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Yes, substances notified under Directive 67/548/EEC (NONS) need to be classified, labelled and packaged in accordance with the CLP Regulation.
These substances are regarded as registered under the REACH Regulation. Therefore, their classification and labelling information must be included in the C&L Inventory. After a registration number has been claimed by the NONS notifier, the respective registration dossier must be updated with the CLP classifications without undue delay, and a separate notification to the Inventory is not required.
For NONS notified below one tonne under Directive 67/548/EEC and for which no tonnage band update has been done, a separate notification to the Inventory will have to be submitted if the substance is classified as hazardous and is placed on the market. So, if the annual volume of the NONS substance remains below one tonne, the company must submit a C&L notification. When the annual volume has reached or exceeds the one tonne threshold, an update in the form of a registration dossier is required.
No, it will not. Waste as defined in the Waste Framework Directive 2006/12/EC is outside the scope of CLP. Waste is any substance or object which the waste holder discards, or intends or is required to discard. This may be waste from households (e.g. newspapers or clothes, food, cans or bottles) or from professionals or industry (e.g. tyres, slag, window frames that are discarded).
As waste is not considered to be a substance, mixture or article under CLP, waste treatment operators are not considered as downstream users. At the same time waste treatment operators will not receive Safety Data Sheets on how to handle a substance or mixture during the waste phase. As long as residues from waste treatment operations are waste, i.e. they are disposed of (e.g. land-filled), they do not fall under the scope of CLP. However, residues which are recovered as substances or mixtures do fall under the scope of CLP.
Since Article 1(5)(e) of CLP only refers to food or feeding stuffs in the final state intended for the final user substances or mixtures used in food or feeding stuffs at any stage of production are not exempt from CLP and therefore must be classified, packaged, labelled and notified. For instance, the CLP Regulation applies to the manufacturer/supplier of a food additive (e.g. preservatives) who supplies the substance to another company that uses it in the production of food. In such a case, the chemical substance in the form in which it is supplied should not be regarded as a product being in the finished state intended for the final user, and the exemption stated in Art. 1(5)(e) CLP is not applicable (see also FAQ ID=179).
Quantities of substances used in R&D are by definition smaller than 1 tonne per year and are therefore not subject to registration under the REACH Regulation. If the substance used in R&D is hazardous and placed on the EU market, it, however, needs to be notified to the C&L inventory notwithstanding its volume.
According to Article 5(1) of the CLP Regulation, manufacturers, importers and downstream users shall identify the relevant information for the purpose of determining whether the substance entails a physical, health or environmental hazard.
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. If sufficient information is available to classify, and the substance is placed on the market, and hence when the notification to the C&L Inventory is necessary, the IUPAC name of substances used in R&D can be kept confidential as set out in the Practical Guide No 7: How to notify substances in the Classification and Labelling Inventory (see also Q&A 226, 227, 228). If further information becomes available that leads to a change of the classification, the C&L notification has to be updated (see also Q&A 224).
Yes, it is, under the conditions of CLP Article 39(b) and 40(1): where a substance is exempted from registration under REACH, CLP requires it to be notified to the C&L Inventory if it is classified as hazardous and is placed on the market either on its own or contained in a hazardous mixture above specified concentration limits.
Examples are hazardous substances that are recovered in the EU and that are exempted from registration under REACH Article 2(7)(d). Also, it should be noted that when substances covered in Annexes IV and V of REACH fulfil the criteria of classification they must be notified.
On the other hand, substances which are exempted from registration under REACH and which are not classified as hazardous and placed on the market do not have to be notified to the C&L Inventory.
Yes, they do. An active substance contained in a plant protection or a biocidal product counts as being registered under REACH under the conditions explained in REACH Article 15. However, where the respective dossiers do not contain the information required for notification in accordance with CLP Article 40, a separate notification to the C&L Inventory has to be made. This is because the update obligation for registration dossiers under REACH Article 22 does not apply to dossiers of active substances used in plant protection or biocidal products.
However, if the same substance has any non-biocidal or non-pesticidal use(s), a registration dossier in accordance with the provisions of REACH has to be submitted where the manufacture or import volume is equal to or above 1 tonne per year per manufacturer/importer for the total of these other uses. If the information required for a notification to the C&L Inventory has already been included in the registration dossier, a separate notification is not needed. If the registration dossier does not contain that information, it needs to be updated with the CLP information without undue delay.
No, they do not. In accordance with Article 3(5) of the REACH Regulation, a polymer is a substance. Importing a polymer does not correspond to the placing on the market of the monomers and any other substance from which the polymer substance originates. The C&L notification provisions for the import of a polymer can therefore only apply to the polymer substance itself.
It should be noted that any residual/unreacted monomers present in the composition of the polymer are considered as constituents of the polymer. Thus, as any other constituent, they should be taken into account for classification of the polymer.
A biocidal product has to comply with the classification, labelling and packaging requirements under the CLP Regulation and until 1 June 2015, Directive 1999/45/EC. This obligation is confirmed by Article 2(3)(e) and (m), and Article 69(1) of the Biocidal Products Regulation (EU) 528/2012 (BPR).
According to the BPR (Article 20(1)), the applicant for an authorisation of a biocidal product will have to provide a draft summary of biocidal product characteristics (SPC), taking into account the properties of the active substance(s) as well as any relevant co-formulant(s). As mandatory information, the SPC includes the hazard and precautionary statements (Article 22(2)(i) of BPR). Once authorisation is granted, the holder of the authorisation must ensure that the authorised product is classified, labelled and packaged in accordance with the approved SPC, as well as with the CLP Regulation and, until 1 June 2015, Directive 1999/45/EC (Article 69(1) of the BPR). In addition, authorised biocidal products are subject to specific label elements to ensure the effective communication of information on risks resulting from their use and risk management measures (Article 69(2)of the BPR).
When an authorisation holder wishes to change the label elements related to classification that are part of the authorisation of a product, i.e. hazard and precautionary statements, or is compelled by the CLP Regulation to do so, the change has to be notified to all the Member States in which the product is authorised or, where relevant, to ECHA (see Article 50(2) of the BPR and Commission Implementing Regulation (EU) No 354/2013 on changes of biocidal products. If the change leads to new hazard or precautionary statements, the authorisation needs to be updated to reflect this new condition.