3 Overview on presentation Aims of EU legislationCore EU Framework RegulationsSpecific or EU harmonised measuresEnforcement
4 A Schematic view of EU Food Contact Material Law General requirement for all contact materialsRegulation (EC) No. 1935/2004Good Manufacturing Practice Regulation (EC) No. 2023/2006Specific measures for 3 groups of materialsOrganicFood Contact Plastics Regulation (EU) 10/2011FibrousRegenerated cellulose film Directive 2007/42InorganicCeramicsDirective 84/500 as amendedThe heavy green box contains the two Horizontal regulations. The first is Regulation EC No /2004 which lays down main principles that food contact materials and articles must be manufactured using GMP so as not to allow constituents to migrate into food at levels that would cause harm to human health or affect the nature or quality of food.The Regulation applies across the EU and to all food contact materials.The second Regulation EC No. 2023/2006 examines in detail the principles in Good Manufacturing Practice.Below these Horizontal measures there are a number of vertical directives that cover3 Groups of contact materials . Organic, fibrous and inorganic.PlasticsRCF andCeramicsUnder the plastics heading we have further subdivision relating to specific substances and their control in food contact materials.There are over 15 sets of EC directives dealing with plastics. The subjects covered include,Migration testing,Use of simulants, Suspension of AZODICARBONAMIDEPlasticizers,VCM,N-Nitrosamines and N-nitrosatable substances in rubber teatsEpoxy derivatives ( BFDGE,NOGE and BADGE)I will not be covering all of these today but I will touch on some key provisions and give you sufficient information and web links to enable you to read further at your leisure.The Commission are gathering information regarding proposed amendments to Council Directive 84/500/EEC for the release of lead and cadmium into food. New limits are proposed for the release of lead, 10 ppb (part per billion) and for cadmium, 5 ppb.A useful site to obtain copies of EU rules isControls on individual substancesVCM Directive 78/142Vinyl chloride monomerNitrosamines Directive 93/11Epoxy Derivatives Regulation (EC) 1895/2005
5 Materials not yet covered by specific directives Varnishes and coatingsPaper and boardMetals and alloysTextile productsElastomers and rubberGlassWood ( including cork)Paraffin waxes andMicro crystalline waxesGeneral requirementsof 1935/2004 apply.The list provided on this slide includes a range of substances for which there are no current specific directives regulating their use in food contact materials and articles, but it must be borne in mind that EC Regulation 1935/2004 main provision do apply and if these materials are used in the manufacture of food contact items thenthey must be made under good manufacturing practice and not allow constituent to migrate into foods at levels that would harm human health or affect the nature or quality of the food.
6 Application of Regulation (EC) No. 1935/2004 The rule applies to materials and articles in theirfinished stateintended to come into contact with foodreasonably expected to come into contact with foode.g. Inside surfaces of refrigerators andthere is a reasonable expectation of the transfer ofconstituents into food e.g. Print inks or adhesive labelsThe rule applies to materials and articles in their finished state that areintended to come into contact with foodreasonably expected to come into contact with foode.g. Inside surfaces of refrigerators andthere is a reasonable expectation of the transfer ofconstituents into food e.g. Print inks or adhesive labelsThe regulations do not apply toAntiquesCovering or coating materials such as materials covering cheese rind,prepared meat products or fruit which form part of the food and may be consumed. Nor do they apply toFixed public or private water supply equipment.
7 What are Food Contact Materials? These are not defined in the regulations but clearly include all elements that make upFood Packaging/wrappingCookwareCutleryTablewareWork surfacesFood contact parts of processing machinery and equipmentTo my knowledge there is no one directive or regulation that defines what food contact materials are but by implication they includeFood Packaging/wrappingCookwareCutleryTablewareWork surfacesFood contact parts of processing machinery and equipment andDisposable plastic cups and plates.
10 Main provisions of Regulation (EC) No. 1935/2004 General protective requirement (Article 3)Active and intelligent materials and articles (Article 4)Specific measuresEuropean Food Safety Authority (EFSA)and Substance authorisations (Article 11)5. Labelling (Article 15)6. Compliance declarations ( Article 16)7. Traceability (Article 17)There are 28 articles but for the purposes of today's talk I will focus only on 7 of them which are listed on the slide.
11 General protective requirement of Regulation (EC) No 1935/2004 Food Contact materials including active and intelligent materials and articles ;Must be made under good manufacturing practice (GMP)Must not transfer constituents in quantities thatwill harm human healthcause unacceptable changes to the composition of foodcause deterioration to organoleptic character of foodLabelling, advertising etc., must not mislead consumersThe general protective requirement asks that Food Contact materialsMust be made under good manufacturing practice (GMP). GMP is referred to in 1935/2004 but it is further elaborated upon in Regulation 2023/2006.Food contact materials and articlesMust not transfer constituents in quantities thatwill harm human healthcause unacceptable changes to the composition of food orcause deterioration to taste,texture, odour or appearance of foodLabelling, advertising etc., must not mislead consumersThe general protective requirement applies traditionally to adventitious migration of substances from Food Contact Materials but it also serves as a Fail Safe provision where intended migration arises from ACTIVE contact materials ( e.g. Additives)
12 Active and intelligent materials and articles Must comply with the EU rules on food (e.g. Food additives)Must be authorised and according to EU rules on food.Released substances are treated as ingredientsMust not change the nature or quality of food to mislead consumersProperly labelledIdentify non-edible parts “Do not eat”Identify material as active or intelligentIdentify nature of released active componentInformation on permitted use of active systemsBy way of explanation what are active and intelligent materials and articles?Active materials: Could release substances into food to increase shelf life or improve condition.Active materials : Might absorb substances from the environment of the food e.g. Gas scavengers or might absorb for example liquid from a packaged meat cut.Intelligent materials: These would monitor the condition of food e.g. Change packaging colour if the temperature or food environment change. The intelligent materials might also indicate if the use by date of a food had expired.Such active and intelligent materials and articles must (Refer to slide)Regulation (EC) No. 450/2009 (Specific measures)
13 Specific Measures Active and intelligent materials and articles AdhesivesCeramicsCorkRubberGlassIon-exchange resinsMetals and alloysPaper and board10. Plastics (virgin & recycled)11. Printing inks12. RCF13. Silicones14. Textiles15. Varnishes and coatings16. Waxes17. WoodThe parent Regulation makes provision for specific measures. There are 17 classes of material listed in Regulation (EC) 1935/2004 for which specific measures can be produced.Specific measures typically includeRegisters of substancesLimits on migrationPurity standardsQuality standards for processesChecking compliance (sampling and analysis)Traceability, Record keeping and labellingCommission is preparing an impact assessment to decide on a way forward for the non-harmonised areas of FCM legislation, which may warrant sector specific, harmonised legislation.
14 European Food Safety Authority Provisions liable to affect public health must be adopted afterconsulting EFSASubstance authorisation:EFSA will give an opinion within 6 months of an applicationbeing made based on the intended conditions of use of thematerial or article in which it is used. The substance must complywith the safety criteria ( Article 3 and 4).EFSA web address:Who is EFSA? The European Food Safety Authority (EFSA) is an independent European agency funded by the EU budget that operates separately from the European Commission, European Parliament and EU Member States.What is EFSA Role in contact materials? The Panel on food contact materials, enzymes, flavourings and processing aids (CEF) deals with questions on the safety of use of materials in contact with food, and with questions related to the safety of processes.EFSA is at the centre of European authorisation procedures providing the necessary risk assessments for the Commission and MS who will take account when developing EC legislation relating to contact material.Provisions liable to affect public health must be adopted afterconsulting EFSASubstance authorisation:EFSA will give an opinion within 6 months of an applicationbeing made based on the intended conditions of use of thematerial or article in which it is used. The substance must complywith the safety criteria ( Article 3 and 4).
15 Labelling Materials and articles must be accompanied by 1. “For food contact” or a symbol indicating their use2. Instructions for safe use.3. Details of manufacturer, processor or seller responsible for first placing on the market.4. Traceability information5. Information of the permitted use of active materialsWhen materials and articles are not in contact with foodwhen placed on the market they must be accompanied byThe term “For food contact” or bear a symbol indicating their use if it is not already obvious. The symbol top right of slide is shown in 1935/2004.2. Instructions for safe and appropriate use where necessary. E.g material might be a cling film that is not suitable for microwave use3. The name or trade name and address or registered office ofmanufacturer, processor or seller responsible for first placingon the market.4. Traceability information5. Information of the permitted use of active materialsincluding the name and quantity of the substancereleasedThis information must be in a language easily understood, conspicuous, legible and indelible
16 Compliance declarations A written declaration indicating that the material or article complies with EU rulesDocumentation must be available to demonstrate compliance and available to authorities on demand.In the absence of specific measures the rules do not prevent Member States from retaining or adopting National provisions for declarations of compliance.FSA Guidance: Guide to UK legal complianceand good practice for business documentation June 20091935/2004 requires that the specific measures on materials and articles in contact with food include provisions that they be accompanied by a written declaration of compliance.Note Declaration and documentation have specific meaning.Documentation must be available to demonstrate how the declaration of compliance has been achieved. This documentation must be made available to authorities on demand.In the absence of specific measures the rules do not prevent Member States from retaining or adopting National provisions for declarations of compliance.The FSA in consultation with stakeholders has prepared specific guidance covering the subject of compliance declarations and also GMP.Details are given in the slide on where to find the download.There are specific requirements for Declarations of compliance in450/2009- Active and intelligent materails and articles.10/2011- Plastic materials and articles.84/500 Ceramic articles in contact with food
17 Typical information required in a Declaration of Compliance: Name/Address of producer/manufacturer/importerMaterial Description/IdentificationDate of DeclarationTest ResultsStatement of compliance including relevant Directive/RegulationsSpecifications on components/materials.Information for downstream useSpecification restricting types of food and intended conditions of useStatement regarding use of functional barrierYou will need to refer to the specific pieces of legislation to get the exact details required for the Declaration of compliance.450/2009- Active and intelligent materials and articles.10/2011- Plastic materials and articles.84/500 Ceramic articles in contact with food
18 TraceabilityTraceability must be ensured at all stages for the control andrecall of defective products, consumer information andAttribution of responsibilityWhere feasible businesses must have systems and proceduresto identify businesses they supply and receive from.Goods placed on EU market must be identifiable in a waythat allows their traceability by means of labelling/Documentation/Information.Traceability must be ensured at all stages for the control andrecall of defective products, consumer information andAttribution of responsibility. Incidentally “All stages” means manufacture, processing and distribution”Where feasible businesses must have systems and proceduresto identify businesses they supply and receive from. (Sometimes referred to as the one up and one down approach)Goods placed on EU market must be identifiable in a waythat allows their traceability by means of labelling/Documentation/Information.This information must be made available to the competent authority.
19 Good Manufacturing Practice (GMP) EC Regulation 2023/2006 (GMP Regulation)Elaborates on GMP in (1935/2004)Defines GMP, QA, QC and other key termsRequires Business operators toEstablish documented QA and QC procedures relating to compliance and safety of finished productsDocument records of manufacturingMake available documents to Competent authorityFSA Guidance: Guide to UK legal complianceand good practice for business documentation June 2009Whilst GMP is mentioned in the main EC Regulation 1935/2004 more specific details are contained in EC Regulation 2023/ It applies to all sectors and stages of manufacture, processing and distributionElaborates on GMP in (1935/2004)Defines GMP, QA, QC and other key termsRequires Business operators toTo Establish documented QA and QC procedures relating to compliance and safety of finished productsTo Document records of manufacturing andTo Make available documents to Competent authorityAnnex in the Regulation requiresPrint inks on non food contact surfaces to be applied in a way that they do not transfer to the food contact side in levels contrary to Art 3 Regulation 1935/2004Printed materials and articles must be handled and stored in their finished or semi finished state such that substances on the printed side do not transfer to the food contact side in levels contrary to Art 3 Reg 1935/2004Printed surfaces must not come in direct contact with the foodThe FSA Guidance document goes into the subject of GMP in more detail and deals with typical production issues. It can be downloaded from the Agency web site.
20 Specific EU measures Vinyl Chloride monomer (VCM) Plastics Active and Intelligent materials and articlesCeramicsRegenerated cellulose film
21 Vinyl Chloride Monomer (VCM) Regulation (EU) 10/2011Council Directive 78/ 142The maximum VCM level in a material or article intended to come into contact with food is1 mg/kg in the final contact material productVCM should not be detectable inFoodstuffs in excess of 0.01 mg/kg.
22 Regulation (EU) 10/2011 on plastic materials and articles intended to come into contact with food Published January 2011 by EU48 recitals setting out the reasoning behind the EU Regulations23 Articles or rulesArticles of particular interestSubject matter Article 1 (Purpose)Scope of the rules Article 2 (What do they apply to ) Whats exempt?Definitions of terms used throughout Article (3)Requirements for placing on the market (Article 4)Compositional requirements for plastics Articles 5- 7Restrictions OML/SML Articles 8-12Multi layers 13 &14Declarations of compliance & supporting documentsAssessing compliance 17-19Remainder are administrative provisions6 Annexes1 Substances and their restrictions2 Restrictions on materials and articles3 Food simulants4 Declarations of compliance5 Compliance testing6 Correlation tables
23 Specific EU Measure on Plastics Regulation (EU) 10/2011 Article 2Covers plastic materials and articles and their partsConsisting exclusively of plastic orComposed of two or more layers of materials eachconsisting exclusively of plastic, bound together byadhesives or other means.When in the finished product state are intended to comeinto contact with food and are intended for thatpurpose.1. This Regulation shall apply to materials and articles which are placed on the EU market and fall under the following categories:materials and articles and parts thereof consisting exclusively of plastics;(b) plastic multi-layer materials and articles held together by adhesives or by other means;(c) materials and articles referred to in points a) or b) that are printed and/or covered by a coating;(d) plastic layers or plastic coatings, forming gaskets in caps and closures, that together with those caps and closures compose a set of two or more layers of different types of materials;(e) Plastic layers in multi-material multi-layer materials and articles.Does not apply in respect of(a) ion exchange resins;(b) rubber;(c) silicones.
24 Plastics Overall Migration Limits(OML) Regulation (EU) 10/2011 Article 12Outlines the amount of a constituent of plastic contact material that is allowed to migrate out of the contact material.The standard is 10 milligrams per square decimetre of surfacearea or in the case of materials in contact with infant food not more than 60 milligrams per kilogram released into a food simulant.Article 12Overall migration limit1. Plastic materials and articles must not transfer their constituents to food simulants in quantities exceeding 10 milligrams of total constituents released per dm 2 of food contact surface.2. However plastic materials and articles intended to be brought into contact with food intended for infants and young children, as defined by Commission Directives 2006/141/EC ( 1 ) and 2006/125/EC ( 2 ), must not transfer their constituents to food simulants in quantities exceeding 60 milligrams of total of constituents released per kg of food simulant.
25 Specific Migration Limit (SML) Regulation (EU) 10/2011 Article 11Where there is no specific migration limit or restriction in Annex 1 the limit is 60 mg/kgArticle 11Specific migration limits1. Plastic materials and articles shall not transfer their constituents to foods in quantities exceeding the specific migration limits (SML) set out in Annex I. Those specific migration limits (SML) are expressed in mg of substance per kg of food (mg/kg).2. For substances for which no specific migration limit or other restrictions are provided in Annex I, a generic specific migration limit of 60 mg/kg shall apply.3. By derogation from paragraphs 1 and 2, additives which are also authorised as food additives by Regulation (EC) No 1333/2008 or as flavourings by Regulation (EC) No 1334/2008 shall not migrate into foods in quantities having a technical effect in the final foods and shall not:(a) exceed the restrictions provided for in Regulation (EC) No 1333/2008 or in Regulation (EC) No 1334/2008 or in Annex I to this Regulation for foods for which their use is authorised as food additive or flavouring substances; or(b) exceed the restrictions set out in Annex I to this Regulation in foods for which their use is not authorised as food additive or flavouring substances.
26 BADGE/BFDGE/NOGE in coatings Regulation (EC) No 1895/2005Applicable to plastics, surface coatings and adhesivesBADGE SML 9 mg/KgBadge-chlorohydrin adducts SML 1 mg/KgBFDGE and NOGE prohibitedDeclaration of compliance and supportingdocumentation requiredBADGE/BFDGE/NOGE in coatingsApplicable to plastics, surface coatings and adhesivesBADGE SML 9 mg/Kg or 9 mg/ 6 square decimetres for containers with capacity <0.5 litres or >10 litresBadge-chlorohydrin adducts SML 1 mg/Kg or 1 mg/ 6 square decimetres for containers with capacity <0.5 litres or >10 litresBFDGE and NOGE prohibitedDeclaration of compliance and supportingdocumentation requiredBADGE: 2,2-bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl) etherBFDGE: bis(hydroxyphenyl)methane bis(2,3-epoxypropyl)ethersNOGE: novolac glycidyl ethers
27 Recycling Plastics – Regulation EC 282/2008 Mechanical recycling processes, not chemical onesAuthorisation for processes required, approval by EFSACommunity RegisterDoC and GMP requirementsEFSA Guideline on submission of dossiers availableUntil March 2008 there were no harmonised rules for the using recycled plastics in contact with food.The Regulation deals with mechanical processes for recycling food contact plastic for further use in contact with food.A person or company must apply for authorisation to use a specific process and the processes authorised must be managed by a quality assurance system that guarantees the reproducible quality of the recycled plastic.
28 Primary aromatic amines Formaldehyde. Enforced by District Councils The Plastic Kitchenware (Conditions of Import from China) Regulations (Northern Ireland) 2011Primary aromatic aminesFormaldehyde.Enforced by District CouncilsCommission Regulation (EU) No 284/2011 lays down specific conditions and detailed procedures for the import of polyamide and of melamine plastic kitchenware originating in or consigned from the People's Republic of China (China) and Hong Kong Special Administrative Region of the People's Republic of China (Hong Kong). These specific conditions include that plastic kitchenware originating in or consigned from China and Hong Kong shall be imported into the Member States only if the importer submits to the competent authority for each consignment a declaration and a laboratory report confirming that it meets the requirements concerning the release of primary aromatic amines and formaldehyde.A temporary import control measure put in place until EU satisfied that these implements can be manufactured to comply with EU legal specifications.
29 Northern Ireland Legislation implementing EU rules Primary legislationFood Safety (NI) Order 1991Secondary LegislationMaterials and Articles in Contact with Food Regulations(NI) 2007 SR. No. 434Materials and Articles in Contact with Food (Amendment)Regulations (NI) 2009 SR. No. 377Plastic Materials and Articles in Contact with FoodRegulations (NI) 2009 SR.No. 56Ceramic Articles in contact with Food Regulations(NI) 2006 SR. No. 217
30 Changes to legislation 12 week Consultation started on 20th January 2012.Consolidation of the food contact materials legislationThe Materials and Articles in Contact with Food Regulations (NI) (Currently being made and proposed coming into operation on 20th November 2012)A 12 week consultation started back in January 2012 drawing attention to plans to create a single piece of legislation after the consolidation of the plastics directives into one European Regulation. Currently FSA working through regulatory procedures and protocols with an anticipated coming into operation date of 20th November 201 for the new food contact materials legislation.
31 Enforcement of legislation Food Standards AgencyDistrict Council EHOsLegislation refers to Competent AuthoritiesFSA is competent authority regarding Article 9 of 1935/2004 ( Authorisations of new substances.)FSA is competent authority regarding Article 13 of 1935/2004 (Competent authority of Member State)s.The DCs and FSA both competent authorities regarding Article 16(1) Declarations of compliance and 17(2) TraceabilityThe competent authority in respect of Art 6(2) 2023/2006 Quality Control Systems and 7(3) of 2023/2007 (documentation) is the District Council.The Competent Authority for Article 13 of Reg 450/2009- Active and Intelligent Materials and Articles is FSA and DCsThe Competent authority for Ceramic materials 84/500 is the District Council.Article 8 of 10/2011 FSA and DCs ( Composition of materials used).Article 16 of 10/2011 Supporting documentation the FSA is the competent authority.Epoxy derivatives Reg 6(4) 1895/2005- Identification of date of filling. DC is the competent authority.As a rule the day to day enforcement of the food contact materials is a function of the District Councils.
32 Powers of authorised officers Enter premises to determine compliance with the regulations (Includes GMP)Inspect records on site e.g. traceabilityInspect GMP and associated records and documents. (Quality Assurance/Quality Control).No offence is needed to look at records.Take samples of materials and articles intended for use as food contact material.Submit samples to a Public Analyst for chemical analysis.The powers of Authorised officers is contained within TheFood Safety (NI) Order 1991Materials and Articles in Contact with Food Regulations (NI) 2012There are also powers regarding detention and seizure under Consumer Protection Legislation.
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