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The European Union’s new chemicals legislation Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) went in effect on June 1. REACH will allow for better knowledge on chemicals and more efficient communication on risk-management measures. This is expected to lead to a lower occurrence of occupational diseases and preventable deaths, thus lowering costs to national health systems. The benefits will come gradually as more substances are assessed under REACH.
This article addresses some frequently asked questions about the legislation.
What are the Objectives and Scope of REACH?The objectives of REACH are to:
- Protect human health and the environment
- Maintain and enhance the competitiveness of the EU chemicals industry
- Prevent the fragmentation of the internal market
- Increase transparency
- Integrate with international efforts
- Promote non-animal testing
- Comply with EU international obligations under the WTO
In addition, REACH will no longer differentiate between so-called “existing” and “new” chemicals. Previously, all chemicals put on the market before 1981 were called “existing” chemicals; chemicals introduced after 1981 were termed “new” chemicals. New chemicals had to be tested rigorously under the legislative provisions, which are repealed by REACH. There were no such provisions for “existing” substances. As a result, knowledge on properties and uses of “existing” substances is limited.
Under REACH, the burden of proof for demonstrating the safe use of chemicals will be transferred from Member States to industry.
How Does REACH Work?Companies that manufacture or import one ton or more of a chemical substance annually will be required to register it in a central database at the European Chemicals Agency.
The registration procedure involves submitting a technical dossier containing information on the substance and guidance on how to handle it safely. For quantities of 10+ tons, companies also need to submit a Chemical Safety Report to document a safety assessment of the substance that demonstrates safe handling for all identified uses and manufacturing.
Evaluation allows regulatory authorities to determine if further testing is needed and to assess whether information provided by industry complies with the requirements (dossier evaluation). Substances suspected to pose a health or environmental risk will be selected for substance evaluation. This may lead to the actions detailed under the restrictions or authorization procedures.
Substances of very high concern are subject to an authorization procedure. Companies who apply for authorization need to demonstrate that the risks posed by these substances are adequately controlled or that the socio-economic benefits from their use outweigh the risks. The aim is to give the industry the incentive to progressively substitute these substances with safer alternatives when technically and economically feasible. Following are substances of very high concern.
- Carcinogens, mutagens or toxic to the reproductive system, categories 1 and 2
- Substances that are persistent, bio-accumulative and toxic
- Substances that are very persistent and very bio-accumulative
- Substances that are of equivalent concern
Restrictions are the safety net of the system. Any substance on its own, in a preparation or in an article, may be subject to community-wide restrictions if its use poses unacceptable health or environmental risks. Restrictions can be imposed on the use of a substance under certain circumstances and in certain products, the use by consumers or even on all uses (complete ban of a substance). Restrictions and authorizations can also apply to substances produced or imported in volumes below 1 ton/year.
What is the Timeframe for the Registration of Chemical Substances?From June 1 to December 1, 2008, the pre-registration of so-called phase-in substances will take place. Companies are strongly encouraged to pre-register their phase-in substances to benefit from staggered registration timelines. Pre-registration requires companies to send only limited information to the agency.
Pre-registration will allow companies to communicate with other companies who intend to register the same substance, and gives them sufficient time to set up substance information exchange forums (SIEFs). In a SIEF, companies are obliged to share animal testing studies to keep the number of animals used for testing to an absolute minimum. They may also share other data voluntarily.
By December1, 2010, the following will have to be registered with the European Chemicals Agency: all substances produced or imported in quantities equal to or greater than 1,000 tons/year; carcinogens, mutagens and substances toxic to reproduction (CMR category 1 and 2) equal to or greater than 1 ton/year and substances classified as very toxic to aquatic organisms (R50/53) at and above 100 tons/year.
On June 1, 2013, all substances produced or imported in quantities of 100 tons/year or more will need to be registered; by June 1, 2018, all substances produced or imported in quantities equal to or greater than 1 ton/year will need to be registered.
Manufacturers and importers who have not met the deadline to register substances according to the appropriate volume levels will no longer be able to manufacture in or import that substance to the EU market.
Non-phase-in substances need to be registered before they are manufactured or imported. Their registration will start on June 1, 2008.
Substances in articles that are on the “candidate list of substances of very high concern” will need to be reported to the European Chemicals Agency starting on June 1, 2011.
Is REACH a Testing Program?No. New testing should only be a last resort if available information is not sufficient. Companies registering the same substance need to share available data. The data owner will get financial compensation from other companies who use this data.
In addition to data sharing, a combination of factors, including the use of alternative methods and exposure-based waiving of testing, will prevent unnecessary animal testing.
Are There Registration Fees?Yes, there are fees to complete the registration process. The fees will be set in a separate fee regulation, which will be published by June 1, 2008.
Will REACH Change the Rules for Classification and Labeling?No, but many REACH provisions refer to and build on classification and labeling, such as registration, chemical-safety assessment, preparation of safety data sheet, authorization, and restriction.
The EU’s chemical legislation has long required industry to classify and label dangerous substances and preparations according to standard criteria. The current EU classification and labeling legislation will be replaced in the coming years. The European Commission is currently finalizing a proposal for a new regulation that is based on the UN Globally Harmonized System for the Classification and Labeling of substances (GHS). Relevant REACH provisions will be updated accordingly.
Which Chemicals are Exempt from REACH?Low-risk substances, such as water, oxygen, noble gases and cellulose pulp, are excluded from registration. Other naturally occurring substances, such as minerals, ores and ore concentrates, and cement clinker, do not need to be registered as long as they are not chemically modified. These substances, as well as other exempted substances, are listed in annexes IV and V of the REACH Regulation.
What is Not Covered by REACH?Several uses are exempted from all or some parts of REACH, including substances in food and medicinal products, which are covered by other specific legislation.
Waste is also exempted. Member states may exempt substances used for defense purposes.
Do Polymers Need to be Registered?Polymers are exempt from registration and evaluation, but their basic ingredients, monomers and other components, must be registered.
The commission may propose legislation for the registration of polymers once a practicable and cost-effective way of managing polymers on the basis of sound technical and valid scientific criteria can be established.
Do Intermediates Need to be Registered?Chemical substances used to manufacture other chemical substances are called intermediates. If manufactured and used inside a closed system (non-isolated intermediates), they are fully exempt from REACH. Intermediates that are separated during the production process (isolated intermediates: on-site and transported) will need to be registered. Simplified information requirements apply in this case since they pose lower risks for human health and the environment.
What Manufactured Products are Covered by REACH?Products such as construction material, electronic components, toys and vehicles are covered by REACH if they contain substances that are intentionally released. These substances need to be registered.
Products with substances on the candidate list of very high-concern substances will need to be reported to the agency. A first candidate list with these substances is likely to be published by the agency in fall 2008.
What are the Main Benefits of the New REACH Regulation?The main benefit of REACH is that it more systematically identifies chemical hazards and risks. This allows companies to identify and communicate appropriate risk-management measures through the supply chain.
Better chemical knowledge and more efficient risk-management communication measures will help prevent health problems caused by chemical exposure. This is expected to lead to a lower occurrence of occupational diseases and preventable deaths, thus lowering costs to national health systems. The benefits will come gradually as more substances are assessed under REACH.
The European chemicals industry will also benefit from a single EU regulation covering all chemicals. REACH provides clear deadlines for decision-making and may enhance consumer confidence in chemical products.
Downstream users of chemicals will get relevant information on the safe use of the chemical substances they use, thus helping them to better protect their workers. Everyday products are expected to become safer for consumers and the environment, facilitating the implementation of companies’ corporate and social-responsibility policies.
Will the Industry Receive Help to Comply with Its Obligations?The European Commission, in cooperation with industry, member states and NGOs, has developed a number of technical guidance documents and IT tools for industry and national authorities to facilitate the implementation of REACH. All necessary information can be obtained from the European Chemicals Agency website. A navigator tool on this site will help companies to identify their obligations under REACH. The IT tool for entering and storing information on chemicals and preparing and submitting registration dossiers to ECHA will be IUCLID 5.
REACH requires EU member states to set up help desks to provide companies with the necessary information to fulfill their obligations under the new chemicals legislation.
What Should Companies Do to Prepare for REACH?To prepare for the implementation of REACH, companies should carry out the following three steps:
1. Nominate a REACH manager
- Identify an individual within the company who will be accountable for preparatory activities and compliance
- Ensure appropriate skill-set and management support
- Regulation (1907/2006/EC)
- Guidance documents (available for all main topics on the ECHA website)
- The ECHA website is a single-point of entry for information on REACH helpdesks in member states
- Create an inventory of substances (on their own, in preparations and those intentionally released from products)
- Consider exemptions for substances and uses in the inventory
- Compile data based on volumes ($ 1 ton, $ 10 tons, $100 tons and $ 1,000 tons)
- Understand the sources of the substances (EU or non-EU supplier)
- Determine the obligation with regard to each substance (manufacturer, importer or downstream user)
What is ECHA?ECHA is the new European Chemicals Agency based in Helsinki. It began with the launch of its website on June 1, the day of entry into force of the REACH regulation, and will become fully operational by June 1, 2008.
What Will ECHA Do?ECHA will manage and coordinate the registration, evaluation, authorization and restriction processes of chemical substances under REACH to ensure consistency in the management of chemicals across the European Union. The agency will provide member states and EU institutions with scientific and technical advice on chemicals covered by the regulation. The agency’s website will provide industry with guidance and tools, and the public with a range of information on registered chemicals.
What is ECHA's Role with Regard to Other EU Bodies?As a regulatory agency, ECHA will be independent from other European Union bodies. It will be managed autonomously and have its own staff with the full legal capacity to act in its own name.
It will be linked to other EU Institutions through the members of the Management Board. The European Union will exercise financial control over the agency, and EU staff regulations will apply.
What's Next?During its first year, the agency will be busy recruiting and training staff, while establishing its operational procedures and preparing its committees and the member state forum. In addition, it will provide REACH guidance, run a helpdesk, coordinate a network of national helpdesks and further extend its website. ECHA will be fully operational by June 1, 2008.
From June 1 to December 1, 2008, the agency will face its first major challenge: handling the pre-registration of substances and intermediates. About 180,000 such pre-registration files are expected to be submitted.
Will the Agency be Responsible for All Work Related to REACH Processes?No, the agency will have a coordinating role in managing the registration, evaluation, authorization and restriction processes. Member States will carry out the evaluation work and in most cases will prepare proposals to subject substances to harmonized classification, restriction or authorization. The decisions on authorizing and restricting the use of a chemical are made by the European Commission.
Is There More Information Available?Further information can be found at the following websites:
- European Chemicals Agency: echa.europa.eu
- European Commission: ec.europa.eu/enterprise/reach/index_en.htm, ec.europa.eu/environment/chemicals/reach/reach_intro.htm and ecb.jrc.it/REACH/