View Past Newsletter, REACH Annex XVII Restricted Substance List, Octylphenol, nonylphenol and their ethoxylates, Substances classified as carcinogenic, mutagenic or toxic to reproduction, Nitroaromatics, aromatic amines and azo dyes, Special provisions relating to heavy metals, Electrical and electronic equipment (see example below), Swiss Chemicals Ordinance (ChemO) Governing Chemicals, Biocides and Biocidal Product Regulations. The picture below shows how chemicals are regulated under the Swiss Chemicals Ordinance (ChemO): Under the Swiss Chemicals Ordinance, all >=1t/y new substances must be notified or declared in Switzerland before they are placed on the market, even if they are already registered under EU REACH. This inventory includes chemical substances deemed to be on the European Community market between January 1, 1971 and September 18, 1981. SGS neither endorses nor disapproves said 3rd parties contents. Target: new substances >=1t/y for product- and process-orientated research and development (PPORD); Required info: substance identity, uses, and expected quantity. This applies by analogy, specifically because MedDO Annex 2 and IvDO Annex 1 list the correspondence of terms between the EU regulation and Swiss ordinance. It: Highlights of several of the aforementioned amendments and Annex 1.16 PFAS are summarized in Table 1. hR=HQ]WnMCD\rHC"Da bQR]CPAD9PR(wEf{o~b l 4MA, P%xNN:?jSj\xMnozQw{wE}bUxf9OjJ.${ULyJb!XEZezt Sk)a.I~00_.(KZ}QX*TwNPe4HpMhpwiY^JcG7'C:9.3 Necessary cookies are absolutely essential for the website to function properly. Switzerland Publishes Updated Ordinance on Materials and Articles Intended to Contact Foodstuffs, The EU Transparency Regulation Potential Challenges for the Submission of Food-Contact Dossiers, Navigating U.S. Federal and State Regulations of PFAS in Applications Involving Food. Specific migration limits. Article 11. A letter of access is required if a late notifier wishes to share the data submitted by a previous registrant. The Ordinance and the relevant provisions of the Swiss Code of Obligations entered into force on January 1, 2022, but are subject to a one-year transition period. Annex 2 stipulates the substances that may be used for the plastic layers in utility articles made of plastic. INX carried out a review of the raw materials used in the products below to determine their status with respect to the Swiss Ordinance and found that the products below meet the Swiss Ordinance Annex 10. These cookies will be stored in your browser only with your consent. Verification by the Swiss national authorities of compliance with the national rules shall be carried out within the time periods laid down in Article 6 of Commission . The Swiss Food Safety and Veterinary Office (FSVO) and German Bundesinstitut fr Risikobewertung (BfR) currently have an informal arrangement whereby they . 149 of November 24, 2020 to replace its list of substances that are allowed for the manufacture of packaging ink and related requirements for food contact materials and articles (RS 817.023.21, in French, German or Italian). We also use third-party cookies that help us analyze and understand how you use this website. Art. In November 2020, Switzerland published RO 2020 4811 (in French, German or Italian) under Official Collection No. Switzerland Revises Chemical Risk Reduction Ordinance SafeGuardS Automotive, Electrical & Electronics, Electrical & Electronics, Hardgoods, Hardgoods, Hardgoods, Hardgoods, Hardgoods, Personal and Protective Equipment, Softlines, Footwear and Leather Products, Softlines, Softlines, Softlines March 24, 2022 2.1.2 Swiss Ordinance 817.023.21 The Swiss Federal Department of Home Affairs (FDHA) issued a revised version of the Ordinance of Materials and Articles (SR 817.023.21), which came into force on 1st May 2017. Ordonnance du DFI sur les matriaux et objets destins entrer en contact avec les denres alimentaires (Ordonnance sur les matriaux et objets) Annexe 9 de l'ordonnance du DFI sur les matriaux et objets destins entrer en contact avec les denres alimentaires (PDF, 292 kB, 15.10.2022) Country: Switzerland . The rules developed by ICAO - which consist of general rules, visual flight rules and instrument flight rules contained The individual ordinances can be consulted on this site. The issuance . 4 The addenda listed in List II of Annex 1 shall not exceed the limit values laid down therein and shall meet the specific . The correspondences in Switzerland for the special provisions in the Implementing Regulation of the EU are considered in Annex 3 OBP. 0 This list contains a non-exhaustive inventory of substances taken from: (1) Table 3 of Annex VI to CLP; (2) the Candidate List of SVHCs; (3) Annex XIV of REACH (Authorisation List); (4) Annex XVII of REACH (Restrictions List); (5) F-gases subject to emission limits/reporting per Regulation 517/2014/EU; and (6) volatile organic compounds (VOCs) listed in the Ambient Air Directive 2008/50/EC. +41 58 462 20 07, info@gs-wbf . On December 1, the Swiss Federal Department of Home Affairs (FDHA) Food Safety and Veterinary Office (FSVO) published a new version of the Ordinance on Materials and Articles (817.023.21), which establishes certain requirements for food contact materials. Data requirement for new substance notification under ChemO is the same as EU REACH registration. 2 The OSAV publishes these instructions in the Official Swiss Trade Sheet. Investigational medicinal products in their final packaging are treated similarly. 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). All versions (Texts on reference publications - annexes 3a, 7, 7a AMZV; annexes 2, 3 VAZV; annexes 4-10 KPAV) 1.7.2022 Annex 7 AMZV . 10 Version according to Annex 2 Section 4 of the Banking Ordinance of 30 April 2014, in force since 1 January 2015 (AS 2014 1269). 186 V. Junod / European Journal of Health Law 15 (2008) 183-195 coverage policy and, of course, the risk-bene t balance. It was decided to select the HPV-chemicals, the highly persistent chemicals and the metals. The measure is introduced by an amendment of Annex 28 of the Ordinance "On measures related to the situation in Ukraine" of 4 March 2022. The correspondences in Switzerland for the special provisions in the Implementing Regulation of the EU are considered in Annex 3 OBP. \j}M2'L~u}0 CHF100, to issue a public deed (see clause 1.2, Annex to the Notary Fee Ordinance of the Canton of Zurich (Notariatsgebhrenverordnung)). In this Alert, prepared in conjunction with attorneys at leading Swiss law firm Advestra, we provide an overview of the new requirements and near-term compliance recommendations. Please note that there is no official Swiss chemical inventory. We do not provide consultancy services. Since the Chemical Risk Reduction Ordinance (ORRChem) is updated frequently, please click here to search the latest restrictions for each substance or product type. The Swiss Federal Council, pursuant to Articles 3(2)(b), 3g, 4(2) and (4), 4 bis(2), 10(4)(a) and 56 of the Banking Act of 8 November 1934 2 . Using our expertise in food contact materials analytical chemistry, regulations, toxicology, and risk assessments gained from decades of experience working at regulatory authorities around the world, with contract and governmental research organizations, and in industry, we can help clients collect relevant information and develop and submit dossiers to the Swiss (and German) Authorities for evaluation and authorization of new substances intended to be used in printing inks intended for food contact materials applications. last required signature was executed (Swiss Federal Supreme Court 129 IV 130 c. 2.3 and 3). teolliseen/ammattimaiseen kyttn : Ainoastaan ammattikyttn Aineen/seoksen kytt : Vedeneristeet . It is similar to C&L notification under CLP regulation. Preparations containing at least one hazardous ingredient that is dangerous to human health or to the environment in an individual concentration>=1%w/w (non-gases) or >0.2% by volume(for gases); Preparations containing at least one PBT or vPvB substance in an individual concentration>=0.1%w/w; Preparations containing at least one SVHC in an individual concentration>=0.1%w/w; Preparations containing at least one substance for which a workplace exposure limit has been laid down in Europe. 13 . All rights reserved. 2 The Swiss Financial Market Supervisory Authority (FINMA) may issue implementing provisions. The cookie is used to store the user consent for the cookies in the category "Other. Ti-Pure products may not be directly added to food, pharmaceuticals, cosmetics, or cigarette papers/filters for . even Swiss companies that are not currently affected will . In this Alert, prepared in conjunction with attorneys at leading Swiss law firm Advestra, we provide an overview of the new requirements and near-term compliance recommendations. First visit by a Swiss president to Botswana. Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004, Food & Nutritional Regulatory Support Services, Manufacturing Technology & Industrial Equipment. List of active substances Annex 2 OBP (XLS, 828 kB, 01.09.2022), Ordinance on the Placing on the Market and Handling of Biocidal Products (Ordinance on Biocidal Products, OBP) - Annex 3, https://www.anmeldestelle.admin.ch/content/chem/en/home/themen/recht-wegleitungen/chemikalienrecht/biozidprodukteverordnung/anhang-2-vbp.html, Common notification authority for chemicals, FDFA: Federal Department of Foreign Affairs, FDJP: Federal Department of Justice and Police, DDPS: Federal Department of Defence Civil Protection and Sport, EAER: Federal Department of Economic Affairs, Education and Research, DETEC: Federal Department of the Environment, Transport, Energy and Communications. A fully summary in IUCLID 5, meeting the criteria of a robust study summary, is sufficient. Who: manufacturer or importer or only representative; Required info: physio-chemical data, toxicology data, eco-toxicology data and chemical safety report. Bisphenol A The core element of the new regulation is a list of "permitted . The ordinance is almost a combined version of EU RoHS, REACH Annex XVII Restricted Substance List and REACH Annex XIV Authorization List. . Switzerland Annex 6, part A Annex 6, part B Germany Annex 14 ("positive list") Inventory list (p ) ((pnot part of the Ordinance) Migration limits in Swiss & German Ordinance are likely to be very 18 similar as both are based on the same scientific opinion. 192 0 obj <>stream Consumers are exposed to too little of the substance for it to have any impact on health (see "More information"). Several substances have been removed from the list due to their carcinogenic, mutagenic, or reprotoxic (CMR) properties. % The assets of sanctioned individuals and companies are frozen with immediate effect. Luckily, the Swiss Authority accepts REACH registration dossier in IUCLID 5 format. EINECS (European Inventory of Existing Commercial Chemical Substances). 5 0 obj The Swiss Chemical Risk Reduction Ordinance (ORRChem) stands for the Ordinance on the Reduction of Risks relating to the Use of Certain Particularly Dangerous Substances, Preparations and Articles which entered into force since 2005. The food industry is subject to strict requirements that are set out in the Ordinance on Materials and Articles (in French). Substances on REACH SVHC list will be added to the Annex 7 of ChemO. Whilst the provisions of this regulation specifically apply to controls on products placed on the market in the EU, the Swiss Authorities apply the same principles, so they will become more relevant for substances used in printing inks that are not listed in the new regulation. 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