Do not quote or refer any information herein without SGSs prior written consent. 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 . 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 The US EPA has issued a final rule to revise the Formaldehyde Standards for Composite wood Products Act. Monochlorobenzene 108-90-7 A Toluene 108-88-3 A 1-methyl-2-pyrrolidone/ N-Methylpyrrolidone 872-50-4 A Table 7: Minimize list . 168 0 obj
<>
endobj
A cookie set by YouTube to measure bandwidth that determines whether the user gets the new or old player interface. I understand that the inclusion of an aluminum foil layer in laminate materials is considered by FDA to be a functional 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). 138 and 182 and (ii) the ILO-IOE Child Labour Guidance Tool for Business and (iii) the OECD Due Diligence Guidance for Responsible Business Conduct or the UN Guiding Principles on Business and Human Rights. We can also assist clients in carrying out the self-assessment of substances in line with the requirements of the Framework Regulation to ensure full compliance of printing ink substances that are not authorized by the Swiss Authorities. The Swiss Federal Council, on the basis of Article 2 paragraph 4, 19, 22 paragraph 2, 24, 38, 39 paragraph 2, . 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. sponsor this page to leave your contact info on this page.. 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. Merkitykselliset tunnistetut kytt Pasiallinen kyttkategoria : Rakennusmateriaalit Erit. 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. We do not provide consultancy services. This website uses cookies to give you the best experience.Learn More OK OK A copy of the fully executed agreement is sent to all parties by email. Processes involving the application of printing inks to the non-food contact side of a material or article. Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. 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. It is the first time a Swiss president has visited the country. All versions (Texts on reference publications - annexes 3a, 7, 7a AMZV; annexes 2, 3 VAZV; annexes 4-10 KPAV) 1.7.2022 Annex 7 AMZV . These cookies will be stored in your browser only with your consent. New Zealand has launched a consultation on its proposal to restrict PFHxS, its salts and PFHxS-related compounds as a persistent organic pollutant (POP). 2 10 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. (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. Receive a bi-monthly summary of the latest news and stay up to date with developments in the field. 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. This may pose a threat to health. This cookie is set by GDPR Cookie Consent plugin. Moreover, the Ordinance contains additional epoxy derivatives from European Commission Regulation (EC) No 1895/2005 on its positive list, including 2,2-bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl) ether (BADGE) and novolac glycidyl ethers (NOGE). Ti-Pure products may not be directly added to food, pharmaceuticals, cosmetics, or cigarette papers/filters for . New Swiss food law including FCM ordinance entered into force May 1, 2017; many CMR-substances deleted from positive list for printing inks. 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. 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 . Notification authority for chemicals of the Swiss Federal Office of Public Health. 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. A fully summary in IUCLID 5, meeting the criteria of a robust study summary, is sufficient. This Chemical Risk Reduction Ordinance prohibits or restricts the marketing and use of certain hazardous substances on its own or in preparations and articles. If you have questions or need any help, please contact our sponsor. 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; . This is a publication of SGS, except for 3rd parties contents submitted or licensed for use by SGS. Chemical substances that are subject to other laws (i.e., medicines, food stuffs, weapon, wastes, ammunition, fertilizer, therapeutic products, etc. Stripe sets this cookie cookie to process payments. 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. Since Switzerland is not a member of the EU or the European Economic Area (EEA), EU REACH regulation does not apply here. 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. For more info, please refer to ChemO registration part. Official Collection 2019 3371 was published on November 5, 2019. Swiss Ink Ordinance 2-Methoxyethanol (methyl glycol) 109-86-4 Deleted from Swiss Ord. These cookies ensure basic functionalities and security features of the website, anonymously. 1.2. This cookie is used by the website's WordPress theme. It: Highlights of several of the aforementioned amendments and Annex 1.16 PFAS are summarized in Table 1. 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. 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. Plastic materials and articles shall not transfer their constituents to foods in quantities exceeding the specific migration limits (SML) set out in Annex I. 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. The issuance . You may also find an expert in CSP business directory below. The food industry is subject to strict requirements that are set out in the Ordinance on Materials and Articles (in French). 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. It is similar to C&L notification under the EU CLP regulation. Disclosures of migrating substances are demanded under both This cookie is set by GDPR Cookie Consent plugin. The chemical authority is the Notification authority for chemicals of the Swiss Federal Office of Public Health. 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. 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. This cookie is installed by Google Analytics. Organization: Swiss Federal Office for the Environment. Annex 10 includes a positive list for binders (monomers), dyes and pigments, solvents . This obligation is called registration. The following banks are listed in Annex 15 of the Ordinance: Belagroprombank, Bank . The _ga cookie, installed by Google Analytics, calculates visitor, session and campaign data and also keeps track of site usage for the site's analytics report. >\o Until now, Annex 10 has consisted of two parts, Part A and Part B. 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. Keller and Heckman LLP. 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. Therefore, GSPR #23.2(d) . stream 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. 4 The addenda listed in List II of Annex 1 shall not exceed the limit values laid down therein and shall meet the specific . For this reason the FSVO has issued regulations governing packaging. For child labour the Ordinance requires in its annex 2 compliance with (i) the ILO Conventions no. Target: new substances >=1t/y for product- and process-orientated research and development (PPORD); Required info: substance identity, uses, and expected quantity. 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. listed in Annex 2 of the GCO Ordinance, when such goods are: (i) destined for or intended for use . 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. 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. %%EOF
. YouTube sets this cookie via embedded youtube-videos and registers anonymous statistical data. last required signature was executed (Swiss Federal Supreme Court 129 IV 130 c. 2.3 and 3). 192 0 obj
<>stream
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. In November 2020, Switzerland published RO 2020 4811 (in French, German or Italian) under Official Collection No. 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. 4 of the Banking Ordinance of 30 April 2014, in force since 1 January 2015 (AS 2014 1269). \j}M2'L~u}0
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. Annex 10: List of 564 substances with their selection criteria Presented are all substances and the 4 selection steps. 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). 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. SGS neither endorses nor disapproves said 3rd parties contents. 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. On the Swiss Federal Food Safety and Veterinary Office's website a logbook of changes regarding the positive list for printing inks is available. Aside from the provisions covering BPA, food contact materials must comply with all new changes to Ordinance 817.023.21 by November 30, 2020. Ordinance on the Incentive Tax on Volatile Organic Compounds (OVOC): . Higher data package is required for higher volume substances. 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. On May 1, 2017 the new Swiss national food law entered into force (FPF reported). restriction outlined in Annex II (as last updated by EU 2020/1245) and 1Severe Metals Migration Testing in . 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. 4 and 5 of the Ordinance), exemptions from the due diligence and reporting obligations due to compliance with internationally recognized and equivalent regulatory frameworks . 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). It is strictly educational and does not replace any legal requirements or applicable regulations. The cookies is used to store the user consent for the cookies in the category "Necessary". 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 concerning Capital Adequacy and Risk Diversification for Banks and Securities Dealers | 7 The cookie is used to store the user consent for the cookies in the category "Analytics". The individual ordinances can be consulted on this site. The use of substances, including printing inks, in the manufacture ofpackaging is therefore regulated by legislation. % PackagingLaw.com is the premier online resource for the global packaging industry. But opting out of some of these cookies may affect your browsing experience. Bisphenol A (BPA) is a synthetic substance used to manufacture various plastic materials intended, among other things, for contact with foodstuffs. . Automotive, Electrical & Electronics, Electrical & Electronics, Hardgoods, Hardgoods, Hardgoods, Hardgoods, Hardgoods, Personal and Protective Equipment, Softlines, Footwear and Leather Products, Softlines, Softlines, Softlines. 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. 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 Swiss Food Safety and Veterinary Office (FSVO) and German Bundesinstitut fr Risikobewertung (BfR) currently have an informal arrangement whereby they . In addition to that, the ChemO has introduced REACH SVHC list into Switzerland and imposed a duty on suppliers of articles which contain substances on the SVHC list in a concentration above 0.1% (w/w) to provide sufficient information to their customers to allow safe use of the articles. . Tags: Topics - CH,REACH-like Regulation and Registration, Subscribe to Free Newsletter I understand that the Japan MHLW Notification No. To this end, it establishes the requirements for honesty, diligence and transparency in the provision of financial services and governs the offering . 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
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; Standard prohibitions on the provision of technical or financial assistance apply as well. All rights reserved. +41 58 462 20 07, info@gs-wbf . Notification applies to a substance on its own, in a mixture or intended to be released from an article under normal conditions of use. YouTube sets this cookie to store the video preferences of the user using embedded YouTube video. 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. The substance may be contained in food can coatings, till receipts and toys, for example. The chemical authority is the Notification authority for chemicals of the Swiss Federal Office of Public 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. 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 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. . . Switzerland also uses EINECS as their existing chemical substance inventory. Annex. 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. This final rule will become effective on March 23, 2023. What is to be considered a conflict and high[1]risk area is now defined in Art. 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. The report concludes that BPA does not represent a risk to consumers' health. Anyone who commercially supplies an article containing a substance of very high concern in a concentration greater than 0.1 % by weight must provide the customer with the following information: This information must be provided free of charge to professional or commercial users without being requested or consumers within 45 days upon request. The correspondences in Switzerland for the special provisions in the Implementing Regulation of the EU are considered in Annex 3 OBP. 2(1)(e) of the Ordinance (same wording as in Regulation (EU) 2017/821 on conflict minerals). For polymer, this notification applies to monomers. 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. The following chemicals are exempt from registrations under ChemO: Note: A notified or declared new substance does not require registration. CHF100, to issue a public deed (see clause 1.2, Annex to the Notary Fee Ordinance of the Canton of Zurich (Notariatsgebhrenverordnung)). The ChemO has also adopted GHS by requiring suppliers to classify, label and package hazardous substances and preparations in accordance with EU CLP regulation. . ( Lists I - V / Part A or B) Remarks Food Contact GMP (Good Manufacturing Practice): Staffelstrasse 10CH-8045 ZurichSwitzerland. If you are a consultant, you may get yourself listed in CSP business directory (free) or 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 (. For this purpose, the Swiss Federal Council has approved the complete revision of the Ordinance on Measures against Belarus, which entered . 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
General restrictions related to plastic materials and articles are laid down in Annex II. 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). The ordinance is almost a combined version of EU RoHS, REACH Annex XVII Restricted Substance List and REACH Annex XIV Authorization List. 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. We do not provide consultancy services. These will be implemented in phases, starting April 1, 2022. The food law includes the ordinance on materials and articles intended to come into contact with food. Aineen tai seoksen merkitykselliset tunnistetut kytt ja kytt, joita ei suositella 1.2.1. Similar to EU REACH, a company based outside of the Switzerland can appoint a Swiss only representative to notify. I. Article 11. 2 and 3 of the Ordinance) and child labor (art. 18 A clinical trial positively reviewed by the ethics committee must then be submitted to the federal admin-istrative authority created by the LTP. Investigational medicinal products in their final packaging are treated similarly. This exemption is usually limited to a quantity required for the purpose and a period not exceeding five years. 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).