On 13 June South Korea’s Ministry of Environment (MoE) proposed major changes designed to ease the country’s K-REACH registration process.
The proposals were issued in the form of draft enforcement rules, and include amendments to Article 13 of the primary legislation.
The key changes include enabling registration without submission of a full registration dossier where this data is available publicly from a credible overseas organisation and where rights to use the data have been established. Submission of test proposals would be allowed without the need to submit a contract of testing.
The ministry says that in cases where data is assessed and the necessary details have been made public by credible organisations – for example Echa – companies will not need to submit the data when registering.
Companies must still receive consent from the author or data owner to use their data for K-REACH registration. For example, while data may be publicly available on the Echa website, that data and the use of that data is the intellectual property of third parties. As such it is subject to usage rights. Also, where data is used from publications, consent must be acquired from the publisher or author.
According to a ministry source, this means it would not be mandatory to attach documents such as a full test report, OECD screening information set (SIDS) report, or EU risk assessment report.
Additionally, when submitting test proposals, companies would not need to include the contract document with a test organisation or data owners. Instead, the test method, schedule and the date of the test data would be accepted.
The other key changes include giving the ministry a role in arbitrating disputes and prioritising hazard assessment based on substance and volume.
In cases where a consortium organised for co-registration has not yet selected a lead registrant, or the necessary agreement is delayed, the environment minister would be able to recommend arbitration on selecting a lead registrant, or wherever there are disputes.
The National Institute of Environment also plans to prioritise hazardous assessment, focusing on high concern substances. A substances’ usage, classification, labelling, volume of manufacturing and volume of imports would be taken in to account when prioritising.
Connected to this, the notification period of registration and of the registration of changes for new small amount (less than one tonne) chemical substances would be extended from the current three days to up to 20 days to ensure sufficient time for evaluating the information. Currently about 2,000 cases a year are registered as a new small amount.
Jean-Philippe Montfort of law firm Mayer Brown said it is a positive development if companies will not need to register full study reports. However this “should not be made dependent on ‘the data being available from a credible overseas organisation’. Under EU REACH, for example, there is also no need to submit such full reports and so they are not ‘publicly available’.
“Under EU REACH, companies must be in ‘legitimate possession’ or have ‘permission to refer’ to such data if they want to use them in their registration dossiers. As the MoE stated, that it is important that they do verify that such consents are indeed real,” he said.
Mr Montfort also said “in some cases, however, data is published by public organisations such as OECD or the US EPA for transparency purposes even if the data owners still have ownership rights to such data. It is thus important that even if data is published, the MoE requires the registrants who cite a publication not only to show the consent of the publisher but also the consent of the data owner”.
Public consultation on the changes runs until 24 July.