GHS & CLP - Classification FAQ
Are massive metals to be classified under STOT?
Specific target organ toxicity (repeated exposure) means specific, target organ toxicity arising from a repeated exposure to a substance or mixture. All significant health effects that can impair function, reversible and irreversible, immediate and/or delayed are included.
Physicochemical properties, such as pH, physical form, solubility, vapour pressure, particle size, can be important parameters in evaluating toxicity studies and in determining the most appropriate classification especially with respect to inhalation where physical form and particle size can have a significant impact on toxicity. The massive form and its bioavailability could be considered here as a parameter in the discussion for STOT RE after inhalation…However, generation of dust /fumes from the massive cannot not always be excluded if it is handled. Other routes (e.g. dermal route) should also be considered.
If there is data to support a dermal of STOT than the substance will be classified. Please see Globally Harmonized System of Classification and Labelling of Chemicals (GHS) 3.8.1 and 3.9.1 for reference. The point is if there is data suggesting STOT under the concentrations guidelines than it will be classified as such.
Are nanomaterials/particles need to be classified and labelled since no ruling exists as yet?
When an existing chemical substance, already placed on the market as bulk substance, is introduced on the market in a nanomaterial form (nanoform), the registration dossier will have to be updated to include specific properties of the nanoform of that substance. The additional information, including different classification and labelling of the nanoform and additional risk management measures, will need to be included in the registration dossier. The risk management measures and operational conditions will have to be communicated to the supply chain.
In order to address the specific properties, hazards and risks associated with nanomaterials, additional testing or information may be required. To determine specific hazards associated with nanomaterials, current test guidelines may need to be modified. Until specific test guidelines for nanomaterials exist, testing will have to be carried out according to already existing guidelines. REF: Brussels, 17.6.2008. Communication from the commission to the European parliament, the council and the European economic and social committee: Regulatory aspects of Nanomaterials [SEC(2008) 2036].
Are there community wide classifications now that the DSD List Annex 6 is deleted?
Harmonised classifications for those substances currently listed on Annex I to DSD have been translated into the new CLP classifications; they can be found in Table 3.1 of Annex VI to CLP. The classifications based on the DSD criteria can be found in Table 3.2 of Annex VI. For substances and mixtures that do NOT have a harmonized classification, self classification will take place (harmonization ultimately through the SIEF) however proposals for a harmonized classification maybe submitted either by Member State competent Authorities or, by manufacturers, importers and downstream users themselves (This is new to CLP) (see section 22 of CLP guidance Document).
In addition, Member States, manufacturers, importers and downstream users might also submit proposals for a harmonized classification to the Agency which refer to other substance properties if justification is provided demonstrating the need for harmonized classification and labelling at Community level (CLP Article 37 (2)).
Can you simply use the CLP conversion table to classify your substances, without going back to original data?
Yes, there are translation table to help translate between the classification under directive 67/548EEC and CLP (see CLP Annex VII, Table 1.1). However, not all substances can be directly translated. Whenever data for the substance or mixture are available, an evaluation and classification shall be done in accordance with Articles 9 to 13 of the CLP Regulation.
Translation tables may only be used directly when : the substance of mixture had been previously classified under DSD and DPD prior to 1 Dec 2010 and 1 June 2015 respectively, and when there is no data (scientific or technical) for the substance or mixture available for an individual hazard class. (Please refer to RIP 3.6 on Annex VII).
Also, while the overall scope of classification under CLP is comparable with DSD, the countable number of hazard classes has increased, in particular for physical hazards (from 5-16), leading to a more explicit differentiation of physical properties. There are also elements which are a part of DSD/DPD but are not (yet) included in UNGHS which are treated differently (see Part 5 of Annex I and in Annex II to CLP).
Do I need to reference to DPD or DSD classifications If I classify and label under CLP after December 2010?
Substances registered between 1 December 2010 and 1 June 2015 shall be registered with a classification according to CLP; a classification according to DSD can be added. (see section 4 “Transition to CLP” in the Basic Guidance to regulation (EC) No 1272/2008 on Classification, labelling and packaging of substance and mixtures. (pg 17).
Do mixtures have to be notified?
Mixtures do not have to be notified under Article 40 of CLP (Obligation to Notify the Agency) if the information has already been submitted to the agency as part of a registration pursuant to Regulation(EC) No 1907/2006 (REACH), OR if it has already been notified by that notifier. Therefore because mixtures must be registered under REACH they need not be notified to the Agency. (Please see Article 40 of CLP.)
Does registration under REACH before December 1, 2010 have to be accompanied by classification according to CLP and NOT according to DSD?
Substances registered before December 1, 2010 shall be registered with a classification according to DSD. However, the registration may also contain the classification according to CLP, as far as available.
It is advisable to include the classification and labelling in accordance with CLP as otherwise you will either have to update and resubmit the registration dossier or submit a notification with this classification and labelling by December 1, 2010.
Is it correct that only substances in quantities of 1000t or more need to be notified?
Manufacturers and importers are required to notify the Agency of the classification and labelling of substance(s) placed on the market (no tonnage band requirements). The Agency will then include the information in a classification and labelling inventory in form of a database. Substances placed on the market on or after 1 December 2010 require notification within one month. However, substances placed on the market before 1 December 2010 may be notified before that date. There is no need to notify the substance if the same information has already been submitted as part of a registration under REACH, as the classification and labelling, when part of the registration package will automatically be added to the inventory. (Please see RIP3.6 and CLP legal text Article 54 for more information).
Once a metal is classified, does it always need to have a label?
A substance or mixture contained in packaging should be labelled according to the CLP rules if:
- the substance of the mixture itself is classified as hazardous (some forms are exempted see section 1.3 of Annex I to CLP) or;
- it is a mixture containing a substance classified as hazardous above the concentrations as referred to in Part 2 of Annex II to CLP, even if the mixture itself is not classified overall as hazardous. In this case the supplemental labelling as set out in Part 2 of Annex II to CLP shall apply (CLP Article 25(6));
- it is an explosive article as described in Part 2.1 of Annex to CLP.
Who do CLP obligations apply to?
CLP obligations lay upon manufactures, importers and downstream users of a substance or mixture. Downstream users should be able to use the classification of a substance or mixture, provided they do not change the composition of the substance or mixture.
See Regulation (EC) N 1272/2008 of the European Parliament and of the council of 16 December 2008 on Classification, labelling and packaging of substance and mixtures, amending and repealing Directive 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006. Article 16.
Who is the leader for the classification under CLP?
CLP is an EU regulation. Please note that both REACH and CLP ask for classification but that their requirements are a bit different. For example:
CLP Regulation (CLP Article 4(1))
If you are a M/I or DU of chemical substances or mixtures to be placed on the market, you should classify these substances or mixtures before placing them on the market, independent from any tonnage manufactured, imported or placed on the market.
REACH (CLP Article 4(2))
If you are a M/I, you should also classify substances which you do not place on the market if they are subject to registration or notification in line with Articles 6, 9, 17 or 18 of REACH (incl. on-site isolated or transported inter- mediates ….).
Will self classification be a uniform process?
In such cases where no harmonised classification is available, or where harmonised classification is available for selected hazards only, the suppliers substances or mixtures or producers or importers of certain specific articles1 have to self classify.
One of the aims of a Substance Information Exchange Forum (SIEF) is to agree the classification and labelling for the same substance where there is a difference in the classification and labelling of the substance between potential registrants (REACH Article 29)
_1 As a producer or importer of an article you are only affected by CLP if you produce or import an explosive article as described in section 2.1 of Annex I to CLP or where REACH Article 7 or 9 provide for registration or notification of a substance contained in an article.
Last page update: 1 October 2018