26 . The provisions governing the obligation to notify, declare and register new substances are contained in its Chemicals Ordinance on Protection against Dangerous Substances and Preparations (known as ChemO). For more info, please refer to new substance declaration part. Annex 2.2 (Cleaning, deodorising and cosmetic products) Placing on the market of deodorisers and air-fresheners intended for . Click here to access all references and resources for Switzerland including the English translation of regulations, regulatory lists and useful links to the websites of competent authorities. English is not an official language of the Swiss Confederation. View Past Newsletter. This exemption is usually limited to a quantity required for the purpose and a period not exceeding five years. Ordinance on electrical low-voltage equipment AS 2015 6 Section 2: Special low-voltage equipment Article 13 Recognised technical regulations 1 Low-voltage equipment which is not subject to the scope of application of Directive 2014/35/EU 11 or which is listed in Annex II to the latter may only be made available on the market if it complies with the recognised technical regulations. 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 lordonnance du DFI sur les matriaux et objets destins entrer en contact avec les denres alimentaires (PDF, 292 kB, 15.10.2022), Annex 10 of the Ordinance of the FDHA on materials and articles intended to come into contact with food-stuffs (PDF, 1 MB, 15.10.2022), The old legislation and the old Annexes remain valid during a transitional period, see "archives de l`ancien droitalimentaire. Swiss Ordinance 817.023.021 Swiss Ordinance 817.023.021 Annex X: All components of the product are listed in Annex X of the Ordinance of the FDHA on articels and materials for the manufacture of packaging inks. This cookie is set by GDPR Cookie Consent plugin. For polymer, this notification applies to monomers. Address for enquiries EAER Communications, Tel. YouTube sets this cookie to store the video preferences of the user using embedded YouTube video. Part II: Bulk and Intermediate Products Bulk and intermediate products 5 should be treated in a similar way to finished . endstream endobj 169 0 obj <> endobj 170 0 obj <>/MediaBox[0 0 842.04 595.32]/Parent 166 0 R/Resources<>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI]/XObject<>>>/Rotate 0/Tabs/S/Type/Page>> endobj 171 0 obj <>stream Tags: Topics - CH,REACH-like Regulation and Registration, Subscribe to Free Newsletter The active substances approved in the EU have been adopted by Switzerland in Annex 2 OBP. The Federal Council's report: Benefits and risks of using bisphenol A (in French) (PDF, 399 kB, 18.12.2015), Ordonnance du DFI sur les matriaux et objets destins entrer en contact avec les denres alimentaires (Ordonnance sur les matriaux et objets), Annexe 2 de lordonnance du DFI sur les matriaux et objets destins entrer en contact avec les denres alimentaires (PDF, 636 kB, 15.10.2022), Annex 10 of the Ordinance of the FDHA on materials and articles intended to come into contact with food-stuffs (PDF, 1 MB, 15.10.2022), Logbook of changes (PDF, 45 kB, 01.12.2020), https://www.blv.admin.ch/content/blv/en/home/gebrauchsgegenstaende/materialien-in-kontakt-mit-lebensmitteln/verpackungen.html, Federal Food Safety and Veterinary Office FSVO, 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, FSVO: Federal Food Safety and Veterinary Office, MeteoSwiss: Federal Office of Meteorology and Climatology, FSIO: Federal Social Insurance Office, Switzerland, Swissmedic: Swiss Agency for Therapeutic Products, Materials and articles in contact with food, The Federal Council's report: Benefits and risks of using bisphenol A (in French), Annexe 2 de lordonnance du DFI sur les matriaux et objets destins entrer en contact avec les denres alimentaires, Annex 10 of the Ordinance of the FDHA on materials and articles intended to come into contact with food-stuffs. A full logbook of these changes and more information about the updated Ordinance can be found at the FSVO Website. How Are Colorants for Food Packaging Regulated in Japan? The tax rate was CHF 2 per kg after entry into force in 2000 and was increased, as planned, to CHF 3 per kg at the beginning of 2003. . . If you have questions or need any help, please contact our sponsor. The Russia Sanctions Ordinance prohibits Swiss banks from accepting deposits by Russian nationals or residents and banks, enterprises and other entities established in Russia if the total Celebrating 60 Years of Excellence: 1962 - 2022. hbbd``b` $3@/`b@\W+D)HRjd100Mg4` 186 V. Junod / European Journal of Health Law 15 (2008) 183-195 coverage policy and, of course, the risk-bene t balance. Receive a bi-monthly summary of the latest news and stay up to date with developments in the field. Reminder: Unlike new substance notification or declaration, this registration needs to be done on a per product basis. The cookies is used to store the user consent for the cookies in the category "Necessary". 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. Annex 10 stipulates the substances that may be used for printing inks (see More information). 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. The European Chemicals Agency has launched a 45-day consultation for listing two chemicals as substances of very high concern (SVHC). 4 of the Banking Ordinance of 30 April 2014, in force since 1 January 2015 (AS 2014 1269). Art. A manufacturer or an importer must notify a new substance before it is placed on the market for the first time in Switzerland. What are the Requirements for Using Aluminum Foil as a Functional Barrier? All dual-use products and technology, according to Annex 2 of the Swiss Goods Control Ordinance of 3 June 2016. I understand that the Japan MHLW Notification No. Specifically, the Ordinance now contains a section (and accompanying Annexes 13 and 14) requiring a Declaration of Compliance for varnishes and coatings, including new language relating to EU regulations on Bisphenol A (BPA) in plastic varnishes and coatings in contact with food. Notification authority for chemicals of the Swiss Federal Office of Public Health. The aim of the trip was to strengthen relations between the two countries. On the Swiss Federal Food Safety and Veterinary Offices website a logbook of changes regarding the positive list for printing inks is available. The issuance . The relevant thresholds are listed in Annex 1 to the Ordinance with the corresponding customs tariff numbers. for a period not exceeding five years (may be extended upon approval); Substances and preparations meeting CLP/GHS classification criteria; Substances listed in the annex 7 of ChemO (. Dr. Hingwo TsangGlobal Information and Innovation Managert: (+852) 2774 7420. Permitted substances are defined as those listed in Annex 2 Lists I and II and in Annex 10, December 2020. . We can also assist clients in carrying out the self-assessment of substances in line with the requirements of the Framework Regulation to ensure full compliance of printing ink substances that are not authorized by the Swiss Authorities. CHEMICAL RISK REDUCTION ORDINANCE, ORRCHEM AMENDMENT OF FEBRUARY 23, 2022, RO 2022 162, MARCH 10, 2022, 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, Clarifies that medicines and medical devices are part of the exemption, Annex 1.16 Per- and polyfluoroalkyl substances, PFAS, 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, 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), CHEMICAL RISK REDUCTION ORDINANCE, ORRCHEM ANNEX 1.16 PER- AND POLYFLUOROALKYL SUBSTANCES AMENDMENT OF FEBRUARY 23, 2022, RO 2022 162, MARCH 10, 2022, 25 ppb PFHxS 1000 ppb PFHxS-related substances (sum). . Several substances have been removed from the list due to their carcinogenic, mutagenic, or reprotoxic (CMR) properties. Switzerland also uses EINECS as their existing chemical substance inventory. which regulatory requirements apply in Switzerland to the FCMs you are interested in, including plastics (Annex 2), printing inks (Annex 10), silicone articles (Annex 9); which substances have already been approved in the current Swiss Ordinance on FCMs; Swiss Ordinance 817.023.021 Swiss Ordinance 817.023.021 Annex X: Not all components of the product are listed in Annex X of the Ordinance of the FDHA on articels and materials for the manufacture of packaging inks. Article 35 of this section details the requirement that only permitted substances should be used in the manufac-turing auf packaging inks. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. 0 I understand that the inclusion of an aluminum foil layer in laminate materials is considered by FDA to be a functional Name: Richard Ballaman . Substances on REACH SVHC list will be added to the Annex 7 of ChemO. . The core element of the new regulation is a list of "permitted . Finally, the Ordinance contains several additions, deletions, and modifications to its provisions covering printing inks, an area that is not currently harmonized at the EU level. This cookie is set by GDPR Cookie Consent plugin. YouTube sets this cookie via embedded youtube-videos and registers anonymous statistical data. Higher data package is required for higher volume substances. Notification applies to a substance on its own, in a mixture or intended to be released from an article under normal conditions of use. Chemical Risk Reduce Ordinance (ORRChem). The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional". To navigate items, use the arrow, home, and end keys. The Ordinance defines exemptions from the due diligence and reporting obligations in the areas of minerals and metals (art. The cookie stores information anonymously and assigns a randomly generated number to recognize unique visitors. In the end, its only trusted because its tested. %PDF-1.7 % For the purpose of this Ordinance, volatile organic compounds (VOCs) are organic compounds with a vapour pressure of at least 0.1 mbar at 20 C or a boiling point of maximum 240 C at 1013.25 mbar. sponsor this page to leave your contact info on this page.. Reference to Annex II, Section II.1, to that Directive: point 6.8. . This cookie is set by the Google recaptcha service to identify bots to protect the website against malicious spam attacks. In November 2020, Switzerland published RO 2020 4811 (in French, German or Italian) under Official Collection No. sponsor this page to leave your contact info on this page.. Swiss Federal Food Safety and Veterinary Office (April 27, 2017). endstream endobj startxref hTmO0+} 8/N&T!>n`&UbIZ6uHSt|o~"g~02?qD=yHq,p-IXmEHR0*);=sJ|^gKm!Lpa/7|0++ {S A^AQos0dfZ1pg6KlKz>ya{, >V'qa!SyM?rs{i2,LnVzm Stripe sets this cookie cookie to process payments. Data requirement for new substance notification under ChemO is the same as EU REACH registration. It is strictly educational and does not replace any legal requirements or applicable regulations. 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 Commission Directive 91/412/EEC, Article 9, para 2 and Annexes 1 and 2 of the Swiss Ordinance of 17 October 2001 on establishment licences). Switzerland issued a revised version of its Ordinance on Materials and Articles (SR 817.023.21), which came into force on 1st May 2017. Similar to EU REACH, a company based outside of the Switzerland can appoint a Swiss only representative to notify. 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. 192 0 obj <>stream A notification fee also needs to be paid. It also specifies personal and professional qualifications required for the use of certain hazardous substances; preparations and articles (for example, plant protection products and some biocides). The purpose of this registration is to provide the Swiss authority with information on the classification and labelling of hazardous chemicals placed on the Swiss market. Investigational medicinal products in their final packaging are treated similarly. Bisphenol A The substances permitted to be used in printing inks are listed in Annex 2 of the Swiss Ordinance, referred to plastics, and Annex 10, referred to printing inks (Annex 6 in former versions of the Ordinance; revised version came into force on May 1st, 2017). For this purpose, the Swiss Federal Council has approved the complete revision of the Ordinance on Measures against Belarus, which entered . The _ga cookie, installed by Google Analytics, calculates visitor, session and campaign data and also keeps track of site usage for the site's analytics report. Staffelstrasse 10CH-8045 ZurichSwitzerland. 138 and 182 and (ii) the ILO-IOE Child Labour Guidance Tool for Business and (iii) the OECD Due Diligence Guidance for Responsible Business Conduct or the UN Guiding Principles on Business and Human Rights. 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. It: Highlights of several of the aforementioned amendments and Annex 1.16 PFAS are summarized in Table 1. The Swiss Federal Council, on the basis of Article 2 paragraph 4, 19, 22 paragraph 2, 24, 38, 39 paragraph 2, . For example, if an American company plans to export 99 tons of a new substance into the EEA, among which 5t is imported into Switzerland, the American company will need to submit a 10-100t technical dossier to Swiss authority by appointing an only representative. Therefore, GSPR #23.2(d) . This is a publication of SGS, except for 3rd parties contents submitted or licensed for use by SGS. CHF100, to issue a public deed (see clause 1.2, Annex to the Notary Fee Ordinance of the Canton of Zurich (Notariatsgebhrenverordnung)). 2 In derogation from para. Belarus. Plastic materials and articles shall not transfer their constituents to foods in quantities exceeding the specific migration limits (SML) set out in Annex I. Substances on packaging materials, such as printed plastics, can migrate into foodstuffs and endanger health. 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 The chemical authority is the Notification authority for chemicals of the Swiss Federal Office of Public Health. 2 The Swiss Financial Market Supervisory Authority (FINMA) may issue implementing provisions. 13 . ( Lists I - V / Part A or B) Remarks Food Contact GMP (Good Manufacturing Practice): Annexes 2, 9, and 10 of the ordinance, containing positive lists of substances to be used in the manufacture of plastic articles, silicone articles, and printing inks, respectively, have been updated. Swiss Chemical Risk Reduction Ordinance (ORRChem); Biocides and Biocidal Product Regulations, Tonnage band: 1-10t/y, 10-100t/y, 100-1000t/y, 1000t/y+ (based on *decisive quantity). This Chemical Risk Reduction Ordinance prohibits or restricts the marketing and use of certain hazardous substances on its own or in preparations and articles. 2 The OSAV publishes these instructions in the Official Swiss Trade Sheet. This website uses cookies to give you the best experience.Learn More OK OK Anyone who commercially supplies an article containing a substance of very high concern in a concentration greater than 0.1 % by weight must provide the customer with the following information: This information must be provided free of charge to professional or commercial users without being requested or consumers within 45 days upon request. . \j}M2'L~u}0 The Financial Services Act seeks to protect the clients of financial service providers and to establish comparable conditions for the provision of financial services by financial service providers. Since the Chemical Risk Reduction Ordinance (ORRChem) is updated frequently, please click here to search the latest restrictions for each substance or product type. Through a global network of laboratories, SGS provides a wide range of services including physical/mechanical testing, analytical testing and consultancy work for technical and non-technical parameters applicable to a comprehensive range of consumer products. Merkitykselliset tunnistetut kytt Pasiallinen kyttkategoria : Rakennusmateriaalit Erit. Luckily, the Swiss Authority accepts REACH registration dossier in IUCLID 5 format. 9 Amended by Annex 3 No II 8 of the O of 22 June 2005 on Movements of Waste, in force . Contact us for more information or visit our website. Since Switzerland is not a member of the EU or the European Economic Area (EEA), EU REACH regulation does not apply here. A substance that is listed on EINECS may still require registration under the Swiss Chemicals Ordinance. First visit by a Swiss president to Botswana. last required signature was executed (Swiss Federal Supreme Court 129 IV 130 c. 2.3 and 3). The information contained herein is provided as is and SGS does not warrant that it will be error-free or will meet any particular criteria of performance or quality. Those specific migration limits (SML) are expressed in . Click here to access all references and resources for Switzerland including the English translation of regulations, regulatory lists and useful links to the websites of competent authorities. Annex 10 of the Swiss Ordinance on materials and articles intended to come into contact with foodstuffs lists substances permitted for use in the production of printing inks for food contact materials and their related requirements. Regulated in Japan need any help, please contact our sponsor Trade Sheet added to the 7... Iv 130 c. 2.3 and 3 ) the user consent for the cookies the! 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May still require registration under the Swiss Federal Food Safety and Veterinary Offices website logbook.
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