MEMO/08/360

Brussels, 3^rd June 2008

Implementing REACH in practice

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
2. The example of a Member State helpdesk
3. REACH

I. How are (small) companies handling REACH in practice?

To show how enterprises handle REACH in practice, 5 case stories are given:

• A large multinational chemical company: Dow Europe
• A small family-owned textile company: Evolon Freudenberg
• A business organisation: The Finnish Cosmetics, Toiletry and Detergent Association
• One of the world’s leading consumer goods companies: P&G
• A leading distributor of industrial chemical specialities: Bang & Bonsomer

Summaries are provided here. The full version of the case stories are available at:

http://echa.europa.eu/news/press_en.asp

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.

• In late 2006, the company set up the REACH Programme Management Office.
• Major IT challenge: In all, over 20 new work processes were introduced, covering pre-registration, customer communication and tracking volumes of substances by legal entity. This work began in June 2007.
• The company organised training sessions and workshops on REACH. The training included employees outside the EU.
• The company is contacting its suppliers to determine whether they will pre-register their product.
• The company has introduced a two-stage process for communicating with its thousands of customers: It informed them of its intention to pre-register and register and established a unique data base providing information on Dow products. The second phase will provide data on the use of, and exposure to, chemical substances.

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.

• 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 substances used in the factory.
• A timetable was created, starting with the opening of the pre-registration period of 1 June 2008.
• In addition to external help from the Strasbourg Chamber of Commerce, Evolon received support from the parent company which had appointed someone with specific responsibility to coordinate operations for REACH.

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.

• 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. 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.

• 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.
• Their REACH requirement is a moving target as it changes its composition of products, chemical use, tonnage, plants etc., on a regular basis. However several IT-tools have been developed to update its inventory of substances.
• They are also working in close collaboration with its suppliers to ensure that they will pre-register and register the substances they supply to them.
• It 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 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.

• The Technical Trade Association has from the very start been organising training on the REACH.
• A REACH Task Force has been active in the company for two years.
• Training has been arranged.
• Suppliers both in and outside the European Union have been contacted.
• The data system has been upgraded to meet the requirements of REACH.
• The website 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 European Chemical Agency (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.

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
Member States have established helpdesks to assist companies with their obligations under REACH. The Belgium helpdesk has been interviewed as an example. A summary is provided here. The full version of this case story is available at:

http://echa.europa.eu/news/press_en.asp

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.

III. REACH

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 1^st 2008.

3.1. 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, e.g. work done in the OECD
• Promote non-animal testing
• Comply with EU international obligations under the WTO.

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.

• Substances of very high concern are:
• carcinogens, mutagens or toxic to the reproductive system, categories 1 and 2
• substances which are persistent, bio-accumulative and toxic
• very persistent and very bio-accumulative
• or substances such as those having endocrine disrupting properties, which give rise to an equivalent level of concerns as the preceding categories Member States and the Agency, on a request from the Commission, can place substances on a candidate list of substances of very high concern. The first list will be available on the Agency's website from 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 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^[1] 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.

More information

European Chemicals Agency

Further information on the pre-registration procedure

Questions and answers on ECHA: MEMO/08/359

² A registration of a substance will comprise[:]

1. Compilation and assessment of the hazard properties of the substance and its conditions for safe use;
2. Submission of this information to the European Chemicals Agency (ECHA); and
3. Payment of the relevant registration fee.