The European Commission issues Adaptations to Technical Progress (ATPs) to the CLP Regulation, which provide updates to the harmonised classification and labelling in Table 3.1 of Annex VI to CLP. The updated version of this table is included in the Classification and Labelling Inventory managed by ECHA.
ECHA has prepared an unofficial excel table containing all updates to the harmonised classification and labelling in Table 3.1 of Annex VI to CLP (http://echa.europa.eu/information-on-chemicals/annex-vi-to-clp).
The table should be used for informative purposes only as it could contain inconsistencies with the legally-binding entries in Annex VI to CLP as published in the Official Journal of the European Union (http://echa.europa.eu/regulations/clp/legislation).
In order to take full account of the work and experience accumulated under DSD, all previously harmonised DSD substance classifications were translated into harmonised CLP classifications. For substances with harmonised classifications for the hazard classes acute toxicity and STOT (repeated exposure), minimum classifications were assigned. These minimum classifications take account of the fact that the exact translation of the DSD criteria into the CLP criteria was not possible, based on the lack of available data.
Manufacturers or importers must apply at least this minimum classification (marked with an asterisk), but must classify in a more severe hazard category when they have further information, e.g. in the form of an LD50 value, which shows that a more severe category is more appropriate.
Yes. A manufacturer, importer or downstream user can submit a proposal to introduce additional harmonised classification and labelling elements to an entry in Part 3 of Annex VI to CLP directly to the Agency. A condition for submitting such a proposal is that the additional harmonised classification and labelling elements concern a hazard class or differentiation not yet covered by the harmonised classification of the substance in Part 3 of Annex VI. The procedure is described in Article 37(2) of CLP.
Where a change to the existing harmonised classification and labelling elements of a substance in Part 3 of Annex VI to CLP is proposed, the manufacturer, importer or downstream user must submit the proposal to a competent authority of a Member State in which the substance is placed on the market (Article 37(6)).
When a manufacturer, importer or downstream user has new information which may lead to a change of the existing harmonised classification and labelling of substances regulated under the Biocidal Products Regulation (EU) 528/2012 (the BPR) or under Regulation (EC) No 1107/2009 on plant protection products (the PPPR), they must act according to Article 37(6) CLP.
As harmonised classifications in Annex VI are binding for the endpoints covered in the entry (except the minimum classifications (section 1.2 in Annex VI to CLP) indicated by the reference * in Table 3.1), it is not possible to use a different classification and labelling from a harmonised one until an ATP amending it has been published.
Yes, you do. A substance, which is listed on Annex VI, must be classified in accordance with the entry in Part 3 of Annex VI. Furthermore, the manufacturer, importer or downstream user of such a substance has to carry out a self-classification in accordance with Title II for those hazard classes or differentiations where no harmonised classification is contained in the entry in Part 3 of Annex VI. For example, a substance may have a harmonised classification for acute oral toxicity, but not for acute dermal toxicity. This means that a supplier would have to explore, using the information available, whether the classification criteria for acute dermal toxicity are fulfilled, and classify accordingly. For harmonised classifications referring to the aquatic hazard classification acute or chronic category 1 where no M-factor appears on Annex VI, the classifier must set an M-factor.
Self-classification may entail new testing for those physical hazards where no harmonised classification exists and where, pursuant to CLP Article 8(2), adequate and reliable information is not available.
A substance may be classified under CLP, even though it was not under the DSD. For a range of hazards, the classification criteria have changed, e.g. for many physical hazards where the test methods which determine the classification criteria are often different from those of the DSD. For other hazards, the applicable concentration limits for taking into account the classification of its constituents, additives and impurities contained in the substance have changed, e.g. for the irritation and corrosive hazards. This means that where there is no reliable test information on the substance as a whole and the bridging principles cannot be applied, use of the calculation rules using concentration limits may lead to a classification under CLP, even though the same substance was not classified under DSD.
No, this is not necessary. A supplier will only have to classify the substance in the form that is going to be placed on the market and in which it can reasonably be expected to be used.As the particle size may have a significant effect on the test result, it should be explicitly specified in the test report for the relevant hazard what the particle size is. This does not mean that several classifications have to be performed in order to cover different particle sizes of the same substance. It means that the classification based on the particle size that is placed on the market has to be provided. In cases where several particle sizes are placed on the market or where the particle size may be altered during transport or storage, a worst-case approach should be used. This would normally imply using the classification based on testing the smallest particle size that could occur.
If particle size is relevant for classification and safe handling and use, this should be mentioned in the Safety Data Sheet. Information on deviating classifications due to different particle sizes should be mentioned in the Safety Data Sheet as well.
According to Article 8(5) of the CLP Regulation, where new tests for physical hazards are carried out for the purposes of this Regulation, they must be carried out, at the latest from 1 January 2014, in compliance with a relevant recognised quality system or by laboratories complying with a relevant recognised standard. The provisions of that Article are further detailed in section 2.0.5 "Quality" of the Guidance on the Application of the CLP criteria. According to the Guidance, even though the quality requirement does not become immediately effective, it is highly recommended to do so if reasonably possible. In general, the following alternative strategies can be pursued:
1. Compliance with the principles of good laboratory practice (GLP) (as formerly required by the DSD).
2. Accreditation according to EN ISO/IEC 17025 "General requirements for the competence of testing and calibration laboratories" (a relevant recognised standard).
3. Other internationally recognised standards of comparable scope.
Yes, you do. As stated in section 188.8.131.52 of Annex VI to the CLP Regulation, impurities are not normally mentioned in Annex VI to CLP entries unless they contribute significantly to the classification of the substance. This means that the entry in Annex VI to CLP relates normally to the toxicity of the "pure" substance and impurities have not been taken into account. Therefore, if the substance placed on the market contains an impurity not specified in the corresponding entry in Annex VI to CLP, the presence of classified impurities must be taken into account for classification purposes in accordance with Article 11(1) CLP.
The Commission Regulation (EC) No 286/2011 (second ATP to CLP) entered into force on 19 April 2011. In accordance with Article 3 of this ATP, Note H is no longer applied to entries marked with the Note from 1 December 2012.
A new or revised harmonised C&L of a substance set out in Annex VI to CLP must be applied from the date specified in the respective ATP, although suppliers may use this classification before that date.
In cases where a supplier decides not to apply the harmonised C&L of a substance before this date, the question arises whether they should nevertheless take into consideration the opinion adopted by the ECHA Risk Assessment Committee (RAC) on the harmonised C&L for that substance in the self-classification of a substance or mixture.
When suppliers consider the self-classification of their substance or mixture before placing them on the market (Article 4(1) of CLP), they must identify and examine all available information (Article 5 of CLP). The classification must reflect the latest scientific knowledge (Articles 5(1)(d) and 15 of CLP). During the transitional period for compliance with a new harmonised C&L for a substance, the RAC opinion for that substance should be considered as the latest reliable scientific evidence that should be reflected in the self-classification of the substance or mixture, unless the supplier has other scientific evidence that differs from the RAC opinion and leads to a different conclusion.
If the C&L of a substance is already harmonised in the same hazard class, compliance with the existing harmonised C&L is legally required until it is formally changed in an ATP to CLP. The new harmonised C&L may be voluntarily applied as soon as the respective ATP enters into force. At the date of applicability, as provided for in the respective ATP, the suppliers are obliged to comply with the new C&L.
Yes, the classification and labelling (C&L) of biocidal products needs to be updated in line with the change in harmonised classification within the timelines specified below. If the C&L of a substance in the product is already harmonised, compliance with the existing harmonised C&L is legally required. The new harmonised C&L may be voluntarily applied as soon as the respective ATP enters into force. At the date of applicability as provided for in the respective ATP, the suppliers are obliged to comply with the new C&L.
Further to this, Article 30(3) of CLP states that the label of a biocidal product should be updated in line with the requirements of the biocidal products legislation. The Commission Implementing Regulation (EU) No 354/2013 on changes of biocidal products gives the authorisation holder 12 months after implementation of the change to notify the updated hazard and precautionary statements to all the Member States in which the product is authorised or, where relevant, ECHA (see Annex, Title 1, Section 2).
It is assumed that pH has been taken into account when setting an SCL for a substance for skin corrosion/skin irritation or eye damage/eye irritation.
When a mixture only contains one corrosive or irritant ingredient (acid or base) with an SCL, the mixture should be classified according to this SCL even if the pH of the mixture is extreme. However, the SCL reflects a situation where the mixture does not contain any other ingredient that might affect the classification for that endpoint. If other ingredients in the mixture affect the irritant/corrosive properties, this has to be taken into account.
If a mixture contains any other substances than the one with an SCL, which may affect the corrosive or irritant properties of the mixture, the SCL may not determine the classification of the mixture. Such ingredients can be surfactants, other acids or bases, which either themselves possess corrosive or irritant properties or may be expected to affect the corrosive or irritant properties of the substance with the SCL, for example, by increasing the permeability of the skin. In that case, the classification should be based on the pH value of the mixture, unless consideration of the acid/alkali reserve suggests that the mixture may not be corrosive, and data from in vitro tests confirm that classification as corrosive is not justified. Classification based on the pH value of the mixture may lead to a more severe classification than if based on the SCL. A more severe classification may also result when either the additivity rule (Tables 3.2.3 or 3.3.3 of Annex I to CLP) or non-additivity rule (Tables 3.2.4 or 3.3.4 of Annex I to CLP) applies.
No, the bridging principle "Review of classification where the composition of a mixture has changed" can only be used for mixtures containing the same constituents (ingredients). It is only the concentrations of the hazardous constituents (ingredients) and not the constituents themselves that are permitted to change, within the ranges specified in Table 1.2 in Part 1 of Annex I which applies Article 15(2)(a).
Where the aspiration toxicity of a mixture is based on its components, two conditions need to be met.
Firstly, a mixture must contain a total of 10 % or more of a substance or substances classified in Aspiration Toxicity Category 1.
Secondly, the kinematic viscosity of the mixture must be at or below 20.5 mm2/s, measured at 40°C (point 184.108.40.206.1.1 of Annex I to CLP).
When these conditions are both met, the mixture must be classified in Aspiration Toxicity Category 1.
Regardless of the classification principle applied, mixtures in aerosol dispensers should be classified for health and environmental effects as follows, depending on the case.
If the added propellant or other gas:
1) is not released upon spraying, it should not be taken into account for the classification of the mixture in the aerosol dispenser
2) is partially or fully released upon spraying, but is separated from the other constituents of the mixture, it should also not be taken into account for the classification of the mixture in the aerosol dispenser from which it is separated. Where the propellant or other gas is partially or fully released, the propellant or other gas is generally assumed to be separated from the other constituents of the mixture if the propellant or other gas either is not liquefied or it is liquefied and has a vapour pressure (20°C) ≥ 10 kPa.
3) is partially or fully released upon spraying and is not separated from the other constituents of the mixture, it should be taken into account for the classification of the mixture in the aerosol dispenser. This third case applies by default if the propellant is a liquid and has a vapour pressure (20°C) below 10kPa, since it can then be generally assumed that the propellant or other gas does not separate from the other constituents of the mixture.
If it can be duly justified either that no separation takes place, or that classification of the entire contents of the aerosol dispenser as placed on the market is more ‘relevant’ within the meaning of Article 6(1) of the CLP Regulation for some other reason, then the third case can be applied.
For cases one and two above, if the propellant or other gas itself is classified as hazardous for health or the environment, that classification should be reflected in the label of the aerosol dispenser.
No. Soluble chromium VI causes the sensitising effect of cement or cement-containing mixtures. Chromium (VI) compounds generally are classified as Skin sens 1, and therefore the classification limit for mixtures containing these substances is 1 %. When the concentration of chromium (VI) is reduced to below 2 ppm (0,0002 %) of soluble chromium (VI) of the total dry weight of the cement, the concentration limit for classification as sensitising is unlikely to be reached and thus the hazard statement H317 would not apply.
It should be noted that the cement mixture containing below 0,0002 % soluble chromium (VI) of the total dry weight of the cement would also not be subject to the labelling requirement set in point 2.3 of Part 2 of Annex II, regarding the statement EUH203.
Please note, however, that if reducing agents are used then the packaging must include the information on the packaging date, the storage conditions and the storage period appropriate to maintaining the activity of the reducing agent and to keeping the content of soluble chromium VI below 0,0002 %.
CLP requires that where a member of the general public can purchase a mixture without first seeing the label, and where that mixture is classified as hazardous or contains a hazardous substance as referred to in CLP Article 25(6), then the advertisement for that mixture must mention the type or types of hazard as indicated on the label.
The type of hazard is best specified by providing the relevant hazard statements, including the supplemental hazard statements as referred to in CLP Article 25(6). It is also recommended that the hazard pictograms and signal word are mentioned, where appropriate, to alert the reader to a potential hazard.
For sales to the general public, it is not sufficient nor relevant to refer to a safety data sheet containing this information.
No, Section 2.2 of the SDS is intended only for supply (CLP) pictograms, which are described in Annex V to the CLP Regulation. The transport labels can be included in Section 14 of the SDS (see also Annex II to REACH).
No, only the inner packaging is required to be fitted with the tactile warning.
The technical specifications of the tactile warning are given in EN ISO standard 11683 (section 220.127.116.11 of Annex II to CLP). The ISO standard states that ‘... the tactile warning shall be placed on the packaging and not on any secondary packaging, such as cardboard box protecting a glass bottle, so that it can be felt prior to fully opening the package'. The warning shall also remain tactile during the expected period of use of the package under normal handling conditions.
Thus, the ISO standard provisions aim to ensure that when handling a chemical product the person who has a visual disability is aware of the danger. The ISO standard refers to ‘primary packaging', which can be understood as ‘inner packaging' in CLP terminology.
Outer and intermediate packaging may be fitted with the tactile warning but this is not obligatory.
Yes, a web page can be regarded as an advertisement in the scope of Article 48. Hazard information must be provided in this type of advertisement for classified and labelled substances, in accordance with Article 48(1).
When a member of the general public can conclude a purchase of a mixture online, without first having sight of the label, the information required by Article 48(2) must be provided.
Re-fillers are downstream users of substances or mixtures whose use is limited to transferring substances or mixtures supplied to them from one container (or packaging) into another. Re-fillers are therefore not obliged to classify in accordance with Title II of CLP, but may also take over the classification derived in accordance with Title II already by another actor in the supply chain provided the re-filler does not change the composition of the substance or mixture that is being refilled. In any case the re-filler has to ensure that the labelling and packaging is in accordance with CLP. This can mean that the original label must be replaced by another one. For example, when the contents of a 200 l drum is decanted into 25 ml bottles, the new label should be in line with the small packaging exemptions, unlike the original bigger one which required full labelling.
Note that re-fillers established within the EU who are supplied with substances or mixtures by an actor outside the EU are considered to be importers under CLP, unless they can benefit from the provisions foreseen for re-importers, see Q&A 168. This means that they have the obligation to classify these substances and mixtures and to notify relevant substance information to the Classification and Labelling (C&L) Inventory.
According to CLP Article 2(19), a re-importer is considered a downstream user. Re-importers are therefore not obliged to notify to the C&L Inventory or to classify in accordance with Title II of CLP, but may also take over the classification derived in accordance with Title II already by another actor in the supply chain. In any case the re-importer has to ensure that the labelling and packaging is in accordance with CLP.
Note that for a re-importer to be considered a downstream user certain conditions have to be fulfilled. First, the re-imported substance must have been registered before it was exported from the EU. In addition, the substance must have been re-imported within the same supply chain. Third, a re-importer needs to be able to show that the re-imported substance is the same as the one that was originally exported. Finally, the re-importer must also be able to show that he has been provided with the respective information in accordance with REACH Article 31 or 32.
When any of the conditions mentioned above is not fulfilled, the re-importer is considered an importer. This means that he has the obligation to classify these substances or mixtures and to notify relevant substance information to the C&L Inventory.
A distributor is a natural or legal person established within the European Union, including a retailer, who only stores and places on the market a substance, on its own or contained in a mixture, for third parties. Distributors are not obliged to derive the classification of the chemicals they place on the market. In contrast to other suppliers, distributor (including a retailers) do not have to classify their substances and mixtures, but may take over the classification that was derived in accordance with Title II of CLP by another actor in the supply chain. Typically, the respective classification is made available on a Safety Data Sheet.
The same derogation is also granted to a downstream user as long as he does not change the composition of the substance or mixture supplied to him.
Note that distributors established within the EU who are supplied with substances or mixtures by an actor outside the EU are considered importers under CLP. This means that they have the obligation to classify these substances and mixtures and to notify the relevant substance information to the C&L Inventory.
Under CLP, recovered substances and mixtures will normally have to be treated in the same way as other substances and mixtures under CLP. This means that they have to be classified in accordance with Title II of CLP and the substances have to be notified to the C&L Inventory, unless the establishment undertaking the recovery (manufacturer of the recovered substance) has already submitted a registration under REACH and included the information necessary for a notification. If the establishment undertaking the recovery can rely on the exemption from the REACH registration provisions for recovered substances pursuant to REACH Article 2(7)(d), it would still have to notify the recovered substances to the C&L Inventory, in accordance with CLP Article 39(b) and 40.
When classifying under the CLP Regulation, the establishment undertaking the recovery may take over the classification already derived in accordance with Title II of CLP by the registrant of the same substance, if this is appropriate. When notifying in such cases to ECHA, it is recommended to retrieve the classification and labelling information provided earlier by the registrant of the original substance from ECHA's Classification & Labelling Inventory and agree to it.
No, they do not. They are considered to be end users of the substances and mixtures supplied to them as long as they do not place the substances and mixtures on the market. Examples of professional users are cleaning personnel, painters or craftsmen who use e.g. paints, lime or cleaning agents in the context of their professional activity. Industrial users may use substances or mixtures supplied to them as processing aids which are not consumed by the industrial activity, e.g. surface cleaners prior to electroplating or users of lubricants for chainsaws. Formulators of mixtures are not considered as end users, but rather as downstream users of substances and mixtures.
Professional and industrial end users are required to respect the information on the label and on the Safety Data Sheet supplied to them. Further to this, they have to comply with the downstream user obligations set out in Title V of REACH on the safe handling and use of substances and mixtures.
Note that end users established within the EU, who are supplied with substances or mixtures by an actor outside the EU, are considered to be importers under CLP. This means that they have the obligation to classify, label and package these substances and mixtures and to notify relevant substance information to the C&L Inventory.
The number of hazard statements on the label is in principle not limited, as they will normally have to reflect all hazard classifications of a substance or mixture. The only exception is for evident duplication or redundancy.
In the EU, only those labels, which comply with the CLP rules, will be accepted. This means that the provisions that are laid down in Title III of the CLP Regulation and the details regulated in its Annexes I – V must be respected. However, many aspects in relation to the arrangement of labelling elements and in relation to supplemental labelling information are at the discretion of the supplier of the hazardous substance or mixture.
It is acknowledged that mass pre-printing of labels is current practice in industry. This means that the label background is printed first before it is overprinted with the specific label information in a second step. In cases where this two-step process leads to a situation where only a few hazard pictograms are needed for the label, one or more pre-printed diamonds may have to be left empty or, alternatively, be blacked-out in a second step.
Although CLP does not explicitly forbid the use of blank or blacked out diamonds on the label, Article 19(1) requires suppliers to include relevant hazard pictograms on the label which are intended to convey specific information on the hazards concerned. Furthermore, Article 25(3) requires that any information which goes beyond the mandatory label elements; must not contradict or cast doubt on the messages provided by the latter.
Therefore, due to the current lack of suitable printing techniques afforded by SMEs, it may not always be possible to only include hazard pictograms that fulfil these conditions. This means that any blank or blacked out diamond(s) should be seen in the light of this provision. In cases where empty diamonds are unavoidable, it is recommended to cover them up with a solid overprint, which blacks them out completely and thereby avoids the impression that relevant hazard symbols may have been left off the label through a printing mistake.
Yes, they do. Active substances, plant protection products within the scope of Regulation (EC) No 1107/2009 or biocidal products within the scope of Regulation (EU) 528/2012, which are classified as hazardous, must bear a CLP label including the relevant hazard statements, precautionary statements, signal word and pictograms.
In addition, the label of a hazardous plant protection product must also display the statement EUH401 ("To avoid risks to human health and the environment, comply with the instructions for use"). However, in relation to any other aspects of labelling, the provisions of the respective regulations apply, e.g. for the update of a label of a plant protection or biocidal product, see CLP Articles 15(5) and 30(3). Further information can be found in the Guidance on labelling and packaging in accordance with the CLP Regulation available on the ECHA website at http://echa.europa.eu/guidance-documents/guidance-mainly-for-industry-use
Note that an active substance can also be placed on the market for non-pesticidal or non-biocidal uses. In these cases, the labelling provisions set out in CLP Title III apply in full. This means, for example, that the update of the relevant label has to follow the provisions of CLP Article 30(1) and (2).
Yes they are. CLP Article 17 (1) (a) states that the name, address and telephone number of the supplier(s) must be included on the label. Furthermore, as stated in Article 4 (4), a supplier must ensure that a hazardous substance or mixture is labelled and packaged in accordance with Titles III and IV of the CLP Regulation, before placing it on the market.
In principle, there can be more than one supplier of the same hazardous substance or mixture in the supply chain at the same time. This can be the case, for example, when a hazardous substance or a mixture containing hazardous substances has been supplied to a distributor, who then supplies it to third parties. If the distributor then changes the packaging to such an extent that the label elements set out in CLP Article 17 have to be displayed differently than on the original label/packaging supplied, then the contact details of the distributor should be added to or replace the contact information of the previous supplier. In this scenario, the distributor has taken on the responsibility for repackaging and re-labelling of the substance or mixture.
If distributors do not change the packaging or labelling, then they do not need to add their contact details to the label nor replace the contact information of their supplier. The distributors may however do so if they wish to.
When a supplier changes the languages(s) displayed on a label, they become responsible for the correct translation of the label content. Thus, they should add their contact details to the contact details of the supplier who issued the original label.
CLP Article 25 introduces the concept of "supplemental information", which is intended to incorporate additional labelling information 'over and above' that listed in CLP Article 17 (1) (a) to (g). Any non-EU hazard information included along with the CLP label elements may be considered as supplemental information and placed alongside the CLP labelling elements so long as it does not contradict or cast doubt on the validity of the information required by CLP Article 17 (1) (a) to (g), nor makes it more difficult to identify such information. This can only be determined on a 'case-by-case' basis depending on the information being proposed by the importer. Additional guidance on supplemental labelling information can be found in Section 4.8- 'Supplemental labelling information' of the CLP labelling and packaging guidance available on the ECHA website at http://www.echa.europa.eu/guidance-documents/guidance-on-clp.
The general rules for the application of labels are outlined in CLP Article 31. For the hazard pictograms, as detailed in CLP Article 31 (4), the provisions of Annex I, Section 1.2.1, to CLP and Annex V to CLP shall apply. According to Annex V to CLP, hazard pictograms shall have a black symbol on a white background with a red frame wide enough to be clearly visible. Hazard pictograms shall be in the shape of a square set at a point. Each hazard pictogram shall cover at least one fifteenth of the minimum surface area of the label dedicated to the information required by CLP Article 17 (as defined in Table 1.3 in Section 18.104.22.168 of Annex I, 2nd ATP to CLP). Where a supplier chooses to use a label that is larger than the minimum dimensions for a certain capacity of the package, it is not necessary for the size of the pictogram also to be increased, provided it covers one fifteenth of the relevant minimum dimensions and remains proportional to the size of the packaging. The minimum area of each hazard pictogram shall not be less than 1 cm². Note that the size of the pictogram relates to the dimensions of the pictogram itself, and not to the size of the virtual square where the pictogram is embedded. Further guidance can be found in Section 5.2- 'Size of the label and of the label elements' of the Guidance on labelling and packaging in accordance with the CLP Regulation available on ECHA's website at: http://www.echa.europa.eu/guidance-documents/guidance-on-clp.
The CLP Regulation does not require the labelling of substances or mixtures that are only exported and that, within the EU, are only subject to transport operations. It is necessary to take worker health and safety considerations into account during the production packaging and storage stages, to ensure that these substances and mixtures are handled safely.
However, the PIC Regulation ((EU) 649/2012) concerning the export and import of hazardous chemicals (which implements the Rotterdam Convention within the EU) requires that all exported chemicals are classified, labelled and packaged in accordance with the CLP Regulation, the Plant Protection Products Regulation ((EC) No 1107/20), the Biocidal Products Regulation ((EU) No 528/2012) or any other relevant EU legislation, unless those provisions would conflict with any specific requirements of the receiving countries. Further information can be found in sections 4.1 and 6.10 of the Guidance for implementation of the PIC Regulation.
The labelling and packaging requirements for hazardous transported goods are laid down in the respective transport legislation, based on the UN Model Regulations.
Yes, they should. It should be kept in mind that labels are meant for health, environment and consumer protection, thus they must be understood by the users of the products. According to 17(2) of CLP, the label must be written in the official languages(s) of the Member State(s) where the substance or mixture is placed on the market, unless the Member State(s) concerned provide(s) otherwise.
Therefore, the translated names of substances listed in Part 3 of Annex VI to CLP or in the C&L Inventory need to be used in the Member State(s) where placed on the market unless the Member State(s) provides otherwise. The public C&L Inventory does not contain translations for substances that do not have a harmonised classification of the Annex VI entries.
According to the criteria given in section 1.2.1 of Annex II to CLP, the hazard statement applies to 'substances and mixtures which in contact with water or damp air, evolve gases classified for acute toxicity in category 1, 2 or 3 in potentially dangerous amounts, such as aluminium phosphide, phosphorous pentasulphide.' No further criteria or guidance are provided as to when this hazard statement should be assigned and no appropriate test methods are indicated. It is recommended that any amount of acute toxic category 1, 2 or 3 gas emitted triggers the inclusion of EUH029. It is thus also recommended to add this sentence to each substance or mixture that releases a toxic gas when in contact with water.
No. Substances or mixtures under the scope of the CLP Regulation can not be exempted from the classification, labelling and packaging requirements regardless of how low the risk is estimated to be and regardless of the size of the packaging. However, certain derogations apply for labelling of small packagings according to Article 29 of CLP.
Article 18(3) of CLP provides that the identity of all substances in a mixture that contribute to the classification of the mixture in certain hazard classes must be given on the label. A maximum of four chemical names are to be included, unless more are needed to reflect the nature and severity of the hazards.
There are no strict rules on how to decide which substances should take precedence to be named on the label, but the following may help in the selection.
For non-additive health hazards (e.g. germ cell mutagenicity, carcinogenicity, reproductive toxicity, respiratory or skin sensitisation and specific target organ toxicity categories 1 and 2), all ingredients which are present in the mixture above the generic or specific concentration limit should be considered as "primarily responsible for the major health hazards" within the meaning of Article 18(3)(b) CLP and included on the label.
For the additive health hazards mentioned in Article 18 (3)(b) CLP (e.g. acute toxicity, skin corrosion, serious eye damage, specific target organ toxicity category 3 and aspiration hazard), all ingredients which are present in the mixture above the generic or specific concentration limits should be included on the label. However, where there are several ingredients contributing to classification for one hazard endpoint, only the ingredients primarily contributing to the classification, for example, those closest to the GCL or SCL, need to be included on the label, and thus the names of other ingredients with limited contribution to the classification are not required.
In addition, specific labelling rules apply to mixtures containing skin and respiratory sensitisers. See Annex I Table 3.4.6 and Annex II, point 2.8.
No, they are not. Article 33(1) of CLP outlines that when a package consists of an outer and an inner packaging, together with an intermediate packaging, and the outer packaging meets the labelling provisions in accordance with the rules on the transport of dangerous goods, the hazard pictograms required by CLP do not need to appear on the outer packaging.
For the purpose of CLP, transport labelling is considered to include the limited/excepted quantity marks (chapters 3.4 and 3.5 of the UN Model Regulations for the transport of dangerous goods).
This is explained in the Guidance on labelling and packaging in accordance with the CLP Regulation (chapter 5.4) that states that labelling in accordance with CLP is required only when neither:
- 'normal' transport labelling elements, nor
- other transport labelling elements such as the ‘limited/excepted quantity marks', the mark for environmentally hazardous substances or elevated temperature marks are needed on the outer packaging.
This means that limited/excepted quantities are considered as transport labelling and therefore CLP pictograms are not required when those limited/excepted quantity marks are carried on the outer packaging and the pictograms depicting the same hazard do not need to appear twice. CLP labelling may however be used, if desired according to Article 33(1) of CLP.
The precautionary statement P501 with appropriate specification of where to dispose of the content/container (e.g. public waste disposal or recycling facility), in accordance with the applicable regulation, must be included on the label of any substance or mixture supplied to the general public if the substance or mixture is classified in the hazard classes and categories listed under P501 in Table 6.5 of Annex IV to the CLP Regulation.
Suppliers of substances and mixtures classified as hazardous according to CLP must label them in accordance with CLP before placing them on the market.
A supplier is any manufacturer, importer, downstream user or distributor placing a substance on the market on its own or in a mixture. Import is considered to be placing on the market (Article 2(18) CLP). Therefore, an importer (supplier) importing (placing on the market) substances or mixtures will have to label them according to CLP. Imported substances and mixtures require CLP labelling, even if the importer and the user are the same legal person.
Where importers make use of a distributor, the importers may not pass this labelling duty to their distributor. The substance/mixture being distributed should be correctly labelled by any supplier (including the importer) in the supply chain.
An importer is not required to classify, notify or label its substances/mixtures in accordance with CLP if the following conditions apply (note that they apply cumulatively):
- the substances/mixtures are under customs supervision;
- there is no treatment or processing activity;
- one of the three following (not cumulative) conditions apply: the substances/mixtures are (a) in temporary storage or, (b) in a free zone or free warehouse with a view to re-exportation or, (c) in transit.
In customs terms, transit means both internal and external transit. In case of doubt, it is recommended to contact the customs authorities, to clarify the applicable customs rules established by Regulation (EU) No 952/2013 on the Union Customs Code.
No, it is not. A hazardous chemical product that is subject to labelling and packaging under CLP must not be confused with a food, medicinal or cosmetic product. For example, a prominent picture of a fruit on the label or packaging can create confusion for the consumer and increase attractiveness to children. Other elements, such as the bright colour, the shape and design of the packaging or the consistency of the chemical may also create a resemblance with food products or with toys.
A hazardous chemical product must not attract the curiosity of children, but apart from children, other vulnerable consumer groups also exist and need to be considered. Therefore, the packaging of a hazardous chemical should not be of a shape or design that, for example, a visually impaired person could confuse with food.
E-liquids for electronic cigarettes are regulated by the Tobacco Products Directive (TPD, Directive 2014/40/EU). The TPD requires Member States to ensure that electronic cigarettes and their refill containers are only placed on the market if they comply with the TPD and with all other relevant Union legislation (Article 20(1)), including the obligations under the CLP Regulation.
Under CLP, the classification, labelling and packaging of an e-liquid is the responsibility of the formulators or importers of the liquid. Under TPD, they must also submit a notification to the competent authorities of the Member States of any such products which they intend to place on the market. This notification should include the classification of the mixture in accordance with CLP.
The TPD sets its own labelling requirements for the unit packets of electronic cigarettes and refill containers (TPD Article 20(4)). In addition, the refill containers must also be labelled and packaged in accordance with CLP if the e-liquid is classified as hazardous. In that case, the unit packet must have a CLP label, with TPD-related information as supplemental. Overlapping information only needs to be indicated once: for example, the list of all ingredients required by TPD vs the list of ingredients contributing to classification under CLP.
It should be noted that the TPD provides that the nicotine content must not exceed 20 mg/ml and only ingredients that do not pose a risk to human health in heated or unheated forms may be used in the nicotine-containing liquid. However, other components of e-liquids have also been identified as hazardous and need to be considered in the classification and labelling of the e-liquid.
According to TPD, electronic cigarette devices and refill containers have to be child- and tamper-proof, protected against breakage and leakage and have to have a mechanism that ensures refilling without leakage (Article 20(3)g).
A refillable electronic cigarette device that is empty when placed on the market is not subject to the labelling obligations under CLP, as the hazards are dependent on the contents of the refill container.
Under CLP, candles are regarded as mixtures. Therefore, if a candle is classified as hazardous or where CLP Article 25(6) applies, then the candle must be labelled and packaged in accordance with CLP before placing it on the market.
An open container of glass or aluminium foil or an openwork paper box are not considered as packaging in the context of CLP Article 35. A candle in such a container, must still be supplied in packaging that complies with the CLP requirements, with the label firmly affixed to one or more surfaces of the packaging immediately containing the candle, and positioned horizontally on the side of the packaging, so that it can be easily read.
For small candles, certain labelling exemptions may apply, in accordance with CLP Article 29.
Yes, they do. All substances and mixtures that fulfil the criteria for classification as hazardous in accordance with the CLP Regulation are subject to the labelling requirements of CLP. For example, where the ink used in a pen is classified as hazardous, that will lead to labelling obligations.
Where the ink reservoir is a fixed component of the pen or marker as it is placed on the market, the pen/marker needs to carry the appropriate labelling. If full labelling is not possible, then the exemptions set out in Article 29 and points 1.5.1 and 1.5.2 of Annex I to CLP can be used.
In the case of empty (blank) pens and re-fillable pens, the pen body does not need to be labelled, as the body of the pen is an article which is not the container of the ink. The hazards depend on the ink used in the replaceable ink cartridge or refill, which need to fulfil the labelling requirements of CLP.
No. All mixtures that are subject to the obligation to submit information under Article 45 and that are still being placed on the market will have to be re-labelled to include the UFI.
From 1 January 2025 (end of the transitional period), all hazardous mixtures placed on the market have to be compliant with the Annex VIII requirements, including the placement of the UFI on the label, as supplemental labelling information, and possibly a notification to the poison centre in accordance with the new format.
Regarding the eventual relabelling, the distributor has an obligation under Article 4(10) to place on the market only mixtures which are compliant with CLP. However, in practice, the decision on who will take the care of doing the actual relabelling can be a private agreement in each supply chain.
Yes, it may. Non-EU supplier information may be considered as supplemental information in accordance with Article 25(3), and included along with the EU supplier(s) information on the CLP label as long as it does not contradict or cast doubt on the validity of the information required by CLP Article 17 (1) (a) to (g), nor makes it more difficult to identify such information.
For information on the effects of the UK withdrawal on labelling obligations related to supplier contact details, see Q&A 1726.
After 1 June 2017, all mixtures placed on the market must be classified and labelled in accordance with CLP. This means that also mixtures which were already placed on the market before 1 June 2015 and are still in the stock of any supplier in the supply chain must be re-labelled in accordance with CLP.
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
Acids and bases in aqueous solutions may be listed with the notation "%" in Annex VI to CLP. Such exceptional entries are treated as substances for the purpose of C&L notification. These exceptions should be notified as such to the C&L Inventory when they are placed on the market under the conditions of CLP Article 39(b). 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.
This approach of treating solutions listed with the notation ‘%’ as ‘substances’ is only applicable to harmonised classification and the C&L notification, and is not to be used for any other process under CLP or REACH.
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.
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 included in the Public C&L Inventory. However, ECHA has received millions of notifications for more than 100,000 substances for the C&L Inventory. Thus, the process of agreement for such a large number of notifiers and substances will be long and requires the active involvement of all parties concerned.
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."
CLP does not apply to products that are covered by any of the product-specific legislation specified in Article 1(5) of CLP. Such products also must be in their finished state and intended for the final user at the moment of placing on the market.
This is also the case for cosmetic products as defined in the Cosmetic Products Regulation (CPR, Regulation No 1223/2009).
A cosmetic product is thus excluded from the scope of CLP if all of the following three conditions are met:
1. The product falls within the definition of a cosmetic product according to the CPR. If it does, the CPR applies, and all requirements set out in that Regulation shall be fulfilled.
2. At the moment of placing on the market, the cosmetic product is intended for the end user, i.e. it is intended to be ultimately used either by a consumer or professional.
3. At the moment of placing on the market, the product is in the finished state, i.e. it is in its final composition or formulation. The finished state of a cosmetic product under Article 1(5)(c) of CLP relates to the substance or mixture and not to its packaging. As long as the re-packing of the substance or mixture in bulk does not alter the chemical composition [e.g. a product in a drum or IBC (intermediate bulk container) that will not be chemically altered after having been produced] can therefore be considered in the finished state.
In such cases, it is not necessary to classify, label and package these bulk cosmetics according to CLP or to notify them to the C&L Inventory.
- You can use the online C&L notification tool directly in REACH-IT to submit a C&L notification of your substance. Here are a few examples, where this is the best option:
- If you agree with the harmonised classification and labelling.
- If you agree with a classification and labelling already notified or registered.
- If you want to provide your own classification and labelling details.
- You can use IUCLID 6 to create a C&L notification dossier and submit it to ECHA via REACH-IT. Here are two examples, where a IUCLID 6 dossier is your only option:
- If your substance has multiple compositions (e.g. same main constituent(s) but different impurities and/or additives)
- If you want to notify one composition with different classification and labelling.
- In the examples above you should identify in section 1.2 of your substance dataset in IUCLID 6 the composition(s) of your substance, as well as any impurities and additives present in the substance. You will also have to indicate the different sets of classification and labelling and link them to the different compositions.
Further information can be found in the manual - How to prepare a classification and labelling notification at:https://echa.europa.eu/manuals
You can edit the C&L notification of harmonised substances by clicking the option below. The wizard will open an additional page, where it is possible to edit the ‘Hazard category’ and ‘Hazard statement’.
At the sixth step of the online C&L notification tool wizard (i.e. C&L inventory) you will be prompted to agree with the:
- Harmonised C&L
This option is pre-selected if the classification and labelling of the substance has been harmonised. You may also notify additional information to the selected harmonised classification and labelling.
- Notified C&L
This option is pre-selected if the classification and labelling of the substance has not been harmonised. Here you can notify the substance using one of the already notified sets of classification and labelling or notify a different C&L.
The purpose of the pre-notified entries is to reduce the administrative work done by the notifier. It is the responsibility of the notifier to provide a valid classification and labelling for their substance.
Manufacturers or importers who place a substance on the market will have to notify certain information to ECHA that will be included in the C&L inventory if the substance is:
- Subject to registration under Regulation (EC) No 1907/2006 (REACH);
- Classified as hazardous under CLP;
- Classified as hazardous under CLP and present in a mixture, which is placed on the market, above the concentration limits specified in Annex I of CLP which results in the classification of the mixture as hazardous.
However, if the classification and labelling information required by the CLP Regulation has already been submitted in a REACH registration dossier, a separate notification to the C&L inventory is not necessary.
Alternatively, a third party who is not a manufacturer or importer (e.g. an OR who has already been appointed for the purposes of registration under REACH) may submit a group notification on behalf of the EU importers. Further information on this topic can be found in our C&L notification pages at http://echa.europa.eu/regulations/clp/cl-inventory/notification-to-the-cl-inventory/who
Notifications can only be submitted electronically via the REACH-IT portal on the ECHA website. You must first sign-up in REACH-IT and create an account to be able to submit your notification.
Further information and step by step instructions on this topic, can be found on the ECHA website at:
a) If the C&L notification was submitted as a IUCLID 6 file via REACH-IT (either as part of a registration dossier or independently as a C&L notification dossier)
- Information to be included in your IUCLID 6 substance data-set
- Indicate the reference number of your substance in section 1.3
- Information to be included in your IUCLID 6 dossier header (dossier creation wizard)
- Tick the box that the dossier is an update
- Indicate the submission number of the last successful submission
- Specify the reason for the dossier update
For Further information please consult the manual ‘How to prepare a classification and labelling notification’ at: https://echa.europa.eu/manuals
b) If the C&L notification was submitted in REACH-IT using the online C&L notification tool
- Search for your C&L notification using the reference number
- Use the button ‘Create and submit online an update’.
a) For substances previously notified above 1tpa under Directive 67/548/EEC
If the registration number for the substance has already been successfully claimed, the classification and labelling can be updated as a spontaneous update of the registration dossier.
Further information on how to proceed can be found in the Questions and Answers for the registrants of previously notified substances at: https://echa.europa.eu/support/qas-support/browse/-/qa/70Qx/view/scope/REACH/NONS-Registrants+of+Previously+Notified+Substances
Please also refer to the section: Other updates of Annex 4 of the manual "How to prepare registration and PPORD dossiers"
b) For substances previously notified below 1tpa under Directive 67/548/EEC
If the substance fulfils the classification criteria as specified in Annex I of the CLP Regulation and
- the annual tonnage band has remained below 1tpa, the registration number cannot be claimed and the submission of a C&L notification for the NONS is required.
- the annual tonnage band has increased above 1tpa, the registration number must be claimed without any delay and an update of the classification and labelling as part of the registration dossier is required.
a) Information that can be updated: Most information can be updated, such as the composition of the substance, the classification and labelling, the contact details, the members of a group of manufacturers/importers etc.
b) Information that cannot be updated: submitting legal entity, EC number, CAS number.
No, if you have already submitted a registration dossier for your substance, you should submit a spontaneous update of your registration dossier in order to update the classification and labelling of this substance.
If you are a member of a Joint Submission, and you submitted the C&L information of your substance jointly in both the lead registration dossier and your member registration dossier before the 30th November 2010, you need to ask the Lead Registrant to submit a lead registration dossier update including the classification and labelling according to the CLP criteria.
A C&L notification can only be submitted for substances previously notified under the Directive 67/548/EEC, where the annual tonnage band has never exceeded 1tpa and the NONS could not be claimed under REACH.
You can inform ECHA that you no longer manufacture/import a substance by using the ‘Cease manufacture or import’ functionality in REACH-IT:
- Search for your C&L notification using the reference number.
- Use the ‘Cease manufacture or import’ and confirm your decision. The status of your notification will changed to ‘Inactive’.
- You can at any point reactivate the notification again by using the "Restart manufacture or import" functionality. The status of your notification will become ‘Active’ again.
- Note that this functionality is shared with the ‘cease/restart manufacture or import’ for registration dossiers (deactivation based on REACH article 50(2)).
After the submission of a C&L notification (created via the online C&L notification tool or by submitting a IUCLID 6 dossier via REACH-IT) a submission number is assigned.
If the submission is successful (i.e., the submission passed the virus check, the format check, and the Business Rules checks), then each notified substance receives a reference number is assigned. Both the submission and reference numbers are available in your submission report.
- If the C&L notification was submitted via the online C&L notification tool or by submitting a IUCLID 6 C&L notification dossier via REACH-IT the reference number (here called the notification number) will have the following format: 02-XXXXXXXXXX-CC-0000.
- If the C&L notification was submitted as part of a registration by submitting a IUCLID 6 registration dossier via REACH-IT the reference number (here called the registration number) will have the following format: 01-XXXXXXXXXX-CC-0000.
After the submission of a C&L notification update, a new submission number will be linked to notification, but the reference number previously assigned will remain the same.
Some of the possible reasons are described below:
- There is a time delay between the moment a reference number has been assigned to a C&L notification, and the moment this C&L notification is stored in the internal C&L inventory. Please, try again later;
- The C&L notification was submitted for a group of manufacturers/importers. Only the group creator who submitted the C&L notification will be able to see it. A member of the group cannot.
- The C&L notification was submitted by the lead registrant for all members of a joint submission. Only the lead registrant who submitted the C&L notification will be able to see it. A member of the joint submission cannot.
- If more than one composition, and more than one set of classification and labelling are specified in the IUCLID 6 dossier without being properly linked, the C&L information cannot be automatically transferred to the C&L inventory. If a reference number was issued, your C&L notification is considered valid, but the transfer to the C&L inventory will happen at a later stage.
The original notifier (i.e. group creator) can add or delete members of the group by using the ‘Add member’ or ‘Delete member’ button.
The original notifier can also delete all members of the group by using the ‘Delete group’ button. In this way the whole group will be deleted. The C&L notifications are not affected by the deletion of the group and remain in possession of the original notifier.
Once a group of manufacturers/importers has been updated, all notifications and submission reports associated to this group will be refreshed. Editing a group of manufacturers/importers is not considered a spontaneous update of the notification and there is no need to inform ECHA of such change.
Note that all the changes in the group definition will be kept and tracked in the REACH-IT database, which means that ECHA and the enforcement authorities will know when a company has joined a group.
The members of a group of manufacturers and importers do not receive a submission report and need to contact the original notifier to receive the reference number (or a copy of the submission report). The original notifier (group creator) is responsible for informing the group members on the status of the notification and for sharing the submission report with the group members.
Only the original notifier (group creator) will be able to update the C&L notification. Members of the group are considered ‘co-notifiers’ of the C&L notification, but cannot update it.
The situation can be illustrated by the following example:
- The initial notifier (group creator, M1) submitted a C&L notification (CL) for a substance (S) on behalf of a group of manufacturers/importers composed of three members (M1, M2 and M3).
- At a later stage one member (M3) realises, that their substance (S3) contains some impurity/additive that is absent from the originally notified substance (S). This impurity/additive calls for a different classification and labelling and the member (M3) askes the group to update the C&L notification.
- The other two members (M1, M2) want to keep the original C&L notification (CL).
- Depending on the agreement between the group members, two scenarios can play out.
Technical solution 1
- In case all members (M1, M2, M3) agree with both sets of classification and labelling for the substance (S), the original C&L notification (CL) should be updated with the new composition and classification
- This technical solution has to be done in IUCLID 6, because only this tool allows multiple compositions and classification. In order to include another composition to your substance, please refer to the manual: How to prepare a classification and labelling notification available at https://echa.europa.eu/manuals.
- When submitting the updated C&L notification dossier for substance (S), you should indicate in REACH-IT that the notification is on behalf of the same group M1+M2+M3.
- The following information will be stored in REACH-IT:
- Substance (S) has two compositions (S, S3)
- Each composition has its own set of classification and labelling (CL, CL3)
- There is a single C&L notification (covering both compositions and both sets of classification and labelling) valid for all group members (M1, M2, M3)
Technical solution 2
- If there is no agreement on a single C&L notification for the substance (S) it is advisable to split the group in two.
- The initial notifier (group creator, M1) can delete the third member (M3), so that the original notification is still valid only for the remaining group members (M1, M2). No other update is needed.
- The third member (M3) has to notify their substance composition (S3) with their own classification and labelling (CL3) independently using either IUCLID 6 or creating the notification online using REACH-IT.
- The following information will be stored in REACH-IT:
- Substance (S) has two compositions (S, S3)
- Each composition has its own set of classification and labelling (CL, CL3)
- There are two independent C&L notifications (each covering one composition and one set of classification and labelling)
- The group (M1, M2) has notified the substance S with the classification and labelling CL
- The single notifier (M3) has notified the substance S3 with the classification and labelling CL3.
At the moment, it is only possible to download the whole C&L inventory in batches using the advanced search (accessible from the home page). Use the starting digits of the EC numbers to limit the number of entries in a batch. We suggest to use the following: 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 3, 4, 5.
You can find the latest consolidated version of CLP via the ECHA website at: http://echa.europa.eu/regulations/clp/legislation. Note that the text has no legal value. For legal purposes please refer to the texts published in the Official Journal of the European Union.