ResAP (2002) 1 Appendix
ResAP (2002) 1 Appendix
POLICY STATEMENT
CONCERNING
Resolution ResAP (2002) 1 on paper and board materials and articles intended
to come into contact with foodstuffs
Technical document No. 3 - Guidelines on paper and board materials and articles,
made from recycled fibres, intended to come into contact with foodstuffs
(Version 2)
Technical document No. 4 - CEPI Guide for good manufacturing practice for paper
and board for food contact (prepared by CEPI)
The documents are available on the Internet website of the Partial Agreement in the Social
and Public Health Field:
www.coe.int/soc-sp
2
Table of contents
Page
Resolution ResAP (2002) 1 on paper and board materials and articles intended
to come into contact with foodstuffs .......................................................................... 5
Technical document No. 4 - CEPI Guide for good manufacturing practice for
paper and board for food contact (prepared by CEPI) ............................................... 109
3
4
RESOLUTION RESAP (2002) 1 ON
PAPER AND BOARD MATERIALS AND ARTICLES INTENDED
TO COME INTO CONTACT WITH FOODSTUFFS
5
RESOLUTION RESAP (2002)1 ON
PAPER AND BOARD MATERIALS AND ARTICLES
INTENDED TO COME INTO CONTACT WITH FOODSTUFFS
(adopted by the Committee of Ministers on 18 September 2002
at the 808th meeting of the Ministers Deputies)
The Committee of Ministers, in its composition restricted to the Representatives of
Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Ireland, Italy,
Luxembourg, The Netherlands, Norway, Portugal, Slovenia, Spain, Sweden,
Switzerland and the United Kingdom, member states of the Partial Agreement in the
Social and Public Health Field,
a. raising the level of health protection of consumers in its widest sense, including a
constant contribution to harmonising in the field of products having a direct or
indirect impact on the human food chain as well as in the field of pesticides,
pharmaceuticals and cosmetics legislation, regulations and practices governing, on
the one hand, quality, efficiency and safety controls for products and, on the other
hand, the safe use of toxic or noxious products;
b. integrating people with disabilities into the community; defining and contributing
to its implementation at European level of a model of coherent policy for people
with disabilities, which takes account simultaneously of the principles of full
citizenship and independent living; contributing to the elimination of barriers to
integration, whatever their nature, whether psychological, educational, family-related,
cultural, social, professional, financial or architectural;
Having regard to the action carried out for several years for the purposes of
harmonising their legislation in the public health field and, in particular, with regard to
paper and board materials and articles intended to come into contact with foodstuffs;
Considering that paper and board materials and articles intended to come into
contact with foodstuffs may, by reason of migration of paper and board constituents
to the foodstuffs, pose under certain conditions a risk to human health;
Emphasizing the fact that this resolution and the technical documents on paper and
board materials and articles intended to come into contact with foodstuffs form a
whole and should be read in conjunction with each other.
Taking the view that each member state, faced with the need to introduce regulations
governing this matter, would find it beneficial to harmonise such regulations at
European level,
6
APPENDIX TO RESOLUTION RESAP (2002)1
1. Field of application
This resolution applies to materials and articles constituted of paper and board
(excluding nonwovens 1 ) which may comprise one or more layer(s) of fibres and are
intended to come into contact with or are placed in contact with foodstuffs. A plastic
layer, or a layer of any other material, such as aluminium, waxes or paraffins applied
to the paper and board is excluded from this resolution 2 . When the materials and
articles consist of two or more layers, exclusively or not exclusively made of paper
and board, any layer which is composed of paper and board must fulfil the
requirements of this resolution, unless separated from the foodstuffs by a functional
barrier 3 to migration.
2. Definition
Paper and board are manufactured from cellulose-based natural fibres from bleached
and unbleached fibre material. Recycled fibre materials may also be used in
accordance with the Guidelines on paper and board materials and articles, made
from recycled fibres, intended to come into contact with foodstuffs, set out in
Technical document No. 3. In addition paper and board may contain functional
additives and synthetic fibres 6 . Paper and board may also contain other treatment
agents and polymeric binders for organic and inorganic pigments.
3. Specifications
3.1. Paper and board used for all food contact applications under normal or
foreseeable conditions of use should meet the following conditions:
3.2. They should not transfer their constituents to foodstuffs in quantities which could
endanger human health or bring about an unacceptable change in the composition of
the foodstuffs or a deterioration in the organoleptic characteristics thereof, in
accordance with Article 2 of Directive 89/109/EEC.
1
As defined by ISO 9092.
2
Examples: Mineral coated papers and their components, including polymeric binders in the coating formula, are subject
to this resolution. The plastic layer, or a layer of any other material, such as aluminium, waxes or paraffins in contact with
foodstuffs, of a coated or laminated paper is excluded from this resolution. The paper behind the layer is not subject to
this resolution if it can be shown that the layer is a functional barrier.
3
A functional barrier is any integral layer which under its normal or foreseeable conditions of use reduces all possible
material transfers (permeation and migration) from any layer beyond the barrier into food to a toxicologically and
organoleptically insignificant and to a technologically unavoidable level.
4
Products with a weight to surface area ratio of 500 g/m2 and above (BgVV Chapter XXXVI/1
Papers and filter beds for use in boiling and hot-filtering).
5
Tissue paper kitchen towels and napkins are covered by specific guidelines.
6
Synthetic fibres should comply with EU Directive 90/128/EEC.
7
3.3. They should be manufactured in accordance with the CEPI guide for good
manufacturing practice for paper and board for food contact set out in Technical
document No. 4 and using the substances of the List of substances used in the
manufacture of paper and board materials and articles intended to come into contact
with foodstuffs set out in Technical document No. 1 and according to the conditions
specified.
3.4. They should be of suitable microbiological quality, taking into account the
intended end use of the material. For materials and articles intended to come into
contact with aqueous and/or fatty foodstuffs, particular attention should be paid to
pathogens.
3.5. They should not release substances which have an antimicrobial effect on
foodstuffs. The method of analysis to be applied is laid down in the Guidelines on
test conditions and methods of analysis for paper and board materials and articles
intended to come into contact with foodstuffs set out in Technical document No 2.
3.6. They should comply with the restrictions laid down in Table 1 and Table 2
hereafter and with either the QM 7 or SML restrictions 8 laid down in the List of
substances used in the manufacture of paper and board materials and articles
intended to come into contact with foodstuffs set out in Technical document No. 1.
Substance Restriction
QM limit (mg/dm2 paper and board)
Cadmium 0.002
Lead 0.003
Mercury 0.002
Table 2 - Restriction limit for pentachlorophenol
Pentachlorophenol 0.15
7
The restrictions in Table 1 of this resolution and of the List of substances used in the manufacture of paper and
board materials and articles intended to come into contact with foodstuffs set out in Technical document No. 1,
expressed as QM (maximum permitted quantity of the substance in the finished material or product expressed as mg
per dm2 of the surface in contact with foodstuffs), have been derived from guideline levels laid down in Council of
Europe Resolution AP (96) 4 on maximum and guideline levels and on source-directed measures aimed at reducing
the contamination of food by lead, cadmium and mercury and from the SML (specific migration limit) restrictions as
laid down in EU Directives, respectively, based on toxicological assessment, applying the conventional ratio of 6 dm 2
of material coming into contact with 1 kg of foodstuffs and assuming 100 % migration. For contact conditions where
the mass of food to contact area ratio differs from the conventional ratio of 1 kg to 6 dm 2, the QM restriction to be
applied should be calculated as specified in the Guidelines on test conditions and methods of analysis for paper and
board materials and articles intended to come into contact with foodstuffs set out in Technical document No. 2.
8
The SML restrictions are those set by the Commission of the European Communities in its directives relating to
plastic materials intended to come into contact with foodstuffs.
8
3.7. Verification of compliance with the quantitative restrictions should to be carried
out according to the conditions laid down in the Test conditions and methods of
analysis for paper and board materials and articles intended to come into contact
with foodstuffs set out in Technical document No. 2.
3.8. Testing for compliance with the restrictions in Table 1 is not required for paper
and board materials and articles intended to come into contact with dry foodstuffs or
foodstuffs which are to be shelled, peeled or washed.
3.10. Paper and board produced with recycled fibres can be used as food contact
material if it originates from specified qualities of recovered paper and board which
has been subjected to appropriate processing and cleaning, provided that the
finished materials comply with the specifications in this resolution and with the
Guidelines on paper and board materials and articles, made from recycled fibres,
intended to come into contact with foodstuffs set out in Technical document No 3.
3.11. Manufacturers of paper and board for food contact applications should make
sure that they use raw materials produced by processes which reduce dioxins
(polychlorinated dibenzodioxins and dibenzofurans) to levels as low as reasonably
achievable.
9
References:
10
TECHNICAL DOCUMENT No. 1
11
Table of contents
Page
2. Introduction ....................................................................................................... 14
Appendix A .......................................................................................................... . 61
Appendix B .......................................................................................................... . 69
Appendix C .......................................................................................................... . 71
12
1. CLASSIFICATION SYSTEM OF SUBSTANCES TO BE USED FOR MATERIALS AND
ARTICLES INTENDED TO COME INTO CONTACT WITH FOODSTUFFS
General specifications
List 1 - Substances approved for the use of materials and articles intended to come
into contact with food
1. Substances evaluated by SCF, classified in list 0-4, and used in compliance with specific
migration limits or other restrictions, if any;
2. Substances evaluated and approved by the Committee of expert on materials coming into
contact with food;
4. Substances authorised as direct food additives in compliance with specific migration limits
or other restrictions;
5. The substances which have been approved by Partial agreement member states or by
FDA applying scientific evaluation criteria of the time of their approval will be listed in a
Temporary Appendix to List 1.
List 2 Substances not approved for the use of materials and articles intended to
come into contact with food
Substances which do not meet the criteria set for List 1 substances.
Complementary specifications
1. The substances of the Temporary Appendix should be integrated in List 1 or List 2 not
later than five years after adoption of the List of substance.
2. List 1 and List 2 will be updated in principle once a year in order to take into account
newly evaluated substances, new submissions by industry or substances to be deleted.
13
2. INTRODUCTION
2.1. The technical document n1 contains the lists of additives which may be used in the
manufacture of paper and board materials and articles intended to come into contact with
foodstuffs.
The monomers used for the manufacture of polymeric additives are included
in 3 appendices:
2.2. The following substances are not included even if they are intentionally used and are
authorised:
(a) salts (including double salts and acid salts) of aluminium, ammonium, calcium, iron,
magnesium, potassium and sodium of authorised acids, phenols or alcohols. However,
names containing acid(s), salts appear in the lists, if the corresponding free acid(s)
is (are) not mentioned;
(b) salts (including double salts and acid salts) of zinc of authorised acids, phenols or
alcohols. For these salts a Group SML = 25 mg/kg (expressed as Zn) applies. The same
restriction for Zn applies to:
(i) substances whose name contains acid(s), salts which appear in the lists, if the
corresponding free acid(s) is (are) not mentioned,
2.3. The list also does not include the following substances although they may be present:
(b) oligomers and natural or synthetic macromolecular substances as well as their mixtures,
if the monomers or starting substances required to synthesise them are included in the
lists;
2.4. Substances shall be of good technical quality as regards the purity criteria
14
3. INFORMATION AND ABBREVIATIONS
ACC : acceptable
DL : detection limit of the method of analysis
FCC : Food Chemicals Codex
ND : not detectable
NS : not specified
QM maximum permitted quantity of the residual substance in the material. For the
purpose of this resolution the quantity of the substances in the material shall be
determined by a validated method of analysis. If such a method does not
currently exist, an analytical method with appropriate performance
characteristics at the specified limit may be used, pending the development of a
validated method
QMA : maximum permitted quantity of the residual substance in the material
expressed as mg per 6 dm2 of the surface in contact with foodstuffs. For the
purpose of this resolution the quantity of the substance in the surface of the
material should be determined by a validated method of analysis. If such a
method does not currently exist, an analytical method with appropriate
performance characteristics at the specified limit may be used, pending the
development of a validated method.
SML : specific migration limit in food or in food simulants
SML(T) : specific migration limit in food or in food simulants expressed as total of
moiety/substance(s) indicated
15
4. NOTES RELATED TO THE COLUMN RESTRICTIONS AND/OR SPECIFICATIONS
(1) Warning : there is a risk that the SML could be exceeded in fatty food simulants
(2) SML(T) in this specific case means that the restriction shall not be exceeded by
the sum of the migration of the following substances mentioned as
PM/REF N : 30015, 30120, 30200, 48030, 48050, 53765, 53860
(3) SML(T) in this specific case means that the restriction shall not be exceeded by
the sum of the migration of the following substances mentioned as
PM/REF N : 40320, 87040
(4) SML(T) in this specific case means that the restriction shall not be exceeded by
the sum of the migration of the following substances mentioned as PM/REF N:
15760, 16990, 53650 and 89440
(5) SML(T) in this specific case means that the restriction shall not be exceeded by
the sum of the migration of the following substances mentioned as
PM/REF N : 48640, 61360, 61600
(6) SML(T) in this specific case means that the restriction shall not be exceeded by
the sum of the migration of the following substances mentioned as
PM/REF N : 17260, 54880, 59280
(7) SML(T) in this specific case means that the restriction shall not be exceeded by
the sum of the migration of the following substances mentioned as
PM/REF N : 64300, 85840
(8) SML(T) in this specific case means that the restriction shall not be exceeded by
the sum of the migration of the following substances mentioned as
PM/REF N : 86960, 87120
(9) Divinylbenzene may contain up to 40 % of ethylvinylbenzene
(10) SML(T) in this specific case means that the restriction shall not be exceeded by
the sum of the migration of the following substances mentioned as
PM/REF N : 10060, 23920
(11) SML(T) in this specific case means that the restriction shall not be exceeded by
the sum of the migration of the following substances mentioned as
PM/REF N : 10690, 10780, 10840, 11470, 11590, 11680, 11710, 11830 and
76463
(12) SML(T) in this specific case means that the restriction shall not be exceeded by
the sum of the migration of the following substances mentioned as
PM/REF N : 19540, 19960, 64800
(13) SML(T) in this specific case means that the restriction shall not be exceeded by
the sum of the migration of the following substances mentioned as
PM/REF N : 20020, 20110, 20170, 20890, 21010, 21130, 21190
(14) SML(T) in this specific case means that the restriction shall not be exceeded by
the sum of the migration of the following substances mentioned as
PM/REF N : 12265, 26170, 26320
(15) SML(T) in this specific case means that the restriction shall not be exceeded by
the sum of the migration of the following substances mentioned as
PM/REF N : 13780, 20590
(16) SML(T) in this specific case means that the restriction shall not be exceeded by
the sum of the migration of the following substances mentioned as
PM/REF N : 15700, 16600, 16630, 18640, 19110, 25208, 25210, 25240
(17) SML(T) in this specific case means that the restriction shall not be exceeded by
the sum of the migration of the following substances mentioned as
PM/REF N : 93120, 93280
(18) The product should have the following specifications:
Content of mineral hydrocarbons with Carbon number less than 25, not more than
5% (w/w)
Viscosity not less than 11 x 10-6 m2/s (=11 centistokes) at 100C
Average molecular weight not less than 500
16
(19) Polyethyleneglycol (EO<=11) tridecyl ether phosphate (mono-and dialkyl ester)
with a maximum 10% content of polyethyleneglycol (EO<=11) tridecylether
(20) The product should have the following specifications:
- Content of mineral hydrocarbons with Carbon number less than 25, not more
than 5% (w/w)
- Viscosity not less than 8,5 x 10-6 m2/s (=8,5 centistokes) at 100C
- Average molecular weight not less than 480
(21) Minimum viscosity 100 x 10-6 m2/s (=100 centistokes) at 25C
(22) Petroleum hydrocarbon resins, hydrogenated are produced by the catalytic or
thermal polymerisation of dienes and olefins of the aliphatic, alicyclic and/or
monobenzenoid arylalkene types from distillates of cracked petroleum stocks with
a boiling range not greater than 220C, as well as the pure monomers found in
these distillation streams, subsequently followed by distillation, hydrogenation
and additional processing.
Properties
Viscosity: > 3 Pa.s at 120C
Softening point: > 95C as determined by ASTM Method E 28-67
Bromine number: < 40 (ASTM D1159)
The colour of a 50% solution in toluene < 11 on the Gardner scale
Residual aromatic monomer 50 ppm
(23) Polydimethylsiloxane, 3-aminopropyl terminated, polymer with
dicyclohexylmethane-4,4-diisocyanate
The fraction with molecular weight below 1000 should not exceed 1.5% w/w
(24) Polydimethylsiloxane, 3-aminopropyl terminated, polymer with 1-isocyanato-3-
isocyanatomethyl-3,5,5-trimethylcyclohexane
The fraction with molecular weight below 1000 should not exceed 1% w/w
(25) Polyvinyl alcohol
Weight average molecular weight should not be less than 2500 Da
(26) Polyvinylpyrrolidone
The substance shall meet the purity criteria established in Commission Directive
96/77/EC
(27) 95858 Waxes, paraffinic, refined, derived from petroleum based or synthetic
hydrocarbon feedstocks
- Average molecular weight not less than 350
- Viscosity at 100C min 2,5 cSt
- Content of hydrocarbons with carbon number less than 25, not more than
40% w/w
17
A. LIST 1 OF ADDITIVES
30610 - and their mono-, di- and triglycerol esters (branched fatty acids at naturally 3
occuring levels are included)
30960 - Acids, aliphatic, monocarboxylic (C6-C22), esters with polyglycerol 1 25
SML(T) = 6 mg/kg (11)
(11470) 000140-88-5 Acrylic acid, ethyl ester 2 0.1 (a.a)
(as acrylic acid)
31542 174254-23-0 Acrylic acid, methyl ester, telomer with 1-dodecanethiol, C16-C18 alkyl 3 QM = 0.5 %
esters
31730 000124-04-9 Adipic acid 1 5
31920 000103-23-1 Adipic acid, bis(2-ethylhexyl) ester 2 SML = 18 mg/kg (1) 0,3
(12310) - Albumin 0
33105 146340-15-0 Alcohols, C12-C14 secondary, beta-(2-hydroxyethoxy), ethoxylated 3 SML = 5 mg/kg
33120 - Alcohols, aliphatic, monohydric, saturated, linear, primary (C4-C24) 3
33350 009005-32-7 Alginic acid 1 NS
33801 - n-Alkyl(C10-C13)benzenesulphonic acid 2 SML = 30 mg/kg 0,5
34230 - Alkyl(C8-C22)sulphonic acid 2 SML = 6 mg/kg 0,1
Alkyl(C8-C22)sulphuric acids, linear, primary, with an even number of
34281 - 3
carbon atoms
RESTRICTIONS AND/OR ADI/TDI
PM/REF No CAS No NAME SCF-L
SPECIFICATIONS mg/kg bw
34560 021645-51-2 Aluminium hydroxide 2 1 (as Al)
34660 001327-41-9 Aluminium hydroxychloride 2 1(as Al)
34720 001344-28-1 Aluminium oxide 2 1 (as Al)
35170 000141-43-5 2-Aminoethanol 3 SML = 0.05 mg/kg
35320 007664-41-7 Ammonia 1 NS
35440 012124-97-9 Ammonium bromide 1 1(as Br)
35600 001336-21-6 Ammonium hydroxide 1 NS
35840 000506-30-9 Arachidic acid 0
36000 000050-81-7 Ascorbic acid 1 ACC
36880 008012-89-3 Beeswax 0
37040 000112-85-6 Behenic acid 0
37280 001302-78-9 Bentonite 3
SML = 0.5 mg/kg. Only to
be used in aqueous
polymer dispersions and
emulsions and at
19
- 009004-53-9 Dextrin -
FCC specifications
46070 010016-20-3 alpha-Dextrin 0
46080 007585-39-9 beta-Dextrin 0
46640 000128-37-0 2,6-Di-tert-butyl-p-cresol (= BHT) 1 SML = 3 mg/kg 0,05
2
46720 004130-42-1 2,6-Di-tert-butyl-4-ethylphenol 3 QMA = 4.8 mg/6 dm
75120 000084-66-2 Phthalic acid, diethyl ester 2 SML = 12 mg/kg (1) 0,2
(23505) 000110-85-0 Piperazine 3
SML(T) = 6 mg/kg (11) (for
76463 - Polyacrylic acid, salts 3
acrylic acid)
76681 - Polycyclopentadiene, hydrogenated 3 SML = 5 mg/kg (1)
009016-00-6
76721 Polydimethylsiloxane (MW < 6800) 2 (21) 1.5
063148-62-9
Polydimethylsiloxane, 3-aminopropyl terminated, polymer with
76723 167883-16-1 3 (23)
dicyclohexylmethane-4,4-diisocyanate
Polydimethylsiloxane, 3-aminopropyl terminated, polymer with 1-
76725 661476-41-1 3 (24)
isocyanato-3-isocyanatomethyl3-,5,5-trimethyl-cyclohexane
76730 - Polydimethylsiloxane, gamma-hydroxypropylated 2 SML = 6 mg/kg 0.1
76960 025322-68-3 Polyethyleneglycol 2 5
77280 009005-02-1 Polyethyleneglycol dilaurate 2 10
77360 009005-07-6 Polyethyleneglycol dioleate 2 10
77520 061791-12-6 Polyethyleneglycol ester of castor oil 2 SML = 42 mg/kg 0.7
77550 - Polyethyleneglycol ester of coconut oil fatty acids 2 10
RESTRICTIONS AND/OR ADI/TDI
PM/REF No CAS No NAME SCF-L
SPECIFICATIONS mg/kg bw
RESTRICTIONS
PM/REF No CAS No NAME SCF-L AND/OR
SPECIFICATIONS
- 000071-48-7 Acetic acid, cobalt(II) salt - To be fixed
- 068440-00-6 Acids, fatty (C8-C18), animal - To be fixed
- 068937-84-8 Acids, fatty (C12-C18), methyl esters - To be fixed
- 067701-06-8 Acids, fatty (C14-C18 and C16-C18 unsaturated) - To be fixed
- 085736-49-8 Acids, fatty (C14-C18 and C16-C18 unsaturated), esters with ethyleneglycol - To be fixed
- 097404-28-9 Acids, fatty (C14-C26), aluminium salts - To be fixed
- 067701-03-5 Acids, fatty (C16-C18) - To be fixed
- 067701-08-0 Acids, fatty (C16-C18 and C18 unsaturated) - To be fixed
- 068955-98-6 Acids, fatty (C16-C18 and C18 unsaturated), branched and linear - To be fixed
- 067762-38-3 Acids, fatty (C16-C18 and C18 unsaturated), methyl esters - To be fixed
31352 085116-93-4 Acids, fatty (C16-C18), esters with pentaerythritol 9 To be fixed
31
4,4'-Bis[[4-[bis(2-hydroxypropyl)amino]-6-(p-sulphoanilino)-s-triazin-2-yl]amino]-2,2'-
067786-25-8 - To be fixed
- stilbenedisulphonic acid, tetrasodium salt
- 142050-95-1 4,4'-Bis[[4-chloro-6-(2,5-disulphoanilino)-s-triazin-2-yl]amino]-2,2'-stilbenedisulphonic - To be fixed
acid, hexasodium salt
- 031075-24-8 Bis(2-chloroethyl) ether - N,N,N',N'-tetramethylethylenediamine, copolymer - To be fixed
- 037138-26-4 4,4'-Bis[[4-chloro-6-(4-sulphoanilino)-s-triazin-2-yl]amino]-2,2'-stilbenedisulphonic - To be fixed
acid, tetrasodium salt
- 061789-77-3 Bis(coco alkyl)dimethylammonium chloride - To be fixed
- 076508-02-6 4,4'-Bis[[4-[(2-cyanoethyl) (2-hydroxypropyl)amino]-6-(2,5-disulphoanilino)-s-triazin-2- - To be fixed
yl]amino]-2,2'-stilbenedisulphonic acid, hexasodium salt
4,4'-Bis[[4-diethylamino-6-(2,5-disulphoanilino)-s-triazin-2-yl]amino]-2,2'-stilbene-
041098-56-0 (7) To be fixed
(38870) disulphonic acid, hexasodium salt
- 030381-98-7 Bis[2-[N-ethyl(perfluorooctane)sulphonamido]ethyl] phosphate, ammonium salt - To be fixed
4-[[4-[Bis(2-hydroxyethyl)amino]-6-methoxy-s-triazin-2-yl]amino]-4'-[[4-methoxy-
085154-06-9 6-[(2-sulphoethyl)amino]-s-triazin-2-yl]amino]-2,2'-stilbenedisulphonic acid, sodium - To be fixed
- salt, compound with diethanolamine
RESTRICTIONS
PM/REF No CAS No NAME SCF-L AND/OR
SPECIFICATIONS
4-[[4-[Bis(2-hydroxyethyl)amino]-6-methoxy-s-triazin-2-yl]amino]-4'-[[4-methoxy-
6-[(2-sulphoethyl)amino]-s-triazin-2-yl]amino]-2,2'-stilbenedisulphonic acid, sodium
085305-32-4 - To be fixed
salt, compounds with 2-aminoethanesulphonic acid, monosodium salt and
- diethanolamine
- 061791-31-9 N,N-Bis(2-hydroxyethyl)cocoalkylamine - To be fixed
39280 000120-40-1 N,N-Bis(2-hydroxyethyl)lauramide 7 To be fixed
39520 000093-82-3 N,N-Bis(2-hydroxyethyl)stearamide 7 To be fixed
- 001854-26-8 N,N'-Bis(hydroxymethyl)-4,5-dihydroxyethyleneurea - To be fixed
4,4'-Bis[[4-methoxy-6-[(2-sulphoethyl)amino]-s-triazin-2-yl]amino]-2,2'-stilbene-
085169-39-7 disulphonic acid, sodium salt, compound with 2-aminoethanesulphonic acid, - To be fixed
- monosodium salt and diethanolamine
4,4'-Bis[[4-methoxy-6-[(2-sulphoethyl)amino]-s-triazin-2-yl]amino]-2,2'-stilbene-
085154-07-0 - To be fixed
- disulphonic acid, sodium salt, compound with diethanolamine
4,4'-Bis[[4-morpholino-6-(2,5-disulphoanilino)-s-triazin--2-yl]amino]-2,2'-stilbene-
052301-70-9 (7) To be fixed
(39945) disulphonic acid, hexasodium salt
35
4,4'-Bis[[4-morpholino-6-(2,5-disulphoanilino)-s-triazin--2-yl]amino]-2,2'-stilbene-
093940-63-7 (7) To be fixed
(39945) disulphonic acid, sodium salt
- 016079-88-2 1-Bromo-3-chloro-5,5-dimethylhydantoin - To be fixed
- 002491-38-5 2-Bromo-4'-hydroxyacetophenone - To be fixed
- 001303-86-2 Boron oxide - To be fixed
40460 000052-51-7 2-Bromo-2-nitro-1,3-propanediol 8 To be fixed
40480 007166-19-0 2-Bromo-2-nitrostyrene 8 To be fixed
40592 000078-92-2 2-Butanol 8 To be fixed
- 013397-26-7 Calcite - To be fixed
- 023570-56-1 Carbonic acid, potassium zirconium salt - To be fixed
- 059419-62-4 Carboxymethyl starch-epichlorohydrin, copolymer - To be fixed
- 068459-67-6 Castor oil, ester with glycerol - To be fixed
43230 008002-33-3 Castor oil, sulphated 9 To be fixed
- 068187-76-8 Castor oil, sulphated, sodium salt - To be fixed
- 009012-54-8 Cellulase - To be fixed
- 010049-04-4 Chlorine dioxide - To be fixed
RESTRICTIONS
PM/REF No CAS No NAME SCF-L AND/OR
SPECIFICATIONS
- 000079-07-2 Chloroacetamide - To be fixed
- 051229-78-8 cis-1-(3-Chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride - To be fixed
43630 000059-50-7 p-Chloro-m-cresol 8 To be fixed
- 060736-58-5 2-Chloro-3-(phenylsulphonyl)acrylonitrile - To be fixed
- 007758-19-2 Chlorous acid, sodium salt - To be fixed
43840 015659-56-0 Chromic chloride myristate 8 To be fixed
- 061788-46-3 Cocoalkylamines - To be fixed
- 061789-18-2 Cocoalkyltrimethylammonium chloride - To be fixed
- 000138-93-2 Cyanothiocarbamic acid, disodium salt - To be fixed
45700 000110-82-7 Cyclohexane 8 To be fixed
45710 000108-93-0 Cyclohexanol 8 To be fixed
- 076386-11-3 1-Decenylsuccinic acid - To be fixed
- 039306-95-1 Dextrin 2-hydroxypropyl ether - To be fixed
- 065546-83-0 Dextrin 2-hydroxy-3-(trimethylammonio)propyl ether, chloride - To be fixed
36
- 479029-28-2 - To be fixed
fluoro-C8-14-alkyl acrylate, acetates, N-oxides
- 783306-31-0 Methacrylic acid, 2-(dimethylamino)ethyl ester, polymers with gamma-omega-per- - To be fixed
fluoro-C8-14-alkyl acrylate, N-oxides
- 000137-41-7 Methyldithiocarbamic acid, potassium salt - To be fixed
- 006317-18-6 Methylenebis(thiocyanate) - To be fixed
- 160808-63-9 3-(15-Methylhexadecylidene)-2-(14-methylpentadecyl)propiolactone - To be fixed
- 000137-20-2 N-Methyl-N-oleoyltaurine - To be fixed
66905 000872-50-4 N-Methylpyrrolidone 8 To be fixed
- 012001-26-2 Mica-group minerals - To be fixed
- 085117-50-6 Monoalkyl(C10-C14)benzenesulphonic acid, sodium salts - To be fixed
- 001318-93-0 Montmorillonite - To be fixed
- 000110-27-0 Myristic acid, isopropyl ester - To be fixed
- 064741-65-7 Naphtha (petroleum), heavy alkylate - To be fixed
- 064742-48-9 Naphtha (petroleum), hydrotreated heavy - To be fixed
- 028777-98-2 Octadecenylsuccinic anhydride - To be fixed
- 014481-60-8 N-Octadecyl-2-sulphosuccinamic acid, disodium salt - To be fixed
RESTRICTIONS
PM/REF No CAS No NAME SCF-L AND/OR
SPECIFICATIONS
69480 000112-62-9 Oleic acid, methyl ester 7 To be fixed
69560 003687-45-4 Oleic acid, oleyl ester 7 To be fixed
- 068188-18-1 Paraffin oils, sulphochlorinated, saponified - To be fixed
- 000079-21-0 Peroxyacetic acid - To be fixed
72046 007727-54-0 Persulphuric acid, ammonium salt 8 To be fixed
72048 007727-21-1 Persulphuric acid, potassium salt 8 To be fixed
72240 000090-43-7 2-Phenylphenol D To be fixed
- 013707-65-8 2-Phenylphenol, potassium salt - To be fixed
- 000132-27-4 2-Phenylphenol, sodium salt - To be fixed
- 010154-75-3 3-(Phenylsulphonyl)propionitrile - To be fixed
Phosphoric acid, mono- and bis(gamma, omega-perfluoroalkyl) esters, compounds
- To be fixed
- - with diethanolamine
73680 000126-73-8 Phosphoric acid, tributyl ester 6B To be fixed
73840 000126-71-6 Phosphoric acid, triisobutyl ester 6B To be fixed
40
RESTRICTIONS
PM/REF No CAS No NAME SCF-L AND/OR
SPECIFICATIONS
- 000125-12-2 Acetic acid, isobornyl ester - To be fixed
- 007585-20-8 Acetic acid, zirconium salt - To be fixed
- 090990-25-3 Acids, fatty (C8-C18 and C18 unsat.), alkyl(C16-C22) esters - To be fixed
31306 092797-30-3 Acids, fatty (C14-C22), alkyl(C16-C24) esters 9 To be fixed
32240 000105-99-7 Adipic acid, dibutyl ester 6B To be fixed
32760 000627-93-0 Adipic acid, dimethyl ester 6B To be fixed
- 090622-25-6 Alcohols, C8-C22, distillation residues - To be fixed
- 068603-18-9 Alcohols, C10-C16, distillation residues - To be fixed
- 068603-17-8 Alcohols, C16-C18, distillation residues - To be fixed
- 068911-61-5 Alcohols, C18-C32 - To be fixed
- 098072-31-2 Alkenes (C7-C9), hydroformylation products, distillation residues, heavy cracked - To be fixed
44
- 097659-51-3 - To be fixed
diamines
Chloroacetic acid, sodium salt, reaction products with 1-(2-hydroxyethyl)-2-imida-
- 068608-65-1 - To be fixed
zoline 2-norcoco alkyl derivatives and sodium hydroxide
- 005915-41-3 2-Chloro-4-ethylamino-6-tert-butylamino-1,3,5-triazine - To be fixed
- 015733-22-9 p-Chloro-m-cresol, sodium salt - To be fixed
- 034911-46-1 2-Chloro-4'-hydroxy-2-isonitrosoacetophenone - To be fixed
- 132186-00-6 3-Chloro-2-hydroxypropyl-N,N,N-tripropylammonium chloride - To be fixed
- 061790-57-6 Cocoalkylamines, acetates - To be fixed
- 068953-13-9 Cocoalkylamines, acetates, reaction products with bentonite - To be fixed
- 061788-90-7 Cocoalkyldimethylamines, N-oxides - To be fixed
N-Cocoalkyl-3-sulphosuccinamic acid, monosodium salts, compounds with
- 084501-44-0 - To be fixed
triethanolamine
- 061791-63-7 N-Cocoalkyltrimethylenediamines - To be fixed
- 061791-64-8 N-Cocoalkyltrimethylenediamines, acetates - To be fixed
RESTRICTIONS
PM/REF No CAS No NAME SCF-L AND/OR
SPECIFICATIONS
061790-63-4
45040 068440-04-0 Coconut oil fatty acids diethanolamide 7 To be fixed
068603-42-9
- 000101-83-7 N-Cyclohexylcyclohexylamine - To be fixed
- 000541-02-6 Decamethylcyclopentasiloxane - To be fixed
- 036362-09-1 2-(Decylthio)ethylamine hydrochloride - To be fixed
- 000135-57-9 2,2'-Dibenzamidodiphenyl disulphide - To be fixed
- 003252-43-5 Dibromoacetonitrile - To be fixed
- 073003-80-2 2,2-Dibromopropanediamide - To be fixed
- 000109-46-6 N,N'-Dibutylthiourea - To be fixed
- 096633-68-0 Dibutyltin bis(coco acyloxy) derivatives - To be fixed
47220 000077-58-7 Dibutyltin dilaurate 8 To be fixed
47265 000095-50-1 1,2-Dichlorobenzene 7 To be fixed
47360 000075-71-8 Dichlorodifluoromethane 7 To be fixed
47
ADI/TDI
PM/REF No CAS No NAME SCF-L RESTRICTION
mg/kg bw
10090 000064-19-7 Acetic acid 1 NS
(30140) 000141-78-6 Acetic acid, ethyl ester 1 NS
10120 000108-05-4 Acetic acid, vinyl ester 2 SML = 12 mg/kg 0,2
10630 000079-06-1 Acrylamide 4A SML = ND (DL = 0.01 mg/kg)
10660 015214-89-8 2-Acrylamido-2-methylpropanesulphonic acid 3 SML = 0.05 mg/kg
10690 000079-10-7 Acrylic acid 2 SML(T) = 6 mg/kg (11) 0,1
0.1 (as
SML(T) = 6 mg/kg (11)
10780 000141-32-2 Acrylic acid, n-butyl ester 2 acrylic
(as acrylic acid)
acid)
0.1 (as
SML(T) = 6 mg/kg (11)
10840 001663-39-4 Acrylic acid, tert-butyl ester 2 acrylic
(as acrylic acid)
acid)
61
ADI/TDI
PM/REF No CAS No NAME SCF-L RESTRICTION mg/kg
bw
11440 044992-01-0 Acrylic acid, ester with trimethylethanolammonium chloride 8 To be fixed
- 013106-44-0 Acrylic acid, ester with trimethylethanolammonium methyl sulphate - To be fixed
- 000106-74-1 Acrylic acid, 2-ethoxyethyl ester - To be fixed
- 025268-77-3 Acrylic acid, N-methylperfluorooctanesulphonamidoethyl ester - To be fixed
12235 000627-93-0 Adipic acid, dimethyl ester 6B To be fixed
(35200) 034730-59-1 N-(2-Aminoethyl)-2-aminoethanesulphonic acid, sodium salt 8 To be fixed
12769 013531-52-7 N-(2-Aminoethyl)-1,3-diaminopropane 8 To be fixed
12772 000140-31-8 N-Aminoethylpiperazine 8 To be fixed
13255 010563-26-5 N,N'-Bis(3-aminopropyl)ethylenediamine 8 To be fixed
- 000105-83-9 N,N-Bis(3-aminopropyl)methylamine - To be fixed
- 003327-22-8 (3-Chloro-2-hydroxypropyl)trimethylammonium chloride - To be fixed
69
ADI/TDI
PM/REF No CAS No NAME SCF-L RESTRICTION
mg/kg bw
- 000108-22-5 Acetic acid, isopropenyl ester - To be fixed
10157 000098-86-2 Acetophenone 8 To be fixed
- 002754-27-0 Acetoxytrimethylsilane - To be fixed
- 000107-02-8 Acrolein - To be fixed
- 045021-77-0. (3-Acrylamidopropyl)trimethylammonium chloride - To be fixed
10720 000999-55-3 Acrylic acid, allyl ester 6A To be fixed
- 024615-84-7 Acrylic acid, 2-carboxyethyl ester - To be fixed
10990 002156-96-9 Acrylic acid, decyl ester 7 To be fixed
11020 019485-03-1 Acrylic acid, diester with 1,3-butanediol 8 To be fixed
11050 001070-70-8 Acrylic acid, diester with 1,4-butanediol 8 To be fixed
11080 004074-88-8 Acrylic acid, diester with diethyleneglycol 8 To be fixed
71
79
Table of contents
Page
1. Introduction ....................................................................................................... 81
2. Sampling ........................................................................................................... 81
8. References ........................................................................................................ 84
80
1. Introduction
The Technical document gives guidance on the conditions and methods of analysis to be
used for testing paper and board intended to come into contact with food. It should be read
in conjunction with the specifications laid down in Resolution ResAP (2002) 1 on paper and
board materials and articles intended to come into contact with foodstuffs.
2. Sampling
Tests pieces from samples should be chosen so that all components are represented at the
same percentage composition as in the original material or article. When an article is being
tested, all auxiliaries used in production of the article should be taken into account, such as
printing inks, lacquers, adhesives etc.
Testing for compliance with QMA restrictions (mg/6dm2) should measure the total
concentration of the substance in the paper.
3.2 . QMA restrictions laid down in Table 1 and Table 2 of Resolution ResAP (2002) 1
on paper and board materials and articles intended to come into contact with
foodstuffs
In principle, testing for compliance with the QMA restrictions in Table 1 of Resolution ResAP
(2002) 1 should measure the total concentration of a substance in the paper. The substance
can be measured in situ or by total release of the substance by extraction from the material
or by degradation of the paper matrix.
The tests for compliance with the QMA restriction for cadmium, lead and mercury of Table 1
of Resolution ResAP (2002) 1 which are listed in Section 7 of this document, are based on
aqueous extraction(2) and do not necessarily determine the total concentration of the
substances in the finished material or article. However, these tests are generally recognised
as appropriate to establish compliance.
Testing for compliance with the purity restriction for pentachlorophenol of Table 2 of
Resolution ResAP (2002) 1 can be made using a method based on extraction of the total
amount in the paper.
In principle, testing for compliance with SML restrictions should be carried out by migration
testing, using the conditions established in Directive 82/711/EEC and amendments, as well
as in Directive 85/572/EEC. However, extraction tests could be used if, on the basis of
scientific evidence, the results obtained using these tests are at least equal to those
obtained by migration testing using the conventional EU test simulants or foodstuffs.
(1)
The numerical value of QMA expressed as mg/6dm 2 of material corresponds to the numerical value of SML
expressed as mg/kg of food or food stimulant.
(2)
Extraction using simulant B (3% aq. acetic acid w/v) should be used for paper intended to come into contact with acidic
foodstuffs.
81
4.2. Migration tests
Testing should take into account the worst foreseeable conditions of use for the material.
This will include the type of foodstuff with which the paper comes into contact, and the time
and temperature of contact.
For contact conditions where the mass of food to contact area ratio differs from the
conventional ratio of 1 kg food to 6 dm2 of paper, the restriction to be applied (Q) is
calculated as follows:
QMAstd.
Q = x 6 x m
CAnor
6. Speciality papers
Migration testing should be carried out using only MPPO as a test medium regardless of the
type of food and using the time and temperature of contact provided in Directive 82/711/EEC
and its amendments.
Testing should take into account possible degradation products formed at elevated
temperatures. When carrying out extraction testing to determine compliance with Resolution
ResAP (2002) 1 the sample should, in principle, be preheated in a closed container,
according to the time and temperature conditions given in Directive 82/711/EEC and its
amendments.
82
6.2. Paper used for filtering large volumes of liquid such as filters for industrial use
and milk filters
Where the total volume to be filtered is from 1 to 10 l/dm2 of paper, before testing, 0.5 l of the
food or food simulant per dm2 should be passed through the test material and discarded. A
further portion, 0.5 l/dm2, of the food or simulant should then be passed through the material
and analysed to obtain the test result.
Where the total volume to be filtered is above 10 l/dm2 of paper, before testing, one litre of
the food or food simulant per dm2 should be passed through the test material and discarded.
A further portion, 1 l/dm2, of the food or simulant should then be passed through the material
and analysed to obtain the test result.
For filtration papers used to filter oils, migration tests should be carried out using olive oil
simulant (or the recognised alternative fatty food simulants or substitute test media) or with
the same type of oil as will be filtered in normal use of the paper.
For testing compliance with a QMA restriction, or when using extraction tests to determine
compliance with an SML restriction, the material should be tested directly after the first 0.5
l/dm2 has been passed through the material and discarded.
7. Methods of analysis
The Council of Europe and the EU Commission do not normally issue resolutions or
directives in the field of methods of analysis. The progress in this area is so rapid that any
method may be considered obsolete after a limited number of years. However, there is a
need to provide guidance to analysts who carry out testing to ensure compliance with the
requirements of Resolution ResAP (2002) 1 (e.g. enforcement authorities, industry, food and
food packaging retailers and certification laboratories).
If such a method does not exist currently, an analytical method with appropriate performance
characteristics (accuracy and precision) at the specified limit may be used.
83
Determination of antimicrobial constituents (EN 1104)
Migration into modified polyphenylene oxide (MPPO) (EN 14338)
Analytical methods for testing of papers made from recycled fibres are summarised in
Appendix A.
8. References
Council Directive of 18 October 1982 laying down the basic rules necessary for testing
migration of the constituents of plastic materials and articles intended to come into contact
with foodstuffs (82/711/EEC). Official Journal of the European Communities L297/26,
23.10.82.
Council Directive of 19 December 1985 laying down the list of simulants to be used for
testing migration of constituents of plastic materials and articles intended to come into
contact with foodstuffs (85/572/EEC). Official Journal of the European Communities
L372/14, 31.12.85.
Commission Directive of 29 July 1997 amending for the second time Council Directive
82/711/EEC laying down the basic rules necessary for testing migration of the constituents
of plastic materials and articles intended to come into contact with foodstuffs (97/48/EC).
Official Journal of the European Communities L222/10, 12.8.97.
Council of Europe Resolution AP (96) 4 on maximum and guideline levels and on source-
directed measures aimed at reducing the contamination of food by lead, cadmium and
mercury, adopted by the Committee of Ministers on 2 October 1996.
84
APPENDIX A
The analytical methods listed below have been used for the analysis of papers made from
recycled fibres. A number of these methods are not internationally recognised and/or
validated. Those wishing to use these methods for testing purposes should ensure that they
evaluate the performance of the methods.
Diisopropylnaphthalenes
For the determination in paper the methods described in (2), (3), and (4) are used.
Phthalates
Analysis can be performed by GC/MS after solvent extraction, for details see (6) and (7).
Solvents
Azo colourants
For analysis the method provided in (9) can be used. Following this method the azo
colourants are cleaved reductively and the formed amines are determined by HPLC/DAD,
TLC, GC/FID and/or MSD, or by CE/DAD. The aromatic amines freely available in paper
before cleavage of the azo bond must be subtracted from the result after the cleavage.
For screening, the summation method as described in (10) can be used. If the sum of
primary aromatic amines is above the detection limit it is necessary to determine the amines
listed in the proposal for the EU Directive amending for the 19th time the Council Directive
76/769/EEC specifically.
N.B.: CEN TC 194 is preparing a screening method and a method for the specific
determination of primary aromatic amines in food simulants.
85
Polycyclic aromatic hydrocarbons
N.B.: CEN TC 172 is preparing a GC/MS-method for the determination of polycyclic aromatic
hydrocarbons in paper.
Benzophenone
References
(1) Castle, L., Damant, A.P., Honeybone, C.A., Johns, S.M., Jickells, S.M., Sharman, M.
and Gilbert, J. Migration studies from paper and board food packaging materials. Part
2. Survey for residues of dialkylamino benzophenone UV-cure ink photoinitiators.
Food Additives & Contaminants, (1997), 14:45-52.
(2) Sturaro, A., Parvoli, G., Rella, R., Bardati, S. and Doretti, L. Food contamination by
diisopropylnaphthalenes from cardboard packages. International Journal of Food
Science & Technology, (1994), 29:593-603.
(5) Sturaro, A., Parvoli, G., Rella, R. and Doretti, L. Hydrogenated terphenyls
contaminants in recycled paper. Chemosphere, (1995), 30:687-694.
(6) MAFF: Food surveillance information sheet, Number 60 May 1995: Phthalates in
paper and board packaging.
http://www.foodstandards.gov.uk/science/surveillance/maffinfo/
(7) Aurela, B., Kulmala, H. and Soderhjelm, L. Phthalates in paper and board packagings
and their migration into Tenax and sugar. Food Additives & Contaminants (1999),
16:571-577.
(11) EN 648 "Paper and board intended to come into contact with food - Determination of
the fastness of fluorescent whitened paper and board".
(12) Johns, S.M., Gramshaw, J.W., Castle, L. and Jickells, S.M. Studies on functional
barriers to migration. 1. Transfer of benzophenone from printed paperboard to
microwaved food. Deutsche Lebensmittel-Rundschau, (1995) 91:69-73.
86
TECHNICAL DOCUMENT No. 3
87
Table of contents
Page
1. Introduction ........................................................................................................... 89
88
1. Introduction
The Guidelines on paper and board materials and articles, made from recycled fibres,
intended to come into contact with foodstuffs are for the guidance of the enforcement
authorities, manufacturers and users in order to ensure that the use of the end-product does
not constitute a risk to health in accordance with Article 2 of EU Framework Directive
89/109/EEC.
Paper and board made in part or in full from recycled fibres intended to come into contact
with foodstuffs should comply with the requirements of Resolution ResAP (2002) 1 on paper
and board materials and articles intended to come into contact with foodstuffs and related
technical documents. However such paper and board should be subject to some additional
requirements to ensure their safety in use due to the presence in the feedstock of
constituents of printing inks, adhesives and other substances, e.g. from paper not intended
for food contact.
In order to ensure the safety of the end product the following aspects should be considered
together:
As further elements of product safety assurance, tests should be carried out where
appropriate or advisable as a matter of prudence, to determine the presence of specific
substances in the end-product.
Good manufacturing practice (GMP) is a fundamental part of quality control and product
safety assurance.
Some of these basic elements, which are particularly important for the production of paper
and board made from recycled fibres intended to come into contact with foodstuffs, are
covered in Chapters 3, 5 and 6 of the Guidelines.
Furthermore, see also Technical document No. 4 - CEPI guide for good manufacturing
practice for paper and board for food contact.
89
3. Recovered paper groups
The aim of this chapter is to define the groups of recovered paper and board that can be
used as raw materials in the manufacture of paper and board intended to come into contact
with foodstuffs, as well as those groups of recovered paper and board which cannot be used
as raw materials. These groups are defined in relation to the potential contaminants which
could be present, so as to assist the selection and processing of raw materials as part of
Good manufacturing practice (see Technical document No. 4 - CEPI guide for good
manufacturing practice for paper and board for food contact).
The groups of recovered paper listed below are defined in generic terms for the purpose of
the Guidelines. Where industry use other definitions such as their own specifications or, for
example, the nomenclature in EN 643:2001 some of which are listed below for illustrative
purposes, they should ensure correspondence with the groups below.
The descriptions within each group are given as examples. Where applicable, some grades
listed in EN 643:2001 are indicated.
Group 1
Paper and board manufactured with substances of Technical document No. 1 - List of
substances to be used in the manufacture of paper and board materials and articles
intended to come into contact with foodstuffs.
Unprinted cuttings, shavings, sheets and rolls from food contact paper and board based on
virgin fibres.
Group 2
Paper and board which may be manufactured with substances not mentioned in the List of
substances used in the manufacture of paper and board materials and articles intended to
come into contact with foodstuffs set out in Technical document No. 1 - List of substances to
be used in the manufacture of paper and board materials and articles intended to come into
contact with foodstuffs, unprinted or lightly printed or lightly coloured1.
Unprinted cuttings, shavings, sheets and rolls of printing and writing papers (EN 643:2001-
3.14, 3.15, 3.16, 3.17, 3.18, 3.19);
Lightly printed or coloured cuttings, shavings, sheets and rolls of printing and writing papers
(EN 643:2001- 2.03, 3.01, 3.02, 3.03, 3.04, 3.09);
White writing and printing paper originating from offices (EN 643:2001 - 3.05);
Unprinted or lightly printed, unused kraft paper (EN 643:2001- 4.07, 4.08);
1
Lightly printed: Papers where the ratio of printed area to unprinted area is very small. Examples of
lightly printed papers are shavings and cuttings, not mixed with misprinted sheets, originating from
printing shops.
Lightly coloured: Papers where only shading dyestuffs have been added during manufacture.(For
example yellow pages in telephone directories are not considered as lightly coloured.)
90
Unprinted or lightly printed, unused packages (EN 643:2001 - 3.12, 3.13, 4.05);
Group 3
Printed paper and board, corrugated board from supermarkets, paper and board from
households and industry.
Printed or coloured material from printing shops, over-issues etc. (EN 643:2001 - 1.06, 2.02,
2.04, 2.07, 3.08, 3.11);
Unsorted white and coloured writing and printing paper originating from offices;
Boxes and sheets of corrugated board collected from supermarkets (EN 643:2001 - 1.04,
1.05);
Printed paper from households, such as newspaper, pamphlets, magazines, catalogues etc.
(EN 643:2001 - 1.11);
Mixed papers and board from households (EN 643:2001 - 1.02, 5.01);
Sheets, boxes and cases of solid and corrugated board and folding boxboard from
households.
3.2. Recovered paper and board not for use as raw materials
Recovered paper and board which has been mixed with garbage and subsequently sorted
out;
Used stained sacks which have contained for example chemicals and foodstuffs;
Covering materials, such as paper used for covering furniture during repair and painting
work;
Waste paper from households containing used hygienic paper, such as used kitchen towels,
handkerchiefs and facial tissue;
For paper intended for contact with hot, aqueous liquids, such as tea bags, coffee filters and
cooking pouches, or for use at high temperature, such as baking paper, recovered paper of
Groups 2 and 3 should not be used.
91
4. Foodstuff types
Foods have been classified into 3 types, taking into account the nature of the food and the
potential for migration in contact with paper and board. The classification laid down in EU
Directive 85/572/EEC should be used to determine the food type for individual foodstuffs
except where Chapter 4 of the Guidelines indicates otherwise.
Aqueous foods range from those which are liquid to those which are solid but have a high to
medium water content. Examples of liquid foodstuffs include beverages and water.
Examples of solid foods with a high to medium water content include fresh fish, shellfish,
meat and some cheeses.
Fatty foods range from those which are fully fatty to those which are solid, with a low to
medium moisture content but which have fat on the surface. Example of the former include
animal and vegetable fats. Examples of the latter include pastry products, pizzas,
hamburgers, cheeses and chocolate.
Frozen foods of Type I can be considered to be dry, non-fatty of Type II provided that the
food is not defrosted in contact with paper and board.
Foodstuffs which are dry or with low moisture content and which do not have fat on the
surface. Examples of such foods include sugar, pulses, some bakery wares, salt, tea and
spices.
Type II foodstuffs, e.g. bread, which come into contact with paper and board at temperatures
above room temperature, e.g. in microwave or conventional ovens, should be considered as
Type I foodstuffs.
Frozen foodstuffs of Type II are considered to be foodstuff Type I if they are defrosted in
contact with paper and board.
4.3. Type III - Foodstuffs which are shelled or peeled or washed before consumption
Examples of Type III foodstuffs are fruits, vegetables, nuts and potatoes.
This chapter describes current process technologies applied to the raw materials taking into
account the intended use of the end-product. It deals with the processes applied to the
recovered paper at the fibre preparation stage. Paper-making processes are not covered.
The information in this chapter is based on current technical knowledge and should be
reviewed in the light of technological developments. It is recognised that the groups of
recovered paper defined in Chapter 3 of the Guidelines differ in their potential for chemical
and microbiological contamination of foodstuffs depending on the intended use of the end-
product. Recycling process technologies should be adequate to counter this potential for
contamination without imposing unnecessary restrictions. The most efficient processes
should therefore be applied where necessary. The use of chemical reagents, the effects of
washing together with process water treatments, and temperature controls provide some of
the means for achieving chemical decontamination of raw materials.
92
These process technologies, which are summarised in Table 1 of Chapter 5 of the
Guidelines and defined in Appendix 1 below should be seen in the context of the
Consolidated matrix of Chapter 7 of the Guidelines. They link raw materials to the intended
use of the end-product, and to the wider context of Good manufacturing practice (see
Technical document No. 4 - CEPI guide for good manufacturing practice for paper and board
for food contact).
Types of process
Repulping, deflaking cleaning and screening are examples of mechanical cleaning and they
are intended to remove physical impurities. However, their impact on chemical
contamination is significant, and is due to the dilution effect since these processes are
carried out at low consistency. Low size components such as fillers and fines (fine fibre
fraction) are released in the process water, and may be removed at subsequent stages. In
addition the level of insoluble contaminants is reduced at this stage. It must be emphasised
that part of the process water, including dissolved and suspended material, is not re-used in
the recycling plant, but is rejected to the wastewater treatment plant.
5.2. Washing
Washing is carried out by successively lowering the consistency by dilution and increasing by
thickening. Some processes are best carried out at high consistency for mechanical and
energy efficiency reasons, such as dispersion. Some screening and cleaning has to take place
prior to this stage at a low consistency, which means that a thickening stage is employed.
Normally, this is carried out by squeezing out excess water, for example in a screw press, belt
press or drum filter. Water-soluble contaminants are dissolved and may be removed if
adequate process water treatments are used.
De-inking may be carried out either by washing or by flotation. The purpose of de-inking is to
remove ink from printed material. Together with ink particles, some dissolved and colloidal
contaminants are removed. Surface-active agents, such as soaps, are used to help
separation.
This stage is carried out at high consistency. The fibres are subjected to high mechanical
forces together with a steam treatment, generally at temperatures of 60 C, but temperatures
of 140 C may be applied. This process is called hot dispersion and it can be combined with a
chemical treatment by adding chemicals. Thermal treatment reduces the level of chemical and
microbiological contamination.
Chemical treatment may be carried out together with hot dispersion. Generally used chemicals
are hydrogen peroxide, formamidine sulfinic acid (FAS) and sodium hydrosulfite.
The purpose of bleaching is to increase the brightness of white grade papers. Generally
used chemicals are hydrogen peroxide, FAS, sodium hydrosulfite, ozone and oxygen.
Process water treatment aims at controlling microbiological activity. It includes the use of
biocides, slimicides and enzymes.
93
The purpose of process water clarification is to remove suspended solids and colloidal
materials from the water to be re-circulated in order to provide water of a suitable quality to be
re-used back in the process. It avoids recontamination at dilution stages.
94
TABLE 1 - CURRENT PROCESS TECHNOLOGIES AND THEIR PURPOSE
95
6. End-product requirements
The aim of this chapter is to specify the requirements for the end-product and tests to be
carried out.
Restrictions laid down in Resolution ResAP (2002) 1 and related technical documents apply to
the end-product. Additional restrictions for the end-product are specified in Table 2 of Chapter
6 of the Guidelines. These additional restrictions are for substances which have the potential to
be present in paper made of recycled fibres, and to migrate into foodstuffs at levels which may
pose a risk to health. The list is based on current knowledge of chemicals which are found in or
could migrate from recycled fibres.
Some of the restrictions for particular substances are based on evaluations by recognised
international bodies, e.g. SCF or JECFA. Where restrictions have not yet been established
by a recognised body, the requirements in Table 2 of Chapter 6 of the Guidelines have been
made on grounds of prudence, to ensure that migration into foods is kept as low as
reasonably achievable.
The end-product should be tested in accordance with the procedure specified in the
Guidelines on test conditions and methods of analysis for paper and board materials and
articles intended to come into contact with foodstuffs set out in Technical document No. 2
Guidelines on test conditions and methods of analysis for paper and board materials and
articles intended to come into contact with foodstuffs, in order to ensure compliance with Art.
2 of EU Directive 89/109/EEC.
It is not necessary to carry out specific testing for compliance if there is conclusive evidence,
assuming 100% migration based on the content in the end-product or in the raw materials,
that the migration of the substances is so low that compliance with Art. 2 of EU Directive
89/109/EEC is ensured.
Tests should be carried out for substances with a demonstrated toxic potential whenever
there are grounds to suspect their presence in the end-product.
Chemical or toxicological screening tests for possible unknown toxic substances are desirable.
However, at present the implementation of chemical screening tests for unknown substances
might not be feasible. Furthermore, the knowledge about the applicability of toxicological
screening tests for paper and board is insufficient for the time being although it should be noted
that studies are in progress to establish the validity of these tests for paper and board. The use
of these chemical or toxicological screening tests on paper and board should be evaluated and
should be recommended in the future where necessary, based on new developments and
results in this field.
96
TABLE 2 - SPECIFIC REQUIREMENTS
Requirements
Substance (Food types I and II unless otherwise specified)
Michlers ketone The migration of this substance should not be detectable in foodstuffs (limit of
detection of 0.01 mg/kg foodstuff)
Testing required for Food Type I only
4,4-Bis (diethylamino) The migration of this substance should not be detectable when measured in
benzophenone (DEAB) foodstuffs (limit of detection of 0.01 mg/kg foodstuff)
Testing required for Food Type I only
Diisopropylnaphthalenes (DIPNs) Levels in paper and board should be kept as low as reasonably achievable, to
minimise migration into food
Partially hydrogenated Levels in paper and board should be kept as low as reasonably achievable, to
terphenyls (HTTP) minimise migration into food
The volatility of most solvents ensures that they are not present in the finished
Solvents product. `However, industry should take the necessary steps to ensure that
residual solvents are reduced to the lowest possible levels in the finished
product, so that migration into food does not pose a risk to health
Soluble azo colourants which may cleave to form aromatic amines listed in
th
Azo colourants the proposal for the EU Directive, amending for the 19 time the Council
Directive 76/769/EEC
The aromatic amines should not be detectable when measured in paper (limit
of detection of 0.1 mg/kg paper) Testing required for Food Type I only
Fluorescent whitening agents The migration of these substances should not be detectable when measured
1
(FWA) in foodstuffs
Testing required for Food type I only
Primary aromatic amines, These substances should not be detectable when measured in paper (limit of
suspected to be carcino- detection of 0.1 mg/kg paper)
2
genic Testing required for Food Type I only
Polycyclic aromatic The migration of these substances should not be detectable when measured
hydrocarbons (PAH) in foodstuffs (limit of detection of 0.01 mg/kg foodstuff)
2
Benzophenone Specific migration limit of 0.1 mg/dm of paper
1
Tests should be carried out according to EN 648
2 th
See: proposal for the EU Directive, amending for the 19 time the Council Directive
76/769/EEC, opinions expressed by SCF, IARC and other competent bodies
97
7. Consolidated matrix
Tests on end-products are necessary where there are actual or potential risks to health.
These risks depend on the nature of the recovered paper, the effectiveness and purpose of
recycling treatments and the nature of the contact with foodstuffs for the end-product. All of
these elements are combined with the requirements in Chapter 6 of the Guidelines.
The process technologies listed in Table 3 of Chapter 7 hereafter provide flexibility to take
account of mill-specific circumstances. The purpose of these processes is to reduce or
eliminate the presence of contaminants in the finished product and to fulfil the requirements
set in Chapter 6 of the Guidelines. Other processes or combination of processes may be
used in order to fulfil these requirements. It is the responsibility of industry to demonstrate
through Good manufacturing practice (see Technical Document No. 4 CEPI Guide for
good manufacturing practice for paper and board for food contact ) that the end-product
meets the requirements of Art. 2 of Council Directive 89/109/EEC.
98
TABLE 3 - CONSOLIDATED MATRIX
PART I
The matrix should be read in conjunction with the rest of the Guidelines
Food type Recovered paper group Process technologies Additional end-product
(Chapter 4) (Chapter 3) (Chapter 5) requirements
(other processes or (Chapter 6)
combinations of (tests should be carried out
processes may be used for other toxic substances
provided that the end- whenever there are grounds to
product fulfils the suspect their
requirements of Chapter 6) presence in the end-
product)
Group 2: Paper and board Mechanical cleaning Michlers ketone, DEAB, DIPNs,
manufactured with substances not Washing HTTP, Phthalates, Solvents, Azo
listed in Technical document No. 1, Chemical treatment, colourants, FWAs, Aromatic
unprinted or lightly printed or lightly unless it is not necessary amines, Polycyclic aromatic
coloured Thermal treatment, hydro-carbons, Benzophenone
unless it is not necessary
Food type II Group 2: Paper and Board which Mechanical cleaning DIPNs, HTTP, Phthalates,
Dry, non-fatty may be manufactured with Washing Solvents, Polycyclic aromatic
foodstuffs, including substances not listed in Technical Thermal treatment, hydrocarbons, Benzophenone
frozen document No. 1, unprinted or lightly unless it is not necessary
printed or lightly coloured
Group 3: Printed paper and board, Mechanical cleaning DIPNs, HTTP, Phthalates,
corrugated board from Washing Solvents, Polycyclic aromatic
supermarkets and paper and board Chemical treatment, unless it hydrocarbons, Benzophenone
from households and industry is not necessary Thermal
treatment, unless it is not
necessary De-inking,
unless it is not necessary
Group 3: Printed paper and board, Mechanical cleaning The requirements of Table 2 of
corrugated board from Washing the Guidelines do not apply
supermarkets and paper and board
from households and industry
99
APPENDIX 1
1.1. Repulping
This is always the first step. During pulping, fibres are separated and some additives added
to the paper during the printing and converting process are separated from the fibres.
Various kinds of devices can be used : low, medium or high consistency pulpers and drums
are proposed by machinery suppliers.
The choice of the type of pulper has to be made by considering various parameters including
the efficiency of defiberizing and energy consumption but mainly with respect to:
- efficient ink detachment when de-inking is to be carried out. Chemicals (e.g. caustic soda,
sodium silicate and soap) are used in the pulping stage in order to improve ink release from
the fibres. Bleaching chemicals (such as hydrogen peroxide) can also be used in this stage;
- minimising the breaking-up of contraries, which could reduce their removal efficiency.
The removal of contraries is based on their physico-chemical properties, which differ from
those of cellulosic fibres :
- differences in size : particles smaller than fibres can be removed by washing and
contaminants larger than fibres can be removed by screening (Fig. 1 and 3);
In order to ensure good cleaning efficiency, size, shape and density must be considered;
flotation efficiency mainly depends on surface properties.
100
Figure 1: Principle of screening
101
Figure 2: Principle of cleaning
102
Washing can remove fillers and finely divided ink particles, as well as colloidal materials
dispersed in water. Very efficient cleaning is obtained. The drawback is the use of important
volumes of water, which need a suitable treatment, and a significant loss of fibrous and non-
fibrous material. The losses are removed as sludge by the water treatment.
Flotation can remove ink (oil-based ink with hydrophobic characteristics), varnishes and
various adhesive particles. Flotation efficiency also depends on particle size, which has to be
severely controlled at the pulping stage.
Cleaning (heavy contaminants) can remove metals, sand, glass, and some varnish particles.
This technique is also used to remove toner ink after agglomeration with appropriate
chemicals.
Cleaning (lightweight contaminants) can remove hot melt adhesives and various plastic
particles.
Screening can remove large contaminants including plastic films, shives, wet strength
papers. Hole screens are efficient with flat contraries, such as varnish particles ; they are
followed by slot screens which remove granular particles. The slot width is usually 150 m.
Screens with 80 m wide slots are currently being developed.
103
Process water treatments are implemented in order to remove fillers and inks from washing
waters and, in some cases, colloids in thickening water. The most common technique involves
microflotation. Additional treatments with biocides are used to control microbial growth in the
circuits. This is also applicable to water on the paper machine.
De-inking lines are made up of a combination of the various techniques. The number of stages
in the process depends on the grade of the furnish and the quality requirement of the de-inked
pulp to be produced.
Recovered papers are defiberised in a medium consistency pulper or a drum pulper (15 to
18% consistency). After dilution, coarse screening removes large contraries such as plastic
films and wet-strength papers. High density cleaning removes heavy contraries such as
staples and sand.
Hole and slot screening are performed at medium consistency (up to 4 %). Then, the pulp is
diluted down to between 1 and 1.4 % consistency and submitted to flotation. Cleaning stages
(heavy and lightweight) take place after flotation, generally after a complementary dilution
(down to 0.7 %). A fine slot screening stage is generally implemented after cleaning. Then the
pulp is thickened on a disk filter. The white water is treated and re-used for dilution in the
various stages of the process. After the filter, the pulp is stored or diluted with water from the
paper machine.
After the thickening stage on the filter, a screw press is used to increase the consistency up
to 30 %, and the pulp may be submitted for hot dispersing and peroxide bleaching.
Post-de-inking (a second de-inking stage, using the same techniques as in the first stage)
performed after hot dispersing and bleaching is carried out in some mills, as an efficient way
to improve brightness and cleanliness.
104
Figure 4: Principle of de-inking by flotation
1.4. Hot-dispersion
This technology, which is not concerned with contraries removal, can also be used in
recovered fibres processing lines. Hot dispersing with low-speed kneaders or high-speed
dispergers can be used to disperse residual contaminants such as hot-melt adhesives or
specks from varnish particles and toner inks. Some contaminants such as adhesive particles
from labels or tapes show little dispersion ability.
Hot dispersion is an efficient treatment for the detachment of residual ink particles in the
case of processes involving two or more de-inking loops[1].
105
1.5. Bleaching
So-called upgrading treatments can be applied to the pulp, whether de-inked or not.
Brightness is often an important concern and bleaching treatments can be applied to the
reprocessed pulp. Hydrogen peroxide (oxidative) bleaching and sodium hydrosulfite (or FAS)
(reducing) bleaching are the most common treatments used for recovered paper bleaching[2].
Bleaching restores the initial brightness of cellulosic fibres by destroying chromophores[3].
This chemical action may also remove undesired chemical substances and micro-
organisms. Bleaching is in certain cases aimed at colour stripping or destruction of optical
brightening agents[4]. Visual uniformity of the pulp (so-called cleanliness) is also an important
quality. As described previously, this can be improved by hot dispersing.
This treatment is carried out in a gaseous oxygen environment, at a high temperature and
under pressure, with metal chelating agents.
Ozone is produced by circulating pure oxygen gas between electrodes at a high voltage. It is
a highly reactive gas, which destroys chromophores and micro-organisms. Under certain
conditions, colourants and fluorescent whitening agents may be removed[5].
Process waters are always re-used to a certain extent. The trend is towards more and more
closed systems. The drawback is an increased concentration of unwanted substances:
dissolved organic and inorganic substances (carbohydrates such as starch and
hemicelluloses, salts, colloids etc.), suspended solids (fines, fibres, filler and ink particles
etc). Increased values of chemical and biological oxygen demand (resp. COD and BOD),
suspended solids and microbiological counts are recorded.
Dissolved air flotation systems are used for the removal of suspended solids. Their efficiency
is poor towards colloids (adhesives or polymeric additives arising from recovered papers). A
chemical destabilisation using strongly cationic polyelectrolytes will cause coagulation of the
colloids, which then may be partially removed in the microflotation cells[6].
The presence of catalase results in hydrogen peroxide decomposition and low brightness
gain at the bleaching stage [7]. An "absolute" microbiological cleanliness of process waters is
unnecessary. A critical control point approach shows that most germs which are present in
process waters are destroyed at further stages of the process.
106
References
[1]
Galland, G., "Overview of de-inking technology", Centre Technique du Papier, Document
No. 1706, 1995
[2]
Carr, B., Galland, G., Vernac. And Suty, H., The effect of hydrogen peroxide bleaching
on ink detachment during pulping and kneading, TAPPI Recycling Symposium, New
Orleans, (Feb. 20-23 1995)
[3]
Galland, G. Vernac, Y., Dubreuil, M. and Bourson, L. Progress in Bleaching Recovered
Paper Pulps, Progress in Paper Recycling, 2(1): 20-30 (Nov. 1992)
[4]
Lachenal D Bleaching of secondary fibres basic principles, Progress in Paper
Recycling, Vol 4, No. 1, 37-43, (Nov. 1994)
[5]
Kogan J. And Muguet M., Ozone bleaching of de-inked pulp, TAPPI Recycling
Symposium, Boston, Proceedings: 237-244, (May 15-18, 1994)
[6]
Carr B., Brun, J., Galland, G., The incidence of the destabilisation of the pulp on the
deposition of secondary stickies, 3rd Research Forum on Recycling, Vancouver, Canada
(20-22 Nov. 1995)
[7]
Galland, G., Bernard, E. and Vernac, Y., (1989): Recent progress in de-inked pulp
bleaching, Pira, Paper & Board Division Conference, Gatwick, Recent developments in
wastepaper progressing and use: paper 19 (28 Feb-2 March 1989) and Paper Technology
30 (12): 28-33 (Dec 1989).
107
108
TECHNICAL DOCUMENT No. 4
109
Table of contents
Page
SECTION III - Explanatory note - the paper-making process and glossary of terms
110
SECTION I SCOPE, GENERAL PRINCIPLES, PARTICULAR ASPECTS
Existing product liability legislation should be considered in order to make sure that due
responsibility is taken by paper and board manufacturers for all manufacturing factors as
they apply to the product end use. It will be the care of paper and board manufacturers to
provide users with appropriate product information.
It shall be the responsibility of the users of the paper and board to inform the manufacturers
of intended end use.
The recommendations offer organisational and practical advice on the management of key
factors affecting product quality and fitness for purpose, especially safety with respect to
food contact. They cover all the production stages from the raw materials order
(procurement) and supply to the point where the product is dispatched from the paper
manufacturer.
A paper or paperboard material, which the customer has ordered, is thus manufactured
according to an agreed quality standard which includes all requirements existing in relevant
Directives or regulations or legislation which is applicable for food contact paper and board.
GMP is based on a quality management system, such as the ISO 9000 series of standards
or another, equivalent, recognised scheme and on the relevant principles of a recognised
hazard analysis system, such as HACCP (Hazard Analysis Critical Control Point, see
Section II, below). These systems are related one to each other since they have the same
principles.
For each stage of production, including the receipt of an order, the procurement of raw
materials, the different steps of processing, manufacturing and testing, finishing and shipping
of the product, a total control has to cover, for example:
manuals;
production instruction documents;
specifications for testing;
handling, storage, packaging, preservation, product identification and
delivery;
personal training and commitment, internal auditing;
production and quality records.
A high level of housekeeping, in terms of appropriate level of cleanliness and order, has to
be maintained throughout the whole process.
111
3. Particular aspects
The management has to make a strong commitment to the quality policy and assure that
appropriate responsibility and authority is given, understood and applied at each level of the
organisation
All personnel should be made aware of their duties and responsibilities concerning the
requirements of the current legislation and of this code of GMP. Their training should be
performed and assessed in a suitable manner. New employees will be made aware of food
contact manufacturing requirements as part of their induction process. Records of
assessments and training received will be maintained.
A quality system has to be installed and maintained in order to assure product conformity to
the specified requirements. Procedures have to be implemented to avoid misunderstanding
when producing the order.
A system has to be implemented to ensure that only raw materials in conformity with the
needs of the end product are purchased. Non-fibrous constituents shall be selected
according to Technical document No 1 List of substances used in the manufacture of paper
and board materials and articles intended to come into contact with foodstuffs.
Pulps shall comply with the resolution and, where applicable, with the guidelines on recycled
fibres.
All materials from a new supplier or of a new grade must be assessed for suitability for
conversion to the final product. If the results are satisfactory, the material is accepted and
can be ordered in the future against an agreed specification.
All incoming raw materials should be clearly identified and stored only in specially
designated areas. Appropriate cleanliness and hygiene are to be maintained in the raw
materials storage areas.
Control upon reception of raw materials is implemented taking into account also the extent of
control carried out by the suppliers, and the fact that a registered proof of raw material
compliance may be provided upon delivery.
112
3.5. Process control
The process has to be clearly defined and planned; it has to be demonstrated that the
process runs continuously under controlled conditions. Great importance must be given to
the control of the process parameters due to the complexity of paper and board technology,
particularly to avoid and remove possible contamination in order to fulfil the end product
requirements.
Each mill/producer has to identify and keep under control in its own process the critical
control points related to the hazard analysis system (see below) and food contact
requirements. The microbiological load within the mill should be monitored but testing should
be performed only where indicated by the hazard analysis (see below).
It is particularly important that items in stock are well identified and can only be dispatched for
an end use that is permitted within the Directives, regulations, and legislation for food contact.
A clear procedure needs to be developed to ensure dispatch of products that meet the
agreed quality standards.
3.7. Traceability
An accurate system to enable tracking through the production process from raw materials
through to final customer order has to be implemented.
3.8. Labelling
All finished products must be labelled so that production history, including details of raw
materials, manufacturing dates, etc. may be traced.
3.9. Testing
Testing and inspection procedures have to be defined, to verify the compliance of the final
product with the agreed quality standards and with the Resolution and Guidelines.
The results have to be recorded and filed. Procedures for quality recording have to be defined
in order to guarantee the correct identification, collection, filing, and distribution of the quality
reports.
When available, standardised testing methods are preferred (e.g. CEN, ISO, etc.).
Inspection, measuring and test equipment must be regularly maintained and calibrated;
records of these activities should be kept.
113
3.13. Auditing
Procedures should be defined to verify the correct performance of the quality system. These
will vary according to the chosen quality scheme.
The manufacturing stages of reeled and sheeted articles intended to come into contact with
foodstuff are listed, from raw materials to shipping.
The method implemented for the present Guide consists of listing the hazards related to each
manufacturing stage using the principles contained in the HACCP method.
For each manufacturing stage, Tables 1 to 5 indicate which hazards may be encountered
and the means of prevention.
In Tables 1 to 5, hazards are defined in conformity with the definition given in the note below.
Note:
The HACCP method, as used in food manufacturing and processing, is described in the
revised draft Guidelines indicated in Annex II of the document referenced ALINORM 97/13A
Revised draft Guidelines for the application of hazards, Analysis and Critical Control Point
(HACCP) and system, document which was elaborated by a commission from the
international authority Codex Alimentarius. This document gives the following definition of
the word hazard: A biological, chemical or physical agent in, or condition of, food with the
potential to cause an adverse health effect . The analysis of hazards through the HACCP
method is a procedure consisting of collecting and estimating the information relative to the
hazards and to the conditions leading to their presence, in order to identify which hazards
and conditions are significant regarding food safety, so that they may be submitted to the
HACCP plan mentioned in the standard.
Raw materials
- selection prior to purchase
- transport (delivery to factory)
- reception
- storage
- handling
Fibre preparation process technologies
- de-flaking, de-inking, hot dispersion, etc.
Preparation and introduction of additives
Refining, cleaning, diluting, sheet formation
Drying
Surface treatments
Winding and finishing (calendering, cutting)
Control of finished product
Labelling
Storage of finished products
Shipping
114
TABLE 1
FIBROUS RAW
MATERIALS
Contamination from a chemical Reference to Technical document No 1
a) Selection prior to List of substances used in the
and/or microbiological source, due to
purchase the use of raw materials whose manufacture of paper and board materials
safety has not been determined. and articles intended to come into contact
with foodstuffs
115
TABLE 2
Labelling error leading to the Indication upon order form about the
introduction of incorrect material. products technical reference.
Definition of requirements upon
ordering.
c) Reception, storage,
handling Contamination from a Appropriate premises. Maintenance of
microbiological source, linked with cleanliness of premises (appropriate
absence of cleanliness. cleaning, rodent control, etc.).
116
TABLE 3
RE-PULPING AND
OTHER PROCESS Contamination of the pulp from Maintenance of cleanliness of premises (rodent control,
TECHNOLOGIES micro-organisms brought by pests. etc.).
Inadequacy of physical
characteristics and/or possible
contamination from a chemical
source, linked with concentration Procedures.
PREPARATION error or overdose of hazardous
Records.
products.
AND
INTRODUCTION
OF ADDITIVES Contamination from micro- Compliance with procedures. Cleaning of preparation
organisms as a consequence of chests. Storage conditions (e.g. temperature).
microbiological growth of a Preventive treatment with biocides.
preparation (e.g. amylaceous
glues).
117
TABLE 4
SUGGESTED MEANS OF
STAGES POSSIBLE HAZARDS
PREVENTION
Contamination from a Cleaning procedures.
REFINING, microbiological source, linked with
absence of cleanliness (chests, Underwire water treatment
CLEANING, circuits).
DILUTING, SHEET Contamination from a chemical Where cleaning agent is not on positive list,
FORMATION source, from cleaning agents of segregation of cleaning water from other parts
clothing. of machine is needed
(FOR REELS)
PALETTISATI0N Contamination from a chemical
and/or microbiological source due
(FOR SHEETS) to the lack of cleanliness of pallets
or inappropriate treatment of the
wood
118
TABLE 5
SUGGESTED MEANS OF
STAGES POSSIBLE HAZARDS
PREVENTION
Inadequacy of physical characteristics Compliance with procedures, process
and/or chemical characteristics possibly control, down-grading and identification
VERIFICATION OF out of the regulatory tolerance. of products which are out of
specification, records.
FINISHED PRODUCTS
Clear and precise identification of
samples for laboratory analysis.
Implementation of specifications
regarding transport.
Compliance with procedures.
Contamination from a microbiological
source, linked with bad condition and
absence of cleanliness of means of
SHIPPING transport.
119
SECTION III - EXPLANATORY NOTE - THE PAPER-MAKING PROCESS AND
GLOSSARY OF TERMS
1. Introduction
This note is designed to accompany the Good Manufacturing Practice written for paper and
board for food contact. It contains a brief description and schematic diagram of the paper-
making process (Figure 2) together with a glossary of terms (Table 6) used in the GMP.
The following diagram shows a simplified form of the manufacturing chain from forest to
foodstuff.
forestry and
pulping operations
paper mill conversion,
operations printing, etc
fibre recovery
operations
area covered packaging
by core GMP application
foodstuffs
customer
This shows clearly that the Good Manufacturing Practice covers only a restricted portion of the
manufacturing chain. For the purposes of this document, this is referred to as paper mill
operations and is now described in more detail and illustrated in the schematic diagram
shown later. It is important to note that certain paper products are converted within the paper
mill and then sold direct to retail outlets. These will be subject to special extensions to the
GMP.
Paper and board is manufactured mainly from pulp which is derived from wood using a
variety of mechanical and chemical processes and recovered paper. The mixture used
depends upon end use and ranges from 100% virgin pulp through to pulp made from 100%
recovered paper. There are speciality areas which also use synthetic fibres, cotton, etc. Pulp
is supplied direct from forestry and pulping operations. It is delivered to the paper mill in a
dry state in stand-alone mills or in a wet state in mills which are integrated with pulp
manufacture. Recovered paper comes from merchants who use collection systems. It may
be subject to those treatments designed for recovered papers before being passed to the
paper machine. These could include: special pulping, de-inking, bleaching, hot dispersion,
washing, oxygen treatment, ozone treatment and enzymatic treatment.
120
Whatever the source, the pulp is passed to a re-pulping unit where it is mixed with up to 100
times its weight of water and subjected to violent agitation intended to produce a suspension
of individual fibres in water. At this, and subsequent stages, auxiliary chemicals, additives
and fillers may be added. The auxiliary chemicals and additives are usually combined with
the fibrous raw materials at levels below 1% - 2%. Typical materials include sizing agents to
bond the sheet together, pH control agents, de-watering aids, etc. Fillers usually consist of
clay, calcium carbonate or titanium dioxide and are added to modify the optical properties of
the paper and board or as a fibre substitute.
The fibrous suspension or stock is pumped, via storage chests, various types of cleaning
equipment and refiners, to the paper machine. Here, yet further water is added to produce a
fibre suspension of as little as 1 to 10 parts fibre to 1000 parts water and the resulting
mixture is passed into a head-box which squirts it through a thin slit across the full machine
width (typically 2 - 6 m) on to a moving woven wire mesh. The water is then removed by a
mixture of gravity and suction in a process known as sheet formation where the cellulose
fibres start to consolidate into a thin mat which is almost recognisable as paper.
This web is then lifted from the wire mesh and squeezed between a series of presses where
its water content is lowered to nearly 50%. It then passes around a series of cast-iron
cylinders, heated to temperatures in excess of 130C, where drying and microbiological
decontamination takes place. It is then wound into a full machine width reel at a water
content of 5% to 8%. Some papers may also undergo surface treatments e.g. sizing, grease-
proofing, etc. before the reeling process. Throughout its passage from the wire mesh to the
reeling operation, the paper web is supported on various types of machine clothing moving
at the same speed.
Samples of paper removed from each machine reel are the subject of quality control testing
and verification against the required specifications as part of the quality system.
Full machine width reels are passed into a separate area where they are subjected to further
operations. These may be either simple operations where the reel is slit into a number of
more narrow reels or cut into sheets. In some cases, intermediate processes may be
performed such as wrapping, coating or calendering.
The products of the above operations are labelled and placed in a despatch area to await
transport. Again, samples may be taken for quality control purposes and the results of earlier
tests will be checked against the inventory to ensure that only approved material goes forward.
121
wood pulp water
slushing, screening &
cleaning operations auxiliary
recovered chemicals,
paper recovered additives,
paper
storage chests fillers
process
technologies
water
stock
preparation cleaning & refining
area
water
head box
paper
sheet formation machine
THE
PAPERMAKING drying
PROCESS
surface treatments
= optional process
winding, sheeting
testing &
verification coating, finishing,
of final calendering, cutting
product
Figure 2
122
4. Glossary of terms
123
Mechanical pulp Paper-making fibres separated by mechanical means mainly from
wood.
Oxygen treatment * Treatment of the stock made by gaseous oxygen at high
temperature and under pressure.
Ozone treatment * Treatment of the stock made by ozone or oxygen/ozone mix.
Paper machine The machine that produces paper or board. There are different
types of paper-machine depending on the web forming technology
(e.g. four drinier, cylinder, twin wire, single ply, multi-ply, etc.).
Press Two rolls, pressed tightly together, through which the moving web
passes and which removes water by suction and transfer to a
moving textile blanket.
Pulp Material, generally of natural vegetable origin, made ready for use
in paper-making processes by conversion to a mass of individual
fibres.
Pulping Process to convert wood (and other fibrous raw materials) to paper-
making fibres.
Quality System The organisational structure, the procedures, the processes and
the resources that are needed to handle the Quality Management
System).
Recovered paper Paper collected by paper printing and other converting plants and
from other parts of the waste stream which is returned into the
paper-making process by collection and sorting.
Refiner/refining A machine through which paper-making stock is pumped before
delivery to the head-box. The machine imparts heavy mechanical
action to the fibres which modifies their properties in different ways
according to the final properties required.
Re-pulping A process to disintegrate, in water, dry pulp or paper for further
processing.
Semi-chemical pulp Pulp obtained by partial removal from the raw material of those
non-cellulosic components that can be removed by chemical
treatment, for example cooking
Sheet formation See web formation.
Sheeting See cutting.
Slitting Dividing a web of paper or board in the longitudinal direction into
two or more narrower webs.
Special pulping* Pulping with a chemical product (soda, peroxide, etc.).
Stock An aqueous suspension of paper-making pulp.
Stock preparation Process steps for conversion of pulp to stock. Can consist of
disintegration, adding water, fillers and auxiliary chemicals, diluting,
mixing and mechanically treat the paper-making components.
Storage chest A large vessel for storing stock awaiting processing into paper and
board.
Surface treatment Treatment consisting of the application of an appropriate material or
additive to the surface of a paper or a board to change certain
characteristics e.g. printability, porosity, grease-proofness, etc.
124
Thermo-mechanical Paper-making pulp made by mechanical means in combination with
pulp heating, from various raw materials, but usually wood.
Unbleached pulp Pulp that has not been subjected to bleaching.
Virgin pulp Pulp supplied to a paper mill which contains fibres not used before
in the paper-making process.
Washing* Treatment operated on a pulp which is alternately thickened and
diluted and passed through a series of filters with counter-current
flow; the operation is carried out to clean the pulp.
Web The continuous length of paper or board during manufacture or
conversion.
Web formation In the paper machine, the initial process of forming the web by
physical de-watering of the stock.
Winding Operation of rolling-up a web of paper or board.
Wire A closely woven wire mesh, normally made of synthetic fibre, on to
which the paper stock is directed and which then allows the
passage of water away from the moving paper web.
* denotes a process technology that can be applied during various parts of the pulping and paper-making
process but, in this context, only applies to the treatment of recovered paper and board
125
126
TECHNICAL DOCUMENT No. 5
127
Table of contents
Page
128
1. INTRODUCTION
The Practical Guide is intended for all bodies and persons concerned with the application of
Resolution ResAP (2002) 1 on paper and board materials and articles intended to come into
contact with foodstuffs and the corresponding technical documents. These bodies and
persons are manufacturers and converters of paper and board, food manufacturers and
distributors, enforcement authorities, surveillance bodies and certification laboratories.
- guidance for a correct application of Resolution ResAP (2002) 1 and the related
technical documents;
- guidelines for checking the compliance of a material or an article;
- explanations to specifications, and background information.
Materials coming into contact with foodstuffs are regulated in EU by the framework Directive
1935/2004/EC, its Amendments and its approximation of the laws of the member states
relating to materials and articles intended to come into contact with foodstuffs. It stipulates
that all kinds of materials and articles intended to come into contact with foodstuffs must be
manufactured in compliance with good manufacturing practice so that, under their normal or
foreseeable conditions of use, they do not transfer their constituents to foodstuffs in
quantities which could endanger human health, bring about an unacceptable change in the
composition of the foodstuffs or a deterioration in the organoleptic characteristics thereof.
Specifications of Resolution ResAP (2002) 1 and the related technical documents are based
on these principles.
2. FIELD OF APPLICATION
Resolution ResAP (2002) 1 covers paper, board and articles made from paper and/or board
used for all food contact applications under normal or foreseeable conditions of use including
contact with fatty, aqueous or dry foods and for filtering liquids and for high temperature use.
Exceptions are expressed in Chapter 2.2.
Paper is sometimes and board is usually made of several layers. An example is corrugated
board, where one or several layers of fluting are inserted between layers of linerboard.
Another multi-layer product is folding boxboard, where the top and bottom layers may consist
of bleached virgin fibres, while the body of the board may be made of recycled fibres. Every
paper layer must fulfil the requirements of Resolution ResAP (2002) 1, unless separated
from the food by a functional barrier to migration. Further information on functional barrier is
given in Chapter 6.
Resolution ResAP (2002) 1 applies to materials and articles, although major attention is paid
to materials. Articles intended for food contact are, for example, packages, coffee filters,
adsorbent pads containing a layer of paper or cellulosic fibres, paper labels to be fastened to
fruits that will be peeled, moulded fibre articles such as trays for eggs and fruits, filter papers
having a grammage below 500 g/m and disposable tableware.
The manufacturer of articles should consider all auxiliary materials and additives used in the
production of the article, such as printing inks, lacquers, adhesives etc. It is the responsibility
of the manufacturer or importer of the materials and articles intended for food contact, as well
as the persons marketing these materials and articles, to ensure that all elements are in
compliance with the Directive 1935/2004/EC.
129
Many board grades consist of a fibrous layer covered by a so-called mineral coating (the
terms mineral coating, pigment coatings and aqueous pigment coating are synonymous).
These coatings are within the scope of Resolution AP (2002) 1, although they contain
polymeric substances such as binders. Polymeric materials, commonly referred to as plastic
pigments, are also used in some cases as pigments in coatings for paper and board.
Dispersion coatings, which provide barriers against moisture or fats, are within the scope of
Resolution ResAP (2002) 1.
2.2. Materials and articles not covered by the Resolution ResAP (2002) 1
Non-wovens are not classified as paper. They are distinguished from paper in accordance
with ISO 9092.
Filtering layers (as specified by BfR XXXVI/1 of 1999-08-01) with a grammage of at least 500
g/m2 whose main components are synthetic fibres, though they may also contain some
cellulosic fibres.
For the time being there are no regulations dealing with non-wovens or with filtering layers at
European level. However, where these materials are used in contact with food, they should
comply with the Framework Directive.
Kitchen towels and napkins made from paper are not within the scope of Resolution ResAP
(2002) 1. A Technical document on paper kitchen towels and napkins has been elaborated
and is available.
A plastic layer applied to a material or article made of paper is excluded from the scope of the
resolution on paper and board. It should be assessed according to the Directives on plastics
materials and articles.
3. VERIFICATION OF COMPLIANCE
Resolution ResAP (2002) 1 states that papers should be manufactured in accordance with
Technical document No. 4 - CEPI Guide for good manufacturing practice for paper and board for
food contact
Good manufacturing practice (GMP) is the basis of internal surveillance and a fundamental
part of quality control and product safety assurance. A separate document describing GMP
has been elaborated: Technical document No. 4 CEPI Guide for good manufacturing
practice for paper and board for food contact.
Typical examples of multi-layer materials are corrugated board and laminates of papers with
other materials such as plastic and/or metal foils.
130
Unless the presence of a functional barrier to the transfer of substances from the paper
layer(s) to foodstuffs can be demonstrated, each paper layer should comply with the
specifications of Resolution ResAP (2002) 1 and related technical documents but tests need
not be carried out for each layer separately. The material is tested as a whole. An example
for assessing compliance is as follows:
For a corrugated board consisting of two layers of board and one of fluting, all layers
containing recycled fibres:
- Each layer should comply with the specifications of Resolution ResAP (2002) 1 and Technical
document No. 3 - Guidelines on paper and board materials and articles, made from recycled
fibres, intended to come into contact with foodstuffs, terms of raw materials, manufacture, use
of substances of Technical document No. 1 List of substances to be used in the manufacture
of paper and board materials and articles intended to come into contact with foodstuffs and the
type of foodstuff with which the material will come into contact.
- Where there is a restriction expressed as QM (QMA) or SML, this restriction refers to the
whole material and must be assessed in terms of the whole material, not for each individual
layer independently.
- Tests for anti-microbial effect and/or sensory tests are done using the whole material.
- Tests to determine compliance with the specific requirements for substances listed in Table
2 of Technical document No. 3 should be carried out on the whole material.
Where a layer in a multi-layer material has been shown to act as a functional barrier to
transfer, only the paper layers on the food contact side of the barrier layer need to comply
with the specifications of Resolution ResAP (2002) 1 and related technical documents.
Migration testing can be carried out as described later because the presence of the
functional barrier will prevent transfer from the layers behind the barrier.
In Technical document No. 1 - List of substances to be used in the manufacture of paper and
board materials and articles intended to come into contact with foodstuffs for some
substances SML restrictions are laid down. The values of SML are identical to those
established for the same substance in EU Directive 90/128/EEC and amendments relating to
plastics materials and articles. These values were based on the restrictions laid down by
SCF/EFSA on the basis of available toxicological documentation. It is recognised that the
toxicological assessments carried out by the SCF/EFSA are based on data supplied for
evaluation of the use of substances in the manufacture of plastics materials and articles and
that they may not be directly applicable for paper and board. However, in the absence of
data more relevant to the use of these substances in paper and board, it would appear
prudent to adopt these restrictions.
The SML restrictions are also expressed on a QM (QMA) basis in the List. The restriction as
QM (QMA) has been derived from the SML restriction by applying the SCF/EFSA convention
of 6 dm2 of material coming into contact with 1 kg of foodstuff and assuming 100% migration.
131
For example, for a substance with an SML restriction of 1 mg/kg food, the restriction
expressed as QMA is 0.17 mg/dm2 paper and board.
For situations where scientific data is established for the SML/QMA ratio which occurs under
normal or foreseeable conditions of use, it is possible to apply the true transfer value which
applies to the case in question to derive the QMA value from the SML restriction for
compliance testing. For example, if the SML/QMA ratio is established as being 0.1, then, for
an SML restriction of 1 mg/kg, the QMA value to be applied is 1.7 mg/dm2, taking into
account the conventional SCF/EFSA contact conditions.
3.2.2. Calculating QMA for contact not corresponding to the SCF conventional ratio
The conventional ratio of 6 dm2 of paper in contact with 1 kg of food adopted for plastics is
not always realistic for many uses of paper. The QM (QMA) restriction to be applied under
normal or foreseeable conditions of use is calculated in accordance with the formula given in
Technical document No. 2 Guidelines on test conditions and methods of analysis for paper
and board materials and articles intended to come into contact with foodstuffs.
If calculation using this worst-case assumption indicates that the QM (QMA) restriction is
exceeded, but it is known that not all the substance will be incorporated into the paper,
further calculations and/or analysis will need to be carried out. Such calculations shall be
based on scientific evidence and/or experimental studies of the percentage incorporation of
the substance into the finished paper.
It is important to note that testing for compliance with a QM (QMA) restriction by analysis
should determine the total concentration of the substance in the paper. The analytical
method used to determine compliance will depend on the substance under consideration.
For some substances, it may be possible to measure the substance in situ, for example by X-
ray fluorescence. Where this is not possible, it will be necessary to separate the substance
from the paper matrix. This may be done by extracting the substance from the paper, or by
degrading the paper matrix, leaving the substance behind, for example by ashing. If
extraction is carried out, extraction conditions must be selected such that as close as
possible to 100% of the substance is extracted. If it is not possible to extract all of the
substance, the percentage extraction should be determined in order that the total
concentration of substance in the paper can be determined. If the paper matrix is degraded,
degradation conditions should be selected such that the substance under examination is not
degraded or volatilised or otherwise lost through the degradation process.
132
Expressing values calculated on mass per mass basis as mass per area
Paper manufacturers typically express content of substances in paper in mass per mass
units, for example as milligrams per kilogram of paper (mg/kg). The following formula can be
used to convert a calculated or analytically determined value in mg/kg to a mass per area
basis (milligrams per square decimetre), so that it can be compared with the applicable QMA
restriction (which is expressed as milligrams per square decimetre):
VA (mg/ dm2 ) VM A
100 1000
where:
A is the grammage of the paper, expressed as grams per square metre (g/m 2).
The concept of QMA has been adopted for reasons of harmonisation between specifications
laid down in Resolution ResAP (2002) 1 and related technical documents and in EU
Directives.
QMA is a restriction which is expressed in mg (of substance) in the material or article per 6
dm (of surface in contact with food).This restriction is often used in the SCF/EFSA opinion
instead of SML (mg per kg of food)where for the substances under examination a method of
analysis is not available. In this specific case it is assumed that the substance migrates
100% and that 1 kg of food is contact with 6 dm of the material or article.
Testing for compliance with the SML restrictions laid down in Technical document No. 1 - List
of substances to be used in the manufacture of paper and board materials and articles
intended to come into contact with foodstuffs, should be carried out by migration testing,
using the conventional conditions. However, in order to determine compliance with the SML
restrictions laid down in Technical document No. 1 - List of substances to be used in the
manufacture of paper and board materials and articles intended to come into contact with
foodstuffs, extraction tests could be used if, on the basis of scientific evidence, the results
obtained using these tests are at least equal to those obtained by migration testing using the
conventional EU test simulants or foodstuffs.
When testing a material for compliance with restrictions there are two possibilities: testing for
compliance with the QM (QMA) restriction for a substance or testing for compliance with the SML
restriction.
In general, it is envisaged that it is likely to be simpler to test for compliance with the QM (QMA)
restriction for a substance, rather than to test for compliance with the SML restriction for that
substance. It also may be possible to test for compliance with a QM (QMA) restriction by
133
calculation. Even if it is not possible to test for compliance by calculation, it is likely to be relatively
simple to carry out an analysis to determine the total amount of substance in the paper (QM).
When the test for compliance with an SML restriction is based on the determination of QM (QMA),
complete transfer of the substance must be assumed (worst case principle). It is not probable that
a substance will transfer completely from a packaging material to a foodstuff in reality, but as the
relation SML/QMA is unknown, complete transfer must be assumed.
There will also be materials for which testing for compliance with the QM (QMA) restriction by
calculation or by analysis indicates that the QM (QMA) restriction will be exceeded. In such a
situation, testing for compliance with the SML restriction should be carried out, if such a restriction
exists.
There are two possibilities for testing for compliance with a restriction expressed as SML: migration
testing or extraction testing.
Migration tests should be designed such that they mimic the contact conditions, which will occur
under normal or foreseeable conditions of use as closely as possible. Tests can either be carried
out using foodstuffs or using so-called simulants, which are intended to mimic foodstuffs.
It should be borne in mind that migration testing for paper and board using a liquid simulant often is
difficult or impossible due to the penetration of the simulant. In this case a more appropriate test,
which might be an extraction test, if adequately designed, could be used.
Extraction tests use solvents in place of foodstuffs. Extraction tests should be designed such that
the results using these tests are equal or higher than those obtained by migration testing.
If for testing compliance using a simulant indicates that the SML restriction is exceeded, testing
can be carried out with foodstuffs of the type which will used in contact with the material in actual
or foreseeable use.
It should be borne in mind that there are no limits set for overall migration for paper, and there is,
therefore, no requirement that such a test be carried out.
The reader should observe that QM (QMA) is expressed as milligrams per square decimetre or
kilogram of paper, whereas SML is expressed as milligrams per kilogram of food or food simulant.
Migration tests should be designed such that they mimic the contact conditions which will
occur under normal or foreseeable conditions of use as closely as possible. Tests can either
be carried out using foodstuffs or using so-called 'simulants' which are intended to mimic
foodstuffs.
Technical document No. 2 - Guidelines on test conditions and methods of analysis for paper
and board materials and articles intended to come into contact with foodstuffs specifies time,
temperature and simulants for testing. Further guidance on simulants, substitute test media
and exposure conditions can be obtained in this Practical Guide.
Food has been divided into the following categories: aqueous, alcoholic, fatty and dry, non-
fatty food (see Technical document No. 2). Wherever possible the tests should be done with
the real foodstuffs, however very often it will be necessary to use simulants. The
recommended procedure depends on the nature of the foodstuff as follows:
134
Contact with fats and oil
The recommended test simulant is olive oil (or recognised alternative fatty simulants).
Alternatively, testing can be carried out with the actual foodstuff. If contact in actual use will
only be with one side of the paper, then migration tests should be carried out using the food
contact side.
Contact with solid fatty foods with a low-medium moisture content with fat on the surface
Under EU Directives for plastics, for these types of food with fat on the surface, the
designated test simulant is olive oil (or a recognised alternative fatty food simulant or test
medium).
Testing with olive oil may not be appropriate for testing these materials for technical reasons.
Such reasons could include situations where there is complete penetration of the material
when testing with olive oil but where this penetration does not occur in actual use of the
material. In these circumstances, testing should be carried out using foodstuffs or with a
more appropriate test medium. There is currently no generally recognised alternative
simulant available for testing paper contacting these types of food, although studies are
underway in Europe to develop suitable test protocols. In the absence of alternative
recognised tests, it is suggested that materials are tested using extraction tests.
Under EU Directives for plastics, testing is not required for materials and articles contacting
dry foods. However, there is evidence to indicate that there can be transfer of substances
from paper to foods and hence testing is required for paper contacting dry non-fatty foods.
Testing should be carried out using foods or using modified polyphenylene oxide (MPPO) as
food simulant as stated in Technical document No. 2 - Guidelines on test conditions and
methods of analysis for paper and board materials and articles intended to come into contact
with foodstuffs.
It may be worth stating, that the food types as given in Technical document No. 3 -
Guidelines on paper and board materials and articles, made from recycled fibres, intended to
come into contact with foodstuffs are only used for the description of the processing and
additional requirements but not for the testing of compliance with the end-product
requirements.
Extraction tests can be used in place of migration testing to determine compliance with SML
restrictions provided it can be shown that the extraction tests used give values equal to or
greater than those obtained by migration testing.
The extraction medium should be selected taking into account the type of foodstuff and the
substance being tested for. See Directive 85/572/EEC.
For paper coming into contact with aqueous foods, a recommended extraction solvent is
water, either cold or hot depending on the contact conditions in use.
135
3.3. Verification of compliance with specifications of Resolution ResAP (2002) 1 and
Technical document No. 3 Guidelines on paper and board materials and articles,
made from recycled fibres, intended to come into contact with foodstuffs
Many paper manufacturers add biocides into the water circulation of the paper mill in order to
avoid formation of microbial slime growth. Biocides are intended to act on microbial growth
during the paper-making process and are not intended to be present in the finished paper.
Substances which have an anti-microbial effect on foodstuffs should not be released.
Raw materials and auxiliaries for the production of paper and board sometimes contain
biocides which can be transferred to the end product. An anti-microbial effect caused by
these biocides also has to be avoided.
A CEN standard has been published for the study of possible release of anti-microbial
substances.
3.3.2. Dioxins
Worst-case calculations indicate that even if there were to be 100% migration into food,
dioxin levels contributed by paper intended for food contact would be considerably below the
t-TDI (temporary tolerable daily intake) value for dioxins (1 pg/kg bw) recently proposed by
the SCF/EFSA.
Therefore the Committee of experts decided not to include any specific limit for dioxins in the
resolution. Instead there is a requirement for the manufacturer to choose raw materials and
processes in such a way as to make sure that the content of dioxin is as low as possible.
The restrictions on cadmium, lead and mercury in Resolution ResAP (2002) 1 have been
derived from guideline levels of Resolution AP (96) 4 on maximum and guideline levels and
source-directed measures aimed at reducing the contamination of food by lead, cadmium
and mercury and are based on toxicological assessment, applying the conventional ratio of 6
dm2 of material coming into contact with 1 kg of food and assuming 100 % migration. For
other ratios of paper area to mass of food (see para 6 in Technical document No. 3
Guidelines on paper and board materials and articles, made from recycled fibres, intended to
come into contact with foodstuffs) to determine the QMA value applicable to the specific case
should be determined. There is no restriction indicated for Cr+6, as this would be reduced
during paper manufacture, and can therefore never be identified in a paper or paper product.
Testing for cadmium, lead and mercury is not required for paper intended for contact with
dry, non-fatty food. For fatty and/or aqueous foods, testing is performed from a water extract,
unless the paper is intended for contact with acidic products, such as fruit juice. In this case
3% acetic acid is used as solvent.
CEN has published standards for hot and cold water extraction and ENs to determine
cadmium, lead and mercury.
136
3.3.4. Pentachlorophenol and polychlorinated biphenyls
Results of a survey in the UK showed that PCP in paper does not readily migrate into foods.
The QM restriction of 0.15 mg/kg of paper should, therefore, provide an acceptable purity
requirement. The determination is based on extraction with water in the EN standard.
Polychlorinated biphenyls (PCBs) were used in the past in the manufacture of carbonless
copy paper. PCBs are no longer used for this purpose and, hence, modern day carbonless
copy paper does not contain these substances. There is, however, the possibility that
archived papers may contain copy paper containing PCBs. Hence, large batches of archived
papers - if they contain PCB - should not be used as a source for recycled fibres. An EN for
determining PCB is available.
Because there is evidence to indicate that PCBs in paper are no longer a major problem, no
restriction is specified in the Resolution for these substances.
The main sensory properties of a foodstuff are odour and taste. It is not usual that a material
in contact with food influences the odour of the foodstuff, though the material itself might
have an odour. An odorous food packaging material has no market. Thus, the market is self-
regulating as regards odour of a material intended for food contact.
The taste of a foodstuff is easily affected by surrounding materials. Unsuitable printing inks or
varnishes on the outer surface of a board may transfer constituents to the content of the
package causing an unpleasant change in the taste of the foodstuff. The storage conditions
of a paper or board can cause transfer of taint. The terms taint and off-flavour are both
used to indicate a deterioration in the taste of a foodstuff.
Resolution ResAP (2002) 1 states that materials and articles should be of suitable
microbiological quality, taking into account the intended end-use of the material. The
microbiological properties of the end product, i.e. the paper, are usually good, as sheet
making and drying on the paper machine reduces the level of microbiological contamination
significantly. When assessing the microbiological quality of a paper it is, therefore, important
to consider the nature of the food to be packed, its microbiological load and the potential for
the paper to influence this load.
Basic elements, which are particularly important for the production of paper and board made
from recycled fibres intended to come into contact with foodstuffs, are covered in Chapters 3,
5 and 6 of Technical document No. 3 Guidelines on paper and board materials and articles,
made from recycled fibres, intended to come into contact with foodstuffs.
137
Furthermore see also Technical document No. 4 CEPI Guide for good manufacturing
practice for paper and board for food contact.
Recycled fibres are used to a great extent in many paper grades, such as newsprint, tissue
and corrugated board. They are also used in some paper grades intended for food contact,
mostly as inner layers in multi-layer materials intended for packing of dry, non-fatty food. A
major volume of recycled fibres originates from recovered paper that has not been deinked,
and sometimes can be identified by its typical greyish colour. Deinked recycled fibres are,
however, very difficult to distinguish from virgin fibres, if at all.
Tests on end products are necessary where there are actual or potential risks to health.
These risks depend on the nature of the recovered paper, the effectiveness and purpose of
recycling treatments and the nature of the contact with foodstuffs for the end-product. All of
these elements are combined with the requirements in Chapter 6 of Technical document
No. 3 Guidelines on paper and board materials and articles, made from recycled fibres,
intended to come into contact with foodstuffs and tied to each other in a matrix (Table 3 in
Technical document No. 3). Descriptions of process technologies given in Technical
document No. 3 provide flexibility to take account of mill-specific circumstances. They are
given as examples but other processes or combination of processes may be used provided
that the end product fulfils the requirements of Chapter 6 of Technical document No. 3. The
purpose of these processes is to reduce or eliminate the presence of contaminants in the
finished product and to fulfil the requirements set in Chapter 6 of Technical document No. 3.
Manufacturers of paper containing recycled fibres shall be able to produce documentation on
the origin of the recycled fibres (the kind of recovered paper that has been used), the main
features of the cleaning process, and the results of analyses. It is in the responsibility of
industry to demonstrate through Good manufacturing practice (see Technical document
No. 4 CEPI Guide for good manufacturing practice for paper and board for food contact)
that the end product meets the requirements of Art. 2 of Council Directive 1935/2004/EC.
More details are given in Chapter 5 and Appendix 1 of Technical document No. 3.
Details of collecting recovered paper and the main sources of recovered paper in Western
Europe can be found in CEPI annual reports.
Further details on quality control at mill entry are given in Technical document No. 4
CEPI Guide for good manufacturing practice for paper and board for food contact.
Analytical methods to be used for testing for compliance with end product requirements are
set out in Technical document No. 2 Guidelines on test conditions and methods of analysis
for paper and board materials and articles intended to come into contact with foodstuffs.
The tests listed in Chapter 6, Table 2 Specific requirements and set out in Technical
document No. 3 Guidelines on paper and board materials and articles, made from recycled
fibres, intended to come into contact with foodstuffs are not required.
138
4.3.2. Contact with dry, non-fatty food
Partially hydrogenated terphenyls (HTP) also originate from carbonless copy paper and can
be found in recovered paper. As a matter of prudence, Technical document No. 3
Guidelines on paper and board materials and articles, made from recycled fibres, intended to
come into contact with foodstuffs state that levels in paper should be kept as low as
reasonably achievable.
Phthalates are ubiquitous in the environment due to their widespread use in various products
and their slow degradation. They can enter food packaging as additives in adhesives and in
printing inks and varnish. Although printing inks are not in direct contact with food, it has
been shown that the plasticisers they contain can migrate into food through the packaging
material or during storage of reels and bales (set-off phenomenon). Phthalates classified as
Toxic under the 28th Amendment of Dangerous Substances Directive 67/548/EEC are
excluded from printing inks (CEPE exclusion list, September 2001, Selection Criteria A). The
usage of phthalates has been significantly declining since a number of years.
The SCF has established a TDI for some phthalates and the limits are given in EU Directive
90/128/EEC or Synoptic Document. The indicated TDI-values should be converted to SMLs
using the convention TDI x 60 [kg bodyweight/kg food] = SML (TDI is expressed as mass per
mass of body weight, and SML as mass per mass of food).
Volatile solvents originate from gravure printing. Technical document No. 3 Guidelines on
paper and board materials and articles, made from recycled fibres, intended to come into
contact with foodstuffs recommend that solvents should be reduced to the lowest possible
levels in the finished product.
Polycyclic aromatic hydrocarbons (PAHs). Some PAHs are suspected carcinogens. They
occur sometimes as contaminants in, for example, printing inks oils. Under the selection
criteria of the CEPE exclusion list, since years, printing inks do not contain mineral oils or any
other hydrocarbon substances which are classified as Toxic under the Dangerous
Substances Directive 67/546/EEC.
Benzophenone can be present in paper from the use of UV-cure inks and varnishes, where it
is commonly used as a photo initiator. EU Directives for plastics list an SML of 0.6 mg/kg
food for benzophenone.
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recommend that the migration of this substance shall not be detectable when measured by a
method with a limit of detection of 0.01 mg/kg of food.
Primary aromatic amines can originate from printing inks. The limit given in Technical
document No. 3 Guidelines on paper and board materials and articles, made from recycled
fibres, intended to come into contact with foodstuffs refers to the sum of the listed amines. A
list of those aromatic amines that are of toxicological concern is given in the 19th amendment
of EU Directive 76/769/EEC (2202/61/EC). Due to the ban in 2002/61/EC these substances
will disappear.
Fluorescent whitening agents (FWAs) are added to many paper grades in order to improve
the apparent brightness of the paper. In the USA and some European countries only a
restricted number of FWAs are allowed in materials in contact with fatty or aqueous food.
FWAs are listed in Technical document No. 1 - List of substances to be used in the
manufacture of paper and board materials and articles intended to come into contact with
foodstuffs, but migration should be not detectable. As the major part of recovered paper
contains FWAs, it is highly probable that paper made of recycled fibres will contain these
substances.
EN 648 specifies the test method for FWAs. The migration of optical brighteners is estimated
visually and noted on a scale from 1 (strong migration) to 5 (no migration). This easurement
should be regarded as a yes/no test: if the mark is 5, there is no migration and the material
can be used in contact with fatty and/or aqueous food. If a value of 4 or lower is obtained,
there is migration and the material is not in compliance.
Certain azo compounds form carcinogenic aromatic amines by cleavage of the azo group(s).
Azo compounds originate from printing inks. The analytical procedure comprises cleaving of
the azo group(s) and determination of the released amines. If the banned amines (see
2002/61/EC, the 19th amendment of EU Directive 76/769/EEC) are found at a content
exceeding 0.1 mg/kg paper, the limit set for azo compounds is exceeded. The limit in
Technical document No. 3 Guidelines on paper and board materials and articles, made
from recycled fibres, intended to come into contact with foodstuffs refer to the sum of the
listed amines. Due to the ban in 2002/61/EC these substances will disappear.
The use of toxicological tests and test conditions will be evaluated and they may be
recommended in the future, based on new developments and results in this field. A project to
develop and to validate toxicological tests for paper and board was being funded under the
Fifth Framework programme of the EU (Biosafepaper).
5. SPECIAL CASES
Testing of materials and articles used in more specialised situations is covered in this
chapter. These specialised uses include paper and board used in microwave and
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conventional ovens; paper used in contact with frozen foods; filter papers; disposable
tableware; adsorbent pads.
In general, diffusion (migration) of a substance increases linearly with the square root of time.
Strictly, this applies only when the content of migrant and the mass of the foodstuff are
infinite, but the rule can be applied in most practical cases when an article is in contact with a
foodstuff. Diffusion also doubles with each 10C increase of temperature. Consequently,
short time tests at high temperatures are more severe than long time tests at low
temperature (2 hours at 70C would be more severe than 24 h at 40C).
For the time being, migration from fibrous materials cannot be estimated by current diffusion
models, though some work is being done in this direction. This is due to the heterogeneous
and very complex structure of paper and board.
Where no specific test conditions are given for a specific situation, refer to Technical
document No. 2 - Guidelines on test conditions and methods of analysis for paper and board
materials and articles intended to come into contact with foodstuffs for selection of simulants
and test conditions.
Ovenable boards are used for purposes such as packing ready-cooked meals that are
heated at home in either microwave or conventional ovens. They are differentiated from
baking papers by their generally lower temperature of use and by the fact that they do not
contact fatty foods directly, although they may be used in the heating of fatty foods when
they are separated from the food by a plastic layer.
Baking paper can be used in contact with fatty foods at high temperatures. Test conditions
for baking papers intended for general household use are given in Technical document No. 2
Guidelines on test conditions and methods of analysis for paper and board materials and
articles intended to come into contact with foodstuffs. EU Directives for plastics should be
consulted for test conditions applicable for more specific uses.
When testing ovenable paper and baking paper, degradation products formed at high
temperatures should be taken into account in testing. For further details see Technical
document No. 2.
If migration testing is carried out for paper intended for contact with hot, aqueous liquids,
such as tea bags, coffee filters and cooking pouches the appropriate conditions (time,
temperature and ratio of paper to liquid) should be chosen taking into account the intended
use of the material.
If extraction testing is carried out to determine compliance, hot water extracts should be
prepared.
The procedures to be followed when filters made of paper are examined, are described in
Technical document No. 2 Guidelines on test conditions and methods of analysis for paper
and board materials and articles intended to come into contact with foodstuffs. The
procedure is not based on scientific study but, in the absence of suitable data, is pragmatic
and reflects what happens in real use.
Filtering layers are not within the scope of the resolution. The reader may find it useful to
consult BfR XXXVI/1, where testing instructions can be found.
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5.4. Disposable tableware
Contact with fatty and/or aqueous food is foreseeable, and contact temperatures must be
considered from +4 C up to 80 C.
For paper beakers used for hot beverages, testing should be carried out for 1 h at 70C.
Where paper beakers are used for acidic juices, 3% (w/v) acetic acid should be used as a
test simulant.
In principle, paper plates should be tested by filling with a foodstuff or simulant but, because
of technical difficulties, extraction tests may be more appropriate. Isooctane [and 95% v/v
ethanol] shall be used as extraction solvents for tableware contacting fatty foods; testing for
0,5 h at 60C.
For materials intended for contact only with foodstuffs to be washed, shelled or peeled, such
as potatoes and apples, the tests listed in Chapter 6 of Table 2 of Technical document No. 3
Guidelines on paper and board materials and articles, made from recycled fibres, intended
to come into contact with foodstuffs are not required. The general requirements of Resolution
ResAP (2002) 1 and of Technical document No. 1 - List of substances to be used in the
manufacture of paper and board materials and articles intended to come into contact with
foodstuffs are valid. Consequently, tests are to be made for pentachlorophenol, for release of
anti-microbial agents and for substances restricted in Technical document No. 1, if these
have been added during manufacture of the material. The same rules apply to moulded fibre
products intended, for example, for eggs.
Typical foodstuffs which are washed, shelled or peeled before eating are for example citrus
fruits, vegetables and peanuts.
Frozen food that is fatty and/or aqueous is considered as dry, non-fatty food, provided that
the food is not defrosted in contact with paper or board. Consequently, MPPO is a suitable
food simulant for this application. Some examples of conditions for migration testing are
given below.
If the package will not be heated together with the content, as for example when berries are
frozen, and there is no hot fill, 10 days at 5C are the appropriate conditions for migration
testing.
A package may be filled with warm food at 60C, for example a soup, then rapidly frozen and
stored for a long period, and finally heated for 30 minutes to 70C in the pack. This package
should be tested for 1 hour at 70C, only. Any transfer occurring during filling and frozen
storage should be covered by the test conditions proposed. In this case, fatty food simulants
(or alternative simulants or test media) are appropriate for migration testing.
Vegetable parchment is a paper that has been modified by the action of sulphuric acid. This
treatment gives it a high degree of resistance to penetration by organic liquids generally, and
particularly fats, oils and greases (ISO 4046-4).
Greaseproof paper is a paper that has a high resistance to penetration by grease or fats.
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This resistance is obtained by intensive mechanical treatment during stock preparation.
There are also paper and board grades on the market which have been treated with
fluorinated agents to provide grease and oil resistance. Substances used as grease-proofing
agents are typically perfluoroalkyl phosphate esters or amine salts.
Vegetable parchment and greaseproof are intended for contact with fatty and/or aqueous
food. No specific test conditions are given.
The perforated plastic in contact with the food is not a functional barrier. Consequently, for
adsorbent pads containing cellulosic fibres, the fibrous layer should fulfil the specifications of
Resolution ResAP (2002) 1 and the related technical documents for materials in contact with
fatty and/or aqueous food.
6. FUNCTIONAL BARRIER
The full applicability of the functional barrier concept is limited currently by the lack of
agreement concerning the level for a concentration of no concern and the lack of agreed
methods to test whether or not materials act as functional barriers. To some extent,
development of definitive methods is dependent upon the agreement of a level for a
concentration of no concern.
Thus, for the time being, the usefulness of the functional barrier concept is generally
restricted to substances included in Technical document No. 1 - List of substances to be
used in the manufacture of paper and board materials and articles intended to come into
contact with foodstuffs and to other substances for which information is available concerning
their toxicology. For a substance on the list with an SML restriction, a material acts as a
functional barrier for the time over which the material prevents transfer to food exceeding the
SML restriction for that substance. The concept cannot currently be applied to substances for
which no toxicological information is available.
Contact conditions
Low temperature High temperature
Short time Long time
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Material properties
Thick barrier material Thin barrier material
High resistance to diffusion Low resistance to diffusion
Inertness to food Interaction (penetration) with food
Inertness to external factors Interaction with external factors
Continuous layer Discontinuous layer, (pinholes, cracks)
Restricted substances
Low concentration in layers behind the High concentration in layers behind the
barrier barrier
Low mobility, high molecular weight of High mobility, low molecular weight of
contaminants in layers behind contaminants in layers behind the
the barrier barrier
The best barrier materials will be impermeable so as to prevent diffusion. Metal foils are the
most effective barriers provided they are not damaged or too thin. They should, however, not
be placed in direct contact with acidic foods because of corrosion problems.
Various plastics can act as barriers but they are not totally impermeable. Thus they will
generally not have as long a barrier effect as totally impermeable materials. Metallised
plastics layers can act as barriers but are not as effective as continuous foil layers.
Some plastics, whilst not being totally impermeable, do delay transfer of organic substances
significantly. Examples of such materials are polyvinylidene chloride, polyvinyl chloride,
polyethylene terephthalate and polyethylene napthenate. Polyolefins generally do not delay
transfer of organic substances as significantly.
Paper generally has a high permeability and will not generally form an effective barrier to
migration where substances which can transfer across an air space are present.
An air gap could act as a barrier provided that the layer behind the barrier is low in volatile
substances and contact between the food is minimal and the packaging is not subjected to
high temperature.
The effectiveness of foil and other barrier layers is reduced if the layer is not continuous. A
standard procedure for the detection of pinholes in a plastic layer on a paper material was
developed by CEN.
The Council of Europe and the EU Commission do not normally issue resolutions or
directives in the field of methods of analysis. The progress in this area is so rapid that any
method may be considered obsolete after a limited number of years. However, there is a
need to provide guidance to analysts who carry out testing to ensure compliance, e.g.
enforcement authorities, industry, retailers and certification laboratories.
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applied. For the purpose of this document this includes methods recognised by the following
bodies:
References to the test methods can be found in Technical document No. 2 Guidelines on
test conditions and methods of analysis for paper and board materials and articles intended
to come into contact with foodstuffs.
If such a method does not currently exist, an analytical method with appropriate performance
characteristics (accuracy and precision) at the specified limit may be used.
8. ABBREVIATIONS
CEPE European Council of Paint, Printing Inks and Artists Colours Industry
EC European Commission
EN European Standard
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9. REFERENCES
General
EC: Food Contact Materials. Practical Guide.
http://cpf.jrc.it/webpack/
EC: Food Contact Materials. Notes for Guidance. Commission Explanatory Guidance for
migration testing.
http://cpf.jrc.it/webpack/
Nonwoven
ISO 9092.1988. Textiles Nonwoven - Definition
Filtering layers
Gesundheitliche Beurteilung von Kunststoffen im Rahmen des Lebensmittel- und
Bedarfgegenstndegesetzes. 200. Mitteilung. XXXVI/I. Koch- und Heissfilterpapiere und
Filterschichten. Stand 01.08.1999.
Sipilinen-Malm, T. et al.: Purity of fibre-based materials. Food Addit. and Contam. 14:6-7
(1997), 695-703.
DIPNs
Sturaro, A. et al.: Food contamination by diisopropylnaphtalenes from cardboard packages. Int. J.
Food Sci. and Technol. 29:5 (1994), 593-603.
Anon.: Diisopropylnaphtalenes in food packaging made from recycled paper and board. MAFF
Food Surveillance Information Sheet No 169 (1999).
http://archive.food.gov.uk/maff/archive/food/infsheet/index.htm
HTP
Sturaro, A. et al,: Hydrogenated terphenyl contaminants in recycled paper. Chemospere 30:3
(1995), 687-694.
Phthalates
Nerin, C., Cacho, J., Gancedo, P.: Plasticizers from printing inks in a selection of food packages
and their migration into food. Food Addit. and Contam. 10:4 (1993), 453-460.
Aurela, B., Kulmala, H., Sderhjelm, L.: Phthalates in paper and board packagings
and their migration into Tenax and sugar. Food Addit. and Contam. 16:12 (1999), 571-577.
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Benzophenone
Benzophenone from cartonboard. Food Standards Agency UK, Food Surveillance Informa-
tion Sheet Number 6/00, October 2000.
http://archive.food.gov.uk/maff/archive/food/infsheet/index.htm
Pentachlorophenol
Survey of pentachlorophenol in paper and board packaging used for retail foods. MAFF UK
Joint Food Safety and Standards Group, Food Surveillance Information Sheet Number 139,
December 1997.
http://archive.food.gov.uk/maff/archive/food/infsheet/index.htm
Polychorinated biphenyls
Survey of retail paper and board food packaging materials for polychlorinated bisphenyls
(PCBs). MAFF UK Joint Food Safety and Standards Group, Food Surveillance Information
Sheet Number 174, April 1999.
http://archive.food.gov.uk/maff/archive/food/infsheet/index.htm
Rate of migration
Crank, J.: The Mathematics of Diffusion. Oxford Science Publications. 1998.
Resolution AP (96)4. Maximum and guideline levels and source-directed measures aimed at
reducing the contamination of food by lead, cadmium and mercury.
82/711/EEC. Council Directive of 18 October 1982 laying down the basic rules necessary for
testing migration of the constituents of plastics materials and articles intended to come into
contact with foodstuffs. Off. J. Eur. Comm. L297, 24.6.81.
85/572/EEC. Council Directive of 19 December 1985 laying down the list of simulants to be
used for testing migration of constituents of plastics materials and articles intended to come
into contact with foodstuffs. L372, 31.12.85.
89/109/EEC. Council Directive of 21 December 1988 on the approximation of the laws of the
Member States relating to materials and articles intended to come into contact with
foodstuffs. L40, 11.2.89.
3/8/EEC. Commission Directive of 15 March 1993 amending Council Directive 82/711/EEC
laying down the basic rules necessary for testing migration of the constituents of plastics
materials and articles intended to come into contact with foodstuffs. Off. J. Eur. Comm. L90,
14.4.93.
97/48/EC. Commission Directive of 29 July 1997 amending for the second time Council
Directive 82/711/EEC laying down the basic rules necessary for testing migration of the
constituents of plastics materials and articles intended to come into contact with foodstuffs.
Off. J. Eur. Comm. L222/10, 12.8.97
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76/769/EEC. Restrictions on the marketing and use of certain dangerous substances and
preparations (azocolourants) - 19th amendment
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