7 March 2008
Reaching Limits(HKTDC Enterprise, Vol 03,2008)
Industry Insight/ Reach
One of the most far-reaching legislative initiatives aimed at protecting human health and the environment took effect in the EU in June 2007
REACH - or the Registration, Evaluation, Authorisation and Restriction of Chemicals - replaced more than 40 laws and streamlined the former regulatory framework for chemicals used in the EU.
The new legislation shifted the burden of proof to businesses to show that the chemicals they use are safe, or, if not, to develop and/or substitute safer chemicals for hazardous ones.
"REACH regulations transfer responsibility for gathering data and carrying out risk assessments from authorities to industry - which is a very crucial turnaround in the burden of regulation," said Keith Bailey, the Head of the European Chemicals Policies Team, Department for Environment, Food & Rural Affairs in the UK. "This will enable authorities to focus much more on the chemicals that pose the greatest hazard or risk."
REACH's scope is comprehensive, covering all substances manufactured in or imported into the EU in quantities of one tonne or more per year - including the 30,000 or so chemicals on the EU market today.
"We know very little about them, their toxicological effects and their effects on the environment," Mr Bailey admitted. "This is where the crucial process comes into play - if there's no data, there's no market."
This legislation is particularly important for the EU, whose chemical industry produces 31% of the world's chemicals and directly employs 1.7 million people, although it does not apply to the use of chemicals in finished products.
Prior to REACH, chemicals thought to be hazardous were tested by public health authorities, but that ineffective system saw only a handful of substances singled out for risk assessment over the past 15 years.
Mr Bailey noted that a pre-registration period would apply from June 1, 2008 to November 30, 2008, with a European Commission proposal seeing the most hazardous chemicals and those used in the largest volumes registered first.
"New and existing substances will be treated equally," he said, adding that existing substances could be phased in if they pre-registered. "There are some exemptions for minimum risk substances, such as water, carbon dioxide, food, medicines or cosmetics that are already regulated, and naturally occurring substances."
Between 2008 and 2018, substances must be registered in tonnage-related tranches, and companies are required to include a "technical dossier" that contains information about the substance and the management of any risks. "A Chemical Safety Report must be submitted for quantities of 10 tonnes or more per year," Mr Bailey observed, "and testing costs are the responsibility of the producer or importer."
Regulatory authorities assess whether the information in "technical dossiers" complies with REACH's requirements. "At least 5% of dossiers in each tonnage band will be evaluated," Mr Bailey confirmed. "In cases where there are concerns over potential risks to human health or the environment, more information can be required."
Substances of "very high concern" such as carcinogens and mutagens require authorisation by the European Chemicals Agency, which may be granted under certain conditions but needs to be regularly renewed. "The European Commission or EU member states may propose restrictions on the manufacturing, marketing and use of certain substances," Mr Bailey added.
Restrictions can apply to the use of substances in certain products, their use by consumers or for all uses - that is, banning the substance. "It will be banned unless it is proved that there is adequate control or a socio-economic case for its use, which must be greater than the potential environmental loss of having that substance around, or there is no suitable alternative," Mr Bailey explained.
Enforcement is an area that EU member states are currently studying, and Mr Bailey noted that the UK had some "broad ideas" about how to apply these to various enforcement agencies.
"We are talking about consistency of enforcement and REACH provides an important forum for that consistency," Mr Bailey explained. "We're comparing ideas so that a business involved in different member states has the same enforcement and penalties."
The European Commission estimates that REACH will cost industry €2.8-5.2bn over 11 years, with other observers putting the figure as high as €12.8bn.
However, the Commission also notes that the savings over 30 years in production losses and as a result of fewer people falling ill from exposure to chemicals will be even higher at some €284bn.
TEXT BY ANDREA PAWLYNA