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 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.
The legal background
European legislation is a nightmare for those in the legal profession as the text is largely written by committees working to come to a compromise. The good news for industry, is that the authors of much of the text are scientists and are 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 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, come back to the question of what you believe to be right and wrong in terms of aiding hazard and risk communication, and the answer is usually clear to see.
The legal text is found almost entirely in Regulation (EC) No 1907/2006, but note minor revisions have already been issued.
· The fees Regulation (EC) No 340/2008 describes fees for registration activities
· Regulation (EC) No 440/2008 covers test methods.
· Annexes IV and V (Regulation (EC) No 987/2008) describe changes to exempt substances
· Annex XI was revised in February 2009 (Regulation (EC) No 134/2009) to clarify data waiving.
· Annex II was revised in 2010 to outline SDS requirements in Regulation (EC) No 453/2010
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 website is a good place to look http://echa.europa.eu/reach/legislation_en.asp
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.
Basics of REACH
Registration is only required for those who manufacture or import > 1 tonne of a chemical substance or if an imported article deliberately releases a substance at over 1 tonne. If chemicals are supplied from within the EU, the registration must be taken care of by the up-stream suppler and not the customer.
Non-EU manufacturers and producers of formulations (or articles releasing substances) can appoint EU-based 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.
Tonnage bands and date of registration
Part of the pre-registration process involved predicting when you expect to register and the date depends on the tonnage band and whether the substance is officially considered r50/53 (very toxic and potentially persistent in the environment). If your predictions were wrong and tonnage is higher or lower than your predicted band, the registration date can be brought forward or put back accordingly.
The deadlines for full registration are outlined below:
30 November 2010 - 1000 tonnes and above, as well as CMR category 1A and 1B (under CLP) above 1 tonne/year and substances classified (R50/53) above 100 tonnes
31 May 2013 - 100 tonnes and more
31 May 2018 - 1 tonne and more
It is still possible to make late pre-registrations for those not due for registration in 2010. Late pre-registration for up to 1000 t per annum will close in May 2012 (12 months before the registration deadline) and the rest in May 2017.
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 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 exempt substances, including 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 will need registration, but such materials may be exempt from certain parts of reach, such as end-use risk assessment.
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 are described in article 3 of the reach regulation, but some key ones are described below.
A substance : defined chemical with ec number or registration number
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).
Mixed substances : multi-component substances that are synthesised in such a way that two or more key chemical components form, such as mixed isomers. These need special pre-registration and cannot be bulk-uploaded and must be pre-registered individually.
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 added together after synthesis, such as solution in solvent or blended product. The mixture does not need registration, but all components must be registered 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
Pre-registration (mainly completed December 2008)
The first real practical activity industry faced was ‘pre-registration'. The purpose was to identify at an early stage of the process exactly which substances we are buying in, producing, extracting, importing and supplying.
A major reason for the ritual of pre-registration was also 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). Pre-registration had a deadline of December 2008 to allow a line to be drawn and for SIEF formation to start, but ‘late pre-registration' options are still open in some cases.
Late pre-registration is aimed to allow continued commercial activity of responding to customer needs to manufacture or import new chemical substances. The criteria for late pre-registration is that the substance should be on EINECS or a NLP and that supply is new for you; ie. The reason you did not pre-register before 1 December 2008 was that supply had not taken place.
SIEF formation; 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.
There are a number of on-line based systems and software management tools. Each of these need to be considered on their own merit and although you cannot be forced to sign up to any of these services, there may be a chance to save time and money.
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.
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, x-ray diffraction 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 sief who you are sharing the registration with.
These need reporting by all registrants as an attachment to section 1of IUCLID 5.
Data evaluation - classification and labelling and the robust summary
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 5. 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.
The proposed classification and labelling is entered into section 2 of IULCID as part of a joint registration and the conclusions will be published in the classification and labelling inventory. This is done in accordance with GHS principles, outlined in the CLP Regulation (EC) No 1272/2008.
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 (DNELl) 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 by the SIEF for each substance.
When working in a SIEF for a joint registration, data considered adequate to avoid new testing will be considered to have a value to the SIEF and the owners of such data will be entitled to compensation if sharing access to the data. Even if not sharing access (eg for non-animal testing where sharing access is not compulsory), the data will still be required to complete the robust summary and classification.
Data for hazardous substances must be made public - even if other members do not have access to use the data for their registration, the data cannot be kept as confidential.
Considering new testing
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.
The exposure scenario
The life cycle of the substance and any preparations made from it must be considered in preparing an exposure scenario. This includes how it is synthesised, handled, formulated, used and how much waste is produced. This also needs to consider the routes of exposure that relate to the physico-chemical properties (volatile, dusts, soluble in water etc).
It is accepted that suppliers cannot know every detail of use by their customer and likewise, customers, or downstream users (DU) may not want to divulge their specific uses to suppliers. Therefore, it is possible for DUs to prepare their own ES.
The ES is primarily a tool to help describe potential anticipated points of exposure to workers, consumers and the environment and must be usable and understandable to those who need to use the ES to help evaluate potential for risk management.
For hazardous substances and mixtures and for mixtures containing hazardous substances above thresholds of concern (ie when SDSs are compulsory), then the ES needs to be provided with the SDS as a technical appendix (the extended SDS).
Risk assessment; the CSR
The CSR is a formatted risk assessment and the template and guidance is available in the ECHA guidance. Part A includes making the declaration that you have communicated risk management measures to your customer.
EUSES and the ECETOC TRA tools together with the CHESAR tool linked to IUCLID provide some support in estimating exposure, but it is important not to rely on models without understanding the science behind them. The conclusions to the CSR are numerical ‘risk characterisation ratios' (RCR) that consider the level of exposure vs. the estimate no-effect levels. If exposure level is lower than the effect level, then risk is considered acceptably low.
Communication - the SDS
The SDS has not changed much with REACH, with the most obvious changes being that Sections 2 and 3 have changed over. Of more importance is the expectation that the hazard sections will be based on the robust summaries of substances and that the PNEC and DNEL / DMEL will be included together with vPvB / PBT or CMR assessments. A glossary is provided below, but the the authors and recipients will be faced with a more technical document.
The SDS is still the ultimate communication tool and writers should be less worried about the format and headings and instead concentrate on communication skills - the SDS must take into account the conclusions of theCSA and the exposure scenarios used to write the CSR. The SDS must therefore consider who is reading the SDS and under the conditions of their use.
The key conclusions to the CSR are the proposed risk management measures (RMM) and these needs putting into plain language in the SDS. The ES used to construct the CSR must also be provided in the case of hazardous substances.
registration is made through reach it using the free software, IUCLID 5. The REACH IT portal can be accessed through the ECHA web-site, with the following link.
With a basic level of it skill, IUCLID 5 can be installed onto a reasonable desktop or laptop computer by following instructions and guidelines given by ECHA. It takes up a lot of memory, and at least 1 GB ram is recommended, although it will run on less. As well as being the source for download, there is help and support available from the IUCLID 5 web-site http://iuclid.eu/ . It is recommended to download all the components and expect the download and installation to take about 2 hours on a reasonable broadband system if installing to a stand-alone computer.
If making a non-phase in registration, it is first essential to make an inquiry using IUCLID . These needs a comprehensive set of analysis data on your production / import material so that ECHA can compare with other registered substances. If the same as other substances or similar (eg. Substance notified under NONS with an ELINCS number) then you will be asked to work with the data holder to share animal data. If the data was submitted over 12 years before your inquiry, the data will be freely available.
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.
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.
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.
It is recommended that DUs provide basic use information to suppliers, following guidance in chapter R-12 of the technical guidance.
Authorisation and restriction
A problem could arise though if your use is unsuitable for the substance and it is restricted for certain uses - in this case you may need an authorisation. This is such a complicated issue, that unless your market and profit is substantial, substitution for other chemicals may be the pragmatic way forward.
Annex XVII of reach lists substance already considered to be substances of very high concern (SVHC) and many of these are already restricted under pre-reach legislation. In addition, chemicals as to be periodically added to the ‘candidate list' of substances to be added to Annex XIV. These will be effectively banned in Europe and special authorisation is needed or industry exemptions applied for. Intermediates will be exempt from this if controlled exposure.
If mixtures or articles contain SVHC at levels of over 0.1%, then customers (DUs) must be informed on the labelling with a suitable warning.
After registration ?
The SIEF will formally cease once all members are registered, but all registration holders have a duty to maintain their CSR and SDS and alert customers of new safety issues. And if new data emerge to suggest a previously unknown hazard, all registrants will be affected as the classification will need to reflect all supplies of the substance.
If a new supplier wants to register the substance, the existing registrants will need to share data and the easiest mechanism for this is to revert back to the SIEF agreement. For the SIEF members, this present an opportunity to recover back a share of the value of shared data - if the SIEF agreement covers this.
this is just a short overview - please contact Denehurst if you have any specific questions.