Manufacturers and Importers Gear Up for New EU Chemicals Law
Producers are getting ready for the EU's new regulation on chemicals, famously referred to as the REACH Regulation, or simply "REACH". The Regulation's date of entry into force is 1 June 2007. Its application, as well as its contents, is certainly far-reaching (as the name suggests): the text covers an incredible 849 pages, and it will apply potentially to all producers and all importers of chemicals, or chemical-containing articles, placed on the EU market. A summary of some of the key provisions of REACH are provided below.
The general rule is that substances (on their own, in preparations, or in articles) must not be placed on the market unless they have been registered with a newly set up European Chemicals Agency (the "Agency"), accompanied by a technical dossier (the principle is no data, no market). Depending on tonnage, it may also be necessary to draw up and submit a chemical safety report (containing a chemical safety assessment).
As a general rule, the Agency has to be notified by the producer or importer of articles where a substance therein is deemed to be carcinogenic, mutagenic or toxic for reproduction, and is identified as such for eventual inclusion in Annex XIV (the list of prohibited substances), if the substance present in those articles totals 1 tonne or more per year per producer or importer, and the substance is present above a concentration of 0.1% weight by weight.
Thus, registration with the Agency is not required until 1 June 2013 for phase-in substances that are manufactured or imported in quantities reaching 100 tonnes or more per year per manufacturer or importer, or until 1 June 2018 for quantities reaching 1 tonne or more per year, per manufacturer or importer. However, if the substance is classified as carcinogenic or very toxic to aquatic organisms and imports of these substances reach 1 tonne or more per year, or in cases of a substance that is being imported in quantities of 1000 or more tonnes per year, the registration requirements will begin as from 1 December 2010. Needless to say, the aforementioned grace periods and tonnage also apply to registration of the substances in preparations or in articles.
While this report has covered some key areas of REACH that could be of relevance to Hong Kong's exporting community, it cannot be emphasised enough that REACH is vast and complex, and imposes novel burdens on manufacturers and importers. If traders are in any doubt over whether, how and when REACH might apply to them, they are advised to seek legal advice.
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