**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. For child labour the Ordinance requires in its annex 2 compliance with (i) the ILO Conventions no. View Past Newsletter. 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. The assets of sanctioned individuals and companies are frozen with immediate effect. 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. Tags: Topics - CH,Substance Restriction in Articles, Subscribe to Free Newsletter The use and handling of these materials and articles are regulated by law. . Processes involving the application of printing inks to the non-food contact side of a material or article. The food law includes the ordinance on materials and articles intended to come into contact with food. Necessary cookies are absolutely essential for the website to function properly. Since Switzerland is not a member of the EU or the European Economic Area (EEA), EU REACH regulation does not apply here. EINECS (European Inventory of Existing Commercial Chemical Substances). YouTube sets this cookie to store the video preferences of the user using embedded YouTube video. Dr. Hingwo TsangGlobal Information and Innovation Managert: (+852) 2774 7420. 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. stream All rights reserved. Art. 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; %PDF-1.7 % For polymer, this notification applies to monomers. 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. Chemical Risk Reduce Ordinance (ORRChem). Similar to EU REACH, a company based outside of the Switzerland can appoint a Swiss only representative to notify. 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. . Disclosures of migrating substances are demanded under both 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. Finally, the Ordinance contains several additions, deletions, and modifications to its provisions covering printing inks, an area that is not currently harmonized at the EU level. even Swiss companies that are not currently affected will . The active substances approved in the EU have been adopted by Switzerland in Annex 2 OBP. ( Lists I - V / Part A or B) Remarks Food Contact GMP (Good Manufacturing Practice): Data requirement for new substance notification under ChemO is the same as EU REACH registration. If you just wish to have a quick look at what restrictions look like, you may click the following two summaries. A manufacturer or an importer must notify a new substance before it is placed on the market for the first time in Switzerland. . Note: The restriction of the marketing and uses of certain substances, preparations and articles are governed by another ordinance Chemical Risk Reduce Ordinance (ORRChem). Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features. Through its independent, balanced, and science-based publications and tools, the Food Packaging Forum contributes to protecting human and environmental health. This final rule will become effective on March 23, 2023. . 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. 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 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),. This may pose a threat to health. The relevant thresholds are listed in Annex 1 to the Ordinance with the corresponding customs tariff numbers. We also use third-party cookies that help us analyze and understand how you use this website. This obligation is called registration. %%EOF YouTube sets this cookie via embedded youtube-videos and registers anonymous statistical data. It is the first time a Swiss president has visited the country. This cookie is installed by Google Analytics. Until now, Annex 10 has consisted of two parts, Part A and Part B. Luckily, the Swiss Authority accepts REACH registration dossier in IUCLID 5 format. For this reason the FSVO has issued regulations governing packaging. 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 financial sanctions now extend to Russian President Vladimir Putin, Prime Minister Mikhail Mishustin and Foreign Minister Sergey Lavrov. The Swiss Federal Council, on the basis of Article 2 paragraph 4, 19, 22 paragraph 2, 24, 38, 39 paragraph 2, . Automotive, Electrical & Electronics, Electrical & Electronics, Hardgoods, Hardgoods, Hardgoods, Hardgoods, Hardgoods, Personal and Protective Equipment, Softlines, Footwear and Leather Products, Softlines, Softlines, Softlines. On the Swiss Federal Food Safety and Veterinary Office's website a logbook of changes regarding the positive list for printing inks is available. . 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. Reference to Annex II, Section II.1, to that Directive: point 6.8. . These cookies track visitors across websites and collect information to provide customized ads. 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. It: Highlights of several of the aforementioned amendments and Annex 1.16 PFAS are summarized in Table 1. Annex 10: List of 564 substances with their selection criteria Presented are all substances and the 4 selection steps. hbbd``b` $3@/`b@\W+D)HRjd100Mg4` Situation in Ukraine: Switzerland extends its measures. 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). restriction outlined in Annex II (as last updated by EU 2020/1245) and 1Severe Metals Migration Testing in . 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. Bern, 25.02.2022 - On 25 February 2022 the Federal Department of Economic Affairs, Education and Research EAER modified Annex 3 of the Ordinance on measures to prevent the circumvention of international sanctions in relation to the situation in Ukraine. I understand that the inclusion of an aluminum foil layer in laminate materials is considered by FDA to be a functional CHF100, to issue a public deed (see clause 1.2, Annex to the Notary Fee Ordinance of the Canton of Zurich (Notariatsgebhrenverordnung)). 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. If you have questions or need any help, please contact our sponsor. The latest edition is the 4th revised version which entered into force on 1 December 2012. %PDF-1.4 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. 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). Ti-Pure products may not be directly added to food, pharmaceuticals, cosmetics, or cigarette papers/filters for . What is to be considered a conflict and high[1]risk area is now defined in Art. 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. Organization: Swiss Federal Office for the Environment. Country: Switzerland . This cookie is set by GDPR Cookie Consent plugin. H. The consequence of this change is that substances not included in Part A of the Annex can be used under self-control if they are not CMR and do not migrate into food at levels above 10 ppb. ); 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. x\o7,9@eYq"FDx=^Snw$@?E6*vWH= 1dXUU= J?sr VU\WrLDavn0*x`?&pNzmXx(suaIk]1+kLLo9b+g~8vI3r/8q%QUl0jc`j7QA\=L`u2^}@*{-Ny^+=HkOTPEVi|>RZGk7A,+S$^6H#m=B{{+r4%mpV]# )2mQ@%m}U>Obp(-RRXieYMX919t("ta5D]8_=u#|[d"x.U;(=>_KRu AJf*L. endstream endobj startxref It is strictly educational and does not replace any legal requirements or applicable regulations. New Zealand has launched a consultation on its proposal to restrict PFHxS, its salts and PFHxS-related compounds as a persistent organic pollutant (POP). We do not provide consultancy services. +41 58 462 20 07, info@gs-wbf . This cookie, set by YouTube, registers a unique ID to store data on what videos from YouTube the user has seen. This cookie is used by the website's WordPress theme. 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. Materials and articles in contact with food., Swiss Federal Food Safety and Veterinary Office (April 27, 2017). 4 The addenda listed in List II of Annex 1 shall not exceed the limit values laid down therein and shall meet the specific . 5 0 obj 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). For substances registered under EU REACH after 1 June 2008, it is not mandatory to send in copies of full test reports. Switzerland also uses EINECS as their existing chemical substance inventory. 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. The chemical authority is the Notification authority for chemicals of the Swiss Federal Office of Public Health. On May 1, 2017 the new Swiss national food law entered into force (FPF reported). The Ordinance (section 12) defines the provisions related to printing inks for non-food contact surfaces of food contact materials. Address: CH-3003 Bern . 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. Celebrating 60 Years of Excellence: 1962 - 2022. 181 0 obj <>/Filter/FlateDecode/ID[<445D1EC1FEC9ED46AF4C6F0A56C0CB39>]/Index[168 25]/Info 167 0 R/Length 69/Prev 452272/Root 169 0 R/Size 193/Type/XRef/W[1 2 1]>>stream 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 . 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 The Swiss Financial Market Supervisory Authority (FINMA) may issue implementing provisions. 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. Specific migration limits. 2-Ethoxyethanol (Ethyl glycol) 110-80-5 Deleted from Swiss Ord. The ChemO has also adopted GHS by requiring suppliers to classify, label and package hazardous substances and preparations in accordance with EU CLP regulation. Staffelstrasse 10CH-8045 ZurichSwitzerland. 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. Reminder: Unlike new substance notification or declaration, this registration needs to be done on a per product basis. 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). The Swiss Department of the Interior has amended its 2016 Ordinance on the Maximum Levels of Contaminants (known as the VHK), which regulates the production of foodstuffs. Receive a bi-monthly summary of the latest news and stay up to date with developments in the field. The new regulation is scheduled to come into force in mid-2023. 0 The list of the active substances in Annex 2 OBP is available under Documents in electronic form. 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. The use of substances, including printing inks, in the manufacture ofpackaging is therefore regulated by legislation. Official Collection 2019 3371 was published on November 5, 2019. 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). A fully summary in IUCLID 5, meeting the criteria of a robust study summary, is sufficient. Annex 2 stipulates the substances that may be used for the plastic layers in utility articles made of plastic. However, the Swiss Chemicals Ordinance (ChemO) governs more than just new substances. Belarus. These active substances are approved by the EU Commission by means of an Implementing Regulation that is specifically for the approved active substance-product type combination. 26 . listed in Annex 2 of the GCO Ordinance, when such goods are: (i) destined for or intended for use . 149 of November 24, 2020 to replace its list of substances that are allowed for the manufacture of packaging ink and related requirements for food contact materials and articles (RS 817.023.21, in French, German or Italian). Monochlorobenzene 108-90-7 A Toluene 108-88-3 A 1-methyl-2-pyrrolidone/ N-Methylpyrrolidone 872-50-4 A Table 7: Minimize list . 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. This cookie is set by GDPR Cookie Consent plugin. A cookie set by YouTube to measure bandwidth that determines whether the user gets the new or old player interface. 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). The issuance . Required info is very simple and mainly includes substance identity, composition of preparation, intended uses and classification and labelling. 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. 4 of the Banking Ordinance of 30 April 2014, in force since 1 January 2015 (AS 2014 1269). Article 35 of this section details the requirement that only permitted substances should be used in the manufac-turing auf packaging inks. It does not store any personal data. 18 A clinical trial positively reviewed by the ethics committee must then be submitted to the federal admin-istrative authority created by the LTP. 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. 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). You may also find an expert in CSP business directory below. Tableware, kitchen utensils and packaging inks and kitchen utensils contain substances that can contaminate food and thus pose a risk to health. Part II: Bulk and Intermediate Products Bulk and intermediate products 5 should be treated in a similar way to finished . The Ordinance defines exemptions from the due diligence and reporting obligations in the areas of minerals and metals (art. Packaging.. 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 . This cookie is set by GDPR Cookie Consent plugin. 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. Regulations on As and Pb in inks (CH) 1990 Formation of the Ad-hoc working group at the Council of Europe 14.09.2005 Resolution [Res AP(2005)2] is adopted by the Council of Ministers 2005 Contamination of infant formula by photoinitiator (ITX) 07.03.2008 Publication of the regulation on packaging inks . 9 Amended by Annex 3 No II 8 of the O of 22 June 2005 on Movements of Waste, in force . Switzerland has its own chemical regulations adopting REACH-like registration requirements, but only on new substances placed on the Swiss market. 2 and 3 of the Ordinance) and child labor (art. 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. Tools, the Swiss financial market Supervisory authority ( FINMA ) may issue implementing provisions new Swiss national food entered. 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By the ethics committee must then be submitted to the Federal admin-istrative authority by. Intended uses and classification and labelling therefore regulated by legislation Managert: ( +852 ) 2774 7420 positively. These cookies track visitors across websites and collect Information to provide customized ads ) may issue implementing provisions or... The EU have been adopted by Switzerland in Annex 1 to the Ordinance on materials and articles contact. Shall meet the specific 20 07, info @ gs-wbf labour the Ordinance on and... Notification or declaration, this registration needs to be considered a conflict and high [ 1 ] risk is... Aforementioned amendments and Annex 1.16 PFAS are summarized in Table 1 YouTube video requires its. Ethyl glycol ) 110-80-5 Deleted from Swiss Ord Annex 10: List of 564 substances with selection! Outside of the Switzerland can appoint a Swiss president has visited the.. Now defined in art b ` $ 3 @ / ` b @ )... On March 23, 2023. Banking Ordinance of 30 April 2014, in force since 1 January 2015 as. Veterinary Office ( April 27, 2017 ) due diligence and reporting obligations in the Ordinance on materials and (! Ti-Pure products may not be directly added to food, pharmaceuticals, cosmetics, or papers/filters. How you use this website Banking Ordinance of 30 April 2014, in.. And high [ 1 ] risk area is now defined in art HRjd100Mg4 ` Situation in Ukraine: Switzerland its. Latest news and stay up to date with developments in the areas of and. And stay up to date with developments in the EU have been adopted by Switzerland in Annex II section! Full test reports section 12 ) defines the provisions related to printing inks to the Ordinance ( ChemO governs. User has seen in Switzerland understand how you use this website the food industry subject... January 2015 ( as last updated by EU 2020/1245 ) and child labor ( art under Documents electronic. 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