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The following substances will have to be notified to the C&L Inventory, irrespective of their quantities:
- Substances which are subject to registration under REACH (= one tonne/year) and placed on the market. This includes substances on their own, substances contained in mixtures and certain substances contained in articles where REACH Article 7 provides for their registration. Notification of these substances is not necessary where a manufacturer, importer or Only Representative (OR) has already registered the substance with the classification and labelling according to CLP when its notification in line with CLP Article 40(1) is due. In particular, notification is not required of the importers covered by a registration that has already been done by an OR on their behalf. However, importers will have to notify a substance within one month of its placing on the market where the OR has not yet submitted the registration.
- Substances classified as hazardous under CLP and placed on the market irrespective of tonnage. This includes substances which are classified as hazardous under CLP, but which are exempted from registration, e.g. polymers referred to in REACH Article 6(3); and
- Substances classified as hazardous under CLP and present in a mixture above the concentration limits specified in Annex I to CLP, which results in the classification of the mixture as hazardous, and where the mixture is placed on the market.
According to CLP Article 40, only manufacturers of substances and importers of substances or mixtures have the obligation to notify. Therefore, it is only the importer who has to notify a substance contained in a mixture to the Inventory, where the substance is hazardous or subject to registration.
No, according to Article 39(b) of the CLP Regulation, the requirement for notification to the Inventory includes all hazardous substances within the scope of CLP, either on their own or contained in a mixture above legally defined concentration limits, and which are imported or manufactured and placed on the market within the EU. In other words: the requirement for notification goes beyond substances manufactured or imported in quantities of one tonne or more per year.
Yes, it is. Article 39(a) of CLP states that "substances subject to registration in accordance with Regulation (EC) No 1907/2006" fall within the scope of the C&L Inventory when they are placed on the market. Therefore, this applies to substances subject to registration under REACH and placed on the market, regardless of whether they are hazardous or not. Where a substance is not classified, the "not classified" option should be selected in IUCLID 6 dossier, or in REACH-IT C&L on-line wizard when notifying it to the Inventory.
However, if the substance is not subject to registration and does not meet the criteria for classification as hazardous there is no notification obligation. It is noted that where a substance has not yet been registered, the registrant/notifier should notify according to the provision of CLP Article 40(3) since notification is independent from the registration deadlines (see also FAQ ID = 209). Note also that if a company has already submitted a registration dossier for the substance including the classification and labelling in accordance with CLP, the same company does not have to submit a separate notification to the C&L Inventory.
The deadline for notification to the Inventory is one month after a substance has been placed on the market.
The one-month period has to be calculated from the date a substance is placed on the market. This also applies to substances which had been placed on the market before 1 December 2010, but which were not placed on the market on 1 December 2010, but only again afterwards.
For example, you as manufacturer or importer placed a substance on the market on 8 November 2010, then you stopped for a while, and later resumed your activity on 1 February 2011. In this case, the obligatory one month notification deadline fell one month after the resumed activity and your notification was due on 1 March 2011.
No, it is not. The term "group" is not defined under the CLP Regulation, in particular it does not equate to a Substance Information Exchange Forum as defined under REACH. Nevertheless, SIEF members can decide to notify to the C&L Inventory as a group. The identity of each member of the group should be specified in the notification.
Under Directive 67/548/EEC, notification was related to new substances. The notification process referred to was the submission of a dossier containing relevant information on a new substance (i.e. a substance placed on the market in the EU after 18 September 1981) to the competent authority of a Member State. The amount of information required depended on the quantity in which the substance was placed on the market. The notification requirement for new substances under Directive 67/548/EEC was replaced by the registration requirement under REACH after its entry into force.
The use of the term "notification" under REACH refers to three different obligations:
- the obligation to provide basic information to the Agency on substances in articles, under Article 7(2).
- the obligation to provide basic information to the Agency on those substances that are exempted from registration for five years because they are manufactured or imported for the purpose of product- and process-orientated research and development, under Article 9(2).
- the obligation for downstream users to inform the Agency when using a substance that is on the Authorisation List (Annex XIV to REACH) based on an authorisation granted to an applicant up their supply chain, under Article 66(1).
Finally, "notification" under CLP relates to the C&L Inventory established by the Agency. Manufacturers and importers are required to submit information on the classification and labelling of substances placed on the market to the Inventory, regardless of their quantities, in accordance with CLP Article 40. The Inventory is a database that was originally introduced by the REACH Regulation; it did not exist under the previous legislation.
Yes, it is. Notification is independent from the REACH registration deadlines. A substance, either on its own or contained in a mixture, must be notified to the C&L Inventory within one month of the first time the company is placing it on the market. Notification can be done using any of the notification tools available at: http://echa.europa.eu/support/dossier-submission-tools/reach-it/notification-to-the-cl-inventory
By definition, a solution composed of two or more substances is a mixture, see CLP Article 2(8) and REACH Article 3(2).
Therefore, substances contained in aqueous solutions should be notified to the C&L Inventory under the conditions of CLP Article 39(a) or (b) when they are placed on the market.
However, certain diluted acids and bases may be listed with the notation "%" in Annex VI to CLP. Such entries are treated as substances and should be notified as such to the C&L Inventory under the conditions of CLP Article 39(b) when they are placed on the market. In these cases, the harmonised entry as listed in Annex VI and any self-classifications for the hazard classes or differentiations not covered by this entry, if applicable, should be notified.
Yes, he does; substances listed in Annex VI have to be notified in accordance with CLP Article 40 if placed on the EU market. Where a particular hazard class or differentiation is harmonised through Annex VI, this classification has to be used when notifying the substance. It is noted that for substances with a minimum classification in Annex VI, the notifier must classify in a more severe hazard category where he has further information which shows that this is more appropriate (see also QnA 260).
For non-harmonised hazard classes or differentiations of substances listed in Annex VI to CLP, the manufacturer or importer should self-classify the substance and introduce the resulting classification and labelling in his notification to the C&L Inventory, according to Article 4(3) of CLP. In case he concludes that the substance should not be classified for these hazard classes or differentiations, the reason should be given in accordance with Article 40 (1) (d) of CLP.
Where a notifier proposes to apply a different non-harmonised classification and labelling for a substance than that which has already been submitted to the Inventory by another actor, the notifier has to provide a reason for his classification as part of his notification to the Inventory.
Yes, it is. On the C&L Inventory differing classifications for the same substance can have different reasons, e.g. different impurity profiles. In other cases, notifiers or registrants may have reached a different classification for the same substance due to interpretation differences in the process of evaluation of available data or in the application of the classification rules for CLP.
However, Article 41 of CLP requires notifiers and registrants to make every effort to come to an agreed entry for the same substance, unless a justification (e.g. impurity profile) can be provided for deviating classifications.
Pursuant to CLP Article 40(1)(f), a notification to the C&L Inventory should include the applicable CLP hazard pictograms, signal words and hazard statements as well as any supplemental hazard statements set out in sections 1.1 and 1.2 of Annex II to CLP or provided in Part 3 of Annex VI to CLP.
For a registration, the same CLP labelling elements as for a notification to the Inventory should be given. In addition, the registrant is requested to provide the relevant precautionary statements. When considering all identified uses covered in the registration dossier, more than six precautionary statements may be necessary to reflect the nature and the severity of the hazards. This reflects the provisions of Section 4 of Annex VI to REACH as amended by CLP Article 58(11).
CLP Article 28(3) states that not more than six precautionary statements shall be given on the label, unless necessary to reflect the nature and the severity of the hazards. Since for many hazardous substances, the number of precautionary statements that can be assigned based on the classification of the substance will exceed the specified number of six statements, the manufacturer or importer will have to select them from those set out in the tables in Annex IV to CLP, in line with CLP Articles 22 and 28.
No, he does not. The submission of a notification to the C&L Inventory is free of charge. Similarly, there are no fees for an update or transfer of the notification.
Yes, it would. As both subsidiaries are separate legal entities, each legal entity would have to notify the substance separately if in both cases it meets the criteria for notification in accordance with Articles 39(a) or (b) and 40(1) of CLP. Alternatively, both subsidiaries (as legal entities) may prefer to notify as a group of manufacturers. See also Q&A 29.
No, according to CLP Article 39(b), the requirement of notification to the C&L Inventory includes all hazardous substances within the scope of CLP, either on their own or contained in a hazardous mixture above defined concentration limits, and which are imported or manufactured and placed on the market within the EU. In other words, the requirement for notification applies irrespective of the tonnage manufactured or imported per year.
When preparing for the REACH registration of substances which have previously been only used for R&D purposes in amounts below one tonne per year used under strictly controlled conditions, potential registrants must collect available data, determine if relevant existing information is in line with Annex XI to the REACH Regulation and develop a testing programme. During this period, there is a high likelihood that the classification of the substance will change.
Article 15(1) of the CLP Regulation obliges manufacturers, importers and downstream users to assess new information "without undue delay". Article 40(2) of the CLP Regulation further requires C&L notifiers to update their C&L notification "when, ---, a decision to change the classification has been taken".
ECHA recommends that the potential registrant carefully considers, on a case-by-case basis, when to update the C&L notification. Factors to be taken into consideration could, for instance, be additional time needed until the registration dossier is submitted, potential impact on the safe uses of the substance and practical consequences of revising the safety data sheet and labels. Companies should also keep all documentation available and consult the relevant authorities of their Member State.
No, it is not. Manufacturers and importers who flag confidentiality of the IUPAC name for a substance referred to by REACH Article 119(2)(f) and (g) do not have to pay a fee when notifying it to the Classification and Labelling Inventory.
Placing a substance or mixture on the market under CLP means supplying or making the substance or mixture available to third parties, whether in return for payment or free of charge within the territory of the EU Member States and those EEA countries which have implemented the CLP Regulation.
In addition, import is deemed to be placing on the market and is defined as the physical introduction of a substance or mixture into the customs territory of the EU and those EEA countries which have implemented the CLP Regulation.
In relation to notification, placing on the market is a pre-condition. Substances which are referred to in CLP Article 39 have to be notified to the C&L Inventory if they are placed on the market. However, no notification is required if the information mentioned under CLP Article 40 has already been provided as part of a previous registration or notification by the same notifier.
The notification deadline is dependent on the date on which the substance is placed on the market. When a substance is placed on the market it must be notified to the C&L Inventory within one month.
In relation to import, the one-month timeline is counted from the day when the substance or mixture is physically introduced into the customs territory of the EU Member States and those EEA countries which have implemented the CLP Regulation.
According to CLP Article 40 (3), substances placed on the market on or after 1 December 2010 must be notified within one month after their placing on the market. In addition, CLP Article 4 (1) stipulates that the manufacturer or importer must classify their substances in accordance with Title II of CLP before placing them on the market.
Furthermore, CLP Article 8 (2) requires that for the purposes of determining whether a substance entails any of the physical hazards referred to in Part 2 of Annex I to CLP, the manufacturer or importer must perform the tests required in that Part, to allow classification of the substance, unless adequate and reliable information is already available.
Therefore, manufacturers and importers are required to perform physical hazard testing so as to classify their substances not included in Annex VI to CLP, or included but not classified for a specific physical hazard, and to notify this classification to ECHA within one month after their placing on the market.
However, substances may be placed on the market in very small quantities only (e.g. the quantity of a substance used in R&D (Research and Development)). These quantities may not be sufficient for the testing of physical hazards. When there is no adequate and reliable information already available on the physical hazards of these substances, it may not be feasible and/or proportionate for the manufacturer or importer to perform the tests required in Part 2 of Annex I to CLP. In those cases physical hazard testing should not be required. Nevertheless, every effort should be made to assess the physical hazards using any available theoretical methods e.g. UN test methods screening tests, along with expert judgment, and the most severe of the resulting classifications should be applied. Finally, as it is explained in FAQ ID=186 for R&D substances in particular, if neither test data are available nor any other adequate information indicates that a substance should be classified, a notification to the C&L Inventory is not required.
No, they are not. When a substance is present in a mixture, and the importer does not know whether it has been added as a substance as such or whether it is a constituent (additive/impurity) of a substance in the mixture, then that component must be notified if it meets the criteria in Article 39 of CLP. However, when the importer of a mixture has information that a substance present in the mixture is a constituent (additive/impurity) of another substance in the mixture, then the fields on impurities and additives can be filled in.
ECHA's REACH-IT system will offer the possibility of creating a group of manufacturers or importers (hereinafter referred to as "M/I Group"), in accordance with CLP Article 40(1). The concept "Group of MI" is not further defined in the CLP. Such a group can, for example, be a corporate company with different legal entities or a SIEF. It is nevertheless important that the members of an M/I Group are all manufacturers or Importers.
When an M/I Group notification is submitted in REACH-IT, the identity of each member should be specified in the notification by indicating the name of the M/I Group at the time of dossier submission. If the membership of the M/I Group is updated by adding a new member, then the new member will automatically be considered as having submitted the notification(s). It is noted that updating a notification made by an M/I Group is possible only by the group leader who has carried out the M/I Group notification. The group leader shall be careful to indicate the name of the M/I Group every time he is updating the notification (otherwise the updated notification will be considered as having been made on behalf of the group leader only).
It is stressed that if the group leader who has carried out the M/I Group notification submits a registration dossier for the same substance, the group is removed from the notification and the other group members are obliged to notify again. For this purpose, one of the M/I Group members has to create an ECHA account in order to become the new group leader. The original group leader can make a legal entity transfer of the notification to another member of the group before or after he submits his registration. A legal entity transfer warrants that the group notification is retained in the REACH-IT.
The confidentiality flag of the IUPAC name should be flagged when creating an online or IUCLID C&L notification.
- set a confidentiality flag for the IUPAC name of the substance by ticking the appropriate box;
- attach a justification, including a clear indication whether the substance ranks among those referred to by REACH Article 119(2)(f) and (g), and
- introduce an alternative name which would be disseminated on the public part of the
Inventory instead of the IUPAC name. To derive an alternative name, he should apply the rules set out in Part B of Annex VI to Directive 1999/45/EC (Dangerous Preparations Directive).
Notifiers are requested to provide all three elements for flagging confidentiality.