The convergence of several chemical reclassification and labelling initiatives being implemented in the global business arena to boost health, safety and environmental protection to an unprecedented level is poised to have a monumental impact on the world’s industrial sector.
Together with chemical sectors which use raw materials and which introduce new formulae, other process industries are being required to make rapid and sweeping changes to comply with a whole new level of regulatory requirements.
The new legislation impacts on product registration, classification and labelling, packaging and transportation, storage, product information and product disposal – making this a ‘hot topic’ throughout the supply chain.
Launched in 2005, the United Nations’ (UN) Globally Harmonised System of Classification and Labelling of Chemicals (GHS) affects more than 60 countries and, since 1st December 2010, directly impacts all chemical substances in European Union (EU) countries.
The GHS aims to achieve uniform worldwide criteria for classifying chemicals according to their health, environmental and physical hazards.
This uniformity will also apply to hazard communication requirements for labelling and safety data sheets. The GHS is not a formal treaty, but is rather a non-legally binding international agreement. In addition to improving health and safety in this arena, a key UN objective with this initiative is to make it easier for companies to conduct international trade.
The GHS addresses the classification of chemicals by types of hazard and proposes harmonised hazard communication elements, including labels and safety data sheets.
The GHS also provides a basis for the harmonisation of rules and regulations on chemicals at national, regional and worldwide level – an important factor for trade facilitation.
REACH and CLP
The EU has already taken the lead in the harmonisation quest with its REACH regulation on chemicals and their safe use, which applies to substances manufactured or imported into the EU in quantities of one tonne or more per year.
Implemented in June 2007, REACH deals with the Registration, Evaluation, Authorisation and Restriction of Chemical substances. The purpose of this regulation is to ensure a high level of protection for human health and the environment. This includes the promotion of alternative methods for assessment of hazards of chemicals, as well as the free movement of substances on the market of the EU.
Substances in volumes over one tonne per year that are either manufactured or imported into the EU (even in preparations/mixtures and articles), now have to be registered.
The CLP regulation meanwhile, a more recent EU initiative implemented in January 2009, has the dual objectives of facilitating international trade in chemicals and improving the protection of human health and the environment. CLP aligns the EU system of Classification, Labelling and Packaging of substances and mixtures to the GHS. It is expected to facilitate the harmonised communication of hazard information of chemicals and to promote regulatory efficiency.
CLP complements REACH and replaces the current system contained in the Dangerous Substances Directive and the Dangerous Preparations Directive.
ISO 10156: 2010
Although less formidable in implication, another critical technical standard coming into play is ISO 10156: 2010, superseding ISO 10156: 1996.
This norm impacts on how mixtures of two or more products are classified and both where and how these products should be labelled, transported, used and stored.
Once this revision comes into effect, the impact on affected products could include a new identification label, a new cylinder shoulder colour to indicate the change from either a non-flammable to a flammable mixture or vice versa, updated safety data sheets to include the changes for cylinder safety and transportation, and a different cylinder valve outlet.
Linde Gases’ Stephen Harrison, Head of Specialty Gases and Specialty Equipment, explains it this way, “Although the physical properties of gases do not change, our understanding of the physics of these gases has certainly changed and this impacts on whether or not they represent a safety hazard. The implication is that even though a product someone may have purchased in the past may have been labelled as non-flammable, in the future it might be labelled as flammable.”
“And there’s knock-on effects associated with this. The implication to customers is how they will train their personnel to handle these gases in future. If the product is now labelled as flammable, they’ll need to look at factors such as fire safety procedures, transport measures and storage configurations. Previously used regulators may not do the trick anymore, because the outlet valve has changed to comply with a new classification.”
REACH, the forerunner of the global harmonisation initiative, is now moving beyond Europe. There are moves to implement it in the US within the next two years and a similar system has already been implemented in China.
Dubbed ‘China REACH’, it draws on many elements of REACH – particularly those concerning risk assessment, risk management and data submission.
Dr Fridtjof Schucht, Linde Gases’ Head of REACH and CLP Implementation Europe, describes the rapidly changing regulatory climate, “This veritable tsunami of new regulations will have a monumental impact on industry – it’s the biggest shake-up we’ve experienced in the last 100 years. It can be compared to the introduction of regulations in the pharmaceutical industry in the 1960s following the Thalidomide issue, which was called one of the biggest medical tragedies of modern times.”
“Fortunately, the new regulations we’re now dealing with are not following in the wake of a large scale tragedy – on the contrary, these are proactive initiatives being driven to prevent major incidents like this.”
Schucht says while the argument in favour of harmonisation is sound, the practical implementation is costly and complex.
“The implementation of REACH and CLP will have a profound effect on all process companies, and will change all applications within that industry tremendously. All products have to comply with the requirements of these. Within the legally required implementation phases, labelling must be adapted to the new standards, all products must be reclassified and safety data sheets amended accordingly.”
“For the companies concerned, this therefore calls for adjustments to the IT systems which generate the labels and requires a considerable additional amount of work and expense,” he explains. “In our case, for example, Linde Gas Germany had to submit 600,000 new safety data sheets to our customers and re-label about 1.5 million gas cylinders before 1st December 2010.”
While most countries have systems for the classification of hazardous chemicals to ensure safe transportation, storage, use and disposal, until now various national or regional systems have not always been compatible.
This incompatibility has often meant re-labelling or the use of multiple labels on a product, increasing the handling risks involved. For organisations operating at an international level, the need to comply with multiple regulations on hazard classification and labelling has created the risk of end-users misinterpreting label warnings.
Harrison says that despite the rapid convergence of these regulations, there has been ‘tremendous success and admirable progress’.
“Using different icons and words to describe hazards and risks is okay if the products remain in that particular country, but once you start to export, confusion can enter into the equation and compromise safety,” he comments.
“At some point in the not-too-distant future, there will be harmonisation of all chemical labels. So we will all see only one label for a particular product. New Zealand and Japan implemented GHS three years ago. Now all eyes are on Europe, before the focus shifts onto other major economic blocks such as the US.”
“Industrial regulations will converge around the middle of this decade and we expect that the harmonisation of chemical labelling will be achieved to a level of about 80%. I doubt we will ever perfect this process, because there are many local regulations which cannot simply be completely removed – and the manufacturers and authorities will have to work around these.”
Harrison concluded, “As an international industrial gases company, Linde is being confronted by the same legislation, processes and timelines as the chemicals sector and we are well placed to transfer our experience and knowledge to this industry.”
With producers of chemicals hard at work to meet harmonisation compliance deadline, the onus of responsibility now extends to suppliers who are required to cascade this updated information not only down their complex supply chains, but ultimately to a global market.