Last reviewed 21 February 2020
In this article, Caroline Raine discusses poison centres and Article 45 of Regulation 1272/2008 (CLP Regulation).
Article 45 of Regulation 1272/2008 (Classification, Labelling and Packaging (CLP) Regulation) introduces a requirement for EU countries to set up an appointed body for receiving data on the health and physical hazards of mixtures. These appointed bodies are often referred to as poison centres. A full list of the European appointed bodies can be found here.
What does this mean?
Article 45 Part 1 describes the requirement for EU countries (Member States) to appoint an advisory body to receive and store information on hazardous ingredients contained within mixtures. This information will be used in the event of an emergency. The hazardous ingredients relate to those with health or physical hazards; environmental hazards do not apply to Article 45.
Part 2 outlines the need for ensuring that all information received remains confidential and defines who can use the information, namely: medical professionals to provide advice in the event of a medical emergency and statisticians to provide data to improve risk management measures.
The need for Member States to have all the information required in order to function is outlined in Part 3. This has resulted in some Member States making and implementing a national law, while some are going through the same process and others are yet to. The requirements vary from country to country and it can be difficult to determine the exact local requirements.
Finally, Part 4 states the fact that the commission must carry out a review, which has been done. The review determined that it is possible to harmonise the information submitted to local poison centres and that there will be a common format for electronic submission. Annex VIII of CLP was published in 2016. The Review of the Commission Services According to Article 45(4) of CLP Regulation can be found here. The paragraphs below show the findings and have been taken directly from the report.
Commission review conclusions and recommendations
The Harmonisation of Information for Poison Centres Review According to Article 45(4) of Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of Substances and Mixtures provides all the findings of a comprehensive consultation on poison centres.
The consultation found that it is in fact possible to harmonise the information submitted to poison centres and as such a common electronic format has been established.
Information on what should be submitted was researched and the findings show that ingredients in a mixture will be notified in concentration ranges, with the ranges being defined as a function of the hazards of the substances. A threshold has been defined and if non-hazardous ingredients are present above that threshold then they too must be notified.
A Unique Product Identifier (UPI) has been introduced, which must be printed on product labels. The Unique Formula Identifier (UFI) contains a company identifier and the poison centres will use the UFI to identify products and source the relevant information relating to that product.
The also consultation found that notifications to poison centres should be possible in all official languages of the Member State where the product is being placed on the market, and/or in English.
In addition to a standard electronic submission tool a European Product Categorisation System will also be used.
What needs to be notified?
Importers and downstream users placing hazardous mixtures on the market and distributors who modify the label or packaging will need to notify ingredients in mixtures classified as hazardous for physical and/or health effects.
Some hazardous mixtures fall out of scope and include those:
classified as dangerous for the environment only
classified as gases under pressure
classified as explosive
placed on the market for research and development (R&D) purposes
placed on the market for product and process orientated research and development (PPORD)
requiring a safety data sheet (SDS) but not classified as hazardous
not in scope for CLP (eg waste, radioactive mixtures, intended for R&D)
not placed on the market, but finished products for defined markets.
What information will need to be provided?
Information about the composition of mixtures.
Information on the product category.
Information on the size and type of packaging.
Information on whether the product is used by consumers and/or industrial users.
In January 2020 COMMISSION DELEGATED REGULATION (EU) 2020/11 amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures as regards information relating to emergency health response, was published. This amendment formally delayed the first deadline for consumer mixtures by a year, bringing it in line with the deadline for professional use mixtures. The dates are now;
Consumer and Professional use — 1 January 2021.
Industrial use — 1 January 2024.
For those who have already made notifications in accordance with Article 45(1) before the dates listed above, there is an extended deadline of the 1 January 2025 by which all existing notifications must be updated to the new requirements.
The amendment also allows for the Unique Formula Identifier (UFI) to be added to either the mixture label or the mixture packaging.
Text of Article 45 from CLP
Appointment of bodies responsible for receiving information relating to emergency health response.
Member States shall appoint a body or bodies responsible for receiving information relevant, in particular, for formulating preventative and curative measures, in particular in the event of emergency health response, from importers and downstream users placing mixtures on the market. This information shall include the chemical composition of mixtures placed on the market and classified as hazardous on the basis of their health or physical effects, including the chemical identity of substances in mixtures for which a request for use of an alternative chemical name has been accepted by the Agency, in accordance with Article 24.
The appointed bodies shall provide all requisite guarantees for maintaining the confidentiality of the information received. Such information may only be used:
to meet medical demand by formulating preventative and curative measures, in particular in the event of an emergency; and
where requested by the Member State, to undertake statistical analysis to identify where improved risk management measures may be needed. The information shall not be used for other purposes.
The appointed bodies shall have at their disposal all the information required from the importers and downstream users responsible for marketing to carry out the tasks for which they are responsible.
By 20 January 2012 the Commission shall carry out a review to assess the possibility of harmonising the information referred to in paragraph 1, including establishing a format for the submission of information by importers and downstream users to appointed bodies. On the basis of this review, and following consultation with relevant stakeholders such as the European Association of Poison Centres and Clinical Toxicologists (EAPCCT), the Commission may adopt a Regulation adding an Annex to this Regulation. Those measures, designed to amend non-essential elements of this Regulation, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 54(3).
Changes are coming with regards to the harmonised format for notifying hazardous mixtures to Poison Centres. Make sure you keep up to date and don’t miss the deadlines. Our Poison Centre topic can also provide more information and detail.