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CW Reports on Hangzhou REACH Workshop 2011

China moves centre stage as Asian programmes push ahead


16 December 2011


From Chemical Watch briefing of December 2011/January 2012 ---- Mr. Sean Milmo on behalf of Chemical Watch, reports over the 3rd Hangzhou International Chemical Regulation REACH Workshop 2011 organized by REACH24H and China Petroleum and Chemical Industry Federation.


New chemical registration and testing requirements in China, Japan and South Korea, different risk assessment approaches in Asia and Europe, and the way classification and labelling rules are being introduced, were among the hot topics at a recent workshop on global chemical regulation in Hangzhou. Sean Milmo, who helped chair the event on behalf of Chemical Watch, reports.


Much of the world has now drafted or has introduced legislation covering the safe management of chemicals. But it has left the global chemical market with a plethora of regulations with more differences than similarities.


A key driving force behind this is the UN’s Strategic Approach on International Chemical Management (SAICM), which calls for chemicals to be produced and used by 2020 in ways which minimise “significant adverse effects” on human health and the environment.


Increased time and costs

“Currently chemical legislations are creating a patchwork of conflicting rules and procedures,” Leo Heezen, global chemicals regulation manager at the European Chemical Industry Council (Cefic) told a workshop on global chemical regulation in Hangzhou, China, organised by REACH24H Consulting Group and and the China Petroleum and Chemical Industry Federation. “Differences in national regulatory requirements lead to an increase in costs and time and to distortions in international competition and trade restrictions.”


“What we are seeing are different requirements, some of which are very specific to particular countries, but which the chemical industry perceives as being barriers to trade in chemicals,” he said. “We need a way of harmonising chemical management systems so that these additional requirements will not exist anymore and there can be freer trade relations between countries.”


The International Council of Chemical Associations could provide a harmonised approach to chemicals management through its Global Product Strategy (GPS), said Mr Heezen. This aims to establish a single global standard in product safety so that there will be uniformity in risk assessments and short, comprehensible safety summaries of products as an alternative to lengthy, hard to understand safety data sheets (SDSs). “A harmonised global standard would increase not only the safety of products but also the benefits for the consumer,” he said.


There are also big differences in the way the UN Globally Harmonized System (GHS) of classification and labelling of chemicals is currently being introduced around the world, said Michele Sullivan, president of US-based consultancy MRS Associates. “The GHS seems to be global, and it’s a system, but it is debatable whether it is harmonised,” she said. “Perhaps it would be better if it was called GhS with a small ‘h’ for ‘harmonised’ rather than a big one.”


Differing national legislation


One of the major reasons for disparities in the way the system is applied across the world is that existing national legislation has affected the way countries choose which parts they wish to implement.



One of the major reasons for disparities in the way the system is applied across the world is that existing national legislation has affected the way countries choose which parts they wish to implement.


“The European Union provides very little in the way of protection of trade secrets in its GHS rules,” Ms Sullivan said. “But in the US the law states that with regard to confidential business information a trade secret is a matter of intellectual property and is not a health and safety issue.”


Growing harmonisation


But moves by countries to incorporate the GHS into their legislation are providing a degree of welcomed uniformity. “I believe that you don’t need to have one hundred per cent harmonisation to get the benefits of some harmonisation within the world,” says Ms Sullivan. “I have a colleague working in a multinational company who tells me that before GHS she had to deal with 207 different classification and labelling regulations. But now, with GHS, there is harmonisation in the one area of classification. So she has the advantage of dealing with just one system of classification instead of 207.”


In the US, much of the GHS as it applies to the workplace is being introduced under a regulation drawn up by the Occupational Safety and Health Administration (OSHA). But separate regulations incorporating other parts of GHS are being, or have been, drafted by different US agencies responsible for the environment, transport and other areas.


In China, the drafting and implementation of recent chemical regulations is placing a greater emphasis on risk controls, particularly on environmental management of chemicals. Earlier this year, the State Council, the chief authority in the Chinese government, stressed the need for a “reinforcement of the environmental management of chemical substances”, Nie Jinglei, Chemical Registration Centre (CRC) deputy director at the Ministry of Environmental Protection (MEP), told the meeting. In October, the State Council issued “comments on the enforcement of environmental protection” with reference to “stringent environmental controls on chemical substances” (CW 8 November 2011). In the International Year of Chemistry, “2011 is regarded as the Year of the Initiation for Environmental Management of Chemical Substances in China, as well as a brand new start for the re-evaluation of chemical substances by the country,” Mr Nie said.


In the law on control of new chemicals, the Measures on the Environmental Management of New Chemical Substances (Order 7 of the MEP), the word ‘risk’ is frequently mentioned in the legal text with a focus on preventative management. “It is a forward looking law, which is a major change,” Mr Nie said.


Tracking controls


Substances which have to be registered under the law, dubbed “China’s REACH”, consist of those not included in China’s Inventory of Existing Chemical Substances (IECSC), raw materials and intermediates for the making of finished products and substances “intended to be released under or reasonably foreseeable conditions of use”.


Registered new substances are subject to “tracking controls “ and inspections by local environmental authorities who will monitor their manufacturing, processing, transportation and use for at least five years.


At the moment the MEP is taking steps to improve the annual reporting of post-registration data of new substances. But it is also tackling difficulties with the notification of new chemicals, particularly with the risk assessment and risk characterisation processes (CW 3 November 2011). Mr Nie said among the main problems at the moment were inappropriate and false classification of hazards, failure to identify the validity of data and inaccurate estimates of emissions and exposure. Currently under the law, testing of new substances has to be carried out at nine government approved laboratories which will themselves be subject to Good Laboratory Practice.


Li Qiuju, a regulatory affairs specialist at REACH24H, which helps companies with the collection of notification data, said the testing of some substances in approved laboratories can take as long as 6-12 months. When the time taken with consultants, CRC and MEP administration work and the evaluation of the notification dossier by an expert review committee is taken into account, the total registration period can extend to almost 18 months, she said.


Data from quantitative structure-activity relationships ((Q)SARs), read-across and other non-test methods was applicable for new substance notifications in “special circumstances” when practical testing could not be carried out, Ms Li pointed out. However data from (Q)SARs and other non-test sources could be used only as a reference in the assessment of the notification by the expert review committee.


Dangerous chemicals


In March this year the State Council approved the Regulation on the Safe Management of Hazardous Chemicals (Decree 591), which overhauled rules on the manufacture, storage and transportation of chemicals, including classification and labelling. The regulation, which came into force on 1 December 2011, includes a list of hazardous chemicals subject to strict environmental controls as well as the collection of information on their release.


The regulation was introduced because of a recent reorganisation of government institutions which gave the State Administration of Work Safety (SAWS) greater responsibilities in chemicals safety, and because some existing management measures on hazardous substances were “not practical”, said Chen Jinhe, director of the National Registration Center for Chemicals at SAWS. Also regulations on chemical management in China needed to be consistent with international standards so the legislation incorporated the GHS rules.


Under Decree 591, SAWS is made responsible for hazardous chemicals registration, identification of hazardous chemicals, and inspection of safety conditions in production, construction, storage and pipeline projects involving hazardous chemicals and the issuing of safety certificates for the production and use of hazardous chemicals.


The decree simplified the definition of dangerous chemicals to those which are toxic, corrosive, explosive or flammable, or which have other properties which cause health or environmental effects. It also applies to companies using chemicals as well as manufacturers. “They all need to be covered but SAWS does not have the resources to do that by itself,” Mr Chen said. “We need other authorities to take on responsibilities as well.”


Japan and South Korea up and running


Obligatory systems for the monitoring and reporting of the usage and emissions of certain chemicals as laid down by regulations being introduced in China are already operating in Japan and South Korea.


In Japan a 2009 amendment to the Chemical Substances Control Law, the country’s main chemical safety regulation, established a system under which chemicals with hazardous properties are designated as priority assessment chemical substances (PACs), said Nishimiya Koji, general manager of Japan’s Overseas Environmental Cooperation Centre. Under the scheme, companies producing and using chemicals must annually notify the government of production and usage quantities of specific chemicals.


“The objective is that the government will then use these figures, as well as its own figures from monitoring of health and the environment, to build up national, regional, and local safety profiles,” said Mr Koji. “The figures are also used to carry out a screening assessment of chemicals for possible PACs classification.” Last year, 88 substances were given PACs designations - 68 as risks to human health, 13 as ecological risks and seven as both.


Annual reporting of chemical usage and emissions has become an established Asian practice in chemical management which companies need to comply with alongside the demands of legislative regimes in Europe and the Americas. It is not surprising that, coupled with a lack of clear communication, such developments can appear to present trade barriers.

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