(Published October 2007) It could be argued that preparation, preparation and preparation is the best way to deal with the European Union's (EU) chemical control system, Reach. And maybe this is truer for the plastics industry than any other.
But plastics companies can be forgiven for being confused. The regulation, which was approved last December and came into force on June 1, is probably the most complex piece of legislation ever devised by the EU – not an institution known for its legislative simplicity.
However, the law was designed in consultation with industry and, as a result, its demands are being phased in slowly.
From now until 1 December 2008, plastics companies really need to concern themselves with the so-called pre-registration process. This involves the newly formed European Chemicals Agency (ECHA) being given basic information about the chemicals used in a plastics product or ingredient – such as a definition of these substances, how much is produced or imported (roughly), how it is used and some contact details.
Companies can then continue using these chemicals until the deadlines for formal registration (a far more onerous task). For existing substances deemed by the EU chemicals agency to be carcinogenic, mutagenic or toxic to reproduction, as well as substances produced or imported by an applicant in volumes exceeding 1,000 tonnes a year, the deadline is 1 December 2010. For those produced or imported in volumes exceeding 100 tonnes annually, it is 1 June 2013. And for smaller volume substances exceeding one tonne annually, it is 1 June 2018.
Pre-registration is critically important. If a business does not ensure that a relevant chemical or a use is pre-registered, then they are treated as new substances and immediate registration is required. That is a tough and expensive proposition.
Jane Lawson of the safety and regulatory affairs department at Uniqema, one of the world's major suppliers of oleochemicals, sees pre-registration as a key step.
“A lot of effort is going into making sure that we get this right for ourselves and our customers so that we can go on doing business as usual whilst we do the registering,” she says.
“There's still a lot which is uncertain and we're awaiting clarification from a number of the guidance documents which we're tracking as they develop. It's a truism but the fact is that the devil is in the detail. It's the sheer scale of doing everything that's a challenge,” she says.
Of course, the big question is: What has to be pre-registered? Dr Wolfgang Siebourg, manager of consumer and environmental affairs at plastics manufacturers association PlasticsEurope stresses that this process entails plastics companies looking at their materials in a new way. Rather than considering them as this or that plastic or ingredient companies have to consider the chemicals that go into making them, and the use to which these chemicals – via the plastics – are actually put.
“They have to get into communication with their suppliers,” he says.
Siebourg says there must be a two way process going on if suppliers are going to carry out pre-registration – they must know the use a plastics processor is going to make of a particular chemical. And processors need to be sure that their suppliers are actually going to undertake the necessary pre-registration.
“Reach requires a tremendous amount of communication”, he says. He recommends companies seek out standardised forms for requesting and passing on data available from industry associations.
“Companies should not create their own communications”, he says. This could lead to confusion in an already complicated process. If this is done properly, and pre-registration is achieved smoothly, then companies will be in a good position to assess the cost of undertaking formal registration and to decide which chemicals will be worth the effort and the money involved.
“They [manufacturers] have to make sure they have their inventories clear – that they know what they are buying. They need to get in touch with vendors and suppliers to communicate the uses of their products. That is very important,” he says.
Furthermore, if a plastics company is not sure that a supplier is pre-registering all the chemicals and all the necessary uses, then they should pre-register chemicals and uses themselves. It doesn't cost too much, Siebourg says, but full registration could be very costly.
Of course, Siebourg's advice assumes that plastics manufacturers and suppliers are willing and able to reveal the chemicals in their products. Lothar Kistenbruegger, Reach technical coordinator for CONCAWE, the European association for health, environment and safety in oil refinery and distribution, which is a key feedstock producer for the plastics sector, is concerned about small companies and their ability to comply.
“The question is not whether Reach is worthwhile, it is whether it is do-able, especially for smaller producers of [chemical] substances and importers of preparations,” he says.
If a small plastics company imported a plastics preparation from China, under Reach they would have to register “every small component of that plastic”, he warns.
“How on earth will they be able to register these substances? Reach is not an esoteric regulatory issue, REACH is a business and strategic issue. If you do not understand it as a manufacturer or importer, you may be faced one day with being out of the market,” he warns.
PlasticsEurope's Siebourg suggests that companies faced with such problems, especially where a supplier wants to protect its confidentiality, should recommend that their suppliers appoint a representative within the EU who is able to undertake pre-registration, and ultimately registration, on their behalf.
Another issue is more technical. REACH does not cover polymers as such or certain stabilisers giving them form. However, almost all processed plastics involve the addition of a number of chemicals, ranging from dyes to impact modifiers, mould release additives to artificial fillers. These substances will have to be registered and their uses controlled under Reach. Furthermore, monomers may have to be controlled under the legislation, and the plastics industry needs to be clear about its requirements.
Uniqema's Lawson adds that plastics companies do need to differentiate between chemicals which are polymeric and others, which are covered. There are, however, additional complications as regards imported polymeric materials, because imported polymers do not require registration with ECHA, provided the monomers within them are registered.
“If you're manufacturing in Europe that's not an issue really because in order for you to have been able to purchase those monomers in the first place they would need to have been registered,” says Lawson. “If you're manufacturing polymers outside of Europe then those monomers are outside of Reach. And if you're importing the polymer you'd need to make sure that the monomers up your supply chain have been registered.”
So there is a lot for plastics companies to do. K'2007 provides an opportunity for processors to secure their sources by finding out exactly what their suppliers' registration plans are.
You can find out more about Reach at the EC and ECHA websites: