Court of Justice's `Groundbreaking’ Decision Upholds ECHA Hazardous Substance Rules

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By Stephen Gardner  

BRUSSELS--The European Chemicals Agency on March 8 welcomed a European Court of Justice ruling that vindicated its decisions to identify a number of substances as “substances of very high concern” (SVHCs) under the European Union’s REACH regulation (Bilbaína de Alquitranes and Others v. ECHA, E.C.R., No. T-93/10, 3/7/13.

Meanwhile, a lawyer for the companies that sought annulment of the ECHA decisions told BNA that aspects of the judgment were “really quite groundbreaking” and will change the relationship between ECHA and REACH registrants in several ways.

The court judgment, handed down March 7, concerned ECHA’s decision to place anthracene oil, anthracene oil (low), anthracene oil (paste), and coal tar high pitch on the REACH candidate list, meaning they could ultimately be banned in the European Union.

The substances were put on the candidate list on the basis that they are persistent, bioaccumulative, and toxic (PBT), and/or very persistent and very bioaccumulative (vPvB), categories identified in the REACH regulation for possible phaseout. REACH (Regulation No. 1907/2006) stands for the registration, evaluation, and authorization of chemicals.

The court judgment was given in joined cases filed by Bilbaína de Alquitranes, Rütgers Germany, and Cindu Chemicals.

Assessment Errors Alleged

The plaintiffs had argued that ECHA was wrong to list the substances as SVHCs because they were assessed on the basis of the properties of their constituents, rather than on the basis of the properties of the substances themselves.

The substances are all considered to be substances of unknown or variable composition, complex reaction products, or biological materials (UVCB substances), because they cannot be fully identified by their chemical compositions.

The plaintiffs had also claimed that ECHA was being discriminatory by identifying certain--but not all--substances containing anthracene as SVHCs.

ECHA said in a statement that the court rulings “confirm the Agency’s approach in identifying PBTs and vPvBs as substances of very high concern,” and the court “also upheld that ECHA’s decisions were proportionate and did not breach the principle of equal treatment.”

ECHA added that it “considers that this ruling is a clear reminder to registrants that in their chemical safety assessment of UVCBs and other multi-constituent substances they have to identify and take into account the properties of the constituents of these substances.”

Ruling 'Sets Precedents’

Ruxandra Cana, a partner in Brussels with the legal firm Field Fisher Waterhouse, which represented the plaintiffs, told BNA the plaintiffs “have to assess the judgment,” and that an appeal is a possibility.

She said that although the court ruled in favor of ECHA, “several conclusions [of the court] can be considered as real legal precedents.”

The case established that an ECHA decision to include a substance in the REACH candidate list is a “regulatory act which has legal effects” by requiring companies to change their safety data sheets for listed substances, Cana said.

ECHA had argued that it does not adopt regulatory acts in placing substances on the candidate list, a distinction that has led the Court of Justice to dismiss as inadmissible previous cases challenging ECHA decisions.

The court in September 2011 dismissed as inadmissible two cases concerning the listing of acrylamide as an SVHC (Polyelectrolyte Producers Group v. ECHA, E.C.R., No. T-1/10, 9/21/11; SNF SAS v. ECHA, E.C.R., No. T-268/10, 9/21/11).

In both cases, appeals have been lodged with the Court of Justice.

Onus on ECHA to Prove PBT/vPvB

Cana said the March 7 rulings also established that “companies do not have to consider that substances are PBT and/or vPvB unless and until ECHA goes through the process” of SVHC identification and listing.

This would put the onus on ECHA and other public authorities to prove that substances have PBT or vPvB properties. ECHA and EU member state authorities “must go through the whole identification procedure under Article 59 of REACH,” Cana said. Article 59 sets out the process for listing substances as SVHCs.

Cana said the situation with PBT/vPvB substances is different from those classified as carcinogenic, mutagenic, or reprotoxic (CMR), which is a recognized category in other EU legislation and imposes obligations on companies.

In particular, companies are required to identify and appropriately label and package CMR substances by the European Union’s CLP Regulation (Regulation (EC) No. 1272/2008 on the classification, labeling, and packaging of substances and mixtures). However, PBT and vPvB “are not hazard classes in the CLP Regulation,” Cana said.

ECHA had argued that companies have a general obligation to update their safety data sheets with appropriate information if their substances have PBT or vPvB properties.

By Stephen Gardner  

The European Union Court of Justice rulings in Bilbaína de Alquitranes and Others v. ECHA, No. T-93/10; Rütgers Germany and Others v. ECHA, No. T-94/10; Cindu Chemicals and Others v. ECHA, No. T-95/10 ; and Rütgers Germany and Others v. ECHA, T-96/10 are available at,,, and

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