Chapter 1	Area
Chapter 2	Definitions
Chapter 3	Marketing, use and withdrawal
Chapter 4	Special production, use and test conditions, etc. for certain food-contact materials
Chapter 5	Special documentation and declaration requirements
Chapter 6	Migration Testing
Chapter 7	Penalty and effective provisions
Appendix 1	List of additives exclusively as surface biocides, which are intended to remain in the finished item, cf. § 11
Appendix 2	Criteria to be applied to the determination of the content of vinyl chloride in food contact materials and for the determination of vinyl chloride given by food contact materials
Appendix 3	List of substances which may be used in the manufacture of cellular generals
Appendix 4	Limits for lead and cadmium from ceramic and embed objects and glazed
Appendix 5	Requirements for the documentation of establishments which bring food contact materials into trade
Appendix 6	Inline on the test of total and specific migration from plastics
Appendix 7	Food simulators
Appendix 8	Migrationtest for total and specific migration : test conditions, duration and temperature
Appendix 9	Fedttests for total and specific migration
Appendix 10	Ceramics, eminated objects and glazed
Appendix 11	List of Annexes

Completion of food contact materials 1)

In accordance with section 25, § 25 a, § 27, § 49, paragraph Paragraph 60 (1) and 60 (2). 3, in the law of foodstuffs, cf. Law Order no. 250 of 8. March 2013 :

Chapter 1

Area

§ 1. The notice shall apply to food-contact materials covered by Regulation (EC) No 2 of the European Parliament and of the Council. 1935/2004 on materials and articles intended for contact with food and for the cancellation of Directive 80 /590/EEC and 89 /109/EEC.

Chapter 2

Definitions

§ 2. In addition to the definitions in section 3-6, the definitions shall apply in Regulation (EC) No 2 of the European Parliament and of the Council. 1935/2004 on materials and articles intended for contact with food and for the suspension of Directive 80 /590/EEC and 89 /109/EEC.

§ 3. Food contact materials shall mean materials and articles, as described in Regulation (EC) No, of the European Parliament and of the Council. 1935/2004 on materials and articles intended for contact with food and for the cancellation of Directive 80 /590/EEC and 89 /109/EEC Article 1 (1). 2

§ 4. For the purpose of foil of celluloseregenerates in this notice, a thin film is produced from the refined cellulose of unreused wood or cotton. For technical reasons, suitable substances may be added to the mass or to the surface. Folier of cellular generators may have surface treatment on one or both sides.

Paragraph 2. Folier of celluloseregenerates, cf. paragraph 1 comprises :

1) non-surfac-treated foil of celluloseregenerates,

2) surface treated foil of celluloseregenerates, the surface treatment of which is manufactured by cellulose, or

3) surface-treated foil of celluloseregenerates, where the surface treatment is made up of plastic.

§ 5. For the purposes of this notice, food contact materials of plastics as defined in Article 3 (2) shall be taken into account. Paragraph 1 (a) and (b) of Regulation (EC) No, 10/2011 on plastic materials and articles intended for contact with food, as well as plastic, as defined in Article 3 (2). 2, in the same Regulation.

Paragraph 2. For the purposes of this notice, the relevant definitions shall apply in Article 3 of Regulation (EC) No 2. 10/2011 on plastic materials and articles intended for contact with food.

§ 6. In the case of ceramics, this notice is made of a mixture of inorganic substances in general, with a large amount of clay or kiolin-containing minerals which may be added to small quantities of organic substances. These items are only formed, and the form obtained will then remain in the form of combustion. They can be glazed, emallied and / or decorated.

Chapter 3

Marketing, use and withdrawal

§ 7. Food contact materials may not be placed on the market if they do not comply with the general requirements of Regulation (EC) No 2. 1935/2004 on materials and articles intended for contact with food and for the cancellation of Directive 80 /590/EEC and 89 /109/EEC and in accordance with the rules laid down in this Regulation.

Paragraph 2. Undertakings which imports, manufacture and / or packages of food must not use food contact materials if they do not meet the general requirements of Regulation (EC) No 2. 1935/2004 on materials and articles intended for contact with food and for the cancellation of Directive 80 /590/EEC and 89 /109/EEC and in accordance with the rules laid down in this Regulation. At the same time, the establishment must ensure that they use food contact materials only for the purposes of which they are intended.

Paragraph 3. The Bisphenol A and all of the compounds included in it may not be used in materials intended to come or be in contact with foodstuffs specially intended for 0 or 3 year olds.

§ 8. If a company operator, producer or importer of food contact materials assumes or has reason to assume that food contact materials produced, imported or distributed, do not comply with the requirements for food safety and the products are no longer controlled by the operator, the producer or the importer, to take the necessary measures to withdraw the food contact materials in question from the market. The operator, the producer or importer shall immediately inform the Authority of the Food Safety Board.

Paragraph 2. If food contact materials have been reached for consumers, the operator, producer, or importer effectively and accurately inform consumers of the background to the product being withdrawn. If necessary, the company should call the goods back from the consumer.

Chapter 4

Special production, use and test conditions, etc. for certain food-contact materials

Plastics and regained plastics

§ 9. in the case of plastic Regulation (EU) No, 10/2011 on plastic materials and articles intended for contact with food, and for the regained plastics apply to Regulation (EC) No 2. Directive 282/2008 on materials and objects of regained plastics intended for contact with foodstuffs and amending Regulation (EC) No 2. 2023/2006.

§ 10. Until 31. December 2015, it is based on Regulation (EC) No 2. 10/2011 on plastic materials and articles intended for contact with Article 16 of the food products referred to in Article 16 for materials, objects and substances at :

1) the rules on migration tests laid down in Article 18 of Regulation (EU) No ; 10/2011 on plastic materials and articles intended for contact with food, or

2) the basic rules for general and specific control of migration laid down in section 20 to 26 of this notice.

Paragraph 2. From the 1. January 2016 shall be based on the basis of Regulation (EC) No 1 10/2011 on plastic materials and articles intended for contact with Article 16 of the foodstuff referred to in Article 16 of the rules on migration tests provided for in Article 18 without prejudice to paragraph 1. 1.

§ 11. For the use of additives which are intended solely for surface biocides and intended to remain in the finished material or the final object, only the biocides listed in Annex 1 may be used, and only with the products listed in Annex 1. the restrictions and / or specifications set out in the Annex.

Vinyl chloride

§ 12. Food contact materials shall not be subject to a vinyl chloride which can be demonstrated according to the method which satisfies the criteria set out in Annex 2 for food or contact with such food contact materials.

Foil of celluloseregenerates

§ 13. Foil of celluloseregenerates, as referred to in section 4 (4). 2, no. The provisions of 1 and 2 shall be produced only by the substances or groups listed in Annex 3, and only on the conditions laid down therein.

Paragraph 2. Folier of celluloseregenerates referred to in section 4 (4). 2, no. 3, before surfactions are made exclusively from the substances or groups of substances listed in Annex 3, and only on the conditions laid down therein. The flat-end treatment for the in section 4 (4). 2, no. The following shall be made exclusively by the substances or groups referred to in the Annexes to Regulation (EC) No 1. 10/2011 on plastic materials and articles intended for contact with food, and only on the conditions laid down in accordance with Article 6 of Regulation (EU) No 2. 10/2011 on plastic materials and articles intended for contact with food.

Paragraph 3. Notwithstanding paragraph 1 1 and 2 other substances or groups of substances may be used as colourants or bonuses where these substances do not provide for the contamination of foodstuffs.

Paragraph 4. Food contact materials produced from cellular generates referred to in Article 4 (4). 2, no. 3, shall be in accordance with the rules of plastic, cf. Regulation (EC) No, 10/2011 on plastic materials and articles intended for contact with food.

§ 14. The provisions of section 13 shall not apply to the synthetic intestines of celluloseregenerates.

§ 15. Insurfaces of cellular generates shall not be allowed in contact with food.

Ceramic and enailed items, and glazed

§ 16. Ceramic and embed objects and glamour shall not give more lead or cadmium in accordance with Annex 4, as specified in Annex 4. however, paragraph 1 2.

Paragraph 2. Where ceramic or packaged objects or glazed lead or cadmium in quantities exceeding the limits set out in Annex 4 but not more than 50 pctates, the batch may be legally sold if analyses of at least 3 other objects of : the same shape and dimensions and with the same decoration and glasurers show that the quantities of lead or cadmium from these objects do not exceed the limits set out in Annex 4, and none of these objects exceed those limits ; More than 50%.

Paragraph 3. Ceramic and embed articles and glamour shall comply with the basic rules for general and specific control of migration laid down in section 27 of this notice.

Active and Smarter Food Contact Materials

§ 17. in the case of active and intelligent food contact materials, Commission Regulation (EC) No 2 is applicable, 450/2009 of 29. May 2009 on active and intelligent materials and articles intended for contact with food.

Epoxextreivats

§ 18. In the case of epox extregerates, Commission Regulation (EC) No 147204 1895/2005 by 18. November 2005 on the limitation of the use of certain epox extregerates in materials and articles intended for contact with food.

Chapter 5

Special documentation and declaration requirements

§ 19. Food contact materials must be accompanied by conformity declarations in accordance with the requirements laid down in Annex 5. In addition, in accordance with request, the company manager must obtain appropriate background documentation, cf. Annex 5.

Paragraph 2. The requirement of paragraph 1. The first sentence of the first sentence shall be deemed to be fulfilled if the declarations of conformity are present on the producer or importers ' s website and the next links in the chain.

Paragraph 3. The food business contact materials shall be documented in accordance with Article 7 of Commission Regulation (EC) No 2023/2006 of 22. In December 2006, on good manufacturing practice for materials and articles intended for contact with food, that food contact materials have been manufactured in accordance with the same regulation, cf. incidentally, section 17, in Bekendtstatement no. 1151 of 12. December 2011 on the authorisation and registration of food businesses, etc.

Chapter 6

Migration Testing

Plastics

20. Testing for compliance with migration limits (specific and total migration) shall be carried out in accordance with the general provisions on migration in Appendix 6 and in the references of section 20 (4). 2-4 and section 21-26.

Paragraph 2. The one in paragraph 1. The test of compliance with the specific migration limits is not required if it is demonstrated that the specific migratory limits are not exceeded when the total migration limit established is complied with.

Paragraph 3. The one in paragraph 1. The test of compliance with the specific migration limits is not required if it is established that the specific migration limits are not exceeded when the residues of the material from the material is assumed to be filled with full migration of the residues. The item.

Paragraph 4. The one in paragraph 1. The test of compliance with the specific migration limits may be handled by determining the quantity of a substance in the finished material or the final item provided that there is a connection between the quantity in question and the value of : the specific migration of the substance either through appropriate tests or by the use of commonly known diffusion models ("mathematical models") based on scientific facts. In order to prove that a material or object is not in accordance with the rules, the computed migration value must be verified by test testing.

Paragraph 5. For certain phthalates (reference number 74640, 74880, 74560, 75100 and 75105), cf. Annex 8 is carried out to test compliance with the specific migration limits, notwithstanding the provisions of paragraph 1. 1 only in food simulators. However, testing of compliance with specific migration limits may be made in the food if the food has not already been in contact with the material or the object and has been pre-tested for phthalate content, and the quantity is not statistically statistical ; significant or greater than or equal to the limit of determination.

§ 21. Where methods of analysis are not developed that enable the migration of the relevant food to be determined, migration is determined by means of the food simulators corresponding to the food type concerned, cf. Annex 7.

Paragraph 2. Testing of the limits of migration to food simulators is carried out using migration tests, cf. Annex 7.

Paragraph 3. Election of the food simulator (s) shall be carried out according to the rules referred to in Annex 7.

§ 22. The simulators to be used for testing on the migration of constituents from food contact materials of plastics to given food / food groups are those referred to in Annex 7.

Paragraph 2. When the analysis results of a food simulant migration test are assessed, the relevant reduction factor may be used in some cases. The analysis result is converted prior to comparison with the migration limit by means of a reduction factor in order to compensate for greater capacity for the simulator than with the food, etc. The reduction factor is chosen for the individual groups ; food in accordance with the rules referred to in Annex 7.

-23. Testing of the limits of food migration to food is carried out under the most extreme conditions as regards duration and temperature likely to occur in practice, cf. the provisions of Annex 8.

§ 24. Where it is shown that the simulators for fatty foods cannot be used for technical reasons related to the method of analysis, a replacement fattest can be fixed according to the rules set out in Annex 9A.

§ 25. It is permissible to use the alternative tests in Annex 9B where a comparative analysis of a given material shows a result of the alternative tests higher than or equal to the result of the test with the simulators D1 (ethanol 50%) or D2 ; (vegetable oil), and the migration of the alternative test does not exceed the limits of migration, possibly after the use of the reduction factors in for the case of the reduction in the limits of the migration. the rules referred to in Annex 7.

SECTION 26. Once the migration analysis is carried out, the final analysis result shall be calculated in accordance with the provisions of Annex V of Regulation (EC) No 2. 10/2011 on plastic materials and articles intended for contact with food.

Ceramic and enailed items, and glazed

§ 27. Migration of lead and cadmium from ceramic or embed objects or objects of glass shall be determined in accordance with Annex 10.

Paragraph 2. When a ceramic object consists of a container with a lid of ceramics, the limit on lead and cadmium is not exceeded (measured in mg/dm 2 or mg/l) shall be the same as that applicable to the container alone.

Paragraph 3. The holder alone and the internal surface of the lid shall be tested separately and under the same conditions. The sum of the two sizes for free lead and / or cadmium shall be placed according to the conditions of the surface or volume of the container alone.

Chapter 7

Penalty and effective provisions

§ 28. Unless higher penalties have been inflited on the other legislation, the penalty shall be punished by the undertaking which is in breach of :

1) § § 7-8, § § 10-13, § § 15 -16, or § 19,

2) Article 3 (4), Paragraph 1 or paragraph 1. 3-6, Article 11 (1). The Regulation (EC) No 5, Article 15 or Article 17 of the Regulation of the European Parliament and of the Council 1935/2004 of 27. In October 2004 on materials and articles intended for contact with food and for the repeal of Directive 80 /590/EEC and 89 /109/EEC,

3) Articles 4 to 7 of Commission Regulation (EC) No, 2023/2006 on good manufacturing practice for materials and articles intended for contact with food ;

4) Articles 2 to 5 or 6 (2) ; 4 of Commission Regulation (EC) No, 1895/2005 by 18. November 2005 on the limitation of the use of certain epox extregerates in materials and articles intended for contact with food ;

5) Article 3 (1). Paragraph 1, Article 7 (1). Paragraph 2 or Article 12 of Commission Regulation (EC) No 2, 282/2008 of 27. in March 2008, on materials and objects of regained plastics intended for contact with foodstuffs and amending Regulation (EC) No 2. 2023/2006,

6) Articles 4 to 5, 9 to 13 or Article 14 of Commission Regulation (EC) No 2, 450/2009 of 29. May 2009 on active and intelligent materials and articles intended for contact with food or

7) Article 4-5, Article 6 (2) ; 3, Articles 8-9, Article 11 (13), 14 (1). Paragraph 1 or paragraph 1. Article 3 (3), 15 or 17 or 22 (3). The Commission Regulation (EC) No 1-4 (4). 10/2011 on plastic materials and articles intended for contact with food.

Paragraph 2. The sentence may rise to a maximum sentence for two years if it has been committed by the action or omission, by means of a premedication or gross negligence and, at the time of the infringement, the following :

1) injury to public health or induced danger ; or

2) obtained or intended to benefit from the economic advantage of the person concerned himself or others.

Paragraph 3. Companies can be imposed on companies, etc. (legal persons) punishable by the rules of the penal code 5. Chapter.

§ 29. The announcement shall enter into force on 1. July, 2013.

Paragraph 2. At the same time, notice No 579 of 1. June 2011 on food contact materials and circular no. 9612 of 16. December 2011 on control of food contact materials.

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Appendix 1

List of additives exclusively as surface biocides, which are intended to remain in the finished item, cf. § 11

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Appendix 2

Criteria to be applied to the determination of the content of vinyl chloride in food contact materials and for the determination of vinyl chloride given by food contact materials

1) Determination of the content of vinyl chloride in food contact materials and the determination of the amount of vinyl chloride to food from food contact materials is carried out by ' gas chromatography ' using the 'head space' method.

2) The detection limit for the determination of the quantity of vinyl chloride to food from food contact materials is 0,01 mg/kg.

3) The determination of the origin of the vinyl chloride to food from food contact materials is carried out in principle on the food supply. If the determination of certain foods proves to be technically impossible, Member States may authorise these special foods to permit the use of simulators.

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Appendix 3

List of substances which may be used in the manufacture of cellular generals

Description of phooil of celluloseregenerates

Foil of celluloseregenerates is a thin film produced by unrefined cellulose of non-recyced wood or cotton. For technological purposes, suitable substances may be added to the mass or to the surface. Folier of celluloseregenerates may be coated on either side or both sides.

List of substances which may be used in the manufacture of cellular generals

-WHAT? The percentages of this Annex, the first and second part of this Annex shall be expressed in weight / weight (w/w) and shall be calculated in relation to the quantity of non-water-free surface-treated foil of celluloseregenerates ;

-WHAT? the general technical terms are given in sharp parentheses ;

-WHAT? the substances used must be of good technical quality in the case of purity criteria,

Section A

Non-surface treated phosphates of celluloseregenerates

Section B

Surface treated foil of celluloseregenerates

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Appendix 4

Limits for lead and cadmium from ceramic and embed objects and glazed

1) When a subject is fitted with a lid, the container alone and the internal surface of the lid must be analysed separately. The sum of the quantities of lead or cadmium (mg) of the quantities of lead or cadmium (mg) shall be related to the volume of the reposition (1) (however the surface dm2 for Kat. I).

2) Krus and similar objects to drink of must comply both with the requirements of Kat. In favour of devotion from the monk and the requirements to Kat. II.

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Appendix 5

Requirements for the documentation of establishments which bring food contact materials into trade

The requirement for documentation applies to all food contact materials placed in the trade in the past than the retail stage. Oh, look at this. 4 on ceramics.

1) Pload

When food contact materials, including half-manufactured products, of plastic are placed in the trade in the previous indent than the retail stage, shall be accompanied by a declaration of conformity, cf. Article 15 of Regulation (EU) 10/2011 on plastic materials and articles intended for contact with food.

The operator shall also provide relevant background documentation on request that the materials and the items and substances intended for the manufacture of such food contact materials comply with the requirements of Regulation (EU) 10/2011 on plastic materials and articles intended for contact with food, cf. Article 16 of the regulation. This background documentation shall be made available to the competent authority.

2) Recrested Plastic

Complementary requirements for the declaration of conformity are laid down in Article 12 of the Commission Regulation (EC) No 282/2008 of 27. in March 2008, on materials and objects of regained plastics intended for contact with foodstuffs and amending Regulation (EC) No 2. 2023/2006.

3) Active and intelligent food contact materials

Requirements for the declaration of conformity and background documentation shall be laid down in Article 12 and Article 13 of the Commission Regulation No 2 ; 450/2009 of 29. May 2009 on active and intelligent materials and articles intended for contact with food.

4) Ceramics

In the case of ceramics which have not yet been brought into contact with food, they shall be accompanied by a written declaration in accordance with Article 16 of the Regulation (EC) No 2 of the European Parliament and of the Council (EC) No 147s. 1935/2004. The written declaration shall make it easier to identify the goods for which it is issued and shall be renewed when significant changes in production cause changes in the release of lead and cadmium. The declaration shall be issued by the manufacturer or by a negotiator established within the Community. The written declaration shall contain the following information :

a) The name and address of the company who manufactures the finished ceramic object and on the importer who imports it into the Community.

b) Identity of the Resurstate

c) Date of declaration

d) Confirmation of the ceramics subject to the relevant requirements of this notice and in Regulation No 1935/2004.

Manufacturers and importers of ceramic objects shall also provide appropriate background evidence to ensure that ceramic objects comply with the limits of lead and cadmium, and make it available to the inspection authorities. This documentation must contain the results of the analyses carried out, the test conditions and the name and address of the laboratory carried out by the laboratory.

5) Other food contact materials including half-manufactured products

Where other food contact materials other than those referred to in 1) to (4) are brought into the trade in the earlier indent than the retail level, they shall also be accompanied by a declaration of conformity. The declaration of conformity must make it easy to identify the food contact materials or substances for which it is issued and must substantiate the rules in force. The declaration of conformity is renewed when significant changes in production cause changes to migration, or when new scientific data are available.

In the case of these food contact materials, the operator shall also provide the appropriate background documentation, as requested, that food contact materials and the substances / semi-manufactured products intended for the manufacture of such products meet the requirements ; in this notice and shall make it available to the inspection authorities. This documentation may contain test conditions and test results, calculations, other information, and evidence of the safety or information shown to show that the requirements are met.

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Appendix 6

Inline on the test of total and specific migration from plastics

1) Migrationstests for the determination of total and specific migration shall be carried out by using one or more of the 'food simulators' referred to in Annex 7 and under the ' conventional migration conditions specified in Annex 8.

2) Replace fats shall be carried out where the migration test is used with the use of the fatty food simulators (cf. Annex 7) cannot be implemented for technical reasons which have the analytical method to do. For the replacement fat test medium (s) of test medium (s) under the " conventional migration conditions for the replacement fat ` ' shall be used (see Annex 9A).

3) Alternative tests (see Annex 9B) are allowed instead of migratory tests with fatty food simulators when the conditions set out in Annex 9B have been met.

In all three cases, it is permissible to :

-WHAT? to reduce the number of tests to be carried out, to the number which, in the specific case in general, is considered to be the strictest on the basis of scientific experience and / or,

-WHAT? exclude migration or replacement fats or alternative tests where there is evidence of clear evidence that the migration limit cannot be exceeded under conditions of use which are predictable to the material or the object.

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Appendix 7

Food simulators

A. Food product types and simulators to be used

If migration limits have been exceeded in the use of one of these non-fatty foods simulators, a confirmation of the result of the use of olive oil is mandatory if it is technically feasible for the purpose of the assessment of : non-compliance with the provisions. If this confirmation is not technically feasible and exceeds the amount of the material or the migration limits, the migration limits shall be deemed to be applicable to the notice of breach of food contact materials at all times.

Since it is not always possible to use food to test materials that come into contact with food, it introduces food simulators. These classification shall be classified as having a character of one or more food types. The food product types and the food simulators to be used are listed in Table 1. In practice, it is possible to apply different mixing types of food, such as obesity and water-containing foods. These are described below, together with an indication of the food simulators, which shall be selected when implementing the relevant migration tests.

* the simulators referred to in this table are the simulators provided for in Directive 87 /711/EEC. The Simulators of Regulation 10/2011 on plastics are different from these.

B. Choice of Food Sims

1. Food contact materials intended to come into contact with all kinds of foodstuffs ;

The test of these materials shall be carried out using the food simulators referred to above, considered to be the strictest under the test conditions specified in Annex 8, taking a new sample of each simulation of samples for each simulator, the plastic material or the object.

If migration limits have been exceeded in the use of any of these non-fatty foods simulators, a confirmation of the result of the use of olive oil is compulsory if it is technically feasible for the purpose of the assessment of : non-compliance with the provisions. If this verification is not technically feasible and exceeds the amount of the material or the migration limits, the migration limits shall be deemed to be applicable to the food contact materials at any time for contact with food ; violated.

2. Food contact materials intended to come into contact with specific types of foodstuffs

This case only relates to the following situations when :

a) the food contact material is already in contact with a known food product,

b) the food contact material is accompanied by a specific indication of the food type described in Part A, Table 1 of this Annex, or may not be used in conjunction with, e.g. 'Only for irrigating foods' according to the rules of labelling in any time applicable to food-contact materials ;

c) the material or object shall be accompanied by a specific indication as to which of the foodstuffs or groups of foodstuffs referred to in Part C of this Annex, may or may not be used in accordance with the rules on labelling, in the case of labelling, at any time ; the notification of food contact materials.

This indication shall be expressed :

1) in the retail stage, by means of a declaration that only a few foods or food groups, preferably with easily understood examples,

2) in other sales outlets other than the retail stage, by means of the "reference number" or the description of the food used in Part C of this Annex.

In such situations, tests must be carried out so that in cases b) the use of the food simulators or the food simulators specified in Table 2 of this Annex must be used. In cases a (a) and (c), the food simulators referred to in Part C of this Annex are used. Where the food or group / group (s) of foodstuffs is not included on the specified list in paragraph 3 of Annex III of Commission Regulation (EU) No 2. 10/2011 on plastic materials and articles intended for contact with foodstuffs referred to in Part C of this Annex, the contact food from Table 2 which comes closest to the food or food or group of foodstuffs to be examined.

If the food contact material is intended to come into contact with more than one food or with groups of food with different reduction factors, the reduction factor of each foodstuff must be applied to the test results. If one or more results of such calculation exceed the limit, the material is not suitable for the food or food concerned of the food concerned.

The tests must be carried out under the test conditions set out in Annex 8, using a new test subject for each simulator.

* the simulators referred to in this table are the simulators provided for in Directive 87 /711/EEC. The Simulators of Regulation 10/2011 on plastics are different from these.

C. Specific food simulation food simulators for the purpose of migrating food contact materials which have not yet been in contact with foodstuffs

The food simulators to be used for the control of the migration of constituents from food contact materials of plastics intended to come into contact with a specific foodstuff or with specific groups of food are set out in section 3 of Annex III to Commission Regulation (EC) No, 10/2011 on plastic materials and articles intended for contact with food.

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Appendix 8

Migrationtest for total and specific migration : test conditions, duration and temperature

' Conventional test conditions `

The test tests shall be carried out by the fact that, among the times specified in Table 1 and temperatures, the conditions which are best matched to the food contact materials examined by plastic most stringent conditions for contact and any possible conditions of contact were chosen ; specified information about the temperature of the highest appliance. If the food contact material of the plastic is intended to come into contact with a foodstuff, which consists of two or more time / temperature combinations in the table, migration will be determined by the material or genre of the material ; be subjected to all the most stringent predictable conditions that match the sample using the same batch of food simulators. In cases where an object has been calculated repeatedly to come into contact with food, the test test must be carried out three times on one and the same test in accordance with the conditions laid down in Annexes 7, 8, 9A and 9B, as each time, a new batch of food or food simulator is used. The assessment of compliance with the migration limits shall be made on the basis of the migration of the migration in the third test. If the migration limits have not been exceeded in the first test, and it has been proven further, that migration is not increased by the second and third tests, it is not necessary to carry out further tests.

1. Test conditions, which are generally regarded as stricter

The determination of migration should be restricted to the test conditions which, in the case in question, are considered to be the strictest on the basis of scientific evidence. The following gives some concrete examples of test conditions.

1.1. Touch of food products during any time and temperature condition

Where no marking or instructions indicate limitations in connection with the contact temperature and the duration expected during use, all the after-food type, simulator (s) A and / or B and / or C for four hours at 100 ; o C, and / or D2 simulation (D2) in two hours at 175 o These times and temperatures conditions are considered to be the strictest.

1.2. Intoxication of foodstuffs at room temperature, or even in a non-specified period of time

Where food contact materials are labelled at room temperature or below, or where food contact materials are clearly intended for use at room temperature or thereunder, the test is carried out at 40 o C for 10 days. These times and temperatures conditions are considered to be most stringent in the strictest terms.

2. Migration of volatile substances

When tested for specific migration of volatile substances, the test must be carried out with simulators in a way that detects the loss of volatile substances which may take place under the worst predictable conditions of use.

3. Test conditions, special cases

3.1. Microwave oven

In the case of food contact materials intended for use in microwave ovens, the test of migration may be carried out either in a conventional oven or microwave, provided that appropriate time and temperature conditions are selected from Table 1.

3.2. Physical changes in testing

Where it is established that the use of the test conditions in Table 1 means that the test subject shall be subject to physical or other changes which do not take place under normal or foreseeable conditions for this material or the object shall be : the test of migration shall be carried out under the worst foreseeable conditions of use, where these physical or other changes do not take place.

3.3. "Hot fill"

If the plastic material or object of its practical application may be applied for a period of less than 15 minutes at temperatures between 70 o C and 100 o C (e.g. "hot fill"), and this is indicated by appropriate marking or instruction, shall be implemented as an exception to the conditions specified in Table 1, for two hours at 70 ; o C. If the food contact material is also intended for storage at room temperature, the test above is replaced by a test at 40 o C for 10 days, which are conventional, to be more stringent.

3.4. Trap outside Table 1

In cases in which the conventional conditions of migration are not adequately covered by the test conditions in Table 1 (e.g. contact temperature of more than 175, o C or duration of contact in less than five minutes) may be used other contact conditions, which are better suited to the relevant cases, provided that the conditions under which they are selected may represent the worst predictable conditions of contact for the parties concerned ; plastic materials or articles.

3.5. Testing of thin plastic material

In the case of test of thin films, note that, in the case of the test for practical reasons, the test material in the simulator must be calculated in the calculation of migration only for the surface area of one page for the calculation of migration ; less it can be proven that migration from both sides at the time of impact is significantly greater than the migration determined by test of the single surface for them (individual testing).

1) This temperature is used only for the simulators D1 or D2. For the simulators A, B or C, the test may be replaced by a test at 100o C or at a time of four times the amount of time chosen by the general rules in this Annex.

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Appendix 9

Fedttests for total and specific migration

A. Replacing grease for total and specific migration

1. Master Rule

If the use of the non-fat food simulators cannot be implemented for technical reasons related to the method of analysis, all of the test media prescribed in Table 1 under test conditions corresponding to the test conditions are used instead of the test medium to be used in Table 1 for the simulators D1 or D2.

Table 1 contains some examples of the most important conventional test conditions and their equivalent conventional conditions for substitutes. For other test conditions which are not set out in Table 1, these samples are taken into account with the existing experience of the type of polymer in question.

For each test, a new test subject is used. For each test medium, the same rules have been applied in respect of the rules referred to in Annex 7 and Annex 8 for the simulators D1 or D2. In order to ensure compliance with all migration limits, the highest value obtained during the use of the test media is selected.

Where it is established that the implementation of these tests shall be carried out to the effect that the test subject shall be subject to physical changes or other amendments which do not take place under the worst foreseeable conditions for the use of this material or of this Directive ; the object of contact with the current food is discarded from this sample medium, and the highest of the remaining values shall be chosen.

2. Exception

By way of derogation from the general rule, it will be possible to exclude one or two of the replacement fatty tests provided in Table 1 if these tests on a scientific basis can generally be considered unfit for the sample in question.

1) MPPO = Modified polyphenylene oxide.

2) The volatile test media are used up to a maximum temperature of 60o C. A precondition for the use of replacement tests is that the material or object may withstand the test conditions which would otherwise be used with the simulators D1 or D2. A test subject shall be reduced in olive oil under appropriate conditions. Where physical properties change (e.g. melting, deformation), the material shall be considered unfit for use at the temperature concerned. The physical properties of the change shall not be continued with replacement tests using new test subjects.

B. Alternative fatty tests for total and specific migration

1. Master Rule

It is permissible to use the result of an alternative test as specified in this Annex, provided that the following conditions are both met :

a) the results obtained in a comparative test on the same material show that the value is equal to or greater than the one obtained in the test with the simulators D1 or D2 ;

b) Migration at the alternative test does not exceed the migration limits, if necessary. in the case of the reduction factors laid down in respect of the rules referred to in Annex 7.

If one or both conditions are not met, normal migration analyses must be carried out.

2. Exception

By way of derogation from the above condition under Title 1 (a), it is possible to exclude comparative testing if other conclu-critical evidence is available, based on scientific test results in order to achieve the values obtained in it ; alternative tests shall be equal to or greater than those obtained in the migration test.

3. Alternative tests with fleeting media

In these tests, volatile media, such as isooctane or 95% ethanol, or other volatile solvents or mixtures of solvents are used. Tests must be carried out at such test conditions that the conditions set out in section B. 1.a are met.

4. "Extraction tests"

Other tests, which under very strict test conditions use the media with very large extractions, may be used if, on the basis of scientific data, it is generally recognized that the results obtained during the use of these tests are carried out ; (The extracthests) shall be equal to or greater than those obtained in the test with the simulators D1 or D2.

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Appendix 10

Ceramics, eminated objects and glazed

A. Basic rules for the determination of lead-and cadmium pantograph

1. Test conditions, etc.

Sample liquid : 4% vol / vol (v/v) acetic acid in fresh-made dissolution. The extract shall be carried out at a temperature of 22 ± 2 ° C and extends over 24 ± 0,5 hours.

The object is covered so that it is ensured that its surface is in total darkness. However, this is not necessary if only the leaflet is to be determined.

2. Test preparations

2.1. Renditions which cannot be filled

First, the part of the surface of the resurrection is not intended to come into contact with food, with a suitable protective layer, which is resistant to a 4% (v/v) acetic acid solution. Then the object of the immersion in a container with a known quantity of acetic acid solution so that the surface that is intended to come into contact with food is completely covered by the sample.

2.2. Reconditions to fill

The object shall be filled with 4% (v/v) acetic acid solution (not more than 1 mm from the spill point). However, if the object is flat or weak, the object is filled so that the distance between the surface of the liquid and the overflow point of the liquid is 6 mm measured along the slope rand.

2.3 The distances to be tested for rendering from "cheerful and"

The object is submersive in a canister 4%. (v/v) acetic acid solution in such a way that a 2 cm wide gum along the top edge of the recorder is covered by the sample. Parts of the item not to be extracted but, as a result of the shape of the genus, is covered by the sample, shall be covered as described in 2.1.

Determination of the surface of items of category I, cf. Annex 4 on ceramic and embed objects and glazed goods.

The surface of articles which cannot be completed (category I, item 1 of Annex 4) shall be calculated as the total drop-down surface which may come into contact with food and is not covered in accordance with. point 2.1, since no account shall be taken of any gaps in the object.

The surface of objects in category I (2) shall be calculated as the area of the surface of the fluids as described in section 2.1.

The surface of items in category I (3) shall be calculated as the surface of a 2 cm wide seat along the upper edge of the artefact on both the Indian and the outer side, the so-called 'mondrand'.

B. Analytical method for determining lead and cadmium pantograph

1. Principle

The specific submission of lead and cadmium from objects shall be determined by reference to 4% acetic acid for 24 hours at 22 ° C. Determination of the release of lead and / or cadmium is done by means of a Instrument Method of Analytic Method.

The quantities of lead and cadmium which have been supplied shall be related to the surface or volume of the reposition.

2. Reagents

All reagents must be of analytical quality, unless the specifications set out in this Annex are set out in this Annex.

When water is mentioned below, it is used to mean distilled water or water of equivalent quality.

2.1. 4% (v/v) acetic acid in aqueous solution

A 1000 ml flask full of water is added to 40 ml iseddike and make up to 1000 ml of water. This solution must be produced on the day of commencement of the extraction.

2.2. Standard solutions

Preparation of standard solutions containing 1000 mg/l of lead and at least 500 mg/l of cadmium in 4% acetic acid (2.1.). ).

3. Requirement for instrumental analysis method

3.1. The limit value for the detection of lead and cadmium shall not be more than :

0.1 mg/l for lead ;

0.01 mg/l for cadmium

The limit value for detection shall be determined as the concentration of the element in 4% acetic acid, cf. point 3.1, which gives a signal equal to the self-noise of the appliance.

3.2. The limit of lead and cadmium limit shall not exceed :

0.2 mg/l for lead ;

0.02 mg/l for cadmium

3.3. Recovery

The recovery of lead and cadmium added to the 4% acetic acid, cf. section 3.1, must be within 80 to 120% of the quantity added.

3.4. Specificity

The instrumental analysis method used must be free of matrix or spectral interference.

4. Procedusitional procedure

4.1. Preparation of the item for extraction

The object must be pure and free of fat or other substances which may influence the analysis. The object shall be washed with a solution containing a liquid detergent for household use at a temperature of approximately 20 000. 40 ° C, then rinsed with ordinary water and then distilled water (or water of equivalent quality). The object is then dripping and dried so as to avoid any contamination of any kind. The test surface must not be affected after it has been cleaned.

4.2. Determination of lead or cadmium

The item is extracted, as described in section A of this Annex. Before taking a sample from the extract for the determination of lead or cadmium, it must be ensured by ensuring that this is homogeneous without any of the extract being lost and unscrape occurs from the face of the face of the resurrection. For each series, a blank test is carried out at the test used.

Bly and / or cadmium are determined under appropriate test conditions.

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Appendix 11

List of Annexes

1) The commuting shall include provisions implementing the following Directives : Council Directive 84 /500/EEC of 15. October 1984 on the approximation of the laws of the Member States relating to ceramic objects intended to come into contact with foodstuffs, the Official Journal of the European Communities, in 277, p. 12, as last amended by Commission Directive 2005 /31/EC of 29. April 2005, EU Official Journal, L 110, p. 36. Commission Directive 2007 /42/EC of 29. June 2007 on materials and articles of phosphates of celluloseregenerates destined for contact with food, EU Official Journal, L 172, p. 71. Council Directive 82 /711/EEC of 18. October 1982 concerning the necessary ground rules for the control of the transfer of constituents from plastic materials and articles intended to come into contact with foodstuffs, the Official Journal of the Official Journal of the Community, L 297, p. 26, as amended by Commission Directive 93 /8/EEC of 15. In March 1993, EC-begging 1993, L 90, p. 22 and Commission Directive 97 /48/EC of 29. July 1997, EC Journal 1997, L 222, p. 10. Council Directive 85 /572/EEC of 19. December 1985 laying down the list of simulators to be used for the control of the migration of constituents from plastic materials and articles intended to come into contact with foodstuffs, 1985, 1985, L 372, p. Amendment No 14, as amended by Commission Regulation (EU) No. 10/2011, EU Official Journal 2011, L 12, p. 1. Council Directive 78 /142/EEC of 30. January 1978 on the approximation of the laws of the Member States relating to materials and articles containing the monomert vinyl chloride and intended to come into contact with the Community Official Journal of 1978, L 44, p. 15. In the notice, certain provisions of the Commission Regulation (EC) No 7 (EU) are included. 10/2011 of 14. January, 2011, on plastic materials and objects intended for contact with food, EU Official Journal 2011, L 12, p. 1. According to Article 288 of the EDF Treaty, a Regulation shall apply immediately in each Member State. The rendition of these provisions in the notice is therefore based solely on practical considerations and is without prejudice to the immediate validity of the regulation in Denmark.