2 Jan 2019
High Non-compliance with REACH Registration Requirements Denounced
According to an announcement from the influential EU non-governmental organisation known as the European Environmental Bureau (EEB), “companies are breaking EU law by marketing hundreds of potentially dangerous chemicals that are widely used in consumer and other products.” The EEB based this statement of lack of regulatory compliance on an in-depth study conducted by the German Federal Institute for Risk Assessment (BfR) and the German Environment Agency (UBA) called “Availability of Health and Environmental Data for High Tonnage Chemicals under REACH”.
The BfR recently presented the results of its three-year long REACH Compliance project, which assessed the information indicated in the course of the registration of a chemical. The project assessed the dossiers of 3,800 substances produced in quantities over 100 tpa.
As Hong Kong traders of chemical products may know, virtually all substances imported into or produced within the EU have to be registered at the European Chemicals Agency (ECHA), in accordance with the REACH Regulation. In order to register a chemical, a certain set of data on the substance has to be collected, generated and compiled by the producer or the importer to demonstrate that the substance is safe for workers, consumers and the environment. This safety requirement applies throughout the entire life-cycle – from production to use and finally to waste disposal.
In principle, registrants have to fulfil the information requirements. However, alternative testing methods may be used or justifications can be given to use alternative data or to waive the requirement according to certain rules as laid down in the REACH Regulation. The Compliance project assessed the quality of registration dossiers with regard to certain selected criteria, taking into account toxicological and eco-toxicological risks with the highest significance.
The Compliance project found that, on average, only 31% of substances registered at 1,000 tpa and more were compliant with the information requirement. This number increased marginally, i.e., to 44%, for substances at lower tonnages between 100 and 1,000 tpa.
The option to deviate from standard testing methods and to provide justifications for such deviations was commonly used by registrants. According to the study, this was the case in an average of 70% of the dossiers across all assessed criteria. However, alternative data or justifications for data-waiving or adaptations were frequently found not to be sufficient.
Specifically, 32% of the dossiers for substances at tonnage levels of 1,000 tpa and more were found to be non-compliant with REACH requirements with respect to the assessed criteria. The average rate of non-compliance for substances at 100-1000 tpa was at 19%.
For all dossiers which were found non-compliant, registering companies have failed to report to ECHA whether the registered substances are carcinogenic, neurotoxic, mutagenic, bioaccumulative, and/or harmful to a child’s development or to fertility. Chemicals were found to be non-compliant with regard to eco-toxicological risks (61%), mutagenic risks (40%) and repro-toxic risks (34%).
It should be noted that the evaluation did not reach a decision on all dossiers. About 37% of the dossiers remained without any conclusion due to the complexity of the dossiers which require further investigation.
An English presentation on the REACH Compliance project can be found on the BfR website. The final report on the project is still in the process of being prepared, along with recommendations to registrants.
The report is said to have angered the industry, whose representatives consider that they should have been consulted before the publication of such results.
BfR and EEB state that the EU’s rules on chemicals are sound, but badly policed. Causes for non-compliance are seen to lie in checks that are too superficial, with too few follow-up checks. From around 40,000 dossiers, there were reportedly only 4 revocations since 2010.
The EEB bemoans the fact that despite these reporting deficiencies, the registered substances can be placed on the market. Not only does this create uncertainty with regard to the question of whether chemicals create health problems and damage the environment, it also causes frustration for companies who do comply and thus compete at an economic disadvantage.
The EEB characterized the German study as “a rare effort by a public authority tasked with enforcement.” It calls for ending the automatic granting of registration to non-compliant dossiers, an immediate withdrawal of registration for non-compliant dossiers under the REACH Regulation, the restriction of substances which entail health risks to humans or the environment, the update of dossiers so as to meet the latest scientific developments, and greater transparency.