This page provides more information on requirements to notify classification and labelling information to ECHA in the EU/EEA, or to the HSE in Great Britain.
The Classification and Labelling (C&L) Inventory was first introduced in 2006 by the REACH Regulation, with the intention to provide a central source of information on the classification and labelling of chemicals. In 2008, the provisions for the Inventory were moved to the new CLP Regulation, however the requirements remain unchanged. The publicly available version of the Inventory includes information on:
- Substance name(s) and identity number(s)
- Classification and labelling
- Any relevant specific concentration limit or M-factor
- If it is a harmonised classification
- If it is an agreed entry between manufacturers or importers
The identities of the notifying companies are not included.
This information is of great interest to downstream users and other interested parties. One of the expected consequences of publishing the C&L Inventory is that it will put pressure on Manufacturers and Importers to work more closely together to agree, whenever possible, a single classification for a substance. Where a single classification has not been agreed, then customers will be asking their suppliers for an explanation. Of course, in some cases, different classifications will be justified, for example where an impurity or a stabilizer affects the classification, or where different physical forms of the substance have an effect on the properties of the substance.
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, including formulators, 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. If, for confidentiality reasons, the non-EU company doesn’t want to share this information with all 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. Where an OR submits the notification on behalf of a group of Importers, similar arrangements should be in place between the OR and the Importer as for REACH Registration, i.e., there should be some sort of written acceptance that the OR is doing this on behalf of the Importer, a record of what information has been submitted on their behalf, and acknowledgement that the Importer remains legally responsible for keeping the notified classification and labelling up to date.
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 CLP and which results in the classification of the mixture as hazardous. 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 are still responsible however for classifying any endpoints not 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 CLP.
Substances in the finished stateand 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.
How?
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. 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 – 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 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. IUCLID 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 must also be used if a company wishes to claim confidentiality of the IUPAC name, as such a claim requires a justification to be prepared and appended to the notification.
- 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. The on-line tool can only be used for substances that have a single classification.
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:
- Your identity – Company details, contact details for a suitable person in the company, the company’s UUID in REACH-IT. If making a group notification, then this information will be required for each company in the group. This can be collected off-line using the Group Creator spreadsheet, and then uploaded, or the details for each company can be entered individually in the on-line tool.
- Substance identity – sufficient information needs to be provided to identify the substance. This includes the information identified in REACH Annex VI 2.1- 2.3.4. Analytical information is not required. Not all of this information may be available, and the minimum requirement is for the IUPAC name and the concentration range of the substance. Information on optical activity of the substance, if any, is also required.
- Classification – either a classification decision or a reason for not classifying must be recorded against each of the classification end points. In IUCLID and the On-line tool, the default value “data lacking” is set for each end point. Other options are “inconclusive” where there is data but it is not sufficient to allow a classification decision to be made and the slightly oddly phrased “conclusive but not sufficient for classification” which means that there is sufficient data to decide that the substance is not classified as hazardous for that particular end point.
- Specific concentration limits and/or M-factors. If these are added, then unless they have been set as part of a harmonised classification, a document giving a scientific justification for these values needs to be provided. It is recommended that this is provided using the relevant parts of the CSR template.
- Precautionary Statements may be provided but are optional.
- Any Supplemental Hazard Statements (EUH) if these are assigned.
Companies must update their notification as soon as possible if new information becomes available, e.g. as part of the REACH process, that changes the classification.
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 minutes to complete using the on-line tool. 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, there may be issues in gathering the necessary data on substance identification and/or mixture composition from overseas suppliers.
GB Notification requirements
Since the UK left the EU, GB Manufacturers and Importers need to make their notifications to the HSE, acting as the GB CLP Agency, instead of to ECHA. NI based suppliers placing Qualifying NI Goods (QNIG) also need to make notifications.
The requirement for what needs to be notified, when, and what information needs to be provided are the same as for the EU, since the GB requirements are based on the EU Regulation which was transferred into UK law. The main difference is that instead of making a submission through the ECHA REACH-IT system, an online web form is used to make the submission.
In order to reduce the burden on suppliers, UK based companies who had already made a notification to ECHA before the UK left the EU on 31 Dec 2020, or who were part of an EU supply chain where a notification had been made before this date, do not need to make a submission to the HSE, unless the classification of the substance changes, or a new supply chain is established.
Further information
A detailed list of available guidance can be found at http://echa.europa.eu/support/guidance. The most useful of these are :
Details of how to make a GB CLP Notification can be found at https://www.hse.gov.uk/chemical-classification/what-to-do/submit-notification.htm.