REACH Compliance
What does REACH stand for?
REACH is the common term used when referring to the European Union’s Regulation (EC) 1907/2006, which concerns the Registration, Evaluation, Authorisation and Restriction of CHemicals.
REACH Compliance
Regulations Involved
REACH was introduced on December 18, 2006 to establish the European Chemicals Agency (ECHA) as an authoritative body, amend Directive 1999/45/EC, and repeal several regulatory texts including Commission Regulation (EC) No 1488/94, Council Regulation (EEC) No 793/93, Council Directive 76/769/EEC, and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC. The purpose of the REACH regulation is to protect the health of humans and the environment by evaluating the safety and regulating the production and sale of chemical substances, mixtures, and articles throughout the EU (European Union) market while enhancing the competitiveness of the EU chemical industry. REACH was also adopted into the UK (United Kingdom) law post-Brexit and is now known in the UK as UK REACH.
Who Does This Apply To?
REACH applies to all industrial/professional and consumer use chemicals in the EU, with some exceptions. The regulation does not apply to radioactive substances, substances under customs supervision, transport of substances in mixtures or on their own, non-isolated intermediates, and waste. Partial exemptions also apply to some product types including but not limited to medicinal products, food and feedstuffs, scientific research and development substances, substances that present minimum risk, and some naturally occurring substances, along with other products/substances that are regulated under more specific laws like biocidal products.
Is This Regulation Mandatory?
Companies who are established outside of the EU are not obligated to comply with REACH; it is the responsibility of the EU importer or only representative to ensure the requirements of REACH are met for each individual substance you use, manufacture, or import. Generally speaking, all substances that are manufactured or marketed in the EU in excess of 1 tonne per year must be registered, with the registration fee and information requirement further depending on the tonnage band for your substance. Additionally, your specific obligations depend on your role in the supply chain.
What are the risks if a company chooses not to comply?
Enforcement of the REACH regulation is the responsibility of the individual member state authorities, therefore the penalties for non-compliance vary between member states. Some member states take an administrative approach to offences such as formal notices and fines; some states treat non-compliance issues under criminal law, resulting in possible prison sentences, deprivation of rights, and prohibitions; and other states use a blended approach between administrative and criminal sanctions. Fines are the most commonly used sanction with the maximum fine ranging from thousands to millions of Euros depending on the country.
For information on the newest updates for REACH compliance, visit our Regulatory News.
What is UK REACH?
Following the United Kingdom’s withdrawal from the European Union (EU), the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation has extended into UK law, under a new domestic regime known as UK REACH.
The regulation came into force on 1 January 2021, following the Brexit transition period and is essentially a replication of EU REACH but is only applicable to the countries of Great Britain (GB), with some changes to make it suitable for its market. Due to the Northern Ireland Protocol, Northern Ireland remains within the jurisdiction of EU REACH.
Who can register under UK REACH?
The responsibility for registering substances under UK REACH remains with either GB-based manufacturers or importers bringing substances into GB. Non-GB manufacturers are unable to register under UK REACH, however, can appoint an Only Representative (OR) to do this on their behalf.
How can non-Great Britain manufacturers and formulators register their substances under UK REACH?
Substances manufactured or exported into GB at greater than 1 tonne per annum now require registering under UK REACH for organisations to be able to trade in the same way.
If you previously exported a substance into GB and wish to continue exporting into or placing products on the market within GB, there are steps you should take to continue this activity.
Your options are:
- Use your own GB legal entity if you have one, to act as importer or OR.
- Request your GB based customer(s) act as a GB based importer and submit the Down Stream User Import Notification (DUIN).
- Use a GB based Only Representative (OR) such as NCEC who can complete a DUIN for you.
The Down Stream User Import Notification (DUIN) is a provision for GB-based importers and ORs of non-GB based manufacturers and formulators. The DUIN allows them to benefit from transitional measures in the form of deferred registration obligations by submitting a DUIN to the UK’s Health and Safety Executive (HSE) before 27 October 2021, provided the substance was registered under EU REACH and imported at least once between 1 January 2019 – 31 December 2020.
If a DUIN is not submitted or the substance was not registered under EU REACH, you will need to complete a full UK REACH registration through an Article 26 Inquiry via an OR.
What are the options if non-Great Britain manufacturers and formulators are not yet exporting substances into Great Britain, but plan to do so?
- Check if your GB based customer is eligible for the substance you wish to begin exporting. Your customer will be eligible if they have imported your substance into GB, at least once between 1 January 2019 and 31 December 2020.
- Check if your eligible GB-based customer has already completed a DUIN for the substance you wish to export. If they have, you are not legally required to take any further action.
- Appoint an Only Representative (OR) such as NCEC to complete a DUIN on your behalf.
To protect your access to the GB market, we would recommend you appoint an OR to submit a DUIN on your behalf, regardless of whether your customer has already completed one.
If a DUIN is not submitted or the substance was not registered under EU REACH, you will need to complete a full UK REACH registration via an Article 26 Inquiry via an OR.
Can non-Great Britain distributors and resellers register substances under UK REACH?
Distributors or resellers cannot do a DUIN directly or appoint an OR to do so. Their GB based customers will need to fulfil notifications as the importer, or their upstream suppliers will need to be encouraged to fulfil this obligation. Distributors or resellers should encourage their upstream suppliers to speak to NCEC today, to ensure that they can continue to sell substances legally in GB markets.
What is an “Only Representative”?
The Only Representative role has been preserved under UK REACH. It allows non-GB manufacturers and formulators to appoint a legal entity based in GB, to complete the DUIN and registration processes on their behalf.
Why should you appoint a UK REACH “Only Representative”?
- Protect your proprietary product data – allowing your GB based customers to complete DUINs on your behalf will mean providing them with analytical information, which will potentially compromise confidentiality and may pose a risk to your business. By appointing an OR with no conflicting commercial interests, you will avoid this risk.
- Relieve regulatory burdens for your customers – appointing an OR will allow you to maintain your competitive edge. By relying on your customers to complete the DUIN process instead, unmanageable regulatory burdens and costs may mean they find an alternate supplier.
- Maintain your access to the GB market – by being reliant on your importers you put your access to the UK market at risk. Should they cease trading or stop using/selling your product, you will no longer be able to import your product without having it registered in full by a GB legal entity.
- Maintain existing supply chains – an alternative to appointing an OR is working with an affiliate importer to continue supplying your customers in the GB market. However, this will mean changing your existing supply chains and being subject to additional charges imposed by the importer.
- Get expert support and advice on UK REACH and ongoing compliance – if you appoint an OR, you will receive support and advice to help you navigate the complexities of UK REACH, whilst ensuring you can continue supplying the GB market.
High Quality Services & Partnerships
We are working closely with our partner, National Chemical Emergency Centre, to guide you through the steps of UK REACH registration; ensuring your organisation’s compliance, in the most cost-effective manner.
The NCEC has over 45-years of experience in providing regulatory compliance support to chemical producers. Initially set up by the UK Government in 1973 to provide emergency response support to incidents involving hazardous chemicals, over the last four decades, the NCEC has developed an in-depth knowledge of the global chemical marketplace and its critical interactions with stakeholders – from regulator to supply chain.
They have been involved in supporting compliance with EU REACH since it started and are well placed to support organisations across the world to manage the impact of UK REACH. By choosing NCEC as your Only Representative, they can help you to navigate the complexities of UK REACH and significantly reduce the costs of compliance.
Working with Nexreg
Nexreg’s REACH Compliance service provides your company with expert interpretation and guidance on applicable product regulations as well as consultation services. Our team has partnered with world-class regulation advisors in Europe to ensure the quality of our services. Our professionals will assist your company with all risk assessments, fulfilling data requirements, and handling administrative responsibilities associated with the evolving REACH legislation.
We’re Regulatory Experts
Quality product compliance resources and services for companies of all sizes across the world.
I am very satisfied with the work provided by Nexreg. The work has been through, timely and reasonable. Additionally, both Mike Harvey and Nazifa Beganovic are very knowledgeable. Mike and Nazifa’s efforts have been an essential part of getting our MSDS program on track and positioned for the Global Harmonized System.
Jack CoverBonsal American, Inc.
We’re often asked by our clients to meet next-to-impossible deadlines, which means that we’re often forced to ask our vendors for the impossible. Working with Nexreg makes my job easier. They are experts at what they do, they pay attention to detail, and they make suggestions and offer advice – which makes us look like the experts. For regulatory compliance and translations, Nexreg ranks as one of the strategic partners we can always count on.
John S. WolowiecZoltun Design