GLOBAL VIEW
Charlotte Niemiec writes for Chemical Watch and specialises in Asia’s chemical industry
China
Risk assessment C
hemical safety is in the public eye in South Korea following a scandal over humidifier disinfectant that surfaced in May 2016. The disinfectant contained two
Companies will have to apply for approval from the Ministry of Environment (MoE) and provide data proving they are safe and effective
chemicals linked to lung disease - and injured or killed over 100 people. It was on the market for ten years before suppliers removed it in 2011. Consumer goods giant, Reckitt Benckiser publicly apologised for selling the product amidst local press claims the company had known of its potential risk. New president, Jae-In Moon responded by announcing in June 2017 that the government will align its system for hazardous chemicals management more closely with that of EU REACH. He has also pledged to reinvestigate the incident, enact a new biocides law and create an ‘integrated management system’ for chemical substances and product safety management to speed up hazard assessment. The government has now passed the biocides
law, which is closely modelled on the EU’s Biocidal Products Regulation (BPR). It will come into force on 1 January 2019. It introduces a ‘pre-approval’ system for biocides (and products containing them) before they can be placed on the market. There are also new rules for treated articles; they must only contain approved biocidal products. Companies will have to apply for approval from the Ministry of Environment (MoE) and provide data proving they are safe and effective. Over in China, meanwhile, a final version of the guidance to new substance regulation, MEP Order 7, may at last be imminent. After a wait of over two years – and three draft versions – a draft copy of a Ministry of Environmental Protection (MEP) notice announcing the proposed changes was distributed to industry in August 2017. In September, the government released the revised data requirements, which are significantly reduced for all three ‘levels,’ covering substances manufactured or imported in volumes from one to 1000t/year. Examples of these changes are, for level one
substances (1-10t/year), the government will require just one route of acute toxicity study and it has removed the need for a 28-day repeated-dose toxicity test. For level two substances (10-100t/ year), it no longer asks for a 90-day repeated-dose toxicity study and has removed the requirement for a 14-day prolonged fish toxicity study. For both level two and three (100-1000t/year) substances, companies do not need to submit full toxicokinetic
Recently a spate of new chemicals safety legislation has been ushered in across China and other parts of Asia
test data. These changes, which come into force on 15 October 2017, should ease the registration obligations for both domestic and foreign manufacturers and importers. Regulators in Taiwan have been busy too.
Now that the ‘pre-registration’ phase has finished, the government has published a draft list of 122 ‘priority’ substances, with a final list expected to be published before 31 December 2017. The substances have been chosen based on their hazard and potential exposure. During phase two, companies will have
to register all substances imported or manufactured in quantities over 1t/year. To register, they must submit dossiers containing information similar to that required by the EU, such as basic information of the registrant and substance; information on the manufacture, use and exposure of substances, hazards assessment, classification and labelling; safe use information; physical and chemical properties; toxicological and ecotoxicological information; and exposure assessment. If data can be obtained from international organisations on physicochemical properties, toxicological and/or ecotoxicological information, test reports do not need to be submitted for that test. Taiwan’s Environmental Protection Agency’s
draft plan for phase two outlines the proposed next steps. Companies will have to register all toxic chemicals on the priority list from 2018 to 2021. Another list will then be issued and companies will have from 2021 to 2024 to register; a third list covers the period 2024 to 2027. Unlike the EU and most other jurisdictions, Taiwan will allow joint registration, but it will not be mandatory. Finally, Vietnam has submitted details of new
draft chemical law to the World Trade Organization. The law was expected to come into force in September 2017, although there was no further news as C&I went to press. It will replace the current law, which has been in place since 2007. Nhat Nguyen of 3E company notes that the most significant changes will be to the country’s Globally Harmonized System (GHS) regulations. The draft decree states that classification for chemicals will follow the sixth revised edition, as opposed to the current (modified) implementation of the 3rd revised edition. He says: ‘While this is not a surprising development given that the UN is about to issue the 7th edition of GHS, it is noteworthy that the 2016 version of this draft decree did not include this provision.’
40 08 | 2017
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