Amendment of the German Chemicals Act

Category: Uncategorized

Fifth Act Amending the Chemicals Act: Adaptation to the F-Gas Regulation 2024/573 and the Ozone Regulation 2024/593

The draft of the fifth law amending the Chemicals Act serves to align national chemicals legislation with Regulation (EU) 2024/573 on fluorinated greenhouse gases and Regulation (EU) 2024/590 on substances that deplete the ozone layer.

The two aforementioned regulations replace the previous provisions of Regulation (EU) No 517/2014 on fluorinated greenhouse gases and Regulation (EC) No 1005/2009 on substances that deplete the ozone layer. The aim is to avoid duplication of regulations, create legal certainty and enshrine in national law the additions required by EU law, such as trade restrictions in the event of infringements or requirements for the subsequent procurement of quotas. At the same time, the law contributes to sustainability goal 13.1 of the 2030 Agenda, which specifically provides for climate protection measures.

A. Current status of proceedings

    The Federal Government originally submitted the draft of a fifth law amending the Chemicals Act to the Federal Council for comment on 7 November 2025 (BR-Drs. 645/25). The committees’ recommendations followed on 5 December 2025 (BR 645/1/25). The Bundesrat then issued its opinion on 19 December 2025 (BR plenary minutes 1060, pp. 521-521, TOP 56) and concluded the procedure with a resolution (BR-Drs. 645/25(B)).

    The Federal Government then submitted the draft of a fifth law amending the Chemicals Act (BT-Drs. 21/3511) to the Bundestag on 7 January 2026. The first consultation in the Bundestag took place on 15 January 2026. The committees are currently reviewing the draft. A final legislative decision by the Bundestag and further steps such as publication in the Federal Law Gazette are still pending.

    B. Overview of the main changes under the ChemG-RefE

    The following is a summary of the key changes introduced by the Fifth Act Amending the Chemicals Act (ChemG-RefE); this list is not exhaustive: 

    • Expansion of the definitions of terms, in particular “manufacturer”, “importer” and “use”
    • Deletion of the prohibition on making available, Section 12i (1) ChemG
    • Retention of national documentation and verification requirements, Section 12i (2) ChemG
    • Elimination of the labelling requirement, Section 12i (6) ChemG
    • Adjustment of information in the supply chain, in particular new insertion of Section 12j (8) ChemG with simplifications for the supply of F-gases for the purpose of final filling
    • New insertion of Section 12k ChemG for the purpose of retrospective quota approval for F-gas products and equipment already on the market
    • Adjustment of the SCIP reporting obligation, in particular deletion of Section 16f No. 2 ChemG
    • Extension of the regulatory authority in Section 17(1) No. 1 letter c ChemG
    • New insertion of Section 23a ChemG as the legal basis for a temporary ban on trade in F-gases

    C. Explanations of the key changes under the ChemG-RefE

    The above-mentioned changes according to the ChemG-RefE are explained in detail below:

    I. Expansion of the definitions (Art. 1 No. 2 ChemG-RefE)

      The definitions of “manufacturer” (Section 3 No. 7 ChemG) and “importer” (Section 3 No. 8 ChemG) are now expanded to include “facilities”. In addition, the term “release” in relation to F-gases and ozone-depleting gases is included in the definition of “use” (Section 3 No. 10 ChemG).

      II. Deletion of the prohibition on making available, Section 12i (1) ChemG (Art. 1 No. 3 letter b ChemG-RefE)

        The previous Section 12i(1) ChemG is deleted without replacement. Section 12i(1) No. 1 ChemG previously regulated a prohibition on provision, while Section 12i(1) No. 2 ChemG contained prohibitions on storage and emptying.

        The previous Section 12i (1) No. 1 ChemG is now directly addressed by Article 11 (1) subparagraph 3 sentence 1 of Regulation (EU) 2024/573. Although this does not contain an explicit prohibition on acquisition, as was the case with the previous Section 12i (1) No. 1 ChemG, it is not necessary to retain it, as the new Regulation (EU) 2024/573 instead targets and prohibits subsequent actions, such as use.

        The previous Section 12i (1) No. 2 ChemG is now directly regulated by Article 11 (3) of Regulation (EU) 2024/573. Article 11(3) of Regulation (EU) 2024/573 prohibits the import, subsequent supply for consideration or free of charge, making available to third parties in the Union, use and export of non-refillable containers for F-gases listed in Annex I and Annex II, Group 1, to Regulation (EU) 2024/573, which may only be stored or transported for subsequent disposal. Although Article 11(3) of Regulation (EU) 2024/573 does not explicitly prohibit emptying, there is no gap in national law. This is because emptying is likely to be considered intentional release, which is prohibited under Article 4(1) of Regulation (EU) 2024/573 and will be punishable under the amended Section 27c(1) (Art. 1 No. 13 ChemG-RefE).

        III. Retention of national documentation and verification requirements, Section 12i(2) ChemG (Art. 1 No. 3 letters c, d, e ChemG-RefE)

          The documentation and verification requirements set out in Section 12i(2) ChemG remain essentially unchanged. However, the reference to Article 11(1) subparagraph 1 in conjunction with Annex IV of Regulation (EU) 2024/573 will be updated as required, instead of the previous reference to Article 11(1) in conjunction with Annex III of Regulation (EU) No 517/2014.

          The national documentation and verification requirements go beyond the EU requirements in Article 11(1)(5) of Regulation (EU) 2024/573 and specify them in more detail with regard to both the relevant point in time and the required verification content.

          Firstly, the EU documentation and verification requirement under Article 11(1)(5) of Regulation (EU) 2024/573 only takes effect one year after the respective prohibition date in Annex IV to Regulation (EU) 2024/573 and thus later than the prohibitions in Article 11(1)(3) of Regulation (EU) 2024/573, which apply immediately after the prohibition date in Annex IV to Regulation (EU) 2024/573. In contrast, the national documentation and evidence requirement demands the necessary evidence at the time of delivery.

          Secondly, the EU documentation and verification requirement does not contain any requirements regarding the content of the verification. This is in contrast to the national documentation and verification requirement, which will probably require the following information in future:

          • Name and address of the supplier
          • confirmation that the product or facility was first placed on the market before the prohibition date specified in Annex III (editorial error, meant to be: IV) to Regulation (EU) 2024/573, and
          • identification features of the product or facility that enable the product or facility to be clearly assigned to the declaration.

          The obligation to retain evidence (Section 12i (4) ChemG), the presumption rule (Section 12i (5) ChemG), and the exemption from the documentation and evidence requirement (Section 12i (5) ChemG) remain unchanged in terms of content, apart from an update of the references to Regulation (EU) 2024/573 and a purely formal restructuring.

          IV. Elimination of the labelling requirement, Section 12i (6) ChemG (Art. 1 No. 3 letter f ChemG-RefE)

            The previously purely national labelling requirement in Section 12i(6) ChemG is also no longer applicable, as it is replaced by the EU requirement in Article 12(1) of Regulation (EU) 2024/573. The EU labelling requirement regulated therein applies both to the placing on the market and to subsequent deliveries, as well as to the provision to third parties.

            V. Adjustment of information requirements in the supply chain (Art. 1 No. 4 letter d ChemG-RefE)

            As part of the planned amendment to Section 12j ChemG, references to the old Regulation (EU) No. 517/2014 are to be replaced by references to Regulation (EU) 2024/573.

            In addition, in Section 12j(3) sentence 1 (Art. 1 No. 4 letter d ChemG-RefE), the deletion of the word “own” clarifies that the obligations of Section 12j ChemG apply to every importer of F-gases, regardless of whether the gas is subsequently used by the company itself or by a third party. This explicitly covers the case where a service provider imports F-gases and subsequently uses them in a third party’s facility.

            Furthermore, Section 12j (8) ChemG (Art. 1 No. 4 letter g ChemG-RefE) is newly inserted. According to this, the provisions of Section 12j (2), (3) sentence 2 and (4) ChemG do not apply if the transfer is for the purpose of the final filling of a product or equipment for its intended use, e.g. motor vehicle air conditioning systems. The reporting obligations introduced by the Third Act Amending the Chemicals Act serve to combat the illegal trade in F-gases by tightening controls on dealers. However, it was not intended that the declaration should be forwarded to the operators of stationary and mobile equipment. Such a comprehensive reporting obligation on the part of the supplier, which would also trigger a storage obligation on the part of the purchaser under Section 21j(6), would be disproportionate, particularly for operators of mobile equipment, such as motor vehicle owners, and for operators of smaller stationary equipment. The situation is different for larger stationary installations, as official control of maintenance operations and refilling with F-gases is already possible via the records required under Article 7 of Regulation (EU) 2024/573.

            VI. New insertion of Section 12k ChemG – Retrospective quota approval for F-gas products and equipment already on the market (Article 1(4)(h) ChemG-RefE)

            Section 12k ChemG is newly added (Art. 1 No. 4 letter h ChemG-RefE). The provision closes a previously existing gap in the EU quota system for F-gases. This is because the EU ban in Art. 11 Regulation (EU) 2024/573 only applies to products placed on the market for the first time without an existing quota. For products already on the market, however, there is neither a ban on supply nor an obligation to obtain retrospective quota approval. Section 12k ChemG remedies this situation: anyone who makes such a product available again must in future ensure that the necessary quota authorisation is in place. This means that previous infringements can be remedied retrospectively and the facilities concerned can be brought into line with the requirements of Regulation (EU) 2024/573.

            VII. Adjustment of SCIP reporting obligations (Art. 1 No. 5 ChemG-RefE)

            Section 16f No. 2 ChemG is deleted because companies are simply not required to state why a substance has been included in the candidate list pursuant to Article 59(1) of Regulation (EC) No. 1907/2006 when submitting their SCIP notification to the European Chemicals Agency. In addition, it should be noted that the EU Commission proposes in the Environmental Omnibus – Omnibus Package VIII – to remove the obligation to submit SVHC data in future (see also our blog post What’s changing in 2026: Chemicals legislation, section B. CLP).

            VIII. Extension of the regulatory authority (Art. 1 No. 6 ChemG-RefE)

            The regulatory authority in Section 17(1)(1)(c) ChemG is being extended so that in future it will also be possible to issue requirements for the sale and purchase of certain substances, mixtures, articles and equipment, including possible restrictions for certain groups of people, thereby ensuring the implementation of Regulation (EU) 2024/573 and Regulation (EU) 2024/590.

            IX. Enactment of Section 23a ChemG – New temporary trade ban (Art. 1 No. 10 ChemG-RefE)

              Section 23a ChemG is newly added (Art. 1 No. 10), thereby transposing Art. 27(3)(c) of Regulation (EU) 2024/590 and Art. 31(3)(c) of Regulation (EU) 2024/573 into national law. These two provisions stipulate that authorities may impose temporary bans in the event of serious or repeated infringements – for example, on the manufacture, use, import, export or placing on the market of ozone-depleting substances or F-gases. As an independent administrative measure, Section 23a ChemG is independent of any criminal or administrative fine proceedings and primarily pursues the goal of preventing further infringements. The prerequisite for such a ban on activities is a serious or repeated infringement. The severity of a violation is assessed in particular on the basis of the quantity of gases placed on the market or used in violation of the aforementioned regulations and their impact on the environment. A serious violation is to be assumed if F-gases are intentionally released or placed on the market unlawfully in significant quantities. A significant quantity is deemed to exist if the quantity of the substance in question is so high that a considerable environmental risk can be assumed. In the case of F-gases, this is regularly assumed to be the case for quantities exceeding 10 tonnes of CO₂ equivalents, which is based on the thresholds recognized under EU law, for example for pre-filled equipment. If the conditions are met, Section 23a ChemG grants the authority discretion and, depending on the severity of the violation, it can determine both the duration and the type of prohibition.

              Conclusion

              The Fifth Act Amending the Chemicals Act accompanies the requirements and objectives arising from Regulation (EU) 2024/573 on fluorinated greenhouse gases and Regulation (EU) 2024/590 on substances that deplete the ozone layer. It significantly strengthens the national enforcement of chemicals law. In view of the expanded scope for regulatory intervention, particularly under the future Section 23a ChemG, companies should review their F-gas compliance and, if necessary, make appropriate adjustments.

              Do you have any questions about this news item or would you like to discuss it with the author? Please feel free to contact: Martin Ahlhaus and Nicole Rauch

              3. February 2026 Nicole Rauch
              Bild Nicole Rauch
              Nicole Rauch
              Lawyer

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              What’s changing in 2026: Chemicals legislation

              As in previous years, chemicals legislation will undergo a wide range of changes in 2026, posing considerable challenges for affected companies.

              This year, there’s a special focus on tweaking and adjusting rules to make things simpler, including cutting down on red tape. But there are also some big new requirements and changes to the legal basis, like the “One Substance, one assessment ” package that’s already come into effect. Further legal changes aimed at correcting regulatory misdevelopments will also be of particular practical relevance. The following article addresses some of the relevant changes in the scope of application of various chemical legislation acts.

              A. REACH

              Even though the European Commission’s proposal for a revision of Regulation (EC) No. 1907/2006 (“REACH“) is still pending, the existing legal framework once again provides scope for a wide range of new requirements. Particularly, the procedure for restricting PFAS will be the focus of attention in 2026.

              I. Revision

              The targeted revision of REACH remains on the agenda. Not least due to the numerous adjustments made by the Commission’s so-called omnibus proposals last year, regular revision processes, such as those relating to REACH, are subject to further delays. For example, in connection with the so-called environmental omnibus of 10 December 2025, the Commission has only very sparingly stated that a targeted revision of REACH is intended. However, no further announcements on the timetable are currently available.

              It is noteworthy, however, that the Commission apparently also wants to use the REACH revision to examine further possibilities for simplification and, if necessary, combine corresponding approaches with its proposal. In view of the approaches developed under the Green Deal and the Commission’s recent ambitious considerations for adapting REACH, it remains questionable whether and, if so, to what extent the REACH revision will actually bring about simplifications.

              II. Substance and dossier evaluation

              The draft Community Rolling Action Plan (CoRAP) for 2026-2028 was presented on 9 December 2025 and is currently being finalised. It is scheduled to be adopted at the next Member State Committee meeting (expected to take place from 9 to 13 February 2026). The draft CoRAP contains 28 substances, including 8 new substances compared to the current CoRAP 2025-2027.

              Affected companies should address the substance-specific reasons for concern, review their respective registration dossiers and update them if necessary.

              III. Authorisation

              Parallel to ongoing discussions and procedures regarding general changes, substance-related regulation under the REACH Regulation continues to develop inexorably.

              1. SVHC identification

              The ECHA last updated the candidate list on 5 November 2025, adding another substance: 1,1′-(ethane-1,2-diyl)bis[pentabromobenzene] (DBDPE) (EC: 284-366-9, CAS: 84852-53-9). The candidate list now comprises a total of 251 entries, which must be taken into account both for communication in the supply chain in accordance with Art. 33 of REACH and for notifications to the SCIP database. For any notification obligations under Art. 7(2) REACH, a transitional period of a further six months currently applies to the most recently added substance (cf. Art. 7(7) REACH).

              In 2025, it was again apparent that the previously established practice of only two updates within 12 months was not being consistently adhered to. As in the previous year, an additional update was made in November 2025. This indicates a trend towards three updates to the Candidate List per calendar year.

              The expected addition to the Candidate List at the beginning of 2026 is still pending. According to the decision taken at Member State Committee level, the substance n-hexane (EC No 203-777-6) is to be identified as an SVHC and added to the Candidate List. The candidate list is scheduled to be updated on 4 February 2026. The initial plan to identify 4,4′-methylenediphenol (EC No 210-658-2) as an SVHC was withdrawn before the Member State Committee meeting in December 2025.

              Furthermore, the continuous changes to the Candidate List continue to pose challenges for affected companies. This is because communication processes in the supply chain must be reviewed for accuracy and completeness with each change.

              2. SCIP database

              In connection with the Candidate List, it is also noteworthy that the European Commission has presented a proposal in the Environmental Omnibus to abolish the reporting requirement for information on SVHCs in the SCIP database. On the one hand, it is to be welcomed that the inadequacies of the existing reporting requirements and the database, which have been emphasised by industry for some time, are thus being acknowledged. On the other hand, the European Commission’s proposal should also be a signal to legislators to carefully examine the consequences and benefits of additional requirements before introducing new legal obligations.

              According to the European Commission, information transparency is to be ensured in future primarily through the digital product passport. It remains to be seen whether the associated costs for industry and the benefits of greater transparency in the supply chain will be proportionate.

              3. Approval requirements

              A total of four substances were proposed by ECHA in the 12th recommendation for inclusion in Annex XIV to REACH; however, a decision by the Commission is still pending. The substances concerned are:

              SubstanceECCAS
              Barium diboron tetraoxide237-222-413701-59-2
              Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide278-355-875980-60
              S-(tricyclo(5.2.1.0’2,6)deca-3-en-8(or 9)-yl O-(isopropyl or isobutyl or 2-ethylhexyl) O-(isopropyl or isobutyl or 2-ethylhexyl) phosphorodithioate X4261401-850-9255881-94
              Melamine203-615-4108-78-1

              The Member State Committee recently discussed the ECHA’s proposals for the 13th recommendation on the inclusion of substances in Annex XIV to REACH. According to this, four substances are currently scheduled for inclusion:

              • UV-326
              • UV-329
              • triphenyl phosphate
              • 2-(dimethylamino)-2-[(4-methylphenyl)methyl]-1-[4-(morpholin-4-yl)phenyl]butan-1-one

              The three-month consultation is currently scheduled for February 2026.

              Otherwise, there are no expiry dates or application deadlines for substances subject to authorisation in accordance with Annex XIV for the year 2026.

              IV. Restrictions

              In 2026, the requirements for a number of existing restrictions will also change:

              1. Entry 63 (lead and its compounds)

              According to paragraph 15 of entry 63 in Annex XVII to REACH concerning lead and its compounds, there is a general ban on the marketing of articles made of polymers or copolymers of vinyl chloride (“PVC”) if the lead concentration is 0.1% by weight or more of the PVC material. Paragraph 18 provides for an extended transition period until 28 May 2033 for certain articles if the lead concentration is less than 1.5% by weight of the recovered rigid PVC. However, a further restriction will apply from 28 May 2026. From this date, rigid PVC made from profiles and sheets

              • for external applications in civil engineering works, except for decks and terraces;
              • for decks and terraces, provided that the recovered PVC is used in a middle layer and is completely covered with a layer of PVC or another material with a lead concentration of less than 0.1% by weight;
              • for use in concealed areas or cavities in civil engineering works (provided that they are not accessible during normal use, except for maintenance purposes, e.g. cable ducts);
              • for interior applications in buildings, provided that the entire surface of the profile or panel facing the occupied areas of a building after installation is made of PVC or another material with a lead concentration of less than 0.1% by weight,

              shall be recovered and used only for the manufacture of new products in one of these categories.

              2. Entry 77 (Formaldehyde)

              From 6 August 2026, the restriction on formaldehyde under entry 77 in Annex XVII to REACH will apply. From this date, articles may no longer be placed on the market if the test conditions specified in Appendix 14 to Annex XVII to REACH exceed the following values for the concentration of formaldehyde released from these articles:

              • 0.062 mg/m3 for furniture and wood-based products;
              • 0.080 mg/m3 for products other than furniture and wood-based products.

              The restriction does not apply to

              • articles in which formaldehyde or formaldehyde-releasing substances are present exclusively in a natural form in the materials from which the articles are made;
              • products intended exclusively for outdoor use under foreseeable conditions;
              • products in buildings that are used exclusively outside the building envelope and vapour barrier and from which no formaldehyde is released into the indoor air;
              • products intended exclusively for industrial or commercial use, unless formaldehyde released from them leads to exposure of the general public under foreseeable conditions of use;
              • Products to which the restriction in entry 72 applies;
              • Products that are subject to Regulation (EU) No 528/2012 of the European Parliament and of the Council as biocidal products;
              • Products falling within the scope of Regulation (EU) 2017/745 of the European Parliament and of the Council;
              • personal protective equipment within the scope of Regulation (EU) 2016/425;
              • Articles intended to come into direct or indirect contact with food falling within the scope of Regulation (EC) No 1935/2004;
              • used products.

              3. Entry 78 (synthetic polymer microparticles)

              According to entry 78 in Annex XVII to REACH, suppliers of in vitro diagnostic medical devices, including products within the scope of Regulation (EU) 2017/746, containing synthetic polymer microparticles must, from 17 October 2026, provide instructions for use and disposal to professional users and the general public, explaining how to prevent the release of synthetic polymer microparticles into the environment.

              In addition, reporting obligations under paragraph 11 of entry 78 in Annex XVII to REACH must be fulfilled by 31 May 2026. By that date, manufacturers and downstream industrial users of synthetic polymer microparticles in the form of granules, flakes and powders used as starting materials for plastic production in industrial facilities must provide the following for the reporting period from 1 January 2025 to 31 December 2025

              • a description of the uses of synthetic polymer microparticles;
              • for each use of synthetic polymer microparticles, general information on the identity of the polymers used;
              • for each use of synthetic polymer microparticles, an estimate of the quantity of synthetic polymer microparticles released into the environment during the previous calendar year, including the quantity of synthetic polymer microparticles released into the environment during transport;
              • for each use of synthetic polymer microparticles, an indication of the exemption referred to in paragraph 4(a) of entry 78 in Annex XVII to REACH

              to ECHA.

              4. PFAS

              Beyond the existing restrictions, the ongoing restriction process concerning PFAS remains of central importance for almost all industrial sectors. Now that the technical evaluation of the restriction proposal by the relevant ECHA committees, i.e. the Committee for Risk Assessment (RAC) and the Committee for Socio-economic Analysis (SEAC), has been largely completed, further consultation on the SEAC draft is expected from March 2026 onwards, according to recent announcements. For affected companies, this consultation represents the last opportunity expressly provided for in the procedure to influence the design of the future restriction by submitting information. Once the consultation has been completed, ECHA will finalise the restriction proposal and forward it to the Commission for further decision.

              5. Chromium VI

              In addition, the process of restricting chromium VI will also continue. The European Commission has published an updated version of the Q&A document “Towards a restriction of hexavalent chromium (Cr(VI)) substances”. The ongoing authorisation procedures and developments regarding restrictions are to be further coordinated. This will also be facilitated by a draft implementing act that was discussed in the REACH Regulatory Committee: CMTD(2025)2107 – Register for the committee procedure. The RAC and SEAC opinions on the restriction proposal are currently expected by the third quarter of 2026, and a restriction (including amendments to Annexes XIV and XVII) could then be adopted in the course of 2027.

              B. CLP

              At the end of 2024, far-reaching amendments to Regulation (EC) No 1272/2008 (“CLP”) were introduced by Regulation (EU) 2024/2865. However, Regulation (EU) 2025/2439 recently postponed the date of application of the transitional provisions of Regulation (EU) 2024/2865 (see our blog post for details).

              However, the postponement of the date of application (“stop-the-clock“) is only the first part of Omnibus Package VI: Chemicals. In a second part, further adjustments to the content are to be made, including with regard to the changes introduced by Regulation (EU) 2025/2439. In particular, flexibility is to be created with regard to font sizes and labelling. The exemptions from labelling requirements for small containers are also to be extended. In addition, the requirements for updating labels and the mandatory information in advertising are to be changed. The parliamentary process is still ongoing, so further developments remain to be seen.

              This year will see the first application of the newly introduced Art. 37(7) CLP. This provision establishes the Commission’s authority to carry out harmonised classifications for substances that have been subject to previous SVHC identification procedures or that have been evaluated as active substances in accordance with Regulation (EU) No 528/2012 or Regulation (EC) No 1107/2009 and which subsequently fall under the newly introduced hazard classes ED HH Cat. 1, ED ENV Cat. 1, PBT or vPvB, without the need for a further evaluation procedure. An initial proposal has been put forward and covers 115 substances. It includes 52 new entries and corresponding changes for 63 entries. A delegated act amending Table 3 of Part 3 of Annex VI to the CLP is expected to be published in the course of the year.

              C. BPR

              A key focus remains on continuing the work programme under Regulation (EU) No 528/2012 (“BPR”), along with updating and revising the relevant Delegated Regulation (EU) No 1062/2014. As usual, ECHA is pointing out any deadlines for 2026.

              In this context, additional data requests are also being made in pending procedures for active substance approval or product authorisation. This applies in particular to ongoing procedures concerning in-situ systems following the adoption of the “BPC Recommendations” for the evaluation of so-called “in-situ” systems.

              Particular attention should also be paid this year to the Commission’s proposal to extend the data protection periods under Art. 95(5) BPR for all active substance-product type combinations for which a decision on active substance approval has not been taken by 7 June 2018. The extended deadline is now set to end on 31 December 2030. For data that was not protected under the previous regulation from 31 December 2025 until the new regulation came into force, eligible data owners are to receive additional compensation if the data was used by third parties. However, the claim must be asserted and enforced by the data owner on a case-by-case basis.

              On the one hand, it is to be welcomed that the European Commission is showing a willingness to correct a tangible lack of clarity and unintended undesirable developments in the BPR. On the other hand, however, the previous mistake is being repeated. The duration of the work programme for existing substances and corresponding product types was extended until 31 December 2030 by Delegated Regulation (EU) 2024/1398, so that the adjustment of the data protection periods now provided for in Art. 95(5) BPR will (once again) expire precisely at the end of the work programme. However, should there be further delays in completing the work programme, the situation that arose at the end of 2025 would recur at the end of 2030. A more flexible design of the data protection rules under Art. 95(5) BPR would have been desirable in this respect. However, as the European Commission rejects a further extension of the work programme beyond 2030 under the existing legal framework anyway, a more flexible approach was not to be expected. It remains to be seen, however, whether supplementary or new regulatory approaches will be established in the course of the further review of the BPR itself.

              The consultation on the possible revision of the BPR will continue until 5 March 2026, but participation has been extremely low so far.

              D. POP

              The inclusion of further substances in Annex I to Regulation (EU) 2019/1021 (“POP”) is scheduled for 2026. Most recently, the European Commission proposed the inclusion of MCCPs, chlorpyrifos and C9-21 PFCAs and conducted a consultation on this at the end of 2025. It is expected that the legal act for the inclusion of these substances in the POP Regulation will be adopted in the course of 2026.

              E. Data platform

              Regulation (EU) 2025/2455 establishing a common data platform for chemicals and laying down rules to ensure that the data contained therein is discoverable, accessible, interoperable and reusable, as well as creating a monitoring and prospective framework for chemicals, was published in the Official Journal of the EU on 12 December 2025.

              1 January 2026 marks the start of the three-year period within which the chemical data specified in Annex IV to Regulation (EU) 2025/2455 must be included in the common data platform.

              According to Art. 4(1) of Regulation (EU) 2025/2455, the Commission shall, by 2 July 2026, adopt an implementation plan by means of an implementing act specifying the chemical data sets to be included in the common data platform, together with a timetable for their inclusion.

              In addition, from 1 January 2026, researchers or research consortia funded by Union framework programmes or national programmes will be required to make data available to the EEA in relation to human biomonitoring data and to the ECHA in relation to relevant data on environmental sustainability.

              The “observatory” for certain chemicals or groups of chemicals to be established under Art. 23 of Regulation (EU) 2025/2455 will also be of particular relevance. To this end, the European Commission will adopt and publish a list of chemicals to be subject to additional testing by 2 July 2026.

              F. Conclusion and outlook

              The manifold changes and readjustments mean that chemicals legislation will remain a complex, demanding and challenging subject in 2026. The European Commission’s latest “corrective measures” concerning, for example, the SCIP database, CLP and BPR do not exactly strengthen the position of those companies that made early efforts to achieve legal compliance.

              Regardless of this, however, companies must still keep a close eye on the many changes. What’s more, beyond the changes in the central legal acts of European chemicals regulation, there are a variety of regulations that focus on specific hazardous properties of substances in products, establishing bans for the placing on the market or use of affected products or further transparency requirements. Corresponding provisions in ESPR, PPWR and many other regulations underscore this. Chemicals legislation thus emphatically and conclusively proves that it is a horizontal regulatory matter that affects companies from all industries, all stages of the supply chain and of all sizes. This makes it all the more important to address the ongoing changes and develop robust internal company monitoring systems in order to identify existing obligations and (liability) risks at an early stage, as well as potential opportunities that may arise from regulatory changes.

              Do you have any questions about this news item or would you like to discuss it with the author? Please feel free to contact: Martin Ahlhaus

              22. January 2026 Martin Ahlhaus
              Bild Martin Ahlhaus
              Martin Ahlhaus
              Lawyer / Partner

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              What’s changing in 2026: product-related civil and competition law

              Regulation continues at full speed in product-related civil and competition law

              The following new developments are worth noting in this area:

              A. Civil law

              Product-related civil law will be shaped in 2026 by the expansion of information requirements for consumers and the introduction of a right to repair.

              I. New information requirements towards consumers

              As previously reported, the EmpCo Directive introduces new information requirements for stationary and online retailers in addition to competition law prohibitions (see below). These relate to the existence of legal warranty rights on the one hand and mandatory information in the case of a commercial durability guarantee on the other. In future, the existence of the legal warranty right and its most important elements, including its minimum duration of two years, must always be pointed out. If the manufacturer offers a commercial durability guarantee for the entire product at no additional cost for more than two years, this guarantee must also be pointed out separately. These changes are incorporated in the EGBGB in Germany; the corresponding implementation law is now available.

              The Commission recently laid down the specific format of this information in Implementing Regulation (EU) 2025/1960.

              The harmonised notification regarding the legal warranty is to be as follows:

              The reference to the commercial durability guarantee will be worded as follows:

              Unfortunately, there is currently no template that obligated parties can use for the specific implementation/customisation of warranty notices.

              These new labels must be used from 27 September 2026 onwards. It is therefore advisable to begin implementing the legal requirements immediately.

              II. Right to repair

              We have already reported several times in this blog on the European Directive on the promotion of the repair of goods (Directive (EU) 2024/1799) (most recently: Further Update on the Right to Repair
              ). Since 15 January 2026, the draft bill from the Federal Ministry of Justice has been available, which is intended to transpose the provisions of the directive into German law.

              In line with the Directive, the law is intended to regulate two core areas. On the one hand, the new right to repair outside of statutory warranty  and, on the other hand, important changes to warranty law under sales law.

              The new right to repair will apply outside the scope of warranty law to goods purchased by consumers. It only covers the product groups listed in Annex II of the Right to Repair Directive (cf. Sec. 479a German Civil Code (BGB)).

              The manufacturer’s obligation to repair, which is at the heart of the new regulation, is implemented in Sec. 479b BGB. The German legislature has opted for a statutory consumer right rather than a (unilateral) obligation to contract. According to this, the manufacturer is obliged to repair the defective goods within a reasonable period of time. The actual scope and time frame of this repair obligation is set out in the ecodesign acts listed in Annex II to the Directive. The manufacturer may charge a reasonable fee for the repair. If the repair is unsuccessful, the consumer will be entitled to warranty claims against the manufacturer under the law governing contracts for work and services.

              In addition, manufacturers are obliged to provide information about their repair obligations and corresponding recommended prices, Sec. 479d BGB.

              Furthermore, selective but highly practical changes to warranty law under sales law are being implemented in German law.

              For example, the reparability of goods becomes part of the normal quality in Sec. 434 (3) sentence 2 BGB and thus part of the definition of a physical defect.

              Even more relevant for retailers is the introduction of an obligation to provide information to consumers in the new Sec. 475(4) of the German Civil Code (BGB). In future, consumers as buyers must be informed before remedial action is taken that they have the right to choose between repair and replacement and that the limitation period for the warranty is extended if they choose remedial action.

              This is accompanied by the most important change in purchase warranty law in practical terms. According to Sec. 475e (5) BGB, if remedial action is taken in the form of repair (i.e. by repairing the goods), the limitation period for warranty claims is extended once by 12 months. This means that the limitation period for consumer claims will be extended from two to three years in this case. This significant extension will affect all B2C sellers.

              These changes will apply from 31 July 2026.

              III. Act Amending Consumer Contract and Insurance Contract Law

              The ‘Act Amending Consumer Contract and Insurance Contract Law,’ which was passed shortly before Christmas, brings some relief for consumers. When it comes into force in June 2026, it will significantly simplify the revocation of contracts concluded on the internet.

              B. Competition law

              In competition law, the focus in 2026 will continue to be on the use of green claims:

              Even though the Green Claims Directive is still pending, the so-called EmpCo Directive (EU) 2024/825 introduces several important restrictions on the use of green claims in the future. These are to be incorporated into the German Unfair Competition Act (UWG) with the Third Act Amending the Unfair Competition Act.

              The Act contains the following relevant prohibitions on the use of green claims:

              • The following aspect is included as a new prohibited misleading practice: making an environmental claim about future environmental performance without clear, objective and verifiable commitments, without a corresponding implementation plan and without verification by an external expert (Sec. 5 (3) No. 4 UWG, new version).
              • New misleading practice (as new item 2a of the ‘black list’): Affixing a sustainability label that is not based on a certification system or has not been established by government agencies. The certification system required in this respect is also defined in detail; in particular, it requires monitoring of compliance with the requirements by an independent third party.
              • New misleading practice (as new No. 4a of the ‘black list’): Making a general environmental claim where the business operator cannot prove the outstanding environmental performance to which the claim refers. This could become the most important provision in practice.
              • New misleading practice (as new No. 4b on the ‘black list’): Making an environmental claim about the entire product or business activity when it actually refers only to a specific aspect.
              • New misleading practice (as new No. 4c on the ‘blacklist’): Making a statement claiming that a product has a neutral, reduced or positive impact on the environment in terms of greenhouse gas emissions,

              The Commission has recently published FAQs on these situations. However, the answers are largely limited to reproducing the wording of the respective provision or the applicable legal regulation. They are therefore of rather limited value in practice.

              Furthermore, this document indicates that the European Commission does not currently anticipate any further transition periods for compliance with these obligations beyond the implementation deadline for the Directive. Despite efforts by interested parties, it therefore remains likely that the new regulations will apply from 27 September 2026. The measures proposed by the Commission in the FAQs to ensure compliance, in this case the affixing of stickers to product packaging or additional information at the point of sale, will in many cases not be practicable or economically viable. It may therefore be necessary to dispose a significant number of products that are no longer marketable after the deadline, which is certainly not in line with the purpose of the Directive.

              Due to the imminent application of the new regulations from 27 September 2026, all companies that use (or wish to use) green claims should take immediate action to ensure compliance with the new and significantly stricter competition law requirements.

              C. Civil procedure law

              In addition to the topics discussed above, changes in civil procedure law will also have a noticeable impact on product-related litigation before civil courts.

              I. Higher thresholds for jurisdictional competence and legal remedies

              Since 1 January 2026, higher thresholds apply to jurisdictional competence and legal remedies. In civil matters, the dispute value limit for the jurisdiction of local courts is now EUR 10,000.00. At the same time, legal representation is now mandatory only for disputes with a value of EUR 10,000.00 or more. The increase applies to all proceedings pending as of 1 January 2026.

              The value limits for appeals have also increased at the turn of the year. The minimum value limit for appeals in civil matters is now EUR 1,000 (instead of EUR 600.00). At the same time, the value limit for appeals against non-admission to the Federal Court of Justice (now EUR 25,000.00) and the value limit for appeals against costs (now EUR 300.00) have also increased.

              II. Additional special chambers at regional courts

              While civil disputes with a value of up to EUR 10,000.00 are now handled by local courts, certain types of cases have been assigned to regional courts since the turn of the year, regardless of their value. These include disputes arising from public procurement law, press and media law disputes concerning publications, and medical malpractice cases.

              III. Testing of online proceedings

              Shortly before Christmas, the ‘Act on the Development and Testing of Online Proceedings in Civil Justice’ was also passed. This creates the framework for testing a purely digital online procedure. In addition, a digital platform for communication between the court and the parties to the proceedings is to be created and tested.

              IV. Digitalisation of debt enforcement

              Debt enforcement is also to be digitalised. In future, both the initiation of debt enforcement and the subsequent exchange of documents between lawyers (or authorities) and enforcement officers will largely take place electronically. The Federal Government’s draft bill on the further digitalisation of debt enforcement is currently being discussed in the Legal Affairs Committee.

              Do you have any questions about this news item or would you like to discuss it with the author? Please contact: Dr Florian Niermeier

              21. January 2026 Dr. Florian Niermeier
              Bild Dr. Florian Niermeier
              Dr. Florian Niermeier
              Lawyer / Partner

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              What’s changing in 2026: Life Science

              In 2026, the developments initiated in 2025 continue. The focus remains on the draft proposal published by the European Commission on 16 December 2025 concerning the reform of the MDR and IVDR. Beyond this, digitalization continues to represent a central theme in the life sciences sector, including at the national level. In this context, particular emphasis is placed on reducing bureaucratic burdens as well as on data protection and data transparency.

              This article is the penultimate part of the blog series “What’s Changing in 2026,” in which the experts of the Produktkanzlei summarize key topics from their respective practice areas. Here, we examine the developments relating to the MDR, including the Commission’s draft amending regulation for the MDR/IVDR (see under A.). At the national level, we discuss the simplification of the conduct and approval of clinical investigations and performance studies (see under B.). Further topics include the Data Act (see under C), the AI Act in the medical device sector (see under D.), the rollout of the electronic patient record (see under E.), and updates regarding digital health applications (see under F.). Finally, we provide an overview of the changes in cosmetics law (see under G.).

              A. MDR and IVDR

              In 2026, the MDR and IVDR continue to be at the forefront of both regulatory and practical developments. The European Commission’s latest reform proposal, the expiration of transitional periods, and emerging advances in digitalization are collectively shaping the evolving regulatory landscape.

              I. Draft Reform

              On 16 December 2025, the Commission published a draft amending regulation for the MDR and IVDR. This proposal contains numerous, in part fundamental, adjustments. The overarching aim of the reform is to make the MDR/IVDR more efficient, transparent, and innovation‑friendly – without reducing the high standards for safety, quality, and patient protection. The primary focus is on simplifying and reducing the regulatory burden, which has proven substantial under the current framework.

              The intended improvements include clearer structuring of conformity assessment procedures, increased predictability, and enhanced cost‑efficiency. For example, fee reductions may be introduced for SMEs and orphan devices, and the Commission would be empowered to define the structure and amount of such fees. A new dispute‑resolution mechanism between manufacturers and notified bodies is also planned: the authority responsible for the notified body would act as an “ombudsman” in case of disagreements.

              At the same time, digitalization should be used to speed up processes and simplify communication between manufacturers, authorities and notified bodies.

              To promote innovation, the draft reform provides for the introduction of so-called ‘regulatory sandboxes’. These enable manufacturers to develop, test, validate and, if necessary, use innovative products under real conditions for a certain period of time under official supervision without having to meet all regulatory requirements.

              A particular focus lies on enhanced harmonization within the EU to avoid regulatory overlap and ensure a coherent framework. For instance, the MDR/IVDR and the AI Act are to be better aligned.

              The draft additionally introduces new information‑sharing and cooperation obligations for Member States to mitigate structural issues related to shortages. The EMA will monitor shortages and support national authorities and the Commission. Moreover, aligned with the newly effective Article 10a MDR/IVDR (early 2025), a positive list of critical medical devices shall be established, and an IT portal for reporting supply interruptions will be created.

              The public consultation runs until 16 March 2026, so comments on the draft can be submitted until then. The proposal will now be presented to the European Parliament and Council for adoption. The trilogue negotiations are planned for spring 2026. It remains to be seen whether the reform will be implemented within 2026.

              II. Transition Periods

              On 26 May 2026, the transitional period for custom‑made implantable Class III devices under the MDR ends.

              2026 also marks the end of the IVDR transition period for Class C products, for which the involvement of a notified body was already required under the IVDD. A formal application for these products must be submitted to the notified body by 26 May 2026. As a result, a written contract with a notified body must be in place no later than four months after the application is submitted, i.e. by 26 September 2026, for these products to continue to be placed on the market.

              III. Electronic Instructions for Use – eIFU

              In 2025, the scope for electronic instructions for use was significantly expanded, but only for professional users, not laypersons. On 25 June 2025, the Commission adopted Implementing Regulation (EU) 2025/1234 amending Implementing Regulation (EU) 2021/2226 regarding the types of medical devices for which instructions may be provided electronically. The amending regulation provides for a significant expansion of the scope of application of electronic instructions for use (eIFU) in place of paper instructions for use, but it is still not possible to introduce eIFU across the board for products intended for use by laypersons. Implementation remains optional for manufacturers. The implementing regulation entered into force on 26 July 2025.

              IV. EUDAMED

              On 27 November 2025, the Commission published Decision (EU) 2025/2371 on the announcement of the functionality and fulfilment of the functional specifications of certain electronic systems contained in the European Database on Medical Devices and on the declaration of functionality of the first four modules in the Official Journal of the European Union. In accordance with the transitional provisions of Regulation (EU) 2024/1860, this marks the start of the six-month transition period.

              Accordingly, the first four EUDAMED modules will become mandatory from 28 May 2026:

              • Actor registration (Art. 30 MDR / Art. 27 IVDR) — already nationally mandatory in Germany since 26 May 2021 
              • UDI database and device registration (Art. 28–29 MDR / Art. 25–26 IVDR) 
              • Notified bodies and certificates (Art. 57 MDR / Art. 52 IVDR) 
              • Market surveillance (Art. 100 MDR / Art. 95 IVDR)

              For legacy products placed on the market before 28 June 2025, an additional transition period applies: Manufacturers and distributors of systems and treatment units must have registered such existing products in the UDI/Product Module by 27 November 2026 at the latest.

              B. Simplification of Clinical Investigations and Performance Studies – Standard Contractual Clauses

              On 18 September 2025, the German Federal Government published the Regulation on on standard contractual clauses for the conduct of clinical trials (Standard Contractual Clauses Regulation – StandVKlV) for medicinal products. This regulation applies to contracts for clinical trials of medicinal products concluded on or after 17 December 2025.

              Sec. 31c of the Medical Devices Implementation Act (MPDG) also provides for the possibility of establishing standard contractual clauses for clinical trials and performance studies by means of a statutory order for medical devices and IVDs.

              The enactment of a corresponding regulation is expected in the near future in 2026. The aim is to standardise and facilitate contract negotiations for manufacturers, sponsors and trial centres.

              C. Data Act

              The Data Act (Regulation (EU) 2023/2854) entered into force in January 2024, establishing a legal framework for fair access to and use of data. Its provisions have been binding since 12 September 2025.

              In Germany, the federal government adopted a draft bill from the Federal Ministry of Digital and Public Service Modernisation on 29 October 2025. The aim is to adapt national legislation so that the provisions of the Data Act can be enforced without hindrance and violations can be effectively sanctioned. In this respect, the designation of the Bundesnetzagentur as the competent national authority (Sec. 2 of the draft) is also of central importance.

              D. Artificial Intelligence Act – AI Act

              The AI Regulation will apply from 2 August 2026. The central classification rules and requirements for high-risk AI systems will only apply from 2 August 2027, in accordance with Art. 6(1) AI Act.

              However, the Commission has now published a proposal for a digital omnibus regulation on AI in order to simplify and relax the rules. According to this omnibus proposal, the rigid application deadlines previously envisaged are to be replaced by a dynamic mechanism. For systems covered by Annex I AI Act, companies would be given 12 months longer to adapt to the changed legal situation. This also applies to the MDR and IVDR. However, the relevant obligations may apply earlier if the Commission confirms that sufficient measures to support compliance (such as harmonised standards and common specifications) are in place. The proposal is currently still in the legislative process – whether and in what form the changes will actually be implemented is currently open. Manufacturers should therefore not rely on this proposal, but should already start addressing the complex additional requirements of the AI Act.

              Irrespective of this, structural changes for medical devices in conjunction with the AI Act are to be expected in view of the planned reform of the MDR and IVDR. The Commission’s draft MDR reform provides for the MDR and IVDR, which are currently listed in Annex I of the AI Act, to be moved to Section B. As a result, the full high-risk regime of the AI Act would no longer apply directly to medical devices and IVDs, but the application of the AI Act would be limited to the horizontal provisions referred to in Art. 2(2) AI Act. At the same time, a revision of Art. 5(8) MDR is intended to clarify that the European Commission must take into account the requirements for high-risk AI systems in accordance with Chapter III, Section 2 AI Act when drafting implementing and delegated acts. As a result, the requirements of the AI Act would not be completely eliminated, but would be systematically integrated into the MDR. In this way, the Commission aims to avoid unclear overlaps between the MDR/IVDR and the AI Act.

              E. Electronic Patient Record (ePA)

              Since 1 October 2025, the use of the ePA has been mandatory for all doctors in Germany.

              From 1 January 2026, software systems that have received confirmation of conformity for the use of the ePA and are therefore ‘ePA-ready’ must be in use. Doctors who use systems that are not ePA-compatible or who cannot provide proof of using a compliant system risk having their fees reduced and their IT flat rate cut. To avoid hardship cases, the National Association of Statutory Health Insurance Physicians can issue corresponding interpretation guidelines.

              In addition, the ePA will be supplemented by a medication plan in the course of 2026. The electronic medication plan supplements the medication list with information such as dosage and instructions for use.

              F. Digital Health Applications (DiGA)

              Further developments are ongoing with regard to DiGA. On 28 October 2025, the Federal Ministry of Health published a draft bill to amend the Digital Health Applications Regulation (DiGAV).

              This draft amendment primarily takes into account applications that constitute an AI system in accordance with the AI Regulation. Furthermore, new regulations for the gradual implementation of the AbEM were defined on the basis of the legal requirements of SGB V.

              G. Changes in Cosmetics Law

              The Omnibus VI Regulation (2025/0531/COD) aims to introduce not only simplifications in chemicals legislation, but also amendments to Regulation (EC) No 1223/2009 (hereinafter “Cosmetic Regulation”). The adoption of the draft is expected later this year.

              The amendments concern, among other things, a new procedure for the inclusion of additional colourants, preservatives and UV-filters in Annexes IV, V and VI of the Cosmetic Regulation. Where it can be scientifically demonstrated that the use of a substance in a cosmetic product is safe, its inclusion should be made possible through a procedure set out in a new Article 14a Cosmetic Regulation. The timeline for this procedure is intended to be accelerated through legally defined deadlines.

              Art. 15 Cosmetic Regulation generally prohibits the use of substances classified as CMR under Regulation (EC) No 1272/2008 in cosmetic products. The changes introduced by Omnibus VI involve a substantial expansion of the possibilities for the exceptional use of such CMR substances.

              Furthermore, the notification requirement for products containing nanomaterials within the meaning of Art. 16 (3) – (7) Cosmetic Regulation is to be removed. In addition, the glossary of ingredient names is to be abolished, with future references made directly to the International Nomenclature of Cosmetic Ingredients (INCI) in order to avoid delays in incorporating new entries into the glossary.

              On 12 January 2026, Regulation (EU) 2026/78 (as part of Omnibus VIII) was adopted, amending the Cosmetic Regulation by adding newly classified CMR substances and placing them on the respective lists of prohibited, restricted or permitted substances.

              Do you have any questions about this news or would you like to discuss it with the author? Please contact: Prof. Dr. Boris Handorn and Anna Christ

              20. January 2026 Prof. Dr. Boris Handorn & Anna Christ
              Bild Prof. Dr. Boris Handorn
              Prof. Dr. Boris Handorn
              Lawyer / Partner
              Bild Anna Christ
              Anna Christ
              Lawyer

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              What’s changing in 2026: Product-related IT regulation and product liability law

              2024 could be the year of regulation of smart and digital products. This is because the EU players already agreed on a Cyber Resilience Act and an AI Act at the end of 2023, meaning that they can be expected to be adopted in 2024. Negotiations on the new EU Product Liability Directive, which will replace Directive 85/374/EEC and comprehensively reform product liability law, are also in the “hot phase”; it is therefore not unlikely that the new EU Product Liability Directive will be adopted in 2024.

              A. Effective date of regulatory reporting obligations pursuant to Art. 14(1), (3) CRA

              The CRA entered into force on 10 December 2024. As the first European legal act of its kind, it introduces binding cybersecurity requirements for products with digital elements throughout their entire life cycle, as well as corresponding obligations for economic operators. The requirements and obligations of the Regulation apply in principle from 11 December 2027 in accordance with Art. 71(1) CRA. An exception to this are the reporting obligations pursuant to Art. 14(1), (3) CRA, which must already be complied with from 11 September 2026. On the one hand, actively exploited vulnerabilities must be reported and, on the other hand, serious security incidents that compromise the security of a product with digital elements. Manufacturers should have implemented a functioning monitoring system in good time that enables the identification of security vulnerabilities and the timely submission of the necessary reports.

              While the new reporting system is generally viewed positively, the very short deadlines have been met with criticism. Many manufacturers fear damage to their image and economic disadvantages if they inform authorities about their own security problems. To alleviate this concern, Art. 17(4) CRA clarifies that a report has no preliminary effect on liability issues.

              B. AI Act

              The AI Act, which came into force on 1 August 2024, is the world’s first set of rules establishing binding requirements for the development and use of artificial intelligence. The Regulation takes a risk-based approach to protect fundamental rights, democracy, the rule of law and personal safety from high-risk AI applications.

              The central subject of the AI Act is so-called high-risk AI systems with potential risks to health, safety, fundamental rights, the environment, democracy and the rule of law. They are subject to strict requirements, such as a mandatory impact assessment for fundamental rights (Art. 27 AI Act). In addition, so-called general AI systems (GPAI) also fall within the scope of application; these must, for example, have technical documentation, ensure compliance with copyright law and provide information on training data (cf. Art. 53 AI Act). Additional requirements are also imposed on GPAI with high systemic risk.

              The AI Act was originally supposed to come into full effectiveness on 2 August 2026, with one exception (Art. 113 AI Act), after a number of provisions (e.g. on GPAI) had already come into effect on 2 February 2025 and 2 August 2025. Following increasing criticism, the Commission has published a legislative proposal to simplify and relax the regulations. This initially concerns the “full” entry into force scheduled for 2 August 2026. This rigid deadline is now to be replaced by a dynamic mechanism. As there are some delays in the preparation of harmonised standards and guidelines, for example, the date of application of the obligations is now to be linked to their availability.

              • For systems covered by Annex III of the AI Act, companies are to be given an additional six months to implement the new regulations. This applies to systems used in employment, critical infrastructure or law enforcement.
              • For systems covered by Annex I of the AI Act, companies will now have 12 months longer to adapt to the changed legal situation. This applies, for example, to high-risk AI systems in the scope of the EU Radio Equipment Directive, the EU Machinery Directive or the EU Toy Safety Directive.

              Nevertheless, the Commission still envisages a strict deadline: the regulations are to apply in any case by 2 December 2027 (AI systems under Annex III of the AI Act) and 2 August 2028 (AI systems under Annex I of the AI Act) at the latest. This adjustment may give economic operators some much-needed leeway, but at the same time it increases the effort companies must make to keep track of regulatory developments.

              This is accompanied by planned relief measures for small and medium-sized enterprises: the privileges for SMEs have been extended to larger companies, which simplifies the technical documentation requirements and means lower fines in the event of an emergency. In addition, the AI competence requirement for providers and operators has been relaxed (Art. 4 AI Act); it is now primarily a funding obligation of the Member States and the Commission. Another simplification: there is to be a clear legal basis for all AI systems (Art. 4a of the future AI Act) in order to avoid discrimination, allowing sensitive personal data to be processed in exceptional cases, provided that strict protective measures are observed.

              Parallel to the European relaxation, the national structure for implementing the AI Act in Germany is taking shape. On 12 September 2025, the Federal Ministry for Digital and State Modernisation published a draft law for the implementation of the AI Act (draft AI Market Surveillance and Innovation Promotion Act – KI-MIG-E). On the basis of this law, the Federal Network Agency (BNetzA) will be established as the market surveillance authority in the sense of a catch-all authority (Section 2 KI-MIG-E). Germany is pursuing a hybrid approach: a coordination and competence center for the AI Regulation (KoKIVO) is being created at the BNetzA, which is intended to support other specific market surveillance authorities with primary responsibility (such as the Federal Motor Transport Authority or BaFin) in their tasks.

              C. NIS 2 Implementation Act – Strengthening cyber security for businesses and public administration

              On 5 December 2025, the “Act Implementing the NIS 2 Directive and Regulating Essential Features of Information Security Management in the Federal Administration” was published in the Federal Law Gazette. Alongside the CRA and the Cyber Security Act (CSA), the NIS 2 Directive forms the third pillar of the EU’s efforts to strengthen cybersecurity with a focus on the resilience of selected economic sectors. Unlike the CRA, the directive does not refer to products, but to organisations. It replaces the first NIS Directive from 2016 and introduces numerous innovations in network and information security law.

              In addition to the enactment of a law on the Federal Office for Information Security and on information security in institutions (BSI Act – BSIG), a number of other regulations are being amended (e.g. the BND Act, the BSI Critical Infrastructure Regulation and the Whistleblower Protection Act).

              The law focuses on the following areas, which are of central importance for companies:

              • Extended scope of application: Regulation is no longer limited to operators of critical infrastructures (KRITIS) or digital services. The introduction of new “facility categories” significantly expands the group of companies affected.
              • New security standards: The EU’s minimum security requirements (Art. 21 NIS-2 Directive) are incorporated directly into the BSI Act. Positive for practice: The intensity of the required measures should be based on proportionality and differentiated according to category.
              • Three-tier reporting system: The previous single-tier reporting requirement for security incidents will be replaced by the three-tier system of the NIS 2 Directive. The legislator promises to keep the bureaucratic effort within the scope of national discretion as low as possible.
              • Stronger supervision: The Federal Office for Information Security (BSI) will be given extended powers and a wider range of tools to enforce the new requirements.

              In addition to the obligations for the business sector, the draft also revises the IT security of the federal government. This includes harmonised requirements for the federal administration and the creation of the role of a “CISO Bund” as the central coordinator for information security at the government level.

              D. Implementation of the EU Product Liability Directive

              On 11 September 2025, the Federal Ministry of Justice published a draft bill to reform product liability law (ProdHaftG-E) – the reason for this is the implementation of the new EU Product Liability Directive (Directive (EU) 2024/2853) into national law. This marks the first comprehensive reform of the current product liability law since 1989. According to Art. 22 (1) of EU Product Liability Directive, implementation must take place by 9 December 2026.

              The new ProdHaftG is scheduled to enter into force on 9 December 2026. The previous ProdHaftG will continue to apply to products placed on the market before this date. Accordingly, software updates or upgrades for products placed on the market before the cut-off date will not lead to the application of the new product liability law. Nevertheless, affected economic operators should familiarise themselves with the new regulations in good time so that they can identify and address liability risks at an early stage.

              The most important changes at a glance:

              I. Expansion of the definition of product

              The new Section 2 of the ProdHaftG-E significantly expands the definition of product. In addition to movable goods and electricity, it will in future also include, for example:

              • Software, including cloud-based and AI software, regardless of its embodiment
              • digital manufacturing files, e.g. CAD files for 3D printing.

              II. Definition of defect pursuant to Section 7 ProdHaftG-E

              Section 7 ProdHaftG-E adopts the EU definition of defect and emphasises that a product is defective if it does not meet legitimate safety expectations. The aspects to be taken into account here include:

              • Learning capabilities of the product (AI systems): undesirable developments after the product has been placed on the market can lead to defectiveness
              • Combination risks: The effects of other products on the product – for example, in the smart home ecosystem – are gaining independent significance in product liability law for the first time
              • Cybersecurity requirements: Compliance with product safety regulations (e.g. under the CRA) is effectively becoming a minimum standard
              • Recalls and regulatory measures: Although they do not give rise to a legal presumption of defectiveness, they will have significant consequences in terms of the burden of proof in practice
              • Specific needs of particular user groups: For example, in the case of life-sustaining medical devices

              III. Expansion of liability addressees

              Sections 3–5 and 9–13 of the ProdHaftG-E redefine the parties liable. In future, authorised representatives of the manufacturer, fulfilment service providers and online platform providers will also be liable. The manufacturer’s authorised representative is liable on the same level as the importer. The supplier continues to be liable only subsidiarily, namely if “no manufacturer, importer, agent or fulfilment service provider based in the European Union can be identified”. Anyone who significantly modifies a product (e.g. through “upcycling”) will in future be considered the manufacturer of the significantly modified product.

              IV. Protected legal interests

              The term “damage” (Section 1 (1) ProdHaftG-E) will in future expressly include:

              • impairments to mental health,
              • privately used items,
              • data, unless used (exclusively) for professional purposes.

              This is a comprehensible adjustment to digital usage scenarios – such as data loss due to faulty software updates.

              V. Disclosure obligation

              The changes in the law of evidence are fundamental. In future, defendant economic operators may be obliged to disclose evidence in order to make it easier for injured parties to enforce their claims. The prerequisite for this is a conclusive presentation of the claim requirements on the part of the claimant. If the defendant fails to comply with such an order, they will then be subject to the legal presumption of a product defect in accordance with Section 20 (1) No. 1 ProdHaftG-E. The old liability limit no longer applies: manufacturers will now be liable for unlimited financial damages..

              Do you have any questions about this news, or would you like to discuss the news with the author? Please contact: Dr. Gerhard Wiebe

              15. January 2026 Dr. Gerhard Wiebe & Johannes Daelen, LL.M.
              Bild Dr. Gerhard Wiebe
              Dr. Gerhard Wiebe
              Lawyer / Counsel
              Bild Johannes Daelen, LL.M.
              Johannes Daelen, LL.M.
              Paralegal

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              What’s changing in 2026: Product Safety Law and Ecodesign Law

              Product safety in 2026 will primarily be shaped by national legislative developments concerning the new Product Safety Act (Produktsicherheitsgesetz – ProdSG). This reform responds to the EU General Product Safety Regulation (Regulation (EU) 2023/988 – GPSR), applicable throughout the EU since 13.12.2024 and recently supplemented by the long-awaited GPSR Guidelines of the European Commission. Sector-specific product safety law will be marked by developments in EU toy law and EU machinery law. Finally, important changes are expected in the field of Ecodesign law.

              A. Amendment to the Construction Products Act (BauPG)

              Just today, on 14 January 2026, the law amending the Construction Products Act and other legal provisions to comply with Regulation (EU) 2024/3110 laying down harmonized rules for the marketing of construction products was published in the German Federal Law Gazette. At the heart of the article law is Art. 1, which amends the German Construction Products Act (BauPG). The reformed BauPG also serves to implement the new EU Construction Products Regulation (Regulation (EU) 2024/3110), which will apply in parallel with the old Construction Products Regulation (Regulation (EU) No 305/2011) for the next few years. Sec. 10 para. 3 BauPG contains numerous new administrative offenses for violations of Regulation (EU) 2024/3110, which will come into force tomorrow, on 15 January 2026. In fact, the new EU Construction Products Regulation is largely applicable throughout the EU since 8 January 2026.

              B. The New Product Safety Act (ProdSG)

              After an unsuccessful attempt by the previous governing coalition to reform the Product Safety Act (Produktsicherheitsgesetz – hereinafter ProdSG), the project was taken up again by the new Federal Government. On 9 October 2025, the Federal Government published its draft act amending the Product Safety Act and other product-safety‑related provisions (BR‑Drs. 548/25). The new Government has largely based its proposal on the earlier draft of the previous coalition, which had been controversial only in certain details. New emphasis has been placed, for example, on the administrative offences set out in Sec. 28 ProdSG‑E. The legislative process is now coming to an end.

              The new Product Safety Act will, alongside Regulation (EU) 2023/988 (the General Product Safety Regulation – hereninafter GPSR), naturally no longer have the central role that the national ProdSG has held from 2011. In the future, the ProdSG will primarily serve to implement various EU directives (Sec. 1 para. 1 ProdSG‑E), supplement the GPSR with additional national provisions (Sec. 1 para. 2 ProdSG‑E), and continue to operate as residual legislation for the non‑harmonised B2B sector, meaning products for professional users without CE marking (Sec. 1 para. 3 ProdSG‑E).

              Of practical importance is the new Sec. 6 ProdSG‑E, which will regulate the language requirements for information, safety information, instructions and warnings. In the Federal Republic of Germany, this will — unsurprisingly — require the use of the German language. The national legislator thereby continues the existing approach under Sec. 3 para. 4 ProdSG, which likewise prescribes the German language for user instructions.

              The legislator is also using the ProdSG reform to introduce several adjustments to the rules governing the GS mark in Sec. 20 ff. ProdSG‑E. Unlike the CE marking, the GS mark is, as is well known, a genuine quality mark awarded exclusively by a third‑party body (a so‑called GS body) following, in particular, a stringent safety assessment of a specimen. Under the key testing programme in Sec. 20 para.3 No 1 ProdSG‑E, future assessments will no longer refer solely to compliance with Sec. 3 ProdSG/ProdSG‑E. For harmonised products subject to directly applicable EU regulations, corresponding references to Union law will be incorporated. For instance, with respect to personal protective equipment (PPE), it is clarified that such products must comply with Art. 5 Regulation (EU) 2016/425 (the so-called PPE Regulation) in conjunction with Annex II to Regulation (EU) 2016/425. The relevant benchmark is therefore the essential health and safety requirements. Furthermore, the decision to award the GS mark must in future be taken solely by the GS body’s own personnel, pursuant to Sec. 21 para. 1 third sentence ProdSG‑E. Conversely, the technical assessment of the test results under Sec. 20 para. 3 ProdSG/ProdSG‑E may be performed by a specialist certifier from an external body. This is intended to facilitate the involvement of external bodies, particularly in Asia, where many GS‑marked products are actually manufactured. The prohibitions on use and advertising relating to the GS mark are also expanded in Sec. 24 para. 2, second sentence ProdSG/ProdSG‑E. A manufacturer may no longer use the GS mark or advertise with it if the GS body has not awarded the mark (No. 1). The same applies where the period of validity under Sec. 20 para. 5, second sentence ProdSG/ProdSG‑E has expired. According to the legislator, both adjustments merely clarify the existing legal situation (BR‑Drs. 548/25, p. 28).

              The amended provision in Sec. 28 para. 2 ProdSG‑E, which sets out administrative offences for culpable infringements of the GPSR, is of substantial practical relevance. No fewer than 32 administrative offences are planned. Most may be punished with fines of up to EUR 10,000, while two infringements of the GPSR may — under Sec. 28 para. 3 ProdSG‑E — lead to fines of up to EUR 100,000. These relate to the respective duties of manufacturers and importers to take corrective action in the field in relation to dangerous products (Sec. 28 para. 2, No 7, 19, para. 3 ProdSG‑E). The administrative offence originally proposed by the previous government coalition in No. 21 — which would have penalised distributors’ violations of the prohibition on making products available under Art. 12 para. 3 GPSR with fines of up to EUR 100,000 (BR‑Drs. 231/24) — has now been softened. Distributors now face only a fine of up to EUR 10,000.

              C. GPSR-Guidelines

              The year 2026 will also be shaped by the new GPSR Guidelines (Commission Notice C/2025/6233). After all, the publication of these guidelines at the end of 2025 had been eagerly awaited for quite some time. The GPSR Guidelines will provide small and medium-sized enterprises in particular with a helpful introduction to the requirements under the GPSR. The checklists and templates the guidelines contain are likely to prove useful in practice. However, as they largely reiterate the statutory requirements set out in the GPSR, they offer only limited added value for larger companies with established compliance structures.

              In detail, we would like to draw attention to the following aspects of the guidelines:

              The GPSR Guidelines are intended to bring clarity with regard to both the personal and material scope of application. For example, they state that the GPSR applies to companies of all sizes (Guideline 1.1, p. 2). In addition, the specific design of a service may determine whether a company is to be classified as a distributor or a manufacturer, or as a manufacturer or a provider of an online marketplace (Guideline 1.1, p. 3). Furthermore, the Regulation is intended to apply not only to tangible products, but also to intangible products such as software, apps and chatbots (Guideline 2.1, p. 6). This classification should, however, be viewed with caution, as the concept of an “item” generally presupposes a tangible nature. From a manufacturer’s perspective, the explanations on risk analysis and technical documentation (including a model template that also addresses risk analysis) are of particular interest (Guideline 3.1.1, p. 10 ff.). With regard to the electronic address — incorrectly referred to there as an email address — the Commission maintains its position that a static website should not be sufficient (Guideline 3.1.1, p. 13), although this does not explicitly follow from the GPSR itself. Existing uncertainties as to the concrete duties of the responsible person under Art. 16 GPSR are reduced by the guidelines, as the tasks of the responsible person are set out in detail (Guideline 3.2, p. 29 f.). Furthermore, operators of online marketplaces are urged by the guidelines to review dangerous products listed in the Safety Gate portal before offering a consumer product online (Guideline 3.3, p. 33).

              D. Reform of EU Toy Laws

              On 26.11.2025, toy legislation was reformed. In the future, this area of product safety law will be governed by Regulation (EU) 2025/2509 (the so-called EU Toy Regulation). Even though the new EU Toy Regulation will only apply from 1 August 2030 pursuant to Art. 59 para. 2 Regulation (EU) 2025/2509, and thus provides for a lengthy transitional period, this time should be used to review the new regulatory framework. As this is a fundamental reform, internal corporate adjustments will often be on the agenda. Until then, Directive 2009/48/EC (the so-called EC Toy Safety Directive) will remain relevant. Given the more than 15 years separating the two legal acts, it comes as no surprise that European toy law is being significantly modified and digitalised. The core pillars of the sector-specific provisions, however, will remain intact.

              The scope of application of European toy law is intended to remain largely unchanged. Nevertheless, there are certain detailed amendments. For example, paintball equipment will in the future be expressly excluded from the material scope of application pursuant to point 20 of Part II of Annex I to Regulation (EU) 2025/2509. With regard to the practically important decorative items for festive occasions and celebrations listed in point 1 of Part II of Annex I to Regulation (EU) 2025/2509, the legislator has now incorporated what the Commission had previously already postulated in its guidelines. According to this, only those decorative articles are excluded “which have no play value”. This means that the vexed debate over the play value of these products—often situated in a toy-law “grey area”—will continue. For the legal certainty of all parties involved, a different interpretation, which would equally be possible, would be far more helpful: namely, that the decorative articles in question should not be assessed under toy safety law regardless of their play value.

              The essential safety requirements are set out in Art. 5 Regulation (EU) 2025/2509. In this respect, the distinction remains between the general safety requirement pursuant to Art. 5 para. 2 Regulation (EU) 2025/2509 on the one hand, and the specific safety requirements pursuant to Art. 5 para. 1 Regulation (EU) 2025/2509 in conjunction with Annex II to Regulation (EU) 2025/2509 on the other. The specific safety requirements are laid down in Annex II to Regulation (EU) 2025/2509, with particular attention to be paid to the chemical properties set out in Part III. The rules on warnings follow from Annex III to Regulation (EU) 2025/2509.

              The obligations of economic operators in Artt. 9 ff. Regulation (EU) 2025/2509 are being brought into line with the current state of legislation. New provisions include the obligations of fulfilment service providers in Art. 11 Regulation (EU) 2025/2509 and the obligations of providers of online marketplaces in Art. 14 Regulation (EU) 2025/2509. The specific obligations of fulfilment service providers deserve particular emphasis, as they have so far only appeared sporadically in product safety law, whereas online sales platforms have already been required, since 13.12.2024, to comply with the extensive catalogue of obligations set out in Art. 22 Regulation (EU) 2023/988.

              Finally, a Digital Product Passport (DPP) will be introduced. The provisions in Artt. 19-25 Regulation (EU) 2025/2509 make up the entirety of Chapter V of the EU Toy Regulation. Pursuant to Art. 19 para. 1 first sentence Regulation (EU) 2025/2509, manufacturers must issue a digital product passport before placing a toy on the market. The individual elements of the DPP are specified in Part I of Annex VI to Regulation (EU) 2025/2509. Security information and warnings on the one hand, and instructions for use on the other, are therefore not mandatory elements (Part II of Annex VI to Regulation (EU) 2025/2509). The DPP is intended to play a role in any customs controls in connection with the digital product passport pursuant to Art.23 Regulation (EU) 2025/2509. In addition, a dedicated register for the passports will be established (see in detail Art. 22 Regulation (EU) 2025/2509).

              E. Preparing for the New EU Machinery Laws

              As well known, the new EU Machinery Regulation (Regulation (EU) 2023/1230) will become applicable across the EU on 20.012027. With the Act Implementing Regulation (EU) 2023/1230 (Maschinenverordnung-Durchführungsgesetz – MaschinenDG), the Federal Republic of Germany has recently created the nationally required legal framework for the application of European machinery law on the German market. The MaschinenDG allocates responsibilities, regulates market surveillance mechanisms and provides for sanctions in the form of administrative fines and criminal penalties in the event of relevant infringements of machinery law. At the same time, it repeals the former Ninth Ordinance to the Product Safety Act (9. ProdSV). The Act entered into force on 06.12.2025.

              As usual, the German legislator requires the German language to be used for the instructions for use pursuant to Art. 10 para. 7 Regulation (EU) 2023/1230, for any information pursuant to Art. 10 para. 7, first sentence Regulation (EU) 2023/1230 in conjunction with Annex III to Regulation (EU) 2023/1230, and for the EU declaration of conformity pursuant to Art. 10 para. 8 Regulation (EU) 2023/1230 in conjunction with Part A of Annex V to Regulation (EU) 2023/1230; see Sec. 2 para. 1 first sentence MaschinenDG. The extensive catalogue of administrative offences is set out in Sec. 9 para. 1 MaschinenDG, while the criminal offences in Sec. 10 MaschinenDG should, based on experience, play no practical role.

              In view of the approaching date of application of the new European machinery law, every manufacturer of machinery and industrial plants would be well advised to familiarise itself with the substantive changes in good time. The key developments lie in European law, whereas the MaschinenDG merely serves its national implementation.

              F. Ecodesign Laws

              Regulation (EU) 2024/1781 (the so-called EU Ecodesign Regulation; hereinafter “ESPR”) entered into force on 18 July 2024. As a framework regulation, the ESPR establishes the regulatory basis for uniform rules and sets out how ecodesign requirements for different product groups are to be specified in the future through the adoption of delegated acts pursuant to Art. 4 ESPR. The ESPR does not specify which products will be subject to which concrete requirements in the future. On the basis of Art. 18 para. 3 ESPR, the Commission presented its first Working Plan for 2025-2030 on 16.04.2025 (COM(2025) 187 final), thereby outlining for the first time when it intends to adopt delegated acts for which prioritised product groups. The focus is on those product groups that have particularly high potential for resource conservation and emission reduction, namely textiles, furniture and tyres, as well as the key basic materials iron, steel and aluminium. The Commission already intends to adopt delegated acts for iron and steel this year.

              The transitional period for a total of 19 product groups that were already regulated under Directive 2009/125/EC (the so-called Ecodesign Directive) will expire on 31 December 2026. Until then, the existing rules will continue to apply unchanged. Sixteen of these products were included in the Working Plan 2025-2030, as the Commission considers that there is potential for improvement. These product groups will remain fully within the existing directive-based system until the end of 2026, while the Commission simultaneously makes preparations to gradually adopt new or revised legal acts under the ESPR. The product groups for which a revision or the initial establishment of requirements is planned in 2026 include the following:

              • Low-temperature radiant heaters
              • Household dishwashers
              • Household washing machines and wash-dryers
              • Commercial washing machines
              • Commercial dishwashers
              • Local space heaters (however, only with regard to energy labelling requirements)

              Once ecodesign requirements are established for a product group, the relevant product will be assigned a digital product passport (Art. 9 para. 1 ESPR). The adoption of an implementing act establishing a digital product passport register pursuant to Art. 13 para. 5 subpara. 3 ESPR is expected in the first quarter of 2026.

              In Chapter VI, the ESPR introduces transparency obligations and prohibitions relating to the destruction of unsold consumer products. Large companies are (partly) already required to disclose information on the destruction of unsold consumer products for the first financial year following the entry into force of the ESPR (Art. 24 para. 1 ESPR). A draft implementing act specifying the format and presentation requirements for such disclosures has already been published. From 19 July 2026, large companies will also be subject, pursuant to Art. 25 para. 1 ESPR in conjunction with Annex VII ESPR, to a ban on the destruction of the following unsold consumer products:

              • Clothing and clothing accessories
              • Footwear

              Medium-sized enterprises will follow in 2030, while small and micro-enterprises are, for the time being, exempted from the prohibition on destruction. The Commission must define exceptions to the prohibition by means of a delegated act (Art. 25 para. 5 ESPR). In this respect, a draft has been available since summer 2025, which specifies the grounds for exemption listed in Art. 25 para. 5 ESPR, such as health, hygiene and safety reasons, damage to products, or the refusal of products for use as donations. The adoption of both drafts was originally planned for the third quarter of 2025. Even though it is currently not yet clear when the drafts will be adopted, adoption can be expected this year.

              For further reading: Schucht, Aktuelle Rechtsfragen zur neuen EU-Produktsicherheitsverordnung (GPSR), CCZ 2025, 44; Schucht/Wiebe, EU-Produktsicherheitsverordnung. General Product Safety Regulation, 2025; Schucht/Wiebe, Die neue EU-Produktsicherheitsverordnung. General Product Safety Regulation (GPSR), 2024; Wiebe/Daelen, Die neue EU-Ökodesignverordnung im Überblick, ESG 2024, 359.

              Do you have any questions about this news item or would you like to discuss it with the author? Please feel free to contact: Dr Carsten Schucht and Marie Carnap, LL.M.

              14. January 2026 Dr. Carsten Schucht & Marie Carnap, LL.M.
              Bild Dr. Carsten Schucht
              Dr. Carsten Schucht
              Lawyer / Partner
              Bild Marie Carnap, LL.M.
              Marie Carnap, LL.M.
              Lawyer

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              What’s changing in 2026: Product-related environmental law and supply chain due diligence

              In the area of product-related environmental law, the year 2026 will be characterized at the European level by further implementation steps within the framework of the EU Battery Regulation and the start of application of the EU Packaging Regulation. At the national level, the implementation of these two legal acts is at the center of attention. In addition, purely national accents are being set in the area of electrical equipment regulation. Further developments regarding the implementation of due diligence obligations in various supply chains will also remain a major topic in 2026.

              The present article represents the prelude to a series of blog posts with the common title “What’s changing in 2026,” in which the experts of the “Produktkanzlei” team summarize the relevant topics from their respective areas of expertise. In this article, the changes in product-related environmental law that have already been decided or are still in the legislative process are presented first (see under A.). In a second part, the foreseeable developments regarding due diligence obligations in the supply chain are summarized (see under B.).  

              A. Product-Related Environmental Law  

              Product-related environmental law in all its facets represents a supporting pillar of the dynamically growing regulatory architecture for sustainability, resource efficiency, waste prevention and management, and climate protection. Unfortunately, however, the legislative architects do not always seem to have practical and implementable ideas of how the overall regulatory construct should look and function. Coupled with typical delays, constant plan changes, and accompanying legal uncertainty, this leads to the fact that the plaster on the formerly bright green shining “Green Deal” has already begun to crumble alarmingly during the construction phase.  

              For the companies and authorities concerned with execution, the EU Packaging Regulation and the further development of the EU Battery Regulation will be in focus in the year 2026. This is flanked at the European level by the recently announced decisions regarding various exemptions for lead within the framework of the RoHS Directive. At the national level, the short-term amendment to the ElektroG (Electrical and Electronic Equipment Act) is currently causing a stir. Looking ahead, numerous aspects of the Omnibus VIII package published shortly before the turn of the year will lead to further changes to already decided and applicable legal acts in 2026.  

              I. EU Packaging Regulation  

              The Packaging Regulation (EU) 2025/40 (PPWR) was published in the Official Journal of the EU on January 22, 2025, and formally entered into force on February 11, 2025. The general date of application is set for August 12, 2026, although further transitional periods apply for numerous obligations, some of which also depend on the adoption of further delegated and implementing acts.  

              From August 12, 2026, the following requirements must be complied with:  

              • Substance restrictions for lead, cadmium, mercury, and hexavalent chromium, the sum of which in packaging must not exceed 100 mg/kg (Art. 5 para. 4 PPWR).  While this substance restriction has applied for many years under the EU Packaging Directive, the PFAS restriction contained in Art. 5 para. 5 PPWR for packaging that comes into contact with food is a genuine novelty. Nevertheless, there are no further transitional periods for this, and the complex requirements must be complied with directly upon the start of application from August 12, 2026. In addition, the article-related substance restrictions and prohibitions, particularly from the REACH and POP Regulations, continue to apply to packaging.  
              • Performance of a conformity assessment procedure on the basis of technical documentation for each packaging and subsequent issuance of an EU declaration of conformity (Art. 38 et seq. in conjunction with Annex VII and VIII PPWR). A CE marking for packaging, however, is not required from a packaging law perspective. From August 12, 2026, the conformity assessment initially only has to cover compliance with the substance restrictions. Further topics, such as specifically recyclability, minimum recycled content in plastic packaging, labeling, minimization, and reuse, are only to be complied with significantly later and only then become the subject of the conformity assessment.  
              • A very central aspect is also the correct role allocation and thus in particular the delimitation between mere suppliers of packaging materials and packaging, manufacturers of packaging, and downstream distributors.  This is of enormous importance because different obligations are assigned to the individual roles according to Art. 15 et seq. PPWR, and these can consequently only be fully and properly assumed and complied with if the role allocation is correct. Primarily decisive here is the distinction between a mere supplier with pure information obligations under Art. 16 PPWR and the manufacturer with the core obligations under Art. 15 PPWR.  According to Art. 3 para. 1 no. 13 in conjunction with Art. 15 para. 6 PPWR, a corresponding marking is decisive for the manufacturer status, whereby in particular with regard to sales packaging, the entity whose products are packed therein will generally be its manufacturer. In practice, however, a case-by-case analysis based on all circumstances and coordination between the individual actors in the supply chain is always required to arrive at a role delimitation suitable for the respective constellation. This should then ideally be contractually established to avoid misunderstandings. If the manufacturer of packaging is established in a non-EU country, an importer with the obligations under Art. 18 PPWR is also added to the supply chain, whereby it should be noted in particular that the importer has an independent labeling obligation regarding their role.  
              • Finally, reference must be made to the obligations for producers of packaging within the meaning of Art. 3 para. 1 no. 15 PPWR in the area of extended producer responsibility under Art. 44 et seq. PPWR. THE EPR requirements have so far been implemented by national law based on the EU Packaging Directive, so that a national patchwork of detailed regulations has developed. Since the PPWR also largely leaves the implementation of packaging-related extended producer responsibility to the Member States, it can be assumed that there will continue to be national particularities. In Germany, a ministerial draft of a law to adapt packaging law and other legal areas to Regulation (EU) 2025/40 is already available, which intends to replace the previous Packaging Act (VerpackG) with a Packaging Implementation Act (VerpackDG). In terms of content, according to the present draft, the known basic structures will largely remain, which are merely to be adapted in some places to the requirements of the PPWR. Worth highlighting here are in particular new cost-bearing and financing obligations for all producers of packaging and the future possibility of participation for packaging not subject to system participation in a so-called “other organization for producer responsibility.” The Central Agency Packaging Register (ZSVR) has already published initial interpretative guidance on this.  

              Finally, it should be pointed out that currently a lot is still in flux and both further interpretative and application notes as well as changes to the text of the PPWR itself and necessary tertiary legal acts are to be expected in the coming weeks and months. For affected companies, close monitoring of further developments is therefore essential in addition to operational preparation in order to recognize possible changes to implementation-relevant aspects at an early stage.  

              II. EU Battery Regulation  

              Also in the context of the Battery Regulation (EU) 2023/1542 (EUBR), which has already been applicable since February 18, 2024, relevant developments are pending for the year 2026.  

              First of all, reference must be made to the obligation to designate a Producer Responsibility Organization (PRO) by January 15, 2026 within the framework of existing registrations according to § 7 in conjunction with § 64 para. 7 BattDG (German Battery Implementation Act). A list of PROs approved so far is available from the stiftung elektro-altgeräte register and is constantly updated. Without the timely designation of a PRO, still existing registrations will lapse without replacement and must be reapplied for if necessary, whereby it must be noted that placing batteries on the market in the period between the lapse of the existing and the granting of the new registration is not permitted.  

              In contrast, the obligation to attach a declaration on the carbon footprint for industrial batteries (Art. 7 para. 1 EUBR), which is actually applicable from February 18, 2026, as well as the labeling obligations (Art. 13 para. 1 to 3 EUBR) actually applicable from August 18, 2026, and the obligations for labeling and classification into performance classes for the carbon footprint for EV batteries (Art. 7 para. 2 EUBR) provided for from the same date, will all not apply from the mentioned dates. The reason for this is that according to the statutory regulation, all these obligations only come into effect when specifying delegated acts and implementing acts from the EU Commission have entered into force. In order to give the affected economic operators sufficient time to implement the requirements, the start of application is automatically postponed to a date 18 months after the entry into force of the tertiary legal acts if they do not enter into force in time. Since all necessary tertiary legal acts have not yet been adopted and entered into force, the mentioned obligations will come into effect in mid-2027 at the earliest.  

              In this context, reference must be made to the consultation procedure running until January 26, 2026, on the necessary specifications for the labeling of batteries according to Art. 13 para. 1 to 3 EUBR. Unfortunately, in terms of content, it must be stated that the drafts submitted for consultation contain no regulations on numerous practice-relevant aspects (e.g., on the labeling of installed batteries in the supply chain) and yet other regulations go significantly beyond the EUBR itself (e.g., obligations to use QR codes in different situations). In this respect, it remains to be seen how the drafts submitted for consultation will develop further to provide genuine legal certainty. Finally, it should be pointed out that the requirements for carbon footprint labeling contained in the draft do not yet lead to the relevant obligations coming into effect, as further specifications on the performance classes to be labeled are required in additional tertiary legal acts, which are not yet available.  

              Furthermore, the so-called Omnibus IV package (proposals COM(2025)504 and COM(2025)501) provides for some facilitations within the framework of the BattVO:  

              • Operating instructions and safety information only for BESS (Battery Energy Storage Systems) instead of for all batteries 
              • Producer identification: instead of previously internet and email address, only “digital contact”  
              • Importer identification: instead of previously internet and email address, only “digital contact”  
              • Threshold for due diligence obligations at €150 million instead of €40 million  
              • Verification of due diligence obligations only every three years instead of annually.  

              Although the legislative procedure for this is currently still ongoing, a conclusion is to be expected in 2026.  

              III. RoHS Exemptions  

              On November 21, 2025, three long-awaited delegated directives with decisions on renewal applications for central exemptions from the generally existing lead restriction were published:  

              • Delegated Directive (EU) 2025/2364 of the Commission of September 8, 2025, amending Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead as an alloying element in steel, aluminum, and copper (Entries 6a to c Annex III RoHS)  
              • Delegated Directive (EU) 2025/1802 of the Commission of September 8, 2025, amending Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead in high melting temperature type solders (Entry 7a Annex III RoHS)  
              • Delegated Directive (EU) 2025/2363 of the Commission of September 8, 2025, amending Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead in electrical and electronic components in glass or ceramic (Entry 7c Annex III RoHS)  

              In terms of content, some previously broadly defined exemptions were significantly restricted and cut back to specific use situations. In terms of time, the extended or newly formulated exemptions were consistently calculated very tightly, so that those actors who continue to rely on certain exemptions just barely have or had enough time left to submit new renewal applications with further substantiation for the necessity of the exemptions in time.  

              An overview of the current renewal situation, including already submitted new renewal applications, is provided by the RoHS 2 exemptions – Validity and rolling plan, updated as of December 19, 2025.  

              IV. National Electrical and Electronic Equipment Act (ElektroG)  

              In contrast to the European developments reported so far, the Second Act to Amend the Electrical and Electronic Equipment Act, published in the Federal Law Gazette on November 27, 2025, and generally applicable since January 1, 2026, represents a purely national development in Germany without an immediate background in EU law. Essentially, the following innovations and changes were introduced:  

              • New requirements for the take-back of single-use and reusable e-cigarettes and electronic tobacco heaters by all distributors of the same from July 1, 2026 (Sec. 17 para. 1a ElektroG). Actually affected by this are those distributors of such products who were previously not yet obliged to take back due to not reaching the size threshold for the general take-back obligation. The take-back obligation must not be made dependent on the purchase of a new product and also applies to distance selling. The new take-back obligation also leads for the first time to the intervention of the information obligations from Secs. 18 and 18a ElektroG for the newly affected distributors, which entails additional implementation effort.  
              • Expansion of the manufacturer and distributor information obligations in Sec. 18 para. 3 and 4 ElektroG by adding an information obligation regarding risks when handling lithium-containing batteries since January 1, 2026.  If the distributor simultaneously has information obligations under Art. 74 para. 4 EUBR and the necessary information on lithium-containing batteries is already contained therein, a duplication of information does not appear necessary.  
              • Furthermore, the distributor information in distance selling must since January 1, 2026, not only be clearly visible but additionally also easy to find. This is concretized in the explanatory memorandum to the law (BT-Drs. 21/1506, p. 26) as follows: “In addition to good visibility of the information, it must also be ensured that the information is easily findable on the website, for example, by being able to be called up via a search function or reached directly via the website’s control menu. To ensure that the information can definitely be perceived without a separate search when ordering corresponding products, it must either be displayed on the pages with the corresponding products or displayed before or during the order. This has to be taken account for the page design on smartphones, where there is less space on the individual page, and it has to be ensured through the display of the symbol before or during the order that the notice is perceived.” 
              • In the newly inserted Sec. 18a para. 2 and 3 ElektroG, supplementary specifications are made for the marking of collection and take-back points in stationary retail, which apply from July 1, 2026. According to this, distributors must place the symbol according to Annex 3a in color as well as clearly visible and legible at least in DIN A4 format in the immediate field of vision of the customer flow in the entrance area of their retail store. They must also inform about how the take-back takes place in their retail store.  
              Symbol according to Annex 3a ElektroG
              • Furthermore, likewise from July 1, 2026, distributors must point out clearly visibly in their retail store with the symbol according to Annex 3 (symbol of the crossed-out wheeled bin) in the immediate vicinity of the sales location of the electrical equipment that waste electrical equipment is to be disposed of separately from unsorted municipal waste. This is concretized in the explanatory memorandum to the law (BT-Drs. 21/1506, p. 26) in such a way that the symbol is to be placed, for example, on the shelf itself immediately next to the price indication. The symbol should accordingly correspond in design and font size to the price indication for the respective product.  
              • Sec. 18a para. 4 ElektroG furthermore concretizes the information obligations for distance sellers likewise from July 1, 2026. According to this, distance sellers must place the symbol according to Annex 3a clearly visibly and legibly in the presentation media used by them on the pages with the corresponding products or before or during the order.  They must also inform about how the pick-up according to Sec. 17 para. 2 sentence 2 ElektroG and the take-back according to Sec. 17 para. 2 sentence 4 ElektroG take place.  
              • Finally, it should be pointed out that since January 1, 2026, it is mandatory to also enclose in writing the information according to Sec. 19a ElektroG for so-called b2b devices. This means a complete enclosure in paper form, and mere accessibility via a link or QR code is not sufficient.  

              VI. Other Topics  

              Beyond the topics highlighted in detail above, other topics will also continue to be of relevance in the year 2026:  

              • Implementation of the new obligations to introduce a national regime of extended producer responsibility based on Directive (EU) 2025/1892 amending the Waste Framework Directive. The scope of the new requirements will cover certain CN codes of Chapters 61 and 62 for textiles, accessories, and shoes (CN codes 6401 to 6405). The main obligated party will be the so-called producer, i.e., the one who is established in a certain Member State and hands over covered products for the first time in this Member State or the one who, as a distance seller, sells products directly to end consumers in another Member State. The obligations will include a national registration and take-back obligations and are to be transposed into national law by June 17, 2027, so that a legislative procedure regarding this is to be expected in the course of the year 2026.  
              • With the Omnibus VIII package published on December 10, 2025, the EU Commission has proposed a great abundance of simplifications in the area of environmental regulation. Many of the requirements have no direct product reference. However, at this point, reference should be made in particular to the plans to fundamentally reform and restrict the system of authorized representatives within the framework of the extended producer responsibility regimes and, furthermore, to further harmonize and simplify the regimes themselves. In addition, packaging law aspects are also to be taken up again in this course.  

              Finally, it should be mentioned that the year 2026 is also likely to be characterized by further enforcement measures and related court decisions, particularly within the framework of the Single-Use Plastics Fund Act and other legal acts introduced in recent years, so that in addition to legislative developments, case law could certainly set interesting accents.  

              B. Due Diligence Obligations in the Supply Chain  

              The regulations on due diligence obligations in the supply chain underwent significant changes at the end of 2025, which economic operators must now prepare for in 2026. At the forefront is the agreement of December 9, 2025, between the Council of the EU, the EU Parliament, and the EU Commission on the Omnibus I package. The resulting legislative amendments, originally initiated by the EU Commission on February 26, 2025 (see also our blog post “OMNIBUS Initiative and possible adjustments to the LkSG – What is planned or already implemented?” of April 23, 2025), lead to substantial innovations for the Directive (EU) 2024/1760 on Corporate Sustainability Due Diligence (CSDDD) and the Directive (EU) 2022/2464 on Corporate Sustainability Reporting (CSRD). These are presented below, as well as the impact of the CSDDD on the LkSG (German Supply Chain Due Diligence Act) as the national implementation act. In addition to the Omnibus I package, the Regulation (EU) 2023/1115 on deforestation-free supply chains (EUDR) was postponed by one year and adjusted content wise at the last possible moment in 2025. Here, too, the most important innovations are presented and the consequences for companies in 2026 are explained.  

              Regardless of the presentation and evaluation of the content-related changes, it is worth mentioning from the authors’ point of view that a majority in the EU Parliament for the mentioned changes only came about due to the vote of the conservative EPP group together with the right-wing and far-right groups “Patriots for Europe,” “Europe of Sovereign Nations,” and “European Conservatives and Reformists.” The agreement was preceded by an often emotional and barely scientifically grounded political discourse about necessary adjustments to the legal acts. In this respect, it is questionable whether the adopted changes actually lead to facilitations for companies as claimed and, in particular, provide a long-term answer to the multiple challenges in supply chains.  

              I. Omnibus I Package  

              The EU Parliament passed the legislative package on December 16, 2025. The formal confirmation in the Council of the EU and the subsequent publication in the Official Journal are still pending. Only then can the changes enter into force.  

              The CSRD undergoes a drastic restriction of the personal scope of application. Only companies that had an annual turnover of 450 million euros and an average of 1,000 employees in the relevant financial year will be covered. Thus, only 10% of the previously obligated companies will be covered by the CSRD in the future. However, the obligation of the Commission to investigate an expansion of the scope and to report on it annually from 2029 remains.  

              In addition to a change in the scope of application, changes with regard to the report-relevant data points can be expected in 2026. The basis for this is the drafts of the revised European Sustainability Reporting Standards (ESRS) published by the European Financial Reporting Advisory Group (EFRAG) at the end of 2025. On their basis, the EU Commission will now adapt Delegated Regulation (EU) 2023/2772, which sets the standards for sustainability reporting. The drafts reduce the relevant data points by 61% and should thus simplify the preparation of the reports. Furthermore, it is also no longer planned to develop sector-specific data requirements, which were previously still being awaited.  

              The amendments to the CSRD must be transposed into national law by the Member States 12 months after entering into force. Germany has already missed the previous implementation deadline of July 6, 2024. It is now to be expected that the CSRD, including the latest amendments, will be implemented in 2026. Even if many companies are no longer directly affected by the CSRD in the future, it is to be expected that, among others, banks and insurance companies will continue to request similar reports form their customers to those to be created under the CSRD. It remains to be seen whether a simplification actually occurs or whether additional work arises for companies due to different reporting requirements on the market.  

              The CSDDD was also severely restricted overall with regard to the scope of application. Only companies that had a turnover of 1.5 billion euros worldwide and an average of over 5,000 employees in the last financial year will be obligated. Member States are free to expand the scope. Furthermore, the regulations are to apply mandatorily for the first time in July 2029 and thus yet another year later than after the last amendment of April 2025. With regard to the due diligence obligations to be fulfilled, it should be easier for companies in future to focus on identifying and assessing particularly likely negative impacts in the supply chain. Accordingly, the prioritisation of activities to prevent, mitigate and end such impacts should also be facilitated. What sounds like a sensible approach at first causes considerable legal uncertainty, as the law works here with a number of undefined legal terms that stand in the way of a clear guideline for companies. Legal violations leading to damage for those affected can, however, not be prosecuted under civil law uniformly across Europe as before, but only according to the applicable national regulations. Furthermore, the obligation to create and implement a climate transition plan was repealed.  

              The amendments to the CSDDD will likely mean no significant changes for the LkSG (German Supply Chain Act). However, since the Federal Government has announced it will implement the CSDDD 1:1, the scope of application of the LkSG could at least be restricted. The currently available draft of the LkSG amendment (BT_Drs. 21/2474) from October 2025 does not yet provide for this. Instead, it contains a strong reduction of sanctionable violations against the LkSG and an abolition of the reporting obligation under § 10 para. 2-4 LkSG. A consultation in the Bundestag is still pending, and it is likely to be expected that in this course the amendment of the CSDDD will find its way into the amendment of the LkSG. Companies should therefore observe this process attentively in 2026.  

              II. EUDR  

              Shortly before the former start of application of the EUDR on December 30, 2025, it was postponed by 1 year to December 30, 2026 by Regulation (EU) 2025/2650. For small and micro-enterprises, it now applies only from July 30, 2027. Furthermore, the “First-Touch Principle” was implemented. According to this, only companies that, as operators, place a relevant product on the market in the EU for the first time must verify without cause whether the goods are deforestation-free, were produced in accordance with the relevant legislation of the country of production, and then submit a corresponding due diligence statement. A facilitation within the group of operators is also made if the operators are so-called micro or small primary producers. These are small companies that produce relevant products in a country with low deforestation risk according to the EU Commission’s benchmarking and place them on the market in the EU. In practice, this mainly concerns European agricultural businesses. Instead of a due diligence statement, they must submit a one-time, simplified declaration and are then assigned an identification number.  

              Unlike before, so-called downstream operators, i.e., those who transform a relevant product already placed on the market in the EU into another relevant product, and traders, provided they are not SMEs, only have to register in the EU portal “Traces”. In addition, they have to collect basic data on their suppliers and customers (including name and email address) and record the reference number of the due diligence statement or the identification number from their suppliers, insofar as these are operators. However, these data only have to be stored internally for five years. They only have an obligation to check the fulfillment of due diligence obligations themselves if they obtain information about a violation. In addition to the changes mentioned above, however, it will be particularly relevant for many companies that have previously been marginally affected that products with HS code 49 (‘Printed books, newspapers, pictures and other products of the printing industry, manuscripts, typescripts and plans, of paper’) are now excluded from the scope of the Regulation. 

              Even though significant simplifications have thus already been made for a multitude of actors, the EUDR obliges the EU Commission to check by April 2026 whether further adjustments are necessary to reduce bureaucratic hurdles. On this basis, a new legislative initiative could be started. It should be noted that this check still cannot draw on experiences from the field and furthermore creates renewed significant legal uncertainty for the affected companies. It is to be hoped that a national legal act will be enacted in 2026 in which the open questions regarding responsibilities and sanctions are regulated.  

              Outlook  

              The year 2026 will continue to remain very dynamic in both product-related environmental law and due diligence regulation and will bring one or two surprises. Therefore, it can only be urgently recommended for companies to closely follow the regulatory developments and court decisions in the relevant areas in order to be able to react to them in a timely and tailored manner.

              Do you have any questions about this news, or would you like to discuss it with the author? Please contact: Michael Öttinger und Paul Jäde

              13. January 2026 Michael Öttinger & Paul Jäde, M.Sc.
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              The New Machinery Regulation Implementation Act – National Specifications Supplementing the EU Machinery Regulation

              With Regulation (EU) 2023/1230 the European regulatory framework for machinery has been comprehensively updated. The new regime was adopted on 14.06.2023 and will apply in full and directly in all Member States from 20.01.2027.

              The Regulation (EU) 2023/1230 (the so-called EU Machinery Regulation, hereinafter MR) modernises the existing machinery law in a fundamental way, strengthens the digital provision of documentation, and clarifies and expands responsibilities along the supply chain. At the same time, it marks the departure from the previous Machinery Directive, aiming to more effectively reflect technological developments such as AI, connectivity, and software.

              Although the MR does not generally require national transposition, a national implementation act is still necessary because the regulation leaves room for Member State provisions in key areas—such as language requirements, procedures, and sanctions.

              Germany provides the necessary legal framework through the Act Implementing Regulation (EU) 2023/1230 (Maschinenverordnung-Durchführungsgesetz, hereinafter: MaschinenDG). The MaschinenDG defines competences, sets out administrative and criminal offences, regulates market surveillance mechanisms, and simultaneously repeals the previous 9th Ordinance to the Product Safety Act (Neunte Verordnung zum Produktsicherheitsgesetz, hereinafter 9. ProdSV). The Act entered into force on 06.12.2025.

              The following provides an overview of key provisions of the MaschinenDG.

              A. Language Requirements

              The MR allows Member States to determine the mandatory language for instructions and safety information under Annex III MR (Art. 10(7), subpara. 5 MR).

              Under Sec. 2(1) No. 1–3 MaschinenDG, German will be mandatory for the following documents:

              • instructions for use,
              • safety information, and
              • the EU declaration of conformity.

              The same applies to assembly instructions and EU declarations of incorporation for partly completed machinery (Sec. 2(2) MaschinenDG). Distributors must ensure that all documentation is available in German.

              The MR permits digital provision of instructions, provided that they can be downloaded, stored and printed, and remain available online for at least ten years (Art. 10(7) MR). The MaschinenDG further specifies these requirements: all access information to the digital instructions must likewise be provided in German (Sec. 2(1) subpara. 2; Sec. 2(2) subpara. 2 MaschinenDG).

              Manufacturers, importers and distributors must therefore verify already prior to placing machinery on the market that all documents are complete and available in the German language.

              B. Notification of Conformity Assessment Bodies

              Chapter V MR (Art. 26 et seq.) governs the notification procedure for conformity assessment bodies (Notified Bodies).

              The Central Office of the Federal States for Safety (Zentralstelle der Länder für Sicherheitstechnik, hereinafter ZLS) will continue to act as the national notifying authority under the MR. Sec. 3 MaschinenDG refers to the existing provision in Sec. 10(1) sentence 1 of the Act on Making Products Available on the Market (Produktsicherheitsgesetz, hereinafter ProdSG), according to which the competent authority holds the power to designate conformity assessment bodies.

              Testing bodies must therefore submit their designation applications to the ZLS and notify any changes directly to the ZLS.

              C. Market Surveillance – Sampling Benchmark and Notification Channels

              Pursuant to Sec. 4(2) MaschinenDG, the nationwide sampling benchmark of 0.5 samples per 1,000 inhabitants per year applies (Sec. 25(2) ProdSG).

              Market surveillance will be subject to stronger central coordination. Market surveillance authorities must notify the Federal Institute for Occupational Safety and Health (Bundesanstalt für Arbeitsschutz und Arbeitsmedizin, hereinafter BAuA) of any non-compliance of machinery, related products or partly completed machinery within the meaning of Art. 43(2) and (4), subpara. 2 MR (Secs. 5–7 MaschinenDG). Risks existing despite the conformity of machinery within the meaning of Art. 45 MR must likewise be reported to BAuA (Sec. 7 MaschinenDG).

              If a market surveillance authority authorises the placing on the market of certain machinery under the emergency procedure provided for in Art. 25c MR (as introduced by Amending Regulation (EU) 2024/2748), it must immediately notify the European Commission and the other EU Member States via BAuA (Sec. 8 MaschinenDG).

              D. Administrative Fines and Criminal Provisions

              Sec. 9 MaschinenDG sets out 26 administrative offences subject to fines of up to EUR 10,000 or EUR 100,000, for instance in cases of missing CE marking or failure to carry out corrective actions. In particular, violations of labelling obligations—e.g., absence of CE marking (Sec. 9(1) No. 21 MaschinenDG)—are covered. Notably, compliance with the safety and health requirements under Annex III MR is not included among the fine provisions.

              In cases of intentional, persistent violations or endangerment of life or health, imprisonment of up to one year or a fine may be imposed (Sec. 10 MaschinenDG).

              The level of the fine depends on the severity of the violation.

              E. Transitional and Applicability Provisions

              In principle, the MaschinenDG, including the language requirements and sanction provisions, will apply from 20.01.2027 (Secs. 12–13 MaschinenDG).

              Under Sec. 11 MaschinenDG, machinery placed on the market under the 9. ProdSV before 20.01.2027 may continue to be operated and marketed. However, new machinery may only be placed on the market under the new law from that date onwards. The transitional regime thus enables an orderly shift to the new framework.

              Conclusion and Outlook

              With the MaschinenDG, Germany establishes the necessary foundation for harmonised and digital machinery regulation under the MR.

              For companies, the new provisions mean:

              • All instructions for use, safety information and EU declarations of conformity must be available in German; this also includes access information for digital instructions.
              • ZLS will continue to serve as the notifying authority for conformity assessment bodies.
              • Economic operators may face fines of up to EUR 10,000 or EUR 100,000 for violations of various obligations under the MR.
              • The key provisions relevant for companies will apply from 20.01.2027.

              The time until entry into effect in 2027 should be used to adapt internal processes—manufacturers and distributors, in particular, should ensure at an early stage that their instructions, compliance processes and IT infrastructure meet the new requirements.

              The MaschinenDG thus marks the next important step towards a modern and digital machinery safety framework.

              Do you have any questions about this news or would you like to discuss it with the author? Please contact: Marie Carnap

              9. December 2025 Marie Carnap, LL.M.
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              Implementation of the Environmental Criminal Law Directive – Draft bill by the Federal Ministry of Justice and Consumer Protection

              Under the radar of the general public, motion 061, “Recognising the crime of ecocide to protect nature”, was passed at the World Conservation Congress from 9 to 15 October 2025. Among other things, the motion invites states to establish so-called “ecocide” as a criminal offence in national law and welcomes the fact that some legal systems have already done so.

              These include the European Union, which has already created a comprehensive basis for punishing environmentally harmful acts with Directive (EU) 2024/1203 (Environmental Criminal Law Directive), adopted at the beginning of 2024, replacing the previous legal framework on the criminal law protection of the environment. EU Member States now have until 21 May 2026 to transpose this Directive into national law.

              Shortly after the World Conservation Congress, the Federal Ministry of Justice and Consumer Protection (BMJV) published a draft bill for the implementation of the Environmental Criminal Law Directive. The deadline for comments from the federal states and associations expired on 14 November this year.

              The draft bill provides for extensive changes to the Criminal Code (StGB) and some ancillary laws, which will be particularly relevant for companies and their employees. Similarly, significantly higher penalties are threatened for environmental offences. It is therefore imperative for companies to familiarise themselves with the changes, review their own actions and, where necessary, remedy (future) violations in order to avoid criminal prosecution or investigation. The following article first provides an overview of the upcoming protection of the “ecosystem” under criminal law (see A.) and actions that may be punishable under criminal law (see B.). After providing an overview of new criminal offences (see C.), it concludes by discussing the financial penalties that may be imposed (see D.).

              A. Protection of the legal interest “ecosystem”

              One of the major innovations is the inclusion of the “ecosystem” as a protected legal interest in the StGB. It is defined in Section 330d (1) No. 2 of the draft (StGB-E) as an

              ecologically significant, complex, dynamic system of plant, animal and microorganism communities and their abiotic environment in a functional unit that encompasses habitat types, habitats of species and species populations;

              It is important to note the deviation from the definition of “ecosystem” in Article 2(2)(c) of the Environmental Crime Directive. The German version adds the characteristic “ecologically significant” and thus restricts the scope of application compared to the Directive. It will be interesting to see how the courts will handle this restriction, what weight will be given to the “significance” of the ecosystem and, at the same time, what impact these restrictions could have on questions of intent or, where applicable, issues of error. Overall, with the inclusion of the “ecosystem“, in addition to soil, water, air, animals, plants and human health, the complex interaction of these elements, i.e. the ecological balance itself, will also be protected under criminal law in future.

              B. Extension of so-called “suitability offences”

              Existing offences under environmental criminal law are to be converted into so-called suitability offences, also known as “potential hazard offences”, in accordance with the Environmental Criminal Law Directive. “Suitability offence” means that an abstract danger to the protected legal interest can already lead to criminal liability without the need for concrete damage to occur. The focus is on whether actions and violations are potentially capable of causing significant damage to animals, plants, water bodies, the air, the soil or an ecosystem. Although suitability offences are not new to German environmental criminal law, the draft bill proposes an expansion in implementation of the Environmental Criminal Law Directive.

              The following sections of the German Criminal Code (StGB) are specifically affected: Section 324a StGB (soil contamination), Section 325 StGB (air pollution), Section 325a (2) StGB (noise from the operation of facilities), Section 327(2) StGB (operation of a wastewater treatment plant), the new Section 327a StGB-E (unauthorised execution of projects), Section 328(3) StGB-E (handling of radioactive substances), as well as some provisions in ancillary legislation, e.g. for violations of the provisions of the REACH Regulation, the Biocidal Products Regulation and other regulations. All of these now contain (extended or entirely new) elements of suitability that refer to the abstract suitability of an act to cause significant damage.

              Unfortunately, the opportunity to amend the existing criminal offence under Section 324 StGB (water pollution) in line with the directive and the above-mentioned offences was missed in the process. In the interests of legal certainty, it would have been desirable if the aforementioned offences had been uniformly defined as “suitability offences” with corresponding wording. Currently, Section 324 StGB is defined as a pure result offence, i.e. for the offence to be committed, (among other things) a body of water must be polluted. The “suitability” explained above is not relevant here, as it is not reflected in the wording. This does not necessarily lead to a narrower or broader scope of application compared to soil contaminations or air pollution, as Section 324 StGB is very broadly defined and, in this respect, also meets the protection requirements of the Directive. However, it carries the risk of unequal treatment of “pollution offences”.

              C. Overview of specific amendments to existing offences and the introduction of new offences

              Changes are being made to the Criminal Code, the Act on Administrative Offences and several ancillary laws. The following is an overview of the most important changes. The Criminal Code is to be amended as follows:

              • Section 324 StGB (water pollution) is to be amended to the effect that the extraction of water from a body of water is now also punishable if this results in an adverse change in the properties of the body of water. This aspect of water pollution, particularly in connection with the increasing restrictions on the use of deep groundwater, for example, may become significantly important in the future.
              • Soil contamination within the meaning of Section 324a (1) StGB (soil contamination) will in future also be realised if noise, vibrations, thermal energy or non-ionising radiation penetrate, are introduced into or are released into the soil. This refers to radiation within the meaning of Section 1 (2) NiSG (Act on Protection against Non-Ionising Radiation), e.g. (electro)magnetic fields, lasers, etc.
              • Section 325 (1) StGB (air pollution) will also be amended. According to the draft bill, this will in future only cover acts that cause “significant” changes to the air. At the same time, the restriction that these changes must occur during the operation of a facility will be removed. Accordingly, the specification that the changes must occur “outside the area belonging to the plant” will also be omitted. Furthermore, the previous exemption in Section 325 (2) StGB for motor vehicles, rail, air and water vehicles is to be omitted. The transport sector must therefore prepare itself for significantly more severe consequences in the event of air pollution.
              • Section 327a StGB-E (unauthorised execution of projects) is newly introduced, which makes the execution of certain (construction) projects in violation of administrative law a criminal offence. The projects covered by the penalty are characterised by the fact that an environmental impact assessment should have been carried out, but this was either omitted or did not lead to the necessary approval, and the project is nevertheless being continued or carried out in the knowledge of this deficiency. The new Section 327a StGB-E is thus a purely intentional offence; negligent commission is not to be punished.
              • The BMJV has decided against the explicit introduction of a separate so-called “ecocide offence”. Instead, it intends to introduce new qualifying offences in both core and ancillary criminal law. These sanction the causing of “catastrophic consequences” for protected environmental legal interests. The qualifications inserted in various places are fulfilled by damage to ecosystems, water bodies, etc. that is particularly intense or cannot be remedied, or can only be remedied after a long period of time. Examples of this qualification can be found, among other places, in Section 330 (2) and (3) StGB-E (particularly serious cases of environmental offences; qualification), which, however, is linked to the intentional commission of a basic offence.

              Ancillary laws that contain criminal sanctions will also be amended in line with the Ecocide Directive. These include, in particular, violations of European legal requirements, such as the REACH Regulation, the Biocidal Products Regulation, the Plant Protection Products Regulation and violations of other EU regulations that are subject to criminal sanctions under German law. Violations were already punishable by law, but existing offences will now also be classified as suitability offences, the penalties have been significantly increased and supplemented by the qualification of causing “catastrophic consequences”.

              • Section 27 (2) ChemG (penal provisions of the ChemG) is amended to the effect that, according to Section 26 ChemG, unlawful acts or omissions (e.g. violations of legal regulations regarding reporting obligations or the use of chemicals, biocides, etc.) are punishable under Section 26 ChemG if they are likely to cause significant damage to animals, plants, water, air, soil or an ecosystem.
              • A new provision, Section 27b ChemG-E (Violations of distribution regulations), has been added, which makes the distribution of substances intended for use in an illegal (criminal) act a punishable offence. However, this only applies if the distributor is aware of the illegal use or recklessly disregards it.
              • The same applies in § 27c (2) ChemG-E with regard to the (unauthorised) placing on the market or use of a substance subject to authorisation under Annex XIV of the REACH Regulation if this action is likely to cause significant damage to animals, plants, water, air, soil or an ecosystem. Here, too, the attempt alone will be punishable.
              • Section 27d ChemG-E is also newly inserted, which, among other things, sanctions the release of fluorinated gases (para. 1 no. 1) as a violation of Article 4 of Regulation (EU) 2024/573 (Fluorinated Gas Regulation) as well as other violations of this regulation. Similarly, the new Section 27e ChemG-E penalises violations of Regulation (EU) 2024/590 (Ozone Regulation).
              • The new Section 27f (1) ChemG-E (serious chemical offences) further emphasises the destruction or causing of catastrophic consequences in ecosystems of “considerable size or value” under criminal law – with a penalty of up to 10 years’ imprisonment, bringing it to the level of the particularly serious environmental offence under Section 330 of the German Criminal Code (StGB).

              Particularly in conjunction with the introduction of the new hazard classes under the CLP Regulation with regard to persistent and mobile substances, the tightening of sanctions poses a considerable liability risk for affected companies. This is because the (unlawful) release of persistent and mobile substances is likely, at least in principle, to cause “catastrophic consequences” in the form of widespread and significant damage that is either irreversible or permanent. Companies should therefore not only closely follow the relevant procedures for harmonised classification and labelling under the CLP Regulation, but also keep an eye on the interactions with potential criminal sanctions.

              D. More severe penalties, especially for companies

              The European guidelines on minimum values for maximum penalties are forcing German legislators to increase numerous penalty ranges. The Environmental Criminal Law Directive not only contains specific guidelines for imposing sanctions on individuals, but also, for the first time, on companies.

              Section 30 of the OWiG, which regulates fines against companies, has also been amended. Previously, fines could amount to up to EUR 10 million under Section 30(2) OWiG. In future, the maximum fine for intentional violations can be increased to EUR 40 million. In the case of negligent violations, the maximum amount will also quadruple from a maximum of EUR 5 million to up to EUR 20 million.

              It is important to emphasise that this increase in the maximum amounts for corporate fines has an impact beyond environmental criminal law and marks a fundamental reassessment of corporate responsibility. Significantly higher fines can now also be imposed for other violations, and a company can thus be punished more severely for criminal offences or administrative offences committed by its managers.

              Outlook

              In particular, the sharp increase in the upper limits for fines under the OWiG, but also the expanded criminal offences in the StGB and ancillary laws, are a clear call for companies in all industries to critically examine their compliance and environmental management systems for possible weaknesses. Even if individual changes are still to be expected in the legislative process, the Environmental Criminal Law Directive leaves little room for manoeuvre in many areas. The effects of a company’s own actions must now also be examined in relation to other legal interests (especially ecosystems) and any adverse effects must be ruled out. However, this is not only advisable because of the new sanctions, but should also be in the companies’ own interests. Value creation processes and supply chains ultimately depend on ecosystems remaining intact and nature continuing to provide ecosystem services (e.g. the supply of water).

              Do you have any questions about this news or would you like to discuss it with the author? Please contact: Paul Jäde, Philipp Kolland and Martin Ahlhaus

              9. December 2025 Paul Jäde, M.Sc.
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              Regulation (EU) 2025/2439 – Postponement of the rules on classification, labelling, and packaging of chemicals until 2028

              With Regulation (EU) 2025/2439, the Parliament has decided to postpone the date of application of the transitional provisions of Regulation (EU) 2024/2865 amending the CLP.

              This Regulation was published on 03.12.025 in the Official Journal of the European Union (see OJ L, 2025/2439, 3 December 2025) and enters into force on 23.12.2025.

              This affects the following requirements under the CLP:

              • Format of labelling, such as the legibility of labels, e.g. appropriate font size in relation to the size of the label
              • Deadlines for re-labelling in the event of changes to classification
              • Information requirements for advertising, including online advertising
              • Information requirements for distance selling offers, e.g. labelling elements comparable to those of the physical CLP label in accordance with Art. 17 CLP, and
              • Labelling requirements for petrol stations.

              The specific content of these aspects is still to be determined. The proposal COM (2025) 531 final or 2025/0531 (COD) provides indications as to what this redesign might be. Its implementation is still pending. Regulation (EU) 2025/2439 deals exclusively with the postponement of the transitional provisions.

              Originally, according to Regulation (EU) 2024/2865, the new CLP requirements for the above-mentioned aspects would have had to be implemented with a transition period until 01.07.2026 or 01.01.2027, depending on the respective provision. Regulation (EU) 2025/2439 has now postponed the date of application of these transitional provisions to 01.01.2028. Nevertheless, companies are of course free to apply the new provisions introduced by the aforementioned regulation voluntarily before the date of their application.

              The reason for this is the EU’s ‘Omnibus Initiative’, which aims to simplify laws and directives in order to reduce bureaucracy. OMNIBUS VI aims to simplify regulations for the chemical industry (see European Chemicals Industry Action Plan, 8 July 2025). Regulation (EU) 2025/2439 forms the first part of the Omnibus VI package.

              The second part of the Omnibus VI package is eagerly awaited. Changes to the content of the CLP have been announced. It remains to be seen whether this will allow a comprehensive revision of the CLP to be pushed through in a streamlined procedure.

              Further links:

              Regulation (EU) 2025/2439 (stop the clock CLP) is available at: https://eur-lex.europa.eu/legal-content/DE/TXT/?uri=OJ:L_202502439.

              The proposal COM (2025) 531 can be viewed at: https://single-market-economy.ec.europa.eu/publications/simplification-certain-requirements-and-procedures-chemical-products_en.

              Do you have any questions about this news or would you like to discuss it with the author? Please contact: Nicole Rauch and Martin Ahlhaus

              5. December 2025 Nicole Rauch
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