Eurobitume is leading the industry’s initiative to prepare for compliance with REACH, the new European procedures for evaluating and registering all chemical substances. This new regulation affects all downstream users or processors of bitumen.
What is REACH?
It is a European Regulation governing the control of chemicals in the European Union, which replaces more than 40 existing pieces of legislation. It stands for Registration, Evaluation and Authorisation of Chemicals.
When did it become law?
It was approved by the European Parliament in 2006 and came into force across the EU on 1 June 2007. Chemicals will be phased into the REACH scheme, with pre-registration of all chemicals by 2008 and mandatory full registration between 2010 and 2018. In most cases manufacturers and importers of bitumen will need to register by December 2010.
What does it aim to do?
It aims to protect both human health and the environment. It will extend and harmonise knowledge of chemicals, putting the responsibility on manufacturers and importers to demonstrate that a chemical can be used safely and, if necessary, tightening controls on the most hazardous substances. It also hopes to encourage development of new safer products.
Where will the chemicals be registered?
The new European Chemicals Agency (ECHA), based in Helsinki, was established to receive the basic registration dossier and control the data. This agency is also evaluating the need for further information, based on the assessed hazards associated with each substance in relation to each of its uses.
How will it work?
The first step was pre-registration. This applied to all existing chemicals manufactured within the EU or imported in quantities over one tonne per year. Each manufacturer or importer of a chemical (an estimated 30,000 chemicals are involved, including bitumen) had to pre-register basic information on their substances with the European Chemicals Agency during the period 1 June – 1 December 2008. The information to be provided for the pre-registration was the same for hazardous and non-hazardous products and included:
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Chemical Identity – name, CAS and EINECS number
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Volume - tonnage band and envisaged registration date
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Identification of Manufacturer/Importer (M/I) – name and address of the legal entity responsible for the manufacture / import of the chemical
Although the pre-registration period has now closed, for further information on the original pre-registration requirements see Article 28 of REACH.
Chemicals will next need to be registered with the Agency, which involves provision of data on their hazards, characteristics and uses. Registration will take place in 2010, 2013 or 2018, dependent on production volume and hazard. The information submitted will be evaluated by the Agency, and the most hazardous chemicals of "very high concern" will be subjected to a further system of testing and authorisation.
What if we didn’t pre-register?
Manufacturers or importers that failed to pre-register needed to submit a full registration by 1 December 2008. They will not be allowed to take advantage of the extended deadlines for fulfilling the full registration process (2010 – 2018) mentioned above, which are permitted for the so-called “phase in” substances. If a substance has not been pre-registered manufacture and import must cease until it has been registered.
What data will be required for registration?
Manufacturers and importers will be required to document the safety of their substances in each of its applications. They will have to secure comprehensive information on uses from their clients, in order to produce a dossier detailing: the chemical's hazard properties; information about the nature of various exposures throughout the entire life cycle of the product; an analysis of the risks to health and the environment; and adequate safety recommendations for transport and handling.
Which chemicals will require further authorisation?
Only substances of very high concern will be subject to authorisation – for example carcinogens and persistent, bioaccumulative and toxic (PBT) chemicals. Bitumen is not currently classed as a substance of high concern.
An authorisation will grant permission for specified uses only. Authorisation can be granted if the producer or importer can show that risks from the use in question can be "adequately controlled", or that the socio-economic benefits of the use of the substance outweigh the risks, and that there is no existing safer substitute.
What information on registration can I obtain from my bitumen supplier?
Bitumen suppliers that are members of Eurobitume or CONCAWE (the oil companies’ European association for environment, health and safety in refining and distribution) will receive a set of guidelines for bitumen REACH registration. CONCAWE is also carrying out a bitumen hazard assessment and will, if necessary, prepare a risk assessment dossier covering the main bitumen applications. This will form the basis of the Chemical Safety Report needed by suppliers for REACH registration. Eurobitume is working with CONCAWE to ensure that all the appropriate applications are included in this body of work. Eurobitume has provided members with guidance on inventory preparation, manufacturing process description & use of EINECS/CAS number definitions and is planning to provide them with REACH-compliant Safety Data Sheets.
My company purchases bitumen for asphalt manufacture - what should I do?
Find out from your supplier of bitumen (and suppliers of other raw materials that you use) how they are preparing for REACH registration and whether your downstream use will be registered. You will need to ensure that your application of bitumen is covered by the exposure scenarios developed by your supplier. He may require you to provide additional information to support any non-standard applications or you can register your use independently with the Chemicals Agency. In addition Eurobitume is in dialogue with the main industry associations for Downstream Users; EAPA, BWA, IBEF and EMAA. If your company is a member of one of these associatiosn you should discuss with them what they are doing to prepare for REACH.
My company purchases bitumen to blend with other chemicals (and for emulsion manufacture) - what should I do?
Obtain information from your supplier, as above. The blending of bitumen with other materials does not normally constitute “manufacture” of a chemical and hence does not require registration under REACH. In some circumstances, however, a chemical reaction may occur and result in the need to register the reaction product. If this is considered likely you should discuss this with the suppliers of your raw materials to confirm what actions you need to take.
What is the current status of the REACH process?
With the closure of pre-registration on 1 December, the next major milestone is the announcement of the SIEFs (Substance Information Exchange Forums). This involves validation of the pre-registrations, elimination of those that do not qualify and publication of the complete list along with the respective pre-SIEFs. However, the total number of pre-registrations - 2.75 million - was some 20 times higher than ECHA had anticipated. As a result the screening process is taking longer than foreseen and as yet no publication date for the final list has been announced.
On 19 December ECHA published an initial list of pre-registered substances. This contained about 150,000 substances which were pre-registered by 65,000 companies between 1 June and 1 December 2008. The pre-registrations cover all the EU existing substances (EINECS) and the list of notified new substances (ELINCS), together totalling around 105,000 substances. The remainder of the substances on the initial list are not in these inventories and are currently being screened. ECHA will update the list as the checking progresses.
During the screening process ECHA removes those pre-registrations that are in all evidence not substances (for example, pre-registrations that are articles, such as shoes). Pre-registrations submitted by companies outside the EU/EEA will also be deleted. ECHA then merges substances that are synonymous into one pre-SIEF. Thus the screening will result in fewer substances on the list and changes to the number of companies in the pre-SIEFs.
Updated: July 2009
For further information, contact:
philippe.dewez@eurobitume.eu or mike.southern@eurobitume.eu
