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 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. . General restrictions related to plastic materials and articles are laid down in Annex II. Staff from the Swiss Humanitarian Aid Unit will accompany the aid shipment. Monochlorobenzene 108-90-7 A Toluene 108-88-3 A 1-methyl-2-pyrrolidone/ N-Methylpyrrolidone 872-50-4 A Table 7: Minimize list . Disclosures of migrating substances are demanded under both We do not provide consultancy services. Switzerland strengthens its ORRChem by implementing provisions from EU REACH and the POP Recast Regulation, as well as new requirements for PFHxS, its salts and PFHxS-related substances. 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. 2(1)(e) of the Ordinance (same wording as in Regulation (EU) 2017/821 on conflict minerals). Aside from the provisions covering BPA, food contact materials must comply with all new changes to Ordinance 817.023.21 by November 30, 2020. ( Lists I - V / Part A or B) Remarks Food Contact GMP (Good Manufacturing Practice): If you are a consultant, you may get yourself listed in CSP business directory (free) or For child labour the Ordinance requires in its annex 2 compliance with (i) the ILO Conventions no. 2023 These modifications enter into force . 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. Tags: Topics - CH,Substance Restriction in Articles, Subscribe to Free Newsletter 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. Automotive, Electrical & Electronics, Electrical & Electronics, Hardgoods, Hardgoods, Hardgoods, Hardgoods, Hardgoods, Personal and Protective Equipment, Softlines, Footwear and Leather Products, Softlines, Softlines, Softlines. This inventory includes chemical substances deemed to be on the European Community market between January 1, 1971 and September 18, 1981. . These cookies will be stored in your browser only with your consent. . 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. It is not intended to constitute consulting or professional advice. Bisphenol A 7 Version according to Annex 2 Sect. Permitted substances are defined as those listed in Annex 2 Lists I and II and in Annex 10, December 2020. . New Swiss food law including FCM ordinance entered into force May 1, 2017; many CMR-substances deleted from positive list for printing inks. In November 2020, Switzerland published RO 2020 4811 (in French, German or Italian) under Official Collection No. 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. The assets of the persons and companies listed in the annex to the ordinance are frozen with immediate effect; the ban on entering into new business relationships remains in place. sponsor this page to leave your contact info on this page.. 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. 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) even Swiss companies that are not currently affected will . Substances on packaging materials, such as printed plastics, can migrate into foodstuffs and endanger health. The cookie is used to store the user consent for the cookies in the category "Other. 2 10 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.. 2.1.2 Swiss Ordinance 817.023.21 The Swiss Federal Department of Home Affairs (FDHA) issued a revised version of the Ordinance of Materials and Articles (SR 817.023.21), which came into force on 1st May 2017. These cookies ensure basic functionalities and security features of the website, anonymously. The correspondences in Switzerland for the special provisions in the Implementing Regulation of the EU are considered in Annex 3 OBP. 26 . 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. 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. This publication is intended to provide technical information and shall not be considered an exhaustive treatment of any subject treated. A substance that is listed on EINECS may still require registration under the Swiss Chemicals Ordinance. Through its independent, balanced, and science-based publications and tools, the Food Packaging Forum contributes to protecting human and environmental health. The Swiss Federal Council, on the basis of Article 2 paragraph 4, 19, 22 paragraph 2, 24, 38, 39 paragraph 2, . 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 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 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). By accepting, you agree to our use of cookies. 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; A new substance is defined a substance that is not listed on EINECS (European Inventory of Existing Commercial Chemical Substances). 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. 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. SGS neither endorses nor disapproves said 3rd parties contents. 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. 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. On the Swiss Federal Food Safety and Veterinary Office's website a logbook of changes regarding the positive list for printing inks is available. This aligns the Swiss Ordinance with provisions from the following EU regulations: Bisphenol A (BPA) is a synthetic substance used to manufacture various plastic materials intended, among other things, for contact with foodstuffs. 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 active substances approved in the EU have been adopted by Switzerland in Annex 2 OBP. But opting out of some of these cookies may affect your browsing experience. The Ordinance defines exemptions from the due diligence and reporting obligations in the areas of minerals and metals (art. 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. 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. 2 The OSAV publishes these instructions in the Official Swiss Trade Sheet. We do not provide consultancy services. Necessary cookies are absolutely essential for the website to function properly. List of active substances approved pursuant to Article 9 of the Regulation (EU) No 528/2012 (Union list of approved active substances). 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; Substances on REACH SVHC list will be added to the Annex 7 of ChemO. Comments are accepted until April 5, 2023. 9 Amended by Annex 3 No II 8 of the O of 22 June 2005 on Movements of Waste, in force . 10 SR 814.610 11 SR 814.620 12 Amended by Annex 4 No 45 of the Customs Ordinance of 1 Nov. 2006, in force since 1 May 2007 (AS 2007 1469). Switzerland also uses EINECS as their existing chemical substance inventory. Part A of Annex 10 of the Swiss Printing Ink Ordinance contains a positive list of substances that can be used in printing inks on the non-contact surface of food contact materials. A letter of access is required if a late notifier wishes to share the data submitted by a previous registrant. 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). Printing inks also contain substances that could pose a risk. Address for enquiries EAER Communications, Tel. Who: manufacturer or importer or only representative; Required info: physio-chemical data, toxicology data, eco-toxicology data and chemical safety report. On May 1, 2017 the new Swiss national food law entered into force (FPF reported). A copy of the fully executed agreement is sent to all parties by email. If you have questions or need any help, please contact our sponsor. 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. Consumers are exposed to too little of the substance for it to have any impact on health (see "More information"). 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 . Annex to the DETEC Ordinance of 3 December 1996 relating to the transport of dangerous goods by rail and . Annex 2 stipulates the substances that may be used for the plastic layers in utility articles made of plastic. Chemical substances that are outside the scope of ChemO (i.e., in-transit substance, medicines, food stuffs, weapon, wastes); Polymer or substance contained in a polymer with a concentration below than 2%; New substances placed on Swiss market with volume less than 1t/y; <1t/y new substances placed on Swiss market purely for scientific R&D; Substances used exclusively as raw materials, active ingredients or additives in food, therapeutic products and animal feed; Substances that are used exclusively as active ingredients in crop protection products and biocidal products; Intermediates, provided that they are not monomers; Substances listed in REACH annex V (by-products, naturally occurring substances, impurities, etc. 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. 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 . 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. This may pose a threat to health. 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 . It is strictly educational and does not replace any legal requirements or applicable regulations. The report concludes that BPA does not represent a risk to consumers' health. You also have the option to opt-out of these cookies. The European Chemicals Agency has launched a 45-day consultation for listing two chemicals as substances of very high concern (SVHC). . Please note that there is no official Swiss chemical inventory. English is not an official language of the Swiss Confederation. endstream endobj startxref 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. sponsor this page to leave your contact info on this page.. 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. Until now, Annex 10 has consisted of two parts, Part A and Part B. The following banks are listed in Annex 15 of the Ordinance: Belagroprombank, Bank . listed in Annex 2 of the GCO Ordinance, when such goods are: (i) destined for or intended for use . 4 The addenda listed in List II of Annex 1 shall not exceed the limit values laid down therein and shall meet the specific . Dr. Hingwo TsangGlobal Information and Innovation Managert: (+852) 2774 7420. Analytical cookies are used to understand how visitors interact with the website. Permitted substances are defined as those listed in Annex 2 Lists I and II and in Annex 10, December 2020. . The ordinance is almost a combined version of EU RoHS, REACH Annex XVII Restricted Substance List and REACH Annex XIV Authorization List. You can search restriction conditions either by substance name or product type by clicking the links we have sorted out below. 192 0 obj <>stream SML values from Union list, Swiss Ordinance or evaluations of MS authorities 2. Since Switzerland is not a member of the EU or the European Economic Area (EEA), EU REACH regulation does not apply here. Art. ANNEX 2 to the Convention on International Civil Aviation Rules of the Air Air travel must be safe and efficient; this requires, among ot her things, a set of internationally agreed rules of the air. 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. Annex 2.2 (Cleaning, deodorising and cosmetic products) Placing on the market of deodorisers and air-fresheners intended for . You may also find an expert in CSP business directory below. A manufacturer or an importer must notify a new substance before it is placed on the market for the first time in Switzerland. Cooperation on printing inks 3 5th EFSA FIP Network FCM Meeting, Parma, 10.-11.7.17 1900s. 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. 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. Ordinance on the Incentive Tax on Volatile Organic Compounds (OVOC): . The assets of sanctioned individuals and companies are frozen with immediate effect. In the end, its only trusted because its tested. It allows the website owner to implement or change the website's content in real-time. We also use third-party cookies that help us analyze and understand how you use this website. For substances registered under EU REACH after 1 June 2008, it is not mandatory to send in copies of full test reports. The following new substances are exempt from new substance notifications in Switzerland under the ChemO: *PPORD: This exemption needs to be declared to authority. 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 The cookies is used to store the user consent for the cookies in the category "Necessary". Part II: Bulk and Intermediate Products Bulk and intermediate products 5 should be treated in a similar way to finished . For >=1t/y new substances which are placed on the market solely for the purpose of product- and process-orientated research, a manufacturer, importer or only representative needs to apply for applications for exemption at least 30 days before he/she intends to place the substance on the market for the first time. 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. The Ordinances provisions on recycled paper are also amended, including removal of the restriction that recycled paper may only be used in contact with certain named foodstuffs. 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. 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. The core element of the new regulation is a list of "permitted . You may also find an expert in CSP business directory below. Name: Richard Ballaman . Entities have until May 31, 2020 to comply with the new provisions covering BPA. PackagingLaw.com is the premier online resource for the global packaging industry. 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. Do not quote or refer any information herein without SGSs prior written consent. 2-Ethoxyethanol (Ethyl glycol) 110-80-5 Deleted from Swiss Ord. The Swiss Food Safety and Veterinary Office (FSVO) and German Bundesinstitut fr Risikobewertung (BfR) currently have an informal arrangement whereby they . Staffelstrasse 10CH-8045 ZurichSwitzerland. What is to be considered a conflict and high[1]risk area is now defined in Art. ); 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. Annex 10 stipulates the substances that may be used for printing inks (see "More information"). Tags: Topics - CH,REACH-like Regulation and Registration, Subscribe to Free Newsletter The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional". 186 V. Junod / European Journal of Health Law 15 (2008) 183-195 coverage policy and, of course, the risk-bene t balance. %PDF-1.7 % 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; On the Swiss Federal Food Safety and Veterinary Offices website a logbook of changes regarding the positive list for printing inks is available. H. 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. 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. to keep Food Packaging Forums work going. To navigate items, use the arrow, home, and end keys. 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; . %%EOF EINECS (European Inventory of Existing Commercial Chemical Substances). I understand that the Japan MHLW Notification No. Section 12 sets out the provisions specific to food contact material inks. 4 and 5 of the Ordinance), exemptions from the due diligence and reporting obligations due to compliance with internationally recognized and equivalent regulatory frameworks . The Ordinance (section 12) defines the provisions related to printing inks for non-food contact surfaces of food contact materials.
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