DECLARATION OF COMPLIANCE PERFORMANCE AND CE MARK

Transcription

1 DECLARATION OF COMPLIANCE PERFORMANCE AND CE MARK Declaration only valid with the purchase invoice for the said product, which indicates the quantity of l./kg acquired, data that will determine approx. m² applied Company: FAKOLITH CHEMICAL SYSTEMS SLU Vat Code (CIF): B Address: Polig. Ind. Baix Ebre, C/ D, Parc. 61 Town/city: Tortosa (Spain) Tel.: (+34) Tortosa, 19/03/2018 Current RSIPAC: /CAT - Sanitary Registry of Industries and Food Products of Catalonia Current RGSEAA: ES /T - Sanitary Registry of Industries and Food Products of Spain (EU) Last Sanitary Authority Inspection: Inspection number ( ). Product: FAKOLITH FK-45 FOODGRADE Material: Heavy-duty modified 2 components epoxy paint, for surfaces that are intended to come into indirect and direct contact or by way of condensation with solid and liquid foods Main use: For floors, walls, ceilings, tanks, pipes, machinery and various elements used in the installations of the food industry, health sector or industry in general. Type of authorised foods: All types of solid and liquid foods, in accordance with the tests carried out to that end, and always insofar as the indications given on the technical sheet are followed. Exception: not suitable for foods intended for infants or young children according to Regulation (EU) No 609/2013. CERTIFYING: That the plastic materials or articles, products in intermediate stages of manufacturing phase or substances used in the Fakolith FK-45 FOODGRADE coating, components A and B, comply with the applicable Technical Health legislation listed in continuation: - (EC) REGULATION 1935/2004/CE, of the European Parliament and the Council, of 27 th October 2004, on materials and articles intended to come into contact with food, and repealing EEC Directives 80/590 and 89/109, and in particular Article 5 thereof, Section 1, paragraphs a), c), d), e), f), h), i), j) y k). - (EU) REGULATION 1895/2005, of 18 th November, along with Spanish Royal Decree 12/2005, of 14 th January, amending Spanish Royal Decree 293/2003, of 7 th March, concerning the use of certain epoxy derivatives in materials and articles intended to come into contact with foods. - (EU) REGULATION 2023/2006, of the Commission of 22 nd December, on good manufacturing processes for materials and articles intended to come into contact with foods. - (EU) REGULATION 10/2011, of the Commission of 14 th January, on plastic materials and articles intended to come into contact with foods, and repealing Commission Directive 2002/72/EC, of 6 th August, relating to plastic materials and articles intended to come into contact with foodstuffs. And also (EU) REGULATION 1282/2011, the REGULATION (EU) 2015/174, the REGULATION (EU) 2016/1416, the REGULATION (EU) 752/2017, amending and correcting (EU) Commission Regulation 10/2011, on plastic materials and articles intended to come into contact with foods. Entered into the Mercantile Register of Tarragona, in Volume 2466 Companies, Folio 215, Sheet No.T-39702, 1 st Entry Page 1 of 6

2 - COMMISSION REGULATION (EU) 2018/213 of 12 February 2018 on the use of bisphenol A in varnishes and coatings intended to come into contact with food and amending Regulation (EU) No 10/2011 as regards the use of that substance in plastic food contact materials. (16) Regulation (EU) No 10/2011 establishes a comprehensive framework for verifying compliance of plastic food contact materials with defined restrictions, including rules on the expression of migration test results. As the varnishes and coatings applied to materials and articles do not have specific characteristics that would require the establishment of different or more specific provisions, it is appropriate to extend the application of the rules laid down in Regulation (EU) No 10/2011 to the verification of compliance of varnishes and coatings applied to materials and articles with the established restrictions. Limitation: not suitable for materials and articles specifically intended to come into contact with infant formula, follow-on formula, processed cereal-based food, baby food, food for special medical purposes developed to satisfy the nutritional requirements of infants and young children or milk-based drinks and similar products specifically intended for young children, as referred to in Regulation (EU) No 609/2013. Article - SPANISH ROYAL DECREE 847/2011, of 17 th June, establishing a positive list of approved substances for the manufacture of polymeric materials intended to come into contact with foods, which in turn repealed Spanish Royal Decree 866/2008, of 23 rd May. - REGULATION (EU) No 305/2011 of the European Parliament and of the Council of 9 March 2011laying down harmonised conditions for the marketing of construction products and repealing Council Directive 89/106/EEC. FK-45 FOODGRADE complies with the limitations indicated in the above Regulations with regard to the migration of the following substances: Overall Migrations 1. Simulants A, B and D2 (10 days at 40 C, OM2), according to migration testing based on UNE-EN :2002 and UNE-EN :2002 Standards and with certificates nos , , , issued by CNTA. 2. Simulant D2, Isooctane, (2 days at 20 C, OM2), according to migration testing based on the Standard ME.E.00/31 and Report No , issued by the CNTA. 3. Simulant C, Ethanol 20%, (1 hour at 100 C, OM4), according to migration testing based on the Standard ME.E.00/31 and Report No , issued by the CNTA. 4. Simulant C, Ethanol 20%, ( 10 days at 40 C, OM2), for primer Temacoat RM40 + Fakolith FK-45, according to migration testing based on the Standard ME.E.00/31 and Report nº (CNTA). 5. Simulant C, Ethanol 20%, ( 10 days at 40 C, OM2), for primer Fakolith FK-44 + Fakolith FK-45, according to migration testing based on the Standard ME.E.00/31 and Report nº (CNTA). 6. Simulant C, Ethanol 20%, ( 10 days at 40 C, OM2), for primer Fakolith FK-44 POX + Fakolith FK-45, according to migration testing based on the Standard ME.E.00/31 and Report nº (CNTA). Specific Migrations: 1. The sum of the migration levels of: BADGE, BADGE.H2O, BADGE.2H20, not in excess of the limit of 9 mg/6 dm 2. BADGE.HCl, BADGE.2HCl, BADGE.H20.HCl not in excess of the limit of 1 mg/6 dm 2. BISPHENOL A (BPA) is not in excess of the limit of no of 0.05 mg/kg food. On the basis of the ME.E.24 Method and Report No and , issued by the CNTA. 2. Heavy metals (barium, cobalt, copper, iron, lithium, manganese, lead, zinc, aluminium, nickel). Tests carried out by the CNTA with stimulant C (10 days at 60ºC), OM2 according to the Regulation 10/2011, migrations are not in excess of the established limits. According to migration tests based on the ME.E.00/30 Method and Report nº issued by the CNTA. 3. Epichlorohydrin, with Simulant B (10 days at 40 C, OM2), the migration level is less than 0.10 mg/l. Based on HS-GC/MS method ME.Q.90 and nº report by the CNTA. 4. Primary aromatic amines, with Simulant B (10 days, 60 ºC), OM2 according to the Regulation 10/2011, is less to 0,01 mg/kg. According to migration tests based on UNE EN and report nº by CNTA. 5. Pigments and mineral fillers approved according to Spanish RD 847/2011. Reports of test No , , , , , , , , y issued by the Page 2 of 6

3 CNTA. Organoleptic Testing: 1. Oily simulant, according to reference standards UNE-ISO 6658:2008, UNE-ISO4121:2006, UNE-EN ISO 4120:2008, EN , ISO No atypical odours or tastes were found in the sample incubated with the specimens to be analysed, according to Report No , issued by the CNTA on 10/10/2013. Mechanical and Chemical Testing. CE Marking: 1. UNE EN ISO :1999 Standard: Determination of abrasion resistance, complying with the specification, in accordance with the UNE EN :2005 Standard, of a weight loss of less than 3,000 mg, as shown by test no. 13_02202, carried out by TECNALIA Research & Innovation. 2. UNE-EN ISO :2013. Determination of the percentage by volume of non-volatile matter, with a final content of 90% of nonvolatile matter both mass and volume, according to test no. 13_03633, carried out by TECNALIA Research & Innovation. 3. UNE EN 13529:2005 Standard: Products and systems for the protection and repair of concrete structures: Resistance to severe chemical attack. Class I, 3 days without pressure, and Class II, 28 days without pressure, according to tests no 14_05424, no 14_04481, no. 13_03706-a, carried out by TECNALIA Research & Innovation. 4. UNE EN :2003, Determination of CO 2 permeability; UNE-EN ISO 7783:2012, Determination and classification of water vapour permeability; UNE-EN :2008, Determination to liquid water; UNE-EN 1542:2000, Determination of adherence by tensile strength, according to tests no 14_05223, carried out by TECNALIA Research & Innovation. Packaging Waste Regulation: 1. The content of the Heavy Metals: Cadmium, lead, mercury and Chrome VI is less the specific limit according Spanish Law 11/1997 of the 24 th of April, of the Packaging and packaging wastes. According to Report No , issued by the CNTA on 10/08/2017. With all that is stated above guaranteed by the Quality Management System DIN EN ISO 9001:2015, audited by TÜV Rheinland Cert GmbH no , and applying the HACCP System, carried out by the Spanish CNTA (National Food Technology and Safety Centre). And in view thereof we confirm its suitability for the intended use. Quality and R&D&i Department Marta García Page 3 of 6

4 DECLARATION OF PERFORMANCE Nº Product-type: Fakolith FK-45 FoodGrade. 2. Type, batch or serial number: XXMM45YCNN (XX: year; MM: month; Y: cod of product A or B; C: colour; NN: production number). 3. Intended use or uses of the construction product: Coating intended to produce a continuous protective layer in concrete surface. 4. Registered trade name and contact address of the manufacturer: FAKOLITH CHEMICAL SYSTEMS, SLU - P. I. Baix Ebre, C/D, 61, Tortosa- TARRAGONA (Spain). 5. System of assessment and verification of constancy of performance of the construction product: Evaluated under the System 3 and verified by TECNALIA RESEARCH & INNOVATION with certificate nº 14_05223-a of July 18 th of Construction product covered by a harmonized standard: UNE-EN ISO :2005 Products and systems for the protection and repair of concrete structures. Definitions, requirements, quality control and evaluation of conformity - Part 2: Surface protection systems for concrete. 7. Notified body: TECNALIA - Nº Notified body Declared performance: Essential characteristics Abrasión resistance Determination of the percentage by volume of non-volatile matter Resistance to severe chemical attacks Performance Harmonised technical specification < mg UNE EN ISO : % UNE EN ISO :2013 Class I: 3 days without pressure Class II: 28 days without pressure UNE EN 13529:2005 Determination of carbon dioxide permeability S D > 50 m UNE EN :2003 Determination and classification watervapour transmission rate (permeability) 5 S D 50 m Class II UNE-EN ISO 7783:2012 Determination of liquid water permeability w < 0,1 Kg/m 2 h 0,5 UNE-EN :2008 Rigid System Measurement of bond strength by pull-off 2,0 N/mm 2 UNE-EN 1542:2000 (with trafficking) The performance of the product FAKOLITH FK-45 FOODGRADE is conforming to the performances Page 4 of 6

5 declared in the point 8. This declaration of performance is issued under EU Regulation 305/2011, and the sole responsibility of Fakolith Chemical Systems SLU FAKOLITH Chemical Systems, SLU, with address in: P. I. Baix Ebre, C/D, 61, Tortosa- TARRAGONA (SPAIN). CIF: B Page 5 of 6

6 UNE-EN :2005 Product: FAKOLITH FK-45 FOODGRADE As Coating intended to produce a continuous protective layer in concrete surface 1. Abrasión resistance: UNE EN ISO :1999: < mg. 2. Determination of the percentage by volume of non-volatile matter: UNE EN ISO :2013: 90%. 3. Resistance to severe chemical attacks: UNE EN 13529:2005: Class I: 3 days without pressure; Class II: 28 days without pressure 4. Determination of carbon dioxide permeability: UNE EN :2003: S D > 50 m 5. Determination and classification water-vapor transmission rate (permeability): UNE-EN ISO 7783:2012: Class II, 5 S D 50 m 6. Determination of liquid water permeability: UNE-EN :2008: w < 0,1 Kg/m 2 h 0,5 7. Measurement of bond strength by pull-off: UNE-EN 1542:2000: 2,0 N/mm 2 Rigid Systems (with trafficking) 8. Fire reaction: No Performance Determined (NPD) Page 6 of 6