Now this is beginning to change. The regulation is starting to affect supplies of what could be crucial chemicals for ink formulations. Also, compliance with its provision on the management of hazardous chemicals in print shops is beginning to become a challenge, not just for ink makers but printers as well.
For the first time for many small and medium-sized ink producers and other players in the printing supply chain, REACH is becoming an administrative burden.
What is REACH?
REACH –the acronym for the registration, evaluation and authorisation of chemicals – covers approximately 30,000 substances that are produced or imported in amounts above one ton a year.
It came into effect in 2007, with the objective of registering the details of the chemicals with their safety profiles in three tranches over 11 years until 2018.
Initially it mainly affected the producers of large volume chemicals, which had to meet a deadline of late 2010 for the registration of chemicals with outputs of more than 1,000 tons a year.
Information from these registration dossiers have had to be added to safety data sheets (SDS) on substances for downstream users. This is to fulfil the key REACH objective of increasing the safety of the application of chemicals in the workplace and among consumers by communicating up-to-date safety information down the supply chain.
At the end of May this year, a second tranche of chemicals – with annual outputs of 100 to 1,000 tons – had to be registering, bringing the total of registered substances to close to 7,000.
The third and last tranche – covering tonnages of between 1 ton and 100, with substances having to be registered by the deadline of mid-2018 – will account for around two-thirds of the total, and will include the chemicals most likely to be used by ink producers in most of their formulations.
REACH and the Ink Industry
Some ink makers, importing or making their own substances, may even have to go through the process of gathering data for the 2018 registration deadline, mainly in collaboration with other companies registering the same chemicals.
A major task for most ink producers in the next five years and beyond will be the drawing up of extended SDSs for their customers with information from the registration dossiers submitted to the European Chemicals Agency (ECHA) in the Finnish capital of Helsinki. The agency is responsible for running the whole REACH project.
Under the REACH legislation, this information has to be passed down the supply chain, so ink producers will be obliged to include in their safety data sheets registration details from suppliers of their raw materials.
With respect to the registration process itself, the main concern for ink producers is about the numbers of chemicals used in their formulations which may not be registered. Substances that are not registered by their deadline are effectively banned in Europe under the REACH rule of “no data, no market.”
Trade associations have been warning that because of the relatively high costs – particularly for smaller companies – of collecting and checking safety data for registration dossiers, some producers and importers would be opting to withdraw their chemicals from the European market.
Withdrawals were a minor worry with the 2010 registration, but are a much greater concern with the ones due in 2013. Only a few months before the May deadline of this year, there was speculation the numbers of “missing” registrations could be around 700.
In fact, the total of 2,923 substances that were registered failed to include 984 chemicals which ECHA had expected would be, on the basis of lists of chemicals for potential registrations that producers and importers had drawn up in 2008.
The numbers of substances that were not registered were the result of companies overestimating the numbers of chemicals they would still be selling in Europe, Christel Musset. ECHA’s registration director, told a press conference in Helsinki. In addition, in some cases “production volumes were lower than expected” so that they would not have to registered until 2018.
However some experts believe that non-European producers have been deliberately reorganizing their distribution channels to bypass REACH, at least for another five years.
“They have been spreading their chemicals around a higher number of importers so that they can keep the annual throughput for individual importers below the 100 tons threshold,” explains one REACH specialist. “It is a nuisance for some formulators because they may have to buy the same chemical from more than one importer.”
So far, however, there have been few formulators like inks and coatings producers complaining about chemicals vanishing from the market because their suppliers did not want to put them through the REACH registration process.
“There has been no evidence of chemicals disappearing,” said Jo Lloyd, technical director of the London-based consultancy ReachReady. “If companies were withdrawing a chemical from the market because of REACH registration costs, they have been telling their customers in advance so that they can find other suppliers. There is, however, a real risk of large numbers of chemicals been taken off the market in 2018.”
The European Commission, the EU’s Brussels-based executive, is taking steps to bring down REACH registration costs for SMEs in order to minimize the numbers of withdrawals before the 2018 deadline.
What’s Next for REACH
In 2010, the vast majority of registrants were large producers and distributors. In 2013, SMEs still made up only 20% of registering companies, with the big chemical manufacturers and importers making up the remainder. In 2018, the majority of registrants are likely to be SMEs, most of whom will be dealing with REACH for the first time.
With around 23,000 chemicals being in the 1 to 100 ton range – the category to covered by the 2018 registration—as many as 5,000 chemicals that ought to be registered might not be, according to some estimates based on the numbers missing from the 2013 registration.
“There will be a lot of pressure on SME chemical suppliers facing extra administrative burden and costs with the 2018 registration deadline,” said Doug Leech, technical director at the UK Chemical Business Association (CBA), which represents distributors of chemicals to ink and coatings producers and other formulators. “There will probably be some SMEs wanting to pull out of the business ahead of 2018 or there will be a lot of substances that will just go missing in 2018 itself.”
Another area of uncertainty for ink producers is the content and style of the extended SDSs on their formulations, which they will have to distribute downstream to comply with REACH.
A key element in these more detailed data sheets are what is called “exposure scenarios,” which spell out what safety precautions need to be taken with specific applications of chemicals. These have to taking into account working conditions and the extent to which workers in print shops, for example, are exposed to the chemicals.
Theoretically provision of information down the supply chain on the application of chemicals within a working environment and the management of possible risks should be straightforward.
However, it is turning out to be highly confusing to both the people drawing up the scenarios and for the downstream users whose safety they are supposed to protect.
One problem is that there is a lack of standardization in structuring the information in an SDSs, the selection of the data and in the language used to convey it. The result is currently that a lot of extended SDSs with exposure scenarios are being distributed along supply chains are highly diverse in content and format.
Some are more than 50 pages long, so that downstream staff do not even bother to make an effort to read them. They have come to symbolize the gulf between the raw material suppliers who are experts in the properties of their chemicals and their customers, whose working conditions they often know little about.
What makes exposure scenarios especially complicated for ink producers and other formulators is that the information on them from raw materials suppliers covers only single substances. REACH only applies to individual chemicals and not combinations of them.
“Exposure scenarios are proving to be a nightmare for formulators like ink producers who might have 20 different chemicals in their product,” said Mr. Leech. “They can put the exposure scenarios for each substance separately in an extended SDS for a formulation, but this would be very confusing for the downstream user. Or the formulator can work out his own exposure scenario with risk management advice for the combination of chemicals. But this can be costly while there would be legal liability issues.”
ECHA has, however, acknowledged the need to help downstream users by putting forward a series of improvement measures – called the Exposure Scenario Roadmap Implementation Plan, which will not now be fully implemented until 2018.
The roadmap cover issues like best practices for describing uses, IT tools and standardization, and, crucially, processing of exposure scenario information at the formulators’ level with particular emphasis on communication of the safe use of mixtures.
“The mechanisms introduced by REACH for producing, communicating and applying exposure scenarios are relatively new and not easy to implement,” ECHA says. “Therefore it will take time for them to be fully understood and fully practiced.”
A charter in support of the roadmap has been backed by the Downstream Users of Chemicals Co-ordination Group (DUCC), on which inks and coatings producers are represented.
“We have now five years ahead for us to come up with practical tools and recommendations for improvements,” said Sylvie Lemoine from DUCC. “All actors, from industry and authorities alike, will need to work together to achieve the roadmap objectives and, ultimately, safer use of chemicals through their entire life cycle.”
Meanwhile ink producers are likely to be only legally required to pass on exposure scenario on individual chemicals from their raw material suppliers, rather than putting together an SDS specifically for mixtures. Some of them are, nonetheless, concerned about their legal position during the transition period if their own downstream customers have safety problems with their ink products.
European Editor Sean Milmo is an Essex, UK-based writer specializing in coverage of the chemical industry.