Contact us for more information or visit our website. Target: new substances >=1t/y for product- and process-orientated research and development (PPORD); Required info: substance identity, uses, and expected quantity. . . 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. 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 Materials and articles in contact with food. This website uses cookies to give you the best experience.Learn More OK OK hbbd``b` $3@/`b@\W+D)HRjd100Mg4` CHF100, to issue a public deed (see clause 1.2, Annex to the Notary Fee Ordinance of the Canton of Zurich (Notariatsgebhrenverordnung)). Swiss Federal Food Safety and Veterinary Office (April 27, 2017). sponsor this page to leave your contact info on this page.. 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 . Aside from the provisions covering BPA, food contact materials must comply with all new changes to Ordinance 817.023.21 by November 30, 2020. 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. 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. A manufacturer or an importer must notify a new substance before it is placed on the market for the first time in Switzerland. Necessary cookies are absolutely essential for the website to function properly. A copy of the fully executed agreement is sent to all parties by email. 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. Vc!Fs1=FzT39!Osn,%u"MVybD/Ih&>7&&?Q Comments are accepted until April 3, 2023. 13 . For polymer, this notification applies to monomers. This cookie is installed by Google Analytics. The correspondences in Switzerland for the special provisions in the Implementing Regulation of the EU are considered in Annex 3 OBP. Therefore, GSPR #23.2(d) . You can search restriction conditions either by substance name or product type by clicking the links we have sorted out below. 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; To navigate items, use the arrow, home, and end keys. YouTube sets this cookie to store the video preferences of the user using embedded YouTube video. List of active substances approved pursuant to Article 9 of the Regulation (EU) No 528/2012 (Union list of approved active substances). Switzerland has its own chemical regulations adopting REACH-like registration requirements, but only on new substances placed on the Swiss market. The cookies is used to store the user consent for the cookies in the category "Necessary". Automotive, Electrical & Electronics, Electrical & Electronics, Hardgoods, Hardgoods, Hardgoods, Hardgoods, Hardgoods, Personal and Protective Equipment, Softlines, Footwear and Leather Products, Softlines, Softlines, Softlines. Staffelstrasse 10CH-8045 ZurichSwitzerland. % The relevant thresholds are listed in Annex 1 to the Ordinance with the corresponding customs tariff numbers. even Swiss companies that are not currently affected will . Packaging.. This cookie is set by GDPR Cookie Consent plugin. Is there guidance on what information must be in a Food Master File? %%EOF Official Collection 2019 3371 was published on November 5, 2019. 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 (. View Past Newsletter. stream 1.2. Annex 2, OBP Implementing Ordinance-Biocidal Products FDHA Certain provisions of the OBP are governed in more detail in the Implementing Ordinance-Biocidal Products. The financial sanctions now extend to Russian President Vladimir Putin, Prime Minister Mikhail Mishustin and Foreign Minister Sergey Lavrov. The chemical authority is the Notification authority for chemicals of the Swiss Federal Office of Public Health. I understand that the inclusion of an aluminum foil layer in laminate materials is considered by FDA to be a functional Name: Richard Ballaman . 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. 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. These will be implemented in phases, starting April 1, 2022. 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). Reminder: Unlike new substance notification or declaration, this registration needs to be done on a per product basis. This cookie is set by GDPR Cookie Consent plugin. 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. *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. On Tuesday, 7 February, President Alain Berset met with President Mokgweetsi Eric Keabetswe Masisi in the capital Gaborone, as part of a two-day trip to Botswana. I. The latest edition is the 4th revised version which entered into force on 1 December 2012. The following banks are listed in Annex 15 of the Ordinance: Belagroprombank, Bank . 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. 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). Belarus. 168 0 obj <> endobj 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). We do not provide consultancy services. The list of the active substances in Annex 2 OBP is available under Documents in electronic form. 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),. The new regulation is scheduled to come into force in mid-2023. 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. **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. This translation is provided for information purposes only and has no legal force. 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. <> Annex to the DETEC Ordinance of 3 December 1996 relating to the transport of dangerous goods by rail and . The cookie stores information anonymously and assigns a randomly generated number to recognize unique visitors. EINECS (European Inventory of Existing Commercial Chemical Substances). This Chemical Risk Reduction Ordinance prohibits or restricts the marketing and use of certain hazardous substances on its own or in preparations and articles. 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) 186 V. Junod / European Journal of Health Law 15 (2008) 183-195 coverage policy and, of course, the risk-bene t balance. Who: manufacturer or importer or only representative; Required info: physio-chemical data, toxicology data, eco-toxicology data and chemical safety report. This exemption is usually limited to a quantity required for the purpose and a period not exceeding five years. 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. Through a global network of laboratories, SGS provides a wide range of services including physical/mechanical testing, analytical testing and consultancy work for technical and non-technical parameters applicable to a comprehensive range of consumer products. Stripe sets this cookie cookie to process payments. What is to be considered a conflict and high[1]risk area is now defined in Art. The Swiss Food Safety and Veterinary Office (FSVO) and German Bundesinstitut fr Risikobewertung (BfR) currently have an informal arrangement whereby they . For substances registered under EU REACH after 1 June 2008, it is not mandatory to send in copies of full test reports. Higher data package is required for higher volume substances. BPA can be detected both in foodstuffs and in utility articles. ( Lists I - V / Part A or B) Remarks Food Contact GMP (Good Manufacturing Practice): 9 Amended by Annex 3 No II 8 of the O of 22 June 2005 on Movements of Waste, in force . last required signature was executed (Swiss Federal Supreme Court 129 IV 130 c. 2.3 and 3). 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. Switzerland also uses EINECS as their existing chemical substance inventory. China Releases Draft Amendment to GB Standard on Additives Used in Food Contact Materials and Articles, FDA Adds Two New Substances to its Inventory of Effective FCS Notifications, Maine Announces Opening of Public Comment Period for its PFAS Reporting Law. General restrictions related to plastic materials and articles are laid down in Annex II. A cookie set by YouTube to measure bandwidth that determines whether the user gets the new or old player interface. 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. Annex 2.2 (Cleaning, deodorising and cosmetic products) Placing on the market of deodorisers and air-fresheners intended for . Data requirement for new substance notification under ChemO is the same as EU REACH registration. 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. 19 is authority, the Swiss Agency for ther- apeutic products (commonly called Swissmedic), has powers approximately 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 . . Bisphenol A It has been amended several times. Since the Chemical Risk Reduction Ordinance (ORRChem) is updated frequently, please click here to search the latest restrictions for each substance or product type. 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 . The core element of the new regulation is a list of "permitted . At this time, the Implementing Ordinance-Biocidal Products governs in detail the following procedures: Procedure for the authorisation of the same biocidal products Country: Switzerland . Substances incorporated intopackaging materials, such as printed plastics, can migrate into foodstuffs and endanger health. 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. 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. Situation in Ukraine: Switzerland extends its measures. 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; 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 The purpose of this registration is to provide the Swiss authority with information on the classification and labelling of hazardous chemicals placed on the Swiss market. 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). Address: CH-3003 Bern . 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. You also have the option to opt-out of these cookies. This cookie, set by YouTube, registers a unique ID to store data on what videos from YouTube the user has seen. 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 food industry is subject to strict requirements that are set out in the Ordinance on Materials and Articles (in French). The use of substances, including printing inks, in the manufacture ofpackaging is therefore regulated by legislation. Packagingcontains substances that may migrate into the foodstuff and thus into the human body. This inventory includes chemical substances deemed to be on the European Community market between January 1, 1971 and September 18, 1981. A substance that is listed on EINECS may still require registration under the Swiss Chemicals Ordinance. Cooperation on printing inks 3 5th EFSA FIP Network FCM Meeting, Parma, 10.-11.7.17 1900s. If you are a consultant, you may get yourself listed in CSP business directory (free) or Ordinance on the Incentive Tax on Volatile Organic Compounds (OVOC): . Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. And 3 ) and high [ 1 ] Risk area is now defined in Art OBP are governed in detail! Intopackaging materials, such as printed plastics, can migrate into foodstuffs and endanger Health set. Force in mid-2023 ofpackaging is therefore regulated by legislation Ordinance 817.023.21 by November 30, 2020 requirement for new before! 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