18 May 2012 11:05 [Source: ICB]
The next deadline for submitting Reach registration dossiers, May 31, 2013, is fast approaching, but distributors also face pressing issues concerning chemical classification and safety data sheets
One of the hardest tasks facing industry under the EU's Reach chemicals policy is the requirement for manufacturers and importers to demonstrate safe use of substances and to pass information on use and exposure up and down the supply chain.
Working through the red tape of the next phase of the EU's Reach chemicals policy is fast-approachng for chemical distributors
For substances classified as dangerous, persistent, bioaccumulative and toxic (PBTs) or very persistent and very bioaccumulative (vPvBs), and which are produced or imported in volumes of 10 tonnes/year or more, exposure scenarios must be included in the chemical safety assessment and chemical safety report produced as part of a registration dossier.
Any actor in the supply chain that has to produce a chemical safety report must annex the relevant exposure scenarios to the safety data sheet for that substance, forming what has become known as an "extended safety data sheet" or eSDS. Distributors must pass on relevant exposure scenarios from SDSs supplied to them when compiling their own SDSs.
However, the amount of information provided in exposure scenarios has proved a major challenge for distributors and their customers. Unfortunately, the IT tool developed by the European Chemicals Agency (ECHA) for dealing with the exposure scenario part of SDSs, known as Chesar (Chemical Safety Assessment and Reporting) was not available early enough to prevent a diversity of formats emerging, with some major manufacturers developing their own tools and templates to fulfil their registration obligations ahead of the first Reach registration deadline at the end of 2010.
As the number of chemical products falling under the new requirements for SDSs has grown, so has the number of companies affected and the scale of the problem a company faces in understanding exposure scenarios and checking if its uses are covered effectively.
"There is a lot of confusion in general about the issue of SDSs and exposure scenarios," says Douglas Leech, technical director at the UK trade association Chemical Business Association. "People are asking: 'Do I need an SDS or an eSDS?' And some downstream users are asking for an exposure scenario when the substance in question isn't even going to be classified."
"For us," says Ahmed Diboune, SHEQ corporate project leader at specialty chemical distributor Azelis, "eSDSs are currently the main issue and can be very difficult to manage." The main concerns, he says, include the fact that very few have been received from manufacturers; it is difficult to know if an eSDS is mandatory or not; the lack of a standardized format and the difficulty in creating eSDSs for mixtures.
Another problem, says Diboune, is that the Chesar tool is still not fully operational for eSDS creation, and is not yet used by the chemical industry. ECHA announced in April that it plans to release a new version at the end of June, but functionalities related to the generation of exposure scenarios for communication will not be added to it until the end of this year or early 2013.
Customer requests for eSDSs are increasing but Biesterfeld ChemLogS cannot compile them because of ongoing software problems, says Enno Hollitzer, the company's head of QSHE. Europe's chemical trade association Cefic's ESCom XML tool and Chesar have been "in sight" for more than a year, but "are still not working", while exposure scenarios are not understood by most customers, few of whom are toxicologists, because they are too technical and scientific.
Few downstream users understand how to correctly apply the concept of "scaling" − the practice whereby the original assumptions in an exposure scenario are changed so that the exposure level fits with the operating conditions or risk management measures used by the downstream user.
To Michael Paetzold, Reach manager at Netherlands-based IMCD and current chairman of the Fecc's SHE committee, the most common problem with eSDSs is that while its customers are willing to accept English language versions initially, they expect to receive a version in their native language at a later date. Another issue is that some suppliers have yet to provide any annex to their SDS, even though they have conducted a chemical safety report as part of their registration dossier for that substance and have been assigned a registration number by ECHA.
A problem for a pan-European distributor like Netherlands-based Univar Europe, says product HSE manager Peter Cooper, is that "suppliers in some regions may have provided an eSDS and suppliers in other regions will not register their substance until 2018, meaning that customers are aware that substances are registered (by someone), but our eSDS cannot be produced until we have the supported use information from all of our suppliers." Customers are adding to the problem, he says, by demanding eSDSs for substances that do not require chemical safety assessments or for mixtures that are covered by the existing SDS.
The big event so far this year has been ECHA's publication in February of the Classification and Labelling Inventory, which includes more than 3.5m notifications and covers 115,000 substances. Although it is widely regarded as a tool that will offer significant benefits in the long term, many people feel its publication was premature because it included many errors and currently excludes certain substances, such as carcinogens, mutagens and reprotoxins (CMRs).
The inventory also lays bare the problem that the same substance is often classified in a number of different ways by different companies. Although this is not, of course, a new problem, and there are often good reasons, such a varying impurity levels, why this may happen, the much greater transparency that now applies to how companies classify their substances is generating a lot of communication across supply chains as suppliers and their customers start to discuss which is the "right" classification for a substance.
Sometimes there are multiple classifications for the substance on the inventory because notifiers have different sets of data, or simply because mistakes were made by companies in assigning classifications, says Anand Shintre of UK-based Reach consultancy Indus Chemie.
He, and others, also make the point that customers also can be confused because the inventory does not include all hazardous substances. It is also supposed to exclude substances for which there is no agreed hazard classification, but such a substance can appear on the inventory if one supplier has classified it as hazardous.
But despite this confusion among some customers, distributors say the inventory's publication has had little effect on their supply chains. Within IMCD's supply chain, the inventory "was no big concern," says Paetzold. "Due to the fact that it just displays notified classifications and is still not harmonized, many companies ignore the database."
"There are many incorrect classifications shown and it is these that are causing the most confusion," says Univar's Cooper. But Univar "has always checked the differing classifications used by its suppliers and the inventory just gives us another tool; as with all tools, the skill is in how it is used."
Reaching agreement with other importers on common classifications can be difficult, says Shintre. "Many Chinese and Indian suppliers have problems with the CLP classification, and if you are a small customer, they are not ready to correct the labelling because they fear it will create problems for other, larger volume customers."
In such cases, the small customer may have to find a repacking contractor in the exporting country and bear the extra cost and delay. In some cases, he says, the same substance sourced from the same manufacturer can end up with divergent SDSs if it is distributed by two different companies with different levels of technical competence.
In cases where a substance previously classified as nonhazardous is now classified as hazardous due to changes in hazard criteria introduced by the CLP regulation, the change can be "hard to accept" for many small businesses, says Shintre, especially if the new classification was a company self-classification instead of a harmonized classification proposed by an EU member state and agreed by the European Commission.
Checking for new imported substances or for the presence of new substances in mixtures, and submitting notifications for them is proving a challenge. "Generally this is not easy to handle," says Biesterfeld's Hollitzer. "Substances in mixtures are especially challenging to deal with."
Azelis checks all new imported substances each month, says Diboune, using a process centralized at a corporate level for all Azelis legal entities. The process uses a system of unique item numbers and forms part of its QSHE offering to customers.
In contrast with these issues, preparations for registering substances by the next deadline seem to be going fairly smoothly. "Communication with substance information exchange forums (SIEFs) seems easier, with generally clear identification of who is the lead registrant and with much more understanding on Reach processes and data sharing," says Azelis's Diboune. "Reach processes seem to be undoubtedly easier and are now well known by all parties in the supply chain."
Geraint Roberts is a contributing editor to Chemical Watch. For more information contact him at firstname.lastname@example.org
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