Following are some recent updates on European hazardous chemical regulations:
1. EU’s Climbdown on Hazardous Chemicals
According to leaked papers, the European Commission is willing to renege on its pledge to outlaw all but the most essential of Europe's hazardous chemical products. The first pledge was included in the 2020 European Green Deal. Between 7,000 and 12,000 hazardous substances, including "forever chemicals" like per- and polyfluoroalkyl substances (PFAS), were expected to be outlawed from all marketed goods. However, EU authorities decided to explore a ban for only 1%, 10%, or 50% of the items containing harmful chemicals currently on the market due to pressure from the European chemical sector and right-wing political groups.
2. New hazard classes 2023
The European Commission has published a Delegated Regulation amending CLP Regulation, outlining the new hazard classes and criteria for the classification, labelling and packaging of substances and mixtures.
It applies to all chemical substances and mixtures placed on the EU market under REACH. It also applies to active substances in biocidal products and plant protection products which are normally prioritised for harmonised classification in the EU.
This EU legislation is binding for manufacturers, importers, downstream users and distributors placing substances on the European Union market. Member States will also draw upon the new hazard classes and criteria when making proposals for harmonised classification and labelling.
The new hazard classes include:
- ED HH in Category 1 and Category 2 (endocrine disruption for human health)
- ED ENV in Category 1 and Category 2 (endocrine disruption for the environment)
- PBT (persistent, bioaccumulative, toxic), vPvB (very persistent, very bioaccumulative)
- PMT (persistent, mobile, toxic), vPvM (very persistent, very mobile)
For new substances that appear on the market, companies need to respect the new rules as of 1 May 2025; for substances already on the EU market, companies have until 1 November 2026 to respect them.
Separate transition times apply for mixtures. The new hazard classes apply from 1 May 2026 to new mixtures; for existing mixtures, companies have until 1 May 2028 to update the classification and labelling.
3. Restrictions Roadmap by the European Commission
The Restriction Roadmap has three general objectives:
- To ensure that the commitments under the strategy can be fulfilled in a transparent and timely manner. The Rolling List included in the Annex (see below) sets out the restrictions which have been planned and prepared and those that have progressed, in particular for the most harmful substances (i.e. those which meet the criteria for CMRs, PBTs, vPvBs, endocrine disruptors (ED), immunotoxicants, neurotoxicants, respiratory sensitisers and STOT substances (Specific target organ toxicity). It will be the cornerstone for the multiannual planning under Article 68 of REACH on introducing new and amending current restrictions and Article 69 of REACH on preparing proposals for the period up to 2025-2027, until the new rules on the generic approach are put in place.
- Give an overview, through its Rolling List, of how we are using the available authority resources. The Rolling List contains (groups of) substances which are being considered for a risk management measure or for which an entry in the Registry of Intentions (RoI) has been submitted.
- Provide transparency to the stakeholders of the restriction work by the authorities and allow companies to anticipate (potential) upcoming restrictions, e.g. by already commencing the substitution activities.
The European Commission's regulatory landscape for hazardous chemicals is evolving with significant amendments. Despite initial plans under the 2020 European Green Deal to ban a broad range of hazardous substances, recent indications show a possible reduction in scope due to industry and political pressures. Concurrently, the Commission's new Delegated Regulation updates the CLP Regulation with new hazard classes, requiring compliance by 2025-2028. The Restriction Roadmap ensures transparent and timely fulfilment of commitments, providing a Rolling List of planned restrictions. Utilizing a chemical regulatory compliance tool is crucial for companies to navigate these changes and adhere to the new regulations.
