« ECHA Must Take a Stand On Compliance’

« Following the REACH “no data, no market” principle, a chemical is only allowed on the market, once manufacturers and importers register the substance and prove it is safe by submitting specific information.

Competent authorities will only be able to regulate chemicals effectively, when they have a clear picture of what’s on the market – and this can only be established through information provided by companies. This information would also better inform citizens about the chemicals they are exposed to.

Registration dossiers are, therefore, the pillar of REACH and this is why it is so crucial that the information provided is accurate, adequate, reliable, relevant and trustworthy.

However, the quality of registration dossiers is embarrassingly poor. According to Echa, 69 % are not even in compliance. The main problems are with the identification of the substance and the waivers or justifications given for not submitting studies or parts of the safety report. This is fundamental information to ensure substance safety.

In order to help companies to improve the quality of the registration dossiers, Echa, since 2009, has launched a very varied bunch of soft measures, such as quality observation letters, informal contact with companies, targeted letter campaigns, lists of substances that are likely to face compliance checks, REACH guidance updates, more streamlined and concise advice and statements of non-compliance (Soncs).

Nevertheless, despite the agency’s efforts, compliance has not improved at all. The percentage of non-compliant dossiers has remained well over 50 % for the last five years as demonstrated in the following figures:

in 2009 – 50 %;

in 2010 – 64 %;

in 2011 – 92 %;

in 2012 – 67 %; and

in 2014 and 2015 – 69 %.

Moreover, the German Federal Institute for Risk Assessment (BfR) released a study, this year on data availability in REACH registrations that showed only one dossier, out of 1,814, was compliant with standard information for all endpoints.

It is evident that the soft measures applied by Echa are highly ineffective. Not only is there a lack of incentives to ensure compliance, there are too many encouraging the opposite, such as the lack of regulatory action and the low chance that a dossier will be evaluated – under REACH, Echa has been required to examine 5% of registration dossiers for the first two deadlines.

It’s time to move on from soft measures, guidance and advice to getting serious about enforcing compliance.

We propose that Echa:

*does not grant registration numbers, in the first place, for empty dossiers or dossiers with inadequate information, such as insufficient description of a substance identity. More manually examined dossiers and fewer automated completeness checks, that don’t evaluate how adequate the information, are needed;

*completeness checks, performed for the whole registration dossier, including chemical safety reports;

*exclude from the market, by cancellation of registration numbers, those substances where safety has not been proven (for example, if the compliance check shows very bad quality dossiers or the dossier is not complete) in order to ensure a level playing field that favours companies taking REACH seriously. Although Echa agreed it may invalidate registration numbers in well-justified cases a few years ago, revocation has only been considered in cases where registration numbers were assigned to non-existent registrants, and where they failed to pay the correct registration fee. However, there are some “good cases”, such as the ongoing Board of Appeal case where an almost empty dossier was accepted by Echa;

*apply a “naming and shaming” mechanism, such as disseminating the names of non-compliant companies, or a traffic light system for the dossiers that pass an evaluation in the dissemination portal. These mechanisms would be a very good incentive to compliance as both market access and reputation are very important for companies. Moreover, it would ensure informed decisions by citizens, increase market pressure and protect human health and environment; and

*increase the compliance checks rate beyond 5 % of registration dossiers.

After eight years, the compliance problem is no different; two thirds of the information provided by companies under REACH is not reliable or compliant, putting the credibility of the process at stake and blocking any protective action by competent authorities.

The compliance checks process is the most important measure to improve the quality of dossiers but Echa is seen as very weak by most registrant companies, which are doing nothing to improve their dossiers.

A more ambitious approach by the agency, that gives fewer carrots and more sticks to non-compliant companies in order to ensure full compliance with the legal text, should be by hook or by crook the minimum. »

Article of Tatiana Santos, senior chemicals and nanotechnology policy officer, EEB

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