA, PFHxS and other PFAS in wide variety of foodstuffs including fruits, vegetables, cereals, oilseeds, or food for infants and young children. The European Commission stated that maximum level should be considered for these products, in combination with measures to reduce sources of contamination. Some Member States however highlighted the current lack of data and analysis method to revise the maximum levels or add new ones.

ECHA launches call for evidence on 1,4-dioxane

On 20 April, ECHA launched a call for evidence to support Germany’s upcoming restriction proposal on the manufacture, use and placing on the market of 1,4-dioxane containing surfactants. The restriction is based on the risk posed by this persistent and mobile substance to drinking water sources. The call for evidence, open until 20 June, aims to gather information on the manufacture, uses, emissions related to manufacture and uses, the feasibility of removal of 1,4-dioxane from other substances / mixtures the socio-economic impacts of a REACH restriction.  

Upcoming consultation deadlines:

• Deadline to comment on the call for evidence and respond to the public consultation on new product priorities under the Ecodesign for Sustainable Products Regulation: 12 May 2023
• Deadline to provide feedback on the draft opinion of the SEAC on the restriction of PFAS in firefighting foams: 15 May 2023.
• Deadline to comment on the proposal for listing Long-chain perfluorocarboxylic acids, their salts and related compounds in Annexes to the Stockholm Convention – consultation on the draft Risk Management Evaluation: 17 May 2023.
• Deadline to provide input to the call for evidence on 1,4-dioxane as well as substances and mixtures containing 1,4-dioxane as a constituent or an impurity (aiming to support the preparation of a Restriction Report): 20 June 2023.
• Deadline to provide feedback on the Commission proposal for the revision of the EU general pharmaceuticals legislation: 28 June 2023 (to be extended).
• Deadline to provide feedback on the PFAS restriction: 25 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 roll out, continuously updated spreadsheet and more information, please visit https://zeropm.eu/regulatory-watch/

Another huge update on the roll out of the Chemicals Strategy for Sustainability as it relates to persistent and mobile substances.

Opening of the public consultation on the PFAS restriction

The public consultation on the PFAS restriction is open until 22 September 2023. An online information session on the consultation will be organised by ECHA on 5 April.

RAC and SEAC support the restriction of PFAS in firefighting foams

ECHA’s Committee for Risk Assessment (RAC) and Committee for Socio-Economic Analysis (SEAC) have adopted their opinions and support the proposed restriction on the placing on the market, formulation and use of firefighting foams containing PFAS. The opinion of the SEAC is open for consultation for 60 days until 15 May 2023.

CoRAP update includes suspected vPvM

The Community rolling action plan (CoRAP) 2023-2025 contains 24 substances suspected of posing a risk to human health or the environment to be evaluated by Member State Competent Authorities under the substance evaluation process of the REACH Regulation. The update from March 2023 added six substances to the list included a suspected vPvM, Sodium 3-(2H-benzotriazol-2-yl)-5-sec-butyl-4-hydroxybenzenesulfonate (CAS no. 92484-48-5), to be evaluated in 2023.

Delegated Regulation on new CLP hazard classes and criteria published in the Official Journal

The Commission Delegated Regulation (EU) 2023/707 amending Regulation (EC) No 1272/2008 as regards hazard classes and criteria for the classification, labelling and packaging of substances and mixtures, introducing the new hazard class for PMT and vPvM substances has been published in the Official Journal of the European Union on 31 March 2023. The Regulation will officially enter into force on the twentieth day following its publication in the Official Journal (20 April 2023).

Adoption of the Implementing Regulation on the identification of unacceptable co-formulants in plant protection products

The implementing Regulation setting out detailed rules for the identification of unacceptable co-formulants in plant protection products was adopted on 13 March 2023 (it was published in the OJ on 14 March and is now in force). The Regulation sets criteria to determine whether a co-formulant might have harmful effect on human or animal health or on groundwater or unacceptable effects on the environment as per Article 27(1) of the Plant Protection Product Regulation (Regulation (EC) 1107/2009) and should consequently not be accepted for inclusion in a plant protection product. Those criteria include, among others, the classification of the co-formulant as CMR, its inclusion in the annexes to the POPs Regulation, its inclusion on the Candidate List (for reasons other than its classification as CMR) or as having endocrine-disrupting properties in accordance with the BPR. The criteria do not refer to new hazard classes under the CLP Regulation (e.g. PMT/vPvM). The Regulation also lays down rules for including new substances in the list of co-formulant not accepted for inclusion in plant protection products (Annex III to the PPPR).

Draft report from European Parliament’s Rapporteur on UWWTD calls for public funding to complement the EPR

The Commission proposal for the recast Directive on urban wastewater treatment, published in October 2022, proposed to introduce Extended producer responsibility (EPR) for producers of pharmaceuticals and cosmetic products to finance the costs of quaternary treatment, newly introduced in the Directive, to remove micro-pollutants from waste water. The draft report from European Parliament’s Rapporteur proposes to share the responsibility of financing quaternary treatment between the EPR, governments and the public, though the establishment of ‘national financing programmes’. These programmes would be financed through contributions from national funding, municipal levies, existing water tariffs, and by those producers. The rapporteur also calls on the Commission to assess by 2030 the possible extension of the scope of the EPR to products containing PFAS placed on the market, taking into account any future restrictions. The draft report will be presented by the rapporteur to the European Parliament’s ENVI Committee at the end of April.

Council reaches an agreement on the revision of the IED

The Council adopted its general approach on the revision of the Industrial Emissions Directive on 16 March 2023. The Council proposed to add to the permit conditions (Article 14 of the IED) and the Environmental Management System (EMS) (Article 14a) a focus on the prevention and reduction of the emissions of the most hazardous substances, including ‘substances fulfilling the criteria of article 57 or substances addressed in restrictions in Annex XVII to the REACH Regulation’. The Council agreement also introduces transitional periods for competent Authorities and installations to comply with the new provisions of 16 years for existing activities and 10 years for new activities. Further details on changes made by the Council can be found in the excel sheet. The adoption of the Parliament’s position is expected in June and the trialogues in September.

European Parliament’s amendments to the revision of the F-gas Regulation adopted in Plenary

The European Parliament adopted on 30 March 2023 its amendments to the Commission proposal on the recast F-gas Regulation. MEPs largely backed the report from the ENVI Committee calling for complete HFC production and consumption phase out in the EU by 2050. The EP amendments make a clear link between F-gases and PFAS pollution. The amendments state that the ‘Regulation should not encourage substitution of HFCs with fluorinated greenhouse gases that are also PFAS, whose production produces PFAS or otherwise decomposes into PFAS’ and introduce an obligation for the Commission to assess, within three months following the adoption of the revised REACH Regulation, the coherence between the revised F-gas Regulation and the revised REACH Regulation, and if necessary to publish a legislative proposal to align the F-gas Regulation with REACH. Further details can be found in the excel sheet.

Upcoming consultation deadlines:

• Deadline to comment on the draft Commission Proposal for a Regulation on Packaging and Packaging Waste: 24 April 2023.
• Deadline to comment on the call for evidence and respond to the public consultation on new product priorities under the Ecodesign for Sustainable Products Regulation: 12 May 2023
• Deadline to provide feedback on the draft opinion of the SEAC on the restriction of PFAS in firefighting foams: 15 May 2023.
• Deadline to provide feedback on the PFAS restriction: 25 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 roll out, continuously updated spreadsheet and more information, please visit https://zeropm.eu/regulatory-watch/