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. 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. For this reason the FSVO has issued regulations governing packaging. 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. Receive a bi-monthly summary of the latest news and stay up to date with developments in the field. Swiss Ink Ordinance 2-Methoxyethanol (methyl glycol) 109-86-4 Deleted from Swiss Ord. If you have questions or need any help, please contact our sponsor. 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. The biocide triclosan (CAS 3380-34-5) has also been deleted from the list. This translation is provided for information purposes only and has no legal force. . Annex 10 of the Ordinance of the FDHA (Federal Department of Home Affairs) on materials and articles intended to come into contact with foodstuffs regarding List of permitted substances for the production of packaging inks, and related requirements, came into force on 1st December, 2020. The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional". . Contact us for more information or visit our website. Annex 2 stipulates the substances that may be used for the plastic layers in utility articles made of plastic. In the end, its only trusted because its tested. . 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. 0 This cookie is set by GDPR Cookie Consent plugin. This cookie is set by the Google recaptcha service to identify bots to protect the website against malicious spam attacks. 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. 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. 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; 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. Since the Chemical Risk Reduction Ordinance (ORRChem) is updated frequently, please click here to search the latest restrictions for each substance or product type. It is similar to C&L notification under the EU CLP regulation. It is not intended to constitute consulting or professional advice. listed in Annex 2 of the GCO Ordinance, when such goods are: (i) destined for or intended for use . What is to be considered a conflict and high[1]risk area is now defined in Art. If you are a consultant, you may get yourself listed in CSP business directory (free) or This is a publication of SGS, except for 3rd parties contents submitted or licensed for use by SGS. 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. Bern, 25.02.2022 - On 25 February 2022 the Federal Department of Economic Affairs, Education and Research EAER modified Annex 3 of the Ordinance on measures to prevent the circumvention of international sanctions in relation to the situation in Ukraine. 2-Ethoxyethanol (Ethyl glycol) 110-80-5 Deleted from Swiss Ord. For substances registered under EU REACH after 1 June 2008, it is not mandatory to send in copies of full test reports. The food law includes the ordinance on materials and articles intended to come into contact with food. 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; . The assets of sanctioned individuals and companies are frozen with immediate effect. Through its independent, balanced, and science-based publications and tools, the Food Packaging Forum contributes to protecting human and environmental health. English is not an official language of the Swiss Confederation. Comments are accepted until April 5, 2023. 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. . BPA can be detected both in foodstuffs and in utility articles. This website uses cookies to give you the best experience.Learn More OK OK Ti-Pure products may not be directly added to food, pharmaceuticals, cosmetics, or cigarette papers/filters for . Official Collection 2019 3371 was published on November 5, 2019. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc. The following banks are listed in Annex 15 of the Ordinance: Belagroprombank, Bank . 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 report concludes that BPA does not represent a risk to consumers' health. For polymer, this notification applies to monomers. The Ordinance defines exemptions from the due diligence and reporting obligations in the areas of minerals and metals (art. A letter of access is required if a late notifier wishes to share the data submitted by a previous registrant. All rights reserved. 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 . Similar to EU REACH, a company based outside of the Switzerland can appoint a Swiss only representative to notify. . 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. 192 0 obj <>stream Bisphenol A (BPA) is a synthetic substance used to manufacture various plastic materials intended, among other things, for contact with foodstuffs. Annex 10 stipulates the substances that may be used for printing inks (see More information). ", 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. The Ordinance (section 12) defines the provisions related to printing inks for non-food contact surfaces of food contact materials. Plastic materials and articles shall not transfer their constituents to foods in quantities exceeding the specific migration limits (SML) set out in Annex I. 1. 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. A new substance is defined a substance that is not listed on EINECS (European Inventory of Existing Commercial Chemical Substances). Substances incorporated intopackaging materials, such as printed plastics, can migrate into foodstuffs and endanger health. %PDF-1.7 % CHF100, to issue a public deed (see clause 1.2, Annex to the Notary Fee Ordinance of the Canton of Zurich (Notariatsgebhrenverordnung)). These cookies ensure basic functionalities and security features of the website, anonymously. 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 . Other uncategorized cookies are those that are being analyzed and have not been classified into a category as yet. This cookie is set by GDPR Cookie Consent plugin. Monochlorobenzene 108-90-7 A Toluene 108-88-3 A 1-methyl-2-pyrrolidone/ N-Methylpyrrolidone 872-50-4 A Table 7: Minimize list . 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. 2 The OSAV publishes these instructions in the Official Swiss Trade Sheet. Notification applies to a substance on its own, in a mixture or intended to be released from an article under normal conditions of use. 2 10 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). 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. 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. sponsor this page to leave your contact info on this page.. 13 . % Investigational medicinal products in their final packaging are treated similarly. 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). I understand that the inclusion of an aluminum foil layer in laminate materials is considered by FDA to be a functional Packaging.. The chemical authority is the Notification authority for chemicals of the Swiss Federal Office of Public Health. 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 . The following new substances are exempt from new substance notifications in Switzerland under the ChemO: *PPORD: This exemption needs to be declared to authority. Staffelstrasse 10CH-8045 ZurichSwitzerland. The core element of the new regulation is a list of "permitted . 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. 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 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. Switzerland issued a revised version of its Ordinance on Materials and Articles (SR 817.023.21), which came into force on 1st May 2017. For more info, please refer to new substance declaration part. 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 The food industry is subject to strict requirements that are set out in the Ordinance on Materials and Articles (in French). By accepting, you agree to our use of cookies. 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. Situation in Ukraine: Switzerland extends its measures. This cookie, set by YouTube, registers a unique ID to store data on what videos from YouTube the user has seen. 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. 4 of the Banking Ordinance of 30 April 2014, in force since 1 January 2015 (AS 2014 1269). This cookie is used by the website's WordPress theme. 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. 2023 It allows the website owner to implement or change the website's content in real-time. Bisphenol A 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). 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; The issuance . 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 . 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. If you just wish to have a quick look at what restrictions look like, you may click the following two summaries. This cookie is set by GDPR Cookie Consent plugin. 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. 7 Version according to Annex 2 Sect. to keep Food Packaging Forums work going. On the Swiss Federal Food Safety and Veterinary Office's website a logbook of changes regarding the positive list for printing inks is available. For this purpose, the Swiss Federal Council has approved the complete revision of the Ordinance on Measures against Belarus, which entered . Switzerland also uses EINECS as their existing chemical substance inventory. This website uses cookies to improve your experience while you navigate through the website. This cookie is installed by Google Analytics. Please note that there is no official Swiss chemical inventory. These cookies will be stored in your browser only with your consent. Annex 4 of DFI Swiss Ordinance 817.023.21 The present review only refers to food-contact applications. The consequence of this change is that substances not included in Part A of the Annex can be used under self-control if they are not CMR and do not migrate into food at levels above 10 ppb. Tags: Topics - CH,Substance Restriction in Articles, Subscribe to Free Newsletter The cookie is used to store the user consent for the cookies in the category "Analytics". hbbd``b` $3@/`b@\W+D)HRjd100Mg4` 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. 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). 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. 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 . 1.2. 186 V. Junod / European Journal of Health Law 15 (2008) 183-195 coverage policy and, of course, the risk-bene t balance. A fully summary in IUCLID 5, meeting the criteria of a robust study summary, is sufficient. 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. Note: The restriction of the marketing and uses of certain substances, preparations and articles are governed by another ordinance Chemical Risk Reduce Ordinance (ORRChem). This obligation is called registration. 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. 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. Target: new substances >=1t/y for product- and process-orientated research and development (PPORD); Required info: substance identity, uses, and expected quantity. 168 0 obj <> endobj 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. The substances permitted to be used in printing inks are listed in Annex 2 of the Swiss Ordinance, referred to plastics, and Annex 10, referred to printing inks (Annex 6 in former versions of the Ordinance; revised version came into force on May 1st, 2017). A copy of the fully executed agreement is sent to all parties by email. Cooperation on printing inks 3 5th EFSA FIP Network FCM Meeting, Parma, 10.-11.7.17 1900s. Amongst them, "Union" would correspond to "Switzerland". 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. 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 \j}M2'L~u}0 These will be implemented in phases, starting April 1, 2022. 5 0 obj Until now, Annex 10 has consisted of two parts, Part A and Part B. Dr. Hingwo TsangGlobal Information and Innovation Managert: (+852) 2774 7420. 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. `` Functional '' the substances that may be used for printing inks for non-food contact surfaces of food materials! 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