The CLP Regulation (Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixture) governs the classification, labelling and packaging of chemicals. It also requires suppliers of hazardous chemical products to provide national poison centres information for emergency health response.
EU countries are required to set up appointed bodies (often known as poison centres) for receiving information on the composition of hazardous mixtures (detergents, paints, adhesives etc.). Importers and downstream users placing the mixtures on the EU market must provide this information. Depending on the EU country, physicians, professional users and consumers can contact these appointed bodies to get recommendations for medical treatment in cases of poisoning.
Poison centres in the EU answer at least 600,000 calls per year from the general public or physicians (about 1,700 calls per day). Roughly half of the cases are related to accidental exposure involving children. It's estimated that the number of fatalities in the EU related to poisoning from hazardous chemicals is at least 400 per year. You can find more information on the ECHA website.
On 22 March 2017, the Commission adopted Regulation (EU) No 2017/542 amending the CLP Regulation by adding an annex on harmonised information relating to emergency health response (Annex VIII). Annex VIII will ensure that producers and importers of chemical mixtures (such as detergents, paints and household chemicals) provide 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. The new unique product identifier (UFI) will help poison centres exactly identify the product and its composition, leading to a better and more adequate medical response and reduced unnecessary over-treatment, which is often given to be on the safe side.
Annex VIII was amended twice. First, by Regulation (EU) No 2020/11 postponing the compliance date for submitting information on mixtures for consumer use from 1 January 2020 to 1 January 2021. This allowed appointed bodies as well as industry duty holders sufficient time to properly prepare for their duties under Annex VIII. Second, by Regulations (EU) No 2020/1677 and 2020/1676 addressing a number of identified workability concerns and proposing one generic solution as well as sector-specific solutions for the gypsum, ready mixed concrete, cement and fuels industry, and bespoke paints. The two Regulations entered into force on 14 November 2020.
See the most recent contact list of appointed bodies on ECHA’s website.
Please note that the list does not provide the emergency telephone number to be given in Section 1.4 of a Safety Data Sheet (Annex II REACH Regulation). Further information on the emergency telephone numbers can be found on the ECHA website.
On 1 February 2018, the Commission and ECHA jointly organised a workshop on the implementation of Annex VIII to CLP. The video recording of the workshop as well as the presentations are available below.
1. Annex VIII to CLP – Introduction and overview
2. Annex VIII to CLP – What are my obligations?
3. Annex VIII to CLP – How do I prepare?
4. Annex VIII to CLP – IT tools
5. Annex VIII to CLP – How can we help you?
On 23 January 2017, the Commission and ECHA jointly organised a workshop on the implementation of the Regulation harmonising the information relating to emergency health response. The video recording of the workshop as well as the presentations are available below.
01. ECHA_IT aspects – Tools
02. NL_Preparation for implementation
03. PL_Preparation for implementation
04. A.I.S.E._View from industry
05. UEAPME_View from industry
06. Recap morning session
07. Guidance and support
08. Poison centre notification portal feasibility study
09. Workability issues_Concawe
10. Workability issues_CEPE
The legal obligations relating to the submission of information to the appointed bodies are laid down in Article 45(4) of Regulation 1272/2008 ('CLP Regulation'). The Commission was mandated to assess the possibility of harmonising the information provided to poison centres. This review (302 kB) was carried out in consultation with stakeholders and with the support of the European Association of Poison Centres and Clinical Toxicology (EAPCCT). It concluded that the Commission shall make a proposal to harmonise data formats.
Preparatory documents to discuss the scope and content of the proposal were held in the REACH and CLP expert group ('CARACAL'). Documents from the CARACAL meetings (14, 16 and 18) are publicly available on the CircaBC platform (no registration or login required) under the group 'CARACAL documents'. Click here for direct access and consult the Library.
A Commission study estimates the positive and negative impacts of a harmonised notification system of data to be transmitted to poison centres in accordance with Article 45 of the CLP Regulation. The elimination of different requirements between EU countries is expected to create net savings of EUR 550 million for companies, and at the same time improve the speed and quality of emergency responses (inter alia through the creation of a Unique Formula Identifier, allowing faster identification of hazardous mixtures).
The study 'Feasibility on interlinked databases, format and basic application to facilitate exchange of information between Poison Centres (Art. 45 CLP Regulation)' defines the technical specifications for a common XML harmonised reporting format with the related XML Schema Definition (XSD) and the basic application to input data in the defined format. The XML Schema Definition (XSD) and the basic application are downloadable from the ECHA website.
It also describes the existing software under current national notification systems, analyses options for a secure data exchange between poison centres in EU countries and proposes tools allowing one-off data submission to a range of EU countries at the same time.
The addition of an alphanumeric code, called a “Unique Formula Identifier” (UFI), on the label of hazardous mixtures will create an unambiguous link between products placed on the market and information related to these products submitted to poison centres. The study on UFIs establishes requirements for the construction of the UFI and derives a suitable algorithm for its generation as a simple 16-character code. Another practical result of the study is the development of an application to generate UFIs. This application has been developed for the benefit of companies and readily enables them to create UFIs. The application is available at ECHA's website.
One of the outcomes of the review of the Commission services according to Article 45(4) of CLP was the suggestion to develop a harmonised European Product Categorisation System (EC PCS). In the product categorisation system study, existing PCS were analysed and relevant literature was reviewed. Together with an extensive stakeholder consultation this led to the development of an EU PCS, which has a hierarchical structure and uses the existing German TDI-CSA/TKS as a backbone. The system covers mixtures classified as hazardous based on their health effects or physical properties in accordance with Article 45 of the CLP Regulation as well as other categories of products (e.g. cosmetic products) beyond the scope of Article 45 of CLP. Products are categorised based on their intended use only. For EU countries with an existing PCS, translation tables were developed for mapping of the existing categories to the new harmonised system.
Annex VIII requests companies to provide uniform information on product composition, as well as to create a unique product identifier (UFI). This would enable poison centres to identify the exact product in a poisoning incident, leading to a better and more appropriate medical response. A number of industry sectors raised concerns about the potential workability of the legal provisions. The European Commission studied those workability issues for specific industries with complex material inputs and supply chains. In addition, the study explored the possibility of establishing an EU toxicovigilance scheme. One of the conclusions of the study was that amendments to Annex VIII to CLP were necessary. The Commission adopted these amendments in 2020 and they entered into force on 14 November 2020 (see above).