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. As the name suggests, there are various sections to the REACH process that companies must adhere to.
In this post:
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.
Key Takeaways
REACH is the acronym for Registration, Evaluation, Authorisation, and Restriction of Chemicals
REACH is a set of EU regulations requiring companies to register hazardous chemicals
Dossiers must be submitted to the European Chemicals Agency (ECHA) to be evaluated
Chemicals for registration are assessed for risks to human health and the environment
The substance being registered may either be authorised, restricted, or banned
The authorisation process ensures substances of very high concern (SVHC) are replaced with alternatives
Specific restrictions can be imposed, such as detailed labelling that emphasises risks
Steps for Successful Registration
Generally, the REACH submission process involves three major steps: preparing and submitting an inquiry, preparing and submitting a joint submission, and registering your substance.
You must first submit an inquiry to ECHA if your chemical product is exempted. If it’s not exempted, you then need to file a joint submission with other companies that have similar products.
Finally, you need to submit the required dossier and pay the fees for evaluation. You can use online tools such as IUCLID to submit your information.
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.
What to Expect During REACH Evaluation
Your substance dossier will be manually evaluated by the European Chemicals Agency, which has the corresponding expertise in various fields related to your documents.
Your chemical product will either be approved, restricted, or banned, depending on the risks associated with it. You may be required to submit additional documents or have your product subjected to further testing.
Tips for Smooth Evaluation
REACH evaluation takes place over two phases. The first phase is the evaluation of the dossier, and the second is the evaluation of the substance itself.
To ensure a smooth evaluation, you must firstly comply with all the documentary requirements, which must be the latest updated documents.
Secondly, you should submit the right samples for testing. Make sure that your samples correspond exactly to the documents you submitted.
It’s also crucial that you check if your substance is in the list of Substances of Very High Concern (SVHC) or contains an SVHC ingredient.
Authorisation of REACH Compliance
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%.
Understanding the Authorisation Process
The ECHA authorisation process can be divided into three phases:
- Identifying if the product contains an SVHC. Your dossier will be examined and consultations will be conducted.
- Drafting recommendations and inclusion in the prioritisation list.
- Applying for authorisation and implementation of possible restrictions.
Preparing for Authorisation
When preparing for authorisation, you must have already undergone evaluation process and should have prepared dossiers for the following:
- Chemical Safety Report (CSR)
- Analysis of Alternatives (AoA)
- Socio-Economic Analysis (SEA)
REACH Restrictions
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.
Identifying Restricted Substances
There are more than 1,000 substances listed in REACH Annex XVIII, which are classified under 59 categories.
There are accepted or allowed maximum thresholds for each substance. These are hazardous, toxic, and environmentally risky substances, including carcinogens and substances that can biologically be amplified.
Identifying restricted substances in your products requires laboratory analysis, unless you already know the exact chemical compositions of your product.
Managing and Substituting Restricted Chemicals
Companies applying for REACH must be able to effectively identify and manage the risks and hazards associated with the products that they manufacture and distribute in the EU market.
You must be able to prove to the ECHA that the substance you are registering is safe to use, and risk management must be effectively communicated to your consumers or end-users.
In many cases, hazardous chemicals can be substituted with safer alternatives. Technology in manufacturing can also be improved by applying green chemistry principles.
Conclusion
Compliance with REACH regulations isn’t just a legality, it’s a matter of moral duty and best industry practice. The main objective is to minimise the risks in terms of potential health hazards and environmental impact. By thoroughly complying with the documentary and technical requirements, any dangerous chemicals your product contains can be effectively managed. Some can be restricted, banned, or substituted with alternative ingredients.
For further reading, including useful short guides to different aspects of REACH, we recommend reading the excellent Health & Safety Executive resources.
