Swiss regulators align with EU on chemicals, biocides


Jun. 10, 2024

The Swiss Notification Authority for Chemicals has announced new adaptations are in the offing that will harmonize parts of the Swiss Chemicals and Biocidal Products ordinances with recent updates to corresponding EU legislation.

Switzerland and the EU’s impact on Swiss chemical regulations

  • Though located in the heart of Europe, Switzerland is not a member of the European Union, nor of the European Economic Area (EEA). Given the importance of its geographical, social, economic, and cultural ties to its surrounding EU neighbors, this country of almost nine million understandably maintains close relations with the 27-member bloc through bilateral agreements. The two parties have entered into over 120 such agreements, though no bilateral agreement addressing chemical regulation exists.
  • Switzerland’s regulation of industrial chemicals, for the most part, follows that of the EU. Between 2008 and 2013, Swiss and EU Commission experts had considered formalizing their relations concerning chemical safety. However, in September 2015, the Federal Council – the Swiss executive – decided in consultation with stakeholders to pursue chemical regulatory policy independently of any formal cooperation with Brussels. Since that time, Switzerland has overhauled (direct download) its chemical rules, including major changes to the notification and registration of chemicals, which largely piggyback on the EU’s framework established through the regulations on the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH – 1907/2006/EC) and on the Classification, Labeling and Packaging of Substances and Mixtures (CLP – 1272/2008/EC).
  • The basis of national chemicals legislation in Switzerland is the Chemicals Act (ChemG) and the Environmental Protection Act (USG). Central to Swiss chemical management is the requirement to regulate one’s own activities vis-à-vis chemicals, taking responsibility “for ensuring that they do not endanger life or health.” This obligation to adhere to “self-regulation” (“Selbstkontrolle” in German) is laid out in Article 5 of ChemG and Article 26 of USG.
  • The Chemicals Ordinance (ChemV) and the Risk Reduction Ordinance (ChemRRV), which contain many elements of REACH and CLP, operationalize these acts. From an organizational perspective, these ordinances differ considerably from REACH and CLP, however. For example, ChemV contains sections based on those found in REACH, like provisions outlining the registration of new substances and substances of very high concern (SVHCs), defined by reference to REACH, along with the Candidate List of SVHCs, and the specific requirements for composing safety data sheets (SDSs). However, this ordinance also includes elements contained in the CLP, such as the latter’s Annexes I-VII (including Annex I classification and labeling criteria for hazardous substances and mixtures, and the list of harmonized classifications found in Annex VI), all incorporated into ChemV by reference to CLP itself. On the other hand, ChemRRV encompasses restrictions taken from REACH Annex XVII (the list of restrictions on the use, placing on the market, and manufacturing of substances), as well as REACH Annex XIV, the list of substances flagged for phase-out from the market, except when specific use authorizations are secured (i.e., the authorization list). Additionally, ChemRRV contains many other restricted and banned substances beyond those found in REACH Annex XVII. These include substances banned under the EU’s Detergents Regulation (EC) 648/2004, as well as those prohibited pursuant to international treaties, like the Stockholm Convention (persistent organic pollutants – POPs) or the Montreal Protocol (ozone-depleting substances).
  • Switzerland has taken steps to accommodate EU chemicals regulation and deepen technical and scientific cooperation with EU chemical regulators. Beyond emulating large parts of the EU chemical regulatory framework, the Federal Council has set up a REACH-CLP helpdesk within the country’s counterpart to ECHA, the Notification Authority for Chemicals (NAC – “Anmeldestelle Chemikalien” in German), which jointly serves the Swiss federal offices for public health and for the environment (BAG and BAFU) and the state secretariat for economic affairs (SECO). It has done so recognizing the outsized impact trade in chemicals with the EU has on Swiss business, especially small and mid-sized companies (SMEs) whose existence often depends on complying with EU chemicals law. Likewise, the Swiss executive has entered into a formal agreement based on an exchange of letters in 2017 with the EU, allowing experts from the two jurisdictions to focus on “exchanging views on the scientific and technical issues related to the assessment of chemicals, their risk management, safety aspects of manufactured nanomaterials as well as occupational exposure models and limits.”

Biocidal Products in Switzerland

Swiss Notification Authority for Chemicals (NAC) announces forthcoming adaptations to ChemV and BPV based on updated EU legislation

  • NAC on May 29 updated its chemicals legislation revisions page, announcing imminent adaptations to ChemV’s Annexes 2 and 3 and to the Annex 1 and 2 lists of active substances contained in BPV, aligning domestic legislation with updates the EU has made to its chemical and biocides regulations.
  • Below, we outline the specific contents of the affected parts of the Swiss legislation and, subsequently, lay out the changes that are being implemented in these two Swiss ordinances. These adaptations are described in detail in four separate explanatory reports (see the Key Documents and Dates section below) accompanying NAC’s announcements about the planned adaptations.

Content of ChemV Annex 2

  • Annex 2 of the ChemV regulates chemicals by reference to the relevant EU legislation and international standards.
  • Section 1 implements Annexes I-VII of the CLP into Swiss law. Note that the harmonized list of substances is contained in Annex VI of the CLP.
  • Section 2 defines the methods for testing the properties of substances and mixtures, referencing (1) the EU’s Regulation (EC) No 440/2008 establishing test methods pursuant to REACH, (2) OECD Guidelines for the Testing of Chemicals, and (3) the test methods specified in the UN Manual of Tests and Criteria.
  • Section 3 addresses the compilation of safety data sheets, requiring SDSs be composed in accordance with the Annex II criteria of REACH.
  • Sections 4 and on establish transitional provisions for implementing into Swiss law the adaptations to technical progress (ATPs) that the EU issues to amend the CLP through time. These ATPs often address amendments to the Annex VI harmonized list.
  • The Swiss regulators amend sections 1-3 of this annex by updating footnotes that indicate which versions of EU legislation or international testing standards are applicable. For the sections concerning the transitional provisions for CLP ATPs (4 and on), provisions are added as new ATPs are integrated into Swiss law.

Changes to Annex 2

  • The adaptation to Annex 2 implements Delegated Regulation (EU) 2024/197, ATP 21 to the CLP. This regulation updated the CLP’s Annex VI harmonized list, adding 28 entries and amending 24 existing ones. [Read AgencyIQ’s analysis here for background on this amendment to the CLP.]
  • Second, it integrates into Swiss law the EU’s new hazard classes and categories (endocrine disruption; persistent, bioaccumulative, toxic properties (PBT/vPvB); and persistent, mobile, toxic properties (PMT/vPvM)). These were introduced in the EU through Delegated Regulation (EU) 2023/707, which updated the CLP’s Annex I on classification and labeling criteria for hazardous substances and mixtures. [See this AgencyIQ analysis for details on this delegated regulation.]
  • Third, the adaptation is amending the references contained in Section 2, citing more recent updates to test methods. These encompass the latest amendment – Regulation (EU) 2023/464 – to Regulation (EC) No 440/2008; as well as updates to the OECD Test Guidelines, including TGs 442B, 442C, 442D, 442E, 456 und 493; and the 2023 update to the Manual of Tests and Criteria (eighth revised edition). (see pages 11-12 of explanatory document regarding Annex 2 in German for details on the new test methods.)

Content of and changes to ChemV Annex 3

  • Annex 3 contains the list of substances of very high concern (SVHCs), which are taken from REACH’s Candidate List.
  • The adaptation harmonizes the Annex 3 list with seven new substances and an amendment to one existing substance made earlier to the Candidate List. (see the explanatory document regarding Annex 3 in French) [For more background, see AgencyIQ’s January 24 article.]

Content of and changes to BPV Annexes 1 and 2

  • Annexes 1 and 2 of BPV contain the EU’s list of active substances suitable for the simplified procedure (Annex I of BPR) and the Union list of approved active substances, respectively. Note that these substances are taken from the EU’s corresponding lists and populated in these annexes.
  • Two separate adaptations are being undertaken to modify these lists. The first is amending Annex 2 by including 21 new active substance-product type combinations (10 active substances); renewing an approval for one active substance-product type combination; and postponing the expiry date of 25 existing active substance-product type combinations. This adaptation enters into force on June 15. For a detailed summary of the changes and the corresponding EU legislation, see this explanatory report (in German; direct download).
  • The second adaptation is introducing one entry to the BPV’s Annex 1 list of active substances subject to simplified procedure. An active substance-product type combination is being included in Annex 2, while the expiry dates for five more are being postponed. This adaptation enters into force on September 1. For a detailed summary of these changes and the corresponding EU legislation, see this explanatory report (in German; direct download).

Analysis and next steps

  • It is critical for practitioners to review the accompanying explanatory reports to fully understand how the EU legislation impacts the Swiss rules. These documents reveal important details about the Swiss context in which the EU regulations are being implemented and further explain additional ways, including knock-on effects, that these changes will impact national chemicals legislation (see section 2.2 on pages 6-11 of the explanatory report on the amendment of Annex 2 ChemV in September 2024 for a detailed account of the impact of ATP 21 on Swiss chemical supply restrictions (Abgabebeschränkungen).
  • While all these changes will impact compliance with Swiss chemical and biocides laws (i.e., under ChemV and BPV), the adaptation introducing the EU hazard classes, including endocrine disruption, is particularly significant, given the far-reaching effects these changes will have on classification and labeling, as well as the potential for downstream effects leading to the restriction of substances and mixtures that fall into these classifications under other pieces of legislation, like Swiss regulations on water protection, major accidents, and youth and maternity protection.
  • The adaptations to Annexes 2 and 3 of ChemV are expected to enter into force on September 1, 2024. The adaptations to Annexes 1 and 2 of BPV are divided into two, with the first set of changes slated for entry into force on June 15 and the second set on September 1.

To contact the author of this analysis, please email Scott Stephens (

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Key Documents and Dates

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