New CLP Regulation Update will Harmonize Poison Center InformationA significant update to the CLP Regulation will see Poison Center information harmonized across the EU Categories: Industry News, Regulatory Advisory Services Mar 03, 2017
A significant CLP Regulation update will see Poison Center information harmonized across the EU. As discussed at the 22nd meeting of the Competent Authorities for REACH and CLP (CARACAL) in October 2016, this new legislation will see the addition of a new Annex VIII into the CLP Regulation, and is expected to be adopted by the end of February 2017. It will apply beginning January 1, 2020 with the following phased deadlines:
•January 1, 2020 for consumer uses
•January 1, 2021 for professional uses
•January 1, 2024 for industrial uses
The regulation will also place various responsibilities on the European Chemicals Agency (ECHA) in relation to the provision of tools, formats and technical/scientific guidance and support to facilitate the implementation of these new requirements.
In accordance with Article 45 of CLP, each Member State has an appointed Poison Center (or equivalent body), who is responsible for receiving information from importers and downstream users who place hazardous chemical mixtures on the market. This information is relevant for formulating preventative and curative measures – particularly in the event of an emergency health response – and is required for any chemical mixtures placed on the market which are classified as hazardous on the basis of their health and physical effects.
Prior to this new legislation the information submitted to Poison Centers across the EU varied widely between Member States, which created administrative strain and resulted in uneven information levels in relation to hazardous chemicals.
Article 45(4) of CLP made provision for the European Commission to review the current system and assess the possibility of harmonizing the information submitted to Poison Centers. This review led to the proposal of a new Annex VIII to be added CLP, and at the REACH Committee meeting on 21st September 2016 the EU Member States voted in favor of this new proposal.
The Regulation establishes a standard format for the submission of information to the appointed Poison Centers, with the responsibility being placed on ECHA to provide the following:
•A harmonized XML format for providing the information. This is to facilitate harmonized submission requirements for industry and provision of the same medical information to emergency responders. Finalized versions are expected to be completed by the end of 2017.
•A means of creating a Unique Formula Identifier (UFI), enabling exact identification of the product and its composition, leading to a more appropriate medical response.
•Introduction of a European Product Category System. This is to facilitate the transmission of information on the intended use of a mixture, and to support the statistical analysis of related poisoning cases. The final version is expected to be published by the end of 2017.
•Technical and scientific guidance, technical support and tools to facilitate the submission of information.
In 2016 ECHA created a dedicated Poison Centers website to provide information, support tools, and to host the draft XML formats. Final versions of the ECHA IT tools and formats (with the exception of the ‘one stop shop’ notification portal, which is explained below) will be available by the end of 2017 together with practical instructions for duty holders – i.e. chemical importers and downstream users.
As their next priority, ECHA will collaborate with the European Commission, Member States and industry to ensure that there is adequate advice on any issues of scope or interpretation arising from the publication of the Regulation, together with practical advice on how to comply.
The European Commission has indicated that this guidance, together with helpdesk support, will be available in full by the end of 2018.
Member State Support
In light of this new legislation, Member State Competent Authorities will need to adapt their submission systems to be able to receive the information in XML format from the duty holders, and will need to update their internal information-sharing systems in an equivalent manner.
At present, there are a range of different formats, submission systems and database infrastructures across the EU Member States. Following a request from both the European Commission and a number of Members States regarding the potential for a ‘one-stop-shop’ submission system, this year ECHA will conduct a feasibility study on the possibility of developing a ‘front-end’ submission system to receive the industry submissions and transfer them to the relevant Member States.
If it is approved, this one-stop-shop submission system is expected to be available by the end of 2018.