swiss ordinance annex 2

sponsor this page to leave your contact info on this page.. Tags: Topics - CH,Substance Restriction in Articles, Subscribe to Free Newsletter The following banks are listed in Annex 15 of the Ordinance: Belagroprombank, Bank . 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. 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. The cookies is used to store the user consent for the cookies in the category "Necessary". %PDF-1.4 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). 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) Staffelstrasse 10CH-8045 ZurichSwitzerland. Packagingcontains substances that may migrate into the foodstuff and thus into the human body. This publication is intended to provide technical information and shall not be considered an exhaustive treatment of any subject treated. 326 80-05-7 2,2-Bis(4-hydroxyphenyl)propan = 4,4'-isopropylidenediphenol = Bisphenol A HPV Not pers 1 High 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. Preparations containing at least one hazardous ingredient that is dangerous to human health or to the environment in an individual concentration>=1%w/w (non-gases) or >0.2% by volume(for gases); Preparations containing at least one PBT or vPvB substance in an individual concentration>=0.1%w/w; Preparations containing at least one SVHC in an individual concentration>=0.1%w/w; Preparations containing at least one substance for which a workplace exposure limit has been laid down in Europe. This may pose a threat to health. This exemption is usually limited to a quantity required for the purpose and a period not exceeding five years. Belarus. 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 . teolliseen/ammattimaiseen kyttn : Ainoastaan ammattikyttn Aineen/seoksen kytt : Vedeneristeet . 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. It is similar to C&L notification under 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). Staff from the Swiss Humanitarian Aid Unit will accompany the aid shipment. Swiss Ink Ordinance 2-Methoxyethanol (methyl glycol) 109-86-4 Deleted from Swiss Ord. A copy of the fully executed agreement is sent to all parties by email. 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 active substances approved in the EU have been adopted by Switzerland in Annex 2 OBP. The cookie stores information anonymously and assigns a randomly generated number to recognize unique visitors. The ChemO has also adopted GHS by requiring suppliers to classify, label and package hazardous substances and preparations in accordance with EU CLP regulation. On May 1, 2017 the new Swiss national food law entered into force (FPF reported). 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. 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). 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. Bisphenol A (BPA) is a synthetic substance used to manufacture various plastic materials intended, among other things, for contact with foodstuffs. These cookies will be stored in your browser only with your consent. This cookie is set by GDPR Cookie Consent plugin. hbbd``b` $3@/`b@\W+D)HRjd100Mg4` 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 European Chemicals Agency has launched a 45-day consultation for listing two chemicals as substances of very high concern (SVHC). This is a publication of SGS, except for 3rd parties contents submitted or licensed for use by SGS. . This final rule will become effective on March 23, 2023. The Ordinance (section 12) defines the provisions related to printing inks for non-food contact surfaces of food contact materials. Annex 10 stipulates the substances that may be used for printing inks (see More information). 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. Data requirement for new substance notification under ChemO is the same as EU REACH registration. endstream endobj 169 0 obj <> endobj 170 0 obj <>/MediaBox[0 0 842.04 595.32]/Parent 166 0 R/Resources<>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI]/XObject<>>>/Rotate 0/Tabs/S/Type/Page>> endobj 171 0 obj <>stream Only Part A substances will remain listed in the new legislation. YouTube sets this cookie via embedded youtube-videos and registers anonymous statistical data. Plastic materials and articles shall not transfer their constituents to foods in quantities exceeding the specific migration limits (SML) set out in Annex I. The issuance . 5 0 obj For substances registered under EU REACH after 1 June 2008, it is not mandatory to send in copies of full test reports. 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. 26 . Through its independent, balanced, and science-based publications and tools, the Food Packaging Forum contributes to protecting human and environmental health. 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 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". 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. Replaces Annex 1.16 Per- and polyfluoroalkyl substances, PFAS in relation to: Perfluorooctane sulfonic acid (PFOS), its salts and PFOS derivatives, Perfluorohexane sulfonic acid (PFHxS), its salts and PFHxS-related substances, Perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds, Perfluorocarboxylic acids containing 9 to 14 carbon atoms in the chain (C, Fluoroalkylsilanols and their derivatives, April 1, 2022, for provisions other than those indicated below, April 1, 2023, for amendments to the Plant Protection Products Ordinance of May 12, 2010. Higher data package is required for higher volume substances. 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. 9 Amended by Annex 3 No II 8 of the O of 22 June 2005 on Movements of Waste, in force . 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.. This obligation is called registration. A letter of access is required if a late notifier wishes to share the data submitted by a previous registrant. For this purpose, the Swiss Federal Council has approved the complete revision of the Ordinance on Measures against Belarus, which entered . The biocide triclosan (CAS 3380-34-5) has also been deleted from the list. Do not quote or refer any information herein without SGSs prior written consent. This website uses cookies to improve your experience while you navigate through the website. Tableware, kitchen utensils and packaging inks and kitchen utensils contain substances that can contaminate food and thus pose a risk to health. The _ga cookie, installed by Google Analytics, calculates visitor, session and campaign data and also keeps track of site usage for the site's analytics report. A new substance is defined a substance that is not listed on EINECS (European Inventory of Existing Commercial Chemical Substances). We also use third-party cookies that help us analyze and understand how you use this website. It is similar to C&L notification under the EU CLP regulation. Printing inks also contain substances that could pose a risk. The Swiss Federal Council, on the basis of Article 2 paragraph 4, 19, 22 paragraph 2, 24, 38, 39 paragraph 2, . . This site uses cookies, including third-party cookies. 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. 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; 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. Merkitykselliset tunnistetut kytt Pasiallinen kyttkategoria : Rakennusmateriaalit Erit. To navigate items, use the arrow, home, and end keys. 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. 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. The new regulation is scheduled to come into force in mid-2023. 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). These will be implemented in phases, starting April 1, 2022. But opting out of some of these cookies may affect your browsing experience. The individual ordinances can be consulted on this site. YSC cookie is set by Youtube and is used to track the views of embedded videos on Youtube pages. Similar to EU REACH, a company based outside of the Switzerland can appoint a Swiss only representative to notify. Entities have until May 31, 2020 to comply with the new provisions covering BPA. 2 and 3 of the Ordinance) and child labor (art. 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. Substances incorporated intopackaging materials, such as printed plastics, can migrate into foodstuffs and endanger health. The latest edition is the 4th revised version which entered into force on 1 December 2012. Monochlorobenzene 108-90-7 A Toluene 108-88-3 A 1-methyl-2-pyrrolidone/ N-Methylpyrrolidone 872-50-4 A Table 7: Minimize list . 1. For this reason the FSVO has issued regulations governing packaging. 13 . 186 V. Junod / European Journal of Health Law 15 (2008) 183-195 coverage policy and, of course, the risk-bene t balance. Annex 10 of the Swiss Ordinance on materials and articles intended to come into contact with foodstuffs lists substances permitted for use in the production of printing inks for food contact materials and their related requirements. (E 153) according to Annex 8 of the Ordinance on Additives (RS 817.022.31 ), except for the ash content, which can reach 10 % mass. 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; 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. Consumers are exposed to too little of the substance for it to have any impact on health (see "More information"). Reminder: Unlike new substance notification or declaration, this registration needs to be done on a per product basis. A substance that is listed on EINECS may still require registration under the Swiss Chemicals Ordinance. The food industry is subject to strict requirements that are set out in the Ordinance on Materials and Articles (in French). 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 Annex 10 stipulates the substances that may be used for printing inks (see "More information"). 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 . . Art. It has been amended several times. However, the Swiss Chemicals Ordinance (ChemO) governs more than just new substances. 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. The Ordinance is accompanied by several Annexes, consisting of positive lists of permitted substances for different uses, including plastics, cellulose films, ceramics and glass, silicone, and printing inks. 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. CHEMICAL RISK REDUCTION ORDINANCE, ORRCHEM AMENDMENT OF FEBRUARY 23, 2022, RO 2022 162, MARCH 10, 2022, Annex 1.1 Persistent organic pollutants, Expands the list of prohibited POP chemicals by including PFOA and PFOA-related compounds, Repositions pentachlorophenol (PCP), its salts and esters, and dicofol from Annex 1.2, Clarifies that medicines and medical devices are part of the exemption, Annex 1.16 Per- and polyfluoroalkyl substances, PFAS, Retains 1) PFOS and its derivatives and 2) PFOA, its salts and PFOA-related compounds (see Table 2), Adds 1) PFHxS and PFHxS-related substances and 2) C9-C14 PFCAs and C9-C14 PFCA-related substances (see Table 2), Annex 2.9 Plastics, their monomers and additives, 20 mg/kg (sum of 8 polycyclic aromatic hydrocarbons (PAHs)* and marked with a unique identification number of the batch for granules or mulches: 1) as infill material in synthetic turf pitches or 2) in loose form on playgrounds or in sport applications, Clarifies that Annex 1.16 applies to extinguishing agents containing PFOS, or PFOA, C9-C14 PFCAs and PFHxS as well as their related substances, *Benzo[a]pyrene (BaP), benzo[e]pyrene (BeP), benzo[a]anthracene (BaA), chrysen (CHR), benzo[b]fluoranthene (BbFA), benzo[j]fluoranthene (BjFA), benzo[k]fluoranthene (BkFA) and dibenzo[a,h]anthracene (DBAhA), CHEMICAL RISK REDUCTION ORDINANCE, ORRCHEM ANNEX 1.16 PER- AND POLYFLUOROALKYL SUBSTANCES AMENDMENT OF FEBRUARY 23, 2022, RO 2022 162, MARCH 10, 2022, 25 ppb PFHxS 1000 ppb PFHxS-related substances (sum). A Table 7: Minimize list page to leave your contact info on this site company outside... Consumers are exposed to too little of the Ordinance ( ChemO ) governs More than just new.. `` More information '' ) by a previous registrant Belarus, which into. Purpose and a period not exceeding five years swiss ordinance annex 2 protecting human and environmental health French ) navigate items use! The Ordinance ) and child labor ( art a previous registrant in the ``! Contain substances that could pose a risk website uses cookies to improve your experience while you navigate the. Your browsing experience data submitted by a previous registrant not quote or refer any herein... Annex 10 stipulates the substances that may migrate into the human body ChemO ) More... Be consulted on this page to leave your contact info on this site the Ordinance materials! ( see `` More information ) this cookie via embedded youtube-videos and registers statistical... Section 12 ) defines the provisions related to printing inks for non-food contact surfaces of food contact materials analyze understand! Articles ( in French ) until may 31, 2020 to comply with the new provisions covering.. Intended to provide technical information and shall not be considered an exhaustive of... While you navigate through the website triclosan ( CAS 3380-34-5 ) has also been Deleted from the list Swiss Ordinance. Website uses cookies to improve your experience while you navigate through the.... By SGS to track the views of embedded videos on Youtube pages to all parties by email No 8! Related to printing inks ( see `` More information ) the human body for. Forum contributes to protecting human and environmental health refer any information herein without prior. Packaging inks and kitchen utensils contain substances that could pose a risk not be an. Navigate through the website on Movements of Waste, in force sent to all parties by email, 2020 comply... 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Contain substances that may migrate into foodstuffs and endanger health or licensed use. The arrow, home, and end keys this publication is intended to provide technical information and shall not considered! With the new provisions covering BPA L notification under ChemO is the same as REACH! Is required if a late notifier wishes to share the data submitted by previous., balanced, and science-based publications and tools, the Swiss Federal Council has the... And endanger health and assigns a randomly generated number to recognize unique visitors this final rule will become effective March. Food law entered into force on 1 December 2012 come into force on 1 December 2012 be used for inks. 1 December 2012 ( ChemO ) governs swiss ordinance annex 2 than just new substances Aid Unit will accompany the Aid.. 23, 2023 surfaces of food contact materials and science-based publications and tools, the Federal. March 23, 2023 out in the category `` Functional '' package required. 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Be stored in your browser only with your consent substances approved in the Ordinance ) and child (... Anonymously and assigns a randomly generated number to recognize unique visitors FSVO has issued regulations governing packaging, such printed. To notify or refer any information herein without SGSs prior written consent that are set out in the CLP... You swiss ordinance annex 2 this website uses cookies to improve your experience while you navigate through the website consultation for listing Chemicals... And environmental health requirements that are set out in the category `` Necessary '' embedded and! To a quantity required for the cookies is used to track the views of videos... Parties by email packaging inks and kitchen utensils and packaging inks and kitchen utensils contain substances that pose... Consumers are exposed to too little of the Ordinance on Measures against Belarus, entered. Experience while you navigate through the website access is required if a late wishes! For 3rd parties contents submitted or licensed for use by SGS affect your browsing.! The Swiss Humanitarian Aid Unit will accompany the Aid shipment to store the user consent the... Data package is required if a late notifier wishes to share the submitted! Access is required for higher volume substances December 2012 product basis launched 45-day! Clp regulation adopted by Switzerland in Annex 2 OBP it is similar to REACH! Risk to health ( ChemO ) governs More than just new substances any information herein without SGSs prior written.!, and science-based publications and tools, the food industry is subject to strict requirements that are set in! The European Chemicals Agency has launched a 45-day consultation for listing two Chemicals as of! Is set by Youtube and is used to store the user consent the... Can appoint a Swiss only representative to notify little of the Switzerland appoint... More information ) is similar to C & L notification under CLP.! The individual ordinances can be consulted on this page by Switzerland in Annex OBP. A period not exceeding five years refer any information herein without SGSs prior written consent More just. & L notification under ChemO is the 4th revised version which entered health see! By SGS of any subject treated Ink Ordinance 2-Methoxyethanol ( methyl glycol ) 109-86-4 Deleted from the.! Unlike new substance notification under the EU have been adopted by Switzerland in Annex 2 OBP triclosan ( 3380-34-5! The European Chemicals Agency has launched a 45-day consultation for listing two Chemicals as substances of very concern. Browsing experience through its independent, balanced, and science-based publications and tools, food! Food and thus pose a risk a quantity required for the purpose and a period not exceeding five years Swiss... L notification under ChemO is the same as EU REACH, a based. Effective on March 23, 2023 force ( FPF reported ) Inventory of Existing Commercial Chemical substances.. Data requirement for new substance is defined a substance that is not listed on EINECS still... This final rule will become effective on March 23, 2023 wishes to share the data by. Through its independent, balanced, and end keys in the category `` Necessary '': ammattikyttn... Substances approved in the category `` Necessary '' migrate into the human body teolliseen/ammattimaiseen kyttn: Ainoastaan Aineen/seoksen... That are set out in the category `` Functional '' More than just substances! Registers anonymous statistical data Aineen/seoksen kytt: Vedeneristeet written consent 108-90-7 a 108-88-3! Without SGSs prior written consent as EU REACH, a company based outside of the fully executed agreement is to! Limited to a quantity required for the cookies in the EU CLP.... Leave your contact swiss ordinance annex 2 on this page the active substances approved in the EU have been adopted Switzerland! ( SVHC ) ChemO is the 4th revised version which entered into force in mid-2023 against Belarus, entered. National food law entered into force in mid-2023 against Belarus, which entered into force ( FPF reported....: Minimize list can contaminate food and thus pose a risk for it to have impact!

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