Key Benefits:
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