The Regulation on Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) entered into force on 1 June 2007. It streamlines and improves the former legislative framework on chemicals of the European Union.

On 13 February 2001, the European Commission adopted a White Paper setting out the strategy for a future Community Policy for Chemicals. The European Commission's original legislative proposal on REACH amending a relating Directive was adopted on 29 October 2003 and was communicated to both the European Parliament and the Council in November 2003.

The work in the European Parliament has been led by the Committee on the Environment, Public Health & Food Safety, with – in first reading - the assistance of nine other parliamentary committees. The European Parliament adopted its first reading opinion on 17 November 2005.

The Council reached a Political Agreement for a Common Position on 13 December 2005. The Environment Council formally adopted the Common Position on June 2006 which served as the basis of discussion during the second reading in the European Parliament, which started in September 2006.

A Commission Communication on the Common Position was adopted on 12 July 2006 and submitted to the European Parliament and Council allowing the second reading to commence.

The representatives of the European Parliament and the Council found a negotiated agreement of the final version of REACH in early December 2006. This agreement was subsequently endorsed at second reading in the European Parliament on 13 December 2006 and got finally adopted at the Environment Council on 18th December 2006.

The text of the law was published on 30 December 2006 in the Official Journal of the European Union and the new EU chemicals Regulation REACH entered into force on 1 June 2007.

The main aims of REACH are to improve the protection of human health and the environment from the risks that can be posed by chemicals, the promotion of alternative test methods, the free circulation of substances on the internal market and enhancing competitiveness and innovation.

REACH makes industry responsible for assessing and managing the risks posed by chemicals and providing appropriate safety information to their users. In parallel, the European Union can take additional measures on highly dangerous substances, where there is a need for complementing action

How does REACH work?

All manufacturers and importers of chemicals must identify and manage risks linked to the substances they manufacture and market. For substances manufactured or imported in quantities of 1 tonne or more per year per company, manufacturers and importers need to demonstrate that they have appropriately done so by means of a registration dossier, which must be submitted to the European Chemicals Agency (ECHA).

The Agency may then check that the registration dossier complies with the Regulation and must evaluate testing proposals to ensure that the assessment of the chemical substances will not result in unnecessary testing, especially on animals.

Where appropriate, authorities may also select substances for a broader substance evaluation to further investigate substances of concern.

REACH also foresees an authorization system aiming to ensure that substances of very high concern are properly controlled, and progressively replaced by suitable alternative substances or technologies where these are economically and technically viable. Where this is not possible, the use of substances may only be authorized where there is an overall benefit for society of using the substance.

In addition, EU authorities may impose restrictions on the manufacture, use or placing on the market of substances causing an unacceptable risk to human health or the environment.

The Member States authorities are responsible for enforcing REACH through inspections as well as penalties in case of non-compliance.

Role of the European Commission

Prior to the entry into force, the European Commission was responsible for the preparing the legislation and supporting the European Parliament and the Council during the decision making process. At the same time, preparatory work for REACH implementation began several years before the legislation was adopted. This included the setting up of the European Chemicals Agency in Helsinki but also the preparation of IT tools, guidance documents and the creation of a network of helpdesks that will support industry and authorities to fulfill their tasks under REACH. More information on the work of the Commission prior to the entry into force of REACH can be found here.

After entry into force of REACH on 1 June 2007, many of those tasks, including the provision of information on REACH to companies and the general public have been transferred to the European Chemicals Agency (ECHA). You can find on its website a wide range of information, including legislative texts, summaries of the legislation, press materials, brochures, guidance documents, Frequently Asked Questions and links to helpdesks.

Nevertheless, the European Commission keeps an important role in updating and completing the REACH legislation and in taking decisions in a number of REACH processes, in particular authorization and restrictions. Moreover, it actively participates in finalizing and updating REACH guidance and supports the European Chemicals Agency in its tasks.

In parallel, the Commission has prepared implementing legislation that is necessary to put the provisions of REACH into effect, such as: a Regulation on fees, which will set fees to be paid by industry for e.g. registration and applications for authorization two Regulations on the arrangements for the Board of Appeal of the European Chemicals Agency a Regulation on test methods.

In these tasks, the Commission is supported by a regulatory Committee composed of representatives from all Member States. In parallel, REACH implementation issues are discussed in the group of Competent Authorities for REACH and CLP (CARACAL). More information about CARACAL can be found here.

The Commission is also involved in giving advice on key issues related to the interpretation of REACH. This concerns giving advice on draft guidance documents and on helpdesk questions to ECHA and the REACH helpdesk network. In this context, the Commission and ECHA have been working on how nano-materials are to be treated under REACH. Information on this work can be found here. Moreover, the Commission has elaborated a paper to clarify REACH obligations of waste and recovered substances. Several drafts of this paper have been consulted with Member States and stakeholders. The paper has been handed over to ECHA for finalization and updating the relevant guidance documents.

The Commission is also preparing for its future tasks under REACH:

It will have a key role in the authorization process, as it will identify substances that are subject to authorization, and decide whether to grant the authorizations. It will also issue decisions regarding restrictions.

The Commission also has representatives in the Management Board of the Agency and may participate to the meetings of the Committees of the Agency.

Benefits of REACH

Various studies have been carried out to determine the costs of REACH for businesses and the European economy at large, however, the description and quantification of benefits for human health, the environment and for businesses has been addressed to a much lesser degree. Well funded information on benefits of REACH is scarce. This is due to the lower emphasis on benefit assessment and the various difficulties connected to benefit estimation - such as the dependency of impacts on the behavior of industry actors, the lack of data on cause-effect links, current chemicals related damage or baseline information at enterprise level.

However, the fact that benefits are created is substantiated at qualitative and quantitative level by the studies analyzed on the request of the Commission. The report identifies the types of benefits linked to actual mechanisms or policy outcomes of REACH and extracts how those benefits have been assessed and quantified.

Since the realization of benefits largely depends on enterprises taking their responsibility for safe products, the study recommends to motivate companies by quantifying expected benefits based on case studies. Furthermore, an illustration of how enterprises could integrate REACH mechanisms in their business strategies in such a way that benefits would be generated, might encourage enterprises to be pro-active, foster quality differentiation in the market and thus promote the implementation of REACH in their own supply chains. The study was performed by the German Institute for Environmental Strategies, Ökopol, and finalized in February 2007.

The report notes that studies and assessments of REACH impacts have focused on the determination of costs for industry, whereas the description and quantification of benefits has been addressed to a much lesser degree.

Due to the lower emphasis on benefit assessment as such and the various difficulties connected to benefit estimation - such as the dependency of impacts on the behavior of industry actors, the lack of data on cause-effect links, current chemicals related damage or baseline information at enterprise level – well funded information on benefits of REACH are scarce. However, the fact that benefits are created is substantiated at qualitative and quantitative level by the studies analyzed. Since the realization of benefits largely depends on the behavior of industry actors and how they will respond to the new requirements as well as chances under REACH, more effort may be put on illustrating business benefits from REACH in more detail.

REACH aims at generating information on properties of and exposures to substances in order to enable the actors in the market to better describe and communicate the conditions of use leading to adequate control of risk. Quantification of costs and benefits would largely need the information which is only to be generated under REACH. Thus, it is a ‘mission impossible’ to determine “pure benefits” like i) reduction of true risk or ii) prevention of “true” current damage, independent of the improvement in the knowledge basis. To this end, it will be very difficult to differentiate between “true” benefits, and “virtual benefits” (related to better information on risks). Thus any benefit study in future will have to cope with the fact that only changes in the perceived risk can be measured since there is no baseline available on “true risks”. Also, in generating risk related information, REACH interacts with current legislation in various fields and with ongoing developments in the chemicals world market. A “pure” REACH triggered impact (advantage or drawback) is therefore unlikely.

REACH shifts the responsibility to document safe use to the manufacturers and importers of substances and provides at the same time for mechanisms to share this responsibility with downstream users. REACH also establishes the duty to make use of the generated information and establishes mechanisms supporting feedback on the quality of risk management information from customers to suppliers. In theory this should lead to an improvement of quality of the current key information instrument, the safety data sheet, the report notes.

It is unlikely that a consolidated benefit assessment methodology (prospective appraisal) related to human health or the environment can be developed. There are numerous different types of methodologies that could be (and are) applied, as evidenced by the findings of this study. It is more promising to adopt and adapt a methodology, so as to ensure that it is most suitable to the issues at hand and the data available.

However, in order to create a basis to monitor and assess success and failure of the REACH regulation (ex-post analysis) and thus being able to make informed and transparent choices when reviewing the legislation after a period of time, a number of arrangements should be made now. As stated above, a careful selection of indicators could help in monitoring policy success and determining reduction of exposures to dangerous chemicals. So far, a study has been launched by the Commission that aims at defining policy success indicators for REACH and the respective baseline. A “quality and risk” indicator has been defined and will be applied to a random sample of 125 out of 10.000 substances. Based on available information on substance properties, use and exposure, the baseline risk connected with each of the substances is established. For this, 125 fast track tier 1 risk assessments are carried out. At the same time the quality of the available data is scored. In 6 and 12 years time the same collective of 125 substances will be re-assessed and changes in risk and quality established. For substances disappearing from the market substances from a reserve list will be added to the sample. Each change will be analyzed to which extent it is directly driven by REACH and/or by other co-factors, The core-indicator of risk and quality will be supplemented by indicators simply monitoring progress in substance registration, data availability with regard to registered substances, use of QSARS and other non-animal testing, The core-benefit indicator in this concept is “decrease of perceived risk” and “increase of information quality”. The improvement of data quality is not a value in itself however it enables more rational allocation of resources for risk management.

It may be also possible to launch a study on monitoring policy success with regard to competitiveness and innovation effects in the same way. This should be based on a representative sample of companies, for which impacts over 12 years can be monitored. An indicator concept around “product safety”, “innovation” and “efficiency of risk management” would still need to be developed. A long term case study approach may be needed to enable identification of REACH related impacts in the overall development of these companies. It is unlikely that such impacts would be traceable with a more general approach.

As REACH builds on enterprises taking their responsibility for safe products, more efforts could be made to motivate enterprises by quantifying expected benefits at company level based on case studies.

Furthermore, an illustration of how enterprises could integrate REACH mechanism in their business strategies in a way that benefits would be generated, might encourage enterprises to be proactive, foster quality differentiation in the market and thus promote the implementation of REACH in the own supply chain, the report notes.