31 No. 4
REACH: Toward the Safer Management of Chemicals*
by Astrid Schomaker and
Cristina de Avila
When the European Chemicals Agency (ECHA) officially started its operations at the beginning of June 2008, it marked a sea change in the management of chemicals in Europe. Regulation (EC) No. 1907/2006 of the European Parliament and the Council of 18 December 2006, an intensely debated piece of legislation—closely monitored by stakeholders within and beyond the European Union (EU)—concerning the registration, evaluation, authorization, and restriction of chemicals (REACH),1 replaces 40 pieces of previous European chemicals legislation. The most distinctive and innovative feature of REACH is the reversal of the burden of proof: It is no longer the task of public authorities to prove that certain substances present certain risks; rather, those who wish to manufacture or import these substances in the EU must provide sufficient information on the effects of their chemicals on human health and the environment (on registration). In addition, to minimize and control the risks associated with chemicals, the manufacturer or importer must request authorization for the use of the most dangerous chemicals, and those substances presenting unacceptable risks to human health or the environment are to be restricted.
REACH is designed to close the knowledge gap on some 30 000 substances in a staggered process over the next 10 years and is expected to have wide-ranging benefits in terms of better public and occupational health and reduced pollution of air, water, and soil. Its impact is not limited to the EU’s borders: It affects a broad range of industrial manufacturing activity and trade with Europe. REACH constitutes one of the EU’s main contributions to achieving global sustainable development, as mandated by the 2002 World Summit on Sustainable Development.2
Starting from a one-tonne threshold, REACH establishes the basic principle that substances on their own, in preparations or in articles, must not be manufactured in the EU or placed on the EU market unless they have been registered with ECHA.3 In practical terms, registration requires that manufacturers and importers compile data on the intrinsic properties of their substances, as well as safety and exposure data, and recommend appropriate risk-management measures. This information must be included in a registration dossier and submitted to ECHA.
Although registration has been considered too burdensome by some industry and non-EU-country stakeholders, it is important to note that in the tonnage bands between 1 and 10 tonnes (which concerns 20 000 of the approximately 30 000 substances), the information requirements are quite limited and in fact less comprehensive than under legislation prior to REACH. If a substance is placed on the EU market in quantities above 10 tonnes, the manufacturer or importer must submit, in addition to the information on intrinsic properties, a chemicals safety report (CSR) that contains a safety assessment of the substance concerned. Details on the relevant information requirements can be found in annexes VI to XI of the REACH regulation. All registration dossiers are checked by ECHA for completeness.
The obligations of producers and importers of articles are more limited than those of manufacturers or importers of substances on their own or in preparations: Producers and importers of articles are required to register the substances used in those articles, particularly if the substance is present in quantities totaling more than one tonne per manufacturer or importer per year and if it is intended to be released under normal conditions of use of the article. ECHA can take the initiative and demand a registration of any substance contained in articles if it has grounds for suspecting that a substance present in articles in quantities totaling more than one tonne is released from an article and presents a risk to human health or the environment.
Substances introduced for the first time on the EU market have been subject to registration since 1 June 2008; for most other so-called “phase-in” substances, REACH creates a transitional regime that foresees their registration by deadlines in 2010, 2013, or 2018. The applicable deadline depends on the tonnage manufactured or imported and the hazard profile of the substance. To benefit from these extended deadlines, REACH stipulates that phase-in substances had to be preregistered between 1 June 2008 and 1 December 2008. Preregistration was a simple process that was free and involved communicating to ECHA the name of the substance, its European Inventory of Existing Chemical Substances and Chemical Abstracts Service Registry numbers, and the tonnage band for the volume intended to be manufactured or imported. During the preregistration period, ECHA received about 2.75 million preregistrations for about 150 000 substances. A comparatively small number of registration dossiers (94) were submitted in 2008. It is worth noting that of these 94 registrations, only 10 passed the completeness check, which raises the questions about the quality of submissions prepared so far, a concern that may become more acute as dossiers are assessed for compliance (see “Evaluation,” below).
|The impact of REACH will not be limited to the EU’s borders, nor will its benefits.
ECHA also undertakes to put companies preparing registrations for the same substances in touch with each other in Substance Information Exchange Fora (SIEFs) to reduce duplicate testing of substances and to minimize the costs associated with registration. The challenges companies are facing in the coming months are forming SIEFs and agreeing on the necessary elements to prepare registration dossiers together. This task presents itself as urgent in the case of high-volume substances. So far, a total of 146 171 pre-SIEFs have been formed to cover the preregistrations submitted to ECHA. The size of the pre-SIEFs varies greatly: 88 percent have less than 25 members, versus 138 pre-SIEFs that have more than 1 000 members.
Evaluation is the process of examining and analyzing the information submitted by the registrants. It serves the dual purpose of ensuring high-quality registration dossiers and preventing unnecessary testing. REACH distinguishes between two types of evaluation: dossier evaluation and substance evaluation. Dossier evaluation is carried out by ECHA and in itself covers two distinct activities: (1) scrutinizing testing proposals to ensure that the data they set out to generate are reliable and adequate while avoiding using vertebrate animals as much as possible; and (2) checking compliance of the registration dossier—i.e., verifying whether the information in the technical report and the CSR correspond to the legal requirements in the REACH regulation. ECHA is required to carry out compliance checks on at least 5 percent of all dossiers received per tonnage band.
Substance evaluation is performed by the competent authorities of the EU member states in a process coordinated by ECHA. It aims to follow up on initial concerns for human health or the environment by requesting additional information from the industry and further assessing the information obtained. ECHA will produce a three-year rolling action plan for substance evaluation by December 2011.
Authorization ensures that the risks associated with the use of substances of very high concern (SVHC) are properly controlled and that these substances are progressively substituted with safer alternatives. Substances requiring authorization include those meeting the criteria for classification as carcinogenic, mutagenic, or reprotoxic (CMR) categories 1 and 2; substances that are persistent, bioaccumulative, and toxic (PBT); and substances that are very persistent and very bioaccumulative (vPvB). Substances for which scientific evidence of probable serious effects on humans or the environment exists, which gives rise to equivalent concern as the aforementioned categories (e.g., endocrine disruptors), can be identified on a case-by-case basis.
Authorization is not an automatic consequence of falling into any of the above categories. Rather, it requires the identification of substances to be included in the system as a first step. This involves the establishment of a candidate list for eventual inclusion in the annex to the regulation listing substances subject to authorization (Annex XIV), based on dossiers prepared by member states or ECHA on request by the European Commission (an EU body representing the common EU interest). From that list, ECHA will prioritize a certain number of substances at regular intervals and recommend the commission to include them in Annex XIV. Manufacturers, importers, or users of substances eventually included in Annex XIV may only place them on the market for use or use them if an authorization has been granted. The authorization process is transparent, granting third parties the possibility to submit information at various stages of the process.
ECHA published a first candidate list in 2008 and will make its first recommendation of priority substances on the basis of this list by 1 June 2009. This first candidate list contains 15 substances, of which 5 are carcinogenic, 3 are toxic for reproduction, 1 is carcinogenic and toxic for reproduction, 1 is a full CMR, 3 are PBTs, 1 is vPvB, and 1 is both PBT and vPvB. This very modest operational start for authorization is disappointing given the number of substances already today identified as CMRs and opens the question of what is to happen in the short term with these substances that have long been identified as SVHC. This concern is shared by many and has led NGOs and trade unions to publish their own lists of substances for which they are seeking substitution.4 A number of EU member states are now working together to reach agreement regarding which of the eligible substances are of most concern, with a view to increasing the number of dossiers they will submit over coming years.
The restriction title of REACH entered into force on 1 June 2009 and is intended to be the “safety net” of REACH. Restrictions can be imposed where an unacceptable risk needs to be addressed on an EU-wide basis. Restriction dossiers can be prepared by a member state or by ECHA (when requested by the European Commission). The dossiers have to include information on hazards and risks causing the concern, information on alternatives, and justifications regarding why action is needed on an EU-wide basis and why the other mechanisms in REACH are not sufficient to address the problem. Once a substance is subject to a restriction, it cannot be manufactured, placed on the market, or used unless it is in compliance with the conditions of the restriction. Final decisions on authorizations and restrictions are rendered by the European Commission, assisted by a committee of member states, while the preparatory work is carried out by ECHA.
Conclusions and Outlook
The impact of REACH will not be limited to the EU’s borders, nor will its benefits. While engaging in the REACH debate, many companies and EU international partners focused on reducing the economic impacts of the regulation on companies. For example, some lobbying focused on lowering the information requirements for registration or exemptions for registration in annexes IV or V, while others focused on limiting the impact of the substitution principle enshrined in authorization. Yet little was said on the foreseen benefits of REACH for humans and the environment.
The outlook for REACH is at present still unclear in terms of the capacity of industry and government authorities to meet expectations. The European Commission also faces a number of challenges in 2009, including developing its proposal for revised rules governing the identification of PBTs as set out in REACH Annex XIII. Over the years, the EU has accumulated considerable experience in this regard, which points to the necessity of a broad-based approach, taking into account information from a variety of sources in a weight-of-evidence approach and using expert judgment.
A new challenge ahead for the implementation of REACH is its application to nanomaterials. Questions arise in relation to substance identification and tonnage thresholds, which may prevent REACH from generating in all cases the comprehensive information it is expected to produce. The REACH approach of using tonnage as a proxy for exposure and hence for risk may need careful examination when applied to nanomaterials.
Knowledge knows no borders; neither does pollution. The EU has taken a first step toward a safer management of chemicals, and, although much work still remains, we should welcome the changes that REACH will bring globally.
1. Regulation (EC) No 1907/2006 established the European Chemicals Agency (ECHA), amending Directive 1999/45/EC and repealing Council Regulation (EEC) No. 793/93 and Commission Regulation (EC) No. 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC, and 2000/21/EC.
2. See the Implementation Plan of the World Summit on Sustainable Development, paragraph 23, <www.worldsummit2002.org>.
3. Although the basic principle of registration is that all substances on their own, in preparations, or in articles must not be manufactured in the EU or placed on the EU market unless they have been registered, wide groups of substances are exempted from the registration (evaluation and downstream user) obligations under REACH. Annexes IV and V to REACH contain substances and group of substances exempted from those obligations (minerals and ores are among those exempted in Annex V). Food, feed, and medicinal products are also exempted from registration and evaluation (the latter is also exempt from authorization).
4. See the NGO list at <www.sinlist.org> and the trade unions’ list at <www.etuc.org>.
Astrid Schomaker <[email protected]> and Cristina de Avila <[email protected]> are at the Chemicals Unit, DG Environment, European Commission, Brussels, Belgium. The views expressed are purely those of the authors and may not be regarded as stating an official position of the European Commission. This article draws up the main provisions of REACH, but it should not be taken as a full description of REACH. For further information, visit <http://ec.europa.eu/environment/chemicals/reach/reach_intro.htm>.
* An earlier version of this article was first published in Chemistry Australia, Vol. 75, No. 9, October 2008, pp. 5–7; revised and updated version reproduced with permission.
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