R E GU L AT ORY I S S UE S
ACHIEVING A FULLY REGISTERED SUPPLY CHAIN Will you be able to achieve a fully registered supply chain by June 2018 to ensure business continuity? Alex Paul, Regulatory Expert at The REACH Centre, provides some top tips!
As the final REACH Registration deadline approaches, companies should already be considering not only their own registration requirements, but how to ensure the continuity of substances and mixtures supplied to them, whose REACH registrations they do not directly control. REACH regulation does not require companies to make clear their intentions to register to third parties; it only obliges companies who manufacture or import substances in the European Union in quantities of greater than 1 tonne per annum (tpa) to share data costs and submit a registration to the European Chemicals Agency (ECHA). Once a registration is in place, REACH obliges companies to pass certain information up and down the supply chain including uses, registration numbers and (extended) Safety Data Sheets (SDS). Prior to registration, if you ask your supplier if they are REACH compliant, they will generally say ‘yes’, as being REACH compliant means different things to different people and does not necessarily mean that they will register by the relevant deadline. Indeed, they may have no intention to register at all and are only using the phase-in period to access the European market as cost effectively as possible. In this case, you may find that your supply chain suddenly dries up in mid-2018, possibly leading to an urgent requirement to find another supplier, reformulate or remove the product from the market. There are various business risks associated with the 2018 REACH registration deadline.
Lack of transparency about intentions to register in the supply chain As highlighted above, a lack of transparency about intentions to register leaves companies with
concerns over whether their European supplier (manufacturer) or European importer, or Only Representative of a non-EU manufacturer will register in time, or if they will be forced to register themselves if they wish to maintain continuity of supply. Unfortunately, there is little companies can do beyond asking the supplier to provide guarantees that they will register in time or seek a supplier with an existing registration.
Who in the EU supply chain is responsible for registration? Only European manufacturers and importers, and Only Representatives acting on behalf of a non-EU manufacturer can register substances in Europe. Downstream users such as formulators or article manufacturers need to ensure their upstream suppliers have taken appropriate measures to enable continuity of supply. Supply chains are invariably complex and, as such, require careful consideration to identify obligations and potential impacts. European and non-EU sources should be considered separately as the obligations generally fall to different entities. For example, a European formulator may source substances from both within and outside of the EU. If the substances are sourced from an EU distributor, generally a number of sources will be available to the distributor so, should a manufacturer choose to cease or reduce production to <1tpa, any impacts should be minimal as other registered manufacturers pick up the slack. Things become more complex when multiple non-EU suppliers each provide relatively low tonnages. Here, if the European entity is acting as importer, then imported tonnages need to be aggregated and an appropriate registration submitted if tonnages are expected to be >1tpa after the final registration deadline on 31st May
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2018. It is worth bearing in mind that some non-EU manufacturers may have appointed an Only Representative to manage their REACH obligations, and providing that tonnages are <1tpa or an appropriate registration is in place, these tonnages can be excluded from the calculations.
Uncertainty over CAS numbers There is often uncertainty over which Chemical Abstracts Service (CAS) number is most suitable for a substance, particularly if it can be manufactured by a number of different processes, can be derived from various sources or is a Chemical Substance of Unknown or Variable Composition, Complex Reaction Product and Biological Material (UVCB). Consequently, the CAS number provided on the SDS or by the supplier may not be appropriate at the time of registration. A detailed substance characterization to determine substance identity and allow for comparison with the lead registrant’s Substance Identity Profile (SIP) will help establish which registration is most suitable to join. If it becomes apparent from the substance characterization report or at the time of registration that the (late) pre-registration could have been in a more appropriate Substance Information Exchange Forum (SIEF) for a similar substance with an alternative CAS number, this is not necessarily a problem because it is often possible to migrate to the correct joint submission using the existing (late) pre-registration number. Once a more suitable identifier for the substance has been established, it is possible to update the existing (late) pre-registration to view the SIEF for the ‘new’ substance by adding the substance to the ‘similar substances’ in REACH-IT. You will then gain access to the ‘new’ SIEF and be able to explain your position to the lead registrant or