data sharing deadline distributors Downstream Users exposure fees non-EU producer OSOR pre-registration REACH registration tonnage band Traders use
EU Manufacturers/ Importers
What is pre-registration?
The pre-registration period was open from 1 June 2008 to 1 December 2008 during which time manufacturers and importers (M/I) were able to submit a very brief set of information, to ECHA via REACH-IT, detailing the substances requiring registration under REACH and specifying the applicable tonnage bands and the relevant deadlines for that registration. The benefit of pre-registration is the applicability of the extended registration deadlines; pre-registration also brings potential registrants together promoting sharing of data to avoid redundant testing.
Further information on pre-registration can be found on the ECHA website.
What is required for pre-registration?
Information required for pre-registration includes:
o Company identification including contact details of relevant representative
o Basic substance identification
o An indication of the tonnage band and relevant registration deadline
An option to volunteer as SIEF Formation Facilitator (SFF) is also open to pre-registrants at pre-registration.
When is a pre-registration required?
A pre-registration is required by all manufacturers and importers who supply a phase-in substance, in the EU, in quantities of one or more tonnes a year who wish to benefit from the extended REACH registration deadlines. Companies who fail to pre-register their substances within the pre-registration window will be required to complete a full REACH registration deadline before they can continue to manufacture or import their substance in the EU.
Pre-registration is only possible for phase-in substances (those that are included on EINECS), all other substances require notification with the Agency followed by full registration unless they have already been assessed under NONS (the Notification of New Substances Regulation).
What is registration?
At registration manufacturers and importers, of substances (including metals) supplied in quantities of 1 and more tonnes per year, are required to submit a dossier of information to the European Chemicals Agency (ECHA), in Helsinki, containing information on the substance properties and guidance on how to use the substance safely. Quantities starting at 10 tonnes additionally require submission of a Chemical Safety Report (CSR) to document the in-depth Chemical Safety Assessment (CSA) in order to demonstrate that the level of eventual risk a substance might pose to the environment or humans can be adequately controlled. Quantities produced or supplied at 1000 tonnes and above are priority substances for this assessment. The amount of information required in the dossier is related to the tonnage of substance manufactured/imported as presented in this data list (the information required is also stipulated in the REACH annexes). The dossier must be submitted in IUCLID format and by the relevant deadline; failure to complete registration by the required deadline will result in loss of access to the EU market.
Further information on registration can be found on the ECHA website.
One Substance One Registration (OSOR)
REACH is based on the principle ‘One Substance, One Registration’ whereby a single dossier is completed for each substance. Under this rule the registration dossier is completed, and submitted, by one company on behalf of the others a process which necessitates information to be shared between all manufactures and importers registering the same substance. The OSOR rule aims to increase efficiency, reduce cost, and to reduce testing on vertebrate animals. REACH also requires communication with ‘downstream users’ of chemicals to help ensure that any hazards, and risks, posed by a substance, are managed effectively throughout the supply chain.
Every manufacturer and importer that pre-registered a substance under the same substance identification parameters will automatically be admitted to a pre-SIEF within REACH-IT. Following the close of pre-registration, all pre-registrants of a substance are required to enter into substance sameness discussions to check, and agree, that they are all intending on registering the same substance under REACH. Once substance sameness has been agreed, pre-SIEF members enter into a Substance Information Exchange Forum (SIEF). REACH provides the formation of SIEFs to aid manufactures and importers of the same phase-in substances share information on the substances that they need to register; the aim of the SIEF is to increase efficiency, and reduce costs, and to prevent repeat testing (particularly on animals). SIEFs also allow for participation of downstream users and other stakeholders with a vested interest in the substance.
Tonnage bands and deadlines
Manufacturers and importers that have pre-registered their substances qualify for the phased-in registration deadlines which are dependent on the classification and tonnage of the substances supplied. REACH sets out the deadlines as follows:
1 December 2010
• ≥ 1000 tonnes per annum (tpa) or;
• ≥ 100 tpa and classified under CHIP as R51 (very toxic to aquatic organisms) or;
• ≥ 1 tpa and classified under CHIP as Cat 1 or 2 CMR (carcinogens, mutagens or reproductive toxicants)
1 June 2013
• ≥ 100 tpa
1 June 2018
• ≥ 1 tpa
What information is included in the registration dossier?
There are two components to the registration dossier, a technical dossier and a chemical safety report (CSR). The technical dossier contains information on the substance properties, classification, and use. The extent of information to be submitted on the substance properties increases with the relevant tonnage band as outlined in the REACH Annexes VI to XI.
A CSR is only required for substances supplied in quantities of ≥10 tpa. The CSR documents the risk assessment associated with the relevant hazards and exposures of the substance. The CSR also includes an assessment of whether the substance is persistent, bioaccumulative or toxic (PBT) or very persistent or very bio-accumulative (vPvB). If the substance is classified as dangerous or is PBT or vPvB, then an exposure assessment and risk characterisation must also be performed to demonstrate that the risks are adequately controlled.
Further information on the REACH information requirements can be found in the ECHA factsheet on information requirements.
What are the fees for registration?
ECHA charges companies for making REACH registrations; the precise fee payable depends on the registration tonnage band, company size and whether the registration has been submitted jointly or separately (for details see the REACH Fees Regulations). Companies who do not pay the registration fee will fail the completeness check and have their registrations rejected. Companies continuing to supply their substances beyond the relevant registration deadline will be in breach of the REACH Regulation and will be subject to penalty.
EU Downstream users
REACH obligations for downstream users
One of the objectives of REACH is to have more substance information available to users to enable them to use those substances safely. Downstream users are not required to register the substances they use unless they import them directly from outside the EU. While there is no direct registration obligation on downstream users, REACH does require users of substances to communicate their use information to their suppliers and ensure that these are adequately assessed by their suppliers, and included in their registration dossiers.
As such downstream users, obtaining substances, should check with their suppliers that those substances have been pre-registered or registered by the original M/I and, if applicable, should make sure that their downstream uses are covered, or will be covered by the registration. It is possible that for business reasons, some M/I may decide not to register some substances; in this instance downstream users may wish to find an alternative M/I of the substance, re-think processes, or consider registering it themselves.
DU should provide their suppliers with their use information, this is particularly important for novel uses of substances which might not be expected. All DU use information provided to suppliers will need to be considered for registration by the M/I making the registration. DU who prefer not to let their suppliers know about their uses (for example because of commercial concerns) are not obligated to provide use information if they let ECHA know about their specific uses by submitting their own risk assessments. DUs wishing to submit their own risk assessments will have 6 months after the time at which the substance was first registered and they had been provided with a safety data sheet, listing the registration number. Suppliers should be able to tell their DUs which uses are covered by the M/I substance registration.
Following the assessment of the downstream uses of the substance, the M/I making the registration will summarise the data on identified uses for inclusion in exposure scenarios (ES), which will be appended to the supplier safety data sheet. The aim of the exposure scenarios is to describe the operating conditions (OC) and risk management measures (RMM) that have been identified by the supplier as necessary to use the substance safely in the uses that have been identified. Under REACH downstream users will be required to follow the advice on risk management measures given in the exposure scenario attached to the safety data sheet, or be able to implement more stringent control measures to those described in the exposure scenario. DUs needing to change the risk management measures implemented at their workplace, in order to comply with the exposure scenario, will have a maximum of 12 months to do this following receipt of the SDS detailing the REACH registration number for that substance.
Further guidance for downstream users of substances can be found in the ECHA Guidance Document on Downstream Users.
One of the aims of REACH is to make substance manufacturers and importers responsible for actively managing their substances in such a way that they do not pose any risks to user’s health or the environment. In line with this downstream users have the right to make their uses known to their suppliers, by providing them with process details as well as information on the control measures that they already have in place to manage risk. The downstream user information needs to be sufficient for the preparation of an exposure scenario by the M/I. This communication up the supply chain is vital as several downstream uses of substances are often not known by the original manufacturers and importers. Where users provide information to their suppliers in a timely manner, their suppliers are more likely to include those uses in their registration dossiers (and may even recommend the control measures that users already have in place if these are evaluated as being adequate). Uses not included in the registration will not be permitted after the relevant deadline. Users are able to submit their own risk assessments to the Agency for uses not included in their supplier’s dossier; however, this option can be very timely and expensive.
In order for M/I to adequately assess uses of their substances, and ensure that the control measures they recommend are adequate for controlling exposure to within safe levels, it is possible they may require downstream users to provide them with data on the relevant environmental emissions (from the workplace to air and water etc) and workplace exposure (from air and worker monitoring programmes). Due to the methods recommended in REACH, more realistic results are gained from the use of measured exposure data than when very conservative default values are applied. It is possible M/I may instruct users to implement stringent control measures if there is no data available to show that real life exposure is much lower than predicted. By providing suppliers with measured data users could relieve themselves from the burden, and expense, of implementing some potentially costly control measures at their sites.
Other actors in the supply chain
EU traders and distributors
Although the REACH Regulation does not specifically include terms for traders and distributors, certain obligations could be relevant to such actors in the supply chain. If a trader or distributor imports substances into the EU they are likely to have full registration obligations. Traders and distributors who do not directly import their substances from outside the EU do not have to register but are required to pass information up and down the entire supply chain.
REACH is an EU Regulation and, as such, it does not place any direct obligations on companies based outside the EU; registration requirements are only relevant to producers and importers based in the EU. However, REACH does provide a method for non-EU producers to register the substances they manufacture outside the EU; although they are not able to register directly themselves, they can register via a company, based in the EU, acting as their Only Representative (OR). Several non-EU producers are choosing to register their substances by this route in an attempt to maintain their current EU supply chains. Many non-EU producers understand that when the REACH requirements are realized, most of their EU customers will choose to buy substances from registered sources to relieve themselves of the burden of registering themselves as importers. As such, many non-EU producers are registering to maintain their EU customer base.