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. In addition to editorial changes, RO 2022 162 contains several important changes to Annex 1 Provisions Concerning Specific Substances and Annex 2 Provisions Concerning Specific Substances of ORRChem. 5 0 obj The following chemicals are exempt from registrations under ChemO: Note: A notified or declared new substance does not require registration. For more info, please refer to ChemO registration part. 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 Plastic materials and articles shall not transfer their constituents to foods in quantities exceeding the specific migration limits (SML) set out in Annex I. This cookie is set by GDPR Cookie Consent plugin. The assets of sanctioned individuals and companies are frozen with immediate effect. 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. 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. 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. 13 . This cookie is set by GDPR Cookie Consent plugin. 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. 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. 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). 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. Contact us for more information or visit our website. 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. % This cookie, set by YouTube, registers a unique ID to store data on what videos from YouTube the user has seen. A copy of the fully executed agreement is sent to all parties by email. Analytical cookies are used to understand how visitors interact with the website. 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. 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. ( Lists I - V / Part A or B) Remarks Food Contact GMP (Good Manufacturing Practice): Staffelstrasse 10CH-8045 ZurichSwitzerland. Several substances have been removed from the list due to their carcinogenic, mutagenic, or reprotoxic (CMR) properties. A notification fee also needs to be paid. Annex 4 of DFI Swiss Ordinance 817.023.21 The present review only refers to food-contact applications. It is strictly educational and does not replace any legal requirements or applicable regulations. If you are a consultant, you may get yourself listed in CSP business directory (free) or Annex 2.2 (Cleaning, deodorising and cosmetic products) Placing on the market of deodorisers and air-fresheners intended for . 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. %PDF-1.4 For polymer, this notification applies to monomers. Annex 10 includes a positive list for binders (monomers), dyes and pigments, solvents . Packaging.. 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. 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 . 1. 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 . 326 80-05-7 2,2-Bis(4-hydroxyphenyl)propan = 4,4'-isopropylidenediphenol = Bisphenol A HPV Not pers 1 High The use of substances, including printing inks, in the manufacture ofpackaging is therefore regulated by legislation. Standard prohibitions on the provision of technical or financial assistance apply as well. SGS neither endorses nor disapproves said 3rd parties contents. Target: Substances and preparations that are hazardous or PBT/vPvB or on Swiss SVHC candidate list; Registration is done on a per product basis; Similar to C&L notification under EU CLP regulation; Required info: substance identity, classification & labelling, uses, quantity, and chemical safety report (if available). The issuance . Section 12 sets out the provisions specific to food contact material inks. It: Highlights of several of the aforementioned amendments and Annex 1.16 PFAS are summarized in Table 1. . This cookie is used by the website's WordPress theme. Notification authority for chemicals of the Swiss Federal Office of Public Health. PackagingLaw.com is the premier online resource for the global packaging industry. You may also find an expert in CSP business directory below. Substances on REACH SVHC list will be added to the Annex 7 of ChemO. This website uses cookies to improve your experience while you navigate through the website. 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. If you have questions or need any help, please contact our sponsor. 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. 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. Swiss Federal Food Safety and Veterinary Office (April 27, 2017). 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. Annex 10 stipulates the substances that may be used for printing inks (see More information). 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. endstream endobj startxref 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. This inventory includes chemical substances deemed to be on the European Community market between January 1, 1971 and September 18, 1981. 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. It also specifies personal and professional qualifications required for the use of certain hazardous substances; preparations and articles (for example, plant protection products and some biocides). Data requirement for new substance notification under ChemO is the same as EU REACH registration. 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. 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. Comments are accepted until April 3, 2023. For this reason the FSVO has issued regulations governing packaging. It is not intended to constitute consulting or professional advice. A letter of access is required if a late notifier wishes to share the data submitted by a previous registrant. 4 of the Banking Ordinance of 30 April 2014, in force since 1 January 2015 (AS 2014 1269). 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) 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. Required info is very simple and mainly includes substance identity, composition of preparation, intended uses and classification and labelling. Stripe sets this cookie cookie to process payments. 2023 I understand that the inclusion of an aluminum foil layer in laminate materials is considered by FDA to be a functional The following banks are listed in Annex 15 of the Ordinance: Belagroprombank, Bank . 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),. Who: manufacturer or importer or only representative; Required info: physio-chemical data, toxicology data, eco-toxicology data and chemical safety report. 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 At this time, the Implementing Ordinance-Biocidal Products governs in detail the following procedures: Procedure for the authorisation of the same biocidal products A cookie set by YouTube to measure bandwidth that determines whether the user gets the new or old player interface. This final rule will become effective on March 23, 2023. I understand that the Japan MHLW Notification No. The Swiss Food Safety and Veterinary Office (FSVO) and German Bundesinstitut fr Risikobewertung (BfR) currently have an informal arrangement whereby they . These cookies track visitors across websites and collect information to provide customized ads. . Target: new substances >=1t/y for product- and process-orientated research and development (PPORD); Required info: substance identity, uses, and expected quantity. Packagingcontains substances that may migrate into the foodstuff and thus into the human body. 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. 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. Similar to EU REACH, a company based outside of the Switzerland can appoint a Swiss only representative to notify. listed in Annex 2 of the GCO Ordinance, when such goods are: (i) destined for or intended for use . A fully summary in IUCLID 5, meeting the criteria of a robust study summary, is sufficient. 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. The food industry is subject to strict requirements that are set out in the Ordinance on Materials and Articles (in French). 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. 186 V. Junod / European Journal of Health Law 15 (2008) 183-195 coverage policy and, of course, the risk-bene t balance. 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. The Ordinance defines exemptions from the due diligence and reporting obligations in the areas of minerals and metals (art. Materials and articles in contact with food., Swiss Federal Food Safety and Veterinary Office (April 27, 2017). This cookie is set by the Google recaptcha service to identify bots to protect the website against malicious spam attacks. %%EOF Amongst them, "Union" would correspond to "Switzerland". 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. All rights reserved. This aligns the Swiss Ordinance with provisions from the following EU regulations: Luckily, the Swiss Authority accepts REACH registration dossier in IUCLID 5 format. These cookies ensure basic functionalities and security features of the website, anonymously. The picture below shows how chemicals are regulated under the Swiss Chemicals Ordinance (ChemO): 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. 4 The addenda listed in List II of Annex 1 shall not exceed the limit values laid down therein and shall meet the specific . Reminder: Unlike new substance notification or declaration, this registration needs to be done on a per product basis. This publication is intended to provide technical information and shall not be considered an exhaustive treatment of any subject treated. Staff from the Swiss Humanitarian Aid Unit will accompany the aid shipment. 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; 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. 2 and 3 of the Ordinance) and child labor (art. For child labour the Ordinance requires in its annex 2 compliance with (i) the ILO Conventions no. 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; 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). 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. 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. Annex 2 stipulates the substances that may be used for the plastic layers in utility articles made of plastic. General restrictions related to plastic materials and articles are laid down in Annex II. 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). 1.2. Art. Address: CH-3003 Bern . (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. SGS Socit Gnrale de surveillance SA - 2022 - All rights reserved - SGS is a registered trademark of SGS Socit Gnrale de surveillance SA. 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. 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. The report concludes that BPA does not represent a risk to consumers' health. 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). BPA can be detected both in foodstuffs and in utility articles. 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. To navigate items, use the arrow, home, and end keys. Since Switzerland is not a member of the EU or the European Economic Area (EEA), EU REACH regulation does not apply here. 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. This may pose a threat to health. 192 0 obj <>stream You may also find an expert in CSP business directory below. 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. hbbd``b` $3@/`b@\W+D)HRjd100Mg4` Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. At the moment, the Swiss Printing Inks Ordinance is the most complete piece of national legislation in Europe regulating substances intended for use in printing inks that are not intended to. 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. In the end, its only trusted because its tested. We do not provide consultancy services. restriction outlined in Annex II (as last updated by EU 2020/1245) and 1Severe Metals Migration Testing in . The list of the active substances in Annex 2 OBP is available under Documents in electronic form. 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. It is similar to C&L notification under the EU CLP regulation. Bisphenol A How Are Colorants for Food Packaging Regulated in Japan? 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 Note: The restriction of the marketing and uses of certain substances, preparations and articles are governed by another ordinance Chemical Risk Reduce Ordinance (ORRChem). Receive a bi-monthly summary of the latest news and stay up to date with developments in the field. 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. Switzerland also uses EINECS as their existing chemical substance inventory. +41 58 462 20 07, info@gs-wbf . ( Lists I - V / Part A or B) Remarks Food Contact A positive assessment of the binder, does not release the user from the du- This obligation is called registration. English is not an official language of the Swiss Confederation. <> Chemical substances that are subject to other laws (i.e., medicines, food stuffs, weapon, wastes, ammunition, fertilizer, therapeutic products, etc. **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.
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