Frequently Asked Questions
The European bitumen association, Eurobitume, of which the Refined Bitumen Association is a member, 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.
It is a new 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.
It was approved by the European Parliament in 2006 and came into force across the EU on 1st 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.
It aims to increase both human and environmental safety. It will extend and harmonise knowledge of chemicals, putting the responsibility on manufacturers and importers to show 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.
The first step is pre-registration. This applies to all existing chemicals manufactured or imported in quantities over one tonne per year. Each manufacturer or importer of a chemical (an estimated 30,000 chemicals will be involved, including bitumen) will have to pre-register basic information on their substances with the European Chemicals Agency in the period 1st June – 30 November 2008. The information to be provided for the pre-registration is the same for hazardous and non-hazardous products and includes:
• Chemical Identity – name, CAS and EINECS number
• Volume - tonnage band and envisaged registration date)
• Identification of Manufacturer/Importer (M/I) – name and address of the legal entity responsible for the manufacture / import of the chemical
For further information on pre-registration requirements see Article 28 of REACH.
Chemicals will then 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.
A new European Chemicals Agency, based in Helsinki, will receive the basic registration dossier and control the data. This agency will also evaluate the need for further information, which will be based on the assessed hazards associated with each substance in relation to each of its uses.
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.
Only substances of very high concern will be subject to authorisation – for example carcinogens and persistent, bio accumulative 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.
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 preparing a bitumen hazard assessment and, if necessary, a risk assessment dossier covering each of 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 is also planning to provide members with guidance on inventory preparation and REACH-compliant Safety Data Sheets.
Find out from your supplier of bitumen (and suppliers of other raw materials that you use) how they are preparing for REACH registration and which downstream uses 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.
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.
For further information, contact:
Refined Bitumen Association
Tel: 01423 876 361