Brussels, 13 February 2012
Classification and labelling Inventory - Questions and Answers
The CLP Regulation1 requires all importers and manufacturers of hazardous substances placed on the EU market to notify the classification and labelling of their substances to the European Chemicals Agency (ECHA). All substances on the EU market on 1 December 2010 should have been notified before the 3 January 2011 and new substances should be notified within one month of placing on the market. As of now, ECHA has received well over 3 million notifications for more than 100.000 substances and the database grows every day. Based on the information received, ECHA will maintain a Classification and Labelling (C&L) Inventory holding all the notified information and make certain elements of the database publicly accessible (the so-called Public C&L Inventory). The Inventory will also contain the information regarding classification and labelling submitted as part of registration dossiers under REACH. ECHA will extract the relevant information directly from the registration dossiers.
1. What is the Classification & Labelling Inventory and what can it be used for?
The Classification & Labelling (C&L) Inventory is a database which will contain classification and labelling information on substance notified under the CLP Regulation and registered under the REACH Regulation. It will also contain the list of legally binding harmonised classifications (Annex VI to the CLP Regulation). It will be established and maintained by ECHA.
The C&L Inventory serves multiple purposes:
It is a source of basic information on classified substances and on non-classified substances subject to registration which are placed on the market, for suppliers of substances, the general public, and Member State Competent Authorities;
It reveals differences in the classification and labelling of the same substance applied by different suppliers, thus pointing to the need for further discussion among companies to explore the reasons for differences and/or agree the most correct classification, evaluation needs or the need for legally binding harmonisation of a particular classification and labelling of a substance;
It is an important tool for hazard communication and risk management, e.g. when Member State Competent Authorities assess the need for potential authorisations and restrictions of hazardous substances under REACH.
2. What is the content of the Public Classification and Labelling (C&L) Inventory?
Article 42 of the CLP Regulation (CLP) stipulates that certain information in the Classification and Labelling Inventory should be publicly accessible. Article 119(1) of the REACH Regulation further defines those elements. From any notification of a substance classified in certain hazard classes referred to in Article 119(1)(a) of the REACH Regulation, the IUPAC2 name and classification and labelling will be published.
Flags in the Public C&L Inventory will also indicate whether the displayed classification and labelling is derived from a joint submission in the REACH registration process and in the future it will be flagged whether the displayed entry is an agreed entry between the notifiers as stipulated in Article 41 to CLP.
One main aim of the inventory is to promote uniform classification of substances. However, based on the experience from the past, it is to be expected that, initially, for many substances different classifications will have been notified. There can, however, be justified reasons to have different classifications for a seemingly single substance (see next question for further details).
3. Why are there differing classifications for the same substance?
There can be many different legitimate reasons for why notifications for the same substance have different classifications. Different compositions or impurity profiles often lead to different classifications and the physical state and form of a substance is often very important when the hazards of a substance are assessed. The Public C&L Inventory displays the notified state and form but does not contain any information on composition or impurities. And finally, technical errors made when notifying to the C&L Inventory can also lead to seemingly different classifications.
However, different notifiers can also disagree on the classification of a substance based on different interpretation of scientific studies or different access to those studies. In any case, notifiers have the legal obligation to make every effort to come to an agreed entry to be included in the inventory and inform ECHA accordingly (see Article 41 of the CLP Regulation). As the names of notifiers will not be publicly listed, ECHA will develop a specific tool to facilitate contacts among notifiers to discuss reasons for differences and, where feasible, agree on a uniform classification.
4. What is NOT in the Public C&L Inventory?
The Public C&L Inventory will not contain contact details of notifiers or registrants, as this is not foreseen in the CLP Regulation. In order not to disclose confidential business information, no detailed information on impurities or additives will be displayed in the Public C&L Inventory either. In addition, notifiers and registrants have the possibility to claim the IUPAC name confidential. If so, it will not be included in the Public C&L Inventory.
5. What did we have before the CLP Regulation?
Before the CLP Regulation the classification and labelling of dangerous substances was governed by the Dangerous Substances Directive3 and the Dangerous Preparations Directive4. The CLP Regulation replaces both Directives and aligns the criteria for classifying chemicals to the Globally Harmonised System (GHS) which intends to harmonise the criteria worldwide.
Under the previous legislation, companies classified by themselves the substances and mixtures they place on the market by using the criteria in the Directives. For around 3000 substances, the Commission and the Member States had laid down legally binding harmonised classifications. These principles have been maintained in the CLP Regulation.
The C&L Inventory is a new element compared to the previous situation, which will make it very transparent how companies classify by themselves the substances they place on the market. The Inventory will reveal where the same substances are classified differently – a situation that existed also previously under the former legislation but was less visible.
6. What happens if a chemical is not notified but marketed in the EU?
Manufacturers and importers who place a substance on the market in the EU without notifying its classification and labelling to ECHA are in breach of their obligations under the CLP Regulation. Enforcement is assured by Member States. In fact they have to introduce penalties and they shall take all measures to ensure the correct application of the CLP Regulation.
7. How can I search information in the Public C&L Inventory?
The Public C&L Inventory provides for multiple search options based on both substance identity and classifications. If one is interested in a particular substance or group of substances it can be searched using full or partial EC name, Annex VI name, IUPAC name or full or partial EC, CAS or Annex VI Index numbers.
For ease of use, the classifications have been separated into Physical, Health and Environmental Hazard classifications and the user can choose either the abbreviated Hazard Class and Category Codes (e.g. Acute Tox. 4) or the Hazard statement Code (e.g. H302).
8. Is it possible to download my search results?
For the first release of the Public C&L Inventory it is not possible to download the list of search results. However, ECHA is aware that this feature would be of added value for the users of the Inventory and therefore it is foreseen to make it available in a future version of the Public C&L Inventory.
9. Can you confirm that these details (molecular formula, structural formula, and molecular weight) will not be visible to the public when the substances are notified to the C&L Inventory?
ECHA does not publish information submitted with C&L notifications that goes beyond Article 119(1) of the REACH Regulation.
10. Can I rely on the classification and labelling information published in the Public C&L Inventory? For example, if the classification and labelling for one substance from various suppliers differ would the C&L Inventory inform me with the ‘correct’ classification for my substance?
The Public C&L Inventory will display the notified classifications as they are reported to ECHA. No verification on the content will be performed by the Agency. The notifications should therefore reflect the situation on the market. While notifiers have an obligation to undertake all efforts to come to an agreement on the classification for their substance, many may legitimately differ based on e.g. impurities or composition. This may not be immediately apparent in the Public C&L Inventory.
We encourage all users to discuss their concerns with their suppliers should they have any but there will be no single “correct” classification identified and highlighted by ECHA. However, the Public C&L Inventory will indicate where legally binding harmonised classification is included in Annex VI of the CLP Regulation and where the classification of a substance is the result of a joint registration under REACH.
11. How can companies get in touch with each other and when will they be able to do it? Would notifier(s) be put in touch with others if there is a disagreement over the classification?
In accordance with Article 41 of the CLP Regulation it is the responsibility of the registrant(s) and notifier(s) of the same substance to make every effort to come to an agreed entry. ECHA is developing a solution to allow notifying companies to get in contact with each other, so that they can start discussing different classification and labelling entries for the same substance.
12. Why is the harmonised list according to DSD criteria (Table 3.2 of Annex VI to CLP) not part of the Public C&L Inventory?
For technical reasons, the harmonised classifications according to the old Dangerous Substances Directive (DSD) could not be included in the first version of the Public C&L Inventory. These will be included as early as possible.
For more information:
Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.
International Union of Pure and Applied Chemistry