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Plastic Regulation 2003

Original Language Title: Änderung der Kunststoffverordnung 2003

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325. Federal Minister for Health, Family and Youth Regulation 2003

On the basis of § 19(2). 1 of the food safety and consumer laws - LMESA, BGBl. I No 13/2006, last amended by the Federal Law BGBl. I No 24/2007, will be prescribed:

The Plastic Regulation 2003 BGBl. II No. 476/2003, last amended by Regulation BGBl. II No 452/2006, as follows:

1. § 2(2). 1 is:

"(1) Plastic objects are

1.

materials and objects or parts thereof consisting exclusively of plastic;

2.

multi-layered materials and plastic items;

3.

Plastic layers or coatings that serve as cap seals and consist of two or more layers of different types of materials. “

2. In § 2, 4 to 6:

“(4) Multi-layered materials and articles of plastic as required. 1 Z 2 consists of two or more layers, each of which is exclusively made of plastic and which are held by adhesives or otherwise.

(5) A functional barrier from plastic is a barrier consisting of one or more layers of plastic and ensures that the subject-matter in the finished article 3 of Regulation (EC) No. 1935/2004 of 27. This Regulation is in line with Directives 80/590/EEC and 89/109/EEC (OJ L 338 of 13 November 2004).

(6) Non-fat food is food for which in Annex 8 other simulates for migration reviews are defined than the simulate proceeding.

3. In § 4(2). 2 "1. July 2006" by the expression "1. April 2008" replaced.

4. The § 4 is the following paragraph. 4:

“(4) The use of Azodicarbonamid, Ref.-No. 36640 (CAS. No. 000123-77-3) in the manufacture of plastic objects is prohibited. “

5. § 8(2). 1 is:

“(1) Plastic objects cannot transfer their ingredients to foods in quantities of more than 60 mg of substances per kilogrammes of food or simulate matter (mg/kg) (total migration limit). However, in the following cases this limit is 10 mg per dm2 the surface of the product (mg/dm)2):

1.

retention or retention-like or other refillable items with a capacity of less than 500 millilitres (ml) or more than 10 litres (l);

2.

plates, foils or other non-fillable items or those where the relationship between the contact area of such plastic items cannot be determined to the amount of food that is in contact.

For plastic items intended for use with foods intended for infants and young children, in accordance with the Regulation on infant and follow-up food, BGBl. No. 531/1995, in the respective version, or in the case-by-case regulation, BGBl. II No. 133/1998, in the respective version, is always at 60 mg/kg."

6. The following paragraphs are set out in § 8. 3 to 6:

"(3) In the case of plastic objects referred to in Section 2(2). 1 Z 2 must match the composition of each plastic layer of this Regulation.

(4) Derogation of paragraph 3 applies to a layer that does not come into contact with food directly and separated from it by a functional barrier of plastic, subject to compliance with the specific and total migration limits set out in this Regulation, in the case of finished arttoff items.

(a)

that they do not need to comply with the restrictions and specifications laid down in this Regulation;

(b)

that they may be made from other substances than those listed in this Regulation or in the national directories for plastic items intended to come into contact with food.

(5) The migration of the substances referred to in paragraph 4 (b) in food or simulate proceeding may be 0,01 mg/kg, with statistical certainty, with an analytical method referred to in Article 11 of Regulation (EC) No 882/2004 of 29. April 2004 on official controls to verify compliance with food and feed law and animal health and welfare provisions (OJ L 165, 30. April 2004, corrected by OJ No L 191 of 28 May 2004). This limit is always expressed as concentration in food or simulate matter. It applies to a group of compounds, if they are structural and toxicological, in particular isomers or compounds of the same relevant functional group, and takes into account any transfer by declave.

(6) The substances referred to in paragraph 4 (b) may not belong to one of the following groups:

(a)

Substances classified in Annex A of the Chemicals Prohibition Regulation 2003 BGBl. II No. 477/2003, as either valid or likely to cause cancer, mutagenic or toxic to reproduction, or

(b)

Substances classified as a proven or likely carcinogenic, mutagenic or toxic to reproduction due to the self-responsibility criteria of Annex B, Part 3, point 6, the Chemical Regulation 1999 - ChemV 1999, BGBl. II No 81/2000. “

7. § 8a is:

"Conformity Statement

§ 8a. (1) Plastic objects and the same specific substances must be attached to a written declaration in accordance with Article 16 of Regulation (EC) No. 1935/2004.

(2) The statement referred to in paragraph 1 shall be made by the entrepreneur and contains the information set out in Annex 5a of this Regulation.

(3) The entrepreneur has to provide the competent authority (Landeshauptmann pursuant to § 24 LMESA) with appropriate documentation at the request that the objects of arttoff and the substances intended for their manufacture conform to the requirements of this Regulation. These documents include a description of the conditions and results of tests, calculations, other analyses as well as safety proofs or a justification which proves conformity. “

8. § 9(2). 4 is:

"(4) Without prejudice to the paragraph. 1 will be carried out in the phthalates mentioned in Annex 2, Section B (Ref.-No 74640, 74880, 74560, 75100, 75105) only for the verification of specific migration limits. However, the verification of SML on food can only be carried out if the food has not yet been in touch with the use of plastic and has been previously tested for the phthalate, and if the value found is not statistically significant and not larger or equal to the limit of desirability. “

9. In § 9, the previous paragraphs will be made. 4 and 5 respectively. 6 and 7.

10. § 11(2). 1 to 3 are:

(1) Plastic items not covered by Regulation BGBl. II No. 325/2007, but still up to 30. manufactured or imported on April 2009 and brought into circulation until the full reduction of the stocks.

(2) Plastic objects, unless they are caps containing a seal, which are not covered by Regulation BGBl. II No 325/2007, but to the extent that it relates to the refer.-No 30340, 30401, 36640, 56800, 76815, 76866, 88640 and 93760, may still be 30 manufactured or imported by June 2008 and brought into circulation until the full reduction of the stocks.

(3) Plastic items not covered by Regulation BGBl. II No 325/2007, but to the extent that it relates to phthalate with the refer.-No 74560, 74640, 74880, 75100 and 75105, may still be until 30. manufactured or imported by June 2008 and brought into circulation until the full reduction of the stocks. “

11. The following Directive is added to § 12:

"

2007/19/EC of the Commission amending Directive 2002/72/EC on materials and articles of plastic intended to come into contact with food and Council Directive 85/572/EEC on the list of simulate proceeds for the migration investigation of materials and articles of plastic intended to come into contact with food (OJ L 91, 31.12. March 2007, corrected by OJ No L 97 of 12 April 2007. “

12. The following Z 2a and b and 5a are inserted in Annex 1 General Introduction:

"2a.

correction of specific migration in food containing more than 20% fat by the fat reduction factor (FRF):

The Fat reduction factor' (FRF) is a factor between 1 and 5, sharing the measured migration of lipophilic substances in fat food or the simulate-soluble D and its substitutes before compared to the specific migration limits.

General rules

Substances used for the purpose of applying the FRF as Lipophil' is listed in Annex 3a. The specific migration of lipophilic substances in mg/kg (M) is corrected by the FRF, which varies between 1 and 5 (MFRF). The following equations must be applied before comparison with the required limit value:

MFRF = M/FRF

and

FRF = (g fat in food/kg food)/200 = (% fat × 5)/100

This correction by the FRF is due in the following cases:

(a)

if the use of plastic with food containing less than 20% fat comes into contact or is intended for this purpose;

(b)

if the use of plastic for infants and young children within the meaning of the Regulation on infant formula and follow-up food, BGBl. No. 531/1995, in the respective version, or in the case-by-case regulation, BGBl. II No. 133/1998, in the respective version, specific foods come into contact or intended;

(c)

substances listed in Annex 1 and 2 for which a restriction is registered in column (4) SML = NN, or for non-listed substances used beyond a functional barrier of plastic with a migration limit of 0.01 mg/kg;

(d)

in the case of plastic items in which the ratio of the contact area to the amount of food that is in contact - for example because of their form or type of use - cannot be determined and where migration can be determined on the basis of the conventional surface/volume factor of 6 dm2/kg is calculated.

This correction by the FRF is made in the following case under certain conditions:

In the case of containers or flat-like or other refillable items with a capacity of less than 500 ml or more than 10 litres, as well as in plates and foils that come into contact with food with a fat content of more than 20%, migration is calculated either as concentration in the food or simulate proceeds (mg/kg) and corrected for the FRF, but it is corrected without the FRF in mg/dm.2 converted. If one of the two values is lower than SML, it is expected that the plastic subject is in line with the rules.

The application of the FRF must not lead to the fact that the specific migration value exceeds the total migration limit.

2b.

Correction of specific migration in the Simulance Bonds D:

The following factors apply to the correction of the specific migration of lipophilic substances in the D and its substitutes:

(a)

the reduction factor referred to in Z 3 of Annex 8, which is referred to below as a reduction factor of the simulate proceeding (DRF).

The DRF is sometimes not applicable if the specific migration to the simulate matter D exceeds 80% of the content of the substance in the finished plastic (e.g. thin foil). To determine whether DRF is applicable, scientific or experimental evidence is required (e.g. experiments with the most critical food). It is also not applicable to substances listed in the Community lists, for which a restriction is registered in column (4) SML = NN, or for non-listed substances used beyond a functional barrier of plastic, with a migration limit of 0.01 mg/kg.

(b)

the FRF, which is applicable to migration in simulate matter, provided that the fat content of the food to be packaged is known and meets the requirements set out in paragraph 2a.

(c)

the total reduction factor (TRF), whose value is maximum 5, is the factor that divides measured specific migration into the D or a substitut before compared to the required limit value. It is calculated by multiplying the DRF with the FRF if both factors are applicable.

5a.

caps, caps, seals, stöpsel and similar conclusions:

(a)

If their intended use is known, such decisions must be examined by linking them to the containers according to the intended or foreseeable use. It is assumed that these decisions come into contact with the amount of food necessary to satisfy the containers. The results are in mg/kg or mg/dm according to § 8 and Z 9 of this plant2 to express the entire contact surface of the closure and the retention.

(b)

If their use is not known, such decisions must be examined in a specific attempt, whose result is expressed in mg/weight. The calculated value will be added to the quantity that will be separated from the container to be closed with the closure."

13. The following is added to Annex 1 Z 9:

(c)

For plastic items intended for infants and young children, in accordance with the Regulation on infant and follow-up food, BGBl. No. 531/1995, in the respective version, or in the case-by-case regulation, BGBl. II No. 133/1998, in the respective version, or already in contact with such foods, the specific migration limits must always be specified in mg/kg. “

14. In Annex 1, Section A, the following monomers and other raw materials are inserted in corresponding numerical order:

Ref. No.

CAS No.

Name

Restrictions and/or specifications

(1)

(2)

(3)

(4)

"15267

21970

24886

000080-08-0

000923-02-4

046728-75-0

4.4'-diaminodiphenylsulfon

N-Methylolmethacrylamid

5-Sulfoisophthalic acid, Monolithium salt

SML = 5 mg/kg

SML = 0.05 mg/kg

SML = 5 mg/kg and for lithium

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

15. For the following monomers and other raw materials listed in Annex 1, Section A, the contents of the column "Restrictions and/or specifications" as follows:

Ref. No.

CAS No.

Name

Restrictions and/or specifications

(1)

(2)

(3)

(4)

"12786

16450

25900

000919-30-2

000646-06-0

000110-88-3

3-Aminopropyltriethoxysilan

1.3-Dioxolan

Trixan

Additional residues to 3 amino-propyltriethoxysilan in case of use for the reactive upper surface treatment of inorganic fillers under 3 mg/kg fillers and SML = 0,05 mg/kg for surface treatment of materials and objects

SML = 5 mg/kg

SML = 5 mg/kg

16. The following monomers and other raw materials are removed from Annex 1 Section B:

Ref. No.

CAS No.

Name

Restrictions and/or specifications

(1)

(2)

(3)

(4)

"21970

000923-02-4

N-Methylolmethacrylamid"

17. In Annex 2, Section A, the following additives are inserted in corresponding numerical order:

Ref. No.

CAS No.

Name

Restrictions and/or specifications

(1)

(2)

(3)

(4)

"38885

42080

45705

62020

67180

71960

74560

74640

74880

75100

75105

79920

81500

93760

95020

95420

002725-22-6

001333-86-4

166412-78-8

007620-77-1

-

003825-26-1

000085-68-7

000117-81-7

000084-74-2

068515-48-0

028553-12-0

068515-49-1

026761-40-0

009003-11-6

106392-12-5

9003-39-8

000077-90-7

6846-50-0

745070-61-5

2.4-Bis(2.4-dimethyl-phenyl)-6-(2-hydroxy-phenyl)

4-n-octyloxyphenyl)-1,3,5-Triazin

Carbon black

1.2-Cyclohexandicarbon Acid, Diisononylester

12Hydroxystearinic acid, lithium salt

Mix of (50 gew-%) n-Decyl-noctylphthalate, (25 gew-%) Di-n-decylphthalate

and (25%) Di-n-octyl-phthalate

Perfluoroctanic acid, ammonia salt

Phthalic acid, benylbutyl ester

Phthalic acid, bis(2-ethylhexyl) ester

Phthalic acid, Dibutylester

Phthalic acid, Diester with primä-ren, saturated C8 C10- diverted alcohol, more than 60% C9.

Phthalic acid, Diester with primä-ren, saturated C9 C11- Alko collect, more than 90% C10

Poly(ethylene propylene)glykol

Polyvinylpyrrolidon

Tri-n-butylacetylcirate

2.2.4-Trimethyl-1,3-pentandioldiisobutyrat

1.3.5-Tris(2-dimethyl-propanamido)-benzol

SML = 0.05 mg/kg. Only for disadvantaged food.

The specifications in Annex 4.

SML(T) = 0.6 mg/kg (T)8)

lithium)

SML = 5 mg/kg (1)

Only in case of multi-way objects

High temperatures are cleaned

to use

Use only as

a) plasticisers in multi-path materials

and items;

b) plasticizers in disposable materials

and items containing fat-free

Food comes into contact, except for infant formula and follow-up foods, in accordance with the Regulation on infant and follow-up food, BGBl. No. 531/1995, in the respective version, or products under the Merger Regulation, BGBl. II No. 133/1998, in the respective version;

c) Technical assistance in conzentra operations of up to 0.1% in the final product.

SML = 30 mg/kg simulate matter

Use only as

a) plasticisers in multi-path materials

and items that come into contact with fat-free food;

b) Technical assistance in conzentra operations of up to 0.1% in the final product.

SML = 1.5 mg/kg simulate matter

Use only as

a) plasticisers in multi-path materials

and items that come into contact with fat-free food;

b) Technical assistance in conzentra operations of up to 0.05 % at the end ofrzeu.

SML = 0.3 mg/kg simulate matter

Use only as

a) plasticisers in multi-path materials

and items;

b) plasticizers in disposable materials

and items containing fat-free

Food comes into contact, except for infant formula and follow-up foods, in accordance with the Regulation on infant and follow-up food, BGBl. No. 531/1995, in the respective version, or products under the Merger Regulation, BGBl. II No. 133/1998, in the respective version;

c) Technical assistance in conzentra operations of up to 0.1% in the final product.

SML(T) = 9 mg/kg simulate matter

(b)42)

Use only as

a) plasticisers in multi-path materials

and items;

b) plasticizers in disposable materials

and items containing fat-free

Food comes into contact, except for infant formula and follow-up foods, in accordance with the Regulation on infant and follow-up food, BGBl. No. 531/1995, in the respective version, or products under the Merger Regulation, BGBl. II No. 133/1998, in the respective version;

c) Technical assistance in demonstrations of up to 0.1% in the final product.

SML(T) = 9 mg/kg simulate matter

(b)42)

The specifications in Annex 4.

SML = 5 mg/kg food. Only in

use disposable gloves.

SML = 0.05 mg/kg food

18. For the following additives listed in Annex 2, Section A, the contents of the columns "Signature" and "Restrictions and/or specifications" as follows:

Ref. No.

CAS No.

Name

Restrictions and/or specifications

(1)

(2)

(3)

(4)

"43480

45200

76845

81760

88640

064365-11-3

001335-23-5

031831-53-5

-

008013-07-8

Active coal

Copperjo stand

Polyester from 1.4-butandiol with Caprolacton

powder, slumps and fibres of brass, bronze, copper, stainless steel, tin and legierun-gen from copper, tin and iron

Soy oil, oxidised

The specifications in Annex 4.

SML(T) = 5 mg/kg (T)7)

Copper) and SML = 1 mg/kg (11) (calculated as Jod)

The restriction on Ref.-No 14260 and Ref.-No 13720 must be respected. The specifications in Annex 4.

SML(T) = 5 mg/kg (T)7(calculated as copper);

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

SML = 60 mg/kg. For PVC-freezing material used to disseminate glass vessels, infant food and follow-up foods in accordance with the Regulation on infant formula and follow-up food, BGBl. No. 531/1995, in the respective version, or cereal-based foods and other baby foods, as provided for in the food aid regulation, BGBl. II No 133/1998, in the respective version, the SML will be reduced to 30 mg/kg.

The specifications in Annex 4 are:

to comply. “

19. The following additives are deleted from Annex 2, Section A:

Ref. No.

CAS No.

Name

Restrictions and/or specifications

(1)

(2)

(3)

(4)

"35760

36640

001309-64-4

000123-77-3

Anti-montrioxide

Azodicarbonamid

SML = 0,04 mg/kg (39) (calculated as an antimon)

Only for use as a greenhouse gas. Prohibition from 2 August 2005"

20. In Annex 2, Section B, the following additives are inserted in corresponding numerical order:

Ref. No.

CAS No.

Name

Restrictions and/or specifications

(1)

(2)

(3)

(4)

"35760

47500

72081/10

93970

001309-64-4

153250-52-3

-

-

Anti-montrioxide

N,N'-Dicyclohexyl-2,6-naphthaldicarboxamid

Oil hydrocarbons (hydrated)

Tricyclodecan-dimethanol-bis(hexahydrophthalate)

SML = 0,04 mg/kg (39) (calculated as antimony)

SML = 5 mg/kg

SML = 5 mg/kg (1) and the specificities in Annex 4.

SML = 0.05 mg/kg

21. For the following additives listed in Annex 2, Section B, the contents of the columns "Signature" or "Restrictions and/or specifications" as follows:

Ref. No.

CAS No.

Name

Restrictions and/or specifications

(1)

(2)

(3)

(4)

"47600"

67360

084030-61-5

067649-65-4

Di-n-dodecylzinn-bis(isooctylthioglycolat)

Mono-n-dodecylzinn-tris(isooctylthioglycolat)

SML(T) = 0.05 mg/kg food (T)41)

Di-n-dodecylzinn-bis(isooctylthiogly-colat), Mono-dodecylzinntrichloride and

Di-dodecylzinndichloride), expressed

as mono and di-dodecylzinn chloride

SML(T) = 0.05 mg/kg food (T)41)

(expressed as a sum of mono-ndodecylzinn-tris(isooctylthioglycolat),

Di-n-dodecylzinn-bis(isooctylthiogly-colat), Mono-dodecylzinntrichloride and

Di-dodecylzinndichloride), expressed

as mono and di-dodecylzinn chloride"

22. The following additives are removed from Annex 2, Section B:

Ref. No.

CAS No.

Name

Restrictions and/or specifications

(1)

(2)

(3)

(4)

"67180

76681

-

-

Mix of (50 gew-%) n-Decyl-noctylphthalate, (25-w-%) Di-n-decylphthalate

and (25%) Di-n-octyl-phthalate

Polycyclopentadiene, hydroelectric

SML = 5 mg/kg (1)

SML = 5 mg/kg (1)

23. After Annex 3, the following Annex 3a is inserted:

"Annex 3 a

Ref. No.

CAS No.

Name

31520

31530

31920

38240

38515

38560

38700

38800

38810

38820

38840

39060

39925

40000

40020

40800

42000

45450

45705

46720

47540

47600

48800

48880

49485

49840

51680

52320

53200

54300

59120

59200

60320

60400

60480

61280

61360

61600

66360

66400

66480

66560

66580

68145

68320

68400

69840

71670

72081/10

72160

72800

73160

74010

74400

76866

77440

78320

81200

83599

83700

84800

92320

92560

92700

92800

92880

93120

93280

95270

95280

95360

95600

061167-58-6

123968-25-2

000103-23-1

000119-61-9

001533-45-5

007128-64-5

063397-60-4

032687-78-8

080693-00-1

026741-53-7

154862-43-8

035958-30-6

129228-21-3

000991-84-4

110553-27-0

013003-12-8

063438-80-2

068610-51-5

166412-78-8

004130-42-1

027458-90-8

084030-61-5

000097-23-4

000131-53-3

134701-20-5

002500-88-1

000102-08-9

052047-59-3

023949-66-8

118337-09-0

023128-74-7

035074-77-2

070321-86-7

003896-11-5

003864-99-1

003293-97-8

000131-57-7

001843-05-6

085209-91-2

000088-24-4

000119-47-1

004066-02-8

000077-62-3

080410-33-9

002082-79-3

010094-45-8

016260-09-6

178671-58-4

-

0009485-2

001241-94-7

-

145650-60-8

-

-

-

009004-97-1

071878-19-8

068442-12-6

000141-22-0

000087-18-3

-

038613-77-3

078301-43-6

000096-69-5

041484-35-9

000123-28-4

000693-36-7

1617-32-4

040601-76-1

0276-62-6

001843-03-4

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

2.4-Di-tert-pentyl-6-[1-(3.5-di-tert-pentyl-2-hydroxyphenyl)ethyl]phenylacrylate

Bis(2-ethylhexyl)adipat

Benzophenon

4.4'-Bis(2-benzoxazolyl)stilben

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

bis(isooctylthioglycolat)

N,N'-Bis[3-(3.5-di-tert-butyl-4-hydroxyphenyl)propionyl]hydrazid

Bis(2.6-di-tert-butyl-4-methylphenyl)pentaerythritoldiphosphit

Bis(2.4di-tert-butylphenyl)pentaerythritoldiphospheat

Bis(-2.4-dicumylphenyl)pentaerythritoldiphospheat

1.1-Bis(2-hydroxy-3,5-di-tert-butylphenyl)ethanol

3.3-Bis(methoxymethyl)-2.5-dimethylhexan

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

2.4-Bis(octylthiomethyl)-6-methylphenol

4.4'-butyliden-bis(6-tert-butyl-3-methylphenyl-ditridecylphosphit)

(2-Carbobutoxyethyl)zinn-tris(isooctylthioglycolat)

p-Kresol-dicyclopentadiene-isobutylen, Copolymer

1.2-Cyclohexandicarbon Acid, Diisononylester

2.6-Di-tert-butyl-4-ethylphenol

Di-tert-dodecyldisulfid

Di-n-dodecylzinn-bis(isooctylthioglycolat)

2.2'-dihydroxy-5,5'-dichlorodiphenylmethane

2.2'-dihydroxy-4-methoxybenzophenon

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

Dioctadecyldisulfide

N,N'-Diphenylthioharn

2-(4-Dodecylphenyl)indol

2-Ethoxy-2'-ethyloxanilid

2.2'-Ethyliden-bis(4.6-di-tert-butylphenyl)fluorphosphonit

1.6-Hexamethylen-bis[3-(3.5-di-tert-butyl-4-hydroxyphenyl)propionamid]

1.6-Hexamethylen-bis[3-(3.5-di-tert-butyl-4-hydroxyphenyl)propionate]

2-[2-Hydroxy-3,5-bis(1.1dimethylbenzyl)phenyl]benzotriazole

2-(2'-Hydroxy-3'-tert-butyl-5'-methylphenyl)-5-chlorbenzotriazole

2-(2'-Hydroxy-3,5'-di-tert-butylphenyl)-5-chlorbenzotriazole

2-Hydroxy-4-n-hexyloxybenzophenon

2-Hydroxy-4-methoxybenzophenon

2-Hydroxy-4-n-octyloxybenzophenon

2.2'-methyl-bis(4.6-di-tert-butylphenyl)natrium phosphate

2.2'-methyl-bis(4-ethyl-6-tert-butylphenol)

2.2'-methyl-bis(4-methyl-6-tert-butylphenol)

2.2'-methyl-bis(4-methyl-6-cyclohexylphenol)

2.2'-methyl-bis[4-methyl-6-(1-methylcyclohexyl)phenol]

2.2',2?-Nitrilo[trimethyl-tris(3.3',5'-tetra-tert-butyl-1,1'-bi-phenyl-2,2'-diyl)phosphit]

Octadecyl-3-(3.5-di-tert-butyl-4-hydroxyphenyl)propionate

Octadecylerucamid

Oleylita

Pentaerythritol-tetrakis (2-cyano-3,3-diphenylacrylate)

Oil hydrocarbons (hydrated)

2-Phenylindol

Diphenyl-2-ethylhexyl phosphate

Mono and Di-n-alkyl(C)16 and C18)-Ester of phosphoric acid

Up to(2.4di-tert-butyl-6-methylphenyl)-ethylphosphit

Tris(nonyl and/or dinonylphenyl)phosphit

Polyester of 1,2-proppandiol and/or 1.3- and/or 1.4-butandiol and/or polypropyleneglykol with adidipineic acid, including endemic acid, or C12-C18fatty acids, or n-Octanol and/or n-Decanol

polyethylene glykoldiricinoleate

polyethylene glykol monoricinoleate

Poly[6-[1,1,3,3-tetramethylbutyl)amino]-1,3,5-triazin-2,4-diyl]-[2,6 tetramethyl-4-piperidyl)imino]-hexamethylen-[(2,6-tetramethyl-4 piperidyl)imino]

Response products of 2-Mercaptoethyloleate with thylordimethylzine, sodium sulphide and trichloromethylzinn

Rizinol Acid

4-Tert-butylphenylsalicylate

Tetradecyl-polyethyleneenglykol(EO=38)ether of Glycolic acid

Tetrakis(2.4di-tert-butylphenyl)-4,4'biphenylen-diphosphonit

2.2.4Tetramethyl-20(2.3-epoxypropyl)-7-oxa-3,20-diazadispiro-[5.1.11.2]-heneicosan-21-on, polymer

4.4'-Thiobis(6-tert-butyl-3-methylphenol)

Thiodiethanol-bis[3-(3.5-di-tert-butyl-4-hydroxyphenyl)propionate]

Didodecylthiodipropionate

Dioctadecylthiodipropionate

2.4.6-Tris(tert-butyl)phenyl-2-butyl-2-ethyl-1,3-propandiolphosphit

1.3,5-Tris(4-tert-butyl-3-hydroxy-2,6-dimethylbenzyl)-1,3,5-triazin-2,4,6(1H,3H,5H)-trion

1.3,5-Tris(3.5-di-tert-butyl-4-hydroxybenzyl)-1,3,5-triazin-2,4,6(1H,3H,5H,5H)-trion

1.1.3-Tris(2-methyl-4-hydroxy-5-tert-butylphenyl)butan”

24. In Annex 4, Part A is as follows:

"Part A: General specifications

Plastics are not allowed to give primary aromatic amine in a detectable quantity (NG = 0,01 mg/kg food or simulate matter). This restriction does not apply to the migration of the primary aromatic amino acids listed in the registries in Annexes 1 and 2. “

25. In Annex 4, Part B, the following Ref. Nos are inserted in corresponding numerical order:

Ref. No.

SPECIFICATIONS

"42080

Carbon black

Specifications:

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

— EIA absorption of cyclohexane extract at 386 nm: < 0,02 AU for a cell of 1 cm or < 0.1 AU for a cell of 5 cm, determined with a generally accepted analytical method

– benzo(a)pyrene content: max. 0.25 mg/kg Carbon Black

= maximum value for the use of carbon black in polymer: 2.5 % w/w

72081/10

Oil hydrocarbons (hydrated)

Specifications:

Hydrocarbonic resins are produced by catalytic or thermal polymerisation of Diens and Olefins of aliphatic, alicyclic and/or monobenzenoidal species of crushed oil distillates with a Siede range of up to 220 °C, and from pure monomers from these distillations with subsequent distillation, hydration and further processing.

Characteristics:

Viscosity: + 3 Pa.s at 120 °C

Derogation point: + 95 °C, according to the Sentinel method E 28-67

Brom number: < 40 (ASTM D1159)

Colour of a 50% solution in Toluol < 11 on Gardner-Skala

residual aromatic monomer 50 ppm

76845

Polyester from 1.4-butandiol with Caprolacton

Group with molecular weight 0.01 000 under 0.5 gew-%

81500

Polyvinylpyrrolidon

The substance must meet the purity criteria set out in the ZuV, BGBl. II No 383/1998, in the respective version.

88640

Soybean oil, epoxidation

Oxiran < 8%, Jodnumer < 6

26. In Annex 5, the remark 8 is as follows:

"8) SML(T) means in this particular case that the sum of the migration values of the following substances referred to in the Ref.-No may not exceed the above limit value: 24886, 38000, 42400, 62020, 64320, 66350, 67896, 73040, 85760, 85840, 85920 and 95725."

27. In Annex 5, the following notes are added:

"41) SML(T) means, in this particular case, that the sum of migration values of the following substances referred to in the Ref.-No. may not exceed the limit value mentioned: 47600, 67360.

(b)42) SML(T) means, in this particular case, that the sum of the migration values of the following substances referred to in the Ref.-No. may not exceed the mentioned limit value: 75100 and 75105. “

28. After Annex 5, the following Annex 5a is inserted:

"Annex 5a

CONFORMITIES

The written declaration referred to in § 8a contains the following information:

1. the identity and address of the entrepreneur who manufactures or manufactures the use of plastic or the substances intended for the manufacture of these plastic items;

2. the identity of plastic items or substances intended for the manufacture of these plastic items;

3. the date of the declaration;

4. confirms that plastic items comply with the provisions of this Regulation and Regulation (EC) No. 1935/2004;

5. adequate information on the substances used for which this Regulation contains restrictions and/or specifications so that downstream operators can comply with these restrictions;

6. adequate information on substances whose use in food is subject to restriction is derived from experimental data or theoretical calculations on the specific migration values, as well as, where appropriate, purity criteria in accordance with the dye regulation, BGBl. No 541/1996, in the respective version, the sweetener regulation, BGBl. No. 547/1996, in the respective version, or the ZuV, BGBl. II No 383/1998, in the respective version. “

7. Specifications for the use of plastic items, e.g.

(a) type or type of food intended to come into contact;

(b) duration and temperature of treatment and storage in contact with food;

(c) ratio of the area in contact with food to the volume in which the conformity of the product is determined from plastic.

8. If a functional barrier from plastic is used in a multi-layered material or subject to plastic: confirming that the product is made from plastic § 8. 4 to 6.

The written declaration must allow a simple identification of the materials, objects or substances to which it relates, and will be re-submitted if major changes in production make migration changes or if new scientific knowledge is available. “

29. Annex 8 Z 3 is:

"3. Folgt on the sign X', separated by a slash, is the result of the migration investigation to be divided by this number. In the case of fatty foods, this conventional number, the so-called Reducing factor of D' (DRF), the higher extraction capacity of the simulate proceeding compared to food. “

30. In Annex 4, the following Z 4a is inserted:

"4.a. certifying the letter (b) in brackets X', the specified test with ethanol is 50% (V/V). “

31. In the table of Annex 8, point 07 is as follows:

Reference

number

Name of the food

simulate proceeds to be used

A

B

C

D

"07"

Milk products

07.01

Milk:

A. Full milk

X(b)

B. thickened milk

X(b)

C. Partially or completely

X(b)

D. Dry milk

07.02

Fertised milk like yoghurt, butter milk and similar products

X

X(b)

07.03

Rahm and saurer Rahm

X(a)

X(b)

07.04

Cheese

A. Overall, with non-exhaustive beef

B. All others

X(a)

X(a)

X/3*

07.05

Lab of calves

A. Liquid or liquefied

X(a)

X(a)

B. in powder form or

dried"

Kdolsky