In this edition of the Weekly Compliance Digest, we cover a regulation that aims to harmonize and standardize information submitted on hazardous chemicals to EU member state bodies.
Commission Regulation (EU) 2017/542
What is it?
Last week, the European Commission amended the EU regulation on the classification, labeling and packaging of chemicals (CLP) by adding Annex VIII on harmonized information relating to emergency health response.
Currently, information about mixtures placed on the market and classified as hazardous on the basis of health and physical effects is submitted to appointed bodies at the national level of each EU member state. Poison centers rely on information provided by those bodies or sometimes constitute the bodies themselves. A review concluded that there are major differences between notification systems, data formats and requirements regarding the requested information, among EU member states. Importers and downstream users placing mixtures on the market in different EU member states need to provide multiple submissions and in different formats, regarding information that is often similar. These differences also lead to inconsistencies in the information available to medical personnel and the general public in cases of poisoning incidents in different EU member states.
To address this situation, the EU decided to harmonize and standardize the information received by each EU member state, and establish a format for the submission of the information. The format for the submission of the information is being harmonized to allow importers and downstream users operating in different EU member states to use the same submission and submission format across all EU member states. The submissions will be made electronically in a harmonized XML format maintained by the European Chemicals Agency (ECHA) and available for free. In addition, to facilitate the transmission of information on the intended use of a mixture and support analysis of related poisoning cases, a European product categorization system will be developed by ECHA and used in the submission of information.
Who is affected?
The following organizations are affected by the new regulation:
- Importers and downstream users placing on the EU market chemical mixtures for consumer use.
- Compliance date: January 1, 2020
- Importers and downstream users placing on the EU market chemical mixtures for professional use (intended to be used by professional users but not at industrial sites).
- Compliance date: January 1, 2021
- Importers and downstream users placing on the EU market chemical mixtures for industrial use (intended to be used at industrial sites only).
- Compliance date: January 1, 2024
If an organization submitted information on hazardous mixtures to an appointed EU member state body before the dates provided above, and if the information is not in accordance with the Annex, the organization would have to comply with the Annex by January 1, 2025. However this extended compliance date would not apply if some changes occur to the mixture before January 1, 2025 (see section Section 4.1 of Part B of the Annex for more details about the changes). The changed mixture would be subjected to the compliance dates in red.
What are the requirements?
Before placing chemical mixtures on the market, companies must submit information on mixtures classified as hazardous on the basis of health or physical effects to the appointed bodies in the EU member state or states where the mixture is placed on the market. The submission must be sent electronically in a XML format provided by ECHA, and include the following:
- Identification of the mixture and of the submitter
- Hazards identification and additional information
- Information on mixture components
A detailed breakdown of the information to submit is available in Part B of the Annex.
In addition, companies must create a unique formula identifier (UFI) by using a tool made available by ECHA. The submission must include the UFI, which is a unique alphanumeric code that links the submitted information on the composition of a mixture to the specific mixture. The UFI must also be included on the label of a hazardous mixture, however in the case of hazardous mixtures for industrial use and mixtures which are not packaged alternatively, the UFI can be indicated on the Safety Data Sheet (SDS).
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