Opinion of the Economic and Social Committee on the "White Paper - Strategy for a Future Chemicals Policy"

(2002/C 36/19)

On 26 March 2001, the Commission decided to consult the Economic and Social Committee, under Article 175 of the Treaty establishing the European Community, on the "White Paper - Strategy for a future Chemicals Policy".

The Section for Agriculture, Rural Development and the Environment, which was responsible for preparing the Committee's work on the subject, adopted its opinion on 27 September 2001. The rapporteur was Mr Colombo.

At its 385th plenary session on 17 October 2001 the Committee adopted the following opinion by 70 votes to none, with three abstentions.

1. Introduction

1.1. The European Commission has adopted a white paper setting out the strategy for a future Community chemicals policy in keeping with the "sustainable development" approach. The main objective of the strategy is to ensure a high level of protection for human health and the environment, while ensuring the efficient functioning of the internal market and promoting innovation and competitiveness in the European chemicals industry.

1.2. The white paper ties in with the initiatives planned under the "Environment 2010: Our future, Our choice"(1) programme, adopted by the Commission in January 2001, which centres on four priority areas: climate change, environment and health, nature and biodiversity, and the management of natural resources.

1.3. A major strand of the environment and health agenda for the coming years will be the total rethink of the Community risk management system for chemicals, coupled with the equally important strategy for reducing the dangers posed by pesticides.

1.4. The challenge is to succeed in setting up a risk evaluation and management system for the chemicals produced, used and sold, in order to enable society to enjoy the benefits of their use while reducing their harmful effects and ensuring that there are no unacceptable risks to human health or the environment.

1.5. In the chapter on chemicals in the new Community environment programme, the Commission clearly identifies the fundamental problem to be addressed: "existing substances" that were on the market in 1981 when Community chemicals legislation came into force. In many cases, we are only now beginning to understand the risks associated with their use. Although existing substances account for over 99 % of the total volume of all substances on the market, they are currently not automatically subject to the same testing requirements as those placed on the market since 1981. At that time, there were approximately 100000 existing substances; currently the number of existing substances marketed in volumes of over 1 tonne is estimated at 30000.

1.6. The Commission has already compiled a list of 140 dangerous substances requiring priority attention and risk assessment. However, the current assessment process is slow and costly, and does not allow the system to work efficiently and effectively. The allocation of responsibilities is inappropriate, as the authorities are responsible for assessment, while the companies producing, importing or using the substances bear no responsibility. For that reason, it is difficult to obtain precise information as to the use of chemicals, and information on exposure arising from downstream uses is also somewhat scarce.

1.7. Decisions on further testing of a given existing chemical can only be taken via the complex committee procedure and can only be requested from industry after authorities have proved that a substance may present a serious risk. Without test results, however, it is practically impossible to provide such proof. Final risk assessments have therefore been completed for only a small number of substances.

1.8. The Commission white paper aims to balance the need to protect human health and the environment with the need to boost the innovative nature and competitiveness of the European chemical industry. Meanwhile, the Commission intends to increase transparency by making information on chemicals more accessible and clarifying the various phases of the decision-making process for the public.

1.9. According to the Commission, the system adopted will help to stimulate innovation and to create a working framework within which the European industry can compete with other world competitors on a level playing field. The Community policy is also designed to dovetail with international efforts, as chemical production and trade and the transnational impact of certain chemical substances have made chemical safety an international issue.

1.10. The guiding principle is the precautionary principle and an important objective is to encourage the substitution of dangerous by less dangerous substances, where suitable alternatives are available.

2. Gist of the White Paper

2.1. The key elements of the white paper are the following:

- a single efficient and coherent regulatory framework that provides equivalent knowledge about the hazards of substances marketed before and after the September 1981 watershed ("existing" and "new" substances) and their uses, in order to provide a consistent level of protection for human health and the environment;

- reversal of responsibility for testing and risk assessment of chemicals, from national authorities to industry;

- promotion of innovation and competitiveness, without compromising the high level of protection for the environment and public health;

- introduction of a tailor-made authorisation system, where stringent control is ensured for the most dangerous substances;

- more transparent and detailed information about chemicals.

2.2. The white paper seeks to convert the current dual system, which has differing testing requirements for new and existing substances, into a single efficient and coherent system for dealing with the majority of chemical substances.

2.3. The strategy addresses the problems inherent in the current risk assessment and risk management system and seeks to deal, in particular, with the large quantities of existing substances on the market whose effects on human health and on the environment are unknown.

2.4. Under the new scheme, a company which places a particular substance on the market will be responsible for supplying all the requisite information concerning risks, and the authorities will be called in to evaluate the data provided by industry and to decide on substance-tailored testing programmes following industry proposals. Increased responsibility will also pass to users in the manufacturing chain (formulators and downstream users) who will be more accountable and will have to supply data on the particular uses they make of a substance.

2.5. The new single system for assessing both existing and new chemicals is known as REACH (registration, evaluation and authorisation of chemicals), and it consists of the following three elements:

- registration of basic information for around 30000 substances (all existing and new substances exceeding an annual production volume of 1 tonne) submitted by companies in a central database; it is estimated that around 80 % of these substances would require only registration;

- evaluation of the registered information for all substances exceeding a production volume of 100 tonnes (approximately 5000 substances, corresponding to 15 % of the total) or, in cases of concern, also for substances at lower tonnage; the evaluation will be carried out by the relevant authorities and will include the development of substance-tailored testing programmes focusing on the effects of long-term exposure;

- specific authorisation will be required for substances that are carcinogenic, mutagenic or toxic to reproduction (CMRs) and persistent organic pollutants (POPs);

- PBTs(2) (excluding the above-mentioned POPs) and VPVBs(3) will be identified through further research. The Commission will decide at a later stage how substances with these properties should be treated.

2.6. Taking the volume placed on the market as the main factor, and subject to a series of other conditions, the suggested deadlines for the submission of registration dossiers are:

- by the end of 2005 at the latest, for substances exceeding a marketed volume of 1000 tonnes per year,

- by the end of 2008 at the latest, for substances exceeding a marketed volume of 100 tonnes per year,

- by the end of 2012 at the latest, for substances exceeding a marketed volume of 1 tonne per year.

2.7. The Commission proposes to establish a central body to administer the REACH system, including a central database containing all the information on registered substances and chemicals, and to provide the Member States with technical and scientific support for the evaluation of chemical substances. This body should also conduct sample checks and computerised screening of registered substances that give particular cause for concern.

3. Background

3.1. In principle, the white paper provides a great opportunity to break the age-old, deeply ingrained common preconception linking chemical production with danger and pollution. It also provides the framework for an overall review of the impact of chemical production and use on human health and the environment.

3.2. To achieve this objective, all the stakeholders must be prepared to agree on a framework for evaluation and regulatory measures that can strike a balance between the sacrosanct concerns of protecting the environment and human health, and the need to produce chemicals safely, efficiently and competitively.

3.3. The strategic importance of the chemicals industry can be highlighted by a number of key figures. The EU chemicals industry employs 1,7 million people directly, and over 3 million jobs are dependent on it. It generates net earnings of EUR 46,4 billion, which amounts to 65 % of the net earnings of all manufacturing industry. The sector includes both multinationals and over 36000 SMEs.

3.4. A sector of this strategic importance must be able to respond rapidly to signs of diminishing competitiveness or social importance. The number of employees in the chemicals sector fell by 13 % in the 1990s, whereas employment levels in the USA remained more or less stable. This trend seems to cast a shadow over Europe's capacity to maintain its position as a world leader.

3.5. It is therefore clear that with the active participation of the interested parties and an informed public behind it, this far-reaching, ambitious process could give the European chemicals industry a chance to dispel the widespread hostility towards the sector, whose products are essential in a modern society for the development of increasingly advanced new processes and technologies. This hostility is worryingly apparent when, for instance, the decentralised authorities come to consider licences for new installations.

3.6. It is clear that the challenge to the innovative capacity of the chemicals industry will have repercussions on many other chemical-using sectors. The Committee therefore welcomes the fact that the Commission has commissioned a study on the effects which measures subsequent to the white paper could have on other sectors of the economy. The Committee reserves the right to comment on the findings of this study in connection with the legislative proposals triggered by the white paper.

3.7. The Committee also believes it is necessary to devise accompanying measures to reward innovative companies and encourage the many producer, importer and user SMEs to cut their use of substances that raise specific health and the environmental concerns, and to develop substitutes.

4. General comments

4.1. By definition, the white paper is limited to tracing the general outline of a future Community strategy in the chemicals field, without providing the detail typical of legislation. The Committee's opinion will therefore reflect the nature of the proposal in question, while nonetheless drawing attention to certain strategically important elements of the white paper that deserve greater attention.

4.2. The ESC endorses the strategy's general approach and in particular the fact that:

- it is founded on the principles of sustainability, precaution and substitution, with a view to safeguarding environmental, user and consumer safety, not least by providing more information;

- it names innovation as a driving force in the recovery of competitiveness and the re-launch of a safe chemicals industry, starting with a major commitment to scientific research at Community level, in order to enable the chemicals industry to continue to play its vital role in modern society;

- it is committed to promoting non-animal testing;

- it makes companies (manufacturers, importers, users) accountable, as they will carry the burden of the substance registration process.

4.3. The Committee notes the conclusions of the Environment Council of 7 June 2001. In particular, it agrees with the principle that the new European chemicals policy must contribute to sustainable development, securing a high level of protection for the environment and public health, including that of workers, and also innovation and competitiveness in the European chemicals industry. The Committee also supports the objective of making 2020 the deadline by which only chemicals that do not have a significantly negative impact on health and the environment should be produced or used.

4.4. The white paper's inadequate mention of workers, however, gives cause for concern, given that the experience gained in bargaining between the social partners has secured major improvements in working conditions and health and safety in the workplace, as well as considerable progress in the relationship between factories and local areas, through the involvement of public authorities.

4.5. In the ESC's view, this experience ought to serve as a major point of reference in the future process, not least because workers are the first to face the risk arising from finished products and also intermediate compound products whose safety credentials are often unknown. In this respect, the Committee notes that it would be useful to launch a process of worker education and training, drawing on the wealth of experience that has been built up on production sites.

4.6. The Committee recommends adopting specific measures to help the 36000 SMEs in the chemicals sector, which account for 28 % of European production, to adapt to the new legislation. The Committee is also of the view that the Community research programmes planned under the Vith framework programme should be geared towards providing adequate support for the white paper's objectives, starting with the need to devise proper support instruments for research and innovation, in order to speed up the identification and use of substitute chemicals that do not present any risks to human health or the environment. More specifically, in vitro tests should be developed to do away with animal experimentation once and for all.

4.7. The ESC agrees on the vital need - as mentioned in the introduction - to uphold the precautionary principle and promote the substitution of certain substances in cases where reliable scientific data indicate that their use is likely to have adverse effects on the environment or human health, even if there is no scientific certainty as to the exact nature or scale of the potential harm. This will involve careful cost-benefit analyses in terms of sustainability. In this respect, the Committee notes the concerns expressed by environmental and consumer associations, who feel that the Commission's proposal is not sufficiently plain on the need to stop producing chemicals that are known to be toxic, persistent and bioaccumulative. The use of substitutes for dangerous substances should be promoted wherever a suitable alternative exists.

4.8. The proportionality principle too should be applied, in relation both to the intrinsic danger of substances and the impact on the costs of the individual company having to supply the documentation required. This principle should guide the search for flexible formulas that enable the European chemical industry to maintain its competitive position as a world leader, without undermining the principle of protecting human health and the environment.

4.9. On the basis of the responsibility principle, companies that produce, import, market or use chemicals will have to provide the requisite information regarding the properties and uses of existing substances. This will speed up the pursuit of the policy objectives listed above, especially if the collection of that data and information is tied into appropriate schemes. Such schemes should be the same for all operators in the use chain (from production to consumption and disposal) and should use the most advanced tests that technological innovation and the scientific community can offer, to identify properties that have been proven or are presumed dangerous for homogeneous categories of substance.

4.10. The Committee supports the Commission's proposal (point 8.2) to make the current European Chemicals Bureau (ECB) into the central body responsible for managing the REACH system and providing Member States with the necessary technical and scientific support for the evaluation of chemical substances in particular. This body must be provided with resources that are commensurate with the new tasks it is to perform.

5. Specific comments

5.1. The white paper (point 3.4) estimates that the collection and analysis of data on the 30000 existing substances produced in quantities of over one tonne will take 11 years, with a total cost to companies of up to EUR 2,1 billion. The Commission is still convinced that the adoption of a "substance-tailored" test is the safest and most efficient way forward. The Committee would mention however that the interested parties have all expressed concern that the testing process will prove too lengthy, complex and burdensome. More specifically, the use of "quantity produced" as the criterion for defining the three categories of chemicals to be tested and registered seems necessary but also inadequate. The danger is that it could encourage evasive behaviour, especially for imports, and neglect the potential risk posed by using even modest amounts. It would be preferable to divide the substances up into groups or families, by chemical structure and/or properties. This could speed up the entire process of reviewing substances while also cutting costs.

5.2. The REACH system (point 4) is undoubtedly a step in the right direction compared with the current convoluted procedures, as it will secure greater transparency and more widespread dissemination of information on the intrinsic properties of existing chemicals. It remains however a complex system that will not be easy to manage, in particular given the diverse competencies and responsibilities of the Commission and Member States. The Committee also believes further clarification is required of the concept of "increased flexibility" in relation to the exemptions in point 4.3 for the authorisation of highly problematic substances. The assessment process must never undermine the precautionary principle.

5.3. The Committee is also concerned that the Member States generally have trouble adjusting their technical, scientific and administrative structures to Community legislation. In view of the need to guarantee producers a level playing field and consumers maximum certainty and information, while respecting confidential information covered by industrial secrecy, the Committee is concerned that the human and financial resources allocated to the ECB must be commensurate with the work required of it. These resources must also take into account the increased adjustments that will be required by enlargement.

5.4. In the Committee's view, to avoid unnecessary data overlaps (the impact of which on costs is inversely proportionate to the scale of production and the size of the company) companies must be encouraged to cooperate and to submit joint dossiers on individual substances, with precise indications of the uses for which the substance was designed and produced. The Committee is aware that this proposal could be difficult to implement from a legal point of view. Nevertheless, with a view to speeding up the application of the white paper's principles, consideration could be given to appropriate forms of cooperation between major producers, importers and users of chemical substances that individually do not exceed the tonnage thresholds, in cases where overall European consumption does.

5.5. On the subject of imports, the repeated assurance that as importers are subject to the same obligations there would be no negative effects on the competitive position of European companies is not convincing as:

- the EU is a major exporter, so an increase in internal costs could make exports more difficult and/or encourage alternative production in countries where safety and environmental protection are not really a consideration;

- it is not clear whether the obligation concerns each legally autonomous company or rather the controlling group (stating the responsibility of a group of companies with common ownership would reduce the risk of evasive behaviour);

- it is not necessarily the case that the need to seek less dangerous substitutes leads to investment in innovation, if the products to be substituted continue to be marketed in other regions of the world and if, more generally, consumers are not made aware of the better health or environmental performance justifying an increase in the cost of a product;

- the cost and burdens imposed by the REACH system may hinder the activities of SME importers, and discourage the import of small quantities into the EU; this could have negative effects for competition and employment.

5.6. The Committee therefore believes that one of the basic keys to defending the competitive position of the European chemicals industry is by striving to transfer EU laws to international level, with a view to establishing harmonised regulations. Far from being a marginal aspect of the strategy, this objective is a cornerstone in the application of the precautionary principle at world level. An initial positive step in this direction was the signing of the convention on POPs (persistent organic pollutants) on 22 May in Stockholm(4).

5.7. The ESC is aware of the practical problems that remain unsolved with regard to translating the broadly acceptable general policies of the white paper into specific laws. Nevertheless, it would stress the need for all the stakeholders to take a positive stance vis à vis the complexities of the implementation phase. It intends to monitor the process and make its own contribution towards a future chemicals industry that maintains and strengthens competitiveness in a context of safety and maximum protection for public health and the environment.

Brussels, 17 October 2001.

The President

of the Economic and Social Committee

Göke Frerichs

(1) COM(2001) 31 final. Committee opinion OJ C 221 of 7.8.2001.

(2) PBT = substances that are persistent, bio-accumulative and toxic.

(3) VPVB = substances that are very persistent and very bio-accumulative.

(4) For the content of the convention, see IP/01/730.