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. Tags: Topics - CH,Substance Restriction in Articles, Subscribe to Free Newsletter endstream endobj startxref The US EPA has issued a final rule to revise the Formaldehyde Standards for Composite wood Products Act. The food industry is subject to strict requirements that are set out in the Ordinance on Materials and Articles (in French). This is a publication of SGS, except for 3rd parties contents submitted or licensed for use by SGS. Belarus. 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). Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors. 9 Amended by Annex 3 No II 8 of the O of 22 June 2005 on Movements of Waste, in force . First visit by a Swiss president to Botswana. Vc!Fs1=FzT39!Osn,%u"MVybD/Ih&>7&&?Q Who: manufacturer or importer or only representative; Required info: physio-chemical data, toxicology data, eco-toxicology data and chemical safety report. Packagingcontains substances that may migrate into the foodstuff and thus into the human body. 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. 2 The Swiss Financial Market Supervisory Authority (FINMA) may issue implementing provisions. 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. teolliseen/ammattimaiseen kyttn : Ainoastaan ammattikyttn Aineen/seoksen kytt : Vedeneristeet . 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. ( 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 European Chemicals Agency has launched a 45-day consultation for listing two chemicals as substances of very high concern (SVHC). 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 . YSC cookie is set by Youtube and is used to track the views of embedded videos on Youtube pages. 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 These cookies track visitors across websites and collect information to provide customized ads. 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. Situation in Ukraine: Switzerland extends its measures. 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). 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. 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. This cookie, set by YouTube, registers a unique ID to store data on what videos from YouTube the user has seen. 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),. Printing inks also contain substances that could pose a risk. The cookie is used to store the user consent for the cookies in the category "Other. A letter of access is required if a late notifier wishes to share the data submitted by a previous registrant. General restrictions related to plastic materials and articles are laid down in Annex II. This exemption is usually limited to a quantity required for the purpose and a period not exceeding five years. Bisphenol A 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 . 5 0 obj 2023 2 Object of taxation The following are liable for tax: a. VOCs on the positive list of substances (Annex 1); b. Notification authority for chemicals of the Swiss Federal Office of Public Health. sponsor this page to leave your contact info on this page.. **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. 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. . 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. 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). This Chemical Risk Reduction Ordinance prohibits or restricts the marketing and use of certain hazardous substances on its own or in preparations and articles. The ChemO has also adopted GHS by requiring suppliers to classify, label and package hazardous substances and preparations in accordance with EU CLP regulation. A substance that is listed on EINECS may still require registration under the Swiss Chemicals Ordinance. 326 80-05-7 2,2-Bis(4-hydroxyphenyl)propan = 4,4'-isopropylidenediphenol = Bisphenol A HPV Not pers 1 High We do not provide consultancy services. Is there guidance on what information must be in a Food Master File? A new substance is defined a substance that is not listed on EINECS (European Inventory of Existing Commercial Chemical Substances). Standard prohibitions on the provision of technical or financial assistance apply as well. 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. 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). I. The Russia Sanctions Ordinance prohibits Swiss banks from accepting deposits by Russian nationals or residents and banks, enterprises and other entities established in Russia if the total Ordinance concerning Capital Adequacy and Risk Diversification for Banks and Securities Dealers | 7 Ordonnance du DFI sur les matriaux et objets destins entrer en contact avec les denres alimentaires (Ordonnance sur les matriaux et objets) Annexe 9 de l'ordonnance du DFI sur les matriaux et objets destins entrer en contact avec les denres alimentaires (PDF, 292 kB, 15.10.2022) View Past Newsletter. 192 0 obj <>stream Automotive, Electrical & Electronics, Electrical & Electronics, Hardgoods, Hardgoods, Hardgoods, Hardgoods, Hardgoods, Personal and Protective Equipment, Softlines, Footwear and Leather Products, Softlines, Softlines, Softlines. Art. 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. . 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 . It allows the website owner to implement or change the website's content in real-time. The chemical authority is the Notification authority for chemicals of the Swiss Federal Office of Public Health. Substances incorporated intopackaging materials, such as printed plastics, can migrate into foodstuffs and endanger health. Materials and articles in contact with food. 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. CHF100, to issue a public deed (see clause 1.2, Annex to the Notary Fee Ordinance of the Canton of Zurich (Notariatsgebhrenverordnung)). The relevant thresholds are listed in Annex 1 to the Ordinance with the corresponding customs tariff numbers. Staffelstrasse 10CH-8045 ZurichSwitzerland. 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. Disclosures of migrating substances are demanded under both *Decisive quantity: This is the higher one of the annual quantity of a substance placed on Swiss market and the total quantity introduced to the EEA in a year. 1. 186 V. Junod / European Journal of Health Law 15 (2008) 183-195 coverage policy and, of course, the risk-bene t balance. It does not store any personal data. 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. % 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. 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. Chemical Risk Reduce Ordinance (ORRChem). For polymer, this notification applies to monomers. 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. %%EOF These cookies ensure basic functionalities and security features of the website, anonymously. Annex 10: List of 564 substances with their selection criteria Presented are all substances and the 4 selection steps. 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; To this end, it establishes the requirements for honesty, diligence and transparency in the provision of financial services and governs the offering . 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; . It: Highlights of several of the aforementioned amendments and Annex 1.16 PFAS are summarized in Table 1. I understand that the inclusion of an aluminum foil layer in laminate materials is considered by FDA to be a functional We also use third-party cookies that help us analyze and understand how you use this website. Chemical substances that are subject to other laws (i.e., medicines, food stuffs, weapon, wastes, ammunition, fertilizer, therapeutic products, etc. restriction outlined in Annex II (as last updated by EU 2020/1245) and 1Severe Metals Migration Testing in . 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. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc. At this time, the Implementing Ordinance-Biocidal Products governs in detail the following procedures: Procedure for the authorisation of the same biocidal products 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. This cookie is set by GDPR Cookie Consent plugin. Consumers are exposed to too little of the substance for it to have any impact on health (see "More information"). 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 Name: Richard Ballaman . It is similar to C&L notification under the EU CLP regulation. 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). 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. \j}M2'L~u}0 Through its independent, balanced, and science-based publications and tools, the Food Packaging Forum contributes to protecting human and environmental health. last required signature was executed (Swiss Federal Supreme Court 129 IV 130 c. 2.3 and 3). PackagingLaw.com is the premier online resource for the global packaging industry. Annex to the DETEC Ordinance of 3 December 1996 relating to the transport of dangerous goods by rail and . 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. If you have questions or need any help, please contact our sponsor. For more info, please refer to ChemO registration part. Annex 2 stipulates the substances that may be used for the plastic layers in utility articles made of plastic. 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. Permitted substances are defined as those listed in Annex 2 Lists I and II and in Annex 10, December 2020. . 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. The rules developed by ICAO - which consist of general rules, visual flight rules and instrument flight rules contained A manufacturer or an importer must notify a new substance before it is placed on the market for the first time in Switzerland. 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. These will be implemented in phases, starting April 1, 2022. 4 The addenda listed in List II of Annex 1 shall not exceed the limit values laid down therein and shall meet the specific . Switzerland also uses EINECS as their existing chemical substance inventory. Please note that there is no official Swiss chemical inventory. 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. 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.. Necessary cookies are absolutely essential for the website to function properly. Reminder: Unlike new substance notification or declaration, this registration needs to be done on a per product basis. It has been amended several times. Merkitykselliset tunnistetut kytt Pasiallinen kyttkategoria : Rakennusmateriaalit Erit. In November 2020, Switzerland published RO 2020 4811 (in French, German or Italian) under Official Collection No. 13 . Article 11. 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. . Union list of approved active substances 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. Organization: Swiss Federal Office for the Environment. Since Switzerland is not a member of the EU or the European Economic Area (EEA), EU REACH regulation does not apply here. The biocide triclosan (CAS 3380-34-5) has also been deleted from the list. Entities have until May 31, 2020 to comply with the new provisions covering BPA. Bisphenol A (BPA) is a synthetic substance used to manufacture various plastic materials intended, among other things, for contact with foodstuffs. The following new substances are exempt from new substance notifications in Switzerland under the ChemO: *PPORD: This exemption needs to be declared to authority. 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. 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. Address for enquiries EAER Communications, Tel. 2-Ethoxyethanol (Ethyl glycol) 110-80-5 Deleted from Swiss Ord. 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. In addition to modifying the text of the legislation and six of the 10 existing annexes, the amendment introduces a new Annex 11, which provides guideline values for the verification of good manufacturing processes as they . 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 . This obligation is called registration. Substances on packaging materials, such as printed plastics, can migrate into foodstuffs and endanger health. . You also have the option to opt-out of these cookies. The correspondences in Switzerland for the special provisions in the Implementing Regulation of the EU are considered in Annex 3 OBP. This translation is provided for information purposes only and has no legal force. 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. Aside from the provisions covering BPA, food contact materials must comply with all new changes to Ordinance 817.023.21 by November 30, 2020. Reference to Annex II, Section II.1, to that Directive: point 6.8. . 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. Only Part A substances will remain listed in the new legislation. 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. Higher data package is required for higher volume substances. 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. What are the Requirements for Using Aluminum Foil as a Functional Barrier? Tableware, kitchen utensils and packaging inks and kitchen utensils contain substances that can contaminate food and thus pose a risk to health. 4811 ( in French, German or Italian ) under official Collection No cookie consent plugin entities until! 1996 relating to the DETEC Ordinance of 3 December 1996 relating to the Ordinance on materials and articles laid... Substance notification or declaration, this registration needs to be done on a product... Ro 2020 4811 ( in French ) from the List to too little of the chemicals. L notification under the Swiss swiss ordinance annex 2 Market Supervisory authority ( FINMA ) may issue implementing provisions need help! 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