In our recent series of blog posts about REACH (Registration, Evaluation, Authorisation, and Restriction of Chemicals) regulations in the EU, we’ve looked at what REACH is, how it works, and what the impact of a no-deal Brexit may be on these regulations and on the UK chemical industry as a whole.
In this article, we’ll look at how chemical suppliers need to comply with REACH regulations in 2019. As the name suggests, there are various sections to the REACH process that companies must adhere to.
REACH Registration Compliance
Chemical companies must document information on the properties, uses, hazards, and potential risks of any products they manufacture or import, as long as they manufacture or import more than one tonne of the product per year. This information culminates in a registration dossier which is given to the European Chemicals Agency (ECHA).
Products which must be registered include single substances, mixtures, and some substances in articles. If a product already falls under other legislation, such as medicines, they may be partially or totally exempt from REACH. Additionally, a product only needs to be registered once. This means that any chemical companies making or importing the same product can submit a joint registration.
Complying with REACH – the Evaluation Process
Following the most recent REACH registration deadline in May 2018, there is currently a clear emphasis on the evaluation process. During this process, the ECHA assesses key aspects of the registration dossiers to ensure compliance with the specific requirements and the essence of REACH, and to clarify whether a given substance poses a risk to human health and/or the environment.
Registration dossiers are ‘living documents’ which should be regularly updated whenever new information is available or a need to improve data quality is identified. It is therefore critical that all registrants ensure that the information they provide in their dossiers is robust, up-to-date, and that human health and the environment are properly protected.
The objective of the REACH authorisation process is to ensure that substances of very high concern (SVHC) are replaced either by less dangerous substances or by technologies with technically and economically viable alternatives. SVHCs include substances which are carcinogenic, persistent, bioaccumulative and toxic (PBT), and mutagenic, amongst others.
The authorisation process is begun when a Member State or the ECHA proposes that a substance should be identified as an SVHC. The first step in the process is a 45-day public consultation. Once a substance is identified as an SVHC it is placed on the Candidate List, which means that suppliers need to provide a safety data sheet (SDS), communicate how to use the substance safely, answer consumer requests within 45 days, and notify the ECHA if the substance they produce contains an SVHC of more than one tonne per manufacturer or importer per year, and if the substance is present above a concentration of 0.1%.
The aim of the ‘restrictions’ section of REACH is to protect human and environmental health from unacceptable risks. Restrictions normally limit or ban manufacturing, importing, selling, and using the restricted substance. Furthermore, the ECHA can also impose conditions, such as requiring specific labels, on these substances.
A restriction doesn’t just apply to a single substance. It can apply to mixtures and articles, including those that do not require registration. This means that even if a chemical importer brings one tonne or less if the substance into a market, restrictions will still apply.
For further reading, including useful short guides to different aspects of REACH, we recommend reading the excellent Health & Safety Executive resources.
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