History of pre-registration and process for late pre-registration
Between the relatively short period between 1 June and 1 December 2008, substances already on the market in Europe were possible to pre-registered. The actual mechanics of pre-registration was very easy, but the electronic submission process was overwhelmed by many (probably unnecessary) pre-registrations.
From 5 January 2009, the REACH IT allowed 'late pre-registrations' to take place. This facility is open for those who are manufacturing or importing chemicals over 1 tonne per annum for the first time after 1 December 2008; for example, those who are asked to supply a new product or those who increase their imports to over 1 tonne.
As part of the process to pre-register, there is an opportunity to e mail ECHA to give reasons for the late pre-registration. Some valid reasons are given above and late pre-registrations are likely to be checked by national inspectors.
This short guide is to help those who need to start manufacture or import of substances that have not yet been pre-registered.
What is Pre-registration ?
The first real practical activity with REACH was ‘Pre-registration’. The basic aim is to identify at an early stage of REACH exactly which substances are in Europe and will need Registration and subsequent evaluation.
A major reason for the ritual of pre-registration was to bring members of industry together who are interested in supplying the same substances so they can get together and avoid duplicating animal testing – the SIEF, substance information exchange forum. (More on the SIEF page)
Late pre-registration will allow you to express this interest in registration and join a SIEF late or to join up with those already registered. The limit on this is that you may not have this facility if it is less than 12 months before your registration deadline (the facility therefore stops in May 2017).
What are the criteria for late pre-registration
Pre-registration is open to all EINECS listed substances and those that escaped EINECS when it was first prepared as they were considered polymers at the time – these are known as ‘no longer polymers’ and have NLP numbers. New substances introduced after EINECS closed had to be Notified and were given ELINCS numbers. Some chemicals not on EINECS or NLP are possible to pre-register and be phased in; these are described below. However, there are also many in-valid substances being supplied in the EU at the moment and many will not be possible to pre-register and will require immediate pre-registration.
Official ECHA guidance on substance identity and polymers give good advice on many issues, but is perhaps a bit weak when describing inorganic substances, salts, derivatives of natural products and by-products with value.
Use the REACH guidance on substance identity to decide if your substance is a single consistent, multi-constituent or an unknown, variable chemical or of biological origin (UVCB). The link http://reach.jrc.it/docs/guidance_document/registration_en.htm will take to you help on identifying your substance. Guides are also available on intermediates and polymers.
A few of the special cases are covered below – but there will be many more examples of ‘borderline’ materials.
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. These EC numbers start ‘4..-...-.)
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 !
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 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
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.
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
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.
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.
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.
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.
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 complicated.
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.
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.
There is only one way to make your late pre-registration and that is through the ECHA web-site portal
This was open from January 2009 and it will be necessary to enter each substance individually. Note that late pre-registration is not possible if within 1 year of your projected full registration date. In such cases, you will need to treat the supply as 'non-phase-in' and make an Inquiry to gain contact with other potential data holders to share vertebrate data.
After pre-registration, access will be given to the pre-SIEF pages and SIEF membership can be sought. If the substance is already registered by a higher tonnage supplier, access will be provided to contact the lead registrant
Denehurst Chemical Safety Ltd
Late Pre-Registration of chemicals under REACH
The late pre-registration option is open to allow new manufacturers or importers of substances that were not pre-registered by them during the June - December 2008 period. The criteria for late pre-registration is the same as for the ‘normal' pre-registration in that substances need to be on EINECS, are No-Longer-Polymers or were manufactured and not place on the EU market (eg export only or intermediates).
The late pre-registration process is open only if the legal entity manufacturing or importing did not manufacturer or import more than 1 tonne of the substance after June 2008. This process does not allow those who simply forgot to pre-register or could not be bothered; in these cases, immediate registration is needed to continue supply.
Note that late pre-registration must be done within 6 months of first manufacture or import and that the option is not available within 12 months of the due registration date for that tonnage band.
When making a late pre-registration, you will need to be prepared to justify your reasons for the late pre-registration. This will pre-empt questions back from ECHA or National Competent Authorities to justify your actions. The list below provides some valid reasons for you to consider.
1 New legal entity - new responsible organisation
This covers new manufacturing organisations or new importers that have started trading after December 2008
2 New production; first time manufacture
If asked to manufacture a substance that you did not pre-register, but which meets the other criteria for pre-registration, late pre-registration is possible
3 Manufacture or import of increased volumes of the substance
If the manufacture or import of the substance had been under 1 tonne in 2008, late pre-registration will allow increase to over 1 tonne to accommodate new orders
4 New import; first time import to a specific site
For multi-site organisations, import to a different location can take place with a late pre-registration to that site; note it is necessary to set up a new legal entity on REACH IT for that location if necessary. Legally, that site can then supply other sites within the EU.
5 You manufacture food additives or other exempt substances and a new customer needs over 1 tonne for a non-exempt application.
Within the scope of REACH, this is technically a new supply as 'chemical'.