Environmental Protection: Chemicals
EU chemicals policy - REACH
Questions and answers: Registration
What is ‘Registration’?
There is a general obligation for manufacturers and importers (M/I) of substances, individually or as part of a consortium, to submit a registration to the Agency for each substance manufactured or imported in quantities of 1 tonne or more a year. The registration will comprise a technical dossier (information requirements largely depending on volume) and a chemical safety report (at 10 tonnes and over per M/I) setting out how ‘identified uses’ can be adequately controlled. Registrants will be required to share data, through a process of ‘One Substance, One Registration’ (OSOR). Failure to register means that the substance will not allowed to be manufactured, imported or placed on the market by the M/I in question.
What are the main elements of the registration process in the REACH Regulation?
The following key elements are included:
Which substances are exempt from Registration?
Individual substances exempt from Registration are listed in Annex IV, and are taken from the Existing Substances Regulation (793/93). Regulation 793/93 states that "the requirement to provide such information should not apply to certain substances which, on the basis of their intrinsic properties, involve only risks generally recognised as minimal". This was the criterion behind the list that was carried across into REACH.
A more general list of criteria for exemptions from the obligation to register is set out in Annex V. These criteria were developed from experience in operating the notification of new substances system (Directive 67/548).
Some substances and categories of substances have been added to the exemptions under Annexes IV and V. Most noteworthy of these perhaps is the exemption for minerals, ores and ore concentrates in Annex V.
Once REACH enters into force on 1 June 2007, Annex IV and V exemptions can be amended (as can all technical Annexes) through the process of Adaptation to Technical Progress (ATP). REACH requires the Commission to perform a complete review of Annexes IV and V by 1 June 2008.
In addition Article 2 sets out exemptions for substances used in various types of activity. These exemptions are generally a result of safety requirements that are already included in sector-specific legislation.
What type of information will need to be registered?
Manufacturers and importers of substances will need to obtain information on the substances they manufacture or import, to assess the risks arising from the uses of the substances, and to ensure that those risks are adequately controlled. Registration records the performance of this duty and requires manufacturers and importers to submit:
The technical dossier contains information on the properties, uses and classification of a substance as well as guidance on safe use. The information requirements in the testing annexes vary according to the tonnage in which the substance is manufactured or imported, and to the needs of the CSA. There is certain information that is required for all registrations (Annex VI), while the hazard data required is set out in Annexes VII – X, depending on the tonnage band. Tonnage thresholds are used as, in many cases, it is a simple indication of the potential for exposure.
General rules are set out for the use of existing information, techniques such as (Q)SARs ((Quantitative) Structure Activity Relationships) and read-across (analogues), and for waiving of tests in Annex XI. New tests are only required when it is not possible to provide the information in any other permitted way. For substances in quantities of 100 tonnes per year or more (i.e. cases where more expensive tests, many on vertebrate animals, may be necessary) the manufacturer or importer who does not already possess the required information only needs to submit proposals for testing necessary to meet the requirements in Annexes IX and X. The evaluation process will verify whether the tests proposed are necessary. This is to reduce the amount of testing on animals and avoid unnecessary costs. Annex XI sets out what information can, and should, be used to satisfy the information requirements in Annexes VII – X.
The chemical safety report (CSR) (which documents a chemical safety assessment (CSA)) - for substances manufactured or imported in quantities of 10 tonnes or more per year - records the hazard classification of a substance and the assessment as to whether the substance is persistent, bioaccumulative, and toxic (PBT), or very persistent and very bioaccumulative (vPvB). The CSR also describes exposure scenarios for specific uses of substances classified as dangerous and for PBT and vPvB substances.
Exposure scenarios are sets of conditions that describe how substances should be manufactured or used during their life-cycle. This includes how the manufacturer or importer controls, or recommends control of, exposures of humans and the environment to the substance. The exposure scenarios must include the appropriate risk management measures that, when properly implemented, ensure that the risks from the uses of the substance are adequately controlled. Exposure scenarios need to be developed to cover all “identified uses”.
“Identified uses” are the manufacturers’ or importers’ own uses, as well as uses which are made known to the manufacturer or importer by his downstream users, and which the manufacturer or importer does not advise against. Relevant exposure scenarios will need to be annexed to the safety data sheets that will be supplied to downstream users and distributors.
How do you calculate the volume of a chemical in a downstream product?
It should be relatively easy to calculate the proportion of a substance contained in a chemical preparation (i.e. a mixture of substances such as paint, glue, etc.). Under current European Community legislation, the composition of imported preparations is already required for classification and labelling, as well as safety data sheets (Directives 1999/45/EC and 91/155/EEC respectively).
For substances in articles the calculation may be more demanding. However, the obligation to register a substance contained in an article only applies when the 1 tonne per year volume threshold is met and release of the substance is intended. If the quantities are either well above or well under the threshold, the calculation of the precise figure will be superfluous. The European Commission, together with the Member States and other stakeholders, is developing technical guidance for those cases where a more precise calculation of the tonnage is needed.
What are the registration demands for polymers?
Polymers are exempted from registration and evaluation, but they may still be subject to authorisation or restriction.
Directive 67/548/EEC (Art. 13(2)) exempts polymers, with the exception of those which contain in combined form 2 % or more of any substance which is not on EINECS (the EU list of existing substances). Under REACH, the exemption is for polymers that consist of 2% weight by weight or more of such monomer substance(s) or other substance(s). The wordings have the same effect but the law approached the issue from different directions. The 67/548 Directive exempted polymers containing less than 2% of a non EINECS monomer from notification. The REACH wording requires registration of monomers if they are contained in a polymer in quantities of 2% or more.
What is the difference between “phase-in” and “non-phase-in” substances?
“Phase-in” substances are those that are eligible for registration using the phased deadlines provided by REACH, based on annual tonnages. These are substances that have been on the EU market since before 1981, and are currently subject to the Existing Substances Regulation (793/93/EEC). This Regulation will be replaced by REACH. There are approximately 30,000 existing (or “phase-in”) substances currently on the market in quantities of 1 tonne or more per year, and will form the main focus of REACH.
“Non-phase-in” substances refers to those that have been placed on the EU market since 1981. These will not be eligible for the phased registrations, and must be registered immediately after 1 December 2008 in order to continue to be marketed and used. However, those substances that have already been subject to an equivalent registration process under the relevant sections of the Dangerous Substances Directive (67/548/EEC), which in the UK is through the Notification of New Substances (NONS) Regulation, are exempted from the need to register under REACH. This is because the NONS registration is deemed to be equivalent to a REACH registration in terms of the data it provides on the substance registered.
New substances introduced to the EU market after REACH enters into force on 1 June 2007 will also be regarded as “non-phase-in”, and must be registered immediately, prior to being placed on the market.
What is “Pre-registration”, and why is it important?
n order to make use of the staggered registration deadlines available under REACH, phase-in substances must first be pre-registered with the European Chemicals Agency between 1 June and 1 December 2008. This is important because without pre-registration, these deadlines cannot be used, and any phase-in substances that are not pre-registered will instead have to be registered immediately after 1 December 2008 to be able to continue to be marketed and used.
The exact pre-registration mechanism has yet to be finalised by the European Chemicals Agency in Helsinki. However, it will be free, and done electronically via the internet. The following information will be needed for each substance:
- name of the substance, including an identifying number (e.g. CAS or EINECS);
- the company’s name and address, and name of a contact within the company;
- the envisaged deadline for registration and tonnage band; and
- identifier information of any structurally similar substance that may provide useful evidence on hazards as part of the registration package
The pre-registration information will be used by the Agency to develop the Substance Information Exchange Fora (SIEFs) needed for the registration process.
Companies should not wait until the pre-registration period starts before taking action, as this might result in missing the closing deadline if a lot of substances need to be pre-registered. Rather, companies should be taking action now to prepare and gather the necessary information, e.g. identify the key substances essential to the business, and contact suppliers to ensure they will be pre-registering/registering the substances concerned, so that they don’t suddenly disappear from the market.
Further information and advice can be obtained from the UK REACH Competent Authority by email at ukreachca@hse.gsi.gov.uk or telephone on 0845 408 9575, or visit the website at www.hse.gov.uk/reach.
How will the ‘One Substance, One Registration’ (OSOR) system work in practice?
A single pre-registration procedure (with a deadline of 1 December 2008) will identify each potential manufacturer and importer of a phase-in substance. These companies will then become members of a Substance Information Exchange Forum (SIEF). All registrants of a substance within a SIEF must cooperate to prepare a hazard data set, although some possibility of opting-out has been included to add flexibility to the system. They should share available data with the costs being shared proportionately. Registrants of the same substance do not have to do a joint registration of the CSA, but may do so if they wish.
What if a company misses the pre-registration deadline?
If the company is new to the market, it will still be able to take advantage of the phase-in deadlines. However, if an existing manufacturer or importer fails to pre-register, they will need to register immediately as a non phase-in substance after 1 December 2008.
Will participation in a Substance Information Exchange Forum (SIEF) be mandatory?
Yes, but a company may opt out of submitting a joint registration (the hazard data element) when it can demonstrate it would be at disproportionate cost, cause a breach of confidentiality, or where there is a disagreement between registrants on data. Under OSOR certain data must be registered separately by a company, for example the name of company, contact details and exact tonnages.
How are the costs of data-sharing divided?
The exact mechanism is left up to the individual companies, provided that costs are shared in a fair, transparent and non discriminatory way. If they cannot reach such an agreement, the costs should be shared equally.
What is the difference between a CSR and a SDS?
Chemical Safety Reports (CSR) provide industry with a tool for demonstrating that it can use chemicals safely. Manufacturers and importers are required to prepare CSRs for substances in volumes above 10 tonnes per year. Downstream users may require their manufacturers or importers to address their use (‘identified uses’) in the chemical safety report. Alternatively, the downstream user may decide to protect information on their use from their manufacturer or importer and prepare their own CSR.
Safety Data Sheets (SDS) are a long-established and effective means of transmitting safety information down the supply chain. The person responsible for placing a substance on the market is required to prepare SDS for substances or preparations that meet the criteria for classification as dangerous (NB there is no volume threshold in this case). A SDS summarises information on the properties of substances and the safety measures necessary to use a substance or preparation. REACH will take over the current safety data sheet requirements, and increase the quality and amount of information presented. In particular, the exposure scenario element of a CSR will be attached to the SDS as an Annex.
How much will registration cost?
The original European Commission REACH proposal in 2003 estimated the total cost of registration across the EU at some €2.3 billion (£1.6 billion). Amendments made during the course of the legislative process reduced this to around €1.6 billion (£1.1 billion). In particular, requiring data sharing through OSOR could deliver savings of some €600 million (£415 million). Predicted costs for the registration of individual substances according to various categories of chemical type, available data, and potential REACH requirements, are included in several of the regulatory impact assessments that have been conducted on REACH.
Will there be a fee for submitting a registration?
Normally, yes. The exact fee required will be set out in a European Commission Regulation to be in place by 1 June 2008, the text of which was adopted on 10 December 2007. The fee set will reflect the tonnage and whether information is submitted jointly (as part of a SIEF) or individually. Fees will be lower for SMEs. No fee will be required for registrations between 1 and 10 tonnes when all Annex VII information is included in the registration dossier.
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Page published: 4 January 2008