Reaching a REACH-Milestone

Related Vendors

DÜPERTHAL Sicherheitstechnik GmbH & Co. KG

Italvacuum, Srl

TRM Filter d.o.o.

Shell Services International

Framework and Process

Large producers like Shell have played a major role in many consortia, and provided a substantial input into both the framework for creating and running these bodies, as well as the process for the development of safety dossiers. Its legal team was instrumental in developing and reviewing consortia contracts, while technology specialists played a vital role in analysing the properties of Shell products and streams.

As part of the registration process safety dossiers for each substance have to be lodged with the European Chemicals Agency (ECHA,) which has been set up to manage the REACH regulation. A producer taking the lead role for each substance is responsible for registering it and submitting the safety dossier on behalf of the SIEF members. Other producers or importers within the SIEF can buy access to the dossiers in order that they can comply with the regulation.

Shell’s first registration under REACH secured the licence to manufacture and import ethylene oxide (EO). Fred Kerkhof, Global Product Steward for EO, the first of around 120 substances being registered by Shell, says: “With a limited number of producers involved and well understood and defined hazards associated with the product, EO was one of the more straightforward registrations.

“Even so, our registrations are the culmination of several years of effort, both within Shell and in the relevant consortia, where we worked closely with our co-producers to pull together the data to support the registration. Our experience also provided learnings for some of the other, more complicated product groups,” he says.

John Greenhough, Global Product Steward for Solvents, played a leading role in six different solvents consortia formed for chemicals with similar technical properties or hazard characteristics. “Although many consortia evolved out of existing trade associations, we still needed a step-change in the way these groups worked and took decisions,” he explains.

“As the solvents sector has some of the most complex supply chains there were a lot of issues to work through, but we were all in the same boat and recognised we had a common mission to ensure the wide range of solvents and uses were covered by the registrations.”

The hydrocarbon solvents consortium comprised 17 members and covered 72 different substances. It had representatives from across the world, as well as from all parts of the Europe, sometimes with different interpretations of the legislation.

“We needed to find smart ways to share the workload, allocate costs and establish a value for the contribution of individual producers,” he says. “We also had to define the processes that would allow members to share data while maintaining confidentiality of proprietary information and staying within the boundaries of competition law.”

He says developing a standardised approach to the way consortia worked was critical. “It was important to avoid unnecessary complexity or duplication of effort across the different product groups by establishing some uniformity around how consortia were formed and collated data.”

While a team of Shell Chemicals Product Stewards was at the heart of the work carried out by industry consortia, they were also able to draw on some expert resources to support the development of exposure scenarios and safe handling guidelines for each product and their end-uses.

This included subject matter experts in toxicology, environmental toxicology and industrial hygiene from the Shell Health organisation. Alison Margary, a Senior Industrial Hygienist, was one of a team of specialists brought in to lead this effort. She chaired a CEFIC task force formed to establish a standardised approach and framework for developing generic exposure scenarios for groups of similar chemicals.

“From the outset it was clear the industry needed an overarching strategy that would address the ‘mind-boggling’ complexity and enormity of the task to assess the risks and hazards associated with every substance and use,” she says.

“By establishing generic exposure scenarios for substances with common properties or risk profiles, consortia could start to extrapolate the appropriate risk management and safe handling guidelines for thousands of substances.

”This approach was accepted by ECHA provided that we could demonstrate our exposure scenarios were based on sound scientific data, and was the only way of ensuring that all products and uses were covered by the registrations,” says Margary.

Shell’s input led to the development of the first generic exposure scenario for the chemical solvent MEK (methyl ethyl ketone), which acted as a pathfinder for other product consortia.

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