Notice On Materials And Articles Intended To Come Into Contact With Foodstuffs

Original Language Title: Bekendtgørelse om materialer og genstande bestemt til kontakt med fødevarer

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Read the untranslated law here: https://www.retsinformation.dk/Forms/R0710.aspx?id=116830

Overview (table of contents) Chapter 1 Area

Chapter 2 Definitions

Chapter 3 placing and withdrawal

Chapter 4 special manufacturing and usage conditions, etc. for certain materials and articles

Chapter 5 Penal-and entry-into-force provisions

Annex 1

Annex 2

Annex 3

Annex 4

Annex 5

Annex 6

Annex 7

Annex 8 the full text notice on materials and articles intended to come into contact with foodstuffs 1)

Under section 5, paragraph 1, § 25, § 25a, paragraph 14, of the basic regulation. § 27, § 49 paragraph 1 and section 60 (3) of law No. 526 of 24. June 2005 on food products, as amended by Act No. 1549 by 20. December 2006 amending the Act on food law on trade licences for food stores and law on catering and hotel business, fixed:

Chapter 1

Area

§ 1. The Ordinance shall apply to materials and articles intended to come into contact with food which is the subject of a European Parliament and Council Regulation (EC) No 1782/2003. 1935/2004 of 27. October 2004 on materials and articles intended to come into contact with food and repealing directives 80/590/EEC and 89/109/EEC.

(2). The notice also applies to foods that in connection with processing and sale is or has been in contact with materials and articles.

Chapter 2

Definitions

§ 2. In addition to the definitions laid down in §§ 3-8 takes the definitions laid down in European Parliament and Council Regulation (EC) No 1782/2003. 1935/2004 of 27. October 2004 on materials and articles intended to come into contact with food and repealing directives 80/590/EEC and 89/109/EEC shall apply.

§ 3. By regenerated cellulose film within the meaning of this Ordinance a thin film obtained from refined cellulose of unrecycled wood or cotton. Of technical terms can suitable substances be added mass or surface. Regenerated cellulose films can be coated (coated) on one or both sides.

(2). Regenerated cellulose films referred to in article 6. (1) includes





1) non-coated regenerated cellulose film,

2) coated regenerated cellulose film, coatings are made of cellulose, or

3) coated regenerated cellulose film, coating consisting of plastics.





§ 4. For the purposes of this Ordinance by plastic the organic macromolecular compounds obtained by polymerisation, polycondensation, polyaddition or by any other similar reaction between molecules with a lower molecular weight or by chemical alteration of natural macromolecules. There may in certain macromolecular compounds enter into other substances or materials.

(2). The following shall not be regarded as plastics:





1) elastomers, natural rubber and synthetic rubber,

2) paper and paperboard, whether or not amended by the addition of plastics,

3) ion-exchange resins (resins),

4) regenerated cellulose film, including surface-treated, see. section 3,

5) Silicones, and

6) coatings, which are manufactured on the basis of





(a)), including synthetic paraffin, paraffin wax

b) microcrystalline wax,

c) mixtures of the waxes listed in (a) and (b) the species, or

d) mixtures of the waxes listed in (a) and (b) species with plastic.









§ 5. By multilayer plastmaterialer and articles for the purposes of this Ordinance the plastic materials or articles which consists of two or more layers of materials, each consisting exclusively of plastics, which are bound together by means of adhesives or by other means.

§ 6. By plastic functional barrier, for the purposes of this Ordinance a barrier that consists of one or more layers of plastics, which ensures that the final materials or objects are in accordance with applicable law.

§ 7. By ceramic objects for the purposes of this Ordinance items made from a mixture of inorganic substances in General with a large content of clay or siliceous minerals that may be added to small quantities of organic substances. These articles are first shaped and the achieved form is then permanently maintained by burning. They can be glazed, enamelled and/or decorated.

§ 8. Don't know fatty foods for the purposes of this Ordinance foods, for which in the circular for the control of materials and articles intended to come into contact with food is provided for other simulators for migration studies than simulant D.

Chapter 3

Marketing and withdrawal

§ 9. Materials and articles intended to come into contact with food shall not be placed on the market provided that these constitute or be assumed that would pose a health hazard to humans. In determining whether a material or object is harmful and dangerous, see article 14 of European Parliament and Council Regulation (EC) No 1782/2003. 178/2002 laying down the General principles and requirements of food law, establishing the European food safety authority and laying down procedures relating to food safety, use.

§ 10. If a business manager, producer or importer of materials and articles intended to come into contact with foods considers or has reason to believe that materials and articles intended to come into contact with foodstuffs, as the company has produced, imported or distributed, does not comply with the requirements for food safety, and the products are no longer controlled by the operator, the manufacturer or importer shall take measures with a view to withdrawing the said materials and articles from the market.

(2). Business operator, manufacturer or importer must immediately inform the Food Agency to that effect.

(3). If the materials and articles intended to come into contact with foodstuffs has reached out to consumers to business operator, manufacturer or importer effectively and accurately inform you of the background to the item be withdrawn and, if necessary, call the item back from consumers, who are already in possession of it.

Chapter 4

Special manufacturing and usage conditions, etc. for certain materials and articles

Plastic

§ 11. The provisions of section 12 (1) and (2), section 13 and section 14 shall apply to materials and articles of plastic, which





1) consist exclusively of plastics, or parts thereof, or

2) multilayer plastmaterialer and articles

3) plastic layers or plastic coatings that act as gaskets in lids that total consists of two or more layers of different types of materials,





(2). Furthermore, the provisions of section 13 and section 14 apply mutatis mutandis on the materials and articles of regenerated cellulose film referred to in article 6. Article 23, paragraph 4.

(3). Without prejudice to the provisions of § 11 (1) (8). 3 find the Executive order does not apply to materials and articles composed of two or more layers, of which at least one is made up of nothing but plastic, even if the layer that comes into contact with food are made up of plastic.

§ 12. Plastic materials and articles shall be exclusively produced from the monomers and other starting substances listed in annex 2, section A and only on the specified therein restrictions and/or specifications. The monomers and other starting substances listed in annex 2, section B has been used legally until 31 December 2005. December 2004.

(2). Products obtained by means of bacterial fermentation, may only the substances listed in annex 4, shall apply where the products are intended to come into contact with food.

(3). In annex 5 shall be laid down in section A general specifications for plastic materials and articles. Specifications for certain individual substances in annex 2-3 and 4 shall be laid down in section B.

(4). Plastic products of polyvinyl chloride (PVC) may not contain more than 1 mg of vinyl chloride monomer per kg of plastic goods.

(5). Food may not be sold if they contain more than 0.01 mg vinyl chloride monomer per kg of food.

(6). It is prohibited to use the substance AZODICARBONAMIDE, reference number 36640 (CAS no 000123-77-3) for the manufacture of materials and articles.

§ 13. Plastic materials and articles shall not release constituents to food in quantities in total exceeding 10 mg/dm ² (total migration).

(2). The overall migration limit (total migration) is fixed at 60 mg/kg food (mg/kg), in the case of





1) which have been, or are comparable to containers or which can be filled, with a capacity of not less than 500 ml and not more than 10 l,

2) articles which can be filled and for which it is impracticable to estimate the surface area in contact with the food, and

3) caps, gaskets, Stoppers and similar sealing system.





§ 14. The specific migration limits in annex 2 and annex 3 is given in mg/kg. These limits are expressed in mg/dm ², however, as regards





1) which have been, or are comparable to containers or which can be filled, with a capacity of less than 500 ml or more than 10 litres, and

2) foil and other materials and articles which cannot be filled or for which it is impracticable to estimate the relationship between the material or the type of surface area and the quantity of food in contact therewith.






(2). In order to express the limit values set out in annex 2 and annex 3 in mg/dm2 limit value expressed in mg/kg shall be divided by the conventional conversion factor of 6.

§ 15. For plastic materials and articles intended to come into contact with foods or already in contact with food for infants and young children as defined in Commission Directive 91/321/EEC and 96/5/EC is the total migration level always 60 mg/kg.

(2). For plastic materials and articles intended to come into contact with foods or already in contact with food for infants and young children as defined in paragraph 1, the specific migration limit always be expressed as mg/kg.

§ 16. Plastic materials and articles shall not release primary aromatic amines in detectable levels (DL = 0.01 mg/kg of food or food simulant).

(2). The migration of the primary aromatic amines listed in the lists in annexes 2 and 3, are not subject to this restriction.

Additives

§ 17. Additives referred to in article 12 and which are approved for food additives by Council Directive 89/107/EEC or as flavourings by Council Directive 88/388/EEC and smoke flavourings in Regulation No 40/94. 2065/2003, may not migrate:





1) in quantities that have a technological function in the final food.

2) to foodstuffs in quantities exceeding the limits for food additives laid down in Directive 89/107/EEC or for flavourings laid down in Directive 88/388/EEC and in regulation 2065/2003 or in annex 3 of this Ordinance, whichever is the lowest limit applies.

3) For food, for which it is not permissible to use additives as food additives or flavourings, in quantities exceeding the limits set out in annex 3.





(2). When the substances referred to in paragraph 1, no. 1 are used as active components of active materials and articles in contact with food, they may, notwithstanding the provisions of paragraph 1 shall be subject to national provisions pending the adoption of Community provisions.

§ 18. By the use of additives for the manufacture of plastic layers or plastic coatings in lids referred to in article 6. the definition in section 11 (1) (8). 4 in annex 3 listed restrictions and/or specifications.

(2). Additives which are not included in the list in annex 3 can be used for, there is a renewed assessment from the EFSA, provided that national legislation must be observed.

§ 19. By the use of additives exclusively acting as polymerisation excipients (taking the following mentioned PPA) and which are not intended to remain in the finished thing, for the manufacture of plastic materials and articles subject to the restrictions and/or specifications provided for in annex 3.

(2). PPA, which is not included in the list in annex 3 can be used for, there is a renewed assessment from the EFSA, provided that national legislation must be observed.

Application for admission of new additives

§ 20. There may, at any time a new additive shall be inserted in the list of substances referred to in annex 3, when EFSA has carried out a risk assessment of the substance.

§ 21. Companies that want to get an additive, which is already marketed in one or more Member States, included in the list in annex 3, shall submit information so that EFSA can undertake a risk assessment of the additive not later than 31st. December 2006.

(2). With a view to 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 assessment of a substance to be used in food contact materials prior two its authorisation".

(3). Application procedures must be in accordance with European Parliament and Council Regulation (EC) No 1782/2003. 1935/2004 of 27. October 2004 on materials and articles intended to come into contact with food and repealing directives 80/590/EEC and 89/109/EEC.

(4). If EFSA during the processing of the information referred to in paragraph 2 is requesting additional information, that additive may continue to be used in compliance with national law until the EFSA has delivered an opinion, provided that the data are submitted by the deadline, the EFSA has provided.

(5). The Commission shall draw up not later than 31 December. December 2007 a provisional list of additives which may continue to be used after 31. December 2007, in compliance with national law until the EFSA has carried out an evaluation of them.

(6). The inclusion of an additive on the preliminary list assumes that the following conditions are met:





1) Additive must be permitted in one or more Member States as at 31 December 2003. December 2006.

2) Information about additives must be posted in accordance with the authority requirements no later than 31st. December 2006.





Multilayer plastmaterialer and articles

§ 22. In multilayer plastmaterialer or – objects must each plastic layer shall be in accordance with this Ordinance.

(2). Notwithstanding the provisions of paragraph 1, it is provided that the finished materials and articles comply with the specific and overall migration limits provided for in this Ordinance allowed a layer that is not in direct contact with food, and is separated from the food with a plastic functional barrier





1) does not comply with the restrictions and specifications set out in this notice and/or,

2) be manufactured with substances other than those listed in this notice. However, this does not apply to substances that are classified as substances which are





a) proven or suspected carcinogenic, mutagenic or toxic to reproduction in annex 1 of Council Directive 67/548/EEC, or

(b)) from egetansvarkriterier are classified as carcinogenic, mutagenic or toxic for reproduction in accordance with annex 6 of Council Directive 67/548/EEC.









(3). Migration of the substances referred to in paragraph 2, no. 2 to the food or simulators shall not exceed 0.01 mg/kg, measured with statistical certainty by means of the method of analysis in accordance with article 11 of European Parliament and Council Regulation (EC) No 1782/2003. 882/2004.

(4). This limit is expressed as a concentration in the food or always the Simulator. The limit applies to a group of compounds, if they are structurally or toxicologically close, in particular isomers or compounds with the same relevant functional group, and it also includes possible contagion.

Regenerated cellulose film

§ 23. Regenerated cellulose film referred to in § 3, paragraph 2, no. 1 and 2 may only be manufactured using only substances or groups of substances listed in annex 1, and only on the conditions laid down therein.

(2). Regenerated cellulose films referred to in § 3, paragraph 2, no. 3, must, prior to surface treatment exclusively manufactured using only substances or groups of substances listed in annex 1, and only on the conditions laid down therein. Coating of the in section 3, paragraph 2, no. 3 mentioned foils must only be manufactured using only substances or groups of substances listed in annexes 2-5 and only on the conditions laid down therein.

(3). Notwithstanding paragraphs 1 and 2, other substances or groups of substances can be used as dyes or Binder, provided that these substances do not give spillover for food.

(4). Materials and articles made of regenerated cellulose film referred to in § 3, paragraph 2, no. 3 must be in accordance with section 13 and section 14.

§ 24. The provisions of § 23 shall not apply to synthetic casings of regenerated cellulose.

§ 25. Printed surfaces of regenerated cellulose film shall not come into contact with food.

Ceramic and enamel objects and glassware

section 26. Ceramic and enamel objects and glass goods, shall not release more lead or cadmium than specified in annex 6.

(2). Emitting ceramic or enamel objects or glassware lead or cadmium in quantities exceeding the limits referred to in annex 6, but not, however, with more than 50 per cent, the party could legally be sold, if the analyses of at least 3 other articles of the same shape and dimension and with the same decoration and glazes shows that the quantities of cast lead or cadmium from these articles are not on average exceeds the limits listed in annex 6, and none of those articles exceeding those limits by more than 50 per cent.

Special documentation and declaration requirements

§ 27. Materials and articles intended to come into contact with foodstuffs must be accompanied by written declarations and documentation in accordance with the requirements laid down in annex 7.

(2). In the case of plastic materials and articles shall make business operator also request relevant evidence that materials and articles, as well as the substances intended for the manufacturing of those materials and articles comply with the requirements of this order, available to the Food Agency. This documentation must include the test conditions and results, calculations, other information and evidence for safety or information indicating that the requirements are met.


(3). In the case of manufacturers and importers of ceramic articles makes this also to request appropriate supporting document proving that the ceramic articles comply with the limits for the emission of lead and cadmium, as laid down in annex 6, available for veterinary and Food Administration. This supporting evidence must include the results of the analyses carried out, test conditions and the name and address of the laboratory that carried out the test.

Chapter 5

Criminal and commencement provisions

section 28. Unless a higher penalty is inflicted upon the rest of the legislation, is punishable by a fine anyone who violates:





1) Article 3, article 4, paragraph 1, as well as paragraphs 3 to 6, article 11, paragraph 5, article 15 and article 17 of the European Parliament and Council Regulation (EC) No 1782/2003. 1935/2004 of 27. October 2004 on materials and articles intended to come into contact with food and repealing directives 80/590/EEC and 89/109/EEC, or

2) article 1 of Council Regulation (EC) No 1782/2003. 372 of 2. April 2007 fixing the temporary limits for plasticisers in sealing materials in lids intended to come into contact with food. This shall apply only until 1. July 2008.

3) Article 4-7 of Commission Regulation (EC) No 1782/2003. 2023/2006 on good manufacturing practice for materials and articles intended to come into contact with food.

4) sections 9 and 10, article 12, paragraphs 1 and 2, paragraphs 4 to 6, section 13, paragraph 1, article 16, paragraphs 1 and 17, paragraph 1, article 22, paragraph 1 – 3, article 23, paragraphs 1-2 and paragraph 4 and §§ 25-27 of this Ordinance.

5) Article 2, article 3, article 4, article 5 and article 6, paragraph 4 of Commission Regulation (EC) No 1782/2003. 1895 by 18. November 2005 on the restriction of use of certain epoxy derivatives in materials and articles intended to come into contact with food.

6) Article 3, paragraph 1, article 7, paragraphs 1 and 2 and article 12 of Commission Regulation (EC) No 1782/2003. 282/2008 of 27. March 2008 on recycled plastic materials and articles intended to come into contact with foods and amending Regulation (EC) No 1782/2003. 2023/2006.





(2). The penalty can rise to imprisonment for up to 2 years, if it knows the action or failure occurred violations are committed with intent or gross negligence and in the infringement is





1) caused damage to the health or caused danger for this or

2) achieved or intentional obtained a financial benefit for the person himself or others.





(3). That can be imposed on companies, etc. (legal persons) criminal liability in accordance with the provisions of the criminal code 5. Chapter.

section 29. The notice shall enter into force on the 1. May 2008.

(2). At the same time repealed Executive Order No. 1102 by 9. November 2006 on materials and articles intended to come into contact with foodstuffs within the meaning of. However, paragraphs 3 and 4.

(3). Until 30 June 1993. June 2008, the manufacture and import of lids containing sealing material, which is not in accordance with the restrictions and specifications for reference number 36640, 30340, 30401, 56800, 88640 and 93760 76815, 76866, be in accordance with Commission Regulation (EC) No 1782/2003. 372 of 2. April 2007 fixing the temporary limits for plasticisers in sealing materials in lids intended to come into contact with food. From the 1. July 2008 to manufacture and import done in accordance with this Ordinance.

(4). Until 30 June 1993. June 2008 can manufacture and importation of plastic materials and articles intended to come into contact with foodstuffs which do not comply with the restrictions and specifications for phthalates with 74640, 74880, 74560 reference number, 75100, 75105 and be in accordance with Decree No. 1102 by 9. November 2006 on materials and articles intended to come into contact with food.
DVFA, the 28. April 2008 Anders Munk Jensen/Rikke Slot Benyahia Annex 1

List of substances which may be used in the manufacture of regenerated cellulose film

Description of regenerated cellulose film

Regenerated cellulose film is a thin film obtained from refined cellulose of unrecycled wood or cotton. Of technological protection, suitable substances be added to the mass or the surface. Regenerated cellulose films can be coated (plated) on one or both sides.

List of substances which may be used in the manufacture of regenerated cellulose film




-The percentages in this annex, first and second parts, are expressed in weight/weight (w/w) and are calculated in proportion to the quantity of anhydrous uncoated regenerated cellulose film treated

– the common technical terms are indicated in brackets

– the substances used shall be of good technical quality as regards the purity criteria



Section Anot-coated regenerated cellulose films









Name





Requirements







(A).





Regenerated cellulose





More than or equal to 72% (w/w)







(B).





Additives (Food Additives)



 



 



1.





Moisture stabilisers





Total quantity less than or equal to 27% (w/w)





 

 



-





Bis (2-hydroxyethyl) ether [= DIETHYLENEGLYCOL] Only to the foils, which later must be surface treated and then used for moist foods, IE. that does not include physical free water on the surface. The total amount of bis (2-hydroxyethyl) ether and ethanediol in foods, which have been in contact with film of this type may not exceed 30 mg/kg of foodstuffs.





 

 



-





Ethanediol [= monoethyleneglycol]



 



 

 



-





1,3 Butandiol



 



 

 



-





Glycerol



 



 

 



-





1.2-Propanediol [= 1.2 propylene glycol]



 



 

 



-





Polyethylenoxid [= polyethyleneglycol]





Average molecular weight between 250 and 1200.





 

 



-





1.2 Polypropylenoxid [= 1.2 polypropylene-glycol]





Average molecular weight less than or equal to 400 and 1.3-Propanediol with a content of less than or equal to 1% (w/w).





 

 



-





Sorbitol



 



 

 



-





Tetraethylenglycol



 



 

 



-





Tri-ethylene glycol



 



 

 



-





Urea



 



 



2.





Other additives (additives)





Total quantity less than or equal to 1% (w/w).





 

 



1. class





The amount of single substances or groups of substances in each indent may not exceed 2 mg/dm2 of the non-coated foil.





 

 



-





Acetic acid and its NH4, CA, mg, k and NA salts



 



 

 



-





Ascorbic acid and its NH4, CA, mg, k and NA salts



 



 

 



-





Benzoic acid and sodium benzoate



 



 

 



-





Formic acid and its NH4, CA, mg, k and NA salts



 



 

 



-






Linear fatty acids, saturated or unsaturated, with an even number of carbon atoms (C8-C20), behen and Castor oil acids and ammonium, calcium, magnesium, potassium, sodium, aluminum and zinc salts of these acids



 



 

 



-





Citric acid, D-and L-lactic acid, maleic acid, L-tartaric acid and sodium and potassium salts



 



 

 



-





Sorbic acid and its NH4, CA, mg, k and NA salts



 



 

 



-





Amides of linear fatty acids, saturated or unsaturated, with an even number of carbon atoms (C8-C20) and of ricinoleic acid and behenic acid



 



 

 



-





Naturally occurring edible starch and melsorter



 



 

 



-





Chemically modified edible starch and melsorter



 



 

 



-





Amylose



 



 

 



-





Calcium and magnesium carbonate, calcium-and magnesium chloride



 



 

 



-





Glycerol esters of linear fatty acids, saturated or unsaturated, with an even number of carbon atoms (C8-C20) and/or citric acid, adipic acid, 12-hydroxystearinsyre (oxystearin) and Castor oil acid



 



 

 



-





Esters of polyoxyethylene (8 to 14 oxyethylene groups) of linear fatty acids, saturated or unsaturated, with an even number of carbon atoms (C8-C20)



 



 

 



-





Esters of sorbitol with linear fatty acids, saturated or unsaturated, with an even number of carbon atoms (C8-C20)



 



 

 



-





Mono-and/or di-esters of stearic acid ethanediol and/or bis (2-hydroxyethyl) ether and/or tri-ethylene glycol



 



 

 



-





Oxides and hydroxides of aluminium, calcium, magnesium and silicon and silicates and hydrated silicates of aluminium, calcium, magnesium and potassium



 



 

 



-





Polyethylenoxid [= polyethyleneglycol]





Average molecular weight between 1200 and 4000.





 

 

 



Natriumpropionat



 



 

 



2. class





The total quantity of substances may not exceed 1 mg/dm2 of the non-coated foil, and total quantity of each substance or group of substances in each indent may not exceed 0.2 mg/dm2 (or a lower value, where this is specified) of the non-coated foil.





 

 



-





Natriumalkyl benzene sulfonate (C8-C18)



 



 

 



-





Sodium isopropylnaphthalensulfonat



 



 

 



-





Natriumalkyl sulphate (C8-C18)



 



 

 



-





Natriumalkyl sulfonate (C8-C18)



 



 

 



-





Sodium dioctylsulfosuccinat



 



 

 



-





Distearat of dihydroxyethyldi-ethylentriaminmonoacetat





Less than or equal to 0.05 mg/dm2 of the non-coated foil.





 

 



-





Ammonium, magnesium and kaliumlaurylsulfat



 



 

 



-





N, N′-distearoyldiaminoethan, N, N′-dipalmitoyldiaminoethan and N, N′-dioleyldiaminoethan



 



 

 



-





2-heptadecyl-4.4-bis (methylene-stearate) oxazolin



 



 

 



-





Polyethylenaminostearamid ethylsulfat





Less than or equal to 0.1 mg/dm2 of the non-coated foil.





 

 



3. class-cross-binding substances





The total quantity of substances (termohærdere) must not exceed 1 mg/dm2 of the non-coated foil.





 

 



-





Condensation product of Melamine-Formaldehyde, either unmodified or modified with one or more of the following products: butanol, diethylentetramin, ethanol, triethylentetramin, tetraethylenpentamin, tri-(2-hydroxyethyl) amine, 3,3 ', 4, 4 '-diaminodipropylamin-diaminodibutylamin





The content of free formaldehyde less than or equal to 0.5 mg/dm2 of the uncoated film free melamine content of treated less than or equal to 0.3 mg/dm2 of the non-coated foil.





 

 



-





Condensation product of melamine-urea-formaldehyde modified with tri-(2-hydroxyethyl) amine





The content of free formaldehyde less than or equal to 0.5 mg/dm2 of the non-coated foil.





 

 

 

 



Free melamine content of less than or equal to 0.3 mg/dm2 of the non-coated foil.





 

 



-





Polyalkylenaminer, cross-bound and on cation form

(a)) Polyamidepichlorhydrinharpiks on the basis of diaminopropylmethylamin and epichlorohydrin

b) Polyamidepichlorhydrinharpiks based on epichlorhydrin, adipic acid, caprolactam, diethylentriamin and/or ethylenediamine

(c)) Polyamidepichlorhydrinharpiks based on adipic acid, diethylentriamin and epichlorhydrin, or a mixture of epichlorhydrin and ammonia

d) Polyamide-polyaminepi chlorhydrinharpiks based on epichlorhydrin, dimethyl adipate and diethylentriamin

e) Polyamide-epichlorhydrin, polyaminepichlorhydrinharpiks based on adipamid and diaminopropyl-methylamine



 



 

 



-





Polyethylenaminer and polyethyleniminer





Less than or equal to 0.75 mg/dm2 of the non-coated foil.





 

 



-





Condensation product of carbamidharpiks, not modified or which may be modified with one or more of the following products: aminomethylsulfonsyre, sulphanilic acid, butanol, diethylentriamin, diaminodiethylamin, triethylentetramin, tetraethylenpentamin, Guanidine, methanol, sodium sulphite, ethanol, 3, 3 '-diaminodipropylamin, diaminopropan, diaminobutan





The content of free formaldehyde less than or equal to 0.5 mg/dm2 of the non-coated foil.





 

 



4. class





The total quantity of substances may not exceed 0.01 mg/dm2 of the non-coated foil.





 

 




-





Reaction products between amines of edible oils and polyethylenoxid



 



 

 



-





Monoethanolaminlaurylsulfat



 







Section BOverfladebehandlede regenerated cellulose films









Name





Requirements







(A).





Regenerated cellulose film





See section A







(B).





Additives





See section A







(C).





Lak



 



 



1. Polymers





The total quantity of substances may not exceed 50 mg/dm2 of the coating on the side in contact with foodstuffs.





 

 



-





Ethylcellulose, methylcellulose, hydroxyethylcellulose, and hydroxypropyl cellulose



 



 

 



-





Cellulose nitrate





Less than or equal to 20 mg/dm2 of the coating on the side in contact with foodstuffs; nitrogen content shall be between 10.8% (w/w) and 12.2% (w/w) in cellulose nitraten.





 



2. Resins





The total quantities of substances may not exceed 12.5 mg/dm2 of the coating on the side in contact with foodstuffs, and only in the manufacture of regenerated cellulose film which is coated with surface treatment on the basis of cellulose nitrate.





 

 



-





Casein



 



 

 



-





Rosin [pine resin], and/or polymerised and/or hydrogenated or Disproportionation and its esters with ethanol, methanol and polyhydric alcohols (C2-C6) or mixtures of these alcohols



 



 

 



-





Rosin and/or reaction products thereof by polymerization and/or hydrogenation, or Disproportionation condensed with acrylic, maleic, citric, fumaric acid and 2.2-bis and/or-(4-hydroxyphenyl) propane formaldehyde and esterified with and/or phthalsyre, and ethanol, methanol or polyhydric alcohols (C2-C6) or mixtures of these alcohols



 



 

 



-





Esters of bis (2-hydroxy-ethyl) ether with addition products of beta-pinene and/or diterpen (DL-limonene) and malein-syreanhydrid



 



 

 



-





Gelatin, (food quality)



 



 

 



-





Castor oil, dehydrated or hydrogenated product thereof, and its condensation products with adipic acid, citric acid, sebacic acid, maleic acid, phthalsyre and polyglycerol



 



 

 



-





Natural Resins [Dammar]



 



 

 



-





Poly-ß-pinene [terpenharpiks]



 



 

 



-





Modified (see krydbindende)



 



 



3. Softeners





The total quantity of substances may not exceed 6 mg/dm2 of the coating on the side in contact with foodstuffs.





 

 



-





Acetyl Tri-butyl citrate



 



 

 



-





Acetyl tri-(2-ethylhexyl)-citrate



 



 

 



-





Di-isobutyladipat



 



 

 



-





Di-n-butyladipat



 



 

 



-





Di-n-hexylazelat



 



 

 



-





Dicylohexylphthalat





Less than or equal to 4.0 mg/dm2 of the coating on the side in contact with foodstuffs.





 

 



-





2-ethylhexyl diphenyl phosphate amount of 2-ethylhexyl diphenyl phosphate shall not exceed: a) 2.4 mg/kg of the food that is in contact with film of this type, or b) 0.4 mg/dm 2 of the coating on the side in contact with foodstuffs.





 

 



-





Glycerol mono acetate [= monoacetin]



 



 

 



-





Glyceroldiacetat [= diacetin]



 



 

 



-





Glyceroltricetat [= tracetin]



 



 

 



-





Di-butylsebacat



 



 

 



-





Di-n-butyltartrat



 



 

 



-





Di-iso-butyltartrat



 



 



4. Other additives





The total quantity of substances may not exceed 6 mg/dm2 in the non-coated foil of cellulosegenerater, inclusive of the coating on the side in contact with foodstuffs.





 



4.1. Additives listed in the first part





The same special provisions as in the first part (the quantities in mg/dm2 concerns, however, the side that is in contact with food





 



4.2. Specific coating additives:





The amount of single substance or group of substances shall not exceed 2 mg/dm2 (or a lower value, where this is specified) on the side in contact with foodstuffs.





 

 



-





1-hexadecanol and 1-octadecanol [Stearyl]



 



 

 



-





Esters of linear fatty acids, saturated or unsaturated, with an even number of carbon atoms from 8 to 20 and Castor oil acid with ethanol, 1-butanol, 1-pentanol [Amyl alcohol] and oleyl linear alcohols



 



 

 



-





Montan wax, including purified montanic (C26-C32) and/or its esters with ethanediol and/or its calcium and potassium salts



 



 

 



-





Carnauba wax



 



 

 



-





Beeswax



 



 

 



-





Espartovoks




 



 

 



-





Candesartan purple wax



 



 

 



-





Dimethylpolysiloxane





Less than or equal to 1 mg/dm2 of the coating on the side in contact with foodstuffs.





 

 



-





Epoxyderet soya bean oil (with a ethylenoxidindhold of 6-8%)



 



 

 



-





Purified paraffin and purified microcrystalline wax (mikrovoks)



 



 

 



-





Pentaerythritoltetrastearat-





Mono-and bis (octadecyl-diethylenoxid) phosphate Less than or equal to 0.2 mg/dm2 of the coating on the side in contact with foodstuffs.





 

 



-





Esters of aliphatic acids (C8-C20) with mono and/or bis-(2-hydroxyethylamin) diethanolamine



 



 

 



-





2-and 3-tert-butyl-4-hydroxyanisole [= butylated hydroxyanisole (BHA)]





Less than or equal to 0.06 mg/dm2 of the coating on the side in contact with foodstuffs.





 

 



-





2.6-di-tert-butyl-4-methylphenol [hydroxytoluen (BHT) butyl]





Less than or equal to 0.06 mg/dm2 of the coating on the side in contact with foodstuffs.





 

 



-





Di-n-octyltin bis (2-ethylhexylmaleat)-





Less than or equal to 0.06 mg/dm2 of the coating on the side in contact with foodstuffs.





 



5. Solvents





The total quantity of substances may not exceed 0.6 mg/dm2 of the coating on the side in contact with foodstuffs.





 

 



-





Butyl acetate



 



 

 



-





Ethyl acetate



 



 

 



-





Isobutylacetat



 



 

 



-





Isopropyl acetate



 



 

 



-





Propyl acetate



 



 

 



-





Acetone



 



 

 



-





1-Butanol



 



 

 



-





Ethanol



 



 

 



-





2-Butanol



 



 

 



-





2-Propanol



 



 

 



-





1-Propanol



 



 

 



-





Cyclohexane



 



 

 



-





Ethylenglycolmonobutylether



 



 

 



-





Ethylenglycolmonobutylether-acetate



 



 

 



-





Methyl ethyl ketone



 



 

 



-





Methylisobutylketone,



 



 

 



-





Tetrahydrofuran



 



 

 



-





Toluene





Less than or equal to 0.06 mg/dm2 of the coating on the side in contact with foodstuffs.







Annex 2

List of monomers and other starting substances which may be used in the manufacture of plastic materials and articles

The list is divided in departments A and B does not include monomers and other starting substances used only in the manufacture of:




(a)) surface coatings obtained from resinous and polymeric products in liquid, powder or basic form, such as varnishes, lacquers, paints, etc.

b) epoxy resins

c) adhesives and klæbeaktivatorer

d) ink



General introduction




1) this annex contains the list of authorised monomers and other starting substances. The list includes





a) substances, of which post polymerisation including polycondensation, polyaddition and other similar processes, manufactured macromolecules.

b) natural or synthetic macromolecular substances used in the manufacture of modified macromolecules, if the monomers or the other starting substances required for their synthesis, not included on the lists.

c) substances used to modify existing natural or synthetic macromolecular substances.





2 does not include the following substances List), even if these are used intentionally and approved:





a) aluminium, ammonium, calcium, iron, magnesium, potassium and sodium salts (including double salts and acid salts) of the authorised acids, phenols or alcohols. The terms ' ... acid (s), salts ' appear in the list, however, if it (they) free acid (s) is not mentioned.

b) Zinc salts (including double salts and acid salts) of authorised acids, phenols or alcohols. For these salts applies a group SML = 25 mg/kg (expressed as Zn). The restriction for Zn applies also to:

in) substances whose names contain descriptions ' ... acid (s), salts ' appear in the list, however, if it (they) free acid (s) is not listed

II) substances referred to in note 38 Annex 2 '





3) List contains neither the following substances although they may be present





a) substances which could be present in the final product in the form of impurities in the substances used-reaction products of the applied substances-degradation products

b) oligomers and natural or synthetic macromolecular substances and mixtures, if the monomers or starting substances required for their synthesis, is included in the list

(c) mixtures of the authorised substances). Materials and articles which contain the substances listed in point 3a, 3b or 3 c, shall comply with the requirements of article 3 of the European Parliament and Council Regulation (EC) No 1782/2003. 1935/2004.





4) the substances used shall be of good technical quality.

5) List contains the following information




(1) Column 1 (PM/REF nr.): the substance of the EEC packaging material number






(2) Column 2 (CAS No): the register number in the CAS (Chemical Abstracts Service)






(3) Column 3 (NAME): the chemical name






(4) Column 4 (RESTRICTIONS and/or specifications). It can be: a) the specific migration limit (SML) b) the maximum quantity of the substance in the material (QM) c) maximum permitted quantity of the substance in the material expressed as mg/6 dm ² of surface that is in contact with food (= QMA) d) other specific restriktionere) all specifications related to the substance or polymer.




6) For a substance that appears on the list as a single connection and is covered by a generic term, subject to the restrictions set out by each connection.

7) If there is inconsistency between the CAS number and the chemical name, the latter which is applicable. By possible inconsistency between the CAS number reported in EINECS and the CAS registered, it is the latter that is applicable.

8) Which is in the table's column 4 used a number of abbreviations and expressions have the following meanings







DG =





the analytical method detection limit







FM =





NCO = finished material





Isocyanate (functional group)







IP =





not detectable. ' Not detectable ' for the purposes of this Ordinance, the drug cannot be detected at a level above the detection limit (DL) specified by a validated method of analysis. Such a method does not exist, an analytical method, may be used as functioning at the detection limit, until the validated method has been developed.







QM =





maximum permitted quantity of the substance in the material or article. The amount of the substance in the material or article should be determined by a validated method of analysis. Such a method does not yet exist, an analytical method, may be used as functioning at the specified border until a validated method has been developed.







QM (T) =





maximum permitted quantity of the substance in the material or article expressed as total of moiety or substance listed. By QM (T) for the purposes of this Ordinance, the maximum permitted quantity of the substance in the material or article should be determined by a validated method of analysis by the specified limit. Such a method does not yet exist, an analytical method, may be used as functioning at the specified border until a validated method has been developed.







QMA =





the maximum permitted quantity of the substance in the material and article expressed as mg per 6 dm2 of the surface in contact with foodstuffs. By QM (A) for the purposes of this notice, to the maximum permitted quantity of the substance on the surface of the material or article should be determined by a validated method of analysis by the specified limit. Such a method does not yet exist, an analytical method, may be used as functioning at the specified border until a validated method has been developed.







QMA (T) =





The maximum permitted quantity of the substance in the material or article expressed as mg of total of moiety or substance indicated per 6 dm2 of the surface in contact with foodstuffs. By QMA (T) for the purposes of this notice, to the largest permitted quantity of the substance on the surface of the material or article should be determined by a validated method of analysis by the specified limit. Such a method does not yet exist, an analytical method, may be used as functioning at the specified border until a validated method has been developed.







SML =





specific migration limit in food or simulant (food simulator), unless otherwise noted. At ' SMG ' for the purposes of this Ordinance, the substance can be detected by a validated method of analysis by acting appropriately, the specified limit. Such a method does not exist, an analytical method, may be used as functioning at the detection limit, until the validated method has been developed.







SML(T) =





specific migration limit in food or simulant (food simulator), expressed as total of moiety or substance specified by. By SML (T) for the purposes of this notice, to the specific migration of the substance must be determined by a validated method of analysis by the specified limit. Such a method does not yet exist, an analytical method, may be used as functioning at the specified border until a validated method has been developed.












9) Notes relating to column 4 ' restrictions and/or specifications ' is the following:




(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 means that the sum of the migration of the substances listed under PM/REF-nr. 10060 and 23920, must not exceed the restriction.






(3) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 15760, 16990, 47680, 53650 and 89440, must not exceed the restriction.






(4) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 19540 19960 and 64800, must not exceed the restriction.






(5) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 14200, 14230 and 41840, must not exceed the restriction.






(6) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 66560 and 66580, must not exceed the restriction.






(7) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 30080, 42320, 45195, 45200, 53610, 81760, 89200 and 92030, must not exceed the restriction.






(8) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 24886, 38000, 42400, 62020, 64320, 66350, 67896, 73040, 85760, 85840, 85920 and 95725, must not exceed the restriction.






(9) Warning: there is a risk that the migration of the substance impairing foodstuff organoleptic properties and, therefore, that the finished product is not in conformity with article 3 of the European Parliament and Council Regulation (EC) No 1782/2003. 1935/2004.






(10) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 30180, 40980, 63200, 65120, 65200, 65280, 65360, 65440 and 73120, must not exceed the restriction.






(11) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 45200, 64320, 81680 and 86800, must not exceed the restriction.






(12) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 36720, 36800, 36840 and 92000, 36840, must not exceed the restriction.






(13) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 39090 and 39120, must not exceed the restriction.






(14) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 44960, 68078, 69160, 82020 and 89170, must not exceed the restriction.






(15) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 15970, 48640, 48720, 48880, 61280, 61360 and 61600, must not exceed the restriction.






(16) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 49595, 49600, 67520 and 83599 76515, must not exceed the restriction.






(17) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 50160, 50240, 50320, 50360, 50400, 50480, 50560, 50640, 50720, 50800, 50880, 50960, 51040 51120, must not exceed the restriction.






(18) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 67600, 67680 and 67760, must not exceed the restriction.






(19) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 60400, 60480 and 61440, must not exceed the restriction.






(20) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 66400 and 66480, must not exceed the restriction.






(21) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 93120 and 93280, must not exceed the restriction.






(22) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 17260, 18670, 54880 and 59280 must not exceed the restriction.







(23) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 13620, 36840, 40320 and 87040, must not exceed the restriction.






(24) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 13720 and 40580, must not exceed the restriction.






(25) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 16650 and 51570, must not exceed the restriction.






(26) QM (T) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 14950, 15700, 16240, 16570, 16600, 16630, 18640, 19110, 22332, 22420, 22570, 25210, 25240 and 25270, must not exceed the restriction.






(27) QMA(T) (T) in this specific case means that the sum of the residual quantities of the substances listed under PM/REF-nr. 10 599/90A, 10 599/91, 10 599/92A and 10 599/93, shall not exceed the restriction.






(28) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 13480 and 39680, must not exceed the restriction.






(29) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 22775 and 69920, must not exceed the restriction.






(30) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 86480, 86960 and 87120, must not exceed the restriction






(31) When there is contact with fat, compliance checks should happen through the use of a simulator, in the form of foods containing saturated fat as simulant d.






(32) When there is contact with fat, should verification of compliance be achieved by the use of isoctan as a replacement for the simulant D (unstable).






(33) QMA(T) (T) in this specific case means that the sum of the residual quantities of the substances listed under PM/REF-nr. 14800 and 45600, must not exceed the restriction.






(34) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-55200, 55280 and 55360 nr., shall not exceed the restriction.






(35) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 25540 and 25550, must not exceed the restriction.






(36) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 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 means that the sum of the migration of the substances listed under PM/REF-nr. 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 means that the sum of the migration of the substances listed under PM/REF-nr. 81515, 96190, 96240 and 96320, and of zinc salts (including double salts and acid salts) of authorised acids, phenols or alcohols should not exceed the restriction. The restriction for Zn applies also to substances whose names contain the terms "... acid (s), salts" which appear in the list, if it (they) free (e) acid (s) is not mentioned.






(39) Migration limit might be exceeded at very high temperatures.






(40) SML(t) in this specific case means that the sum total of the substances listed under PM/REF-nr. 38940 and 40020, must not exceed the restriction.






(41) SML(t) in this case means that the sum of the migration of the substances listed under ref.nr. 47600, 67360 and not exceed the restriction.






(42) SML(t) in this specific case, brtyder to the sum of the migration of the substances listed under 75100 and 75105, must not exceed the restriction.



10) Warning: there is a risk that the migration of the substance impairing foodstuff organoleptic properties and, therefore, that the finished product is not in conformity with article 3 of the European Parliament and Council Regulation (EC) No 1782/2003. 1935/2004.



Section AListe of authorised monomers and other starting substances









PM/REF-nr.





CAS No.





Chemical formula






Restriktionerog/ellerspecifikationer 10030





000514-10-3





Abietinsyre



 





10060





000075-07-0





Acetaldehyde





SML(t) = 6 mg/kg (2)







10090





000064-19-7





Acetic acid



 





10120





000108-05-4





Vinyl acetate





SML = 12 mg/kg







10150





000108-24-7





Acetic anhydride



 





10210





000074-86-2





Acetylene



 





10 599/90A





061788-89-4





Dimers of unsaturated fatty acids (C18), distilled





QMA = 0.05 (s) mg/6 dm2 (27)







10 599/91





061788-89-4





Dimers of unsaturated fatty acids (C18), non distilled





QMA = 0.05 (s) mg/6 dm2 (27)







10 599/92A





068783-41-5





Dimers, hydrogenated, of unsaturated fatty acids (C18), distilled





QMA = 0.05 (s) mg/6 dm2 (27)







10 599/93





068783-41-5





Dimers, hydrogenated, of unsaturated fatty acids (C18), non distilled





QMA = 0.05 (s) mg/6 dm2 (27)







10630





000079-06-1





Acrylamide





SML = IP (DL = 0,01 mg/kg)







10660





015214-89-8





2-Acrylamido-2methylpropansulfonsyre





SML = 0.05 mg/kg







10690





000079-10-7





Acrylic acid





SML(t) = 6 mg/kg (36)







10750





002495-35-4





Benzylacrylat





SML(t) = 6 mg/kg (36)







10780





000141-32-2






n-butyl acrylate





SML(t) = 6 mg/kg (36)







10810





002998-08-5






SEC-butyl acrylate





SML(t) = 6 mg/kg (36)







10840





001663-39-4






tert-butyl acrylate





SML(t) = 6 mg/kg (36)







11005





012542-30-2





Dicyclopentenyla-crylat





QMA = 0.05 mg/6 dm2 11245





002156-97-0





Dodecylacrylat





SML = 0.05 mg/kg (1)







11470





000140-88-5






Ethyl acrylate





SML(t) = 6 mg/kg (36)







11500





000103-11-7





2-ethylhexyl acrylate





SML = 0.05 mg/kg







11510





000818-61-1





Hydroxyethylacetat





View Ethylenglycolmonoacrylat







11530





000999-61-1





2-hydroxypropyl acrylate QMA = 0.05 mg/6 dm2 for the sum of 2-hydroxypropyl acrylate and 2-hydroxyisopropylacrylat and in accordance with the specifications in annex 5







11590





00106-63-8





With isobutyl acrylate





SML(t) = 6 mg/kg (36)







11680





000689-12-3





Isopropylacrylat





SML(t) = 6 mg/kg (36)







11710





000096-33-3





Methyl acrylate





SML(t) = 6 mg/kg (36)







11830





000818-61-1





Ethylenglycolmonoacrylat





SML(t) = 6 mg/kg (36)







11890





002499-59-4






n-Octylacrylat





SML(t) = 6 mg/kg (36)







11980





000925-60-0





Propylacrylat





SML(t) = 6 mg/kg (36)







12100





000107-13-1





Acrylonitrile





SML = IP. (DG = 0.020 mg/kg, analytical tolerance included)







12130





000124-04-9





Adipic acid



 





12265





004074-90-2





Divinyladipat





QM = 5 mg/kg in FM or for use only as comonomer 12280





002035-75-8





Adipinsyreanhydrid



 





12310



 



Albumin



 





12340



 



Albumin, coagulated by formaldehyde



 





12375



 



Alcohols, aliphatic, MONOHYDRIC, saturated, linear, primary (C4-C22)



 





12670





002855-13-2





1-Amino-3-aminomethyl-3, 5,5-trimethylcyclohexan





SML = 6 mg/kg







12761





000693-57-2





12-Aminododecansyre





SML = 0.05 mg/kg







12763





000141-43-5





2-Aminoethanol





SML = 0.05 mg/kg. The drug should not be used in polymers intended to come into contact with foods for which simulant D is laid down in the circular on the control of materials and objects, and only for indirect contact with food behind a layer PET







12765





084434-12-08





Sodium n-(2-aminoethyl)-beta-alaninat





SML = 0.05 mg/kg







12786





000919-30-2





3-aminopropyltriet-hoxysilan





Residual extractable content of 3-aminopropyltriet-hoxysilan must 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 surface treatment of materials and objects.







12788





002432-99-7





11-Aminoundecanoic acid





SML = 5 mg/kg







12789





007664-41-7





Ammonia



 





12820





000123-99-9





Azelaic acid



 





12970





004196-95-6





Azelainsyreanhydrid



 





13000





001477-55-0





1.3-Benzendimethanamin





SML = 0.05 mg/kg







13060





004422-95-1





1, 3, 5-Benzentricarboxylsyretrichlorid





QMA = 0.05 mg/6 dm ² (measured as 1, 3, 5-benzentricarboxylsyre)







13075





00091-76-9





Benzoguanamin





See 2.4-Diamino-6-phenyl-1, 3.5-triazin







13090





000065-85-0





Benzoic acid



 





13150





000100-51-6





Benzyl alcohol



 





13180





000498-66-8





Bicyclo [2.2.1] hept-2-a (= norbornen)





SML = 0.05 mg/kg







13210





001761-71-3





Bis (4-aminocyclohexyl) methane





SML = 0.05 mg/kg







13317





132459-54-2





N, N ´-bis [4-(ethoxy-carbonyl) phenyl] -1,4, 5,8-naphthalente-tracarboxydiazen





SML = 0.05 mg/kg. Purity > 98.1% (w/w). For use only as comonomer (max. 4%) to poly-esters (PET, PBT) 13323





000102-40-9





1.3-bis (2-hydroxy-ethoxy) benzene





SMG 0.05 mg/kg







13326





000111-46-6





Bis (2-hydroxyethyl) ether





See ' Diethyleneglycol '







13380





000077-99-6





2.2-Bis (hydroxymethyl)-1-butanol





See ' 1, 1, 1-Trimet-hylolpropan '







13390





000105-08-8





1.4-Bis (hydroxymethyl) cyclohexane



 





13395





004767-03-7






2.2-Bis (hydroxymethyl) propionic acid





QMA = 0.05 mg/6 dm2 13480





000080-05-7





2.2-Bis (4-hydroxyphenyl) propane





SML = 0.6 mg/kg (28)







13530





038103-06-9





2.2-Bis (4-hydroxyphenyl) propane bis (phthalsyreanhydrid)





SML = 0.05 mg/kg







13550





000110-98-5





Bis (hydroxypropyl) ether





View» Dipropylene Glycol '







13560





005124-30-1





Bis (4-isocyanotocyclohexyl) methane





View» Dicyclohexylmethan-4, 4'-diisocyanate "







13600





047465-97-4





3.3-Bis (3-methyl-4-hydroxy-phenyl-2-indolinon





SML = 1.8 mg/kg







13607





000080-05-7





Bisphenol A





View» 2.2-bis (4-hydroxy-phenyl) propane '







13610





001675-54-3





Bisphenol A-bis (2,3-epoxy propyl) ether





View» 2.2-Bis (4-hydroxyphenyl) propane bis (2,3-epoxy propyl) ether '







13614





038103-06-9





Bisphenol A-bis (phthalsyreanhydrid)





View 13530







13617





000080-09-1





Bisphenol S





See "4.4 ´-Dihydroxy-diphenylsulfon '







13620





10043-35-3





Boric acid





SML(t) = 6 mg/kg (23) (expressed as boron) without prejudice. However, the Danish rules for drinking water







13630





000106-99-0





But adien





QM = 1 mg/kg in FM or SML = not detectable (DG = 0.02 mg/kg, analytical tolerance included)







13690





000107-88-0





1.3-Butanediol



 





13720





00110-63-4





1.4-Butanediol





SML(t) = 5 mg/kg (24)







13780





002425-79-8





1.4-Butanediol-bis (2,3-epoxy propyl) ether





QM = 1 mg/kg in FM (expressed as epoxy groups, molecular weight = 43)







13810





000505-65-7





1.4-Butandiolformal





QMA = 0.05 mg/6 dm2 13840





000071-36-3





1-Butanol



 





13870





000106-98-9





1-Butene



 





13900





000107-01-7





2-Butene



 





13932





000598-32-3





3-Butene-2-ol





QMA = IP (DL = 0.02 mg/6 dm2). Only for use as a co-monomer in the manufacture of polymeric additives







14020





000098-54-4





4-tert-Butylphenol





SML = 0.05 mg/kg







14110





000123-72-8





Butyraldehyd



 





14140





000107-92-6





Butyric acid



 





14170





000106-31-0





Smørsyreanhydrid



 





14200





000105-60-2





Caprolactam





SML(t) = 15 mg/kg (5)







14230





002123-24-2





Caprolactam, sodium salt





SML(t) = 15 mg/kg (5) (expressed as caprolactam)







14260





000502-44-3





Caprolacton





SML = 0.05 mg/kg (expressed as the sum of the caprolac-ton and 6-hydroxyhe-xansyre)







14320





000124-07-2





Caprylic acid



 





14350





000630-08-0





Carbon monoxide



 





14380





000075-44-5





Carbonylchlorid





QM = 1 mg/kg in FM







14411





008001-79-4





Castor oil



 





14500





009004-34-6





Cellulose



 





14530





007782-50-5





Chlorine



 





14570





000106-89-8





1-chloro-2.3-epoxy propane





See ' Epichlorohydrin '







14650





000079-38-9





Chlorotrifluoroethylen





QMA = 0.5 mg/6 dm ²







14680





000077-92-9





Citric acid



 





14710





000108-39-4






m-Cresol



 





14740





000095-48-7






o-Cresol



 





14770





000106-44-5






p-Cresol



 





14800





003724-65-0





CROTONIC ACID, esters





QMA = 0.05 (s) mg/6 dm2 (33)







14841





000599-64-4





4-Cumylphenol





SML = 0.05 mg/kg







14880





000105-08-8






1.4-Cyclohexanedimethanol





View» 1.4-Bis (hydroxyme-thyl) cyclohexane '







14950





003173-53-3





Cyclohexylisocyanat





QM (T) = 1 mg/kg (expressed as NCO) in FM (26)







15030





000931-88-4





Cycloocten





SML = 0.05 mg/kg. Only for use in food contact polymers for which a simulator (A) is prescribed in the circular on the control of materials and articles







15070





001647-16-1





1.9-Decadien





SML = 0.05 mg/kg







15095





000334-48-5





Decanoic acid



 





15100





000112-30-1





1-Decanol



 





15130





000872-05-9





1-Decene





SML = 0.05 mg/kg







15250





000110-60-1





1.4-Diaminobutan



 





15267





000080-80-0





4, 4 '-Diaminodiphenylsulfon





SML = 5 mg/kg







15272





000107-15-3





1.2-Diaminoethan





See ' Ethylenediamine '







15274





000124-09-4





1.6-Diaminohexan





View» Hexamethylenediamine '







15310





00091-76-9





2.4-Diamino-6-phenyl-1, 3.5-triazin





QMA = 5 mg/6 dm2 15565





000106-46-7





1.4-Dichlorobenzene





SML = 12 mg/kg







15610





000080-07-9





4.4 ´ Dichlordiphenylsulfon





SML = 0.05 mg/kg







15700





005124-30-1





Dicyclohexylmethan-4, 4'-diisocyanate





QM (T) = 1 mg/kg (expressed as NCO) (26)







15760





000111-46-6





Diethylene glycol





SML(t) = 30 mg/kg (3) 15790





000111-40-6





Diethylentriamin





SML = 5 mg/kg







15820





000345-92-6





4, 4 '-Difluorbenzophenon





SML = 0.05 mg/kg







15880





000120-80-9





1.2-Dihydroxybenzen





SML = 6 mg/kg







15910





000108-46-3





1.3-Dihydroxybenzen





SML = 2.4 mg/kg







15940





000123-31-9





1.4-Dihydroxybenzen





SML = 0.6 mg/kg







15970





000611-99-4





4, 4 '-Dihydroxy-Benzophenone





SML = 6 mg/kg (15)







16000





000092-88-6





4, 4 '-Dihydroxybiphenyl





SML = 6 mg/kg







16090





000080-09-1





4.4 ´ Dihydroxydiphenylsulfon





SML = 0.05 mg/kg







16150





000108-01-0





Dimethylaminoethanol





SML = 18 mg/kg







16210





006864-37-5





3, 3 '-Dimethyl-4, 4'-diaminodicyclohexylmethan





SML = 0.05 mg/kg (32). For use only in polyamides







16240





000091-97-4





3, 3 '-Dimethyl-4, 4'-diisocyanatobiphenyl





QM (T) = 1 mg/kg (expressed as NCO) (26)







16360





000576-26-1





2.6-Dimethylphenol





SML = 0.05 mg/kg







16390





000126-30-7





2,2-Dimethyl-1.3-propanediol ´





SML = 0.05 mg/kg







16450





000646-06-0





1.3-Dioxolan





SML = 5 mg/kg







16480





000126-58-9





Dipentaerythritol



 





16540





000102-09-0





Diphenylcarbonat





SML = 0.05 mg/kg







16570





004128-73-8





Diphenyl ether-4, 4'-diisocyanate





QM (T) = 1 mg/kg (expressed as NCO) (26)







16600





005873-54-1





Diphenylmethan-2, 4'-diisocyanate





QM (T) = 1 mg/kg (expressed as NCO) (26)







16630





000101-68-8





Diphenylmethan-4, 4'-diisocyanate





QM (T) = 1 mg/kg (expressed as NCO) (26)







16650





00127-63-9





Diphenylsulfon





SML (T) = 3 mg/kg (25)







16660





000110-98-5





Dipropylene glycol



 





16690





01321-74-0





Divenylbenzen





QMA = 0.01 mg/6 dm2 or SML = IP (DL = 0.02 mg/kg, analytical tolerance included) for the sum of divinylbenzene and ethylvinylbenzen and in accordance with the specifications in annex 5







16694





013811-50-2





N, N′-Divinyl-2-imidazolidinon





QM = 5 mg/kg in FM








16697





00693-23-2






n-Dodecanedioic acid



 





16704





000112-41-4





1-Dodecen





SML = 0.05 mg/kg







16750





000106-89-8





Epichlorohydrin





QM = 1 mg/kg in FM







16780





000064-17-5





Ethanol



 





16950





000074-85-1





Ethylene



 





16955





000096-49-1





Ethylcarbonat





Residual content = 5 mg/kg hydro gels in quantities of up to 10 grams of hydrogel per kg of food. Hydrolysatet docu-that ethylene glycol, which has a SML = 30 mg/kg







16960





000107-15-3





Ethylenediamine





SML = 12 mg/kg







16990





000107-21-1





Ethylene glycol





SML(t) = 30 mg/kg (3) 17005





000151-56-4





Ethylenimin





SML = IP (DL = 0.01 mg/kg)







17020





000075-21-8





Ethylene oxide





QM = 1 mg/kg in FM







17050





000104-76-7





2-Ethyl-1-hexanol





SML = 30 mg/kg







17110





016219-75-3





5-Ethylidenbicyclo [2.2.1] hept-2-a





QMA = 0.05 mg/6 dm2. The relationship between the surface area and volume of food must be less than 2 dm2/kg







17160





000097-53-0





Eugenol





SML = IP (DL = 0.02 mg/kg, analytical tolerance included)







17170





061788-47-4





Coconut fatty acids



 





17200





068308-53-2





Soya fatty acid



 





17230





061790-12-3





Talloliefedtsyrer



 





17260





000050-00-0





Formaldehyde





SML(t) = 15 mg/kg (22)







17290





000110-17-8





Fumaric acid



 





17530





000050-99-7





Glucose



 





18010





000110-94-1





Glutarsyre



 





18070





000108-55-4





Glutarsyreanhydrid



 





18100





000056-81-5





Glycerol



 





18220





068564-88-5





N-Heptylaminoundecansyre





SML = 0.05 mg/kg (1)







18250





000115-28-6





Hexachlorendomethylentetrahydrophthalsyre





SML = IP (DL = 0.01 mg/kg)







18280





000115-27-5





Hexachlorendomethylentetrahydrophthalsyreanhydrid





SML = IP (DL = 0.01 mg/kg)







18310





036653-82-4





1-Hexadecanol



 





18430





000116-15-4





Hexa fluoride propylene





SML = IP. (DL = 0.01 mg/kg)







18460





000124-09-4





Hexamethylenediamine





SML = 2.4 mg/kg







18640





000822-06-0





Hexamethylendiisocyanat





QM (T) = 1 mg/kg (expressed as NCO) (26)







18670





000100-97-0





Hexamethylentetramin





SML(t) = 15 mg/kg (22) (expressed as formaldehyde)







18700





000629-11-8





1.6-Hexanediol





SML = 0.05 mg/kg







18820





000592-41-6





1-Hexene





SML = 3 mg/kg







18867





000123-31-9





Hydroquinone





See 1.4-Dihydroxybenzen «»







18880





000099-96-7






p-Hydroxybenzosyre



 





18896





001679-51-2





4-(hydroxymethyl)-1-cyclohexene





SML = 0.05 mg/kg







18897





16712-64-4





6-Hydroxy-2-naphthoesyre





SML = 0.05 mg/kg







18898





000103-90-2





N-(4-hydroxyphenyl) acetamide





SML = 0.05 mg/kg







19000





000115-11-7





Isobutene



 





19060





000109-53-5





Isobutylvinylether





QM = 5 mg/kg in FM







19110





004098-71-9





1-Isocyanato-3-isocyanatomethyl-3, 5,5-trimethylcyclohexan





QM (T) = 1 mg/kg (expressed as NCO) (26)







19150





000121-91-5





Isophthalic acid





SML = 5 mg/kg








19210





001459-93-4





Dimethylisophthalat





SML = 0.05 mg/kg







19243





000078-79-5





Isoprene





See ' 2-Methyl-1.3-butadiene '







19270





000097-65-4





Itaconic acid esters



 





19460





000050-21-5





Lactic acid



 





19470





000143-07-7





Lauric acid



 





19480





002146-71-6





Vinyllaurat



 





19490





000947-04-6





Laurolactam





SML = 5 mg/kg







19510





011132-73-3





Lignocellulosics



 





19540





000110-16-7





Maleic acid





SML(t) = 30 mg/kg (4)







19960





000108-31-6





Maleic anhydride





SML(t) = 30 mg/kg (4) (expressed as maleic acid)







19975





000108-78-1





Melamine





See ' 2, 4, 6-Triamino-1, 3.5-triazin '







19990





000079-39-0





Methacrylamid





SML = IP (DL = 0.02 mg/kg, analytical tolerance included)







20020





000079-41-4





Methacrylic acid





SML(t) = 6 mg/kg (37)







20050





000096-05-9





Allylmethacrylat





SML = 0.05 mg/kg







20080





002495-37-6





Benzylmethacrylat





SML(t) = 6 mg/kg (37)







20110





000097-88-1





Butyl methacrylate





SML(t) = 6 mg/kg (37)







20140





002998-18-7






SEC-butyl methacrylate





SML(t) = 6 mg/kg (37)







20170





000585-07-9






tert-butyl methacrylate





SML(t) = 6 mg/kg (37)







20260





000101-43-9





Cyclohexylmethacrylat





SML = 0.05 mg/kg







20410





02082-81-7





Tetramethylendimethacrylat





SML = 0.05 mg/kg







20440





000097-90-5





Ethylenglycoldimethacrylat





SML = 0.05 mg/kg







20530





002867-47-2





2-(Dimethylamino) ethylmethacrylat





SML = IP (DL = 0.02 mg/kg, analytical tolerance included)







20590





000106-91-2





2.3-Epoxypropylacrylat





QMA = 0.02 mg/6 dm2 20890





000097-63-2





Ethylmethacrylat





SML(t) = 6 mg/kg (37)







21010





000097-86-9





Isobutyl methacrylate





SML(t) = 6 mg/kg (37)







21100





004655-34-9





Isopropylmethacrylat





SML(t) = 6 mg/kg (37)







21130





000080-62-6





Methyl methacrylate





SML(t) = 6 mg/kg (37)







21190





000868-77-9





Ethylenglycolmonomethacrylat





SML(t) = 6 mg/kg (37)







21280





002177-70-0





Phenylmethacrylat





SML(t) = 6 mg/kg (37)







21340





002210-28-8





Propylmethacrylat





SML(t) = 6 mg/kg (37)







21370





010595-80-9





2-sulfoethylmetha-crylat





QMA = IP (DG = 0.02 mg/6 dm2 21400





054276-35-6





Sulfopropylmethacrylat





QMA = 0.05 mg/6 dm2 21460





000760-93-0





Methacrylsyreanhydrid





SML(t) = 6 mg/kg (37)







21490





000126-98-7





Methacrylonitrile





SML = IP (DL = 0.020 mg/kg, analytical tolerance included)







21520





001561-92-8





Sodium-2-methylprop-2-en-1-suphonat





SML = 5 mg/kg







21550





000067-56-1





Methanol



 





21640





000078-79-5





2-Methyl-1.3-butadiene





QM = 1 mg/kg in FM or SML = IP (DL = 0.02 mg/kg, analytical tolerance included)







21730





000563-45-1





3-Methyl-1-butene





QMA = 0.006 mg/dm ² (Only for use in polypropylene)







21765





106246-33-7





4.4 ´-Methylene-bis (3-chloro-2.6-diethyleanilin)





QMA = 0.05 mg/6 dm2 21821





000505-65-7





1.4-(Methylenedioxy) butane






See 1.4-Butandiolformal «»







21940





000924-42-5





N-Methylolacrylamid





SML = IP (DL = 0.01 mg/kg)







21970





000923-02-4





N-Methylolmeth-acrylamide





SML = 0.05 mg/kg







22150





000691-37-2





4-Methyl-1-penten





SML = 0.05 mg/kg







22210





000098-83-9





Alpha-methylstyrene





SML = 0.05 mg/kg







22331





025513-64-8





Mixture of (35-45% w/w) 1.6-diamino-2, 2,4-trimethylhexan and (55-65% w/w) 1.6-diamino-2, 4.4-trimethylhexan





QMA = 5 mg/6 dm ²







22332





-





Mixture of (40% w/w), 2, 2, 4-trimethylhexan-1.6-diisocyanate and (60% w/w) 2,4,4-trimethylhexan-1.6-diisocyanate





QM (T) = 1 mg/kg (expressed as NCO) (26)







22350





000544-63-8





Myristic acid



 





22360





001141-38-4





2.6-Naphtalendicarboxylsyre





SML = 5 mg/kg







22390





000840-65-3





Dimethylnaphthalen-2.6-dicarboxylat





SML = 0.05 mg/kg







22420





003173-72-6





1.5-Naphtalendiisocyanat





QM (T) = 1 mg/kg (expressed as NCO) (26)







22437





000126-30-7





Neopentylglycol





See 2.2-Dimethyl-1.3-» propanediol '







22450





009004-70-0





Nitrocellulose



 





22480





000143-08-8





1-Nonanol



 





22550





000498-66-8





Norbornen





Bicyclo [2.2.1] hept ' see-2-a '







22570





000112-96-9





Octadecylisocyanat





QM (T) = 1 mg/kg (expressed as NCO) (26)







22600





000111-87-5





1-Octanol



 





22660





000111-66-0





1-Octene





SML = 15 mg/kg







22763





000112-80-1





Oleic acid



 





22775





000144-62-7





Oxalic acid





SML(t) = 6 mg/kg (29)







22778





007456-68-0





4.4 ´-Oxybis (benzensulfonylsyre)





QMA = 0.05 mg/6 dm2 22780





000057-10-3





Palmitic acid



 





22840





000115-77-5





Pentaerythritol



 





22870





000071-41-0





1-Pentanol



 





22900





000109-67-1





1-Penten





SML = 5 mg/kg







22932





001187-93-5





Perfluormethyl-perfluorvinylether





SML = 0.05 mg/kg. Only for use in anti-adhesive coatings







22937





001623-05-8





Perfluorinated propyl perfluorinated vinyl ether





SML = 0.05 mg/kg







22960





000108-95-2





Phenol



 





23050





000108-45-2





1.3-Phenylenediamine





SML = IP (DL = 0.02 mg/kg, analytical tolerance included)







23070





000102-39-6





(1, 3phenylendioxy) di-acetic acid





QMA = 0.05 mg/6 dm2 23155





000075-44-5





Phosgen





See ' Carbonylchlorid '







23170





007664-38-2





Phosphoric acid



 





23175





000122-52-1





Triethylphosphit





QM = IP (DL = 1 mg/kg in FM)







23187



 



Phthalsyre





View» Terephthalic Acid '







23200





000088-99-3






o-Phthalsyre



 





23230





000131-17-9





Diallylphthalat





SML = IP (DL = 0.01 mg/kg)







23380





000085-44-9





Phthalsyreanhydrid



 





23470





000080-56-8





Alpha-pinene



 





23500





000127-91-3





Beta-pinene



 





23547





009016-00-6

063148-62-9





Polydimethylsiloxane (molecular weight greater than 6800)





In accordance with the specifications in annex 5







23590





025322-68-3





Polyethylene glycol



 





23651





025322-69-4





Polyethyleneglycol



 





23740






000057-55-6





1.2-Propanediol



 





23770





000504-63-2





1.3-Propanediol





SML = 0.05 mg/kg







23800





000071-23-8





1-Propanol



 





23830





000067-63-0





2-Propanol



 





23860





000123-38-6





Propionaldehyd



 





23890





000079-09-4





Propionic acid



 





23920





000105-38-4





Vinylpropionat





SML(t) = 6 mg/kg (2) (expressed as acetaldehyde)







23950





000123-62-6





Propionsyreanhydrid



 





23980





000115-07-1





Propylene



 





24010





000075-56-9





Propylene oxide





QM = 1 mg/kg in FM







24051





000120-80-9





Pyrocatechol





View» 1.2-Dihydroxy-benzene '







24057





000089-32-7





Pyromellitanhydrid





SML = 0.05 mg/kg (expressed as pyromellitsyre)







24070





073138-82-6





Resin acids



 





24072





000108-46-3





Resorcinol





View» 1.3-Dihydroxybenzen '







24073





000101-90-6





Resorcinoldiglycidylether





QMA = 0.005 mg/6 dm2. The drug should not be used in polymers intended to come into contact with foods for which simulant D is laid down in the circular on the control of materials and objects, and only for indirect contact with food behind a layer PET







24100





008050-09-7





Resin



 





24130





008050-09-7





Resin rubber





See ' Resin '







24160





008052-10-6





Harpikstallolie



 





24190





065997-05-9





Harpikstræ





See ' Resin ' (REF.-nr. 24100) '







24250





009006-04-6





Natural rubber



 





24270





000069-72-7





Salicylic acid



 





24280





000111-20-6





Sebacic acid



 





24430





002561-88-8





Sebacinsyreanhydrid



 





24475





001313-82-2





Sodium sulphide



 





24490





000050-70-4





Sorbitol



 





24520





008001-22-7





Soybean oil



 





24540





009005-25-8





Starch, food quality



 





24550





000057-11-4





Stearic acid



 





24610





000100-42-5





Styrene



 





24760





026914-43-2





Styrensulfonsyre





SML = 0.05 mg/kg







24820





00110-15-6





Succinic acid



 





24850





000108-30-5





Ravsyreanhydrid



 





24880





00057-50-1





Sucrose



 





24886





046728-75-0





Lithiumdihydrogen-5-sulfonatoisoph-thalat





SML = 5 mg/kg and for lithium

SML(t) = 0.6 mg/kg (8) (expressed as lithium)







24887





006362-79-4





5-Sulfoisophthalsyre, monosodium salt





SML = 5 mg/kg







24888





003965-55-7





Dimethyl-5-sulfoisophthalat, monosodium salt





SML = 0.05 mg/kg







24903





068425-17-2





Syrups, hydrolysis-rede stivelseshydrogenerede in accordance with the specifications in annex 5 24910





000100-21-0





Terephthalic acid





SML = 7.5 mg/kg







24940





000100-20-9





Terephthalsyredichlorid





SML(t) = 7.5 mg/kg (expressed as terephtalsyre)







24970





000120-61-6





Dimethyl terephthalate



 





25080





001120-36-1





1-Tetradecen





SML = 0.05 mg/kg







25090





000112-60-7





Tetraethylenglycol



 





25120





000116-14-3





Tetrafluoroethylene





SML = 0.05 mg/kg







25150





000109-99-9






Tetrahydrofuran





SML = 0.6 mg/kg







25180





000102-60-3





N, N, N ', N '-Tetrakis (2-hydroxy-propyl) ethylenediamine



 





25210





000584-84-9





2.4-toluene diisocyanate





QM (T) = 1 mg/kg (expressed as NCO) (26)







25240





000091-08-7





2.6-toluene diisocyanate





QM (T) = 1 mg/kg (expressed as NCO) (26)







25270





026747-90-0





2.4-toluene diisocyanate, dimer





QM (T) = 1 mg/kg (expressed as NCO) (26)







25360



 



2.3-Epoxypropyltrialkyl (C5-C15) acetate





QM = 1 mg/kg in FM (expressed as epoxy groups, molecular weight = 43)







25380



 



Vinyl-trialkyl C7-C17) acetate (= vinylversatat)





QMA = 0.05 mg/6 dm2 25385





000102-70-5





Triallylamin





In accordance with the specifications in annex 5







25420





000108-78-1





2, 4, 6-Triamino-1, 3.5-triazin





SML = 30 mg/kg







25450





026896-48-0





Tricyclodecandimethanol





SML = 0.05 mg/kg







25510





000112-27-6





Tri-ethylene glycol



 





25540





000528-44-9





Trimellitsyre





SML(t) = 5 mg/kg (35)







25550





000552-30-7





Trimellitsyreanhydrid





SML(t) = 5 mg/kg (35) (expressed as trimellitsyre) '







25600





000077-99-6





1,1,1-Trimethylolpropane





SML = 6 mg/kg







25840





03290-92-4





1, 1, 1-Trimethylolpropantri-methacrylate





SML = 0.05 mg/kg







25900





000110-88-3





Trioxan SML = 5 mg/kg







25910





024800-44-0





Tripropylenglycol



 





25927





027955-94-8





1,1,1-Tris (4-hydroxyphenyl) ethane





QM = 0.5 mg/kg in DC. For use only in polycarbonates







25960





000057-13-6





Urea



 





26050





000075-01-4





Vinyl chloride





SML(t) = 0.01 mg/kg food (expressed as vinyl chloride)







26110





000075-35-4





Vinylidene chloride





QM = 5 mg/kg in FM or SML = IP (DG = 0.05 mg/kg)







26140





000075-38-7





Vinylidenfluorid





SML = 5 mg/kg







26155





001072-63-5





1-Vinylimidazol





QM = 5 mg/kg in FM







26170





003195-78-6





N-Vinyl-N-methylacetamid





QM = 2 mg/kg in FM







26320





002768-02-7





Vinyltrimethoxysilan





QM = 5 mg/kg in FM







26360





007732-18-5





Water





In accordance with the Danish rules for drinking water













Section B







List of monomers and other starting substances which could be used until 31 December 2004. December 2004, see. § 12 (1), (2). PT.







PM/REF-nr.





CAS No.





Chemical formula






Restriktionerog/or specifications 13050





000528-44-9





1, 2, 4-Benzentricarboxylsyre





See ' Trimellitsyre '







15730





000077-73-6





Dicyclopentadiene



 





18370





000592-45-0





1.4-Hexadien



 





26230





000088-12-0





Vinyl pyrrolidone



 





Annex 3

Incomplete list of additives which may be used within the restrictions stated in the manufacture of plastic materials and articles

General introduction




1) this annex contains an incomplete list of additives which may be used for the manufacture of plastic materials within the stated restrictions. Section A is a incomplete list of additives fully harmonised at Community level. The specific migration limits specified in section B shall apply only from 1. May 2008; This, however, only when checks are carried out in simulant D (olive oil) or in test media of substitute tests as referred to in the circular on the control of materials and objects. The annex contains the list of:





a) substances which are added to the plastic in order to achieve a technical effect in the finished product, including polymeric additives. They are intended to be present in the finished products,

b) substances used for the polymerization.

c) substances which directly influence the formation of polymers.





2) for the purposes of this annex, "additives" substances referred to in point (a)) and (b)).

3) for the purposes of this annex, "polymeric additives" polymers and/or prepolymers and/or oligomers, which may be added to plastics in order to achieve a technical effect but which cannot be used unless other polymers simultaneously constitute the main structural component of finished materials and articles. It also includes substances which may be added to the medium in which polymerisation occurs.

4) List in annex 3 section (A) and (B) does not include the following additives:






a) additives, used exclusively for the manufacture of:-surface coatings obtained from resinous or polymerised products in liquid, powder or dispersion form, such as varnishes, lacquers, paints, etc.-epoxy resins-adhesives and klæbeaktivatorer-ink-substances which directly influence the formation of polymers

b) colorants

c) solvents





5) nor the following list includes substances, not even if these are used intentionally and approved:





a) aluminium, ammonium, calcium, iron, magnesium, potassium, sodium salts (including double salts and acid salts) of authorised acids, phenols or alcohols. The terms ' ... acid (s), salts ' (nevertheless seems in the list, if the free acid (s) is not mentioned.

b) zinc salts (including double salts and acid salts) of the authorised acids, phenols or alcohols. For these salts applies a group SML = 25 mg/kg (expressed as Zn). The restriction also applies to fori) substances whose names contain the terms "... acid (s), salts" which appear in the list, if the (de) free (e) acid (r) ii) substances on acted in note 38 of annex 2

c) Materials and articles which contain the substances listed in point 5a or 5b shall comply with the requirements of article 3 of the European Parliament and Council Regulation (EC) No 1782/2003. 1935/2004





6) List contains neither the following substances although they may be present:





a) substances which could be present in the final product in the form of







-impurities in the substances used

-reaction intermediates

-degradation products




(b) mixtures of the authorised substances).

7) the substances used shall be of good technical quality as regards the purity criteria.

8) List contains the following information:





1) Column 1 (PM/REF-nr.): the substance of the EEC packaging material number in the list

2) Column 2 (CAS No): the register number in the CAS (Chemical Abstracts Service)

3) Column 3 (name): the chemical name

4) Column 4 (Restrictions and/or specifications). It can be:







(a)) the specific migration limit (SML)

(b)) the maximum quantity of the substance in the material or article (QM)

(c)) the largest permitted quantity of the substance in mg/6 dm ² of surface that is in contact with food (= QMA)

(d)) other specific restrictions

e) all specifications related to the substance or polymer.




9) For a substance that appears on the list as a single connection and is covered by a generic term, subject to the restrictions set out by each connection.

10) If there is inconsistency between the CAS number and the chemical name, it is the latter that is applicable. By possible inconsistency between the CAS number reported in EINECS and the CAS registry, it is the latter that is applicable.

11) Notes relating to column 4 ' restrictions and/or specifications ':



(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 means that the sum of the migration of the substances listed under PM/REF-nr. 10060 and 23920, must not exceed the restriction.

(3) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 15760, 16990, 47680, 53650 and 89440, must not exceed the restriction.

(4) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 19540.19960 and 64800, must not exceed the restriction.

(5) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 14200, 14230 and 41840, must not exceed the restriction.

(6) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 66560 and 66580, must not exceed the restriction.

(7) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 30080, 42320, 45195, 45200, 53610, 81760, 89200 and 92030, must not exceed the restriction.

(8) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 38000, 42400, 64320, 67896, 73040, 85760, 85840, 85920 and 95725, must not exceed the restriction.

(9) Warning: there is a risk that the migration of the substance impairing foodstuff organoleptic properties and, therefore, that the finished product is not in conformity with article 3 of the European Parliament and Council Regulation (EC) No 1782/2003. 1935/2004.

(10) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 30180, 40980, 63200, 65120, 65200, 65280, 65360, 65440 and 73120, must not exceed the restriction.

(11) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 45200, 64320, 81680 and 86800, must not exceed the restriction.

(12) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 36720, 36800, 36840 and 92000, must not exceed the restriction.

(13) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 39090 and 39120, must not exceed the restriction.

(14) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 44960, 68078, 82020 and 89170, must not exceed the restriction.

(15) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 15970, 48640, 48720, 48880, 61280, 61360 and 61600, must not exceed the restriction.

(16) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 49600, 67520 and 83599, must not exceed the restriction.

(17) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 50160, 50240, 50320, 50360, 50400, 50480, 50560, 50640, 50720, 50800, 50880, 50960, 51040 51120, must not exceed the restriction.

(18) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 67600, 67680 and 67760, must not exceed the restriction.

(19) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 60400, 60480 and 61440, must not exceed the restriction.

(20) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 66400 and 66480, must not exceed the restriction.

(21) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 93120 and 93280, must not exceed the restriction.

(22) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 17260 and 18670, 54880 and 59280 must not exceed the restriction.

(23) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 13620, 36840, 40320 and 87040, must not exceed the restriction.

(24) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 13720 and 40580, must not exceed the restriction.

(25) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 16650 and 51570, must not exceed the restriction.

(26) QM (T) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 14950, 15700, 16240, 16570, 16600, 16630, 18640, 19110, 22332, 22420, 22570, 25210, 25240 and 25270, must not exceed the restriction.

(27) QMA(T) (T) in this specific case means that the sum of the residual quantities of the substances listed under PM/REF-nr. 10 599/90A, 10 599/91, 10 599/92A and 10 599/93, shall not exceed the restriction.

(28) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 13480 and 39680, must not exceed the restriction.

(29) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 22775 and 69920, must not exceed the restriction.

(30) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 86480, 86960 and 87120, must not exceed the restriction

(31) When there is contact with fat, compliance checks should happen through the use of a simulator, in the form of foods containing saturated fat as simulant d.

(32) When there is contact with fat, should verification of compliance be achieved by the use of isoctan as a replacement for the simulant D (unstable).

(33) QMA(T) (T) in this specific case means that the sum of the residual quantities of the substances listed under PM/REF-nr. 14800 and 45600, must not exceed the restriction.

(34) SML(t) in this specific case means that the sum of the migration of the substances listed under PM/REF-nr. 55200, 55280 and 55360, must not exceed the restriction.





12) Warning: there is a risk that the migration of the substance impairing foodstuff organoleptic properties and, therefore, that the finished product is not in conformity with article 3 of the European Parliament and Council Regulation (EC) No 1782/2003. 1935/2004.

13) the list set out in annex 3 of additives is considered an incomplete list until the Commission decides that it must be for a community positive list of authorised additives-thereby all other excluded. Not later than 31st. December 2007, the Commission shall establish, when this list must have the character of a positive list.

43) after 31 December 2006. December 2006 Member States shall not authorise additives referred to in annex 3, and which has never been evaluated by the Scientific Committee on food or by the EFSA.



Section AUfuldstændig list of additives fully harmonised at Community level









PM/REF-nr.





CAS No.





Chemical formula






Restrictions and/or specifications 30000





000064-19-7





Acetic acid



 





30045





000123-86-4





Butyl acetate



 





30080





004180-12-5





Copper acetate





SML(t) = 5 mg/kg (7) (expressed as copper)







30140





000141-78-6





Ethyl acetate



 





30280





000108-24-7





Acetic anhydride



 





30295





000067-64-1





Acetone



 





30340





330198-91-9





12-(acetoxy) stearic acid, 2.3-bis (acetoxy) propyl-lester



 





30370





-





Acetylsalicylic acid, salts



 





30401



 



Acetylerede mono-and di-glycerides of fatty acids



 





30610





-





Monocarboxylic acids, C2-C24, aliphatic, linear, from natural oils and fats, and their mono-, di-and triglycerol esters (multiple-chain fatty acids from all sources, including natural occurrence)



 





30612





-





Monocarboxylic acids, C2-C24, aliphatic, linear, synthetic and their mono-, di-and triglycerol esters



 





30960





-





Esters of aliphatic monocarboxysyrer (C6-C32) with polyglycerol



 





31328





-





Fatty acids from animal or vegetable fats and oils, which are considered as foods,



 





31530





123968-25-2





2.4-Di-tert-penthyl-6-[1-(3,5-di-tert-penthyl-2-hydroxyphenyl) ethyl]-phenylacrylat





SML = 5 mg/kg







31542





174254-23-0





Methyl acrylate, telomer with 1-dodecanthiol, C16-C18-alkyl esters





QM = 0.5% (w/w) in FM







31730





000124-04-9





Adipic acid



 





33120





-





Alcohols, aliphatic, MONOHYDRIC, saturated, linear, primary (C4-C12)



 





33350





009005-32-7





Alginic acid



 





33801





-





n-Alkyl (C10-C13) BENZENESULFONIC ACID





SML = 30 mg/kg







34240



 



Esters afalkyl (C10-C20) sulfunsyre with phenols





SML = 6 mg/kg. Authorized until 1. January 2002 34281





-





Alkyl (C8-C22) sulphuric acids, linear, primary with an even number of carbon atoms



 





34475





-





Aluminum-calcium hydroxyphosphit hydrate



 





34480





-





Aluminium fibers, flakes and powders



 





34560





021645-51-2





Aluminum hydroxide



 





34690





011097-59-9





Aluminiummagnesiumhydroxycarbonat



 





34720





001344-28-1





Aluminum oxide



 





34850





143925-92-2





Amines, bis (hydrogenated tallow alkyl) oxidized





QM = for use only in a) polyolefins with 0.1% (w/w), but not in LDPE when it is in contact with foods for which in circular on the control of materials and articles are provided for a reduction factor of less than 3 (b)) PET with 0.25% (w/w) in contact with foods other than those for which simulant D is laid down in the circular on the control of materials and articles







34895





000088-68-6





2-aminobenzamid





SML = 0.05 mg/kg. Only for use in PET for water and beverages







35120





013560-49-1





Diester of 3-aminocrotonsyre with thiobis (2-hydroxyethyl) ether



 





35160





006642-31-5





6-Amino-1.3-dimethyluracil





SML = 5 mg/kg







35170





000141-43-5





2-Aminoethanol SML = 0.05 mg/kg. The drug should not be used in polymers intended to come into contact with foods for which simulant D is laid down in the circular on the control of materials and objects, and only for indirect contact with food behind a layer of PET







35284





000111-41-1





N-(2-Aminoethyl) ethanolamine





See ' 2-Aminoethanol '







35320





007664-41-7





Ammonia



 





35440





012124-97-9





Ammonium bromide



 





35600





001336-21-6





Ammonium hydroxide




 





35840





000506-30-9





Arachinsyre



 





35845





007771-44-0





Arachidonic acid



 





36000





000050-81-7





Ascorbic acid



 





36080





000137-66-6





Ascorbylpalmitat



 





36160





010605-09-1





Ascorbylstearat



 





36640





000123-77-3





AZODICARBONAMIDE





Only for use as blowing. Use is prohibited from the 2. August 2005.







36840





12007-55-5





Bariumtetraborat





SML(t) = 1 mg/kg (12) (expressed as barium) and SML(t) = 6 mg/kg (23) (expressed as boron) without prejudice. the Danish rules for drinking water.







36880





008012-89-3





Beeswax



 





38885





002725-22-6





2.4-Bis (2, 4dimethylphenyl)-6-(2-hydroxy-4-n-octyloxyphenyl)-1,3,5-triazin





SML = 0.05 mg/kg. Only for aqueous foods.







36960





003061-75-4





Behenamid



 





37040





000112-85-6





Behenic acid



 





37280





001302-78-9





Bentonite



 





37360





000100-52-7





Benzaldehyde





(9)







37600





000065-85-0





Benzosyre



 





37680





000136-60-7





Butylbenzoat



 





37840





000093-89-0





Ethylbenzoat



 





38080





000093-58-3





Methylbenzoat



 





38160





002315-68-6





Propylbenzoat



 





38510





136504-96-6





1.2-Bis (3-Aminopropyl) ethylenediamine, polymer with N-butyl-2, 2, 6, 6 – tetra-methyl-4-piperidinamin and 2, 4, 6-tri-chloro-1, 3.5-triazin





SML = 5 mg/kg







38515





001533-45-5





4.4 ' Bis (2-benzoxazolyl) stilbene





SML = 0.05 mg/kg (1)







38810





080693-00-1





Bis (2,6-di-tert-butyl-4-methylphenyl)-pentaerythritoldiphosphit





SML = 5 mg/kg (sum of phosphit and phosphate)







38840





154862-43-8





Bis (2,4-dicumylphenyl) pentaerythritoldiphosphit





SML = 5 mg/kg (as the sum of the substance itself, its oxidized form bis (2,4-dicumylphenyl) pentaerythritolphosphat and its hydrolysis product (2.4-dicumylphenol)







38879





135861-56-2





Bis (3,4-dimetylbenzyliden) sorbitol



 





38950





079072-96-1





Bis (4-ethylbenzyliden) sorbitol



 





39200





006200-40-4





Bis (2-hydroxyethyl)-2-hydroxypropyl-3-(dodecyloxy) methylammoniumchlorid)





SML = 1.8 mg/kg







39680





000080-05-7





2.2-bis (4-hydroxyphenyl) propane





SML(t) = 0.6 mg/kg (28)







39815





182121-12-6





9.9-Bis (methoxymethyl) the fluoride





QMA = 0.05 mg/6 dm ²







39890





087826-41-3069158-41-4054686-97-4081541-12-0





Bis (methylbenzyliden) sorbitol



 





39925





129228-21-3





3.3-Bis (methoxymethyl)-2.5-dimethylhexan





SML = 0.05 mg/kg







40120





68951-50-8





Bis (polyethylene glycol) hydroxymethylphosphonat





SML = 0.6 mg/kg







40320





10043-35-3





Boric acid





SML(t) = 6 mg/kg (23) (expressed as boron) without prejudice. the Danish rules on drinking water







40400





010043-11-5





Boron Nitride



 





40570





000106-97-8





Butane



 





40580





00110-63-4





1.4 Butanediol





SML(t) = 5 mg/kg (24)







41040





005743-36-2





Calcium butyrate



 





41120





010043-52-4





Calcium chloride



 





41280





001305-62-0





Calcium hydroxide



 





41520





001305-78-8





Calcium oxide



 





41600





012004-14-7037293-22-4





Calciumsulfoaluminat



 





41680





000076-22-2





Camphor





(9)







41760





008004-44-8





Candesartan purple wax



 





41840





00105-60-2





Caprolactam






SML(t) = 15 mg/kg (5)







41960





000124-07-2





Caprylic acid



 





001333-86-4



 



Vegetal coal





In accordance with the specifications given in annex 5.







42160





000124-38-9





Carbon dioxide



 





42320





007492-68-4





Kobbercarbonat





SML(t) = 5 mg/kg (7) (expressed as copper)







42500





-





-, Salts



 





42640





009000-11-7





Carboxymethylcellulose



 





42720





008015-86-9





Carnauba wax



 





42800





009000-71-9





Casein



 





42880





008001-79-4





Castor oil



 





42960





064147-40-6





Castor oil, dehydrated



 





43200





-





Castor oil, mono-and diglycerides



 





43280





009004-34-6





Cellulose



 





43300





009004-36-8





Cellulose-acetoburyrat



 





43360





068442-85-3





Regenerated cellulose film



 





43440





008001-75-0





Ceresin



 





43480





064365-11-3





Coal, actively





In accordance with the specifications in annex 5-ne.







43515





-





Cholinesterchlorider of coconut oil fatty acids





QMA = 0.9 mg/6 dm ²







44160





000077-92-9





Citric acid



 





44640





000077-93-0





Triethyl citrate



 





45705





166412-78-8





1.2-cyclohexandicarboxylsyre, diisononylester



 





45195





007787-70-4





Copper bromide





SML(t) = 5 mg/kg (7) (expressed as copper)







45200





001335-23-5





Kobberiodid





SML(t) = 5 mg/kg (7) (expressed as copper) and SML = 1 mg/kg (11) (expressed as iodine).







45280





-





Cotton fibers



 





45450





068610-51-5






p-cresol-dicyclopentadiene-isobutylen, copolymer





SML = 5 mg/kg







45560





014464-46-1





Cristobalit



 





45600





003724-65-0





CROTONIC ACID, esters





QMA = 0.05 (s) mg/6 dm2 (33)







45640





005232-99-5





Ethyl-2-cyan-3.3-diphenylacrylat





SML = 0.05 mg/kg







45760





000108-91-8





Cyclohexylamine



 





45920





009000-16-2





Dammar



 





45940





000334-48-5





n-Decanoic acid



 





46070





010016-20-3





Alpha-Dextrin



 





46080





007585-39-9





Beta-Dextrin



 





46375





061790-53-2





Diatomite



 





46380





068855-54-9





Diatomite, annealed with a melting of calcined soda



 





46480





032647-67-9





Dibenzylidensorbitol



 





46700





-





5.7-di-tert-butyl-3-(3,4-and 2.3-dimethylphenyl)-3 h-benzofuran-2-on containing: a) 5.7-di-tert-butyl-3-(3.4-dimethylphenyl)-3 h-benzofuran-2-on (80 to 100% w/w) 5.7-di-, and b) tert-butyl-3-(2,3-dimethylphenyl)-3 h-benzofuran-2-on (0 to 20% w/w)





SML = 5 mg/kg







46720





004130-42-1





2.6-di-tert-butyl-4-ethylphenol





QMA = 4.8 mg/6 dm2 46790





004221-80-1





2.4-Di-tert-butylphenyl-3.5-di-tert-butyl-4-hydroxybenzoate



 





46800





067845-93-6





Hexadecyl-3.5-di-tert-butyl-4-hydroxybenzoate



 





46870





003135-18-0





Dioctadecyl-3.5-di-tert-butyl-4-hydroxy-benzylphosphonat



 





46880





065140-91-2





Monoethyl-3.5-di-tert-butyl-4-hydroxy-benzylphosphonat, calcium salt





SML = 6 mg/kg







47210





026427-07-6





Dibutylthiostannonsyre, polymer [= Thiobis (butyltinsulfid), polymer]





In accordance with the specifications in annex 5







47440





000461-58-5





Dicyandiamide



 





47540






027458-90-8





Di-tert-dodecyldisulfid





SMG 0.05 mg/kg







47680





000111-46-6





Diethylene glycol





SML(t) = 30 mg/kg (3)







48460





000075-37-6





1.1-Difluorethan



 





48620





000123-31-9





1.4-Dihydroxybenzen





SMG 0.6 mg/kg







48720





000611-99-4





4.4 ´-Dihydroxybenzophenon





SML(t) = 6 mg/kg (15)







49485





134701-20-5





2.4-Dimethyl-6-(1-methylpentadecyl)-phenol





SML = 1 mg/kg







49540





000067-68-5





Dimethyl sulfoxide



 





51200





000126-58-9





Dipentaerythritol



 





51700





147315-50-2





2-(4,6-Biphenyl-1, 3.5-triazin-2-yl)-5-(effects) phenol





SML = 0.05 mg/kg







51760





025265-71-8000110-98-5





Dipropylene glycol



 





52640





016389-88-1





Dolomite



 





52645





010436-08-5





CIS-11-icosenamid



 





52720





000112-84-5





Erucamid



 





52730





000112-86-7





Erucic acid



 





52800





000064-17-5





Ethanol



 





53270





037205-99-5





Ethylcarboxymethylcellulose



 





53280





009004-57-3





Ethyl cellulose



 





53360





000110-31-6





N, N′-Ethylene-bis-oleamid



 





53440





005518-18-3





N, N′-Ethylene-bis-palmitamid



 





53520





000110-30-5





N, N′-Ethylene-bis-stearamid



 





53600





000060-00-4





N. N′-Ethylene Diamine



 





53610





054453-03-1





Kobberethylendiamintetraacetat





SML(t) = 5 mg/kg (7) (expressed as copper)







53650





000107-21-1





Ethylene glycol





SML(t) = 30 mg/kg (3) 54005





005136-44-7





Ethylene-N-palmitamid-N '-stearamid



 





54260





009004-58-4





Ethyl hydroxyethyl cellulose



 





54270





-





Ethylhydroxymethylcellulose



 





54280





-





Ethylhydroxypropylcellulose



 





54300





118337-09-0





2, 2 ' Ethylidenbis (4,6-di-tert-butylphenyl) fluorphosphonit





SML = 6 mg/kg







54450





-





Fats and oils of animal or vegetable food ingredients



 





54480





-





Fats and oils, hydrogenated, from animal or vegetable food ingredients



 





54930





025359-91-5





Formaldehyde-1-naphthol, copolymer [= Poly (1-hydroxynaphthyl-methane)]





SML = 0.05 mg/kg







55040





000064-18-6





Formic acid



 





55120





000110-17-8





Fumaric acid



 





55190





029204-02-2





Gadoleic acid



 





55440





009000-70-8





Gelatin



 





55520





-





Glass fibres



 





55600





-





Glasmikrokugler



 





55680





000110-94-1





Glutarsyre



 





55920





000056-81-5





Glycerol



 





56020





099880-64-5





Glycerol-dibehenat



 





56360





-





Esters of glycerol with acetic acid



 





56486





-





Esters of glycetol with aliphatic linear saturated acids with an even number of carbon atoms (C14-C18) and with aliphatic unsaturated linear acids with an even number of carbon atoms (C16-C18)



 





56487





-





Esters of glycerol with butyric acid



 





56490





-





Glycerol, esters with erucic acid



 





56495





-





Esters of glycerol with 12-hydroxy stearic acid



 






56500





-





Esters of glycerol with lauric acid



 





56510





-





Esters of glycerol with linoleic acid



 





56520





-





Glycerol, esters with myristic acid



 





56535





-





Esters of glycerol with nonansyre



 





56540





-





Esters of glycerol with oleic acid



 





56550





-





Esters of glycerol with Palmitic acid



 





56570





-





Esters of glycerol with propionic acid



 





56580





-





Glycerol, esters with ricinoleic acid



 





56585





-





Glycerol, esters with stearic acid



 





56610





030233-64-8





Glycerolmonobehenat



 





56720





026402-23-3





Glycerolmonohexanoat



 





56800





030899-62-8





Glycerolmonolauratdiacetat



 





56880





026402-26-6





Glycerolmonooctanoat



 





57040





-





Glycerolmonooleat, ester with Ascorbic acid



 





57120





-





Glycerolmonooleat, ester with citric acid



 





57200





-





Glycerolmonopalmitat, ester with Ascorbic acid



 





57280





-





Glycerolmonopalmitat, ester with citric acid



 





57600





-





Glycerolmonostearat, ester with Ascorbic acid



 





57680





-





Glycerolmonostearat, ester with citric acid



 





57800





018641-57-1





Glyceroltribehenat



 





57920





000620-67-7





Glyceroltriheptanoat



 





58300





-





Glycine, salts



 





58320





007782-42-5





Graphite



 





58400





009000-30-0





Guar gum



 





58480





009000-01-5





Gum Arabic



 





58720





000111-14-8





Heptansyre



 





59280





000100-97-0





Hexamethylentetramin





SML = 15 mg/kg (22) (expressed as formaldehyde)







59360





000142-62-1





Hexansyre



 





59760





019569-21-2





Huntit



 





59990





007647-01-0





Chlorsvovlsyre



 





60030





012072-90-1





Hydro magnesite



 





60080





012304-65-3





Hydrotalkit



 





60160





000120-47-8





Ethyl 4-hydroxybenzoate



 





60180





004191-73-5





Isopropyl 4-hydroxybenzoate



 





60200





000099-76-3





Methyl 4-hydroxybenzoate



 





60240





000094-13-3





Propyl 4-hydroxybenzoate



 





60480





003864-99-1





2-(2-Hydroxy-3.5-di-tert-butylphenyl)-5-chlorbenzotriazol





SML(t) = 30 mg/kg (19)







60560





009004-62-0





Hydroxyethylcellulose



 





60880





009032-42-2





Hydroxyethylmethylcellulose



 





61120





009005-27-0





Hydroxyethyl starch



 





61390





037353-59-6





Hydroxymethylcellulose



 





61680





009004-64-2





Hydroxypropyl cellulose



 





61800





009049-76-7





Hydroxypropylstivelse



 





61840





000106-14-9





12-Hydroxystearinsyre



 





62020





007620-77-1





Lithium-12-hydroxysterat





SML(t) = 0.6 mg/kg (8) (expressed as lithium)







62140





006303-21-5





Hypophosphorigesyre



 





62240





001332-37-2





Iron oxide



 





62245





012751-22-3





Jernphosphid






Only for use in PET polymers and copolymers







62450





000078-78-4





Isopentan



 





62640





008001-39-6





Japan wax



 





62720





001332-58-7





Kaolin



 





62800





-





Kaolin, calcined



 





62960





000050-21-5





Lactic acid



 





63040





000138-22-7





Butyllactat



 





63280





000143-07-7





Lauric acid



 





63760





008002-43-5





Lecithin



 





63840





000123-76-2





Levulinsyre



 





63920





000557-59-5





Lignoceric acid



 





64015





000060-33-3





Linoleic acid



 





64150





028290-79-1





Linolenic acid



 





64500





-





Lysine, salts



 





64640





001309-42-8





Magnesium hydroxide



 





64720





001309-48-4





Magnesium oxide



 





64800





000110-16-7





Maleic acid





SML(t) = 30 mg/kg (4)







64990





025736-61-2





Styrene-maleic anhydride copolymers, sodium salt





In accordance with the specifications in annex 5







65020





006915-15-7





Malic acid



 





65040





000141-82-2





Malonic acid



 





65520





000087-78-5





Mannitol



 





65920





066822-60-4





N-N, N-dimethyl-methacryloyloxyethyl-N-carboxymethylammoniumchlorid, octadecylmethacrylat, ethylmethacrylat, cyclohexylmethacrylat and N-vinyl-2-pyrrolidone, copolymers of sodium salt



 





66200





037206-01-2





Methylcarboxymethylcellulose



 





66240





009004-67-5





Methylcellulose



 





66560





004066-02-8





2, 2 '-Methylene bis (4-methyl-6-cyclohexylphenol)





SML (T) = 3 mg/kg (6)







66580





000077-62-3





2, 2 ' Methylenbis [4-methyl-6-(1-methylcyclohexyl) phenol]





SML (T) = 3 mg/kg (6)







66640





009004-59-5





Methylethylcellulose



 





66695





-





Methylhydroxymethylcellulose



 





66700





009004-65-3





Methylhydroxypropylcellulose



 





66755





002682-20-4





2-Methyl-4-isothiazolin-3-one





SML = IP (DL = 0.02 mg/kg, analytical tolerance included)







66905





000872-50-4





NMP



 





66930





068554-70-1





Methylsilsesquioxan





Residual monomer in methylsilsesquioxan: methyltrimethoxysilan 1 mg/kg methylsilsesquioxan <







67120





012001-26-2





MICA



 





67155



 



Mixture of 4-(2-benzoxazolyl)-4 ´-(5-methyl-2-benzoxazolyl) stilbene ´, 4.4-bis (2-benzoxazolyl) stilbene and 4.4 ´-bis (5-methyl-2-benzoxazolyl) stilbene-





Not more than 0.05% (w/w) (quantity of substance used/quantity of the formulation). In accordance with the specifications in annex 5







67180





-





Mixture of (50% w/w) n-decyl-n-octylphthalat, (25% w/w) di-n-decylphthalat and (25% w/w) di-n-octylphthalat





SML = 5 mg/kg (1)







67200





001317-33-5





Molybdendisulfid



 





67840





-





Montansyrer and/or their esters with ethyleneglycol and/or with 1.3-Butanediol and/or with glycerol



 





67850





008002-53-7





Montan wax



 





67891





000544-63-8





Myristic acid



 





68040





003333-62-8





7-[2-H-Naphto-(1,2-D) triazole-2-yl]-3-phenylcumarin



 





68078





027253-31-2





Neodecansyre, cobaltsalt





SML(t) = 0.05 mg/kg (expressed as neodecansyre) and SML(t) = 0.05 mg/kg (14) (expressed as cobalt). Not for use in polymers in contact with foods for which simulant D is laid down in the circular on the control of materials and articles







68125





037244-96-5





Nepheline syenite waste



 





68145





080410-33-9





2, 2 ', 2''-Nitrilo [triethyl-tris (3, 3 ', 5, 5 '-tetra-tert-butyl-1, 1 '-bi-phenyl-2, 2 '-diyl) phosphit]






SML = 5 mg/kg (sum of phosphit and phosphate)







68960





000301-02-0





Oleamid



 





69040





000112-80-1





Oleic acid



 





69760





000143-28-2





Oleyl linear alcohols



 





69920





000144-62-7





Oxalic acid





SML(t) = 6 mg/kg (29)







70000





070331-94-1





2, 2 '-Oxamidobis [ethyl-3-(3,5-di-tert-butyl-4-hydroxy-phenyl) propionate]



 





70240





012198-93-5





Ozokerite



 





70400





000057-10-3





Palmitic acid



 





71020





000373-49-9





Palmitoleic acid



 





71440





009000-69-5





Pectin



 





71600





000115-77-5





Pentaerythritol



 





71635





025151-96-6





Pentaerythritoldioleat





SML = 0.05 mg/kg. The drug should not be used in polymers in contact with foods for which simulant D is laid down in the circular on the control of materials and articles







71670





178671-58-4





Pentaerythritoltetrakis (2-cyan-3.3-diphenylacrylat)





SML = 0.05 mg/kg







71680





006683-19-8





Pentaerythritol tetrakis-[3-(3,5-di-tert-butyl-4-hydroxy-phenyl) propionate]



 





71720





000109-66-0





Pentane



 





71960





003825-26-1





Ammoniumperfluoroctanoat





May only be used in recycled objects are sintered at high temperatures.







72640





007664-38-2





Phosphoric acid



 





73160



 



Mono-and di-n-alkyl (C16 and C18) phosphates





SML = 0.05 mg/kg







73720





000155-96-8





Trichlorethylphosphat





SML = IP (DL = 0.02 mg/kg, analytical tolerance included)







74010





145650-60-8





Bis (2,4-di-tert-butyl-6-methylphenyl) ethylphosphit





SML = 5 mg/kg (sum of phosphit and phosphate)







74240





031570-04-4





TRIS (2.4-di-tert-butylphenyl) phosphit



 





74480





000088-99-3






o-Phthalsyre



 





74560





000085-68-7





Benzylbutylphthalat





May be used only as:

1. Softener in materials and articles intended for repeated food contact.

2. Plasticizer in disposable materials and objects in contact with non-fatty foods, with the exception of infant formulae and follow-on formulae--children and young children as defined in Directive 91/321/EEC and products in accordance with Directive 96/5/EC.

3. Technical excipient at concentrations exceeding 0.1% in the final product.

SML = 30 mg/kg food simulant.







74640





000117-81-7





Bis (2-ethylhexyl) phthalate





May be used only as:

1. Softener in materials and articles intended for repeated contact with non-fatty food items.

2. Technical help-fabric in order-

tions exceeding 0.1% in the final product.

SML = 1.5 mg/kg food simulant.







74880





000084-74-2





Dibutyl phthalate





May be used only as:

1. Softener in materials and articles intended for repeated contact with non-fatty food items.

2. Technical help-fabric in order-

tions of not more than 0.05% of the finished product.

SML = 0.3 mg/kg food simulant







75100





068515-48-0

028553-12-0





Diphthalat with primary, saturated C8-C10 branched alcohols, over 60% C9 may only apply as:

1. Softener in materials and articles intended for repeated food contact.

2. Plasticizer in disposable materials and objects in contact with non-fatty foods, with the exception of infant formulae and follow-on formulae--children and young children as defined in Directive 91/321/EEC and products in accordance with Directive 96/5/EC.

3. Technical help-substance in concentrated residues exceeding 0.1% in the final product.

SML(t) = 9 mg/kg food simulant

(42).







75105





068515-49-1

026761-40-0





Diphthalat with primary, saturated C9-C11-branched alcohols, over 90% C10 shall only apply as:

1. Softener in materials and articles intended for repeated food contact.

2. Plasticizer in disposable materials and objects in contact with non-fatty foods, with the exception of infant formulae and follow-on formulae--children and young children as defined in Directive 91/321/EEC and products in accordance with Directive 96/5/EC.

3. Technical help-substance in concentrated residues exceeding 0.1% in the final product.

SML(t) = 9 mg/kg food simulant

(42).







76320





000085-44-9





Phthalsyreanhydrid



 





76415





019455-79-9





Pimelinsyre, calcium salt



 





76721





009016-00-6063148-62-9





Polydimethylsiloxane (molecular weight greater than 6800)





In accordance with the specifications in annex 5







76730



 



Polydimethylsiloxane, gamma-hydroxypropyleret





SMG 6 mg/kg







76815



 



Polyester of adipic acid with glycerol or pentaerythritol, esters with uforgrendede C12-C22 fatty acids (even number)






In accordance with the specifications in annex 5







76845





031831-53-5





Polyester of 1.4-Butanediol with caprolacton Restriction of ref.nr. 14260 and 13720 must be adhered to. In accordance with the specifications given in annex 5.







76866





-





Polyesters of 1.2-propanediol and/or 1.3-and/or 1.4-Butanediol and/or with adipic acid, which can be polyproplylenglycol with acetic acid or fatty acid (C12-C18) or n-octanol and/or n-decanol in endeterminalposition





SML = 30 mg/kg







76960





025322-68-3





Polyethylene glycol



 





77370





070142-34-6





Polyethyleneglycol-30 dipolyhydroxystearat



 





77600





061738-85-0





Polyethyleneglycol esters with hydrogenated castor oil



 





77702





-





Esters of polyethylene glycol with aliphatic mono carboxylic acids (C2-C22) and their ammonium and sodium sulphates



 





77895





068439-49-6





Polyethyleneglycol (EO = 2-6) monoalkyl (C16-C18) ether





SML = 0.05 mg/kg and in compliance with the specifications laid down in annex 5







79040





009005-64-5





Polyethylenglycolsorbitanmonolaurat



 





79120





009005-64-5





Polyethylenglycolsorbitanmonooleat



 





79200





009005-66-7





Polyethylenglycolsorbitanmonopalmitat



 





79280





009005-67-8





Polyethylenglycolsorbitanmonostearat



 





79360





009005-70-3





Polyethylenglycolsorbitantrioleat



 





79440





009005-71-4





Polyethylenglycolsorbitantristearat



 





79600





009046-01-9





Polyethylenglycoltridecyletherphosphat





SML = 5 mg/kg. Only for materials and articles intended to come into contact with watery foodstuffs. In accordance with the specifications in annex 5







79920





009003-11-6

106392-12-5





Poly (ethylenpropylen) glycol



 





80000





009002-88-4





Polyethylenvoks



 





80240





029894-35-7





Polyglycolricinoleat



 





80640





-





Polyoxyalkyl (C2-C4) dimethylpolysiloxane



 





80720





008017-16-1





Polyphosphoric acids



 





80800





025322-69-4





Polyethyleneglycol



 





81060





009003-07-0





Polypropylenvoks



 





81220





192268-64-7





Poly [[6-[N-(2, 2, 6, 6,-tetramethyl-4-piperidinyl)-n-butylamino]-1,3,5-triazin-2.4-diyl] [(2, 2, 6, 6,-tetramethyl-4-piperidinyl) imino] 1.6-hexandiyl [(2, 2, 6, 6,-tetramethyl-4-piperidinyl) imino-]]-alpha-[N, N, N, N ´ ´-tetrabutyl-N ´ ´-(2, 2, 6, 6,-tetramethyl-4-piperidinyl)-N ´ ´-[6-(2, 2, 6, 6,-tetramethyl-4-piperidinylamino)-hexyl]-[1, 3, 5-triazin-2, 4,6-triamin]-omega-N, N, N, N ´ ´-tetrabutyl-1, 3.5-triazin-2.4-diamine]





SML = 5 mg/kg







81500





9003-39-8





Polyvinylpyrrolidone





In accordance with the specifications given in annex 5.







81515





087189-25-1





Poly (zinkglycerolat)





SML(t) = 25 mg/kg (38) (as zinc)







81520





007758-02-3





Potassium bromide



 





81600





001310-58-3





Potassium hydroxide



 





81760





-





Powders, flakes and fibres of brass, bronze, copper, stainless steel, tin and alloys of copper, tin and iron





SML(t) = 5 mg/kg (7) (expressed as copper).

SML = 48 mg/kg (expressed as iron).







81840





000057-55-6





1.2-Propanediol



 





81882





000067-63-0





2-Propanol



 





82000





000079-09-4





Propionic acid



 





82080





009005-37-2





1.2-Propylenglycolalginat



 





82240





022788-19-8





1.2-Propylenglycoldilaurat



 





82400





000105-62-4





1.2-Propylenglycoldioleat



 





82560





033587-20-1





1.2-Propylenglycoldipalmitat



 





82720





006182-11-2





1.2-Propylenglycoldistearat



 





82800





027194-74-7





1.2-Propylenglycolmonolaurat



 





82960





001330-80-9





1.2-Propylenglycolmonooleat



 





83120





029013-28-3





1.2-Propylenglycolmonopalmitat



 





83300





001323-39-3





1.2-Propylenglycolmonostearat



 





83320





-





Propylhydroxyethylcellulose




 





83325





-





Propylhydroxymethylcellulose



 





83330





-





Propylhydroxypropylcellulose



 





83440





002466-09-3





Pyrophosphorsyre



 





83455





013445-56-2





Pyrophosphorigesyre



 





83460





012269-78-2





Pyrophyllit



 





83470





014808-60-7





Quartz



 





83599





068442-12-6





Reaction products of oleic acid, 2-mercaptoethyloleat with dichlordimethyltin, sodium sulphide and trichlormethyltin





SML(t) = 0.18 mg/kg (16) (expressed as tin)







83610





073138-82-6





Resin acids



 





83840





008050-09-7





Resin



 





84000





008050-31-5





Rosin, ester with glycerol



 





84080





008050-26-8





Rosin, ester with pentaerythritol



 





84210





065997-06-0





Rosin, hydrogenated



 





84240





065997-13-9





Rosin, hydrogenated, ester with glycerol



 





84320





008050-15-5





Rosin, hydrogenated, ester with methanol



 





84400





064365-17-9





Rosin, hydrogenated, ester with pentaerythritol



 





84560





009006-04-6





Natural rubber



 





84640





-





Salicylic acid



 





85360





000109-43-3





Dibutylsebacat



 





85601





-





Silicates, natural (except asbestos)



 





85610





-





Silicates, natural, silylated (except asbestos)



 





85680





001343-98-2





Silicic acid



 





85840





053320-86-8





Lithiummagnesiumnatriumsilicat





SML(t) = 0.6 mg/kg (8) (expressed as lithium)







86000





-





Silicic acid, silylated



 





86160





000409-21-2





Silicon Carbide



 





86240





007631-86-9





Silicon dioxide



 





86285





-





Silicon dioxide, silylated



 





86560





007647-15-6





Sodium bromide



 





86720





001310-73-2





Sodium hydroxide



 





87040





01330-43-4





Natriumtetraborat





SML(t) = 6 mg/kg (23) (expressed as boron) without prejudice. the Danish rules on drinking water







87200





000110-44-1





Sorbic acid



 





87280





029116-98-1





Sorbitandioleat



 





87520





062568-11-0





Sorbitanmonobehenat



 





87600





001338-39-2





Sorbitanmonolaurat



 





87680





001338-43-8





Sorbitanmonooleat



 





87760





026266-57-9





Sorbitanmonopalmitat



 





87840





001338-41-6





Sorbitanmonostearat



 





87920





061752-68-9





Sorbitantetrastearat



 





88080





026266-58-0





Sorbitan trioleate



 





88160





054140-20-4





Sorbitantripalmitat



 





88240





026658-19-5





Sorbitantristearat



 





88320





000050-70-4





Sorbitol



 





88600





026836-47-5





Sorbitolmonostearat



 





88640





008013-07-8





Soybean oil, epoxidised





SML = 60 mg/kg. In terms of pvc gaskets used to seal glass with infant formula and complementary treatments for infants and young children as defined in Directive 91/321/EEC or processed foodstuffs, cereal-based foods and baby foods for infants and young children as defined in Commission Directive 96/5/EC, however, lowered to 30 mg/kg.

In accordance with annex 5.







88800





009005-25-8





Starch, food quality



 





88880





068412-29-3





Starch, hydrolysed



 






88960





000124-26-5





Stearamid



 





89040





000057-11-4





Stearic acid



 





89200





007617-31-4





Kobberstearat





SML(t) = 5 mg/kg (7) expressed as copper







89440





-





Esters of stearic acid with ethylene glycol





SML(t) = 30 mg/kg (3)







90720





058446-52-9





Stearoylbenzoylmethan



 





90800





005793-94-2





Calciumstearyl-2-lactylat



 





90960





000110-15-6





Succinic acid



 





91200





000126-13-6





Saccharoseacetat-isobutyrat



 





91360





000126-14-7





Saccharoseoctaacetat



 





91840





007704-34-9





Sulphur



 





91920





007664-93-9





Sulphuric acid



 





92030





010124-44-4





Copper sulphate





SML(t) = 5 mg/kg (7) (expressed as copper)







92080





014807-96-6





Talcum powder



 





92150





001401-55-4





Tannic acid





In accordance with the JECFA specifications (= FAO/WHO Joint Expert Committee on Food Additives)







92160





000087-69-4





Tartaric acid



 





92195





-





Taurine, salts



 





92205





057569-40-1





Diester of Terephthalic acid with 2, 2 '-methylenbis (4-methyl-6-tertbutylphenol)



 





92350





000112-60-7





Tetraethylenglycol



 





92640





000102-60-3





N, N, N ', N '-Tetrakis (2-hydroxypropyl) ethylenediamine



 





92700





078301-43-6





2, 2, 4, 4-Tetramethyl-20-(2,3-epoxy propyl) 3.20-diazadispiro oxå-7-[5.1.11.2] heneicosan-21-on-, polymer





SML = 5 mg/kg







92930





120218-34-0





Thiodiethylen-bis (2.6-dimethyl-5-methoxycarbonyl-1.4-dihydropyridine-3-carboxylate)





SML = 6 mg/kg







93440





013463-67-7





Titanium dioxide



 





93520





000059-02-9010191-41-0





Alpha-Tocopherol



 





93680





009000-65-1





Tragantgummi



 





93720





000108-78-1





2, 4, 6-Triamino-1, 3.5-triazin





SML = 30 mg/kg







93760





000077-90-7





Tri-n-butylacetylcitrat



 





94320





000112-27-6





Tri-ethylene glycol



 





94960





000077-99-6





1,1,1-Trimethylolpropane





SML = 6 mg/kg







95000





028931-67-1





Trimethylolpropantrimethacrylat-methyl methacrylate copolymer



 





95020





6846-50-0





2, 2, 4-trimethyl-1.3-pentanediol-diisobutyrat





SML = 5 mg/kg food. May only be used in disposable gloves.







95200





001709-70-2





1, 3, 5-Trimethyl-2, 4,6-tris (3,5-di-tert-butyl-4-hydroxybenzyl) benzene



 





95270





161717-32-4





2, 4, 6 – Tris (tert-butyl) phenyl-2-butyl-2-ethyl-1.3-propandiolphosphit





SML = 2 mg/kg (as the sum of phosphit, phosphate and hydrolysis product = TTBP)







95420





745070-61-5





1, 3, 5-tris (2,2-dimethylpropanamido)-benzene





SML = 0.05 mg/kg food.







95725





110638-71-6





Vermiculite, reaction product with lithiumcitrat





SML(t) = 0.6 mg/kg (8) (expressed as lithium)







95855





007732-18-5





Water





In accordance with the Danish rules for drinking water







95859





-





Refined grows, derived from hydrocarbons or synthetic hydrocarbons produced





In accordance with the specifications in annex 5







95883





-





White mineral oils, paraffinic, derived from hydrocarbons from crude oil





In accordance with the specifications in annex 5







95905





013983-17-0





Wollastonit



 





95920





-





Wood flour and fibers, untreated



 





95935





011138-66-2





Xanthan gum



 





96190





020427-58-1





Zinc hydroxide





SML(t) = 25 mg/kg (38) (as zinc)







96240





001314-13-2






Zinc oxide





SML(t) = 25 mg/kg (38) (as zinc)







96320





001314-98-3





Zinc Sulfide





SML(t) = 25 mg/kg (38) (as zinc)









Section BUfuldstændig list of additives









PM/REF-nr.





CAS No.





Chemical formula






Restrictions and/or specifications 30180





002180-18-9





Manganese acetate





SML(t) = 0.6 mg/kg (10) (expressed as manganese)







31500





025134-51-4





Acrylic acid, 2-ethylhexyl acrylate, copolymer





SML(t) = 6 mg/kg (36) (expressed as acrylic acid) and SML(t) = 0.05 mg/kg (expressed as 2-ethylhexylacylat)







31520





061167-58-6





2-tert-Butyl-6-(3-tert-butyl-2-hydroxy-5-methylbenzyl)-4-methylphenylacrylat





SML = 6 mg/kg







31920





000103-23-1





Bis (2-ethylhexyl) adipat





SML = 18 mg/kg (1)







34230



 



Alkyl (C8-C22) sulphonic acid





SML = 6 mg/kg







34650





151841-65-5





Aluminiumhydroxybis [2, 2 '-methylene-bis (4,6-di-tert-butylphenyl) phosphate





SML = 5 mg/kg







35760





001309-64-4





Antimontrioxid





SML = 0.04 mg/kg (39) (expressed as antimony)







36720





017194-00-2





Barium hydroxide





SML(t) = 1 mg/kg (12) (expressed as barium)







36800





010022-31-8





Barium nitrate





SML(t) = 1 mg/kg (12) (expressed as barium)







38000





000553-54-8





Lithiumbenzoat





SML(t) = 0.6 mg/kg (8) (expressed as lithium)







38240





000119-61-9





Benzophenone





SML = 0.6 mg/kg







38505





351870-33-2





CIS-endo-bicylo [2.2.1] heptane-2.3-dicarboxylic acid, disodium salt





SML(t) = 5 mg/kg. Must not be used with polyethylene in contact with acidic foods. Purity: > or = 96% 38560





007128-64-5





2.5-Bis (5-tert-butyl-2-benzoxazolyl) Thiophene





SML = 0.6 mg/kg







38700





063397-60-4





Bis (2-carbobutoxyethyl) tin-bis (isooctylmercaptoacetat)





SML = 18 mg/kg







38800





032687-78-8





N, N-Bis ´ (3 (3,5-di-tert-butyl-4-hydro-xyphenyl) propionyl) hydrazid





SML = 15 mg/kg







38820





026741-53-7





Bis (2,4-di-tert-butylphenyl) pentaeythritoldiphosphit





SML = 0.6 mg/kg







38940





110675-26-8





2.4-bis (dodecylthiomethyl)-6-methylphenol





SML(t) = 5 mg/kg (40)







39060





035958-30-6





1.1-Bis (2-hydroxy-3,5-di tert.-butyl-phenyl) ethane





SML = 5 mg/kg







39090



 



N, N-Bis (2-hydroxyethyl) alkyl (C8-C18) amine





SML(t) = 1.2 mg/kg (13)







39120



 



N, N-Bis (2-hydroxyethyl) alkyl (C8-C18) aminhydrochlorider





SML(t) = 1.2 mg/kg (14) (expressed as tertiary Amine (expressed without HCl)







40000





000991-84-4





2.4-Bis (octylthio)-6-(4-hydroxy-3.5-di-tert-butylanilino)-1,3,5-triazin





SML = 30 mg/kg







40020





110553-27-0





2.4-Bis (octylthiomethyl)-6-methylphenol





SML(t) = 5 mg/kg (40)







40160





061269-61-2





N, N ´-Bis (2, 2, 6, 6,-tetramethyl-4-piper Idyll) 1.2-dibromoethane, copolymer-hexamethylenediamine





SML = 2.4 mg/kg







40720





025013-16-5





Tert-butyl-4-hydroxyanisole (BHA =)





SML = 30 mg/kg







40800





013003-12-8





4.4 ´-Butyliden-bis (6-tetramethyl-3-methylphenyl-ditridecylphosphit)





SML = 6 mg/kg







40980





019664-95-0





Manganbutyrat





SML(t) = 0.6 mg/kg (10) (expressed as manganese)







42000





063438-80-2





(2-Carbobutoxyethyl) tin-tris (isooctylmercaptoacetat)





SML = 30 mg/kg







42400





010377-37-4





Lithium Carbonate





SML(t) = 0.6 mg/kg (8) (expressed as lithium) = 12 mg/kg







42480





000584-09-8





Rubidiumcarbonat





SML = 12 mg/kg







43600





004080-31-3





1-(3-Chlorallyl) -3,5, 7-triaza-1-azonia-adamantanchlorid





SML = 0.3 mg/kg







43680





000075-45-6





Chlordifluormethan





SML = 6 mg/kg. In accordance with the specifications in annex 5







44960





011104-61-3





Cobaltoxid





SMGT = 0.05 mg/kg (14) (expressed as cobalt)







45440



 



Cresols, butylerede, controls the end






SML = 12 mg/kg







45650





7,041-30-4





2-Ethylhexyl-2-cyan-3.3-diphenylacrylat





SML = 0.05 mg/kg







46640





000128-37-0





2.6-di-tert-butyl-p-cresol-(= BHA)





SML = 3.0 mg/kg







47500





153250-52-3





N, N-Dicylohexyl-2.6-naphtalendicarboxamid ´





SML = 5 mg/kg







47600





084030-61-5





Di-n-dodecyltin bis (isooctylmercaptoacetat)-





SML(t) = 0.05 mg/kg food (41) (sum of mono-n-dodecyltin tris (isooctylmeraptoacetat), di-n-dodecyltin bis (isooctylmeraptoacetat), mono-and di-dode-dodecyntintrichlorid dichloride) expressed as the sum of mono-and di-dodecyltinchlorid.







48640





000131-56-6





2.4-Dihydroxybenzophenon





SML(t) = 6 mg/kg (15)







48800





000097-23-4





2.2 ´-Dihydroxy-5, 5-dichlordiphenyl-methane ´





SML = 12 mg/kg







48880





000131-53-3





2.2 ´-Dihydroxy-4-methoxybenzo-phenon





SML(t) = 6 mg/kg (15)







49595





057583-35-4





Dimethyltin bis (ethylhexylmercaptoacetat)-





SML(t) = 0.18 mg/kg (16) (expressed as tin)







49600





026636-01-1





Dimethyltin bis (isooctylmercaptoacetat)-





SML(t) = 0.18 mg/kg (16) (expressed as tin)







49840





002500-88-1





Diotadecyldisulfid





SML = 3 mg/kg







50160



 



Di-n-octyltin bis-(n-alkyl (C10-C16) mercaptoacetat)





SML(t) = 0.006 mg/kg (17) (expressed as tin)







50240





010039-33-5





Di-n-octyltin bis (2-ethylhexylmaleat)-





SML(t) = 0.006 mg/kg (17) (expressed as tin)







50320





015571-58-1





Di-n-octyltin bis (2-ethylhexylmercaptoacetat)-





SML(t) = 0.006 mg/kg (17) (expressed as tin)







50360



 



Di-n-octyltin bis (ethylmaleat)-





SML(t) = 0.006 mg/kg (17) (expressed as tin)







50400





033568-99-9





Di-n-octyltin bis (isooctylmaleat)-





SML(t) = 0.006 mg/kg (17) (expressed as tin)







50480





026401-97-8





Di-n-octyltin bis (isooctylmercaptoacetat)-





SML(t) = 0.006 mg/kg (17) (expressed as tin)







50560



 



Di-n-octyltin 1.4-Butanediol-bis-(mercaptoacetat)





SML(t) = 0.006 mg/kg (17) (expressed as tin)







50640





003648-18-8





Di-n-octyltindilaurat





SML(t) = 0.006 mg/kg (17) (expressed as tin)







50720





015571-60-5





Di-n-octyltindimaleat





SML(t) = 0.006 mg/kg (17) (expressed as tin)







50800



 



Di-n-octyltindimaleat, esterifiseret





SML(t) = 0.006 mg/kg (17) (expressed as tin)







50880



 



Di-n-octyltindimaleinat, polymers (n = 2-4)





SML(t) = 0.006 mg/kg (17) (expressed as tin)







50960





069226-44-4





Di-n-octyltin-ethylene-glycol-bis (mercaptoacetat)





SML(t) = 0.006 mg/kg (17) (expressed as tin)







51040





015535-79-2





Di-n-octyltinmercapoacetat





SML(t) = 0.006 mg/kg (17) (expressed as tin)







51120



 



Di-n-octyltin-thiobenzoat-2-ethylhexylmercaptoacetat





SML(t) = 0.006 mg/kg (17) (expressed as tin)







51570





000127-63-9





Diphenylsulfon





SML (T) = 3 mg/kg (25)







51680





000102-08-9





N, N-Diphenylthiourinstof ´





SML = 3 mg/kg







52000





027176-87-0





Dodecylbenzenensulfonsyre





SML = 30 mg/kg







52320





052047-59-3





2-(4-Dodecylphenyl) indole





SML = 0.06 mg/kg







52880





023676-09-7





Ethyl-4-ethoxybenzoat





SML = 3.6 mg/kg







53200





023949-66-8





2-Ethoxy-2-ethyloxanilid ´





SML = 30 mg/kg







54880





000050-00-0





Formaldehyde





SML(t) = 15 mg/kg (22)







55200





001166-52-5





Dodecylgallat





SML(t) = 30 mg/kg (34)







55280





001034-01-1





Octylgallat





SML(t) = 30 mg/kg (34)







55360





000121-79-9





Propyl gallate





SML(t) = 30 mg/kg (34)







58960





000057-09-0





Hexadecyltrimethylammoniumbromid





SML = 6 mg/kg







59120





023128-74-7





1.6-Hexamethylen-bis (3-(3,5-di-tert-butyl-4-hydroxyphenyl) propionamid)





SML = 45 mg/kg








59200





035074-77-2





1.6-Hexamethylen-bis (3-(3,5-di-tert-butyl-4-hydroxyphenyl) propionate)





SML = 6 mg/kg







60320





070321-86-7





2-(2-Hydroxy-3.5-bis (1,1-dimethylbenzyl) phenyl) benzotriazol





SML(t) = 1.5 mg/kg







60400





003896-11-5





2-(2-Hydroxy-3 ´ ´-tert-butyl-5-methylphenyl ´)-5-chlorbenzotriazol





SML = 30 mg/kg (19)







60800





065447-77-0





dimethyl 1-(2-hydroxyethyl)-4-hydroxy-2, 2-6, 6-tetramethyl-, piperidinsuccinat, copolymer





SML = 30 mg/kg







61280





003293-97-8





2-Hydroxy-4-n-hexyloxybenzophenon





SML(t) = 6 mg/kg (15)







61360





000131-57-7





2-Hydroxy-4-methoxybenzophenon





SML(t) = 6 mg/kg (15)







61440





002440-22-4





2-(2-Hydroxy-5 ´ ´-methylphenyl) benzotriazol





SML(t) = 30 mg/kg (19)







61600





001843-05-6





2-Hydroxy-4-n-octyloxybenzophenon





SML(t) = 6 mg/kg (15)







63200





051877-53-3





Manganlactat





SML(t) = 0.6 mg/kg (10) (expressed as manganese)







63940





008062-15-5





Ligninsulfonsyre





SML(t) = 0.24 mg/kg-must only be used as a dispersant for plastdispertioner 64320





010377-51-2





Lithiumjodid





SML(t) = 1 mg/kg (11) (expressed as iodine) and SML (T) = 0.6 mg/kg (8) (expressed as lithium)







65120





007773-01-5





Manganese





SML(t) = 0.6 mg/kg (10) (expressed as manganese)







65200





012626-88-9





Manganese hydroxide





SML(t) = 0.6 mg/kg (10) (expressed as manganese)







65280





010043-84-2





Manganhypophosphit





SML(t) = 0.6 mg/kg (10) (expressed as manganese)







65360





011129-60-5





Manganese oxide





SML(t) = 0.6 mg/kg (10) (expressed as manganese)







65440



 



Manganpyrophosphit





SML(t) = 0.6 mg/kg (10) (expressed as manganese)







66350





085209-93-4





2.2 ´-methyl-bis (4,6-di-tert-butylphenyl) lithiumphosphat





SML(t) = 5 mg/kg and SML(t) = 0.6 (8) (expressed as lithium)







66360





085209-91-2





2 ´, 2-Methylene-bis ´ (4,6-di-tert-butyl-phenyl) sodium phosphate





SML = 5 mg/kg







66400





000088-24-4





2.2 ´-Methylenbis (4-ethyl-6-tert-butyl-phenol)





SML(t) = 1.5 mg/kg (20)







66480





000119-47-1





2.2 ´-Methylenbis (4-methyl-6-tert-butylphenol)





SML(t) = 1.5 mg/kg (20)







67360





067649-65-4





Mono-n-dodecyltin tris (isooctylmercaptoacetat)-





SML(t) = 0.05 mg/kg. food (41) (sum of mono-n-dodecyltin tris (isooctylmeraptoacetat), di-n-dodecyltin bis (isooctylmeraptoacetat), mono-and di-dode-dodecyntintrichlorid dichloride) expressed as the sum of mono-and di-dodecyltinchlorid.







67515





057583-34-3





Monomethylin-tris (ethylhexyl-mercaptoacetat)





SML(t) = 0.18 mg/kg (16) (expressed as tin)







67520





054849-38-6





Monomethyltin tris (isooctylmercaptoacetat)-





SML(t) = 0.18 mg/kg (16) (expressed as tin)







67600



 



Mono-n-octylin-tris (alkyl (C10-C16) mercaptoacetat)





SML(t) = 1.2 mg/kg (17) (expressed as tin)







67680





027107-89-7





Mono-n-octylin-tris (2-ethyl-hexylmercaptoacetat)





SML(t) = 1.2 mg/kg (17) (expressed as tin)







67760





026401-86-5





Mono-n-octylin-tris (isooctylmercaptoacetat)





SML(t) = 1.2 mg/kg (17) (expressed as tin)







67896





020336-96-3





Lithiummyristat





SML(t) = 0.6 mg/kg (8) (expressed as lithium)







68320





002082-79-3





Octadetyl-3-(3,5-di tert-butyl-4-hydroxyphenyl) propionate





SML = 6 mg/kg







68400





010094-45-8





Octadecylerucamid





SML = 5 mg/kg







68860





04724-48-5






n-Octylphosphonsyre





SML = 0.05 mg/kg







69160





014666-94-5





Oleic acid, cobaltsalt





SML(t) = 0.05 mg/kg (14) (expressed as cobalt)







69840





016260-09-6





Oleylpalmitamid





SML = 5 mg/kg







71935





007601-89-0





Weight monohydrate





SML = 0.05 mg/kg (31)







72081/10





-





Petroleum hydrocarbon resins (hydrogenated)





SML = 5 mg/kg (1) and in accordance with the specifications given in annex 5.







72160





000948-65-2






2-Phenylindon





SML = 15 mg/kg







72800





001241-94-7





2-ethylhexyl diphenyl phosphate





SML = 2.4 mg/kg







73040





013763-32-1





Lithiumphosphat





SML (T) = 0.6 mg/kg (8) (expressed as lithium)







73120





010124-54-6





Manganphosphat





SML(t) = 0.6 mg/kg (10) (expressed as manganese)







74400



 



TRIS (nonyl-and/or dinomylonylphenyl)-phosphit





SML = 30 mg/kg







77440



 



Polyethylene glycol-di-cricinoleat





SML = 42 mg/kg







77520





061791-12-6





Ester of polyethylene glycol with castor oil





SML = 42 mg/kg







78320





009004-97-1





Polyethylenglycolmonoricinoleat





SML = 42 mg/kg







81200





071878-19-8





Poly [6-[(1, 3, 3, 3-tetramethylbutyl) amino]-1,3,5-triazin-2.4-diyl ([2, 2, 6, 6-tetra methyl-4-piper Idyll)-imino-hexametilen-[(2, 2, 6, 6,-tetramethyl-4-piper Idyll) imino]





SML = 3 mg/kg







81680





007681-11-0





Potassium iodide





SML(t) = 1 mg/kg (11) (expressed as iodine)







82020





019019-51-3





Cobaltpropionat





SML(t) = 0.05 mg/kg (14) (expressed as cobalt)







83595





119345-01-6





Reaction product of di-tert-butylphosphonit with biphenyl from condensation of 2.4-di-tert-butylphenol with Friedel Craft reaction product of phosphortriclorid with biphenyl





SML = 18 mg/kg. In accordance with the specifications given in annex 5.







83700





000141-22-0





Ricinoleic acid





SML = 42 mg/kg







84800





000087-18-3





4-Tert-butylphenylsalicylat





SML = 12 mg/kg







84880





000119-36-8





Methyl salicylate SML = 30 mg/kg







85760





012068-40-5





Aluminiumlithiumsilicat (2:1: 1)





SML (T) = 0.6 mg/kg (8) (expressed as lithium)







85920





012068-14-4





Lithiumsilicat





SML (T) = 0.6 mg/kg (8) (expressed as lithium)







85950





037296-97-2





Silicic acid, magnesium sodium fluoridsalt





SML = 0.15 mg/kg (expressed as fluoride). May only be used in layers of multilayer materials which do not come into contact with foodstuffs







86480





007631-90-5





Natriumbisulfit





SML (T) = 10 mg/kg (30) (expressed as SO2)







86800





007681-82-5





Sodium iodide





SML(t) = 1 mg/kg (11) (expressed as iodine)







86880



 



Natriummonoalkyldialkylphenoxybenzendisulfonat





SML = 9 mg/kg







86920





007632-00-0





Sodium nitrite





SML = 0.6 mg/kg







86960





007757-83-7





Sodium sulphite





SML (T) 10 mg/kg (30) (expressed as SO2)







87120





007772-98-7





Sodium Thiosulphate solution





SML (T) = 10 mg/kg (30) (expressed as SO2)







89170





013586-84-0





Cobaltstearat





SML(t) = 0.05 mg/kg (14) (expressed as cobalt)







92000





007727-43-7





Barium sulphate





SML(t) = 1 mg/kg (12) (expressed as barium)







92320



 



Tetradecyl-polyethylenoxid (EO = 3-8) ether of glycolic acid





SML = 15 mg/kg







92560





038613-77-3





Tetrakis (2,4-di-tert-butylphenyl)-4-4 ´-biphenylendiphosphonit





SML = 18 mg/kg







92800





000096-69-5





4.4 ´-Thiobis (6-tert-butyl-3-methyl-phenol)





SML = 0.48 mg/kg







92880





041484-35-9





Thiodiethanol-bis (3-(3,5-di-tert-butyl-4-hydroxyphenyl) propionate





SML = 2.4 mg/kg







93120





000123-28-4





Didodecylthiodipropionat





SML(t) = 5 mg/kg (21)







93280





000693-36-7





Dioctadecylthiodipropionat





SML(t) = 5 mg/kg (21)







93970





-Tricyclodecanimethanol-bis (hexahydrophthalat)





SML = 0.05 mg/kg.







94400





036443-68-2





Triethylenglycolbis [3-(3-tert-butyl-4-hydroxy-5-methylphenyl) propionate]





SML = 9 mg/kg







94560





000122-20-3





Triisopropanolamin





SML = 5 mg/kg







95265





227099-60-7





1, 3, 5-tris (3-benzoylphenyl) benzene





SML = 0.05 mg/kg







95280





040601-76-1






1, 3, 5-Tris (4-tert-butyl-3-hydroxy-2.6-dimethylbenzyl)-1,3,5-triazin-2, 4,6 (1 h, 3 h, 5 h)-trion





SML = 6 mg/kg







95360





027676-62-6





1, 3, 5-Tris (3,5-di-tert-butyl-4-hydroxy-phenyl) 1,3,5-triazin-2, 4-6-(1 h, 3 h, 5 h)-trion





SML = 5 mg/kg







95600





001843-03-4





1, 1, 3-tris (2-methyl-4-hydroxy-5-tert-butylphenyl) butane





SML = 5 mg/kg







Annex 4









Products obtained by means of bacterial fermentation







PM/REF-nr.





CAS No.





Chemical formula






Restrictions and/or specifications 18888





80181-31-3





3-hydroxybutansyre-3-hydroxypentansyre, copolymer





In accordance with the specifications in annex 5







Annex 5

Specifications for some of the substances in annexes 2, 3 and 4

Section AGenerelle specifications

Plastic materials and articles shall not release primary aromatic amines in detectable levels (DL = 0.01 mg/kg of food or food simulant). The migration of the primary aromatic amines listed in the lists in annexes 2 and 3, are not subject to this restriction.

Section BSpecifikationer for certain individual substances









PM/REF-nr.





Specifications for certain individual substances 11530





2-hydroxypropyl acrylate

Can contain up to 25% (m/m) 2-hydroxyisopropylacrylat (CAS no 002918-23-2)







16690





DivinylbenzenKan contain up to 45% (m/m) ethylvinylbenzen







18888





3-hydroxybutansyre-3-hydroxypentansyre-copolymer





 



Definition





These copolymers are produced by the controlled fermentation of Alcaligenes eutrohus using mixtures of glykose and propane acid as carbon sources. They used is not genetically engineered organisms and are derived from a single wild-type organism, strain H16 NCIMB 10442 Alcaligens eutrophus,. The organism must be stored as freeze-dried ampoules. Apart from these ampoules are produced a working culture, which are stored in liquid nitrogen and used to prepare podestoffer to the fermenter. Fermentation samples examined daily both in the microscope and for changes in colony morphology on a number of different agarer at different temperatures. Copolymererne isolated from heat-treated bacteria by controlled decomposition of the other cell components, leaching and drying. These copolymers are normally offered as formulated, melt formed granules containing additives such as nucleating agents, plasticisers, fillers, stabilisers and pigments which all comply with the General and individual specifications





 



Chemical formula





Poly (3-D-hydroxybutanoat-co-3-D-hydroxypentanoat)





 



CAS number





080181-31-3





 



Structural formula





Ch3 | CH3O CH2O | || | || (-O-CH-CH2-C-) m-(O-CH-CH2-C-) n





 

 

 



where n/m (+ n) is greater than 0 and less or equal to 0.25





 



Average molecular weight not less than 150 000 Daltons (measured by gelpermeationskromatografi).





 



Content





Not less than 98% poly (3-D-hydroxybutanoat-co-3-D-hydroxypentanoat) analysed after hydrolysis as a mixture of 3-D-hydroxybutansyre and 3-D-hydropentansyre.





 



Description is presented as a white to ivory white powder after isolation.





 



Properties





 



Identification tests:





 

 



Dissolve-equality





Soluble in chlorinated hydrocarbons such as chloroform or dichloromethane but practically insoluble in ethanol, aliphatic alkanes and water Restriction





QMA for CROTONIC ACID, esters is 0.05 mg/6 dm2 Purity





Prior to granulation the raw material powder in copolymers shall contain:





 



-





Nitrogen





Not more than 2500 mg/kg of plastic





 



-





Zinc





Not more than 100 mg/kg of plastic





 



-





Copper





Not more than 5 mg/kg of plastic





 



-





Lead





Not more than 2 mg/kg of plastic





 



-





Arsenic





Not more than 1 mg/kg of plastic





 



-





Chromium





Not more than 1 mg/kg of plastic







23547





Polydimethylsiloxane (molecular weight greater than 6800) Minimum viscosity 100 x 10-6 m2/s (= 100 centistoke) at 25 oC







24903





Syrups, hydroliserede starch, hydrogenated

In accordance with the purity criteria for maltitol syrup E 965 (ii) (Commission Directive 95/31/EC (OJ L 178 of 28.7.1995 p. 1). As last amended by Commission Directive 2004/46/EC (OJ L 114 of 21.4.2004, p. 15)).







25385





Triallylamin40 mg/kg hydro gels in an amount up to a maximum of 1.5 grams of hydrogel per kg of food. Only for use in hydro gels, which are not intended for direct contact with food.







38320





4-(2-benzoxazolyl)-4 '-(5-methyl-2-benzoxazolyl) stilbenIkke of 0.05% w/w (quantity of substance used/quantity of the formulation) 42080





Vegetal coal

Specifications:

Tolueneekstraherbare substances: maximum 0.1%, determined according to ISO method 6209.

UV absorption of cyclohexane extract at 386 nm: 0.02 AU for a cm 3 Pa · s at 120 ° c

Softening point: > 95 ° c as determined by ASTM method E 28-67

Bromtal: 40 (ASTM D1159) <

Color on a 50% solution in toluene: 11 on Gardner-gamut