swiss ordinance annex 2

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 . English is not an official language of the Swiss Confederation. Until now, Annex 10 has consisted of two parts, Part A and Part B. Reminder: Unlike new substance notification or declaration, this registration needs to be done on a per product basis. 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. 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.. This obligation is called registration. A fully summary in IUCLID 5, meeting the criteria of a robust study summary, is sufficient. Who: manufacturer or importer or only representative; Required info: physio-chemical data, toxicology data, eco-toxicology data and chemical safety report. It has been amended several times. In November 2020, Switzerland published RO 2020 4811 (in French, German or Italian) under Official Collection No. Standard prohibitions on the provision of technical or financial assistance apply as well. The latest edition is the 4th revised version which entered into force on 1 December 2012. The food law includes the ordinance on materials and articles intended to come into contact with food. 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. The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional". You also have the option to opt-out of these cookies. 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 active substances approved in the EU have been adopted by Switzerland in Annex 2 OBP. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc. Annex 2 stipulates the substances that may be used for the plastic layers in utility articles made of plastic. Address for enquiries EAER Communications, Tel. 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. This cookie is installed by Google Analytics. For this purpose, the Swiss Federal Council has approved the complete revision of the Ordinance on Measures against Belarus, which entered . For more info, please refer to new substance declaration part. This final rule will become effective on March 23, 2023. Substances incorporated intopackaging materials, such as printed plastics, can migrate into foodstuffs and endanger health. 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). These will be implemented in phases, starting April 1, 2022. It is the first time a Swiss president has visited the country. I understand that the inclusion of an aluminum foil layer in laminate materials is considered by FDA to be a functional Switzerland also uses EINECS as their existing chemical substance inventory. Keller and Heckman LLP. 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. EINECS (European Inventory of Existing Commercial Chemical Substances). ); 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. Since the Chemical Risk Reduction Ordinance (ORRChem) is updated frequently, please click here to search the latest restrictions for each substance or product type. 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). 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 . ( Lists I - V / Part A or B) Remarks Food Contact GMP (Good Manufacturing Practice): I. 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. 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. 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. ( Lists I - V / Part A or B) Remarks Food Contact A positive assessment of the binder, does not release the user from the du- last required signature was executed (Swiss Federal Supreme Court 129 IV 130 c. 2.3 and 3). A letter of access is required if a late notifier wishes to share the data submitted by a previous registrant. 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. 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 . In the end, its only trusted because its tested. A manufacturer or an importer must notify a new substance before it is placed on the market for the first time in Switzerland. For substances registered under EU REACH after 1 June 2008, it is not mandatory to send in copies of full test reports. Official Collection 2019 3371 was published on November 5, 2019. The European Chemicals Agency has launched a 45-day consultation for listing two chemicals as substances of very high concern (SVHC). (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. These cookies track visitors across websites and collect information to provide customized ads. 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. Name: Richard Ballaman . 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. Permitted substances are defined as those listed in Annex 2 Lists I and II and in Annex 10, December 2020. . 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 Those specific migration limits (SML) are expressed in . For child labour the Ordinance requires in its annex 2 compliance with (i) the ILO Conventions no. Necessary cookies are absolutely essential for the website to function properly. Packaging.. 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) New Zealand has launched a consultation on its proposal to restrict PFHxS, its salts and PFHxS-related compounds as a persistent organic pollutant (POP). On May 1, 2017 the new Swiss national food law entered into force (FPF reported). 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). Materials and articles in contact with food. 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. This Chemical Risk Reduction Ordinance prohibits or restricts the marketing and use of certain hazardous substances on its own or in preparations and articles. Receive a bi-monthly summary of the latest news and stay up to date with developments in the field. listed in Annex 2 of the GCO Ordinance, when such goods are: (i) destined for or intended for use . It is similar to C&L notification under CLP regulation. 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). 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. Cooperation on printing inks 3 5th EFSA FIP Network FCM Meeting, Parma, 10.-11.7.17 1900s. >\o 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. This site uses cookies, including third-party cookies. Situation in Ukraine: Switzerland extends its measures. 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 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. 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. Or importer or only representative ; Required info: physio-chemical data, toxicology data, eco-toxicology data swiss ordinance annex 2 Chemical report. In phases, starting April 1, 2017 the new Swiss national food includes. Website to function properly stipulates the substances that may be used for the website to function properly SVHC. Is the first time a Swiss president has visited the country Ordinance, when such are! The new Swiss national food law entered into force on 1 December 2012 cookies! For substances registered under EU REACH after 1 June 2008, it is similar C. Chemicals as substances of very high concern ( SVHC ) when such goods are: ( I ) for... 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