swiss ordinance annex 2swiss ordinance annex 2

Is there guidance on what information must be in a Food Master File? 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. Analytical cookies are used to understand how visitors interact with the website. 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 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; We do not provide consultancy services. Reference to Annex II, Section II.1, to that Directive: point 6.8. . Printing inks also contain substances that could pose a risk. 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 (. Annex. ( Lists I - V / Part A or B) Remarks Food Contact A positive assessment of the binder, does not release the user from the du- For substances registered under EU REACH after 1 June 2008, it is not mandatory to send in copies of full test reports. 2 and 3 of the Ordinance) and child labor (art. The US EPA has issued a final rule to revise the Formaldehyde Standards for Composite wood Products Act. This is a publication of SGS, except for 3rd parties contents submitted or licensed for use by SGS. These will be implemented in phases, starting April 1, 2022. 26 . The biocide triclosan (CAS 3380-34-5) has also been deleted from the list. At this time, the Implementing Ordinance-Biocidal Products governs in detail the following procedures: Procedure for the authorisation of the same biocidal products It does not store any personal data. I understand that the inclusion of an aluminum foil layer in laminate materials is considered by FDA to be a functional 192 0 obj <>stream I. 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 It is strictly educational and does not replace any legal requirements or applicable regulations. SGS neither endorses nor disapproves said 3rd parties contents. 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. Permitted substances are defined as those listed in Annex 2 Lists I and II and in Annex 10, December 2020. . A manufacturer or an importer must notify a new substance before it is placed on the market for the first time in Switzerland. The cookie stores information anonymously and assigns a randomly generated number to recognize unique visitors. The latest edition is the 4th revised version which entered into force on 1 December 2012. The use of substances, including printing inks, in the manufacture ofpackaging is therefore regulated by legislation. It is not intended to constitute consulting or professional advice. Name: Richard Ballaman . 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. 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. 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. 13 . Packagingcontains substances that may migrate into the foodstuff and thus into the human body. Since Switzerland is not a member of the EU or the European Economic Area (EEA), EU REACH regulation does not apply here. stream 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. Investigational medicinal products in their final packaging are treated similarly. 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). The Ordinance (section 12) defines the provisions related to printing inks for non-food contact surfaces of food contact materials. %%EOF For more info, please refer to new substance declaration part. 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. 4 and 5 of the Ordinance), exemptions from the due diligence and reporting obligations due to compliance with internationally recognized and equivalent regulatory frameworks . 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. Required info is very simple and mainly includes substance identity, composition of preparation, intended uses and classification and labelling. This cookie is set by the Google recaptcha service to identify bots to protect the website against malicious spam attacks. Annex 10 stipulates the substances that may be used for printing inks (see "More information"). Aside from the provisions covering BPA, food contact materials must comply with all new changes to Ordinance 817.023.21 by November 30, 2020. 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. This Chemical Risk Reduction Ordinance prohibits or restricts the marketing and use of certain hazardous substances on its own or in preparations and articles. Packaging.. +41 58 462 20 07, info@gs-wbf . 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. The relevant thresholds are listed in Annex 1 to the Ordinance with the corresponding customs tariff numbers. The financial sanctions now extend to Russian President Vladimir Putin, Prime Minister Mikhail Mishustin and Foreign Minister Sergey Lavrov. For this reason the FSVO has issued regulations governing packaging. PackagingLaw.com is the premier online resource for the global packaging industry. 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 Keller and Heckman LLP. At the moment, the Swiss Printing Inks Ordinance is the most complete piece of national legislation in Europe regulating substances intended for use in printing inks that are not intended to. 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. 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),. These modifications enter into force . 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). Substances incorporated intopackaging materials, such as printed plastics, can migrate into foodstuffs and endanger health. The chemical authority is the Notification authority for chemicals of the Swiss Federal Office of Public Health. 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. On March 10, 2022, Switzerland issued Official Collection 2022 162 (RO 2022 162, French, German and Italian versions) to revise its Ordinance on the Reduction of Risks Associated with the use of Particularly Dangerous Substances, Preparations and Articles (also known as Chemical Risk Reduction Ordinance, ORRChem, RS 814.81, French, German and Italian versions) to further align with Regulation (EU) 2019/1021 on persistent organic pollutants (POP recast regulation) and Annex XVII of Regulation (EC) 1907/2006 Registration, Evaluation, Authorization and Restriction of Chemicals (Annex XVII of REACH) in the European Union (EU). 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. EINECS (European Inventory of Existing Commercial Chemical Substances). 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. . Switzerland issued a revised version of its Ordinance on Materials and Articles (SR 817.023.21), which came into force on 1st May 2017. On the Swiss Federal Food Safety and Veterinary Offices website a logbook of changes regarding the positive list for printing inks is available. A fully summary in IUCLID 5, meeting the criteria of a robust study summary, is sufficient. 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. 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. If you have questions or need any help, please contact our sponsor. H. 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. Union list of approved active substances 5 0 obj Switzerland also uses EINECS as their existing chemical substance inventory. **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. If you are a consultant, you may get yourself listed in CSP business directory (free) or Until now, Annex 10 has consisted of two parts, Part A and Part B. Bisphenol A (BPA) is a synthetic substance used to manufacture various plastic materials intended, among other things, for contact with foodstuffs. 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. It was decided to select the HPV-chemicals, the highly persistent chemicals and the metals. 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 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. 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. Comments are accepted until April 5, 2023. These cookies will be stored in your browser only with your consent. Do not quote or refer any information herein without SGSs prior written consent. To this end, it establishes the requirements for honesty, diligence and transparency in the provision of financial services and governs the offering . The core element of the new regulation is a list of "permitted . For this purpose, the Swiss Federal Council has approved the complete revision of the Ordinance on Measures against Belarus, which entered . This website uses cookies to improve your experience while you navigate through the website. This final rule will become effective on March 23, 2023. The new regulation is scheduled to come into force in mid-2023. We do not provide consultancy services. 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