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Implementing REACH in practice
Commission Européenne - MEMO/08/360 03/06/2008
Brussels, 3rd June 2008
The European Chemicals Agency (ECHA) in Helsinki is opening today. This coincides with the start of the key processes of pre-registration and registration under REACH. The European Commission and ECHA therefore remind companies to pre-register their chemicals before 1 December 2008. Mandatory registration of non phase-in substances started on 1 June 2008.
1. Companies case stories
I. How are (small) companies handling REACH in practice?
To show how enterprises handle REACH in practice, 5 case stories are given:
Summaries are provided here. The full version of the case stories are available at:
1. Large chemical company will have to pre-register 800 substances in about 10000 REACH relevant products
This is a major multinational company with a strong European base. One-third of its manufacturing takes place on the continent and 37% of its annual sales of $54 billion are generated in Europe. It will have to pre-register substances in about 10,000 REACH relevant products.
To prepare for REACH the company undertook a target to meet the REACH requirements in advance of its 2018 final deadline.
2. The example of a SME
Headquartered in Colmar in the East of France, this company produces microfilament technical textiles and has 50 employees.
The company has found establishing a comprehensive inventory of all the substances that come into and go out of the premises very useful and recommends this to other companies that will be affected by REACH.
3. An industry association battles for its Members
The Finnish Cosmetics, Toiletry and Detergent Association (TY) has 55 members in Finland. Almost all are small businesses, some are larger companies, the majority are importers, while a few are manufacturers. The secretariat has a staff of three.
4. Downstream user of chemicals sees REACH as an opportunity to further build consumer confidence
With more than 30 manufacturing sites in the EU producing more than 200 consumer branded products, this company will play a key role under REACH as a downstream user.
5. Distributor of industrial chemical specialities, plastics, and basic chemicals
This company is a leading Finnish distributor of industrial chemical specialities, plastics, and basic chemicals. Founded in 1927 Bang & Bonsomer today operates in 9 countries and employs some 270 people.
Suppliers have been unable to inform the company whether they will provide all the needed products in the future. Therefore the company is not yet able to inform its customers about the availability of products.
II. Member States helpdesks
The Belgian REACH helpdesk has been established in 2005. It is hosted by the ministry of economy, SMEs, self-employed, and energy. It is run by a small team who can get support from their colleagues, within the ministry or from other departments if needed. The helpdesk's role is factual and explanatory: it provides information on the obligations involved, but cannot give advice on how these should be met, as this responsibility lies with the companies themselves.
The helpdesk has established partnership with the Belgian Federation of Enterprises and the chemical industry. It also provides practical implementing tools and brochures. The workload of the helpdesk really began to pick up in early 2007. It currently receives about 60-70 requests per month, some containing several questions. It aims to answer within a week. The response time is between 2 days and 2 weeks, depending on the nature of the question.
REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) is the EU's new chemicals legislation. It entered into force on 1 June 2007 but its main provisions, especially the pre-registration and registration, started to apply on June 1st 2008.
3.1. What are the objectives and scope of REACH?
The objectives of REACH are to:
By creating an EU-wide system for the management of chemicals REACH will bring together the EU chemicals legislation. 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 while chemicals introduced after 1981 were termed "new" chemicals. New chemicals had to be tested quite 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 rather limited.
Under REACH, the burden of proof for demonstrating the safe use of chemicals will be transferred from Member States to industry.
3.2. How does REACH work?
Companies that manufacture or import one tonne 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 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 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 risk to health or the environment will be selected for substance evaluation. This may lead to the actions under the restrictions or authorisation procedures.
Substances of very high concern are subject to an authorisation procedure. Companies who apply for authorisation need to show that the risks posed by those substances are adequately controlled, or that the socio-economic benefits from their use outweigh the risks and there are no suitable alternatives. The aim is to give industry the incentive to progressively substitute these substances with safer alternatives when technically and economically feasible.
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 risks to health or the environment. Restrictions can be imposed on the use of a substance in certain circumstances and products, the use by consumers or even on all uses (complete ban of a substance). Restrictions and authorisations can also apply to substances produced or imported in volumes below 1 tonne per year.
3.3. What is the timeframe for the registration of chemical substances?
From 1 June 2008 to 1 December 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 get in touch with other companies who are intending to register the same substance and gives them sufficient time to set-up 'Substance Information Exchange Forums' (SIEF). 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 1 December 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 1000 tonnes/year; carcinogens, mutagens and substances toxic to reproduction (CMR category 1 and 2) equal to or greater than 1 tonne/year and substances classified as very toxic to aquatic organisms (R50/53) at and above 100 tonnes/year;.
On 1 June 2013 all substances produced or imported in quantities equal to or greater than 100 tonnes/year will need to be registered as are substances produced or imported in quantities equal to or greater than 1 tonne/year by 1 June 2018.
Manufacturers and importers not having registered substances in time 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 1 June 2008.
Substances in articles which are on the “candidate list of substances of very high concern” will need to be reported to the European Chemicals Agency from 1 June 2011.
3.4 What will happen to companies that do not pre-register a substance?
A company that has not pre-registered a phase-in substance must suspend manufacturing or importing it after 1 December 2008 until it has submitted a full registration dossier for the substance to the European Chemicals Agency.
3.5. Are there registration fees?
Yes, there are fees to complete the registration process. The fees are set in a separate Fee Regulation, which was adopted on 16 April 2008.
3.6. What are the main benefits of the new REACH Regulation?
The main benefit of REACH is that the hazards and risks of chemicals will be more systematically identified. This will allow for more effective risk management measures by industry and more speedy regulatory action by the public authorities where required.
This should contribute to the prevention of health problems caused by exposure to chemicals, leading to a lower occurrence of diseases and preventable deaths, 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 should also benefit consumers who will have access to more information on the hazards and risks of chemicals.
The European chemicals industry will benefit from a single EU regulatory system, a decision-making system with clear deadlines, and more consumer confidence in their products. A positive impact on innovation is also expected, as 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. Downstream users of chemicals will get relevant information on the safe use of the chemical substances they use in their production processes which will help them to ensure better protection of their workers.
As with any major project such as REACH teething problems are unavoidable particularly as we enter into the operational part of the system from 1 June 2008. But such problems will be overcome and we can expect to see real progress as more substances are phased-in to the system.
Further information on the pre-registration procedure
Questions and answers on ECHA: MEMO/08/359
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