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On 12 December 2025, the European Union published Directive (EU) 2025/2456 in the Official Journal, amending the Restriction of Hazardous Substances (RoHS) Directive (2011/65/EU) to transfer specific scientific and technical responsibilities from the European Commission to the European Chemicals Agency (ECHA).

Adopted on 26 November 2025, the Directive introduces amendments affecting both the substance restriction framework under Annex II and the procedures for exemption applications under Annex V, with different application dates.

Changes to Substance Restrictions Under Annex II

The Directive amends the framework governing substance restrictions set out in Annex II of the RoHS Directive. Under the revised provisions, ECHA is assigned a formal role in the preparation of restriction dossiers. Restriction proposals may be prepared either by a Member State or by ECHA acting at the request of the European Commission.

The Directive also introduces a requirement for the Annex II list of restricted substances to be reviewed periodically, at least every four years. The provisions related to Annex II will apply from 13 August 2027.

Key Changes to RoHS Exemption Procedures Under Annex V

The Directive revises the procedural rules governing RoHS exemption applications set out in Annex V, transferring responsibility for the scientific and technical assessment of applications to ECHA.

• Submission of exemption applications: Under the revised framework, all future RoHS exemption applications, including renewals, must be submitted directly to ECHA rather than to the European Commission. This change applies to exemptions listed in Annex V of the RoHS Directive. Once an application is deemed complete, ECHA will manage the subsequent assessment steps.
• Scientific and socio-economic assessment: As part of the new procedure, ECHA must seek the opinions of both the Committee for Risk Assessment (RAC) and the Committee for Socio-Economic Analysis (SEAC) when evaluating exemption applications.
• Renewals and decision timelines: The Directive does not amend the existing deadline for submitting renewal applications. Applications for renewal must continue to be submitted no later than 18 months before the expiry of the relevant exemption.

Following receipt of the committees’ opinions, the European Commission has nine months to adopt a decision. Existing exemptions will remain valid until a renewal decision has been made.

ECHA is also tasked with developing a harmonised format and guidance for exemption applications. The revised Annex V procedures will apply from 27 August 2027.

Broader Shift in EU Chemicals Governance

The reassignment of responsibilities under RoHS reflects a broader EU policy trend of consolidating scientific and technical assessments within ECHA to strengthen consistency across EU chemicals and product legislation. This approach aligns with the EU’s ‘One Substance, One Assessment’ framework, which aims to streamline chemical risk assessments by centralising scientific expertise within ECHA and reducing duplication across regulatory regimes.

On 17 December 2025, the European Commission published a formal Note for Guidance clarifying the implementation of Commission Regulation (EU) 2024/3190, which bans the use of bisphenol A (BPA; 80-05-7) and restricts other hazardous bisphenols and bisphenol derivatives in certain food contact materials and articles.

Scope and materials covered

The guidance confirms that the Regulation applies to the material groups listed in Article 1(2) of Regulation (EU) 2024/3190. These groups include plastics, varnishes and coatings, printing inks, adhesives, ion-exchange resins, silicones and rubber. Paper and board are not within the scope of the regulation, although the rules apply where regulated materials form part of a multi-material food contact article. Enamel, where it constitutes a glass-based material melted onto substrates, is also excluded.

Recycled food contact materials are considered outside the scope of the ban where BPA or other bisphenols are present only as unavoidable adventitious contamination and are not intentionally used in the manufacturing process.

Other bisphenols and current allowances

The guidance explains how the Regulation applies to bisphenols other than BPA and their derivatives. While salts of BPA are banned, certain BPA derivatives, such as bisphenol A diglycidyl ether (BADGE; CAS 1675-54-3), may still be used provided that residual BPA is not present. The use of other hazardous bisphenols with harmonised CMR or endocrine-disrupting classifications is prohibited unless authorisation is granted.

Use of bisphenol S (BPS; CAS 80-09-1) remains permitted for now, subject to existing limits, until the European Food Safety Authority (EFSA) publishes guidance on the data required for risk assessment. Once this guidance has been issued, businesses will have a defined timeframe in which to apply for derogations to continue placing affected materials on the market.

Compliance documentation, testing and declarations

The Commission clarifies that a Declaration of Compliance is required for all food contact materials within scope, including intermediate materials, even where BPA has not been used. All bisphenols and bisphenol derivatives used in the manufacturing process must be listed in the declaration.

While analytical testing is not mandatory in all cases, it may be required where BPA is permitted under specific derogations or where other bisphenols are used and residual BPA must be excluded. A detection limit of 1 µg/kg has been identified as feasible for both migration and residual content testing, pending further work by EU reference laboratories.

Transitional timelines through 2026 to 2029

The guidance provides detailed explanations of the transitional provisions, including the differences between intermediate materials and final food contact articles. In general, final food contact articles may first be placed on the EU market 18 or 36 months after the provisions come into force, depending on the use case. Additional sell-through periods apply for filled packaging and repeat-use articles, with timelines extending to January 2029 in some cases.

The Commission emphasises that transitional deadlines primarily apply to final food contact articles, while intermediate materials may only continue to circulate insofar as is necessary to complete compliant final products before the relevant deadlines.

Who is affected

The guidance is particularly relevant for manufacturers, converters, brand owners and importers involved in food contact materials, especially where BPA or alternative bisphenols such as BPS, BADGE or bisphenol AF (BPAF; CAS 1478-61-1) are used in materials, coatings, inks or adhesives. The guidance is intended to support consistent enforcement and compliance planning across the EU during the transition to BPA-free food contact materials.

The complete Note for Guidance can be accessed here.