Where can I get more information on REACH?
Further information about REACH can be found on the European Chemicals Agency (ECHA) website.
A list of the Member State (MS) Competent Authority (CA) contact details can be found here.
A complete FAQ document, as prepared by the Agency, can be found here.
What if I didn’t pre-register?
Companies failing to pre-register their substances do not qualify for the extended registration deadlines applicable to phase-in substances. Full substance registration is required before supply, and use, of the substance in the EU is legal.
What if I don’t register?
Companies failing to register their substances within the required timescales will be in breach of the REACH Regulation, and open to sanction by the Member State Competent Authorities, if they continue to manufacture or import the substance into the EU.
What enforcement measures are there for REACH?
The REACH Regulation will be enforced by the Member State Competent Authorities each of which has been required to put in place an enforcement regime for ‘effective, proportionate and dissuasive’ penalties for non-compliance. Penalties include fines and imprisonment. As of 1 June 2010, the results of inspections, monitoring and penalties are required to be reported to the European Commission every five years.
What is the role of the European Chemicals Agency?
The European Chemicals Agency (ECHA), located in Helsinki, Finland, will manage the registration, evaluation, authorisation and restriction processes for chemical substances to ensure consistency across the European Union. It will be the public face of REACH and will be a key player in ensuring that the system has credibility with all stakeholders and the public.
The tasks of the Agency include, but are not limited to, the following: management of the registration process, ensuring consistency of evaluation, providing criteria to guide Member States’ selection of substances for evaluation, and taking decisions about when further information is needed on substances under evaluation. It also provides opinions and recommendations in the authorisation and restriction procedures and has duties with regard to confidentiality.
In its decision-making the Agency will take the best available scientific, technical, and socio-economic information into account. It will also provide advice on chemicals and technical and scientific issues. The Agency will also minimse animal testing through careful consideration of testing proposals.
Who has to comply?
EU producers and importers are obliged to register substances they produce or import in quantities of 1 tonne, or more, per year. Failure to register means that the substance cannot be manufactured, imported or used on the EU market.
Who can register a substance (on its own or in a preparation)?
EU manufacturers (each legal entity of a company must register the substance), importers and EU-based representatives of non-EU manufacturers (called Only Representatives).
What are the Registration deadlines?
The deadlines for chemical registration are staggered as follows. It is expected that over 30,000 chemicals will be registered with the Agency by 2018, of these about 1,500 are likely to be considered of high concern.
1st December 2010
• CMR* (category 1 and 2) substances in quantities of 1 tpa and above
• substances classified as very toxic to aquatic organisms in quantities of 100 tpa and above
• substances in quantities of 1000 tpa and above
1st June 2018: substances in quantities of 1-99 tpa
*Carcinogens, mutagens and substances toxic to reproduction
Are there any exemptions?
There are exemptions for certain pharmaceuticals, polymers, ubiquitous substances (e.g. oxygen and water) as well as naturally occurring minerals and ores (so long as these have not been chemically modified). Radioactive substances, non-isolated intermediates, wastes, substances under customs supervision and substances necessary for the interests of defence are also exempted from the REACH Regulation.
What is to be included in the registration dossier?
The registration dossier consists of:
• a technical dossier
and, for tonnages of >10 tonnes per year,
• a chemical safety report
All technical dossiers must contain the following information:
• Registrant identity
• Substance identity
• Information about the manufacturing and uses of the substance
• Classification and labelling of the substance
• Guidelines for the safe use of the substance
• Study summaries of tests carried out
• Robust study summaries of tests carried out
• Information regarding which of the above mentioned points has been reviewed by an assessor, having appropriate experience
• Test recommendations, in the case tests are required according to Annexes IX and/or X
• All physico-chemical, toxicological and ecotoxicological information that is relevant and available to the registrant. The data requirements here depend on production and import quantities.
What is a CSR?
A Chemical Safety Report (CSR) should be completed for all substances subject to registration in quantities of 10 tonnes or more per year per registrant. The CSR shall document the Chemical Safety Assessment (CSA). The CSA of a substance aims to establish the safe conditions of manufacture and use of a substance for all life cycle stages.
What is included in the CSR?
The chemical safety report contains the following information:
• Overview of risk management measures
• Explanations about the implementation of risk management measures
• Explanations about communication of risk management measures
• Identity and physical and chemical properties of the substance
• Manufacturing and uses
• Classification and labelling
• Movement and fate in the environment
• Human health risk assessment
• Human health risk assessment based on physical and chemical properties
• Environmental risk assessment
• PBT- und vPvB assessment
• Exposure assessment
• Risk characterisation
Does the risk assessment depend on classification?
Yes. If the substance is not classified, then there is no need to include exposure scenarios. Instead, general advice should be given to enable the safe handling on the substance.
Who will manage REACH?
The European Chemicals Agency (ECHA) will manage the technical, scientific and administrative aspects of REACH at Community level. It aims to ensure that REACH functions well and has credibility among all stakeholders.
Who will manage REACH in the UK?
REACH requires Member States of the EU to appoint Competent Authorities (CA) to manage the domestic aspects of the legislation and to liaise with the ECHA. In the UK, the CA is the Health and Safety Executive (HSE), working with the Environment Agency and other governmental departments.
What is the cost to industry?
Registration under REACH is a complex and expensive process. The estimated cost to the whole chemical industry and its downstream users is between € 2.8 – 5.2 billion. To enhance industry cooperation and reduce costs the regulators adopted the one substance one registration (OSOR) system which requires manufacturers/importers of the same substance to provide joint submission of data. It ultimately requires that each substance is only registered once. However, commercially confidential information can be submitted separately.
Along with these direct costs there are also the indirect costs of having to source alternative substances for substitution. In some cases substances will be banned altogether as a result of restrictions and safer alternatives will have to be found.
Metal specific Q & A
Is there an obligation to register metals?
Metals are “substances” according to REACH and must be registered. Minerals and ores however are exempt from Registration unless they are chemically modified.
What about alloys?
Alloys are preparations under REACH, albeit special ones where the properties of the alloy, as a preparation, do not always simply match the properties of the constituent metals. As preparations alloys do not have to be registered but their component metals must be registered if present in quantities of 1 tonne or more a year. If the CSR needs to be undertaken for the component metals, the way in which these components are bonded in the chemical matrix should be taken into account.