Questions and Answers

CLP

A new Regulation

[159] What is CLP? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
A new Regulation
Version: 1.0
Latest update: 02/02/2016

"CLP" or "the CLP Regulation" is Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (REACH). It implements the United Nations Globally Harmonised System of classification and labelling of chemicals (GHS) into EU law:

Regulation (EC) No 1272/2008 (CLP):
http://www.echa.europa.eu/regulations/clp/legislation

Regulation (EC) No 1907/2006 (REACH): http://www.echa.europa.eu/regulations/reach/legislation

The CLP Regulation came into force on 20 January 2009. It fully replaced the Dangerous Substances Directive 67/548/EEC (DSD) and the Dangerous Preparations Directive 1999/45/EC (DPD) from 1 June 2015.

[160] Does CLP apply to me? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
A new Regulation
Version: 1.0
Latest update: 04/06/2015

CLP applies to you if you manufacture, import, use or distribute chemical substances or mixtures. You must classify, label and package any substance or mixture, regardless of its annual tonnage, in accordance with the CLP Regulation before you place it on the EU market. Placing on the market of a substance or mixture means making it physically available to third parties, whether in return for payment or free of charge.
 
If you are a manufacturer or importer, you are required under CLP to classify substances that are subject to registration or to notification in line with Article 7 or 9 of REACH, even if you do not place them on the market. This includes e.g. the classification of substances that are used for product and process-orientated research and development (PPORD).
 
If you are a manufacturer or importer, you must notify hazardous substances that you place on the market on their own or contained in hazardous mixtures above certain applicable concentration limits, regardless of the annual tonnage manufactured or imported, as well as substances subject to registration under REACH and that you place on the market, to the Classification & Labelling Inventory established at the Agency. However, the duty to notify does not apply in case you have already submitted the information which is relevant for a notification under CLP as part of a registration.
[163] Is there any change in the existing EU transport legislation resulting from the new CLP Regulation? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
A new Regulation
Version: 1.0
Latest update: 04/06/2015

Directive 2008/68/EC on the inland transport of dangerous goods which shall have been transposed by Member States into national law by 30 June 2009 includes neither references to CLP nor to the previous legislation on classification and labelling. CLP Article 1(6) states "Save where Article 33 applies this Regulation shall not apply to the transport of dangerous goods by air, sea, road, rail or inland waterways." Accordingly, CLP does not change the transport legislation. However, CLP lays down in Article 33 specific rules for labelling of outer packaging and single packaging which are transported.
[164] What is GHS? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
A new Regulation
Version: 1.0
Latest update: 04/06/2015

GHS stands for the Globally Harmonised System of classification and labelling of chemicals. It provides a basis for uniform physical, environmental, health and safety information on hazardous chemicals at global level through the harmonisation of the classification criteria, labelling rules and guidance on the preparation of Safety Data Sheets. 
 
The GHS is developed and maintained at United Nations level with the aim of avoiding different hazard information requirements on physical, health and environmental hazards for the same chemicals around the world. In addition, it also aims to facilitate trade: by applying GHS across different countries, it will no longer be necessary for an exported chemical to be reclassified and relabelled in order to comply with different classification criteria, labelling rules and Safety Data Sheet requirements of the importing country.
 
For further information on the development of the UN GHS, please see: http://www.unece.org/trans/danger/publi/ghs/histback_e.html 
[165] What are the differences between GHS and CLP? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
A new Regulation
Version: 1.0
Latest update: 04/06/2015

The GHS was implemented through Community legislation in the form of Regulation (EC) No. 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP Regulation) which is legally binding and directly applicable in the Member States of the EU, whereas GHS is not legally binding.
 
GHS and CLP are not identical because CLP is also based on the old EU legislation on classification and labelling, i.e. the Dangerous Substances Directive 67/548/EEC (DSD) and the Dangerous Preparations Directive 1999/45/EC (DPD).
 
In addition, and based on the so-called UN GHS "building block approach", CLP does not include all the hazard categories included for a hazard class because they were not part of DSD, e.g. category 4 of the hazard class flammable liquids, or category 3 (mild irritant) of the hazard class skin corrosion/irritation. CLP includes special labelling and packaging rules that are not part of the UN GHS, but which were brought over from the DSD and DPD, e.g. the rules on small packaging (CLP Article 29), on supplemental information for certain mixtures (Part 2 of Annex II to CLP) and for the provision of child-resistant fastenings or tactile warnings. Also, it includes rules for the situation when a substance is both covered by CLP and by transport legislation (CLP Article 33).
 
It should be noted that in contrast to the UN GHS, CLP does not include specific rules on Safety Data Sheets as they are already regulated by REACH, through its Article 31 and Annex II.
[166] Where can I find the consolidated version of the CLP Regulation? --New Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
A new Regulation
Version: 1.0
Latest update: 04/06/2015

You can find the latest consolidated version of CLP via the ECHA website at: http://echa.europa.eu/web/guest/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.

Annex VI to CLP

[258] Where can I find the updated version of Table 3.1 of Annex VI to CLP? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Annex VI to CLP
Version: 1.1
Latest update: 10/03/2016

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 may not be entirely in line 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 [PDF]).

[259] What is the meaning of the "Footnote" mentioned in particular substance entries in the column displaying the specific concentration limits in Table 3.2 of Annex VI to CLP? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Annex VI to CLP
Version: 1.0
Latest update: 04/06/2015

Table 3.2 of Annex VI to the CLP Regulation took over the harmonised classifications previously contained in Annex I to Directive 67/548/EEC. The "Footnote" in the Specific Concentration Limits column of Table 3.2 contained in Annex VI to CLP reflects, for a number of substances, the "Footnote" appearing for those substances in Annex I to Directive 67/548/EEC where differing concentrations resulted in differing classifications for the flammable, explosive and oxidizing hazards. In other words, these specific concentration limits have been retained in Table 3.2 of Annex VI to CLP with mention of the related differing classification.
 
For example, the entry 007-004-00-1 relating to nitric acid is displayed with the following specific concentration limits: C; R35: C = 20 %, C; R34: 5 % = C < 20 %, Footnote: O; R8: C = 70 %.
 
The Footnote refers to the classification as O; R8 (oxidising) of the substance; a mixture containing that substance, e.g. a water-based solution of nitric acid, will only have to be classified as oxidising if it contains nitric acid in concentrations at or above 70%.
 
Using the term "Footnote" helps those familiar with Directive 67/548/EEC to see the parallel to the system under that Directive. The term "Footnote" does not mean that there is an explanation for the term to be found in Part 1 of Annex VI, which is in contrast to the explanations provided in that Part for the Notes appearing in the Notes column of Table 3.2, e.g. Note B, C or H.
[260] What should you do where you have to use a harmonized classification which is marked as minimum classification in Table 3.1 of Annex VI to CLP? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Annex VI to CLP
Version: 1.0
Latest update: 04/06/2015

In order to take full account of the work and experience accumulated under DSD, all previously harmonised DSD substance classifications have been translated into harmonised CLP classifications. They can be found in Table 3.1 of Annex VI to CLP. 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 should apply this minimum classification ("asterisk classification"), but must classify in a more severe hazard category in cases where they have further information, e.g. in the form of an LD50 value, which shows that this is more appropriate. In other cases the minimum classification should be further refined based on the translation table in Annex VII to CLP: when the physical state of the substance used in the acute inhalation toxicity test is known to the manufacturer or importer, the classification as obtained from Annex VII shall then substitute the minimum classification indicated in Table 3.1 of Annex VI if there is a difference.
[261] When were the harmonised classifications contained in the 1st adaptation to technical progress (1st ATP) of the CLP Regulation to be applied? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Annex VI to CLP
Version: 1.0
Latest update: 04/06/2015

The CLP Regulation was adapted to technical progress for the first time by Commission Regulation (EC) No 790/2009 of 10 August 2009 that entered into force on 25 September 2009. This first Adaptation to Technical Progress (ATP) requires manufacturers, importers and downstream users to apply the harmonised classifications of the substances included in the first ATP from 1 December 2010.
[262] Can a manufacturer, importer or downstream user submit to the Agency a proposal to introduce additional harmonised classification and labelling elements to an existing entry in Part 3 of Annex VI? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Annex VI to CLP
Version: 1.0
Latest update: 02/02/2016

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. 

[263] If a substance is subject to harmonised classification, do I have to classify it for the hazards which are not covered by the entry in Part 3 of Annex VI? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Annex VI to CLP
Version: 1.0
Latest update: 04/06/2015

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.
C&L Platform

[698] What is the C&L Platform?
CLP
C&L Platform
Version: 1.0
Latest update: 04/06/2015

The C&L Platform is a web-based discussion forum, established by ECHA to assist registrants and notifiers of substances to the C&L Inventory in agreeing on entries to be included in the Inventory. Multiple different classifications have been notified for many substances and Article 41 of the CLP Regulation stipulates that “...where the notifications of classification and labelling to the C&L Inventory result in different entries for the same substance, the notifiers and registrants shall make every effort to come to an agreed entry to be included in the inventory…” The Platform is an easy solution for notifiers and registrants to contact each other and discuss the appropriate classification and labelling of their substances.
[699] How can I access the C&L Platform?
CLP
C&L Platform
Version: 1.0
Latest update: 04/06/2015

The C&L Platform can only be accessed through the C&L Inventory and is only accessible to registrants and notifiers of substances to the C&L Inventory. When two or more different classifications have been notified for the same substance, a discuss button becomes available in the summary page for that substance in the C&L Inventory. Upon clicking this button, the users are guided to a login page where they enter the platform discussion room for that substance using their REACH-IT account login details. Only those registrants and notifiers who have submitted a notification for this substance through REACH-IT can access the relevant discussion room. Discussion rooms for other substances are not available and they need to be accessed through their relevant C&L Inventory summary pages.
[700] What should I do after reaching an agreement on the classification and labelling of my substance with other notifiers?
CLP
C&L Platform
Version: 1.0
Latest update: 04/06/2015

When an agreement on the appropriate classification has been reached, the notifiers must update their notifications accordingly through REACH-IT. When updating the notification, the notifiers should indicate that the update is as a result of an agreement reached through the C&L Platform by ticking the appropriate tick-box. All notification tools are compatible with one another when updating. The updated notification will be included in the C&L Inventory upon the next data refresh. When you update a notification by submitting a IUCLID file (e.g. by updating a registration dossier), please indicate that the update is due to a change in the classification and labelling by ticking the appropriate tick box and mention agreement in the C&L Platform in the free-text field alongside it.
[701] Can I use the C&L Platform without revealing my identity?
CLP
C&L Platform
Version: 1.0
Latest update: 04/06/2015

You will not have to reveal your identity to other participants. When you access a discussion room for the first time you can choose whether to post using an automatically generated alias or your real identity. The real identity is the name and surname provided in your REACH-IT user account details. Should you choose to post using an alias, you are presented with the option of continuing to post under the same alias or to use your real identity whenever you access the discussion room. Once you post using your real identity, you cannot revert back to using an alias and all your previous posts will be associated with your real identity. The moderators of the platform (members of ECHA staff) will have access to your real identity. When accessing other discussion rooms, you are presented with the option of using an existing alias, your real identity or a new alias. The identity chosen in each discussion room is independent of other rooms.
[702] I have been banned from a discussion room in the C&L Platform. What should I do now?
CLP
C&L Platform
Version: 1.0
Latest update: 04/06/2015

Users are expected to follow the terms of use of the C&L Platform and, for example, not post inflammatory messages or material of a commercial nature. Upon violation, users may be banned from a discussion room. A banned user cannot access the discussion room or post messages. When a banned user has been posting under an alias, they can opt to continue to post using their real identity or appeal to the C&L Platform moderators to repeal the ban. If a user has posted under their real identity and is subsequently banned, they will need to contact the platform moderators for access. A banned user will receive an email notification with instructions on how to contact the moderators. Banning in one discussion room will not affect access to other rooms.
[703] What is the role of ECHA in the platform?
CLP
C&L Platform
Version: 1.0
Latest update: 04/06/2015

ECHA hosts the C&L Platform and manages its functions, ensuring interlinks with the C&L Inventory and REACH-IT. Members of ECHA staff act as moderators, responding to reports of abuse by users and providing technical assistance to users. ECHA does not participate in and/or actively monitor on-going discussions in the C&L Platform.
Classification

Changes to pre-registration after 1st December 2008

[1152] Can the bridging principle "Review of the classification where the composition of a mixture has changed" be applied where the identity of the hazardous constituents (ingredients) of a mixture change? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Classification
Version: 1.0
Latest update: 26/02/2016

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).


[264] If a substance does not meet the classification criteria under the Dangerous Substances Directive, will it therefore also not be classified under CLP? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Classification
Version: 1.0
Latest update: 04/06/2015

No, not necessarily. 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 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 in cases 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.
[265] May a supplier use data which is available in open literature, e.g. from the internet, online databases, for the purpose of physical hazard classification under CLP? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Classification
Version: 1.0
Latest update: 04/06/2015

Yes, he may, provided the data is reliable and adequate for the purpose of hazard classification. Further to this, available studies should be sufficiently documented to assess their quality and adequacy.  
 
The physical hazards of substances and mixtures should be determined through testing based on the methods or standards referred to in part 2 of Annex I to CLP. These methods can be found for example in the UN Manual of Tests and Criteria, which is normally used to classify substances and mixtures for transport:http://www.unece.org/trans/danger/publi/manual/manual_e.html.
However, testing is not mandatory in cases where adequate and reliable information from reference literature or databases is already available and where the substance to be classified and the substance described in the reference are comparable with regard to homogeneity, impurities, particle size etc. 
 
Open literature or databases often use secondary data sources. When such data is used, the original source should be cited and checked by an expert. This should involve the check that there is sufficient documentation to assess the suitability of the test used, and that the test was carried out using an acceptable level of quality assurance. Useful data compilations containing physicochemical data are listed in section R.7.1.1.2- 'Available information on physicochemical properties' of the Guidance on information requirements and chemical safety assessment on ECHA's website: http://www.echa.europa.eu/guidance-documents/guidance-on-clp
[266] In a case where the classification for physical hazards depends on the particle size of a substance, will a supplier have to classify for all particle sizes? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Classification
Version: 1.0
Latest update: 04/06/2015

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.

[267] In relation to the determination of the aspiration hazard of paints and varnishes: how to convert the viscosity derived from flow time measurements using a flow cup at 23°C ± 5°C according to ISO 2431 into the kinematic viscosity of the paint or varnish at 40°C? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Classification
Version: 1.0
Latest update: 04/06/2015

Under CLP, the classification criteria for the aspiration hazard require the determination of the kinematic viscosity while the viscosity based on flow time is not part of the classification criteria. ISO 2431 contains correlations between flow time and kinematic viscosity. However, there is no general correlation describing the temperature dependence of the viscosity, and expert judgement is necessary.
[268] What are the quality requirements when testing for physical hazards? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Classification
Version: 1.0
Latest update: 04/06/2015

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 shall 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 2.1.5 "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.
 
Any testing organisation that carries out physical hazard tests for classification purposes can therefore choose how to fulfil the quality requirements of CLP.
[269] When classifying and labelling substances that are included in Annex VI to the CLP Regulation, do I need to consider any impurities that might be relevant to classification as stipulated in Article 11(1) CLP? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Classification
Version: 1.0
Latest update: 04/06/2015

Yes, you do. As stated in section 1.1.1.4 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 shall be taken into account for classification purposes in accordance with Article 11(1) CLP.
[270] When does the deletion of Note H in the second ATP to CLP apply to entries in Tables 3.1 and 3.2? --New Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Classification
Version: 1.0
Latest update: 04/06/2015

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 no longer applies to entries marked with the Note from 1 December 2012.
[849] Does Article 37(6) of CLP apply to companies that possess information which obliges them to divert from the minimum classification indicated in Annex VI? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Classification
Version: 0.0
Latest update: 04/06/2015

No, where a minimum classification is given in Table 3.1 of Annex VI to CLP there is no need to submit a proposal amending a harmonised classification to a Member State competent authority in accordance with Article 37(6) of the CLP Regulation in order to apply the more stringent classification.
 
For certain hazard classes, including acute toxicity and STOT RE, Table 3.1 of Annex VI to CLP gives a minimum classification, indicated with an asterisk. For such a minimum classification, a more severe classification shall be used when the conditions described in section 1.2.1 of Annex VI to CLP are fulfilled (Guidance on the application of CLP criteria, section 1.1.10). According to the Guidance, section 1.7.2.1, the minimum classification should only be used if no additional hazard information is available. Thus, a company must assess all information and apply a more stringent classification if appropriate and record the decision basis. A company applying a more stringent classification has therefore classified the substance in agreement with the harmonised classification in Part 3 of Annex VI to CLP.
[850] Is it possible to ‘waive’ a classification by assuming that there is no exposure based on the identified uses or uses advised against communicated in the safety data sheet under REACH? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Classification
Version: 0.0
Latest update: 04/06/2015

No, this is not possible. The classification of hazards is only dependent on the intrinsic properties of a substance or mixture and exposure shall not be taken into account. 
 
The hazards of a substance or mixture are communicated in the supply chain via the label elements and classification/labelling in the safety data sheet. The necessary risk management measures further down the supply chain are based on that information. ‘Waiving’ a classification would interrupt that flow of information down the supply chain. Therefore, it is not possible to waive the requirement for classification based on assumed lack of exposure. 
 
It should, however, be remembered that the form and physical state of a substance or mixture need to be considered in the framework of the hazard classification, in accordance with Articles 5 and 6 of the CLP Regulation.
[1049] Do suppliers have to comply with the harmonised classification and labelling (C&L) of a substance in Annex VI to CLP before the application date indicated in the respective adaptation to technical progress (ATP)? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Classification
Version: 1.0
Latest update: 04/06/2015

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.

[1053] Must you re-classify and label your biocidal product when there is a change in harmonised classification? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Classification
Version: 1.0
Latest update: 04/06/2015

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).

[1138] Should extreme pH be considered when classifying a mixture for skin corrosion/skin irritation or eye damage/eye irritation when it contains an Annex VI substance with a specific concentration limit (SCL) for that endpoint? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Classification
Version: 1.0
Latest update: 09/10/2015

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.

[1186] How can I determine the aspiration toxicity of a mixture based on its components? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Classification
Version: 1.0
Latest update: 26/04/2016

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 3.10.3.3.1.1 of Annex I to CLP).

When these conditions are both met, the mixture must be classified in Aspiration Toxicity Category 1.

Hazard communication with means other than labelling

[271] When does a supplier have to introduce the CLP classifications into the safety data sheet (SDS) for substances and mixtures? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Hazard communication with means other than labelling
Version: 1.0
Latest update: 02/02/2016

Suppliers had to introduce CLP classifications into the safety data sheet (SDS) for substances from 1 December 2010 and for mixtures from 1 June 2015. However, mixtures already placed on the market before 1 June 2015 and classified, labelled and packaged according to the Dangerous Products Directive (DPD) do not need to be re-labelled or re-packaged according to CLP before 1 June 2017. Their SDSs also do not need to be aligned with the CLP classification until 1 June 2017.

In conformity with Article 2 of Regulation (EU) 2015/830, without prejudice to Article 31(9) of REACH, the SDS for mixtures provided to any recipient at least once before 1 June 2015 may continue to be used and need not comply with the Annex to Regulation (EU) 2015/830 until 1 June 2017. For both substances and mixtures, Annex II to REACH was replaced by the Annex to Regulation (EU) 2015/830 from 1 June 2015. 

[272] Which kind of information must be provided in an advertisement for hazardous substances according to CLP Article 48? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Hazard communication with means other than labelling
Version: 1.0
Latest update: 04/06/2015

CLP Article 48(1) outlines the information which must be provided in an advertisement for a substance classified as hazardous. The advertisement shall contain the hazard class and/or the applicable hazard categories, as appropriate, e.g. acute oral toxicity category 3.
[273] What kind of information must be provided in an advertisement for mixtures according to CLP Article 48(2)? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Hazard communication with means other than labelling
Version: 2.0
Latest update: 25/04/2016

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.

[274] Can transport labels be included in section 2.2 of an SDS? --New Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Hazard communication with means other than labelling
Version: 1.0
Latest update: 04/06/2015

No, section 2.2 of an 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).
[847] Where the inner packaging of a chemical product requires a tactile warning to be fitted, does the outer and intermediate packaging also require a tactile warning? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Hazard communication with means other than labelling
Version: 1.0
Latest update: 04/06/2015

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 3.2.2.2 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.
Industry roles under CLP

[167] What roles and obligations do re-fillers have under CLP? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Industry roles under CLP
Version: 1.0
Latest update: 04/06/2015

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 FAQ ID=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.

[168] What roles and obligations do re-importers have under CLP? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Industry roles under CLP
Version: 1.0
Latest update: 04/06/2015

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 should be able to show that the re-imported substance is the same as the one that was originally exported. Finally, the re-importer should 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.
[169] Do distributors have to classify under CLP? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Industry roles under CLP
Version: 1.0
Latest update: 04/06/2015

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 classify themselves. In contrast to other suppliers, a distributor (including a retailer) does not have to classify substances and mixtures himself, 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 relevant substance information to the C&L Inventory.
[170] Is an establishment which is recovering a substance obliged to classify and notify it to the Classification and Labelling Inventory? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Industry roles under CLP
Version: 1.0
Latest update: 04/06/2015

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 according to 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. In case 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 derived in accordance with Title II of CLP already 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.

[171] Do professional and industrial end users have obligations under CLP? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Industry roles under CLP
Version: 1.0
Latest update: 04/06/2015

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 classed 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.
Labelling

[234] Should substances or mixtures which were already placed on the market before 1 December 2010 or 1 June 2015, respectively, and are still in stock after 1 December 2010 or 1 June 2015, respectively, be relabelled according to CLP? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Labelling
Version: 1.0
Latest update: 04/06/2015

According to Article 61(4) CLP, if the substance or mixture classified, labelled and packaged in line with Directive 67/548/EEC (Dangerous Substances Directive, DSD) or in case of mixtures Directive 1999/45/EC (Dangerous Preparations Directive, DPD) has already been placed on the market before 1 December 2010 or 1 June 2015 respectively, the substance or mixture which is still in stock does not have to be relabelled and repackaged in accordance with the CLP rules by the supplier before 1 December 2012 or 1 June 2017 respectively.
 
It is pointed out that under certain conditions, substances manufactured before 1 December 2010 and stored in the manufacturer's warehouse after 1 December 2010 and mixtures prepared before 1 June 2015 and stored in a formulator's warehouse after 1 June 2015 can benefit from the transitional arrangements provided for in Article 61(4). This would normally be the case where the transfer of ownership of the substance or mixture has taken place before 1 December 2010 or 1 June 2015 respectively although the substance or mixture does still remain in the manufacturer's or formulator's warehouse, i.e. no physical hand-over of the substance or mixture. For the notion of "placing on the market" under CLP see also FAQ ID=229
[236] Is the number of hazard statements on the label limited? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Labelling
Version: 1.0
Latest update: 04/06/2015

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.
[237] Is the number of precautionary statements on the label limited? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Labelling
Version: 1.0
Latest update: 04/06/2015

In contrast to the number of hazard statements, the number of precautionary statements is limited on the label. The general rule is that no more than six precautionary statements shall appear on the label unless they are necessary to reflect the nature and the severity of the hazards. Advice on the selection from more than 100 different precautionary statements is given in the Guidance on labelling and packaging available at:
[238] Is a label which is designed according to legislation of non-EU countries implementing the GHS accepted in the EU? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Labelling
Version: 1.0
Latest update: 04/06/2015

In the EU, only those labels which comply with the CLP rules will be accepted. This means that those 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.
[239] Is it mandatory to include the hazard and precautionary statements together with their codes on the label? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Labelling
Version: 1.0
Latest update: 04/06/2015

No, it isn't. CLP Articles 21 and 22 require that the statements as such are put on the label, in accordance with the wording provided in Annex III and Annex IV, Part 2. The codes corresponding to these statements are not required for the label, but are not explicitly excluded. It is up to the supplier to decide whether he will include the codes on the label as well.
[240] When preparing hazard labels, the pre-printing of the diamond form may result in labels where not all diamonds are filled with hazard symbols. Would such empty diamonds be allowed on labels of hazardous substances and mixtures? (EDITED) Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Labelling
Version: 1.0
Latest update: 04/06/2015

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.
[241] Do active substances, plant protection products and biocidal products have to be labelled in accordance with CLP? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Labelling
Version: 1.0
Latest update: 02/02/2016

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).

[242] Is a supplier always required to provide their contact details on the label? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Labelling
Version: 1.0
Latest update: 04/06/2015

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, pursuant to Article 4 (4) a supplier shall 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, e.g. 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.
 
In case 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.
[243] May non-EU hazard information be included on the label along with CLP labelling elements for substances placed on the EU market? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Labelling
Version: 1.0
Latest update: 04/06/2015

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

[244] When designing a label, what are the requirements regarding dimensions and make up of the hazard pictograms, to be used on the label? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Labelling
Version: 1.0
Latest update: 04/06/2015

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 1.2.1.4 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

[245] When a package carries a transport label or mark that corresponds to the same hazard as a CLP pictogram, can the CLP pictogram be omitted? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Labelling
Version: 1.0
Latest update: 04/06/2015

Yes, it can. It is specified in Article 33 (1) and (3) of the CLP Regulation that where a hazard pictogram required by CLP relates to the same hazard as in the rules for the transport of dangerous goods then the CLP pictogram for that same hazard can be omitted from the outer packaging. 
 
In section 5.4 "Interaction between the CLP and the transport labelling rules" of the Guidance on labelling and packaging in accordance with the CLP Regulation, available at http://echa.europa.eu/guidance-documents/guidance-on-clp, it is stated that transport labelling, as referred to in CLP Article 33, includes all marks required by transport legislation, e.g. the mark for environmentally hazardous substances, elevated temperature marks or limited/exempted quantities marks. Therefore, the pictograms depicting the same hazard do not need to appear twice.
[246] If a substance or mixture is produced exclusively for the non-EU market, does it need to be labelled in accordance with CLP before export? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Labelling
Version: 1.0
Latest update: 02/02/2016

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.

[247] Can the outer packaging display both CLP and DPD labelling when the inner components are made up of a CLP compliant substance and a DPD compliant mixture? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Labelling
Version: 1.0
Latest update: 04/06/2015

Yes, it can. Although it was not foreseen to have both CLP and DPD labelling on the outer packaging at the same time, in cases where both the inner and outer labels are compliant with their respective legislative remits, namely CLP and DPD during the transitional period, it is acceptable to have both types of labels on the outer packaging until 1 June 2015, as long as the labelling of the different components is clearly distinguished in the outer packaging. However, if the mixture is voluntarily classified in accordance with CLP before that date, both the inner and outer label for the mixture need to be updated to meet the requirements of CLP.
 
However, as this type of combined CLP and DPD labelling may cause some confusion for end users during the transitional period, those with the responsibility of labelling such products are advised to avoid mixed CLP and DPD labelling where practicable.
[248] Should substance names used on the label be in the official language(s) of a Member State? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Labelling
Version: 1.0
Latest update: 04/06/2015

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 shall 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, substances currently listed in English only in Part 3 of Annex VI to CLP or in the C&L Inventory need to be translated into the official languages(s) of the Member State(s) where it is placed on the market unless the Member State(s) provides otherwise.
 
ECHA plans to make available the translated chemical names of the Annex VI entries in a later version of the public C&L Inventory.
[249] Do containers used for the transport of bulk chemicals (e.g. portable tanks and trailers) meet the definition of a package and fall within the remits of CLP Article 33(3) and as a consequence should they be labelled accordingly? --New Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Labelling
Version: 1.0
Latest update: 04/06/2015

CLP Regulation is not applicable to transport of dangerous goods by air, sea, road, rail or inland waterways, except for the labelling requirements set out in CLP Article 33. Article 33(3) CLP states that single packages that meet the labelling provisions set out in the rules on the transport of dangerous goods shall be labelled both in accordance with CLP Regulation and the transport rules.
 
As CLP does not define what constitutes a 'single package', for the present purposes the definition of 'single package' is taken from the rules on the transport of dangerous goods. The rules on road, rail and inland waterway transport are implemented in Europe by Directive 2008/68/EC. From Annex I, Annex II, and Annex III to Directive 2008/68/EC and the definitions of the ADR it can be inferred that packaging (e.g. boxes, drums and jerry cans), large packaging and IBC are considered to be packaging for transport purposes in the context of CLP Article 33(3) and therefore both a CLP and transport label are required.
 
In contrast, tanks, bulk containers and freight containers are not considered packaging or single package according to Directive 2008/68/EC and the exclusion stated in CLP Article 1(6) may be considered fully applicable during the transport activities. 
[250] When should an importer label their substances/mixtures in line with CLP? --New Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Labelling
Version: 1.0
Latest update: 04/06/2015

Substances and mixtures must be appropriately labelled in accordance with CLP before they are placed on the market, i.e. made available to third parties.Under REACH and CLP Regulations, import is considered to be placing on the market and it is the obligation of an importer to provide labels in line with CLP for substances/mixtures they place on the market. It is, however, at the discretion of the importer to decide when and how this happens, as long as the labels are on the packages when the substance/mixture is placed on the market. They may decide whether this is done by a non-EU supplier, during customs supervision or without undue delay after it reaches its destination.
 
Where importers make use of a distributor, they may not pass this labelling duty to their distributor. The substance/mixture being distributed should be adequately labelled by the importer before it reaches the distributor. 
[251] When is it relevant to allocate the supplemental hazard statement EUH029 - "Contact with water liberates toxic gas" -to a substance or mixture? --New Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Labelling
Version: 1.0
Latest update: 04/06/2015

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.
[252] Are there any exemptions in the CLP Regulation for chemicals supplied in very small quantity packages, when they are considered to present a very low risk? --New Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Labelling
Version: 1.0
Latest update: 04/06/2015

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.

[848] May a supplier put the name, address and phone number of another supplier on the label? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Labelling
Version: 0.0
Latest update: 04/06/2015

Yes, they may. Private labelling is commonly used by industry whereby products are made by a contract manufacturer under licence using different brand labels for different suppliers. Although the CLP Regulation does not explicitly refer to private labelling, its provisions apply in this case. 
 
In accordance with Article 17(1)(a) of the CLP Regulation, a substance or mixture classified as hazardous and contained in packaging shall bear a label including, among others, the name, address and telephone number of the supplier(s). Based on this provision, it is possible to place the name, address and telephone number of more than one supplier on the label. The contact details of any supplier in the supply chain are allowed to be included on the label. More information can be found in the Guidance on labelling, section 4.1, and in the CLP FAQ on labelling (unique ID 242).
 
The responsible supplier should be able to provide additional information in the language of the country where the product is placed on the market.
[1050] If a mixture contains more than four substances contributing to the classification of the mixture, which substances should be identified on the label? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Labelling
Version: 1.0
Latest update: 04/06/2015

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 3.4.3 and Annex II, point 2.8.

[1051] Are CLP pictograms required when outer packaging is marked with the ‘limited/excepted quantity marks’ according to the rules on the transport of dangerous goods? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Labelling
Version: 1.0
Latest update: 04/06/2015

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 (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 ‘limited/excepted quantity 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. CLP labelling may however be used, if desired according to Article 33(1) of CLP.

[1137] When must the precautionary statement P501 be included on the label of a substance or mixture supplied to the general public? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Labelling
Version: 1.0
Latest update: 09/10/2015

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.

Notification-Classification & Labelling (C&L) Inventory

[195] Which substances have to be notified to the Classification and Labelling Inventory? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Notification-Classification & Labelling (C&L) Inventory
Version: 1.0
Latest update: 04/06/2015

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 (= 1 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 of CLP or as specified in Directive 1999/45/EC, where relevant, 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.
[196] Would only substances manufactured or imported in quantities of 1 tonne or more per year be subject to notification? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Notification-Classification & Labelling (C&L) Inventory
Version: 1.0
Latest update: 04/06/2015

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 1 tonne or more per year.
[197] Is it necessary to notify a non-hazardous substance that is also registered under REACH to the Inventory? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Notification-Classification & Labelling (C&L) Inventory
Version: 1.0
Latest update: 04/06/2015

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 Bulk XML file or in IUCLID 5 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 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 according to CLP, the same company does not have to submit a separate notification to the C&L Inventory.

[198] What are the deadlines for notification to the Classification and Labelling Inventory? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Notification-Classification & Labelling (C&L) Inventory
Version: 1.0
Latest update: 04/06/2015

After 1 December 2010, 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 after 1 December 2010. 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 itself, but only again afterwards.
 
For example, you as manufacturer or importer place a substance on the market on 8 November 2010, then you stop doing so for a while, and then you place it on the market again on 1 February 2011. You will then have to calculate the obligatory one month notification deadline from 1 February 2011, and therefore your notification is due on 1 March 2011.
[200] Do I have to notify substances that are classified for a physical hazard and contained in a hazardous mixture? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Notification-Classification & Labelling (C&L) Inventory
Version: 1.0
Latest update: 04/06/2015

Yes, you do. CLP Article 39(b) refers to all hazards. This includes notification of a substance classified for a particular physical hazard and contained in a mixture whenever the mixture is placed on the market and needs to be classified for a physical hazard due to the presence of that substance. It should be noted that the physical hazard class to which the mixture belongs could be different from that of the substance(s) causing the hazard. Expert judgment should be sought in case of doubt.
[201] In view of the obligation to notify according to CLP Article 39(b): How should an importer proceed in case he has only information on the DSD classifications of the substances contained in the mixtures he imports? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Notification-Classification & Labelling (C&L) Inventory
Version: 1.0
Latest update: 04/06/2015

If a mixture that is classified as dangerous (according to DPD - until 01/06/2015) or as hazardous (according to CLP) is imported, CLP Article 39(b) requires that the substances in the mixture which led to this classification be notified to the C&L Inventory. According to CLP Article 40(1), the notified classifications of substances must be the CLP classifications. It may happen that importers are only provided with the DSD classifications of the substances contained in the mixtures, e.g. by means of a Safety Data Sheet, while further data on the substances are not available to them. At the same time the mixture has to be classified as dangerous according to the DPD criteria, due to the presence of these substances. In these situations importers should use the translation table in Annex VII to the CLP and notify the relevant CLP classifications of the substances in the mixture. Further explanation on the use of the Annex VII translation tables is provided in chapter 1.7.- 'THE APPLICATION OF ANNEX VII' of the Guidance on the application of the CLP criteria as published on the ECHA website under http://www.echa.europa.eu/guidance-documents/guidance-on-clp

[202] CLP refers in its Article 40(1) to a "group of manufacturers or importers". Is this the same as a SIEF? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Notification-Classification & Labelling (C&L) Inventory
Version: 1.0
Latest update: 04/06/2015

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. In this case the identity of each member should be specified in the notification.
[203] How should a group of manufacturers/importers for the purpose of notification to the Classification and Labelling Inventory be set up? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Notification-Classification & Labelling (C&L) Inventory
Version: 1.0
Latest update: 04/06/2015

ECHA's REACH-IT system will offer the possibility of signing up as 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 a M/I Group are all manufacturers or Importers. Further guidance can be found in the REACH-IT Industry User Manual Part 15 – Manage your Group of Manufacturers or Importers available at:http://www.echa.europa.eu/support/dossier-submission-tools/reach-it/data-submission-industry-user-manuals
 
When a M/I Group notification is made in REACH-IT, the identity of each member should be specified in the notification. 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 a 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 mention that he is submitting on behalf 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 without the M/I Group, the group is removed from the notification and the other group members are obliged to notify again. For this reason it is recommended that at least one of the group members creates his own REACH-IT account, even if this is not necessary for the group notification itself. If the group members also have their own REACH-IT account, the group leader can make a legal entity transfer to another member of the group before he submits his registration. A legal entity transfer warrants that the group notification is retained in the REACH-IT.
[204] The term "notification" has been used in various contexts in EU chemicals legislation. What is the difference between a notification under Directive 67/548/EEC, a notification under REACH, and a notification under CLP? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Notification-Classification & Labelling (C&L) Inventory
Version: 1.0
Latest update: 04/06/2015

Under Directive 67/548/EEC, notification is related to new substances. The notification process referred to is 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 two different obligations: First, it refers to the obligation to provide basic information to the Agency on substances in articles under the meaning of REACH Article 7(2). Secondly, it refers to the obligation to provide basic information on those substances to the Agency 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, within the meaning of REACH Article 9(2).
 
Finally, "notification" under CLP relates to the C&L Inventory established by the Agency. Manufacturers and importers are required to submit to the Inventory information on the classification and labelling of substances placed on the market, 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.
[205] Who must notify to the Classification and Labelling Inventory? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Notification-Classification & Labelling (C&L) Inventory
Version: 1.0
Latest update: 04/06/2015

Both manufacturers who place a hazardous substance on the market and importers of a hazardous substance will have to notify the classification and labelling of the substance to ECHA. This applies to substances on their own or contained in a hazardous mixture above a relevant concentration limit, which results in the classification of the mixture as hazardous, and irrespective of the quantity placed on the market. The obligation to notify will also apply to manufacturers and importers placing on the market a substance that is subject to registration under REACH, regardless of the classification. A separate notification is not required where the same information (i.e. the classification in accordance with the CLP criteria) has already been submitted as part of a registration under REACH by the same manufacturer or importer. If the registration dossier does not contain that information, it needs to be updated with the CLP information without undue delay. Notification can also be done by a group of manufacturers or importers.
[206] Who is not expected to notify to the Classification and Labelling Inventory? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Notification-Classification & Labelling (C&L) Inventory
Version: 1.0
Latest update: 04/06/2015

Downstream users, including formulators of mixtures, producers of articles as well as distributors of hazardous substances and mixtures do not need to notify to the C&L Inventory. This is because the notification of the respective substances should already have occurred at an earlier stage in the supply chain.
 
Importers of articles are also exempted from the obligation to notify the substances contained in imported articles in all cases where registration of these substances is not required, in accordance with REACH Article 7.
 
Natural or legal persons that manufacture substances, formulate mixtures or produce articles outside the EU cannot notify a substance to the C&L Inventory.
 
Only Representatives (OR) established under REACH only have a formal role when submitting the information which is needed for notification to the C&L Inventory as part of a registration dossier. The CLP Regulation does not foresee a formal role for an OR. However, it is accepted by ECHA that third parties are taking care of the submission of a notification on behalf of a group of manufacturers or importers which they represent. If such a solution is used, the submitting entity must be able to document that it has been mandated to act on behalf and in the name of the manufacturer(s)/importer(s) that are part of the group and that the manufacturer(s)/importer(s) acknowledge that they remain solely and fully responsible to fulfil all their obligations associated with the notification
[207] Can Only Representatives who have been appointed under the REACH Regulation notify to the Classification and Labelling Inventory? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Notification-Classification & Labelling (C&L) Inventory
Version: 1.0
Latest update: 04/06/2015

The CLP Regulation does not foresee a formal role for an OR. However, Only Representatives (OR) appointed under REACH may submit the information needed for notification to the Inventory as part of a REACH registration dossier. They may also submit separate notifications to the Inventory where they are notifying on behalf of a group of importers. Such a group notification should be done using REACH-IT. Contrary to the role of an OR under REACH, where such a solution is sought the importers will still remain responsible for the information notified to the Inventory. The submitting entity must be able to document that it has been mandated to act on behalf and in the name of the manufacturer(s)/importer(s) that are part of the group and that the manufacturer(s)/importer(s) acknowledge that they remain solely and fully responsible to fulfil all their obligations associated with the notification.
[208] The registration deadline for a phase-in substance which is manufactured/ imported in quantities of 1 tonne per year is 1 June 2018. Will this substance have to be notified to the C&L Inventory before that? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Notification-Classification & Labelling (C&L) Inventory
Version: 1.0
Latest update: 04/06/2015

Yes, it will. Any hazardous or non-hazardous substance subject to registration and placed on the market on or after 1 December 2010 has to be notified to the C&L Inventory, unless it has been registered or notified earlier by the same manufacturer or importer. It should be noted that the duty to notify to the C&L Inventory applies to substances subject to registration under REACH irrespective of their registration deadline.
[209] For substances with REACH registration deadlines in 2018, is it necessary to notify a substance to the C&L Inventory before the registration deadline? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Notification-Classification & Labelling (C&L) Inventory
Version: 1.0
Latest update: 02/02/2016

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/web/guest/support/dossier-submission-tools/reach-it/notification-to-the-cl-inventory

[211] What substance identity information is required for notification to the Classification and labelling Inventory? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Notification-Classification & Labelling (C&L) Inventory
Version: 1.0
Latest update: 04/06/2015

The substance identity information required for notification to the C&L Inventory is set out in CLP Article 40 (1) (b); it includes the items listed in point 2.1 to 2.3.4 of Annex VI to REACH. In order to ensure proper identification of a substance, the provided information on substance identity should be consistent and unambiguous.
 
For example, in the case of a multi-constituent substance, the concentrations of its constituents should ideally add up to 100%. The identifiers provided by the notifier (i.e. IUPAC name, EC number, CAS name and CAS number) should also be consistent and they should refer to one substance.
 
For the purpose of notification of an imported substance either on its own or contained in a mixture, the importer should contact his non-EU supplier(s) to find out as much as possible about the identity of his substance.
 
Further guidance on the information required for the identification of substances is provided in the document Guidance for identification and naming of substances under REACH as published on the ECHA) website under http://www.echa.europa.eu/guidance-documents/guidance-on-clp
[212] Is analytical information such as HPLC data, gas chromatograms or a description of the analytical method required for notification to the Classification and labelling Inventory? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Notification-Classification & Labelling (C&L) Inventory
Version: 1.0
Latest update: 04/06/2015

The following substance identity information is not required for the purposes of notifying to the C&L inventory: spectra, HPLC (high-pressure liquid chromatography) data, gas chromatograms nor a description of the analytical methods used for the identification of the substance and its possible impurities and additives. This is in contrast to the registration requirements under REACH where this information is required.
[213] When notifying a substance to the Classification and Labelling Inventory, do its constituents, additives and impurities also have to be notified separately? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Notification-Classification & Labelling (C&L) Inventory
Version: 1.0
Latest update: 04/06/2015

No, they do not. Constituents, additives and impurities of a substance do not need to be notified individually, even if they are hazardous and contribute to the classification of the substance. This is because they are included in the definition of a substance, pursuant to CLP Article 2(7): 'substance' means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition. However, if these impurities, additives or constituents are also marketed as separate substances, these will of course have to be notified.
 
IUCLID 5.2 allows the indication of the presence of any impurities and additives necessary to preserve the stability of a substance as well as their contribution to a classification of the notified substance in section 1.2.
[214] Can a company appear in more than one group of manufacturers/importers? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Notification-Classification & Labelling (C&L) Inventory
Version: 1.0
Latest update: 04/06/2015

Yes, this is possible. A company may appear in more than one group of notifiers provided the substances being notified are different.
[215] How should aqueous solutions of substances be notified according to Article 39 and 40 of CLP? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Notification-Classification & Labelling (C&L) Inventory
Version: 1.0
Latest update: 04/06/2015

By definition, a solution composed of two or more substances is a mixture, see CLP Article 2(8) and REACH Article 3(2).
 
Therefore, substances contained in aqueous solutions should be notified to the C&L Inventory under the conditions of CLP Article 39(a) or (b) when they are placed on the market.
 
However, certain diluted acids and bases may be listed with the notation "%" in Annex VI to CLP. Such entries are treated as substances and should be notified as such to the C&L Inventory under the conditions of CLP Article 39(b) when they are placed on the market. In these cases, the harmonised entry as listed in Annex VI and any self-classifications for the hazard classes or differentiations not covered by this entry, if applicable, should be notified.
[216] Does a manufacturer or importer have to notify substances listed in Annex VI of CLP? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Notification-Classification & Labelling (C&L) Inventory
Version: 1.0
Latest update: 04/06/2015

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 in cases where he has further information which shows that this is more appropriate (see also FAQ ID=260).
 
For non-harmonised hazard classes or differentiations of substances listed on 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.
[217] In relation to non-harmonised classifications, is it possible to notify a classification to the Inventory which differs from already existing entries on the Inventory for the same substance? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Notification-Classification & Labelling (C&L) Inventory
Version: 1.0
Latest update: 04/06/2015

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.
[218] Once a substance has been notified to the C&L Inventory, will manufacturers or importers still have to notify the same substance although it is already on the Inventory? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Notification-Classification & Labelling (C&L) Inventory
Version: 1.0
Latest update: 04/06/2015

Yes, they will. A notification must be made by each legal entity that places the substance on the market. Nevertheless, manufacturers or importers may prefer to notify as a group where only one notifier introduces the notification in REACH-IT on behalf of the other notifiers while introducing the identity of the latter as well.
 
In addition, if you are using the online REACH-IT tool for the submission of a notification and: a) the substance has already been notified by other manufacturer or importer and; b) you consider the displayed C&L for that substance appropriate, you can just tick the box "I agree" and the relevant fields of your notification dossier are automatically filled in.
[219] Does the notifier have to give the reason for no classification according to CLP Art. 40 (1) (d) in cases where classification for an endpoint is excluded by definition? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Notification-Classification & Labelling (C&L) Inventory
Version: 1.0
Latest update: 04/06/2015

Yes, he does. Notifiers, i.e. manufacturers and importers, will always have to provide a justification for "no classification". In line with the principles applied in Data Submission Manual 5 - How to Complete a Technical Dossier for Registrations and PPORD Notifications (page 23), available on the ECHA web site at:http://www.echa.europa.eu/support/dossier-submission-tools/reach-it/data-submission-industry-user-manuals
 
"The reason for no classification should be selected according to the following principles:
- "data lacking" should be selected if you do not have relevant data or other adequate and reliable information that can be compared with the classification criteria; 
- "inconclusive" should be selected if you have data or other information but which is not reliable (e.g. data of poor quality) or if you have several equivocal study results or information. The available data/information cannot be regarded as a firm basis for classification; 
- "conclusive although insufficient for classification" should be selected in cases where a substance is tested with the appropriate high quality study or where other high quality information is available.
 
It is also pointed out that there are certain 'classification waivers' in CLP:
- if a substance is classified for skin corrosion cat.1, it does not need to be classified for serious eye damage (but not vice versa),
- if a substance is classified for certain physical hazards, it does not need to be classified for certain others,
- if a substance has a particular physical state, e.g. it is a gas, it does not need to be classified as an oxidising solid or as corrosive to metals.
 
In case of such classification waivers you should select "conclusive, but not sufficient for classification" as a reason for no classification. 
 
Note that one reason must be selected where a particular classification is not provided. It is up to the company to decide which reason to select. In case you do not fill in any reason for "no classification" in IUCLID 5, the dossier will fail the TCC (technical completeness check).
[220] What is the difference between the labelling information required for a notification to the C&L Inventory under CLP and for a registration under REACH? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Notification-Classification & Labelling (C&L) Inventory
Version: 1.0
Latest update: 04/06/2015

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 of CLP or provided in Part 3 of Annex VI of CLP.
 
For a registration from 1 December 2010, 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 for a hazardous substance. 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. The Agency is currently preparing guidance on the selection of precautionary statements for the CLP hazard label.
[221] Does a notifier have to pay a fee when notifying to the Classification and Labelling Inventory? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Notification-Classification & Labelling (C&L) Inventory
Version: 1.0
Latest update: 04/06/2015

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 of the notification.
[222] Would a company with subsidiaries in two Member States have to notify a substance twice, when it manufactures it in both Member States? --Edited Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Notification-Classification & Labelling (C&L) Inventory
Version: 1.0
Latest update: 04/06/2015

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 REACH FAQ ID=29).

[223] Would only substances manufactured or imported in quantities of 1 tonne or more per year be subject to notification? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Notification-Classification & Labelling (C&L) Inventory
Version: 1.0
Latest update: 04/06/2015

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.
[224] When preparing for the REACH registration of substances which have previously been only used for R&D purposes in amounts below 1 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. Is it required to update the C&L notification every time new information relevant for classification becomes available or are companies allowed to wait until they register the substance? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Notification-Classification & Labelling (C&L) Inventory
Version: 1.0
Latest update: 04/06/2015

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.
[226] Is it possible to flag confidentiality of certain information when notifying to the C&L Inventory? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Notification-Classification & Labelling (C&L) Inventory
Version: 1.0
Latest update: 04/06/2015

Yes, it is. Manufacturers and importers can flag confidentiality of the IUPAC name when notifying certain substances to the Inventory. The substances for which confidentiality of the IUPAC name is possible are those listed in Articles 119(2)(f) and (g) of REACH, i.e.
- non-phase in substances,
- substances only used as one or more of the following:
- as intermediates,
- in scientific research and development,
- in product and process orientated research and development.
 
Where confidentiality of the IUPAC name is flagged when a substance is notified to the Inventory, the IUPAC name will not be displayed on the public part of the Inventory on ECHA's website. Where the IUPAC name has already been claimed confidential under a registration of the substance and ECHA has accepted the justification, the confidentiality claim will automatically be valid for the Inventory as well.
[227] How to flag confidentiality of the IUPAC name for an eligible substance when notifying it to the C&L Inventory? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Notification-Classification & Labelling (C&L) Inventory
Version: 1.0
Latest update: 04/06/2015

To flag confidentiality of the IUPAC name in the C&L Inventory, a manufacturer or importer has to prepare a IUCLID dossier for notification of the substance to the Inventory. In that IUCLID dossier, he is requested to:
- 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), see FAQ ID=216, 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), which is available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:1999:200:0001:0068:EN:PDF
 
Notifiers are requested to provide all three elements for flagging confidentiality.
 
Nota bene: When notifying substance classifications to the C&L Inventory, notifiers must introduce the confidentiality flag through a IUCLID dossier. The other notification tools, i.e. the online and the bulk tool, do NOT include the possibility to flag confidentiality of the IUPAC name.  
[228] Is it necessary to pay a fee for flagging confidentiality? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Notification-Classification & Labelling (C&L) Inventory
Version: 1.0
Latest update: 04/06/2015

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.

[229] What is the meaning of "placing on the market" in the context of CLP? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Notification-Classification & Labelling (C&L) Inventory
Version: 1.0
Latest update: 02/02/2016

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. 

[230] In order to meet the classification and notification requirements, is a manufacturer or importer required to perform physical hazard testing for substances not included in Annex VI to CLP or for substances included in Annex VI, but not classified for a specific physical hazard, and for which no adequate and reliable information is already available for the physical hazards? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Notification-Classification & Labelling (C&L) Inventory
Version: 1.0
Latest update: 04/06/2015

According to CLP Article 40 (3), substances placed on the market on or after 1 December 2010 shall be notified within one month after their placing on the market in accordance with CLP Article 40 (1), while CLP Article 4 (1) stipulates that the manufacturer or importer shall 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 shall 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.
[231] How to notify to the C&L Inventory a specific form of a substance when there is already a harmonised C&L for the same substance in another form in Annex VI to CLP? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Notification-Classification & Labelling (C&L) Inventory
Version: 1.0
Latest update: 04/06/2015

When a notifier is using the REACH-IT online tool to notify a substance already listed in Annex VI to the CLP Regulation, the C&L online functionality will automatically display the harmonised C&L without considering the potential form of the substance being notified.
 
Harmonised classification has to be respected and a notifier should not modify any of those harmonised hazard classes/differentiations. Nevertheless, in some cases, the classification of a substance has been harmonised only for a specific form (e.g. for zinc the harmonised entries refer to the powder or dust form and not to the massive form). In this situation, the substance may be self-classified in a specific form that is different from the form in Part 3 of Annex VI to CLP for some or all hazard classes or differentiations. The self-classification shall be based on the available data for that specific form. 
 
To do so in the REACH-IT online tool, select <I want to notify further classification and labelling information> (cf. Figure 45 of Industry User Manual 16, see link below), and click on the button "Next" to proceed. The C&L page switches to a "write" mode where one can notify further information related to the classification and labelling of the substance (e.g. provide the reason for no classification for all the non-classified hazard classes). We advise notifiers to clearly specify in the online notification the exact form of the notified substance.
 
[232] Can the C&L notification number be used to identify a substance when searching the public C&L inventory? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Notification-Classification & Labelling (C&L) Inventory
Version: 1.0
Latest update: 04/06/2015

No, a substance can only be identified by searching either with the CAS number, EC number or the substance identity. The C&L notification number can only be used by the notifier via REACH-IT.
[233] Does the notification number received when a substance is notified to the Classification and Labelling Inventory need to be communicated through the supply chain (SDS, label, etc.)? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Notification-Classification & Labelling (C&L) Inventory
Version: 1.0
Latest update: 04/06/2015

No, manufacturers or importers do not have the obligation to inform downstream users that they have submitted a notification to the C&L Inventory. Furthermore, there is no need for downstream users to receive confirmation from upstream suppliers that substances have been notified to the C&L Inventory in order to continue the use of the substances in their own products. Similar to the REACH pre-registration number, the C&L notification number is for internal use for the importer/manufacturer as receipt/proof of notification. It does not need to be communicated to the DU/distributor.
 
A notification number cannot be considered as an identifier according to Article 18 CLP and it is not the inventory reference number published in the C&L Inventory.
[253] What is the process to request the use of an alternative chemical name for a substance contained in a mixture? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Notification-Classification & Labelling (C&L) Inventory
Version: 1.0
Latest update: 02/02/2016

A request to use an alternative name is made in line with the provisions under Article 24 of the CLP Regulation. This request is submitted to ECHA and any request approved by the Agency will be applicable in all EU Member States.

It should be noted that requests made and approved by Member State competent authorities under Article 15 of the Dangerous Products Directive before 1 June 2015 remain valid under CLP as indicated in Article 24(9) of CLP. 

[846] Are importers obliged to submit information on the impurities/additives of an imported substance in a mixture to fulfil the notification obligation under Article 40 (1) of CLP? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Notification-Classification & Labelling (C&L) Inventory
Version: 1.0
Latest update: 04/06/2015

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.

Public C&L Inventory

[628] What is the Classification & Labelling Inventory?
CLP
Public C&L Inventory
Version: 1.1
Latest update: 04/06/2015

The Classification & Labelling (C&L) Inventory is a database which contains classification and labelling information on substances notified under Regulation (EC) No 1272/2008 (the CLP Regulation) and registered under Regulation (EC) No 1907/2006 (the REACH Regulation). It also contains the list of legally binding harmonised classifications (Tables 3.1 and 3.2 of Annex VI to the CLP Regulation). It is established and maintained by ECHA.

The C&L Inventory serves multiple purposes:

- It is a tool for hazard communication and a source of basic information on substances placed on the market which meet the criteria for classification as hazardous or are subject to registration, for suppliers of substances, the general public and Member State Competent Authorities (MSCAs);

- It reveals differences in the classification and labelling of the same substance applied by different suppliers, thus pointing to the need for further discussion among companies to explore the reasons for differences and/or agree on the correct classification, evaluation needs or the need for a legally binding harmonisation of a particular classification and labelling of a substance;

- It is an important tool for hazard communication and risk management, e.g. when MSCAs assess the need for potential authorisations and restrictions of hazardous substances under REACH.

[629] What is the content of the public Classification and Labelling (C&L) Inventory?
CLP
Public C&L Inventory
Version: 1.1
Latest update: 04/06/2015

Article 42 of the CLP Regulation and Article 119(1) of the REACH Regulation stipulate which elements of a notification should be publicly accessible in the Classification and Labelling Inventory.  These consist of certain elements of the substance identity and all classification and labelling (C&L) elements.   The EC name and number of all notifications for EINECS substances and, wherever possible, all other substances in the EC inventory, are published.  In addition, when a substance is classified in certain hazard classes referred to in Article 119(1)(a) of the REACH Regulation by at least one notifier then the C&L elements are published from all notifications for that substance.  The IUPAC name is only published from notifications classifying in the hazard classes referred to in Article 119(1), however.

Flags in the Public C&L Inventory also indicate whether the displayed classification and labelling is derived from a joint submission in the REACH registration process and in the future agreed entries between the notifiers according to Article 41 to CLP will be flagged.

The information published in the C&L Inventory is not reviewed or verified by ECHA or any other authority and can be changed without prior notice. ECHA does not guarantee the correctness of the information published in the database as it is automatically disseminated from the notifications and registration dossiers.

[630] What is NOT in the Public C&L Inventory?
CLP
Public C&L Inventory
Version: 1.0
Latest update: 04/06/2015

The Public C&L Inventory does not contain contact details of notifiers or registrants, as this is not foreseen in the CLP Regulation. In order not to disclose confidential business information, no detailed information on impurities or additives is included in the Public C&L Inventory either. In addition, notifiers and registrants have the possibility to claim the IUPAC name confidential (further information on how to flag the IUPAC name confidential can be found in Data Submission Manual Part 12). If so, it will not be included in the Public C&L Inventory.

Furthermore, IUPAC names of substances from notifications which do not classify in one or more of the hazard classes stipulated in Article 119(1)(a) of REACH, are not included.  If no substance identifier (EC name or number, IUPAC name, CAS no etc.) can be published, the notification cannot be displayed in the public inventory.

[631] How can I search information in the Public C&L Inventory?
CLP
Public C&L Inventory
Version: 1.0
Latest update: 04/06/2015

The Public C&L Inventory provides for multiple search options based on both substance identity and classifications. If one is interested in a particular substance or group of substances it can be searched using the full or partial EC name, the name as contained in Annex VI of the CLP Regulation, the IUPAC name or the full or partial EC, CAS or Annex VI Index numbers.

For ease of use, the classifications have been separated into physical, health and environmental hazard classifications and the user can choose either the abbreviated hazard class and category codes (e.g. Acute Tox. 4) or the hazard statement code (e.g. H302).  Combining the substance identity and classification elements will further refine the search results.

The search results are provided based on substances. By selecting one substance from the results, the user is guided to a summary page listing first the harmonised entries (if any) and then the aggregated classifications from the notifications. A further selection of a particular aggregation will provide the detailed view of the aggregated notification.

ECHA has noticed that in individual cases a wrong substance name has been supplied by notifiers with their notification. As ECHA displays the information as provided in the notifications, without verification of the accurateness of the data, this may result in spurious results when searching by substance name, as a seemingly unrelated substance could be displayed in the results. In such cases, it is advised to use the second page view where all published IUPAC names are listed, to identify whether the initially displayed name was incorrect. The grouping of substances is based on numerical identifiers and is not affected by inaccuracies in the substance name.

[632] Are notifications for the same substance grouped? If so, what aggregation rules are applied?
CLP
Public C&L Inventory
Version: 1.0
Latest update: 04/06/2015

The notifications for each substance are grouped together based on numerical identifiers such as EC or CAS numbers, where they exist. For display purposes, identical classifications are aggregated and are displayed as one entry. The number of notifications behind each aggregated classification is also indicated. The aggregation is done automatically based on both classification and labelling elements. Different states/physical forms and different reasons for no classification have not been considered during aggregation. Those differences, if any, are reflected in the detailed view of the classification entry.
[633] I have notified a substance but cannot find it in the Public C&L Inventory. What could be the reason for this?
CLP
Public C&L Inventory
Version: 1.0
Latest update: 04/06/2015

If you have just recently submitted your notification it will be included with the next data refresh of the Public C&L Inventory. A time-stamp on the search page indicates when the last refresh was made. Furthermore, ECHA only publishes those substances that are either in the EC inventory or have been notified as hazardous (according to Article 119(1) of REACH) by at least one notifier. Should your substance not be included in the above, ECHA cannot display a suitable substance identifier and the notification is not displayed.
[634] Can you confirm that details such as molecular formula, structural formula, and molecular weight will not be visible to the public when the substances are notified to the C&L Inventory?
CLP
Public C&L Inventory
Version: 1.0
Latest update: 04/06/2015

ECHA does not publish information submitted with C&L notifications which is not referred to in Article 119(1) of the REACH Regulation.
[635] Can I use the list number of the substance to search in the Public C&L Inventory?
CLP
Public C&L Inventory
Version: 1.0
Latest update: 04/06/2015

No, you cannot. During pre-registration ECHA has automatically assigned list numbers to substances not yet listed in the European Inventory of Existing Commercial Chemical Substances (EINECS), the European List of New Chemical Substances (ELINCS) and the No-Longer Polymers (NLP) list. These automatically assigned list numbers during (pre-) registration have no formal status and thus will not be published in the C&L Inventory. The only numerical substance identifiers that can be used to perform a search are official EC and CAS numbers and the Annex VI Index number (for substances with a harmonised classification and labelling).
[636] Can the C&L notification number be used to identify a substance when searching the Public C&L Inventory?
CLP
Public C&L Inventory
Version: 1.0
Latest update: 04/06/2015

No, a substance can only be identified by searching either with the CAS number, the official EC number, for substances with a harmonised classification and labelling the Annex VI Index number, or the substance name, while the C&L notification number can only be used by the notifier via REACH-IT.
[637] Why are there differing classifications for the same substance?
CLP
Public C&L Inventory
Version: 1.0
Latest update: 04/06/2015

One main aim of the inventory is to promote uniform classification of substances. However, it is to be expected that, initially, for many substances different classifications will have been notified. Some of these can be explained by technical errors made during the notification process (e.g. not assigning all labelling elements correctly) or slight differences in seemingly identical notifications (e.g. affected organs or route of exposure differs). However, notifiers can also disagree on the classification of a substance based on different interpretation of scientific studies or different access to those studies. In any case, notifiers have the legal obligation to make every effort to come to an agreed entry to be included in the inventory and inform ECHA accordingly (see Article 41 of the CLP Regulation).

There can also be different legitimate reasons why notifications for the same substance have different classifications. Different compositions or impurity profiles often lead to different classifications and the physical state and form of a substance is often very important when the hazards of a substance are assessed. The Public C&L Inventory displays the notified state and form but does not contain any information on composition or impurities.

[638] Can I rely on the classification and labelling information published in the public C&L Inventory? For example, if the classification and labelling for one substance from various suppliers differ would the C&L Inventory inform me with the 'correct' classification for my substance?
CLP
Public C&L Inventory
Version: 1.0
Latest update: 04/06/2015

The public C&L Inventory displays the notified classifications as they are reported to ECHA. No verification of the content is performed by the Agency. The notifications should therefore reflect the situation on the market. While notifiers have an obligation to undertake all efforts to come to an agreement on the classification for their substance, many may legitimately differ based on e.g. impurities or composition. This may not be immediately apparent in the public C&L Inventory. We encourage all users to discuss their concerns with their suppliers should they have any but there will be no single "correct" classification identified and highlighted by ECHA. However, the public C&L Inventory will indicate where a legally binding harmonised classification is included in Annex VI of the CLP Regulation and where the classification of a substance is the result of a joint registration under REACH.
[639] How can companies get in touch with each other and when will they be able to do so? Would notifiers be put in touch with others if there is a disagreement over the classification?
CLP
Public C&L Inventory
Version: 1.1
Latest update: 04/06/2015

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.

In order to aid this process, ECHA has launched the C&L platform to allow notifying companies to get in contact with each other, so that they can start discussing different classification and labelling entries for the same substance. The C&L Platform is accessible through the “Discuss” button on each substance summary page.  For more information please see http://echa.europa.eu/web/guest/information-on-chemicals/cl-inventory/cl-platform

[640] It is not possible to make a C&L notification redundant. Does this mean that if a company makes a notification for a substance and then stops supply their C&L notification for that substance will still be on the C&L inventory many years after they have stopped supply and may no longer be accurate?
CLP
Public C&L Inventory
Version: 1.0
Latest update: 04/06/2015

Cease of manufacture or import does not automatically mean that a substance is no longer on the market. However, ECHA is currently investigating the possibilities of being able to indicate the submission date or when the notification has been updated for the last time in the public C&L Inventory. This information may allow concluding on the actuality of the classification and labelling information for the substance displayed in the Inventory.
[641] Is the harmonised list according to DSD criteria (Table 3.2 of Annex VI to CLP) in the Public C&L Inventory?
CLP
Public C&L Inventory
Version: 1.1
Latest update: 04/06/2015

The classification and labelling of harmonised substances according to the DSD criteria (Table 3.2 to Annex VI of CLP) is included in the C&L Inventory.  The DSD classification of each harmonised substance can be found directly underneath the CLP classification.  We have also included the categorisation of harmonised substances according to the Seveso II Directive.

[642] Why are the precautionary statements not published?
CLP
Public C&L Inventory
Version: 1.0
Latest update: 04/06/2015

Pursuant to Article 40(1)(f) of the CLP Regulation, 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 of CLP or provided in Part 3 of Annex VI to CLP. ECHA does not consider precautionary statements as part of the classification and labelling within the meaning of Article 119(1) of the REACH Regulation. In addition, the provision of precautionary statements is not compulsory in C&L notifications. Furthermore, the precautionary statements are not listed in the tables with harmonised classification and labelling.
[643] Some aggregated notifications have no classification elements visible while others are labelled "not classified". What is the difference between these?
CLP
Public C&L Inventory
Version: 1.1
Latest update: 04/06/2015

When notifiers wish to notify a substance for which they believe no classification is required, they can tick the appropriate tick-box (labelled "not classified"). In this case, no further details on the classification and labelling of the substance are needed. The C&L Inventory displays these notifications with the label "not classified" and the third page view is disabled. Some notifiers have submitted notifications with no C&L elements but which the tick-box "not classified" was not ticked. For these notifications, ECHA cannot verify whether their intention was to submit no classification or whether the notifier simply forgot to add the C&L elements. These notifications are therefore displayed separately.

[644] Will I have the possibility to download my search results from the C&L Inventory?
CLP
Public C&L Inventory
Version: 1.1
Latest update: 04/06/2015

Yes, there is a possibility to download and export the search results in excel or csv format.  No classification and labelling information can be downloaded.

[645] How can I use my search results from the C&L Inventory?
CLP
Public C&L Inventory
Version: 1.0
Latest update: 04/06/2015

Reproduction or further distribution of search results may be subject to copyright protection. Please note that using this information without obtaining the permission from the owners of the respective information might violate the rights of the owner. ECHA is not responsible for any copyright or other infringements that may be caused by you using the information.
Request for use of an alternative chemical name

[255] Is there a form available for an application to request the use of an alternative chemical name for a substance contained in a mixture? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Request for use of an alternative chemical name
Version: 1.0
Latest update: 04/06/2015

A request for the use of an alternative chemical name, according to Article 24 of the CLP Regulation, can be submitted to ECHA for substances in mixtures which are classified, labelled and packaged according to CLP.
 
The request is to be prepared and submitted as is explained on the specific web page at:http://echa.europa.eu/support/dossier-submission-tools/reach-it/requesting-an-alternative-chemical-name-in-mixtures
[256] What fees are payable for requests for use of an alternative name? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Request for use of an alternative chemical name
Version: 1.0
Latest update: 04/06/2015

A manufacturer, importer or downstream user of a substance in a mixture may submit a request to the European Chemicals Agency, hereinafter 'the Agency', to use an alternative chemical name on the label and in the safety data sheet. Such requests under Article 24(1) should be accompanied by a fee. The level of the fees collected by the Agency, as well as the rules for payment are determined by Regulation (EU) No 440/2010 of 21 May 2010 on the fees payable to the European Chemicals Agency, are pursuant to Regulation (EC) No 1272/2008.
[257] When diluting a substance in water, can we consider the result of this dilution as a mixture and, as such, to fulfil the conditions of Article 24 (1) of the CLP Regulation allowing submission of a request to use an alternative chemical name? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Request for use of an alternative chemical name
Version: 1.0
Latest update: 04/06/2015

According to CLP Article 24(1), a request to use an alternative chemical name on the label and on the safety data sheet refers to a substance in a mixture where the substance meets the criteria set out in Part 1 of Annex I to CLP.
 
When a substance is diluted with water, the water can be separated from the substance without affecting the stability or changing the composition of the latter, see CLP Article 2(7). Consequently, the diluent water must be considered as a substance on its own. When a diluent is mixed with another substance, a mixture in accordance with the definition set out in CLP Article 2(8) is generated.
 
Thus, a substance which is diluted in water and which meets the criteria set out in part 1 of Annex I to CLP is eligible for a request for an alternative chemical name according to CLP Article 24.
Scope and exemptions under CLP

[172] Will radioactive substances and mixtures have to be classified or notified under CLP? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Scope and exemptions under CLP
Version: 1.0
Latest update: 04/06/2015

No, they will not.Radioactive substances and mixtures within the scope of Directive 96/29/Euratom are exempted from the scope of CLP. The reason for the exemption is that this legislation already lays down provisions for the protection of workers and the general public arising from ionising radiation, so there is no need to apply CLP in addition.
[173] Will substances and mixtures under customs supervision have to be classified and notified under CLP? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Scope and exemptions under CLP
Version: 1.0
Latest update: 04/06/2015

No, they will not. These substances and mixtures are not subject to the provisions of the CLP Regulation, provided that they are either in temporary storage, in a free zone or a free warehouse with a view to re-exportation, in transit, and remain under customs supervision.
 
Importers of substances or mixtures, who wish to rely on the exemption from CLP, need to ensure that these substances and mixtures meet all of the following conditions:
  • they are placed in a free zone or free warehouse as defined under customs legislation or placed under another relevant customs procedure (transit procedure, temporary storage)
  • they are kept under the supervision of the customs authorities and
  • they do not undergo any form of treatment or processing.
For this purpose, a free zone or a free warehouse on EU territory is regarded as being part of the EU.
 
If there is doubt, it is recommended to contact the customs authorities, who can clarify the applicable customs rules established by Regulation (EEC) No 2913/92 on the Community Customs Code.
[174] Will a non-isolated intermediate have to be classified and notified under CLP? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Scope and exemptions under CLP
Version: 1.0
Latest update: 04/06/2015

No, they will not: As long as an intermediate falls under the definition of REACH Article 3(15)(a) concerning non-isolated intermediates, it is exempted from any obligations under CLP.It must be noted, however, that quantities of the same substance may be used in other operations or under other conditions than mentioned in this definition, which would imply that those quantities cannot be regarded as "non-isolated intermediate", but rather as a substance that may be placed on the market. Only the quantities of the substance used under the conditions qualifying it as a "non-isolated intermediate" are exempted from CLP. For the remaining quantities, the relevant requirements under CLP must be fulfilled.
[176] Do "new" substances notified under Directive 67/548/EEC (NONS) have to be classified, packaged and labelled in accordance with the CLP criteria and notified to the Classification and Labelling Inventory? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Scope and exemptions under CLP
Version: 1.0
Latest update: 02/02/2016

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. 

[177] Will waste have to be classified and notified to the Classification and Labelling Inventory? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Scope and exemptions under CLP
Version: 1.0
Latest update: 04/06/2015

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.

[178] Will medicinal products need to be classified and notified to the Classification and Labelling Inventory? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Scope and exemptions under CLP
Version: 1.0
Latest update: 04/06/2015

Substances and mixtures which are in the finished state and intended for the final user and which are medicinal products within the scope of Directive 2001/83/EC on the Community code for medicinal products for human use, or veterinary medicinal products within the scope of Directive 2001/82/EC on the Community code relating to veterinary medicinal products are on the whole exempted from the provisions of the CLP Regulation, i.e. they do not have to be classified, packaged, labelled and notified to the C&L Inventory.
 
However, in cases where a manufacturer or importer supplies substances and mixtures, e.g. active pharmaceutical ingredients (APIs) or excipients, that are not yet in the finished state, this manufacturer or importer will have to classify, package and label these substances and mixtures in accordance with CLP. In addition, if these substances are placed on the market, they will also have to be notified to the C&L Inventory.
 
The exemption from the provisions of the CLP Regulation does not distinguish between active and non-active pharmaceutical ingredients: it applies to any substance or mixture used in medicinal products, e.g. excipients, which is in the finished state and intended for pharmaceutical use.
[179] Are medicine tablets in a drum being sent to the EU for packaging considered to be "in the finished state and intended for the final user" and therefore exempted from Article 1(5)a of the CLP Regulation? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Scope and exemptions under CLP
Version: 1.0
Latest update: 04/06/2015

Yes they are. According to Directive 2001/83/EC on the Community code for medicinal products for human use, medicine tablets are medicinal products and exempted from the provisions of the CLP Regulation if they are in the finished state. The finished state of the medicinal product relates to the substance or mixture and not to its package since re-packing the tablets does not alter the substance/mixture.Bulk tablets that will not be altered after having been produced are therefore considered in the finished state intended for the final user. Therefore, it is neither necessary to classify, label and package these bulk tablets according to CLP nor to notify them to the C&L inventory.
 
However, it will be necessary to take worker health and safety considerations into account to ensure the safe handling of these bulk tablets during the transfer and packaging stages, until they reach the final user in the appropriate package with appropriate safe use instructions.
[180] Will medical devices need to be classified and notified to the Classification and Labelling Inventory? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Scope and exemptions under CLP
Version: 1.0
Latest update: 04/06/2015

Substances and mixtures which are medical devices as defined in Directives 90/385/EEC and 93/42/EEC and which are invasive or used in direct physical contact with the human body, as well as those covered by Directive 98/79/EC, are exempted from the provisions of CLP on the whole if they are in the finished state and intended for the final user:
- Substances and mixtures covered by Directive 90/385/EEC that are invasive or used in direct physical contact with the human body would include cochlear implants, implantable cardiac pacemakers, implantable defibrillators and implantable nerve stimulators,
- Substances and mixtures covered by Directive 93/42/EEC that are invasive or used in direct physical contact with the human body would include sutures, catheters, stents, balloon catheters and wound dressings and
- Substances and mixtures covered by Directive 98/79/EEC would include reagents for diagnostic of Hepatitis C and HIV, self-diagnosis devices for the measurement of blood sugar and IVD Analysers.
 
As the substances and mixtures mentioned above are exempted from the provisions of CLP, they do not need to be classified, packaged, labelled and notified to the C&L Inventory. However, for substances that are manufactured or imported in volumes of at least 1 tonne per year, either on their own or contained in a mixture, the obligation to classify (but not label, package and notify) may still arise from REACH because such substances would have to be registered.
[181] Will cosmetic products have to be classified and notified to the Classification and Labelling Inventory? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Scope and exemptions under CLP
Version: 1.0
Latest update: 04/06/2015

Similarly to other exempted substances and mixtures referred to in CLP Article 1.5 which are in the finished state and intended for the final user, substances and mixtures in the form of cosmetic products as defined in Directive 76/768/EEC on the whole are exempted from the provisions of CLP. However, for substances that are manufactured or imported in volumes of at least 1 tonne per year, either on their own or contained in a mixture, the obligation to classify (but not label, package and notify) may still arise from REACH because such substances would have to be registered.
 
Note that a manufacturer, importer or downstream user (formulator) who supplies a substance or mixture which is not yet in the finished state is obliged to classify, package and label it in accordance with CLP. Furthermore, a manufacturer or importer is obliged to notify the relevant substances in line with the provisions on notification to the C&L Inventory.
[182] Will food and feeding stuffs have to be classified, labelled and packaged according to CLP, and their substances notified to the Classification and Labelling Inventory? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Scope and exemptions under CLP
Version: 1.0
Latest update: 04/06/2015

According to Article 1(5)(e) of CLP, the CLP Regulation does not apply to food and feeding stuffs, as defined in Regulation (EC) No 178/2002 (Food Safety Regulation), and which are in the finished state intended for the final user. The CLP Regulation does not define the term "final user", but Regulation (EC) No 178/2002 defines "final consumer" as "the ultimate consumer of a foodstuff who will not use the food as part of any food business operation or activity". The same concept can be applied in the context of CLP. This also applies to the use of a substance or a mixture 
- as a food additive in foodstuffs within the scope of Directive  89/107/EEC,
- as a flavouring in foodstuffs within the scope of Directive 88/388/EEC and Decision 1999/217/EC,
- as an additive in feeding stuffs within the scope of Regulation (EC) No 1831/2003 or
- in animal nutrition within the scope of Directive 82/471/EEC.
 

Since Article 1(5)(e) of CLP only refers to food or feeding stuffs in the final state intended for the final user substances or mixtures used in food or feeding stuffs at any stage of production are not exempt from CLP and therefore must be classified, packaged, labelled and notified. For instance, the CLP Regulation applies to the manufacturer/supplier of a food additive (e.g. preservatives) who supplies the substance to another company that uses it in the production of food. In such a case, the chemical substance in the form in which it is supplied should not be regarded as a product being in the finished state intended for the final user, and the exemption stated in Art. 1(5)(e) CLP is not applicable (see also FAQ ID=179).

[183] Do I have to notify explosive articles to the Classification & Labelling Inventory? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Scope and exemptions under CLP
Version: 1.0
Latest update: 04/06/2015

If you are a manufacturer or importer of an explosive substance (explosive according to the CLP criteria) that will be incorporated into an article at a later stage you do need to notify that substance. However, you do not have to notify explosive articles.
[184] Must the classification and labelling of polymers be notified to the Inventory? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Scope and exemptions under CLP
Version: 1.0
Latest update: 04/06/2015

A polymer is a substance and must be notified on the basis of Article 39(b) and 40(1) of the CLP Regulation if it fulfils the criteria for classification as hazardous and it is placed on the market.
[185] Will substances and mixtures used in scientific research & development have to be classified and notified under CLP? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Scope and exemptions under CLP
Version: 1.0
Latest update: 04/06/2015

Both substances and mixtures used in scientific experimentation, analysis or chemical research are exempted from the obligations of CLP as a whole, provided they are not placed on the market and they are used under controlled conditions in accordance with Community workplace and environmental legislation. However, as soon as substances and mixtures used in scientific research & development (R&D) are physically made available or supplied to another legal entity, for example by sending samples from a university to another research institute or by importing such samples, this is considered as "placing on the market" (see CLP Article 2(18)). In this case CLP requires the supplier or importer to classify according to the available information, to label and package the sample of a hazardous substance or mixture according to CLP and to notify to the C&L Inventory the substance(s) contained therein if it/they meet(s) the criteria for classification as hazardous on the basis of available information.
[186] Should companies notify substances used in scientific research & development (R&D) to the C&L inventory for which – in particular in the early stages of research – insufficient data is available for classification in line with the criteria in Title II and Annex I of the CLP Regulation? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Scope and exemptions under CLP
Version: 1.0
Latest update: 04/06/2015

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 FAQ ID=226, 227 and 228). If further information becomes available that leads to a change of the classification, the C&L notification has to be updated (see also FAQ ID=224).

[187] Is it necessary to notify substances to the C&L Inventory that are exempted from registration under REACH? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Scope and exemptions under CLP
Version: 1.0
Latest update: 04/06/2015

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). 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.
[188] Is it necessary to notify substances to the C&L Inventory that are exempted from registration through Annex IV to REACH? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Scope and exemptions under CLP
Version: 1.0
Latest update: 04/06/2015

Yes, in principle it is, if they are placed on the market and meet the criteria for classification as hazardous. On the other hand, Annex IV only includes those substances which, according to common available information, display marginal hazardous properties only. As long as a manufacturer or importer concludes that it is inappropriate to classify a specific substance listed in Annex IV as hazardous, he does not need to notify it to the C&L Inventory.
[189] Is it necessary to notify substances to the C&L Inventory that are exempted from registration through Annex V to REACH? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Scope and exemptions under CLP
Version: 1.0
Latest update: 04/06/2015

Yes, it is, if they are placed on the market and meet the criteria for classification as hazardous. Annex V to REACH lists categories of substances as well as individual substances, e.g. certain naturally occurring substances, fatty acids and glass, which are exempted from registration under REACH as registration is deemed inappropriate or unnecessary. For certain categories, the absence of classification is a pre-condition for the exemption from registration. Other substances which are included in Annex V may have hazardous properties and therefore need to be notified according to CLP whenever they are placed on the market. However, as long as a manufacturer or importer concludes that it is inappropriate to classify a specific substance covered by Annex V, he does not need to notify information on that substance to the C&L Inventory.
[190] Will alloys have to be classified, labelled and notified under CLP? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Scope and exemptions under CLP
Version: 1.0
Latest update: 04/06/2015

Alloys are considered as special mixtures under the REACH and CLP Regulations. Alloys as well as their components need to be classified and labelled in accordance with CLP. The components of an alloy will have to be notified if they are hazardous and contained in an alloy above specified concentration limits, in accordance with CLP Article 39(b).
 
In relation to classification for the aquatic hazard class, Annex IV, section 5.5- 'Classification of mixtures of metal compounds' of the Guidance on the Application of the CLP Criteria notes that metal alloys, or alloy manufacturing products, are not simple mixtures of metals or metal components, since the alloy clearly has distinctive properties compared to a classical mixture of its component metals. 
 
Regarding labelling, point 1.3.4 of Annex I to CLP provides that metals in the massive form, as well as alloys, do not require a label if they do not present a hazard to human health by inhalation, ingestion or contact with skin or to the aquatic environment in the form in which they are placed on the market, although classified as hazardous in accordance with the classification criteria of CLP. However, the supplier shall provide the information on the classification of an alloy to downstream users or distributors by means of the Safety Data Sheet. 
 
According to point 2.7 of Annex II to CLP, special labelling rules apply to alloys containing cadmium and which are intended to be used for brazing or soldering.  They shall bear the following statement: "Warning! Contains cadmium. Dangerous fumes are formed during use. See information supplied by the manufacturer. Comply with the safety instructions." (EUH207).
[191] Do active substances contained in plant protection or biocidal products have to be classified in accordance with CLP? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Scope and exemptions under CLP
Version: 1.0
Latest update: 04/06/2015

Yes, they do. Active substances contained in plant protection or biocidal products have to be classified according to the CLP criteria as of 1 December 2010. In contrast to other substances supplied and used in the industrial supply chain, all hazard classifications of these substances will normally be harmonised at the EU level. The harmonised classifications appear in Tables 3.1 and 3.2 of Annex VI to CLP. However, where new information is available which may lead to a change of the harmonised classification, the procedure for harmonisation of classification and labelling of substances shall apply in accordance with Articles 36 (2) and 37 (1), (4), (5) and (6). It is also noted that the requirement for self-classification for hazard-classes and differentiations not covered by the harmonised classification as provided for in Article 4 (3) equally applies to plant protection or biocidal products.
[192] Do active substances contained in plant protection products and biocidal products have to be notified to the Classification and Labelling Inventory? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Scope and exemptions under CLP
Version: 1.0
Latest update: 04/06/2015

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.

[193] Do the monomers and any other substance used for the manufacturing of a polymer have to be notified to the Classification and labelling Inventory by the importer of the polymer? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Scope and exemptions under CLP
Version: 1.0
Latest update: 04/06/2015

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.

[194] Are substances occurring in nature exempted from CLP? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Scope and exemptions under CLP
Version: 1.0
Latest update: 04/06/2015

A number of substances and mixtures are exempt from the requirements of CLP in accordance with CLP Article 1. Substances occurring in nature, as defined in Article 3(39) of REACH, are not explicitly included in these exemptions. If substances occurring in nature are placed on the market in a form not listed in Article 1(5) of CLP, which are in the finished state and intended for the final user, they should be classified, labelled and packaged in accordance with CLP.
[1052] What are the classification, labelling and packaging requirements for a biocidal product? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Scope and exemptions under CLP
Version: 1.0
Latest update: 04/06/2015

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.

Technical questions and answers on C&L notifications

Choosing the right tool to create a C&L notification

[305] There are many notification tools, which one is the more suitable for me?
CLP
Technical questions and answers on C&L notifications
Version: 1.0
Latest update: 04/06/2015

There is a tool for all your needs:
There are easy questions you can ask yourself to find out what is the most suitable tool to create your C&L notification(s): 
If your substance has multiple compositions (e.g. same main constituent(s) but different impurities) and/or different classification and labelling, the only notification tool you can use is IUCLID 5;
If you want to claim the IUPAC name of your substance confidential, then the only notification tool you can use is IUCLID 5;
If you have a lot of substances to notify, and if your substances are identified by CAS or EC number, then the Bulk XML might be the more convenient tool for you;
If you want to agree with a classification and labelling already notified or registered, then the online REACH-IT tool is the advised tool to use;
If you want to notify agreed classification and labelling on behalf of several manufacturers, or importers, use the group submission (submission on behalf of a group of manufacturers or importers).
All the C&L notifications created using IUCLID 5, the Bulk XML or the online REACH-IT tool have to be submitted to ECHA via REACH-IT.
 
Figure 1: A tool for your need

[306] I have to notify a substance that has different "qualities" and different C&L, which tool shall I use?
CLP
Technical questions and answers on C&L notifications
Version: 1.0
Latest update: 04/06/2015

To be able to submit a classification and labelling notification for different compositions of the same substance, you will have to create a notification with IUCLID 5.
In section 1.2 of your IUCLID substance dataset, you have indeed the possibility to identify multiple compositions of your substance, as well as the different impurities contained in the different compositions.
Then, in section 2.1, you can indicate the different classification and labelling and link them to the different compositions in section 1.2.
Further information can be found in Data Submission Manual Part 12 - How to prepare and submit a C&L notification using IUCLID at
http://www.echa.europa.eu/web/guest/support/dossier-submission-tools/reach-it/notification-to-the-cl-inventory
Details on how to create a notification for mutiple composition are provided in chapter 5.4 of that manual.

[307] I cannot edit “Hazard category” and “Hazard statement” in C&L section. Why?
CLP
Technical questions and answers on C&L notifications
Version: 1.0
Latest update: 04/06/2015

You are only able to edit the “Hazard category” or “Hazard statement” if you select the option “Blank” in the “Reason for no classification”. For each hazard class or differentiation either the two fields “Hazard category” or “Hazard statement” are selected or the field “Reason for no classification” must be specified.

[308] Is there a tool that allows me to check my C&L notification before I send it to ECHA?
CLP
Technical questions and answers on C&L notifications
Version: 1.0
Latest update: 04/06/2015

IUCLID 5: If you create your C&L notification using IUCLID5, you can use the TCC tool available on the IUCLID website at:
http://iuclid.eu/index.php?fuseaction=home.menuNOTSignedUp&page=home.showUserInfo.
Check the Business Rule validation on your IUCLID dossier with the IUCLID TCC plug-in before submitting it via REACH-IT. To do so
- Click on Run;
- Select Add reference button;
- From Select query result type, select “Dossier” and in the substance chemical name field type the wildcard character (*). Search, select the dossier and assign. Click Next.

If you receive an error message, modify your substance dataset according to the information provided in that error message and create a new dossier. Check this new dossier again with the TCC plug-in.
Online submission: REACH-IT already contains parameters that verify your C&L notifications when you enter your data using the online tool module.
Bulk XML tool: When the bulk C&L notification is created, the macros inside the file will allow you to confirm if the format of your file is compliant in terms of file format and Business Rules. If some mandatory information is missing, the cell in which the data should have been entered is marked in red, and you will not be able to create a xml file using the “Validate data and create XML” button.
Some Business Rules which are related to the submission of the C&L notification, i.e. whether your submission is an initial submission or an update, can only be checked when you actually submit your C&L notification in REACH-IT.

Group of manufacturers-importers in REACH-IT

[331] I need to include one/several members in my Group of manufacturers/importers. Shall I submit a new C&L notification for the same substance?
CLP
Technical questions and answers on C&L notifications
Version: 1.0
Latest update: 04/06/2015

If you have already submitted one or several C&L notifications on behalf of a group of manufacturers/importers, in order to update the composition of the group, you just need to add the new member(s) into your already created group of manufacturers/importers (MI) associated to your C&L notification(s). You can proceed as follows:
-
In REACH-IT: Go to <Classification and Labelling> - <Manage the Group(s) of Manufacturer(s)/Importer(s)> ;
-
Select the group you want to modify;
-Click on the ‘View/update group’ button;
-Update your group composition.
While doing that, all the notifications and submission reports associated to this group of manufacturers and importers will be updated with the new group composition.
Thanks to this group management in REACH-IT, it is not necessary to submit an update of the notification every time there is a new member in the group that has submitted this notification.
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.
Example:
LE submits one or several notifications on behalf of a group composed of LE A and LE B. If he updates the group definition in REACH-IT by adding LE X to the group, then automatically LE X will be considered as having submitted the notification too. LE, LE A, LE B and LE X will be considered as notifiers.

[332] Will the members of a C&L notification(s) submitted by a group of manufacturers/importers receive a submission report?
CLP
Technical questions and answers on C&L notifications
Version: 1.0
Latest update: 04/06/2015

The members of a group of manufacturers and importers will not receive a submission report. They will have to contact the original notifier to receive the reference number (or a copy of the submission report). The company submitting the notification will be responsible for informing the group members after successful (or unsuccessful) notification to ECHA and for sharing the submission report received with the members.

[333] Can I update a C&L notification as a member of a group of manufacturers/importers?
CLP
Technical questions and answers on C&L notifications
Version: 1.0
Latest update: 04/06/2015

Only the company who has submitted the C&L notification file will be able to update the C&L notification. This means that a member of a group is considered as "co-notifier" of a C&L notification, but cannot update a notification.

[334] How to communicate a different classification and labelling for the same substance when some of the members of a C&L notification submitted as a group of manufacturers/importers (M/I) do not agree to that new classification?
CLP
Technical questions and answers on C&L notifications
Version: 1.0
Latest update: 04/06/2015

The situation can be illustrated by the following example:
-In December 2010: you have submitted, on behalf of a group composed of M1 + M2 + M3, a bulk file for the substances S1 (CL1) + S2.
- Now: M1 and M2 want to update S1 with CL2, but not M3 who wants to keep the original C&L (CL1).
There might be different ways to handle this situation depending on the type of agreement that you have made with M1, M2 and M3 outside REACH-IT when you have decided to agree on the C&L of S1 and S2 and submit them as a group of M/I.
Depending on the exact type of agreement between the different members of the group, the following technical solutions are possible:
Technical solution 1:
In the case you, M1, M2, and M3 do agree with both C&L for S1 (the old CL1 and the updated one CL2) for example if the C&L differs because of impurity/additive/form.
Then the C&L notification for S1 can be updated to include a different composition and a different classification and labelling for the same substance.
IUCLID5 is the only tool that allows you to indicate more than one C&L and more than one composition for the same substance. In order to include another composition to your substance, please refer to the Data Submission Manual 12: How to Prepare and Submit a Classification and Labelling Notification using IUCLID available at http://echa.europa.eu/web/guest/support/dossier-submission-tools/reach-it/notification-to-the-cl-inventory, specially chapters 5.4, 5.7.1 and chapter 8.
When submitting this updated C&L notification for S1, you should indicate in REACH-IT that the submission is still on behalf of the same group M1+M2+M3.
While doing that, the following information will be stored in REACH-IT:
-S1 with CL1 and CL2 – notified by M1+M2+M3
-S2 – notified by M1+M2+M3

Technical solution 2:
In the case you, M1 and M2 agree with the new C&L for S1, but not M3.
We advise you to create a new group in REACH-IT (with M1+M2 only). Submit an update of S1 with CL1 on behalf of the new group (M1+M2). This update can be made using the bulk tool or IUCLID or the online tool in REACH-IT.
M3 can then submit his own C&L (CL2) for S1 (with his own REACH-IT account). M3 will then have his own submission report for S1 that he can present to the enforcement authorities if needed.

While doing that, the following information will be stored in REACH-IT:

-S1 with CL1 – notified by M1+M2
-S1 with CL2 – notified by M3
-S2 – notified by M1+M2+M3

Online C&L notification in REACH-IT

[321] What are the limitations of the online C&L notification tool?
CLP
Technical questions and answers on C&L notifications
Version: 1.0
Latest update: 04/06/2015

The online tool cannot be used if:
- Your substance has multiple compositions or multiple classification and labellings;
- You want to claim confidentiality on the IUPAC name.
If you are in such a case, IUCLID shall be used to create your C&L notification.on.

[322] I know that there is an option where I can agree to a previous C&L. Where?
CLP
Technical questions and answers on C&L notifications
Version: 1.0
Latest update: 04/06/2015

If you use the Online REACH-IT tool, it will be displayed at the bottom of your webpage in the C&L tab of the REACH-IT online C&L notification module. The "I agree" option will be displayed on your screen once you have entered relevant information regarding the substance identity and optical information of the C&L notification created via REACH-IT (<Classification and Labelling> - <Notify a C&L online>). The system will automatically display a substance already included in the C&L inventory that matches your substance, if applicable, and it will give you the possibility to select the "I agree" option. Within the C&L inventory, two groups of substances should be differentiated:
- Substances with an already harmonised C&L in Annex VI of CLP. The harmonized C&L is legally binding;
- Substances that have already been registered under REACH Regulation including a C&L notification or that have already been notified under CLP Regulation. In this case you can select between one of the classification and labelling notifications provided or propose a different C&L.
However, you, as a notifier, should know that the responsibility to verify that a valid classification and labelling of a substance is provided remains with the notifier. REACH-IT only provides you the means to minimise the administrative work and agree with previous entries.
If your substance has not been previously harmonised, registered or notified, the "I agree" option will not be enabled.

Reference numbers granted to a C&L notification

[315] Which number do I receive after having submitted a C&L notification?
CLP
Technical questions and answers on C&L notifications
Version: 1.0
Latest update: 04/06/2015

When submitting a dossier (created by the Online REACH-IT tool, IUCLID 5, or the XML bulk) a submission number is assigned to each file submitted.
If the submission is successful (i.e., the virus check, the format check, and the Business Rules checks are passed successfully), then each substance notified receives a “Reference number”, which is also called “Notification number” in the case of a C&L notification, or “Registration number” if a registration dossier was submitted. A notification number will have the following format: 02-XXXXXXXXXX-CC-0000.
The submission and reference number are available in your submission report.

[316] Which number do I receive after having submitted a C&L notification update?
CLP
Technical questions and answers on C&L notifications
Version: 1.0
Latest update: 04/06/2015

If you update your C&L notification, you will receive a new submission number, but the reference number previously assigned will remain the same.

Searching for my C&L notification in REACH-IT

[317] How do I verify the submission and reference numbers of my C&L notification?
CLP
Technical questions and answers on C&L notifications
Version: 1.0
Latest update: 04/06/2015

You can check the classification and labelling (according to the CLP criteria) of substances you have already notified or registered by selecting <Classification and Labelling> - <View submitted C&L> in your REACH-IT account. The results can be exported either in .pdf format or .csv format.
You can also retrieve your notification number (reference number of a C&L notification) from the received submission report, or from the reference number history in REACH-IT: <Registration/Notification> - <Reference number history>.

Figure 4: Search for your submission and reference numbers

[318] How can I check in REACH-IT all the C&L notifications I have already submitted?
CLP
Technical questions and answers on C&L notifications
Version: 1.0
Latest update: 04/06/2015

You have the possibility to search in the internal classification and labeling (C&L) inventory for all the C&L notifications you have submitted as part of:
 
A bulk file;

A IUCLID notification;

An Online REACH-IT notification; and

A registration dossier (after a successful registration, i.e. after you have received the registration number).

Only the classification and labelling notifications made according to the CLP criteria are searchable, and you can search only for the C&L notification(s) you have submitted.
To do so, use the <View submitted C&L> functionality available in the C&L menu of REACH-IT:
<Classification and Labelling> - <View submitted C&L>.

Figure 5: View your submitted C&L
There are different search options: by reference number (notification or registration number), EC number, CAS number or Name of the group of manufacturers/importers.
The search results can also be exported in .csv format or .pdf file format.

[319] How can I export to an Excel file the C&L notifications that I have submitted to ECHA?
CLP
Technical questions and answers on C&L notifications
Version: 1.0
Latest update: 04/06/2015


How can I export to an Excel file the C&L notifications that I have submitted to ECHA?

Once you have searched for the C&L notifications that you have submitted to ECHA, you can export the information in .csv format or .pdf format (see previous question for details).
In case that you wish to export the information to an Excel file, please proceed in the following way:
 
• Click on “Export the results in .csv”. A dialog box will open asking you to open or save the file;

• Select “save” and save the file to your computer in .csv;

• Open a new excel file;

• Import the .csv data in the excel sheet by selecting “Data” from the excel file menu, then select “Import External data” and finally “Import Data (see screenshot below).



• Select the .csv file that you just saved to your computer and follow the import wizard.

[320] I have successfully submitted my C&L notification, I received my reference number, but I do not find my classification and labelling in the ‘View submitted C&L’ REACH-IT functionality. Why?
CLP
Technical questions and answers on C&L notifications
Version: 1.0
Latest update: 04/06/2015

There may be different reasons to that:
- There is a time delay between the moment a C&L notification is assigned a reference number, and the moment the C&L is stored in the internal C&L inventory. Please try again later;
- You are a member of a group, but you are not the one who has submitted the C&L notification on behalf of the group. So, you cannot see the C&L; only the company who has submitted the file can see it. The same applies to joint submission members;
- The C&L information cannot be transferred automatically to the C&L inventory because you have specified more than one composition, and more than one classification and labelling, without linking them together in your IUCLID dossier. Your C&L notification is valid if you have received a reference number, nevertheless it will be transferred later to the C&L inventory

Updating a C&L notification

[309] If I need to update my C&L notification, do I need to use a specific tool?
CLP
Technical questions and answers on C&L notifications
Version: 1.0
Latest update: 04/06/2015

All the tools to create a C&L notification are compatible between each other. This means that you will be able to update your notification via Bulk XML tool (this bulk submission can contain different substances than the initial bulk submission), IUCLID 5, or Online REACH-IT tool; whatever the initial submission tool was.
If you want to update the C&L section from a registration dossier, you will have to update your registration dossier (according to Article 22 of the REACH Regulation). Only if you want to update the classification and labelling of your NONS registration dossier below 1 tonne, a C&L notification instead of a registration dossier update is required.
Further information on how to proceed to submit an update can be found in the Practical Guide 7: How to notify substances to the Classification & Labelling Inventory – chapter 3.5 at: http://echa.europa.eu/web/guest/support/dossier-submission-tools/reach-it/notification-to-the-cl-inventory

[310] How to fill-in my C&L notification in case of update?
CLP
Technical questions and answers on C&L notifications
Version: 1.0
Latest update: 04/06/2015

If you want to update a classification and labelling notification, you should clearly indicate that the notification is an update of a previous successful notification.
If you create your C&L notification update using IUCLID 5:
On top of the usual information to be submitted, do not forget to specify in your IUCLID substance data-set the following information:

• The EC number or EC list numbers of your substance in section 1.1; and

• The reference number of the notification you want to update in section 1.3.

In the dossier header of the IUCLID dossier:

• Select that the dossier is an update;

• Specify the previous submission number; and

• Give an update reason in the dossier header.

For a successful C&L notification update using IUCLID, please consult chapter 8 of the Data Submission Manual 12 - How to prepare and submit a C&L notification using IUCLID? available at: http://echa.europa.eu/web/guest/support/dossier-submission-tools/reach-it/notification-to-the-cl-inventory
If you create your C&L notification update using the Online REACH-IT tool:
In the Online REACH-IT tool, chose the option “Update a C&L notification successfully submitted”, and enter the assigned reference number.
For a successful C&L notification update using the Online REACH-IT tool, please consult chapter 6.2.3 of the Industry User Manual 16 - How to create and submit a C&L notification using the REACH-IT online tool available at:
http://echa.europa.eu/web/guest/support/dossier-submission-tools/reach-it/notification-to-the-cl-inventory.

Figure 2: Update your C&L notification using the online tool

Bulk XML tool
If you want to update your C&L notification(s) using the bulk XML tool, you should also clearly indicate in your file that the notification is an update.
To do so:

• In the tab ”3- Substances”, specify the assigned reference number of the notification you want to update in column D “Reference number”;

• In the tab ”3- Substances“, select a reason for update in the picklist of column E “Reason for update”.

Figure 3: Update your C&L notification using the bulk XML tool

Nevertheless, if you want to update the classification and labelling provided in a registration dossier, you will have to update your registration dossier (according to Article 22 of the REACH Regulation).

[311] Is there a procedure to update the classification and labelling of a NONS registration and to submit a C&L notification?
CLP
Technical questions and answers on C&L notifications
Version: 1.0
Latest update: 04/06/2015

Yes, there is. If you have already successfully claimed a registration number for a substance previously notified under Directive 67/548/EEC, you shall update your registration dossier without undue delay, rather than submit a C&L notification. Further information on how to proceed can be found in the Questions and Answers for the registrants of previously notified substances at: http://echa.europa.eu/web/guest/support/dossier-submission-tools/reach-it/nons. Please be referred to chapter – 3.3 How to prepare my IUCLID5 substance dataset in case of NONS update? – Case 2: Other updates.
For substances previously notified below 1t under Directive 67/548/EEC, and for which no tonnage band update has been done and no update under REACH is required, a separate C&L notification has to be made if the substance fulfils the classification criteria as specified in Annex I of the CLP Regulation. This means:
- If the annual volumes of the NONS substance remain below 1 t, you shall do a C&L notification for this substance. As soon as the volume goes increases beyond this threshold; an update of the registration dossier in form of a complete registration dossier is requested;
- If the annual volume is already above 1 t, an update, in form of a spontaneous update of a registration dossier, is requested.

[312] May I update any data in my C&L notification?
CLP
Technical questions and answers on C&L notifications
Version: 1.0
Latest update: 04/06/2015

A notifier can update all data of his C&L notification except the submitting legal entity, the EC number or CAS number. A notifier can, among other things, add more information related to the composition of the substances, update the contact details, update the C&L or update the group of manufacturers/importers. In case of a change of the submitting legal entity you should use the Legal Entity Change tool of REACH-IT.

[313] Can I update the classification and labelling of my registration dossier by submitting a C&L notification?
CLP
Technical questions and answers on C&L notifications
Version: 1.0
Latest update: 04/06/2015

No, if you have already submitted a registration dossier for your substance, you should submit a spontaneous update of your registration dossier if you want 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 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.
The only exception is applicable to substances previously notified under Directive 67/548/EEC where the annual volume does not exceed 1 t. In this case a C&L notification shall be submitted.

[314] Why is there a different contact name in the submission report when I update the contact details in my C&L notification?
CLP
Technical questions and answers on C&L notifications
Version: 1.0
Latest update: 04/06/2015

Your contact name has been modified correctly if you have validated successfully your C&L notification update. There is no need to update again your contact details. However, the submission report will display only a contact person with the ‘invoice manager’ status.
If you want to modify the contact person in your C&L notification submission report, follow these steps:
- Create a new contact person in the “Contact” tab available at Company >> View (note: REACH-IT may assign this contact in the submission report of other items, i.e., registrations, if no other contact with ‘invoice manager’ status has been previously defined);
- Update your C&L notification and select the previously created contact.

[1187] How do I communicate that a substance notified previously is not imported nor manufactured anymore?
CLP
Technical questions and answers on C&L notifications
Version: 1.0
Latest update: 24/05/2016

You can inform ECHA that the manufacture/import of a substance by your company has ceased using the available functionality in REACH-IT (Registration/notification >> Cease manufacture):

  • Upon selecting the desired notification and following the steps to confirm it, the status of your notification is changed to “inactive”.
  • You can at any point activate the notification again by using the “Restart manufacture” functionality.
  • Note that this functionality is shared with the cease/restart manufacture for registration dossiers (deactivation based on REACH article 50(2)).

Further information and step by step instructions can be found under section 3.4 “Cease and restart manufacture” in the REACH-IT Industry User Manual Part 6 – Dossier submission available at: http://echa.europa.eu/support/dossier-submission-tools/reach-it/industry-user-manuals

 

XML bulk C&L

[323] Is there a manual for the bulk XML tool?
CLP
Technical questions and answers on C&L notifications
Version: 1.0
Latest update: 04/06/2015

No, unfortunately there is no specific manual, but you are kindly referred to guidance already available at http://echa.europa.eu/web/guest/support/dossier-submission-tools/reach-it/notification-to-the-cl-inventory. You should observe the following steps to submit successfully your C&L bulk notification:
-Read the Practical guide 7: How to notify substance in the Classification and Labelling Inventory (refer to the website mentioned above);
-Read the Introductory Guidance on the CLP Regulation or the Guidance on the Application of the CLP criteria for specific questions related to the C&L applicable to your substance;
-Download the Bulk XML tool available in the previously mentioned website and extract the contents of the CLnotification.zip file to any folder in your computer;
-Remember to enable macros as described in the release_notes.txt in the CLnotification.zip file;
-Read carefully the instructions in the “About” tab of your downloaded CL notification file;
-Check the C&L notification examples available in your downloaded CLnotification zip file;
- If you need further explanation on the meaning of a specific field, place your mouse over commented fields (with a red triangle on the right-hand corner);
- Save your data using the “Validate data and create XML” button rather than “Save as” option. The tool will save your data without any inconsistent format.
When you submit your bulk XML file via REACH-IT, make sure that you select <Classification and Labelling> - <Notify a bulk C&L> and follow the instructions provided in the submission wizard until you confirm your notification submission.

[324] What are the limitations of the bulk XML tool?
CLP
Technical questions and answers on C&L notifications
Version: 1.0
Latest update: 04/06/2015

The Bulk XML tool cannot be used if:
-Your substances are not identified by CAS or EC number;
-Your substances have multiple compositions or multiple C&L;
-You want to claim the confidentiality on the IUPAC name;
-You want to set a new M-Factor or Specific Concentration Limit (SCL).
If you are in such a case, IUCLID shall be used to create your C&L notification

[325] . Can I specify a SCL or M-Factor(s) in the bulk file?
CLP
Technical questions and answers on C&L notifications
Version: 1.0
Latest update: 04/06/2015

Yes, you can. If a specific concentration limit or M-Factor(s) is already defined in Annex VI to CLP, you must specify it in accordance with the Annex VI entry. Where Annex VI does not provide for a binding value, you may still specify your own specific concentration limit or M-Factor(s) upon the strict conditions of Article 10 to CLP. In this case you shall provide a scientific justification (cf. Article 40(1)(e)). A document cannot be attached in a xml bulk file; therefore the only way to specify a Specific Concentration Limit or M-Factor(s) and to attach the requested scientific justification is to submit a C&L notification using IUCLID or the Online REACH-IT tool.

[326] . The Bulk XML tool is requesting a password. How can I get it?
CLP
Technical questions and answers on C&L notifications
Version: 1.0
Latest update: 04/06/2015

The tab “Substance” and "Classifications" of the Bulk XML tool is password protected to remind users that the classification of your substances should follow a specific format. Please follow these steps to avoid the use of the password:
-Make sure that your macros are enabled when you open the tool. If you cannot have your macros enabled, once you open your Excel sheet select Tools >> Macro >> Security and select Medium or low. If you change your macro security, close and reopen the Bulk XML tool;
-If you need to enter data into a password protected area, the Bulk XML tool should not be used to create your notification (i.e., more than one composition or more than one classification for a specific substance);
-If you are going to copy and paste data to your Bulk XML tool, we strongly recommend that you use the tabs named after "Personal sheet 1", "Personal sheet 2" to check whether your data format is compliant with Excel;
-When you save your file, do not use the “Save as” option, but rather the “Validate data and create XML” button so you can submit your file to ECHA via REACH-IT. However, if you want to include more substances at a later stage, we recommend that you also save your file in xls format.

[327] How can I enter a harmonised entry using the Bulk XML tool?
CLP
Technical questions and answers on C&L notifications
Version: 1.0
Latest update: 04/06/2015

Enter the “index number” of the classification already harmonised in Annex VI to CLP under the field “Classification name” within the tab “2-classifications” of your Bulk XML tool. The Annex VI on the Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging of Dangerous Substances can be found at http://ecb.jrc.ec.europa.eu/classification-labelling/clp/.
Once you have filled in the classification name, the C&L information will be automatically populated in the tab “2-classifications” of your Bulk XML tool.
Check the classification and labelling displayed.
Then in the tab “3-Substances”, enter the substance identity of your substance, and select the index number to this substance in the “classification selection” column.



Figure 6: Harmonised C&L in the bulk XML tool

[328] I have created a xml bulk file with the Bulk XML tool, and the file is not accepted by REACH-IT because of a validation problem. Why?
CLP
Technical questions and answers on C&L notifications
Version: 1.0
Latest update: 04/06/2015

Your XML files might have been created with the Bulk XML tool version 1.0, 1.1 or 1.2.
Those versions of the xml file are not accepted anymore by REACH-IT. We would therefore recommend you to download the new version of the bulk XML tool (version 2.0) which is now available from the ECHA website.
All information previously entered in the former version of the Bulk XML tool are not lost, they cannot only be copied / pasted to the new bulk XML Tool version 2.0; but also imported using the import XML button located on the “about” page.
We therefore advise you to download the new Bulk XML tool:
-Download the complete zip file from:
http://echa.europa.eu/web/guest/regulations/clp; and
-Perform the 4-steps procedure explained in the next question (question 25) in order to check your different files that have not been accepted by REACH-IT at the XML validation step

[329] How to check your different xml files that have been not accepted by REACH-IT at the XML validation step?
CLP
Technical questions and answers on C&L notifications
Version: 1.0
Latest update: 04/06/2015

Step 1: download the new version of the Bulk XML tool:

1.1- Download the zip file containing the “C&L Bulk XML creator tool for Excel 2003 and 2007” from the following webpage: http://echa.europa.eu/clp/inventory_notification/tools_download_en.asp .

1.2- Extract all the files contained in the zip. All files shall be extracted in the same folder on your computer.

Step 2: open the Bulk XML tool and enable the macros:
Enable macros before creating a C&L notification to ensure that the application works as designed. Follow these steps to confirm the availability of macros in your program:

2.1- Open the Bulk XML tool: open the file CLNotification2.0.xls;

2.2- You should confirm that your macros are enabled. Follow these steps to confirm the macro security level in your computer:
 
a. Select the Tools >> Options from your menu bar;

b. Select security and click on macro security;

c. Set the security level to medium or low. If you already have it set to medium or low, go to step 3;

d. Close your CLNotification2.0.xlsb and open it again;

e. Click on the button “Enable macros” (only when security level = medium).

Step 3: check former XML files not accepted:

3.1- In the tab <About>, click on <Import data from XML>



3.2- Select the XML file that you want to check (the one created with the old Bulk XML tool, and that failed the XML validation in REACH-IT), and click on <open>

3.3- After successful import of the file in the Bulk XML tool v2.0, the following message is displayed:


3.4- Click on <OK>
3.5- Go to the tab <1- Contacts> and check it
3.6- Go to the tab <2- Classifications> and check it
3.7- Go to the tab <3- Substances> and check it
3.8- Go to the tab <4- Generate XML> and click on <Validate data and create XML>

3.9- In case of remaining mistakes you will get directed to the error page.
3.10- Correct the remaining mistakes and perform again step 3.8.

Step 4: Import the generated XML file in REACH-IT.

[330] How should I re-submit a bulk C&L notification when certain substances show status “Failed”?
CLP
Technical questions and answers on C&L notifications
Version: 1.0
Latest update: 04/06/2015

The C&L notification submission report will indicate those substances of your bulk notification that have been successfully submitted. When the notification for some substances fails, it is recommended to exclude the successfully submitted notifications before you submit again your bulk C&L notification.
You can check in the submission report of the bulk submission which notifications have failed and the reason of the failure.
You can also use the <View submitted C&L> module to confirm successful C&L notifications. Select <Classification and Labelling> - < View submitted C&L > and search for your substance using one of the search criteria. If your substance does not appear in the <View notified C&L> table, then it means that the notification has not been successful.