INTRODUCTION

The current EU legislation for chemical substances is a patchwork of many different directives and regulations developed since 1967 when the first Dangerous Substances Directive was introduced. There are different rules for existing and new substances (or substances that were put on the market before 1981 and which are known as existing substances). This system has not produced as much information about the effects of the majority of these substances on human health and the environment.

The current distinction between so called existing and new substances is based on the somewhat arbitory cut off date of 1981. In 1981 they numbered 100,000 different substances which are listed on EINECS – The European Inventory of Existing Chemical Substances. All substances introduced to the market after 1981 are termed new substances.

The claim by the Commission is that whilst new substances have been tested extensively before they are placed on the market there are no such provisions for existing substances, as a result although some information exists on the properties and uses of existing substances there is a lack of sufficient information publicly available to assess and control these substances effectively.

REACH seeks to be all embracing on a number of levels. Firstly it covers virtually all substances (there are some exemptions) and secondly it places responsibilities throughout the supply chain. A further important feature of REACH is that it is based on the premise that there is simply insufficient information available for many substances and a good deal of emphasis is placed on the need to gather information in order to “prove the case” for each substance.

SUPPLIERS

Because REACH deals with chemicals the major challenge resides with suppliers who need to Register the substances they supply. Article 5 of the Regulations is unambiguous;

“No data, no market”

“………………substances on their own, in preparations or in articles shall not be manufactured in the community or placed on the market unless they have been registered in accordance with the relevant permissions.

Article 6 reaffirms this:

“Save where this Regulation provides otherwise, any manufacturer or importer of a substance, either on its own or in one or more preparations in quantities of 1 tonne or more per year shall submit a registration to the Agency.”

Before getting down to the nitty gritty we need to understand a few additional fundamentals and time scales.

In the first place, all players in the supply chain have responsibilities under REACH; these are predominately the suppliers and importers of chemicals and their customers (downstream users). These responsibilities are dictated by a prescribed timetable:-

The timetable is designed to ensure that substances of high priority are dealt with first. However, distinction between existing and new substances is also reflected; except that the terminology has changed and existing substances are now called phase in substances and new substances are called non-phase in.

All non-phase in substances will be subject to the above timetable (at various stages), however phase in substances are also subject to pre-registration.

For phase-in substances which have been pre-registered there is more time to complete the full registration process. Any manufacturer or importer who manufactures or imports a phase-in substance in quantities of more than 1 tonnes per annum and intends to register these substances under REACH should therefore pre-register.

1 PRE-REGISTRATION

The information required of Pre-Registration should be submitted within a time period:-

a) starting 12 months after REACH enters into force or;

b) ending 18 months after REACH enters into force, in other words only allowing a 6 month period for the actual pre-registration process.

The information required for pre-registration will include the name of the substance and any of the other names which are used in the context of the substance and additional information relating to the name of the organisation, the contact person and address etc.

In due course the HSE will publish names of those substances which have been pre-registered. At this point a Substance Information Exchange Forum (SIEF) will be established through which companies share and agree on hazard data for registration and classification purposes.

Participation in a substance information exchange forum is mandatory for registrants of a phase in substance. It is optional for downstream users and third parties but repeating animal test work or withholding animal test data is not permitted.

2 REGISTRATION

The Registration should include the following information:-

i) A technical dossier including:

· The identity of the manufacturer(s) or importer(s)

· The identity of the substance

· Information on the manufacture and use(s) of the substance; this information shall represent all the registrant’s identified use(s). This information may include, if the registrants deems appropriate, the relevant use and exposure categories.

· The classification and labelling of the substance.

· Guidance on safe use of the substance.

· An indication as to which of the information submitted has been reviewed by an assessor chosen by the manufacturer or importer and having appropriate experience.

· Proposals for testing

ii) A chemical safety report in the format specified (see Annex 3). The relevant sections of this report may include, if the registrant considers appropriate, the relevant use and exposure categories.

Once the registration has been made the Agency shall assign a submission number to each registrant, along with a submission date. From this the Agency shall undertake a completeness check in order to ascertain that all the elements required have been provided. This completeness check does not include an assessment of the quality or adequacy of any data or justifications submitted. If the registration is incomplete the Agency will advise the registrant what further information is required.

Once the registration is complete the Agency shall assign a registration number to the substance. At this point the Agency will notify all relevant parties (e.g. member state competent parties) of the registration and the registrant may start or continue the manufacture or import of a substance provided there is no indication to the contrary from the Agency.

Following registration, a registrant shall be responsible for updating his registration without due delay with relevant new information to the Agency in the following cases:-

a) any changes in his status, such as being a manufacturer, an importer or a producer of articles, or in his identity, such as his name or address;

b) any change in the composition of the substance

c) Changes in the annual or total quantities manufactured or imported by him or in the quantities of substances present in articles produced or imported by him if these result in a change of tonnage band, including cessation of manufacture or import;

d) New identified uses and new uses

e) New knowledge of the risks of the substance to human health and/or the environment of which he may reasonably be expected to have become aware which leads to changes in the safety data sheet or the chemical safety report;

f) Any change in the classification and labelling of the substance;

g) Any update or amendment of the chemical safety report

h) The registrant identifies the need to perform a test, in which case a testing proposal shall be developed;

i) Any change in the access granted to information in the registration.

The Agency shall communicate this information to the competent authority of the relevant Member State.

In its simplest terms this then describes the registration process but there are other matters which require consideration. The Commission are keen to minimise the amount of animal testing that occurs and one way in which this can be achieved is by reducing the number of registrations.

For example, when a substance is produced in the community by more than one manufacturer and/or imported by more than one importer then all the required information shall first be submitted by one registrant acting with the Agreement of other assenting registrants and in the context of registration where more than one company teams up to submit one registration the term applied to such an arrangement is the establishment of consortium.

Such consortium are necessary for submitting a joint registration, these are not strictly mandatory and there are several levels of participation possible. Any company that wants to completely opt-out must however, have documented reasons for why it decides to submit its own registration.

3 EVALUATION

Evaluation is a process by which registration dossiers can be examined by the Agency, it may result in a request for further information on substances from the registrant. There are two types of evaluation with different aims;

3.1 Dossier Evaluation, i.e. per individual registration

Checking of testing proposals to prevent unnecessary animal testing, i.e. the repetition of existing tests and poor quality of unnecessary tests. The Agency will be responsible for checking the testing proposals submitted as part of the registrations before the tests are performed.

Compliance Check the Agency will check the compliance of a minimum 5% registration dossiers against the registration requirements.

3.2 Substance Evaluation, i.e. per substance

The Agency in conjunction with member state authorities may clarify suspicions of risks to human health or the environment by requesting further information from Industry on particular substances. Any costs incurred should be shared amongst the registrants of the substance.

Substance evaluation should be prioritised on the basis of risk following guidance being developed by the Agency. Evaluation may lead to the conclusion that action needs to be taken under the restrictions or authorisation procedures. All the information needs to be passed onto other authorities relevant for other legislation. The evaluation process should ensure that reliable and useful data is provided and made available to the relevant bodies by the Agency.

To that extent therefore evaluation is part and parcel of the information exchange within REACH.

4 AUTHORISATION

For substances of very high concern an authorisation is required for their use and their placing on the market of substances required to be authorised are:-

i) Those that are carcinogenic, mutagenic or toxic for reproduction (CMRs category 1 and 2).

ii) There are persistent bio-accumulative and toxic or very persistent and very bio-accumulative according to a given criteria and/or;

iii) Those that give rise to an equal level of concern of those mentioned above where there is scientific evidence of probable serious effects to humans or the environment, e.g. endocrine disrupters. Authorisation therefore is the means by which substances of concern can be regulated centrally through a mechanism that ensures that the risks related to their actually uses are assessed, considered and then decided upon on an EU wide basis.

The restrictions procedure is designed as a safety net to enable conditions up to and including prohibition to be placed on the manufacturer or importer. Restrictions apply on a community wide basis if it can be demonstrated that the risk posed by the substance or use are not adequately controlled.

Adequately controlled refers to an exposure below a derived No Effect Level for humans or below a Predicted No Effect Concentration for the relevant compartment.

5 SUBSTITUTION

The aim of authorisation and considerations for substitutions is to ensure that substances are progressively replaced by suitable alternative substances were economically and technically viable. All manufacturers, importers and downstream users applying for authorisation have to analyse the availability of alternatives, consider their risks, and the technical and economic feasibility of substitution.

For substances with carcinogenic and mutagenic properties, in order to be granted authorisation a company will only be required to prove that the substances are adequately controlled. Their application would, however, still have to make an analysis of whether alternative substances exist and if so, provide a substitution plan.

For pbt (persistent, bio-accumulative, toxic) and vpvb (very persistent, very bio-accumulative) substances, authorisation will only be granted, if an analysis of alternative substances is provided and if alternative substances exist a substitution plan will also have to be provided.

For substances which cannot be included in the above two categories (i.e. if no alternative substances exists and the risks can not be adequately controlled) an authorisation will be granted if the socio and economic benefits are proved to be higher than the risks.

DOWNSTREAM USERS

1 INTRODUCTION

Paper No 1 dealt with the responsibilities of the supplier and the requirements for registration. Registration to the Agency must include information relating to the purposes to which the substances are put by the supplier’s customer or, in the case of REACH the downstream user and the only way he can fulfil this requirement is by communicating with his customers.

2 Implications of REACH for Downstream Users

Once REACH is implemented, downstream users can only use substances (on their own or in preparations) that have been registered for their use by their supplier. Manufacturers and importers (suppliers) of substances will begin to decide at an early stage whether to register their substances and what uses to include in the registration. Downstream users need to know as early as possible what their decision is likely to be.

Because of this one of the key, if not obvious, features of REACH is the need for communication along the supply chain. Suppliers will seek information from downstream users to help in making their decision on registration.

Where a downstream user is also a supplier to further recipients, his customers may also expect information from him about REACH and whether or not the supply of substances and preparations can be ensured in the future. Preparing in advance will help downstream to respond more easily to such information requests.

This Briefing Note aims to help downstream users to prepare for REACH, by identifying and prioritising their communication needs.

Failure to prepare for REACH could mean that substances you use are not registered for your use. By preparing in good time for REACH, you can avoid potential problems and ensure that you, your suppliers and customers work together to implement REACH in the most cost-effective manner.

Once a substance is registered, the supplier must provide downstream users with a revised safety data sheet (or other information). This may include an exposure scenario setting out how the substance must be used - operational conditions of use and risk management measures - to ensure safety.

The downstream user must comply with the conditions set out in the safety data sheet or other information 12 months at the latest after receiving this information.

What happens if a substance is not registered for my use?

If a substance is not registered at all, you may not continue to use it. If a substance is registered, but not for your use, this could also have significant implications for your business. You may need to:

· identify a new supplier who has registered the substance for your use,

· replace the substance for one that is registered for your use,

· make changes to your processes or costly reformulations, or

· prepare your own chemical safety assessment.

All of these changes could take time, and involve significant costs. For this reason, it is important to begin preparation as soon as possible. Waiting until your supplier has made his decision and supplied you with a new safety data sheet or other information could leave you very little time to plan your response.

What are the implications of authorisation?

If a substance requires authorisation an application must be made for each use of that substance. If the application for your use is not successful, your use of the substance must be phased out by a specified date. If you are not prepared for this, it could be costly and disruptive for your business.

3 The benefits of early preparation

By contrast, early preparation for REACH will ensure that you are aware of any potential problems and can work out ways to address them over time.

What are the benefits of contacting suppliers early?

Contacting your supplier early will let you know whether or not he plans to register the substance, whether your use will be included, whether a chemical safety assessment will be required and whether it is likely to be subject to authorisation. Knowing this will help you to plan more effectively for REACH and to prepare for any changes that you may need to make to your use of substances.

Contacting a supplier before he has made a decision on registration can help to ensure that the registration takes proper account of your conditions of use and risk management measures. Provided the supplier considers that these are safe, this may prevent you having to make costly changes to your process.

Under REACH, downstream users should provide information on a voluntary basis to assist in the preparation of a registration. They may also request that a use becomes an identified use.

4 Next Steps

Preparation for REACH involves:

· knowing what substances you use, how and what they are used for

· gathering available information that might be needed, e.g. which of them are hazardous?

· deciding who to contact, when and how

What information could my suppliers request and how can I prepare for this?

Manufacturers and importers may seek input from you to prepare registrations and develop exposure scenarios. If you do not respond, then the supplier may chose not to include your use in his registration or may make incorrect assumptions about how you use the substance. This could mean that the safety data sheet and exposure scenario, where provided, give guidance on safe use that is not appropriate for you. Because of this you may like to consider taking the initiative and contacting your supplier direct.

What about confidential business information?

Providing information to suppliers will benefit you as it will make it more likely that your use will be included as an identified use within the registration of the substance. However, you will need to weigh these advantages against any concerns that you would need to provide confidential business information to suppliers.

There are a number of ways to overcome this problem. One is to use a standard exposure scenario (a general description of conditions of use and risk management measures in your sector) prepared by your industry association.

Another is to prepare your own chemical safety report; which basically means that you would register the substance and its use, this process may also require considerable preparation, so it may be useful to hold early discussions with suppliers to establish whether this step is likely to be necessary.

Setting up an in-house REACH team

One of the most valuable sources will be the expertise of your staff. It may be helpful to hold a meeting, or set up a working group, of people from different departments to help bring the information together. This could include people from the purchasing, manufacturing, operations, warehousing, transport and sales departments as well as technical, safety and environmental experts.

Sources of information

The first step is to gather together information on the substances you use, either on their own or in preparations or articles, and who supplies them. You should already have prepared a substance inventory as part of your COSHH. If not, information may be available from a number of different sources within your company. This could include:

· purchasing department inventories;

· safety data sheets supplied with substances and preparations and labels on packaging;

· instructions provided by suppliers;

· risk assessments and other information prepared for workers’ health purposes;

· information held at the warehouse to fulfil transport regulations;

· environmental permits.

As well as preparing an inventory, you could also begin to gather information on the way in which a substance is used (operational conditions of use) and the measures you use to control the risks.

5 Identifying priorities for communication

Once a substance inventory has been prepared, the inventory can be reviewed to identify triggers for prioritising communication needs (see timetable on page 2). It may not be feasible (or necessary) to contact all of your suppliers immediately. Identifying priorities for communication will allow you to focus your resources on the most important substances.

An overview of factors that might lead you to prioritise a substance is given in the following work flow.

5.1 Dangerous substances

If a substance is manufactured or imported in amounts over 10 tonnes per year by your supplier, the registrant will have to carry out a chemical safety assessment. If it is a dangerous substance (or a PBT or vPvB – see 1.3 below) he will have to prepare an exposure scenario, which will require more information from downstream users. Early contact with your supplier will help to establish what information will be needed to register your use.

5.2 Substances of very high concern (SVHC)

Substances of very high concern (including those with carcinogenic, mutagenic and reprotoxic properties – CMRs category 1 and 2; those that are persistent, bioaccumulative and toxic - PBTs – and those that are very persistent and very bioaccumulative – vPvBs) may be subject to authorisation. The existing safety data sheet should indicate if a substance is a CMR, but it may not be possible for you to determine whether a substance is a PBT or vPvB but your supplier should. If the substance is classified as R50/53, this may be an indication. It is the manufacturer/importer’s responsibility to determine if a substance meets the criteria for SVHC.

5.3 Critical substances

A substance may be critical to your process because, for example, there are no alternatives with the same properties, because any alternatives have a higher price or lower performance, or because they would require changes to your process or product.

5.4 Substance used in small amounts

Some downstream users are concerned that their suppliers may consider substances that they only use in small amounts as of low value, and thus fail to register them. However, there are often other, larger, markets for the same substance which make it important to the supplier’s business. If you consider your use of a substance is special, the supplier may be less likely to include that use in his registration. This may apply in particular to new or innovative uses.

5.5 Further assessment

Once you have a list of prioritised the substances, you can then decide what action is most appropriate. This might include:

· Contacting your supplier informally to determine his plans for registration/authorisation of the substance and providing information on your use, if your use is not confidential. Your initial contact can be quick and general, with more detailed follow-up if needed;

· If your supplier does not plan to register/authorise your use, making a formal request that your supplier includes your use in his registration once REACH enters into force and/or identifying alternative suppliers, if your use is not confidential;

· If you wish your use to remain confidential: contact your industry association (if you are a member of one) to identify whether it is preparing generic information for suppliers that may include your use or consider preparing a downstream user CSA;

· Examining the options for substitution of the substance with one that is less dangerous and will be registered by your supplier.

Annex 1

Annex 2

Table 1: Example of a substance inventory

Process 1: Inputs: substances
Name	Form (substance on its own; for substances in preparations, go to Table 2)	CAS number	Substance properties		Supplier information		Use (amount and purpose)
			Classification (according to Directive 67/548/EEC)	Is it a CMR category 1 or 2, PBT, vPvB	Name of supplier	EU/non-EU company	Tonnes per year	Remains in product? If so, customer use known?