“REACH Compliance continues to be a DyStar priority for substances both manufactured in and imported into the European Economic Area (i.e. the EU member states including Norway, Iceland and Liechtenstein).”
By the end of 2013, six month after the end of the second REACH registration deadline, DyStar is quite satisfied with its progress during the past three years. For the most important dyes and basic chemicals DyStar has successfully submitted its registration dossiers to the ECHA so that we are in full compliance with the obligation to register all chemicals in the tonnage band > 100 – < 1000 tons per year by 31.05.2013.
The number of registration dossiers submitted for both phase-in and non-phase-in substances is now more than eighty in total. In this second registration phase DyStar acted as LEAD registrant for more than a dozen of mostly reactive dyes, making use of its expertise and the archives of existing toxicological and eco-toxicological test reports.
But the greatest effort yet has to be provided, as all the other chemicals manufactured and imported above 1 ton per year will have to be registered by end of May, 2018.
Interview with Dr. Clemens Grund, Vice-President Technology, DyStar
The second registration phase ended on June 1, 2013. Which new insights result from these past years?
We gained a lot of experience how to organize the different pieces of the work that are related to a successful registration. Beginning with the appropriate registration sample, the selection of the testing institutes, the handling of all information required for a full dossier and ending with how data have to be entered to pass the automatic checks of the registration software tool, the IUCLID. This program has been updated several times, always presenting new plug-in tools or program checks.
What are the expectations for the third registration period?
By far the majority of chemicals used in the textile industry still require registration. Even though this last registration period is longer than the first two, there are a lot of chemicals for which the work in the SIEFs did not start so far. This organizational step has to be done soonest and the work has to be shared by as many consortia partners as possible to accelerate the output of registrations.
In the first and second registration phase, DyStar acted as LEAD, now we additionally will have to submit more so-called “Member Dossiers” for chemicals that have been or will be registered by other companies first.
What will be the role of DyStar?
DyStar with its team of experts will go on preparing IUCLID dossiers for the registration of substances under REACH. But as we are owners of a comprehensive archive of toxicological testing reports, we will be able to supply a lot of data required by other companies as well.
Our toxicological background enables us to use the two principles of waiving and read-across to avoid unnecessary animal testing, which saves both animals and money. This expertise is also needed to use risk assessment tools such as the ECETOC TRA (Toxicology of Chemicals – Targeted Risk Assessment), EUSES (European Union System for the Evaluation of Substances) and CHESAR (CHEmical Safety Assessment and Reporting. The consortia will cooperate with a university team to tailor a newly developed program for computational molecular modeling (QSAR) especially for the needs of dyes.
What about REACH outside Europe?
There are other countries in the world that already announced the publication of a REACH-like legislation as an outcome of the commitment from the World Summit on Sustainable Development in Johannesburg (WSSD 2002) and on the Strategic Approach to International Chemical Management in Dubai (SAICM 2006), e.g. Turkey, China, India and Korea. So far, only Turkey – and only for high-volume chemicals – has published the obligation to register chemicals by submitting dossiers comparable to the European IUCLID (International Uniform ChemicaL Information Database) registration files.
We still stress that, regardless where the textile articles have been produced, the responsibility of a non-EU manufacturer for all stages in their supply chain does exist. Non-European manufacturers who export to the EU have to comply with REACH if they do not wish to put their business at risk. We offer our support to our customers worldwide. By using DyStar products our customers can have confidence that textiles imported into Europe are REACH-compliant.
What is the most important outcome of the REACH Regulation for downstream users?
The need of having an adequate supply chain communication to ensure REACH compliance is a big challenge. The more substances will be evaluated for listing under Annex XIV, the Authorization List, the more important will be proper communication as well as product and chemistry know-how. DyStar with its more than 150 years of experience in textile dyes and its econfidence™ program will act as sustainable and reliable partner in the textile supply chain world-wide.
Are there any concluding remarks?
DyStar experienced that implementing REACH is a very challenging legislative program, and it continues to require the commitment and resources of all the key players including DyStar as one representative of the industry.
It has to be stressed that now almost all players gained their first experience on the registration procedure, but the other procedures still are just evolving: On the one hand the evaluation of submitted dossier including a possible request for further data from ECHA and on the other hand the authorization procedure. Both procedures have been newly introduced with the REACH regulation and -as before with the registration- all actors are just experiencing them for the first time. Difficulties and discussions are expected within the SIEFs as well as with the agency and the member state authorities but hopefully these will also lead to an enhancement of the entire processing to finally improve the safe use of chemicals both for human health and the environment.
One thing is for sure – the workload for all key players will even increase during the following years.