Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (Reach), establishing a European Chemicals Agency and amending Directive 1999/45/EC and Regulation (EC) {on Persistent Organic Pollutants} {SEC(2003 1171}

(presented by the Commission)

Extended Table of contents

Volume I

- Proposal for a Regulation of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restrictions of Chemicals (Reach), establishing a European Chemicals Agency and amending Directive 1999/45/EC and Regulation (EC) {on Persistent Organic Pollutants}

- Proposal for a Directive of the European Parliament and of the Council amending Council Directive 67/548/EEC adapting it to the "REACH Regulation"

Volume II

Annex I General provisions for Assessing Substances and Preparing Chemical Safety Reports

Annex II Exemptions from obligation to register in accordance with article 6 (a)

Annex III Exemptions from the obligation to register in accordance with article 6 (b)

Annex IV Information requirements referred to in article 9

Annex V Standard information requirements for substances manufactured or imported in quantities of 1 tonne or more

Annex VI Additional standard information requirements for substances manufactured or imported in quantities of 10 tonnes or more

Annex VII Additional standard information requirements for substances manufactured or imported in quantities of 100 tonnes or more

Annex VIII Additional standard information requirements for substances manufactured or imported in quantities of 1000 tonnes or more

Annex IX General rules for adaptation of the standard testing regime set out in Annexes V to VIII

Volume III

Annex X to the Proposal for a Regulation (Test Methods) part A

Volume IV

Annex X to the Proposal for a Regulation (Test Methods) part B

Volume V

Annex X to the Proposal for a Regulation (Test Methods) part C

Volume VI

Annex XI General provisions for Downstream Users to Assess substances and prepare Chemical safety reports

Annex XII Criteria for the identification of Persistent, Bioaccumulative and Toxic Substances, and Very Persistent and Very Bioaccumulative Substances

Annex XIII List of substances subject to authorisation

Annex XIV Dossiers

Annex XV Socio-economic analysis

Annex XVI Restrictions on the manufacture, placing on the market and use of certain dangerous substances, preparations and articles

Annex XVII Persistent organic pollutants (POPs)

LEGISLATIVE FINANCIAL STATEMENT

TABLE OF CONTENTS

EXPLANATORY MEMORANDUM

Background to the proposal

Results of public consultations and impact assessments

Legal elements of the proposal

Introduction to the proposal

1. Reasons and Objectives

2. Content of the Regulation

3. Annexes

TITLE I GENERAL ISSUES

Chapter 1 Subject matter and scope

Chapter 2 Definitions

TITLE II REGISTRATION OF SUBSTANCES

Chapter 1 Scope

Chapter 2 General obligation to register and information requirements

Chapter 3 Obligation to register and information requirements for polymers

Chapter 4 Obligation to register and information requirements for certain types of isolated intermediates

Chapter 5 Common provisions for all registrations

Chapter 6 Transitional provisions applicable to certain types of substances: phase-in substances and notified substances

TITLE III DATA SHARING AND AVOIDANCE OF UNNECESSARY ANIMAL TESTING

Chapter 1 Objectives and general rules

Chapter 2 rules for non-phase-in substances

Chapter 3 Rules for phase-in-substances

TITLE IV Information in the supply chain

TITLE V DOWNSTREAM USERS

TITLE VI EVALUATION OF SUBSTANCES

Chapter 1 scope and competent authority

Chapter 2 Dossier Evaluation

Chapter 3 substance evaluation

Chapter 4 Evaluation of intermediates

Chapter 5 Common provisions

TITLE VII AUTHORISATION

Chapter 1 Authorisation requirement

Chapter 2 The granting of authorisations

Chapter 3 Authorisations in the supply chain

TITLE VIII RESTRICTIONS ON THE MANUFACTURING, MARKETING AND USE OF CERTAIN DANGEROUS SUBSTANCES AND PREPARATIONS

Chapter 1 General Issues

Chapter 2 The restrictions process

TITLE IX AGENCY

TITLE X CLASSIFICATION AND LABELLING INVENTORY

TITLE XII INFORMATION

TITLE XII COMPETENT AUTHORITIES

TITLE XIV ENFORCEMENT

TITLE XV TRANSITIONAL AND FINAL PROVISIONS

Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Council Directive 67/548/EEC in order to adapt it to Regulation (EC) of the European Parliament and of the Council concerning the registration, evaluation, authorisation and restriction of chemicals

EXPLANATORY MEMORANDUM

Background to the proposal

Reasons for and objectives of the proposal

In February 2001 the Commission issued a White Paper on a 'Strategy for a future Chemicals Policy' (ref.: COM(2001) 88 final) based on a review of the existing EU system for regulating the safe use of chemicals. The Commission concluded that reform of the current legislation was necessary in order to meet the following objectives:

- protection of human health and the environment,

- maintenance and enhancement of the competitiveness of the EU chemical industry,

- prevention of the fragmentation of the internal market,

- increased transparency,

- integration with international efforts,

- promotion of non-animal testing,

- conformity with EU international obligations under the WTO.

General background

There are a number of factors that place the chemicals industry at the heart of the Community's sustainable development strategy. It plays a very important economic role, supplying materials to manufacturing industry, as well as stimulating innovation and supplying products needed to sustain and improve the quality of life. The chemicals industry is also a major contributor to economic development and Europe's balance of payments surplus. Maintaining a competitive and innovative chemicals industry in Europe is therefore a major goal.

At the social level, improving the health and safety of workers and the general public is a key political objective of the Community chemicals policy. Maintaining high levels of employment is also a key objective.

In relation to the environment, the avoidance of chemical contamination of air, water, soil and buildings, as well as preventing damage to biodiversity are also major goals. Improved control of persistent, bioaccumulative and toxic substances is of particular importance in this respect.

The need to advance these objectives has been endorsed at the highest political levels. The European Council in Brussels on 20/21 March 2003, on the one hand, stressed that competitiveness "must once again be placed centre stage" and that increased business investment in research and development (R & D) and innovation must be promoted. On the other hand, the Council emphasised the need to curb environmental pressures and preserve natural resources within the framework of the comprehensive sustainable development strategy launched at Gothenburg and to promote sustainable development on a global scale, including a follow up to the goals agreed in Johannesburg in relation, inter alia, to sound management of chemicals.

Current chemicals legislation

The present system for general industrial chemicals distinguishes between "existing substances" i.e. all chemicals declared to be on the market in September 1981, and "new substances" i.e. those placed on the market since that date.

There are some 3 000 new substances. Directive 67/548 requires new substances to be tested and assessed for possible risks to human health and the environment before they are marketed in volumes starting at 10 kg. For higher volumes more in-depth testing, focusing on long-term and chronic effects, has to be provided.

In contrast, existing substances amount to more than 99% of the total volume of all substances on the market, and are not subject to the same testing requirements. The number of existing substances reported in 1981 was 100 106, the current number of existing substances marketed in volumes starting at 1 tonne is estimated at 30 000. Some 140 of these substances have been identified as priority substances and are subject to comprehensive risk assessment carried out by Member State authorities under Regulation 793/93.

There is a general lack of publicly available knowledge about the properties and uses of existing substances. The risk assessment process is slow and resource-intensive and does not allow the system to work efficiently and effectively. The allocation of responsibilities is inappropriate because the public authorities are responsible for the assessment instead of the enterprises that produce, import or use the substances. Furthermore, current legislation requires only the manufacturers and importers of substances to provide information, but does not impose similar obligations on downstream users (industrial users and formulators). Thus, information on uses of substances is difficult to obtain and information about the exposure arising from downstream uses is generally scarce. Decisions on further testing of substances can only be taken via a lengthy committee procedure and can only be requested from industry after authorities have proven that a substance may present a serious risk. Without test results, however, it is almost impossible to provide such proof. Final risk assessments have therefore only been completed for a small number of substances.

Under Directive 76/769/EEC, restricting the marketing and use of certain dangerous substances and preparations, the Commission has committed itself to carry out risk assessments and adequate analyses of the costs and the benefits prior to any proposal or adoption of a regulatory measure affecting the chemical industry. Indications of unacceptable risk (typically arising from notifications of restrictions at national level) are the subject of reports, which are peer-reviewed by the Scientific Committee on Toxicology, Ecotoxicology and Environment (Cstee) of the Commission.

Current liability regimes are insufficient to remedy the problems identified in the Commission's review. Liability is usually based on the principle that those who cause damage should pay compensation for that damage. However, in order to be held liable, it is generally required that a causal connection be proven between the cause and the resulting damage. This is often virtually impossible for injured parties if cause and effect occur far apart in time and if adequate test data on the effects of substances are not available. Even if a causal connection can be established, compensation payments awarded by courts of EU Member States are generally not as high as, for example, in the US, and hence have a limited deterrent effect.

Coherence with other policies

Chemicals policy interfaces with a wide range of other policy sectors. In preparing its proposal, the Commission has been careful to avoid duplication of the provisions of other legislation, while not creating loopholes and ensuring that necessary information is made available to other sectors.

Results of public consultations and impact assessments

Public consultations

Following publication of the White Paper, there was a wide measure of consensus on the need for reform. Both the Council of Ministers and the Parliament clearly favoured development of more effective mechanisms and procedures which would place a greater onus on industry to make available information on the hazards, risks, and risk reduction measures for chemicals currently in use, and which would create greater confidence that dangerous substances were being used safely. Industry welcomed the new policy orientation towards enterprises themselves taking greater responsibility for the safety of their chemicals. At the same time they were concerned about the impact on competitiveness. Environmental non-governmental organisations (NGOs) and consumer organisations were strongly supportive of the need for change.

Internet consultation

In May 2003, the Commission decided to launch an Internet consultation to consider the workability of the draft legislation, including the technical requirements, without calling into question the scope and objectives of the system proposed. The consultation took place between 15 May and 10 July 2003. Respondents were able to submit their responses in several ways: through an online questionnaire, or via e-mail, fax and ordinary letter using a standardised template or free text. All responses were published on the Internet; names were withheld for respondents who wished to remain anonymous.

More than 6 000 distinct contributions were received. 42% of these were sent by industry - firms or associations. 142 NGOs, including trade unions, responded.

From the Member States, five governments (A, IRL, F, NL, UK) sent comments, as well as a number of public authorities (A, B, D, DK, FIN, GR, I, NL, S, UK). Public authorities from three Accession countries (LAT, LIT, PL) gave their input as well as authorities and governments from third countries (Australia, Canada, Chile, China, Israel, Japan, Malaysia, Mexico, Norway, Singapore, Switzerland, Thailand, USA). The international organisations Asia-Pacific Economic Cooperation (APEC) and Organisation for Economic Co-operation and Development (OECD) sent comments.

Approximately half of the contributions came from individuals. Many raised issues in relation to animal testing, others voiced fears of job losses or demanded increased protection of the environment and human health and better information for consumers. In addition, two petitions were submitted, supported by 34 000 individuals and organisations.

Main concerns and how they were addressed

Scope of the system: The inclusion of polymers and of substances in articles in the scheme was criticised by EU industry and foreign trade partners as excessive and difficult to implement. The requirement for all manufacturers, importers and downstream users to undertake chemical safety assessments was also criticised as going beyond the White Paper proposals.

- Polymers have been exempted from registration and evaluation, but may still be subject to authorisation and restriction. This may be amended by the Commission when sound scientific criteria have been developed for defining which polymers might be registered.

- Substances in articles have been addressed in a lighter way.

- The requirement to undertake chemical safety assessments has been considerably restricted.

Legal certainty: Industry feared that the duty of care would expose them to unlimited liability claims. They also raised concerns about the lack of an appeal mechanism in the Agency.

- Duty of care has been replaced by an explanation of the principles underpinning the Regulation.

- An appeal board has been included in the Agency.

Costs: Industry, some Member States and many foreign trade partners voiced concerns about excessive costs, in particular for low volume chemicals, downstream users and small and medium sized enterprises (SMEs).

- For downstream users, the requirement to undertake chemical safety assessments and produce chemical safety reports has been strictly limited.

- Registration obligations were simplified for 1-10 tonnes (no chemical safety reports need be submitted; testing requirements were reduced).

- Polymers (see above).

- Requirements for intermediates transported under strict control were reduced.

Bureaucracy/ Powers of the Agency: Many stakeholders criticised the fact that REACH was too bureaucratic and that the distribution of tasks (Member States and Agency) was too complex. They also expressed concerns that there would not be a harmonised approach to decision-making.

- Streamlined registration: the Agency will be solely responsible.

- Evaluation: the Agency will have a greater responsibility for the smooth running of the system and monitoring decision-making. The procedures have been restructured and made clearer.

- The system of chemical safety reports has been better co-ordinated with the already existing system of safety data sheets.

- The Agency now has boosted powers with regard to decisions on data sharing, research and development (R&D) exemptions and confidentiality.

Confidentiality and right to information about chemicals: Industry, in particular downstream users, has voiced concerns that they may be forced to disclose business secrets. NGOs have argued for a high level of transparency with regards to chemical composition of articles.

- Stricter protection of confidential business information: some types of information will always be treated as confidential, such as exact tonnage, customers' names etc. It will also be possible for companies to claim confidentiality if specific reasons are given and approved.

- All information that is non-confidential will be available on request (EC Regulation on public access), some items are published and freely available.

Substitution: NGOs, some branches of industry and some Member States have urged that there should be stronger provisions for substitution.

- There will be a clearer reference to substitution in the recitals and in the provisions on authorisation; companies will be encouraged to present substitution plans that will influence the authorisation decision.

Animal testing: Limiting animal testing has been one of the guiding principles in the drafting of the proposal. The Scientific Committee on Toxicology, Ecotoxicology and the Environment (CSTEE) voiced concerns that the animal tests envisaged would not yield sufficient information to avoid risks and stated that more tests would be necessary.

- Due to strong public pressure to limit animal testing, the number of tests has not been increased.

- To further reduce the need for animal testing without jeopardising human health and the environment, the use of qualitative or quantitative structure-activity relationship models, (Q)SARs, is encouraged; the text also clarifies that data sharing will be obligatory.

Impact assessments

Specific studies, notably in relation to the likely impact of the system proposed, were also initiated. The outcome of these are taken into account in preparing the impact assessment. As the proposal evolves, its impact will be monitored and followed up. Stakeholders will be involved in this exercise.

As regards the administrative aspects, the White Paper indicated that the administration of the new system would require the creation of a "central entity" which would have a key role in the management of Reach. The appropriate format of the "entity" was then considered to be the European Chemicals Bureau (ECB), part of the Joint Research Centre at Ispra, which would need to be enlarged to take on the extra tasks. Subsequent enquiry has raised serious doubts as to whether an enlarged ECB would be the most effective structure to meet the much increased demands of the new system. The Commission therefore undertook a feasibility study. Having carefully examined all elements, the Commission concluded that the establishment of a separate Agency is essential for the effective implementation of the proposed Reach system. Accordingly, the proposals provide for a new Agency. The interests of efficiency, continuity and optimum use of available expertise would point to Ispra as the most appropriate site for the Agency.

Collection and use of expertise

Following the publication of the White Paper, the Commission consulted widely with experts. This was done in the course of conferences, stakeholder working groups and in bilateral contacts between the services and stakeholders. The eight technical working groups convened by the Commission in 2001-2002 are of particular note in this regard. The consultation of relevant experts then continued throughout the drafting process.

Legal elements of the proposal

Legal basis

Article 95 of the EC Treaty is the appropriate legal basis because of the need to ensure a level playing field for all economic actors in the internal market while at the same time ensuring a high level of protection of health and the environment.

The choice of this legal basis ensures that the requirements for substances are harmonised and that substances complying with those requirements benefit from free movement throughout the internal market. This rewards the efforts which will be required from economic actors to maintain the level of protection required by this Regulation. Moreover, as substances, whether on their own or in preparations or articles are goods circulating within the internal market, it is important that they can do so under harmonised requirements.

Moreover, Article 95 paragraph 3 requires a high level of protection to be sought for proposals concerning health, safety, environmental and consumer protection. The Reach Regulation falls within this remit; hence the use of this legal basis does not compromise the level of protection.

Principles of subsidiarity and proportionality

Subsidiarity

In considering the issue of subsidiarity in the sense of Article 5 of the EC Treaty, it should be taken into account that the present legislation on chemicals already provides for an extensive control over the classification, labelling, marketing and use of substances and preparations. The new Regulation will to a large degree replace several existing pieces of legislation and will extend it to areas that have hitherto not been adequately dealt with. The subsidiarity issue therefore only arises with regard to this extension.

As chemicals are being traded across borders and as many of them can lead to cross-border contamination, Member States cannot by themselves achieve the objectives of the proposal sufficiently. Community wide legislation is therefore appropriate. In this context, it should be recalled that the opinions of both the Council and the European Parliament call for a strong system of EU legislation in order to achieve a high level of protection of health and the environment while at the same time ensuring a level playing field for all economic actors in the Internal Market.

Proportionality

An important feature of the new legislation in terms of proportionality (Article 1, paragraph 3 of the proposal) is the fact that the responsibility for the safe management of the risks of chemical substances will be placed on industry. This will permit industry to apply risk reduction measures from an early point in the life-cycle of the substance concerned and thereby to avoid negative impacts on downstream users and customers. It will also permit Member State competent authorities to direct their resources towards evaluating the quality of the information submitted by industry rather than doing risk assessments themselves.

While the new legislation is designed to cover all those chemical substances that can lead to a certain exposure of citizens or the environment, great care has been taken to ensure that the new legislation does not overreach in terms of scope, costs and administrative burden. This is why the new legislation provides for a tiered approach for certain classes of chemical substances. This is in particular the case with regard to low tonnage substances or special uses (e.g. for research and development).

At the same time this tiered approach leads to a somewhat lighter regime in terms of cost and administrative burden from which SMEs will be able to benefit, without diminishing the protection of health and the environment.

Choice of legal instrument

The use of a Regulation (that replaces some 40 existing Directives) is justified, as it will lead to the direct application of such legislation throughout the Community. In the area of technical legislation, this is a widely used technique that has already met with the support of Member States in other areas of Community competence [1]. It is all the more justified in the perspective of an enlarged Community that will soon comprise 25 Member States and will certainly benefit from homogenous and directly applicable rules throughout its territory.

[1] See the recent Regulation (EC) No 178/2002 on Food Law, as well as the Commission's recent proposals for Regulations on Fertilisers (COM(2001) 508), Detergents (COM(2002) 485) and Drug Precursors (COM(2002) 494).

Introduction to the proposal

This proposal establishes the Reach system and creates a European Chemicals Agency. In a nutshell, Reach consists of the following elements:

- Registration requires industry to obtain relevant information on their substances and to use that data to manage them safely.

- Evaluation provides confidence that industry is meeting its obligations and prevents unnecessary testing.

- Risks associated with uses of substances with properties of very high concern will be reviewed and, if they are adequately controlled, or if the socio-economic benefits outweigh the risks and there are no suitable alternative substitute substances or technologies, then the uses will be granted an Authorisation.

- The Restrictions procedure provides a safety net to manage risks that have not been adequately addressed by another part of the Reach system.

The Agency will manage the technical, scientific and administrative aspects of the Reach system at Community level, aiming to ensure that the Reach system functions well and has credibility with all stakeholders.

1. Reasons and Objectives

1.1. General Issues: Subject matter, scope and definitions

This sets out the scope of the Reach system and defines the terms used throughout the Regulation, and explains the principles on which the Regulation is based.

1.2. Registration

There is a general obligation to register substances manufactured or imported in quantities starting at 1 tonne. Failure to register means that the substance cannot be manufactured or imported.

The registration provisions oblige manufacturers and importers of substances to obtain, where necessary by performing new tests, knowledge on the substances they manufacture or import and to use this knowledge to ensure responsible and well informed management of the risks which the substances may present.

Manufacturers and importers shall address the risks of any use identified to them by their downstream users. A downstream user has the right not to identify a use, in which case he would have responsibility for performing a chemical safety assessment. Conversely, the manufacturer is not obliged to supply a substance for a use that he feels he cannot support. For purposes of enforcement as well as for reasons of transparency, the registration information is to be submitted to the authorities.

The Regulation exempts certain substances that are adequately regulated under other legislation or that generally present such low risks as not to require registration.

Registration requires submission of a technical dossier containing information on the substance and information on risk management measures, as well as - starting at 10 tonnes -the chemical safety report that documents the choice of these measures. The information requirement is modulated by tonnage, since this gives an indication of the potential for exposure. There are provisions on generation of information, which aim to ensure that it is of acceptable quality. To reduce costs for industry and authorities, it provides for joint submission of data.

For the registration of substances in articles, a special regime applies: in the interests of proportionality and, on the one hand, bearing in mind the millions of articles placed on the market in the EU and, on the other hand, the potential some of them may have to cause harm to human health and the environment, certain substances incorporated into articles have to be registered. This is required when the substance in question has hazardous properties and is intended to be released from the article. For substances that are released incidentally to the use of the article, a simple notification is required, on the basis of which the Agency may request a registration. The volume thresholds are as for any substance manufactured in, or imported into, the EU and apply per article type.

These requirements for certain substances in articles are necessary because of their potential impact on human health and the environment. It should be noted that no declaration of contents in articles is required from importers. The provisions place the same duties on importers and EU manufacturers of articles.

The enforcement activities of the authorities in regard to these provisions is largely expected to focus on cases where there is evidence that a substance released from articles is causing adverse effects on human health or the environment. Guidance will be developed by the Agency to assist producers and importers of articles, and the competent authorities, in implementing these provisions.

Polymers are exempted from the requirement to register. The Commission may introduce certain polymers into the requirement to register following a report on the risks posed by polymers in comparison with other substances and the need, if any, of registering certain types of polymers, taking account of competitiveness and innovation on the one hand and the protection of health and the environment on the other. A limited form of registration is required for certain isolated intermediates. A distinction is made between those intermediates that do not leave the site on which they are used, and those that are transported between sites under controlled conditions. In the latter case, where more than 1 000 tonnes are transported, as the risk of exposure is potentially slightly higher, more information is required.

There are a number of common provisions for all registrations, including the procedure for the Agency to manage registrations. Given that tens of thousands of registrations are expected, a simple completeness check will be performed. If the registration is not rejected within a set deadline, then industry may begin or continue to manufacture or import the substance.

In order to facilitate the transition to the Reach system, provisions are contained that phase in the registration requirements for substances that are already on the Community market. Finally, notifications under Directive 67/548/EEC are considered to be registrations, since such notifications provide a comparable level of information.

1.3. Data sharing and avoidance of unnecessary animal testing

A number of rules regarding data sharing are set out in order to reduce testing on vertebrate animals and to reduce costs to industry. Relevant data are to be shared, in exchange for payment. For phase-in substances, a system is established to help registrants to find other registrants with whom they can share data. They are then required to share data.

1.4. Information in the supply chain

The information through the supply chain provisions ensure that all users of substances have the information they need to use them safely. This requires information to be passed both up and down the supply chain, and between all actors in that supply chain. The primary tool for information transfer is the safety data sheet, as set out in Annex Ia. The Reach regulation replaces the current Safety Data Sheets Directive (91/155/EEC).

1.5. Downstream Users

These provisions oblige downstream users to consider the safety of their uses of substances, based primarily on information from their supplier, and to take appropriate risk management measures. They also allow authorities to have an overview of the uses of a substance as it moves through the supply chain and so can, if necessary, request further information and take appropriate measures.

For an identified use, a downstream user may use the risk management measures prepared by the manufacturer or importer but he must satisfy himself that the relevant exposure scenarios are consistent with his use and that he has implemented all the relevant risk management measures. Guidelines will be developed to ensure that this process is manageable, in particular for small and medium enterprises.

If a downstream user is using a substance in a way not covered by a manufacturer's or importer's chemical safety assessment (including incorporating it into an article) or if he intends to use different risk management measures, then he must send a short report to the Agency. This enables authorities to monitor the unidentified uses and could lead them to evaluate substances having unintended uses giving rise to concern.

Downstream users are not required to submit chemical safety assessments to the authorities because the administrative burden on both industry and authorities would be disproportionate. Furthermore this would require an obligation on downstream users to resubmit all updated safety assessments.

1.6. Evaluation

There are two types of evaluation:

- dossier evaluation which is twofold again:

- one aim is to prevent unnecessary animal testing. Therefore the regulation requires authorities to examine proposals for testing in order to check the quality before a test is performed and to prevent the same animal test to be performed repeatedly;

- furthermore, the regulation gives authorities the task to check compliance of registration dossiers with the requirements of the registration title;

- substance evaluation: provides a mechanism for an authority to require industry to obtain and submit more information in case of suspicion of a risk to human health or the environment.

To promote a consistent approach, the Agency will develop guidance on prioritisation of substances for evaluation. Member States then prepare rolling plans of the substances that they wish to evaluate. There is a procedure for resolving disagreements over which Member State should evaluate any substance.

When a draft decision is prepared by a Member State competent authority requiring further information on a substance, it must be accepted by other Member State competent authorities through a written procedure. The Agency is given responsibility for assuring the consistency of such decisions at the draft stage and takes those decisions when agreement is reached between Member States.

Evaluation may lead authorities to the conclusion that action should be taken under the restrictions or authorisation procedures in Reach, or that information should be passed to other authorities responsible for relevant legislation. The common feature of these regulatory activities is that they rely on good data. The evaluation process will ensure that such data is provided and made available to the relevant bodies by the Agency.

1.7. Authorisation

An authorisation system for uses of substances and the placing on the market of substances for such uses is established for the substances of very high concern. The substances selected for the authorisation system have hazardous properties of such high concern that it is essential to regulate them through a mechanism that ensures that the risks related to their use are assessed, weighed and then decided upon by the Community prior to actual use. This is justified because the effects of CMRs category 1 and 2 on humans are generally so serious and cannot normally be reversed so that such effects have to be prevented rather than remedied, and because PBTs/vPvBs accumulate in living organisms, so that accumulation would already have taken place and could not be reversed if regulatory action were only taken a posteriori. The same applies to the other substances of equivalent concern that may be made subject to authorisation on a case-by-case basis.

In line with the general Reach approach, the requirements for the applicants under the authorisation approach are risk-based, as he has to demonstrate that the risks related to the use of the substance concerned are adequately controlled or that they are outweighed by socio-economic benefits.

Thus, the authorisation provisions ensure that risks from the use of substances with properties of very high concern are either adequately controlled or authorised on socio-economic grounds, taking account of available information on alternative substances or processes, in which case the authorisations will normally be time-limited. Substances of very high concern are defined as: substances that are category 1 and 2 carcinogens or mutagens; substances that are toxic to the reproductive system of category 1 and 2; substances that are persistent, bioaccumulative and toxic or very persistent and very bioaccumulative; and substances such as endocrine disrupters which are demonstrated to be of equivalent concern.

The authorisation provisions require those using or making available substances with properties of very high concern to apply for an authorisation of each use within deadlines set by the Commission. Deadlines shall be set for a number of substances at a time. These are normally those that are considered to pose the greatest current risk, in accordance with the criteria identified in the text. The intent is that those selected should be those with the 'Highest Expected Regulatory Outcome' (Heros).

The burden of proof is placed on the applicant to demonstrate that the risk from the use is adequately controlled or that the socio-economic benefits outweigh the risks. Downstream users may use a substance for an authorised use provided they obtain the substance from a company for whom an authorisation has been granted and that they keep within the conditions of that authorisation. Such downstream users shall have to inform the Agency of this fact. This is so that the authorities are fully aware of how and where substances of very high concern are being used.

1.8. Restrictions

The restrictions provisions enable risk reduction measures to be introduced across the Community where this is shown to be necessary. The restrictions provisions act as a safety net for the whole Reach system as well as for the Community legislation as a whole because any substance on its own, in a preparation or in an article may be subject to Community-wide restrictions if a risk needs to be addressed.

Proposals for restrictions may consist of conditions for the manufacture, use(s) and/or placing on the market of a substance or of the prohibition of these activities if necessary. They shall be prepared by Member States or the Commission in form of a structured Dossier. This Dossier is required to demonstrate that there is a risk to human health or the environment that needs to be addressed at Community level and to explore the options for managing that risk.

The restrictions provisions are the result of a balance of the need to ensure that action is taken where required as rapidly as possible, to provide a sound scientific basis for any restriction and to enable all interested parties to participate in the procedure.

Up to now, Directive 76/769/EEC as amended approximated the laws governing the restrictions in the Member States.. The current restrictions are now taken over in a recast version as a starting point for the new restrictions procedure.

1.9. European Chemicals Agency

These provisions create the European Chemicals Agency (Agency) to manage the technical, scientific and administrative aspects of the Reach system, and ensuring consistency of decision making, at Community level.

The Agency manages the registration process, plays a key role in ensuring consistency of evaluation, provides criteria to guide Member States' selection of substances for evaluation and takes decisions requiring further information on substances under evaluation. It also provides opinions and recommendations in the authorisation and restriction procedures and has duties with regard to confidentiality.

In its White Paper on the strategy for a future chemicals policy, the Commission proposed to create a central entity to administer the Reach system and provide scientific and technical support. It also proposed a feasibility study on this entity. This study considered two main options for the structure of the entity: an enlarged European Chemicals Bureau (ECB) within the Commission's Joint Research Centre and an independent central agency. The study concluded that an independent central agency offered a number of advantages over an enlarged ECB.

The first advantage of the Agency is that it can use income from fees to fund staff posts whereas an enlarged ECB could not. The ECB would have to receive the fees into a dedicated line in part B of the Community budget. The other advantages are set out in the White Paper on European Governance [2], which notes that regulatory agencies:

[2] COM(2001) 428 final, 25.7.2001.

- improve the way rules are applied and enforced across the Union. The work of the Committees, the Secretariat and the Forum will meet this goal,

- increase the visibility for the sector concerned. The existence of a separate, independent body provides a clear focus for discussions and so raises the profile of the sector,

- have an advantage in drawing on highly technical sectoral know-how. The Agency, in particular the Committees, the Secretariat and the Forum, provide a structure to use this know-how,

- offer cost savings to business. The Agency has a clearly defined role and so can focus on developing the most cost-effective methods and so limit the fees charged to industry,

- allow the Commission to focus on its core tasks. The task of the Agency is the technical implementation of Reach and this is not appropriate for a Commission service.

The main advantage of an enlarged ECB would be short-term continuity. However, this alone does not outweigh the advantages of an independent Agency which will operate in the long-term. Accordingly, the Agency option was chosen.

In designing the structure of the new Agency, the Commission considered the experience with existing agencies in other fields, in particular those in related fields. It also followed the principles set out in its recent Communication [3] on the operating framework for European Regulatory Agencies. The European Agency for the Evaluation of Medicinal Products (Emea) provided the most useful model because it is the regulatory agency whose role is closest to that of the proposed chemicals Agency, in that it deals with a continuous stream of products requiring evaluation and that there are established Member States' competent authorities (CAs). The European Food Safety Authority (Efsa) model has provided some useful elements for this proposal but it differs from the proposed chemicals Agency in that a significant part of its role is to deal with specific problems as they arise and in an area where not all Member States have long-standing national authorities. A number of new elements have also been developed to address the specific nature of the chemicals sector.

[3] COM(2002) 718 final, 11.12.2002.

The Agency will be the public face of the new Reach system and will be a key player in ensuring that the system has credibility with all stakeholders and the public.

The Agency will comprise the following elements:

- a Management Board of 15 members,

- an Executive Director, reporting to the Management Board,

- a Committee on risk assessment, a Committee on socio-economic analysis and a Member State Committee. These Committees may be asked to provide opinions under the evaluation, authorisation and restriction procedures. Each Member State may nominate a member to each Committee,

- a Forum for exchange of information on enforcement activities. This Forum implements the White Paper proposal to create a network of enforcement authorities. The tasks of the Forum are essentially a continuation of those previously undertaken by an informal network of Member States authorities. Work in this area would benefit from operating in a more formal framework. Each Member State shall nominate a member to the Forum,

- a Secretariat that will provide technical, scientific and administrative support for the Committees. It will also undertake a number of tasks without reference to the Committees. Involving the Committees would overburden them and would provide no added value,

- a Board of Appeal that will consider any appeals against the decisions of the Agency.

Accession countries, on joining the European Union, will be represented on the Management Board, Committees and Forum on the same basis as existing Member States.

1.10. Classification and Labelling Inventory

The provisions for a classification and labelling inventory ensure that classifications (and consequent labelling) of all dangerous substances manufactured in, or imported into, the EU are available to all to ensure the smooth running of the Reach system. Industry will be required to include all its classifications on the inventory. Any divergences between classifications of the same substance should be removed over time either through co-operation between notifiers and registrants or by EU harmonisation. EU harmonised classifications will only be required for the following properties: Substances that are category 1, 2, and 3 carcinogens, mutagens or toxic to the reproductive system; or respiratory sensitisers.

1.11. Information

These provisions ensure non-confidential information on chemicals is available, for example to allow those exposed to chemicals to make decisions on the acceptability of the related risks. This is done in such a way that the interests of the public's 'right to know' is balanced with the need to keep certain information confidential.

1.12. Competent authorities

These provisions require that there are authorities in each of the Member States with the competence and resources necessary to fulfil the tasks allocated to them.

1.13. Enforcement

These provisions ensure that all Member States take a broadly common approach to enforcement of the Regulation.

1.14. Transitional and final provisions

These provisions ensure that the Regulation enters into force in a practical and effective way. The provisions ensure a smooth start-up as well as introducing the provisions of the Regulation in such a way that the current levels of protection are not reduced.

2. Content of the Regulation

2.1. General Issues

Article 1 - Subject matter

This sets out the purpose of this Regulation, namely to ensure the effective functioning of the common market for chemical substances, whilst ensuring that human health and the environment are not adversely affected by the manufacture or use of chemicals under reasonably foreseeable conditions. This Regulation is underpinned by the precautionary principle whose conditions of application are outlined in the Communication from the Commission on the precautionary principle (COM(2000) 1 final).

Article 2 - Scope

Radioactive substances are excluded from the scope because they are addressed by other legislation. Substances under customs supervision which are in temporary storage, in free zones or free warehouses with a view to re-exportation or in transit are not used within the meaning of Reach and so are also excluded. Non-isolated intermediates are not within the scope. Reach provides information on substances that will support the operation of worker protection and transport legislation, which operate unchanged.

Article 3 - Definitions

The essential terms in this Regulation are defined.

2.2. Registration of substances

Article 4 - Scope

This Article exempts substances in applications for which other legislation requires adequate information. Substances listed in Annex II are exempted as their properties and risks are considered to be adequately well known. This follows historical precedent in existing EU legislation. Most of the categories of substance in Annex III are exempted because their risks will be addressed through the assessment of other registered substances. Registered substances which have been exported from the Community and which are subsequently re-imported (e.g. in preparations) are exempted from registration provided that the re-importer possesses the information for the management of the risks as required by the Regulation. Finally, information is required for certain intermediates. This is addressed in Chapter 4.

Article 5 - General obligation to register substances on their own or in preparations

This Article lays down the basic obligation to submit a registration to the Agency as the central receiving authority in the Community. The obligation is imposed for manufacturers and importers established within the Community who manufacture or import a substance in quantities starting at 1 tonne per year. Below this quantity, there is no requirement to submit information, in view of the more limited potential for exposure and the workability of the system. Creating a manufacture-based system eliminates current problems with the re-import of notified substances and assists worker protection. Monomers have to be registered as any other substance, even if they are used as intermediates, and it is clarified that the lighter rules on intermediates do not apply to them. This is necessary because the polymers resulting from their use as intermediates are not subject to registration. Moreover, this article requires the registration of certain monomers and other substances, which are not yet registered and are present in proportions of more than 2% in polymers.

Article 6 - General obligation to register substances in articles

This Article places a duty on producers and importers of articles to register the substances incorporated in them if they meet the criteria for classification as dangerous, are intended to be released during normal and reasonably foreseeable conditions of use, and are present in the article type in quantities of 1 tonne or more per year. The registration requirements will follow those for the different thresholds as laid out in Article 9.

Manufacturers or importers shall also notify the Agency of certain specified information if substances contained in articles meet the criteria for classification as dangerous, are known to be released during normal and reasonably foreseeable conditions of use even though this is not an intended function of the article in quantities that may adversely affect human health or the environment, and are present in the article type in quantities of 1 tonne or more per year. The Agency shall be able to require the producers and importers concerned to register such notified substances.

To assist enforcement authorities, including customs authorities in the implementation of this Article and to promote consistency, express provision is made for further legislation to be developed.

Article 7 - Exemption from the general obligation to register for product and process orientated research and development (Ppord)

To promote innovation, substances used for product and process orientated research and development (Ppord) are exempted. This exemption shall be for up to 5 years and apply to the quantity of substance being used for Ppord and a limited number of listed customers. Certain information has to be provided to the Agency. The Agency shall be responsible for checking the information provided as well as imposing any relevant conditions. The exemption period may be extended by the Agency for up to a further 5 years upon application as long as this can be justified by the programme of research and development. In the case of development of medicinal products, extension is possible for up to 10 years. Competent Authorities in Member States in which the manufacture, import or Ppord takes place shall be provided with all information submitted in notifying a request for a Ppord exemption. The Agency shall take into account the views of the Competent Authorities concerned when making decisions on Ppord exemptions or extensions.

There is no need for a separate explicit exemption for scientific research and development below one tonne per year because production, import and use of substances, including for such purposes, up to a volume of one tonne per year is already outside the scope of the registration obligation.

Article 8 - Substances in plant protection and biocidal products

These substances are deemed registered only in as afar as they are used for biocides and plant protection products because the relevant legislation requires the submission of substantial information. Downstream users, who employ these substances as biocides or plant protection products are deemed to be making an identified use within the meaning of Reach. However, if a downstream user makes another, unidentified, use of such a substance, he shall report this use and can use the information supplied to him to prepare his chemical safety assessment.

Article 9 - Information to be submitted for general registration purposes

Information is required on the identity of the registrant, the identity of the substance, and its intrinsic properties. A chemical safety report (CSR), including details of risk management measures, is required for registrations of substances manufactured or imported in quantities starting at 10 tonnes per year by a manufacturer or importer.

Annexes IV to IX set out the requirements for generating information on the substance to be registered. Further details of these annexes are given below.

Article 10 - Joint submission of data by members of consortia

To reduce costs for industry and authorities, joint submission of data is encouraged. The reduced fee balances encouragement of joint submission with the need to ensure adequate income for the operation of the Agency.

Article 11 - Information to be submitted depending on tonnage

The information requirements are tiered, since the potential exposure increases with volume. The requirements of paragraph 2 ensure that information available to authorities is up to date and apply as soon as a higher tonnage threshold is crossed.

The information required at the different tonnages balances the costs of developing such information and the impact on industry with the benefits to human health and the environment likely to accrue from this information.

Article 133(3) provides that the information at the 1 to 10 tonne level will be reviewed as part of the first review of the operation of this Regulation, 6 years after the establishment of the Agency. As a result of the review the Commission may, through a Committee procedure, modify these information requirements. It is recognised that considerable work is currently under way to develop alternative approaches to identifying the information required for registrations. For example, in vitro methods and the use of (quantitative) structure activity relationships ((Q)SARs). The development of such approaches shall also be taken into account in any proposals to modify the information requirements for 1 to 10 tonne registrations.

Article 12 - General requirements for generation of information on intrinsic properties of substances

This Article lays down the basic rules for generating information, whether by testing, (Q)SARs or other means. The test methods set out in Annex X have been approved for use under current legislation and so are carried over to Reach. Other methods may be used if the registrant can justify their suitability. This is especially important in the case of data generated before the entry into force of the legislation, for example for existing substances or for substances that were already manufactured or marketed outside the Community. Any new testing is required to adhere to good laboratory practice to ensure the quality of the information and to the legislation on the protection of animals used for experimental and other scientific purposes.

The article also requires registrants wishing to refer to data already submitted to the Agency to demonstrate that they have the agreement of the owner of those data.

Article 13 - Chemical safety report and duty to apply and recommend risk reduction measures

The chemical safety report (CSR) details a chemical safety assessment (CSA). This is a risk assessment in which the registrant takes account of the risk management measures that he either implements himself for his own uses or proposes to downstream users for their uses. The uses addressed in the registrant's CSA are known as identified uses. This is not the classic model of risk assessment as understood by persons involved in chemicals' regulation today. The terms "chemical safety report" and "chemical safety assessment" are chosen to make this change clear.

In the interests of proportionality, CSRs are not required for registrations of substances manufactured or imported in quantities of less than 10 tonnes per year by a manufacturer or importer, on-site isolated intermediates, or transported isolated intermediates. Article 133(1) empowers the Commission to review the application of the requirement to substances in those quantities 12 years after the Regulation enters into force.

A registrant's CSA shall address all uses identified to the registrant by his downstream users, unless he chooses not to supply the substance for that use. This requirement ensures that those creating or importing substances cannot shift responsibility for assessing the safe management of a substance onto downstream users, who may be ill-equipped to deal with it. It also facilitates the work of authorities.

Certain uses do not need to be addressed in the CSA as they are adequately addressed by other EU legislation.

A CSA does not need to be conducted if the concentration of the substance in a preparation is below defined concentration limits because below these concentration limits the substance is considered not to pose a significant risk to human health and the environment. A CSA only needs to consider the steps of exposure assessment and risk characterisation if the substance meets the criteria for classification as dangerous or is assessed to be a PBT or vPvB. This is because it is only in these cases that there is a significant risk to human health or the environment.

Article 14 - Polymers

In view of the potentially large number of polymer registrations and given that most of them pose a limited risk because of their nature, polymers are exempted from registration for reasons of workability, and to focus resources on substances of more concern. However, the Commission is committed to considering how polymers should be addressed in Reach in the future. Before any proposal for introducing certain polymers into the requirement to register is made the Commission shall prepare a report looking at the risks of polymers in comparison with other substances and whether, considering the balance between protecting human health and the environment and ensuring competitiveness and innovation on the other, certain types of polymers should be registered.

Articles 15 and 16 - Registration of on site and transported isolated intermediates

For reasons of workability and to focus resources on substances of more concern, these articles introduce limited registration requirements for certain isolated intermediates. Non-isolated intermediates are excluded from Reach.

A distinction is made between isolated intermediates that remain on site, and those that are transported to other sites under controlled conditions. For the latter type of intermediate, where more than 1000 tonnes per manufacturer per year are transported, more data is required as the risk of exposure is potentially higher.

Article 17 - Joint submission of data by participants of consortia

See Article 10 for explanation.

Article 18 - Duties of the Agency

This Article defines the processing of registrations submitted and the role of the Agency at the registration stage of Reach. Registrations will be submitted and handled electronically in order to facilitate the management of many thousands of registrations. The Agency is the central receiving authority for all registrations. It assigns to each of them a registration number and date and will perform a completeness check which, again in view of the large number of registrations to be handled, is essentially an automated process. Having the Agency perform the completeness check ensures the necessary consistency of approach at the registration stage. The Agency shall let the registrant know if the registration is incomplete and, if so, the information needed and a deadline to complete the registration. The result of the completeness check will be referred to the Member State Competent Authority in which the manufacturer or importer is established. The Agency does not explicitly accept registrations because registration is not an approval system.

Article 19 - Manufacturing and import of substances

This Article prohibits the manufacture or import of substances that have not been registered in accordance with the registration provisions. It permits the manufacture or import of a substance 3 weeks after the registration date, unless the Agency indicates otherwise. If the Agency requests further information, manufacture or import of a substance is permitted 3 weeks after this further information is submitted unless the Agency indicates otherwise. The deadline is chosen to allow time for a completeness check. If a manufacturer or importer is acting as the lead in a consortium the other members of the consortium are not allowed to manufacture or import the substance until the deadlines have passed for the 'lead' registrant.

A longer deadline is not needed for this purpose as the completeness check is largely automated and would unnecessarily delay the manufacture or import of new substances.

Article 20 - Further duties of registrants

This Article places a duty on the registrant to inform the Agency of any changes in certain elements of his registration. It ensures that the authorities receive the latest information on safety of chemicals, while not requiring updates for minor changes. The obligation to report significant changes in manufactured or imported volumes provides essential information for the development of a chemicals indicator and keeps the information in the database up-to-date. Significant new knowledge of risks of the substance is such as would lead to changes in the chemical safety assessment.

Article 21 - Specific provisions for phase-in substances

This Article phases the vast majority of substances currently being manufactured or marketed into the registration system. The deadlines are chosen, bearing in mind the large number of phase-in substances, to ensure that the process is manageable for both industry and authorities. The registration process for phase-in substances starts with substances manufactured or imported in high volumes, given the high potential exposure, and substances with properties of very high concern.

Article 22 - Notified substances

Because the notification requirements under Directive 67/548/EEC are substantially similar to those for registration, this article provides that previously notified substances shall be deemed registered. Such registrations will have to be updated as for any other registration. It is intended that the Agency will assure the transfer of the notified data to its central database. If such substances subsequently exceed the next higher tonnage threshold of Article 9, then full information will be required as for any other substance, including information not yet submitted for the lower tonnage threshold.

2.3. Data sharing and avoidance of unnecessary testing

Article 23 - Objectives and general rules

This Article sets out the general principles for sharing data and ensuring that unnecessary animal testing is avoided. Paragraph 2 ensures that there are no concerns under Community competition rules. Paragraph 3 allows the Agency to make data that have been in the possession of the Agency for at least 10 years, freely available to others for the purposes of registration.

Article 24 - Duty to inquire prior to registration

This Article allows potential registrants of a substance that they have not manufactured or placed on the market at the moment that the Reach system enters into force to obtain data from previous registrants of that substance. Payment for data is required within ten years of the first registration that contains the relevant data, since this is the period when an innovative registrant has most to gain from marketing his substance.

Article 25 - Sharing of existing data involving tests on vertebrate animals between registrants

Registrants are encouraged to reach agreement on data sharing directly or via an arbitration board. However, given the importance of animal protection, the Agency is empowered to make the information available to the subsequent registrant if no deal has been reached. The subsequent registrant is expected to pay an equal share of the costs incurred. If necessary the first registrant can make a claim through the national courts for such an equal share of the costs they incurred in generating the information from the subsequent registrant.

Article 26 - Duty to pre-register for phase-in substances

Registrants wishing to use the phase-in provisions in the registration chapter are required to pre-register information on their substances so as to permit sharing of data that is already available. The provision enables manufacturers and importers of substances in quantities of less than 1 tonne to voluntarily contribute to the sharing of data.

Article 27 - Substance Information Exchange Fora

This Article creates a substance information exchange forum (Sief) composed of all those who have pre-registered the same substance and imposes duties on its participants in order to avoid duplicate animal testing.

Article 28 - Communication within the Sief prior to registration

This Article sets out the steps to be taken by participants of a Sief to fulfil their duties. Note that the provisions in paragraph 2 are presented only to clarify what actions other participants in the Sief may take if an owner of a study refuses to provide information. The owner of the study will be in breach of his obligations and will be subject to sanctions. If the owner of a study has already submitted his registration containing the study, the Agency will make it available to other participants of the Sief.

2.4. Information in the Supply Chain

Article 29 - Requirements for safety data sheets

This Article explains that the safety data sheet (SDS) is the instrument for conveying the relevant information from manufacturer, importer or downstream user down the supply chain. SDS are the best instrument to do this because they are now well known and understood by all actors in the supply chain and to require a new instrument would increase costs for little benefit to human health and the environment. The current duties and responsibilities for SDS remain and will be extended by the requirement to convey information from any relevant chemical safety assessment.

It is recognised that to prepare an SDS for a preparation containing many registered substances could be a complicated exercise. The option is therefore open for those preparing SDS for a preparation to carry out a CSA for the preparation as a whole and for the SDS to reflect this CSA rather than the individual CSAs for all registered components of the preparation.

The 16 headings required for SDS are consistent with those agreed in the Globally Harmonised System for the Classification and Labelling of Dangerous Chemicals (GHS). If a CSA was performed, the relevant exposure scenarios examined there provide useful and adequately structured information for others in the supply chain. It is therefore foreseen that they be placed in an annex to the SDS.

Article 30 - Duty to communicate information down the supply chain for substances and preparations for which a safety data sheet is not required

Downstream users and distributors need certain information on substances even if a SDS is not required so that they can take any necessary action. For example, requesting details of the registration of the substance, ensuring that their use complies with any authorisation or restriction. This information needs to be updated in a timely manner so that any appropriate action can be taken as a result.

Article 31 - Duty to communicate information on substances and preparations up the supply chain

This Article specifies the information that must be passed up the supply chain. Information is passed up the supply chain so that identified risk reduction measures can be refined if necessary. For example, this might be exposure information, additional information on the effects of a substance, or information on how the risk reduction measures work in practice.

The system set out in the Regulation will be at its most effective if information is supplied along the length of the supply chain and in both directions.

Article 32 - Access to the safety data sheet information for workers

The information in SDS and that communicated under Article 30 when an SDS is not required shall be made available to workers and their representatives. Making SDS available to workers and their representatives is consistent with the GHS.

Article 33 - Obligation to keep information

This requires all actors in the supply chain to keep all the information generated under the Regulation and make it available as requested. This information should be kept together so that authorities can have ready and immediate access to it so that any action to help protect human health and the environment can be taken quickly and to ensure that all relevant information is available when decisions are being taken under other parts of the system (e.g. evaluation, restrictions, authorisation).

2.5 Downstream Users

Article 34 - Downstream user chemical safety assessments and duty to apply and recommend risk reduction measures

The system for registration and in particular CSAs has been constructed in such a way that manufacturers and importers cannot pass down to downstream users responsibility for preparing CSAs if the downstream user does not wish them to do so. Downstream users are of course free to assist their suppliers in the preparation of a registration and this possibility is expressly laid down in the text. Moreover, if the downstream user wants the supplier's CSA to address their uses he should tell them in writing. This act makes the downstream user's use an identified use and must therefore be covered, as long as sufficient notice is given, in the manufacturer's or importer's CSA.

Downstream users must prepare chemical safety reports in accordance with Annex XI for uses outside the conditions described in an exposure scenario included in the SDS supplied to them. This provision enables downstream users to keep their use(s) confidential from their supplier if they should wish to do so. However, downstream users need not prepare a chemical safety report:

- if they take more thorough risk management measures than those recommended by their supplier, as in this case, there is no real added value to be gained from an obligation to prepare a chemical safety report, nor

- for non-hazardous substances, nor

- in cases where their supplier would not have had to prepare a chemical safety report.

Downstream users must apply the risk reduction measures identified in the SDS for identified uses and identified in their CSA for unidentified uses. Information on risk reduction measures identified in the SDS for identified uses or identified in the downstream user's CSA for unidentified uses must be passed on as relevant to their downstream users so that they, in turn, can apply the identified risk reduction measures or, if their use is not covered, conduct their own CSA.

Article 35 - Obligation for downstream users to report information

If his downstream use is outside the conditions described in the exposure scenario included in an SDS communicated to him, the downstream user must report the use to the Agency.

The scope of the report is limited so as to minimise the burden on industry and on authorities. It is sufficient, however, to allow authorities to decide whether to take further action under, for example, the evaluation or restrictions provisions or to take enforcement action. A report may, in some exceptional cases, contain proposals for testing. If such tests were drawn from Annexes VII or VIII the authorities would subject them to a dossier evaluation.

A downstream user may, through conducting a CSA or otherwise, conclude that the classification and labelling for a substance is different to that given to them by their supplier. This fact must be reported to the Agency.

A pre-defined format for reports is used to help downstream users to meet their obligations and to permit the Agency to handle efficiently the downstream user reports.

Updating of reports ensures that the Agency and hence Member States Competent Authorities are always aware of the latest relevant information on the use of a substance and so can, where necessary, take appropriate action.

Downstream users do not have to report if they are using a substance in quantities of less than 1 tonne.

Article 36 - Application of downstream user obligations

Downstream users will receive information on the safe use of their substances through safety data sheets provided by their suppliers. They should also already have performed a risk assessment for worker protection in accordance with Directive 98/24/EC. Nevertheless it is prudent to delay the application of the provisions of Article 35 to allow time for new safety information to flow down the supply chain and for downstream users to complete and update their risk or chemical safety assessments, if required. Application of the provisions of Article 36 is delayed until after a substance is registered, to avoid unnecessary reporting.

2.6. Evaluation of substances

Article 37 - Scope

Since polymers are exempted from registration, they are also exempted from evaluation. However, this exemption is also subject to the review foreseen in Article 133(3) and may be adapted accordingly.

Article 38 - Competent Authority

This Article sets out how the evaluating Member State competent authority is identified.

For dossier evaluations this shall be the competent authority of the Member State in which the manufacture takes place or the importer is established. This is because the dossiers are examined individually anyway and it avoids language and communication problems. In the case of consortia, the competent authority of the Member State in charge of the dossier of the 'leader' is the competent authority for evaluation.

For substance evaluations a different rule applies: Member States are required to establish evaluation rolling plans covering three years and listing the substances they intend to evaluate. This is to enable Member States to plan for and assign resources to substance evaluation. A specific allocation mechanism is foreseen for the event that more than one Member State plans to evaluate the same substance, to avoid duplication of work and encourage swift evaluation of the substance concerned. A factor taken into account when applying this mechanism is each Member State's proportion of the total Community gross domestic product.

Article 39 - Examination of testing proposals

This article requires the evaluating authority to perform a dossier evaluation of all proposals for testing to fulfil the information requirements in Annexes VII and VIII. These Annexes are chosen because they contain the tests that are the most expensive and require the greatest number of vertebrate animals to be used. It is therefore important for animal welfare reasons that the authorities are convinced that such testing is appropriate. Furthermore experience with present legislation has shown there is rarely any disagreement between industry and authorities over whether to perform the animal tests now contained in Annex V and VI.

Downstream users may make proposals for testing if their use is not an identified use and not therefore covered by the information in the safety data sheet.

If the authority agrees with a proposal, it drafts a decision requiring the test to be carried out and setting a deadline. This is so that the obligations on the registrant are clear and other authorities will know when the data will be available.

Article 40 - Compliance check of registrations

A competent authority may check that any registration it is responsible for is in compliance with the Registration requirements. If not, the competent authority may prepare a draft decision requiring the registrant to supply the missing information. Information is missing when no data was submitted or when the data submitted was insufficient.

Article 41 - Check of information submitted and follow-up to dossier evaluation

Once any additional information required under Articles 39 and 40 has been submitted the competent authority shall examine the registration and additional information and draft a further decision if yet further information is required.

Once a dossier has been evaluated the competent authority may decide that further action should be taken to manage the substance in question. This may mean proposing action under Authorisation or Restrictions or by referring relevant information to the authorities responsible for other legislation.

Article 42 - Procedure and time periods for examination of testing proposals

This Article sets a deadline of 120 days for completing dossier evaluations of testing proposals for non phase-in substances. This is to ensure that industry receives permission to perform any testing and so can collect all relevant information within the deadlines foreseen. It also sets deadlines for performing dossier evaluations of testing proposals for phase-in substances in order to make the operation of the system more predictable and transparent for all stakeholders.

It gives precedence to evaluations of testing proposals in view of the need to meet the deadlines set and reflecting the importance of animal protection.

Article 43 - Procedure and time periods for compliance check

A competent authority shall have a maximum of 12 months to complete a compliance check once started, including preparing a draft decision.

Article 44 - Request for further information

This Article enables the responsible competent authority to draft a decision requiring further information to clarify whether a substance presents a particular risk to human health or the environment. For example, the substance may appear to be similar to another that has particular properties that have not been identified yet for the substance in question.

A competent authority shall have a maximum of 12 months to complete a substance evaluation, including preparing a draft decision.

Article 45 - Coherence with other activities

To ensure consistency of decision-making, an evaluation must take account any previous evaluation of the substance. Any decisions under evaluation requiring further information on a substance previously evaluated can only be justified if further information has become available or circumstances have changed.

Article 46 - Check of information submitted and follow-up to substance evaluation

Once any additional information required under Article 44 has been submitted the competent authority shall examine the registration(s) and additional information and draft a further decision if yet further information is required.

Once a dossier has been evaluated the competent authority may decide that further action should be taken to manage the substance in question. This may mean taking action under Authorisation or Restrictions or by referring relevant information to the authorities responsible for other legislation.

Article 47 - Further information on on site isolated intermediates

For reasons of workability, this article excludes isolated intermediates on site from dossier and substance evaluation. However, Member States may ask for additional information and take necessary action on such a substance if they can demonstrate that its use gives rise to a risk equivalent to the level of concern arising from the use of substances subject to authorisation.

Article 48 - Registrants' rights

Registrants or downstream users potentially affected by an evaluation decision shall have the right to comment on the draft decisions being prepared by a competent authority and to have those comments taken into account.

In normal circumstances a registrant shall not be responsible for producing the additional information required by evaluation if they have either stopped the manufacture or import of the substance, and informed the Agency that this is the case, or if they decide to stop manufacturing or importing the substance in light of the additional information requirements as a result of evaluation, and again have informed the Agency that this is the case. Only if there is a potential long-term risk to man or the environment and the registrant in question is responsible for contributing significantly to the exposure to that substance shall the registrant be responsible for providing the additional information. This is to avoid, in all but the most extreme cases, registrants being retrospectively liable.

Article 49 - Adoption of decisions under evaluation

This Article creates a procedure for securing agreement on evaluation decisions among Member State competent authorities before such decisions are taken by the Agency, without the necessity for a time consuming and resource intensive comitology procedure in every case. In case of disagreement, the Agency's Member State Committee provides a technical forum to resolve differences, again without the need for comitology. The Executive Director of the Agency is given the right to initiate this procedure in order to ensure consistent decision-making. Any Member State can require that a decision be taken by comitology.

Article 50 - Cost sharing in case of performance of tests involving vertebrate animals without an agreement reached between registrants

In the interests of animal welfare it is essential to ensure that information is shared. The quid pro quo is that costs are also shared. This article ensures the sharing of costs and information when additional information is required under evaluation. An arbitration board may be used to decide on claims for remuneration. If agreement cannot be reached on cost sharing then national courts shall make a decision.

Article 51 - Obligations for Member States to report to the Agency

In the interests of ensuring that the burden is fairly shared, every Member State shall prepare a report annually on the evaluations of testing proposals conducted over the previous year.

2.7. Authorisation

Article 52 - Aim of authorisation

The aim of the authorisation system is to ensure the good functioning of the internal market and that the substances of very high concern are used either in a way where the risks are adequately controlled or are replaced by suitable alternative substances or technologies. The reasoning behind this aim is explained above, under section 1.7.

Article 53 - General provisions

This Article specifies that substances included in Annex XIII can only be used and placed on the market by those companies who have been granted an authorisation and their customers, for the particular uses authorised, and in accordance with any conditions set in that authorisation, unless a specific use of that substance has been exempt from the authorisation requirement.

Substances of very high concern subject to authorisation but which are yet not on Annex XIII may continue to be used as long as they fulfil the other requirements placed on them under the Regulation and other applicable legislation.

The authorisation process shall not apply to the use of substances in preparations where the substance is not present in sufficient concentration for the preparation itself to be classified as having one of the properties that make substances on their own subject to authorisation. It shall also not apply to PBT or vPvB substances present in concentrations below 0.1%, this limit being the same as for CMR substances.

To help encourage innovation, the authorisation process shall not apply to substances being used solely for scientific research and development purposes or for product and process-orientated research and development purposes in quantities under 1 tonne.

Certain uses of substances are not subject to authorisation because their human health and environmental effects are considered to be addressed by equivalent Community legislation. It would be unreasonable to subject such uses to two systems with the cost and resources this would imply. The Commission will propose a modification of the legislation on medicinal products for human use and veterinary use respectively to address risks related to the environment. This will be part of the benefit/risk assessment which has to be positive as a prerequisite for approval of the medicinal product.

However uses in cosmetic products and in food contact materials addressed by Community legislation only consider human health impacts. Whilst these impacts do not need to be considered again, if a substance for these uses is identified as a PBT, vPvB or of equivalent concern to the environment it shall be subject to authorisation for those effects because the environmental impact has not been considered previously.

Article 54 - Substances to be included in Annex XIII

This specifies the properties of substances that make them subject to the authorisation process. Clear and objective criteria are available for the identification of substances that are category 1 and 2 carcinogens, mutagens, toxic to the reproductive system, and for some PBTs and vPvBs. However, some PBTs, vPvBs are not possible to identify through the application of the numeric criteria in the Regulation. Some substances of equivalent concern are also not possible to identify through objective criteria, although some endocrine disrupters will have already been identified through the CMR criteria. If these can be identified through other scientific or technical evidence on a case-by-case basis and are considered to be of an equivalent level of concern as regards their effects on human health or the environment to those identified through application of the objective criteria, they shall also be subject to the authorisation process. PBTs, vPvBs, and other substances considered to be of equivalent concern (e.g. some endocrine disrupters), shall be identified on a case-by-case basis following the process described in Article 56.

Persistent organic pollutants (POPs), as a sub-set of vPvBs, are subject to authorisation. However, the Stockholm Convention requires prescribed restrictions to be put in place for particular POPs. The application of prescribed restrictions for particular POPs is incompatible with the authorisation process; a company would not apply for authorisation for a use they know will not be granted. These POPs will therefore be subject to restrictions under the restrictions process to ensure that the Community meets its obligations under the Stockholm Convention and the United Nations Economic Committee for Europe (Unece).

Article 55 - Inclusion of substances into Annex XIII

This Article specifies what information has to be included in Annex XIII when a substance is included: first of all the identity of the substance as well as its properties that make it subject to the system. As it could be expected that very few, if any, new substances having these properties would be placed on the market, most of the substances with these properties of very high concern have already been used. Therefore, transitional arrangements are necessary for those substances that are already on the market at the moment when a substance is included in the Annex, in order not to force companies to interrupt their business until an authorisation can be granted to them. The Annex therefore specifies a 'sunset date' and a deadline. The 'sunset date' is the date by which unauthorised uses shall be prohibited. This is required so that authorities and applicants can plan, knowing when a decision should be reached. The deadline is the date by which applications for continued use of the substance must be received. Again this gives certainty to applicants in planning the preparation of their application and to authorities in planning the work necessary to process an application. If applications for authorisation are received by the deadline given, the uses concerned may be continued until a decision is taken even if this is after the 'sunset date'. This is to ensure that concerns do not have uses prohibited by default if the authorities have not taken a decision.

Certain uses may be exempted from the requirement to be authorised. Such a decision needs for example to take account of the application of other EU legislation to the use in question and whether the use is sufficiently controlled so ensuring that the risks to human health and the environment are adequately controlled. This would allow the authorisation process to concentrate on the uses of substances that are likely to pose the greatest risk rather than devoting resources to considering uses that are known to be adequately controlled and corresponds to the principle of proportionality. If as a result of the Reach system or of developing Community legislation, further uses are justified to be exempt from the authorisation requirement, such exempted uses can be added to the Annexes at a later stage in accordance with Article 130.

Whilst the authorisation process is designed to address substances of very high concern some will still be of higher concern than others. This shall address primarily substances with the 'highest expected regulatory outcome' (Hero), i.e. the control will have a greater impact on the protection of human health and the environment. The Agency shall prepare a draft list of priority substances for inclusion on Annex XIII so that there is a technical basis for a political decision taken by the Member States. Priority shall be given to substances with PBT or vPvB properties, wide dispersive use or high volumes. Third parties are given the opportunity to comment on the draft list. This list and the final list agreed through the regulatory procedure shall take account of the resources available for considering applications for authorisation. If the list includes too many substances and/or the deadlines are too short the system will not be able to cope. There is therefore no benefit in placing more substances on Annex XIII than can reasonably be dealt with.

Prior to being placed on Annex XIII any substance subject to authorisation may be subject to the restrictions process as there may be risks that need to be addressed at Community level in advance of any authorisation decision. However once substances are placed on Annex XIII they may not be subject to the restrictions process, addressing the risks to human health and the environment from the intrinsic properties set out in Article 54. If certain uses of these substances need not be authorised, conditions for such uses shall be added in Annex XIII when these uses are exempt from the authorisation requirement. However, substances for which all uses are prohibited, shall be banned under the general restrictions in Title VIII. An example for this are POPs. These may have been subject to authorisation but under the terms of the Stockholm Convention these may, once added to the list of POPs, need mostly be banned or otherwise restricted. This shall be carried out through the restrictions process.

Article 56 - Identification of substances referred to in Article 54 (d), (e) and (f)

This sets out the process by which PBTs, vPvBs and other substances which are considered on a case by case basis to have equivalent levels of concern as regards their effects on human health or the environment (e.g. some endocrine disrupters) shall be identified and agreed at Community level before they can be included in Annex XIII. The proposal shall be presented by a Member State in the form of a Dossier (see Annex XIV).

Article 57 - The granting of authorisations

The Commission shall be responsible for the granting or refusing of authorisations. The authorisation application and decision shall not address risks to human health and/or the environment of emissions of the substance from an installation for which a permit was granted in accordance with the IPPC Directive (Directive 96/61/EC) or from a point source governed by requirement for prior regulation under the Water Framework Directive (Directive 2000/60/EC) or arising from the use in a medical device as these emissions are adequately controlled under other Community instruments which are applied by the Member States. Therefore, this is necessary not to interfere with such other competences and to avoid differences between the decisions taken under different regulatory regimes as well as the resources in examining an impact twice.

Authorisations shall be granted if the risk to human health and the environment posed by a use is adequately controlled. A description of the notion of adequate control is given in section 6 of Annex I. If the risk is not considered to be adequately controlled, an authorisation may be granted if socio-economic benefits outweigh the risk to human health and the environment and if there are no suitable alternative substances or technologies. In this case alternatives will be carefully analysed. If the use posed a high risk and a reasonable alternative (taking into account cost, availability, and efficacy) were available this will be a key consideration in making an authorisation decision.

Authorisations granted have to specify whom the authorisation is given to, the substance and use authorised as well as any conditions that apply. This is important for the holder of the authorisation and also for their downstream users who would have to abide by the conditions of the authorisation. Authorisations may be subject to a review period and/or monitoring requirements. Review periods for authorisations may be established, for example, because of the use, the potential availability of an economic substitute, or the type of substance may make it inappropriate to grant an indefinite authorisation. Authorisations granted for socio-economic reasons shall normally be time-limited. Therefore, if such an authorisation is applied for an unlimited time, this has to be justified.

Authorisation decisions are taken after consideration of the effects on human health and the environment of the effects that required the substance to be authorised in the first place (specified in Annex XIII). They shall not consider other effects, for example, flammability. If a substance needs to be restricted because of effects not leading to authorisation they may be addressed through the restrictions process. The authorisation process concentrates on this limited number of effects because it will focus resources on the effects of highest concern thus enabling the system to efficiently process the highest number of substances and uses.

Article 58 - Review of authorisations

Authorisation decisions may need to be amended or withdrawn as a result of a review which can be done at any time when there is a change of circumstances. Such a change of circumstances can for example be changes in the scientific basis for an authorisation decision or that environmental quality objectives as defined under the IPPC Directive or Water Framework Directive are not met because of diffuse emissions to water or the air. Emissions from point sources however are dealt with under those Directives.

Authorisations may therefore be amended or even withdrawn if necessary, subject to the setting of deadlines for the original applicant to update their case, if further information comes to light that places doubt on the appropriateness of the original authorisation. While a review is ongoing, the Commission is empowered to suspend the authorisation in cases of serious and immediate risk, provided proportionality is taken into account.

A streamlined procedure is provided for renewal of time-limited authorisations.

Article 59 - Applications for authorisations

Any grouping of substances, uses and/or applicants will need to be justified in the application. The uses applied for can be for the applicant's own uses or for uses by their downstream users. The possibility of grouping is to enable the authorisation process to be as efficient as possible with no reduction in protection as well as allowing the possibility for sharing the burden of application between a number of applicants.

The information accompanying an application includes a chemical safety report detailing their chemical safety assessment. The assessment only needs to address the properties that led to an authorisation being required (specified in Annex XIII: CMR, PBT, vPvB etc). If the applicant has already submitted a registration for the substance they do not have to resubmit the chemical safety report as this will already have addressed the risk management measures required for the substance and use in question.

Bearing in mind the conditions for granting an authorisation, an applicant may submit a socio-economic analysis (SEA) of the impact of a granted or refused authorisation, in accordance with Annex XV, as well as an analysis of alternatives and a substitution plan, if this is considered to be appropriate. An authorisation decision shall be based on the information made available to the authorities. If an application for authorisation is turned down on the basis that the risks to human health and the environment are not adequately controlled, and no SEA has been submitted, the 'sunset date' will still apply. The applicant would therefore need to make a new application for authorisation for the use including a SEA. The implications of this are that the use in question would be prohibited until the authorisation were granted.

Article 60 - Subsequent applications for authorisation

This allows a subsequent applicant for authorisation to make use of the chemical safety report and, if applicable, a socio-economic analysis and available information on alternative substances or preparations, submitted previously if permission is given by the previous applicant. This is to save applicant and authority resources by avoiding repeat work for no benefit.

Article 61- Procedure for authorisation decisions

This sets out the process that will be followed. Applications for authorisations must be made to the Agency. Once received, the Agency has 10 months in order to prepare an opinion. If the applicant has been given permission to refer to a previous authorisation application this shall be reduced to 5 months. The opinion shall take account of the information made available to it by the applicant as well as any other information available. The setting of deadlines gives industry certainty on which to base commercial decisions and also encourages the authorities to come to decisions as rapidly as is reasonably possible.

When an application is received, non-confidential information on the identity of the substance and use(s) applied for will be put on the Agency's website. This is so that other interested parties can make the Agency aware of alternative substances or processes that may be less harmful to human health and the environment. The information posted on the website must however not be so detailed as to allow others access to commer