Required info is very simple and mainly includes substance identity, composition of preparation, intended uses and classification and labelling. Annex 10 stipulates the substances that may be used for printing inks (see More information). Based on our extensive experience working under the requirements of the EU food contact materials legislative framework, it is our opinion that self-control refers to compliance with Article 3 of Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food, the so-called Framework Regulation, which states: Materials and articles, including active and intelligent materials and articles, shall be manufactured in compliance with good manufacturing practice so that, under normal or foreseeable conditions of use, they do not transfer their constituents to food in quantities which could: (b) bring about an unacceptable change in the composition of the food; or, (c) bring about a deterioration in the organoleptic characteristics thereof.. What are the Requirements for Using Aluminum Foil as a Functional Barrier? . However, the Swiss Chemicals Ordinance (ChemO) governs more than just new substances. Art. For child labour the Ordinance requires in its annex 2 compliance with (i) the ILO Conventions no. Therefore, GSPR #23.2(d) . 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. 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. For >=1t/y new substances which are placed on the market solely for the purpose of product- and process-orientated research, a manufacturer, importer or only representative needs to apply for applications for exemption at least 30 days before he/she intends to place the substance on the market for the first time. 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. A copy of the fully executed agreement is sent to all parties by email. 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. Staffelstrasse 10CH-8045 ZurichSwitzerland. According to RO 2022 162, there are several effective dates: SGS is committed to providing information about development in regulations for consumer products as complimentary services. Self derived TDI or SML values based on literature Tox data (for example REACH) Derived from NOAEL, DNELlong term oral-general population, TDI Data Studies must be of sufficient quality (Klimisch Score I or II) Assessment Factor of 10 x 10 as minimum 3. I. If you have questions or need any help, please contact our sponsor. 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. The cookie is used to store the user consent for the cookies in the category "Other. . 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). The latest edition is the 4th revised version which entered into force on 1 December 2012. Contact us for more information or visit our website. 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. Stripe sets this cookie cookie to process payments. But opting out of some of these cookies may affect your browsing experience. 1. 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 Annex 2.2 (Cleaning, deodorising and cosmetic products) Placing on the market of deodorisers and air-fresheners intended for . Chemical substances that are outside the scope of ChemO (i.e., in-transit substance, medicines, food stuffs, weapon, wastes); Polymer or substance contained in a polymer with a concentration below than 2%; New substances placed on Swiss market with volume less than 1t/y; <1t/y new substances placed on Swiss market purely for scientific R&D; Substances used exclusively as raw materials, active ingredients or additives in food, therapeutic products and animal feed; Substances that are used exclusively as active ingredients in crop protection products and biocidal products; Intermediates, provided that they are not monomers; Substances listed in REACH annex V (by-products, naturally occurring substances, impurities, etc. 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. The aim of the trip was to strengthen relations between the two countries. listed in Annex 2 of the GCO Ordinance, when such goods are: (i) destined for or intended for use . These will be implemented in phases, starting April 1, 2022. This cookie is set by GDPR Cookie Consent plugin. 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. The financial sanctions now extend to Russian President Vladimir Putin, Prime Minister Mikhail Mishustin and Foreign Minister Sergey Lavrov. . 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. The active substances approved in the EU have been adopted by Switzerland in Annex 2 OBP. GENEVA, SWITZERLAND / AGILITYPR.NEWS / December 16, 2019 / On December 1, 2019, Switzerland brought into effect several food contact materials and articles requirements that align its ordinance with many European Union (EU) provisions. If you are a consultant, you may get yourself listed in CSP business directory (free) or +41 58 462 20 07, info@gs-wbf . Annex 2 stipulates the substances that may be used for the plastic layers in utility articles made of plastic. 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. 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. All rights reserved. The food law includes the ordinance on materials and articles intended to come into contact with food. 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 (C, Fluoroalkylsilanols and their derivatives, April 1, 2022, for provisions other than those indicated below, April 1, 2023, for amendments to the Plant Protection Products Ordinance of May 12, 2010. Belarus. 2 The OSAV publishes these instructions in the Official Swiss Trade Sheet. Union list of approved active substances In addition to modifying the text of the legislation and six of the 10 existing annexes, the amendment introduces a new Annex 11, which provides guideline values for the verification of good manufacturing processes as they . Bisphenol A (BPA) is a synthetic substance used to manufacture various plastic materials intended, among other things, for contact with foodstuffs. SGS Socit Gnrale de surveillance SA - 2022 - All rights reserved - SGS is a registered trademark of SGS Socit Gnrale de surveillance SA. . This Regulation defines the special provisions for the use in biocidal products as well as the approval date of the active substance, up to when a corresponding application has to be submitted for the approval of a biocidal product for this active substance-product type combination. 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. The correspondences in Switzerland for the special provisions in the Implementing Regulation of the EU are considered in Annex 3 OBP. A manufacturer or an importer must notify a new substance before it is placed on the market for the first time in Switzerland. 1.2. This exemption is usually limited to a quantity required for the purpose and a period not exceeding five years. 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 (. Ordinance of the Swiss Financial Market Supervisory Authority on the Insolvency of Banks and Securities Firms 1 (FINMA Banking Insolvency Ordinance, BIO-FINMA) of 30 August 2012 (Status as of 1 January 2021) 1 Term in accordance with Annex No 3 of the FINMA O of 4 Nov. 2020 on Financial Institutions, in force since 1 Jan. 2021 (AS 2020 5327 . The issuance . 326 80-05-7 2,2-Bis(4-hydroxyphenyl)propan = 4,4'-isopropylidenediphenol = Bisphenol A HPV Not pers 1 High Processes involving the application of printing inks to the non-food contact side of a material or article. 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. . Dr. Hingwo TsangGlobal Information and Innovation Managert: (+852) 2774 7420. Authored by our Global Sanctions Team On 28 February 2022, the Swiss Government decided to adopt the sanctions imposed by the EU on 23 and 25 February 2022. Swiss Ink Ordinance 2-Methoxyethanol (methyl glycol) 109-86-4 Deleted from Swiss Ord. PackagingLaw.com is the premier online resource for the global packaging industry. The chemical authority is the Notification authority for chemicals of the Swiss Federal Office of Public Health. The Swiss Printing Inks Ordinance outlines that a petition for a food contact printing ink should include the following data: the identity of the substance; the physical and chemical properties of the substance; the intended use of the substance; authorizations applicable to the substance; Comments are accepted until April 5, 2023. Annex 10 includes a positive list for binders (monomers), dyes and pigments, solvents . 186 V. Junod / European Journal of Health Law 15 (2008) 183-195 coverage policy and, of course, the risk-bene t balance. 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 The Food Packaging Forum enables stakeholders to make better decisions by applying the latest science on chemicals in food contact materials and on the environmental impacts of food packaging. It is the first time a Swiss president has visited the country. Similar to EU REACH, a company based outside of the Switzerland can appoint a Swiss only representative to notify. Even though these substances are classed as non-evaluated, evidence that they meet the listing requirements (i.e., migration <10 ppb and no CMR properties) must be provided to the Swiss authorities before they can be added to Part B. You may also find an expert in CSP business directory below. 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. Switzerland has its own chemical regulations adopting REACH-like registration requirements, but only on new substances placed on the Swiss market. Ordinance concerning Capital Adequacy and Risk Diversification for Banks and Securities Dealers | 7 This is a publication of SGS, except for 3rd parties contents submitted or licensed for use by SGS. 19 is authority, the Swiss Agency for ther- apeutic products (commonly called Swissmedic), has powers approximately A cookie set by YouTube to measure bandwidth that determines whether the user gets the new or old player interface. Part A lists substances that have been fully evaluated by the Swiss authorities (Federal Department of Home Affairs and the Federal Food Safety and Veterinary Office), whereas Part B lists substances that may only be used if the user can demonstrate that ink constituents do not transfer to food when assessed using a method with a detection limit of 0.01 mg/kg (10 ppb) AND the substances in question are not carcinogenic, mutagenic, or toxic to reproduction (CMRs). 4 and 5 of the Ordinance), exemptions from the due diligence and reporting obligations due to compliance with internationally recognized and equivalent regulatory frameworks . List of active substances approved pursuant to Article 9 of the Regulation (EU) No 528/2012 (Union list of approved active substances). We do not provide consultancy services. The correspondences in Switzerland for the special provisions in the Implementing Regulation of the EU are considered in Annex 3 OBP. Standard prohibitions on the provision of technical or financial assistance apply as well. 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. Annex 4 of DFI Swiss Ordinance 817.023.21 The present review only refers to food-contact applications. Notification authority for chemicals of the Swiss Federal Office of Public Health. New Swiss food law including FCM ordinance entered into force May 1, 2017; many CMR-substances deleted from positive list for printing inks. Higher data package is required for higher volume substances. General restrictions related to plastic materials and articles are laid down in Annex II. Automotive, Electrical & Electronics, Electrical & Electronics, Hardgoods, Hardgoods, Hardgoods, Hardgoods, Hardgoods, Personal and Protective Equipment, Softlines, Footwear and Leather Products, Softlines, Softlines, Softlines. 181 0 obj <>/Filter/FlateDecode/ID[<445D1EC1FEC9ED46AF4C6F0A56C0CB39>]/Index[168 25]/Info 167 0 R/Length 69/Prev 452272/Root 169 0 R/Size 193/Type/XRef/W[1 2 1]>>stream Permitted substances are defined as those listed in Annex 2 Lists I and II and in Annex 10, December 2020. . This website uses cookies to give you the best experience.Learn More OK OK It is similar to C&L notification under the EU CLP regulation. To this end, it establishes the requirements for honesty, diligence and transparency in the provision of financial services and governs the offering . This publication is intended to provide technical information and shall not be considered an exhaustive treatment of any subject treated. endstream endobj startxref The following new substances are exempt from new substance notifications in Switzerland under the ChemO: *PPORD: This exemption needs to be declared to authority. Switzerland last updated the Ordinance in 2017 to align more closely with principles contained in European Union (EU) food contact regulations, and the most recent updates represent a continuation of that effort. **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-relatedsubstances (sum) for non-invasive and non-implantable medical devices and their components. Those specific migration limits (SML) are expressed in . The core element of the new regulation is a list of "permitted . Disclosures of migrating substances are demanded under both Annex 2 stipulates the substances that may be used for the plastic layers in utility articles made of plastic. However, the Swiss authorities have indicated they are preparing new printing ink legislation that will not include a list of non-evaluated substances, and as such, they are no longer accepting applications for adding substances to Part B of Annex 10. 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). hbbd``b` $3@/`b@\W+D)HRjd100Mg4` 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. The active substances approved in the EU have been adopted by Switzerland in Annex 2 OBP. A full logbook of these changes and more information about the updated Ordinance can be found at the FSVO Website. ", Materials and articles in contact with food, https://www.blv.admin.ch/content/blv/en/home/gebrauchsgegenstaende/materialien-in-kontakt-mit-lebensmitteln.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, Annexe 9 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. This may pose a threat to health. First visit by a Swiss president to Botswana. At this time, the Implementing Ordinance-Biocidal Products governs in detail the following procedures: Procedure for the authorisation of the same biocidal products ); Substances and preparations solely for R&D; Gas mixtures consisting exclusively of registered gases; Preparations <100kg/y and intended exclusively for professional users; all other information required to allow safe use of the object. For this reason the FSVO has issued regulations governing packaging. 2023 SGS Socit Gnrale de Surveillance SA, Annex 1.1 Persistent organic pollutants, POP, Annex 1.2 Halogenated organic substances, Annex 1.5 Substances stable in the atmosphere, Annex 1.10 Carcinogenic, mutagenic or reprotoxic substances, CMR 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. to keep Food Packaging Forums work going. For this reason the FSVO has issued regulations governing packaging. The substance may be contained in food can coatings, till receipts and toys, for example. \j}M2'L~u}0 Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors. 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. At the moment, the Swiss Printing Inks Ordinance is the most complete piece of national legislation in Europe regulating substances intended for use in printing inks that are not intended to. SML values from Union list, Swiss Ordinance or evaluations of MS authorities 2. 7 Version according to Annex 2 Sect. Chemical Risk Reduce Ordinance (ORRChem). The Ordinance (section 12) defines the provisions related to printing inks for non-food contact surfaces of food contact materials. Regulations on As and Pb in inks (CH) 1990 Formation of the Ad-hoc working group at the Council of Europe 14.09.2005 Resolution [Res AP(2005)2] is adopted by the Council of Ministers 2005 Contamination of infant formula by photoinitiator (ITX) 07.03.2008 Publication of the regulation on packaging inks . 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. You also have the option to opt-out of these cookies. Vc!Fs1=FzT39!Osn,%u"MVybD/Ih&>7&&?Q This cookie is set by GDPR Cookie Consent plugin.

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