European Chemicals Agency Gives Guidelines on Implementing REACH
June 4, 2008 // Published as a news service by IHS
Mandatory registration of non-phase-in chemical substances with the new European Chemicals Agency (ECHA) began on June 1.
ECHA, which is managing the implementation of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation for the European Union (EU), reminded companies to preregister their chemicals before Dec. 1, 2008.
To give practical guidelines for companies needing to meet the new REACH legislative requirements, ECHA provided five case stories concerning:
- A large multinational chemical company: Dow Europe
- A small family-owned textile company: Evolon Freudenberg
- An industry association: The Finnish Cosmetics, Toiletry and Detergent Association
- A global consumer goods company and downstream user of chemicals: Procter & Gamble
- A distributor of industrial chemical specialties: Bang & Bonsomer
Summaries are provided below; the complete case stories are available on the ECHA web site at http://echa.europa.eu/news/press_en.asp.
1. Large multinational chemical company
Dow Europe 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.
Dow Europe will have to preregister 800 substances in about 10,000 REACH-relevant products - a major challenge for its information technologies (IT) department. To prepare for REACH, the company undertook a target to meet the REACH requirements in advance of its 2018 final deadline.
- In late 2006, the company set up the REACH Programme Management Office.
- In all, over 20 new work processes were introduced, covering preregistration, customer communication and tracking volumes of substances by legal entity. This work began in June 2007.
- Dow Europe organised training sessions and workshops on REACH, which included employees outside the EU.
- Dow Europe is contacting its suppliers to determine whether they will preregister their product.
- Dow Europe has introduced a two-stage process for communicating with its thousands of customers. In the first phase, it informed them of its intention to preregister and register, and then it established a unique database providing information on Dow products. The second phase will provide data on the use of, and exposure to, chemical substances.
2. Small family-owned company
Headquartered in Colmar in the east of France, Evolon Freudenberg produces microfilament technical textiles and has 50 employees.
It 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.
- Implementing measures linked to REACH were initiated in January 2007.
- In April and May 2007, suppliers were contacted about REACH.
- A particular challenge was to get more safety and environmental information about the hazardous chemical substances used in the factory.
- A timetable was created, starting with the opening of the preregistration period of June 1, 2008.
- In addition to external help from the Strasbourg Chamber of Commerce, Evolon Freudenberg received support from the parent company, which had appointed someone with specific responsibility to coordinate operations for REACH.
3. An industry association
The Finnish Cosmetics, Toiletry and Detergent Association (TY) has 55 members in Finland. Almost all are small businesses although some are larger companies; the majority are importers, while a few are manufacturers. The secretariat has a staff of three.
- TY began discussing REACH in internal meetings and the minutes of these sessions were circulated to members.
- The association worked closely with the Finnish chemical industry and other organisations, tailoring the information it received to suit the specific needs of its members.
- Last summer, TY prepared two sets of guidelines for members - one on cosmetics, the other on detergents – describing how REACH would impact each sector.
- TY has a regular newsletter for members and aims to operate an intranet. Companies are also encouraged to contact the TY secretariat if they have queries.
- The association has organised seminars on the future legislation and emphasises the importance of understanding how the new measures will be implemented in Finland.
4. Global consumer goods company and downstream user of chemicals
With more than 30 manufacturing sites in the EU producing more than 200 consumer-branded products, Procter & Gamble will play a key role under REACH as a downstream user. It sees REACH as an opportunity to further build consumer confidence.
- More than 15 scientists have actively contributed to the preparation of guidelines to support the practical implementation of REACH.
- Since 2005, a solid multifunctional REACH "compliance team" has been set-up. The company has created an inventory of its substances and is developing REACH-compliance strategies.
- Procter & Gamble's REACH requirement is a moving target, as it regularly changes its composition of products, chemicals use, tonnage, plants etc. However, several IT-tools have been developed to update its inventory of substances.
- The company is also working in close collaboration with its suppliers to ensure that they will preregister and register the substances they supply to them.
- Procter & Gamble has pro-actively prepared exposure scenarios with industry associations, like AISE and Colipa. Also, scientists in the company continue to be actively working with ECETOC to develop key technical guidance.
5. Distributor of industrial chemical specialties
Bang & Bonsomer is a leading Finnish distributor of industrial chemical specialties, plastics, and basic chemicals. Founded in 1927, today it operates in nine 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, Bang & Bonsomer is not yet able to inform its customers about the availability of products.
- From the very start, the Technical Trade Association has been organising training on REACH.
- A REACH task force has been active in the company for two years.
- Suppliers both inside and outside the EU have been contacted.
- The data system has been upgraded to meet the requirements of REACH.
- The web site contains a REACH section and customers have received a letter with information about REACH requirements.
- The Commercial Chamber of China and Russia have been informed about the impacts of REACH.
- The Navigator tool, the brochure for third countries prepared by the ECHA, the web site of the Ministry of Social Affairs and Health and the access to the national REACH help desk have been helpful.
- Mastering the guidance on REACH is also a challenge and other companies are advised to start getting prepared as soon as possible.
Help desks in member states
EU member states have established help desks to assist companies with their obligations under REACH. The Belgium help desk has been interviewed as an example - a summary is provided below, and the full version is available at http://echa.europa.eu/news/press_en.asp.
The Belgian REACH help desk was established in 2005. Hosted by the ministry of economy and businesses, it is run by a small team who can get support from their colleagues, within the ministry or from other departments if needed. The help desk'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 help desk 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 help desk 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 all inquiries within a week; the current response time is 2-14 days, depending on the nature of the question.
Background information about REACH
REACH is the EU's new chemicals legislation. It entered into force on June 1, 2007, but its main provisions, especially the preregistration and registration, started to apply on June 1.
1. 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, such as work done in the Organisation for Economic Co-operation and Development.
- Promote non-animal testing.
- Comply with EU international obligations under the World Trade Organisation.
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 were 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.
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 or more, companies also need to submit a Chemical Safety Report to document a safety assessment of the substance and 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 that 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.
Substances of very high concern are:
- Carcinogens, mutagens or substances that are toxic to the reproductive system.
- Substances that are persistent, bio-accumulative and toxic, or substances that are very persistent and very bio-accumulative.
- Endocrine disrupters, as identified on a case-by-case basis.
Member states and the ECHA, on a request from the European Commission (EC), can place substances on a candidate list of substances of very high concern. The first list will be available on ECHA's web site in late 2008.
Restrictions are the safety net of the system. Any substance on its own, in a preparation or in an article may be subject to EU-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, use by consumers or even all uses (complete ban of a substance). Restrictions and authorisations can also apply to substances produced or imported in volumes below one tonne per year.
3. What is the timeframe for the registration of chemical substances?
From June 1 to Dec. 1, 2008 the preregistration of so-called phase-in substances will take place. Companies are strongly encouraged to preregister their phase-in substances to benefit from staggered registration timelines. Preregistration requires companies to send only limited information to ECHA.
Preregistration 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 a "substance information exchange forum" (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 Dec. 1, 2010, the following will have to be registered with the ECHA:
- All substances produced or imported in quantities equal to or greater than 1,000 tonnes per year.
- Carcinogens, mutagens and substances toxic to reproduction (CMR category 1 and 2) equal to or greater than one tonne per year.
- Substances classified as very toxic to aquatic organisms (R50/53) at and above 100 tonnes per year.
On June 1, 2013, all substances produced or imported in quantities equal to or greater than 100 tonnes per year will need to be registered; by June 1, 2018, all substances produced or imported in quantities equal to or greater than one tonne per year will need to be registered.
Manufacturers and importers who do not register substances in time 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 started 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 ECHA from June 1, 2011.
4. What will happen to companies that do not preregister a substance?
A company that has not preregistered a phase-in substance must suspend manufacturing or importing it after Dec. 1, 2008 until it has submitted a full registration dossier for the substance to the European Chemicals Agency. Registration of a substance will consist of:
- Compilation and assessment of the hazard properties of the substance and its conditions for safe use.
- Submission of this information to the ECHA.
- Payment of the relevant registration fee.
5. Are there registration fees?
Yes, there are fees to complete the registration process. The fees are set in a separate fee regulation adopted on April 16, 2008.
6. What are the 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 correspondingly 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.
REACH should also benefit consumers, who will have access to more information on the hazards and risks of chemicals.
In addition, 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, which began on June 1. 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
For more information, see the ECHA web site and the REACH preregistration FAQ.
Source: European Commission.