- Environmental law
Overview: Waste Shipment Regulation Regulations for the MedTech industry
The MedTech industry is directly or indirectly affected by numerous environmental regulations. With our information service on environmental law, BVMed provides an overview of the most important national (Germany) and European legal acts as well as the resulting obligations. This article focuses on the Waste Shipment Regulation – german version of the article here. You can find more legal acts here
Artikel31.07.2025
Name of the legal act
Status
Consolidated version of 9 January 2025.Externer Link. Öffnet im neuen Fenster/Tab.Background information
Regulation (EC) No. 1013/2006 was repealed with the new Regulation. Compared to the old legal situation, the shipment of numerous types of waste within the EU and exports to non-EU countries have been further restricted or prohibited. In the future, exports from the EU will be subject to mandatory auditing of disposal facilities and the export of plastic waste will be further restricted. The new requirements will generally apply as of 21 May 2026, with additional transition periods specific to certain processes.National implementation and sanction provisions are contained in the following legal acts:
- Act implementing Regulation (EC) No. 1013/2006 of the European Parliament and of the Council of 14 June 2006 on shipments of waste 1) and the Basel Convention of 22 March 1989 on the control of transboundary movements of hazardous wastes and their disposal 2) (Waste Shipment Act - AbfallverbringungsGExterner Link. Öffnet im neuen Fenster/Tab.)
- Ordinance on the European Waste Catalogue (Waste Catalogue Ordinance - AVVExterner Link. Öffnet im neuen Fenster/Tab.)
Scope of application
The Waste Shipment Regulation regulates procedures and controls for the shipment of waste, which depend on the origin, destination, transport route, type of waste shipped, and the treatment of the waste shipped at the destination. The Waste Shipment Regulation applies to the following constellations:- Shipments of waste within the EU (including transit through third countries) - Art. 4 et seq.
- Shipments of waste from third countries to the EU - Art. 50 et seq.
- Shipments of waste from the EU to third countries - Art. 37 et seq.
- Shipments of waste from third countries to third countries if transit through the EU takes place - Art. 57 et seq.
In principle, the Waste Shipment Regulation does not apply to the transportation of waste within one EU Member State; the respective national law applies (Art. 36 of the Waste Shipment Regulation). The exceptions contained in Art. 1 (3) Waste Shipment Regulation do not specifically concern medical devices.
The determination of whether an object can be classified as waste in the sense of the Waste Shipment Regulation (Art. 3 No. 1 Waste Shipment Regulation with reference to Regulation 2008/98/EC) or not, is both the key factor for the applicability of the waste shipment regime and, at the same time, potentially highly complex. It must be assessed individually in each case, taking all relevant circumstances into account. According to Art. 3 (1) Directive 2008/98/EC, waste is defined as "any substance or object which the holder discards, intends or is required to discard“. For the determination of hazardousness, Art. 2 No. 2 Waste Shipment Regulation contains, at the end of the legal text, a reference to Directive 2008/98/EC. In addition, the classification based on the various lists pursuant to Art. 4 Waste Shipment Regulation is central to determining the applicable procedure. All of the areas mentioned are heavily influenced by a largely inconsistent and highly case-specific application by national authorities as well as the case law of national and European courts.
NOTE: The dangerous goods regulations from ADR, RID, ADN, IMDG Code and IATA-DGR must - where applicable - be taken into account in parallel.
Roles
Art. 3 Nos. 5 to 8 Waste Shipment Regulation define various roles which, depending on the individual case, may be involved in shipment and subject to obligations under waste shipment law. Particularly relevant in this context are the waste producer and the waste holder, as they are typically required to act as the notifier pursuant to Art. 3 (6) Waste Shipment Regulation, especially in a commercial context outside of waste-specific industries, thereby bearing the primary responsibilities.Duties in bullet points
The starting point for all evaluations under the Waste Shipment Regulation is, after determining that an item qualifies as waste, the identification of the applicable procedure for shipment pursuant to Art. 4 Waste Shipment Regulation. In this regard, particular attention is given to the type of waste, the point of origin, and the destination country of the shipment.The procedure for prior written notification and consent under Art. 5 et seq. establishes stringent requirements and a comprehensive administrative process in the country of dispatch, the receiving country, and the affected transit countries. For shipments within the EU, this process is expected to be made less bureaucratic in the future through the implementation of electronic data exchange. This procedure must be initiated by the notifier in the country of dispatch and the competent authority there will take over further coordination with the authorities if the application is complete. In principle, a separate notification is required for each individual shipment, unless the requirements for a general notification (Art. 13 Waste Shipment Regulation) are met. Notification form in accordance with Annex IA of the Waste Shipment RegulationExterner Link. Öffnet im neuen Fenster/Tab..
In contrast, the requirements of the second procedure, the general duty to provide information under Art. 18, are significantly less stringent and essentially limited to preparatory measures and document retention obligations.
If, in individual cases, a shipment cannot be completed as planned, the waste concerned must generally be taken back or retrieved. The same applies to illegal shipments (Art. 22 et seq. Waste Shipment Regulation).
Violations are generally criminal offences in the case of illegal shipments; otherwise, they are administrative offences.
Comprehensive information can be found in the EU Commission's topic portalExterner Link. Öffnet im neuen Fenster/Tab., in the Environment Agency's topic portalExterner Link. Öffnet im neuen Fenster/Tab. and in the EU Commission's FAQsExterner Link. Öffnet im neuen Fenster/Tab..
Latest news
The national Waste Shipment Act must be adapted to the new EU regulation within the next two years.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.
