EU / GB REACH – introduction and summary
The first principle adopted in any training or support by Denehurst is to ensure that the concepts and reasons for legislation are understood. Once it is known ‘why’ certain parts of the regulatory process are needed, the pieces of the jigsaw will fit together.
The overriding concept of REACH is to that those supplying chemicals and articles are satisfied that they are only being supplied for uses that are of acceptable risk to users and the environment.
There is no such thing as a ‘safe’ chemical, but only chemicals where exposure is less than the levels considered to be hazardous; this is the corner-stone of chemical safety assessment and can be presented as a ‘risk characterisation ratio’ (RCR).
Precautions for safe use (Risk Management Measures) must be adequately communicated by the SDS and label.
Compliance with the legal position will normally be assured if concepts are followed – and of course the necessary ‘forms’ are filled in – sadly, many Regulatory Agencies and customers are more interesting in the form-filling than real risk management.
For now at least, GB REACH is a direct transcript of EU REACH, with the only key differences relating to processes of appeals and legal procedures; this guide covers both, but a separate GB Regulatory page is on this site [link].
And what is the difference between GB and UK? The United Kingdom is England, Scotland, Wales and Northern Ireland and Great Britain politically refers to the main island of England, Scotland and Wales. The Northern Ireland Protocol is a political compromise meaning Northern Ireland is in the EU for purposes of trade and Regulations and therefore EU REACH applies. More or less. This is explained in more detail in the GB REACH pages [link]
Also, more detailed guidance is given on other pages
- Determining roles for responsibility in the supply chain
- Considering data-gaps and new laboratory testing
- Evaluation of test data and use to prepare Chemical Safety Report
- GHS / CLP and SDS
- IUCLID and REACH IT
- Review of dossiers and CoRAP
Useful external links (open in new pages)
EU REACH (ECHA web site)
https://echa.europa.eu/guidance-documents/guidance-on-reach
GB REACH (HSE web-site)
A short history of REACH
This short guide is aimed at those who need to know enough about REACH to get on with their ‘day-jobs’ of buying or selling chemical products, manufacturing goods or just working with chemicals. It is important that industry believes that REACH is not an impenetrable tangle of legislation, but a tool to catalogue the hazards and risks of chemicals. From the outside, REACH appears very complicated and frightening if just reading the legal texts, but the concepts are simple and we need to continually go back to the spirit of the law to find the answers.
There are three ways to look at REACH.
The first is from a legal perspective that starts by reading and memorising the legal text of Regulation (EC) No 1907/2006 (and the GB REACH version) and this continues into a check-list of things you must do and those you must not. The problem with this approach is that the concepts and principles can be lost in the detail. If attempting to read the Regulation, concentrate on the Recitals in the opening sections.
A second approach is to follow the spirit of the legislation that sets out, quite rightly, to ensure that chemicals manufactured, supplied and used are ‘fit for purpose’. This has no set boundaries and without keeping the regulations and practicalities in perspective, time and money can quickly disappear while aiming for perfection.
The third approach, favoured by this guide, is to do sufficient to ensure that adequate hazard and risk communication is taking place and to ensure that you are doing enough for compliance. To meet this objective, we do need to know a bit about the legal text and also need to understand the science of why we are doing all this to ensure that the chemicals are fit for purpose.
Unfortunately, there are many individuals, consultancies and law firms who appear to like the confusion and would rather discuss minute details of the law than concentrate on risk management. The UK HSE is aware of this and hopes to redress the balance away from pedantic legal argument and instead revert to the spirit of the law as originally intended.
But the law must be understood
The legal background
EU (and GB) REACH is a nightmare for those in the legal profession as the text was largely written by committees working to come to a compromise. The good news for industry, is that the authors of much of the text were scientists (and not lawyers) and the ambiguity that can disturb the legal profession can be a gift to those in industry wanting an interpretation to meet their practical needs.
What we end up with is a text that is full of wonderful compromise, vagueness and uncertainty. The letter of the law is not concise and those who try to work to the black and white text will struggle to find answers to many of the questions facing industry; or in some cases, will find two answers. However, returning to first principles terms of hazard and risk communication, and the answer is usually clear to see.
If in doubt, seek advice from others and record your opinion; if it ultimately turns out to have been the wrong choice, you will have on record your best intent to get it right.
The legal text is found almost entirely in the consolidated Regulation (EC) No 1907/2006 and the not very catchy title of GB REACH ‘The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019’. This is to be changed and also note minor further enacting Regulations that are updated on an irregular basis, including Regulations on fees, SDS formatting and test methods.
Other amendments may yet follow, but the reality is that that these amendments consider details that perhaps go beyond what to expect in a short guide.
To check on the latest incarnations of the legal text, the ECHA and HSE websites need to be consulted.
History of the legislation
To put the legal framework into context, you need to go back over 40 years. In 1967, the first major piece of European chemical supply legislation was published which set the framework for the control of dangerous chemicals. With the exception of finished pharmaceuticals, direct food additives, radioactive substances, ammunition etc, the dangerous substances Directive 67/548/EEC, and the myriad of Directives spawned from it, formed the basis of all subsequent chemical control directives.
The key part of Directive 67/548/EEC was to make suppliers of chemicals submit a list of substances they manufactured or imported with details of chemical identity, and the final list was known as EINECS – European Inventory of Existing Chemical Substances. Effectively, this was the same as the ‘pre-registration’ phase of REACH.
Any substance not listed on EINECS (the list closed in 1983) was considered a ‘new substance’ and notification was necessary. The legacy of this with REACH is that the new substances are now considered registered under REACH and those on EINECS are the ones that could be pre-registered as phase-in.
Some complications arose from the exemption to notify if exported from the EU and the exemption if used as an on-site isolated intermediate (these substances not ‘placed on the market’ did not need to be on EINECS or notified, but could be considered phase-in under REACH). A further complication was caused by a change in rules for polymers during the Seventh Amendment to 67/548/EEC, and substance omitted from EINECS as they were originally considered polymers, subsequently needed listing as ‘no longer polymers’ (NLP); these were also considered ‘phase-in’ and many were only found in 2008 when industry looked hard at what substances were actually being made.
EC list numbers provide a bit of history, with their starting numbers showing the origin:
2 = Original EINECs substances
3 = Those that got left out and added later
4 = New substances after EINEC (NONs Notified)
5 = No-longer polymers added after polymer rule change
6 = Substances REACH pre-registered without CAS or EC number and unofficial
7 = Assigned by ECHA to substances without CAS or EC number and unofficial
8 = Substances REACH pre-registered with CAS number and unofficial
9 = Substance subject to REACH Inquiries and designated official EC list number
Basics of REACH
Registration is only required for those who manufacture or import > 1 tonne of a chemical substance into the EU or UK – or of course, both. Since the departure of the UK from the EU, those wishing to enter the UK and EU markets need to make two Registrations and pay two sets of fees. Registration also applies in the rare example of a deliberate releases of a substance at over 1 tonne from articles (eg fragranced products).
If chemicals are supplied from within the EU / GB the registration must be taken care of by the up-stream suppler in that jurisdiction.
Non-EU / GB manufacturers and producers of formulations (or articles releasing substances) can appoint local legal entities to be their ‘Only Representative’ (OR) to handle the registration process and to be the official legal entity. However, even if appointing an OR, much of the actual work of data evaluation, negotiation on a SIEF, preparation of registration documents etc. can be done by the non-EU manufacturer as long as the final registration is in the name of the official EU-based legal entity.
Post-Brexit, EU companies have ORs in the UK and UK companies can appoint ORs in the EU
Exempt materials
Exempt materials are described in the REACH Regulation (legal text) in Article 2 and includes pharmaceuticals, food additive and other specific types of substance. Note that crop protection products and biocides are not fully exempt, but are considered ‘registered’ under their own parallel systems. Substances that are used in exempt applications, but are used in other areas, need registration under REACH; eg food grade colourants used in inks.
Specific exemption for registration exist; these include certain elements and natural products are described in Annex IV and V of the legal text. These may change in time and the Annexes will be updated as adaptations to the REACH Regulation as Regulations in their own right.
Cosmetics, food contact materials, medical devices and other specific types of chemical that are covered under their own Directives or UK law, will need registration, but such materials may be exempt from certain parts of REACH, such as end-use CSR.
Waste is exempt from registration if it meets the criteria of the waste Directive, but if sold for recovery, may not be exempt. This needs case-by-case consideration, but recovery from designated waste does not need registration if the substance is already registered in Europe.
Definitions
Definitions are described in Article 3 of the REACH Regulation, but some key ones are described below.
A substance: defined chemical
Impurities: unwanted by-products or residual starting materials that do not enhance the substance. These will not need registration in their own right if they do not contribute to the nature of the substance (typical accepted maximum limit of 20% impurities).
Multi-constituent substances: synthesised in such a way that two or more key chemical components form, such as mixed isomers.
Polymers: at least three repeating unit of monomer unit with no single constituent at > 50% by weight composition. Therefore, there it needs good molecular weight spread as well as number of units. Post-reacted polymers are still polymers, but the substance reacted with them will need registration.
Unknown Variable Chemicals (or of Biological origin) (UVCB): poorly defined substances or biological extracts and derivatives that need special consideration for registration. These include reaction products, but where there is no clear understanding of the actual constituents or the proportions of such constituents. Some biological materials may be exempt.
Mixtures (preparation): one or more substances deliberately added together after synthesis, such as solution in solvent or blended product. The mixture does not need registration, but all components must be registered (if over 1 tonne) and if importing, it is necessary to determine the components in the preparation from the supplier.
If importing mixtures, remember that the tonnage band that triggers registration is the quantity of the specific component of the mixture; for example, if importing 10 tonnes of a cleaning fluid with 60% water, 30% surfactant and < 10% fragrances, colourants, preservatives etc, registration will only need to consider the 3 tonnes of surfactant. Those less than a tonne do not need registration and water is exempt.
Article: a material that is supplied primarily to fulfil a function based on its size or shape and dried paint providing a water proof coloured surface is considered part of the article it has coated. Polymer supplied as bead to make plastic cups are ‘chemical’ (polymer), but the finished cup is an article.
Even though the definition is easier to work out when the logic is understood, there are many grey areas, such as metals, where it is necessary for suppliers to make their own decision, record that decision in case of later questioning, and then do what is appropriate in terms of hazard assessment and communication.
The metal industry is one where there is confusion, with the best example being that a lump of iron is a chemical if the user melts and makes steel from it, but is an article if used to hold a door open as a doorstop. The function and use of the material is key.
Chemicals delivered by articles, such as pens, printing cartridges, wet-wipes etc. Are considered as chemical for purposes of registration. These are delivered by ‘speciality containers’ even though the container is an article (eg. Pen case). This can also apply to some chemicals in serviceable parts of machinery (eg lubricants) or screen wash in imported cars.
Substances deliberately released from an article: the object has a primary physical form, but secondary chemical nature. Examples include toys with special smells (eg toy banana smelling like a banana) where the scent is a chemical released and will need registration.
Foreseeable release chemicals expected to be released from an article during normal use by wearing and during re-working, such as metal dust from grinding, polymers from tyres etc. These do not need registration by importers of the article.
No foreseeable release: chemicals are considered to be bound tightly in the matrix of the article, such as plasticisers in plastics where there is no evidence of leaching or loss from the article. This is an important point when the chemical is hazardous
Proving this is very difficult!
SIEF; working together to save work. After pre-registration, those who had pre-registered had access to lists of other potential registrants to see who else had a potential interest in the same (or similar) substance; SIEF stands for ‘substance information exchange forum’ and this is its primary function – to facility data exchange.
This is now redundant and the groups who joined together are Joint Registrants.
Substance sameness (Substance Identity Profile – SIP): The initial evaluation of the substance is essential for all those registering a chemical substance and who need to demonstrate that their substance has the same identity and purity as other members of the SIEF or those who have already registered – to file an Inquiry to ECHA, basic substance identity details are required.
Inquiry: If it is not possible to pre-register (eg not on EINECS or past the respective deadline for late pre-registration, it is necessary to file an Inquiry so that ECHA can check if the substance is the same as other registered or pre-registered substances. If it is the same, any data already generated to evaluate the substance can be shared; a major reason for this process is to avoid the risk of repeating animal testing.
The basic requirements are spectral evaluation (typically IR, UV-Vis, NMR, Mass-Spec) and this can be requested even in cases where it is not possible to interpret the results to least provide a ‘fingerprint’ for future reference. Chromatography and other analysis including HPLC, GC, MS etc are required as appropriate for the type of substance the analysis must be sufficient to demonstrate that the substance you are registering is equivalent to others in the same Joint Registration.
More information is given here [link]
PPORD: The production and process orientated research and development exemption is very much the same as the PORD under NONS, but allows a longer period of supply (normally up to 5 years) and has no real limit for volume. There are no formal test requirements for PPORDs, but remember that classification and labelling is required and an SDS is needed. Notification under CLP is also needed.
More information is given here [link]
Intermediates (strictly Controlled): Substances that are used exclusively for conversion to other chemicals and which are closely controlled (ie no supply to the general public and limited exposure to workers or the environment at named sites) need less testing for registration. Non-isolated intermediates do not need registration. The term ‘strictly controlled’ is not precisely defined and is open to discussion, ultimately, local inspectors need to be assured that there is minimal (or zero) exposure to workers and the environment and will vary for region to region depending on local inspection policy.
Data evaluation: Having spent time and money gathering, assessing or generating data, there needs to be a reasonable attempt to do something useful with it. The minimum is to look at the answers and propose a classification (the SIEF should make a proposal as part of a joint registration), but as part of the registration process, it is necessary to make a ‘robust summary’ in IUCLID . The data put into these summaries are being disseminated by ECHA on their web-site and these provide valuable source of data for all to see.
If the data are not considered adequate for classification or to complete the robust summary, further data generation (testing, modelling, read-across etc) is needed.
Part of the conclusion for data evaluation will be the derived no-effect level (DNEL) or minimal effect (DMEL) for health effects from different routes of administration and also the predicted no-effect concentration (PNEC) for environmental endpoints. DNEL / DMEL and PNECs will be established for each substance.
Authorisation and Restriction: A problem could arise though if your use is unsuitable for the substance and it is restricted for certain uses. This is such a complicated issue, that unless your market and profit is substantial, substitution for other chemicals may be the pragmatic way forward.
Substances are periodically added to the ‘candidate list’ of substances to be added to the lists for Restriction or Authorisation
Restrictions, Annex XVII of reach lists substance considered to be substances of very high concern (SVHC) and many of these are already restricted under pre-REACH legislation. The uses listed are prohibited.
Authorisations are needed for substances listed on Annex XIV; these are effectively banned in Europe and special Authorisation is needed for those specific uses. Some exemptions are possible, but the process is expensive and may be time limited.
If mixtures or articles contain SVHC at levels of over 0.1%, then customers must be informed on the labelling with a suitable warning.
Registration process
Registration is made through reach it using the free software, IUCLID. The REACH IT portal can be accessed through the ECHA web-site – in based in the UK, IUCLID is still needed for GB REACH and you will need to set up an ECHA ‘foreign user’ account.
https://iuclid6.echa.europa.eu/download
With a basic level of it skill, IUCLID can be installed onto a computer by following instructions and guidelines given by ECHA. Alternatively, this can be installed on a company server to be shared. As well as being the source for download, there is help and support available from the ECHA web-site. On-line submissions are also possible using Cloud REACH, but this is not recommended as we are aware of various issued in terms of speed and access.
Higher tonnage Registrations
The annexes VII – X of REACH describing test data are frightening. There were many reports scaring industry of high costs, but Annex XI tells you how to avoid testing. Effectively, the requirement for industry is to do sufficient testing and data assessment (modelling, read across etc) to justify the end points listed in the respective annexes VII – X according to the tonnage being registered. For example, if your substance is water soluble and biodegrades rapidly, it is most likely justifiable to avoid most, if not all, of the terrestrial ecotoxicity testing described in annexes IX and X.
New animal testing not explicitly required in Annex VII or VIII should be proposed to, and agreed by, ECHA before starting. Even if testing is required, but there is no capacity at laboratories, it can be stated on the IUCLID 5 input that testing is planned or in progress. In these cases, we would also be unable to complete the CSR, but we can give it our best effort and then update as the new data became available.
The spirit of REACH is that we take a scientific approach to testing and we should have sufficient justification to meet the objectives of each annex. This is known as the ‘intelligent testing strategy’ and guidance on how to approach testing is provided by ECHA and is described on the Laboratory Testing page [link].
Downstream user obligations
Most of industry will be a downstream user (DU) as this covers anyone buying in, handling or supplying chemicals that are already registered. If you supplier has not covered your, the du can prepare their own ES and can even prepare their own CSR using the robust summary from the registrant. This sounds easy, but communication routes will be complex.
The only legal obligation of the DU is to inform the supplier of any adverse effects noted, such as health problems with workers exposed to the substance. The du does not have to inform their supplier of the use patterns and can keep commercial applications secret. However, if using for a non-registered use, the DU will need to inform ECHA using REACH IT.
This guide was first prepared in 2008 and interestingly, has needed few changes to keep up to date