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/