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. 19 is authority, the Swiss Agency for ther- apeutic products (commonly called Swissmedic), has powers approximately Reference to Annex II, Section II.1, to that Directive: point 6.8. . New Swiss food law including FCM ordinance entered into force May 1, 2017; many CMR-substances deleted from positive list for printing inks. 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. For child labour the Ordinance requires in its annex 2 compliance with (i) the ILO Conventions no. What is to be considered a conflict and high[1]risk area is now defined in Art. A substance that is listed on EINECS may still require registration under the Swiss Chemicals Ordinance. 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. 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 _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. 168 0 obj <> endobj Based on our extensive experience working under the requirements of the EU food contact materials legislative framework, it is our opinion that self-control refers to compliance with Article 3 of Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food, the so-called Framework Regulation, which states: Materials and articles, including active and intelligent materials and articles, shall be manufactured in compliance with good manufacturing practice so that, under normal or foreseeable conditions of use, they do not transfer their constituents to food in quantities which could: (b) bring about an unacceptable change in the composition of the food; or, (c) bring about a deterioration in the organoleptic characteristics thereof.. On the Swiss Federal Food Safety and Veterinary Office's website a logbook of changes regarding the positive list for printing inks is available. The following new substances are exempt from new substance notifications in Switzerland under the ChemO: *PPORD: This exemption needs to be declared to authority. Ordinance on the Incentive Tax on Volatile Organic Compounds (OVOC): . If you have questions or need any help, please contact our sponsor. Is there guidance on what information must be in a Food Master File? English is not an official language of the Swiss Confederation. If you have questions or need any help, please contact our sponsor. 192 0 obj <>stream Necessary cookies are absolutely essential for the website to function properly. 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. to keep Food Packaging Forums work going. General restrictions related to plastic materials and articles are laid down in Annex II. 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. \j}M2'L~u}0 View Past Newsletter. . Name: Richard Ballaman . sponsor this page to leave your contact info on this page.. For more info, please refer to new substance declaration part. A manufacturer or an importer must notify a new substance before it is placed on the market for the first time in Switzerland. 9 Amended by Annex 3 No II 8 of the O of 22 June 2005 on Movements of Waste, in force . 2 In derogation from para. If you just wish to have a quick look at what restrictions look like, you may click the following two summaries. 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. 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),. It is the first time a Swiss president has visited the country. 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. 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. However, the Swiss Chemicals Ordinance (ChemO) governs more than just new substances. 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. 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). List of active substances approved pursuant to Article 9 of the Regulation (EU) No 528/2012 (Union list of approved active substances). This site uses cookies, including third-party cookies. A notification fee also needs to be paid. This cookie, set by YouTube, registers a unique ID to store data on what videos from YouTube the user has seen. SGS neither endorses nor disapproves said 3rd parties contents. 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 OSAV publishes these instructions in the Official Swiss Trade Sheet. The assets of sanctioned individuals and companies are frozen with immediate effect. 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). Substances on REACH SVHC list will be added to the Annex 7 of ChemO. 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). We also use third-party cookies that help us analyze and understand how you use this website. 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 This cookie is set by GDPR Cookie Consent plugin. BPA can be detected both in foodstuffs and in utility articles. 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. Even though these substances are classed as non-evaluated, evidence that they meet the listing requirements (i.e., migration <10 ppb and no CMR properties) must be provided to the Swiss authorities before they can be added to Part B. YSC cookie is set by Youtube and is used to track the views of embedded videos on Youtube pages. 4 and 5 of the Ordinance), exemptions from the due diligence and reporting obligations due to compliance with internationally recognized and equivalent regulatory frameworks . . The 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. 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. This applies by analogy, specifically because MedDO Annex 2 and IvDO Annex 1 list the correspondence of terms between the EU regulation and Swiss ordinance. Bisphenol A (BPA) is a synthetic substance used to manufacture various plastic materials intended, among other things, for contact with foodstuffs. Entities have until May 31, 2020 to comply with the new provisions covering BPA. 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). This may pose a threat to health. Ordonnance du DFI sur les matriaux et objets destins entrer en contact avec les denres alimentaires (Ordonnance sur les matriaux et objets), Annexe 9 de lordonnance du DFI sur les matriaux et objets destins entrer en contact avec les denres alimentaires (PDF, 292 kB, 15.10.2022), Annex 10 of the Ordinance of the FDHA on materials and articles intended to come into contact with food-stuffs (PDF, 1 MB, 15.10.2022), The old legislation and the old Annexes remain valid during a transitional period, see "archives de l`ancien droitalimentaire. Processes involving the application of printing inks to the non-food contact side of a material or article. Annex to the DETEC Ordinance of 3 December 1996 relating to the transport of dangerous goods by rail and . Celebrating 60 Years of Excellence: 1962 - 2022. 2 Object of taxation The following are liable for tax: a. VOCs on the positive list of substances (Annex 1); b. The biocide triclosan (CAS 3380-34-5) has also been deleted from the list. 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. A full logbook of these changes and more information about the updated Ordinance can be found at the FSVO Website. The cookies is used to store the user consent for the cookies in the category "Necessary". 1.2. 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. It allows the website owner to implement or change the website's content in real-time. 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. Substances incorporated intopackaging materials, such as printed plastics, can migrate into foodstuffs and endanger health. This cookie is set by GDPR Cookie Consent plugin. The Russia Sanctions Ordinance prohibits Swiss banks from accepting deposits by Russian nationals or residents and banks, enterprises and other entities established in Russia if the total The food law includes the ordinance on materials and articles intended to come into contact with food. For this reason the FSVO has issued regulations governing packaging. 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. 0 The new regulation is scheduled to come into force in mid-2023. Cooperation on printing inks 3 5th EFSA FIP Network FCM Meeting, Parma, 10.-11.7.17 1900s. This obligation is called registration. Permitted substances are defined as those listed in Annex 2 Lists I and II and in Annex 10, December 2020. . Consumers are exposed to too little of the substance for it to have any impact on health (see "More information"). 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). Switzerland issued a revised version of its Ordinance on 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. In November 2020, Switzerland published RO 2020 4811 (in French, German or Italian) under Official Collection No. 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. Address for enquiries EAER Communications, Tel. 2 The Swiss Financial Market Supervisory Authority (FINMA) may issue implementing provisions. 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 . . Through its independent, balanced, and science-based publications and tools, the Food Packaging Forum contributes to protecting human and environmental health. 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 (. We do not provide consultancy services. The active substances approved in the EU have been adopted by Switzerland in Annex 2 OBP. The Federal Council's report: Benefits and risks of using bisphenol A (in French) (PDF, 399 kB, 18.12.2015), Ordonnance du DFI sur les matriaux et objets destins entrer en contact avec les denres alimentaires (Ordonnance sur les matriaux et objets), Annexe 2 de lordonnance du DFI sur les matriaux et objets destins entrer en contact avec les denres alimentaires (PDF, 636 kB, 15.10.2022), Annex 10 of the Ordinance of the FDHA on materials and articles intended to come into contact with food-stuffs (PDF, 1 MB, 15.10.2022), Logbook of changes (PDF, 45 kB, 01.12.2020), https://www.blv.admin.ch/content/blv/en/home/gebrauchsgegenstaende/materialien-in-kontakt-mit-lebensmitteln/verpackungen.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, Materials and articles in contact with food, The Federal Council's report: Benefits and risks of using bisphenol A (in French), Annexe 2 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. Annex 10 includes a positive list for binders (monomers), dyes and pigments, solvents . 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. Situation in Ukraine: Switzerland extends its measures. New Zealand has launched a consultation on its proposal to restrict PFHxS, its salts and PFHxS-related compounds as a persistent organic pollutant (POP). It is similar to C&L notification under CLP regulation. 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. 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. The cookie is used to store the user consent for the cookies in the category "Other. The chemical authority is the Notification authority for chemicals of the Swiss Federal Office of Public Health. 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 . The Swiss Federal Council, on the basis of Article 2 paragraph 4, 19, 22 paragraph 2, 24, 38, 39 paragraph 2, . Country: Switzerland . 2023 Merkitykselliset tunnistetut kytt Pasiallinen kyttkategoria : Rakennusmateriaalit Erit. 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. Monochlorobenzene 108-90-7 A Toluene 108-88-3 A 1-methyl-2-pyrrolidone/ N-Methylpyrrolidone 872-50-4 A Table 7: Minimize list . The ordinance is almost a combined version of EU RoHS, REACH Annex XVII Restricted Substance List and REACH Annex XIV Authorization List. The use and handling of these materials and articles are regulated by law. We do not provide consultancy services. 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. I understand that the Japan MHLW Notification No. Comments are accepted until April 3, 2023. 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. Packaging.. . This final rule will become effective on March 23, 2023. 2 10 You can search restriction conditions either by substance name or product type by clicking the links we have sorted out below. Dr. Hingwo TsangGlobal Information and Innovation Managert: (+852) 2774 7420. You may also find an expert in CSP business directory below. This cookie is installed by Google Analytics. All dual-use products and technology, according to Annex 2 of the Swiss Goods Control Ordinance of 3 June 2016. Swiss Ink Ordinance 2-Methoxyethanol (methyl glycol) 109-86-4 Deleted from Swiss Ord. 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. ( Lists I - V / Part A or B) Remarks Food Contact A positive assessment of the binder, does not release the user from the du- %PDF-1.4 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. 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. For this reason the FSVO has issued regulations governing packaging. A copy of the fully executed agreement is sent to all parties by email. hbbd``b` $3@/`b@\W+D)HRjd100Mg4` 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 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. stream Printing inks also contain substances that could pose a risk. Tableware, kitchen utensils and packaging inks and kitchen utensils contain substances that can contaminate food and thus pose a risk to health. Permitted substances are defined as those listed in Annex 2 Lists I and II and in Annex 10, December 2020. . It does not store any personal data. Article 11. Until now, Annex 10 has consisted of two parts, Part A and Part B. 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. 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. Comments are accepted until April 5, 2023. 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. Luckily, the Swiss Authority accepts REACH registration dossier in IUCLID 5 format. This is a publication of SGS, except for 3rd parties contents submitted or licensed for use by SGS. % How Are Colorants for Food Packaging Regulated in Japan? 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. 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). Analytical cookies are used to understand how visitors interact with the website. Packagingcontains substances that may migrate into the foodstuff and thus into the human body. The cookie is used to store the user consent for the cookies in the category "Performance". >\o 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. For more info, please refer to ChemO registration part. 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. 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). The active substances approved in the EU have been adopted by Switzerland in Annex 2 OBP. Aineen tai seoksen merkitykselliset tunnistetut kytt ja kytt, joita ei suositella 1.2.1. For example, if an American company plans to export 99 tons of a new substance into the EEA, among which 5t is imported into Switzerland, the American company will need to submit a 10-100t technical dossier to Swiss authority by appointing an only representative. 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. 186 V. Junod / European Journal of Health Law 15 (2008) 183-195 coverage policy and, of course, the risk-bene t balance. 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. SML values from Union list, Swiss Ordinance or evaluations of MS authorities 2. Since the Chemical Risk Reduction Ordinance (ORRChem) is updated frequently, please click here to search the latest restrictions for each substance or product type. Commission Directive 91/412/EEC, Article 9, para 2 and Annexes 1 and 2 of the Swiss Ordinance of 17 October 2001 on establishment licences). 13 . 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 food industry is subject to strict requirements that are set out in the Ordinance on Materials and Articles (in French). If you are a consultant, you may get yourself listed in CSP business directory (free) or Investigational medicinal products in their final packaging are treated similarly. Please note that there is no official Swiss chemical inventory. CHF100, to issue a public deed (see clause 1.2, Annex to the Notary Fee Ordinance of the Canton of Zurich (Notariatsgebhrenverordnung)). 2(1)(e) of the Ordinance (same wording as in Regulation (EU) 2017/821 on conflict minerals). Substances on packaging materials, such as printed plastics, can migrate into foodstuffs and endanger health. For this purpose, the Swiss Federal Council has approved the complete revision of the Ordinance on Measures against Belarus, which entered . Switzerland Revises Chemical Risk Reduction Ordinance SafeGuardS Automotive, Electrical & Electronics, Electrical & Electronics, Hardgoods, Hardgoods, Hardgoods, Hardgoods, Hardgoods, Personal and Protective Equipment, Softlines, Footwear and Leather Products, Softlines, Softlines, Softlines March 24, 2022 I understand that the inclusion of an aluminum foil layer in laminate materials is considered by FDA to be a functional . %PDF-1.7 % Contact us for more information or visit our website. 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. Annex 2.2 (Cleaning, deodorising and cosmetic products) Placing on the market of deodorisers and air-fresheners intended for . 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. In utility articles 1 ] risk area is now defined in Art frozen immediate! Importer must notify a new substance before it is similar to C L. Strict requirements that are set out in the EU have been adopted by Switzerland in Annex OBP! Intended for substances approved in the EU have been adopted by Switzerland in Annex 10, December 2020. goods rail... Have a quick look at what restrictions look like, you may also find an expert in business... 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Hingwo TsangGlobal information and Innovation Managert: ( +852 ) 2774 7420 `` Performance '' in IUCLID format... User consent for the cookies is used to store data on what videos from YouTube the user consent for cookies! The website to function properly regulation ( EU ) 2017/821 on conflict minerals ) cookies are essential... And endanger health goods by rail and considered a conflict and high [ ]... On conflict minerals ) name or product type by clicking the links we have out! To new substance declaration part food and thus pose a risk to health to all parties by.... Under the Swiss Chemicals Ordinance 2 compliance with ( I ) the ILO no... I ) the ILO Conventions no.. for more info, please refer ChemO. 2023 Merkitykselliset tunnistetut kytt Pasiallinen kyttkategoria: Rakennusmateriaalit Erit all dual-use products and technology, according to Annex compliance. Use the arrow, home, and end keys Authority ( FINMA may! 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