Is 31 May in your diary? It’s not another safety or health awareness day, but the final registration deadline for REACH, the European chemicals regulation. As the deadline approaches, organisations that didn’t think it applied to them are discovering otherwise. Some, particularly small and medium-sized enterprises (SMEs) are only just realising that they count as importers under REACH.
“I have found several companies were not aware of their legal obligations regarding REACH registrations,” says Carlos Miguel Fazendeiro, managing director of OnlyCoreChem, a specialist chemicals consultancy based in Lisbon, Portugal. “The most common is the situation when substances or mixtures are being imported from outside the EU without a registration.”
Even if your company does not manufacture or import substances, the deadline might still have important implications for your business.
For businesses in the UK, all European Union (EU) requirements, be they REACH, food labelling or CE marking, will apply in the UK until at least 29 March 2019, and possibly beyond, depending on transition arrangements. Post-Brexit there will be implications, whether you are based in the UK, in another EU country, or in a non-EU country which trades with the EU, and we will cover these in more detail in our next article.
What is REACH?
REACH is the EU regulation on the Registration, Evaluation, Authorisation and restriction of Chemicals, which came into force on 1 June 2007. The European Chemicals Agency (ECHA), based in Helsinki, Finland, administers the programme.
By replacing what the UK’s trade union body the TUC described as a “confusing range of European directives covering the manufacture of chemicals”, REACH aims to protect human health and the environment from harmful effects of substances, making the whole supply chain responsible for their safety.
Until REACH, hazardous substances that had been in use for a long time could not be banned or restricted until a regulator could prove that the substance was unsafe; with REACH, manufacturers and importers of substances in quantities of more than one tonne a year must provide some safety data, with greater proof required that it can be used safely for quantities of more than ten tonnes. If a manufacturer or importer cannot show that the risks can be managed, the ECHA can ban the use of the substance or restrict its use. Having identified the most hazardous substances, the long-term aim is to eliminate them after finding safe substitutes.
REACH also aims to reduce testing on animals, by making it possible to accept animal tests in one country as evidence of chemical safety by another country, and by actively encouraging non-animal based approaches to generating data on the hazards of a substance.
For more about what counts as a “chemical” under REACH, and how substances, preparations, chemicals and the related thresholds differ, the Health and Safety Executive Bitesize resources at www.hse.gov.uk/reach/bitesize.htm provide useful summaries. For the detailed lists of exemptions see bit.ly/2EFMBWZ
All substances manufactured in, or imported into, the EU in quantities above one tonne a year should have been “pre-registered” as long ago as 1 December 2008, so that all organisations involved at the sharp end could form a SIEF (Substance Information Exchange Forum) to share knowledge of hazards and risks and to pool safety data.
Substances made or imported at quantities over 100 tonnes a year should already have been registered by 31 May 2013, so the May 2018 deadline applies only to substances at quantities above one tonne.
Rule of four
REACH has four key elements. The first is substance registration (the R in the acronym). The SIEFs formed after pre-registration, working with their downstream users, have to produce dossiers of information about the substance, including its toxicological and environmental properties. A lead registrant then submits these to the European Chemicals Agency (ECHA) using software it provides (REACH-IT and IUCLID) to collate all the information.
Companies manufacturing outside the EU can appoint an “only representative” (OR) based in the bloc to fulfil the responsibilities of REACH. Without an OR they will not be allowed to bring the substances into the EU, unless each EU-based customer holds a registration as an importer for the product.
Substances defined as hazardous under CLP (classification, labelling and packaging) Regulation (CE) 1272/2008 (see bit.ly/2Fq6q5R) and registered at over ten tonnes per year will require a new extended safety data sheet (eSDS) which includes exposure scenarios, describing how the substance can be used without harm to people or the environment.
Registered substances are then prioritised for evaluation. This is the E in REACH and there are two types. First, the dossier is assessed by the ECHA to determine if adequate data has been submitted to meet the requirements of the registration tonnage band (higher tonnage bands required more detailed information). If the dossier is satisfactory, substance evaluations are carried out by competent authorities from each member state – among them UK Health and Safety Executive (HSE) experts on toxicity. This decides whether the use of the substance poses a risk to human health or to the environment. The ECHA can ask for more information from registrants at this stage.
The outcome of the evaluation is usually either that:
risks are sufficiently under control with existing measures, or
the ECHA proposes further EU-wide risk management measures. This could include defining the chemical as a substance of very high concern (SVHC), proposing restrictions on its use, setting occupational exposure limits or enhancing labelling.
The third stage (REACH’s A) is authorisation.
By January 2018, 181 substances had been identified as SVHCs, because they are carcinogenic or affect the human reproductive system, or have other toxic properties (see bit.ly/2onTUMM for a detailed definition). SVHCs are used to produce glass, porcelain and ceramic products, in laboratory chemicals, in the manufacture of electrical, electronic and optical equipment, and as plasticisers in manufacturing.
Even if you think your organisation has nothing to do with REACH it is almost certainly a downstream user
The ultimate aim of authorisation is to replace SVHCs with less dangerous substances or processes. SVHCs are placed on the Candidate List, which prohibits supply without a safety data sheet (SDS). Jeff Kelsey is a REACH and toxicology specialist at Chemsage and runs the REACH compliance website www.reachsupport.eu. He explains a further requirement for articles: “Anyone using an SVHC substance in their product at levels exceeding 0.1% must include this fact in their SDS.”
All substances on the Candidate List are assessed to determine the priority for adding to the Authorisation List (also known as REACH’s Annex XIV). IOSH Magazine occasionally reports on ECHA recommendations of substances to add to the list (for example bit.ly/2BpgzQj).
If a substance is added, a “sunset date” is set, from which time it should not be used or sold within the EU, unless a separate authorisation is granted. If an organisation can show that risks to human health and the environment can be controlled adequately, or that the societal benefits of continued use outweigh the risks, they can apply for an authorisation (typically for up to seven years) to continue to use it. The authorisation can be renewed, but the hope is that organisations will use the seven years to find a safer alternative.
The fourth element of REACH (which doesn’t appear in the acronym) is restriction. The ECHA can propose restrictions on articles on the Authorisation List, but a member state can propose a restriction on any substance that they have evidence poses an unacceptable risk to human health or to the environment. Typical restrictions are that substances cannot be supplied to the public – they are for industrial use only, there is a maximum concentration for supply, or prohibitions on a specific use, such as spraying as an aerosol. Restricted uses must be described in the eSDS.
All proposals for authorisation or restriction are subject to public consultation in the member states, giving stakeholders a say in decision-making.
Even if you think your organisation has nothing to do with REACH it is almost certainly a downstream user, for example if it uses any chemicals, whether in manufacturing, to keep equipment running, or to clean the premises. The HSE examples include paints, metals, glues, solvents, cleaning materials, lubricating fluid for machinery, fence panels containing wood-stain and even T-shirts containing dye.
As a downstream user you could be affected if you rely on a substance that is an SVHC, especially if it ends up on the Authorisation List. Your business might not be aware of the use of the substance – for example, you might be buying a product such as equipment for a laboratory, or electronic equipment, that has previously used an SVHC. The product might become unavailable if authorisation is not granted for that use, or it might become more expensive if your supplier has to find an alternative method of production. If you do use an SVHC that has been authorised, you will be able to use the substance only in the way it has been authorised and then probably for a limited time.
Other products might disappear from the supply chain, not because they are hazardous, but because the supplier doesn’t believe the profit margins are large enough to make registration cost effective, particularly in light of post-Brexit uncertainty. Other products could vanish because the supplier fails to register on time.
Fazendeiro warns of the backlog of unregistered substances: “Statistics from ECHA show that by January 2018 only around 4,000 of the expected 25,000 substances have been registered for the 31 May 2018 deadline.”
He says that not only are registrations behind where the ECHA would like them to be, but the number of SMEs registering is lower than expected – suggesting perhaps that some smaller businesses may still be unaware of their obligations.
Geraint Roberts, editorial director for Chemical Watch (www.chemicalwatch.com), which publishes advice on chemical risk and regulatory management, is less convinced of a backlog. “The ECHA recently said it expects around 20,000 substances to be registered, in total, by the next REACH deadline. This is two-thirds of the original estimate ten years ago, so it may be that we had all overestimated the number of substances that are actually used in Europe on a regular basis.”
Other products might be subject to restrictions. These could relate to the way you use them, the protective and preventive measures needed, the concentration available, or the form in which they are available, whether it is liquid, powder or spray.
Even the experts can’t say which critical products might disappear or face restrictions. Roberts says:
“A number of sectors, such as engineering, have warned that this could happen, but little evidence has been provided because companies are understandably reluctant to let the market know they may be facing a serious problem.”
Kelsey suggests one area to watch is phthalates used as plasticisers. “The use of phthalates in articles is one area that has already caused problems, and several of them are already on the list for authorisation, severely restricting their use, and with a sunset date after which they can no longer be used.” However, as to which critical products might be affected, “nobody knows the precise answer”, he says.
What to do
If you have not prepared for the 31 May deadline, there is still time.
Create an inventory of all substances you use. This should list all chemicals and compounds, how and where they are used, in what quantities and how often. You should also list the name and address of your supplier, and highlight those from outside the EU. It can be surprising to find what is kept in cupboards. It is a good opportunity to do some housekeeping – if no one knows why you have a substance, or where it is used, perhaps it is time to dispose of it through the appropriate waste stream. Details on developing a chemical inventory are available in the HSE Bitesize number 11, Creating an Inventory for Downstream Users (bit.ly/2BQR1eZ).
Identify substances most critical to your process. A cleaning product might be caustic or corrosive, but if it was banned you could probably find a replacement, given there will be many other organisations similarly affected. Another chemical might be less hazardous, but less common, and critical to the way you do something, for example a raw material used in manufacturing.
Starting with the most critical substances, contact your suppliers. Find out whether the substances you use have been registered or will be registered by May. You can contact the ECHA directly to make sure that substances and the way you use them have been registered. Check that the SDS has been updated and request new copies if it has. Too many organisations rely on SDSs that are decades old. Kelsey says: “We suggest a three-year maximum to update SDSs.” New copies should have more information and follow a standard layout, making it easier to find information. The HSE has a useful list of places to look for substances that have been or might be authorised in Bitesize 19, Authorisation (bit.ly/2orqFJ5).
If SDSs have been updated, review your risk assessments. Some new SDSs will include specific exposure scenarios, along with the risk management measures so the substance can be used at an acceptable level of risk. Do the exposure scenarios match your use? If not, can you scale a scenario to match your own use? Let the supplier know whether your use is different from the circumstances given. If you rely on lots of substances, consider subscribing to a service to update as they change. Check new controls and make sure these are incorporated into risk assessments and method statements.
If your supplier has decided not to register the chemical, review your process. You will have to rethink your use of chemicals and find an alternative. This could be an opportunity to seek a less hazardous way of achieving the same end. Roberts reminds us of the implications of substituting: “If a company does switch to a new chemical this could have big implications. It might have to alter its production processes and workplace safety measures, and if it is a producer of mixtures it might have to amend its own safety data sheets.”
If you import substances from outside the EU, check whether your supplier has appointed a representative in the EU to meet its REACH obligations. If your supplier hasn’t, you might be liable for registering the product. Roberts points out another financial impact: “If you have to switch from an EU-based product to one imported from outside the EU, this could have customs and tariff implications.”
If you buy from a UK company acting as or for a non-EU manufacturer, ask them what they are going to do if the UK becomes out of REACH post Brexit.
In our next article we will look at the scenarios for REACH compliance in the UK after Brexit.