Annex 2 stipulates the substances that may be used for the plastic layers in utility articles made of plastic. 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. View Past Newsletter. 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. For more info, please refer to new substance declaration part. You can search restriction conditions either by substance name or product type by clicking the links we have sorted out below. The individual ordinances can be consulted on this site. Therefore, GSPR #23.2(d) . PackagingLaw.com is the premier online resource for the global packaging industry. For polymer, this notification applies to monomers. 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. Please note that there is no official Swiss chemical inventory. We do not provide consultancy services. 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. This is a publication of SGS, except for 3rd parties contents submitted or licensed for use by SGS. Substances on REACH SVHC list will be added to the Annex 7 of ChemO. The substances permitted to be used in printing inks are listed in Annex 2 of the Swiss Ordinance, referred to plastics, and Annex 10, referred to printing inks (Annex 6 in former versions of the Ordinance; revised version came into force on May 1st, 2017). If you are a consultant, you may get yourself listed in CSP business directory (free) or The cookie is used to store the user consent for the cookies in the category "Analytics". Union list of approved active substances The use of substances, including printing inks, in the manufacture ofpackaging is therefore regulated by legislation. 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. Annex to the DETEC Ordinance of 3 December 1996 relating to the transport of dangerous goods by rail and . 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. Chemical Risk Reduce Ordinance (ORRChem). In 2008 an amendment to the Swiss Ordinance on Materials and Articles (SR 817.023.21) was made, detailing certain provisions specific to food packaging inks. **Contains certain derogations, including: 100 ppb for the sum of C9-C14 PFCAs in fluoropolymers containing perfluoroalkoxy groups, 2000 ppb each of PFOA, PFOA-related compounds (sum), C9-C14 PFCAs and C9-C14 PFCA-relatedsubstances (sum) for non-invasive and non-implantable medical devices and their components. Note: The restriction of the marketing and uses of certain substances, preparations and articles are governed by another ordinance Chemical Risk Reduce Ordinance (ORRChem). 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. to keep Food Packaging Forums work going. 2 10 You also have the option to opt-out of these cookies. A new substance is defined a substance that is not listed on EINECS (European Inventory of Existing Commercial Chemical Substances). This cookie, set by YouTube, registers a unique ID to store data on what videos from YouTube the user has seen. For this reason the FSVO has issued regulations governing 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 . 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 . Merkitykselliset tunnistetut kytt Pasiallinen kyttkategoria : Rakennusmateriaalit Erit. These cookies track visitors across websites and collect information to provide customized ads. 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; Keller and Heckman LLP. 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. Country: Switzerland . Staffelstrasse 10CH-8045 ZurichSwitzerland. 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. It is the first time a Swiss president has visited the country. last required signature was executed (Swiss Federal Supreme Court 129 IV 130 c. 2.3 and 3). 4 The addenda listed in List II of Annex 1 shall not exceed the limit values laid down therein and shall meet the specific . It does not store any personal data. 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). 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. The chemical authority is the Notification authority for chemicals of the Swiss Federal Office of Public Health. Annex 2 stipulates the substances that may be used for the plastic layers in utility articles made of plastic. 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. 326 80-05-7 2,2-Bis(4-hydroxyphenyl)propan = 4,4'-isopropylidenediphenol = Bisphenol A HPV Not pers 1 High Substances incorporated intopackaging materials, such as printed plastics, can migrate into foodstuffs and endanger health. It is similar to C&L notification under CLP regulation. However, the Swiss Chemicals Ordinance (ChemO) governs more than just new substances. 2-Ethoxyethanol (Ethyl glycol) 110-80-5 Deleted from Swiss Ord. In addition to modifying the text of the legislation and six of the 10 existing annexes, the amendment introduces a new Annex 11, which provides guideline values for the verification of good manufacturing processes as they . 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. 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; . These modifications enter into force . 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. 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. Packaging.. 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). 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. Required info is very simple and mainly includes substance identity, composition of preparation, intended uses and classification and labelling. The biocide triclosan (CAS 3380-34-5) has also been deleted from the list. The correspondences in Switzerland for the special provisions in the Implementing Regulation of the EU are considered in Annex 3 OBP. 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. YouTube sets this cookie to store the video preferences of the user using embedded YouTube video. Permitted substances are defined as those listed in Annex 2 Lists I and II and in Annex 10, December 2020. . 2 and 3 of the Ordinance) and child labor (art. Stripe sets this cookie cookie to process payments. 18 A clinical trial positively reviewed by the ethics committee must then be submitted to the federal admin-istrative authority created by the LTP. Annex. Tableware, kitchen utensils and packaging inks and kitchen utensils contain substances that can contaminate food and thus pose a risk to health. 19 is authority, the Swiss Agency for ther- apeutic products (commonly called Swissmedic), has powers approximately This cookie is set by GDPR Cookie Consent plugin. Do not quote or refer any information herein without SGSs prior written consent. This aligns the Swiss Ordinance with provisions from the following EU 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). The assets of sanctioned individuals and companies are frozen with immediate effect. 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. 2(1)(e) of the Ordinance (same wording as in Regulation (EU) 2017/821 on conflict minerals). Annex 2.2 (Cleaning, deodorising and cosmetic products) Placing on the market of deodorisers and air-fresheners intended for . 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. 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 Belarus. SML values from Union list, Swiss Ordinance or evaluations of MS authorities 2. The US EPA has issued a final rule to revise the Formaldehyde Standards for Composite wood Products Act. Notification applies to a substance on its own, in a mixture or intended to be released from an article under normal conditions of use. Name: Richard Ballaman . Switzerland also uses EINECS as their existing chemical substance inventory. Investigational medicinal products in their final packaging are treated similarly. Annex 10 includes a positive list for binders (monomers), dyes and pigments, solvents . . 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. 2 The Swiss Financial Market Supervisory Authority (FINMA) may issue implementing provisions. 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. The following new substances are exempt from new substance notifications in Switzerland under the ChemO: *PPORD: This exemption needs to be declared to authority. 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. % Vc!Fs1=FzT39!Osn,%u"MVybD/Ih&>7&&?Q 1.2. The cookies is used to store the user consent for the cookies in the category "Necessary". Specific migration limits. Who: manufacturer or importer or only representative; Required info: physio-chemical data, toxicology data, eco-toxicology data and chemical safety report. Ti-Pure products may not be directly added to food, pharmaceuticals, cosmetics, or cigarette papers/filters for . We do not provide consultancy services. 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. . <> . 0
This website uses cookies to give you the best experience.Learn More OK OK These cookies will be stored in your browser only with your consent. Only Part A substances will remain listed in the new legislation. 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. Consumers are exposed to too little of the substance for it to have any impact on health (see "More information"). 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. Switzerland strengthens its ORRChem by implementing provisions from EU REACH and the POP Recast Regulation, as well as new requirements for PFHxS, its salts and PFHxS-related substances. The list of the active substances in Annex 2 OBP is available under Documents in electronic form. Tags: Topics - CH,REACH-like Regulation and Registration, Subscribe to Free Newsletter . The active substances approved in the EU have been adopted by Switzerland in Annex 2 OBP. 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. ", Materials and articles in contact with food, https://www.blv.admin.ch/content/blv/en/home/gebrauchsgegenstaende/materialien-in-kontakt-mit-lebensmitteln.html, Federal Food Safety and Veterinary Office FSVO, 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, FSVO: Federal Food Safety and Veterinary Office, MeteoSwiss: Federal Office of Meteorology and Climatology, FSIO: Federal Social Insurance Office, Switzerland, Swissmedic: Swiss Agency for Therapeutic Products, Annexe 9 de lordonnance du DFI sur les matriaux et objets destins entrer en contact avec les denres alimentaires, Annex 10 of the Ordinance of the FDHA on materials and articles intended to come into contact with food-stuffs. You may also find an expert in CSP business directory below. Through its independent, balanced, and science-based publications and tools, the Food Packaging Forum contributes to protecting human and environmental health. What are the Requirements for Using Aluminum Foil as a Functional Barrier? The aim of the trip was to strengthen relations between the two countries. 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). 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. For substances registered under EU REACH after 1 June 2008, it is not mandatory to send in copies of full test reports. Standard prohibitions on the provision of technical or financial assistance apply as well. This may pose a threat to health. In the end, its only trusted because its tested. 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 1. Organization: Swiss Federal Office for the Environment. Materials and articles in contact with food. 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. . CHF100, to issue a public deed (see clause 1.2, Annex to the Notary Fee Ordinance of the Canton of Zurich (Notariatsgebhrenverordnung)). It is similar to C&L notification under the EU CLP regulation. Swiss Federal Food Safety and Veterinary Office (April 27, 2017). Replaces Annex 1.16 Per- and polyfluoroalkyl substances, PFAS in relation to: Perfluorooctane sulfonic acid (PFOS), its salts and PFOS derivatives, Perfluorohexane sulfonic acid (PFHxS), its salts and PFHxS-related substances, Perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds, Perfluorocarboxylic acids containing 9 to 14 carbon atoms in the chain (C, Fluoroalkylsilanols and their derivatives, April 1, 2022, for provisions other than those indicated below, April 1, 2023, for amendments to the Plant Protection Products Ordinance of May 12, 2010. 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. . Annex 4 of DFI Swiss Ordinance 817.023.21 The present review only refers to food-contact applications. 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). Address for enquiries EAER Communications, Tel. 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. The food industry is subject to strict requirements that are set out in the Ordinance on Materials and Articles (in French). To this end, it establishes the requirements for honesty, diligence and transparency in the provision of financial services and governs the offering . Data requirement for new substance notification under ChemO is the same as EU REACH registration. The cookie stores information anonymously and assigns a randomly generated number to recognize unique visitors. I understand that the inclusion of an aluminum foil layer in laminate materials is considered by FDA to be a functional The European Chemicals Agency has launched a 45-day consultation for listing two chemicals as substances of very high concern (SVHC). Analytical cookies are used to understand how visitors interact with the website. By accepting, you agree to our use of cookies. This cookie is set by the Google recaptcha service to identify bots to protect the website against malicious spam attacks. 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 correspondences in Switzerland for the special provisions in the Implementing Regulation of the EU are considered in Annex 3 OBP. A notification fee also needs to be paid. 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 Swiss Food Safety and Veterinary Office (FSVO) and German Bundesinstitut fr Risikobewertung (BfR) currently have an informal arrangement whereby they . ANNEX 2 to the Convention on International Civil Aviation Rules of the Air Air travel must be safe and efficient; this requires, among ot her things, a set of internationally agreed rules of the air. These will be implemented in phases, starting April 1, 2022. What is to be considered a conflict and high[1]risk area is now defined in Art. Preparations containing at least one hazardous ingredient that is dangerous to human health or to the environment in an individual concentration>=1%w/w (non-gases) or >0.2% by volume(for gases); Preparations containing at least one PBT or vPvB substance in an individual concentration>=0.1%w/w; Preparations containing at least one SVHC in an individual concentration>=0.1%w/w; Preparations containing at least one substance for which a workplace exposure limit has been laid down in Europe. 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). On May 1, 2017 the new Swiss national food law entered into force (FPF reported). 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. 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. 2 Object of taxation The following are liable for tax: a. VOCs on the positive list of substances (Annex 1); b. H. Bisphenol A Higher data package is required for higher volume substances. 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 . This cookie is set by GDPR Cookie Consent plugin. Article 11. You may also find an expert in CSP business directory below. Until now, Annex 10 has consisted of two parts, Part A and Part B. even Swiss companies that are not currently affected will . This Chemical Risk Reduction Ordinance prohibits or restricts the marketing and use of certain hazardous substances on its own or in preparations and articles. 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). 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`
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. 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. >\o Part A of Annex 10 of the Swiss Printing Ink Ordinance contains a positive list of substances that can be used in printing inks on the non-contact surface of food contact materials. Necessary cookies are absolutely essential for the website to function properly. %%EOF
The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional". Luckily, the Swiss Authority accepts REACH registration dossier in IUCLID 5 format. To understand swiss ordinance annex 2 visitors interact with the website to function properly been Deleted from the list of 564 with. 4 the addenda listed in list II of Annex 1 shall not exceed the limit values down... Correspondences in Switzerland for the plastic layers in utility articles a substance is. For this reason the FSVO has issued regulations governing swiss ordinance annex 2 products may not be directly to... Fs1=Fzt39! Osn, % u '' MVybD/Ih & > 7 & &? Q 1.2 the use of.. Printing inks, in the new legislation and transparency in the new legislation risk Reduction Ordinance prohibits or the! Cookie stores information anonymously and assigns a randomly generated number to recognize unique visitors to opt-out of these track. 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