Aims & Objectives of REACH
Introduction
REACH is the European Community Regulation on chemicals and their safe use (EC 1907/2006). The provisions of this regulation came into force in June 2007.
REACH covers all substances on their own, in preparations and in some articles. Under REACH, substances that are manufactured or imported in quantities above 1 tonne per year per manufacturer/importer will have to be registered. Exemptions from the scope of REACH (e.g. waste) apply where other EU legislation provides a similar level of protection for human health and the environment. In addition, REACH Annexes IV and V, respectively, list individual substances (e.g. argon, nitrogen, etc) and groups of substances (e.g. minerals, ores, process gases, etc) that are exempt from registration because their properties are well-known and they are deemed to cause minimal harm.
REACH consists of four main stages:
- Registration – Importers and manufacturers of substances in quantities over 1 tonne per year must register their substance(s) with the new European Chemicals Agency (ECHA) based in Helsinki, which is responsible for coordinating registration at community level.
- Evaluation – ECHA in conjunction with Member State competent authorities will review registration dossiers to determine the impact of substances on human health and the environment and, where necessary, they may request further information or testing.
- Authorisation – SVHC, substances of very high concern, (i.e. carcinogens, mutagens, reproductive toxicants and those harmful to nature classified R50/53) will require authorization for each use.
- Restriction – Member State competent authorities may request restriction of the manufacture or use of a substance where there is an unacceptable risk to human health or the environment that needs to be addressed on a Community-wide basis.
Manufacturers and importers have certain duties to manage the risks posed by using chemicals. These include an obligation to:
- prepare risk assessments and to register their substances;
- provide appropriate safety information to downstream users and, for the more hazardous substances, to consumers; and
- pass information on chemical hazards and management techniques up and down the supply chain.
Downstream users of chemical substances:
- must apply the risk management measures identified by the supplier and communicated to them via Safety Data Sheets (SDS) and pass this information down the supply chain; and
- should make their suppliers aware of how they use each substance so that the supplier can include these uses in the risk assessment and risk management information in the SDS.
The REACH Process
Pre-registration
Pre-registration is one of the key stages of the REACH process, which takes place between 1 June 2008 and 1 December 2008. During this period, manufacturers and importers may in accordance with Article 28 provide the following information concerning the substances that they intend to register:
- The name of the substance;
- EINECS and CAS numbers of the substance or, if not available, other identity codes;
-
The name and address of the potential registrant (i.e. manufacturer, importer or
person representing them); - The name of the contact person;
- The envisaged deadline for the registration and the tonnage band
Substance Information Exchange Forums (SIEFs)
On 1 January 2009, 1 month after the pre-registration phase has ended, ECHA will publish a list of pre-registered substances on its website. The list will comprise only the names of the substances, including their EINECS and CAS numbers if available and other identity codes, and the first envisaged registration deadline.
In accordance with REACH Article 29, SIEFs will be formed by groups of producers and importers of the same substance with the following aims:-
(a) facilitate, for the purposes of registration, the exchange of specified information between potential registrants in order to avoid the duplication of studies; and
(b) agree classification and labelling where there is a difference in the classification and labelling of the substance between potential registrants.
It is important to differentiate the legal status of SIEFs and consortia. SIEFs are a legal requirement In contrast, membership of a consortium is purely voluntary.
Registration
Registrations may be submitted to the ECHA from 1 June 2008, when the registration process commences. If, however, a phase-in substance has been pre-registered in accordance with REACH Article 23, the transition period applies and registration is permitted in the following three stages based on the tonnage manufactured in EU or placed on the EU Market:
1 December 2010: Registration deadline for:
- substances in quantities of 1000 tonnes per year and above;
- carcinogens, mutagens and reprotoxic substances (CMR category 1 and 2) above one tonne per year; and
- substances classified as very toxic to aquatic organisms (R50/53) above 100 tonnes per year.
June 2013: Registration deadline for substances in quantities of 100 tonnes per year and more.
June 2018: Registration deadline for substances in quantities of 1 tonne per year and more.
Legal entities (i.e. manufacturers and importers) may voluntarily register phase-in substances at any time between 1 June 2008 and the transitional deadlines listed above, while new substances must be registered before being placed on the market.
It is recommended to consult the ECHA REACH Navigator website for detailed guidance on registration, while the Commission Regulation on the fees and charges payable to the European Chemicals Agency is published on the website of the Official Journal of the EU.
REACH Articles 6 (substances on their own or in preparations) and 7 (substances in articles) require manufacturers and importers to submit a ‘technical dossier’ for substances manufactured or imported in quantities of 1 tonne or more. For substances manufactured, imported, or used in quantities over 10 tonnes per year an additional more detailed Chemical Safety Report (CSR) is also required.
Application of REACH to the steel industry
Eurofer’s plan to host the Iron & Steel Cooperation Platform (including consortia for metallic iron and iron oxide) has been abandoned in favour of working in smaller more manageable clusters based primarily on the iron and steel production routes/steel types.
The clusters consist of groups of steel producers with similar interests working together to implement REACH. The clusters that have been identified are as follows:
Each cluster will map its uses of iron and steel, which will be used to generate a chapter concerning its uses of iron for the REACH Technical dossier. Some members of the Clusters will act as Lead Registrant and SIEF Formation Facilitator in the Fe SIEF.
In order to assist its members in their implementation of REACH and to overcome certain difficulties identified with the concept of working in clusters, Eurofer has introduced its REACH Forum.
The Iron Platform and Eurofer
Early May 2009, a Partnership Agreement (PA) was established between Eurofer and the Iron Platform (IP). With this PA, Eurofer became an associate member of the IP and has a seat in both its Steering Committee and the Technical Working Group. Meanwhile, 36 companies completed and signed the letter of intent to become a "Eurofer Member of the IP".
Eurofer Members that decided not to become "Eurofer member of the IP" are entitled to free access and unrestricted use of Safety Data Sheets and Exposure Scenarios generated by the Eurofer REACH clusters in connection with the work of the Iron Platform. This however does not include technical dossiers nor chemical safety reports (both needed for making the registration) which in that case can be obtained via the letter of access. "Eurofer Members of the IP" are not contributing to the administrative costs of the IP.
Iron Platform website: www.ironconsortium.org