Explanatory Memorandum to COM(2003)644-1 - Registration, Evaluation, Authorisation and Restriction of Chemicals (Reach), establishing a European Chemicals Agency and amending Directive 1999/45/EC and Regulation (EC)

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dossier COM(2003)644-1 - Registration, Evaluation, Authorisation and Restriction of Chemicals (Reach), establishing a European Chemicals Agency and ...
source COM(2003)644 EN
date 29-10-2003
Background to the proposal

3.

Results of public consultations and impact assessments


Contents

1.

Legal elements of the proposal



4.

Introduction to the proposal


5.

1. Reasons and Objectives


6.

2. Content of the Regulation


7.

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.

8.

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.

9.

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.

10.

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.

11.

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.

12.

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.

13.

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.

14.

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.

15.

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.

2.

Legal elements of the proposal



16.

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.

17.

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.

18.

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.

19.

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 i. 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.

20.

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.

21.

1. Reasons and Objectives


22.

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.

23.

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.

24.

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.

25.

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).

26.

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.

27.

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.

28.

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.

29.

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.

30.

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 i, which notes that regulatory agencies:

- 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 i 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.

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.

31.

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.

32.

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.

33.

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.

34.

1.13. Enforcement


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

35.

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.

36.

2. Content of the Regulation


37.

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).

38.

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.

39.

Article 3 - Definitions


The essential terms in this Regulation are defined.

40.

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.

41.

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.

42.

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.

43.

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.

44.

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.

45.

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.

46.

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.

47.

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 i 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.

48.

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.

49.

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 i 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.

50.

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.

51.

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.

52.

Article 17 - Joint submission of data by participants of consortia


See Article 10 for explanation.

53.

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.

54.

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.

55.

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.

56.

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.

57.

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.

58.

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.

59.

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.

60.

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.

61.

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.

62.

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.

63.

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.

64.

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.

65.

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.

66.

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.

67.

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.

68.

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).

69.

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.

70.

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.

71.

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.

72.

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 i and may be adapted accordingly.

73.

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.

74.

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.

75.

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.

76.

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.

77.

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.

78.

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.

79.

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.

80.

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.

81.

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.

82.

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.

83.

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.

84.

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.

85.

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.

86.

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.

87.

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.

88.

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.

89.

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).

90.

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.

91.

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).

92.

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.

93.

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.

94.

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.

95.

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.

96.

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 commercially important and sensitive information.

The Agency shall prepare two opinions. One shall address the risk posed to human health and the environment and the second socio-economic factors. In the interests of fairness and openness the applicant will be given 2 months to comment on the opinions if they wish to do so, with the Agency given up to a further two months to amend its draft opinion if it sees fit. Once the opinion has been finalised, to aid transparency, it shall be made available to the Commission, Member States and the applicant and its non-confidential parts shall be published on the Agency website. The Commission shall then adopt its decision on the application under the advisory committee procedure.

97.

Article 62 - Obligation of holders of authorisations


In order for customers to know if a substance has been subject to and granted an authorisation, any label for a substance on the market for an authorised use (this could include its use in a preparation or in an article) shall include its authorisation number. The downstream user will then be able to check easily on the Agency website whether they are using the substance within the conditions of its authorisation.

98.

Article 63 - Downstream users


A downstream user may, according to Article 54, paragraph 2, use a substance within the conditions of an authorisation given to an actor further up the supply chain. In this case he shall notify the Agency if he is using a substance for such an authorised use. This is to enable the Member State authorities to check that the risks posed by substances of very high concern are being adequately controlled and/or within the conditions of an authorisation.

99.

2.8. Restrictions on the manufacturing, marketing and use of certain dangerous substances and preparations


Article 64 - General Provisions

This Article sets out in general terms that all restrictions for substances set out in Annexes XVI and XVII have to be followed by all who manufacture, use or place those substances on the market. The division into two paragraphs results from the different background of the restrictions: paragraph 2 and Annex XVII deal with restrictions that have their origin in the Stockholm Convention or the Unece Protocol on Persistent Organic Substances, i.e. in a broad international agreement, paragraph 1 and Annex XVI deal with all other restrictions.

As a starting point, the restrictions included in Directive 76/769/EEC as amended are taken over in Annex XVI in a recast version.

The restrictions in Annex XVI do not apply to substances being used for scientific research and development purposes and for product and process orientated research and development, if these substances are used in amounts of less than 1 tonne. The restrictions in Annex XVII do not apply to substances being used for laboratory scale research or as a reference standard. Thereby the exemption is tighter than the one applying to substances included in Annex XVI.

The Restrictions in Annex XVI or XVII do not apply to substances that are waste and where authorities have given permission for it to be treated in a waste treatment installation (e.g. being destroyed or recycled). The requirements on waste in the Community's earlier implementation of the Stockholm Convention and the Unece protocol will also apply as they may be more restrictive.

100.

Article 65 - Introducing new and amending current restrictions


This Article specifies the conditions that have to be fulfilled in order to include a substance in Annex XVI and XVII as well as the procedure that has to be followed: the regulatory committee decides directly on restrictions for substances which meet the criteria as carcinogenic, mutagenic or toxic, categories 1 and 2, and for which the Commission proposes restrictions for consumer use as well as for substances for which restrictions are included in the Stockholm Convention or the Unece protocol. For all other restrictions however the process in Articles 66 to 70 has to be followed. For the first two categories of substances, a sound scientific basis has already been provided either within the classification procedure or during the international agreement procedure whereas Articles 66 to 70 ensure that such a scientific basis is prepared for the other restrictions as well. Provision is also made to ensure an appropriate interface with the Directive on cosmetic products, as Reach should not be used as the tool to address issues which are only relevant to cosmetic products.

101.

Article 66 - Preparation of a Proposal


This article details that either Member States or the Commission - via the Agency - may prepare a proposal for restrictions and what has to be done for proposed restrictions to be considered.

Proposals for restrictions shall be based on a risk assessment that identifies why Community-wide action is required. To help ensure that the process for restrictions can work quickly - the previous system for introducing restrictions was criticised as being too slow - risk assessments must adhere to certain requirements that are set out in Annex XIV. If Member State risk assessments do not in the opinion of the Agency meet those requirements, the proposal for restrictions shall not be considered further until these shortcomings are addressed.

In the interests of consistency across EU legislation, both Member States and the Agency shall take into account any risk assessment on the substance under any EU legislation.

To help ensure transparency in the process and that all those with an interest in a proposed restriction have the opportunity to provide relevant information to help in the decision making process, all risk assessments satisfying the requirements set out in Annex XVI are published on the Agency web-site. All interested parties are invited to both comment on the risk assessment and to provide information on the socio-economic impact of the restrictions proposed.

102.

Article 67 - Agency opinion: Committee for risk assessment


This Article details the process that shall be followed within the Agency for the preparation of an opinion on the risk assessment on which the proposed restrictions are based and any comments submitted.

Deadlines are specified to ensure that the process is as fast as possible commensurate with the need for accuracy, fairness and a high level of protection for human health and the environment.

The opinion shall be prepared by a risk assessment rapporteur and shall be adopted by the Committee for Risk Assessment. This is to ensure that expertise available in the Agency in the field of risk assessment is fully brought to bear on the opinion.

103.

Article 68 - Agency opinion: Committee for socio-economic analysis


This Article details the process that shall be followed within the Agency for the preparation of an opinion on the socio-economic impact of the proposed restrictions.

Deadlines are specified to ensure that the process is as fast as possible commensurate with the need for accuracy, fairness and a high level of protection for human health and the environment. The deadline is longer than that for the Committee for Risk Assessment so that their opinion can be taken into account.

The opinion shall be prepared by a socio-economic analysis rapporteur and shall be adopted by the Committee for socio-economic analysis. This is to ensure that expertise available in the Agency in the field of socio-economic analysis is fully brought to bear on the opinion.

It is recognised that many interested parties will either not have the resources or the information to prepare a full socio-economic analysis. For this reason, information that contributes to one may also be submitted for consideration by the Committee and its rapporteur.

104.

Article 69 - Submission of an opinion to the Commission


This Article requires the Agency to give the opinions of the two Committees as well as any supporting material, if required, to the Commission so that it can make a proposal based on full information and the expert opinion of the two Agency Committees.

The article also requires the Agency to let the Commission know if either or both of the Committees have failed to develop an opinion within the deadlines given in Articles 67 and 68.

The opinions shall be published on the Agency's web-site in the interests of transparency and openness.

105.

Article 70 - Commission decision


This Article requires the Commission to draft an amendment or addition to Annex XVI within 3 months of receiving the two opinions from the two Agency Committees or 3 months after the deadlines in Articles 67 and 68 if no opinion has been provided.

The deadline is provided to help ensure that proposals for restrictions are introduced as rapidly as is reasonably possible commensurate with the need for fairness, accuracy and a high level of protection for human health and the environment.

It is the responsibility of the Commission to consider the evidence from, and opinions of, the two Agency Committees. The Commission shall weigh up the evidence and make a proposal. The Commission may exceptionally come forward with a proposal that is not in accordance with the opinion of either Committee. In this case, the Commission shall make a detailed explanation of the proposal and the reasons for its differences with the opinions of the two Committees.

106.

2.9. Agency


Article 71 - Establishment and responsibility of the Agency

This Article establishes the European Chemicals Agency which will contribute to a high level of protection of human health and the environment in the context of the operation of the internal market. The Agency is responsible for ensuring that it operates properly the tasks assigned to it by this regulation and for co-ordinating the resources of Member States competent authorities under the Reach system. This co-ordination role, as opposed to giving the Agency a role as a pan-European regulator, is consistent with the principle of subsidiarity.

107.

Article 72 - Composition of the Agency


This Article sets out the structure of the Agency:

- the Management Board;

- the Executive Director;

- the Committee for Risk Assessment, which prepares the Agency's opinion on risks to human health and the environment under the authorisation and restriction procedures;

- the Committee for Socio-economic Analysis, which prepares the Agency's opinion on any question related to the socio-economic analysis of substances;

- the Member State Committee, which co-ordinates work on evaluation, classification and labelling and identification of substances of very high concern;

- the Forum on exchange of information on enforcement, which co-ordinates a network of Member States' enforcement authorities but does not prepare Agency opinions;

- the Secretariat to support the Committees and the Forum and to execute the administrative parts of the Reach system; and

- the Board of Appeal, which considers any appeals against the decisions of the Agency.

They are described in more detail below.

The second paragraph allows the Committees and the Forum to establish working groups. These could be used, for example, to prepare the work of a Committee under a particular procedure such as restrictions or to address specific technical issues. The Risk Assessment Committee has different, but related, tasks under the restrictions and authorisation procedures. It might be useful to establish working groups for each of these, while the Committee assures coherence between the approaches taken in each working group.

The third paragraph allows the Committees and the Forum to seek specialist advice from appropriate external sources as necessary.

108.

Article 73 - Tasks of the Agency


This Article provides that the Agency shall advise the Member States and the Community within the context of the Reach System.

The second paragraph sets out the tasks to be performed by the Secretariat, without participation of the Committees. These tasks are essentially administrative, requiring a good understanding of the Reach system but limited technical expertise judgement, so it would be inappropriate to involve the Committees. Tasks (a)-(c) require dissemination of information to Member States and other interested parties. Task (d) provides for the establishment and maintenance of the database that is the primary store of information that will be available to the Competent Authorities as well as the source of non-confidential information to be made available on request. Task (e) requires the Agency to make publicly available information on which substances have been, and are, subject to evaluation. Task (f) requires the preparation of documents for companies concerning their obligations under the Reach system. As these documents are not expected to be highly technical, it is appropriate to allocate this task to the Secretariat. Task (g) establishes a help desk to support Member State competent authorities' own help desks. The Member States competent authorities' help desks provide advice to companies and the Agency's help desk promotes a harmonised approach by the Member States competent authorities. The Agency's help desk does not provide advice direct to industry because maintaining the language capabilities and knowledge of local conditions needed to respond to many thousands of potential enquiries in an enlarged Union would require a disproportionate investment of resources. Task (h) involves the preparation of descriptive documents to help non-industry stakeholders understand the Reach system.

The third paragraph sets out the tasks to be performed by the Committees. Tasks (a) to (e) provide for the work under the relevant procedures leading to the adoption of opinions or recommendations for substances to be included in Step 1 of authorisation or to be classified at Community level. Task (f) provides for technical support to Community participation in international harmonisation activities, since the Agency's expertise makes it the natural contact point in such work. Task (g) gives the Commission the right to request ad hoc opinions on specific issues related to the safety of substances.

The fourth paragraph sets out the work of the Forum. This is based largely on the work of the existing informal network of Member State competent authorities. The tasks are largely self-explanatory. The work of the Forum will be undertaken by the Member States' representatives with administrative and logistical support from the Agency. The Agency itself will not have a monitoring role with regard to enforcement. It is expected that the Forum will have an important role to play in assuring the effective working of the Reach system.

The fifth paragraph explains that the Board of Appeal shall decide appeals against any Agency decision.

109.

Article 74 - Powers of the Management Board


This Article defines the powers of the Management Board in accordance with the principles laid out in the Commission Communication on the operating framework for European regulatory agencies.

110.

Article 75 - Composition of the Management Board


This Article defines the composition of the Management Board in accordance with the principles laid out in the Commission Communication on the operating framework for European regulatory agencies.

111.

Article 76 - Chairmanship of the Management Board


Article 77 - Meetings

Article 78 - Voting

These Articles are self-explanatory.

112.

Article 79 - Duties and Powers of the Executive Director


This Article defines the powers of the Executive Director in accordance with the principles laid out in the Commission Communication on the operating framework for European regulatory agencies.

The tasks listed in the second paragraph are generally self-explanatory but certain points merit a little more discussion. Task (c) will require the Executive Director to follow closely the work of the Committees to ensure that they meet the deadlines set down in the legislation. The timely co-ordination of the work of the Committees under task (e) will in particular require that the Risk Assessment Committee provides timely information to the Socio-economic Committee and that the latter Committee provides timely feedback to the former.

The tasks in the third paragraph relate to annual activities on reporting, work planning, accounting and budget forecasting.

113.

Article 80 - Appointment of the Executive Director


This Article provides a transparent procedure for the selection and appointment of a suitable candidate.

114.

Article 81 - Establishment of the Committees


This Article provides that each Member State may nominate candidates to the Risk Assessment and Socio-economic Analysis Committees.. The Management Board will appoint at least one member from each Member State having made a nomination to that committee. The Member States shall appoint one member each to the Member State Committee. The members shall have the technical expertise relevant to the Committee on which they serve. It is intended that the members of the Risk Assessment and Socio-economic Analysis Committees shall give their views as experts and not as representatives of their Member State. It is nevertheless appropriate to draw the members from the Member States because this will give the Committees access to the collective expertise of the Member States, will promote mutual acceptance of decisions and so support the harmonisation of regulatory practices across the Community.

In order to provide a good range of expertise on each Committee, the Committees may co-opt up to five further members. Recognising that Committee members cannot have the expertise needed to discuss all issues that may come before a Committee, members may be accompanied by scientific and technical advisers having the expertise relevant to a particular item. Meetings of the Committees shall be open to the Commission and to the Executive Director of the Agency.

Committee members shall ensure appropriate co-ordination between the work of Member States competent authority and that of their Committee in order to promote a common European approach. In this context it is useful to note that members of the equivalent committees within the Emea spend around a quarter of their time at the Agency and the rest back in their Member State. It is expected that members of the Committees will spend at least a similar proportion of their time at the Agency.

The Member States are required to provide scientific and technical support to the work of the Committees and working groups. This is the Agency's primary means of 'co-ordinating the scientific and technical resources put at its disposal by the Member States' as required in Article 71. Member States are not permitted to give instructions to members of the Risk Assessment Committee and of the Committee for Socio-Economic Analysis that might conflict with an objective scientific and technical analysis of the issues under discussion.

To facilitate the work of the committees, opinions may be adopted by a majority of Committee members, with due recording of minority views.

115.

Article 82 - Establishment of the Forum


This Article provides that each Member State shall nominate a member to the Forum. The members shall have expertise relevant to the Forum. It is intended that the members shall give their views as experts and not as representatives of their Member State. In order to provide a good range of expertise on the Forum, it may co-opt up to five further members. Recognising that Forum members cannot have the expertise needed to discuss all issues that may come before it, members may be accompanied by scientific and technical advisers having the expertise relevant to a particular item.

Forum members shall ensure appropriate co-ordination between the work of Member State competent authority and that of the Forum in order to promote a common European approach to enforcement and to ensure that the Forum's work is informed by practical experience.

The third paragraph provides the Agency's primary means of 'co-ordinating the scientific and technical resources put at its disposal by the Member States', here in particular by its competent authorities, as required in Article 71. The Member States are required to provide scientific and technical support to the work of the Forum and its working groups. They are not permitted to give instructions to Forum members that might conflict with an objective scientific and technical analysis of the issues under discussion. They are also required to monitor the quality and independence of the work of the Forum and its working groups to ensure that all members are fulfilling their role appropriately.

116.

Article 83 - Rapporteurs of committees and use of experts


Rapporteurs may be appointed where a Committee's opinion is required under the evaluation, restrictions or authorisation procedures. A Committee may also appoint a co-rapporteur. This may prove particularly useful where the co-rapporteur has better access to expertise, perhaps within his Member State competent authority, related to a particular aspect of a dossier.

The Committees should develop the modalities for replacement of a rapporteur or co-rapporteur in their rules of procedure.

The third paragraph provides for contracts to pay for the work of rapporteurs, non-governmental experts serving on working groups and any expert performing other functions for the Agency. The Executive Director is responsible for managing such contracts. In this context, it should be noted that a rapporteur is not expected to work alone but rather to co-ordinate the work of a team of experts who prepare the report for the Committee.

The fourth paragraph provides, where appropriate, for calls for expressions of interest. This is not expected to be appropriate in the case of rapporteurs.

The fifth paragraph gives the Agency the discretion to engage experts to discharge other specific tasks. These could include cases where the Commission requests ad hoc opinions on specific issues, as provided for in Article 73(3)(f).

117.

Article 84 - Qualification and interests of members of committees and boards


The identity and qualifications of members of Committees should be published in the interests of transparency. Members may request that their identity not be published if they are concerned for their personal safety. This is a concern in certain Member States for animal protection issues.

To ensure the provision of objective advice, servants of the Agency shall make declarations of interests and not discuss or vote on issues relating to those interests.

118.

Article 85 - Establishment of the Board of Appeal


This Article sets out the membership of the Board of Appeal, how they shall be appointed and their voting rights.

119.

Article 86 - Members of the Board of Appeal


This Article sets out the term of office of members of the Board of Appeal, who may serve on it, under what conditions they might be removed, and how potential conflicts of interest will be dealt with.

120.

Article 87 - Decisions subject to appeal


This article explains that appeals can be brought against decisions taken:

- to reject a registration,

- to grant, reject or place conditions on an application for a PPORD exemption,

- under the evaluation provisions;

- to grant or reject a declaration that information be kept confidential, and

- to deny access to information.

Any decision being appealed against shall not apply until the appeal is considered.

121.

Article 88 - Persons entitled to appeal, time limit and form


This Article provides that the person to whom a decision is directed has 1 month to appeal against that decision.

122.

Article 89 - Examination and decisions on appeal


Decisions on appeals shall be made within 30 days. Those involved in the appeal shall have the right to present their case to the Board.

123.

Article 90 - Actions before the Court of Justice


Appeals against the decisions of the Board of Appeal, or proceedings against the Agency for failing to make a decision, can be made to the Court of Justice. The Agency has to comply with the judgement of the Court of Justice.

124.

Article 91 - Complaints to the ombudsman


This article is necessary to make the provisions on the Agency consistent with Article 195 of the EC Treaty.

125.

Article 92 - Conflicts of opinion with other bodies


Other agencies, particularly Emea and Efsa, have responsibilities that relate to those of the Agency. It is conceivable that these other agencies may adopt opinions related to certain substances that differ from those of the Agency. This Article therefore provides a mechanism for resolution of such differences. Similarly, there are Community scientific committees that may be called on to provide opinions that relate to substances and so this mechanism applies to them also. The relationship of Member State competent authorities to the Agency is extensively addressed in the Reach system and so it would be inappropriate for this mechanism to apply to them. Relevant national bodies within individual Member States are also not covered, since Member State competent authorities are expected to consider the views of such bodies in formulating their own views.

126.

Article 93 - The budget of the Agency


This Article sets out the provisions related to the establishment of the budget of the Community Agency. The budget will be funded through a Community subsidy, through fees collected, more particularly for registration and authorisation, and through voluntary contributions from Member States. All substances produced or imported in volumes starting at 100t are subject to evaluation and so a higher fee for registration of such substances is charged to fund this evaluation work. Other substances may be subjected to evaluation on the initiative of authorities but it would be inappropriate to charge a fee to industry for this. Similarly it would be inappropriate to charge a fee when a restrictions procedure is started. These and other activities of the Agency will be funded from a general reserve drawn from the basic registration fee and from the subsidy from the Community budget.

The Commission proposes that the Community subsidy should, over a number of years, approximate to the cost to the Community budget under existing legislation of supporting the European Chemicals Bureau. It is important to note that the Community subsidy will vary substantially over the first decade of the Agency's life while substances are phased into the system. This is because the registration deadlines for phase-in substances will yield very large fee incomes in certain years but relatively little in others.

127.

Article 94 - Implementation of the Agency's budget


This Article sets out the standard provisions related to the implementation of the budget of a Community Agency.

128.

Article 95 - Fees


This Article empowers the Management Board to set and adjust the fees to be paid by industry to fund the work of the Agency. This will assist the Agency in balancing its budget in the light of experience with the operation of the Reach system. This is to allow the costs incurred by the Agency under the respective parts of this Regulation to be reflected in the fee structure.

129.

Article 96 - Combating fraud


This Article sets out standard provisions related to combating fraud.

130.

Article 97 - Financial regulation


This Article sets out standard provisions concerning the adoption of the Agency's financial Regulation.

131.

Article 98 - Legal personality and seat of the Agency


This Article grants legal personality to the Agency, allowing it to buy and sell property, start legal proceedings and so forth.

Under the present chemicals legislation, the European Chemicals Bureau of the Commission's Joint Research Centre fulfils a role analogous to that of the Agency. It will be the centre of the Commission's detailed preparatory work for the Reach system and, immediately following the entry into force of the Reach system, it will temporarily fulfil the role of the Agency. Given the importance of continuity in chemicals regulation and the Agency's need to recruit quickly a core of experienced staff, the Commission proposes that the Agency should have its seat in the same location as the present European Chemicals Bureau.

132.

Article 99 - Liability of the Agency


This Article sets out standard provisions related to the liability of the Agency and gives the Court of Justice jurisdiction over disputes or arbitration. For the liability of servants towards the Agency reference is made to Article 101.

133.

Article 100 - Privileges and immunities of the Agency


This Article accords the Agency the privileges and immunities applicable to the European Communities.

134.

Article 101 - Staff rules and regulations


This Article subjects the staff of the Agency to the rules and regulations applicable to officials and other staff of the European Communities and nominates the Agency as the appointing authority within the meaning of those staff rules and regulations. The Management Board, in agreement with the Commission, is enabled to adopt the necessary implementing provisions.

135.

Article 102 - Duty of confidentiality


This Article imposes a normal duty of confidentiality on servants of the Agency.

136.

Article 103 - Participation of third countries


This Article provides for the participation of third countries in the work of the Agency. They may participate to a degree that the Agency deems appropriate for a particular country at a particular time. This may be useful in, for example, preparing candidate countries for their future role as Member States or in promoting co-operation with members of the European Economic Area.

137.

Article 104 - International harmonisation of regulations


This Article provides for international organisations having interests in the harmonisation of international regulations to participate as observers in the work of the Agency. The aim is to provide a focus for Community input to such activities. The Agency will agree on the terms for such participation.

138.

Article 105 - Contacts with stakeholder organisations


This Article provides for the involvement of industry, consumer protection, worker protection and environmental protection organisations in the work of the Agency. The aim is to promote transparency and so secure widespread acceptance of the work of the Agency among key stakeholders.

139.

Article 106 - Rules on transparency


This article provides for rules to ensure that the Agency operates in an appropriately transparent manner. The rules will be subject to approval by the Agency and the Commission.

140.

Article 107 - Relations with relevant Community bodies


This Article provides that there should be no duplication of competences between the Agency and the European Food Safety Authority, the European Agency for the Evaluation of Medicinal Products or the Commission's Advisory Committee on Safety, Hygiene and Health Protection at Work. In view of the need to ensure effective co-operation with the European Food Safety Authority on substances that are used in plant protection products the Executive Director is required to develop rules of procedure for co-operation. There is also a need for co-operation on worker protection issues with the Advisory Committee and so the Executive Director is again required to develop rules of procedure.

The Commission and the Agency shall consider the possibility of exchanging staff with a view to enhancing understanding of their respective roles under this Regulation.

141.

Article 108 - Formats and software for submission of information to the Agency


To aid the efficient operation of the Reach system and to help actors in the supply chain meet their duties under Reach, formats for submitting information will be made available free of charge and software packages will be made available on the Internet.

142.

2.10. Classification and Labelling Inventory


Article 109 - Scope

This Article outlines what the Title applies to.

143.

Article 110 - Obligation to notify the Agency


This Article specifies the information that must be provided by all those who place substances on the market. As the duty to classify and label already applies to all substances placed on the market, this information shall be required from the first phase-in deadline (three years after entry into force of the Regulation). Classification and labelling data are part of the normal information requirements for registration. Therefore, if a registration was already submitted, there is no need to notify the information again. Subsequently, if further information comes to light, as a result of the Reach system or otherwise, the entry shall be updated. It is anticipated that for some substances the classifications notified or registered will vary. Over time it is expected that notifiers and registrants will work together to agree an entry.

144.

Article 111 - The classification and labelling inventory


This Article details the information that will be included in the inventory. This inventory will be widely available as a source of information on substances and also act as an encouragement to industry to harmonise their classification and labelling proposals when entries for the same substance differ.

145.

Article 112 - Harmonisation of classification and labelling


This Article specifies that once the Regulation comes into force only substances having one or more of certain dangerous properties may be added to Annex I of Directive 67/548/EEC. The purpose of this requirement is to concentrate resources on looking at the classification of those substances with properties of very high concern. The other provisions of the Regulation should adequately deal with properties of lesser concern.

146.

Article 113 - Transitional arrangements


All substances placed on the market are subject to classification and labelling requirements. Notifications to the Agency for the classification and labelling inventory can therefore to be made rather quickly, at the date of the first phase-in deadline.

147.

2.11. Information


Article 114 - Reporting

The Regulation will introduce a new and comprehensive system for the management of industrial chemicals. It is necessary therefore for the operation of the system to be monitored at the levels of the Member State, the Agency and the Commission so that issues and problems can be identified. This establishes the need for all Member States, the Agency and the Commission to report on the operation of all aspects of the Regulation.

148.

Article 115 -Access to information


One of the objectives of the new system is to make information on chemicals more widely available. Some items are published and freely available in accordance with Article 74(2)(d). Certain non-confidential information shall be made available by the Agency on request in accordance with Regulation (EC) No 1049/2001 but when such a request for access is made, the third parties concerned by this information may submit a declaration asking that it be kept confidential. For this it has to justify that disclosure of the information could actually harm him commercially. Appropriate procedures are foreseen. Directive 2003/4/EC applies to requests to obtain information from Member State Competent Authorities, but if the data concerned come from the Agency, it is the Agency who decides whether access can be granted.

149.

Article 116 - Confidentiality


This Article identifies what information shall not be treated as confidential and hence is made available on the database, and what shall always be automatically treated as confidential and hence will not be made available. All other information may be claimed to be confidential in accordance with Article 115 i if it can be demonstrated that disclosure of the information could actually harm the party concerned commercially. The minimum information required to adequately control a substance cannot be kept confidential, including basic information on the hazards of a substance, guidance on safe use, those elements of the safety data sheet not considered to be confidential and information needed to identify the substance.

150.

Article 117 - Cooperation with third countries and international organisations


This Article allows data held by the Agency to be exchanged, under appropriate confidentiality arrangements, with third countries or international organisations fulfilling tasks under legislation similar to Reach. This is in order to avoid duplication of work internationally and to share experience. Any such arrangement has to be in compliance with the EC Treaty.

151.

2.12. Competent authorities


Article 118 - Appointment of competent authorities

In order to ensure that competent authorities are able to fulfil the duties allocated to them under the Reach system, this article requires Member States to create such authorities and to allocate them sufficient resources to perform their duties.

152.

Article 119 - Co-operation between competent authorities


Co-operation between competent authorities is important to the good functioning of the Reach system.

153.

Article 120 - Public communication of information on risks of substances


In certain cases, the provision of information to the public may be the most appropriate risk management measure. Member State competent authorities, rather than the Agency, are the appropriate bodies to provide such information given the importance of cultural and linguistic elements in a successful information campaign.

154.

Article 121 - Other responsibilities of the competent authorities


Given that the Reach system places a number of new obligations on industry, it is important that companies, especially small and medium sized enterprises, know where to go for advice. Many competent authorities already offer advice to industry but this article formalises that requirement. It is expected that competent authorities will create help desks, with appropriate information available on-line. It is appropriate to give this task to competent authorities rather than the Agency because they have the language capabilities and knowledge of local conditions needed to respond effectively.

155.

2.13. Enforcement


Article 122 - Tasks of the Member States

This requires the Member States to establish appropriate approaches to enforcement of the Regulation. The experience of the Chemical Legislation European Enforcement Network (Cleen) with activities looking at the enforcement of various pieces of chemical legislation across a number of Member States will be a valuable resource in establishing such approaches. The Forum to be set-up under the auspices of the Agency will continue the work of Cleen in developing a consistent approach to the enforcement of chemicals legislation through controls and other activities.

156.

Article 123 - Sanctions for non-compliance


This requires the Member States to establish sanctions for non-compliance with this Regulation. The sanctions imposed must be proportionate to the extent and impact of the non-compliance. The experience of Cleen points to the need to harmonise to some degree the sanctions imposed, taking account the need for subsidiarity. The Forum should enable Member States to establish a coherent approach to sanctions.

157.

Article 124 - Report


This requires Member States to report on their enforcement activities and the sanctions imposed for non-compliance over the previous calendar year. This information will be useful to the Forum in identifying any action that might usefully be taken.

158.

2.14. Transitional and final provisions


Article 125 - Free Movement Clause

This is the explicit complement to the various requirements in the Regulation and covers those substances on their own, in preparations, or in articles that are complying with the provisions of the Regulation.

159.

Article 126 - Safeguard clause


Despite the thorough and far reaching nature of the Regulation it is possible that effects of a substance may be identified by a Member State that need to be addressed urgently.

160.

Article 127 - Motivation of decisions


In the interests of transparency and legal certainty, the reasons for all decisions taken by the various authorities must be given.

161.

Article 128 - Amendments to the annexes


This enables the Commission to revise Annexes I to XVII to the Regulation through a Committee procedure, as these relate to scientific and technical matters and do not touch the fundamental rules established in the body of the Regulation.

162.

Article 129 - Implementing legislation


This enables the Commission to complement the Regulation through the Comitology procedure. This is essential to enable the Commission to adopt measures that will ensure that the implementation of Reach can be carried through efficiently.

163.

Article 130 - Committee procedure


Two Committee procedures are proposed: the advisory committee and the regulatory committee as established under Decision 1999/468/EC. The committee procedure proposed in particular articles of the regulation depends on the measure to be taken, i.e. the advisory procedure for individual decisions and the regulatory procedure for measures of general application.

164.

Article 131 - Transitional measures regarding the Agency


For some of the provisions in the Regulation to act as anticipated, a managing body must be operational from the day the Regulation comes into force. Until the Agency becomes operational, the Commission fulfils this role, especially in respect of appointment of personnel.

165.

Article 132 - Transitional measures regarding restrictions


Extensive work has been performed under Directive 76/769/EEC and Regulation (EEC) No 793/93. It is likely that some of that restrictions identified in these pieces of legislation will not have been taken all the way through to a Commission decision before this Regulation comes into force, including repealing Directive 76/769/EEC and Regulation (EEC) No 793/93. This enables such restrictions to still be brought forward and implemented without having to go through all the new procedures set out in this Regulation.

166.

Article 133 - Review


This Regulation carefully balances workability with the need to protect human health and the environment and maintain and enhance the competitiveness of EU industry. The first paragraph of this Article sets out the requirement for the Commission to review 12 years after the Regulation comes into force whether the CSA requirements in this Regulation are adequate or whether it is necessary to extend them to substances manufactured or imported in quantities of less than 10 tonnes per year, and to amend the Regulation accordingly. Paragraph 2 contains the review and adaptation provision discussed above under section 2.2, with regard to Articles 14 and 37. Similarly, paragraph 3 provides for review and possible modification of information requirements for substances of 1 tonne or more, but less than 10 tonnes per year.

167.

Article 134 - Repeal


This establishes which Directives and Regulations are to be replaced by this Regulation that covers their relevant provisions.

168.

Articles 135 and 136 Amendments


These Articles contain consequential amendments to Directive 1999/45/EC and to Regulation (EC) No .../...[POPs]

169.

Article 137 - Entry into Force and Application


This establishes when the Regulation enters into force and when the duties under various parts of the Regulation apply. Not all duties apply when the Regulation first enters into force because other duties may need to be met first.

The Registration provisions shall apply 60 days after the Regulation enters into force so that the Commission and the Agency has sufficient time to ensure all the systems are in place to receive registrations. It is also undesirable to postpone the registration provisions too long as this would prevent new substances coming onto the market.

The provisions in Articles 81 and 82 applying to the risk assessment and socio-economic analysis committees and the Forum apply one year after the Regulation enters into force to allow for the appointment of an Executive Director, a number of other personnel, to informally convene the Committees and the Forum, and to discuss working methods.

The restrictions provisions in Articles 66 to 70 apply 18 months after the Regulation enters into force to ensure that the necessary Committees are in place. The Commission can use Article 132 to bring in restrictions based on existing work.

The provisions for substance evaluation apply two years after the Regulation enters into force when it is likely that a number of registrations will be available for substance evaluation.

170.

3. Annexes


Annex I - General provisions for assessing substances and preparing chemical safety reports

Together with safety data sheets, the Chemical Safety Report will be a key tool for development of risk assessments under Directive 98/24/EC on the protection of the health and safety of workers from the risks related to chemical agents at work. In consultation with stakeholders, the Commission will investigate how the assessment requirements under Directive 98/24/EC and those of the Reach system can be made compatible with respect to guidance and software.

171.

Annex Ia - Guide to the compilation of safety data sheets


The safety data sheet is the main tool used in industry for communicating information on the risks of dangerous substances and preparations through the supply chain. Annex Ia is the old annex to the safety data sheet Directive (91/155/EEC) that explains what information should be included under each of the 16 safety data sheet headings. It has been integrated with the concept of chemical safety assessments and chemical safety reports introduced by Reach. The CSR developed in accordance with Annex I, and in particular the exposure scenarios, should be used to complete the safety data sheet.

172.

Annex Ib - Chemical Safety Assessments for Preparations


This short Annex sets out a methodology for undertaking chemical safety assessments for preparations. This differs in a number of technical aspects from the methodology used for substances, set out in Annex I. Chemical safety assessments for preparations are permitted by article 30 i.

173.

Annex II - Exemptions from obligation to register in accordance with Article 4(2)(a)


Annex II and III list substances that are exempted from registration based on current practice. This Annex exempts individual substances following historical precedent.

174.

Annex III - Exemptions from obligation to register in accordance with Article 4(2)(b)


This Annex lists types of substances for which registration would be inappropriate.

175.

Annex IV - Information requirements referred to in Article 9


Annex IV contains a guidance note on how to use Annexes IV to IX, and sets out the basic information required on: general registrant information, identity of substance, information on manufacture and use(s) of the substance(s), and guidance on safe use.

176.

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

Progressively more information is required on a substance with increasing tonnage, with only Annex V required for lower tonnages and V-VIII for the highest.

Annexes V-VIII contain specific rules concerning the applicability of individual information requirements, which aim to ensure both that no unnecessary information is required and that registrants are required to consider when further information is appropriate. Annex IX sets out more general rules concerning the adaptation of the specific rules in Annexes V to VIII.

177.

Annex X - Testing methods


This Annex takes over the testing methods currently contained in Directive 67/548/EEC.

178.

Annex XI - General Provisions for Downstream Users to assess substances and prepare Chemical Safety Reports


Annex XI sets out a clear methodology that enables downstream users to undertake chemical safety assessments and prepare chemical safety reports for uses that they make of a substance that are not covered by the safety data sheet supplied to them. Downstream users will use the information provided by their suppliers via the safety data sheet and information from other sources to develop (an) exposure scenario(s), and, if necessary, refine the hazard assessment or risk characterisation, for their own use, or other uses down the supply chain.

179.

Annex XII - Criteria for the identification of persistent, bioaccumulative and toxic substances, and very persistent and very bioaccumulative substances


This Annex sets out the identification criteria for PBTs and vPvBs.

180.

Annex XIII - List of substances subject to authorisation


This Annex will contain the substances for which uses have to be authorised, specifying the information set out in Article 55.

181.

Annex XIV - Dossiers


This Annex sets out the requirements for a proposal for any restriction, as well as proposals for harmonised classification and labelling, and the identification of substances as PBT, VPVB or of equivalent concern.

Any proposal has to be based on a risk assessment following the relevant sections of Annex I, and has to justify why action at Community level is necessary.

These requirements are specified to ensure that adequate information is available for interested parties to comment on the risk assessment and the associated proposed restrictions and for the Agency's Committees to develop an informed opinion.

This Annex was considered to be necessary because risk assessments submitted to the Commission were of such variable consistency and content that it was difficult to make considered decisions based on them. This meant that risk assessments sometimes had to be repeated resulting in a considerable delay to restrictions being introduced.

182.

Annex XV - Socio-Economic Analysis


This Annex outlines such of the issues that may be addressed in a socio-economic analysis, or information that could be provided by interested parties to help the Agency's Socio-Economic Analysis Committee develop an opinion.

The Annex does not specify requirements because socio-economic analyses can be carried out on a range of levels (e.g. international, national, regional, local) and to address a wide variety of impacts (e.g. social, consumer, industry) and it was considered that no one set of requirements could meet all these needs.

The socio-economic analysis or contribution to it, is therefore the responsibility of the person submitting the information. They must decide on the most appropriate methodology to take and information to submit.

It is possible that with experience the Agency's Socio-Economic Analysis Committee may be able to recommend to the Commission more precise requirements for inclusion in this Annex.

183.

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


This Annex lists all the substances which are subject to restrictions and indicates the nature of the restrictions for these substances on their own, in preparations or in articles. These restrictions may be either conditions for the manufacture, use or the placing on the market or prohibitions of any of these activities. The restrictions in this Annex are essentially those carried over from Directive 76/769/EEC. That Directive will be repealed with the entry into force of this Regulation. Over the coming years the Annex will be revised as new restrictions are adopted following the provisions of this Regulation.

Annex XVI follows the rules set out within the Inter Institutional Agreement concerning recasting techniques (OJ C 77/1, 28.03.2002). Annex XVI has been drawn up in order to recast the legislation dealing with restriction of chemicals, Directive 76/769/EEC that has been adapted or amended many times.

The recast presented in Annex XVI does not intend to bring about changes of substance to the text. In particular, Annex XVI does not contain any additions of substances not previously restricted under Directive 76/769/EEC.

However, a number of minor changes were introduced (highlighted with adaptation markers), e.g. with the objective of harmonising the presentation with that of Directive 67/548/EEC. This applies to entry nos. 26, 31a, 31b, 31c, 31d, 31e, 31g, 31i, 33, 39. Some of these minor changes have been added in order to improve the readability of the text. This applies to entries 6.1, 6.2, and 23.1. It is also the case for entries 28, 29 and 30 (ex entries 29, 30 and 31) that have been merged into one block because their respective provisions are similar. Consequently, redundant provisions have been deleted.

Some deletions have been introduced in order to update the text and withdraw for example old date references. It applies for example to entries 1.1(a), 1.1(b), 1.1(c), 1.1(d), 1.1.e, 1.5, 18.2, 23.1.2, 23.4, 24.1, 24.2.(a), 24.3, 42.2. Some additions have also been included in order to update references to several directives quoted in the consolidated text. This applies for example to entries 3, 5.3.(a), 5.3(c), 12 i, 28, 29 and 30 (paragraphs 1 and 2) and 32.

A few changes became necessary for PCB because the substance in question was included in Annex XVII instead of Annex XVI as a result of the Persistent Organic pollutants Convention (so called 'POPs convention'). This concerns entries 1(c), 1.4 and 1.6.

In some cases, changes were introduced because the Regulation addresses itself to operators instead of Member States. This applies for example to entries 1.6 and Appendix 7 (point 7).

184.

Annex XVII - Persistent Organic Pollutants (POPs)


This Annex will list all the substances and the details of restrictions from the Stockholm Convention and the UN ECE Protocol on Persistent Organic Pollutants. By including these restrictions in this Annex and thereby in Community law, the European Community fulfils part of its obligation under the international Convention.