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SIEF Formation - early problems and issues

Since early January 2009, there has been pre-SIEF activity with many letters and e mails circulating as SIEFs start to form.  There are some misconceptions about this process and this short guide is aimed to clarify the position.

By May 2009, it was still apparent that little progress is being made in some areas, especially where the self-appointed SIEF Formation Facilitators have been over ambitious in volunteering to run too many SIEFs.  The other area of concern is where no one is stepping forward.

It was expected that by the end of 2009, with less than a year to prepare the dossiers for high tonnage materials, SIEFs would have been established.  In reality, there is still a lot to be done. However, the text below (initially drafted September 2008) is still current - little has changed in terms of the purposes and functions of the SIEF.

(Up-dated March 2010)

Pre-SIEF discussions have been going on since the closure of the main pre-registration phase.  There are still some late pre-registrations taking place (link to late pre-registration page).

It is already apparent that a very large proportion of pre-registrations will not be followed up with full registrations; not only were several hundred thousand added as a result of uncertainty over monomers, re-imports and recycled chemicals, there are many who pre-registered ‘just in case’ their suppliers had not done so or due to uncertainty of Only Representatives. 

Letters and e mails are now being circulated as part of the SIEF formation process.  However, despite the best intentions of those trying to move SIEF formation forward, there are many misconceptions and potential pitfalls to be aware of.

Articles 29 and 30 of the REACH Regulation legal text describes very clearly the legal role of the SIEF; Recital 54 in the pre-amble of the Regulation sets out the spirit of the SIEF and this must be followed.  SIEFs should not be seen as an opportunity to seek commercial advantage and members should always aim for the win-win result.


SIEF Facilitator (SFF)

The role of SIEF facilitator has no legal basis under REACH and whether ticking the box during pre-registration or not puts all SIEF members in an equal position to assume the role. Do not assume that by ticking the you are automatically the facilitator and in the same manner, if receiving a letter from an organisation claiming the right to be facilitator, their position is not definitive.  Those offering to be facilitator did just that – they have taken the initiative, but it does not give the right to leadership. 

The motives of facilitators will differ; some large companies have a lot of commercial interest in driving the registration forwards and members of industry groups and pre-existing consortia will have expertise and experience to offer.  There will also be consulting companies active as Only Representatives who have management skills and will already have in place mechanisms for recording time and charging for management services at commercial rates.

It you disagree with the appointment of the volunteer facilitator, even if they have ticked the box in pre-registration, you can object.  SIEFs should be formed on consensus and not autocratically. 

Lack of progress 
A complaint heard increasingly is that the SFF is not making progress.  In many cases this is due to the poor response they will be receiving from other potential SIEF members, but in some cases, the SFF have been overwhelmed by the contacts generated or there has been a failure of software systems. 
Although there is still time to sort things out, if it is genuinely considered that the SFF are not performing, let them know and offer to take over.  This has already happened in many examples (often pre-existing consortia are taking over from volunteer SFF); however, if taking over the role, you will need to put the work in.  
There are also many examples of potential SIEFs with no SFF and here it will be up to the first company to panic into action to take on the SFF role 'de-facto'.

Costs to join a SIEF

A SIEF should not cost anything to join.  Every potential registrant has the right to be a member whether paying or not.  However, the facilitator and / or lead registrant can ask members of a SIEF to contribute to running costs where there has been mutual benefit on a fair and equitable basis.  What is ‘fair’ is open to discussion and if considered unfair, debate within the SIEF or ask national Competent Authorities for advice.
 

Time pressure

There is a concern among those planning to Register that some members of a SIEF may hold up progress due to delays in responding or because they need to refer to legal departments that slow everything down.  The worry is that slow starts may mean dossiers not being ready for Registration. 

It has become practice so far for many potential SIEF facilitators to put a time limit on response so that a lack of response suggests that the potential member of the SIEF does not want to play an active part in the SIEF agreement.

There is a balance here between allowing sufficient time for response and to allow those not showing interest in the SIEF to be by-passed to allow progress.  The balance should be seen as allowing a defensible period for response in case the organisation by-passed takes the facilitator to court for lack of inclusion in the process. In by-passing a company that has not responded, recorded mail should be used or other evidence obtained of ‘reasonable’ attempts to provoke a reply.

A lack of response does not imply that the company does not intend to Register.  Unless a formal deactivation is made, every pre-registrants retains the right to register and take part in the SIEF.

Your status in the SIEF

Those who definitely do not need to register can deactivate their pre-registration and play no further part in the SIEF process (even though their names will still be listed).

Of the remaining active pre-registrations (probably still over 2 million), there will be many who are uncertain and do not wish to take the official step of deactivation, but who will almost certainly not need to register in full.  These pre-registrations will be considered dormant and it is important for those in this position to let other SIEF members know (or at least the SIEF facilitator) so that they can be left out of cost sharing estimates and day-to-day management.

There will also be companies who do not want to play an active part in the SIEF or who want to be involved in leading progress to ensure registration deadlines are not missed.  To help categorise the status of pre-registrants, many companies have devised a strategy to divide their substances into different groups and the common model that seems to have been accepted, and has indeed been promoted by CEFIC, is to define 4 categories:

1          Leader

2          Active

3          In-active ‘follower’

4          Dormant

Changes in your status

It needs to be made clear that these categories have been defined by industry for industry and are not official regulatory positions.  As such, these have no legal basis and if a company wishes to be active in a SIEF to start with and then decides that through either  lack of resource or due to confidence in the way the SIEF is working, they are happy to be less active and take a follow-on role.  Likewise, a company not taking an active role, perhaps even dormant, can decide to take a more active role if they find that the substance suddenly becomes more commercially important to them.

There are clear advantages in this system in that the SIEF manager knows who is likely to respond to e mails or to take part in meetings, and those in an in-active role can avoid getting plagued with correspondence on details that may not be of interest to them; for example, when planning new testing, many SIEF members will not have an opinion on which test laboratory to use or how to select dose levels.

Confidentiality and competition law

SIEF formation is a balance between sharing technical information to save work on testing (especially that involving animals) and to ease the financial burden of REACH.  However, there is a lot of information not to share and indeed, discussing tonnages (outside the official ‘banding’), markets, future sales volumes, strategic importance of substances and other commercial data is illegal.

Other information that can be legally shared, but may be best kept to yourself include:

Pre-registration number

Suppliers (if importers or Only Representatives)

Your UUID Number (although this is embedded in the pre-SIEF pages and can be accessed by other pre-SIEF members using xlm)

Your REACH IT log-in details

Precise product specification (although a generic specification is needed for ‘sameness’)

Impurities (residual solvents may provide information on production methods)

Suppliers of raw materials


It is strongly advised that members of staff entrusted to take part in SIEF discussions are fully briefed on the legal restrictions and on knowing what is commercially sensitive.  However, unnecessary secrecy will slow and inhibit progress.

Training and advice

Training is being provided by Denehurst, including in-house events to discuss SIEF working with those responsible for REACH in your organisation.  In-house events are held in confidence to allow company policy and strategies to be discussed.


Training by Denehurst



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