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Safety Data Sheets and Labelling for supply

GHS – Global Harmonisation System

A REFERENCE FOR THOSE HANDLING CHEMICALS

IN THE WORKPLACE

The production, transport, storage and supply of chemicals are covered by a number of regulations with the objective of protecting man and the environment during the use of chemicals that are essential to our standard of living. It is not just the chemical industry that is affected by these regulations - any organisation using chemicals, including printing, electronics, textiles, motor trade, health care etc. needs to be aware of chemical safety issues.

For those of us working with chemicals, it is important that we know how to recognise those that are hazardous, how to prevent exposure and ultimately reduce any risk to ourselves, our colleagues and to the environment.

In Europe, there is a general requirement to identify chemical substances and to understand their hazards so that products can be classified, labelled with suitable risk and safety phrases and packaged in an appropriate manner. To communicate hazards and to help identify potential risks, a Safety Data Sheet (SDS) needs to be provided to commercial users so that they in turn can ensure suitable protection to their own staff.

REACH is changing this regulatory framework and the UN Global Harmonisation System (GHS) for classification and labelling is bringing changes to SDS and labelling, with new symbols and phrases.  Note that GHS refers to the ‘Safety Data Sheet’ or SDS and the word ‘Material’ is not required – therefore, in theory, even US ‘Material Safety Data Sheets’ will be SDS without the ‘M’ in future.  However, when considering how serious a topic hazard communication is, one questions whether the use of ‘M’ is really worth worrying about – the quality of information communicated is of far greater importance than the title.

Chemical Regulations

Why have controls and regulations?

Chemicals are an integral part of or modern lives and to ensure that these are handled in a manner safe for workers, consumers and the environment, it is necessary to control their supply.  Mostly, this control is to ensure that users are made aware of potential hazards and are advised on safe handling.  It is only the exceptionally hazardous materials that are restricted in supply and generally, the onus is on the user to act responsibly to potential hazards, relying on good communication from their supplier. 

Background to European chemical supply regulations

Along with most of the World, legislation has been enacted in Europe to control the supply of dangerous chemicals.  In Europe, the system is based on hazard identification and the control of particular chemicals is set according to the hazard with the objective of reducing risk.  The process of chemical control was set out in the parent Directive 67/548/EEC and almost all pieces of EU legislation relating to the chemical industry since then refer back to the principles laid out in this Directive including REACH. 

The first stage in the reduction of risk is to ensure that the potential hazards of the chemical product (either a single substance or a mixture) are suitably identified and then communicated to those in contact with the product.  In Europe, the identification of hazards has been formalised into symbols and numbered Risk and Safety phrases.  Anyone in Europe can therefore look at a pictogram symbol and associated Risk and Safety numbers and know the potential hazard of the chemical and be advised on the basics of safe handling or disposal.  GHS is not changing this principle, but over time with adoption of GHS globally, the symbols (pictograms) and phrases will be used universally.

National legislation 

Pre-REACH legislation was mostly based on Directives and these needed enacting through national legislation in Member States.  REACH is based on a Regulation and should (in theory) result in a more unified approach to chemical legislation in Europe (including Norway, Iceland and Liechtenstein).  Switzerland will follow GHS, but is not signing up to REACH. 

Examples of nation legislation include: 

COSHH – UK Control of Substances Hazardous to Health

The Control of Substances Hazardous to Health Regulations (COSHH) relates to the use of chemicals in the workplace and is the most important piece of legislation affecting workers.  The legislation covered is mirrored by other national legislation throughout Europe, covering the use of all substances. 

Under COSHH, the first step is to assess the potential hazards and risk of the material. This is done by ensuring suppliers have suitably labelled and packaged the material and have provided a Safety Data Sheet (SDS). If this is not available or appropriate, product testing may be required to provide sufficient information to prepare an MSDS and make a hazard assessment.

CHIP - Chemicals (Hazard Information and Packaging for Supply) Regulations

CHIP  is the UK enacting legislation for the classification and labelling of dangerous substances and preparations, currently issued as CHIP 3, to mirror the latest EU Directives and came into effect July 2002. 

CHIP is concerned with correct labelling of chemicals and with the communication of hazards when chemicals are supplied.  There is a legal responsibility for suppliers of chemicals to provide certain minimum standards of information to their customers and those receiving chemicals from European suppliers, can demand this information.

Safety Data Sheets (SDSs) and labelling for supply are the most significant part of CHIP, but these regulations also cover types of packaging and advertising for dangerous chemicals as well as providing legislation for the restriction of supply of certain dangerous chemicals.

National data-bases for SDSs

Article 17 of Directive 1999/45/EC indicates that Member States have a responsibility to appoint ‘national bodies responsible for receiving information relating to [dangerous] preparations placed on the market’.  The draft CHIP 3 regulation included a similar statement in Regulation 14, but this disappeared in the final version of CHIP 3. 

In Poland, for example, suppliers must inform the Bureau for Chemical Substances and Preparations when they place a dangerous preparation on the market.  The Bureau then stores information on dangerous preparations that are currently on the market and under obligations of Directive 1999/45/EC, ensures that data are held in commercial confidence, but made available for medical personnel.

Similar systems exist in Spain, Finland, Austria, Latvia, Estonia and Italy and in some cases, there are specific forms that should be completed.  In France, it is only necessary to submit information (within 30 days of supply) for very toxic, toxic or corrosive chemicals. 

Safety Data Sheet - SDS

The European SDS was formalised in the ‘16-point’ format in Directive 91/151/EEC and amended significantly be Directive 2001/58/EC and was based on the UN International Labour Organisation (ILO) format, also used in other parts of the World.  GHS changes this slightly, with section s 2 and 3 changing position.  REACH is also introducing other changes for Europe – more later.

A Safety Data Sheet (SDS) must be prepared for chemical products considered hazardous to health or the environment, supplied within European Union, European Free Trade Association Member States or other specific countries as requested. The definition ‘hazardous’ is defined in Directive 67/548/EEC and subsequent amendments – REACH does not change this requirement, but does expand the meaning of ‘hazardous’ to vPvB materials (very Persistent, v Bioaccumulative – see [link]).  However, anyone being supplied a chemical can demand an SDS even if it is not hazardous if the mixture contains hazardous components above certain thresholds.  This requirement applies to all chemical products, unless being supplied for non-professional use, such as retail sales. 

The content of an SDS must reflect all information available to the supplier, relating to the hazardous chemical, that is considered necessary to provide adequate warning and advice on safe handling to the users. 

Although suppliers are not expected to conduct extensive testing on their products to generate data for safety data sheets, there should be sufficient data on the product (or derived from similar materials) to enable a suitable classification to be made and R phrases assigned.  Suppliers must be able to justify their data sheets and retain records of how decisions were made to classify (or not classify).

Ultimately, the function of the SDS is to communicate potential hazards and it is unacceptable to supply a material if those hazards are not known.

Format

Headings to be used in European SDS are as follows;

       1    Identification of the substance/preparation and the organisation responsible

       2    Hazards identification (assessment)

       3    Composition including information on components

       4    First aid

       5    Fire fighting measures

       6    Accidental release measures

       7    Handling and storage

       8    Exposure controls

       9    Physico-chemical properties

      10   Stability and reactivity

      11   Toxicological information

      12   Ecological information

      13   Disposal considerations

      14   Transport information

      15   Regulatory information

      16   Other information

This ‘16-point’ format, based on GHS recommendations, will be acceptable throughout the world.  Changing to this format in Europe is starting from the introduction of REACH (June 2007), but until nation legislation is repealed, there will be no obligation for industry to change format – it is thought that be 2018, all SDSs should be in the new format with GHS classification.  Industry is recommended to implement changes as new products are supplied or when reviewing the SDS and labels.

Labelling for supply

Labels for supply need to communicate more information than the labels for transport – this is because supply labels are designed to be read by those in regular contact with the material and not only concerned with immediate hazards as in the case of transport.

The basic elements of the label are:

·        Identity of substance / preparation

·        Classification symbol

·        R and S phrases (hazard)

·        Name address and emergency contact number

·        Confirmation of EU Compliance, issue date etc

Note that this format of labelling is only required for dangerous chemicals. 

Declaration of content

Labels and safety data sheets need to identify any dangerous chemicals present within prescribed concentration limits.  For substances, this is a simple requirement to provide the chemical name of the substance if classified, but for preparations containing diluted substances, limits are set at which the content needs to be declared.  Components classified only in relation to certain short-term or physical hazards are permitted to be identified by generic names, if below limits for classification.

Components subject to occupational exposure limits or are defined as special cases in the Approved Supply List (Annex I to Directive 67/548/EEC) will need to be named.  REACH is not changing this concept, but as substances are Registered and reviewed, a Classification and Labelling Inventory will replace the old Annex I.

Concentration limits for identification on SDS or label for supply

(non gaseous preparations – different limits apply for gases)

Note that Classification and Declaration of content on label may be specified on Annex I for certain dangerous substances, such as those considered sensitising or contain, lead, cadmium or other specific substances.

Exemptions for confidentiality

Article 15 of Directive 1999/45/EC specifically covers when it is possible to request an exemption to the need to identify the dangerous components of preparations on labels and SDSs.  Annex VI of this Directive describes the information that should be given to the national Competent Authority and also gives details on groupings of chemicals into generic names. 

To put it simply, it is possible to request the use of a generic name in Section 2 of the SDS or on the label of a dangerous preparation if the component is classified only as Harmful Xn or Irritant Xi.  Exception are those labelled with R41 (permanent eye damage) or are Harmful due to long-term health effects. 

Note that exemptions cannot be requested for components that require identification in Section 2 of the SDS due to classification of the preparation as Dangerous for the Environment N, even though they need not be included on the label.

There is an apparent contradiction in CHIP and Directive 1999/45/EC in that it appears that components harmful or irritant AND dangerous for the environment may be possible to name generically, but careful reading would suggest that if a preparation  was itself classified as Dangerous for the Environment, these exemptions would not apply.  For example, a material classified as Xi R36 and N R51/53 is not exempt from being identified - if you turn it around so that the material is N R51/53 and Xi R36, it is more obvious.  

Exemptions for confidentiality do not apply for materials with community exposure limits.

REACH will also allow commercial confidentiality to be applied and this will be across the EU and not just under national derogations.

More information on GHS will be provided when the European Regulation is finalised.