Innovation and enterprise earn recognition ...In Business: January 2008
Time was. Time was that trade in chemicals, unless agreed to be dangerous drugs, flammable hydrocarbons or explosives was a fairly free-and-easy business. If no immediately identifiable harm was caused, interference from official sources was minimal.
With the coming into force of the European Union’s Registration, Evaluation and Authorisation of Chemicals (REACH) Regulation in June last year all that changed. Companies that manufacture, import, sell and use chemical substances, under a definition so broad that even some naturally occurring ores are caught in the dragnet, are all responsible in some measure for demonstrating that their usage and disposal is safe. Of course, some are more responsible than others.
Although it was originally written for organic chemicals, the scope of the legislation covers metals and alloys. It is fiendishly complicated, but its immediate effect is to place on manufacturers and importers of PM materials a large bureaucratic burden of assembling the Registration Dossiers that lie at the heart of the legislation.
Irrespective of whether it has been a problem in the past, the Dossier must demonstrate that a chemical’s intrinsic hazards have been quantified, and measures to control human and environmental exposure have been made clear right down the supply chain to disposal.
Bad dream? Bureaucratic nightmare? Without a great deal of care on the part of the PM community, it could be both, says the European Powder Metallurgy Association’s technical director, Olivier Coube…
REACH: Six months before it bites
Europe is shrouded in seasonal darkness and new things for the New Year are as yet unformed.
But things are happening, be it plant life renewing itself or legislation limbering up for full implementation.
It will be six months – in June – before the provisions of the Registration, Evaluation, and Authorisation of CHemicals (REACH) Directive will really start to bite. In reality, this year is the opportunity for industry to ensure that it is ready for implementation. But it won’t be easy.
The half year between 1 June and 1 December will be the Pre-Registration period, when manufacturers and importers intending to register inform the REACH authorities - the European Chemicals Agency (ECHA) based in Finland - of that intention. Pre-registration is free of charge, but after the six-month deadline it will be illegal for a manufacturer or importer to market a substance without having first registered it.
To ensure continuity of supply, downstream users should ensure that their key suppliers have pre-registered as required. Lists of pre-registrants are to be published and are intended to assist the formation of Consortia of companies dealing with the same substance and Substance Information Exchange Forums (SIEF) for exchange of data.
The overarching scope and scale of the new law make it difficult to summarise, says the European Powder Metallurgy Association’s (EPMA) technical director, Olivier Coube. “REACH is a comprehensive EU risk assessment of all ‘substances’. It includes organic chemicals such as fertilisers and pesticides as well as inorganic chemical like metals and metal powders. The final aim is the substitution of all substances that will become classified as Substances of Very High Concern, and the legislation is based on the precautionary principle which, in essence, says: If in doubt, don’t.
“Information Dossiers have to be produced for the European Chemicals Agency (ECHA) that show an appreciation of a substance across its life cycle, and the importance of these Dossiers is not to be downplayed. For without the data, official sanction will be withheld, making further trade illegal. For those substances classified as ‘dangerous’ there is another twist at the core of the Registration Dossier – the Exposure Scenario (ES).
“These have proved difficult and time-consuming to complete and describe and evaluate the different routes by which humans and the environment may be exposed to the substance. This includes historical data on emissions; data related to each use down the supply chain and data to differentiate between exposure and absorption.”
Substances defined as “dangerous”, and the definition is quite wide, have to be registered as “soon as possible”, irrespective of tonnage. The authorities expect that generally manufacturers and importers of the same chemical to share data through Consortia and SIEFs. Membership of Consortia is not necessarily free. And while, like so many other aspects of this legislation, future reality is still opaque, substantial costs could be involved. In the first instance, chemicals classed as hazardous may be put on a “candidate list” for further scrutiny.
“The text of the Regulation is extremely complicated and needs expert interpretation. We would hope that industry’s interpretation will be seen as a co-operative attempt to ensure correct implementation. Official guidance is still under development but, given the very wide scope of the legislation, it is likely to stimulate more questions when eventually it emerges”, said Dr Coube.
Given the breadth and depth of the REACH legislation the European Chemicals Agency has a series of stepped implementation deadlines, the first of which for manufacturers and importers of more than 1000 tonnes per annum runs from December this year to December 2010. Those manufacturing or importing between 100 tonnes and 1000 tonnes have until June 2013 to comply with implementation and those using between one tonne and 100 tonnes until June 2018.
“On the face of it, some companies have 10 years to comply, but in reality the Registration Dossiers for most metals will have too be completed by December 2010. After that deadline it will be illegal for unregistered suppliers to place chemicals on the market. Additionally, users of chemicals share legal responsibilities for correct risk management under the Duty of Care provisions of the Regulation. Now that the legislation is in force, the community as a whole has to find ways to make it work right from the beginning. That means we need to have the small companies on board as well as the major operators,” said Dr Coube.
It is important, he said, that there should be widespread awareness of REACH and its implications for PM companies, be they big or small. And the onus is on companies’ management to make sure that the business implications of REACH are identified and that sufficient staffing and financial muscle are in place to make sure that their organisations stay within the law.
For those in any doubt about the importance and relevance of the new
law – and that’s what it is – to the way they do business, and even if they can do business, a visit to the EPMA’s website at www.epma.com/REACH should provide the advice and contacts they need.
On the face of it, finished articles are not subject to regulation, unless hazardous chemicals are emitted to humans or the environment during normal
handling or use. However, there is an obligation of notification for manufacturers and importers of articles that contain dangerous substances, and the ECHA may take a decision – on grounds that are not yet clear – that would require manufacturers or importers to submit a registration.
What is abundantly clear, however, is that REACH will have a three-fold effect on industry:
• Preparation of the Registration Dossier;
• Generation of new toxicity data where required; and
• Generation of non-hazardous substitutes.
These pose significant costs internally in terms of personnel and externally through toxicity and application testing. REACH also has substantial commercial consequences for manufacturers and importers:
• Imported articles containing hazardous chemicals being exempt gives an incentive for large end-users to purchase finished articles from outside Europe; and
• The “public candidature” list could blight metals and alloys containing allegedly hazardous chemicals.
So how are major European PM enterprises approaching REACH? Presentations at EuroPM2007 in Toulouse gave some answers, but it is clear that there are still areas of uncertainty. One basic question for PM companies to consider is: “What role do you want?” It is clear from the law that many responsibilities fall on the manufacturer or importer. So would it be better to be classed as a downstream user? It was a point raised in more than one presentation. On the face of it, life could be simpler by sourcing “sanitised” product from within the EU, although almost certainly more expensive.
Höganäs AB, the largest iron and steel powder producer, is taking the issue seriously from Board level down and has appointed Olle Thornblad as full time REACH manager. But so far they have not decided which Consortia to join.
“It is still too early to decide which Consortia we will join as some have not yet started or are just about to start,” he said. “We are members of the Swedish Iron and Steel Works Association (Jernkontoret) and through that active in Eurofer and Euroslag.”
GKN Sinter Metals, a major parts maker and downstream user, has been though its substance inventories in an effort to validate its supplies, in itself no mean task. They have appointed staff at a senior level to deal with REACH. They have asked questions of the supply train and got detailed answers. And they too have Consortia questions. Speaking after his presentation at Toulouse Volker Arnhold said: “It has yet to be found out how the Consortia will function and it will be a challenge to bring the specific issues of powders into Consortia. That will most probably mean working via the powder makers and the EPMA to forward the specific powder topics to the respective Consortia.
“But the whole PM community has to treat the topic in a harmonised way and take it very seriously, as just one wrong input into the registration process because of misunderstanding or limited know-how can damage the whole PM community.”
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