This guide explains what importers and manufacturers must know about regulations and standards applicable to lithium batteries in the European Union. Keep reading to learn more about the Battery Directive, the General Product Safety Directive (GPSD) and more.
The Battery Directive regulates lithium batteries and other types of batteries manufactured, imported, and sold in the EU market. Similar to the RoHS Directive, it sets limits for the use of certain heavy metals and labelling requirements.
The Battery Directive covers restricted substances, as well as requirements regarding labelling and registration.
Here we list the substances that are restricted under the Battery Directive:
- Lead (less than 0.0004 % by weight)
- Mercury (less than 0.0005 % by weight)
- Cadmium (less than 0.002 % by weight)
The Battery Directive requires importers and manufacturers to ensure that their batteries and accumulators carry a label that provides the following information:
a. Separate collection symbol – batteries must carry this symbol, and should not be discarded with regular waste
b. Substance symbol – batteries exempt from substance restrictions and that have substances above the limit should bear the chemical symbol, e.g. “Hg” for mercury, “Pb” for lead, and “Cd” for cadmium
c. Battery capacity – batteries must state the battery’s capacity in V, mAh, or Ah.
To register their batteries with the authorities of their market destination, importers and manufacturers are required to provide information such as the following:
a. Company and brand name and address
b. Contact details (phone number and email address) and contact person
c. Battery type (e.g.automotive, industrial, portable)
d. Evidence of importer’s or manufacturer’s compliance with relevant requirements (e.g., test report)
e. Application date for registration
f. Importer’s or manufacturer’s national identification code, including EU or national tax number
g. A statement declaring that the provided information is factual
Different EU member states may have slight differences regarding registration requirements and the handling fee or registration fee, so contacting the relevant destination market for details is highly suggested. Below we list three EU nations and their registration fees:
- Germany: 143 Euro
- Sweden: 1000 SEK (approx. 91 Euro at the time of writing)
- Ireland: minimum 75 Euro
Not all batteries are compliant
Far from all lithium batteries on the market are ‘designed for compliance’ with the Battery Directive. As such, we recommend that you procure lithium batteries (or other batteries for that matter) from well-known and established brands – for example, Samsung or TDK.
Another option is to book third-party lab testing. That said, lab testing might be costly, which makes the total unit cost higher when buying OEM batteries without pre-existing test reports, compared to brand-name batteries. Further, there’s no guarantee that an OEM lithium battery can even pass testing.
General Product Safety Directive (GPSD)
The General Product Safety Directive (GPSD) requires importers and manufacturers to ensure that their products, including batteries, are safe to use before placing them on the European market.
Harmonised standards are developed by established European Standards Organisations and are incorporated by reference into regulations or directives such as the GPSD. You may use other national or international standards if no harmonised standards exist for a particular product.
The GPSD covers a wide range of product categories, including electronics, which may include batteries, such as the following:
- Button batteries
- Coin batteries
- Lithium-ion batteries
The GPSD requires distributors, importers, and manufacturers to provide documentation such as the following to facilitate product tracking and mitigate risk:
EN standards are widely used to improve the product’s safety and performance. They provide specific test methods and procedures to help importers and manufacturers to reach these goals.
For lithium batteries, EN standards might provide typical specifications and technical solutions that can be served as a reference point at the product design stage. Following EN standards is generally not mandatory but highly recommended.
a. EN 60086-4 – Safety of lithium batteries
b. EN 62133 – Safety requirements for portable sealed secondary cells
c. EN 61960 – Specifies performance tests, designations, markings, dimensions and other requirements for lithium battery products
You can find more additional EN standards that apply to your product on CENELEC’s website.
Battery Safety Testing
Testing companies have the capability to conduct a wide range of test standards to verify whether your products are compliant, or need further improvement. Examples of companies that offer lithium battery testing services include the following:
Far from all lithium batteries are designed for compliance with EN 60086-4, and other European Union standards. As mentioned, our recommendation is that you or your manufacturer procure brand-name batteries from Samsung, TDK or other recognized brands.
Such brands can provide pre-existing lab test reports, meaning that you don’t need to spend money on third-party safety testing. Buying OEM batteries can be cheaper on a unit-cost basis, but when factoring in testing costs, that’s rarely the case.
The Waste Electrical and Electronic Equipment (WEEE) Directive requires importers and manufacturers to affix the WEEE label to their electric and electronic products, and register their companies with relevant EU authorities.
The WEEE covers batteries and many types of EEE, such as the following (some of which may be powered by batteries):
- Electrical toys
- Monitoring and control instruments
- Medical equipment
- Lighting equipment
- Temperature exchange equipment
- Video displays
It is crucial to abide by labelling and registration requirements to facilitate better the efficient collection and recycling of electrical and electronic waste.
The EU mandates that most electric and electronic equipment bear the WEEE label, indicating that the product should be collected separately and sent to recycling facilities.
The WEEE label should be a symbol of a crossed-out wheeled bin, with a bar underneath it if the product was placed on the market after 2005.
It should be placed on the product or, if the product is too small, on the packaging or the user instructions.
The WEEE Directive requires importers and manufacturers to provide the following information upon registration:
a. Producer’s or authorised representative’s name and address
b. Producer’s national identification (plus EU / national tax number)
c. Category, type, and brand of EEE
d. Information on how the producer fulfils its responsibilities to individual or collective schemes
e. Selling technique (e.g. distance selling)
f. Statement that the provided information is factual
The Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) lists chemicals, heavy metals, and substances that it bans or restricts to certain migration limits.
EU’s REACH regulation covers a wide range of consumer products, including electronics and batteries, as those products may contain heavy metals such as lead, which is regulated by REACH.
REACH’s Annex XVII lists numerous restricted substances as they are considered to be harmful to health and the environment. Depending on factors such as age group or product category, some substances may be limited while others may be banned.
Lithium batteries may include substances such as the following:
a. Lead and its compounds – 0.05% by weight
b. Nickel and its compounds – < 0.2 μg/cm2/week
Substances of Very High Concern (SVHC) under REACH are defined by the European Chemicals Agency (ECHA) as substances that may result in permanent negative harm to the environment and human health.
Any substance listed in the SVHC Candidate List is regulated under REACH, but not outright banned. Importers and manufacturers are required to notify ECHA by registering their product to the SCIP database, as well as inform consumers if requested if their product contains a concentration of an SVHC that is more than 0.1% weight by weight (w/w) of the product.
SVHCs that may be found in lithium batteries include the following:
- Cadmium nitrate
Products containing lithium batteries: CE Marking
Stand-alone lithium batteries or cells may not require CE marking. However, products that contain lithium batteries might be covered by one or more CE directives such as the EMC Directive, the RoHS Directive, or the Radio Equipment Directive.
In such cases, importers and manufacturers must comply with the relevant CE directives and CE mark the products.
CE label file
Importers shouldn’t expect their suppliers to provide the CE label file. Instead, importers must provide CE label file in .ai or .eps file, then instruct suppliers with the following information:
- Print type
Importers or manufacturers are also responsible to affix a permanent traceability label on the product and its packaging. The label should at least include the following information:
- Product type
- Batch or serial number
- Company name and address
- Contact details
You need more than a CE mark on your product for compliance. Importers and manufacturers must also comply with additional documentation requirements. Below you find an overview.
Declaration of Conformity (DoC)
The Declaration of Conformity is a primary document that is often requested by other authorities, retailers or marketplaces. The importer or manufacturer should issue the DoC with the following information:
- Produce description
- Product features
- Name and address of the manufacturer or importer
- List of EN standards or directives
- Responsible individual contact
Importers and manufacturers might need to provide user instructions for their lithium battery-powered product, with information such as:
1. Instructions on how to install the product
2. An overview of the relevant parts and part names of the product
3. Safety instructions
4. Instructions on how to use the product
5. Instructions on how to recharge and/or refill the product and
6. Instructions on how to dispose of the product in an environmentally friendly manner
The technical file is somehow similar to the product specification which includes product design, material, packaging, and labelling information. Importers shall at least include the following information:
- Bill of materials
- Design drawings
- Label files
- Packaging files
- List of applied standards and directives (e.g. EMC Directive)
- Test reports
- QC reports
- Risk assessment
All relevant test reports must be attached to the documents according to the applicable standards or regulations stated.
In this section, we provide some additional requirements for lithium batteries.
Amazon has a strict policy on lithium battery products. Before you list your products on Amazon, you must ensure compliance and submit relevant test reports and other relevant documents to get approval.
Safety Data Sheet (SDS)
Amazon generally requires importers and manufacturers to submit an SDS for lithium batteries. The SDS should include information such as:
- Product description
- Product usage
- Potential hazards and safety instruction
- Disposal instruction
- Storage instruction
UN 38.3 is published by the United Nations’ Manual of Tests and Criteria Part III. It provides requirements that cover lithium-ion batteries and lithium-metal batteries, which are classified into the following four standards:
- UN 3090: Lithium metal batteries
- UN 3480: Lithium-ion batteries
- UN 3091: Lithium metal batteries contained, or packed with equipment
- UN 3481: Lithium-ion batteries contained, or packed with equipment
The International Air Transport Association (IATA) has published a Lithium Battery Guidance Document, which notes that compliance with the requirements in UN 38.3 is mandatory to safely transport lithium batteries by air.
Importers and manufacturers are required to abide by requirements such as the following:
a. Testing to ensure safety and quality, using tests that measure shock and forced discharge, for instance
b. Provision of a test summary (including items such as name and contact details, list of conducted tests, and battery description)
c. Shipper’s Declaration
d. Blister packaging of batteries
e. Proper labelling (e.g. “Cargo Aircraft Only” label, lithium battery mark label)
f. Provision of UN and Proper Shipping Name and UN number
Agreement concerning the International Carriage of Dangerous Goods by Road (ADR)
The Agreement concerning the International Carriage of Dangerous Goods by Road (ADR) is the European Agreement concerning the international carriage of dangerous goods by road. Lithium batteries are classified as dangerous goods in class 9.
The ADR requires lithium batteries covered by UN standards 3480, 3481, 3090, and 3091 to meet requirements in UN 38.3, such as those mentioned in the section above.
As such, you must attach a designated warning label 9A on the lithium-ion batteries, and comply with ADR packaging requirements before shipping the products to the EU. ADR’s packaging requirements include examples such as the following:
a. Batteries should be secured within the outer packaging to prevent movement
b. Individually pack batteries or cells into a non-combustible protective layer
c. The outer packaging should carry one cell or battery if its net mass exceeds 30 kg