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 . 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). 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). Permitted substances are defined as those listed in Annex 2 Lists I and II and in Annex 10, December 2020. . Several substances have been removed from the list due to their carcinogenic, mutagenic, or reprotoxic (CMR) properties. Who: manufacturer or importer or only representative; Required info: physio-chemical data, toxicology data, eco-toxicology data and chemical safety report. Automotive, Electrical & Electronics, Electrical & Electronics, Hardgoods, Hardgoods, Hardgoods, Hardgoods, Hardgoods, Personal and Protective Equipment, Softlines, Footwear and Leather Products, Softlines, Softlines, Softlines. Until now, Annex 10 has consisted of two parts, Part A and Part B. 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. The Ordinance defines exemptions from the due diligence and reporting obligations in the areas of minerals and metals (art. 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. Address: CH-3003 Bern . The Swiss Federal Council, on the basis of Article 2 paragraph 4, 19, 22 paragraph 2, 24, 38, 39 paragraph 2, . Swiss Federal Food Safety and Veterinary Office (April 27, 2017). even Swiss companies that are not currently affected will . Ordinance concerning Capital Adequacy and Risk Diversification for Banks and Securities Dealers | 7 The active substances approved in the EU have been adopted by Switzerland in Annex 2 OBP. This cookie is set by GDPR Cookie Consent plugin. 5 0 obj But opting out of some of these cookies may affect your browsing experience. Receive a bi-monthly summary of the latest news and stay up to date with developments in the field. 7 Version according to Annex 2 Sect. Substances on REACH SVHC list will be added to the Annex 7 of ChemO. The report concludes that BPA does not represent a risk to consumers' health. to keep Food Packaging Forums work going. 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. However, the Swiss Chemicals Ordinance (ChemO) governs more than just new substances. The core element of the new regulation is a list of "permitted . 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 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. . 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. 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. 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 2 stipulates the substances that may be used for the plastic layers in utility articles made of plastic. . What are the Requirements for Using Aluminum Foil as a Functional Barrier? 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. +41 58 462 20 07, info@gs-wbf . A notification fee also needs to be paid. On Tuesday, 7 February, President Alain Berset met with President Mokgweetsi Eric Keabetswe Masisi in the capital Gaborone, as part of a two-day trip to Botswana. 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). Those specific migration limits (SML) are expressed in . 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 . The financial sanctions now extend to Russian President Vladimir Putin, Prime Minister Mikhail Mishustin and Foreign Minister Sergey Lavrov. 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. 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.. 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. Switzerland has its own chemical regulations adopting REACH-like registration requirements, but only on new substances placed on the Swiss market. This inventory includes chemical substances deemed to be on the European Community market between January 1, 1971 and September 18, 1981. Reminder: Unlike new substance notification or declaration, this registration needs to be done on a per product basis. 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. Staffelstrasse 10CH-8045 ZurichSwitzerland. The cookies is used to store the user consent for the cookies in the category "Necessary". This website uses cookies to improve your experience while you navigate through the website. At this time, the Implementing Ordinance-Biocidal Products governs in detail the following procedures: Procedure for the authorisation of the same biocidal products What is to be considered a conflict and high[1]risk area is now defined in Art. Since the Chemical Risk Reduction Ordinance (ORRChem) is updated frequently, please click here to search the latest restrictions for each substance or product type. 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. Friday, December 20, 2019 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. >\o A fully summary in IUCLID 5, meeting the criteria of a robust study summary, is sufficient. 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 (. 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 . Tags: Topics - CH,Substance Restriction in Articles, Subscribe to Free Newsletter On the Swiss Federal Food Safety and Veterinary Offices website a logbook of changes regarding the positive list for printing inks is available. 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). YouTube sets this cookie via embedded youtube-videos and registers anonymous statistical data. . It is the first time a Swiss president has visited the country. The food law includes the ordinance on materials and articles intended to come into contact with food. 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),. 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. 4 and 5 of the Ordinance), exemptions from the due diligence and reporting obligations due to compliance with internationally recognized and equivalent regulatory frameworks . These cookies will be stored in your browser only with your consent. English is not an official language of the Swiss Confederation. sponsor this page to leave your contact info on this page.. The US EPA has issued a final rule to revise the Formaldehyde Standards for Composite wood Products Act. 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. Belarus. %%EOF Vc!Fs1=FzT39!Osn,%u"MVybD/Ih&>7&&?Q Printing inks also contain substances that could pose a risk. Introduction and summary On 16March 2022, the Swiss Federal Council, in view of Belarus' involvement in Russia's warfare in Ukraine, decided to adopt in full the extended sanctions against Belarus introduced by the EU on 2 and 9 March 2022. It is strictly educational and does not replace any legal requirements or applicable regulations. General restrictions related to plastic materials and articles are laid down in Annex II. 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: List of 564 substances with their selection criteria Presented are all substances and the 4 selection steps. A manufacturer or an importer must notify a new substance before it is placed on the market for the first time in Switzerland. This final rule will become effective on March 23, 2023. Analytical cookies are used to understand how visitors interact with the website. For substances registered under EU REACH after 1 June 2008, it is not mandatory to send in copies of full test reports. 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. 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. 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). You may also find an expert in CSP business directory below. . It allows the website owner to implement or change the website's content in real-time. Similar to EU REACH, a company based outside of the Switzerland can appoint a Swiss only representative to notify. 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. Materials and articles in contact with food., Swiss Federal Food Safety and Veterinary Office (April 27, 2017). This cookie is installed by Google Analytics. Annex 2 stipulates the substances that may be used for the plastic layers in utility articles made of plastic. Monochlorobenzene 108-90-7 A Toluene 108-88-3 A 1-methyl-2-pyrrolidone/ N-Methylpyrrolidone 872-50-4 A Table 7: Minimize list . The cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. . 26 . 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. In the corresponding SoC template the listing status of all potentially migrants in the National Standard GB 9685-2016 ("Standard for Uses of Additives in Food Contact Materials and Articles") is provided and furthermore an information about the listing status in the Swiss Ordinance SR 817.023.2, the Regulation (EU) No 10/2011, the FDA . 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. For this reason the FSVO has issued regulations governing packaging. We do not provide consultancy services. Keller and Heckman LLP. 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 assets of the persons and companies listed in the annex to the ordinance are frozen with immediate effect; the ban on entering into new business relationships remains in place. 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. 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. Higher data package is required for higher volume substances. 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; . Organization: Swiss Federal Office for the Environment. 19 is authority, the Swiss Agency for ther- apeutic products (commonly called Swissmedic), has powers approximately 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. Part II: Bulk and Intermediate Products Bulk and intermediate products 5 should be treated in a similar way to finished . 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). 1.2. PackagingLaw.com is the premier online resource for the global packaging industry. listed in Annex 2 of the GCO Ordinance, when such goods are: (i) destined for or intended for use . Comments are accepted until April 5, 2023. The rules developed by ICAO - which consist of general rules, visual flight rules and instrument flight rules contained The Swiss Food Safety and Veterinary Office (FSVO) and German Bundesinstitut fr Risikobewertung (BfR) currently have an informal arrangement whereby they . Data requirement for new substance notification under ChemO is the same as EU REACH registration. These modifications enter into force . Packaging.. 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. 2 Object of taxation The following are liable for tax: a. VOCs on the positive list of substances (Annex 1); b. Required info is very simple and mainly includes substance identity, composition of preparation, intended uses and classification and labelling. Staff from the Swiss Humanitarian Aid Unit will accompany the aid shipment. 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 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. 186 V. Junod / European Journal of Health Law 15 (2008) 183-195 coverage policy and, of course, the risk-bene t balance. In the meantime, manufacturers and importers are required to submit the classification and labelling info of hazardous substances (including <1t/y new substances and exempt new substances) and preparations to the Swiss authority within 3 months after first placing them on the Swiss market. This aligns the Swiss Ordinance with provisions from the following EU regulations: sponsor this page to leave your contact info on this page.. Dr. Hingwo TsangGlobal Information and Innovation Managert: (+852) 2774 7420. 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. 2(1)(e) of the Ordinance (same wording as in Regulation (EU) 2017/821 on conflict minerals). 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. This is a publication of SGS, except for 3rd parties contents submitted or licensed for use by SGS. Test reports not currently affected will of the GCO Ordinance, when goods. Of plastic should be treated in a similar way to finished a publication of SGS except! Info on this page 1, 1971 and September 18, 1981 selection criteria Presented are all and! A Toluene 108-88-3 a 1-methyl-2-pyrrolidone/ N-Methylpyrrolidone 872-50-4 a Table 7: Minimize list the 's... Is sufficient owner to implement or change the website Ordinance, when such goods are: ( )! 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