EU CLP Regulation | Special Rules on Packaging and Labelling

The REGULATION (EC) No 1272/2008 on Classification, Labelling and Packaging of Substances and Mixtures, commonly known as CLP Regulation, entered into force on 20 January 2009. It aligns existing EU legislation to the United Nations Globally Harmonised System of Classification and Labelling of Chemicals (GHS).

Main Requirements of CLP Regulation

The CLP Regulation requires that suppliers of chemicals classify, label and package substances and mixtures in accordance with the CLP Regulation. Different deadlines are set for substances and mixtures.

The CLP Regulation also requires that suppliers of a hazardous substance (on its own or mixture) notify the European Chemicals Agency (ECHA) of its classification and labeling within one month of placing the substance on the market for the first time. This is often called C&L notification. Please note that there is no small volume exemption for C&L notification.

Classification

The classification of a substance or mixture reflects the type and severity of the hazards of that substance or mixture. Suppliers need to decide on the classification of a substance or mixture by gathering available data and referring to chemical classification criteria given in CLP regulation. This is often called self-classification.

For example, a liquid with flash point between 23 and 60 Celsius degrees will be classified as Flammable Liquid Category 3. Based on this classification, you can easily find its signal word, pictogram, hazard statement, and precautionary statement (see picture below).

Currently CLP's classification criteria are aligned with UN GHS Rev. 5(5th ATP). Certain building blocks are not adopted such as acute toxicity category 5 and flammable liquids category 4.

Annex VI to CLP - Compulsory Classification List

Annex VI of CLP includes harmonized classification and labelling for thousands of hazardous substances. It is mandatory for the suppliers of the respective substances or mixture to apply harmonized classification and labelling.

A few important notes when using compulsory classifications:

• For certain hazard classes, including acute toxicity and STOT repeated exposure, the classification in the Annex shall be considered as a minimum classification;
• For some entries (indicated by the reference ****), harmonized classification has not included physical hazards due to insufficient data. In this case, the correct classification for physical hazards shall be confirmed by testing;
• Please do read notes (i.e., A, B, H) for each entry which contain conditions for the harmonized classifications to apply;

Compulsory classifications in annex VI are available for from ECHA's classification &labelling inventory (C&L Inventory). C&L Inventory also contains classification and labelling information on notified and registered substances received from manufacturers and importers.

If you search ethanol (CAS 64-17-5), the following screenshot will pop up with harmonized classification for ethanol:

CLP Labelling

CLP label contains standard GHS label elements plus supplementary hazard statements (please refer to special rules on packaging and labelling). The picture below is an example of a CLP label from ECHA's guidance:

CLP regulation has also specified minimum dimensions of labels and pictograms under CLP for packages with different capacities (see picture below).

You can check global size requirements for GHS labels here.

Other CLP labelling requirements include:

• 6 p-statements rule: Not more than six precautionary statements shall appear on the label unless it is necessary;
• Language: shall be prepared in the official language of destination Member States;
• Hiding composition info: A request for the use of an alternative chemical name shall be submitted to ECHA and approved by ECHA;
• Small packages (<=125mL): certain GHS elements can be omitted (see example below);

Annex II to CLP - Special Rules on Packaging and Labelling

Supplemental hazard information which have not yet been included in the GHS but which have been part of the EU system in the past shall also be included in SDSs and on labels. A few examples are given below:

Example 1: Mixtures containing more than 0.15% lead by weight

EUH201- 'Contains lead. Should not be used on surfaces liable to be chewed or sucked by children' shall be labelled.

Example 2: Mixtures not classified as sensitising but containing at least one sensitising substance

EUH208-'Contains (name of sensitising substance). May produce an allergic reaction' shall be labelled.

Example 3: Labelling of plant protection products

EUH401-'To avoid risks to human health and the environment, comply with the instructions for use' shall be labelled.

In addition to that, CLP also requires child-resistant fastenings and tactile warning of danger on packages for certain hazardous chemicals.

Child-resistant fastenings	For chemicals sold to the general public and classified with acute toxicity, categories 1 to 3, STOT- single exposure category 1, STOP- repeated exposure category 1, skin corrosion category 1 or aspiration hazard; For a substance or mixture containing more than 3% methanol or 1% dichloromethane and sold to the general public;
Tactile danger warning	Normally a small raised triangle(see example below); The purpose is to alert the blind and the partially sighted that they are handling a dangerous chemical; Required for chemical sold to the general public and classified for acute toxicity, skin corrosion, germ cell mutagenicity category 2, carcinogenicity category 2, reproductive toxicity category 2, respiratory sensitisation, or Stot, categories 1 and 2, aspiration hazard, or flammable gases, liquids and solids in categories 1 and 2;

C&L Notification

CLP regulation requires that information on substance identity, classification and labelling of a substance should be notified to ECHA within one month since a substance is placed on the EU market for the first time. C&L notification is very easy and it is usually done by manufactures or importers in the EU. There are various options to submit C&L notifications among which online submission may be the easiest. Please be noted that <1t/y non-hazardous substances do not need to be notified.

Safety Data Sheets

CLP classification and labelling info must be included in Safety Data Sheets. However, SDSs are governed by the REACH regulation. The Annex II of REACH has set out detailed requirements on the format and content of SDSs.

REACH SDS follows a 16 section format which is internationally agreed. The SDS must be supplied in an official language of the Member State(s) where the substance or mixture is placed on the market.

• Section 1: Registration number for substances subject to REACH registration must be provided; Email address mandatory;
• Section 8: List applicable DNELs, OELs, and PNEC;
• Section 15: Info on substances subject to authorization and restrictions; Indication of whether a chemical safety assessment has been conducted;
• eSDSs: Registrants and downstream users that are required to prepare a CSR, must place the relevant exposure scenario(s) into an annex to the Safety Data Sheet.

- See more at: http://www.chemsafetypro.com/Topics/EU/CLP_Regulation_EC_No_1272_2008.html