4 Material specific regulations and demands

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1 4 Material specific regulations and demands This chapter contains information about material specific legislations/regulations/recommendations. In the following sub-chapters, you will find for each material: A short description of the material and examples of products An overview of applicable rules (EEC/BfR/Warenwet/FDA) Links to information on material specific recommendations and to European material specific organisations Notes regarding documentation for the Normpack Certificate For the specific material or construction where there it is no European legislation covering the whole construction, the producer /owner of the materials/articles have to decide which national regulation/recommendation should be used. The same regulation or recommendation has to be followed for all material/articles in the construction or composition. E.g.: if you have a construction built on several layers and you have different vendors for these, you should receive documentation from each vendor. If the documentation is based on different rules it is up to you select the rules you will follow for the final construction as ready for use. Then all vendors must supply their information based on the same rules. The different legislations (EEC/BfR/Warenwet/FDA) are built on different principles, e.g.: EEC and Warenwet is written from a consumer s perspective with restrictions of migration of substances into the food. BfR has been written from a producer s perspective with limits of amount of substances you allowed to use. FDA is based on positive list and the risk evaluation is based on both consumers and industry need. Many paragraphs in one legislation/regulation/recommendation are linked to each other by the limits on the specific substances. Different legislations are update almost each year, which means that the reader has to follow the present stat of information. NOTE: Since there are lack of European harmonized requirements for some materials, national legislation can be applied in accordance with the Mutual Principle. NOTE: In addition to the material specific requirements, the general regulations should always be taken in consideration. The general regulations are: the framework L1935/2004, GMP L 2023/ GMP and Epoxy derivates L1895/2005. Table 2 gives an overview of the specific materials and the applicable legislations/regulations/recommendations covered by the Normpack-Norm. Normpack Guide version page

2 Food Contact Materials EEC Regulations Warenwet Netherland- Regulation Germany BfR Recommendation Framework regulation L1935/2004 and Good Manufacturing Practice L2023/2006 apply as for all type of FCM USA FDA 21 CFR Recommendation Other legislations for all types materials: about epoxy derivatives L1895/2005 Active and intelligent materials 450/ /2009 -relevant Chapters of annex 450/2009,LIII Application to FDA Adhesives see Plastics Chapter I, X XIV, XXVIII, XXV , , Ceramics 2005/31, 84/500 * Chapter V, VI 2005/31, 84/ Cork Chapter IX , , and prohibit Rubber 1993 /11 * Chapter III XXI, XXX , 177, , 178, Glass Chapter V, VI XLVIII, LIII Many parts depends on the type of food Ion-exchange resins Metals and alloys (* Sweden) Chapter IV , , , Paper and board Chapter II XXXVI, XXXVI/1, , XXXVI/2, XXXVI/3, LIII Plastics (EU) No 10/2011 Chapter I EEC Regulation for plastics and additional information Adhesive Printing inks Regenerated cellulose Amendments; 282/2008, 321/2011, 1282/2011, 1183/2012, 202/2014, 174/2015, 2016/1416, 2017/752 I, II, III, V, VI, IX, X, 177, 178 XI, XII, XVI, XVII, XX, XXII, XXVIII, XXXIII,XXXIV, XXXV XXXVII, XXXIX, XLII, XLIII, XLIV, XLVI, XLIX request of certification 2007/42 (*Sweden) Chapter VIII XLIV , , , , Silicones Chapter III XV, LII , 175,320, , Textiles Chapter VII Varnishes and coatings Chapter X, VIII, XII XIV, LI, LII, XLVIII, XLI 170, 172, 175, 176, 177, 178, 179, depends on the chemistry and the food type Waxes Chapter III, X XXV 73, 101, 172, 175, 176, 177, 178, depends on the chemistry Wood Chapter IX , 186 depends on the chemistry and the food type Colorants/ pigments Chapter XI IX Generally safe substances for polymers * Sweden LIVSFS 2011:7 ( only in swedish) Table 2 Overview of the Material Specific Regulations and Recommendations Normpack Guide version page

4.9 Plastics It is recommended to read the introduction of chapter 4 before reading this section. What is plastics? Plastic are polymers to which additives or other substances may have been added.

L10/2011 regulates substances that are permitted, some with restrictions, for the manufacture of plastic.

The Regulation shall apply to materials and articles which are placed on the EU market and fall under the following categories: a) materials and articles and parts consisting exclusively of plastics

3 4.9 Plastics It is recommended to read the introduction of chapter 4 before reading this section. What is plastics? Plastic are polymers to which additives or other substances may have been added. Figure 18 Examples of plastic articles intended for food contact Legislations/regulations/recommendations EEC Plastic Regulation (EC) No 10/2011 is the most comprehensive EU regulation for FCM. L10/2011 regulates substances that are permitted, some with restrictions, for the manufacture of plastic. In addition, L10/2011 covers the requirements to determine the compliance of plastic materials and articles. The Regulation shall apply to materials and articles which are placed on the EU market and fall under the following categories: a) materials and articles and parts consisting exclusively of plastics b) plastic multi-layer materials and articles held together by e.g. adhesives c) printed and/or coated plastic materials/articles or multi-layer materials/articles d) plastic layers or plastic coatings, forming gaskets of two or more layers in caps and closures e) plastic layers in multi-material multi-layer materials (MMML) and articles. The Plastics Regulation covers bio-based and bio-degradable plastics if they are manufactured with synthetic polymers, chemically modified natural or synthetic polymers or polymers manufactured by microbial fermentation. Natural polymers that have not been chemically modified, ion exchange resins, rubber and silicones are not covered by the scope of the Plastics Regulation. For example, a material based on modified starch is covered by the scope of the Plastics Regulation, while a material based on natural macromolecule that is not chemically modified, such as non-modified starch, is not covered by the scope of regulation. The regulation also describes types of products which are covered, e.g. plastic components which only need to be brought together or assembled, to make the final article New amendments and requirements are entering in force continuously, with various transition periods. Normpack Guide version page

4 Due to the regularly published amendments of the L10/2011, a consolidated version was published in May This text is meant purely as a documentation tool and has no legal effect. The Consolidated text cover the amendments (1282/2011, 1183/2012, 202/2014, 865/2014, 2015/174, 2016/1416, 2017/752). More information on how to interpret and apply the regulations, are found in the EU Guidance published of the EU commission. Declaration of Compliance (DoC) A Declaration of Compliance (DoC) shall be provided according to the Plastic Regulation (EC) No 10/2011, Annex IV. The DoC is based on supporting documentation which verifies the safety of the plastic material. The DoC must be provided to authorities on request. The written declaration shall contain information about, e.g. the identity of the business operator and the manufactures, specification of the FCM, information on substances with restriction and dual functions. The Normpack Certificate cover all information requested for a DoC in compliance of L10/2011. Requirements There are different types of requirements to assure the quality and safety of the plastic material and all have to be taken into consideration for the overall evaluation. A general quality control is Overall Migrations Limit (OML: 60mg/kg food, or 10 mg/dm 2 ). Specific migration by testing or calculation. Control of Specific Migrations Limits (SML) of some metals, and primary aromatic amines (PAA) are required for all plastics. Restriction and specification, listed in Column 10 of L10/2011. Food additives/flavouring substances with E-numbers in Food legislation, i.e. dual use additives. More than 40% of the substances of the positive list have specific migrations limits. About 5% of the total number, also have additional specific restrictions or specifications. Non Intentionally Added Substances (NIAS) are substances used or reaction intermediates formed during the process which can occur in the final product. In certain cases, the Plastics Regulation may include restrictions on NIAS A plastic layer behind the plastic layer in contact with food can be manufactured with additives or monomers not included in the Union list and does not need to comply with all restrictions or specifications, if one of the layers which separated it from the food works as a functional barrier. This means that a monomer or additive not listed in the Union list can be used in the manufacture of the layer behind the functional barrier if the migration of this substance is not detectable in food with a detection limit of 10ppb. Normpack Guide version page

5 Migration testing For the testing of plastic materials, simulants are used to imitate food. FOOD FOOD SIMULANTS ABBR. Hydrophile 10% Ethanol (v/v) A ph <4.5, hydrophilic 3 % Acetic acid (w/v) B Alcohol content of up to 20 %, even hydrophilic 20 % Ethanol (v/v) C Lipophilic 50 % Ethanol (v/v) D1 Lipophilic, free fats at the surface Vegetable oil * 95% Ethanol or Isooctane (v/v) as substitute Dry, frozen, fruit and vegetables Poly (2,6-diphenyl-p-phenylene oxide = MPPO ( Tenax ) * This may be any vegetable oil with a fatty acid distribution specification publishes by L10/2011 Table 3 Food simulants listed in L10/2011 The migration tests are performed in standardized time/temperature conditions, listed as table 1-3 in L10/2011. (EC) NO 2017/752 explains which simulants has to be used for tests to demonstrate compliance with the overall migration limit. D2 E FOODS COVERED all types of food all types of food except for acidic foods all aqueous and alcoholic foods and milk products all aqueous, acidic and alcoholic foods and milk products all aqueous foods and alcoholic foods up to an alcohol content of 20 % all aqueous and acidic foods and alcoholic foods up to an alcohol content of 20 % FOOD SIMULANTS A or distilled water or water of equivalent quality B D2 A or distilled water or water of equivalent quality D2 D1 D1 B C C B Table 4 Food simulant assignment for demonstrating compliance with the overall migration limits. In L10/2011 table 2, there is a list of food categories with specific assignment of food simulants. Normpack Guide version page

6 Normpack Advisor Normpack has compiled a tool NormpackAdvisor, to find which migration tests necessary for a specific construction of the plastic material. The tools can be downloaded from the member site Normpack/ Recycled plastic Plastics manufactured with recycled plastics from mechanical recycling processes are covered by Commission Regulation (EC) No 282/2008 on recycled plastic materials and articles intended to come into contact with foods, with the exception of those separated from food by a functional barrier layer. Only recycled plastic materials from approved factories, with a Recycling process numbers, can be used as new material for FCM. Evaluation of recycled process and the scientific opinion on safety evaluations is performed by EFSA. There is a list of valid recycling process to produce recycled plastic materials and article as FCM. The list is not updated and more processes could be approved, these processes could be found on EFSA website. Nanomaterial in Plastics EU Commission has published a Recommendation where substances in nanoform are defined, mainly as substance containing particles in the size range 1 nm-100 nm. The Plastic Regulation (EC) No 10/2011 states that any authorisation of substances in nanoform will be on a case-by-case basis for evaluation of the substance in nanoform. There is a list of substances in nanoform on the positive list of the Plastic Regulation (EC) No 10/2011. Table 5 lists the substances. FCM SUBSTANCE NO SUBSTANCE NAME 87 Silicon dioxide, silanated 410 Kaolin 411 Carbon Black 504 Silicon dioxide 807 Titanium nitride 859,998, 1043 Butadiene, ethyl acrylate, methyl methacrylate, styrene 1016 (methacrylic acid, ethyl acrylate, n-butyl acrylate, methylacrylate and butadiene) copolymer in nanoform 1030 montmorillonite clay modified by dimethyldialkyl (C16-C18) ammonium chloride 1050 Zinc oxide (uncoated and coated with 3-(methacryloxy)propyl Table 5 The substances in nanoform on the positive list of the Plastic Regulation (EC) No 10/2011 Normpack Guide version page

7 Warenwet Chapter I Plastics. The chapter have a positive list of substances, where some also are listed in the Plastic Regulation (EC) No 10/2011. Polymerisation additives and their decomposition products are permitted for use at national level (NIAS by Warenwet). BfR The focus of the BfR Recommendations FCM, was originally on plastics. But after the mandatory Plastic Regulation (EC) No 10/2011 was entered into force, the BfR Recommendations only contain substances for which there are no harmonised EU regulations, i.e.: aids to polymerisation, e.g. constituents of the catalytic system (catalysts and initiators), polymerisation production aids, e.g. emulsifiers, which are needed in the manufacturing process. I. High Polymers Containing Plasticizers II. Plasticizer-free polyvinyl chloride, plasticizer-free copolymers of vinyl chloride and mixtures of these polymers with other copolymers and chlorinated polyolefins containing mainly vinyl chloride in the total mixture III. Polyethylene V. Polystyrene Produced exclusively from the Polymerisation of Styrene VI. Styrene Copolymers and Graft Polymers, and Mixtures of Polystyrene with other Polymers VII. Polypropylene IX. Colorants for Plastics and other Polymers Used in Commodities X. Polyamides XI. Polycarbonates and Mixtures of Polycarbonates with other Polymers or Copolymers XII. Unsaturated Polyester Resins XVI. Polyvinyl Ethers XVII. Poly (terephthalic acid diol esters) XX. Polyisobutylene, Isobutylene Copolymers and Mixtures of Polyisobutylene with other Polymers XXII. Polymers Based on Esters of Acrylic and Methacrylic Acids, their Copolymers, and Mixtures of these with other Polymers XXVIII. Cross-Linked Polyurethanes as Adhesive Layers for Food Packaging Materials XXXIV. Vinylidene Chloride Copolymers with a Predominant Content of Polyvinylidene Chloride XXXV. Copolymers of Ethylene, Propylene, Butylene, Vinyl Esters and Unsaturated Aliphatic Acids, and their Salts and Esters XXXVII. Polybutene-(1) XXXIX. XLII. XLIII. Commodities Based on Polyurethanes Plasticizer-Free Chlorinated Polyvinyl Chloride, Plasticizer-Free Chlorinated Copolymers of Vinyl Chloride and Mixtures of these Polymers with other Copolymers Poly(4-methylpentene-1) Normpack Guide version page

8 XLIV. XLVI. XLIX. Artificial Sausage Casings Cross-linked Polyethylene Soft Polyurethane Foams as Cushion Packaging for Fruit FDA PART Indirect food additives: polymers Subpart B Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces Subpart C Substances for Use Only as Components of Articles Intended for Repeated Use PART Indirect food additives: adjuvants, production aids, and sanitizers Links Link to the EC Plastic regulation: COMMISSION REGULATION (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food Amendments Commission Implementing Regulation (EU) No 321/2011 of 1 April 2011 amending (EU) No 10/2011 as regards the restriction of use of Bisphenol A in plastic infant feeding bottles Commission Regulation (EU) No 1282/2011 of 28 November 2011amending and correcting (EU) No 10/2011 Commission Regulation (EU) No 1183/2012 of 30 November 2012 amending and correcting Regulation (EU) No 10/2011 Commission Regulation (EU) No 202/2014 of 3 March 2014 amending (EU) No 10/2011 Commission Regulation (EU) 2015/174 of 5 February 2015 amending and correcting (EU) No 10/2011 Commission Regulation (EU) No 2016/1416 of 24 August 2016 amending and correcting (EU) No 10/2011 Commission Regulation (EU) 2017/752 amending and correcting (EU) NO 10/2011 Consolidated version L 10 / 2011 consolidated version This text is meant purely as a documentation tool and has no legal effect. (will be regularly updated) Guidelines Commission has published documents as support for plastics regulation. We would like to recommend reading them to better understand the intention behind the plastics regulations. 1. Union Guidelines on Regulation (EU) No 10/2011 in support of the implementation of the general requirements of (EU) No 10/ Union Guidance on Regulation (EU) No 10/2011, as regards information in the supply chain, including Declaration of Compliance. Normpack Guide version page

9 Test methods There are more than 1000 substances with SML/QM limits listed by Plastic regulations. But only 320 analytical methods for migration testing have been published by JRC and these European Reference laboratory EURL Food Contact Materials. To support the information on possible analytical methods for specific or overall migration please follow the information publish by European Reference laboratory EURL. To learn more about migrations and plastics see EFSA website, topic Food Contact Material. Food legislations Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on Food Additives Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods Recycled plastic Link to Commission Regulation (EC) No 282/2008 Link to List of licenced recycling processes Link to EFSA website Nanomaterial Link to Commission Recommendation 2011/696/EU (61) of 18 October 2011 on the definition of nanomaterial. Other legislation Link to Warenwet legislation Link to BfR Kunststoffempfehlungen des BfR Normpack Guide version page

10 Documentation for Normpack Certificate The description of the requested supporting documentation for Normpack Certificate is described in chapter 3.3. Requested documentation for Normpack Certificate is related to the harmonised Plastic Regulation (EC) No 10/2011 and should include: Information on how the materials or article will be used; type of foods, time and temperature The Declaration of Compliance in line with L10/2011 with amendments, for each plastic layer Test report on overall migration Test or calculation reports on substances regulated with specific migrations limits Supporting documentation for layers with are not plastics in line with the Commission guide If the recycled plastics are present the following information is requested. type of material the authorisation number of the recycling process mentioned in the community register of recycling processes Normpack Guide version page

NORMPACK GUIDE. A guideline for evaluation and documentation of Food Contact Materials (FCM) according to the Normpack Norm.

NORMPACK GUIDE. A guideline for evaluation and documentation of Food Contact Materials (FCM) according to the Normpack Norm. NORMPACK GUIDE A guideline for evaluation and documentation of Food Contact Materials (FCM) according to the Normpack Norm Kristina Salmén Foreword The Normpack guide is a support for Normpack members