European Chemicals Agency ECHA – guide

— last modified 03 June 2008

The European Chemicals Agency (ECHA) was officially opened on 3 June 2008 by European Commission President José Manuel Barroso and Finnish Prime Matti Vanhanen. Located in Helsinki, ECHA is responsible for managing the implementation of the REACH requirements in relation to the registration, evaluation, authorisation and restriction processes of chemical substances. ECHA formally began its activities a year ago and its work has been devoted to intensive preparations, including staff recruitment and establishing support structures and procedures. On 1st June 2008 two key processes of REACH entered into operation: Registration of chemicals and pre-registration of the some 30,000 chemicals currently in use (e.g. acids, metals, solvents, surfactants). Manufacturers or importers of chemicals have to pre-register them by 1 December 2008 if they want to continue manufacturing or importing them without interruption. It has been estimated that over 180,000 pre-registration files will be submitted.

The European Chemicals Agency

• manages and carries out technical, scientific and administrative aspects of REACH: it receives the pre-registrations and registrations and will co-ordinate the evaluation, authorisation and restriction processes.
• ensures consistency at Community level in relation to these aspects
• provides 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
• manages IT based tools, data bases and guidance documents
• supports national helpdesks and runs a helpdesk for registrants
• The Agency’s website is providing industry with guidance and tools and will provide the public with a range of information on registered chemicals

In other words, the Agency 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 the Agency to meet these demands.

A European chemicals management ensures efficiency, consistency, 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 set into motion a communication flow among the different levels of industry sectors and users, and which ultimately will lead to less testing on animals.
• The Agency 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 undertake new tests, often after seeking explicit approval by ECHA.
• The 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 on the basis of the Agency’s recommendations.

The European Chemicals Agency has decision powers which cover the registration and evaluation processes.

The task of the Agency is to implement the Regulation. It will ensure that the chemicals used in Europe do not cause risk to the consumer or the environment. And if for certain chemicals risks are unavoidable, the Agency 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, accessible to the public. It will also pay attention that unnecessary tests on animals are not carried out.

As a regulatory Agency, ECHA will be independent from other European Union 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 European Union will exercise financial control over the Agency, and EU Staff Regulations will apply.

– the legal representative of the Agency, responsible for the day-to-day management and administration, including responsibility over its finances. The Executive Director reports to the Management Board.

– the governing body of the Agency, responsible for nominations, adopting the financial planning, budget work programme, annual reporting & strategic documents. Its membership comprises representatives from each EU Member State, the Commission, the EU Parliament and observers from NGOs and industry.

– consisting of various Directorates, supports the Committees and Forum and undertakes work on registration & evaluation processes as well as preparation of guidance, maintenance of databases, website and helpdesk.

-resolves potential differences of opinion on draft evaluation decisions proposed by the Agency or Member States and makes proposals for identification of substances of very high concern.

–composed of independent experts, itprepares opinions on applications for authorisation, on proposals for restrictions and on classification and labelling.

–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.

– coordinates a network of Member States’ competent authorities

responsible for enforcement

– considers appeals against decisions taken by the Agency

• By the completion of the pre-registrations on 1 December 2008, ECHA should have about 220 well-trained staff members and 370 in 2009
• By 2010, the Agency 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.

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, e.g. when registering chemicals or applying for authorisations. The remaining balance will be covered by the EU budget as approved by the European Parliament and Council.

ECHA, the new European Chemicals Agency based in Helsinki, becomes fully operational by 1 June 2008, after an intensive set-up period of 12 months. During its first year, the Agency 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 helpdesk, coordinated a network of national helpdesks and has extended its website.

Setting up the new Agency in 12 months in Helsinki has been a challenging task. Certain activities like the ECHA helpdesk and website were running from day one. The organisation of the Management Board and of its June and July meetings as well as recruiting attracted most of the focus in 2007.

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

From 1 June to 1 December 2008 the Agency will face its first major challenge. It will handle the pre-registration of substances and intermediates. About 180,000 – 200,000 such pre-registration files are expected to be submitted. At the same time, from 1 June 2008, 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 pre-registration and registration management, including completion of the IT tools. The recruitment will continue on high level.

The next big challenge is 2010. More obligations will come then. 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. Then, in 2010, the Agency 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 on-line to the agency. The current ECHA building will accommodate the entire staff.

Helsinki and Finland were candidates from the beginning. Finland wanted to have one of the new EU agencies since the early years of 2000s. Different proposals were underway to locate agencies. It wasn’t until the end of 2004 when the location of those ten different agencies was decided by the heads of states. Of those, Finland wanted to have either EFSA (European Food Safety Authority) or ECHA. Those were the two biggest to be located.

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.

• Cooperation and communication with all stakeholders – including chemical and other industry – is important for ECHA and in many cases also provided n the REACH Regulation
• ECHA’s core tasks are to supply the Member States, the Commission and other 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 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 for the companies – big and small- as possible.
• 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
• Continuing dialogue with the industry in the context of the finalisation and updating of guidance documents
• A representative of Industry/NGOs has an observer status on the ECHA Management Board;
• Access of stakeholders to Committee meetings remains to be discussed, first by the Committees and the Forum themselves, then by the Management Board
• Informal exchange of views in the context of conferences and seminars
• Dissemination: equal treatment

The participation of the 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 Agency perspective, the networks and working relationships which 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 the Agency which will interact with industry and other stakeholders and maintain the already established relationships.

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 consumers 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.

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 the Agency agrees that they are necessary and useful to complete the information about a particular chemical. Before authorising any new animal tests the Agency 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.

The objectives of REACH are to improve the protection of our citizensand the environment from harmful chemicals while maintaining and enhancing the competitiveness of industry. For the European Community both aspects, health & safety as well functioning of our economy, are very important. It is also important 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 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.

Through the Forum, the Member States can co-ordinate their enforcement activities and harmonise them. The Commission 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.