Published: 16 August, 2018
In accordance with Article 45 of CLP (1272/2008), a new annex was published in March 2017. The new annex laid out the requirement that each Member State has an appointed Poison Centre (or equivalent body), who is responsible for receiving data from importers and downstream users who place hazardous chemical mixtures on the market. This information is relevant 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.The requirements of the new annex are applicable to all products which fall under CLP, apart from products which are classified only for one or more of the following hazards: explosives, gases under pressure, mixtures with environmental hazards
The main premise of the annex is that importers and downstream users placing hazardous chemical mixtures on the market have to submit harmonised information to Member States appointed bodies relating to those mixtures for emergency health response. Part of the notification process is to provide compositional information in the form of a concentration width which varies dependent on the percentage inclusion and category of hazard.
The requirement to provide so much compositional information has caused many suppliers to question how their data will be held and who will have access to confidential formulation information. Stakeholders from the petroleum, construction and industrial gases sectors have raised concerns with the workability of the new poison centre requirements. Notably, CONCAWE (a division of the ‘European Petroleum Refiners Association’) and CEPE (the ‘European Council Of The Paint, Printing Ink And Artists’ Colours Industry’) have highlighted the following issues;
Although group submissions are allowed under the regulation for similar mixtures the paints industry have raised concerns that ‘thousands of individual submissions’ will be required for products in their sector due to variations in components with health hazards.
The CEPE have offered a specific example within the decorative market where Alkyd paints contain tinters which are made up of differing compositions of ‘~20 hazardous ingredients at levels ranging from 15% down to <0.1%’. These compositional variations will result in ‘thousands of individual submissions under current rules’. CEPE state that under the current requirements the large volume of individual submissions will become burdensome for the sector casting doubt on the commission’s costs/benefit assessment findings as the cost of resourcing such submissions will be high. They have also suggested that a proactive solution should be found to ‘enable the benefits of group submission to be leveraged’.
Lack of exemptions
CONCAWE have proposed for the inclusion of an exemption covering the exclusion of petroleum products from the requirements of notifying against the concentration widths detailed within the regulation. They use many examples to suggest that the current requirements will cause workability issues for petroleum mixtures including;
CONCAWE state that ‘changes in the composition of mixtures do not change hazard classification, because the most severe hazard classification and labelling is recommended as default for all possible mixtures of components listed in the SDS’ meaning that ‘All hazard information and first aid measures are available in the Safety Data Sheets. This information is shared with authorities in several member states’. As it stands, they claim that ‘the proposed maximum widths of concentration ranges in Annex 1 will result to high number of submissions for the same product’.
Taking the above concerns into consideration, the European Commission have commissioned a study aimed at addressing the concerns which stakeholders have on the workability of new requirements for the notification of information on hazardous chemical mixtures for emergency health response. The study will focus on those industries with ‘complex material inputs and supply chains’ and aims to propose a solution to make the notification process more workable for all involved. The study is run by the Commission and is planned to last for one year. The interim results will be presented and discussed in the study Steering Group and Stakeholder Advisory Group in the beginning of 2019 as well as to CARACAL.
Read more here.
For more information on how the new annex impacts your business, call our expert team on +44 (0)1524 510278 or email email@example.com.