A few of the special cases are covered below – but there will be many more examples of ‘borderline’ materials.

Non-EINECS substances

Substances that were supplied for export only from the EU or were used as isolated on-site intermediates did not need to be on EINECS and did not need Notification under the pre-REACH system; however, under REACH, these will need registration and manufacturers can make us of pre-registration and phase in.  There is a facility for such materials in the pre-registration process.  There are also substances that were supplied in good faith but it appears that EINECS is imprecise of isomers were not identified – it is unofficially expect to be an amnesty for such materials, but the absence of an EINECS number needs justification.

Substances that have been Notified under NONS will be ‘considered’ registered and will be given a registration number from December 2008.  However, only those who Notified will be given registration numbers and only these ‘registration holders’ can supply the substances – if other suppliers want to supply the substance, they will need to prepare an immediate registration as a ‘non-phase in’ substance and share data with the Notifier.

Polymers

Polymers are exempt from REACH and do not need pre-registration.  However, anything that goes into the reaction process at > 2% to make the polymer will need pre-registration, including monomers and other substances.  There is a mistaken belief by some that only ‘free polymer’ needs pre-registration; this is wrong !

Mixtures

If supplying a substance that is synthesised as 70% component A and 30% B (but not mixed after synthesis), you effectively have a choice – make one registration on the mixed components, by testing the substance as manufactured, or register separately as A and B.  The advantage of two registrations is that if other registrants are supplying A and B separately, you can share data with them.  Advice in this case is to pre-register A/B mixture, A and B then see who is on the SIEFs and decide later how to register.

Effectively, the material to be registered is what you claim it to be; xylene is often given as an example with ortho- meta- or para- isomers or a blend of bog basic xylene.  The four are listed separately on Annex I to Directive 67/548/EEC – if you are importing ‘xylene’ for use as a solvent, does it matter which isomer ?  Your supplier may just send what they have most of and the isomeric composition may change between batches; as long as the isomeric composition is within limits set out when the straight xylene was registered, variation is OK.  However, if you ask your supplier for o-xylene for use as a chemical pre-cursor, you will need a registration of o-xylene.

The pre-registration tools will ask if your substance is a single constituent substance or a mixed substance (noting that UVCB materials are considered ‘single’).

Purity

Purity figures and the identity of impurities do not need to be included in the pre-registration process. Unless the ‘impurities’ actually have a function and enhance the product.  The rough rule us that if you or your customer would rather that ‘impurity’ was not there, it can be ignored for pre-registration. 

If there is residual solvent, such as toluene, that has the advantage of making the substance into a wet cake that is easier to handle than the powder formed if without solvent, then you are effectively supplying a mixture of substance and solvent.  If you are an EU manufacturer, and have bought the toluene from an EU supplier, you obviously do not need to pre-register the toluene yourself and if a 90% substance 10% solvent material, the tonnage supplied of the substance is obviously 90% of the total tonnage.

If you are importing the 90% material and the toluene is helpful to you for handling purposes, you are an importer of toluene.  If you would rather it was not there and ‘tolerate’ the impurity, you can consider it an impurity.

Purity is one of the first things that a SIEF will need to discuss.  See SIEF pages

Salts

It is allowable to adjust the pH of substances and preparations and in doing so, consider only the substances in the mixture; for example, adding a little citric acid to reduce the pH of a potassium phosphate solution can be considered a mixture of citric acid, potassium phosphate and water where the two substances need to be considered individually for pre-registration (water being thankfully exempt).  However, if a claim was made that you were supplying potassium citrate, this would need registration as a substance; effectively, it is what you claim to be selling and the decision to consider it a mixture of a new salt would need to be justified to any Competent Authority that asked.  More importantly from a business point of view, you would also need to be able to persuade customers that what they are buying is pre-registered correctly.

The advice is to consider what is claimed to be supplied and then pre-register that substance or substances.

‘Natural’ products

Substances dug out of the ground or squeezed from plants are considered ‘natural’ chemicals.  Some of there are helpfully listed in Annexes IV and V of the Book of REACH, but most are not.  Note that these Annexes were revised June 2008 and were published as final in October 2008 and these differ significantly from the original texts in the main Regulation. 

There are also complications if you take a natural material and process it in some way; what type of process makes it ‘un-natural’ and requiring registration.  And how about the limitation that natural materials are only exempt if non-hazardous ?  At pre-registration stage, data to determine if hazardous or not is possibly not available.

As with many substance identity issues the advice is to see what other suppliers in your industry are doing and attempt to find a common position (there is safety in numbers).  If you can agree a common position, use this to consider the pre-registration.

Processed natural products are difficult, especially if reacting them with chemicals to product a derivative; for example, hydrolysing cellulose or adding reactive groups to clays.  In these cases, the advice is that all starting materials going into the reaction should be registered (unless exempt).

By-products and waste

As with impurities, substances only need pre-registration and subsequent registration if they are intentionally supplied; waste collected for disposal is outside the scope of REACH and needs considering under Waste Legislation. 

Waste materials can fall into two categories; the first includes solvents, left over starting materials and un-used product.  None of these will need pre-registration, even if you sell them for recovery because they will have already been pre-registered up the supply chain for them to be used on your site already.  The second type of ‘waste’ will be by-products of reaction that are removed during the process.  Sometimes, these have a value to someone and it may be possible to either sell it, give it away or at worst, pay less to a waste disposal organisation.  In order to get paid, or receive a discount on disposal costs, the material being supplied will normally have a specification and if there is a specification, or a claim of composition, you will find it hard to justify that this is still waste.  An example may be that the waste stream generates acetic acid in water and do get a cheaper deal from the waste disposal contractor, they insist on a minimum 15% concentration – this now has a product specification and is not waste and needs pre-registration.

If the waste contractor takes waste from a number of sources that do not have specifications (ie real waste) but finds that they can extract certain substances of value to recycle, the waste contractor may find themselves liable for pre-registration.  Obviously, if these are solvents or left over starting materials, they do not need pre-registering for a second time in their life.

Articles or not

The article vs substance debate still continues with many substances in the grey area between the two.  In such cases, the importer needs to make a decision whether it is a substance or article and then justify that decision.  If you are a manufacturer, the chemical vs article dilemma is less critical as the substances going into it would need pre-registration for you to have it on site to start with. 

If there is any doubt, you should consult with trade groups or competitors and perhaps seek advice from the Competent Authorities; as with all these cases, you should be able to demonstrate that your decision whether to pre-register or not is based on sound consideration.
 

More on articles

Justification

As indicated above, your final decision will need to be within the scope of the legal text, hopefully following the guidance documents and be justifiable.  The simple rule is if it is not implicit in the legal text or guidance, put your reasons in writing in case you are asked by a regulatory agency or customer to justify why you are not pre-registering or ultimately registering a substance.  Put this on file somewhere to cover your decision in case of dispute at a later date; even if you are in hindsight wrong, at least it demonstrates you acted in good faith with the best available information at that time. 

Who makes the pre-registration

There are four ‘entities’ described in the legal text who can make the pre-registration.  However, anyone can physically make the pre-registration if they have the log in details of any of these entities.  There is flexibility in the system to allow commercial decisions to be made. However, once the pre-registration is made, it is fixed in that name and

Manufacturer

An EU based manufacturer can make the pre-registration in their name or they can do it in the name of a Third Party Representative (TPR).  The advantage of using a TPR is that the manufacturer’s details are not publicised and they can retain some confidentiality – not even other members of the SIEF know who it is.

As a manufacturer, pre-registration is in your control.

Importer

As an importer, you need to ensure that all eligible substances are pre-registered.  However, with any luck, the non-EU supplier may have appointed an Only Representative to make the pre-registration, but to ensure that this is the case, there will need to be formal communication between the importer and Only Rep to prove that both parties are aware of their position in the REACH system.  If you have not been given the Only Rep details by the supplier by 1 December, it is possible they have not done the pre-registration – it is not too late to make a ‘late pre-registration’ yourself.  Formal letter exchanges of appointment will only be required for full registration.

It is also worth noting that if buying from more than one non-EU supplier, there will probably need to be more than one OR involved as well and the exchange of communication needs to be with all ORs involved. 

Only Representative

As an OR, you have roughly the same responsibility as an importer that makes a registration, but need to be appointed by the non-EU supplier.  The term 'supplier' is officially a manufacturer or formulator of the chemical being exported to the EU.

The OR must be appointed by the non-EU producer and their role must be agreed by the importers.  Drawing a parallel with the Sole Representative under New Substance Notification, three stages are involved:

1          Letter from supplier naming their OR

2          Letter from importers covered by the OR arrangement recognising the OR

3          Letter from OR to supplier and importers agreeing to their role

The concept of writing ‘letters’ is not explicitly implied in the Regulation, but there needs to be a defined recognition of roles between the relationships and documentary evidence needs attaching to the IUCLID 5 registration form when registering as an OR. 

The OR must be formally in place by 30 November 2008 and importers contacted.

Sacking an Only Rep

An OR can be easily ‘sacked’ as their status is entirely as a representative of the non-EU supplier.  However, if sacked, another OR would need appointment in their place for supply to continue and to do this, the new legal entity would be pre-registering late or going straight into a registration.  This is obviously quite troublesome and the advice is to make sure you are satisfied with the OR before pre-registration take place.

Third party representatives

If you are relying on your sales agent to be the formal OR, and the good reason for this is that they are part of your organisation or if they are trusted agent and you already have a good relationship with them, they can appoint a ‘third party representative’ to actually do the pre-registration and represent your organisation on the SIEF.  They can be easily sacked and replaced if not performing well, whereas changing the OR is more completed.

Therefore, if you have an established and trusted agent or a sales office with employees, it is strongly recommended that they are the OR and if they do not have the time or feel that they have the skills required for REACH support, an external consultant / support organisation can be appointed to do the work as a third party rep.  The added advantage is that the true registrant, the OR, can keep their position confidential from the rest of industry as only the contact details of the third party rep is published in the SIEF after pre-registration.

EU manufacturers can also appoint Third Party Reps to retain some confidentiality.

Consultant

As already indicated, anyone with access to the internet anywhere in the World can physically make the pre-registration as long as it is in the name of a recognised EU legal entity or recognised TPR and assuming they have the log-in details of the organisation they represent.

Tonnage bands and predicted date of registration

Part of the pre-registration process involves predicting when you expect to register.  This mainly relates to the tonnage band, but also if the substance is a Category 2 CMR (carcinogen, mutagen or toxic by reproduction) or is R50/53 (Very toxic to aquatic organisms and may cause long term adverse effects in the aquatic environment).  The R50/53 is an indicator that the substance may be vPvB or PBT and should be assessed at an earlier stage.

Many substances have not been fully evaluated (which is why we have REACH !) and you may not know if the substance is CMR or R50/53 and you can therefore be forgiven if in 2018 when tested for registration you find it is very toxic in the environment.  To qualify for early registration, you need to check Annex I of Directive 67/548/EEC to see if it falls in these categories and the best place is to search the ESIS web-site under classification and labelling. http://ecb.jrc.it/esis/index.php?PGM=cla 

How do we pre-register late ?

Once you have gone through the decisions on what you need to pre-register, who will do it and confirmed that you are eligible for late pre-registration, the actual process of preparing the late pre-registration and submitting is easy. 

For additional support, contact REACHReady www.reachready.co.ukor the ECHA web site http://reach.jrc.it/guidance_en.htm