Guidance for Battery Manufacturers: UK REACH & Battery Directive 2006/66/EC
Battery manufacturers often need a strong grasp of shifting regulatory requirements relating to their activities. In recent years REACH regulations have been amended in addition to recent proposals affecting the well-known Battery Directive.
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UK REACH
Under the European Union (Withdrawal) Act 2018, the EU REACH Regulation was brought into UK law on 1 January 2021 and is known as UK REACH.
The UK REACH and the EU REACH regulations operate independently from each other. You must ensure you comply with both regulations, where necessary.
UK REACH regulates chemicals placed on the market in GB.
You will need to consider your role in the supply chain in GB and how you use chemicals to determine what your obligations may be.
REACH Registration
Generally, UK REACH applies to all individual chemical substances on their own, in mixtures or in articles. Some aspects of UK REACH only apply at one tonne per year or more. For more information refer to guidance on UK REACH registration.
Under UK REACH, as a registrant, you must collect information on the properties and uses of the substances you manufacture or import above one tonne a year. You should also assess the hazards of the substance and any potential risks presented by its uses.
Also, the principle of "one substance, one registration" has been retained. This means that manufacturers and importers of the same substance should be part of a 'joint registration'. This is to minimise the use of animal testing and to allow the costs of generating the registration data to be shared. For new substance registration a fee is usually charged.
Manufacturers: produce or extract a substance either through chemical synthesis, smelting or extraction. They are required to hold a valid registration for these substances under UK REACH.
Importers: bring chemical substances into GB from either the EU/EEA or NI or from the rest of the world. They have responsibilities to hold registrations for these substances unless their non-GB suppliers, where applicable, have appointed an Only Representative to take on the duties on behalf of the GB importers.
Downstream users: are companies or individual workers who directly handle chemical substances in the course of their business activities and are not themselves the GB-based manufacturer or importer of the substances.
Any GB-based legal entity intending to manufacture or import a substance into Great Britain (England, Scotland and Wales) at or above 1 tonne per year is required to submit a registration to HSE for that substance.
Though registration is not required for mixtures (formulations), the substances that comprise a mixture must be registered if the aggregated import volumes for any of those substances reach 1 tonne or more per year.
Registration is per substance, per legal entity.
The first step of any new registration is to submit an Article 26 Inquiry.
An inquiry dossier is compiled using the freely-available IUCLID software package and contains information about your company and the specific substance you intend to manufacture/import in GB.
The process for compiling an inquiry dossier is analogous to the process under EU REACH and the requirements are the same. Therefore, ECHA's manual How to prepare an inquiry dossier remains a valid guide. There is also a helpful video to guide you through the process of creating an inquiry dossier.
Inquiry dossiers can be submitted to HSE via the Comply with UK REACH service on GOV.UK.
Once you have successfully inquired about a substance and received your inquiry number, your contact details (as input during the 'account creation' process), or the contact details of your appointed Third Party Representative (TPR) will be shared with existing registrants, grandfathered registrants and other successful inquirers regarding that substance. This will enable you to engage in the data sharing process.
Under UK REACH, as under EU REACH, registrations are to be submitted jointly, the concept of 'one substance, one registration' has been retained. Each legal entity must still submit their own registration dossier. New registrations must be accompanied by the appropriate registration fee.
If there is more than one registrant for a substance, co-registrants should agree between themselves who the "lead registrant" will be.
The UK REACH Candidate List is a list of substances of very high concern (SVHCs) that may be prioritised for inclusion on the Authorisation List (Annex 14) of UK REACH.
When UK REACH came into force, all substances on the EU REACH Candidate List were carried over onto the UK REACH Candidate List.
Sample extract, below.
Probably the most critical aspect in relation to SVHCs is that some may go forward and be included on Annex 14 of UK REACH (Authorisation List). Such substances will be subject to the authorisation provisions of UK REACH. Once a substance has been listed, businesses cannot generally use that substance for the specified use beyond a sunset date that is specific for that substance, unless they are granted an authorisation.
Supplier Responsibilities
If you supply an article (article definition) containing a substance that appears on the Candidate List in a concentration above 0.1% weight by weight (w/w) you must provide the recipient of the article with sufficient information, available to you, to allow safe use of the article including, as a minimum, the name of the substance (Article 33). This applies when the article is supplied to recipients who are to use or handle it as part of their work.
You must also supply the equivalent information to consumers (the general public) if requested. You must provide this information within 45 days of receipt of the request.
If you produce or import supply articles containing substances that appear on the UK REACH Candidate List you may need to submit a notification to HSE.
If you supply a mixture not classified as hazardous according to GB CLP you must provide the recipients on request, with a safety data sheet if the mixture contains at least one substance on the UK REACH Candidate List, present at concentration of at least 0.1% (w/w) for non-gaseous mixtures.
If you supply a substance that appears on the UK REACH Candidate List you must provide a safety data sheet for the substance to your customers.
Battery Producer Registration
If you are a producer of industrial and/or automotive batteries you must register on the National Packaging Waste Database (NPWD) within 28 days of the first day that you place batteries on the market. The NPWD is an integrated system that maintains a register of all types of battery producer - portable, industrial and automotive. (Source)
Battery Labelling
In accordance with Directive 2006/66/EU, Article 21 - Member States shall ensure that all batteries, accumulators and battery packs are appropriately marked with the symbol shown in Annex II.
Member States shall ensure that the capacity of all portable and automotive batteries and accumulators is indicated on them in a visible, legible and indelible form by 26 September 2009.
Batteries, accumulators and button cells containing more than 0,0005 % mercury, more than 0,002 % cadmium or more than 0,004 % lead, shall be marked with the chemical symbol for the metal concerned: Hg, Cd or Pb. The symbol indicating the heavy metal content shall be printed beneath the symbol shown in Annex II and shall cover an area of at least one-quarter the size of that symbol.
The symbol shown in Annex II shall cover at least 3 % of the area of the largest side of the battery, accumulator or battery pack, up to a maximum size of 5 × 5 cm. In the case of cylindrical cells, the symbol shall cover at least 1,5 % of the surface area of the battery or accumulator and shall have a maximum size of 5 × 5 cm.
Where the size of the battery, accumulator or battery pack is such that the symbol would be smaller than 0,5 × 0,5 cm, the battery, accumulator or battery pack need not be marked but a symbol measuring at least 1 × 1 cm shall be printed on the packaging. 6. Symbols shall be printed visibly, legibly and indelibly.
Proposal repealing the existing Battery Directive 2006/66/EC
The Proposal for a Regulation on batteries and waste batteries was adopted on 10 March 2022. The proposed EU Battery Regulation supercedes the Battery Directive (Source – Page 4), the subsequent Draft Agreement was made available in September 2022 (Page 21).
One of the main changes introduced by the Regulation regards its applicability. While the Battery Directive provided for three battery categories (portable, automotive, and industrial), the Regulation develops a new batteries classification to better reflect new developments in the use of batteries, in particular the quick growth of electric road transport vehicles. As such, the Regulation applies to all categories of batteries, including electric vehicle (EV) batteries, light means of transport (LMT) batteries such as e-bikes and e-scooters, and automotive Starting, Lighting, and Ignition (SLI) batteries, alongside the existing portable and industrial classes.
In addition to a new battery classification, the Regulation introduces main changes in four areas:
• Sustainability requirements to prevent and reduce adverse impacts of batteries on the environment, taking into account, for example, the carbon footprint of battery manufacturing, the recycled content, durability, removability, and replaceability;
• Labelling, marking and information requirements, mandating, for example, the set-up of an electronic exchange system for batteries information (i.e., battery passport);
• Supply chain due diligence requirements for ethical sourcing of raw materials, requiring the set up and implementation of supply chain due diligence policies verified by a third-party;
• End-of-life management requirements, including new collection rates targets, recycling efficiencies, and material recovery targets. Source – Page 24
Further Reading
Joint industry position paper on the Batteries Regulation - EUROBAT
EU Batteries Regulation: Where do we stand? (nickelinstitute.org)
We hope you found this article useful!
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This article was written by Luay Zayed, founder of Biyat Energy & Environmental Ltd. A global energy and environmental consultancy specializing in turnkey engineering solutions that protect the environment and improve energy efficiency in the manufacturing & industrial sectors.