22 Jan 2019
EU Agency Starts Enforcement Programme on REACH Compliance
Earlier in January 2019, the European Chemicals Agency (ECHA) and national customs officials started an EU-wide enforcement programme to check if importers and manufacturers comply with registration obligations under REACH. This is the seventh REACH enforcement project. Previously, ECHA and national bodies identified “gaps and severe shortcomings in the chemical safety information submitted by industry”.
The seventh REACH enforcement project (REF-7) will examine imported and manufactured substances in all tonnage bands. The project will particularly target substances manufactured or imported in quantities between 1 and 100 tonnes per annum (tpa).
According to ECHA officials, companies should be prepared to expect inspections starting January 2019. As recently as October last year, ECHA is said to have organised an annual training for officials from national enforcement authorities (NEA) which focused on REF-7 inspections.
As Hong Kong traders of chemicals or products that contain them may know, virtually all substances imported into or produced within the EU have to be registered with 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.
Checks will be conducted to assess the completeness of registration dossiers and to determine if registrants are complying with their obligation to update their dossiers on a regular basis. Inspections will also be conducted with regard to the question of whether chemicals registered as intermediates, which are transformed into other substances and not used in the production of articles directly, meet the applicable definition of intermediates and requirement for strict control of their manufacture and use. Similarly, substances registered as monomers in polymers will be scrutinised.
A work programme adopted by the Forum for Exchange of Information on Enforcement for the five-year period between 2019 and 2023 by ECHA and NEAs identifies key areas of focus for the five-year action plan. Priorities for that period will include: (i) control of imports through close cooperation with customs authorities; (ii) internet sales of chemicals; and (iii) improved cooperation between NEAs in cross-border cases.
ECHA reportedly recognises the need to accelerate its work on the implementation of REACH as well as the related Classification, Labelling and Packaging (CLP) Regulation. Issues with compliance of chemicals were raised by several other bodies, too.
In 2018, a study conducted by the German Federal Institute for Risk Assessment (BfR) and the German Environment Agency (UBA) established that about a third of substances at tonnage levels of over 1,000 tpa are non-compliant with REACH registration requirements. These high-volume chemicals make up 95% of the total market and are used in a large number of consumer products, such as paints, packaging, furniture and building materials. The project assessed the registration dossiers of 3,800 substances produced in quantities over 100 tpa.
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 German 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 to 44%, for substances at lower tonnages between 100 and 1,000 tpa.
Moreover, for all dossiers which were found non-compliant, registering companies had failed to report to ECHA whether the registered substances are carcinogenic, neurotoxic, mutagenic, bioaccumulative, and/or harmful to development of children or fertility. Chemicals were found to be non-compliant with regard to eco-toxicological risks (61%), mutagenic risks (40%) and repro-toxic risks (34%).
The BfR stated that the EU’s rules on chemicals are sound, but badly policed. Causes for non-compliance appear to lie in generally superficial checks and too few follow-up checks. From around 40,000 dossiers, there were reportedly only 4 revocations since 2010.
The REF-7 enforcement project is expected to address the findings of the German study. A report on the results of REF-7 is expected to be published at the end of 2020.