Widely heard after the 31 May 2018 was the shouting of “Hooray, we made it!”, when the final registration deadline for phase-in substances was finally passed. Some companies thought that this is it: REACH done, over and out. Well, the registration of a substance is just one part of the whole story. Though registrations were, without doubt, a major part of REACH work from 2007 to 2018, this is not the only part.
Let us for a moment travel back to a time prior to the first registration deadline for substances in volumes of more than 1000 tonnes per year per legal entity. REACH was new; ECHA was new and industrial chemical management was more or less obsolete or in a transition period. In the beginning, guidance documents were not yet developed or published. Many terms and procedures were new for the industry as well as the authorities. Therefore, registration dossiers were submitted that had been generated to the best knowledge and capability of all stakeholders at that time. Happy to have overcome the registration burden and having kept products on the market, registrations were considered to be fixed and settled.
Several years later it is rather obvious that these registration dossiers, some several years old now, might have been of a very high quality – indeed, “state of the art” – at the time they were prepared but fall short of today’s expectations of sound chemicals management.
The German Federal Institute for Risk Assessment (BfR) has completed a REACH compliance project that started back in 2014. They reported that only 31% of the dossiers for substances at greater than 1000 tonnes per year and 44% of the dossiers for volumes between 100 and 1000 tonnes per year were considered to be compliant. For the rest of the dossiers, data were considered to be missing. However, one has to keep in mind that it is not possible to simply skip required data endpoints in registration dossiers and, hence, registrants deviated from standard data requirements towards the optional use of alternative data like read-across or QSAR1. The problem identified was that the justifications for the use of these alternative types of data were not considered to be sufficient when applying today’s standards. Here we come full circle to what was mentioned above. At the time the dossiers were prepared, everything was deemed to be fine.
On 21st February of this year, ECHA released a news article with the topic: “REACH compliance – an agency priority for 2019”. This tells the story about many registration dossiers not containing all required information and referred to the above mentioned BfR study about REACH compliance. ECHA further stated that this result is also comparable to the results of ECHA’s own compliance checks.
On the other hand ECHA also tried to explain what happened and this is in accordance with the preparation of registration dossiers a couple of years ago. ECHA stated that REACH was built in a way such that industry does its job and ECHA checks the results. Wherever data is missing, industry is encouraged to avoid animal testing and to use alternative methods. Such alternative methods could not be developed at a sufficient pace and put industry in a problematic situation: they should (and wanted to) avoid animal testing but there were insufficient alternatives. That left industry with the alternative data options already mentioned, like read-across. Since a lot of data was missing years ago, this option was used to a much higher degree than expected by ECHA. The pressure to use data waivers may however leave an uncertainty about the hazard and subsequently the risk of a chemical substance. Hence, there is no other way than to tackle such uncertainties.
A substance for which the registration dossier is considered to be incompliant according to today’s standards, does of course not necessarily pose a hazard or risk to man and/or the environment, but there are of course worries, because one simply does not know for sure.
Therefore, take Article 22 of the REACH regulation very seriously and keep your dossier up-to-date! Check the basic data about volumes and uses (also uses advised against): are they still accurate? Remove uses that are not active any more. Keep an eye on the scientific data: is there something new with regard to hazards to man &/or the environment? Check your justifications for read-across or QSAR data. Do they sufficiently and reliably explain why you chose this approach?
Sometimes just a few additional sentences in a justification may change a dossier that is considered non-compliant into a well-received piece of work by the authorities.