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Product Name: Ameroyal™ 710 ANTISCALANT

Information Has Already Been Submitted!

Product Information

Solenis LLC
Ameroyal™ 710 ANTISCALANT

Contact Information

Solenis LLC
Natalia J. Ribeiro
Product Regulatory Specialist
RegulatoryRequestsNA@Solenis.com

Food Contact Compliance

  • Good Manufacturing Practices
    Provide information on the systems and processes used to ensure products are consistently produced and controlled according to Good Manufacturing standards.

      • Is the product produced utilizing Good Manufacturing Practices (GMPs)?

      • Is an appropriate Quality Assurance System is in place that ensures compliance of the finished product with all applicable regulations?

      • Has your facility been audited?

        • Provide Site and Name of Auditor

        • Provide Audit Results

  • Europe

    • EU Directives
      Is your product compliant with or listed in:

      • Are all components of the product as supplied listed in Annex I of the Regulation EU 10/2011 as amended? **If carbon black is not present please select Not Applicable.

      • Are all components of the product as supplied listed in Annex I of the Regulation EU 10/2011 as amended?

        • Other Ingredients. Please specify below the identity and category of any non-intentionally added substances.

          CAS NumberChemical NamePercentCategory
          • 1
          items per pageNo record found.

      • Please provide the Food Contact Material (FCM) substance number

      • PM Reference Number

      • Is the Fat consumption Reduction Factor (FRF) applicable? If yes specify the amount.

      • Is this substance subject to any restrictions and/or specifications?

        • Specific Migration Limit (SML) - mg/kg

        • Specific Migration Limit (T) (Group restriction ) - mg/kg

        • QM

        • List specifications

        • Are there any Notes on verification of compliance (column 11 in Annex I of R. 10/2011/EU)? If so please specify.

      • EU Framework Regulation (EC) 1935/2004 - When the product is used under normal and foreseeable conditions will the product meet the safety requirements on materials and articles intended to come into contact with food?

      • Allergens listed in ANNEX II of the EU Regulation 1169/2011

      • Does the ingredient fulfill the definition of nanomaterial as defined by the commission recommendation 2011/696/EU?

      • Per Annex II of the Regulation EU 10/2011 is Aluminum present above 1 mg/kg. If present above this level, please specify the quantity.

      • Per Annex II of the Regulation EU 10/2011 is Barium present above 1 mg/kg. If present above this level, please specify the quantity.

      • Per Annex II of the Regulation EU 10/2011 is Cobalt present above 0.05 mg/kg. If present above this level, please specify the quantity.

      • Per Annex II of the Regulation EU 10/2011 is Copper present above 5 mg/kg. If present above this level, please specify the quantity.

      • Per Annex II of the Regulation EU 10/2011 is Iron present above 48 mg/kg. If present above this level, please specify the quantity.

      • Per Annex II of the Regulation EU 10/2011 is Lithium present above 0.6 mg/kg. If present above this level, please specify the quantity.

      • Per Annex II of the Regulation EU 10/2011 is Manganese present above 0.6 mg/kg. If present above this level, please specify the quantity.

      • Per Annex II of the Regulation EU 10/2011 is Zinc present above 5 mg/kg. If present above this level, please specify the quantity.

      • Absence of primary aromatic amines [-excluding those appearing in Table 1 of Annex I of Regulatory 10/2011/EU] < DL (Detection Limit) = 0.01 mg/kg

      • Absence of components classified as "Carcinogenic", "Mutagenic" or "toxic to reproduction" in accordance with the criteria set out in section 3.5, 3.6 and 3.7 of Annex I to Regulation (EC) N° 1272/2008

        • If any of the specified components are present please specify in the table below.

      • Is that product or component of the product also listed as a food additive by Regulation (EC) 1333/2008 or as flavourings by Regulation (EC) 1334/2008

        • Please disclose the identity of the food additive and its lowest restriction in food

        • Does the product meet the criteria of purity required?

        • Specify E Number

      • EU Commission Regulation (EC) 1895/2005 on the restriction of use of certain epoxy derivatives in materials and articles intended to come into contact with food

      • Is that product produced following the requirements of the Regulation (EC) 2023/2006 of 22 December 2006 on good manufacturing practice for materials and articles intended to come into contact with food?

    • Council of Europe (CoE) Resolutions
      Is your product compliant with or listed in:

      • RESOLUTION AP (2004) 4 ON RUBBER. If applicable please indicate the version you refer to.

      • Is the product in listed in Resolution AP (89)1. If yes please specify if in compliance with specifications

      • Is the product listed in Resolution AP (92) 2. If yes please specify the restriction.

        • Specific Migration Limit (SML) - mg/kg

        • Specific Migration Limit (T) (Group restriction ) - mg/kg

  • European Union National Legislations

    • Austria
      Is your product compliant with or listed in:

      • Regulation N° 775 (Plastic Regulation , KVO), Appendix 1, Section A (23.09.1194) including subsequent amendments like "KVO N° 69" ( 01.20.1995 ), "KVO N° 898" (29.12.1995) "KVO N° 528" (4.10.1996) , "KVO N° 262 "(16.9.1997) and KVO N° 93" (22.2.2001) If applicable please indicate the version you refer to.

    • Belgium
      Is your product compliant with or listed in:

      • Royal Decree of 03/07/2005 (Belgian Official Gazette of 29/07/2005) on plastic articles intended to come into contact with food. If applicable please indicate the release you refer to.

      • Is the product listed in List 3 - AR 03 07 2005

    • France
      Is your product compliant with or listed in:

      • Materials in contact with food and foodstuffs intended for human consumption. Brochure 1227 (2002) If applicable please indicate the release you are referring to

      • Decree of 19/10/2006 relating to plastic materials and articles placed or intended to come into contact with foodstuffs, products and drinks. If applicable please indicate the release you are referring to

    • Germany
      Is your product compliant with or listed in following regulations in Bundesinstitut für Risikobewertung (BfR) - German Federal Institute for Risk Assessment:

      • Bedarfsgegenständeverordnung 23 Dezember 1997 zuletzt geândert 24 Juni 2013. If applicable please indicate the version you refer to.

      • Recommendation III Polyethylene. If applicable identify the specific regulation and any limitations in the comments.

      • Recommendation VI styrene mixed and graft polymers and mixtures of polystyrene with other polymers. If applicable identify the specific regulation and any limitations in the comments.

      • Recommendation VII Polypropylene. If applicable identify the specific regulation and any limitations in the comments.

      • Recommendation IX colorant for coloring plastics and other polymers used in commodities. If applicable identify the specific regulation and any limitations in the comments.

      • Recommendation XXI Commodities based on natural and synthetic rubber. If applicable identify the specific regulation and any limitations in the comments.

      • Recommendation XXXVI Paper and board for food contact. If applicable identify the specific regulation and any limitations in the comments.

      • Recommendation XXXVI/1 Cooking Papers, Hot Filter Papers and Filter Layers. If applicable identify the specific regulation and any limitations in the comments.

      • Recommendation XXXVI/2 Paper and Paperboard for Baking Purposes. If applicable identify the specific regulation and any limitations in the comments.

      • Recommendation XXXVI/3 Absorber pads based on cellulosic fibres for food packaging. If applicable identify the specific regulation and any limitations in the comments.

      • Is product listed or compliant with another BfR recommendation? If applicable please specify which recommendation in the comments.

      • BfR 39 (1996) 124 - Guidelines for sanitary and personal sanitary products. If applicable identify the specific regulation and any limitations in the comments.

    • Italy
      Is your product compliant with or listed in:

      • Italian Ministerial Decree of 21/03/1973. If applicable identify the specific regulation and any limitations in the comments.

    • Spain
      Is your product compliant with or listed in:

      • Resolution of 11.4.1982 Amended by Royal Decrees 2207/1994, 510/1996, 1042/1997. If applicable Please Indicate the version you refer to.

    • Switzerland
      Is your product compliant with or listed in:

      • SR 817.023.21 dated 23th November 2005. Status as of 1 April 2013 and compliance with article 34 of SR 817.02.

        • Specific Migration Limit (SML) - mg/kg

      • 817.0 Federal Act on Foodstuffs and Utility Articles.

      • SR 817.02 Ordinance on foodstuffs and consumer products (ODAJOUs).

        • Specific Migration Limit (SML).

    • The Netherlands
      Is your product compliant with or listed in:

      • Verpakkingen en Gebruiksartikelen Besluit 44e Supplement 2016. If applicable please indicate the version you refer to.

      • § 2.2.1 Table 1 polymerisation aids or their degradation products

    • United Kingdom
      Is your product compliant with or listed in:

      • England: Statutory Instruments 2012/2619

      • Northern Ireland: Statutory rules 2012/384

      • Scotland Statutory instruments 2012/318

      • Wales Statutory instruments 2012/2705

  • Americas

    • USA

      • Please specify all allowable Food Types and Conditons of Use:

      • Temperature

      • Food Types

      • FDA Citations
        Select all relevant regulations that your product is compliant with or listed in the US Food & Drug Administration (FDA) Sections of Title 21 Code of Federal Regulations (CFR)
      • CitationDescriptionLimitationsRestrictionsComments
        • 1
        items per pageNo record found.
      • Part 170 – Food Additives

      • § 170.39 Threshold of regulation for substances used in food-contact articles. If yes, identify specific regulation and any limitations in the comments section

      • PART 172 - Food additives permitted for direct addition to food for human consumption. If yes, identify specific regulation and any limitations in the comments section.

      • § 172.878 white mineral oil

      • § 172.880 petrolatum

      • PART 173 – Secondary direct food additives permitted in food for human consumption. If yes, identify specific regulation and any limitations in the comments section

      • PART 174 - Indirect food additives: General

      • § 174.5 general provisions applicable to indirect food additives

      • Part 175 - Indirect food additives: Adhesives and components of coatings

      • § 175.105 Adhesives

      • § 175.300 Resinous and Polymeric Coatings

      • § 175.320 Resinous and Polymeric Coatings

      • PART 176 - Indirect food additives: Paper and paperboard components

      • § 176.170 - Components of paper and paperboard in contact with aqueous and fatty foods. If yes, identify specific regulation and any limitations in the comments section

      • § 176.170 - Table 1 & 2. If yes please specify

      • § 176.180 Paper and Paperboard in contact with dry foods

      • § 176.200 - Defoaming agents used in coatings. If yes, identify specific regulation and any limitations in the comments section

      • § 176.210 - Defoaming agents used in manufacture of paper and paperboard. If yes, identify specific regulation and any limitations in the comments section

      • § 176.300 - Slimicides. If yes, identify specific regulation and any limitations in the comments section

      • PART 177 - Indirect food additives : Polymers

      • § 177.1210 closures with sealing gaskets for food containers

      • § 177.1350 Ethylene-vinyl acetate copolymers

      • § 177.1520 olefin polymers

      • § 177.1640 polystyrene and rubber modified polystyrene

      • § 177.1810 styrene block-polymers

      • § 177.2600 rubber articles intended for repeated use

      • Part 178 - Indirect food additives: Adjuvants, production aids, and sanitizers

      • § 178.3297 colorants for polymers

      • §178.3530 isoparaffinic petroleum hydrocarbons, synthetic

      • § 178.3570 lubricants with incidental food contact

      • § 178.3620 mineral oil

      • § 178.3710 petroleum wax

      • § 178.3720 Petroleum Wax, Synthetic

      • § 178.3740 plasticizers in polymeric substances

      • PART 178 - Indirect food additives: Adjuvants, production aids, and sanitizers

      • § 178.2010 Antioxidants and/or stabilizers for polymers If listed please provide restriction or specification.

      • PART 181 – Prior sanctioned food ingredients granted prior to September 6, 1958. If yes, identify specific regulation and any limitations in the comments section

      • PART 182 -Substances generally recognised as safe If listed please provide restriction or specification

      • PART 184 - Direct food products affirmed as generally recognized as safe If listed please provide restriction or specification

      • PART 186 - Indirect food substances affirmed as generally recognised as safe If listed please provide restriction or specification

      • PART 189 - Substances prohibited from use in human food. If listed please provide restriction or specification

      • PART 700 - Banned Substances in Cosmetics. If listed please provide restriction or specification

      • Other FDA Food Contact listing, including Parts 174-199?

      • Food Contact Notifications (FCN)

        Is your product subject to FDA Food Contact Notification?

      • Generally Recognized as Safe (GRAS)

          • Do you have a component that is certified as GRAS?

            • Is GRAS component listed in a regulation PART 182, 184 or 186?

              • Do you self certify a component as GRAS with no listed regulation or FCN?

              • Please give all the details of the component that is self certified and all the details on how you arrived at that decision.

      • Additional Questions

          • Has a Letter of No Objection been granted for direct food contact by the FDA?

          • Is the required FDA letter of Guaranty or Statement of Assurance available?

          • Does your substance meet the purity requirement for its intended use as required by the relevant regulation?

          • Does the product have any Regulatory Clearance beyond those specified above?

      • Is your product subject to other FDA Administrative Rulings and Decisions? If yes, specify in the comments section

      • OTHER Food Contact Notifications - If your chemical is suitable for use in food-contact applications but is not subject to the above listings provide citations and any limitations or restrictions on such use in the comments section and attach separate regulatory assurance statement.

      • U.S. Food Allergens, as listed in FDA Guidance Sec. 550.250 (Milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, gluten and soybeans)

    • Canada
      Is your product compliant with the following regulatory requirements set by the Food Directorate?
      Answer
      Comment

      • Does the packaging material comply with Division 23 for Food Packaging Materials of the Food and Drugs Act?

      • Has the packaging material received a "Letter of No Objection" from the Food Directorate?

      • Are any polymers included in the Lists of Acceptable Polymers For Use in Food Packaging Applications?

        • Trade NameGradeCodeIssue DateLimitations
          • 1
          items per pageNo record found.

    • Mercosur
      Is your product compliant with or listed in:

      • MERCOSUR / GMC / RES. No. 32/07 TECHNICAL REGULATION ON MERCOSUR "POSITIVE LIST OF ADDITIVES FOR PLASTICS INTENDED FOR THE PRODUCTION OF CONTAINERS AND EQUIPMENT IN CONTACT WITH FOOD" (REPEAL OF RES. GMC No. 95/94 and 50/01)

        • Specific Migration Limit (SML) - mg/kg

        • QM

        • Specifications. If yes please specify.

      • MERCOSUR / GMC / RES No. 3/92: General criteria for packaging and food equipment food contact.

      • MERCOSUR / GMC / RES No. 56/92: General provisions for plastic containers and equipment in contact with food.

      • MERCOSUR / GMC / RES No. 02/12: Mercosur technical regulation on positive list of monomers, other starting substances and polymers approved for development of packaging and plastics equipment food-contact. Repeal of RES. GMC No. 47/93, 86/93, 13/97, 14/97 and 24/04.

        • Restrictions. If yes please specify.

      • MERCOSUR / GMC / RES Np. 32/10: MERCOSUR Technical Regulation on migration in materials, plastic packaging and equipment intended to come into contact with food. Repeal of res GMC No. 30/92, 36/92, 10/95, 11/95 15/97, 32/97 and 33/97.

        • Specific Migration Limit (SML) - mg/kg

        • QM

        • Specifications. If yes please specify.

      • MERCOSUR/GMC/RES Nº 40/15: Technical regulations on cellulosic materials, containers, and equipment intended to contact food

      • MERCOSUR/GMC/RES Nº 41/15: Technical regulations on cellulosic materials for hot cooking and filtration

      • MERCOSUR/GMC/RES Nº 42/15: Technical regulations on materials, containers, and cellulose equipment intended to be in contact with food during cooking or heating in oven

  • Asia Pacific

    • China
      Is your product compliant with or listed in:

      • GB 9685-2016 Hygienic Standards for Uses of Additives in Food Containers and Packaging Materials. If listed please answer the additional questions below.

        • Restrictions. If yes please specify.

        • QM

        • Specific Migration Limit (SML)

        • Specification. If yes please list in the comments field.

      • GB 31603-2015 National Food Safety Standard General Hygienic Practice for Production of Food contact Materials and its Products.

      • GB 4806.1 2016 General Safety requirements for FCMs.

      • GB 4806.6 -2016 National Food Safety Standard for Resins Used to make Plastics in contact with foodstuffs.

      • GB 4806.7-2016 National Food Safety Standard for Plastic Materials and Articles in contact with foodstuffs.

    • India
      Is your product compliant with or listed in:

      • IS 3395 (1997): Low density polyethylene (LDPE) and linear low.

      • IS 7328 (1992): High density polyethylene materials for moulding and extrusion (first revision).

      • IS 9833 (1981): List of pigments and colourants for use in plastics in contact with foodstuffs, pharmaceuticals and drinking water.

      • IS 9845 (1998): Determination of overall migration of constituents of plastic materials and articles intended to come in contact with foodstuffs.

      • IS 10141 (2001): Positive list of constituents of polyethylene in contact with foodstuffs, pharmaceuticals and drinking water.

      • IS 10142 (1999): Polystyrene (Crystal and High Impact) for its Safe Use in Contact with Foodstuffs, Pharmaceuticals and Drinking Water - Specification.

      • IS 10149 (1982): Positive list of constituent of styrene polymers in contact with foodstuffs, pharmaceuticals and drinking water.

      • IS 10149 (1982): Positive list of constituents of polystyrene (crystae and high impact) in contact with foodstuffs, pharmaceuticals and drinking water.

      • IS 10909 (2001): Positive list of constituents of polypropylene and its copolymers in contact with foodstuffs, pharmaceuticals and drinking water [pcd 12: plastics].

      • Amendments N°1 to IS 10909 (2001): Specification for positive list of constituents of polypropylene and its copolymers in contact with foodstuffs , pharmaceuticals and drinking water (first revision ) (2012).

      • IS 10910 (1984): Polypropylene and its copolymers for its safe use in contact with foodstuffs, pharmaceuticals and drinking water (first revision ) (2012).

      • IS 10951 (2002): Polypropylene materials for moulding and extrusion [pcd 12:plastics]

    • Japan
      Is your product compliant with or listed in:

      • Japanese hygienic olefin and styrene plastics association (JHOSPA) March 1996. If listed please provide Reference Number

    • International
      Does your product contain any of the following?

      • International (or "Other") Food Allergens: Buckwheat, celery, lupin, molluscan, shellfish, mustard, sesame, sulfites, bee pollens/propolis, royal jelly, peach, pork, tomato, mango

Authorizer Information

Natalia J. Ribeiro
Product Regulatory Specialist
RegulatoryRequestsNA@Solenis.com

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