FAQ on European Chemicals Agency

June 4, 2008 // Published as a news service by IHS

1. How does ECHA work?
The European Chemicals Agency:

• Manages and carries out technical, scientific and administrative aspects of REACH. It receives the preregistrations and registrations and co-ordinates the evaluation, authorisation and restriction processes.
• Ensures consistency at the European Community level in relation to these aspects.
• Provides the European Union (EU) member states and the institutions of the European Community with the best possible scientific and technical advice on questions relating to chemicals that fall under REACH.
• Manages IT-based tools, databases and guidance documents.
• Supports national help desks and runs a help desk for registrants.
• Provides industry with guidance and tools, and the public with a range of information on registered chemicals through the ECHA web site.

In other words, ECHA will play a key role in day-to-day REACH operations. It will also provide information on ECHA, REACH and chemicals to its stakeholders, media and the general public. The organisation structure of ECHA enables ECHA to meet these demands.

2. What are the advantages of having a European chemicals system?
A European chemicals management ensures efficiency, consistency and expertise. As REACH is applied at the European level, a central agency can achieve the advantages of consistency and efficiency while guaranteeing an equal treatment at lowest cost to companies manufacturing or importing chemicals throughout the EU.

REACH will create an unprecedented and complete registry of the characteristics of all the chemical substances that are produced or imported in the EU, providing high-quality data and information that is currently not available. Information on dangerous chemicals will be publicly available.

REACH also provides a unique data-sharing mechanism, which sets into motion a communication flow among the different levels of industry sectors and users, and which ultimately will lead to less testing on animals.

ECHA is not alone in its responsibility for all work related to the REACH processes. Whilst ECHA will have a coordinating role in managing the registration, evaluation, authorisation and restriction processes of chemicals, companies have the burden of proof and will be responsible for collecting information on chemicals and undertaking new tests, often after seeking explicit approval by ECHA.

Member states will carry out the evaluation on substances and, in most cases, will prepare proposals to subject substances to harmonised classification, to restriction or authorisation. The decisions on authorising and restricting the use of a chemical will be made by the European Commission (EC) on the basis of ECHA's recommendations.

3. How much power of decision does it have?
The European Chemicals Agency has decision powers that cover the registration and evaluation processes.

4. How important is ECHA for REACH?
The task of ECHA is to implement the REACH regulation. It will ensure that the chemicals used in Europe do not cause risk to the consumer or the environment. If risks are unavoidable for certain chemicals, ECHA will make sure that those risks are properly controlled and that these chemicals are progressively replaced by more suitable alternatives.

ECHA will build up a complete registry of the characteristics of all the chemical substances that are produced or imported in the EU, providing high-quality data and information that is accessible to the public. It will also pay attention that unnecessary tests on animals are not carried out.

5. What is ECHA's role with regard to other EU bodies?
As a regulatory agency, ECHA will be independent from other EU 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 EU will exercise financial control over ECHA, and EU staff regulations will apply.

6. What is the organisational structure of ECHA and the role of its various parts?
ECHA's structure consists of the following:

Executive director - The legal representative of ECHA, responsible for the day-to-day management and administration, including responsibility over its finances. The executive director reports to the management board.

Management board - The governing body of ECHA, responsible for nominations, adopting the financial planning, budget work programme, annual reporting and strategic documents. Its membership comprises representatives from each EU member state, the EC, the European Parliament and observers from nongovernmental organisations and industry.

Secretariat - Consists of various directorates, supports the committees and forum, and undertakes work on registration and evaluation processes as well as the preparation of guidance and the maintenance of databases, web site and help desk.

Member state committee - Resolves potential differences of opinion on draft evaluation decisions proposed by ECHA or member states and makes proposals for identification of substances of very high concern.

Risk assessment committee - Composed of independent experts, it prepares opinions on applications for authorisation, on proposals for restrictions and on classification and labelling.

Committee for socio-economic analysis - Composed of independent experts, it prepares opinions on applications for authorisation, on proposals for restrictions and on questions relating to the socio-economic impact of possible legislative action.

Forum - Coordinates a network of member states' competent authorities responsible for enforcement.

Board of appeal - Considers appeals against decisions taken by ECHA.

7. How many people will work at ECHA?
By the completion of the preregistrations on Dec. 1, 2008, ECHA should have about 220 well-trained staff members and 370 in 2009. By 2010, ECHA is expected to have its full capacity of 450 staff members. By that time, ECHA will have started also the authorisation and restriction processes. Moreover, by that date companies also need to provide the inventory information on classification and labelling on all dangerous substances.

8. What is the annual budget of ECHA? Where do the funds come from?
The agency's budget for 2008 is about €66 million. Over the next 15 years, the annual budget is expected to be, on average, €90 million. It will be largely financed from the fees paid by industry, such as when registering chemicals or applying for authorisations. The remaining balance will be covered by the EU budget as approved by the European Parliament and European Council of Ministers.

9. How has the start of work proceeded since June 1, 2007 and what are your priorities in the coming months?
ECHA became fully operational June 1, 2008, after an intensive set-up period of 12 months. During its first year, ECHA has been busy recruiting and training staff, while establishing its operational procedures and preparing its committees and the member state forum. In addition, it has provided REACH guidance and run a help desk, coordinated a network of national help desks and has extended its web site.

Setting up the new agency in 12 months in Helsinki has been a challenging task. Certain activities, like the ECHA help desk and web site, were running from day one. The main activities in 2007 were the organisation of the management board and its June and July meetings, as well as recruiting.

It was considered essential to rapidly establish first office infrastructures and work processes so that ECHA staff, growing continuously, would be able to work efficiently and carry out the necessary REACH processes.

From June 1 to Dec. 1, 2008 ECHA will face its first major challenge: the preregistration of substances and intermediates. Some 200,000 such preregistration files are expected to be submitted.

At the same time, from June 1, companies can start registering new substances. It's difficult to predict how many new substances will be registered in the beginning but there may be many. This is because registration requirements under REACH for such chemicals are lighter than before so as to stimulate innovation in Europe.

In the second half of 2008, the main focus will be on successful preregistration and registration management, including completion of the IT tools. The recruitment will continue on high level.

10. What will be the challenges after 2008?
The next big challenge is 2010, when more obligations will occur. ECHA will have the first registration deadline for the high-volume substances and the very hazardous chemicals. By that date, all companies need to present their inventory documentation for the classification and labelling of any dangerous substances.

Then, in 2010, ECHA has to start with the authorization process. Therefore, it will double its workforce to at least 400 by 2010 in order to process this high volume of files coming in online to the agency. The current ECHA building will accommodate the entire staff.

11. Why was Helsinki chosen as a site of ECHA?
Helsinki and Finland were candidates from the beginning. Finland wanted to have one of the various new EU agencies since the early 2000s. By the end of 2004, the location of those different agencies was decided by the heads of states. Of these agencies, Finland wanted to have either EFSA (European Food Safety Authority) or ECHA.

In the final negotiation, Finland got ECHA. Finland has been happy with this choice, and Helsinki, the capital and the most international city in Finland, was an obvious choice.

12. How does ECHA co-operate with the chemical industry?
Cooperation and communication with all stakeholders - including those in the chemical other industries - is important for ECHA. In many cases, this is also provided for in the REACH regulation.

ECHA's core tasks are to supply the member states, the EC and other European Community institutions with the best possible scientific and technical advice on issues relating to chemicals, to manage the different REACH procedures and to ensure consistency at the community level.

Chemical manufacturers and importers can be seen, in a way, as ECHA's major clients. 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. ECHA has to be able to develop tools and guidance that make REACH as workable as possible for companies of all sizes.

It is to be noted that almost all industry sectors have to apply the REACH downstream user provisions, so, in fact, ECHA interacts with companies far beyond the chemical industry.

ECHA expects to continue a strong dialogue with the chemical industry while finalising and updating guidance documents. For example, a representative of the chemical industry and nongovernmental organisations has observer status on the ECHA management board. An informal exchange of views will happen at conferences and seminars.

13. The whole European industry was involved in the preparation of REACH. Many experts, well experienced by their daily practical work gave input to help optimize the legislation and make it workable. How does the European Chemicals Agency plan to proceed with this exchange of expertise?
The participation of industry and other stakeholders has been very active and productive in projects preparing for REACH. The expert contributions of future users of the guidance and tools have been, and still are, helping us to tailor them for relevance and user-friendliness.

From the ECHA perspective, the networks and working relationships that have been established during the past years are extremely valuable and ECHA wants to keep them alive. For that reason, ECHA will have a stakeholder team in ECHA that will interact with industry and other stakeholders and maintain already-established relationships.

14. What sort of changes will EU consumers see in their daily lives with the enactment of the REACH provisions?
The benefits of REACH to consumers will arise 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 chemical uses will also be restricted or banned for safety reasons.

Consumers will also have access to more information on the properties of chemicals, such as from public information on the ECHA web site. Consumers will be better informed, as well as 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.

15. It is mentioned that "by assessing and approving testing proposals" ECHA will minimize animal testing? How will this happen?
Companies registering the same substance to ECHA need to share the available data from animal tests and are encouraged to share data from other tests. This is expected to reduce animal testing in the long run.

For substances above 100 tonnes, new animal tests can only be conducted after receiving explicit agreement from ECHA.

If new tests must be carried out, and particularly for the potentially most dangerous substances, companies cannot perform the tests unless ECHA agrees that they are necessary and useful to complete the information about a particular chemical. Before authorising any new animal tests, ECHA will verify whether reliable data cannot be provided for by the use of alternative testing methods, such as computer simulation or the "read-across" of test results concerning other similar substances.

16. How important is REACH for the EU?
The objectives of REACH are to improve the protection of European citizens and the environment from harmful chemicals while maintaining and enhancing the competitiveness of industry. Consumer health and safety, as well as the functioning of the EU economy, are very important.

It is also vital that when we generate new information on chemicals, we do it in such a way that testing studies will keep the number of animals used 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 EC "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.

17. With ECHA, for the first time there is a single European agency responsible for the uniform risk assessment of chemicals. This is a significant step forward towards equal opportunities for all manufacturers in the EU. But how does the EC ensure a uniform level of enforcement in member states?
Through the forum, member states can co-ordinate their enforcement activities and harmonise them. The EC recognised the need to accelerate the preparation of the forum in an early stage by establishing a group of the future competent authorities for REACH on enforcement in 2006.

Further information
For more information, see the ECHA web site and the REACH preregistration FAQ.

Source: European Commission.