A new substance is defined a substance that is not listed on EINECS (European Inventory of Existing Commercial Chemical Substances). Aineen tai seoksen merkitykselliset tunnistetut kytt ja kytt, joita ei suositella 1.2.1. 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; On May 1, 2017 the new Swiss national food law entered into force (FPF reported). ( Lists I - V / Part A or B) Remarks Food Contact GMP (Good Manufacturing Practice): This cookie is set by GDPR Cookie Consent plugin. SML values from Union list, Swiss Ordinance or evaluations of MS authorities 2. 192 0 obj <>stream Materials and articles in contact with food. 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. Annex 2 stipulates the substances that may be used for the plastic layers in utility articles made of plastic. . \j}M2'L~u}0 This site uses cookies, including third-party cookies. These cookies track visitors across websites and collect information to provide customized ads. Tableware, kitchen utensils and packaging inks and kitchen utensils contain substances that can contaminate food and thus pose a risk to health. ", 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. 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 For more info, please refer to new substance declaration part. 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. In the end, its only trusted because its tested. 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. This is a publication of SGS, except for 3rd parties contents submitted or licensed for use by SGS. 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 . The following new substances are exempt from new substance notifications in Switzerland under the ChemO: *PPORD: This exemption needs to be declared to authority. The active substances approved in the EU have been adopted by Switzerland in Annex 2 OBP. stream Substances incorporated intopackaging materials, such as printed plastics, can migrate into foodstuffs and endanger health. 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 lordonnance du DFI sur les matriaux et objets destins entrer en contact avec les denres alimentaires (PDF, 292 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), The old legislation and the old Annexes remain valid during a transitional period, see "archives de l`ancien droitalimentaire. 19 is authority, the Swiss Agency for ther- apeutic products (commonly called Swissmedic), has powers approximately 4 and 5 of the Ordinance), exemptions from the due diligence and reporting obligations due to compliance with internationally recognized and equivalent regulatory frameworks . Comments are accepted until April 3, 2023. For substances registered under EU REACH after 1 June 2008, it is not mandatory to send in copies of full test reports. This cookie is set by GDPR Cookie Consent plugin. Since Switzerland is not a member of the EU or the European Economic Area (EEA), EU REACH regulation does not apply here. 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. 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. It: Highlights of several of the aforementioned amendments and Annex 1.16 PFAS are summarized in Table 1. Until now, Annex 10 has consisted of two parts, Part A and Part B. 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 core element of the new regulation is a list of "permitted . Plastic materials and articles shall not transfer their constituents to foods in quantities exceeding the specific migration limits (SML) set out in Annex I. Higher data package is required for higher volume substances. Consumers are exposed to too little of the substance for it to have any impact on health (see "More information"). Annex 2, OBP Implementing Ordinance-Biocidal Products FDHA Certain provisions of the OBP are governed in more detail in the Implementing Ordinance-Biocidal Products. 2 and 3 of the Ordinance) and child labor (art. I. First visit by a Swiss president to Botswana. Belarus. Notification authority for chemicals of the Swiss Federal Office of Public Health. 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. To navigate items, use the arrow, home, and end keys. View Past Newsletter. On November 5, 2019, Switzerland amended its 2017 Ordinance on food contact materials (Ordinance of the Federal Department of Home Affairs on materials and articles intended to come into contact with foodstuffs, RS 817.023.21, FPF reported) to better align with some of the EU FCM regulations, including the Regulation (EC) 1895/2005 on epoxy A cookie set by YouTube to measure bandwidth that determines whether the user gets the new or old player interface. ); Substances and preparations solely for R&D; Gas mixtures consisting exclusively of registered gases; Preparations <100kg/y and intended exclusively for professional users; all other information required to allow safe use of the object. 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. 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 . 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. Contact us for more information or visit our website. 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). The aim of the trip was to strengthen relations between the two countries. Substances on packaging materials, such as printed plastics, can migrate into foodstuffs and endanger health. %PDF-1.4 Annex 2.2 (Cleaning, deodorising and cosmetic products) Placing on the market of deodorisers and air-fresheners intended for . In November 2020, Switzerland published RO 2020 4811 (in French, German or Italian) under Official Collection No. 2 10 Art. 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. The food industry is subject to strict requirements that are set out in the Ordinance on Materials and Articles (in French). +41 58 462 20 07, info@gs-wbf . 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 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. The active substances approved in the EU have been adopted by Switzerland in Annex 2 OBP. Merkitykselliset tunnistetut kytt Pasiallinen kyttkategoria : Rakennusmateriaalit Erit. The ChemO has also adopted GHS by requiring suppliers to classify, label and package hazardous substances and preparations in accordance with EU CLP regulation. This publication is intended to provide technical information and shall not be considered an exhaustive treatment of any subject treated. This website uses cookies to improve your experience while you navigate through the website. 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 Specific migration limits. 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. Switzerland issued a revised version of its Ordinance on Materials and Articles (SR 817.023.21), which came into force on 1st May 2017. Official Collection 2019 3371 was published on November 5, 2019. 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. Bisphenol A (BPA) is a synthetic substance used to manufacture various plastic materials intended, among other things, for contact with foodstuffs. 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 . It does not store any personal data. 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. %PDF-1.7 % A full logbook of these changes and more information about the updated Ordinance can be found at the FSVO Website. H. If you have questions or need any help, please contact our sponsor. The relevant thresholds are listed in Annex 1 to the Ordinance with the corresponding customs tariff numbers. 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. 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). It is not intended to constitute consulting or professional advice. 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. sponsor this page to leave your contact info on this page.. Dr. Hingwo TsangGlobal Information and Innovation Managert: (+852) 2774 7420. 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). 9 Amended by Annex 3 No II 8 of the O of 22 June 2005 on Movements of Waste, in force . The following chemicals are exempt from registrations under ChemO: Note: A notified or declared new substance does not require registration. The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional". 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. . I understand that the inclusion of an aluminum foil layer in laminate materials is considered by FDA to be a functional %%EOF Keller and Heckman LLP. 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