Background

With the development of technology and the acceleration of industrialization, chemicals are widely used in production. These substances may cause pollution to the environment during production, use, and discharge, thereby disrupting the balance of the ecosystem. Some chemicals with carcinogenic, mutagenic, and toxic properties may also cause various diseases under long-term exposure, posing a threat to human health.

As an important promoter of international environmental protection, the European Union (EU) therefore has been actively taking measures and enacting regulations to restrict various harmful substances while strengthening the evaluation and supervision of chemicals to reduce the harm to the environment and human. The EU will continue to update and improve laws and regulations in response to new environmental and health issues as scientific and technological progress and cognitive awareness advance. Below is a detailed introduction to the EU’s relevant regulations/directives on chemical substance requirements.

The RoHS Directive

The 2011/65/EU Directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS Directive) is a mandatory directive formulated by the EU. The RoHS Directive establishes rules for restricting the use of hazardous substances in electrical and electronic equipment (EEE), aiming to protect human health and environmental safety, and promote the recycling and disposal of waste electrical and electronic equipment.

Scope of application

Electronic and electrical equipment with a rated voltage not exceeding 1000V AC or 1500V DC includes, but is not limited to, the following categories:

large household appliances, small household appliances, information technology and telecommunications equipment, consumer devices, lighting equipment, electrical and electronic tools, toys and recreational sports equipment, medical equipment, monitoring instruments (including industrial detectors), and vending machines.

Requirement

The RoHS Directive requires that the restricted substances in electrical and electronic equipment should not exceed their maximum concentration limits. The details are as follows:

Label

Manufacturers are required to issue a declaration of conformity, compile technical documentation, and affix the CE marking to products to demonstrate compliance with the RoHS Directive. The technical documentation should include substance analysis reports, bills of materials, supplier declarations, etc. Manufacturers must retain the technical documentation and EU declaration of conformity for at least 10 years after the electrical and electronic equipment is placed on the market to prepare for market surveillance checks. Products that do not comply with the regulations may be subject to recall.

REACH Regulation

(EC) No 1907/2006 REGULATION concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), which is the regulation on the registration, evaluation, authorization, and restriction of chemicals, represents a critical piece of legislation for the EU’s preventive management of chemicals entering its market. The REACH regulation aims to ensure a high level of protection for human health and the environment, promote alternative methods for assessing the hazards of substances, facilitate the free circulation of substances within the internal market, and simultaneously enhance competitiveness and innovation. The main components of the REACH regulation encompass registration, evaluation, authorization, and restriction.

Registration

Every manufacturer or importer who manufactures or imports chemicals in a total quantity exceeding 1 ton/year is required to submit a technical dossier to the European Chemicals Agency (ECHA) for registration. For substances exceeding 10 tons /year, a chemical safety assessment must also be conducted, and a chemical safety report must be completed.

• If a product contains Substances of Very High Concern (SVHC) and the concentration exceeds 0.1% (by weight), the manufacturer or importer must provide a Safety Data Sheet (SDS) to downstream users and submit information to the SCIP database.
• If the concentration of SVHC exceeds 0.1% by weight and the quantity exceeds 1 tonne/ year, the manufacturer or importer of the article must also notify the ECHA.
• If the total quantity of a substance that has been registered or notified reaches the next tonnage threshold, the producer or importer must immediately provide ECHA with the additional information required for that tonnage level.

Evaluation

The evaluation process comprises two parts: dossier evaluation and substance evaluation.

The dossier evaluation refers to the process by which ECHA reviews the technical dossier information, standard information requirements, chemical safety assessments, and chemical safety reports submitted by enterprises to determine their compliance with the established requirements. If they do not meet the requirements, the enterprise is required to submit the necessary information within a limiting time. ECHA selects at least 20% of files in excess of 100 tons/year for inspection each year.

Substance evaluation is the process of determining the hazards posed by chemical substances to human health and the environment. This process encompasses an assessment of their toxicity, exposure routes, exposure levels, and potential harm. Based on the hazard data and tonnage of chemical substances, ECHA develops a rolling three-year evaluation plan. Competent authorities then carry out the substance evaluation in accordance with this plan and communicate the results.

Authorization

The purpose of authorization is to ensure smooth operation of the internal market, that the risks of SVHC are properly controlled and that these substances are gradually replaced by economically and technically appropriate alternative substances or technologies. Authorization applications should be submitted to the European Environmental Agency along with an authorization application form. The classification of SVHC mainly includes the following categories:

（1）CMR substances: Substances are carcinogenic, mutagenic and toxic to reproduction

（2）PBT substances: Substances are persistent, bioaccumulative and toxic (PBT)

（3）vPvB substances：Substances are highly persistent and highly bioaccumulative

（4）Other substances for which there is scientific evidence that they may have serious effects on human health or the environment

Restriction

ECHA will restrict the production or importation of a substance or article in the EU if it considers that the process of producing, manufacturing, placing on the market poses a risk to human health and the environment that cannot be adequately controlled. Substances or articles included in the Restricted Substances List (REACH Appendix XVII) must comply with the restrictions before they can be produced, manufactured or placed on the market in the EU, and products that do not comply with the requirements will be recalled and penalized.

Currently, the requirements of REACH Annex XVII are incorporated into the EU’s new Battery Regulation. To import into the EU market, it is necessary to comply with the requirements of REACH Annex XVII.

Label

The REACH regulation is currently not within the scope of CE control, and there are no requirements for conformity certification or CE marking. However, the European Union Market Supervision and Administration Agency will always carry out random checks on the products in the EU market, and if they do not meet the requirements of REACH, they will face the risk of being recalled.

POPs Regulation

(EU) 2019/1021 Regulation on Persistent Organic Pollutants, referred to as POPs Regulation, aims to reduce the emission of these substances and protect human health and the environment from their harm by banning or restricting the production and use of persistent organic pollutants. Persistent organic pollutants (POPs) are organic pollutants that are persistent, bio-accumulative, semi-volatile, and highly toxic, which are capable of long-range transport that pose a serious hazard to human health and the environment through air, water, and living organisms.

The POPs Regulation applies to all substances, mixtures, and articles within the EU. It lists the substances that need to be controlled and specifies the corresponding control measures and inventory management methods. It also proposes measures to reduce and control their release or emission. In addition, the regulation also covers the management and disposal of waste containing POPs, ensuring that the POPs components are destroyed or undergo irreversible transformation, so that the remaining waste and emissions no longer exhibit POPs characteristics.

Label

Similar to REACH, compliance proof and CE labeling are not required for the time being, but the regulatory restrictions still need to be met.

Battery Directive

2006/66/EC Directive on batteries and accumulators and waste batteries and accumulators (referred to as the Battery Directive), applies to all types of batteries and accumulators, with the exception of equipment related to the essential security interests of the EU Member States and equipment intended to be launched into space. The Directive sets out provisions for the placing on the market of batteries and accumulators, and also specific provisions for the collection, treatment, recovery and disposal of waste batteries. This Directive is expected to be repealed on 18 August 2025.

Requirement

1. All batteries and accumulators placed on the market with a mercury content (by weight) exceeding 0.0005% are prohibited.
2. All portable batteries and accumulators placed on the market with a cadmium content (by weight) exceeding 0.002 % are prohibited.
3. The above two points do not apply to emergency alarm systems (including emergency lighting) and medical equipment.
4. Enterprises are encouraged to improve the overall environmental performance of batteries throughout their life cycle, and develop batteries and accumulators with less lead, mercury, cadmium and other hazardous substances.
5. EU Member States shall draw up appropriate waste battery collection plans, and manufacturers/distributors shall register and provide free battery collection services in the Member States in which they sell. If a product is equipped with a battery, its manufacturer is also considered a battery manufacturer.

Label

All batteries, accumulators, and battery packs should be marked with a crossed-out dustbin logo, and the capacity of all portable and vehicle batteries and accumulators shall be indicated on the label. Batteries and accumulators which contain more than 0.002 % cadmium or more than 0.004 % lead shall be marked with the relevant chemical symbol (Cd or Pb) and shall cover at least a quarter of the area of the symbol. The logo shall be clearly visible, legible and indelible. The coverage and dimensions shall comply with the relevant provisions.

Dustbin logo

WEEE Directive

2012/19/EU Directive on waste electrical and electronic equipment (WEEE) is a key EU regime for WEEE collection and treatment. It sets out measures to protect the environment and human health by preventing or reducing the adverse impacts of the production and management of WEEE and promoting sustainable development by improving the efficiency of resource use.

Scope of Application

Electronic and electrical equipment with a rated voltage not exceeding 1000V AC or 1500V DC, including the following types:

Temperature exchange equipment, screens, displays and equipment containing screens (with a surface area greater than 100 cm2), large equipment (with external dimensions exceeding 50cm), small equipment (with external dimensions not exceeding 50cm), small information technology and telecommunications equipment (with external dimensions not exceeding 50cm).

Requirement

1. The Directive requires Member States to take appropriate measures to promote the reuse, disassembly and recycling of WEEE and its components in accordance with the eco-design requirements of Directive 2009/125/EC; producers shall not prevent the reuse of WEEE through specific structural features or manufacturing processes, except in special cases.
2. Member States shall take appropriate measures to correctly sort and collect WEEE, giving priority to temperature exchange equipment containing ozone-depleting substances and fluorinated greenhouse gases, mercury-containing fluorescent lamps, photovoltaic panels and small equipment. Member States shall also ensure the implementation of the “producer responsibility” principle, requiring companies to establish recycling facilities to achieve the minimum annual collection rate based on population density. Sorted WEEE should be properly treated.
3. Businesses selling electrical and electronic products in the EU shall be registered in the target Member State for sale in accordance with the relevant requirements.
4. Electronic and electrical equipment should be marked with the required symbols, which should be clearly visible and not easily worn off on the outside of the equipment.
5. The Directive requires Member States to establish appropriate incentive systems and penalties to ensure that the content of the Directive can be fully implemented.

Label

The WEEE label is similar to the battery directive label, both of which require the “separate collection symbol” (dustbin logo) to be marked, and the size specifications can refer to the battery directive.

ELV Directive

2000/53/EC Directive on End-of life vehicles (ELV Directive) covers all vehicles and end-of-life vehicles, including their components and materials. It aims to prevent the generation of waste from vehicles, to promote the reuse and recovery of end-of life vehicles and their components and to improve the environmental performance of all operators involved in the life cycle of vehicles.

Requirement

1. The maximum concentration values by weight in homogeneous materials shall not exceed 0.1% for lead, hexavalent chromium and mercury, and 0.01% for cadmium. Vehicles and their parts that exceed the maximum concentration limits and are not within the scope of exemptions shall not be placed on the market.
2. The design and production of vehicles shall give full consideration to the dismantling, reuse and recycling of vehicles and their parts after they are scrapped, and more recycled materials can be integrated.
3. Economic operators shall establish systems to collect all end-of-life vehicles and, where technically feasible, waste parts arising from the repair of vehicles. End-of-life vehicles shall be accompanied by a certificate of destruction and be transferred to an authorized treatment facility. Producers shall make available dismantling information etc. within six months after placing a vehicle on the market and shall bear all or the majority of the costs of the collection, treatment and recovery of end-of-life vehicles.
4. Member States shall take the necessary measures to ensure that economic operators establish adequate systems for the collection of end-of-life vehicles and achieve the corresponding recovery and reuse and recycling targets and that the storage and treatment of all end-of-life vehicles takes place in accordance with the relevant minimum technical requirements.

Label

The current ELV directive has been included in the requirements of the EU’s new battery law. If it is an automotive battery product, it needs to meet the requirements of ELV and the battery law before the CE mark can be applied.

Conclusion

To sum up, the EU has a wide range of restrictions on chemicals to reduce the use of hazardous substances and protecting human health and environmental security. This series of measures has had a profound impact on the battery industry, both promoting the development of more environmentally friendly battery materials and promoting technological innovation and development, and improving consumers’ awareness of relevant products and spreading the concept of sustainable development and green consumption. As relevant laws and regulations continue to improve and regulatory efforts are strengthened, there are reasons to believe that the battery industry will continue to develop in a healthier and more environmentally friendly direction.