Annex VIII to EU Regulation (EC) 1272/2008 (CLP) article 45 aims to harmonise the information on hazardous mixtures that must be submitted to appointed bodies and how to submit it. Herewith the requirements will be the same within EU/EES and the poisons centres, health care professionals and the general public will have the same prerequisites to handle incidents with hazardous mixtures in the different member states.
Companies that according to CLP are importers or downstream users and place chemical products on the market are obliged to notify their products. This obligation applies to mixtures that are classified as hazardous on the basis of their health or physical effects.
The information should be sent to the appointed body in each country before the mixture is placed on the market. The Swedish Poisons Information Centre is the appointed body in Sweden.
The submission shall be in the official language of the Member State where the mixture is placed on the market, unless the Member State concerned provide otherwise. The notification can be made in Swedish or English to the Swedish Poisons Information Centre.
You can read more about CLP at the website of the European Chemicals Agency (ECHA).
Tools and format to submit the information
Companies shall submit the information by electronic means in a tool and format that will be provided by ECHA on their website and free of charge. The application of Annex VIII will be implemented in several steps depending on their intended use, see dates below. When Annex VIII applies, the only approved way of notifying products to the Swedish Poisons Information Centre will be through ECHA’s Submission portal.
ECHA has created a web-based tool for companies to create UFI-codes. UFI stands for Unique Formula Identifier. These codes identify a specific mixture and can be used by poisons centres to retrieve information about the mixture if an incident occurs. A UFI-code is mandatory information in a submission. For the Swedish Poisons Information Centre the name of the product will, like today, be the most important way to identify the product and thereby help them find the correct information. The UFI-code will be used as a complement to the product name.
Upon a notification the companies must describe the main intended use of a product according to the harmonised European product categorisation system (EuPCS). This information may be used for follow-ups and retrieving statistics of poisonings in Europe.
When do the harmonized requirements according to Annex VIII apply?
Note: In the amended Annex VIII the compliance date to submit information on hazardous chemical mixtures for consumer use has been postponed from 1 January 2020 to 1 January 2021. Other compliance dates are not affected.
The application of the new requirements will be implemented in several steps depending on the intended use of the products/mixtures.
- The requirements of Annex VIII will apply for mixtures for consumer use from 1 January 2021.
- The requirements of Annex VIII will apply for mixtures for professional use from 1 January 2021.
- The requirements of Annex VIII will apply for mixtures for industrial use from 1 January 2024.
- If a mixture has several uses, the earlier corresponding deadline applies.
If a hazardous mixture has been notified according to the national requirements before the dates of applicability mentioned above, the company does not have to comply with the requirements of Annex VIII until 1 January 2025 as long as the mixture does not change and need to be updated according to section 4.1 part B in Annex VIII.
Products that are not classified as hazardous
The Swedish Poisons Information Centre also need information about products that are not classified as hazardous on the basis of their health or physical effects, although they are not mandatory to notify. Incidents also occur with these products and the poisons centre therefore needs to know the composition. The notifications can be submitted the same way as classified products, i.e. through ECHA's submission portal. If the number of the Swedish Poisons Information Centre is used in section 1.4 in a safety data sheet, the company needs to notify the product regardless if it is classified as hazardous or not.
It is at the discretion of each Member State to decide if they want to collect a fee for the notification or not. The Swedish Poisons Information Centre currently does not have the intention of collecting any fees associated with notification of products or the use of the emergency telephone number on safety data sheets.
Questions regarding notification of products to the Swedish Poisons Information Centre according to today's national requirements, i.e. before Annex VIII applies, can be sent to email@example.com
The Swedish Chemicals Agency is the national helpdesk for questions related to CLP. Questions can be sent to https://www.kemi.se/en/ask-the-swedish-chemicals-agency-helpdesk/
Technical questions regarding ECHA's IT-tools, needed in order to prepare and submit product notifications, are referred to ECHA: https://echa.europa.eu/sv/contact/clp
More information regarding notifications to poison centres and ECHA's IT-tools, is available at ECHA:s website. Here you can find information on the UFI-generator, EuPCS, the submission portal, a guide for the industry with seven steps to help you meet the requirements in Annex VIII and more.
Annex VIII in full: Commission Regulation (EU) 2017/542, Annex VIII
The latest version of the guidance to Annex VIII:
Information from the Commission:
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