environment magazine

REACHing Safe Use of Chemicals

By Lisa Allen, REACHReady Technical Manager

Understanding REACH

The Registration, Evaluation and Authorisation of Chemicals (REACH) regulation has been in force since 2007. Its overarching aim is to improve environmental and human health protection from the risks of chemicals. It is important that all manufacturers, importers and downstream users of chemicals are fully aware of the impact that this European Regulation has on their business.

REACH is fundamentally changing the shape of every supply chain within Europe. It is not limited to business sectors traditionally regarded as “the chemical industry,” and it touches almost every product on the European market as far as high street consumer goods such as clothing and electronics. Even if we focus on what happens in just one part of European industry and on one product sector or type, there is still a huge variety in how those chemicals are used and around the risks they pose. In the paints and coatings sector for instance, there is everything from high-end precision coatings for the automotive, aerospace and defence sectors, to the use of paints and varnishes by the general public in the home.

Registration obligations

Registration is the first contact many companies will have with REACH. Registration is an industry-managed process to generate a dossier of information on identity, intrinsic properties, identified uses, risk assessment and risk management for the substances those companies introduce to Europe. It applies to substances manufactured or imported at one tonne or more per year, and it affects both hazardous and many non-hazardous chemicals.

For anyone who fails to meet their registration duties, the “no data, no market” provision of REACH makes manufacture and import of the substance illegal. If disruption to supply is not enough to encourage companies into compliance, than the threat of an unlimited fine and up to two years in prison may just provoke the desired result.

For the vast majority of substances known to the European market, companies declared their intentions to register in late 2008– a process known as “pre-registration.” Some 143,000 substances were pre-registered by over 65,000 legal entities – figures that reflected the huge task ahead for full registration. To ease the burden, registration is phased in with deadlines in 2010, 2013 and 2018. A company’s registration deadline depends on both the nature of the substance it manufactures or imports and its annual tonnage. Risk is dependent on both the intrinsic hazards of a substance and the potential for exposure to the environment, workers or the general public; the highest risk substances must be assessed and registered before those of lower hazard or annual tonnage.

Manufacturers and importers have registered over 4,000 individual substances since registration began on 1 June 2008, from commodity solvents such methyl ethyl ketone and xylene, to more specialist raw materials such as inorganic pigments for anti-corrosion coatings. At least as many will be registered in 2013, but more are likely to be specialty chemicals in innovative applications, inevitably meaning more bespoke assessments of risk.

Top-down approach to risk management

Viable registration relies on the chemical manufacturers and importers scrutinising the lifecycle of the chemicals they introduce to Europe, assessing their safety throughout the supply chain, and recommending measures to manage risk. The initial output of this difficult and often costly work is the submission of a dossier of information to the European Chemicals Agency (ECHA) in Helsinki. ECHA is the body responsible for the administration of REACH.

For customers, it means more comprehensive advice on managing risks to workers, the general public and to the environment, but before the benefits of the work can be realised, reliable risk assessment depends on good communication. While the intrinsic properties of a chemical substance do not change, how, where, how much and how often it is used will usually affect the risks it poses to both human health and the environment.

Within the legal framework of REACH, those at the top of the supply chain need not ask how their customers use their products, but in order to assess those risks properly, it is vital they understand their customers’ processes and conditions. So here, the onus, and the opportunity, is on the supply chain to give enough and relevant information to their supplier. At this stage, good communication between customer and supplier is important to help ensure the use is assessed and registered: effectively an approval for safe use in a given application.

Assessing the risks

All manufacturers and importers must provide guidance on safe use to their customers based on the information gathered through registration. This risk assessment is an inherent part of any registration.

For a substance registered at 10 tonnes or more per year, a detailed risk assessment, known as a Chemical Safety Assessment, is required for registration. If that substance is hazardous or has the potential to persist in the environment and build up in body tissue, perhaps with toxic effects, the Chemical Safety Assessment must consider much more detailed patterns of exposure.

Each step of a process or use of the substance is a point of potential exposure to the environment and/or to humans, either directly or as a secondary effect such as in the food chain or water supply. Thus for each stage of the substance’s lifecycle – from its synthesis to its incorporation into an article, or its disposal as waste (when the Waste Framework Directive takes over from REACH) – safe use needs to be demonstrated.

Understanding uses in the supply chain

The supply chain can do a lot to help the beleaguered REACH registrant. A supplier will code those known customer uses in the early stage of risk assessment, usually in line with ECHA’s “Use Descriptor System” which is also commonly known as “Chapter R12”. A use is described by means of the categories of the process (PROC), product (PC), Environmental Release (ERC) and sector of use (SU).

Professional painting of an office interior by brushing or rolling: human exposure is mainly driven by the substance properties (for example evaporation rate) or direct skin contact. Environmental exposure will result from drying (where solvents are emitted to air) and the clean-up operation (waste water and/or waste). Formation of dust and aerosols is unlikely.

PROC 10: Low energy spreading such as rolling, brushing PC 9a:  Coatings and paints, thinners, paint removers ERC 8a or 8c: Wide dispersive professional use SU 22:  Professional uses: public domain (administration, education, entertainment, services, craftsmen)

Chapter R12 offers a good starting point for generic exposure assessment. In some cases it might be enough to demonstrate safe use, particularly where the use is common in the sector. However, where the risk is greater or more difficult to calculate, more detailed information may be required. For example: how often does the process take place? What is its duration? What existing measures are used to minimise worker exposure? How is any release to air controlled? How is waste water treated on site before release? In all but the most confidential and novel applications, chemical users will be able to share enough information for the supplier to prepare a more specific exposure assessment or to tell the user how to apply an existing exposure assessment.

The balance to strike is between providing too much or too little detail. Too much and the supplier may suffer information overload. Too little and the recommended controls may be inappropriate or safe use is not demonstrable. Three key words should help any supply chain with its risk assessments: cooperation, communication and iteration.

Improved information in the supply chain

To the chemical user, the output of the entire registration process should be better information on managing chemical risks. Everyone handling hazardous chemicals will already be familiar with the Safety Data Sheet (SDS); however, under REACH, the requirements for SDS have changed significantly, both in terms of the amount and quality of information presented and in its format. Also working alongside REACH is the European Union’s Classification, Labelling and Packaging (CLP) Regulation. CLP changes the way we classify and label hazardous chemicals to align with the United Nations’ Globally Harmonised System (GHS).

Perhaps the two most important aspects to the new SDS are content and communication. A wealth of reliable information on substance properties is generated through the REACH registration process. This information should be used by all those supplying a given substance to promote safe use of chemicals regardless of whether they are required to register under REACH. To facilitate this widespread sharing of knowledge, ECHA publishes information on registered substances via their Dissemination Portal (http://apps.echa.europa.eu/registered/registered-sub.aspx).

Where a manufacturer or importer of a hazardous substance such as white spirit has registered it at 10 tonnes or more per year, the new SDS must also include summaries of those detailed exposure assessments carried out for the Chemical Safety Assessment. Such “Exposure Scenarios” will usually be found in an annex to the SDS and should complement the information in the 16 main sections of the SDS. An Exposure Scenario sets out the conditions of use and measures to control risk to ensure a process is safe. A good Exposure Scenario will be relevant to the customer and easy to understand and apply.

Finally, with the change to the way chemicals are classified and labelled under CLP new terminology, new labelling elements and new rules on how to classify chemicals are being phased in. Over the next four years, the familiar Risk Phrases, Safety Phrases and the orange and black symbols we know under the UK’s CHIP regulations will disappear, being replaced by Hazard Statements, Precautionary Statements and Hazard Pictograms taken from the UN GHS.

Wider regulatory impact of REACH

As more companies receive new and updated Safety Data Sheets, the vast consequential impact of REACH at site level will become apparent. REACH applies without prejudice to other pieces of European legislation such as the Chemical Agents Directive (implemented as COSHH in the UK) and the SEVESO Directive (COMAH in the UK). Obligations under many such laws are triggered by the classification of the substance in question. The wealth of information generated by REACH will highlight previously unknown hazards of substances on the European market, meaning many companies may find themselves affected by additional laws. For example, a substance not previously classified as hazardous to the environment may now fall into scope of COMAH based on the information generated by REACH.  Cases in point may be few and far between in the wake of the first registration deadline, but expect this situation to change in 2013.

As well as meeting its duties for worker protection under COSHH, companies must ensure their site processes are safe according to REACH. With the Precautionary Principle at its heart, risk assessment under REACH can be much more stringent than that under COSHH. In many cases, implementing the risk management measures recommended under REACH will afford compliance with COSHH – but making that assumption is not enough: COSHH assessments must be reviewed in light of REACH.

Realising the benefits

Think back, now, to the key aim of REACH which is to improve human health and environmental protection. Europe is still coping with the impact of environmental contamination of highly hazardous chemicals long-since regulated. One case in point was the high rates of deformity and mortality in herons in the 1990s, linked to polychlorinated biphenyls. Moreover, in 2003 the World Health Organisation and the International Agency for Research into Cancer, estimated some 3% of cancers are caused by pollution and chemicals in the environment, costing upwards of £120 million per year to the UK’s healthcare system alone. Whilst meeting its aims may not be instantaneous, the benefits of REACH have certainly been a long time coming.

About the Author

Lisa Allen, REACHReady’s Technical Manager, is a chemist with many years commercial experience and has a background in product development and project management. Lisa is also a key member of the team that provides REACH and CLP related training through a programme of workshops and seminars. She is an experienced speaker on REACH both within the UK and internationally and has also had a number of articles published.

REACHReady is a wholly-owned subsidiary of the Chemical Industries Association (CIA) and was set up to assist companies worldwide with their understanding and implementation of REACH and CLP.