In a press release published on October 12, 2018, non-governmental organization (NGO) European Environmental Bureau (EEB) announced that “companies are breaking EU law by marketing hundreds of potentially dangerous chemicals that are widely used in consumer and other products.”
The findings on the lack of regulatory compliance for almost a third of the examined 1,814 high production volume chemicals come from a study of REACH dossiers, carried out by the German Federal Institute for Risk Assessment (BfR) and German Environment Agency (UBA). The results of this three-year-long analysis were presented at a workshop on data quality in REACH registration dossiers, held by BfR in August 2018. The outcomes were also summarized in the BfR communication on this workshop, published on September 25, 2018.
Screening and formal check of data on human health and environmental endpoints provided in the dossiers found that only 31 % of chemicals with production volumes above 1000 metric tons per annum were “compliant,” while 32% were found to be “non-compliant.” For chemicals with production volumes between 100 and 1000 metric tons per annum, 44% and 19% were described as “compliant” and “non-compliant,” respectively. For all the remaining chemicals, the compliance situation was characterized as “complex,” with further investigation necessary.
This means that companies are “failing to report . . . whether their substances are cancer causing, neurotoxic, mutagenic, bioaccumulative and/or harmful to developing children or human fertility,” the EEB explained. Despite these reporting deficiencies, “these substances have flowed into the production of all manner of consumer and industrial goods, from paint to packaging, furniture to construction materials, since 2010.”
The EEB characterized the German study as “a rare effort by a public authority tasked with enforcement,” but criticized the facts that “no extra enforcement activities are foreseen in the short-term” and that “even when companies have declared that substances pose a risk to human health or the environment, only a handful of restriction actions have been taken.” According to EEB, “fewer restrictions occur today than before REACH regulations entered into force.”
In response to the BfR/UBA report, EEB formulated a set of measures that could be taken to improve the situation. In particular, EEB calls for “an end to the automatic granting of registration to non-compliant dossiers, under the ‘no data, no market’ rule” and “an immediate withdrawal of registration of non-compliant dossiers.” Further, “dossiers . . . [should be] kept updated with the latest science,” and “substances . . . [should be] restricted where risk to humans or the environment is declared in dossiers.” EEB further suggests that transparency could be increased “through the naming, shaming or praising of dossiers that are compliant or not.”
Jack Hunter (October 12, 2018). “A third of chemicals break EU safety laws.” European Environmental Bureau
Chemical Watch (October 3, 2018). “German Reach registration project finds low compliance rates.”
Cefic (October 12, 2018). “Cefic statement on the BfR study on compliance of REACH dossiers.”
Romain Loury (October 16, 2018). “32% of chemicals non-compliant with EU rules.” Euractiv
Clelia Oziel (October 16, 2018). “EU ‘blindly’ allows hazardous chemicals on the market – NGO.” Chemical Watch
ECHA (October 17, 2018). “Data on chemicals need to be improved.”
BfR (September 25, 2018). “REACH compliance workshop at the BfR.” (pdf)
Oertel, A., et al. (August 2018). “REACH compliance project “Availability of health and environmental data for high tonnage chemicals under REACH” – Data quality of environmental endpoints in registrations.” BfR (pdf)
Dolores Romano (August 2018). “No data, no market?” BfR (pdf)