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). Investigational medicinal products in their final packaging are treated similarly. This Chemical Risk Reduction Ordinance prohibits or restricts the marketing and use of certain hazardous substances on its own or in preparations and articles. 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. A full logbook of these changes and more information about the updated Ordinance can be found at the FSVO Website. This inventory includes chemical substances deemed to be on the European Community market between January 1, 1971 and September 18, 1981. 4 The addenda listed in List II of Annex 1 shall not exceed the limit values laid down therein and shall meet the specific . 0 The financial sanctions now extend to Russian President Vladimir Putin, Prime Minister Mikhail Mishustin and Foreign Minister Sergey Lavrov. A fully summary in IUCLID 5, meeting the criteria of a robust study summary, is sufficient. Who: manufacturer or importer or only representative; Required info: physio-chemical data, toxicology data, eco-toxicology data and chemical safety report. Notification applies to a substance on its own, in a mixture or intended to be released from an article under normal conditions of use. Those specific migration limits (SML) are expressed in . BPA can be detected both in foodstuffs and in utility articles. 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. A cookie set by YouTube to measure bandwidth that determines whether the user gets the new or old player interface. This cookie, set by YouTube, registers a unique ID to store data on what videos from YouTube the user has seen. 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. 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. 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; INX carried out a review of the raw materials used in the products below to determine their status with respect to the Swiss Ordinance and found that the products below meet the Swiss Ordinance Annex 10. EINECS (European Inventory of Existing Commercial Chemical Substances). 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. PackagingLaw.com is the premier online resource for the global packaging industry. Belarus. This website uses cookies to give you the best experience.Learn More OK OK 2 The Swiss Financial Market Supervisory Authority (FINMA) may issue implementing provisions. last required signature was executed (Swiss Federal Supreme Court 129 IV 130 c. 2.3 and 3). The list of the active substances in Annex 2 OBP is available under Documents in electronic form. Plastic materials and articles shall not transfer their constituents to foods in quantities exceeding the specific migration limits (SML) set out in Annex I. We also use third-party cookies that help us analyze and understand how you use this website. The biocide triclosan (CAS 3380-34-5) has also been deleted from the list. 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. The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional". 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. For substances registered under EU REACH after 1 June 2008, it is not mandatory to send in copies of full test reports. sponsor this page to leave your contact info on this page.. % Processes involving the application of printing inks to the non-food contact side of a material or article. Ordinance concerning Capital Adequacy and Risk Diversification for Banks and Securities Dealers | 7 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. The active substances approved in the EU have been adopted by Switzerland in Annex 2 OBP. INX carried out a review of the raw materials used in the products below to determine their status with respect to the Swiss Ordinance and found that the products below meet the Swiss Ordinance Annex 10. Materials and articles in contact with food. Reminder: Unlike new substance notification or declaration, this registration needs to be done on a per product basis. The European Chemicals Agency has launched a 45-day consultation for listing two chemicals as substances of very high concern (SVHC). 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. 1, plastic materials and articles intended to come into contact with foodstuffs for infants and young children within the meaning of the Ordinance of the DFI of 16 December 2016 on food for persons with needs Individuals 1 Shall not assign their constituents to foodstuffs or simulants of foodstuffs in quantities To navigate items, use the arrow, home, and end keys. ( Lists I - V / Part A or B) Remarks Food Contact A positive assessment of the binder, does not release the user from the du- Contact us for more information or visit our website. Dr. Hingwo TsangGlobal Information and Innovation Managert: (+852) 2774 7420. Similar to EU REACH, a company based outside of the Switzerland can appoint a Swiss only representative to notify. 2023 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 . Automotive, Electrical & Electronics, Electrical & Electronics, Hardgoods, Hardgoods, Hardgoods, Hardgoods, Hardgoods, Personal and Protective Equipment, Softlines, Footwear and Leather Products, Softlines, Softlines, Softlines. Notification authority for chemicals of the Swiss Federal Office of Public Health. 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. The correspondences in Switzerland for the special provisions in the Implementing Regulation of the EU are considered in Annex 3 OBP. Switzerland has its own chemical regulations adopting REACH-like registration requirements, but only on new substances placed on the Swiss market. It has been amended several times. This site uses cookies, including third-party cookies. The cookie is used to store the user consent for the cookies in the category "Analytics". Several substances have been removed from the list due to their carcinogenic, mutagenic, or reprotoxic (CMR) properties. 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 (. 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). %PDF-1.4 2 The OSAV publishes these instructions in the Official Swiss Trade Sheet. 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. even Swiss companies that are not currently affected will . 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. 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),. Ti-Pure products may not be directly added to food, pharmaceuticals, cosmetics, or cigarette papers/filters for . Annex. 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. I understand that the Japan MHLW Notification No. This may pose a threat to health. Substances on REACH SVHC list will be added to the Annex 7 of ChemO. Note: The restriction of the marketing and uses of certain substances, preparations and articles are governed by another ordinance Chemical Risk Reduce Ordinance (ORRChem). Tableware, kitchen utensils and packaging inks and kitchen utensils contain substances that can contaminate food and thus pose a risk to health. 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 168 0 obj <> endobj 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. The following chemicals are exempt from registrations under ChemO: Note: A notified or declared new substance does not require registration. Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features. SML values from Union list, Swiss Ordinance or evaluations of MS authorities 2. This final rule will become effective on March 23, 2023. . This cookie is set by GDPR Cookie Consent plugin. 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. listed in Annex 2 of the GCO Ordinance, when such goods are: (i) destined for or intended for use . Since Switzerland is not a member of the EU or the European Economic Area (EEA), EU REACH regulation does not apply here. It is similar to C&L notification under CLP regulation. 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. 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. Since the Chemical Risk Reduction Ordinance (ORRChem) is updated frequently, please click here to search the latest restrictions for each substance or product type. This cookie is installed by Google Analytics. The cookie is used to store the user consent for the cookies in the category "Performance". The cookie stores information anonymously and assigns a randomly generated number to recognize unique visitors. Annex 10: List of 564 substances with their selection criteria Presented are all substances and the 4 selection steps. All rights reserved. Aineen tai seoksen merkitykselliset tunnistetut kytt ja kytt, joita ei suositella 1.2.1. I. YouTube sets this cookie via embedded youtube-videos and registers anonymous statistical data. 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. Moreover, the Ordinance contains additional epoxy derivatives from European Commission Regulation (EC) No 1895/2005 on its positive list, including 2,2-bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl) ether (BADGE) and novolac glycidyl ethers (NOGE). 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. It does not store any personal data. Target: new substances >=1t/y for product- and process-orientated research and development (PPORD); Required info: substance identity, uses, and expected quantity. What is to be considered a conflict and high[1]risk area is now defined in Art. All dual-use products and technology, according to Annex 2 of the Swiss Goods Control Ordinance of 3 June 2016. 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. All versions (Texts on reference publications - annexes 3a, 7, 7a AMZV; annexes 2, 3 VAZV; annexes 4-10 KPAV) 1.7.2022 Annex 7 AMZV . 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 We do not provide consultancy services. 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. The food industry is subject to strict requirements that are set out in the Ordinance on Materials and Articles (in French). **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. 10 Version according to Annex 2 Section 4 of the Banking Ordinance of 30 April 2014, in force since 1 January 2015 (AS 2014 1269). The ordinance is almost a combined version of EU RoHS, REACH Annex XVII Restricted Substance List and REACH Annex XIV Authorization List. 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. What are the Requirements for Using Aluminum Foil as a Functional Barrier? For this reason the FSVO has issued regulations governing packaging. 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. Data requirement for new substance notification under ChemO is the same as EU REACH registration. If you just wish to have a quick look at what restrictions look like, you may click the following two summaries. You also have the option to opt-out of these cookies. 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. Section 12 sets out the provisions specific to food contact material inks. 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 applies by analogy, specifically because MedDO Annex 2 and IvDO Annex 1 list the correspondence of terms between the EU regulation and Swiss ordinance. Comments are accepted until April 5, 2023. These will be implemented in phases, starting April 1, 2022. If you have questions or need any help, please contact our sponsor. 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. Part II: Bulk and Intermediate Products Bulk and intermediate products 5 should be treated in a similar way to finished . Packagingcontains substances that may migrate into the foodstuff and thus into the human body. The National Council Social Security and Health Committee asked the Federal Council to prepare a report on the benefits and risks of using BPA in packaging and utility articles. The chemical authority is the Notification authority for chemicals of the Swiss Federal Office of Public 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. 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 that this list follows the Annex of Regulation (EU) 2021/821 and includes a total of 6'251 goods enclosed in 929 6-digits tariff subheadings; . 2 and 3 of the Ordinance) and child labor (art. This annex sets the price cap for crude oil and petroleum products which originates in or are exported from Russia falling under CN codes 2710.12, 2710.19, 2710.20, 2710.91, and 2710.99. The rules developed by ICAO - which consist of general rules, visual flight rules and instrument flight rules contained SGS Socit Gnrale de surveillance SA - 2022 - All rights reserved - SGS is a registered trademark of SGS Socit Gnrale de surveillance SA. Annex 10 includes a positive list for binders (monomers), dyes and pigments, solvents . 18 A clinical trial positively reviewed by the ethics committee must then be submitted to the federal admin-istrative authority created by the LTP. 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; This cookie is set by the Google recaptcha service to identify bots to protect the website against malicious spam attacks. This obligation is called registration. The assets of sanctioned individuals and companies are frozen with immediate effect. 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). 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. Specific migration limits. You may also find an expert in CSP business directory below. On the Swiss Federal Food Safety and Veterinary Office's website a logbook of changes regarding the positive list for printing inks is available. The cookie is used to store the user consent for the cookies in the category "Other. 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 following new substances are exempt from new substance notifications in Switzerland under the ChemO: *PPORD: This exemption needs to be declared to authority. I understand that the inclusion of an aluminum foil layer in laminate materials is considered by FDA to be a functional Annex to the DETEC Ordinance of 3 December 1996 relating to the transport of dangerous goods by rail and . . This cookie is used by the website's WordPress theme. endstream endobj startxref For more info, please refer to new substance declaration part. 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. It allows the website owner to implement or change the website's content in real-time. Is there guidance on what information must be in a Food Master File? Annex 2, OBP Implementing Ordinance-Biocidal Products FDHA Certain provisions of the OBP are governed in more detail in the Implementing Ordinance-Biocidal Products. CHF100, to issue a public deed (see clause 1.2, Annex to the Notary Fee Ordinance of the Canton of Zurich (Notariatsgebhrenverordnung)). Only Part A substances will remain listed in the new legislation. A substance that is listed on EINECS may still require registration under the Swiss Chemicals Ordinance. 26 . It: Highlights of several of the aforementioned amendments and Annex 1.16 PFAS are summarized in Table 1. 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. 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. 7 Version according to Annex 2 Sect. Switzerland now also prohibits the sale, supply, export, transit or transport of goods intended for industrial strengthening as listed in Annex 23 of the Ukraine Ordinance to or for use in Russia. 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. The substance may be contained in food can coatings, till receipts and toys, for example. Target: Substances and preparations that are hazardous or PBT/vPvB or on Swiss SVHC candidate list; Registration is done on a per product basis; Similar to C&L notification under EU CLP regulation; Required info: substance identity, classification & labelling, uses, quantity, and chemical safety report (if available). 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.