One of our recent articles provided an introduction to REACH, and here we’ll look in more detail at the obligations the chemical industry has in meeting REACH regulations.
In this post:
What Does REACH Stand For?
REACH is a European Regulation relating to the safe use of chemicals. Its goal is to improve the protection of both human and environmental health through a process of:
Registration
Evaluation
Authorisation and Restriction of
Chemicals
REACH is complex EU legislation, and chemical companies are obliged to comply if they manufacture or import one tonne or more per year of chemical substances within the EU. Chemical companies must have specific knowledge of the properties of the substances they are handling, and show that they are managing and communicating potential risks and hazards.
Key Takeaways
REACH is the acronym for Registration, Evaluation, Authorisation & Restriction of Chemicals
REACH is a regional treaty ratified by member countries of the European Union
It requires manufacturers, importers, and distributors of hazardous chemicals in the EU to register their products
The European Chemicals Agency (ECHA) is the implementing agency that evaluates and either authorises or restricts chemical products and items
There are five conditions that chemical suppliers or manufacturers must comply with
Which Companies Does REACH Apply to?
REACH applies to chemical companies which are:
- Chemical manufacturers – you make and sell chemicals, or supply chemicals to other companies to sell
- Distributors of chemicals – you store and distribute individual chemicals or chemical mixtures
- Importers of chemicals – you buy chemicals, chemical mixtures or items such as clothes and plastic goods from outside the European Union
- An end-user of chemicals – you use individual or mixtures of chemicals
If you fall into any one of these categories, you must comply with REACH regulations. That means you must identify and manage any risks arising from the chemicals you manufacture, distribute, import, or use within the EU/EEA.
Five Obligations of Chemical Suppliers in Meeting REACH Regulations
1. The REACH Registration Dossier
Companies required to comply with REACH legislation must complete a registration dossier. This document indicates if the chemicals they are handling cause adverse effects to human and/or environmental health. REACH provides Standard Information Requirements (SIRs), which is the minimum amount of data needed for chemical companies to meet their obligations.
2. Dossier Upkeep and Evaluation
REACH registration dossiers are considered ‘live’ documents, meaning they have to be updated with any new information. Depending on this information, it may also be necessary to update the Safety Data Sheets (SDSs) in order to make customers aware of the changes and ensure they still handle the chemicals safely. Another reason it’s important to keep your registration dossier up to date is that the European Chemicals Agency (ECHA) may select it for evaluation and compliance checks.
On occasion, changes to the regulations may be issued by REACH. It’s important to react quickly to any changes so that you remain compliant.
Best Practices for Dossier Maintenance
Specific REACH regulations may change without prior notice. That means you need to update your dossier to be compliant. This may require hiring a consultant to help you update your dossier since you must always be ready with basic REACH information.
You may also need to upgrade some of your information based on latest studies and tests. You can use the IUCLID Cloud to share information.
3. Changes to Business Legal Entity
You should be aware that REACH obligations affect business changes, including mergers, acquisitions, and transfers of assets. A legal entity change means that you will need to update existing registration dossiers so that your company can continue to manufacture, import, distribute or use chemicals.
Reporting and Compliance Requirements
All chemical substances that are manufactured or sold in amounts above one tonne per year in the EU must be REACH registered.
This is especially true for substances that have ingredients listed as hazardous – and that means hazardous to humans and to the environment. Potential risks are evaluated and safety information is provided, and some chemicals may be either restricted or banned.
4. Changes to Manufacturing Processes
You must also update your REACH dossier in the event of any changes to your manufacturing processes. This may include new product development, any changes in raw material, updates to product composition, changes to your manufacturing processes, and simply producing more chemicals which take you over your existing tonnage band (different tonnage bands place different testing requirements on companies).
Impact on REACH Compliance
Whenever there are changes in manufacturing processes, whether that’s in terms of ingredients or methods, these changes must be reflected in your REACH dossier.
If not, you may no longer be compliant with REACHrequirements. This means you’ll need to update the data and other details in your dossier for reevaluation.
5. Candidate List, Authorisation and Restriction
The EU is committed to having all Substances of Very High Concern (SVHCs) road-mapped by 2020. The Candidate List – the list of SVHCs – is updated bi-annually. When a chemical is added to this list, companies which manufacture, distribute, supply or use this chemical have to meet certain legal obligations. These obligations include communicating information about the chemical, assessing the impact on products which contain the chemical, and assessing any impact on the supply chain.
Managing the Candidate List
The list of Substances of Very High Concern (SVHCs), or the Candidate List, is continually being updated.
Its main goal is to restrict and eventually replace these substances with safer alternatives. You must always update your information based on the candidate list, which is published on the REACH website.
Conclusion
REACH regulations are a dynamic set of regulations that are continually being updated based on advances in manufacturing technologies. Alternative greener methods are being developed to replace unsustainable processes. New chemical formulations are also being discovered. Your compliance with REACH regulations must be in line with these improvements. That means it’s crucial to be up to date with the latest information to ensure you’re always REACH compliant.
For helpful short guides to different aspects of REACH, we recommend reading the excellent Health & Safety Executive resources.
