One challenge for those placing hazardous substances on the EU market is lack of consistency between different Member States in relation to the information to be provided to national poison centres and the relevant format. This increases the administrative burden for industry. It has also lead to EU citizens impacted by accidental poisoning in different EU Member States receiving an unequal level of emergency health response.
The basis for this is Article 45 of the CLP Regulation 1272/2008 under which Member States are required to appoint a body/bodies (poison centres) responsible for receiving information from importers and downstream users placing hazardous mixtures on the market in order to provide emergency health information.
A draft Regulation, approved by the EU Member States and expected to come into force in 2017 harmonises the information which must be submitted.
The harmonised requirements will apply to mixtures for consumer use from 1 January 2020, for professional use from 1 January 2021 and for industrial use from 1 January 2024. Submissions of information to poison centres made prior to these deadlines remain valid until 31 December 2024 (unless there is a change triggering a requirement to update).
Information required to be provided
Under the harmonised requirements generally importers and/or downstream users will have to provide information including:
- product identifier of the mixture
- contact details of the party submitting the information
- hazard classification of the mixture
- label elements including hazard pictograms, signal words, hazard statement codes and precautionary statement codes (following the provisions of Art 17 CLP and the CLP Annexes)
- toxicology information
- composition of the mixture
- Hazardous components must be identified when present in concentrations ≤0.1% and/or in lower concentrations unless they can be shown as irrelevant for the purposes of emergency health response
- Non-hazardous components must also be indicated when present in concentrations ≤1%
- Concentration can be provided in ranges. The width of these ranges depends on the hazardous classification of the component and its concentration within the mixture
- a Unique Formula Identifier (UFI), an alphanumeric code that links information submitted to a particular mixture. The UFI must appear on the label for hazardous mixtures (unless for industrial use and/or mixtures which are not packaged alternatively in which case the UFI must appear on the SDS (Safety Data Sheet)). ECHA (the European Chemicals Agency) will develop a system to produce UFI
- updated information in certain circumstances such as where the composition of the mixture is changed.
ECHA (the European Chemicals Agency) will develop a form for electronic submission of the information. This will be made available free of charge.
Some key points to note
- What happens when you use a mixture in the production of a second mixture which is then placed on the market (a mixture in mixture) and you do not have access to full compositional information? There are specific provisions which apply here, also for group submissions and for perfumes and fragrances
- Can you supply more limited information where mixtures are placed on the market for industrial use only? Yes, where a telephone number (available 24/7) and e mail address for rapid access to additional information are provided
- What about confidential business information (CBI)? Confidentiality was raised during the consultation on the draft Regulation. CLP provides that poison centres must provide all requisite guarantees to maintain the confidentiality of the information received. Such information may only be used to meet medical demand and to undertake statistical analysis to identify where improved risk management measures may be needed. There is potentially a conflict between these provisions and more general EU legislation providing for public disclosure. The use of concentration ranges go some way to ensuring CBI can be protected. However, does this go far enough and can information submitted be protected
- For business operating across the EU, the new EU Regulation will level the playing field - uncertainty over what information must be submitted in different Member States has not been helpful. The obligations to provide information fall on “importers” and “downstream users” only. Business will have to assess how these obligations impact their own supply chains (e.g. a manufacturer of substances and mixtures selling directly to end users)
- Brexit - Despite the Brexit vote, the UK remains bound by the CLP Regulation and other EU legislation whilst it remains in the EU, including the requirement to submit the appropriate information to the relevant poison centre(s). The Government has indicated its intention to convert EU law including CLP and REACH into UK law “wherever practical” on Brexit, This means having equivalent requirements in UK law, and no doubt this new EU Regulation will help inform what those requirements should be.