swiss ordinance annex 2

swiss ordinance annex 2

30.12.2020, , 0

A fully summary in IUCLID 5, meeting the criteria of a robust study summary, is sufficient. listed in Annex 2 of the GCO Ordinance, when such goods are: (i) destined for or intended for use . 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. 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. Dr. Hingwo TsangGlobal Information and Innovation Managert: (+852) 2774 7420. These cookies will be stored in your browser only with your consent. The cookie stores information anonymously and assigns a randomly generated number to recognize unique visitors. The food industry is subject to strict requirements that are set out in the Ordinance on Materials and Articles (in French). Since the Chemical Risk Reduction Ordinance (ORRChem) is updated frequently, please click here to search the latest restrictions for each substance or product type. SGS Socit Gnrale de surveillance SA - 2022 - All rights reserved - SGS is a registered trademark of SGS Socit Gnrale de surveillance SA. 13 . 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. 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. 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),. 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). This cookie, set by YouTube, registers a unique ID to store data on what videos from YouTube the user has seen. hbbd``b` $3@/`b@\W+D)HRjd100Mg4` Notification authority for chemicals of the Swiss Federal Office of Public Health. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc. This final rule will become effective on March 23, 2023. English is not an official language of the Swiss Confederation. 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. Packagingcontains substances that may migrate into the foodstuff and thus into the human body. 192 0 obj <>stream Do not quote or refer any information herein without SGSs prior written 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). Required info is very simple and mainly includes substance identity, composition of preparation, intended uses and classification and labelling. This cookie is set by GDPR Cookie Consent plugin. It has been amended several times. ); 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. Disclosures of migrating substances are demanded under both It is similar to C&L notification under CLP regulation. 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. 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. The chemical authority is the Notification authority for chemicals of the Swiss Federal Office of Public Health. For more info, please refer to new substance declaration part. 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). Comments are accepted until April 3, 2023. 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 cookie is set by the Google recaptcha service to identify bots to protect the website against malicious spam attacks. 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. 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. 326 80-05-7 2,2-Bis(4-hydroxyphenyl)propan = 4,4'-isopropylidenediphenol = Bisphenol A HPV Not pers 1 High even Swiss companies that are not currently affected will . 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). A full logbook of these changes and more information about the updated Ordinance can be found at the FSVO Website. 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 4 of DFI Swiss Ordinance 817.023.21 The present review only refers to food-contact applications. It is the first time a Swiss president has visited the country. 0 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. 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. 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). 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. 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. Specific migration limits. This obligation is called registration. 2 The Swiss Financial Market Supervisory Authority (FINMA) may issue implementing provisions. 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 Target: Substances and preparations that are hazardous or PBT/vPvB or on Swiss SVHC candidate list; Registration is done on a per product basis; Similar to C&L notification under EU CLP regulation; Required info: substance identity, classification & labelling, uses, quantity, and chemical safety report (if available). The European Chemicals Agency has launched a 45-day consultation for listing two chemicals as substances of very high concern (SVHC). The cookie is used to store the user consent for the cookies in the category "Performance". Cooperation on printing inks 3 5th EFSA FIP Network FCM Meeting, Parma, 10.-11.7.17 1900s. Bisphenol A (BPA) is a synthetic substance used to manufacture various plastic materials intended, among other things, for contact with foodstuffs. Ordonnance du DFI sur les matriaux et objets destins entrer en contact avec les denres alimentaires (Ordonnance sur les matriaux et objets) Annexe 9 de l'ordonnance du DFI sur les matriaux et objets destins entrer en contact avec les denres alimentaires (PDF, 292 kB, 15.10.2022) Merkitykselliset tunnistetut kytt Pasiallinen kyttkategoria : Rakennusmateriaalit Erit. Switzerland Annex 6, part A Annex 6, part B Germany Annex 14 ("positive list") Inventory list (p ) ((pnot part of the Ordinance) Migration limits in Swiss & German Ordinance are likely to be very 18 similar as both are based on the same scientific opinion. For more info, please refer to ChemO registration part. Part II: Bulk and Intermediate Products Bulk and intermediate products 5 should be treated in a similar way to finished . Switzerland has its own chemical regulations adopting REACH-like registration requirements, but only on new substances placed on the Swiss market. 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. . 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. CHF100, to issue a public deed (see clause 1.2, Annex to the Notary Fee Ordinance of the Canton of Zurich (Notariatsgebhrenverordnung)). 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. 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