CHEMICALS: EUROPEAN COMMISSION PRESENTS PROPOSAL TO MODERNISE EUROPEAN UNION LEGISLATION

News Release

Erkki Liikanen

Margot Wallström

No. 67/03
October 29, 2003

CHEMICALS: COMMISSION PRESENTS PROPOSAL TO MODERNISE EU LEGISLATION

The European Commission today presented a proposal for a new EU regulatory framework for chemicals. Under the proposed new system called REACH (Registration, Evaluation and Authorisation of CHemicals), enterprises that manufacture or import more than one tonne of a chemical substance per year would be required to register it in a central database. The aims of the proposed new Regulation are to improve the protection of human health and the environment while maintaining the competitiveness and enhancing the innovative capability of the EU chemicals industry. REACH would furthermore give greater responsibility to industry to manage the risks from chemicals and to provide safety information on the substances. This information would be passed down the chain of production. The proposal has been drafted in close consultation with all interested parties, including via an Internet consultation. This has allowed the Commission to propose a streamlined and cost-effective system. The proposal will now be forwarded to the European Parliament and the EU's Council of Ministers for adoption under the so-called co-decision procedure.

Enterprise Commissioner Erkki Liikanen said: “I believe that we now have arrived at a proposal that strikes the right balance between maintaining growth and employment in Europe on the one hand and improving health and the environment in Europe on the other. Both the chemicals industry itself and Europe's manufacturing sectors that depend on chemicals are key contributors to economic activity in all Member States. Safeguarding their competitiveness is a priority. The mechanisms built into today's proposal are cost-effective and they will enhance the innovative capability of our industry. The proposal will also provide for a stable framework within the internal market and a new independent chemicals agency will help guaranteeing that.”

Environment Commissioner Margot Wallström said: "REACH is a groundbreaking proposal. Once adopted, It will allow us to take advantage of the benefits of chemicals without exposing ourselves and the environment to risks. Thus it will create a win-win situation for industry, workers and citizens, and our ecosystem. It will give Europe's citizens the high level of protection that they have the right to expect. The EU will have one of the most progressive chemicals management systems in the world.”

The REACH system

The proposed Regulation would replace over 40 existing Directives and Regulations. At the core of the proposed system is REACH a single, integrated system for Registration, Evaluation and Authorisation of CHemicals. REACH would require companies that produce and import chemicals to assess the risks arising from their use and to take the necessary measures to manage any risk they identify. This would reverse the burden of proof from public authorities to industry for ensuring the safety of chemicals on the market.

Registration: This is the main element of REACH. Chemicals that were manufactured or imported in quantities of more than one tonne per year and per manufacturer/importer would be registered in a central database. Some groups of substances would not have to be registered (such as certain intermediates, polymers and some chemicals managed under other EU legislation). The registration would include information on properties, uses and safe ways of handling the chemicals. The information required would be proportional to production volumes and the risks that a substance poses. The safety information will be passed down the supply chain, so that those that use chemicals in their own production processes - to produce other products - could do so in a safe and responsible way, without jeopardising the health of workers and consumers and risking damage to the environment.

A new European Chemicals Agency would manage the database, receive the registration dossiers, and be responsible for providing non-confidential information to the public. It is expected that around 80% of all registered substances would require no further action.

Evaluation: There would be two types of evaluation; of dossiers and of substances. Firstly, a dossier evaluation would have to be carried out on all animal testing proposals The main purpose of this compulsory evaluation would be to minimise animal testing. REACH has been designed with the goal of restricting animal testing and costs to industry to the necessary minimum. It would require the sharing of data obtained in tests and encourages the use of alternative sources of information. A dossier evaluation could also be performed to check that the registration was in compliance with the registration requirements.

Secondly, the competent authorities could evaluate any substance where they had justified reasons to suspect that there was a risk to human health or the environment. This would represent a quality and compliance check. The programme of substance evaluations would be based on rolling plans prepared by Member State Competent Authorities. The programme would take account of criteria for setting priorities drawn up by the Agency.

For both types of evaluation, the outcome could be a request for further information. The Agency would take the final decision on requests for further information if all Member States agreed. In case of disagreement, the European Commission would make a decision.

Authorisation: Substances of very high concern would require authorisations for particular uses from the Commission. Substances of very high concern include CMRs, PBTs, vPvBs and substances identified as having serious and irreversible effects to humans and the environment equivalent to the other three categories. If the risks emanating from the use of such a substance could be adequately controlled, authorisation would be granted.

If they could not be adequately controlled, the Commission would look at the level of risk, whether the use of the substance was socially and economically important and if there were substitutes. Based on these factors the Commission would decide whether the substance would be authorised. The Commission would also be able to introduce restrictions at EU level on substances that needed to be managed at an EU-wide level to ensure that the risks they posed were acceptable.

A balanced new system

The proposed new system would set high standards for protection of health and the environment while safeguarding the competitiveness of enterprises and improving the potential for product innovation. This balance would be to the long-term benefit of chemicals manufacturers, importers, users, small and medium sized enterprises, consumers and for health and the environment.

To safeguard the competitiveness and enhance the innovative capability of the chemicals industry in the EU, REACH has been designed to simplify the existing EU regulatory framework for chemicals. The proposed new system would thus focus on:

substances of high concern, including those that are carcinogenic, mutagenic or toxic to reproduction (CMRs), persistent, bio-accumulative and toxic (PBTs) or very persistent and very bio-accumulative (vPvBs);
avoiding unnecessary bureaucracy by only requiring essential safety and use information for chemicals manufactured or imported in volumes of 1-10 tonnes per year;
encouraging research and innovation by lengthening the trial period, raising the threshold for the registration of research substances and simplifying the regulation for downstream users;
preventing increased bureaucracy for downstream enterprises by utilising existing systems for the exchange of safety information ie Safety Data Sheets (SDS). The SDS is an internationally accepted tool for the communication of information about chemical hazards, risks and risk reduction measures;
helping enterprises deliver the objectives of the system at minimum costs.

Innovation

Incentives for research have been built into REACH, which would enhance innovation. The proposed new system would encourage research and innovation by raising the threshold for registration from currently 10 kg to 1 tonne, thus allowing research and development on substances to be carried out below this volume without registration. In addition, the trial period for research and development would be lengthened to up to ten years. This period would be extended by a further 5 years for medicinal products. For downstream users the new system would mean a simplification of the regulation which would make it easier for them to find new innovative uses of substances.

Costs and benefits

The overall costs of the proposal would be substantially reduced compared to earlier estimates. The draft proposal posted on the Internet earlier this year has been thoroughly revised to cut costs and minimise bureaucracy. In the new Impact Assessment, the direct costs of REACH to the chemicals industry are estimated at a total of some € 2.3 billion over an 11 year period representing a saving of 82% costs from the Internet draft.

The costs to downstream users of chemicals are estimated at € 2.8 to 3.6 billion over a period of 11 and 15 years respectively - if the market reacts as expected with 12 per cent of substances being withdrawn because continued production would not be profitable. Costs could rise to € 4.0 to 5.2 billion if industry faced higher supply chain adaptation costs. These estimates include the direct costs passed on from the chemicals sector to downstream users.

The total costs for the chemicals industry and the downstream users are thus estimated to € 2.3 to 5.2 billion.

The anticipated benefits to environment and human health are expected to be significant. An illustrative scenario put the health benefits in the order of magnitude of € 50 billion over a 30-year period.

Consultation

REACH is an example of participatory policymaking. The new system has been drafted in close consultation with all interested parties, and various studies have been conducted to examine the costs and benefits of different options.

In May of this year, the Commission presented a draft of the proposed Regulation on the Internet to gather further comments on the workability of REACH. Some 6,000 replies were sent in. The main contributors were industry associations and individual companies, as well as environmental and animal rights NGOs. A number of Member States also provided comments, alongside several countries outside the EU. In addition, many individuals, including workers, expressed their opinions.

The comments have resulted in important changes to make the proposed new system less costly, less bureaucratic and more workable, while reinforcing the guarantees for health and environmental protection.

Background - problems with the current legislation

The current legislative system for chemicals has been largely unable to identify the risks posed by many chemicals and is slow to act where risks have been established.

The current legislation distinguishes between so-called "existing" and "new" chemicals using 1981 as a cut-off date. "Existing” substances are those that had been introduced before 1981; "new" chemicals are those that have been introduced since.

New chemicals have to be notified and tested in production volumes as low as 10kg per year, while there are no such provisions for existing chemicals. This has encouraged the continued use of "existing", untested substances and inhibited research and development and innovation. The number of new chemicals put on the market since 1981 has reached only around 3,000.

The number of "existing" chemicals in 1981 was 100,106. It has been up to the public authorities to determine whether any of them need to be examined, and if so, to do it. The procedures have been lengthy and cumbersome. For example, since 1993 140 high-volume chemicals have been singled out for risk assessment. Only a very limited number has completed the process so far.

REACH would put an end to the artificial distinction between "new" and "existing" chemicals.

The text of the proposal can be found at:

http://europa.eu.int/comm/enterprise/chemicals/chempol/whitepaper/reach.htm

http://europa.eu.int/comm/environment/chemicals/whitepaper.htm

Q AND A ON THE NEW CHEMICALS POLICY REACH

Questions:

1. Why is a new EU chemicals policy needed?

2. What are the overall aims of the new chemicals strategy?

3. How will registration under REACH work?

4. Will each registration require testing?

5. What is evaluation?

6. What is authorisation, and which types of chemicals will require authorisation?

7. How long will it take to register all chemicals under REACH?

8. In which category are high-risk substances, i.e. those that may have to be evaluated?

9. Will all chemicals on the market have to be registered, evaluated and authorised?

10. If a substance is registered/evaluated/authorised can it then be used in any field of application?

11. Will any chemicals be excluded from REACH?

12. Will the use of hazardous substances be restricted or banned?

13. Will chemicals in pesticides, pharmaceuticals and cosmetics be included in REACH?

14. Will mixtures of chemicals, such as paint, have to be registered under REACH?

15. Will chemicals in everyday articles have to be registered?

16. Will products that contain chemicals be labelled?

17. Will consumers have access to the information on chemicals registered in the database?

18. What is the difference between REACH and the present system of chemicals management?

19. Who will do what under REACH?

20. What will be the role of public authorities in the Member States under REACH?

21. What will be the role of the new Chemicals Agency?

22. What will be the role of the Commission?

23. Which responsibilities will industry shoulder under REACH?

24. What impact will REACH have on SMEs?

25. How will REACH promote innovation and development of safer substitutes?

26. How much will REACH cost?

27. What are the main benefits of REACH?

28. Will REACH result in the loss of substances?

29. Will REACH result in more animal testing?

30. How will REACH complement other EU legislation?

31. What consultation has taken place before adoption?

32. Who has commented during the Internet consultation?

33. Which issues were raised during the Internet consultation?

34. What changes have been made following the Internet consultation?

35. What international initiatives exist on chemicals safety?

36. Is the REACH proposal WTO compatible?

37. What is the legal base of the new policy?

38. Where can the proposals be found?

Glossary and abbreviations

Disclaimer : This document has been produced for information purposes only and is not in any respect a legal interpretation of the Commission's proposals

1. Why is a new EU chemicals policy needed?

The current legislative framework for chemicals is inadequate. It has not produced sufficient information about the effects of chemicals on human health and the environment, and where risks are identified, it is slow to assess them and introduce risk management measures. These shortcomings have potentially put human health and the environment at risk. The current system has also hampered research and innovation, causing the EU chemicals industry to lag behind its counterparts in the US and Japan in this regard.

The current legislation distinguishes between so-called "existing" and "new" chemicals, based on the cut-off date of 1981. All chemicals that were put on the market before 1981 are called "existing" chemicals. In 1981, they numbered 100,106. Chemicals introduced after 1981 are termed "new" chemicals.

While new chemicals have to be tested, there are no such provisions for the 100,106 "existing" substances. Whilst there is a Commission Regulation that requires information on high volume existing substances to be submitted, it has been up to the public authorities to determine which of them need to be examined, and if so, to do the work themselves. The procedures have been lengthy and cumbersome. For example, since 1993, 140 high-volume chemicals have been singled out for risk assessment. Only a very limited number have completed the process so far, including agreeing appropriate risk management measures.

New chemicals have to be notified and tested in production volumes as low as 10kg per year; volumes above 1 tonne require extensive testing. This has inhibited research and development and stifled innovation. It encourages the continued use of "existing" untested chemicals because it is easier and cheaper. The number of chemicals introduced since 1981 is about 3,000.

2. What are the overall aims of the new chemical strategy?

The two most important aims are to improve protection of human health and the environment from the hazards of chemicals and enhance the competitiveness of the EU chemicals industry.

In the White Paper on the Strategy for a Future Chemicals Policy, published in February 2001 (COM (2001) 88), the Commission outlined its strategy for ensuring a high level of chemicals safety and a competitive chemicals industry through a system for the Registration, Evaluation and Authorisation of Chemicals - the REACH system.

The White Paper is based on seven objectives that need to be balanced within the overall framework of sustainable development:

Protection of human health and the environment;
Maintenance and enhancement of the competitiveness of the EU chemical industry;
Prevention of fragmentation of the internal market;
Increased transparency;
Integration with international efforts;
Promotion of non-animal testing;
Conformity with EU international obligations under the WTO.

The system proposed by the Commission on 29 October 2003 achieves all these objectives. It thus represents a model of sustainable development by pursuing objectives in three areas: economic (industrial competitiveness), social (jobs) and environmental (protection of human health and the environment).

3. How will registration under REACH work?

Registration is the basis of REACH. Manufacturers and importers will be required to gather information on the properties of their substances, which will help them manage them safely, and submit the information in a registration dossier to a central data base. Companies will be required to register all substances produced or imported in volumes of 1 tonne and more per year per manufacturer or importer. A new independent agency at European level will receive the dossiers and manage the database. Information requirements will largely depend on volume, but may be tailored to the intrinsic properties and conditions of use of certain substances

Registration will involve providing information on:

The intrinsic properties and hazards of each substance (such as physicochemical, toxicological and eco toxicological properties). This information - if not already available - can be found through a variety of means such as computer modelling and epidemiological studies, or through testing. Where testing is necessary and involves animals, it will be kept to a minimum by requiring companies to share existing data. This will also reduce the associated costs. Any proposals for testing on animals will also be subject to a 'dossier evaluation'.
The use(s) of the substance identified by the importer or manufacturer or by their customers. A report of an assessment of risks for human health and the environment, and how those risks are adequately controlled, for the identified uses for substances produced or imported in volumes of 10 tonnes or more per year per manufacturer or importer (known as chemical safety reports). For lower volumes, safety information produced for the safety data sheets will be submitted as part of the technical dossiers.

To cope with the large number of 'existing' substances a phased approach is proposed. The deadlines for registration are set according to the volume of the substance on the market or the hazard. The shortest deadlines apply to very high volume substances (above 1000 tonnes), and carcinogenic, mutagenic or reproduction toxic substances above 1 tonne. These will have to be registered within 3 years.

4. Will each registration require testing?

No. There is already a lot of information available, and REACH accepts the submission of existing information. New testing will be required only where there is no sufficient information available and other sources of information are not appropriate. Registrants will be required to share animal testing data; this will avoid many new tests.

5. What is evaluation?

There are two types of evaluation: dossier and substance evaluation. Both evaluations will be performed by competent authorities in the Member States.

Dossier evaluation will be conducted to check proposals for testing on animals and ensure that unnecessary animal testing is avoided. Registration dossiers can also be subject to a dossier evaluation to ensure their compliance with the registration requirements.

Substance evaluations can be performed when there is reason to believe that a substance may present a risk to human health or the environment (for example, because of its structural similarity to another substance or for other reasons). Therefore, substance evaluations will look at all the registration dossiers submitted for the same substance and take into account any other available information. It is expected that substance evaluations will focus on those substances that may pose the greatest risk to human health and the environment. The Agency will develop risk-based criteria to assist with the prioritisation of substance evaluations.

To help ensure that the system operates efficiently, a competent authority from one Member State will be designated in each case to carry out an evaluation based on rolling plans they will develop, setting out the substances they will evaluate. The outcome of an evaluation may be that the registrant(s) have to provide additional information, either to bring their registration into compliance with the requirements or to help clarify risks.

If all Member States agree to request more information, the Agency will take the decision. If not, the Commission decides whether or not more information should be requested.

6. What is authorisation, and which types of chemicals will require authorisation?

All substances of very high concern will be subject to authorisation. Authorisations apply to particular uses of the substance in question. Authorisation will be granted only if the producer or importer can show that risks from the use in question can be adequately controlled, or that the socio-economic benefits of the use of the substance outweigh the risks. In the latter case, the possibility of substitution should be considered.

The authorisation decision will take into account substitution plans showing for example that the industry is researching substitutes. Third parties will also be able to provide information to the Agency about possible substitute substances or technologies.

Examples of substances that will be subject to authorisation are:

- CMRs (carcinogenic, mutagenic or toxic to reproduction), category 1 and 2,

- PBTs (persistent, bio-accumulative and toxic),

- vPvBs (very persistent, very bio-accumulative).

- Substances identified as having serious and irreversible effects to humans and the environment equivalent to the other three categories, for example certain endocrine disrupting substances (substances disturbing the body's hormone system). These will be identified on a case by case basis and be subject to authorisation.

7. How long will it take to register all chemicals under REACH?

Substances that are already on the market will be phased gradually into REACH.

Substances produced in high volumes and CMRs will have to be registered first. Registration deadlines will be calculated from the year the legislation enters into force so that the new obligations will apply from:

year 3 for high production volume chemicals (1,000 tonnes or more/year/ manufacturer or importer) and CMRs in volumes of 1 tonne or more;
year 6 for production volumes in the range of 100 - 1,000 tonnes;
year 11 for low production volume chemicals (1 - 100 tonnes).

8. In which category are high-risk substances, i.e. those that may have to be evaluated?

They are in all three categories although known CMRs will have to be registered in the first wave. We don't know in detail until we receive the registration dossiers

9. Will all chemicals on the market have to be registered, evaluated and authorised?

No, only those chemical substances produced or imported in volumes of 1 tonne or more per year, per manufacturer/importer, have to be registered in REACH. This means that around 30 000 marketed substances will need to be registered. Of these 30 000 around 20 000 are produced or imported in volumes of between 1 and 10 tonnes.

The number to be evaluated will depend on the concerns of the Member States' authorities but the White Paper predicted that around 20% of substances would go through this process.

Up to 1500 substances of very high concern will be subject to authorisation.

Approximately 40,000 intermediates will also need to be registered although for most of them the registration requirements will be significantly lighter than for other substances.

10. If a substance is registered/evaluated/authorised can it then be used in any field of application?

No, a substance is registered, evaluated and authorised for particular uses. Manufacturers who want to use the substance for another use must update their registration for this specific field of application. This further use may also be subject to authorisation if it is a substance of very high concern.

11. Will any chemicals be excluded from REACH?

Non-isolated intermediates are fully exempt. Intermediates are chemicals used to make other chemical substances. Non-isolated intermediates are never separated from the mixture of other chemicals inside a chemical system.

Isolated intermediates will have to be registered, but with simplified information requirements commensurate with their lower risk. Isolated means that these substances have been separated out from other substances.

Polymers are exempted from registration and evaluation. However, the Commission may introduce requirements for the registration of polymers once a practicable and cost-effective way of identifying dangerous polymers on the basis of sound technical and valid scientific criteria have been established. Polymers are large molecules consisting of repeated chemical units (monomers) joined together. Plastics are examples of polymers.

12. Will the use of hazardous chemical substances be restricted or banned?

Many hazardous chemicals can be used safely if the right risk management measures are respected, such as the use of good ventilation or protective clothing. Under REACH, substances of very high concern will be subject to Authorisation and any other substance may be subject to a Restriction. Restrictions are the safety net of the system. The Commission will be able to introduce restrictions at EU level for any substance that poses unacceptable risks, taking due account of socio-economic factors. Restrictions include banning uses in certain products, banning uses by consumers or even complete bans.

13. Will chemicals in pesticides, pharmaceuticals and cosmetics be included in REACH?

Some will, others will not. REACH has been designed to complement but not overlap with other EU legislation.

14. Will mixtures of chemicals, such as paint, have to be registered under REACH?

As the REACH system is substance based, it is the substances in the mixture (preparations) that will need to be registered, not the preparations themselves. When the preparation is sold, the safety information accompanying it will apply to the entire preparation.

15. Will chemicals in everyday articles have to be registered?

Most articles, e.g shoes or textiles, contain chemicals. Some of these are potentially hazardous to environment and health, if they are released. Those substances that are intended to be released as part of the utility of the article (e.g. the ink in a cartridge ) will need to be registered if they are classified as dangerous. The same tonnage thresholds and information requirements as for other substances apply. If the release is not intended as part of the functioning of the article, but happens anyway (e.g. formaldehyde released from fibreboard), the substance may have to be notified to the Agency, who will decide whether a registration is needed.

16. Will articles that contain chemicals be labelled?

Not necessarily, because all articles contain chemicals and most articles are safe. However, industry will have to show that their use is safe and this may involve labelling and instructions for safe use.

17. Will consumers have access to the information on chemicals registered in the database?

Yes, much of the key safety information will be available on-line on the Agency's website and more will be available on request.

18. What is the difference between REACH and the present system of chemicals management?

Under the present legislation public authorities are required to identify and address possible safety issues for the chemicals on the market. REACH aims to change this balance by requiring industry to take responsibility for assessing the risks of chemicals and for ensuring their safe use. At the same time, improvements in the efficiency of the system are designed to ensure that there are better incentives for developing new and safer chemicals and that requirements are drawn up in such a way that the competitiveness of EU industry is safeguarded.

The Safety Data Sheets (SDS) used for transfer of information in the present system will continue to be used in REACH. The SDS are a well-understood, and internationally accepted, tool for the communication of information about chemical hazards, risks, and risk reduction measures. SDS will be used as the primary communication tool for information developed under REACH.

Comparison between the present system and REACH

Present system	REACH
There are gaps in our knowledge about many of the chemicals on the European market.	REACH will close the knowledge gap by providing safety information about chemicals produced or imported in volumes higher than 1 tonne/year per manufacturer/importer.
The 'burden of proof' is on the authorities: they need to prove that the use of a chemical substance is unsafe before they may impose restrictions.	The 'burden of proof' will be on industry. It has to be able to demonstrate that the chemical can be used safely, and how. All actors in the supply chain will be obliged to ensure the safety of the chemical substances they handle.
Notification requirements for 'new substances' start at a production level of 10 kg. Already at this level, one animal test is needed. At 1 tonne, a series of tests including other animal tests have to be undertaken.	Registration will be required when production/import reaches 1 tonne . As far as possible, animal testing will be minimised.
It is relatively costly to introduce a new substance on the market. This encourages the continued use of "existing", untested chemicals and inhibits innovation.	Innovation of safer substances will be encouraged under REACH through: more exemptions for research and development; lower registration costs for new substances; and the need to consider substitute substances for decisions on authorisation and restrictions.
Public authorities are obliged to perform comprehensive risk assessments that are slow and cumbersome.	Industry will be responsible for assessing the safety of identified uses, prior to production and marketing. Authorities will be able to focus on issues of serious concern.

19. Who will do what under REACH?

Division of responsibilities

	Industry	Agency	Member States authorities	European Commission
Registration	Collects and submits data. Assesses risks and identifies risk management measures. Keeps registrations updated. Proposes testing schemes.	Receives registration dossiers. Checks them for completeness. Maintains the database and provides information to the public.	Enforcement.	---
Evaluation	Provides further information if required.	Co-ordinates the work of the Member State authorities, develops evaluation criteria, takes decisions on requesting more information from industry if all Member States agree.	Review individual dossiers. Prepare rolling plans for substance evaluations and carry them out. Prepare draft decisions on further information requirements.	Takes decision on requesting more information from industry if Member States don't all agree
authorisation	Submits application dossier	Publishes applications on its website. Recommends priorities. Committees draft opinions. Supports Commission in decision-making.	Submit proposals for substances that are considered to pose serious and irreversible effectsequivalent to CMRs, PBTs and vPvBs..	Takes decisions on priority setting (step 1) and on granting authorisations (step 2)
Restriction	Provides socio-economic assessments.	Provides opinions and comments. Publishes the Member State restriction proposals and its Committee's draft opinions on the Internet.	Submit proposals	Takes decisions on restrictions of production, marketing and use.

20. What will be the role of public authorities in the Member States under REACH?

The competent authorities in the Member States will be responsible for performing evaluations. They can initiate the procedure for restrictions and will enforce the new system within their territory. They will provide much of the expertise to ensure that the Agency is able to operate.

21. What will be the role of the new Chemicals Agency?

The Agency, to be funded mainly through fees charged for registrations and authorisations, will act as the central point in the REACH system. It will run the databases necessary to operate the system and co-ordinate the evaluation procedures. It will take any decisions to require further information from industry. The Agency will provide advice to the Commission on priorities regarding treatment of substances and on issues linked to authorisation. It will also run a number of technical committees advising, and drafting opinions for, the Commission.

22. What will be the role of the Commission?

The Commission will oversee the work of the Agency, and will decide on proposals following evaluation if Member States fail to reach an agreement. It will also decide on authorisations and restrictions of uses of specific substances following review of relevant risk assessment and socio-economic analyses.

23. Which responsibilities will industry shoulder under REACH?

The new legislation addresses manufacturers, distributors, importers and downstream users.

Manufacturers produce substances. Importers import substances from non-EU countries, and downstream users make industrial or professional use of chemicals. Distributors only store or place a substance on the market. Some of them mix chemicals to make preparations (such as ink), others use substances or preparations to make articles (such as ballpoint pens, chairs or cars), or use them in their business (such as CD-manufacturers who use degreasing agents to clean their machines).

The vast majority of the REACH requirements apply directly to manufactures and importers of substances. They will supply data on the properties of their chemicals, develop chemical safety assessments and implement risk management measures.

Downstream users will be supplied with safety information about the chemicals they purchase and should follow them when handling the chemicals. They will also need to make sure that their customers (e.g. other industries and consumers) have all the information necessary to use their products safely. When a chemical is to be used in a way not covered by the original registration, the new uses or risk reduction measures will have to be reported to the Agency if the volume is higher than 1 tonne. Distributors must also ensure safety information is provided with the substances they sell.

24. What impact will REACH have on SMEs?

Small and medium-sized enterprises (SME) are a vital part of the EU chemicals industry. Since safety is a key concern, regardless of company size, the REACH information requirements relate to production volumes, uses and properties of the chemicals, and not to turnover or the number of employees of the companies.

Many of the SMEs that will be affected by the present legislative proposal are 'downstream users', i.e. companies that buy chemicals and use them as ingredients in their own products or use chemicals in an industrial or professional way. As a result of their position in the value-added chain, most chemicals will already be registered when they are utilised by downstream users. When assessing risks, manufacturers and importers must address the uses identified by downstream users. This will help to ensure a high level of chemical safety for downstream users and will reduce their costs. Downstream users who wish to keep their uses secret can choose to do their own risk assessments.

SMEs that are manufacturers will be able to take advantage of the incentives for innovation that the REACH system will create, such as:

- Exemption from testing requirements for substances used in product- and process- orientated research and development.

- No registration below 1 tonne.

- Light information requirements for low volume substances (registration threshold at 1 tonne/year per manufacturer/importer, normally only in vitro testing for substances between 1 and 10 tonnes). This should reduce the costs for manufacturing SMEs, who will typically work in this range.

- Administrative burdens and costs can partly be shared between registrants in the pre-registration process.

25. How will REACH promote innovation and development of safer substitutes?

To enhance industry's competitiveness, one of the objectives of REACH is to promote R&D and innovation. For example:

Uses of substances in product- or process-oriented R&D do not need to be registered for up to 5 years, renewable for a further 5 years (For substances used in medicinal products, the maximum total exemption is 15 years).
The REACH threshold for registration (1 tonne/year) is much higher than the current 10 kg threshold for new substances.
The costs of registering a new substance will be significantly lower than the current cost of notification.
Registration will be quicker than the current notification, thus reducing the time to market.
The requirements for authorisation should encourage companies to increase their search for safer substitutes.
The discrimination of new substances versus existing substances will come to an end.

26. How much will REACH cost?

Testing and registration costs: The Commission's Impact Assessment estimates the direct costs of REACH to the chemicals industry at a total of some €2.3 billion over an 11 year period, including fees to the Agency of €0.3 billion.

Costs to downstream users: The costs to downstream users of chemicals are estimated at €2.8 - 3.6 billion if the market behaves as expected with 1 - 2 per cent of substances withdrawn because continued production would not be profitable. Costs could rise to €4.0 - 5.2 billion if industry faces higher supply chain adaptation costs. These estimates include the direct costs passed on from the chemicals sector to downstream users.

Total costs: The overall costs to the chemicals industry and its downstream users would then be €2.8 - 5.2 billion. From a macroeconomic perspective, the overall impact in terms of the reduction in the EU's Gross Domestic Product (GDP) is expected to be very limited.

27. What are the main benefits of REACH?

The benefits of the REACH system are twofold: risks to human health will be reduced and environmental quality will be improved through the better and earlier identification of the properties of chemical substances. The identification of hazards and better management of risks resulting from the use of chemicals will contribute to the prevention of health problems caused by exposure to chemicals, e.g. lower occurrence of diseases and preventable deaths, and lower costs for the national health systems. The benefits will come gradually as more and more substances are phased into REACH. The anticipated benefits to environment and human health are expected to be significant. The Commission's Impact Assessment developed an illustrative scenario which put the health benefits in the order of magnitude of €50 billion over a 30 year period. The expected environmental benefits have not been expressed in monetary terms.

The European chemicals industry will benefit from a single EU regulatory system, decision-making with set deadlines, and a high quality image for their products. Downstream users of chemicals will get relevant information on the safe use of each chemical substance they buy. They will have closer contacts with their suppliers, and will be able to ensure better protection of their workers. Their products will be safer for consumers and the environment.

28. Will REACH result in the loss of substances?

It is likely that some substances will not be registered because manufacturers will not consider it worthwhile to pay the cost of registration. The Commission estimates that this will be the case for approximately 1-2 % of substances currently on the market.

Due to the dynamic nature of the market for chemicals, it is difficult to imagine that essential chemicals will disappear without being substituted. The REACH system will act as a spur to innovation, by encouraging companies to develop substitute products for some of those substances which might otherwise need to go through the authorisation process. Downstream users may participate in consortia by providing information and may identify uses.

29. Will REACH result in more animal testing?

For low volume chemicals (1-10 tonnes/year per manufacturer or importer), animal testing will be avoided as far as possible. For higher volumes, animal testing may be necessary if existing information and validated alternative methods are not sufficient. Testing programmes involving animals, required for certain higher volume substances, need to be agreed with the competent authorities, through the evaluation procedure, before the experiments start. This is to ensure that the endpoints studied are relevant, that the scientific validity of the research is sufficiently high, and finally to ensure that the testing programme is not duplicating other studies. To minimise duplicate testing, data sharing between enterprises will be required.

30. How will REACH complement other EU legislation?

REACH legislation has been drafted to avoid overlaps with other legislation. The information generated by REACH will enable other relevant legislation to function more efficiently. For example, REACH will replace some 40 Directives and Regulations on chemicals, but leave more than 20 other pieces of legislation on chemicals in place, for example those related to labelling of dangerous substances. The information generated by REACH will provide input into this and many other pieces of legislation.

31. What consultation has taken place before adoption?

Before and during the entire process of drafting the new legislation, the Commission has had extensive information contacts with Member States, third countries, industry and non-governmental organisations (NGOs), both informally and through many working groups:

Member States: Regular contacts through meetings with the competent authorities. Several Member States participated in Technical Expert Working Groups. A number of Member States provided position papers.

Third countries: Position papers, informal "non-papers" and letters highlighting the views of third countries or third country associations were received and many meetings and discussions took place.

Industry: Many industrial associations representing different branches of industry submitted position papers on the chemicals strategy. Bilateral meetings and participation in different conferences organised by industry allowed for a regular exchange of views. Experts nominated by different industrial organisations participated in the Technical Expert Working groups.

NGOs: Environmental, consumer and animal welfare NGOs submitted position papers on the chemicals strategy. Major environmental NGOs and the European Consumers Organisation (BEUC) were invited to competent authorities meetings. The animal welfare groups have had opportunities on several occasions to voice their concerns about animal testing, including at the meetings of the Commission with Member State Competent Authorities for the protection of experimental animals. Experts nominated by several of the NGOs have participated in the Technical Expert Working groups.

A draft text prepared by Directorates-General Enterprise and Environment was posted on the Internet in May 2003 for an 8-week consultation period.

32. Who has commented during the Internet consultation?

Over 6,000 responses were received through the Internet consultation, from industry, including many individual enterprises, workers, non-governmental organisations (NGOs), individuals, public authorities and agencies. About half of respondents were enterprises, including the major chemical producers, formulators of chemical products, and many small and medium sized companies (SMEs). The main EU and national trade associations also contributed. A number of EU and national NGOs provided comments. Some of the NGO submissions, from both EU and US, included petitions from more than 30,000 individuals calling for better protection of health and the environment. Trade Unions also replied. Six of the EU Member States (UK, FR, DE, IRL, NL and A) presented their respective positions and many comments were received from regional authorities and from state agencies. Many key trading partners (including US, Japan, Canada and China) also made contributions.

33. Which issues were raised during the Internet consultation?

Although a wide variety of comments were received, the main issues raised can be summarised as follows:

concerns about the scope and cost of the proposed system;
worries about the administrative burden of the system, in particular arising from the requirements for Chemical Safety Assessments and Chemical Safety Reports (CSRs);
calls for more prioritisation in REACH, in particular for low volume substances and those of low concern;
concern that the inclusion of polymers in the system would overburden it and add costs;
calls for protection of the commercial confidentiality of data;
calls for publicly accessible data about risks of chemicals, and the right to access information about chemicals used in products;
a desire for a clearer and more effective role for the proposed Chemicals Agency, particularly with regard to handling registrations and in ensuring uniformity and consistency in evaluation decisions taken by Member States;
calls to include the principle of substitution of dangerous substances by safer alternatives in the proposal;
a desire to ensure a level playing field for articles produced inside the EU and in third countries;
concerns about the impact of REACH with regard to animal welfare and the need to avoid testing on animals.

34. What changes has been made following the Internet consultation?

The comments received through the Internet consultation provided valuable information on ways of improving the workability of REACH. This information, coupled with new data generated through further work on the impact assessment, enabled improvements to the proposal to be identified, whilst retaining the main features of the system set out in the White Paper:

Substantial simplification of the requirements to be met by manufacturers and importers and a much reduced burden for downstream users. The latter will not normally be required to complete Chemical Safety Assessments or Chemical Safety Reports; this will be the responsibility of the producer or importer of chemicals, which registers the substance. Registrants will be required to register substances for all "identified" uses. Downstream users will have the right to insist that their use of a substance is identified by their supplier, or they can choose, for reasons of commercial confidentiality, to do their own Chemical Safety Assessment and Report and simply report this to the Agency.
No preliminary Chemical Safety Reports. The obligation to develop Chemical Safety Reports for all substances within one year of entry into force has been deleted.
No registration or evaluation for polymers. This situation will be reviewed, as soon as a practicable and cost-effective way of identifying dangerous polymers on the basis of sound technical and valid scientific criteria can be established. The Commission will be empowered to make any necessary changes to the requirements. To minimise any risk arising, polymers will be subject to authorisation and restriction within REACH where risk management measures are needed.
Lighter registration for substances produced between 1 - 10 tonnes, with reduced testing requirements and no need to complete Chemical Safety Assessments or Chemical Safety Reports; these requirements will also be reviewed at an appropriate stage by the Commission which will be empowered to adapt the requirements as necessary.
Encouragement for substitution. Authorisation will be granted for uses where the risks of a substance are adequately controlled. In cases where the risks cannot be controlled, the risks will be weighed against the socio-economic benefits of a substances and the possibility for substitution. Those that apply for authorisation on socio-economic grounds will be able to present a substitution plan, which would have to be taken into account in the Commission's decision.
Streamlined administration of REACH, by giving the proposed chemicals Agency full responsibility for all aspects of registration. Arrangements for evaluation of substances will be rationalised which will enable the Agency to focus on priorities. That the Agency will take the evaluation decisions is a guarantee of uniform and consistent administration. The Agency's role as regards sharing of data between enterprises is also reinforced.
Greater legal certainty will be provided through deletion of the duty of care, the treatment of confidential data, exemptions for research and development and sanctions, while still protecting health and the environment.
Requirements for preparations have been eased. Chemical safety assessments will have to be performed only for substances above certain concentration limits (the same as in the Dangerous Preparations Directive). They may also be carried out for the preparation as a whole instead of for the different substances used in the preparation. The relevant safety information for a preparation will always be transmitted in a single Safety Data Sheet.
A number of other important changes are also included, aimed at ensuring smoother application of the requirements, eliminating inconsistencies, and clarifying the legal provisions, including improved definitions. Among the improvements made is the identification of a more practical formula for determining when substances in articles need to be registered or notified to the authorities; in this case registration will be required for substances intended to be released; in other cases where there is likely to be release of chemicals a simple notification procedure is envisaged, with the possibility for the Agency to require a registration.
The provisions on public access to information have been adjusted to ensure more effective safeguards in relation to business confidentiality. Non-confidential information will be made available to the public by the Agency. The provisions on sanctions have been simplified to ensure an approach that is proportionate and takes account of damage to health and the environment. Finally, it is proposed to give the Commission implementing powers to take decisions to ensure the smooth application of the system.

35. What international initiatives exist on chemicals safety?

As chemical substances are traded internationally, chemical safety is a global concern, which is shown by the number of international initiatives in this area.

United Nations Environment Programme (UNEP): A strategic approach to international chemical management is under development, (a high-level multi-sector conference is scheduled in late 2005). The World Summit on Sustainable Development in Johannesburg in September 2002 agreed that by 2020 chemicals should be used and produced in ways that minimise significant adverse effects on human health and the environment.

The OECD has initiated a co-operative action programme for testing and assessing High Production Volume (HPV) chemicals in a systematic way. When important data gaps are identified or concerns are raised, further investigation, in-depth assessment or risk assessment measures are recommended.

Several international conventions have been adopted, aiming at reducing the risk connected with chemicals. These include the Rotterdam Convention on Prior Informed Consent (PIC), which sets up a system regulating trade in certain dangerous substances. It is expected to enter into force early in 2004. The PIC convention was signed by the European Community in 1998 and was ratified 20 December 2002 by the Community. To date, seven Member States have ratified the convention.

The Stockholm Convention on Persistent Organic Pollutants (POPs) sets out to control the production, use, import, export, disposal and releases of twelve POPs. The convention bans deliberate production and use of POPs and development of new POPs, and also aims at preventing the development of new POPs and minimising releases of unintentionally produced POPs. The POPs convention was signed by the European Community and the Member States in 2001 and has so far been ratified by six Member States. The Commission has adopted proposals for ratification and implementation of the Stockholm Convention in June 2003.

The Commission takes an active part in the ongoing UN negotiations on a Global Harmonised System (GHS) for the classification and labelling of chemicals. The first part of the GHS was adopted by UN ECOSOC in July 2003. The Commission has already started work on the implemention of this decision into Community legislation. The Commission participates in the Intergovernmental Forum on Chemicals Safety (IFCS), a forum where governments and intergovernmental and non-governmental organisations meet. IFCS aims to promote chemical risk assessment and the environmentally sound management of chemicals.

36. Is the REACH proposal WTO compatible?

The WTO rules allow members to take measures to protect public health, as long as these protective measures are non-discriminatory towards other members. They also require that the rules to be established should be proportionate to the objectives prescribed. The REACH system has been designed to put EU and non-EU producers of chemicals on an equal footing thus the requirements for imported chemicals and chemicals manufactured within the EU are the same. The REACH system also takes into account comparable non-EU data- and test-results on chemicals, especially those resulting from internationally recognised tests. The requirements set down are the minimum necessary to ensure that the health and safety objectives established can be achieved, every effort having been made to reduce the costs and burdens of the system, as demonstrated in the Commission's Impact Assessment.

37. What is the legal base of the new policy?

The Commission's proposal is for a Regulation based on Article 95 of the EC Treaty in keeping with the objective of safeguarding the internal market, while ensuring a high level of health, safety, consumer and environmental protection. The precautionary principle (Article 174.2 of the Treaty in combination with Article 6 and Article 95.3) will continue to guide the approach in the implementation of necessary measures.

38. Where can the proposals be found?

The proposals is be published at the following websites:

http://europa.eu.int/comm/enterprise/chemicals/chempol/whitepaper/whitepaper.htm

http://europa.eu.int/comm/environment/chemicals/whitepaper.htm