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| GUIDELINE TO THE NEW REGULATION 10/2011 | ||||||||||||||||||||||||||||||||
INTRODUCTION
Near these "technological "developments which involved, among other things, not only packs "shelf", but also the article for the cooking, conservation, food processing, there has been a progressive adaptation of European legislation and act in individual Member States to monitor the safety of these materials. Of course, since the growth of globalization, which are then linked to import and export of materials and raw materials for the production of food items, checks have been intensified and were created special bodies to monitor compliance to legislative parameters defined and reporting at European level of alert for any unsafe products to the consumer (RASFF).
Plastic is the material which, given its multiple use, has been and is currently on the focus of attention. Fortunately, for about 10 years, for plastics has been set a harmonized European legislation (implemented by specific national measures), so in all Member States in relation to this material "we can speak the same language." Specifically, the legislation which has so far referred to, the key legislation, is the European Directive 2002/72/EC of 6 August 2002 relating to materials and articles made of plastics intended to come into contact with food. Over time, this Directive has been amended and revised several times (7 amendments), in order to adapt to technological advances in the field. Following several amendments and developments increasingly massive, the European Commission has decided to establish a new regulation to replace, in part initially and then completely, the old Directive including its amendments (the start was given to the work in 2010 with the PIM, a copy of the Draft Rules, and then realize all the new Regulation 10/2011). Important defining the difference between a Directive and Regulations. As for a Directive, it is necessary in order to become active in a single Member State, to be transposed by the Member State itself. On the contrary with regard to the Regulations, its publication in the Official Journal of the European automatically makes it active across Europe (member states) without requiring that it be implemented (by decree, for example). As already mentioned, the new Regulation introduces several changes from the old directive, but of course the Commission took note of the time necessary to producers and the industry in adapting to the new rules, has decided to gradually introduce these innovations. Following the individual changes will be treated in the specific, and their dates of "activation"
NEW REGULATION (EU) 10 / 2011 on materials and articles intended to come into contact with foodstuffs
Also arises in relation to the need for technical adaptation compared to the many innovations introduced to improve the articles intended for food contact substances of use to which it is currently difficult to think of packaging and objects as consisting of a single type of plastic (currently items could be constituted of multiple layers, up to 15 different plastic materials in order to optimize the functionality and protection of food products and reducing packaging waste). In this type of materials or objects of plastic multi-layer, the layers can be separated from food by a functional barrier. This is a barrier consisting of a layer within the materials or articles intended to come into contact with food that prevents the migration of substances through the barrier in food. razione di sostanze attraverso la barriera nei prodotti alimentari.
The new Regulation, issued by publication in the Official Gazette, dated January 14, 2011, is made up of 23 articles divided into s6 chapters and 6 annex.
6 Chapter with 23 Articles:
CHAP.1: General Provisions (Articles 1-4) CHAP.2: Compositional Requirements (Articles 5-12) CHAP.3: Specific Provisions for certain materials and articles CHAP.4: Declaration of compliance and documentation CHAP.5: Compliance (Articles 17-19) CHAP.6: Final Provisions (Articles 20-23)
6 Annex:
ANN.I: List of Substances (fixed eventual SML and restrictions) ANN.II: Restrictions on materials and articles ANN.III: Food Simulants ANN.IV: Declaration of compliance ANN.V: Compliance testing ANN.VI: Correlation Tables
CHAP.1: General Provisions (Articles 1-4) The new Regulation 10/2011 is a specific measure within the meaning of article 5 of Regulation 1935/2004 that fixes:
Materials and articles, including active and intelligent materials (a) endanger human health; or (b) bring about an unacceptable change in the composition of the food; or (c) bring about a deterioration in the organoleptic characteristics thereof.
The new Regulation 10/2011 shall apply to: (a) 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. With the term “multi-material multi-layer materials” are intended all materials and articles that are not constituted exclusively by plastic materials. This is a news introduced by the new Regulation 10/2011 (the old Directive did not cover this kind of articles) but, as we can see later, for these kind of articles evaluation of Overall Migration and Specific Migration parameters, is not required. It is important defining that all plastic materials, as explained above, can be printed or coated but: * Adhesives * Printing Ink * Coating ARE NOT covered by the new Regulation 10/2011.
Moreover the Regulation does not cover: - Ion Exchange Resins - Rubber - Silicones
Info: The rubber (elastomer) is a material characterized by the ability to be stretched considerably and can then quickly return to the initial length (elasticity).
The rubber has elastic properties to its being composed of molecules of high length (molecular weight of tens of thousands of atomic mass units), which at rest are folded on themselves, and are able to relax when subjected to traction, and then resume the original configuration to the end of the solicitation. But unlike the thermoplastic polymers, the macromolecules that make up the rubber has a degree of crosslinking of the macromolecules that have a structure "wiry," but more "twisted" (as a network), and this allows the macromolecules to restore configuration prior to the solicitation. Among the most commonly used are the polymers of isoprene (natural rubber or rubber), polybutadiene, styrene rubber (or styrene), nitrile rubber, butadiene-vinylpyridine copolymers and polymers of clorobutadiene (neoprene).
Simplifying, in order to put a plastic material or a finished article on the european market, the following points must be satisfied: al fine di immettere sul mercato europeo un un materiale plastico o un oggetto finito in plastica o composto da più plastiche differenti, devono essere soddisfati I seguenti punti:
A) The articles must comply with: • Articles 3, 15 and 17 of Regulation (EC) 1935/2004
B) The articles must meet: • the compositional requirements • the specific rules for multi-layer (homogeneous and heterogeneous) • must be manufactured in accordance with Regulation (EC) 2023 / 2006
C) The articles must be accompanied by: • the declaration of conformity (and supporting documentation)
Info: A plastic material is any of a wide range of synthetic or semi-synthetic organic solids used in the manufacture of industrial products. Plastics are typically polymers of high molecular mass, and may contain other substances to improve performance and/or reduce production costs. Monomers of plastic are either natural or synthetic organic compounds. The common word plastic should not be confused with the technical adjective plastic, which is applied to any material which undergoes a permanent change of shape (plastic deformation) when strained beyond a certain point. Aluminum which is stamped or forged, for instance, exhibits plasticity in this sense, but is not plastic in the common sense; in contrast, in their finished forms, some plastics will break before deforming and therefore are not plastic in the technical sense. There are two types of plastics: thermoplastics and thermosetting polymers. Thermoplastics are the plastics that do not undergo chemical change in their composition when heated and can be moulded again and again; examples are polyethylene, polypropylene, polystyrene, polyvinyl chloride and polytetrafluoroethylene (PTFE). Thermosets can melt and take shape once; after they have solidified, they stay solid. The raw materials needed to make most plastics come from petroleum and natural gas. Plastics can be classified by chemical structure, namely the molecular units that make up the polymer's backbone and side chains. Some important groups in these classifications are the acrylics, polyesters, silicones, polyurethanes, and halogenated plastics. Plastics can also be classified by the chemical process used in their synthesis, such as condensation, polyaddition, and cross-linking.
Other classifications are based on qualities that are relevant for manufacturing or product design. Examples of such classes are the thermoplastic and thermoset, elastomer, structural, biodegradable, and electrically conductive. Plastics can also be classified by various physical properties, such as density, tensile strength, glass transition temperature, and resistance to various chemical products.
Due to their relatively low cost, ease of manufacture, versatility, and imperviousness to water, plastics are used in an enormous and expanding range of products, from paper clips to spaceships. They have already displaced many traditional materials, such as wood, stone, horn and bone, leather, paper, metal, glass, and ceramic, in most of their former uses
CHAP.2: Compositional Requirements (Articles 5-12)
A single community list (Annex I) is fixed; in includes: • Monomers and other starting substances; • additiives (colorants excluded) • PPA (Polymer Production Aids) with the exclusion of solvents •macromolecular substances obtained by microbiological fermentation
Listed substances must comply with fixed restrictions (some substances can be used eclusively as monomers or as additives) and the specification provided (eventual specific migration limits, SML, or Maximum Quantity Allowed, QMA). The list could be however updated by the Commission according to the procedure established in the CE Regulation 1935/2004.
Article 6: Derogations for substances not included in the Union list
Certain substances, ubstances other than those included in the Union list may be used as polymer production aids in the manufacture of plastic layers in plastic materials or articles designed to contact food substances. The following substances, in example, can be used, also if not present in the list: • Colorants and solvents covered by specific national legislations; • PPA not present in the list can be used according to national legislations; • Salts (including double salts and acid salts) of aluminium, ammonium, barium, calcium, cobalt, copper, iron, lithium, magnesium, manganese, potassium, sodium, and zinc of authorised acids, phenols or alcohols; • mixtures obtained by mixing authorised substances without a chemical reaction of the components;
Can be also used: • non-intentionally added substances [NIAS] (def.9): means an impurity in the substances used or a reaction intermediate formed during the production process or a decomposition or reaction product; • aids to polymerisation. (def. 10): means a substance which initiates polymerisation and/or controls the formation of the macromolecular structure;
The substances used in the production of plastics must have a technical quality and a purity appropriate to the foreseeable use of article or material in object. About this point, the resins employed need FOOD GRADE DECLARATION, issue that will be treated specifically below. Important defining that the composition of substances employed must be available for checking authorithies on demand.
Info: A monomer (from Greek mono "one" and meros "part") is an atom or a small molecule that may bind chemically to other monomers to form a polymer; the term "monomeric protein" may also be used to describe one of the proteins making up a multiprotein complex. The most common natural monomer is glucose, which is linked by glycosidic bonds into polymers such as cellulose and starch, and is over 76% of the weight of all plant matter. Most often the term monomer refers to the organic molecules which form synthetic polymers, such as, for example, vinyl chloride, which is used to produce the polymer polyvinyl chloride (PVC). . The process of transformation of monomer to polymer is called polymerization. When the monomers are used to produce copolymers, more specifically using the term comonomer.
Examples of monomers in the case of addition polymerization may be: - Vinyl chloride, from which originates the PVC; - Ethylene, polyethylene, from which it originated; - Cyanoacrylate acid component of some adhesives; - Styrene, which produces polystyrene polymerization; - Methyl acrylate, the polymerization is achieved when the Plexiglas. In the case of condensation polymerization, some examples are: - Amino acids, which enter into the constitution of biological proteins; - The couple adipic acid-hexamethylenediamine, used to produce Nylon 6-6; - Para-phenylenediamine and terephthalic acid, which are condensing Kevlar; - Ethylene glycol with terephthalic acid, the condensation which produces PET, the material they are made of plastic bottles.
Instead additives play a vital role both in the process that the performance of polymer systems. They can be classified according to their general function and the second their specific action as outlined below:
1. Additives for the transformation a. Process Stabilizers b. Lubricants c. Promoters of fusion 2. Modifying the mechanical properties a. Plasticizers b. Reinforcing fillers c. Agents Impact Modifiers 3. A. anti-aging additives Antioxidants b. Ultraviolet stabilizers 4. Modifying surface properties of a. Surface antistatic agents b. Agents, anti-lock 5. Modifying the optical properties a. Pigments and dyes b. Nucleating agents 6. Flame retardant additives a. Inhibitors ignition b. Self-extinguishing agents c. Anti-smoke 7. foaming additives a. blowing agents
The process of mixing of additives in polymers is usually called "compounding."
Article 9, Annex I: Specific requirements on substances
• Verification of SML (Specific Migration Limits) • Verification of OML (Overall Migration Limits)
SML: Specific Migration Limits For certain substances, limits of migration are fixed. It is intended that the maximum quantity of migratable substance that the sample can be release to the foods (or to the food simulants), must not exceed the fixed specific limitation. The respect of SML must be verified on each of food simulants employed and representing the real foreseable use of item. Near this parameters it is needed highlighting the existence of QMA (Maximum Quantity Allowed), value that indicates, for certain substances, the maximum quantity employable during the production of article or material.
OML: Overall Migration Limit With Overall Migration is intended the maximum quantity of substances (non volatile) that the article can release to the foods or food simulants. The compliance of OML must be verified on each of food simulants employed and representing the real foreseable use of item. Susbtantially this value indicates in aspecific manner, the quantity of substance that migrates in the foods, independently from the kind or the nature of substances.
Article 10, Annex II: General restrictions on plastic materials and articles
• Specific Migration Limits of certain substances
Barium = 1 mg/kg food or food simulant. Cobalt = 0,05 mg/kg food or food simulant. Copper = 5 mg/kg food or food simulant. Iron = 48 mg/kg food or food simulant. Lithium = 0,6 mg/kg food or food simulant. Manganese = 0,6 mg/kg food or food simulant. Zinc = 25 mg/kg food or food simulant.
• Restriction for Primary Aromatic Amines Release (0,01mg/kg)
In this case, the legislation does not specify exactly what kinds of foods simulant should be used for the check of these parameters. Some studies indicate that ethanol and oil could be react with these susbtances and for this reason they could be not appropriate to perform this analysis. The appropriate food simulant so could be Acetic Acid because it represents the “worst case” for the migration of substances above defined.
Article 11, Specific Migration Limits
• Specific Migration Value (related to SML) must be reported in mg/Kg of foodstuf. • If a SML is not fixed and there are not restrictions for a specific substance, the generic SML value is 60 mg/Kg of foodstuffs. • Specific Rules are fixed for Dual Use Additives, additives employable in some cases, also as food additives or flavouring agent in the foods. They also hall not migrate into foods in quantities having a technical effect in the final foods and shall not:
Article 12, Overall Migration Limit
• The Overall Migration Limit (OML) is fixed to 10 mg/dm2 • For plastic materials and articles designed for infants and small children foods (as defined in the European Commission Directives 2006/141/CE and 2006/125/CE, the limit is always 60 mg/Kg of food. There is a change from the old Directive, where the expression of result was in mg/Kg also for: - Container with capacity between 500ml and 10 Liters; - Closures, Lid, Gasket and other closure devices;
The new Regulation 10/2011 establishes that the Overall Migration Value is always reported in mg/dm2 (only exception for articles destined to contain food for infants and small children).
CHAP.3: SPECIFIC PROVISIONS FOR CERTAIN MATERIALS AND ARTICLES (Articles13-14) Article 13, Plastic multi-layer materials and articles
• In a plastic multi-layer material or article, the compositionof each plastic layer shall comply with the new Regulation. • SML and OML must be verified • Declaration of compliance must be present • The concept of “Functional Barrier” can be applied, in particular:
... Behind a functional barrier, non-authorised substances may be used, provided they fulfil certain criteria and their migration remains below a given detection limit. Taking into account foods for infants and other particularly susceptible persons, as well as the large analytical tolerance of the migration analysis, a maximum level of 0,01 mg/kg in food should be established for the migration of a non-authorised substance through a functional barrier. Substances that are mutagenic, carcinogenic or toxic to reproduction should not be used in food contact materials or articles without previous authorisation and should therefore not be covered by the functional barrier concept.
Mutagenic, carcinogenic or toxic to reproduction substances cannot be used in the production of articles and materials destined to contact food substances. Consequently the “functional barrier” concept cannot be applied to this kind of substances. A detail regards the verification of specific migration for not allowed substances: the evaluation should be performed on the first attack, also in case of articles designed to repeated use.
Article 14, Multi-material multi-layer materials and articles
• Only the plastic material layer is regulated by the new Regulation 10/2011; • The composition of plastic layer must respect the community list; • The restrictions imposed for CVM must be respected; • SML and OML are not applied to multi-material multi-layer materials and articles also if it is made of plastic; • The declaration of compliance must be present only for the plastic layer involved; • Behind a funtional barrier can be used also non-listed substances (but not Mutagenic, carcinogenic or toxic to reproduction substances)
Substantially, in multi-material articles and materials, the plastic layer must respect the ccompositional criteria and it must provide a declaration of compliance to the Regulation, but the eventual SML and OML restrictions are not applied. The specific migration limits and overall migration limits for this kind of article could be defined by national legislation, according to the market of destination of item.
CHAP.4: DECLARATION OF COMPLIANCE AND DOCUMENTATION (Article 15-16)
Articles 15,16, Annex IV Declaration of compliance and Supporting documents At the marketing stages other than at the retail stage, a written declaration shall be available for plastic materials and articles, products from intermediate stages of their manufacturing as well as for the substances intended for the manufacturing of those materials and articles. Business operators are currently basing their declaration of compliance on supporting documentation following the requirements set out in Directive 2002/72/EC. Declaration of compliance need, in principle, only to be updated when substantial changes in the production bring about changes in the migration or when new scientific data are available. In order to limit the burden to business operators, materials which have been lawfully placed on the market based on the requirements set out in Directive 2002/72/EC should be able to be placed on the market with a declara tion of compliance based on supporting documentation in accordance with Directive 2002/72/EC until 5 years after the adoption of the Regulation. The minimum requirements for a correct declaration are reported in the Annex IV of the Regulation. As supporting documents are intended documentation containing the conditions and results of testing, calculations, including modelling, other analysis, and evidence on the safety or reasoning demonstrating compliance.
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CHAP.5: COMPLIANCE (Articles 17-19)
Article 17 Expression of Migration Test Results The Specific Migration value must be expressed in mg/Kg of food. For caps, gaskets, stoppers and similar sealing articles the specific migration value shall be expressed in: - mg/Kg if it is used, during the tests, the real volume of article under normal and foreseable use conditions; - mg/dm2 if it is used, during the tests, only the real surface exposed of article under normal and foreseable use conditions; - mg/article if the final and real destination is unknown;
For caps, gaskets, stoppers and similar sealing articles the Overall migration value shall be expressed in: - mg/dm2 if the if the final and real destination is known; - mg/article if the final and real destination is unknown;
Article 18, Annex III and V Rules for assessing compliance with migration limits
- Rules for materials and articles already in contact with foods; - Rules for materials and articles not yet in contact with foods;
• For materials and articles already in contact with food verification of compliance with specific migration limits shall be carried out in accordance with the rules set out in Chapter 1 of Annex V. • For materials and articles not yet in contact with food verification of compliance with specific migration limits shall be carried out in food or in food simulants set out in Annex III in accordance with the rules set out in Chapter 2, Section 2.1 of Annex V. (food simulants and conventional classification of foods)
For materials and articles not yet in contact with food, the compliance to fixed limitations could be evaluated through screening methods; however: • The results obtained using food prevail on results obtained with food simulants; • The results obtained using food simulants prevail on results obtained through screening approach; In case of non-compliance after screening test, the results must be confirmed with traditional tests using food or food simulants.
SCREENING METHODS: The new Regulation esatblishes the possibility of using screening methods, in support or sostituting the traditional food contact tests. • Evaluation of Global Migration Value for the respect of eventual Specific Migration Value; • Calculation of Residual Content (QM) :calculation of theorical maximum migration, supposing a complete migration of a specific substance; • Migration modelling: To screen for specific migration the migration potential can be calculated based on the residual content of the sub stance in the material or article applying generally recognised diffusion models based on scientific evidence that are constructed such as to overestimate real migration. • Food simulant substitutes: To screen for specific migration, food simulants can be replaced by substitute food simulants if it is based on scientific evidence that the substitute food simulants overestimate migration compared to the regulated food simulants.
CHAP.6: FINAL PROVISIONS (Article20-23) Article 20--23
A) - 1 May 2011: Date of come into effect of Regulation 10/2011. - 31 December 2012: First Deadline Until 31 December 2012, the structure of legislation (old European Directive 2002/72/EC) is taken by the Regulation 10/2011. Test Conditions (SIMULANTS, TIME, TEMPERATURES) shall be based on European Directive 85/572 [Article 23] and 82/711 [Article 22].
The limits of Overall and Specific Migration must be evaluated at the conditions fixed by the old Directive, but the compliance mus be given to the Regulation 10/2011 (so the compliance to specific migration of certain substances and primary aromatic amines release mus be furnished). FOOD GRADE: must be in compliance to the new Regulation 10/2011, starting from 1st May 2011.
B) - 1 January 2013: First Deadline - 31 December 2015: Second Deadline As reported above, the control is taken frome the new Annexes to Regulation 10/2011, but in order to check the compliance, the old conditions could be used (double chance of choice) only for tests conditions [Article 22]
C) - 1 January 2016: Regulation 10/2011 comes into effect completely Old conditions cannot be used, all references must be take from Regulation 10/2011
ANNEX I // ANNEX II ANN. 1: Susbtances (currently: 885 substances) Union list contains authorised monomers, other starting substances, macromolecules obtained from microbial fermentation, additives and polymer production aids and eventual limitations and restrictions on their use.
ANN. 2: Restrictions on materials and articles and primary aromatic amines (0,01mg/kg) Barium = 1 mg/kg food or food simulant. Cobalt = 0,05 mg/kg food or food simulant. Copper = 5 mg/kg food or food simulant. Iron = 48 mg/kg food or food simulant. Lithium = 0,6 mg/kg food or food simulant. Manganese = 0,6 mg/kg food or food simulant. Zinc = 25 mg/kg food or food simulant.
Plastic materials and articles shall not release primary aromatic amines, excluding those appearing in Table 1 of Annex I, in a detectable quantity into food or food simulant. The detection limit is 0,01 mg of substance per kg of food or food simulant. The detection limit applies to the sum of primary aromatic amines released.
ANNEX III :Food Simulants
• Ethanol 10 % (v/v) Food simulant A • Acetic acid 3 % (w/v) Food simulant B • Ethanol 20 % (v/v) Food simulant C • Ethanol 50 % (v/v) Food simulant D1 • Vegetable oil (*) Food simulant D2 • poly(2,6-diphenyl-p-phenylene oxide), particle Food simulant E
Distilled Water is removed from food simulant list (ex simulant A)
The choosen of appropriate food simulants must be performed according to foreseeable real use conditions and/or according to instructions attached to the article.
- ALL KINDS OF FOODS: SimulantisA+B+D2 - ALL KINDS OF FOODS [NO ACID]: Simulants A+D2 - AQUEOUS, ALCOHOLIC, MILKY: Simulant D1 - AQUEOUS, ACID, ALCOHOLIC, MILKY: Simulants D1+B - AQUEOUS, ALCOHOLIC (up to 20%): Simulant C - AQUEOUS, ACID, ALCOHOLIC: Simulants B+C
ANNEX IV: Declaration of Compliance The written declaration referred to in Article 15 shall contain the following information: (1) the identity and address of the business operator issuing the declaration of compliance; (2) the identity and address of the business operator which manufactures or imports the plastic materials or articles or products from intermediate stages of their manufacturing or the substances intended for the manufacturing of those materials and articles; (3) the identity of the materials, the articles, products from intermediate stages of manufacture or the substances intended for the manufacturing of those materials and articles; (4) the date of the declaration; (5) confirmation that the plastic materials or articles, products from intermediate stages of manufacture or the substances meet relevant requirements laid down in this Regulation and Regulation (EC) No 1935/2004; (6) adequate information relative to the substances used or products of degradation thereof for which restrictions and/or specifications are set out in Annexes I and II to this Regulation to allow the downstream business operators to ensure compliance with those restrictions; (7) adequate information relative to the substances which are subject to a restriction in food, obtained by experimental data or theoretical calculation about the level of their specific migration and, where appropriate, purity criteria in accordance with Directives 2008/60/EC, 95/45/EC and 2008/84/EC to enable the user of these materials or articles to comply with the relevant EU provisions or, in their absence, with national provisions applicable to food;
(8) specifications on the use of the material or article, such as: (i) type or types of food with which it is intended to be put in contact; (ii) time and temperature of treatment and storage in contact with the food; (iii) ratio of food contact surface area to volume used to establish the compliance of the material or article; (9) when a functional barrier is used in a multi-layer material or article, the confirmation that the material or article complies with the requirements of Article 13(2), (3) and (4) or Article 14(2) and (3) of this Regulation.
ANNEX V: Compliance Testing a) Test Method for Specific Migration (for materials and articles already in contact and not yet in contact with foods)
b) Test Method for Overall Migration (7 comination of different time and temperature and 2 conditions of alternative tests)
TEST CONDITIONS FOR SPECIFIC MIGRATION TEST EVALUATION Choosen based on worst foreseeable real use conditions
Definition of time of contact during tests
Contact Time Contact Time in the test
t ≤ 5 min 5 min 5 min < t ≤ 0,5 hrs 0,5 jrs 0,5 hrs < t ≤ 1 hrs 1 hrs 1 hrs < t ≤ 2 hrs 2 hrs 2 hrs < t ≤ 6 hrs 6 hrs 6 hrs < t ≤ 24 hrs 24 hrs 1 day < t ≤ 3 days 3 days 3 days < t ≤ 30 days 10 fays Above 30 days Specific Condit.
Definition of temperature of contact during tests Real Contact Temperature Test Temperature
T ≤ 5 °C 5 °C 5 °C < T ≤ 20 °C 20 °C 20 °C < T ≤ 40 °C 40 °C 40 °C < T ≤ 70 °C 70 °C 70 °C < T ≤ 100 °C 100 °C or reflux 100 °C < T ≤ 121 °C 121 °C (*) 121 °C < T ≤ 130 °C 130 °C (*) 130 °C < T ≤ 150 °C 150 °C (*) 150 °C < T < 175 °C 175 °C (*) T > 175 °C Based on actual temperature
For temperatures exceeding 100°C, for aqueous food simulants, test must be performed at 100°C (or reflux temperature) for a time equal to 4 time the foreseeable real time condition.
CONDITIONS OF OVERALL MIGRATION TESTS The choosen of conditions is performed on worst forseeable real use conditions, and they are STANDARDIZED in order to represent the different uses:
* Test OM 7 covers also food contact conditions described for OM1, OM2, OM3, OM4, OM5.
* Test OM 6 covers also food contact conditions described for OM1, OM2, OM3, OM4 and OM5.
* Test OM 5 covers also food contact conditions described for OM1, OM2, OM3, OM4.
* Test OM 2 covers also food contact conditions described for OM1 and OM3
TEST ON ARTICLE DESTINED TO REPEATED FOOD CONTACT Where a material or article is intended to come into repeated contact with foods, the migration test shall be carried out three times on a single sample using another sample of the food simulant on each occasion with evaluation performed on the third solution obtained. Its compliance shall be checked on the basis of the level of the migration found in the third test. However, if there is conclusive proof that the level of the migration does not increase in the second and third tests and if the overall migration limit is not exceeded on the first test, no further test is necessary.
LEGISLATIVE REFERENCE: * European REGULATION (EU) 10 / 2011 on materials and articles intended to come into contact with foodstuffs * European Directive 2002/72/EC relating to plastic materials and articles intended of food contact substances. DISCLAIMER Lo scopo di questa guida è fornire informazioni il più aggiornate, accurate e complete possibile. L'autore è escluso da ogni responsabilità per danni materiali o immateriali derivanti dall'uso o dal non utilizzo delle informazioni riportate in questa guida.
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