In this feature article Desmond Waight describes the classification, labelling and Safety Data Sheet (SDS) requirements applicable to importers into the EU of general hazardous chemicals.
This article will cover only the requirements that apply to general chemical products. It does not attempt to deal with specialised chemical provisions such as those applicable to plant protection products.
Although one might expect Regulation (EC) No. 689/2008 on the Export and Import of Dangerous Chemicals (known in short as the PIC Regulation) to be applicable to classification and labelling and SDSs of imports, that is not the case. Nor will its successor, Regulation (EU) No. 649/2012 concerning the Export and Import of Hazardous Chemicals (which will also be called the PIC Regulation), cover this either.
In relation to imports, both the 689/2008 and the 649/2012 PIC Regulations only deal with the Prior Informed Consent (PIC) issues of such trade, and do not cover classification, labelling and SDS issues. In contrast, both the 689/2008 and the 649/2012 PIC Regulations do apply to classification, labelling and SDSs of exports.
The applicable regulations are in fact the following.
For substances imported, the directly acting Regulation (EC) No. 1272/2008 on the classification, labelling and packaging of hazardous (CLP). This states in Article 2, para 18 that: “‘placing on the market’ means supplying or making available, whether in return for payment or free of charge, to a third party. Import shall be deemed to be placing on the market”.
For preparations/mixtures, either the CLP or the British Chemicals (Hazard Information and Packaging for Supply) Regulations 2009 (CHIP), which implement the EC 67/548/EEC Dangerous Substances Directive (DSD) and 1999/45/EC Dangerous Preparations Directive (DPD). CHIP states that: “‘supply’, in relation to a substance or preparation, means making that substance or preparation available to another person and includes importation of the substance or preparation into Great Britain”.
For SDSs, for both substances and preparations/mixtures, the directly acting Regulation (EC) No. 1907/2006 (known as REACH), which defines placing on the market in exactly the same way as CLP.
Labelling for supply of hazardous substances
Once a substance has been imported, it must be classified under CLP and if found to be hazardous, then the labelling must be checked; if it is not in accordance with CLP, it must be relabelled to meet CLP requirements. Additionally, any special labelling information required under Annex XVII of REACH shall be added in the supplemental area of the CLP label of a substance label, eg for chloroform (CAS No. 67-66-3), the following must also appear: “‘For use in industrial installations only”, in addition to the rest of the labelling required by CLP.
This shall be done without delay (although no time-specific allowance is given in practice as long as it is done as soon as reasonably practicable), and certainly before the substance is in the longer term, stored, processed or used within the importer’s operations; this will normally be acceptable to the enforcing authority. This requirement exists so that the importer’s staff will be “protected” by a hazards labelling system to the same standard as if the goods had been supplied by an EU-based entity.
When classifying it will be necessary to:
undertake, until 30 May 2015, a classification to the DSD system as well as to the CLP system. From 1 June 2015, a classification solely to CLP will be required
submit a notification of the classification to the EU Classification and Labelling Inventory at ECHA within 31 days of importation, unless such a notification has previously been made by that importer for that substance.
Labelling for supply of preparations/mixtures
Once a preparation/mixture has been imported it must be classified under CHIP, and if found to be hazardous, then the labelling must be checked; if it is not in accordance with either CHIP or CLP labelling requirements, it must be relabelled accordingly. After 1 June 2015, the classification and labelling must be in compliance with CLP.
Additionally, any special labelling information required under Annex XVII of REACH shall be added in the supplemental area of the CLP label. For example, for mixtures containing chloroform, at 0.1% or more, the following must also appear: “For use in industrial installations only”, in addition to the rest of the labelling required by CLP, if the substance is intended for supply to the general public and/or is intended for diffusive applications such as in surface cleaning and cleaning of fabrics.
In some cases, CHIP/CLP will require labelling of mixtures that are not classified as dangerous under CHIP or classified (as hazardous) under CLP. For instance, a mixture containing a sensitiser in a mixture that is not classified under CHIP or CLP will need to state: “Contains [name of sensitising substance]. May produce an allergic reaction”.
When classifying it will be necessary to:
undertake, until 30 May 2015, a classification of the preparation as a whole to the DSD system, as well as to the CLP system, even if the decision is taken to label to CLP ahead of the 30 May 2015 deadline; from 1 June 2015, a classification only to CLP will be required
submit a notification to the EU Classification and Labelling Inventory at ECHA of the classification of any hazardous (under CLP) substance(s) within the mixture if they contribute to the classification of the mixture as hazardous under CLP; this to be done within 31 days of importation, unless such a notification has previously been made by that importer for that substance.
The requirements apply equally to small packaged quantities as to larger packaged quantities. Where the chemical is imported in a tank container and that tank container remains with the importer for a while (acting effectively as a very large delivered package), then that tank container must be labelled to comply with CHIP or CLP. The labelling and marking that was applied for transport of dangerous goods purposes can fulfil some, but not all, of that requirement.
In respect of the importer’s storage and use
Because of the definition of “placing on the market”, the importer should, at least in legislation terms, ensure that they supply themselves with a REACH-compliant SDS as soon as a chemical is imported that needs an SDS supplied to the recipient as per REACH (generally those chemicals which are dangerous/hazardous for supply).
This is because legislation such as the Control of Substances Hazardous to Health (COSHH) and the Dangerous Substances and Explosive Atmospheres Regulations 2002 (DSEAR) assume the availability of an EU-compliant SDS in order to support the risk assessment and hazard communication to employees that this legislation requires.
In respect of onward supply
However, where the imported substance or preparation is not to be used by the importer but merely supplied onward, to someone at work, then the importer (as an EU supplier) must provide an SDS that is compliant with the REACH requirements for formatting, content and language. Since 1 December 2012, this must be the 16 section format with mandatory sub-headings, as set out in the Regulation (EU) No. 453/2010 that amended REACH Annex II SDS provisions.
In this short article we have attempted to briefly identify the requirements applicable to the importer in respect of labelling and SDS of general chemicals that they may import, including any that they may import for their own use, and not merely for onward supply. Full reference to the applicable legislation and any official guidance should however, be undertaken by importers.
Last reviewed 20 March 2013