A. Non-defined roles within the regulation
1. Only Representative (OR)
B. Obligations under the regulations
1. Notification of the Inventory of classification and labelling
2. Harmonised Classification
3. Lack of data
1. Content of the label
2. Place of the information on the label
3. Language on the label
4. Product identifiers
6. Request to use another chemical name
1. Outer packaging
2. Small packaging
F. Relationship with REACH
1. Safety data sheets
2. Notification and registration
A. Non-defined roles within the regulation
1. Only Representative (OR)
1.1. Does the Only Representative (OR; article 8 of REACH) have a role within the CLP regulation?
No, the role of the ‘only representative’ is not defined in the CLP regulation 1272/2008. Under REACH regulation 1907/2006, the OR is responsible for the registration of substances made by non-EU manufacturers.
1.2. Does the OR have a duty to notify?
The OR cannot make an individual notification to the Inventory because he has no role under the CLP regulation 1272/2008, unless he himself is an actual importer. Under REACH regulation 1907/2006 the OR can replace the importer provided that he fulfils all the obligations of the importer. So, if the OR takes care of the registration file he can bring the details of the registration file up-to-date and adopt the classification according to the CLP regulation for 3/1/2011. Then separate notification is not required.
1.3. Does the OR draw up the safety data sheets?
As regards the drawing up of safety data sheets REACH regulation 1907/2006 explicitly mentions that this is a role of the OR.
2.1. Article 40 (1) of the CLP regulation refers to group manufacturers or importers. Is this the same as a SIEF (Substance Information Exchange Forum)?
No, it is not. The term ‘group’ is not defined in the CLP regulation 1272/2008, it is particularly not equal to a Substance Information Exchange Forum as this is defined in REACH. Despite this members of a SIEF can decide to submit their notification to the C&L Inventory as a group. In this case the identity of each member must be specified in the notification.
For more information about the SIEF see the REACH regulation 1907/2006 and the ECHA website (FIES)
B. Obligations under the regulation
1. Notification of the Inventory of classification and labelling
1.1. Is there a way to notify REACH-IT of a large number of substances in one go? If so, how?
Yes. This is described on the ECHA (regulations) website: “How can I draw up and submit a notification?” There are three notification methods including notification in bulk.
So as to announce a large quantity of substances in one go, the notification in bulk must be used.
Attention: there are a number of limitations in connection with this type of notification. Submission by means of an XML bulk file is only possible when every substance is identified with the aid of the CAS or EC number, and is identified by no more than one composition. In addition, no multiplication factor or specific concentration limit can be established for the substances, of which a notification is given. If the M factor of the specific concentration limit has already been included in the Annex VI of the CLP regulation 1272/2008, it is not permitted to change this. In these cases, notification by means of bulk may be used.
See the ECHA website (guidance) for more information and guide documents.
1.2. What can we do if along with a number of companies we have to notify the same substances or mixtures? Is it possible to make a joint notification per substance/mixture?
In conformity with article 40 the CLP regulation 1272/2008 manufacturers or importers can together notify as a group (group of information providers). Such a group can, for example, be made up of various legal entities under the same parent company, a number of independent companies without specific link or a SIEF. It is, however, necessary that all members of the group are agreed upon the proposed classification of the substance.
For smaller companies (SME) submitting their notification directly online there is the option to click on ‘I agree’, with which they declare to be in agreement with the proposed classification from another information provider.
1.3. Can the SIEF play a part here?
Yes, this can be a role for the SIEF. For a full description of the SIEF we refer to the REACH regulation 1907/2006 and for the possible role of the SIEF under the CLP regulation to the “‘Basic guide to Regulation (EC) no. 1272/2008 concerning the classification, labelling and packaging of substances and mixtures”
1.4. What if the information providers are not agreed upon the classification and labelling elements?
The CLP regulation requires that the information providers (CLP) and registrants (REACH) make every effort to reach agreement on the notification, i.e. agreed classification and labelling in the inventory (CLP regulation, article 41) as in the inventory of classification and labelling various notifications occur for the same substance.
If various impurity profiles of the same substance make it impossible to reach an agreement concerning the classification and labelling, then for the same substance several listings may occur in the inventory, each with a different classification and labelling.
Many registrants and information providers already having contact with each other through the SIEFs makes it easier to reach agreement on the notifications.
Participation in the SIEF is not compulsory. If you are a downstream user of a substance or if you have not preregistered your substance(s) under REACH, either because you manufacture or import a substance in quantities of less than 1 tonne per year or because you are in possession of a non-phase-in substance, you do not have to be a member of a SIEF (REACH, article 28 and 29). You are, however, bound to make every effort to achieve an agreed notification of classification and labelling for your substance. It is therefore advisable to consult the SIEF for your substance or substances about this.
1.5. Does CLP notification with the Inventory of classification and labelling have to be done for an object?
As a producer or importer of an object you are only involved with the regulation if you produce or import an explosive object as described in the CLP regulation 1272/2008 Annex I, point 2.1, or if article 7 or 9 of REACH regulation 1907/2006 provides for the registration or notification of a substance in an object.
If you are a producer or importer of an explosive substance (explosive according to the CLP criteria) that will be later combined to form an object, the substance itself must be registered in the Inventory. The object itself does not have to be registered in the Inventory.
2.1. Is a notification with the ECHA required every time new substances are brought to the market?
Yes, once they are placed on the market, they must be registered within a month after being placed on the market by their manufacturer or importer. A distributor taking substances from the shelves that have been stored there for a while is not bound to submit notification to the Inventory of classification and labelling before selling them to others because this is an obligation that only concerns manufacturers and importers.
1.1. How do I classify substances if the R phrases from the Dangerous Substances Directive cannot be converted with the correlation table (Annex VII) to an associated H phrase? Preceding important remark: You may use these translation tables of Annex VII of the CLP regulation 1272/2008 with which existing DSD or DPD classifications can be converted into CLP classification, can only be used: in case you or your supplier
* have already classified a substance according to the Dangerous Substances Directive 67/548/EEC (DSD) before 1 December 2010
* or mixture according to the Dangerous Preparations Directive 1999/45/EC (DPD) before 1 June 2015 and you have no further data available for the substance or mixture and for the hazard class considered.
If the R phrases from the Dangerous Substances Directive 67/548/EEC (DSD) cannot be converted to H phrases with the conversion table you must use the criteria in Annex 1 of the CLP regulation (self-classification). Paragraph 1.7 of the ‘Guidance on the Application of the CLP Criteria’ takes a closer look at this subject. Table 18.104.22.168(a) of the same paragraph mentions which classification according to the Dangerous Substances Directive 67/548/EEC (DSD) cannot be converted using the correlation table in Annex VII. This concerns, for example, substances with classification R2, R3, R8 (liquid/solid substance), R11 (solid substance) and R15. Section 2 of the same guidance explains how you can classify these substances according to the CLP criteria.
2. Harmonised Classification
2.1. It is possible to propose a different classification for a substance already in Annex VI, part 3, being one with a less dangerous classification? How is this best done? What action needs to be taken? By who?
Yes, it is possible to propose a new classification for existing harmonised classification and labelling already in Annex VI, part 3. See Article 37 (6)of the CLP regulation 1272/2008 : “Manufacturers, importers and downstream users having new information that can result in a change to the harmonised classification and labelling elements of a substance in Annex VI, part 3, submit a proposal to the competent authority in one of the Member States in which the substance is placed on the market in accordance with paragraph 2 (article 37), second paragraph.”
The competent authorities in the Member States then decide based on the discussions and the new evidence if they are to submit a proposal to change the existing classification to the Agency (ECHA). The change proposal must include information about the current classification and labelling, the proposed changes, and how the new classification and labelling would appear. If this forms part of a group notification this is mentioned with the proposal.
A manufacturer, importer or downstream user cannot directly make a proposal to the ECHA for a change to an existing classification. For as long as the proposal for amending the harmonised classification and labelling elements of Annex VI, part 3 has not been approved at Community level and changed in Annex VI, the existing harmonised classification and labelling elements in conformity with Annex VI, part 3 must be used.
For a substance that must be registered under REACH regulation 1907/2006, the supplier must mention all relevant hazard information in his registration file (IUCLID 5) as well as information that suggests a different classification to that noted in Annex VI to the CLP regulation.
2.2. Is it compulsory to classify a substance already included in part 3 of Annex VI for hazards not mentioned here?
Yes, this is compulsory. A substance in Annex VI of the CLP regulation 1272/2008 must be classified according to the classification and labelling in part 3 of Annex VI. Then the manufacturer, importer or downstream user must himself further classify the substance according to Title II for all the hazard classifications or subdivisions of a hazard classification for which no harmonised classification and labelling is included in part 3 of Annex VI. For example, a substance can have a harmonised classification and labelling for acute oral toxicity, but not for acute dermal toxicity. This means that based on the available information the supplier must check if the classification criteria of acute dermal toxicity are complied with or not before classifying and labelling.
For harmonised classification and labelling which refer to a classification for acute or chronic category 1 aquatic environment danger where there is no M factor in Annex VI, an M factor must be established.
When one must make a classification for physical dangers for which there is no harmonised classification and labelling and for which in conformity with article 8(2) no adequate and reliable information is available, it may be necessary to conduct new experiments.
- Where can one find the list of harmonised classification and labelling?
on ECHA's website in the section “C&L inventory”
3. Lack of data
3.1. How can I classify a substance for which there is little data available? Do I then have to have testing done to make the C&L notification?
Yes, but not for all hazards.
1. For the physical hazards of a substance or mixture, the manufacturer, importer or downstream user carries out tests, such as prescribed in part II of Annex I, unless there are already adequate and reliable data available (in the literature or databases) of substances and mixtures, which are comparable with the substance or mixture to be classified in the areas of homogeneity, impurities, ...
These tests shall be conducted in accordance with one of the following methods:
(a) the test methods referred to in Article 13(3) of the REACH regulation 1907/2006;
(b) sound scientific principles that are internationally recognized or methods validated according to international procedures.
2. In order to verify whether a health or environment risk such as described in Annex I of this regulation is connected with a substance or mixture, the manufacturer, importer or downstream user may carry out new tests, provided he has examined first all other ways to generate information, amongst which the application of the rules of point 1 of Annex XI with the Regulation (EC) no. 1907/2006.
“Not later than from the January 1, 2014, new tests for physical hazards, which are carried out for the application of this regulation, are executed in accordance with an applicable, recognised quality guarantee system, or by laboratories which comply with the applicable recognised standard.” For this, see also article 8 of the CLP regulation.
In article 40 we also read: A manufacturer, importer or a group of manufacturers or importers, hereafter called „the information providers”, who place a substance as referred to in article 39 on the market, provides the Agency with the following information for inclusion in the
inventory referred to in article 42: …; if a substance is classified in a number of but not all hazard classifications or subdivisions in the Inventory, notification of if this is because of missing information, information that is not convincing, or information that is convincing but not sufficient to base a classification on it.
- In practice in version 5.2 of IUCLID, the ECHA tool for notifications, one can check the “data lacking” box after which one specifies why the substance is not classified.
1. Content of the label
1.1. Is there a maximum number of hazard statements that may be put on the label?
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. An exemption can be made if there is duplication or redundancy.
1.2. Is it compulsory to place all hazard statements on the label, or can one choose how many to place on the label?
“If a substance or mixture is classified in different hazard classifications or in different subdivisions of a hazard classification, all hazard statements resulting from the classification are put on the label unless this clearly leads to duplication or redundancy.” Check also article 29 (of the CLP regulation 1272/2008) for possible derogations.
If a substance classification is harmonised and included in the CLP regulation Annex VI, part 3, the corresponding hazard statement applicable to this classification must be mentioned on the label together with other hazard statements for a non-harmonised classification.
1.3. Is it compulsory to place all precautionary statements on the label or can one choose how many to place on the label? Is the number of precautionary statements on the label limited?
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.
2. Place of the information on the label
2.1. Is there a rule for the order of the hazard statements and precautionary statements?
No, the order of the hazard statements is free to choose, but they must be grouped on the label by language. The precautionary statements must also be grouped per language.
3. Language on the label
3.1. We are a company from outside the EU and want to export a number of hazardous products to our establishment in Belgium. The labels on packaging only mention the composition and hazard symbols in English. Is it a correct assertion that because there are sales across the whole of Europe labelling must be in Dutch, French, German, English and each language of the country through which the products are to be transported and the destination country?
As regards the language of the labels, article 17 of the CLP regulation 1272/2008 stipulates that ‘the label is provided in the official language or languages of the Member State(s) in which the substance or the mixture are placed on the market, unless determined otherwise by the relative Member State(s). Suppliers may put more languages on the label than required by the Member States providing that the same information is mentioned in all languages used.” Hence, in Belgium this is the three official national languages: Dutch, French and German.
Note: The situation is different for safety data sheets, however. These have to be drawn up in the language or languages of the region where the hazardous substances or mixtures are offered for sale. For this see the Royal Decree (of 11 February 2010) for the amending of the Royal Decree of 24 May 1982 and the Royal Decree of 11 January 1993, and the repealing of the Royal Decrees of 25 February 1996, 5 October 1998 and 18 June 2003 for the implementation in Belgian law of Regulation (EC) no. 1907/2006 and Regulation (EC) no. 1272/2008.
3.2. Do the various languages actually have to be on the label, or may they also be provided on the consignment note, invoice or through paperwork to the buyers (because it always involves the same products)?
Yes, the various languages (art. 17 of the CLP regulation 1272/2008) must be mentioned on the label.
As regards the language of the documents for transport we refer to the relative transport law.
4. Product identifiers
4.1. For product identification on the label must account also be taken of the various languages, or is it sufficient to for example only mention the name in English of the substance together with the CAS number?
Article 17 of The CLP regulation 1272/2008 clearly states that: “The label is provided in the official language or languages of the Member State(s) where the substance or the mixture is placed on the market, unless determined otherwise by the relative Member State(s).” So this also applies for the names of the substances and/or mixtures. In Belgium this therefore means that all information on the labels must be in the three national languages, French, Dutch and German.
You must use the same product identifiers on your labels as on the safety data sheets for your products.
Taking account of the above rules for the use of languages, product identifiers for substances must consist of :
1. a name and an identification number as mentioned in the CLP regulation Annex VI, part 3; or
2. a name and an identification number as mentioned in the inventory of classification and labelling to the extent the substance is not included in the CLP regulation Annex VI, part 3; or
3. the CAS number and the IUPAC name, or the CAS number and another internationally recognised name , if the substance is not recorded in either the CLP regulation Annex VI, part 3, nor in the inventory of classification and labelling kept by the Agency; or
4. if there is no CAS number available and none of the abovementioned points are applicable, the IUPAC name or another internationally recognised name.
Taking the above mentioned rules for the use of languages into account, product identifiers for mixtures must comply with both the following descriptions:
1. the trade name or the name of the mixture; and
2. the identity of all substances in the mixture that contribute to the classification of the mixture as regards acute toxicity, skin corrosion or serious eye injury, mutagenicity in reproductive cells, carcinogenicity, reproductive toxicity, sensitization of the airways or the skin, specific target organ toxicity (STOT) or aspiration danger.
To limit the number of chemical names on the label you need use no more than four chemical names unless this is needed due to the nature and severity of the hazards. The chemical names you choose must indicate the substances that in the first instance cause the most important health dangers on which your classification and choice of hazard statements are based.
4.2. Is it compulsory to mention the percentages of the separate substances in a mixture?
No, there is no obligation to mention the percentages of the separate substances in a mixture.
Note: The label on packaging of substances and mixtures classified as hazardous that are packaged and sold to the public must, among other things, mention the nominal quantity of the substance or the mixture unless the quantity is mentioned elsewhere on packaging.
5.1. What are the deadlines for the introduction of the new labels and packaging according to the CLP legislation for substances and mixtures?
Classified substances and mixtures must have labels and packaging according to the CLP regulation 1272/2008 from 1 December 2010 and 1 June 2015 respectively.
Note: If a substance or a mixture has already been classified, labelled and packaged according to the CLP regulation before the relevant deadlines, only the labels and packaging according to the CLP regulation may be used and not those under the directive 67/548/EEC (DSD) or the Dangerous Preparations Directive 1999/45/EC (DPD).
5.2. How must the extension of the deadline (see derogation article 61 of the CLP regulation) be interpreted?
An extension of the deadlines for relabeling and repackaging are permitted if the substances or mixtures have already been placed on market before the relevant deadlines (1/12/2010 and 1/6/2015 respectively). If the substances or mixtures are already in the supply chain before these deadlines (‘on the shelves’), relabeling and repackaging can be deferred to 1/12/2012 for the substances and 1/6/2017 for the mixtures. The additional two years is granted to facilitate the transition from the existing to the new system of classification, labelling and packaging, in particular for products with a longer shelf life.
This derogation applies for the whole period of two years irrespective of whether or not the substance or mixture is further circulating in the supply chain. In other words, the substance or the mixture can still be traded and/or sold to consumers for two more years with the ‘old’ label and the ‘old’ packaging, on condition that the composition doesn’t change. A substance (or mixture) that had already been placed on the market before 1 December 2010 (or 1 June 2015) and that is packaged and labelled in accordance with directive 67/548/EEC (or directive 1999/45/EC) does not have to be packaged and labelled again up to 1 December 2012 (or to 1 June 2017), even if in this period it is supplied or made available to third parties a number of times. After 1 December 2012 (or up to 1 June 2017) these substances (or mixtures) will obviously have to be packaged and labelled in conformity with the provisions of the CLP regulation.
5.3. Does this exception also apply to the deadlines for the safety data sheet?
Yes, see article 2 (6, 7) of Regulation No. 453/2010 of the Commission of 20 May 2010 for the amending of Regulation (EC) no. 1907/2006 of the European Parliament and the Council concerning the registration and assessment of, and the authorisation and limitations with regard to chemicals (REACH):
“6. For substances placed on the market before 1 December 2010 and that do not have to be relabelled and repackaged in accordance with article 61, paragraph 4, of Regulation (EC) no. 1272/2008, without prejudice to article 31, paragraph 9, of Regulation (EC) no. 1907/2006, the safety data sheet does not have to be replaced before 1 December 2012 by a safety data sheet in compliance with Annex I to this regulation.
For mixtures placed on the market before 1 June 2015 and that do not have to be relabelled and repackaged in accordance with article 61, paragraph 4, of Regulation (EC) no. 1272/2008, without prejudice to article 31, paragraph 9, of Regulation (EC) no. 1907/2006, the safety data sheet does not have to be replaced before 1 June 2017 by a safety data sheet in compliance with Annex II to this regulation.
7. Up until 30 November 2012, and without prejudice to article 31, paragraph 9, of Regulation (EC) no. 1907/2006 safety data sheets for mixtures that before 1 December 2010 had been supplied at least once to a buyer may be further used and these do not have to comply with Annex I to this regulation.”
6. Request to use another chemical name
6.1. Which procedure must be followed to submit a request to use another chemical name?
With a request for use of an alternative chemical name various procedures and requirements can apply under the CLP regulation 1272/2008 depending if the request is submitted before or after 1 June 2015.
Before 1 June 2015
If you have already classified, labelled and packaged your mixture before 1 June 2015 according to the CLP regulation, you send a request to use an alternative chemical name to the European Chemicals Agency (ECHA (clp)) in conformity with the provisions of the CLP regulation.
Should you have not yet classified, labelled and packaged your mixture in conformity with the CLP regulation, you send a request for use of an alternative chemical name to a competent authority in one of the Member States according to the provisions of the last system of classification and labelling as explained in article 15 of Directive 1999/45/EC concerning dangerous preparations (DPD). In your request you must demonstrate that the announcement of the chemical identity of the substance concerned in a mixture on the label or the safety data sheet would endanger the confidentiality of your intellectual property.
From the 1st of June, 2015
Your request for an alternative chemical designation can only be addressed to ECHA in accordance with the stipulations of the CLP regulation.
6.2. Can Annex VI of Directive 1999/45/EC still be used for such requests?
Yes, this can still be used if a mixture is still classified, labelled and packaged according to the Dangerous Preparations Directive 1999/45/EC (DPD) and not yet according to the CLP regulation, where the request must be submitted to a competent authority in one of the Member States.
6.3. Which substances are involved?
You can only a request use of an alternative chemical name for substances in a mixture classified in accordance with the DSD (Dangerous Substances Directive 67/548/EEC), for example as an irritant (with the exception of chemicals that cause serious eye injury) or acutely toxic or harmful, and for which the Community has imposed no limit value for occupational exposure.
6.4. How do I submit a request?
You must send your request to 'the competent authority' of your Member State (see question 6.7.) in accordance with the conditions of Annex VI to the Dangerous Preparations Directive 1999/45/EC (DPD) while providing the required information in the form of part A of the Annex. Your competent authority can ask you for extra information if it needs it to assess the validity of the request.
Your competent authority informs you of its decision; you must send a copy of the decision to all Member States in which you want to place your substance or mixture on the market.
6.5. What happens after 1 June 2015?
Should your request be approved before 1 June 2015 in accordance with the Dangerous Preparations Directive 1999/45/EC (DPD), you may continue to use the approved alternative chemical name under the CLP regulation 1272/2008 (article 24).
After 1 June 2015
After 1 June 2015 you must send a request for an alternative chemical name to ECHA (clp) as explained in article 24 of the CLP regulation. In your request you must demonstrate that announcement of the chemical identity of your substance or mixture on the label would endanger the confidentiality of your activities, and in particular your intellectual property.
- Which substances are involved?
You can submit a request for an alternative chemical name for each substance in the mixture for which the Community has imposed no limit value for exposure, providing that the substance is only classified in one or more of the hazard categories as mentioned in point 1.4.1 of part 1 of the CLP regulation Annex I, being:
• one of the hazard categories applicable for physical hazards (part 2 of CLP Annex I.);
• acute toxicity, category 4;
• skin corrosion/irritation, category 2;
• serious eye injury/eye irritation, category 2;
• specific target organ toxicity with single exposure, category 2 or 3;
• specific target organ toxicity with repeated exposure, category 2; and
• danger to the aquatic environment, chronic category 3 or 4.
Furthermore, when use is made of the alternative chemical name sufficient information must be provided for the necessary precautionary statements relating to health and safety to minimise the risks of using the mixture. It is up to the applicant to demonstrate that this is the case.
6.6. How do you submit a request?
You send your request to ECHA (clp) in the format specified by the Agency using the resources made available for this by the Agency (the CLP regulation 1272/2008, article 24, paragraph 2) in which reference is made to article 111 of the REACH regulation 1907/2006). The Commission charges a payment for the request. The Agency may ask you for extra information if the information is needed to make a decision.
The Agency informs you of its decision within six weeks of your request or after receipt of any required extra information. If the Agency makes no objection within six weeks of the request or of receipt of any required extra information, use of the requested name is regarded as allowed.
6.7. Is there a standard form to submit a request to use another chemical name?
At the Agency:
The Agency has worked out a procedure, through which you can submit your application online (ECHA online).
At the competent authority in the Member State:
In Belgium this is the 'Federal Public Service (FPS) Health, Food Chain Safety and Environment”. There is no standard form for submitting this application.
You may send the application to:
Federal Public Service Ministry of Health, Food Chain Safety, and Environment
Risk Management – Helpdesk REACH
Avenue Galilée 5/2
B – 1210 BRUXELLES
For information: The normal period for processing such an application is approx. 2 weeks. There are no costs associated with such an application.
As a distributor, which classification system should I use for electronic cigarettes containing nicotine ? Should I use the classification of nicotine that the manufacturer communicates to his distributors according to article 4, paragraph 6 of the CLP, or should I use the diverging classification that is currently promoted by the ECHA’s Committee for Risk Assessment ?
In order to comply with the CLP regulation, all the information under article 17 of this regulation must be mentioned on the label:
“Article 17 – General rules
1. A substance or mixture classified as hazardous and contained in packaging shall bear a label including the following elements:
a) the name, address and telephone number of the supplier(s);
b) the nominal quantity of the substance or mixture in the package made available to the general public, unless this quantity is specified elsewhere on the package;
c) product identifiers as specified in Article 18;
d) where applicable, hazard pictograms in accordance with Article 19;
e) where applicable, signal words in accordance with Article 20;
f) where applicable, hazard statements in accordance with Article 21;
g) where applicable, the appropriate precautionary statements in accordance with Article 22;
h) where applicable, a section for supplemental information in accordance with Article 25.
2. The label shall be written in the official language(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. Suppliers may use more languages on their labels than those required by the Member States, provided that the same details appear in all languages used.”
A number of exceptions to these provisions are described in Annex I, point 1.5.2 of the regulation. This concerns packages smaller than 125 ml. However, a substance/mixture classified as acutely toxic cat 1, 2, 3 or cat 4 and destined for the general public, does not qualify for these exemptions.
This means that the appropriate pictogram(s) and hazard statements are obligatory, both on the bottle and on the external packaging. Please bear in mind that Dutch, French and German are obligatory on the label of dangerous products in Belgium (Art. 2,§1 of the Royal Decree of 7 September 2012). In case there is not enough space on your label, you are allowed to use fold-out labels, with the following requirements, as in the example included :
- Limited information on the front page
- Full labelling information on the inside pages (for each language)
- Back page firmly attached to the packaging
In order to determine the correct classification and labelling, the scientific data available must be used.
Article 4 of CLP regulation (1272/2008/EC) also states that:
General obligations to classify, label and package
1. Manufacturers, importers and downstream users shall classify substances or mixtures in accordance with Title II before placing them on the market.
3. If a substance is subject to harmonised classification and labelling in accordance with Title V through an entry in Part 3 of Annex VI, that substance shall be classified in accordance with that entry, and a classification of that substance in accordance with Title II shall not be performed for the hazard classes or differentiations covered by that entry.
However, where the substance also falls within one or more hazard classes or differentiations not covered by an entry in Part 3 of Annex VI, classification under Title II shall be carried out for those hazard classes or differentiations.
4. Where a substance or mixture is classified as hazardous, suppliers shall ensure that the substance or mixture is labelled and packaged in accordance with Titles III and IV, before placing it on the market.
5. In fulfilling their responsibilities under paragraph 4, distributors may use the classification for a substance or mixture derived in accordance with Title II by an actor in the supply chain.
6. In fulfilling their responsibilities under paragraphs 1 and 4, downstream users may use the classification of a substance or mixture derived in accordance with Title II by an actor in the supply chain, provided that they do not change the composition of the substance or mixture.
9. Suppliers in a supply chain shall cooperate to meet the requirements for classification, labelling and packaging in this regulation.
10. Substances and mixtures shall not be placed on the market unless they comply with this Regulation.”
You can use the information provided by your supplier, but ultimately, as the person responsible for placing a product on the market, you are also responsible for the classification of this product. If the classification and labelling are not correct, this constitutes an infringement of the provisions of the CLP regulation.
The harmonised classification for nicotine is currently being reviewed. However, the current harmonised classification does not apply for the acute toxicity through inhalation, which means that for this specific endpoint the person responsible for the placing on the market must comply with article 5, namely examination of all available information.
Recent and validated information about nicotine is available via this link: https://echa.europa.eu/documents/10162/f9510930-4e5e-45ff-bb3a-888cefaf6592
The ATE (acute toxicity estimate) to be used for inhalation when calculating the classification of a mixture is as follows:
ATE inhalation = 0,19 mg/l (substance or mist)
As the person responsible for the placing on the market of a product that may be dangerous, it is your duty to make sure that your clients receive the correct information. In order to obtain the correct classification of the eventual mixture, you can calculate the acute toxicity yourself, or you can make sure that your supplier has used the information above for his calculation.
Finally, do not forget to check whether a child-resistant fastening (CRF) and/or a tactile warning of danger (TWD) should be foreseen (Art. 35, paragraph 2 of the CLP regulation).
1. Outer packaging
1.1. A company wants to sell a kit, a receptacle containing a number of products including two products that can be classified according to a certain hazard classification. These different elements are sold as a whole. Do the various hazardous products have to be separately labelled (intermediate packaging) or only the outer packaging? Or is compliance with the labelling conditions for the transport of hazardous goods sufficient?
In principle every packaging, both the inner, the center and the outer packaging, are labelled according to the CLP regulation 1272/2008.
However, if the labelling of the outer packaging falls under both the transport provisions and under the CLP provisions, then labelling or marking according to the transport legislations will suffice. If one decides to label the outer packaging according to the CLP standard after all, and if the hazard pictogram, which is required in the CLP regulation, refers to the same hazard as the rules for the transport of hazardous substances, then the CLP hazard pictogram should not be applied to the outer packaging.
2. Small packaging
2.1. Can the exceptions of Annex I to article 17 of the CLP regulation 1272/2008 ”Labelling of packages with a total volume of at most 125 ml” also be used for substances or mixtures if these are also classified according to other hazard classes?
Yes, but the exceptions only apply for the classifications as discussed in Annex I. If there are other additional classifications not mentioned in Annex I, these hazard statements and these precautionary statements for them must be mentioned on the label.
2.2. Can the exceptions in Annex I to article 17 of the CLP regulation 1272/2008 ”Labelling of packages with a total volume of at most 125 ml” also be used if there is a lack of space on the label because its content is described in different languages that are not all official languages of one specific country? In the UK and Germany, for example, the same product is distributed with a bilingual label so there is not sufficient space on the label to mention all hazard statements and precautionary statements.
No. There are no exceptions provided here. Furthermore, the reason for the lack of space here appears more of an economic nature, and there is no real impossibility to provide the information. Article 17 remains applicable, there are no exceptions.
2.3. Is there a way provided for in the regulation to limit the number of hazard pictograms? For some substances four pictograms are required, and there is not sufficient space on the label with three already present in three languages. Are there certain priority or exception rules to be able to omit one or a number of pictograms?
Yes, there are some priority rules with which in some cases a pictogram can be omitted. For this we refer you to article 26 of the CLP regulation 1272/2008.
F. Relationship with REACH
1. Safety data sheets
1.1. What are the consequences of the CLP regulation on the safety data sheets? Must these safety data sheets follow the new classification and labelling according to the CLP regulation?
Yes, the safety data sheets must be adapted to the new CLP regulation 1272/2008. If the classification of a substance or mixture changes as a result of implementing CLP, it will be necessary to update Safety Data Sheets. It may also be necessary to prepare new Safety Data Sheets for substances or mixtures which were not classified as hazardous under DSD or DPD. Registration deadlines may also change as a result of a reclassification under the CLP regulation. Moreover, the format of the safety data sheets will change so that their graphic representation becomes much more complex. You can find more information in the ‘Introductory Guidance on the CLP Regulation’ and in the Commission Regulation (EU) No. 453/2010 of 20 May 2010 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH regulation 1907/2006)
Adaptation takes place in various phases depending on the CLP deadlines. From the 1st December 2010, the CLP regulation replaces the DSD for classification, labelling and packaging of substances.
Up until 1 June 2015
• the classification of a substance in conformity with the DSD must be mentioned on the safety data sheet. This applies for both safety data sheets for substances as such, and safety data sheets for mixtures that contain these substances;
• the classification of a mixture in conformity with the DPD must be mentioned on the safety data sheet;
• if a mixture is classified, labelled and packaged in conformity with the CLP, the CLP classification must be mentioned on the safety data sheet besides the classification under the DPD. A supplier can, however, decide for the CLP classification of a mixture before he fully applies the CLP to the mixture. In this case the supplier can include this information on the safety data sheet supplied under the 'other information' header';
From 1 June 2015 :
• the CLP regulation replaces the DPD for the classification, labelling and packaging of mixtures
• Classifications of substances and mixtures in conformity with the CLP must be mentioned on the safety data sheet.
Remark: The exceptions to these deadlines are included in article 2 (6, 7) of aforementioned regulation 453/2010.
1.2. The provisions of the safety data sheets are mentioned in the REACH regulation 1907/2006. If a company has no registration obligation under REACH, does it have to adapt the safety data sheets for substances or not?
Yes. Even if the substances are exempt from the REACH registration obligation they do concern the safety data sheets. Even if the substance is exempt according to title II of REACH (REGISTRATION OF SUBSTANCES), this does not mean that this substance is exempt from the whole regulation, also not under title IV (INFORMATION IN THE SUPPLY CHAIN).
Also see ‘Regulation (EU) No. 453/2010 of the Commission of 20 May 2010 for the amending of Regulation (EC) no. 1907/2006 of the European Parliament and the Council concerning the registration and assessment of, and the authorisation and limitations with regard to chemicals (REACH) or you can request this at the helpdesk Reach of the FPS Economy.
2. Notification and registration
2.1. Is CLP notification required for NONS that already have a REACH registration number?
Yes, notification is required. Substances that were already notified under Directive 67/548/EEC, the so-called ‘NONS’, are regarded as registered under the REACH regulation 1907/2006 and must consequently be notified to the Inventory (of classification and labelling). Because the respective files currently only contain the DSD classification these must, without unnecessary delay, be completed with the CLP classification in conformity with article 22 of the REACH regulation.
The notification obligation is also applicable to dangerous NONS produced and placed on the market or imported in volumes lower than 1 tonne a year. The respective files can, however, only be updated with the CLP classification when the manufacturer or importer has requested a registration number for the substance concerned. Otherwise separate notification must take place. ECHA advises industry to request a registration number and submit an update of the NONS file as soon as practically feasible.
2.2. Do these NONS have to be classified, labelled and packaged according to the CLP criteria?
Yes, they must be classified, labelled and packaged according to the CLP regulation 1272/2008.
From 1 December 2010 these ‘new substances’ (NONS) must be classified according to the CLP regulation before they are placed on the market. Such NONS must also be packaged and labelled according to Titles III and IV of the CLP regulation from 1 December 2010. NONS that have already been classified, packaged and labelled according to the Dangerous Substances Directive 67/548/EEC (DSD) and that were placed on the market before 1 December 2010 will only have to be relabelled and repackaged according to the CLP regulation by 1 December 2012.
For any further questions concerning the NONS we refer to the ECHA document ‘Questions and Answers for the registrants of previously notified substances’ and to the ‘Frequently Asked Questions on CLP’
2.3. Is it compulsory to register substances with the Inventory of classification and labelling if these are exempt from registration according to Annex V of REACH?
Yes this is compulsory, see articles 39(b) and 40(1) of the CLP regulation: when a substance is exempt from registration according to REACH, the CLP regulation still requires the substance to be registered with the Inventory of classification and labelling if it can be classified as hazardous and is placed on the market as itself or a part of a hazardous mixture above certain concentration limits. Substances exempt from registration according to REACH, that are not classified as hazardous and that are placed on the market, on the other hand, do not need to be notified to the Inventory of classification and labelling.
2.4. What does this mean for notification according to the CLP regulation 1272/2008?
The company submits a proposal for the changing of a harmonised classification to the competent authorities (see question D.6.7.) of one of the Member States in which the substance is placed on the market. This proposal must be in conformity with the relevant parts of point 1, 2 and 3 of Annex I of Regulation 1907/2006 (REACH) and with Part B of point 7 (Classification of the Chemical Safety Report) of the same Annex. It will contain the relevant information as described in Part 1 of Annex VI of REACH.
For more information and support, visit the website of ECHA (clp)