Food contact compliance in European Union We give you the position of the components of this product with reference to requirements on products, as articles or components of articles, intended for use in contact with food. European Union 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, article 3, 11(5), 15 and 17. Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food and its amendments: Commission Implementing Regulation (EU) No 321/2011 of 1 April 2011 and Commission Regulation (EU) No 1282/2011 of 28 November 2011; Commission Regulation (EU) No 1183/2012 of 30 November 2012; Commission Regulation (EU) No 202/2014 of 3 March 2014; Commission Regulation (EU) No 865/2014 of 8 August 2014; Commission Regulation (EU) 2015/174 of 5 February 2015; Commission Regulation (EU) 2016/1416 of 24 August 2016; Commission Regulation (EU) No 752/2017 of 28 April 2017; Commision Regulation (EU) 2018/79 of 18 January 2018; Commision Regulation (EU) 2018/213 of 12 February 2018; Commission Regulation (EU) No 831/2018 of 5 June 2018; Commission Regulation (EU) 2019/37 of 10 January 2019. Conformity to Regulation (EC) No 1935/2004 article 3, 11(5), 15 and 17 is based on assessment carried out by our suppliers on raw materials and assured by Viba Quality System which is in compliance with UNI EN ISO 9001 and follows requirements of Regulation (EC) 2023/2006 on good manufacturing practice for materials and articles intended to come into contact with food. The product is not authorized as a direct food additive/colorant. Overall Migration Please note that according to the provisions of the Regulation (EC) No. 1935/2004 and Commission Regulation (EU) No 10/2011, the overall migration limit has to be controlled on the finished articles intended to come into contact with foodstuffs. The overall migration has to be tested on the final materials and articles because it could depend on the type of material used or on different components, as well as on the processing conditions. So, in addition to the above compositional compliance status certification, appropriate overall migration tests on the final material or article has to be carried out in order to determine the regulatory suitability for contact with different food types and various end-use conditions. Substance restricted by SML and/or Dual use This product contains substances for which restrictions and/or specifications are set out in Annexes I and II of Regulation (EU) N. 10/2011, and subsequent amendments, and/or dual use substances : EC ref.n. Dual use max Content Substance / SML / comments 15760 No ** Diethyleneglycol SML(T) = 30 mg/kg (3) 16990 No ** Ethyleneglycol SML(T) = 30 mg/kg (3) 19150 No ** Isophthalic acid SML(T) = 5 mg/kg (43) 24910 No ** Terephthalic acid SML = 7,5 mg/kg 35760 No ** antimony trioxide SML = 0,04 mg/kg (39) (expressed as antimony) 1/5
EC ref.n. Dual use max Content Substance / SML / comments 38840 No ** Bis(2,4-dicumylphenyl)pentaerythritol-diphosphite SML = 5 mg/kg [as sum of the substance itself, its oxidised formbis(2,4-dicum ylphenyl) pentaerythritol-phosphate and its hydrolysis product (2,4-dicumylphenol)]. ** The migration testing on this substance with SML is necessary. The worst case scenario shows that the migration limit might be exceeded 95280 No ** 1,3,5-Tris(4-tert-butyl-3-hydroxy-2,6-dimethylbenzyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione SML = 6 mg/kg ** The migration testing on this substance with SML is necessary. The worst case scenario shows that the migration limit might be exceeded The above data should be considered as a "worst case" and may actually be less or even absent. The sum of migration of substances PM 15760, 16990, 47680, 53650 and 89440 shall not exceed the specific migration limit. Testing, according to 82/711/ /EEC, 85/572/EEC, 2007/19/EC, show that they meet migrational limits. (3) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as Reference N. 15760, 16990, 47680, 53650 and 89440. (43) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Reference N. 19150 and 19180 (39) Migration limit might be exceeded at very high temperature. The data related to the max content of a substance with SML come from the ones given by our raw material suppliers. They can be used as an indication to determine which tests should be performed and which tests can be replaced by calculations. This product does not contains dual use additives (substances regulated for Food contact application by Regulation (UE) No 10/2011 and for Food application by Regulations (EC) No 1333/2008 and (EC) No 1334/2008) with specific migration limit. NIAS (non-intentionally added substances) and/or other restriction Our masterbatches are not analysed to perform a NIAS risk assessment, on this purpose, according to art. 19 of Regulation (EU) No. 10/2011 and to art. 3 of Regulation (EC) No. 1935/2004, we take into account risk assessments carried out by our suppliers on the used raw materials and any known limitation is communicated hereby. Food contact compliance in European Union Member States For substances already listed in EU Regulation the status of the components of the product with reference to the single Member States is identically the same of the one reported in the Europen Union section. On this purpose please take into consideration the limits and restriction reported in EU section. For non-listed substances in EU regulation, we report hereby the legal compliance in European Union Member States. Austria Kunststoffverordnung 2003 [Full title - Verordnung der Bundesministerin für Gesundheit und Frauen über Gebrauchsgegenstände aus Kunststoff, die für die Verwendung bei Lebensmitteln und Verzehrprodukten bestimmt sind] BGBl. II Nr. 476/2003 as amended by last BGBl - Teil. II - N.140/2009. 2/5
Belgium "Arrêté Royal du 11.05.1992 concernant les matériaux et objets destinés à entrer en contact avec les denrées alimentaires", until it's last amendment, "Arrêté Royal du 18.09.2008" and "Arrêté Royal relatif aux matériaux et aux objets en matière plastique destinés à entrer en contact avec les denrées alimentaires", until it's last amendment, "Arrêté Royal du 10.02.2011", all published in the "Belgisch Staatsblad-Moniteur Belge". Germany BfR Recommendation on Food Contact Materials (last update as of 01.01.2010). For colorants: BfR IX Recommendation: "Farbmittel zum Einfärben von Kunststoffen und anderen Polymeren für Bedarfsgegenstände" (Recommendation IX: Colorants for the coloration of plastics and other polymers for materials and articles). Concerning Primary Aromatic Amines (PAA) we refer to the here above section on NIAS. Viba does not perform any tests on PAA but any information provided to us by our suppliers on this subject will be communicated in the NIAS section. As German requirements on NIAS are more strict than the ones foreseen by European Regulation, even in case of absence of indication, we cannot completely exclude their presence or formation, at levels exceeding the ones prescribed by German law on finished articles. Spain Real Decreto 866/2008, de 23 de Mayo de 2008 modified by Real Decreto N.103/2009 of 06/02/2009 and by Real Decreto N. 847/2011, de 17 de junio, por el que se establece la lista positiva de sustancias permitidas para la fabricación de materiales poliméricos destinados a entrar en contacto con los alimentos. (B.O.E.de 11/07/2011). France French Positive List "Circulaire nr 176 of 2.12.1959 relatif aux pigments et colorants des matières plastiques et emballages (Journal Officiel, Brochure nr 1227)" as updated. "Arrêté du 2 janvier 2003, relatif aux matériaux et objets en matière plastique mis ou destinés à être mis au contact des denrées, produits et boissons alimentaires", as modified by Arrêté du 1 Avril 2011. 3/5
4/5 United Kingdom "The Plastic Materials and Articles in Contact with Food Regulations 2009", and its subsequent amendments including: Statutory Instrument 2009/205 (England), Statutory Instrument 2009/56 (Northern Ireland), Statutory Instrument 2009/481 (Wales), Statutory Instrument 2009/30 (Scotland). Italy Decreto Ministeriale of 21/03/1973: "Disciplina igienica degli imballaggi, recipienti, utensili destinati a venire a contatto con le sostanze alimentari o con sostanze d'uso personale"amended on 26/4/1993 by Decreto Ministeriale N. 220 and following updates (last update: D.M. of 16/02/2011). Decreto Ministeriale of 06/04/2004, n.174, "Regolamento concernente i materiali e gli oggetti che possono essere utilizzati negli impianti fissi di captazione, trattamento, adduzione e distribuzione delle acque destinate al consumo umano" and subsequent amendments. Netherlands Regulation of the Minister for Public Health, Welfare and Sport of 14 March 2014, laying down the Commodities Act Regulation on packagings and consumer articles coming into contact with foodstuffs (Commodities Act (Packagings and Consumer Articles) Regulation [Warenwetregeling verpakkingen en gebruiksartikelen]) Restrictions on pigments and dyes, according to Chapter XI points 3 and 4, for substances not covered by the EU Regulation 10/2011, Annex II, or with lower limits. This product contains the following substances: EC ref.n. max Content Substance / SML / comments - ** Antimony (soluble) SML = 0,04 mg/kg ** The migration testing on this substance with SML is necessary. The worst case scenario shows that the migration limit might be exceeded The above data should be considered as a "worst case" and may actually be less or even absent. The data related to the max content of a substance with SML come from the ones given by our raw material suppliers. They can be used as an indication to determine which tests should be performed and which tests can be replaced by calculations.
Food contact compliance in Switzerland Switzerland Food contact compliance in United States of America We give you the position of the components of this product with reference to requirements on products, as articles or components of articles, intended for use in contact with food. United States of America Food and Drug Administration/FDA, 21 CFR 177: Indirect food additives: Polymers. Food and Drug Administration/FDA, 21 CFR 178: Indirect food additives: Adjuvants, production aids, and sanitizers. Max. 1.87% Food contact compliance in Australia Australia Food contact compliance in Japan Japan Our declaration is only regarded to above mentioned product, supplied in original packaging, and not cover any subsequent modification of the composition of the product whatever that modification may be. This declaration replaces all previous ones relating to this subject. Viba S.p.A. via Mantova, 2-21049 Tradate (VA) - ITALY The information contained in this document are the current state of our knowledge. We believe that they are correct, but they are not as absolute guarantees of the product. In view of the many factors which may influence the process and the application of our product, the final user has the responsibility of making all the assessments and the necessary checks to the specific final use for which the product is intended. 5/5