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Switzerland Revises Chemical Risk Reduction Ordinance

SafeGuardSAutomotive, EE Restricted Substances, Electrical Medical Devices, DIY Tools and Hardware, Food Contact Material, HG Restricted Substances, Home Furnishings and Houseware, Sports and Leisure, Personal and Protective Equipment, Clothing, Footwear and Leather Products, Home Textiles, Jewelry Bags and Accessories, SL Restricted SubstancesMarch 24, 2022

Switzerland strengthens its ORRChem by implementing provisions from EU REACH and the POP Recast Regulation, as well as new requirements for PFHxS, its salts and PFHxS-related substances. These will be implemented in phases, starting April 1, 2022.

 SG 04122 Chemicals

On March 10, 2022, Switzerland issued Official Collection 2022 162 (RO 2022 162, French, German and Italian versions) to revise its Ordinance on the Reduction of Risks Associated with the use of Particularly Dangerous Substances, Preparations and Articles (also known as Chemical Risk Reduction Ordinance, ORRChem, RS 814.81, French, German and Italian versions) to further align with Regulation (EU) 2019/1021 on persistent organic pollutants (POP recast regulation) and Annex XVII of Regulation (EC) 1907/2006 ‘Registration, Evaluation, Authorization and Restriction of Chemicals (Annex XVII of REACH) in the European Union (EU).

In addition to editorial changes, RO 2022 162 contains several important changes to Annex 1 ‘Provisions Concerning Specific Substances’ and Annex 2 ‘Provisions Concerning Specific Substances’ of ORRChem. It:

  • Amends the following Annexes:
    • Annex 1.1 ‘Persistent organic pollutants, POP’
    • Annex 1.2 ’Halogenated organic substances’
    • Annex 1.4 ‘Ozone depleting substances’
    • Annex 1.5 ‘Substances stable in the atmosphere’
    • Annex 1.6 ‘Asbestos’
    • Annex 1.10 ‘Carcinogenic, mutagenic or reprotoxic substances, CMR substances’
    • Annex 2.9 ‘Plastics, their monomers and additives’
    • Annex 2.10 ‘Refrigerants’
    • Annex 2.11 ‘Extinguishing agents’
  • Replaces Annex 1.16 ‘Per- and polyfluoroalkyl substances, PFAS’ – in relation to:
    • Perfluorooctane sulfonic acid (PFOS), its salts and PFOS derivatives
    • Perfluorohexane sulfonic acid (PFHxS), its salts and PFHxS-related substances
    • Perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds
    • Perfluorocarboxylic acids containing 9 to 14 carbon atoms in the chain (C9-C14 PFCAs), their salts and C9-C14 PFCA-related substances 
    • Fluoroalkylsilanols and their derivatives

Highlights of several of the aforementioned amendments and Annex 1.16 ‘PFAS’ are summarized in Table 1.

CHEMICAL RISK REDUCTION ORDINANCE, ORRCHEM
AMENDMENT OF FEBRUARY 23, 2022, RO 2022 162, MARCH 10, 2022

Annex to ORRChem  

Highlight

Annex 1.1 ‘Persistent organic pollutants’

  • Expands the list of prohibited POP chemicals by including PFOA and PFOA-related compounds

  • Repositions pentachlorophenol (PCP), its salts and esters, and dicofol from Annex 1.2 

Annex 1.10 ‘CMR substances’

  • Clarifies that medicines and medical devices are part of the exemption

Annex 1.16 ‘Per- and polyfluoroalkyl substances, PFAS’

Entire Annex is replaced:

  • Retains 1) PFOS and its derivatives and 2) PFOA, its salts and PFOA-related compounds (see Table 2)

  • Adds 1) PFHxS and PFHxS-related substances and 2) C9-C14 PFCAs and C9-C14 PFCA-related substances (see Table 2)

Annex 2.9 ‘Plastics, their monomers and additives’

  • ≤ 20 mg/kg (sum of 8 polycyclic aromatic hydrocarbons (PAHs)* and marked with a unique identification number of the batch for granules or mulches: 1) as infill material in synthetic turf pitches or 2) in loose form on playgrounds or in sport applications

  • Prohibits oxo-degradable plastics

Annex 2.11 ‘Extinguishing agents’

Clarifies that Annex 1.16 applies to extinguishing agents containing PFOS, or PFOA, C9-C14 PFCAs and PFHxS as well as their related substances

*Benzo[a]pyrene (BaP), benzo[e]pyrene (BeP), benzo[a]anthracene (BaA), chrysen (CHR), benzo[b]fluoranthene (BbFA), benzo[j]fluoranthene (BjFA), benzo[k]fluoranthene (BkFA) and dibenzo[a,h]anthracene (DBAhA)

Table 1

CHEMICAL RISK REDUCTION ORDINANCE, ORRCHEM
ANNEX 1.16 ‘PER- AND POLYFLUOROALKYL SUBSTANCES’
AMENDMENT OF FEBRUARY 23, 2022, RO 2022 162, MARCH 10, 2022

Entry

Substance

Scope

Requirement

1

PFOS and its derivatives

  • Substances

Prohibited

  • Constituent of another substance

  • Mixtures

< 10 mg/kg

  • Articles or parts thereof

≤ 1000 mg/kg

  • Textiles or other coated materials

≤ 1 µg/m²

2

PFHxS and its salts

PFHxS-related substances

  • Substances

Prohibited

  • Constituent of another substance

  • Mixtures

  • Articles or parts thereof

≤ 25 ppb PFHxS
≤ 1000 ppb PFHxS-related substances (sum) 

3

PFOA and its salts 

  • Substances

Prohibited

  • Constituent of another substance

  • Mixtures

  • Articles or parts thereof

≤ 25 ppb

4

PFOA-related compounds

  • Substances

Prohibited

  • Constituent of another substance

  • Mixtures

  • Articles or parts thereof

≤ 1000 ppb (sum)

5

C9-C14 PFCAs and their salts

  • Substances

Prohibited

  • Constituent of another substance

  • Mixtures

  • Articles or parts thereof

≤ 25 ppb 

6

C9-C14 PFCA-related substances

  • Substances

Prohibited

  • Constituent of another substance

  • Mixtures

  • Articles or parts thereof

≤ 260 ppb (sum)

**Contains certain derogations, including:

  • ≤ 100 ppb for the sum of C9-C14 PFCAs in fluoropolymers containing perfluoroalkoxy groups

  • ≤ 2000 ppb each of PFOA, PFOA-related compounds (sum), C9-C14 PFCAs and C9-C14 PFCA-related substances (sum) for non-invasive and non-implantable medical devices and their components 

Table 2 

It is interesting to note that Switzerland regulates perfluorohexane sulfonic acid (PFHxS), its salts and PFHxS-related substances (Annex 1.16), a measure that is under consideration in the Stockholm Convention and the European Union (EU).

According to RO 2022 162, there are several effective dates:

  • April 1, 2022, for provisions other than those indicated below
  • October 1, 2022, for Annex 1.16 ‘PFAS’
  • April 1, 2023, for amendments to the Plant Protection Products Ordinance of May 12, 2010

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