Downstream users get first helping hand with Reach

The first Reach guidelines aimed at downstream users of chemicals have emerged from the European chemicals agency. Paul Kaye looks at how they advise firms to begin preparing for the EU’s new chemical policy
The European Chemicals Agency (ECHA) last month published the first Reach guidelines aimed at downstream users of chemicals.
Two chapters of a comprehensive guidance package have been released early to help firms identify their obligations under Reach and to advise on initial compliance preparations.
Downstream users are by far the biggest business class affected by the EU’s new chemicals policy. Essentially they come from every industry sector except chemical manufacturers, according to Jan Vernon of RPA, a British consultancy helping to write the guidance.
These chemicals users will have get the full package of guidelines developed under the Reach implementation project (RIP) 3.5 in December or early next year.

Role in reach
The first chapter helps firms find their place in the Reach chain. It distinguishes between formulators and end users.
Formulators use substances to produce preparations which they deliver down the supply chain. End users use substances (or preparations) industrially or professionally but do not supply them further downstream.
Formulators are likely to be busier under Reach: they will often be carrying out chemical safety reports (CSRs), the basic chemical safety assessments required for substances manufactured or imported in volumes over 10 tonnes.
However, end users will be much more numerous. “Most of the time, for end users, there won’t be a huge amount to do,” says Ms Vernon. Once the registration process is complete, Reach will mainly require them simply to communicate new safety information up and down the supply chain.
But the precise obligations of end users will vary according to their business. The guidance subdivides them further: industrial users use substances as processing aids which do not remain in the articles produced; article producers incorporate substances into finished articles; and professional service providers use substances in the context of an activity not considered an industrial process.
There are other downstream user categories: refillers transfer substances from one container to another; importers buy from manufacturers outside the EU that have designated a different importer as the “only representative” responsible for substance registration; and reimporters import into the EU substances that were originally manufactured inside the EU.
Separate from downstream users, but also covered by the guidance, are distributors. These include firms that buy and sell substances and articles without processing them further, as well as retailers and storage providers. Many larger firms will fall into several downstream user and distributor classes. The different categories have been devised so as to better target the detailed guidance in the full package.
Some Reach obligations will fall on all downstream users and distributors: they must all give suppliers any new information on the hazards of substances and preparations, including any information that might affect a substance’s classification and labelling. They must also tell suppliers of anything casting doubt on the adequacy of risk management measures outlined in substance safety data sheets.
Besides this, formulators, end users and refillers must apply the risk management measures that their suppliers set out as essential to ensuring safe chemical use. This basic requirement on most downstream users will encourage them to liaise with suppliers early in the Reach registration process.
Formulators and refillers will also have to provide safety information to their customers. Article producers will have to provide information allowing the safe use of articles that contain substances deemed of “very high concern” under Reach in concentrations above 0.1 per cent.
The second chapter of the newly released guidance advises firms how to proceed once they have identified their role (or roles) in Reach. It stresses the need to act early.
The first step is to gather into inventories all available information on substances and preparations the firm uses. “We shouldn’t underestimate what a task that is for downstream users,” says Jan Vernon. “The information on substances can be in so many different places in the company. Finding the right person to talk to can take months.”
Downstream firms should then make contact with suppliers as soon as possible. Their objective will be to ensure registration of the substances they use and continuation of supply. They will not carry out registrations – this will be done by manufacturers and importers. But they will need to provide information so their substances are covered. If a substance is not registered, it cannot be supplied to the market in volumes over 1 tonne per year.
“Manufacturers and importers will begin to decide at an early stage whether to register their substances and what uses to include in the registration,” says the guidance. “Many have already begun this process. By preparing early for Reach you will ensure that you become aware of potential problems with the future supply of your substances or of tasks you need to carry out under Reach.”
Initially much of this contact will happen through industry associations. Firms that are not members of one are advised to begin the process especially early. And downstream users that want to keep some parts of the information confidential are advised to work through industry associations.

Since downstream users will only be able to use substances and preparations in line with conditions set out in safety data sheets, they need to make sure suppliers take into account the ways they want to use them.
And if the substance is defined as especially hazardous under Reach, downstream users will have to make sure their use of it is included in the “exposure scenarios” that will form part of the CSR necessary for registration. These will define the use conditions within which exposures are safe. Downstream users that do not use substances in line with these conditions will be in breach of the law.
Ensuring their uses are written into exposure scenarios from the start will often mean communicating early with the manufacturer or importer of the substance. But for end users this is also likely to mean communicating with substance formulators. This will happen where the manufacturer or importer decides the end user’s use of its substance is too small a part of his market to invest in a CSR covering the use.
In these cases the formulator will have an incentive to carry out the CSR on behalf of the downstream user to keep its market. The formulator might also decide to carry out the CSR itself because it does not want to supply commercially sensitive formulation details to a manufacturer.
In this case downstream users have several options: switch to a supplier who has registered a use for their substance; change their use of the substance in line with conditions in the CSR; or find a new way to use it that they can prove is as safe. They could also find an alternative substance or process and stop using the substance in question.

Registration will be kicked off by a six-month pre-registration exercise which will reveal by January 2009 which substances manufactures and importers intend to register. If none plans to register a particular substance of interest to a downstream user, the downstream user can notify ECHA, which will act as a ‘clearing house’ by publishing lists of firms interested so manufacturers can decide whether to reconsider.
Downstream users will also be able to join the substance information exchange fora (Siefs) coordinating the data gathering and testing required to register a substance. Later in the Reach process some substances will require a special authorisation, in addition to registration, for use to continue. Downstream users will be able to initiate this process.
Ms Vernon insists a well-organised firm should not have to panic about its obligations. She offers a story to illustrate the point. In a case study carried out to test the guidance she visited a Portuguese textile firm preparing for Reach. It had received only basic information about the policy and had been “scared witless” about the prospect of complying.
But it had kept good records of suppliers and customers, and after running through the guidance, “within five or six hours they were saying ‘There’s nothing to this Reach business’.” Time will tell if the company’s confidence was justified.

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