- Environmental law Overview: Battery Act (BattG) / Directive 2006/66/EC (Battery Directive) Regulations for the MedTech industry

Name of the legal act

Act on the placing on the market, return and environmentally sound disposal of batteries and accumulators (Battery Act - BattGExterner Link. Öffnet im neuen Fenster/Tab.).

Status

Battery Act of 25 June 2009 (BGBl. I p. 1582Externer Link. Öffnet im neuen Fenster/Tab.), last amended by Art. 1 of the Act of 3 November 2020 (BGBl. I p. 2280Externer Link. Öffnet im neuen Fenster/Tab.).

Background information

The BattG serves to implement Directive 2006/66/EC of the European Parliament and of the Council of 6 September 2006 on batteries and accumulators as well as waste batteries and accumulators and repealing Directive 91/157/EEC (consolidated version of 4 July 2018Externer Link. Öffnet im neuen Fenster/Tab.).

Scope of application

The BattG applies to all types of batteries, regardless of shape, size, mass, material composition or use. It also applies to batteries that are incorporated into or added to other products. Batteries are sources of electrical energy consisting of one or more non-rechargeable primary cells or rechargeable secondary cells, which are obtained by direct conversion of chemical energy. To determine the applicable obligations, a distinction must be made between starter, industrial and portable batteries (Sec. 2 (4) to (6) BattG). According to Sec. 1 (2) BattG, there are three use-related exceptions from the scope of application, which do not specifically concern medical devices.

ATTENTION: The BattG is not applicable to electrical and electronic equipment. Thus, there is no direct connection with the RoHS Directive 2011/65/EU or WEEE Directive 2012/19/EU. For battery-operated electrical and electronic devices, the BattG and in particular the ElektroG and ElektroStoffV are therefore generally applicable in parallel. Details on the delimitation of the stiftung elektro-altgeräte register (Stiftung ear) can be found in an application guideExterner Link. Öffnet im neuen Fenster/Tab..

Roles

The producer plays the central role within the meaning of Sec. 2 (15) BattG. A producer is anyone who, "regardless of the method of distribution, places batteries commercially on the market for the first time within the scope of this Act". In particular, the actual production of a battery is therefore not relevant. Batteries incorporated into devices are also covered.

Placing on the market is defined as "the supply to third parties, whether in return for payment or free of charge, with the aim of distribution, consumption or use. The commercial import into the area of application of this law is considered to be placing on the market. This shall not apply to batteries that are demonstrably re-exported from the area of application of this Act. The supply of batteries manufactured under the brand name or according to the special requirements of a client and batteries intended for further distribution to the client is not considered to be placing on the market (…)” (especially in the case of trademarks and production by extended workbench).

According to Sec. 2 (14) BattG, a distributor is "anyone who, regardless of the distribution method, offers batteries commercially to the end user within the scope of this law. Offering batteries (...) is the presentation of batteries or making them available to the public with the aim of concluding a sales contract; this also includes the invitation to submit an offer”. Intermediaries are therefore not obliged to act as distributors.
A distributor can also simultaneously be the producer of a battery and is then required to fulfill both sets of obligations.

Duties in bullet points

Producer obligations

• Substance restrictions (Sec. 3 (1) and (2) BattG)
• Registration obligation for producers (Sec. 4)
• Take-back obligation of the producer (Sec. 5 et seq.)

• Producer's own take-back system for portable batteries (Sec. 7)
• Self take-back for industrial and starter batteries (Sec. 8)

• Labelling (Sec. 17)
• Duty to inform (Sec. 18 (2))

Distributor obligations

• Ban on offering batteries from non-registered producers (Sec. 3 (4) BattG)
• Obligation to take back in stationary trade and distance selling (Sec. 9 (1)) - otherwise prohibition of offering (Sec. 3 (4))
• Obligation to hand over or recycle used batteries that have been taken back (Sec. 9 (2))
• Deposit obligation for starter batteries (Sec. 10)
• Documentary duty for starter and industrial batteries (Sec. 15 (3))
• Duty to inform (Sec. 18 (1))

Violations of substance restrictions, registration and take-back obligations lead to a traffic ban at all levels. Violations are regularly administrative offences.

Latest news

Since 18 February 2024, Regulation (EU) 2023/1542 of the European Parliament and of the Council of 12 July 2023 on batteries and waste batteries, amending Directive 2008/98/EC and Regulation (EU) 2019/1020 and repealing Directive 2006/66/EC (Battery Regulation) has been in effect throughout the EU. It was published in the Official Journal of the EU on 28 July 2023. The first obligations must be implemented from 18 August 2024 (detailed information can be found in the "Battery Regulation" information sheet).

The BattG will remain in force for the time being but will have to be adapted to the Battery Regulation by 18 August 2025 at the latest. Since June 2025 the draft billExterner Link. Öffnet im neuen Fenster/Tab. for the adaptation of battery law to Regulation (EU) 2023/1542 (Battery EU Adjustment Act) is in the formal legislative process. In terms of content, the draft largely updates the existing obligations in the BattG and adds obligations with regard to the Battery Regulation, whereby most of the changes relate to the area of extended producer responsibility. In addition, fines are provided for violations of the Battery Regulation, which can generally amount to up to EUR 100,000.00, but in the case of violations of due diligence obligations pursuant to Art. 47 et seq. of the Battery Regulation can also reach 500,000.00 in individual cases.

Imprint

© Bundesverband Medizintechnologie e.V. (BVMed), the German MedTech Association, in cooperation with the law firm "Ahlhaus Handorn Niermeier Schucht Rechtsanwaltsgesellschaft mbH" („Produktkanzlei“).

This overview does not replace an individual case assessment.