Luckily, the Swiss Authority accepts REACH registration dossier in IUCLID 5 format. Staffelstrasse 10CH-8045 ZurichSwitzerland. Article 11. Bisphenol A (BPA) is a synthetic substance used to manufacture various plastic materials intended, among other things, for contact with foodstuffs. %PDF-1.4 The latest edition is the 4th revised version which entered into force on 1 December 2012. We do not provide consultancy services. sponsor this page to leave your contact info on this page.. It is strictly educational and does not replace any legal requirements or applicable regulations. Ordinance concerning Capital Adequacy and Risk Diversification for Banks and Securities Dealers | 7 These modifications enter into force . A manufacturer or an importer must notify a new substance before it is placed on the market for the first time in Switzerland. Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. listed in Annex 2 of the GCO Ordinance, when such goods are: (i) destined for or intended for use . Aineen tai seoksen merkitykselliset tunnistetut kytt ja kytt, joita ei suositella 1.2.1. It is similar to C&L notification under the EU CLP regulation. +41 58 462 20 07, info@gs-wbf . 26 . Bisphenol A The assets of sanctioned individuals and companies are frozen with immediate effect. On the Swiss Federal Food Safety and Veterinary Office's website a logbook of changes regarding the positive list for printing inks is available. If you have questions or need any help, please contact our sponsor. Reference to Annex II, Section II.1, to that Directive: point 6.8. . Annex 2 stipulates the substances that may be used for the plastic layers in utility articles made of plastic. The correspondences in Switzerland for the special provisions in the Implementing Regulation of the EU are considered in Annex 3 OBP. This cookie is set by the Google recaptcha service to identify bots to protect the website against malicious spam attacks. . Comments are accepted until April 3, 2023. The Swiss ordinance (SR 817.023.21) is issued by the Swiss Federal Department of Home Affairs (FDHA) and it is the revised version of the previous Ordinance on Material and Articles. CHF100, to issue a public deed (see clause 1.2, Annex to the Notary Fee Ordinance of the Canton of Zurich (Notariatsgebhrenverordnung)). 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. . **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. The following chemicals are exempt from registrations under ChemO: Note: A notified or declared new substance does not require registration. Materials and articles in contact with food. Required info is very simple and mainly includes substance identity, composition of preparation, intended uses and classification and labelling. This inventory includes chemical substances deemed to be on the European Community market between January 1, 1971 and September 18, 1981. The cookie is used to store the user consent for the cookies in the category "Analytics". Tags: Topics - CH,REACH-like Regulation and Registration, Subscribe to Free Newsletter Disclosures of migrating substances are demanded under both 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. 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. You also have the option to opt-out of these cookies. Annex 2.2 (Cleaning, deodorising and cosmetic products) Placing on the market of deodorisers and air-fresheners intended for . On May 1, 2017 the new Swiss national food law entered into force (FPF reported). 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. Ti-Pure products may not be directly added to food, pharmaceuticals, cosmetics, or cigarette papers/filters for . ( Lists I - V / Part A or B) Remarks Food Contact GMP (Good Manufacturing Practice): List of active substances approved pursuant to Article 9 of the Regulation (EU) No 528/2012 (Union list of approved active substances). ); 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 more info, please refer to ChemO registration part. Plastic materials and articles shall not transfer their constituents to foods in quantities exceeding the specific migration limits (SML) set out in Annex I. Vc!Fs1=FzT39!Osn,%u"MVybD/Ih&>7&&?Q 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. 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 . This cookie, set by YouTube, registers a unique ID to store data on what videos from YouTube the user has seen. On the Swiss Federal Food Safety and Veterinary Offices website a logbook of changes regarding the positive list for printing inks is available. Swiss Ink Ordinance 2-Methoxyethanol (methyl glycol) 109-86-4 Deleted from Swiss Ord. A fully summary in IUCLID 5, meeting the criteria of a robust study summary, is sufficient. This website uses cookies to give you the best experience.Learn More OK OK Is there guidance on what information must be in a Food Master File? Annex 10: List of 564 substances with their selection criteria Presented are all substances and the 4 selection steps. The biocide triclosan (CAS 3380-34-5) has also been deleted from the list. 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. This cookie is set by GDPR Cookie Consent plugin. If you are a consultant, you may get yourself listed in CSP business directory (free) or The chemical authority is the Notification authority for chemicals of the Swiss Federal Office of Public Health. 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. 10 SR 814.610 11 SR 814.620 12 Amended by Annex 4 No 45 of the Customs Ordinance of 1 Nov. 2006, in force since 1 May 2007 (AS 2007 1469). The list contains active substances that have been assessed and approved in the EU under Guideline 98/8/EC (Biocidal product guidelines) and Regulation (EU) No 528/2012 (Biocidal Product Regulation). Annex to the DETEC Ordinance of 3 December 1996 relating to the transport of dangerous goods by rail and . It provides a wide range of information on laws and regulationsboth in the U.S. and other countries throughout the worldthat affect packages and packaging materials. 18 A clinical trial positively reviewed by the ethics committee must then be submitted to the federal admin-istrative authority created by the LTP. SGS Socit Gnrale de surveillance SA - 2022 - All rights reserved - SGS is a registered trademark of SGS Socit Gnrale de surveillance SA. . 192 0 obj <>stream Annex 2, OBP Implementing Ordinance-Biocidal Products FDHA Certain provisions of the OBP are governed in more detail in the Implementing Ordinance-Biocidal Products. endstream endobj startxref Until now, Annex 10 has consisted of two parts, Part A and Part B. The cookies is used to store the user consent for the cookies in the category "Necessary". 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 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. 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. China Releases Draft Amendment to GB Standard on Additives Used in Food Contact Materials and Articles, FDA Adds Two New Substances to its Inventory of Effective FCS Notifications, Maine Announces Opening of Public Comment Period for its PFAS Reporting Law. Annex 10 stipulates the substances that may be used for printing inks (see More information). However, the Swiss Chemicals Ordinance (ChemO) governs more than just new substances. 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. View Past Newsletter. These cookies will be stored in your browser only with your consent. 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). Art. stream The correspondences in Switzerland for the special provisions in the Implementing Regulation of the EU are considered in Annex 3 OBP. The Ordinance (section 12) defines the provisions related to printing inks for non-food contact surfaces of food contact materials. Permitted substances are defined as those listed in Annex 2 Lists I and II and in Annex 10, December 2020. . The Ordinances provisions on recycled paper are also amended, including removal of the restriction that recycled paper may only be used in contact with certain named foodstuffs. to keep Food Packaging Forums work going. Amongst them, "Union" would correspond to "Switzerland". This cookie is set by GDPR Cookie Consent plugin. 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. It has been amended several times. Since Switzerland is not a member of the EU or the European Economic Area (EEA), EU REACH regulation does not apply here. 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. teolliseen/ammattimaiseen kyttn : Ainoastaan ammattikyttn Aineen/seoksen kytt : Vedeneristeet . This website uses cookies to improve your experience while you navigate through the website. These active substances are approved by the EU Commission by means of an Implementing Regulation that is specifically for the approved active substance-product type combination. A copy of the fully executed agreement is sent to all parties by email. 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. ( Lists I - V / Part A or B) Remarks Food Contact A positive assessment of the binder, does not release the user from the du- 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; Dr. Hingwo TsangGlobal Information and Innovation Managert: (+852) 2774 7420. For this reason the FSVO has issued regulations governing packaging. . 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. H. 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. Substances prohibited under the Ordinance on Chemical Risk Reduction / Swiss chemicals legislation / Current as of October 2022 3 of 63 Substance/Preparation/Article Regulations Exemptions/Transitional provisions . How Are Colorants for Food Packaging Regulated in Japan? Consumers are exposed to too little of the substance for it to have any impact on health (see "More information"). 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 . Uses and classification and labelling regarding the positive list for printing inks for non-food contact surfaces of food materials. 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