Topic of the Month: REACH

REACH

  (Photo: BMU; H.-G. Oed )

The European new Chemicals Policy, REACH [Registration, Evaluation, and Authorisation of Chemicals], that replaces in a single regulation the current EU legislation will come into force in June 2007.

The new system includes:
Registration of chemical substances manufactured or imported and associated requirements for information and communication in the supply chain;
Evaluation of the information supplied and safety in use of selected substances by Member States;
Authorisation for CHemicals of high concern, based on health (eg. carcinogens and mutagens) or environmental hazards (eg. persistent and bioaccumulative);

Restrictions at EU-level triggered by other concerns.
REACH introduces some fundamental changes from the current legislation. There is a new responsibility for manufacturing companies (and those importing into the EU) to demonstrate that the substances they produce can be used safely both on their own premises and by their customers (called Downstream Users [DUs]), throughout the entire life cycle of the substance. The principle is 'no data, no market'.

One of the main objectives of the new legislation is that dangerous substances (manufactured or imported in quantities above a certain tonnage) will have to be used under demonstrated safe conditions for workers, consumers and the environment. This requires a chemical safety report [CSR] to be prepared and identification of appropriate Risk Management Measures [RMM] by the manufacturer or importer. Hazard assessment of the chemical and identification of Exposure Scenarios [ES] are essential elements in complying with these requirements. For REACH, the term 'Exposure Scenario' is currently defined as "the set of conditions that describe how the substance is manufactured or used during its life-cycle and how the manufacturer or importer controls, or recommends downstream users to control, exposures of humans and the environment". The ES in essence contains practical handling guidance for the substance.

A number of REACH Implementation Projects [RIPs] are currently underway and through one of these, the Commission is developing the general framework of ESs and guidance on the implementation in practice. This requires an interaction between M/Is and DUs to understand in full how the substance under consideration is used and what RMMs are, or should be, in place. This is an essential step to produce effective and transparent ESs and to assist with their successful implementation. The resulting ESs will be communicated to DUs as appendices to the safety data sheet.

The Regulation requires industry to register all existing and new substances used in quantities greater than 1 tonne/annum (tpa) with the new European Chemicals Agency (ECA) to be located in Helsinki, Finland. Registration applies to chemicals whether in pure form or supplied as part of preparations or articles (such as printer cartridges). A phase-in period of three to 11 years is planned for registration of existing substances (estimated to be around 30,000), with higher tonnage substances and those of high concern being done first. All new substances will have to be registered before they are allowed to be manufactured or marketed.

This represents a major shift in the approach to risk assessment of chemicals. The responsibility for ensuring the safe manufacture, use and disposal of chemicals throughout their life cycle is placed with the supplier (either the manufacturer or the importer). The supplier has to give guidance to downstream users on the risk management measures needed to achieve adequate control. Good communication both ways in the supply chain is essential for this to work effectively.

A technical dossier containing basic information is required for registration of low volume (1-10 tpa) existing substances. For high volume substances (greater than 10 tpa) registration dossiers will also require a detailed Chemical Safety Report (CSR - not to be confused with the acronym for Corporate Social Responsibility!). The CSR will include a chemical safety assessment covering human health and environmental risk, classification and labelling information, and risk characterisation for each identified use of the substance. Suppliers must demonstrate that risks are adequately controlled throughout the chemical life cycle through recommended risk management measures and appropriate operational conditions.

Exposure scenarios describing processes, tasks, exposure estimates and risk management measures will provide the basis for the chemical safety assessment.

Evaluation of registration dossiers is done by the ECA or Member State Competent Authorities. There are two types of evaluation: a review of the documents, including animal testing proposals (for all dossiers), and a full dossier evaluation including a compliance check (covering at least 5% of dossiers registered in each tonnage band and those substances where authorities may have identified properties or uses of a substance that give rise to concern).

An authorisation procedure will be used for substances of very high concern, in other words, those classified as carcinogenic, mutagenic or toxic to reproduction in categories 1 and 2 (CMR), substances which are persistent, bioaccumulative and (eco)toxic (PBT), and substances which are very persistent and very bioaccumulative (vPvB). Other substances with a similar level of concern (for example, endocrine disrupters) may also be subject to authorisation. The authorisation will cover one or more specific uses of a substance where safe use can be demonstrated or where a socio-economic analysis shows that societal benefits outweigh the risks.

Restrictions - the 'missing R' in REACH - on the marketing and use of substances will be proposed by the European Commission or a Member State where it is deemed that risks to human health and the environment are unacceptable.

REACH AND OCCUPATIONAL HEALTH
REACH has been driven by the European Directorate-Generals for the Environment and for Enterprise at European Commission level, and the most intensive lobbying has come from groups interested in the environmental rather than health issues. Nevertheless, this is changing as industry and regulators start grappling with the detail of how it will work in practice. Many aspects of REACH touch on fundamental occupational hygiene practice and occupational health professionals must be engaged to deliver effective implementation.

Further information

Implications for occupational hygiene
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Some Economic Benefits of REACH
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Occupational Diseases in the European Chemical Industry - Impact of REACH
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Impact on Occupational Health
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RIP - Guidance & Tools
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Getting ready for REACH
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The impact of REACH on occupational health with a focus on skin and respiratory diseases
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Environment fact sheet: REACH
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Q&A: Reach chemicals legislation
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REACH impact on workers
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Sheffield Report: The impact of REACH on occupational health
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