A manufacturer or an importer must notify a new substance before it is placed on the market for the first time in Switzerland. Keller and Heckman LLP. The Swiss Department of the Interior has amended its 2016 Ordinance on the Maximum Levels of Contaminants (known as the VHK), which regulates the production of foodstuffs. Situation in Ukraine: Switzerland extends its measures. 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 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 This final rule will become effective on March 23, 2023. 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. Manufacturers or importers must register the following hazardous substances or preparations with the Notification Authority within 3 months after first placing them on the Swiss market. The aim of the trip was to strengthen relations between the two countries. 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. Belarus. Dr. Hingwo TsangGlobal Information and Innovation Managert: (+852) 2774 7420. 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. Therefore, GSPR #23.2(d) . 19 is authority, the Swiss Agency for ther- apeutic products (commonly called Swissmedic), has powers approximately This cookie is set by GDPR Cookie Consent plugin. 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. Examples include 2-methoxy-ethanol (CAS 109-86-4), aniline (CAS 62-53-3), dimethylformamide (68-12-2), and diisobutyl phthalate (DIBP, CAS 84-69-5). BPA can be detected both in foodstuffs and in utility articles. Annex 10 includes a positive list for binders (monomers), dyes and pigments, solvents . This exemption can only be claimed if the substances meet the following conditions: Compared to full notification, new substance declaration only requires information on legal entity, substance identity, uses and expected quantity. 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. Substances on REACH SVHC list will be added to the Annex 7 of ChemO. % The Ordinance (section 12) defines the provisions related to printing inks for non-food contact surfaces of food contact materials. 2023 Swiss Ink Ordinance 2-Methoxyethanol (methyl glycol) 109-86-4 Deleted from Swiss Ord. First visit by a Swiss president to Botswana. Data requirement for new substance notification under ChemO is the same as EU REACH registration. 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 Ti-Pure products may not be directly added to food, pharmaceuticals, cosmetics, or cigarette papers/filters for . Art. endstream endobj startxref 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. 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). 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. In addition to that, the ChemO has introduced REACH SVHC list into Switzerland and imposed a duty on suppliers of articles which contain substances on the SVHC list in a concentration above 0.1% (w/w) to provide sufficient information to their customers to allow safe use of the articles. Annex 2, OBP Implementing Ordinance-Biocidal Products FDHA Certain provisions of the OBP are governed in more detail in the Implementing Ordinance-Biocidal Products. Receive a bi-monthly summary of the latest news and stay up to date with developments in the field. 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 . 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. Monochlorobenzene 108-90-7 A Toluene 108-88-3 A 1-methyl-2-pyrrolidone/ N-Methylpyrrolidone 872-50-4 A Table 7: Minimize list . I understand that the inclusion of an aluminum foil layer in laminate materials is considered by FDA to be a functional . This inventory includes chemical substances deemed to be on the European Community market between January 1, 1971 and September 18, 1981. sponsor this page to leave your contact info on this page.. 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 ( Lists I - V / Part A or B) Remarks Food Contact GMP (Good Manufacturing Practice): Necessary cookies are absolutely essential for the website to function properly. Who: manufacturer or importer or only representative; Required info: physio-chemical data, toxicology data, eco-toxicology data and chemical safety report. For child labour the Ordinance requires in its annex 2 compliance with (i) the ILO Conventions no. Comments are accepted until April 5, 2023. The Swiss Food Safety and Veterinary Office (FSVO) and German Bundesinstitut fr Risikobewertung (BfR) currently have an informal arrangement whereby they . The active substances approved in the EU have been adopted by Switzerland in Annex 2 OBP. Annex 10 stipulates the substances that may be used for printing inks (see More information). 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. Annex 2.2 (Cleaning, deodorising and cosmetic products) Placing on the market of deodorisers and air-fresheners intended for . ANNEX 2 to the Convention on International Civil Aviation Rules of the Air Air travel must be safe and efficient; this requires, among ot her things, a set of internationally agreed rules of the air. Staffelstrasse 10CH-8045 ZurichSwitzerland. . The correspondences in Switzerland for the special provisions in the Implementing Regulation of the EU are considered in Annex 3 OBP. The report concludes that BPA does not represent a risk to consumers' health. 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). The following new substances are exempt from new substance notifications in Switzerland under the ChemO: *PPORD: This exemption needs to be declared to authority. The Swiss Federal Council, on the basis of Article 2 paragraph 4, 19, 22 paragraph 2, 24, 38, 39 paragraph 2, . 2 The Swiss Financial Market Supervisory Authority (FINMA) may issue implementing provisions. >\o 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. These cookies ensure basic functionalities and security features of the website, anonymously. Standard prohibitions on the provision of technical or financial assistance apply as well. A substance that is listed on EINECS may still require registration under the Swiss Chemicals Ordinance. 5 0 obj SGS Socit Gnrale de surveillance SA - 2022 - All rights reserved - SGS is a registered trademark of SGS Socit Gnrale de surveillance SA. The cookie is used to store the user consent for the cookies in the category "Analytics". Materials and articles in contact with food., Swiss Federal Food Safety and Veterinary Office (April 27, 2017). Swiss Federal Food Safety and Veterinary Office (April 27, 2017). 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. . Tableware, kitchen utensils and packaging inks and kitchen utensils contain substances that can contaminate food and thus pose a risk to health. 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. Chemical Risk Reduce Ordinance (ORRChem). What is to be considered a conflict and high[1]risk area is now defined in Art. 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. Part A of Annex 10 of the Swiss Printing Ink Ordinance contains a positive list of substances that can be used in printing inks on the non-contact surface of food contact materials. . YouTube sets this cookie to store the video preferences of the user using embedded YouTube video. In February 2023, the International Organization for Standardization (ISO) launched ISO 4484-1, a new test method to help the textile industry select fabrics that reduce shedding or material loss during use and laundering. Reminder: Unlike new substance notification or declaration, this registration needs to be done on a per product basis. If you are a consultant, you may get yourself listed in CSP business directory (free) or 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. Organization: Swiss Federal Office for the Environment. 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. 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. **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. Part II: Bulk and Intermediate Products Bulk and intermediate products 5 should be treated in a similar way to finished . We also use third-party cookies that help us analyze and understand how you use this website. This cookie is set by the Google recaptcha service to identify bots to protect the website against malicious spam attacks. This website uses cookies to give you the best experience.Learn More OK OK Packaging.. This cookie is installed by Google Analytics. Analytical cookies are used to understand how visitors interact with the website. The Ordinance is accompanied by several Annexes, consisting of positive lists of permitted substances for different uses, including plastics, cellulose films, ceramics and glass, silicone, and printing inks. New Swiss food law including FCM ordinance entered into force May 1, 2017; many CMR-substances deleted from positive list for printing inks. Please note that there is no official Swiss chemical inventory. . 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). Notification authority for chemicals of the Swiss Federal Office of Public Health. 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 . These cookies track visitors across websites and collect information to provide customized ads. Substances incorporated intopackaging materials, such as printed plastics, can migrate into foodstuffs and endanger health. The updated language now aligns more closely with Article 3 of the EUs Framework Regulation to allow use of recycled paper, provided that any migration of components from recycled paper to foodstuffs 1) does not pose a danger to human health, (2) is technically unavoidable, and (3) does not cause unacceptable changes to the composition of food in keeping with Article 49 of Swiss Ordinance 817.02 on Foodstuffs and Commodities. 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. To this end, it establishes the requirements for honesty, diligence and transparency in the provision of financial services and governs the offering . Annex 10: List of 564 substances with their selection criteria Presented are all substances and the 4 selection steps. 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. ); 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. A fully summary in IUCLID 5, meeting the criteria of a robust study summary, is sufficient. 13 . In 2008 an amendment to the Swiss Ordinance on Materials and Articles (SR 817.023.21) was made, detailing certain provisions specific to food packaging inks. Aside from the provisions covering BPA, food contact materials must comply with all new changes to Ordinance 817.023.21 by November 30, 2020. 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. Contact us for more information or visit our website. The Swiss Printing Inks Ordinance outlines that the following data should be included in a petition for a food contact printing ink: information regarding the toxicology of the substance; the nature and concentration of the substance migrating to the foodstuffs or to the food simulants; If you have questions or need any help, please contact our sponsor. For this purpose, the Swiss Federal Council has approved the complete revision of the Ordinance on Measures against Belarus, which entered . This cookie is used by the website's WordPress theme. Country: Switzerland . Luckily, the Swiss Authority accepts REACH registration dossier in IUCLID 5 format. 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). Annex 4 of DFI Swiss Ordinance 817.023.21 The present review only refers to food-contact applications. 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. stream SML values from Union list, Swiss Ordinance or evaluations of MS authorities 2. Switzerland also uses EINECS as their existing chemical substance inventory. 1.2. 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 cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional". 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. Note: The restriction of the marketing and uses of certain substances, preparations and articles are governed by another ordinance Chemical Risk Reduce Ordinance (ORRChem). However, the Swiss Chemicals Ordinance (ChemO) governs more than just new substances. Until now, Annex 10 has consisted of two parts, Part A and Part B. It is strictly educational and does not replace any legal requirements or applicable regulations. even Swiss companies that are not currently affected will . 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