Annex 10 stipulates the substances that may be used for printing inks (see More information). Permitted substances are defined as those listed in Annex 2 Lists I and II and in Annex 10, December 2020. . 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). 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. Do not quote or refer any information herein without SGSs prior written consent. We do not provide consultancy services. 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 . However, the Swiss Chemicals Ordinance (ChemO) governs more than just new substances. 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 Verification by the Swiss national authorities of compliance with the national rules shall be carried out within the time periods laid down in Article 6 of Commission . The use of substances, including printing inks, in the manufacture ofpackaging is therefore regulated by legislation. This cookie is set by GDPR Cookie Consent plugin. BPA can be detected both in foodstuffs and in utility articles. 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. The correspondences in Switzerland for the special provisions in the Implementing Regulation of the EU are considered in Annex 3 OBP. 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. This cookie is set by GDPR Cookie Consent plugin. The food law includes the ordinance on materials and articles intended to come into contact with food. This cookie, set by YouTube, registers a unique ID to store data on what videos from YouTube the user has seen. Swiss Ink Ordinance 2-Methoxyethanol (methyl glycol) 109-86-4 Deleted from Swiss Ord. 2 The Swiss Financial Market Supervisory Authority (FINMA) may issue implementing provisions. %PDF-1.7 % Since the Chemical Risk Reduction Ordinance (ORRChem) is updated frequently, please click here to search the latest restrictions for each substance or product type. The assets of sanctioned individuals and companies are frozen with immediate effect. Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. The report concludes that BPA does not represent a risk to consumers' health. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc. Address: CH-3003 Bern . 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. This inventory includes chemical substances deemed to be on the European Community market between January 1, 1971 and September 18, 1981. Switzerland Publishes Updated Ordinance on Materials and Articles Intended to Contact Foodstuffs, The EU Transparency Regulation Potential Challenges for the Submission of Food-Contact Dossiers, Navigating U.S. Federal and State Regulations of PFAS in Applications Involving Food. This cookie is set by GDPR Cookie Consent plugin. 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. These cookies ensure basic functionalities and security features of the website, anonymously. On the Swiss Federal Food Safety and Veterinary Offices website a logbook of changes regarding the positive list for printing inks is available. 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). last required signature was executed (Swiss Federal Supreme Court 129 IV 130 c. 2.3 and 3). I understand that the inclusion of an aluminum foil layer in laminate materials is considered by FDA to be a functional YouTube sets this cookie to store the video preferences of the user using embedded YouTube video. This cookie is installed by Google Analytics. Several substances have been removed from the list due to their carcinogenic, mutagenic, or reprotoxic (CMR) properties. 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. 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. Annex. Standard prohibitions on the provision of technical or financial assistance apply as well. Chemical Risk Reduce Ordinance (ORRChem). 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. . Union list of approved active substances 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. This website uses cookies to improve your experience while you navigate through the website. SML values from Union list, Swiss Ordinance or evaluations of MS authorities 2. 19 is authority, the Swiss Agency for ther- apeutic products (commonly called Swissmedic), has powers approximately This final rule will become effective on March 23, 2023. 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. These modifications enter into force . Annex 2.2 (Cleaning, deodorising and cosmetic products) Placing on the market of deodorisers and air-fresheners intended for . . 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. For this reason the FSVO has issued regulations governing packaging. to keep Food Packaging Forums work going. 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. It has been amended several times. This obligation is called registration. Part A lists substances that have been fully evaluated by the Swiss authorities (Federal Department of Home Affairs and the Federal Food Safety and Veterinary Office), whereas Part B lists substances that may only be used if the user can demonstrate that ink constituents do not transfer to food when assessed using a method with a detection limit of 0.01 mg/kg (10 ppb) AND the substances in question are not carcinogenic, mutagenic, or toxic to reproduction (CMRs). YouTube sets this cookie via embedded youtube-videos and registers anonymous statistical data. 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. 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. How Are Colorants for Food Packaging Regulated in Japan? It is interesting to note that Switzerland regulates perfluorohexane sulfonic acid (PFHxS), its salts and PFHxS-related substances (Annex 1.16), a measure that is under consideration in the Stockholm Convention and the European Union (EU). This cookie is set by the Google recaptcha service to identify bots to protect the website against malicious spam attacks. 26 . 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. 2 The OSAV publishes these instructions in the Official Swiss Trade Sheet. 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. 168 0 obj <> endobj A substance that is listed on EINECS may still require registration under the Swiss Chemicals Ordinance. Annex 10 includes a positive list for binders (monomers), dyes and pigments, solvents . 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 . 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. 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 (. Disclosures of migrating substances are demanded under both Comments are accepted until April 5, 2023. 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. Country: Switzerland . 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. Only Part A substances will remain listed in the new legislation. To this end, it establishes the requirements for honesty, diligence and transparency in the provision of financial services and governs the offering . 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. This may pose a threat to health. 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. 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. Ordinance on the Incentive Tax on Volatile Organic Compounds (OVOC): . The correspondences in Switzerland for the special provisions in the Implementing Regulation of the EU are considered in Annex 3 OBP. But opting out of some of these cookies may affect your browsing experience. Packagingcontains substances that may migrate into the foodstuff and thus into the human body. ); 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. 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 latest edition is the 4th revised version which entered into force on 1 December 2012. . Until now, Annex 10 has consisted of two parts, Part A and Part B. 186 V. Junod / European Journal of Health Law 15 (2008) 183-195 coverage policy and, of course, the risk-bene t balance. A notification fee also needs to be paid. You may also find an expert in CSP business directory below. PackagingLaw.com is the premier online resource for the global packaging industry. 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. For substances registered under EU REACH after 1 June 2008, it is not mandatory to send in copies of full test reports. 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 financial sanctions now extend to Russian President Vladimir Putin, Prime Minister Mikhail Mishustin and Foreign Minister Sergey Lavrov. The cookie is used to store the user consent for the cookies in the category "Analytics". 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.. GENEVA, SWITZERLAND / AGILITYPR.NEWS / December 16, 2019 / On December 1, 2019, Switzerland brought into effect several food contact materials and articles requirements that align its ordinance with many European Union (EU) provisions. It: Highlights of several of the aforementioned amendments and Annex 1.16 PFAS are summarized in Table 1. 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 The following chemicals are exempt from registrations under ChemO: Note: A notified or declared new substance does not require registration. It does not store any personal data. 13 . 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. It is strictly educational and does not replace any legal requirements or applicable regulations. However, the Swiss authorities have indicated they are preparing new printing ink legislation that will not include a list of non-evaluated substances, and as such, they are no longer accepting applications for adding substances to Part B of Annex 10. 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. Dr. Hingwo TsangGlobal Information and Innovation Managert: (+852) 2774 7420. The cookie stores information anonymously and assigns a randomly generated number to recognize unique visitors. For this purpose, the Swiss Federal Council has approved the complete revision of the Ordinance on Measures against Belarus, which entered . Section 12 sets out the provisions specific to food contact material inks. A manufacturer or an importer must notify a new substance before it is placed on the market for the first time in Switzerland. 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 . Similar to EU REACH, a company based outside of the Switzerland can appoint a Swiss only representative to notify. 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; . For more info, please refer to ChemO registration part. In February 2023, the International Organization for Standardization (ISO) launched ISO 4484-1, a new test method to help the textile industry select fabrics that reduce shedding or material loss during use and laundering. 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