BFR XXXVI Paper and board for food contact

This is an unofficial translation. Only the German version is binding.
XXXVI. Paper and board for food contact
谷氨酰胺合成酶As of 01.06.2013
Preamble
1. This Recommendation is valid for single and multi-layered commodities (articles, materials)
made of paper or paperboard which are intended to come into contact with or affect food-stuffs. It includes paper or paperboard which is intended to be used at temperatures up to
90 °C (holding and reheating of food). For the following listed special applications (e.g.
higher temperature range) the respective special Recommendation has to be noted:
- For paper that in its intended use will be subject to hot extraction (boil-in-bag packages, tea bags, hot filter papers), and for filter layers that in their intended use will be subject to extraction (filtration) Recommendation XXXVI/1 applies.
- For paper, paperboard and board which comes into contact with or affects foodstuffs dur-ing baking Recommendation XXXVI/2 applies. This recommendation also applies for usage in microwave ovens.
- For Absorber pads based on cellulosic fibres for food packaging Recommendation
XXXVI/3 applies.
2. Regarding the substance groups that are covered by this Recommendation the following
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restrictions have to be noted:
a) This Recommendation applies to raw materials (section A), production aids (section B),
and special paper refining agents (section C) used in the production process for paper, pa-perboard and board that comes into contact with foodsstuffs. Moreover, in the paper pro-duction process subst
ances are used to keep manufacturing devices clean and to protect them from corrosion. This Recommendation shall not apply for these substances. The manufacturer or distributor of the paper is responsible to comply to food regulations (espe-cially Regulation (EU) No. 1935/2004) for these substances1. However, substances listed in this Recommendation subject to the above stated applications were listed before 2013.
b) Substances that are used for manufacturing of paper raw materials listed in section A or
substances that are used for formulation of active ingredients listed in section B and C (e.g.
emulsifiers, solvents, set-up chemicals, stabilizer, pH modifiers) are not subject to this BfR-Recommendation. For their application requirements of article 3 of the Regulation (EU) No.
1935/2004 shall be used1. However, substances listed in this Recommendation subject to the above stated applications were listed before 2013. Preservatives that are used to pre-vent microbial spoilage of formulations and slimicides are still covered by this Recommen-dation.
1For guidance on compliance of the manufacturer’s responsibility the following guidelines and assessments of substances may be used exemplarily: other Recommendations of the BfR, assessm
ents of the European Food Safety Authority or the Scientific Committee on Food (SCF), Regulation (EU) No. 10/2011, European rules on food additives and drinking water. Moreover, an assessment can be made by the manufacturer on his own responsibil-ity.
3. Methods for testing commodities (materials and articles) made of paper or paperboard are
published under the title "Untersuchung von Papieren, Kartons und Pappen für den Le-bensmittelkontakt" and can be obtained from the German Pulp and Paper Association (Ver-band Deutscher Papierfabriken e. V. (VDP), Bonn).
4. The finished paper or paperboard must have no preserving effect on the foodstuffs with
which they come into contact2.
5. To the extent that in this Recommendation the use of certain substances is restricted the
maximum quantities given, if not applied to surface area or otherwise stated, refer to the dry finished product.
6. If in the production of a certain paper or paperboard a particular production aid, on account
of its wide spectrum of use, is listed more than once in the Recommendation, the largest maximum amount given is to be taken as the “in total” maximum. Adding the different
maximum amounts together is not permissible.
7. The finished paper must not contain more than 0.15 mg/kg pentachlorophenol.
8. It is assumed that under normal conditions of use there is no transfer of metal ions to food-
stuffs when their concentration (determined in cold water extract) does not exceed A µg per gram paper, whereby “A“ has the following values: cadmium 0.5, lead 3 and mercury 0.3 µg per gram paper. Testing is not necessary for paper or paperboard intended for contact with dry, non-fatty foodstuffs.
9. Azo dyes after Annex 1, No. 7 (§ 3) of the Commodities Regulation (Bedarfsgegenstände-
verordnung), must not be used in the manufacture of food-contact paper or paper board3. 10. In a composite, multi-layered or coated material, if the layer which comes into contact with
the foodstuff is made of paper or paperboard it must comply with this Recommendation.
Also, except for traces that are harmless to health and have no effect on taste or smell of the foodstuff, there must be no migration of substances from other layers into foodstuffs or on their surface.
There are no objections to the use of paper or paperboard in the manufacture of commodities in the sense of § 2, Para. 6, No. 1 of the Food and Feed Code (Lebensmittel- und Futtermittel-gesetzbuch (LFGB)), provided they are suitable for their intended purpose and comply also with the following conditions:
2DIN EN 1104: “Determination of the transfer of antimicrobial constituents”
3Detecting the use of prohibited azo dyes according to "Amtliche Sammlung von Untersuchungsverfahren nach
§ 64 LFGB", method B 82.02-2.
A. Raw materials4
The following raw materials may be used:
I. Fibrous materials:
1. Natural and synthetic cellulose fibres, bleached or unbleached.
2. Fibres of synthetic high polymers, provided they comply with the prevailing requirements of
food law.
3. Wood pulp, bleached or unbleached.
4. Recycled fibres made from paper or paperboard provided that the finished articles comply
with the requirements in the annex of this Recommendation.
II. Fillers:
Natural and synthetically produced, insoluble minerals that are harmless to health, such as  carbonates of calcium and magnesium, silicon dioxide, silicates, or mixed silicates of sodium, potassium, magnesium, calcium, aluminium and iron, calcium sulfate, calcium sulfoaluminate (satin white), barium sulfate (free of soluble barium compounds), titanium oxide. Microspheres5 made from a copolymer of vinylidene chloride, methyl methacrylate and acryloni-trile, filled with isobutane, max. 1.5 %, based on the dry fibres weight.
B. Production aids
The following production aids may be used:
I. Sizing agents:
1. Colophony, addition products of maleic and fumaric acid and/or of formaldehyde with colo-
phony. No more than 1.0 mg formaldehyde/ dm2 must be detectable in the extract of
the finished product.
2. Casein and glue of animal origin
3. Starch6
3.1 Native7 starch, physically modified starch, enzymatically modified starch and
acid-treated starch, as well as the chemically modified starches listed in
A nnex 2, List B, Part I of the Regulation on Food Additives (Zusatzstoff-
Verkehrsverordnung)
3.2 Other modified starches
3.2.1 Bleached starch, also treated with sodium, potassium or ammonium peroxy-
4  Since 2013 additives to raw material are not subject for this Recommendation (see preamble, sect
ion 2). The following substances were listed before 2013 and are still part of this Recommendation: a) Xylanase (There must be no detectable residual activity of this enzyme in the finished product.), b) Diethylene triamine pentamethylene phosphonic acid, max. 0.22 %, based on dry, fibres weight, c) Potassium sulfite, max. 0.01 %.Tetrasodium imino-disuccinate, max. 0.17 %, based on dry fibres weight, d) Tetrasodium iminodisuccinate, max. 0.17 %, based on dry fibres weight, e) Activated carbon (The activated carbon must comply with the purity requirements for E 153 established by Regulation (EU) No. 231/2012) The application of the substances mentioned above in accordance with the stated limitations continues to comply with this Recommendation. The application of anthraquinone as additive to raw material is no longer recommended.
5 The function of the microspheres is to reduce the density of the paper. The initiator, Bis(4-tert-
butylcyclohexyl)peroxidicarbonate may be used, max. 0.45 % based on the micropheres.
6The general and specific purity requirements after Annex 2, List A, Part II of the Regulation on Food Additives (Zusatzstoff-Verkehrsverordnung) apply.
7Native food starch is a carbohydrate polymer consisting almost entirely of α-D-glucose units. It occurs in granular form in the organs of certain plants, from which it is extracted.
disulfate, as well as with peroxyacetic acid and/or hydrogen peroxide
3.2.2 Oxidatively degraded starch, also treated with hydrogen peroxide, sodium,
potassium or ammonium peroxydisulfate, including dialdehyde starch produced
from oxidised starch with an aldehyde content of at least 90 %8
3.2.3 Starch esters
3.2.3.1 Monostarch phosphate, also treated with ammonium phosphate or orthophos-
phoric acid in the presence of urea
3.2.3.2 Starch acetate, also treated with vinyl acetate (specification of starch:
max. 2.5 % acetyl groups)
3.2.3.3 Starch succinate
3.2.
4. Starch ethers
3.2.
4.1 Treated with propylene oxide to produce neutral starch ethers (specification
of starch: propylene chlorohydrin, max. 1 mg/kg; degree of substitution (DS),
max. 0.2).
3.2.
4.2 Treated with monochloroacetate to produce anionic starch ethers (specification
of starch: sodium glycolate, max. 0.4 %; degree of substitution, max. 0.08).
3.2.
4.3 Treated with 3-chloro-2-hydroxypropyl trimethyl ammonium chloride or glycidyl
trimethyl ammonium chloride (specification of starch: epichlorohydrin, max.
1 mg/kg; nitrogen, max. 4.0 %).
3.2.
4.4 Treated with 3-chloro-2-hydroxypropyl trimethyl ammonium chloride and succinic
anhydride (specification of starch: epichlorohydrin, max. 1 mg/kg; nitrogen,
max. 1.6 %).
3.2.5 Starch, crosslinked with epichlorohydrin and treated with 3-chloro-2-
hydroxypropyl trimethyl ammonium chloride (specification of starch: epichloro-
hydrin, max. 1mg/kg; nitrogen, max. 0.5 %).
3.2.6 Monostarch phosphate, treated with 3-chloro-2-hydroxypropyl trimethyl ammo-
nium chloride (specification of starch: epichlorohydrin, max. 1 mg/kg; nitrogen,
max. 0.5 %).
4. Cellulose ether
5. Sodium salt of carboxymethyl cellulose, technically pure9
6. Alginates6, xanthane6, mannogalactanes6
7. Galactomannane ethers
7.1 Carboxymethylgalactomannane, residual content in sodium glycolate
max. 0.5 %
7.2 Galactomannane, treated with 3-chloro-2-hydroxypropyl-trimethylammonium
chloride or glycidyl-trimethylammonium chloride (specification: epichlorohydrin
max.1 mg/kg, nitrogen max. 4.0 %)
8. Water-glass and alumina gel
9. Dispersions of wax and paraffin, provided the waxes and paraffins comply with amended
Recommendation XXV, Part I10, in total max. 2.0 %.
10. Plastics dispersions, provided they comply with amended Recommendation XIV. In addi-
tion, may also be used as a monomer:
2-(Dimethylamino)ethyl acrylate with a residual content of max. 0.01 mg/dm2
N-[3-(dimethylamino) propyl] methacrylic amide
2-(N,N,N-trimethyl ammonium)ethylmethacrylat chloride
11. Reemulsifiable polyvinyl chloride, provided it complies with amended Recommendation II11.
12. Di-alkyl(C10-C22)diketenes, which can contain up to 65 % isoalkyl groups, max. 1.0 %
8See method for analysing tobacco additives, "Bestimmung der Dialdehydeinheiten in Oxi- bzw. Dialdehydstärke", Bundesgesundheitsblatt 8 (1965) 110.
9The Sodium glycolate content may not exceed 12 %.
10 Recommendation XXV. " Hard paraffins, microcrystalline waxes and mixtures of these with waxes, resins and plastics "
11 Recommendation  II. "Plasticizer-free polyvinyl chloride ..."
13. Condensation products of melamine, formaldehyde and ω-aminocaproic acid, max. 1.0 %.
No more than 1.0 mg formaldehyde/dm2 must be detectable in the extract of the finished product.
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14. Sodium and ammonium salts of copolymers of isopropyl maleate half ester
(approx. 25 %), acrylic acid (approx. 16 %) and styrene (approx. 59 %), in total max. 0.5 %, based on weight of the dry paper.
15. A mixture consisting of the ammonium salt of a copolymer of styrene and maleic acid
anhydride (50 : 50) with a copolymer of acrylic acid n-butyl ester and acrylonitrile (70 : 30)  in the ratio of 1 : 2, max. 0.6 %, based on weight of the dry paper.
16. Ammonium salt of a copolymer of maleic acid anhydride, isopropyl maleate half ester and
diisobutylene, max. 0.5 %, based on weight of the dry paper.
17. Ammonium salt of a copolymer of styrene (approx. 60 %), acrylic acid (approx. 23 %) and
maleic acid (approx. 17 %), max. 0.5 %, based on weight of the dry paper.
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18. Di-sodium salt of a copolymer of styrene (approx. 50 %) and maleic acid (approx. 50 %),
max. 0.7 %, based on weight of the dry paper.
19. Cationic, water-soluble polyurethane, cross-linked with epichlorohydrin12, made from
glycerol monostearate, toluylene diisocyanate and N-methyl diethanol amine (mean
郑天一
mol. wt. 100 000), max. 0.6 %, based on the dry fibres weight
or
Cationic, water-soluble polyurethanes, made from glycerol monostearate, toluylene diisocy-anate and N-methyl diethanol amine (mean mol. wt. 10 000), max. 0.15 %, based on the fi-bres weight
or
Anionic, water-soluble polyurethanes, made from glycerol monostearate, toluylene diisocy-anate, dimethylol propionic acid and N-methyl diethanol amine (mean mol. wt. 10 000), max. 0.15 %, based on the dry fibres weight.
In producing the aforementioned polyurethanes, in each case a maximum of 0.03 % dibutyl tin diacetate, based on the sizing agent, may be used; 1 dm2 of sized paper must not con-tain more than 0.3 µg dibutyl tin diacetate. Primary aromatic amines must not be detectable in extract of the finished product.13
As preservative for the aforementioned polyurethanes, max. 0.5 % formaldehyde, based on the sizing agent, may be used.
20. Copolymer of maleic acid and dicyclopentadiene (ammonium salt), max. 2.0 mg/dm2.
21. 3-Alkenyl(C15-C21)-dihydrofuran-2,5-dione, max. 1.0 %.
22. Cereal flour
1. treated with acids
2. treated with monochloroacetic acid to produce anionic cereal flour ethers (specification:
sodium glycolate, max. 0.4 %; degree of substitution, max. 0.08)
3. treated with glycidyl trimethyl ammonium chloride (specification: epichlorohydrin,
max. 1 mg/kg).
23. Copolymer of acrylamide and acrylic acid, cross-linked with N,N’-methylene-
bis(acrylamide), max. 1.0 %
溢价能力
24. Copolymer of acrylamide, 2-[(methacryloyloxy)ethyl]trimethyl ammonium chloride,
N,N'-methylene-bis(acrylamide) and itaconic acid, max. 1.0 %, based on the dry fibres weight.
12 No ethyleneimine must be detectable in the resin (detection limit 0.1 mg/kg). 1,3-Dichloro-2-propanol must not be detectable in water extract of the finished product (detection limit 2 µg/l). The transfer of 3-monochloro-1,2-propanediol into the water extract of the finished products must be as low as technically achievable, a limit of
12 µg/l must not be exceeded in any case. For compliance with the requirement in respect to chloropropanols,
a transitional period has been granted until the 31.03.2002.
13 On the determination of primary aromatic amines in aqueous extracts see: Amtliche Sammlung von Unter-suchungsverfahren nach § 64 LFGB, Method L. No. 00.00-6, "Untersuchung von Lebensmitteln - Bestimmung von primären aromatischen Aminen in wäßrigen Prüflebensmitteln".

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