Chemical reaction

The chemicals legislation REACH (Registration, Evaluation and Authorisation of Chemicals) has created a single system for the management of all chemical substances and streamlined the EU chemicals regulatory system. This has removed the difference in treatment between so-called ‘existing’ chemicals, which have been on the market for a long time (before 1981), and ‘new’ chemicals, which have been subject to much higher information requirements. “REACH replaces this system and reverses the burden of proof for demonstrating the safe use of chemicals from public authorities to industry,” says Patrick Hennessy, Director Responsible for Chemicals at the European Commission.

The legislation will require the registration of some 30,000 substances produced at above one tonne, the deeper evaluation of registered substance in case of suspicion, the introduction of a new authorisation system in the case of substances of highest concern, and accelerated procedures for introducing restriction on substances where unacceptable risk is identified.

Impact

REACH will affect all companies that produce, import or use chemicals in the EU. “The obligations under REACH are essentially the same for manufacturers and for importers of chemical substances,” remarks Hennessy. “Manufacturers and importers bear the key responsibility for registration of chemicals, and must provide the appropriate safety information to their customers. Users of chemicals in downstream industries have different obligations.”

All manufacturers and importers of chemicals must identify and manage risks linked to the substances they manufacture and put on the market. For substances produced or imported in quantities of one tonne or more per year per company, this means submitting a registration dossier to the European Chemicals Agency. The registration procedure includes a technical dossier containing information on the substance and guidance on how to handle it safely. For quantities of 10 tonnes and more, companies also need to submit a Chemical Safety Report to document a safety assessment of the substance demonstrating safe handling for all identified uses and in manufacturing.

“Manufacturers and importers must provide their downstream industry users with the risk information they need to use the substance safely. This will be done via the classification and labeling system and the provision of Safety Data Sheets (SDS), where needed,” says Hennessy. The main obligations of downstream users is to comply with the safety recommendations made by their suppliers and, in turn, provide their own customers with appropriate information on how to use their products safely, and to report back to manufacturers. In this way, the risk information is conveyed throughout the whole industrial supply chain.

Hennessy also mentions that particular care has been taken to limit the burden for SMEs as far as possible. REACH establishes the highest and most costly information requirements for substances that are produced at higher quantities. Smaller companies are therefore less likely to be affected by high registration requirements. SMEs also benefit from a significant reduction in registration and other fees payable under REACH, in some cases up to 90 percent.

Implementation

In order to ensure a smooth implementation and ease the transition to REACH, the registration provisions apply on a phased basis. This, together with the information sharing requirements will help to spread the costs and reduce animal testing. “REACH distinguishes between ‘phase-in’ substances – those that are already on the market – and ‘non phase-in’ substances,” explains Hennessy. “The obligation to register substances as from 1 June 2008 applies to non phase-in substances, which in most cases will be new substances.”

Hennessy goes on to explain that for phase-in substances, manufacturers and importers can benefit from staggered deadlines for registration, provided that they pre-register their substances between 1 June and 1 December 2008. By pre-registering, the manufacturer or importer of the substance benefits from an extension of the deadline for registration to 2010, 2013 or 2018, depending on the tonnage and hazardous properties of the substance. High tonnage and hazardous substances must be registered in the first place.

Challenges

For Hennessy at the European Commission, there are several challenges when considering the implementation of the REACH legislation. He cites the first challenge as making sure that companies do not miss the pre-registration window. “The window is important because if a company fails to pre-register a chemical by 1 December 2008, it cannot continue manufacturing or importing it until a complete registration dossier has been submitted to the European Chemicals Agency (ECHA),” he says.

Hennessy says concerns remain that many companies could still not be aware of their obligations. “Some believe that REACH does not affect them if they are not part of the chemicals sector,” remarks Hennessy. However, the Commission has launched an awareness campaign and is working with member states authorities, industry, third countries and other stakeholders to help make known the obligations to the companies concerned.

Exemptions

In principle, REACH applies to all chemicals. However, some chemicals are exempted, either completely or partially from various requirements under REACH. “Completely excluded from REACH are radioactive substances, substances under customs supervision and so-called ‘non-isolated intermediates’,” confirms Hennessy. “Waste is also specifically exempted.”

A number of other substances are exempted from parts of REACH where other equivalent legislation applies – for example, substances used in medicinal products. Substances that are considered to pose minimum risk to human health and the environment, or for which registration is deemed inappropriate or unnecessary, are also exempt from registration. These substances are typically of natural origin and the list of exempted substances includes corn oil and nitrogen. In addition, polymers are exempted from registration, while substances used for process and product-orientated research and development simply require a notification to the Agency rather than full registration.

Future optimism

Although REACH is an ambitious project, it has the potential to deliver important benefits to EU citizens and the environment. Hennessy is optimistic about the future and believes that the main benefits will allow for more effective risk management measures by industry and more speedy regulatory action by the public authorities where required. “This should lead to the prevention of health problems caused by exposure to chemicals, leading to a lower occurrence of diseases and preventable deaths,” predicts Hennessy. “And, with that, lower costs for the national health systems. The benefits will come gradually as more and more substances are phased into REACH and the necessary risk reduction measures are taken on the basis of the data gathered. This will also benefit consumers who will have access to more information on the hazards and risks of chemicals.”

The European chemicals industry will undoubtedly benefit from a single EU regulatory system, a decision-making system with clear deadlines, and more consumer confidence in their products. Hennessy believes this will also have a positive impact on innovation as the industry will have incentives to develop safer substances and technologies.

REACH will also intensify the communication within industrial supply chains, allowing closer relationships between suppliers and customers. Suppliers will better understand the needs of their customers and downstream users of chemicals will get relevant information on the safe use of chemical substances they use in their production processes, which will help them ensure better protection of their workers. “As with any major project like REACH, we expect teething problems,” reflects Hennesssy. “But such problems will be overcome and once we enter into the operational part of the system from 1 June 2008 onwards, we can expect to see real progress.”

For more information on REACH please consult the European Chemicals Agency: echa.europa.eu/home_en.asp

REACH objectives

• Ensure a high level of protection of human health and the environment
• Enhance competitiveness and innovation
• Promote non-animal testing methods
• Prevent the fragmentation of the internal market

Timeline
June 2008: Registration of non-phase in substances starts
December 2008: Pre-registration ends
June 2009: Candidate list of very high concern
December 2010: Registration of phase in substances >1000t, or classified as R50-53 >1000t, CRMs 1 and 2 >1t. Notification of phase-in substances in products starts (candidate list)
June 2013: Registration of phase-in substances >100t
June 2018: Registration of phase-in substances >1t

Source: www.reachimpact.com
 
Other facts

• 30,000 chemicals will have to be registered over 11 years
• It is estimated the cost to the industry will be between €2.8-5.2 billion
• Savings of €54 billion over 30 years are expected as fewer people fall ill from exposure to chemicals
• The EU’s chemical industry produces 31% of the world’s chemicals
• The industry employs 1.7 million people
• One in three occupational diseases in the 15 older EU member states is due to chemical exposure