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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.
Substances or mixtures intended for use in cosmetic products, but which are not yet in the finished state or intended for the final user, are covered by the provisions of CLP. Therefore, the suppliers of these products must classify, label and package them accordingly.
Furthermore, these manufacturers or importers are obliged to notify the relevant substances in line with the provisions on notification to the C&L Inventory, unless they have already registered the substance under REACH.
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.
According to Article 1(5)(e) of CLP, the CLP Regulation does not apply to food, as defined in Regulation (EC) No 178/2002 (Food Safety Regulation), which is in the finished state intended for the final user.
The CLP Regulation does not define the term 'intended for final user', but Regulation (EC) No 178/2002 defines 'final consumer' as 'the ultimate consumer of a foodstuff who will not use the food as part of any food business operation or activity'. The same concept can be applied in the context of CLP, i.e. intended for the final user should be read as intended for the 'ultimate consumer of a foodstuff who will not use the food as part of any food business operation or activity'. This also applies to the use of a substance or a mixture
- as a food additive in foodstuffs within the scope of Directive 89/107/EEC,
- as a flavouring in foodstuffs within the scope of Directive 88/388/EEC and Decision 1999/217/EC.
Since Article 1(5)(e) of CLP only refers to food in the finished state, intended for the final user, substances or mixtures used in food 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. preservative) 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).
According to Article 1(5)(e) of CLP, the CLP Regulation does not apply to feedingstuffs within the scope of Regulation (EC) No 178/2002 (Food Safety Regulation), which are in the finished state, intended for the final user, including when they are used:
- as an additive in feedingstuffs within the scope of Regulation (EC) No 1831/2003;
- in animal nutrition within the scope of Directive 82/471/EEC.
It is important to note that the conditions 'in the finished state' and 'intended for the final user' must both be fulfilled at the same time, otherwise CLP applies.
The terms 'finished state' and 'intended for final user' are not defined in CLP. The CLP definition of 'use' includes 'consumption', which would mean that a consumer qualifies as a user. Drawing a parallel between the term 'final user' in CLP and the definition 'final consumer of foodstuff'* in Regulation (EC) No 178/2002, feedingstuff can only be considered to be 'intended for the final user', if it is ready for direct oral feeding to animals.
In accordance with Article 2(a) and Article 2(e) of Regulation (EC) No 1831/2003 (Regulation on additives for use in animal nutrition), neither feed additives nor premixtures can be used directly to feed animals. They do not fulfil the condition of 'intended for the final user', since they require the additional activity of mixing/processing before being used by the ultimate consumer (animals). Therefore, CLP applies to all additives and premixtures, including those authorised, labelled and packaged in accordance with Regulation 1831/2003.
Feeding stuffs 'intended to be used by the final users' (animals), i.e. to be fed directly to animals, such as feed material or compound feedingstuffs are exempted from the scope of CLP, provided they are in the finished state. This includes both complete and complementary feedingstuffs - where the latter (although not sufficient for a daily ration) could be directly fed to animals and would thus also be exempted from CLP.
*Intended for the final user should be read as intended for the 'ultimate consumer of a foodstuff who will not use the food as part of any food business operation or activity'.
The obligations under CLP apply to any hazardous substance or mixture that is not regulated by product-specific EU legislation with more specific rules on classification and labelling.
Pure essential oils are placed on the market for several different uses. They may, for example, be intended for use as a cosmetic product. The intended use will determine whether a particular product is subject to product-specific legislation.
For instance, if a pure essential oil falls under the definition of a cosmetic product*, the product also has to fulfil all the requirements of the Cosmetic Products Regulation (CPR, Regulation No 1223/2009).
A cosmetic product is excluded from the scope of CLP if all of the following three conditions are cumulatively met:
- The product falls within the definition of a cosmetic product according to the CPR. If the CPR applies, all requirements set out in that regulation have to be fulfilled, otherwise the cosmetic product will be considered as incompliant. This means that, among other things, the cosmetic product must have been assessed and notified as defined in Article 10 and Article 13 of the CPR, respectively, as well as be fully labelled in accordance with the regulation with the appropriate label information and instructions for use.
- At the moment of placing on the market, the product is intended for the end user, i.e. either a consumer or professional ultimately using the cosmetic product.
- The product is in the finished state, i.e., its final formulation, as placed on the market and made available to the end user.
In fulfilling all of the above, the cosmetic product would be meeting the conditions for exemption provided in Article 1(5) of CLP, i.e., being in the finished state and intended for the final user.
The obligation to label an essential oil in accordance with CLP applies unless the product is outside the scope of CLP. To be outside the scope of CLP, the product must be covered by any of the product-specific pieces of legislation specified in Article 1(5) of CLP, must have undergone the processes defined in the relevant regulation or directive, and at the moment of the placing on the market must be in its finished state and intended for the final user.
*Definition of ‘cosmetic product’, Article 2(1)(a) of the CPR: "Any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours."