What’s happening?

What’s happening? Here is an update for December 2025:

Classification, labelling and packaging (CLP): Council signs off postponing rules to 2028
EU REACH: new hazardous chemical on Candidate List
US: update on food contact materials

Classification, labelling and packaging (CLP): Council signs off postponing rules to 2028

On 17 November 2025, the Council of the EU approved pushing back the dates of entry into application of many provisions in the revised CLP regulation.

The newly adopted law ensures more time and legal certainty for businesses and will now enter into force in January 2028.

The legislation known as ‘Stop-the-clock’ is the first part of the Omnibus VI package submitted by the European Commission in July 2025.

Under this legislation, all the dates of application of transitional provisions will now fall on 1 January 2028 for:

re-labelling
mandatory formatting requirements
advertisements
online and distance sales, and
labelling of fuel pumps

The co-legislators adopted the amendment without making any changes to the Commission’s proposal.

The new regulation also gives the European Parliament and the Council more time to finalise the second part of the Omnibus VI package, which covers further amendments to the CLP regulation.

This work is now in progress, following the Council’s agreement on a negotiating mandate on 5 November 2025.

The EU’s Official Journal published the legislative act on 3 December, which now enters into force 20 days after publication.

EU REACH: new hazardous chemical on Candidate List

The following chemical is now on the Candidate List of substances of very high concern (SVHC) for Authorisation:

1,1′-(ethane-1,2-diyl)bis[pentabromobenzene] (DBDPE) (CAS number 84852-53-9)

The substance is very persistent and very bioaccumulative, and it is used as a flame retardant in various industries.

The list currently contains 251 entries for hazardous chemicals (although some of them are groups so the actual number of substances is higher).

What does it mean for companies?

European producers, importers and suppliers of products containing Candidate List substances must:

inform their customers of its presence, provide sufficient information on safe use, and notify the European Chemicals Agency (ECHA) – under the REACH Regulation
notify ECHA’s database of substances of concern in products (SCIP), if the articles they produce or import contain SVHCs in a concentration > 0.1% weight by weight – under the present version of the Waste Framework Directive, which is undergoing revision
Products containing SVHCs cannot have the ecolabel award – under the Ecolabel Regulation

The substance may be placed on the Authorisation List in the future. If so, its use will be prohibited unless a company obtains authorisation for its use from the European Commission.

An updated reference substance package, aligned with the latest inclusion of new hazardous chemicals to the Candidate List, is now available for SCIP notifiers.

ECHA recommends that companies import this package to their IUCLID instances and use it when creating SCIP notifications for articles containing the newly added Candidate List substances.

US: update on food contact materials

A food contact material (FCM) is any chemical, substance or material that is in contact with food but is not intended to be added directly to the food (also known as indirect food additives).

One example of how FCMs are regulated in the US is the market phase-out of per- and polyfluoroalkyl substances (PFAS) for grease-proofing of paper and paperboard packaging as required by the Food and Drug Administration (FDA).

On 6 January 2025, the FDA announced that food contact notifications (FCNs) for 35 PFAS are no longer effective.

The FDA revoked the authorisations for these specific FCNs following agency confirmation that the manufacturers had ceased production, supply, sale and/or use of these materials for this purpose.

Although the current reorganisation of the FDA may impact activities, the following changes are expected to take place for FCMS:

Elimination of GRAS for FCMs

In March 2025, the Health and Human Services secretary, Robert F Kennedy Jr., instructed the FDA to make changes to the Generally Recognized As Safe (GRAS) program that would prevent manufacturers from using the GRAS option for new food contact substances (FCSs) or additives without pre-market agency review. Different options are currently being explored for this program.

Regulation at state level

A review of state legislative agendas for 2025 indicates that policies for regulation of plastics and packaging are likely to be enacted in at least 17 states and the District of Columbia.

The policies include elimination of harmful plastics and additives, requiring reuse, restricting chemical reuse and restricting the use of intentionally added microplastics.

These initiatives are in line with both global and corporate interests that intend to eliminate harmful plastic additives, such as phthalates and bisphenols, from their products and packaging.

The California Proposition 65 (Prop 65) legislation also targets FCMs that are listed as either carcinogens or reproductive toxicants.

In the past, this listing has led to changes in labelling and reformulation of final products to remove the identified substance. Substances are continuously added to the list so it is likely that future impacts will occur.

Landbell Group company, H2 Compliance provides FCM information and support. Find out more here.