Last reviewed 27 March 2017
Deadlines for demanding new EU 2018 REACH chemical safety registration are fast approaching and in parallel with the UK’s changing relationship with Europe. Jon Herbert reports.
It is important that smaller companies abide by the letter of new chemical safety regulations, even though the shape of Britain’s forthcoming relationship with Europe will almost certainly affect their future obligations. Until clarification is available, many duties continue to be a legally enforceable requirement.
The European Chemical Agency (ECHA) set out in 2014 the framework by which companies must comply with complex Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) 2018 registration deadlines. UK chemical exports worth billions of pounds to other EU countries are affected. A major demand is for the supply of detailed data.
By 31 May 2018, companies producing or importing chemical materials — known more generally as substances — falling under REACH regulations in volumes of between 1 and 100 tonnes per annum must complete the ECHA’s registration process.
REACH, originally introduced under the EC Regulation 1907/2006 on REACH, applies directly to all 28 EU Member States, plus Iceland, Norway and Liechtenstein. As one of the broadest and most far-reaching pieces of EU legislation, its status as a regulation is so powerful that it doesn’t need to be transposed into UK law.
Many companies might take the view that meeting REACH’s challenging demands is a wise precautionary move whatever the eventual outcome of Brexit negotiations. However, some future scenarios could affect not only the costs but also the future administration and process involved with implementing REACH.
This may result in some companies eventually opting to manufacture and trade outside of Europe or, alternatively, to simply cease production altogether.
However, while the UK remains part of the EU the current law prevails. Based on what we know of the negotiation timescale, it is generally understood that UK-based companies affected by REACH retain a legal obligation to register their substances in line with the 2018 deadline.
On this point it is worth working closely with qualified consultants who understand individual circumstances; experience shows that do-it-yourself approaches can be fraught with problems.
Reasons for REACH
REACH is designed to ensure a high level of protection for human health and environment from the possible risks posed by chemicals. It applies both to industrial and domestic substances.
The process evolves continuously; it also promotes the use of non-animal testing methods. A further goal is the free circulation of fully-compliant substances within the open internal EU market that REACH covers. Enhanced innovation is an additional aim, with an eye to commercial needs; so is greater competitiveness.
Importantly, REACH makes it the responsibility of industries and individuals to assess and manage risks, and provide appropriate safety information to all handlers, storers and users. The EU can also take additional steps where highly dangerous substances call for extra precautionary measures.
REACH legislation text is organised into 15 titles: the first 8 refer to REACH processes; the next 7 detail REACH administration elements such as the ECHA’s roles, data confidentiality and enforcement issues.
Within each title are chapters that together include a total of 141 Articles setting out legal obligations. Many amendments have been added to the regulations.
There are also 17 Annexes giving technical details to the obligations. These are updated and adapted as legal positions evolved and are interpreted, plus new or amended legislation.
Legal text is supplemented by guidance documents, factsheets, guides and user manuals involving thousands of pages. As such, unless the organisation has an in-house expert, specialist advice is strongly recommended.
REACH registration is the regulation for what are termed phase-in substances; from 1 June 2018 onwards, any substance that has been pre-registered must be registered if a company is to continue manufacturing and importing it in quantities of 1 tonnes per annum or more.
It affects phase-in substances used in quantities of 100 tonnes per annum or more, or those carcinogenic, mutagenic or toxic to reproduction (CMRs) supplied in quantities of 1 tonnes per annum or more.
The benefit of registration is being allowed to stay in the market, linked with access to better quality information. Following the registration process carefully also helps to avoid future supply chain disruption, which may result if a substance a company relies on has not been registered and is suddenly unavailable on the market. This could hit downstream users who depend, for example, on a particular feedstock product.
Although the regulation process can be complex, there are established routes in. Companies should be active in what is known as their appropriate Substance Information Exchange Forum (SIEF).
There must also be a Lead Registrant (LR); deciding who to nominate is important. Another early priority is to start data sharing negotiations. Again, many companies will already be well along this route. Since discussions can be lengthy, the Health and Safety Executive (HSE) recommends starting as soon as possible.
Useful advice for downstream users, or distributors, is to make early enquiries further up their supply chains to ensure essential suppliers are also well along with the process.
Information requirements for substance quantities below 100 tonnes per annum are less onerous than above this threshold, which can help to reduce some small and medium-sized enterprises (SME) costs.
Rather than reinventing the wheel each time, it is accepted that costs can be shared across the industry. Large organisations have historically invested heavily in substance safety assessments from which SMEs benefit at no charge.
Even so, it is also seen to be reasonable that smaller firms pay proportionately.
The alternative could be costly errors resulting from a DIY approach. As examples, some SMEs opt for the wrong SIEF, in which case corrections can be expensive and difficult. Missing deadlines, even inadvertently, can trigger enforcement action.
The wisest policy is generally to take specialist REACH support. Choosing a consultant needs care. There are no official standards or certification; quality and support levels can vary.
Taking on LR roles involves responsibilities too. SMEs may need to form consortia with other SIEF members. An alternative can be to make a Joint Submission registration. Here, the bulk of the technical work is done by consortia members and their consultants. Charging rates are complex and the domain of experts, who can also help non-EU companies selling to EU customers.
Only EU companies can participate in certain aspects of REACH. Companies outside of the EU must use a third-party and pay costs. They must also comply for a minimum of two years.
Exiting as planned
If leaving the EU goes ahead as planned, the current options could include arrangements similar to the European Economic Area (EEA) with members such as Iceland and Norway. That would mean the UK remaining part of the single European market, an arrangement not currently on the table. With the Government’s present determination to leave the single market, a free trade agreement of the Swiss-type could prevail.
However, if none of the above may apply, predictions are more difficult. For example, being outside the single market would fall out of the scope of the ECHA.
In this scenario, UK chemical companies wanting to work in the EU would be seen as part of a non-EU country and non-EU manufacturers.
Instead of registration taking place in the UK, this would have to be replaced by registrations carried out by EU importers or “only representatives” (ORs) in the EEA. UK-based ORs could no longer make registrations for non-EU manufacturers, which represent an estimated 40% of UK registrations.
Two other REACH processes — authorisation and restriction intended to protect human health and the environment from unacceptable chemical risks — would also be affected adversely. Authorisation applies to substances of very high concern (SVHC) not allowed on the market because of their serious impacts that may require authorisation for use in limited circumstances.
With the UK outside the EU, these measures may no longer apply. This raises the possibility of reintroduction, although that would almost certainly be resisted strongly. We will, of course, keep you updated as Brexit changes become apparent.