On December 12, 2025, Regulation (EU) 2025/2455 was published in the Official Journal of the European Union, establishing a common digital platform on chemicals managed by the European Chemicals Agency (ECHA), aimed at centralizing and integrating chemical data from various industrial sectors.

This measure is part of the “One Substance, One Assessment” (OSOA) package, which is itself a pillar of the Chemical Strategy for Sustainability and the European Green Deal, designed to support the transition towards a toxic‑free, zero‑pollution environment for the protection of human health.

The goal is not to overlook the specificities of a substance’s use – whether in a toy, food, or cosmetic – but to ensure that the intrinsic hazard assessment is shared across different sectors.

Structure and purpose of the platform

The platform integrates data from five EU agencies: ECHA, EEA, EFSA, EMA and EU-OSHA and collects information derived from over 70 Union legal acts, including REACH, CLP, regulations on cosmetics, food, pesticides, biocides, and medicinal products.

Key Objectives of Regulation (EU) 2025/2455

• To collect data on chemical substances in a structured way and to guarantee their findability, accessibility, interoperability, and reuse.
• To guarantee consistent assessments of chemical hazards and risks.
• To allow the development and use of safe and sustainable chemical substances, to protect human health and the environment.
• To reduce animal testing where possible.
• To improve transparency towards authorities, operators, and the public.
• To consolidate a scientific basis as broadly as possible for the elaboration and updating of Union law and policies on chemical substances.
• To establish a rapid alert and early intervention system in case of emerging risks.

Data included in the platform

• Cosmetic ingredients, treated as chemicals, under other Union acts (e.g. REACH, CLP, etc.);
• Human biomonitoring data (with specific arrangements for the protection of personal data);
• National, international and EU research data;
• Voluntarily provided data.

Data excluded from the platform

• Data on final cosmetic products notified via the CPNP (Article 13 of Regulation 1223/2009);
• Information on the exact composition of hazardous mixtures (Article 45 of Regulation 1272/2008);
• Internal working documents of authorities.

Among the many services foreseen on the platform, of particular interest is the Database on Alternatives, which supports the substitution of problematic substances.

Obligation to notify studies from 2 November 2027

The provision with direct operational impact is Article 26 of Regulation (EU) 2025/2455, which introduces the obligation to notify ECHA’s database of all studies commissioned by economic operators that generate data on chemicals, whether considered as single substances or when present in products, whenever such studies are commissioned to obtain an authorisation or registration, or to assess risks and safety under the Union rules listed in Annex I.

This obligation concerns two distinct categories of actors, operating in parallel and independently:

1. Economic operators (study commissioners);
2. Laboratories or testing facilities (study performers).

The underlying logic is to ensure traceability of studies even if one of the two parties fails to fulfil its obligation, thereby creating a double‑coverage system.

It should be noted that studies that must already be communicated to the European Food Safety Authority (EFSA) are excluded from this notification requirement.

The obligation to notify will enter into force on 2 November 2027; ECHA, in close cooperation with EFSA and stakeholders, will define the practical implementation arrangements.

Cosmetic sector: what to do

For the cosmetic sector, for those who produce finished cosmetic products no new obligation applies.
For those who produce raw materials (including those intended for cosmetic use), in addition to the existing obligations under REACH and CLP, compliance with the notification obligation effective from 2 November 2027 will be required.
In other words, there is an obligation to communicate every commissioned study that produces scientific evidence on chemicals, whenever such data are generated to complete a regulatory dossier or a file to be submitted to the competent authorities.

According to the principle of dual notification described above, the following are foreseen:

1. Notification obligations of the commissioner:
   The party commissioning the study must communicate to ECHA the following information:

• Identity of the facility: laboratory or testing facility entrusted with carrying out the study.
• Planned start and completion dates of the study.
• A specific indication of whether the study is required to comply with an ECHA decision (under Articles 40, 41 or 46 of the REACH Regulation), so that authorities can monitor studies formally requested.

2. Notification obligations of laboratories and testing facilities

In parallel, the facilities performing the tests have an autonomous obligation to notify the ECHA database, providing:

• Study data: the same information provided by the study commissioner regarding timelines and types of tests.
• Name of the economic operator commissioning the study.

Pending implementation

In summary, Regulation (EU) 2025/2455 has been in force since 1 January 2026, and many components of the platform are expected to become operational on 2 November 2027, the key date for fulfilling the study‑notification obligations. Further developments are expected in subsequent phases. Practical implementation details are still awaited.

>>> Complife supports economic operators through strategic–regulatory consulting and testing services.

SOURCE:
https://eur-lex.europa.eu/legal-content/IT/TXT/?uri=CELEX%3A32025R2455&qid=1771328221975

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