Submitting your Notification to the Classification and Labelling Inventory
Who needs to notify?
Notification is required by Manufacturers and Importers of substances. The definitions of Manufacturer and Importer under CLP are the same as for REACH. Downstream users who purchase all their raw materials within the EU do not need to submit any notifications, as this should already have been done by a company further up the supply chain.
Non-EU companies should not submit notifications, instead, they should provide the necessary data to their customers who are the Importers of these substances. If, for confidentiality reasons, the non-EU company doesn’t want to share this information with all of its customers, it can ask one of its customers to submit on behalf of a group of importers. Where an Only Representative (OR) has been appointed, then the non-EU company may wish to use them to submit the notification. However, ORs have no legal role or obligations under CLP. EU guidance suggests the non-EU company supplies the OR with a sample of the product, so that they become responsible for import and are therefore entitled to submit a notification.
What needs to be notified?
Notification is required for:
All substances subject to REACH Registration, whether they are hazardous or not. This includes isolated intermediates. Substances contained in articles and subject to registration under REACH Article 7 also need to be notified
Hazardous substances which are placed on the market, in quantities of less than 1 tonne per year. There is no minimum quantity threshold for notification, so notification will be required even if only a few grams are supplied.
Hazardous substances present in mixtures placed on the market, where the amount of the hazardous substance in the mixture is above the concentration limits specified in either CLP or the Dangerous Preparations Directive (CHIP in the UK) and which results in the classification of the mixture as hazardous. A useful table of these concentration limits is provided at the end of Practical Guide 7: How to notify substances to the classification and labelling inventory. Importers of mixtures which are classified as hazardous will therefore need to obtain sufficient information from their suppliers to understand which components of the mixture are hazardous and above the relevant concentration limits.
Placing on the market is defined as making a substance available either commercially or free of charge. For Importers, introducing a substance into the territory of the EU is also considered placing on the market, so notification is required even if the substance is imported for their own use.
Where a substance has been given a harmonised classification (i.e. in Annex VI of CLP), companies are still required to submit a notification for that substance, however, in this case the task is simplified as they must use the harmonised classification. Companies may however, identify additional hazards for a harmonised substance that has not been covered by the harmonised classification.
Notification is not required if the substance has already been registered, and the registration dossier includes the classification according to both the DSD and CLP. Where a NONS dossier has been transferred into REACH then the registrant will need to update their dossier with the CLP classification as soon as possible. Where a NONS dossier has not been transferred into REACH, e.g. because the tonnage is less that 1 tonne per year, then a notification will still be required.
Substances in the finished state and intended for the final user or for uses for which there is specific legislation in place, e.g. radioactive materials, medicinal products, cosmetic products and food and feeding stuffs are exempted from the requirement to notify.
Substances for R&D may also be exempted provided they are not placed on the market and are used under controlled conditions in accordance with Community workplace and environmental legislation. Companies wishing to take advantage of this exemption need to take care however with the definition of not placing on the market. Transfer of the substance between two different laboratories in a company is considered to be placing on the market if the two laboratories are part of different legal entities.
When?
Notification is required for the substances outlined above within 1 month of placing them on the market as from 1 Dec 2010. Substances already on the market should have been notified by 3rd January 2011. ECHA are advising that anyone who has missed this deadline should notify as soon as possible , or they may face enforcement action. Substances placed on the market for the first time after 1 December 2010 should be notified within 1 month of the placing on the market.
How can I submit a notification?
Notifications can be submitted either individually by companies, or together by a group of companies. Groups of companies submitting a notification will need to agree on a classification for their substance. The most straightforward groups will be those containing members of a SIEF who do not need to register until 2013 or 2018. Such groups already have the mechanisms in place to contact each other and agree a classification. However, CLP does not limit group notifications to SIEFs and other groups may also be created, for example members of a trade association, manufacturers and importers with tonnages below the REACH registration threshold, etc. Although the notification is submitted as a group, each member remains responsible for their own notification – if anything changes the individual company is still responsible for updating their notification. ECHA also recommends that groups document their agreement with the classification decision – depending on the size of the group, this could be by email, electronic survey, etc.
Notification needs to be made through the REACH-IT portal, so if a company does not already have a REACH-IT account the first step is to create one. The portal can be accessed at https://reach-it.echa.europa.eu/reach/public/welcome.faces
Companies then have several options for how to make their notification submission:
IUCLID 5 - Companies may want to use this tool if they are familiar with the system and/or are preparing a registration dossier for a later date. IUCLID 5 is the only way to submit a notification if you have more than one classification for a substance. For example, a metal in powdered form may have different hazards to the same substance in massive form, such as flammability. Substances with different compositions, for example a substance manufactured at several different sites with different impurity profiles, may also have more than one classification. Again IUCLID 5 must be used in such cases, as this tool can be used to store information on multiple compositions and the classification and labelling associated with each one. IUCLID 5 must also be used if you wish to claim confidentiality for a substance name.
Bulk Notification Tool - Allows you to create a submission file for multiple substances, which is useful if you have a lot of notifications to make. This tool is good for large companies who have some or all of the necessary information already stored in their in-house IT system. Two versions of the tool are available – a MS Excel based spreadsheet, or an XML schema for those with suitable IT expertise available. The Bulk Notification Tool can only be used for substances that have either an EC no or CAS no, and have only a single classification.
On-line notification tool – This tool aims to help SMEs through the notification process, especially where companies have only a few substances to notify, and are not familiar with IUCLID. The tool flows logically through the process and there are plenty of helpful tool tips and explanations to guide the user in completing the forms. A further benefit of the on-line notification system is that if there is a harmonised classification, or if someone else has already submitted a notification for the same substance, the user can simply say “I agree” with the one of the existing notifications and they will not have to fill out any further classification information. This will clearly ,make life much easier for companies with only small quantities and limited resources, however, it may result in a cat and mouse game of waiting for another company to make the first classification. The On-lineTool can only be used for substances that have only a single classification
Group Creator Tool - An MS Excel based is also available to help companies gather the necessary data from other companies who wish to join together with them to submit a group notification.
The Bulk Notification and Group Creator Tools can be downloaded from http://echa.europa.eu/clp/inventory_notification/tools_download_en.asp.
What information will I have to provide?
Whichever tool you use to submit your notification, you will need to provide at least the following information:
Companies must update their notification as soon as possible if new information becomes available, e.g. as part of the REACH process.
To give an idea of resources needed for notification, then assuming that all the necessary data and documents have been gathered and the classification of the substance determined, then the notification process takes approximately 10-20 minutes to complete using the on-line tool. This is a little longer than REACH pre-registration, but is by no means as scary as some have predicted. Assembling the necessary information is of course the hardest part, and will vary depending on the substance. For a common substance with a reasonable amount of data available then this will probably take an hour or two. For substances with a very large amount of data, or with very little data, then it may take considerably longer.
For importers, then there may be issues in gathering the necessary data on substance identification from overseas suppliers.
Further information
A detailed list of of available guidance can be found at http://echa.europa.eu/help/help_docs_en.asp. The most useful of these are :
This page last updated 17th February 2012.
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Denehurst Chemical Safety Ltd