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CLP

Scope and exemptions under CLP

Will radioactive substances and mixtures have to be classified or notified under CLP?
No, they will not.Radioactive substances and mixtures within the scope of Directive 96/29/Euratom are exempted from the scope of CLP. The reason for the exemption is that this legislation already lays down provisions for the protection of workers and the general public arising from ionising radiation, so there is no need to apply CLP in addition.
Will a non-isolated intermediate have to be classified and notified under CLP?
No, it will not. As long as an intermediate falls under the definition of REACH Article 3(15)(a) concerning non-isolated intermediates, it is exempted from any obligations under CLP.It must be noted, however, that quantities of the same substance may be used in other operations or under other conditions than mentioned in this definition, which would imply that those quantities cannot be regarded as "non-isolated intermediate", but rather as a substance that may be placed on the market. Only the quantities of the substance used under the conditions qualifying it as a "non-isolated intermediate" are exempted from CLP. For the remaining quantities, the relevant requirements under CLP must be fulfilled.
Do "new" substances notified under Directive 67/548/EEC (NONS) have to be classified, packaged and labelled in accordance with the CLP criteria and notified to the Classification and Labelling Inventory?

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. 

Will waste have to be classified and notified to the Classification and Labelling Inventory?

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.

Will medicinal products need to be classified and notified to the Classification and Labelling Inventory?
Substances and mixtures which are in the finished state and intended for the final user and which are medicinal products within the scope of Directive 2001/83/EC on the Community code for medicinal products for human use, or veterinary medicinal products within the scope of Directive 2001/82/EC on the Community code relating to veterinary medicinal products are on the whole exempted from the provisions of the CLP Regulation, i.e. they do not have to be classified, packaged, labelled and notified to the C&L Inventory.
 
However, in cases where a manufacturer or importer supplies substances and mixtures, e.g. active pharmaceutical ingredients (APIs) or excipients, that are not yet in the finished state, this manufacturer or importer will have to classify, package and label these substances and mixtures in accordance with CLP. In addition, if these substances are placed on the market, they will also have to be notified to the C&L Inventory.
 
The exemption from the provisions of the CLP Regulation does not distinguish between active and non-active pharmaceutical ingredients: it applies to any substance or mixture used in medicinal products, e.g. excipients, which is in the finished state and intended for pharmaceutical use.
Are medicine tablets in a drum being sent to the EU for packaging considered to be "in the finished state and intended for the final user" and therefore exempted from Article 1(5)a of the CLP Regulation?
Yes they are. According to Directive 2001/83/EC on the Community code for medicinal products for human use, medicine tablets are medicinal products and exempted from the provisions of the CLP Regulation if they are in the finished state. The finished state of the medicinal product relates to the substance or mixture and not to its package since re-packing the tablets does not alter the substance/mixture.Bulk tablets that will not be altered after having been produced are therefore considered in the finished state intended for the final user. Therefore, it is neither necessary to classify, label and package these bulk tablets according to CLP nor to notify them to the C&L inventory.
 
However, it will be necessary to take worker health and safety considerations into account to ensure the safe handling of these bulk tablets during the transfer and packaging stages, until they reach the final user in the appropriate package with appropriate safe use instructions.
Will medical devices need to be classified and notified to the Classification and Labelling Inventory?
Substances and mixtures which are medical devices as defined in Directives 90/385/EEC and 93/42/EEC and which are invasive or used in direct physical contact with the human body, as well as those covered by Directive 98/79/EC, are exempted from the provisions of CLP on the whole if they are in the finished state and intended for the final user:
- Substances and mixtures covered by Directive 90/385/EEC that are invasive or used in direct physical contact with the human body would include cochlear implants, implantable cardiac pacemakers, implantable defibrillators and implantable nerve stimulators,
- Substances and mixtures covered by Directive 93/42/EEC that are invasive or used in direct physical contact with the human body would include sutures, catheters, stents, balloon catheters and wound dressings and
- Substances and mixtures covered by Directive 98/79/EEC would include reagents for diagnostic of Hepatitis C and HIV, self-diagnosis devices for the measurement of blood sugar and IVD Analysers.
 
As the substances and mixtures mentioned above are exempted from the provisions of CLP, they do not need to be classified, packaged, labelled and notified to the C&L Inventory. However, for substances that are manufactured or imported in volumes of at least 1 tonne per year, either on their own or contained in a mixture, the obligation to classify (but not label, package and notify) may still arise from REACH because such substances would have to be registered.
Will cosmetic products have to be classified and notified to the Classification and Labelling Inventory?
Similarly to other exempted substances and mixtures referred to in CLP Article 1.5 which are in the finished state and intended for the final user, substances and mixtures in the form of cosmetic products as defined in Directive 76/768/EEC on the whole are exempted from the provisions of CLP. However, for substances that are manufactured or imported in volumes of at least 1 tonne per year, either on their own or contained in a mixture, the obligation to classify (but not label, package and notify) may still arise from REACH because such substances would have to be registered.
 
Note that a manufacturer, importer or downstream user (formulator) who supplies a substance or mixture which is not yet in the finished state is obliged to classify, package and label it in accordance with CLP. Furthermore, a manufacturer or importer is obliged to notify the relevant substances in line with the provisions on notification to the C&L Inventory.
Will food and feeding stuffs have to be classified, labelled and packaged according to CLP, and their substances notified to the Classification and Labelling Inventory?
According to Article 1(5)(e) of CLP, the CLP Regulation does not apply to food and feeding stuffs, as defined in Regulation (EC) No 178/2002 (Food Safety Regulation), and which are in the finished state intended for the final user. The CLP Regulation does not define the term "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. 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,
- as an additive in feeding stuffs within the scope of Regulation (EC) No 1831/2003 or
- in animal nutrition within the scope of Directive 82/471/EEC.
 

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).

Do I have to notify explosive articles to the Classification & Labelling Inventory?
If you are a manufacturer or importer of an explosive substance (explosive according to the CLP criteria) that will be incorporated into an article at a later stage you do need to notify that substance. However, you do not have to notify explosive articles.
Must the classification and labelling of polymers be notified to the Inventory?
A polymer is a substance and must be notified on the basis of Article 39(b) and 40(1) of the CLP Regulation if it fulfils the criteria for classification as hazardous and it is placed on the market.
Will substances and mixtures used in scientific research & development have to be classified and notified under CLP?
Both substances and mixtures used in scientific experimentation, analysis or chemical research are exempted from the obligations of CLP as a whole, provided they are not placed on the market and they are used under controlled conditions in accordance with Community workplace and environmental legislation. However, as soon as substances and mixtures used in scientific research & development (R&D) are physically made available or supplied to another legal entity, for example by sending samples from a university to another research institute or by importing such samples, this is considered as "placing on the market" (see CLP Article 2(18)). In this case CLP requires the supplier or importer to classify according to the available information, to label and package the sample of a hazardous substance or mixture according to CLP and to notify to the C&L Inventory the substance(s) contained therein if it/they meet(s) the criteria for classification as hazardous on the basis of available information.
Should companies notify substances used in the early stages of scientific research & development (R&D) to the C&L inventory?

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).

Is it necessary to notify substances to the C&L Inventory that are exempted from registration under REACH?

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.

Will alloys have to be classified, labelled and notified under CLP?
Alloys are considered as special mixtures under the REACH and CLP Regulations. Alloys as well as their components need to be classified and labelled in accordance with CLP. The components of an alloy will have to be notified if they are hazardous and contained in an alloy above specified concentration limits, in accordance with CLP Article 39(b).
 
In relation to classification for the aquatic hazard class, Annex IV, section 5.5- 'Classification of mixtures of metal compounds' of the Guidance on the Application of the CLP Criteria notes that metal alloys, or alloy manufacturing products, are not simple mixtures of metals or metal components, since the alloy clearly has distinctive properties compared to a classical mixture of its component metals. 
 
Regarding labelling, point 1.3.4 of Annex I to CLP provides that metals in the massive form, as well as alloys, do not require a label if they do not present a hazard to human health by inhalation, ingestion or contact with skin or to the aquatic environment in the form in which they are placed on the market, although classified as hazardous in accordance with the classification criteria of CLP. However, the supplier shall provide the information on the classification of an alloy to downstream users or distributors by means of the Safety Data Sheet. 
 
According to point 2.7 of Annex II to CLP, special labelling rules apply to alloys containing cadmium and which are intended to be used for brazing or soldering.  They shall bear the following statement: "Warning! Contains cadmium. Dangerous fumes are formed during use. See information supplied by the manufacturer. Comply with the safety instructions." (EUH207).
Do active substances contained in plant protection or biocidal products have to be classified in accordance with CLP?
Yes, they do. Active substances contained in plant protection or biocidal products have to be classified according to the CLP criteria as of 1 December 2010. In contrast to other substances supplied and used in the industrial supply chain, all hazard classifications of these substances will normally be harmonised at the EU level. The harmonised classifications appear in Tables 3.1 and 3.2 of Annex VI to CLP. However, where new information is available which may lead to a change of the harmonised classification, the procedure for harmonisation of classification and labelling of substances shall apply in accordance with Articles 36 (2) and 37 (1), (4), (5) and (6). It is also noted that the requirement for self-classification for hazard-classes and differentiations not covered by the harmonised classification as provided for in Article 4 (3) equally applies to plant protection or biocidal products.
Do active substances contained in plant protection products and biocidal products have to be notified to the Classification and Labelling 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.

Do the monomers and any other substance used for the manufacturing of a polymer have to be notified to the Classification and labelling Inventory by the importer of the polymer?

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.

Are substances occurring in nature exempted from CLP?
A number of substances and mixtures are exempt from the requirements of CLP in accordance with CLP Article 1. Substances occurring in nature, as defined in Article 3(39) of REACH, are not explicitly included in these exemptions. If substances occurring in nature are placed on the market in a form not listed in Article 1(5) of CLP, which are in the finished state and intended for the final user, they should be classified, labelled and packaged in accordance with CLP.
What are the classification, labelling and packaging requirements for a biocidal product?

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.

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