Source: https://www.global-regulation.com/translation/denmark/609890/order-on-materials-and-articles-intended-for-food-contact.html
Timestamp: 2019-04-24 16:43:41+00:00

Document:
§ 1. This Order shall apply to materials and articles intended for contact with food which are covered by European Parliament and Council Regulation (EC) no. 1935/2004 of 27 October 2004 on materials and articles intended for contact with food and repealing Directive 80/590 / EEC and 89/109 / EEC.
PCS. 2. The notice shall also apply to foods in processing and sales are or have been in contact with materials and articles.
§ 2. In addition to the definitions in §§ 3-8, the definitions in the European Parliament and Council Regulation (EC) no. 1935/2004 of 27 October 2004 on materials and articles intended for contact with food and repealing Directive 80/590 / EEC and 89/109 / EEC apply.
§ 3. The regenerated cellulose film purposes of this Order a thin film made from refined cellulose non-recycled wood or cotton. For technical requirements, suitable substances may be added mass or surface. Regenerated cellulose film may be coated (coated) on one or both sides.
3) coated regenerated cellulose film where the coating consisting of plastics.
§ 4. The plastic purposes of this Order the organic macromolecular compounds obtained by polymerization, polycondensation, polyaddition or any other similar process from molecules with a lower molecular weight or by chemical alteration of natural macromolecules. In certain macromolecular compounds other substances or materials.
d) mixtures of the points a and b above with plastics.
§ 5. The multi-layer plastic materials and articles referred to in this publication the plastic material or article, consisting of two or more layers, each of which is composed exclusively of plastic, and which is connected by means of adhesives or by other means.
§ 6. For plastic functional barrier purposes of this Order a barrier consisting of one or more layers of plastics which ensures that the finished material or article complies with applicable law.
§ 7. For ceramic articles purposes of this Order articles manufactured from a mixture of inorganic materials with a generally high content of clay or siliceous minerals may be added small quantities of organic substances. These articles are first formed and the resulting shape is then permanently fixed by firing. They can be glazed, enamelled and / or decorated.
§ 9. The materials and articles intended to come into contact with food shall not be placed, where they constitute, or are liable to constitute a hazard to human health. In determining whether a material or object is harmful and dangerous, Article 14 of the European Parliament and Council Regulation (EC) no. 178/2002 on general principles and requirements of food law and establishing the European Food Safety Authority (EFSA) and the procedures relating to food safety, apply.
§ 10. If a company director, producer or importer of materials and articles intended for contact with food operator considers or has reason to believe that materials and articles intended for contact with food, the company has produced, imported or distributed does not conform to food safety, and they are no longer controlled by the operator, manufacturer or importer must take measures to withdraw those materials and articles from the market.
PCS. 2. The operator, manufacturer or importer shall immediately inform the Food Agency in this respect.
PCS. 3. If materials and articles intended for food contact is reached consumers must operator, manufacturer or importer effectively and accurately inform them of the reason for its withdrawal, and if necessary, recall from consumers who are already in possession of it.
PCS. 2. Furthermore, the provisions relating to plastic also apply to materials and articles cellulose see. § 3, paragraph. 2, # 3.
PCS. 3. Subject to § 11 paragraph. 1, no. 3, the notice shall not apply to the materials and articles composed of two or more layers, of which at least one consists of other than plastic, even if the layer comes into contact with the food product consists of plastic.
§ 12. Materials and articles of plastics may be produced only from the monomers and other starting substances listed in Annex 2, Section A and exclusively mentioned therein restrictions and / or specifications. The monomers and other starting substances listed in Annex 2, Section B, could be used legally until 31 December 2004.
PCS. 2. Of the products produced by bacterial fermentation, only the substances listed in Annex 5 shall apply where the products are intended to come into contact with food.
PCS. 3. In Annex 6 sets out in Section A general specifications for plastic materials and articles. Specifications for certain individual substances in Annex 2 and Annex 4-5 down in Section B.
PCS. 4. Plastic Goods of polyvinyl chloride (PVC) may not contain more than 1 mg vinyl chloride monomer per. kg of plastic goods.
PCS. 5. Food may not be sold if they contain more than 0.01 mg vinyl chloride monomers per. kg food.
PCS. 6. It is forbidden to use the substance azodicarbonamide with reference number 36640 (CAS no. 000123-77-3) in the manufacture of materials and objects.
§ 13. Materials and articles of plastics must not transfer their constituents to food in quantities which in total exceed 10 mg / dm (total migration).
3) caps, gaskets, stoppers and similar sealing.
2) film or other materials and items that can not be filled or for which it is impracticable to estimate the relationship between the material and the surface area and the quantity of food in contact therewith.
§ 15. For plastic materials and articles intended to come into contact with food, or already in contact with food for infants and young children, as defined in Commission Directive 91/321 / EEC and 96/5 / EC, the total migration level is always 60 mg / kg.
PCS. 2. For plastic materials and articles intended to come into contact with food, or already in contact with food for infants and young children as defined in paragraph. 1 expressed the specific migration limit shall always be applied as mg / kg.
§ 16. Plastic materials and articles shall not release primary aromatic amines in a detectable quantity (DL = 0.01 mg / kg of food or food simulant).
PCS. 2. The migration of the primary aromatic amines appearing in the lists in Annexes 2 and 4 are not subject to this restriction.
§ 17. Appendix 4 contains a Community list of additives which may be used in the manufacture of plastic materials and articles with the restrictions and / or specifications.
PCS. 2. additives which are not included in the Community list of additives may until 31 December 2009 continue to be used in accordance with national legislation.
PCS. 3. From 1 January 2010, only additives included in the Community list of additives used in the manufacture of plastic materials and articles (positive list).
1) quantities having a technological function in the final food.
2) For foods in quantities exceeding the limits for food additives laid down in Directive 89/107 / EEC or for flavorings laid down in Directive 88/388 / EEC and Regulation 2065/2003 or in Annex 4 of this Order, whichever is lower limit applies.
PCS. 2. When the substances referred to in paragraph. 1 pt. 1 are used as active components of active materials and articles in contact with food, they may, notwithstanding paragraph. 1, be subject to national provisions pending the adoption of the Community.
§ 19. By the use of additives for the manufacture of plastic layers or plastic coatings in lids referred to. The definition in § 11 paragraph. 1, no. 3, applies in Annex 4 restrictions and / or specifications.
PCS. 2. additives which are not listed in Annex 4 may be used pending a re-assessment of the Authority, if national legislation.
§ 20. By the use of additives exclusively acting as polymerisation (hereinafter referred PPA) and are not intended to remain in the finished article, for the manufacture of plastmaterialer- and objects subject to the restrictions and / or specifications listed in Annex 4.
PCS. 2. PPAs not listed in Annex 4 can be used up, there is a renewed assessment of the Authority, if national legislation.
§ 21. By the use of additives exclusively acting as overfladebiocider, and intended to remain in the finished material or the finished article, the restrictions and / or specifications listed in Annex 3.
§ 22. A provisional list of additives that are under evaluation by the Authority, published by the Commission and kept updated.
PCS. Second Notwithstanding Article 4. 1, third paragraph of Commission Directive 2002/72 / EC, additives not included in the Community list referred to in Article 4 continue to be used in accordance with national law after 1 January 2010, so long as they are included in the provisional list.
§ 23. After 31 December 2006 Member States shall not authorize additives referred to in Annex 4, and which have never been assessed by the Scientific Committee on Food or the Authority.
§ 24. There may always be added to a new additive to the list of substances referred to in Annex 4 when EFSA has carried out a risk assessment of the substance.
§ 25. Companies wishing to have an additive, which is already marketed in one or more Member States listed in Annex 4 shall submit data for the EFSA to carry out a risk assessment of the additive later d. 31 December 2006 | || PCS. 2. For the submission of the required information, the applicant must apply the "Guidelines of the European Food Safety Authority for the presentation of an application for safety assesment of a substance two benyttes in food contact materials prior two its an authorization".
PCS. 3. Application procedures should be in accordance with European Parliament and Council Regulation (EC) no. 1935/2004 of 27 October 2004 on materials and articles intended for contact with food and repealing Directive 80/590 / EEC and 89/109 / EEC.
PCS. 4. If EFSA during the processing of the information referred to in paragraph. 2, requests additional information, the additive may continue to be used subject to national law until the Authority has issued an opinion, provided that the information is submitted within the time limit set out by EFSA.
PCS. 5. The Commission shall not later than 31 December 2007 the provisional list of additives which may continue to be used after d. 31 December 2007 subject to national law until the Authority has evaluated them.
1) the additive must be permitted in one or more Member States per. 31 December 2006.
2) information about the additives must be submitted in accordance with the Authority requirements no later than d. 31 December 2006.
§ 26. The multilayer plastic material or article, the individual plastic layers comply with this Order.
b) the self-responsibility criteria are classified as carcinogenic, mutagenic or toxic for reproduction under Annex 6 of Council Directive 67/548 / EEC.
PCS. 3. The migration of the substances referred to in paragraph. 2, no. 2 into food or simulant shall not exceed 0.01 mg / kg, measured with statistical certainty by using the method of analysis in accordance with Article 11 of the European Parliament and Council Regulation (EC) no. 882/2004.
PCS. 4. This limit shall always be expressed as concentration in the food or the simulator. The limit applies to a group of compounds, if they are structurally and toxicologically related, in particular isomers or compounds with the same relevant functional group, and shall include possible contagion.
3) if during the examination of the information requests additional information and the information is not submitted within the time specified by the Authority.
§ 28. Regenerated cellulose film referred to in § 3, paragraph. 2, no. 1 and 2 may be produced only from the substances or groups of substances listed in Annex 1, and only under the conditions specified therein.
PCS. 2. The regenerated cellulose films referred to in § 3, paragraph. 2, no. 3, must, within surface produced exclusively of the substances or groups of substances listed in Annex 1, and only under the conditions specified therein. The coating of the in § 3, paragraph. 2, no. 3, the films must be produced only from the substances or groups of substances listed in Annex 2 and Annex 4-6 and only under the conditions specified therein.
PCS. 3. Notwithstanding paragraph. 1 and 2, other substances or groups of substances used as colourants or adhesives, provided that these substances do not give contagion to food.
PCS. 4. The materials and articles made of regenerated cellulose film referred to in § 3, paragraph. 2, no. 3, shall be in accordance with § 11 paragraph. 2.
§ 29. The provisions of § 28 shall not apply to synthetic casings of regenerated cellulose.
§ 30. Printed surfaces of regenerated cellulose film must not come into contact with food.
PCS. 2. Gives ceramic or enameled objects or glassware lead or cadmium in amounts that exceed the limits set out in Annex 7, but not by more than 50 per cent., The party can legally be sold if analyzes of at least 3 other items of same shape and dimension and with the same decoration and glazes shows that the quantities of delivered lead or cadmium from these articles do not exceed the limits specified in Annex 7, and none of those articles exceeding those limits by more than 50 per cent.
PCS. 2. In the case of plastic materials and articles provide the operator also request relevant evidence that the materials and articles and substances intended for the manufacturing of those materials and articles comply with the requirements of this Order, available to DVFA. This documentation shall contain the conditions and results of testing, calculations, other information and evidence on the safety or showing that the requirements are met.
PCS. 3. As far as manufacturers and importers of ceramic articles providing this also request relevant evidence that the ceramic articles comply with the migration limits for lead and cadmium, as set out in Annex 7 at the disposal of the DVFA. This documentation shall include the results of the analyzes conducted, test conditions and the name and address of the laboratory which carried out the test.
2) Article 1 of Commission Regulation (EC) no. 372 of 2 April 2007 laying down temporary limits for plasticisers in gaskets in lids intended to come into contact with food as amended by Commission Regulation (EC) no. 597 of 24 June 2008 .
3) Article 4-7 of Commission Regulation (EC) no. 2023/2006 on good manufacturing practice for materials and articles intended for contact with food.
4) §§ 9 and 10, § 12, § 13, § 15, § 16, § 17, 18, § 19, § 20, § 21, § 26 paragraph. 1-3, § 28 and §§ 30-32 of this Order.
5) Article 2, Article 3, Article 4, Article 5 and Article 6. 4 of Commission Regulation (EC) no. 1895 of 18 November 2005 on the restriction of use of certain epoxy derivatives in materials and articles intended for contact with food.
6) Article 3, paragraph. 1, Article 7. 1 and 2 and Article 12 of Commission Regulation (EC) no. 282/2008 of 27 March 2008 on materials and articles made of recycled plastics intended for contact with foods and amending Regulation (EC) no. 2023/2006.
7) Article 4, Article 5, Article 7, Article 9, Article 10, Article 11, Article 12, Article 13 and Article 14. 5 of Commission Regulation (EC) no. 450/2009 of 29 May 2009 on active and intelligent materials and articles intended for contact with food.
8) Article 1 of Commission Regulation (EC) no. 975/2009 of 19 October 2009 amending Directive 2002/72 / EC relating to plastic materials and articles intended to come into contact with foodstuffs.
§ 34. This Order shall enter into force on 18 November 2009.
PCS. 2. From 7 March 2009 allowed trade in and use of plastic materials and articles intended for contact with food if they are in accordance with this notice rules on plastic.
PCS. 3. From 7 March 2010 prohibited the manufacture and import into the Community of plastic materials and articles intended for contact with food if they are not in accordance with this notice rules on plastic.
PCS. 4. From June 18, 2010 allowed trade in and use of biocides in materials and articles intended for contact with food if they are in accordance with this notice rules on biocides.
PCS. 5. At the same time, Executive Order no. 167 of 3 March 2009 on materials and articles intended for contact with food.
Regenerated cellulose film is a thin film made from refined cellulose non-recycled wood or cotton. To meet technical requirements, suitable substances may be added mass or surface. Regenerated cellulose film may be coated (coated) on one or both sides.
Only for films intended to be coated and then used for non-moist foods, ie which do not contain natural free water on the surface. The total amount of bis (2-hydroxyethyl) ether and ethanediol present in foodstuffs that have been in contact with film of this type may not exceed 30 mg / kg of food.
Average molecular weight between 250 and 1200.
Average Molecular weight less than or equal to 400 and with a content of 1,3-propanediol is less than or equal to 1% (w / w).
Total amount less than or equal to 1% (w / w).
Quantity of the substance or group of substances in each indent may not exceed 2 mg / dm2 of the uncoated film.
Average molecular weight between 1200 and 4000.
The total quantity of substances may not exceed 1 mg / dm2 of the uncoated film and the quantity of the substance or group of substances in each indent may not exceed 0.2 mg / dm2 (or a lower limit where one is specified) of the uncoated film.
Less than or equal to 0.05 mg / dm2 of the uncoated film.
Less than or equal to 0.1 mg / dm2 of the uncoated film.
The total quantity of substances (termohærdere) must not exceed 1 mg / dm2 of the uncoated film.
Free formaldehyde content lower than or equal to 0.5 mg / dm2 of the uncoated film Free melamine content less than or equal to 0.3 mg / dm2 of the uncoated film.
Free formaldehyde content lower than or equal to 0.5 mg / dm2 of the uncoated film.
Free melamine content less than or equal to 0.3 mg / dm2 of the uncoated film.
Less than or equal to 0.75 mg / dm2 of the uncoated film.
The total quantity of substances may not exceed 0.01 mg / dm2 of the uncoated film.
The total quantity of substances may not exceed 50 mg / dm2 of the coating on the side in contact with food.
Less than or equal to 20 mg / dm 2 of the coating on the side that is in contact with the food; nitrogen content must be between 10.8% (w / w) and 12.2% (w / w) in cellulosenitraten.
The total quantity of substances may not exceed 12.5 mg / dm2 of the coating on the side in contact with foodstuffs and solely for the preparation of regenerated cellulose films coated with coatings based on cellulose nitrate.
The total quantity of substances may not exceed 6 mg / dm2 of the coating on the side in contact with food.
Less than or equal to 4.0 mg / dm 2 of the coating on the side that is in contact with the food.
The amount of 2-ethylhexyl diphenyl phosphate shall not exceed: a) 2.4 mg / kg of the food, which is in contact with the film of this type, or b) 0.4 mg / dm 2 of the coating on the side which is in contact with food.
The total quantity of substances may not exceed 6 mg / dm2 of the uncoated film of cellulose nuisance rates, including the coating on the side in contact with food.
quantity of the substance or group of substances may not exceed 2 mg / dm2 (or a lower limit where one is specified) on the side in contact with food.
Less than or equal to 1 mg / dm 2 of the coating on the side that is in contact with the food.
Less than or equal to 0.2 mg / dm 2 of the coating on the side that is in contact with the food.
Less than or equal to 0.06 mg / dm 2 of the coating on the side that is in contact with the food.
The total quantity of substances may not exceed 0,6 mg / dm2 of the coating on the side in contact with food.
A) surface coatings obtained from resinous and polymer in liquid, powder or base form, such as varnishes, lacquers, paints, etc.
a) substances of which by polymerisation, including polycondensation, polyaddition or any other similar process, to manufacture macromolecules.
b) natural or synthetic macromolecular substances used in the manufacture of modified macromolecules, if the monomers or other starting substances required to synthesise them are not included in the lists.
c) substances which are used to modify the existing natural or synthetic macromolecular substances.
a) aluminum, ammonium, calcium, iron, magnesium, potassium and sodium salts (including double salts and acid salts) of the authorized acids, phenols and alcohols. The terms'. . . acid (s), salts' appear in the list if it (they) free acid (s) are not mentioned.
ii) substances referred to in note 38 Annex 2 "
c) mixtures of the authorized substances. Materials and articles containing the substances in point 3a, 3b and 3c, must meet the requirements of Article 3 of the European Parliament and Council Regulation (EC) no. 1935/2004.
4) The substances used shall be of good technical quality.
(4) Column 4 (RESTRICTIONS AND / OR SPECIFICATIONS). It can be: a) the specific migration limit (SML), b) the maximum permitted quantity of the substance in the material (QM) c) the maximum permitted quantity of the substance in the material expressed as mg / 6 dm² of the surface in contact with food (= QMA) d) other specific restriktionere) all specifications related to the substance or polymer.
6) If a substance appearing on the list as an individual compound is also covered by a generic term, the restrictions listed for the individual compound.
7) If there is any inconsistency between the CAS number and the chemical name, the latter shall prevail. In the event of inconsistency between the CAS number reported in EINECS and the CAS registered the latter is applicable.
not påviselig.Ved 'not detectable' purposes of this Order that the substance can not be detected in an amount above the detection limit (DG) using a validated method of analysis. If such a method does not exist, an analytical method with appropriate performance characteristics at the detection limit until the validated method has been developed.
maximum permitted quantity of the substance in the material or article. The amount of the substance in the material or article is determined by a validated analytical method. If such a method does not currently exist, an analytical method with appropriate performance characteristics at the specified limit until a validated method has been developed.
maximum permitted quantity of the substance in the material or article expressed as total of moiety or stof.Ved QM (T) purposes of this Order, the maximum permitted quantity of the substance in the material or article should be determined by a validated method of analysis at the specified limit. If such a method does not currently exist, an analytical method with appropriate performance characteristics at the specified limit until a validated method has been developed.
the maximum permitted quantity of the substance in the material and the object, expressed as mg / dm2 of the surface 6, which is in contact with the food. QM (A) For the purposes of this Order, the maximum permitted quantity of the substance on the surface of the material or article should be determined by a validated method of analysis at the specified limit. If such a method does not currently exist, an analytical method with appropriate performance characteristics at the specified limit until a validated method has been developed.
The maximum permitted quantity of the substance in the material or article expressed as mg of total of moiety or substance per. 6 dm2 of the surface which is in contact with the food. By QMA (T) purposes of this Order, the maximum permitted quantity of the substance on the surface of the material or article should be determined by a validated method of analysis at the specified limit. If such a method does not currently exist, an analytical method with appropriate performance characteristics at the specified limit until a validated method has been developed.
specific migration limit in food or simulant (food simulant), unless otherwise anført.Ved 'SML' means in this Order that the substance can be detected using a validated, appropriate method of analysis at the specified limit. If such a method does not exist, an analytical method with appropriate performance characteristics at the detection limit until the validated method has been developed.
specific migration limit in food or simulant (food simulant) expressed as total of moiety or stof.Ved SML (T) defined in this Order that the specific migration of the substances should be determined by a validated method of analysis at the specified limit. If such a method does not currently exist, an analytical method with appropriate performance characteristics at the specified limit until a validated method has been developed.
(1) Warning: There is a risk that the SML could be exceeded in the simulator for fatty foods.
(2) SML (T) in this specific case, the sum of the migration of the substances mentioned as PM / REF. 10060 and 23920, shall not exceed the restriction.
(3) SML (T) in this specific case, the sum of the migration of the substances mentioned as PM / REF. 15760, 16990, 47680, 53650 and 89440, shall not exceed the restriction.
(4) SML (T) in this specific case, the sum of the migration of the substances mentioned as PM / REF. 19540 19960 and 64800 must not exceed the restriction.
(5) SML (T) in this specific case, the sum of the migration of the substances mentioned as PM / REF. 14200, 14230 and 41840, shall not exceed the restriction.
(6) SML (T) in this specific case, the sum of the migration of the substances mentioned as PM / REF. 66560 and 66580, shall not exceed the restriction.
(7) SML (T) in this specific case, the sum of the migration of the substances mentioned as PM / REF. 30080, 42320, 45195, 45200, 53610, 81760, 89200 and 92030, shall not exceed the restriction.
(8) SML (T) in this specific case, the sum of the migration of the substances mentioned in ref. no. 24886, 62020, 30607, 38000, 42400, 64320, 66350, 67896, 73040, 85760, 85840, 85920 and 95725, shall not exceed the restriction.
(9) Warning: There is a risk that the migration of the substance deteriorates the organoleptic characteristics, and therefore that the finished product does not comply with Article 3 of the European Parliament and Council Regulation (EC) no. 1935/2004.
(10) SML (T) in this specific case, the sum of the migration of the substances mentioned as PM / REF. 30180, 40980, 63200, 65120, 65200, 65280, 65360, 65440 and 73120, shall not exceed the restriction.
(11) SML (T) in this specific case, the sum of the migration of the substances mentioned as PM / REF. 45200, 64320, 81680 and 86800, shall not exceed the restriction.
(12) SML (T) in this specific case, the sum of the migration of the substances mentioned as PM / REF. 36720, 36800, 36840, 36840 and 92000, shall not exceed the restriction.
(13) SML (T) in this specific case, the sum of the migration of the substances mentioned as PM / REF. 39090 and 39120, shall not exceed the restriction.
(14) SML (T) in this specific case, the sum of the migration of the substances mentioned as PM / REF. 44960, 68078, 69160, 82020 and 89170, shall not exceed the restriction.
(15) SML (T) in this specific case, the sum of the migration of the substances mentioned as PM / REF. 15970, 48640, 48720, 48880, 61280, 61360 and 61600, shall not exceed the restriction.
(16) SML (T) in this specific case, the sum of the migration of the substances mentioned as PM / REF. 49595, 49600, 67520, 76515 and 83599, shall not exceed the restriction.
(17) SML (T) in this specific case, the sum of the migration of the substances mentioned as PM / REF. 50160, 50240, 50320, 50360, 50400, 50480, 50560, 50640, 50720, 50800, 50880, 50960, 51040 51120, shall not exceed the restriction.
(18) SML (T) in this specific case, the sum of the migration of the substances mentioned as PM / REF. 67600, 67680 and 67760, shall not exceed the restriction.
(19) SML (T) in this specific case, the sum of the migration of the substances mentioned as PM / REF. 60400, 60480 and 61440, shall not exceed the restriction.
(20) SML (T) in this specific case, the sum of the migration of the substances mentioned as PM / REF. 66400 and 66480, shall not exceed the restriction.
(21) SML (T) in this specific case, the sum of the migration of the substances mentioned as PM / REF. 93120 and 93280, shall not exceed the restriction.
(22) SML (T) in this specific case, the sum of the migration of the substances mentioned as PM / REF. 17260, 18670, 54880 and 59280 must not exceed the restriction.
(23) SML (T) in this specific case, the sum of the migration of the substances mentioned as PM / REF. 13620, 36840, 40320 and 87040, shall not exceed the restriction.
(24) SML (T) in this specific case, the sum of the migration of the substances mentioned as PM / REF. 13720 and 40580, shall not exceed the restriction.
(25) SML (T) in this specific case, the sum of the migration of the substances mentioned as PM / REF. 16650 and 51570, shall not exceed the restriction.
(26) QM (T) in this specific case, the sum of the migration of the substances mentioned as PM / REF. 14950, 15700, 16240, 16570, 16600, 16630, 18640, 19110, 22332, 22420, 22570, 25210, 25240 and 25270, shall not exceed the restriction.
(27) QMA (T) in this specific case, the sum of the residual quantities of the substances mentioned as PM / REF. 10599 / 90A, 10599/91, 10599 / 92A and 10599/93 shall not exceed the restriction.
(28) SML (T) in this specific case, the sum of the migration of the substances mentioned as PM / REF. 13480 and 39680, shall not exceed the restriction.
(29) SML (T) in this specific case, the sum of the migration of the substances mentioned as PM / REF. 22775 and 69920, shall not exceed the restriction.
(31) When there is a fat contact should verification of compliance through the application of simulator in the form of saturated fatty food as simulant D.
(32) When there is a fat contact should verification of compliance through the application of isoctan as substitute of simulant D (unstable).
(33) QMA (T) in this specific case, the sum of the residual quantities of the substances mentioned as PM / REF. 14800 and 45600, shall not exceed the restriction.
(34) SML (T) in this specific case, the sum of the migration of the substances mentioned as PM / REF nr.55200, 55280 and 55360, shall not exceed the restriction.
(35) SML (T) in this specific case, the sum of the migration of the substances mentioned as PM / REF. 25540 and 25550, shall not exceed the restriction.
(36) SML (T) in this specific case, the sum of the migration of the substances mentioned as PM / REF. 10690, 10750, 10780, 10810, 10840, 11470, 11590, 11680, 11710, 11830, 11890, 11980 and 31500 must not exceed the restriction.
(37) SML (T) in this specific case, the sum of the migration of the substances mentioned as PM / REF. 20020, 20080, 20110, 20140, 20170, 20890, 21010, 21100, 21130, 21190, 21280, 21340 and 21460 must not exceed the restriction.
(38) SML (T) in this specific case, the sum of the migration of the substances mentioned as PM / REF. 81515, 96190, 96240 and 96320, and zinc salts (including double salts and acid salts) of authorized acids, phenols and alcohols not exceed the restriction. The same restriction for Zn applies to substances whose name contains "... acid (s), salts" which appear in the list ,, if (they) free (s) is (are) not mentioned.
(39) Migration limit might be exceeded at very high temperatures.
(40) SML (T) in this specific case, the sum of the substances mentioned as PM / REF. 38940 and 40020, shall not exceed the restriction.
(41) SML (T) in this case, the sum of the migration of the substances mentioned as Reference No. 47600, 67360, shall not exceed the restriction.
(42) SML (T) in this specific case, the sum of the migration of the substances listed under 75100 and 75105, shall not exceed the restriction.
(43) The SML could be exceeded from polyolefins.
(44) The SML could be exceeded from plastics containing more than 0.5% w / w of the substance.
(45) The SML could be exceeded in contact with foods with high alcoholic content.
(46) The SML could be exceeded from low-density polyethylene (LDPE) containing more than 0.3% w / w of the substance when in contact with fatty foods.
10) Warning: There is a risk that the migration of the substance deteriorates the organoleptic characteristics and, therefore, that the finished product is not in conformity with Article 3 of the European Parliament and Council Regulation (EC) no. 1935/2004 .
Residual extractable content of 3-aminopropyltriet-hoxysilan to be less than 3 mg / kg filler when used for the reactive surface treatment of inorganic fillers and SML = 0,05 mg / kg when used for the surface treatment of materials and articles.
See "2,2-Bis (4-hydroxyphenyl) propane-bis (2,3-epoxypropyl) ether"
See "Resin" (Ref 24100) "
List of monomers and other starting substances which could be used until 31 December 2004 pursuant to. § 12 paragraph. 1, 2nd sentence.
b) substances used to achieve the desired polymerization.
c) substances which directly influence the formation of polymers.
2) In this Annex, "additives" the substances referred to in subparagraph a) and b).
3) In this Annex, "Polymeric additives" polymers and / or prepolymers and / or oligomers that can be added to plastics to achieve a technical effect but which can not be used unless other polymers together constitute the main structural component of finished materials and objects. This also includes substances that may be added to the medium in which polymerization takes place.
a) aluminum, ammonium, calcium, iron, magnesium, potassium, sodium salts (including double salts and acid salts) of authorized acids, phenols and alcohols. The terms'. . . acid (s), salts' (appear in the list if it (they) free acid (s) are not mentioned.
b) mixtures of the authorized substances.
7) The substances used shall be of good technical quality as regards the purity criteria.
e) any specification related to the substance or polymer.
9) If a substance appearing on the list as an individual compound is also covered by a generic term, the restrictions listed for the individual compound.
10) If there is any inconsistency between the CAS number and the chemical name, the latter shall prevail. In the event of inconsistency between the CAS number reported in EINECS and the CAS Registry, the latter shall prevail.
(4) SML (T) in this specific case, the sum of the migration of the substances mentioned as PM / REF. 19540.19960 and 64800 must not exceed the restriction.
(8) SML (T) in this specific case, the sum of the migration of the substances mentioned as PM / REF. 38000, 42400, 64320, 67896, 73040, 85760, 85840, 85920 and 95725, shall not exceed the restriction.
(12) SML (T) in this specific case, the sum of the migration of the substances mentioned as PM / REF. 36720, 36800, 36840 and 92000, shall not exceed the restriction.
(14) SML (T) in this specific case, the sum of the migration of the substances mentioned as PM / REF. 44960, 68078, 82020 and 89170, shall not exceed the restriction.
(16) SML (T) in this specific case, the sum of the migration of the substances mentioned as PM / REF. 49600, 67520 and 83599, shall not exceed the restriction.
(22) SML (T) in this specific case, the sum of the migration of the substances mentioned as PM / REF. 17260 and 18670, 54880 and 59280 must not exceed the restriction.
(34) SML (T) in this specific case, the sum of the migration of the substances mentioned as PM / REF. 55200, 55280 and 55360, shall not exceed the restriction.
appears in the list if it (they) free (s) is (are) not mentioned.
12) Warning: There is a risk that the migration of the substance deteriorates the organoleptic characteristics and, therefore, that the finished product is not in conformity with Article 3 of the European Parliament and Council Regulation (EC) no. 1935/2004.
13) The list in Annex 4 of additives considered to be an incomplete list until the Commission decides that it shall become a positive Community list of authorized additives - exclusion of all others. Within d. 31 December 2007 the Commission shall, when that list shall become a positive.
Only for use as a blowing agent. Use is prohibited from 2 August 2005.
SML (T) = 1 mg / kg (12) (expressed as barium) and SML (T) = 6 mg / kg (23) (expressed as boron) see. Danish regulations for drinking water.
SML = 0.05 mg / kg. for aqueous food.
SML (T) = 5 mg / kg (7) (expressed as copper) and SML = 1 mg / kg (11) (expressed as iodine).
Only to be used in repeated use articles, sintered at high temperatures.
1. The plasticizer in materials and articles intended for repeated contact with food.
2. plasticizer in single-use materials and articles contacting non-fatty foods except for infant formulas and grant mixtures for infants and young children as defined in Directive 91/321 / EEC and products according to Directive 96/5 / EC.
3. Technical support agent in concentrations up to 0,1% in the final product.
SML = 30 mg / kg food simulant.
1. The plasticizer in materials and articles intended for repeated contact with non-fatty food.
tions up to 0,1% in the final product.
SML = 1,5 mg / kg food simulant.
tions of 0,05% in the final product.
3. Technical adjuvant in concentrations up to 0,1% in the final product.
SML (T) = 5 mg / kg (7) (expressed as copper).
SML = 48 mg / kg (as iron).
SML = 60 mg / kg. What case of PVC gaskets used to seal glass jars containing infant formula, and supplements treatments for infants and young children as defined in Directive 91/321 / EEC or containing processed cereal-based foods and baby foods for infants and young children as defined in Commission Directive 96/5 / EC, the SML is lowered to 30 mg / kg.
SML = 5 mg / kg food. Only to be used in disposable gloves.
SML = 0,05 mg / kg food.
SML (T) = 0.05 mg / kg of food (41) (the sum of mono-n-dodecyl tris (isooctylmeraptoacetat), di-n-dodecyl bis (isooctylmeraptoacetat), mono- and di-dodecyntintrichlorid dead-cyltindichlorid) expressed as the sum of mono- and di-dodecyltin chloride.
SML (T) = 0.05 mg / kg. food (41) (the sum of mono-n-dodecyl tris (isooctylmeraptoacetat), di-n-dodecyl bis (isooctylmeraptoacetat), mono- and di-dodecyntintrichlorid dead-cyltindichlorid) expressed as the sum of mono- and di-dodecyltin chloride.
SML = 0.05 mg / kg.
Plastic materials and articles shall not release primary aromatic amines in a detectable quantity (DL = 0,01 mg / kg food or food simulant). The migration of the primary aromatic amines appearing in the lists in Annexes 2 and 4 are not subject to this restriction.
Not less than 150,000 daltons (as measured by gel permeation chromatography).
Not less than 98% poly (3-D-hydroxybutanoate-co-3-D-hydroxypentanoate) analyzed after hydrolysis as a mixture of D-3-hydroxybutyric acid and 3-D-hydro-pentanoic acid.
Appears as a white to off-white powder after isolation.
In compliance with the purity criteria for maltitol syrup E 965 (ii) (Commission Directive 95/31 / EC (OJ L 178, 28.7.1995 p. 1). Directive as last amended by Commission Directive 2004/46 / EC (OJ L 114, 21.4.2004 , p. 15)).
Triallylamin40 mg / kg of hydrogel at a maximum ratio of 1.5 grams of hydrogel. kg food. For use in the hydrogels which are not intended for direct contact with food.
Tolueneekstraherbare substances: maximum 0,1%, determined according to ISO method 6209.
UV absorption of cyclohexane at 386 nm: <0,02 AU for a cm. The cell or <0,1 AU for a 5 cm cell, determined according to a generally recognized method of analysis.
Benzo (a) pyrene content: max 0,25 mg / kg carbon black.
Maximum use level of carbon black in the polymer: 2,5% w / w.
The mixture resulting from the production process must be the ratio of 58-62%: 23-27%: 13-17%, which is the typical conditions.
Hydrocarbon resins crude oil (hydrogenated) produced by the catalytic or thermal polymerisation of dienes and olefins of the aliphatic and / or alicyclic types and / or monobenzenoidarylalken types from distillates of cracked petroleum stocks with a boiling range greater than 220 ° C as well as the pure monomers found in these distillation streams, subsequently followed by distillation, hydrogenation and additional processing.
Objects that can not be filled.
Objects filled, the internal depth measured between the lowest point and the top edge horizontal plane is not more than 25 mm (flat products).
Packaging and containers with a content of more than 3 liters.
* When an object is provided with a lid, the container alone, and the lid inner surface is analyzed separately. The sum of the votes amounts of lead or cadmium (mg) related to the object's volume (1) (except genstadens surface dm2 for Cat. I).
** Mug and similar items for drinking must satisfy the requirements for Kat. In the submission from the mouth rim and the requirements for Kat. II.
1) When materials and articles intended for contact with food is put on sale upstream from retailers they must be accompanied by a written statement that they are manufactured in accordance with the law for materials and articles intended for food contact , however, see no. 3 on ceramics.
a) Name and address of the business operator which manufactures or imports the plastic materials or articles or the substances intended for the manufacturing of those materials and articles.
b) The identity of the materials, articles or substances intended for the manufacturing of those materials and articles.
d) confirmation that the plastic materials or articles meet relevant requirements in the notice and Regulation (EC) no. 1935/2004.
e) Relevant information on the substances used for which restrictions and / or specifications in this order so that the downstream business operators to ensure compliance with those restrictions.
f) Relevant information concerning the substances subject to a restriction in food, which is obtained by experimental data or theoretical calculation about the level of their specific migration and, where appropriate, purity criteria in accordance with Directive 95/31 / EC and 96/77 / EC so that the user of these materials or articles to comply with relevant legislation.
g) specifications on the use of the material or article, such .: i) the (n) food type (s) that / it is intended to come into contact with, ii) time and temperature of treatment and storage in contact with food iii) the ratio of surface area in contact with the food product and volume, which are used to establish that the material or article is in accordance with the claims.
h) When using a plastic functional barrier layer materials or objects must be in the written statement included a confirmation that the material or article complies with the requirements of this Order.
a) Name and address of the company which manufactures the finished ceramic article and of the importer who imports it into the Community.
d) confirmation that the ceramic article meets relevant requirements in the notice and in regulation 1935/2004.
1) The Order contains provisions implementing parts of Council Directive 78/142 / EEC of 30 January 1978 on the approximation of laws relating to materials and articles containing monomer vinychlorid and which is intended to come into contact with foodstuffs (Official Journal 1978 no. L 44, p. 15), parts of Council Directive 84/500 / EEC of 15 October 1984 on the approximation of laws relating to ceramic articles intended to come into contact with foodstuffs (EC -Tidende 1984 no. L 277, p. 12) as amended by Commission Directive 2005/31 / EC of 29 april 2005 amending Council Directive 84/500 / EEC as regards a declaration of conformity and requirements for analytical method for ceramic articles intended to come into contact with food (EU Official Journal. L 110, 30.04 2005, p. 36-39), Commission Directive 2007/42 / EC of 29 June 2007 on materials and articles of regenerated cellulose film intended to food contact (Official Journal 2007 no. L 172 p.71), and Commission Directive 2002/72 / EC of 6 august 2002 relating to plastic materials and articles intended to come into contact with foodstuffs (Official Journal 2002 no. L 221, p. 18), as amended by Commission Directive 2004/1 / EC of 6 January 2004 amending Directive 2002/72 / EC as regards the suspension of the use of azodidiocarbonamid as blowing agent (Official Journal 2004 no. L 7 d. 45), Commission Directive 2004/19 / EC of 1 March 2004 amending Directive 2002/72 / EC relating to plastic materials and articles intended to come into contact with foodstuffs (Official Journal 2004 no. L 17, p. 8), Commission Directive 2005/79 / EC of 18 november 2005 amending Directive 2002/72 / EC relating to plastic materials and articles intended to come into contact with foodstuffs (Official Journal 2005 no. L 302, p . 25), Commission Directive 2007/19 / EC of 2 april 2007 amending Directive 2002/72 / EC relating to plastic materials and articles intended to come into contact with foodstuffs (Official Journal 2007 no. L 97, p. 50) and Commission Directive 2008/39 / EC of 6 March 2008 amending Directive 2002/72 / EC relating to plastic materials and articles intended to come into contact with foodstuffs (Official Journal 2008 no. L 63, p. 6 ).

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