Reaching for success

EU Infrastructure takes a look at new chemicals legislation, REACH, and what it means for the paints and coatings industry.

“As with any major project such as REACH, teething problems are unavoidable but such problems will be overcome and we can expect to see real progress as more substances are phased in”
-Geert Dancet, European Chemicals Agency

The EU’s new chemical legislation REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) entered into force on 1 June 2007. It covers all substances, manufactured or imported into the EU, in quantities of one tonne or more per year. The legislation requires manufacturers and importers of chemical substances to register information on the physicochemical, health and environmental properties of their substances and uses it to determine how they can be used safely.

“The ECHA is aiming to co-ordinate its work on risk assessment and risk management of chemicals with various EU bodies in the field of worker and consumer legislation, environmental and health issues, animal welfare legislation, research and development co-operation,” says Geert Dancet, Executive Director of the European Chemicals Agency.

It is important that when new information on chemicals is generated it is done in such a way that testing studies will keep the number of animals used for testing to an absolute minimum. The active debate during the legislative process clearly indicated that various stakeholders felt that the EU required a new chemicals policy. This process also allowed everybody to participate and influence the final regulation. As an outcome the new legislation is balanced and realistic in the spirit of the Commission Better Regulation initiative. Therefore, REACH is not only important in what it must achieve but also in how it was drafted and how the stakeholders participated in the preparatory work.

On 1 June 2008, companies started to submit data to the European Chemicals Agency (ECHA) in a pre-register stage, which will last until 1 December 2008. Companies who pre-register their phase-in substance will benefit from extended registration deadlines, however, a company that fails to pre-register a phase-in substance may neither import nor manufacture it after that date until it has fully registered the substance with the ECHA. Low-risk substances such as water, oxygen, noble gases and cellulose pulp are excluded from registration. Other substances naturally occurring in nature such as minerals, ores and ore concentrates, and cement clinker do not need to be registered as long as they are not chemically modified.

Implementation
Co-operation and communication with all stakeholders – including chemical and other industries – is important for the ECHA. In many cases it is also provided in the REACH regulation. Chemical manufacturers and importers can be seen as the major clients of the ECHA. They will have to pay for the different REACH procedures and in return they have the right to expect to get their dossiers processed efficiently and correctly. The ECHA has to be also able to develop tools and guidance that make REACH workable for the companies – big and small – as possible. Therefore, dialogue with industry in the context of the preparing and updating of guidance is essential.

“Transparency is one of the guiding principles of ECHA and we want to promote it by various means,’ explains Dancet. “Importantly, we launched this spring the first call for expression of interest for stakeholders to participate as observers in ECHA work.” Around 60 industry and interest groups (trade unions, environmental NGOs) have observer seats on the ECHA Management Board. In the future, stakeholders may also have access to follow committee meetings as observers. Presentation in conferences and seminars and an informal exchange of views with stakeholders is also part of the ECHA work. “Public consultations have also enabled interested parties to participate in the work of the ECHA and to express their opinions. The consultations take place in the ECHA website,” adds Dancet.

Enterprises have access to a lot of information on REACH at the ECHA website, for example, technical guidance documents, FAQ documents, several submission manuals as well as IUCLID user manuals. Following the approach that it is more effective to ‘teach hungry people how to fish, rather than to serve them the fish on a plate’, the ECHA Helpdesk is helping the industry in finding their own answers on their particular REACH obligations by ‘teaching fishing in the existing pool of information’.

Timeline
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 one 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 one 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.

Challenges
“The major goal set for ECHA was to make it ready for the entry into operation of REACH on 1st June 2008, and we were successful in reaching this objective,” says Dancet. “On 1 June the main provisions of REACH entered into operation, and the companies were able to begin to submit their pre-registrations, enquiries, registrations and notifications and thus fulfill their legal obligations.”

In the second half of 2008, the main focus will be on successful pre-registration and registration management, including completion of the IT tools. The recruitment will continue on high level. About 180,000 pre-registration files are expected to be received before December. At the same time, from 1 June 2008, companies started sending notifications, inquiries and registrations. By end of the year over 2000 research and development related notifications, enquires on substances and registrations may arrive in total.

“An effective co-operation between ECHA, other EU institutions, the Member States, other institutional partners and involved stakeholders is vital for the success of REACH,” stresses Dancet. “But, we are confident that together we will manage the tasks and achieve its objectives: high level of protection of citizens and the environment, creation of a safe management of chemicals and a shift in testing methods.”

The next big challenge is 2010. ECHA will have the first registration deadline for the high volume substances and the very hazardous ones. By that date, all the companies need to present all the inventory documentation for the classification and labelling of any dangerous substances.

Advantages
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.

And it’s not just Europe that has the potential to benefit from the REACH regulation: “Already now we can say that REACH has set a vast process in motion. In Europe and other parts of the world, manufacturers, importers, downstream users are getting ready for the European standard on chemicals safety,” explains Dancet. “Countries outside the European Union take keen interest in the REACH legislation, its obligations and in our experiences. There is great potential to export our standard to the rest of the world thanks also to our potential IT tools.”

Future
The benefits of REACH to consumers will rise from improved information on chemicals during their entire life cycle and the more detailed assessments carried out by companies on dangerous chemicals, leading to better safety instructions for users and, ultimately, for consumers. Some uses will also be restricted or banned for safety reasons. The consumer will also have access to more information on the properties of chemicals, e.g. the public information on the Agency website. Consumers will be better informed, less exposed to and better protected from dangerous chemicals. In addition, REACH introduces a duty to communicate information on substances in articles, especially with regard to very toxic chemicals. The use of that category of chemicals will also be subject to the authorisation procedure leading ultimately to much more limited risks for consumers or complete substitution of the chemical.

Timeline
JUNE 2008: Registration of non-phase-in substances start
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
JUNE 2013: Registration of phase-in substances > 100t
JUNE 2018: Registration of phase-in substances > 1t

ECHA mission
The mission of the European Chemicals Agency is to:

• Manage and carry out technical, scientific and administrative aspects of REACH
• Ensure consistency at community level in relation to these aspects
• Provide the Member States and the institutions of the community with the best possible scientific and technical advice on questions relating to chemicals, which fall under REACH
• Manage IT-based guidance documents, tools and databases
• Support national helpdesk and run a helpdesk for registrants
• Make information on chemicals publicly accessible

Fast Facts

• 30,000 chemicals will have to be registered over 11 years
• It is estimated that 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