On the creation of REACH (2006)

The EU Parliament and the Council have now concluded an unparalleled three-year process of law formation by way of their agreement that provides for the registration of some 30,000 substances in a database.

Regardless of whether you examine water from the clearest mountain streams, air from a “pure air area”, a soil sample from a primeval forest, a core sample from the Arctic, umbilical cord blood or breast milk: synthetic chemicals will always be detectable. And frequently, they will occur in extremely low concentrations, yet sometimes also in unexpectedly high concentrations.

By 2020, the community of states – according to what it agreed at the 2002 Rio Earth Summit – intends to minimise the release of chemicals that are damaging to the environment and to health.  Some 100,000 substances are known on the European market – yet only a minuscule share of it is documented in such a way so as to provide a sound basis for assessing the risks emanating from the use of these substances.

The “2020 goal” mentioned above can only be reached if, on the one hand, validated documentation becomes the prerequisite for market access (the main properties of the substances must be known before these substances are used), and if, on the other hand, the precautionary principle is applied in a consistent manner. This principle requires measures for the reduction of exposure already if there is a justified suspicion of a risk. It aims at prevention and is thus in stark contrast to measures that will only take effect after a risk has become reality, i.e. when the damage can merely be repaired. This approach is pursued by e.g. the US in the form of its liability regime. After the damage has occurred, the polluter is presented with the bill. Focused on two fundamental principles, the European “better safe than sorry” approach is opposed to the US “polluter pays” approach.

Responding to the pressure coming from European environment ministers, the EU Commission devised a system three years ago that makes the documentation of the main properties of chemicals the prerequisite for them remaining on the market. The acronym “REACH” stands for a Regulation on the Registration, Evaluation and Authorisation of CHemicals. This new comprehensive EU chemicals policy is based on the pooling of the bulk of the chemicals-policy measures devised so far under a new and overarching scheme.

REACH provides for the registration of some 30,000 substances (production volume of more than 1 t p.a. and manufacturer) in a database, thus covering substance identity, distributors as well as basic physico-chemical, toxicological and eco-toxicological information. This way, far more than 90% of the chemicals available on the market are recorded.

The registered substances will be subject to a multi-tier risk assessment system. The individual applications of the substances are being assessed – and also the users are prompted to feed their experiences into the system. In any event, all substances the production of which exceeds 100 tonnes are officially assessed and tested (e.g. with regard to the demand for additional tests). The authorisation procedure is to record particularly hazardous chemicals – such as carcinogenic, or poorly-degradable, toxic and persistent substances. Even for chemicals that are used in innumerable articles of daily use, REACH provides for a reporting system.

In the operational implementation of the REACH system, the future European Chemicals Agency (Helsinki) is to assume a key role.

The future of chemicals policy: no data, no market

The first pillar of a chemicals policy based on precaution: In the framework of its decision-making process on REACH, the European Parliament holds a co-decision right and massively pushed for anchoring a general duty of care to be displayed by manufacturers and importers, yet had to content itself with respective passages in the preamble to the REACH Regulation that are politically relevant yet hardly binding from a legal point of view for the time being.

The second central and decisive implementation of the precautionary principle will consist of excluding particularly hazardous chemicals a priori from certain applications. Substances that may e.g. cause cancer or disrupt the hormonal balance and accumulate in the food chain are only to be allowed for use in authorised areas of application. 

The design of this authorisation system and the anchoring of the substitution principle therein was the core topic of the now-completed negotiations between the Council and the European Parliament in Brussels. Following pressure coming from the Parliament, a plan for the replacement of the hazardous substance must be part and parcel of each application for authorisation. Thus, the companies are prompted to come up with a strategy of their own (including an assessment of time schedules and a feasibility study) for replacing substances of very high concern by alternative substances or also by alternative technologies. This approach has always constituted the Austrian negotiating position: creating an environment that is as substitution-and-innovation-friendly as possible – increasing the effort for using a particularly hazardous substance and optimally promoting the development of alternative options – without imposing the point-in-time of change-over. Experience has shown that, within the newly-found compromise scenario, change-over takes place in a swifter and safer way than if it had been imposed.

The path that REACH has followed up to the decision on its adoption by the European institutions also proved to be the litmus test (to stick with chemical technology) for European legislative procedures proper:

• REACH replaces more than 40 EU Regulations and Directives, respectively, that are currently in force.
• Together with the numerous technical annexes, several hundreds of pages of legal text had to be negotiated.
• 7 presidencies, among them the Austrian presidency, dealt with the further development of the Commission proposal.
• Almost 4,000 amendments were tabled in the course of the 1^st reading.

This endeavour constituted a stress test and, at the same time, a litmus test for the EU institutions that was unique in terms of scope and complexity, as it had to chart a completely new pathway for an entire legal area that had grown over a period of 40 years in order for it to be in a position to reflect and consider the gained insights.

The aim of the new toolbox “Securing a high level of protection for health and the environment” is uncontested. In the course of the negotiations, also the cost efficiency of REACH has now been optimised and red tape has now been curbed. An impact assessment for Austria (conducted by a syndicate made up of: the Institute of Industrial Science, the Institute of Industrial Ecology; Denkstatt, an economic consultancy; and the Economics Chair at the University of Klagenfurt, Austria) arrives at the – rather difficult-to-digest – conclusion:

”In summary, there will be – also when considering existing data uncertainties – a relatively higher probability of the REACH implementation in Austria having overall favourable net effects on the national economy than can be assumed had REACH not been implemented (national-economy resource consumption in the case of introduction of REACH).“

The core message of this impact assessment is that REACH will provide the Austrian national economy with much more benefits when compared to the costs although many expected favourable effects on the environment were hardly quantifiable. The relevant and quantifiable benefit is constituted by the predicted prevention of work-related deaths, as, e.g., the carcinogenic property of certain agents is shown by REACH at an early stage. Still under Austrian presidency, the now-completed negotiations between the Council and the Parliament were kicked off: A 2-day conference in Vienna brought together the relevant stakeholders for the first time, prompted an analysis of viewpoints, showed possible approaches to solutions and thus laid the basis for the compromise. While the European chemical industry meanwhile plays a rather constructive role, the established US chemical industry is still caught in utter turmoil. The political pressure that the EU is triggering with its project is outright enormous.

The US lacks a precautionary strategy for tackling the problems caused by chemicals. Officially, problems with the world trade regime are cited as arguments against the future EU chemicals regime, and the precautionary idea is denounced as unscientific. Environmental and consumer associations are, however, not only pushing for abandoning the resistance against the EU initiative, but also for providing a similar regime for the US. 

Despite these difficult circumstances, agreement could be reached at UN level in Dubai in February 2008 on a globally applicable catalogue of principles and measures for precautionary chemicals management. Under the auspices of Austria, the EU managed to reach an impressive result – in particular with the US – in tough negotiations that now establishes many aspects of the REACH philosophy on a global scale.  

The preliminary works for life in the “REACH world” have begun long ago. Numerous dry runs and simulation projects have been designed to ensure a landing that is as soft as possible and guarantees that there are no unpleasant surprises. Work on the set-up of national “REACH helpdesks” in the EU Member States is in full swing. The same goes for Austria. Former Federal Minister Pröll tasked Umweltbundesamt, the Environment Agency Austria, with devising a scheme for an Austrian REACH helpdesk. This is not only to provide for a catalogue of REACH-related questions and answers that is as complete as possible but also to include all documents that are required for complying with documentation obligations. Yet the Austrian REACH helpdesk is also to include offers for achieving competitive gains from the newly emerging partnerships with REACH and communications structures between chemicals manufacturers and users – e.g. through the implementation of service-minded business models (keyword “chemicals leasing”) that the Austrian Environment Ministry has successfully developed, promoted and documented over the last years.

As a legal instrument, REACH is not only subject to stringent international monitoring after the decision on it has been adopted, but will also be under massive pressure to succeed. Yet this goes, at minimum to the same extent, for all stakeholders from politics, the business world and the society that have been involved in its design over the last years and that have meanwhile come to unanimously embrace this remarkable instrument that is second to none among global examples of environmental protection instruments.