The Swedish Poisons Information Centre is the appointed body in Sweden, according to the EU regulation (EC) 1272/2008 (CLP) Article 45, responsible for receiving information about the composition of chemical products classified as hazardous on the basis of their health or physical effects. Companies are therefore obligated to provide the information the Poisons Centre needs to carry out the tasks for which it is responsible.
You can read more about CLP at the website of the European Chemicals Agency (ECHA).
The main responsibility for the Swedish Poisons Information Centre is to give advice to the general public, physicians and other health care personnel in cases of acute poisonings. Many accidents happen with chemical household products (almost 30 000 inquiries to the Poisons Information Centre per year). Children get hold of the products and taste, adults get splashes in their eyes or accidentally drink them. In some cases people drink large amounts thinking that they are drinking something else or with the intention to harm themselves. To be able to make a correct assessment of the acute risk and provide adequate advice in all incidents of poisoning, the Poisons Centre must have accurate information about the composition of chemical products.
The product information is kept strictly confidential according to the Swedish secrecy law, 2009:400, 25 kap 9§ and the EU Regulation 1272/2008 (CLP) article 45.2, and is only used for evaluation of acute toxicity. The product composition will never be revealed except in cases when it, for medical reasons, is of importance to inform a physician about ingredients that will influence the treatment.
Annex VIII – Harmonised requirements of notifications
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.
The application of the new requirements is implemented in several steps depending on the intended use of the products/mixtures.
- The requirements of Annex VIII apply for mixtures for consumer use from 1 January 2021.
- The requirements of Annex VIII apply for mixtures for professional use from 1 January 2021.
- The requirements of Annex VIII 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.
So, from 1 Jan 2021 the Swedish Poisons Centre will only accept notifications of mixtures intended for consumer and professional use through the ECHA submission portal (see below). It is still possible to send information about products intended for industrial use through the national system until 1 Jan 2024. The preferred route of notification is however the ECHA submission portal. You can find instructions for the national system here.
The information should be sent to the appointed body in each country before the mixture is placed on the market.
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.
Tools and format to submit the information
To provide support to industry and Member States’ appointed bodies, ECHA has developed IT tools to support preparing, submitting and receiving information on hazardous mixtures.
The tools are available from ECHA’s website
On their website you can also find an Overview of Member States decisions on implementing Annex VIII to the CLP
Among the IT tools, 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.
Emergency telephone number on safety data sheets
The number to use is "112 – ask for Poisons Information" (in Swedish this will be: "112 – begär Giftinformation").
Many companies write "112 – Begär Giftinformation" or only "112" as the emergency telephone number on their safety data sheets. Regardless of whether you refer to the Poisons Information Centre or not, the call during an emergency situation will most likely be transferred to the Poisons Information centre. In order for the Poisons Centre to be able to assist during these emergencies, companies need to provide the Poisons centre with information about the mixture that the safety data sheet concern. For mixtures not classified due to their health or physical effects, there are no legal requirements for this, however, without access to information, the Poisons centre cannot provide adequate advice in an emergency situation.
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 the ECHA submission portal.
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 industrial products to the Swedish Poisons Information Centre in the national system can be sent to firstname.lastname@example.org
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
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