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One third of all chemicals used in high quantity in Europe is not respecting EU safety laws

(14.10.2018)


Background:
Exposure to many types of industrial chemicals is a leading cause of falling human fertility,  various forms of cancer, reproductive abnormalities, lung diseases, diabetes and learning disabilities, among other adverse health impacts. According to the European chemicals regulation REACH, substances with import or production quantities of 1 ton per year and more have to be registered at the European Chemicals Agency ECHA. Since 2010, the principle of ‘no data, no market’ applies. To register a chemical, a certain set of data on the substance has to be collected, generated and compiled by the producer or importer. The registrants have to demonstrate a safe use of the substance for workers, consumers and the environment throughout the whole life-cycle – from the production to its use and finally to its disposal as waste.  The final deadline to register was end of May this year.


The REACH compliance project:
The REACH Compliance project is a joint project of the BfR and the German Environment Agency (UBA).  Together, they investigated the availability of human health and environmental data in the REACH registrations of chemicals regarding their compliance with the requirements on toxicological and eco-toxicological information as laid down in REACH.  No other national authority has conducted such an inspection for years, ongoing since 2014. Their report was presented at a workshop hosted by BfR on both 23 and 24 August 2018, aimed to inform stakeholders about the dossier quality of the majority of registrations for high tonnage substances and to facilitate dialogue between industry and regulators on how it can be improved. According to an NGO expert present, the report was met with an angry reaction by industry.

Within the project, the information given in the registration on 3,800 substances at 100 tons per year and more were assessed with regard to the endpoints of highest significance for human health and environment. By checking the available information on selected toxicological and eco-toxicological endpoints in this high number of dossiers, the project provides a representative outcome on the quality of registration dossiers. According to the study, one third (32%) of the 1,814 high production volume chemicals made or imported into Europe since 2010 break EU laws, while only 31 percent were declared as legally compliant, with the rest needing more investigation.

Despite the low level of compliance, the chemicals will continue to be used with no extra enforcement activities foreseen in the short-term. Guidance to industry will be produced, followed by dialogue and a ‘workshop’ next year. However, the guidance will have no legal force.


Related information


BfR: BfR Commnunication No. 030/2018 of 25 September 2018: REACH Compliance Workshop at the BfR

BfR Workshop presentation: REACH Compliance Project  “Availability of Health and Environmental Data for High Tonnage Chemicals under REACH” – Introduction to the project

BfR Workshop presentation: REACH Compliance Project  “Availability of Health and Environmental Data for High Tonnage Chemicals under REACH”  – Data Quality of Environmental Endpoints in Registrations

BfR Worshop presentation: REACH Compliance Project  “Availability of Health and Environmental Data for High Tonnage Chemicals under REACH” – Data quality of human health data in registrations

UBA:  Report 43/2015: REACH Compliance: Data Availability of REACH Registration -Part 1: Screening of chemicals > 1000 tpa



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last time modified: October 14, 2018









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