The Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulations are a European Union legislative act. Established by the European Chemicals Agency (ECHA), they aim to protect human health and the environment from potential dangers posed by chemicals. REACH requires companies that manufacture, import, or use substances in their products to register these substances and evaluate their safety.
The UK, despite leaving the EU, has adopted many of these regulations into law. As such, UK-based manufacturers need to be aware of their responsibilities under REACH. This article will provide a comprehensive guide on the specific steps that UK manufacturers need to take to ensure they are in compliance with REACH.
The first step towards compliance with REACH is the registration of substances. Any substance manufactured in the EU in quantities of one tonne or more per year, must be registered with ECHA. For UK manufacturers, this requirement still applies. You must prepare a full registration dossier for each substance you manufacture or import. This includes detailed information about the substance, its uses, and how it can be managed safely.
In case you're using a substance for the first time, you will need to register it within 12 months of its first manufacture or import. If the substance is already on the market, you should update your registration as soon as you become aware of new information concerning its safety.
The process of registration can be a complex one, but fortunately, ECHA provides a number of tools and resources to assist companies. These include the REACH IT system, which allows you to submit your registration electronically, and the Chemical Safety Assessment and Reporting Tool (Chesar), which can help you to assess the safety of your substances.
Once you've registered your substances, the next step is to evaluate their safety. ECHA will review your registration dossier and may ask for additional information if they believe it's necessary to confirm the safety of a substance. This is known as an evaluation.
During an evaluation, you may be required to carry out new tests, or to provide further analysis of your existing data. Moreover, you will need to develop an exposure scenario that describes how your substance is used, and the measures you have in place to control exposure. The exposure scenario is a crucial part of the safety assessment and should be included in the registration dossier.
Your safety assessment should be based on the most up-to-date scientific knowledge, and you should be prepared to regularly revise and update it as new information becomes available. It's also recommended to consult with experts in the field of chemical safety during this process.
Some substances, due to their potential to cause significant harm to human health or the environment, are subject to authorisation under REACH. These are often substances that are carcinogenic, mutagenic, or toxic to reproduction, among others.
If you manufacture, import, or use any of these substances, you will need to apply for an authorisation. This involves demonstrating that the risks associated with the substance are adequately controlled, or that the socio-economic benefits of its use outweigh the risks.
The authorisation process can be lengthy and complex, and it's crucial that you start preparing your application well in advance of the sunset date for the substance. Additionally, you will need to develop a plan for replacing the substance with a safer alternative, where feasible.
Finally, REACH imposes restrictions on the manufacture, use, or sale of certain substances. These restrictions can apply to all uses of a substance, or they could be specific to certain products or industries.
As a UK manufacturer, you need to ensure that your products do not contain any substances that are subject to REACH restrictions, unless you have an authorisation for that use. If ECHA introduces a new restriction, you will need to review your operations and products to ensure you remain in compliance.
ECHA maintains an updated list of restricted substances on their website, and it's important to regularly check this to ensure you are aware of any changes.
In conclusion, complying with REACH regulations can be a complex process, but it's a legal requirement for UK manufacturers. By registering your substances, assessing their safety, applying for authorisation where necessary, and adhering to restrictions, you can ensure that you are doing your part to protect human health and the environment.
The REACH regulation predominantly operates within the framework of the European Union. However, since the United Kingdom’s departure from the EU, a new marking known as the UKCA (UK Conformity Assessed) has come into existence. This marking is the new UK product marking used for certain goods placed in the market in Great Britain. It covers most products that previously required the CE marking.
For UK-based companies, it is crucial to understand that the UKCA marking is currently not recognized in the EU market. Products need both UKCA and CE marking for selling in both regions. The transition period, during which CE marking was accepted in the UK, ended on January 1, 2023. Therefore, since this date, it is a requirement for products placed in the market in Great Britain to carry the UKCA marking, except for medical devices.
Northern Ireland, however, follows a different set of rules. Under the Northern Ireland Protocol, the EU REACH continues to apply to the province. This means that UK-based companies who have their supply chain passing through Northern Ireland will have to comply with REACH regulation.
The UKCA marking does not negate the need for REACH compliance. UK manufacturers and importers need to ensure that their substances, mixtures, and articles are fully compliant with REACH regulation. This means that downstream users of chemicals in the UK will need to refer to safety data sheets that align with REACH compliance, irrespective of their market location.
Compliance with REACH regulations is not a one-time task for UK-based companies. It requires constant attention, regular updates and adherence to evolving legal requirements. Whether you are a lead registrant, a downstream user or part of the supply chain, staying abreast with REACH is essential to ensure health safety, environmental protection and legal compliance.
Moreover, as the United Kingdom has departed from the EU, it has brought in the UKCA marking, which is a new game player for manufacturers, importers, and downstream users. This has added a critical dimension to compliance and requires careful understanding and implementation, particularly due to the unique situation presented by Northern Ireland.
Balancing the requirements of both the UKCA marking and REACH compliance might seem daunting, but it remains crucial for market access in both Great Britain and Northern Ireland, respectively. Therefore, maintaining an up-to-date knowledge of these regulations, checking for new additions to the restricted substances list, and understanding the implications for your products is essential for your business.
Remember, it's not just about complying with the law; these regulations are in place to safeguard human health and the environment. As UK-based companies, understanding and adhering to the REACH regulations and UKCA marking is a significant step towards building a sustainable and responsible business.