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Authorisation: it's a business choice
LANXESS Deutschland GmbH was the lead company for the registration of chromium trioxide (CrO3) in 2010. Chromium trioxide was subsequently added to the Authorisation List in April 2013. LANXESS were then contacted by members of their registration consortium and asked if they had any plans for the authorisation process. ECHA Newsletter recently spoke to Martin Kleban, Director of Health, Safety, Environment and Quality of the Business Unit Leather at LANXESS, to learn about his experience.
"We contacted the actors in our supply chain to evaluate our options knowing that we had a business decision to make. Authorisation was the route we decided to take. However, it was obvious that the work could not be carried out by any manufacturer or importer alone but would need the heavy involvement of downstream users. So we created the Chromium Trioxide Authorisation Consortium (CTAC) and outsourced the management and technical work to consultants," Mr Kleban says.
By the start of 2012, the consortium agreement had been signed by 150 companies and later that year CTAC began preparing the documents for an application for authorisation for the use of chromium trioxide for surface treatment.
Mr Martin Kleban.
Starting well in advance
They plan to apply for authorisation in May 2015. The work on the application has been ongoing for nearly three years, which shows how important it is to start preparing early.
"The 18-months foreseen in REACH as a minimum period for preparing for authorisation, is clearly an underestimate for a situation as complex as surface treatment with chromium trioxide. Therefore, it is vital to start early," Mr Kleban warns.
It is also important to be ready for delays and surprises along the way. "We experienced a few difficulties in collecting data and had to make our members aware of how important it is for them to supply the data efficiently. Gathering the data is a big issue," Mr Kleban says and continues, "some members only sent their data after the deadline had passed. This delayed us a little. With this in mind and with some forward thinking and planning, we could have been a few months quicker in our preparations. However, we expected this sort of timeframe," Mr Kleban explains.
Finding the right expertise
Authorisation is a very specific process, unique to the substance, the manufacturing processes, the uses being applied for, and the companies' role in the process. It is important to have the right expertise when deciding whether to pursue authorisation because if you fail with your application for authorisation, you will be off the market after the sunset date.
"For larger companies, deciding to apply for authorisation may not be overly problematic because they are likely to have their own regulatory affairs departments to help them evaluate their position pretty well," Mr Kleban points out.
The decision for small and medium-sized enterprises (SMEs) can be more difficult and it is important that they ask for help. "If they do not have the knowhow, they may need to look for help from a competent partner. If they are lucky, their trade associations will already be working towards this goal," he adds.
Understanding the cost
LANXESS estimates that the cost for the joint application is around EUR 4 million. Approximately half of this was spent on managing the consortium and the other was for the application itself. Even if filing as a single applicant would allow you to avoid the costs of managing the consortium, this was not an option for LANXESS. "If we had been doing this on our own, we might not have applied for authorisation," Mr Kleban stresses and continues, "this is the amount that both we and our competitors were willing to invest to keep using this particular substance."
The financial cost was, however, only one aspect for LANXESS and the consortium to consider. "As part of a multi-tiered supply chain, every member has to take their own decision on whether to proceed. If the consortium had not decided to apply for authorisation, it would have had a huge impact on the whole sector," he points out.
Companies considering applying for authorisation should only make their decision once the authorities have concluded their risk management option analysis for the substance and shown that authorisation is the most appropriate regulatory intervention.
Advice for downstream users
"The final decision on whether or not to grant authorisation to use the substance of very high concern (SVHC) lies in the hands of the European Commission. Therefore, suppliers cannot guarantee that they will be able to continue to supply the substance after the sunset date. The most positive assurance a downstream user can receive from their supplier is the commitment to apply for authorisation," Mr Kleban remarks.
To all actors involved in the authorisation, Mr Kleban says that communication is key. "My advice to downstream users is that they have to be aware of the potential impact of authorisation. Not being granted authorisation at the sunset date means that all operations related to the substance have to stop," he stresses.
An incentive to replace hazardous substances
Mr Kleban's main business at LANXESS is in the manufacture of chemicals, used in leather processes, where he deals with end-user articles and the substances contained within them.
"I see many brands starting to pay closer attention to the developments on the Candidate and Authorisation lists and pushing for replacements when SVHCs are identified. This is driven by end-user companies putting pressure on suppliers to change. They are investing time and money in making sure that the SVHCs are also made obsolete in regions outside Europe," Mr Kleban explains and continues, "the fact that end-user organisations are not limiting their markets only to Europe but are looking at chemical safety on a global level is an indirect benefit of the authorisation process," he concludes.
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LANXESS Deutschland GmbH
LANXESS Deutschland GmbH is a chemicals company specialising in the development, manufacture and marketing of plastics, rubber, intermediates and specialty chemicals.
Interview by Paul Trouth
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