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Regulatory information | ECHA promotes SMEs to comply with authorization require

Date:2023-03-16 09:25:21 Classification :【Statute】 Visits:
The EU-wide project of the Law Enforcement Forum on the inspection of REACH authorization responsibilities found that most users, mainly small and medium-sized enterprises, have complied with the authorization requirements to control risks. The law enforcement measures taken by the authorities during the project are aimed at promoting the company's compliance.

Helsinki, March 8, 2023 - During the project, law enforcement authorities in 28 countries conducted 690 inspections on 516 companies. The most common substances of high concern (SVHC) are chromium trioxide and strontium chromate, which are used for surface treatment or chrome plating. The inspection is mainly aimed at downstream users, especially small and medium-sized enterprises (SMEs), who are the end users of SVHC.

In four inspections of downstream users, one inspector (26%) found that the use of the substance did not meet the conditions specified in the authorization decision granted by the European Commission to its suppliers. Therefore, in these companies, workers or the environment are not adequately protected from the adverse effects that SVHC may have.

The inspectors also found that for 20% of the inspected authorized substances, downstream users did not notify ECHA of their use. In addition, for 35% of the inspected substances, the supplier failed to convey the information of the operating conditions, risk management or monitoring arrangements specified in the authorization decision to the rest of the supply chain.

Although there is obvious room for improvement on the level of compliance with specific authorization requirements, the results show that most downstream users comply with basic authorization responsibilities. In 3% of the inspections, it was found that the company used or sold substances without obtaining or applying for authorization or obtaining applicable exemption.

Law enforcement measures

When the non-conformance was found, the inspectors took 254 enforcement measures to make all companies comply. These measures mainly include written recommendations and administrative orders, but also include fines and, in some cases, criminal complaints.

proposal

The project report outlines recommendations for industry, law enforcement forums, national authorities, ECHA and the European Commission. For example, suppliers of authorized substances should improve the quality of safety data sheets, while downstream users should ensure that the use of authorized substances meets the conditions in the authorization decision.

In order to improve the implementation of the responsible person and the enforceability of REACH authorization, some suggestions on the content and clarity of future authorization decisions were also provided to the European Commission.


The background inspector of the Forum REF-9 project checks whether it meets the REACH authorization requirements. The authorization requirements apply to substances of high concern (such as carcinogens or substances toxic or mutagenic to reproduction), which are included in REACH's authorization list (Annex XIV).


These substances can only be used or sold after the company or its supplier has obtained the authorization of the European Commission for their specific use. The authorization clauses in REACH are designed to protect workers and the environment, while gradually eliminating these highly hazardous substances from the market.


The REACH-EN-FORCE-9 (REF-9) project operates in 28 member countries. The inspection will be conducted in 2021. The control measures include the requirement to obtain authorization before the use or sale of authorized substances, and the notification obligation of the European Chemical Administration to use these substances or downstream users only according to the conditions specified in the authorization decision.

In addition, the project also examined the information flow on the safe use of authorized substances in the supply chain. The project concluded a series of three forum law enforcement projects, focusing on REACH authorization responsibilities.

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