Notification to Poison Centres
The existing rules around public health notification (commonly referred to as Poison Centre notification) are laid out Article 45 of the CLP regulations (Regulation 1272/2008 (Classification, Labelling and Packaging (CLP) Regulation). This requires EU Member States to appoint an advisory body to receive and store information to assist ‘in the event of emergency health response’. The list of European appointed bodies in the varius Member States can be found here.
The regulation requires that the appointed bodies provide guarantees for maintaining the confidentiality of the information provided. This is intended to provide reassurance as Aricle 45 stipulates that the information to be provided ‘shall include the chemical composition of mixtures placed on the market and classified as hazardous on the basis of their health or physical effects’. In practice, this means providing full and precise formulation information. Note that environmental hazards are not one of the criteria listed in Article 45.
Following a review carried out (which is referred to in Article 45 of CLP), the European Commission (EC) has published Regulation 2017/542 which makes changes to the CLP regulations, specifically amending Article 25 to include the introduction of a unique formula identifier (UFI) to the label and adding a new Annex VIII. This annex contains the detail around the new arrangements for Poison Centre notification.
The Regulation will lead to producers and importers of chemical mixtures (such as detergents, paints and household chemicals) providing uniform information on the product composition. At the same time, emergency responders in all EU countries will have the same medical information available. This will allow improved services in some countries. Through a new uniform product identifier (UFI) poison centres will be able to exactly identify the product and its composition.
To this end, there are moves to harmonise the notification process via the establishment of a centralised portal managed by ECHA. Following the ECHA Management Board decision in December 2017, ECHA will develop an EU portal enabling submissions from companies, dispatching of submissions to the appointed bodies (and their designated poison centres), and central storage of the submissions for auditing purposes and possible retrieval by submitters. However, Member States may opt-out and develop their own national submission systems. Since the format and requirements for the notifications have been harmonised across the EU, any submission system (be it centralised or national) must ensure that it complies with these legal requirements. The first version of the portal will be launched in Q1 2019 with an additional release foreseen for Q3 in 2019.
When to notify
Anyone importing or placing hazardous mixtures on the market needs to notify if the ingredients in those mixtures are classified as hazardous for physical effects and/or health effects in the following uses:
- Consumer use – intended to be used by consumers
- Professional use – intended to be used by professional users (but not at industrial sites)
- Industrial use – intended to be used at industrial sites only
However this does not apply to mixtures:
- Classified as environmentally hazardous only
- Classified as gases under pressure
- Classified as explosive
- Used for scientific research and development (R&D)
- Used for product and process orientated R&D – defined in REACH
- Require a safety data sheet (SDS) but are not classified as hazardous
- Not in scope for CLP (eg waste, radioactive mixtures)
- Not placed on the market, but finished products for defined markets.
Information Required in the Notification
The information that needs to be submitted is set out in Part B of Annex VIII of CLP and includes the following.
- Identification of the mixture and the submitter
- Product identifier of the mixture — the trade name or names (including the brand name or other names)
- UFI of the mixture
- The name, address, phone number and email address of the submitter
- Hazards identification and additional information
- Classification of the mixture (hazard class and category)
- Label elements
- hazard pictogram codes
- signal word
- hazard statement codes, including supplemental hazard information codes
- precautionary statement codes
- Toxicological information
- Description of the toxicity of the mixture or its components (as required in Section 11 of the SDS)
- Additional information
- pH (where applicable)
- Physical state
- Packaging (type and size)
- Intended use (product categorisation code)
- Uses (consumer, professional, industrial)
- Product identifiers of the mixture components
- Chemical/trade name of the components
- CAS number (where applicable)
- EC number (where applicable)
- UFI (where applicable)
- Exact concentration or concentration ranges of the mixture components
- Classification of mixture components (substances and mixture in mixture (MIM))
- Hazard classification of each component (where applicable)
- Additional identifiers (where applicable and relevant for health response)
There are options to group submissions to a single submission for mixtures provided that all the mixtures have the same classifications for health and physical hazards, they all have the same product category code and the concentration ranges are the same. Group submissions are also permissible for perfumes and fragrances provided that the total concentration of each contained in each mixture does not exceed 5% w/w.
Reduced submissions -defined by Annex VIII as limited submissions – are available for producers of mixtures for industrial use only. The reduced submission allows for notifiers to submit only information contained in the SDS, without the full composition details. This reduced submission is only an option if a 24–hour, seven days per week telephone number and an email address for rapid access to additional product information is provided (for example the 24-7 Emergency Advice service). If 24–hour telephone response is not available a full notification must be made.
The UK and Brexit
The UK is one of the few EU Member States never to have officially appointed a body to receive information. However, the National Poisons Information Service (NPIS) has always accepted voluntary submissions of SDS with only minimal requirements regarding their format. The updated requirements under Annex VIII of CLP for providing information to poison centres, will not take effect until after the UK has officially left the EU in March 2019. While there is uncertainty as to the precise terms of Brexit, it remains to be seen whether or how these additional requirements will be transposed into UK law. In the meantime, the advice from the Health and Safety Executive (HSE) is to continue to notify with the NPIS (further details on how to do this can be obtained from the NPIS – see below link).
If supplying products to other EU Member States, the current arrangements continue until the UK formally leaves the EU in 2019 and any mandatory requirements should continue to be met after this date.
Note that companies that notify now can then take advantage of the extended deadline of the 1 January 2025, by which all existing notifications must be updated to the new requirements.
- EC Regulation 1272/2008 of the European Parliament and the Council on classification, labelling and packaging of substances and mixtures
- EC Regulation 1907/2006 of the European Parliament and the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
- EU Commission Regulation 2017/542 of 22 March 2017 amending EC Regulation 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures by adding an Annex on harmonised information relating to emergency health response.
- UFI Generator