swiss ordinance annex 2

teolliseen/ammattimaiseen kyttn : Ainoastaan ammattikyttn Aineen/seoksen kytt : Vedeneristeet . I. The information contained herein is provided as is and SGS does not warrant that it will be error-free or will meet any particular criteria of performance or quality. What is to be considered a conflict and high[1]risk area is now defined in Art. This cookie, set by YouTube, registers a unique ID to store data on what videos from YouTube the user has seen. 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. . For this reason the FSVO has issued regulations governing packaging. 2-Ethoxyethanol (Ethyl glycol) 110-80-5 Deleted from Swiss Ord. 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). Staffelstrasse 10CH-8045 ZurichSwitzerland. We also use third-party cookies that help us analyze and understand how you use this website. Higher data package is required for higher volume substances. 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. 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. 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. 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. <> 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. Investigational medicinal products in their final packaging are treated similarly. The cookie is used to store the user consent for the cookies in the category "Other. This cookie is set by GDPR Cookie Consent plugin. 2(1)(e) of the Ordinance (same wording as in Regulation (EU) 2017/821 on conflict minerals). Cooperation on printing inks 3 5th EFSA FIP Network FCM Meeting, Parma, 10.-11.7.17 1900s. 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. 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 ); 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. >\o The new regulation is scheduled to come into force in mid-2023. The Swiss Federal Council, on the basis of Article 2 paragraph 4, 19, 22 paragraph 2, 24, 38, 39 paragraph 2, . However, the Swiss Chemicals Ordinance (ChemO) governs more than just new substances. The following chemicals are exempt from registrations under ChemO: Note: A notified or declared new substance does not require registration. Packaging.. 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. If you are a consultant, you may get yourself listed in CSP business directory (free) or At this time, the Implementing Ordinance-Biocidal Products governs in detail the following procedures: Procedure for the authorisation of the same biocidal products We do not provide consultancy services. Annex 2 stipulates the substances that may be used for the plastic layers in utility articles made of plastic. The ordinance is almost a combined version of EU RoHS, REACH Annex XVII Restricted Substance List and REACH Annex XIV Authorization List. A cookie set by YouTube to measure bandwidth that determines whether the user gets the new or old player interface. 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. A manufacturer or an importer must notify a new substance before it is placed on the market for the first time in Switzerland. 26 . Substances prohibited under the Ordinance on Chemical Risk Reduction / Swiss chemicals legislation / Current as of October 2022 3 of 63 Substance/Preparation/Article Regulations Exemptions/Transitional provisions . PackagingLaw.com is the premier online resource for the global packaging industry. ( 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 food law includes the ordinance on materials and articles intended to come into contact with food. 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. SML values from Union list, Swiss Ordinance or evaluations of MS authorities 2. It is the first time a Swiss president has visited the country. 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. Tags: Topics - CH,REACH-like Regulation and Registration, Subscribe to Free Newsletter 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. 1.2. 7 Version according to Annex 2 Sect. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc. Similar to EU REACH, a company based outside of the Switzerland can appoint a Swiss only representative to notify. 168 0 obj <> endobj Therefore, GSPR #23.2(d) . 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. 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 has been amended several times. The latest edition is the 4th revised version which entered into force on 1 December 2012. Celebrating 60 Years of Excellence: 1962 - 2022. H. 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. Please note that there is no official Swiss chemical inventory. 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. 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. 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. 1, plastic materials and articles intended to come into contact with foodstuffs for infants and young children within the meaning of the Ordinance of the DFI of 16 December 2016 on food for persons with needs Individuals 1 Shall not assign their constituents to foodstuffs or simulants of foodstuffs in quantities 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; . Tags: Topics - CH,Substance Restriction in Articles, Subscribe to Free Newsletter Annex 2 stipulates the substances that may be used for the plastic layers in utility articles made of plastic. The ChemO has also adopted GHS by requiring suppliers to classify, label and package hazardous substances and preparations in accordance with EU CLP regulation. These will be implemented in phases, starting April 1, 2022. Tableware, kitchen utensils and packaging inks and kitchen utensils contain substances that can contaminate food and thus pose a risk to health. 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. 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.. General restrictions related to plastic materials and articles are laid down in Annex II. Name: Richard Ballaman . The cookies is used to store the user consent for the cookies in the category "Necessary". What are the Requirements for Using Aluminum Foil as a Functional Barrier? \j}M2'L~u}0 On May 1, 2017 the new Swiss national food law entered into force (FPF reported). Substances on packaging materials, such as printed plastics, can migrate into foodstuffs and endanger health. Switzerland last updated the Ordinance in 2017 to align more closely with principles contained in European Union (EU) food contact regulations, and the most recent updates represent a continuation of that effort. Since Switzerland is not a member of the EU or the European Economic Area (EEA), EU REACH regulation does not apply here. Ordinance on electrical low-voltage equipment AS 2015 6 Section 2: Special low-voltage equipment Article 13 Recognised technical regulations 1 Low-voltage equipment which is not subject to the scope of application of Directive 2014/35/EU 11 or which is listed in Annex II to the latter may only be made available on the market if it complies with the recognised technical regulations. Note: The restriction of the marketing and uses of certain substances, preparations and articles are governed by another ordinance Chemical Risk Reduce Ordinance (ORRChem). 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 Do not quote or refer any information herein without SGSs prior written consent. 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. Address: CH-3003 Bern . 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. 5 0 obj This obligation is called registration. The relevant thresholds are listed in Annex 1 to the Ordinance with the corresponding customs tariff numbers. 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. Who: manufacturer or importer or only representative; Required info: physio-chemical data, toxicology data, eco-toxicology data and chemical safety report. To this end, it establishes the requirements for honesty, diligence and transparency in the provision of financial services and governs the offering . Is there guidance on what information must be in a Food Master File? . Amongst them, "Union" would correspond to "Switzerland". 2 The Swiss Financial Market Supervisory Authority (FINMA) may issue implementing provisions. The chemical authority is the Notification authority for chemicals of the Swiss Federal Office of Public Health. 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 . All rights reserved. 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. I understand that the inclusion of an aluminum foil layer in laminate materials is considered by FDA to be a functional Annex 10 includes a positive list for binders (monomers), dyes and pigments, solvents . 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. stream The biocide triclosan (CAS 3380-34-5) has also been deleted from the list. 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. 326 80-05-7 2,2-Bis(4-hydroxyphenyl)propan = 4,4'-isopropylidenediphenol = Bisphenol A HPV Not pers 1 High 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) . 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. Switzerland Revises Chemical Risk Reduction Ordinance SafeGuardS Automotive, Electrical & Electronics, Electrical & Electronics, Hardgoods, Hardgoods, Hardgoods, Hardgoods, Hardgoods, Personal and Protective Equipment, Softlines, Footwear and Leather Products, Softlines, Softlines, Softlines March 24, 2022 You can search restriction conditions either by substance name or product type by clicking the links we have sorted out below. 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). Vc!Fs1=FzT39!Osn,%u"MVybD/Ih&>7&&?Q This site uses cookies, including third-party cookies. 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 list contains active substances that have been assessed and approved in the EU under Guideline 98/8/EC (Biocidal product guidelines) and Regulation (EU) No 528/2012 (Biocidal Product Regulation). Staff from the Swiss Humanitarian Aid Unit will accompany the aid shipment. 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. The chemical authority is the Notification authority for chemicals of the Swiss Federal Office of Public Health. YSC cookie is set by Youtube and is used to track the views of embedded videos on Youtube pages. 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. 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. *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. These cookies track visitors across websites and collect information to provide customized ads. 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. 4 and 5 of the Ordinance), exemptions from the due diligence and reporting obligations due to compliance with internationally recognized and equivalent regulatory frameworks . Entities have until May 31, 2020 to comply with the new provisions covering BPA. Belarus. Since the Chemical Risk Reduction Ordinance (ORRChem) is updated frequently, please click here to search the latest restrictions for each substance or product type. Examples include 2-methoxy-ethanol (CAS 109-86-4), aniline (CAS 62-53-3), dimethylformamide (68-12-2), and diisobutyl phthalate (DIBP, CAS 84-69-5). Merkitykselliset tunnistetut kytt Pasiallinen kyttkategoria : Rakennusmateriaalit Erit. 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. 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. This exemption is usually limited to a quantity required for the purpose and a period not exceeding five years. 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.

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swiss ordinance annex 2