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Client accessHave you ever wondered how chemical companies ensure compliance with regulations across the European Union? This is where the REACH-EN-FORCE (REF) projects organized by ECHA come into play.
These projects are designed to verify that companies correctly adhere to REACH, CLP, and PIC regulations and to ensure uniform application of these rules across all Member States.
The purpose of the REF projects is twofold: to ensure that companies meet established obligations and to improve the quality of information provided throughout the supply chain. National inspectors work together to assess compliance, and the results are summarized in a report identifying problems and proposing improvements.
In this content, we’ll explore how these ECHA projects are developed, highlight common errors in Safety Data Sheets (SDS), and examine the main profiles of companies inspected.
Development of REACH-EN-FORCE Projects
The REACH-EN-FORCE inspection projects are organized by ECHA’s Forum for Exchange of Information on Enforcement, aiming to ensure the implementation of described regulations.
Every five years, Member States must submit a report to the Commission regarding the functioning of the Regulation in their territories.
These reports must include sections on the assessment and enforcement of the regulation, results of official inspections, supervisory activities carried out, sanctions imposed, and other measures planned during the specified period. This process follows the agreements made at the Forum for Exchange of Information on Enforcement.
ECHA and the Forum Working Group collect the data to compile a final report summarizing the results of each REF project. These findings help propose improvement measures, particularly regarding safety.
To determine the focus of a REF project:
Forum members, ECHA, and Accredited Stakeholder Organizations (ASOs) submit proposals.
The Forum Working Group on REF Project Prioritization creates a list of potential topics for focus.
The Forum as a whole selects and approves the project at a plenary meeting.
Previous REACH-EN-FORCE Projects
Let’s review past REF projects, the topics addressed, and future expectations so, companies can prepare for inspections:
REACH-EN-FORCE-7: Compliance with chemical substance registration obligations under REACH.
REACH-EN-FORCE-8: Compliance with online product regulations, verifying hazard information, safety data sheets, and restrictions on hazardous substances.
REACH-EN-FORCE-9: Compliance with authorization obligations for substances listed in Annex XIV of REACH.
REACH-EN-FORCE-10: Compliance with substance restrictions in products, including substances, mixtures, and articles under REACH, POP, RoHS, and the Toy Safety Directive.
REF-11: A Project Focused on the New SDS Regulation
REACH-EN-FORCE-11, developed in 2023, responds to the implementation of Regulation (EU) 2020/878, which introduced significant changes to SDS content under REACH.
This regulation updated REACH Annex II, aligning it with the 6th and 7th revisions of the Globally Harmonized System (GHS) and introducing new subsections and information requirements.
Key updates include details on nanoforms, endocrine-disrupting properties, UFI codes for mixtures, environmental multiplication factors, acute toxicity estimates (ATE), and use conditions for substances requiring authorization.
The primary objective of REF-11 was to evaluate suppliers’ compliance with these new requirements in the EU/EEA market. The results showed significant progress compared to previous reports:
Of 2,528 SDS assessed, 87% complied with the new regulations.
81% of suppliers had active procedures to update and share SDS with clients.
However, 35% of SDS still showed non-compliance in specific details.
Common Errors in Safety Data Sheets
Section 1
In subsection 1.1, mandatory UFI codes were missing or incorrectly placed in subsection 2.2.
Information on nanoforms (a new requirement) was missing.
Section 2
Subsection 2.2 lacked some authorization numbers.
Subsections 2.1 and 2.2 frequently had incorrect classification and labelling.
Subsection 2.3 was missing information on endocrine-disrupting properties (a new requirement).
Section 3
Subsections 3.1 and 3.2 failed to include specific concentration limits (SCLs), M-factors, or ATEs (new requirements).
Classification was often incorrect.
Section 8
Subsection 8.1 lacked data on OEL values, required notations, and legal bases.
Subsection 8.2 had incomplete PPE information (e.g., glove thickness, standards, permeability times).
Section 9
Subsection 9.1 omitted available data and information on nanoforms (a new requirement).
Subsection 9.2 missed information on physical hazard classes or safety characteristics (a new requirement).
Most inspected companies were small and medium-sized enterprises (SMEs), emphasizing the crucial role these companies play in the industry.
Of the 903 non-compliant SDS, authorities adopted a predominantly advisory approach, issuing written guidance in 69% of cases rather than imposing strict penalties.
Towards REF-12 and REF-13
ECHA has two key projects underway focusing on compliance with EU regulations:
REF-12: Focused on the safety of imported products, particularly chemicals, entering the EU. Inspections will begin in 2024 to ensure proper documentation, correct labelling, and compliance with restrictions. Import-dependent companies must meet all requirements to avoid sanctions and legal issues.
REF-13: Targeting the online sale of products such as toys, chemicals, and household items. Starting in 2025, this project aims to verify that online products meet classification, labelling, and packaging requirements under REACH and CLP.
Given the high non-compliance rate in e-commerce, the new legislation, such as the Digital Services Act, will equip inspectors with more effective tools to ensure that hazard information is correctly communicated and accessible to consumers.
A Well-Informed Industry
In recent years, we’ve seen various regulatory changes introduced by the EU, significantly impacting the chemical sector and related industries. It is crucial to pay close attention to all stages of substance and mixture documentation management.
As reflected in the evaluations from Forum inspection programs, large companies often have the resources to handle compliance effectively, while SMEs frequently face challenges.
SMEs must focus on ensuring compliance, seeking expert advice and support where necessary.
José Olmo, creator of the eQgest solution for compliance with community and international chemical safety regulations, understands the industry’s needs for successfully navigating programs like REACH-EN-FORCE.
According to his experience, these projects “play a critical role as a tool for EU authorities to gather essential information about the level of compliance with these regulations and the challenges faced by the industry.”
José Olmo notes that many companies using eQgest have been inspected as part of these programs and require assistance to address identified deficiencies, particularly in mixture classification, SDS content, and management.
He also emphasizes: “We’ve often observed that companies have limited knowledge about the REACH-EN-FORCE programs and their objectives, which has led us to incorporate this topic into our training initiatives to enhance regulatory understanding among our users.”
Do you need support to comply with regulations? Reach out one of our specialists to learn about eQgest, a software that simplifies chemical product management so your company can comply with regulations and grow safely.
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