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Clearly the flavor and fragrance industry is far more complex than REACH’s creators ever imagined, a fact illustrated by companies’ innovative maneuvering under this looming regulatory burden. IFF alone has preregistered all of the eligible—and even some of the non-required—ingredients it manufactures, according to the company’s REACH compliance manager, Joris Theewis. Comprising ~1,000 materials, the company’s portfolio preregistration process—shared with IFF subsidiary Laboratoire Monique Remy—began with Theewis’ appointment in 2004. “Things are moving fast,” he said during his address to Centifolia’s delegates. “Since last year we have added a second full-time person to help me out.” In addition, the company has brought on a full-time REACH toxicologist. The group further liaises with US-based toxicologists and another REACH expert. The periods before and after preregistration require coordination of these personnel with everyone from R&D staff to purchasing. Despite the total number of materials with which IFF deals, only a select number rise above the one ton threshold, meaning that in the future there will be REACH compliant fragrances containing just, for instance, 80% REACH-registered ingredients, with the remainder being more exclusive, low-volume ingredients.
With REACH preregistration coming to a close, Theewis took some time following his address to provide P&F magazine an insider’s view into the next phase of the process: data sharing within consortia.
Well over a year ago, Theewis attended IFF’s first fragrance industry consortia meetings in Brussels. “Our industry has a long history of cooperation,” he said. “Our answer for dealing with [substance information exchange forums (SIEF)] is the consortia.” IFF belongs to 15 consortia (of which two are focused on so-called “natural complex substances”), which seek to ease the REACH process by grouping similar materials and facilitating read-across data. The costs for testing some high-volume substances can cost companies vast sums of money. As a case in point Theewis cited IFF’s REACH testing budget, which is currently several million euros and expected to increase over the years. While the costs are a hindrance, the amount of collected safety data will be unprecedented. “There will be fewer ingredients when REACH is done,” he noted. However, he added, there are opportunities for companies to innovate with low-volume exotic naturals, which do not need to be registered.
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“The only thing the [REACH] agency provided was the pre-registry tool,” Theewis says. “After that there are very few tools [available] to communicate with the other pre-registrants.” Once a substance was preregistered, companies found themselves dumped onto a list among other SIEF members who had registered the same material. By all accounts this was less than user-friendly. “They are slow,” said Theewis of the online lists. “They can take several minutes per substance.” For companies registering as many materials as IFF, this added up to prohibitively long periods. In addition, the sheer number of SIEF members can be daunting, sometimes numbering well over 100. “SIEFS take a lot of energy and leadership,” Theewis noted.
Following the consortia kick-off meetings, says Theewis, “You really saw people’s attitudes changing. It works so much more efficiently now. We share all the data. There’s a lot of willingness to cooperate; people know each other now.” (Of course there remain companies that preregistered but did not wish to join the consortia.) “In our consortia, we have data sharing—a Web site to store files—which is very well organized.”
REACH requires data cost sharing “to be carried out in a fair, transparent and non-discriminatory way. … It is up to the registrants to decide and agree on how the costs for the test should be documented.” The question remains: What exactly is fair, transparent and non-discriminatory? “In our consortia we hired a lawyer to write down the agreement [among members], so that should take care of these concerns,” explained Theewis. He believes that these members generally are moving forward with a cooperative mindset in determining the best data and sharing it. While the larger companies that manufacture a wide range of materials tend to have the most extensive data and expertise in dealing with REACH issues, Theewis has been very impressed also with the level of engagement by smaller players.
Complicating matters, Theewis said, customers that indirectly import substances to Europe have asked IFF to help them assign only representatives. However, this would create a huge and daunting administrative issue for the company. “You need to know which fragrance materials they’re bringing in, and how much,” he explained. These customers may ask for IFF to graft their tonnage (since IFF has already preregistered the material in Europe) onto their own totals—however, under the rules of REACH, this is not a simple matter, and liability needs to be carefully managed. By default, each importing company must separately preregister for its own tonnage figures. Even companies the size of IFF have come to realize that they are first and foremost fragrance houses and not regulatory consultants. Customers are increasingly accustomed to their suppliers taking the initiative on regulatory issues. However, under REACH this scenario is not practical. “It’s very complex. It takes a lot of time to explain to people,” says Theewis. Overall, how well have customers been keeping up with REACH? “It really depends, company by company.”
At the time of the discussion, with preregistration coming to a close on Nov. 30, 2008, Theewis was focused primarily on that segment of the program. However, he noted that the company, as end-usage reports came in from customers, could find some surprises with regard to end-use of the raw materials they manufacture. “It provides better insight into how the product is used. If there’s a use that is hazardous we can advise against it. On the other side, customers will learn more about the substances in their fragrances, what the safety of those products is.” That knowledge will trickle down to retailers and consumers, he added. “Consumers under REACH have the right to request information about ‘are there any substances of concern in the product I’m going to buy?’ The retailer has 45 days or so to react. All of those things will hopefully help stimulate consumer confidence.” In the end, the positive outcome for the industry is that consumers will come to better understand that natural does not necessarily equal safe and synthetic does not equal hazardous.