Guidance on harmonised information relating to emergency health response - Annex VIII to CLP
Guidance to Regulation (EC) n° 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures
Version 4.0 March 2021
This document is the Guidance on the harmonised information relating to emergency health response. It is a comprehensive technical and scientific document on the implementation of Article 45 and Annex VIII to Regulation (EC) No 1272/2008 on the classification, labelling and packaging of substances and mixtures (CLP). CLP is based on the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) and is implementing the provisions of the GHS within the EU. CLP now has relevance for European Economic Area (EEA) countries (i.e. it is implemented in the EU countries and in Norway, Iceland and Liechtenstein).
The objective of this document is to provide detailed guidance on the obligation to submit to Member State’s responsible bodies relevant information on hazardous mixtures placed on the market for formulating preventative and curative measures in case of accidents. The guidance is developed to primarily assist companies placing hazardous mixtures on the market in complying with their obligations. It is also intended to be a support tool for the appointed bodies in the Member States.
The first version of this guidance document was developed by ECHA with the support of a dedicated Working Group consisting of experts from Industry, Member State appointed bodies and poison centres. The project started in April 2017 and the working group had meetings and continuous discussions to develop the guidance text until December 2017. Finally, version 1.0 of the text was consolidated and edited by ECHA and underwent the formal consultation with ECHA Partners during 2018 and beginning of 2019. The document has been subsequently updated and consulted again with the same ECHA Partners to implement the changes in the legal text in 2020 and 2021.
Update to implement the amendment of the legal text due to Commission Delegated Regulation 2020/1677 and Commission Delegated Regulation 2020/1676 of 31 August 2020 (the “workability amendments”). In particula
- Added in section 188.8.131.52 reference to articles with integral substance or mixture intended to be released.
- Added in section 3.3 clarification about the borderline between mixture and substance.
- Added new section 184.108.40.206.1 to address the exemption for bespoke paints.
- Added in section 3.4 a clarification about mixture with end use not subject to notification requirements.
- Added in section 4.1 an introduction on the new workability solutions.
- Added in section 4.2.1 a clarification of the UFI concept applied to Interchangeable Component Groups, Standard Formulas and Fuels.
- Added in section 4.2.7 clarification about the need to update the UFI in case of notifications concerning Standard Formulas, fuels or containing Interchangeable Component Groups.
- Added new section 220.127.116.11 to provide details on the labelling requirements for bespoke paints.
- Added in section 5.3.1 clarification about the extended exemption to the obligation not to notify components which are not present.
- Added in section 5.3.2 a recommendation to report the presence of microorganisms in the mixture when relevant.
- Clarified in section 5.3.3 the identification requirements for mixtures in mixture.
- Added new section 5.5 on the Interchangeable Component Group solution.
- Added new section 5.6 on the special provisions for ready-mixed concrete, gypsum and cement products (Standard Formulas solution).
- Added new section 5.7 on the special provisions for certain fuels.
- Added in section 7.3.1 clarification about security of submitted information.
- Added new section 18.104.22.168 clarification about update rules applying to submissions made referring to Standard Formulas.
- Added new section 22.214.171.124 clarification about update rules applying to submissions for fuels made referring to the safety data sheet.
- Other editorial changes and typos corrected.