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Legal Status of Waxes from Clariant with Respect to Food Legislation

Legal Status of Waxes from Clariant with Respect to Food Legislation

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Pigments & Additives Division<br />

<strong>Legal</strong> <strong>Status</strong> <strong>of</strong> <strong>Waxes</strong><br />

<strong>from</strong> <strong>Clariant</strong> <strong>with</strong> <strong>Respect</strong><br />

<strong>to</strong> <strong>Food</strong> <strong>Legislation</strong><br />

> General Leaflet<br />

Exactly your chemistry.


<strong>Legal</strong> status <strong>of</strong> waxes <strong>from</strong> <strong>Clariant</strong><br />

<strong>with</strong> respect <strong>to</strong> food legislation<br />

According <strong>to</strong> the German Lebensmittelund<br />

Bedarfsgegenständegesetz (LMBG)<br />

(German <strong>Food</strong> and Utensils Law) only<br />

substances which are expressly permitted<br />

may be used in food (Article 11).<br />

Substances are permitted which for<br />

example prevent the spoilage <strong>of</strong> foods,<br />

preserve their natural appearance and<br />

taste (preservatives, colouring agents)<br />

or in certain cases even enabling them<br />

<strong>to</strong> be manufactured. Additives permitted<br />

for these purposes are stipulated by<br />

name – <strong>of</strong>ten <strong>with</strong> their chemical designation<br />

– in the appropriate regulations.<br />

This group includes many waxes manufactured<br />

by chemically refining natural<br />

2<br />

> General Leaflet<br />

montan wax acids, and also several<br />

waxes on the basis <strong>of</strong> low-molecular<br />

polyolefins. They are permitted as<br />

food additives in accordance <strong>with</strong> the<br />

appropriate legislation on the admissibility<br />

and marketing <strong>of</strong> food additives.<br />

The rapid development <strong>of</strong> plastics,<br />

and in particular their favourable properties<br />

for many uses, has led <strong>to</strong> an<br />

ever-increasing degree <strong>of</strong> acceptance<br />

<strong>of</strong> their use in the food industry, e.g.<br />

as eating, drinking and cooking utensils,<br />

as containers and surface protection<br />

agents and above all as packaging<br />

material.<br />

The Lebensmittel- und Bedarfsgegenständegesetz<br />

(German <strong>Food</strong> and<br />

Utensils Law) also contains regulations<br />

on utensils and packaging for food.<br />

Utensils must be so constituted that<br />

they cannot cause damage <strong>to</strong> health<br />

when used for their designated and<br />

foreseeable purpose (LMBG Articles<br />

30, 31). In addition, it is forbidden <strong>to</strong><br />

use, or <strong>to</strong> introduce on<strong>to</strong> the market<br />

for such purposes, utensils <strong>from</strong> which<br />

substances are transferred <strong>to</strong> food or<br />

its surface, except for technically unavoidable<br />

residues which are safe <strong>to</strong><br />

health and have a neutral odour and<br />

taste (Article 31, Paragraph 1).<br />

As the manufacture, processing and<br />

application <strong>of</strong> most plastics is only<br />

possible <strong>with</strong> additives, such as catalysts,<br />

stabilizers, lubricants, plasticizers<br />

etc., the appropriate regulations naturally<br />

also apply <strong>to</strong> them. The assessment<br />

<strong>of</strong> plastics intended <strong>to</strong> come in<strong>to</strong> contact<br />

<strong>with</strong> food is carried out in conjunction<br />

<strong>with</strong> the Kunstst<strong>of</strong>f-Kommission (Plastics<br />

Commission) in the Bundesinstitut für<br />

Risikobewertung (German Federal<br />

Institute for Risk Assessment) (BfR),<br />

formerly the Bundesinstitut für gesundheitlichen<br />

Verbraucherschutz<br />

und Veterinärmedizin (German Federal<br />

Institute for Consumer Health Protection<br />

and Veterinary Medicine) (BgVV).<br />

The recommendations <strong>of</strong> the BfR are<br />

published as reports in the Bundesgesundheitsblatt<br />

(German Federal Health<br />

Bulletin).


These reports do not mention any brand<br />

names, but use the chemical composition<br />

<strong>to</strong> characterize the substances<br />

which are recommended subject <strong>to</strong><br />

quantity limitations. In addition, purity<br />

requirements and further limiting properties<br />

<strong>of</strong> the substances are frequently<br />

specified.<br />

The recommendations <strong>of</strong> the BfR are<br />

not legally binding. However, manufacturers<br />

and users <strong>of</strong> utensils bear<br />

full responsibility in the case <strong>of</strong> any<br />

complaints based on the food laws.<br />

In view <strong>of</strong> the progressive integration<br />

<strong>of</strong> the single market in the EU it became<br />

necessary <strong>to</strong> specify uniform assessment<br />

criteria for plastics which come<br />

in<strong>to</strong> contact <strong>with</strong> food.<br />

EU directives were drawn up for this<br />

purpose and these were incorporated<br />

in<strong>to</strong> German law by the Bedarfsgegenständeverordnung<br />

(Regulations on<br />

Utensils) dated April 10, 1992 and subsequent<br />

guidelines. These regulations<br />

encompass substances admissible for<br />

the manufacture <strong>of</strong> cellophane and<br />

includes a list <strong>of</strong> monomers and other<br />

starting materials permitted for the<br />

manufacture <strong>of</strong> plastic utensils used<br />

in connection <strong>with</strong> food.<br />

The European <strong>Food</strong> Safety Agency<br />

(EFSA) <strong>of</strong> the EU Commission has<br />

already assessed an incomplete list <strong>of</strong><br />

additives <strong>with</strong> regard <strong>to</strong> their impact<br />

on health. This assessment is published<br />

in a Synoptic Document and its<br />

Annexes. The Synoptic Document<br />

contains a “List <strong>of</strong> Additives for Plastics<br />

and Coatings”.<br />

A legal binding directive comprising<br />

monomers and additives for plastics<br />

on an european level is EU directive<br />

2002/72/EC and amendments.<br />

The German Ministry <strong>of</strong> Health has<br />

recommended that the assessment <strong>of</strong><br />

the EFSA in the Synoptic Document –<br />

in addition <strong>to</strong> the recommendations <strong>of</strong><br />

the BfR – be taken in<strong>to</strong> consideration<br />

when evaluating additives and processing<br />

aids in plastic utensils used<br />

in connection <strong>with</strong> food.<br />

Some <strong>of</strong> the additives listed in the<br />

Synoptic Document are already included<br />

in EU Commission Directive<br />

2002/72/EC and amendments.<br />

Montan wax esters and oxidized polyethylene<br />

waxes are also permitted as<br />

coatings for citrus fruits in EU Directive<br />

No. 95/2/EC dated January 20, 1995<br />

concerning food additives other than<br />

colouring agents and sweeteners.<br />

<strong>Waxes</strong> <strong>from</strong> <strong>Clariant</strong> are used on a<br />

large scale for the manufacture and<br />

processing <strong>of</strong> numerous plastics.<br />

Their main use is in the processing <strong>of</strong><br />

PVC, in which they are highly estimated<br />

as very effective lubricants. In addition,<br />

waxes <strong>from</strong> <strong>Clariant</strong> are used e.g. in<br />

the manufacture <strong>of</strong> pigment concentrates,<br />

release agents, impregnating<br />

agents, coatings (lacquers) and contact<br />

adhesives.<br />

The application <strong>of</strong> waxes for direct<br />

and indirect food contact in the USA<br />

is regulated by <strong>Food</strong> and Drugs<br />

Administration (FDA) and is codified<br />

in Title 21 <strong>of</strong> the Code <strong>of</strong> Federal<br />

Regulations (<strong>Food</strong> and Drugs, 21 CFR).<br />

After regula<strong>to</strong>ry compliance <strong>of</strong> an<br />

additive is determined the FDA specifies<br />

detailed criteria for the use <strong>of</strong> the<br />

additive in question according <strong>to</strong> the<br />

area <strong>of</strong> application.<br />

In Japan, the Ministry <strong>of</strong> International<br />

Trade and Industry (MITI) and the<br />

Ministry <strong>of</strong> Health and Welfare (MHW)<br />

regulate questions <strong>of</strong> industrial safety<br />

and health. This includes problems relating<br />

<strong>to</strong> regula<strong>to</strong>ry approval and registration<br />

<strong>of</strong> industrial products and their<br />

bearing on food hygiene. Applications<br />

<strong>of</strong> waxes in fields relevant <strong>to</strong> food legislation<br />

are included in the positive lists<br />

<strong>of</strong> the Japan Hygienic PVC Association<br />

and the Japan Hygienic Olefin and<br />

Styrene Plastics Association.<br />

This leaflet summarizes the status <strong>of</strong><br />

waxes <strong>with</strong> regard <strong>to</strong> food legislation<br />

according <strong>to</strong> the recommendations <strong>of</strong><br />

the BfR and the regulations which<br />

apply in the EU and other countries.<br />

<strong>Status</strong>: date <strong>of</strong> printing<br />

3


The status <strong>of</strong> <strong>Clariant</strong> waxes <strong>with</strong> regard <strong>to</strong> food legislation<br />

in the Federal Republic <strong>of</strong> Germany<br />

Product Characterisation Application<br />

4<br />

Licowax ® E Ester <strong>of</strong> montan wax acids Lubricant for polymers containing plasticizers, in<br />

Licowax OP <strong>with</strong> ethandiol and/or accordance <strong>with</strong> recommendation II<br />

Licowax KPS 1,3-butandiol and/or glycerine<br />

Licowax KSL and mixtures <strong>of</strong> these esters Additive <strong>to</strong> plasticized PVC shrink foil <strong>with</strong> a high<br />

Licolub ® WE 4 <strong>with</strong> non-esterified montan wax<br />

acids and their calcium salts<br />

permeability <strong>to</strong> oxygen<br />

Lubricant for plasticizer-free PVC<br />

Lubricant for plastic piping used in equipment<br />

for draught beverages, e.g. in accordance <strong>with</strong><br />

recommendations II and XI<br />

Additive <strong>to</strong> plastic coating <strong>of</strong> cellophane and <strong>to</strong><br />

lacquers in conjunction <strong>with</strong> other recommendations<br />

Additive <strong>to</strong> polyterephthalic acid diol ester<br />

Lubricants for conveyor belts on the basis <strong>of</strong> plasticizer<br />

containing PVC, in accordance <strong>with</strong> recommendation II<br />

Lubricant for piping in the beverage industry<br />

Additive for fillers for plastic utensils<br />

Licowax E Esters <strong>of</strong> montan wax acids Lubricant or release agent for polyamide<br />

Licowax OP <strong>with</strong> ethanediol and/or<br />

Licowax KPS 1,3-butanediol and mixtures Lubricant for polycarbonate<br />

Licowax KSL <strong>of</strong> these esters <strong>with</strong> nonesterified<br />

montan wax acids<br />

and their calcium salts<br />

Release agent for unsaturated polyester resins<br />

Lubricant for plasticizer-free plastic dispersions<br />

Processing aid in hard paraffin and wax dispersions silicon<br />

resin for coating paper, in accordance <strong>with</strong> recommendation XXV


Content limited <strong>to</strong> 1) published in the Bundesgesundheitsblatt 2) BfR 3) recommendation<br />

4 % 1981, p. 238, 149 th report I<br />

– 1981, p. 295, 151 st report I<br />

4 % 1981, p. 238, 149 th report II<br />

– 1960, p. 235, 3 rd report VIII<br />

– 1970, p. 182, 59 th report<br />

0.5 % 1987, p. 112, 173 rd report XVII<br />

– 1964, p. 362, 19 th report XXVII<br />

3 % 1981, p. 295, 151 st report XXIX<br />

2 % 1984, p. 289,167 th report LII<br />

2 % 1971, p. 265, 68 th report X<br />

0.1 % 1965, p. 110, 23 rd report XI<br />

– 1964, p. 380, 20 th report XII<br />

2.5 % 1977, p. 28, 123 rd report XIV<br />

10 % 1968, p. 54, 46 th report XV<br />

1) = The reference figure must be taken <strong>from</strong> the relevant recommendations, e.g. <strong>with</strong> respect <strong>to</strong> the final product, the plastic content, solids etc.; if necessary,<br />

as the sum <strong>of</strong> various additives<br />

2) = Bundesgesundheitsblatt (German Federal Health Bulletin), Carl Heymanns Verlag KG<br />

3) = Bundesinstitut für Risikobewertung (German Federal Institute for Risk Assessment) Berlin;<br />

the latest complete version <strong>of</strong> the recommendations is published in “Kunstst<strong>of</strong>fe im Lebensmittelverkehr” (Plastics Used in the <strong>Food</strong> Industry) by Pr<strong>of</strong>. Dr. R. Frank and<br />

Dr. Helmut Wieczorek, Carl Heymanns Verlag KG<br />

5


Product Characterisation Application<br />

Licowax E Esters <strong>of</strong> montan wax acids Lubricant for melamine resin bonded boards<br />

Licowax OP <strong>with</strong> ethanediol and/or<br />

Licowax KPS 1,3-butanediol and mixtures Additive <strong>to</strong> utensils on the basis <strong>of</strong> natural and synthetic<br />

Licowax KSL these esters <strong>with</strong> nonesterified<br />

montan wax acids<br />

synthetic in accordance <strong>with</strong> recommendation XXV<br />

and their calcium salts Additive <strong>to</strong> paraffin and microwax for impregnation,<br />

coatings, contact adhesives<br />

1) = The reference figure must be taken <strong>from</strong> the relevant recommendations, e.g. <strong>with</strong> respect <strong>to</strong> the final product, the plastic content, solids etc.; if necessary,<br />

as the sum <strong>of</strong> various additives<br />

2) = Bundesgesundheitsblatt (German Federal Health Bulletin), Carl Heymanns Verlag KG<br />

6<br />

Lubricant for elas<strong>to</strong>mers made <strong>of</strong> natural and synthetic<br />

latex and for dispersions <strong>of</strong> solid rubber, in accordance<br />

<strong>with</strong> recommendation XIV<br />

Lubricant for acetal resin<br />

Additive <strong>to</strong> extender for mixed polymers made <strong>of</strong> ethylene,<br />

propylene, butylene, vinyl ester and unsaturated aliphatic<br />

acids etc., in accordance <strong>with</strong> recommendations XXV, II, III<br />

Manufacturing aid for paper, car<strong>to</strong>n and cardboard in<br />

food packaging, in accordance <strong>with</strong> recommendation<br />

XXV, and as a component <strong>of</strong> plastic dispersions in<br />

accordance <strong>with</strong> recommendation XIV<br />

Lubricant for plastic tubes used in milk processing machines<br />

Additive <strong>to</strong> utensils on the basis <strong>of</strong> polyurethane<br />

Release agent for linear polyurethane<br />

Lubricant for chlorinated PVC, plasticizer-free<br />

Surface treatment (in a mixture <strong>with</strong> paraffin microwax)<br />

for synthetic sausage skins made <strong>of</strong> cellophane,<br />

in accordance <strong>with</strong> recommendation XXV<br />

Additive <strong>to</strong> synthetic sausage skins made <strong>of</strong> polyamide<br />

Additive <strong>to</strong> <strong>to</strong>ys made <strong>of</strong> plastic and other polymers etc.,<br />

in conjunction <strong>with</strong> various other recommendations


Content limited <strong>to</strong> 1) published in the Bundesgesundheitsblatt 2) BfR 3) recommendation<br />

1 % 1961, p. 294, 9 th report XVIII<br />

0.3 % 1968, p. 9, 42 nd report XXI<br />

10 % 1967, p. 168, 38 th report XXV<br />

2.5 % 1966, p. 288, 32 nd report XXXII<br />

0.2 % 1969, p. 313, 54 th report XXXIII<br />

– 1966, p. 209, 30 th report XXXV<br />

2 % 1967, p. 24, 34 th report XXXVI<br />

2.5 % 1977, p. 28, 123 rd report<br />

3 % 1967, p. 316, 40 th report XXXVIII<br />

1.5 % 1975, p. 105, 111th report<br />

1980, p. 100, 139<br />

XXXIX<br />

th report<br />

1.5 % 1975, p. 105, 111 th report XLI<br />

8 % 1969, p. 209, 53 rd report XLII<br />

10 % 1971, p. 245, 67 th report XLIV<br />

2 % 1971, p. 245, 67 th report XLIV<br />

– 1973, p. 170, 93 rd report XLVII<br />

3) = Bundesinstitut für Risikobewertung (German Federal Institute for Risk Assessment) Berlin;<br />

the latest complete version <strong>of</strong> the recommendations is published in “Kunstst<strong>of</strong>fe im Lebensmittelverkehr” (Plastics Used in the <strong>Food</strong> Industry) by Pr<strong>of</strong>. Dr. R. Frank and<br />

Dr. Helmut Wieczorek, Carl Heymanns Verlag KG<br />

7


Product Characterisation Application<br />

Licowax E Esters <strong>of</strong> montan wax acids Additive <strong>to</strong> outer coating <strong>of</strong> hollow glassware<br />

Licowax OP <strong>with</strong> ethanediol and/or<br />

Licowax KPS 1,3-butanediol and mixtures Lubricant in PVC and its mixed polymers for the<br />

these esters <strong>with</strong> non-esterified<br />

montan wax acids and their<br />

calcium salts<br />

drinking water sec<strong>to</strong>r<br />

Licowax KPE Esters <strong>of</strong> montan wax acids<br />

<strong>with</strong> ethanediol and/or<br />

butanediol and mixtures <strong>of</strong><br />

Lubricant for melamine resin bonded boards<br />

their esters <strong>with</strong> non-esterified Manufacturing aid for paper, car<strong>to</strong>n, cardboard coming<br />

montan wax acids and their in<strong>to</strong> contact <strong>with</strong> food (as a component <strong>of</strong> plastic<br />

calcium salts, alkyl and<br />

alkylaryl ethoxylates<br />

dispersions in accordance <strong>with</strong> recommendation XIV)<br />

Licowax S Montan wax acids Additives in lacquers for cellophane<br />

Licowax E purified and/or their esters<br />

Licowax OP <strong>with</strong> ethanediol and/or<br />

Licowax KPS 1,3-butanediol and/or its<br />

Licowax KSL calcium salts<br />

Licowax OP Esters <strong>of</strong> montan wax acids Coating on citrus fruits<br />

Licowax KPS <strong>with</strong> ethanediol and/or 1,3-<br />

Licowax KSL butanediol and mixtures <strong>with</strong><br />

calcium salts <strong>of</strong> the montan<br />

wax acids<br />

Licowax C<br />

Licolub FA 1<br />

Ethylene Bisstearamide Lubricant for polymers containing plasticizers<br />

Lubricant for plasticizer-free PVC<br />

1) = The reference figure must be taken <strong>from</strong> the relevant recommendations, e.g. <strong>with</strong> respect <strong>to</strong> the final product, the plastic content, solids etc.; if necessary,<br />

as the sum <strong>of</strong> various additives<br />

2) = Bundesgesundheitsblatt (German Federal Health Bulletin), Carl Heymanns Verlag KG<br />

8<br />

Lubricant and release agent for polyethylene<br />

Lubricant and release agent for polystryrene<br />

Lubricant for styrene mixed polymers and graft


Content limited <strong>to</strong> 1) published in the Bundesgesundheitsblatt 2) BfR 3) recommendation<br />

– 1974, p. 26. 100 th report XLVIII<br />

8 % 1977, p. 12, 1st KTW report (report on the health KTW recommendation<br />

assessment <strong>of</strong> plastics and other non-metal (recommendations for the use <strong>of</strong><br />

materials for the drinking water sec<strong>to</strong>r) plastics and other non-metal<br />

materials for the drinking water<br />

sec<strong>to</strong>r)<br />

1.3.1 Polyvinyl chloride<br />

2.5 % or 4.0 mg/dm2 1972, p. 188, 77th in dispersion film<br />

report XIV<br />

1967, p. 24, 34 th report XXXVI<br />

– Bedarfsgegenständeverordnung (Regulations on<br />

utensils) dated April 11, 1994 Bundesgesetzblatt<br />

(Federal Gazette) 1994, Part I, p. 776<br />

140 mg/kg fruit Zusatzst<strong>of</strong>f-Verkehrsverordnung (Regulations on<br />

the Marketing <strong>of</strong> Additives) and Zusatzst<strong>of</strong>f-Zulassungsverordnung<br />

(Regulations on the Approval<br />

<strong>of</strong> Additives) Bundesgesetzblatt (Federal Gazette)<br />

Part I, No. 88 dated Dec. 23, 1977, p. 2696 und p. 2720<br />

2 % 1974, p. 44, 102 nd report I<br />

2 % 1974, p. 44, 102 nd report II<br />

2 % 1975, p. 49, 110 th report III<br />

2 % 1968, p. 24, 43 rd report V<br />

3 % 1976, p. 308, 121 st report VI<br />

3) = Bundesinstitut für Risikobewertung (German Federal Institute for Risk Assessment) Berlin;<br />

the latest complete version <strong>of</strong> the recommendations is published in “Kunstst<strong>of</strong>fe im Lebensmittelverkehr” (Plastics Used in the <strong>Food</strong> Industry) by Pr<strong>of</strong>. Dr. R. Frank and<br />

Dr. Helmut Wieczorek, Carl Heymanns Verlag KG<br />

9


Product Characterisation Application<br />

Licowax C<br />

Licolub FA 1<br />

Ethylene Bisstearamide Lubricant and release agent for polypropylene<br />

Lubricant for plastic piping used in equipment for draught<br />

beverages, in conjunction <strong>with</strong> other recommendations<br />

1) = The reference figure must be taken <strong>from</strong> the relevant recommendations, e.g. <strong>with</strong> respect <strong>to</strong> the final product, the plastic content, solids etc.; if necessary,<br />

as the sum <strong>of</strong> various additives<br />

2) = Bundesgesundheitsblatt (German Federal Health Bulletin), Carl Heymanns Verlag KG<br />

10<br />

Lubricant or release agent for polyamide<br />

Surface treatment for cellophane film<br />

Additive <strong>to</strong> plastic coatings <strong>of</strong> cellophane,<br />

in conjunction <strong>with</strong> other recommendations<br />

Processing aid for polyterephthalic acid diol ester<br />

Additive <strong>to</strong> conveyer belts on the basis <strong>of</strong> PVC<br />

containing plasticizer, in accordance <strong>with</strong> recommendation II<br />

Lubricant for acetal resin<br />

Additive <strong>to</strong> mixed polymers made <strong>of</strong> ethylene, propylene,<br />

butylene, vinyl esters etc., in accordance <strong>with</strong><br />

recommendations II, III<br />

Processing aid in plastic for surface coating <strong>of</strong> paper and<br />

cardboard, in conjunction <strong>with</strong> various other recommendations<br />

Additive <strong>to</strong> utensils on the basis <strong>of</strong> polyurethane<br />

Additive <strong>to</strong> plasticizer-free chlorinated PVC, its mixed<br />

polymers and polymer blends, in accordance <strong>with</strong><br />

recommendation II<br />

Additive <strong>to</strong> PVC for the surface treatment <strong>of</strong> synthetic<br />

sausage skins made <strong>of</strong> cellophane, in accordance <strong>with</strong><br />

recommendation II


Content limited <strong>to</strong> 1) published in the Bundesgesundheitsblatt 2) BfR 3) recommendation<br />

2 % 1975, p. 49, 110 th report VII<br />

– 1960, pS. 235, 3 rd report VIII<br />

2 % 1971, p. 265, 68 th report X<br />

0.5 % mg/dm 2 1979, p. 401, 136 th report XIII<br />

– 1970, p. 182, 59 th report XIII<br />

0.5 % Report <strong>of</strong> the BfR dated March 6, 1996 XVII<br />

2 % 1964, p. 362, 19 th report XXVII<br />

0.2 % 1969, p. 313, 54 th report XXXIII<br />

0.03 % 1988, p. 365, 179 th report XXXV<br />

– 1967, p. 14, 34 th report XXXVI<br />

2 % 1974, p. 43, 101st report<br />

1980, p. 100, 134<br />

XXXIX<br />

th report<br />

< 1 % 1969, p. 209, 53 rd report XLII<br />

2 % 1971, p. 245, 67 th report XLII<br />

3) = Bundesinstitut für Risikobewertung (German Federal Institute for Risk Assessment) Berlin;<br />

the latest complete version <strong>of</strong> the recommendations is published in “Kunstst<strong>of</strong>fe im Lebensmittelverkehr” (Plastics Used in the <strong>Food</strong> Industry) by Pr<strong>of</strong>. Dr. R. Frank and<br />

Dr. Helmut Wieczorek, Carl Heymanns Verlag KG<br />

11


Product Characterisation Application<br />

Licowax C Ethylene Bisstearamide Additive <strong>to</strong> polyethylene and polypropylene for synthetic<br />

Licolub FA 1 sausage skins, in accordance <strong>with</strong> recommendation III or VII<br />

12<br />

Additive <strong>to</strong> cross-linked polyethylene<br />

Additive <strong>to</strong> <strong>to</strong>ys made <strong>of</strong> plastic, in conjunction <strong>with</strong><br />

various other recommendations<br />

Additive for fillers for utensils made <strong>of</strong> plastic<br />

Lubricant in PVC and its mixed polymers for the<br />

drinking water sec<strong>to</strong>r<br />

Lubricant in polyethylene for the drinking water<br />

Licomont ®CaV 102 Montan acids calcium salt Stabilizer for polyethylene<br />

Licomont NaV 101 Montan acids sodium salt Nucleating agent for PET<br />

Licowax PE 130 Low-molecular polyolefins Lubricant for polymers containing plasticizers,<br />

Licowax PE 190<br />

Licowax PE 520 Lubricant for plasticizer-free PVC<br />

Licowax PP 230<br />

Additive <strong>to</strong> plastic piping used in equipment for draught<br />

beverages, in accordance <strong>with</strong> recommendation II<br />

Processing aid for colorants <strong>to</strong> colour plastics<br />

Surface treatment for cellophane film, in accordance<br />

<strong>with</strong> recommendations II and XXV<br />

1) = The reference figure must be taken <strong>from</strong> the relevant recommendations, e.g. <strong>with</strong> respect <strong>to</strong> the final product, the plastic content, solids etc.; if necessary,<br />

as the sum <strong>of</strong> various additives<br />

2) = Bundesgesundheitsblatt (German Federal Health Bulletin), Carl Heymanns Verlag KG


Content limited <strong>to</strong> 1) published in the Bundesgesundheitsblatt 2) BfR 3) recommendation<br />

2 % 1971, p. 245, 67 th report XLIV<br />

2 % 1972, p. 205, 79 th report XLVI<br />

– 1973, p. 170, 93 rd report XLVII<br />

– 1984, p. 289, 167 th report LII<br />

2 % 1977, p. 12, 1st KTW report (report on the health KTW recommendation<br />

assessment <strong>of</strong> plastics and other non-metal (recommendations for the use <strong>of</strong><br />

materials for the drinking water sec<strong>to</strong>r) plastics and other non-metal materials<br />

for the drinking water sec<strong>to</strong>r)<br />

1.3.1. Polyvinylchlorid<br />

2 % 1977, p. 58, 1st KTW report (report on the health KTW recommendation<br />

assessment <strong>of</strong> plastics and other non-metal (recommendations for the use <strong>of</strong><br />

materials for the drinking water sec<strong>to</strong>r) plastics and other non-metal materials<br />

for the drinking water sec<strong>to</strong>r)<br />

1.3.2. Polyethylen<br />

0.3 % 1993, p. 114, 189 th report III<br />

0.4 % 1972, p. 31, 73 rd report XVII<br />

8 % 1964, p. 407, 21 st report I<br />

8 % 1968, p. 272, 48 th report II<br />

– 1960, p. 235, 3 rd report VII<br />

– 1971, p. 278, 69 th report IX<br />

– 1970, p. 182, 59 th report XIII<br />

3) = Bundesinstitut für Risikobewertung (German Federal Institute for Risk Assessment) Berlin;<br />

the latest complete version <strong>of</strong> the recommendations is published in “Kunstst<strong>of</strong>fe im Lebensmittelverkehr” (Plastics Used in the <strong>Food</strong> Industry) by Pr<strong>of</strong>. Dr. R. Frank and<br />

Dr. Helmut Wieczorek, Carl Heymanns Verlag KG<br />

13


Product Characterisation Application<br />

Licowax PE 130 Low-molecular polyolefins Additive <strong>to</strong> coatings <strong>of</strong> cellophane, in conjunction <strong>with</strong><br />

Licowax PE 190 other recommendations<br />

Licowax PE 520<br />

Licowax PP 230 Additive <strong>to</strong> hard paraffin and wax dispersions for silicon resin<br />

for coating paper, in accordance <strong>with</strong> recommendation XXV<br />

14<br />

Additive <strong>to</strong> polyterephthalic acid diol ester<br />

Additive <strong>to</strong> utensils on the basis <strong>of</strong> natural and synthetic<br />

rubber, in accordance <strong>with</strong> recommendation XXV<br />

Additive <strong>to</strong> impregnations, coatings, contact adhesives<br />

Additive <strong>to</strong> conveyer belts on the basis <strong>of</strong> PVC containing<br />

plasticizer, in accordance <strong>with</strong> recommendation II<br />

Additive <strong>to</strong> latex and dispersions <strong>of</strong> natural and synthetic<br />

rubber, in accordance <strong>with</strong> recommendation XXI Licowax PP 230<br />

Additive <strong>to</strong> mixed polymers made <strong>of</strong> ethylene, propylene,<br />

butylene etc., in accordance <strong>with</strong> recommendation II<br />

Additive <strong>to</strong> surface treatments and coatings on paper, car<strong>to</strong>n<br />

and cardboard, in accordance <strong>with</strong> recommendation XXV<br />

Additive <strong>to</strong> plasticizer-free PVC, its mixed polymers and<br />

polymer blends, in accordance <strong>with</strong> recommendation II<br />

In mixtures <strong>with</strong> paraffin for the surface treatment <strong>of</strong><br />

synthetic sausage skins made <strong>of</strong> cellophane in accordance<br />

<strong>with</strong> recommendation XXV<br />

Additive <strong>to</strong> <strong>to</strong>ys made <strong>of</strong> plastic, in accordance <strong>with</strong><br />

various recommendations<br />

Additive <strong>to</strong> outer coating <strong>of</strong> hollow glassware<br />

Additive for fillers for utensils made <strong>of</strong> plastic<br />

1) = The reference figure must be taken <strong>from</strong> the relevant recommendations, e.g. <strong>with</strong> respect <strong>to</strong> the final product, the plastic content, solids etc.; if necessary,<br />

as the sum <strong>of</strong> various additives<br />

2) = Bundesgesundheitsblatt (German Federal Health Bulletin), Carl Heymanns Verlag KG


Content limited <strong>to</strong> 1) published in the Bundesgesundheitsblatt 2) BfR 3) recommendation<br />

– 1970, p. 182, 59 th report XIII<br />

< 50 % 1968, p. 54, 46 th report XV<br />

0.5 % 1975, p. 328, 116 th report XVII<br />

< 1.5 % 1968, p. 9, 42 nd report XXI<br />

< 50 % 1967, p. 168, 38th report<br />

1984, p. 27, 162<br />

XXV<br />

nd report<br />

8 % 1964, p. 362, 19 th report XXVII<br />

< 1.5 % 1966, p. 288, 32 nd report XXXII<br />

< 4 % 1966, p. 209, 30 th report XXXV<br />

– 1967, p. 24, 34 th report XXXVI<br />

< 4 % 1969, p. 209, 53 rd report XLII<br />

– 1971, p. 245, 67 th report XLIV<br />

– 1973, p. 170, 93 rd report XLVII<br />

– 1974, p. 26, 100 th report XLVIII<br />

12 % 1984, p. 289, 167 th report LII<br />

3) = Bundesinstitut für Risikobewertung (German Federal Institute for Risk Assessment) Berlin;<br />

the latest complete version <strong>of</strong> the recommendations is published in “Kunstst<strong>of</strong>fe im Lebensmittelverkehr” (Plastics Used in the <strong>Food</strong> Industry) by Pr<strong>of</strong>. Dr. R. Frank and<br />

Dr. Helmut Wieczorek, Carl Heymanns Verlag KG<br />

15


Product Characterisation Application<br />

Licowax PE 130 Low-molecular polyolefins Lubricant in PVC and its mixed polymers for the<br />

Licowax PE 190 drinking water sec<strong>to</strong>r<br />

Licowax PE 520<br />

Licowax PP 230<br />

16<br />

Additive <strong>to</strong> chewing gum<br />

(only Licowax PE 130, PE 190, PE 520)<br />

Coating on cheese<br />

Licowax PED 121 Oxidized polyethylene wax Lubricant for polymers containing plasticizers,<br />

Licowax PED 136 in accordance <strong>with</strong> recommendation II<br />

Licowax PED 153<br />

Licowax PED 191 Lubricant for plasticizer-free PVC<br />

Licowax PED 521<br />

Licowax PED 522 Lubricant and release agent for polystryrene<br />

Licolub H 12<br />

Licolub H 22<br />

Licowax PED 121 Oxidized polyethylene wax Lubricant and release agent for stryrene mixed and<br />

Licowax PED 1101<br />

Licowax PED 136<br />

graft polymers<br />

Licowax PED 153<br />

Licowax PED 191<br />

Lubricant for PVDC polymer<br />

Licowax PED 192<br />

Licowax PED 521<br />

Licowax PED 522<br />

Licolub H 12<br />

Licolub H 22<br />

Coating on citrus fruits


Content limited <strong>to</strong> 1) published in the Bundesgesundheitsblatt 2) BfR 3) recommendation<br />

8 % 1977, p. 12, 1st KTW report (report on the KTW recommendation<br />

health assessment <strong>of</strong> plastics and other (recommendations for the use <strong>of</strong><br />

non-metal materials for the drinking water plastics and other non-metal materials<br />

for the drinking water sec<strong>to</strong>r)<br />

1.3.1 Polyvinylchloride<br />

– Zusatzst<strong>of</strong>f-Verkehrsverordnung (Regulations on<br />

the Marketing <strong>of</strong> Additives) and Zusatzst<strong>of</strong>f-<br />

Zulassungsverordnung (Regulations on the<br />

Approval <strong>of</strong> Addites) 1990<br />

10 % Käse-Verordnung (Regulations on Cheese)<br />

Bundesgesetzblatt (Federal Gazette) Part I, No. 88<br />

dated Dec. 23, 1977, p. 2738<br />

3 % 1992, p. 362, 188th report<br />

1996, p. 120, 193<br />

I<br />

rd report<br />

3% II<br />

3% V<br />

3% VI<br />

0.3 % 1993, p. 115, 189 th report XXXIV<br />

140 mg/kg fruit Zusatzst<strong>of</strong>f-Verkehrsverordnung (Regulations on the<br />

Marketing <strong>of</strong> Additives) and Zulassungsverordnung<br />

(Regulations on the Approval <strong>of</strong> Additives) Bundesgesetzblatt<br />

(Federal Gazette)<br />

Part I No. 88 dated Dez. 23, 1977, p. 2699 und p. 2720<br />

1) = The reference figure must be taken <strong>from</strong> the relevant recommendations, e.g. <strong>with</strong> respect <strong>to</strong> the final product, the plastic content, solids etc.; if necessary,<br />

as the sum <strong>of</strong> various additives<br />

2) = Bundesgesundheitsblatt (German Federal Health Bulletin), Carl Heymanns Verlag KG<br />

3) = Bundesinstitut für Risikobewertung (German Federal Institute for Risk Assessment) Berlin;<br />

the latest complete version <strong>of</strong> the recommendations is published in “Kunstst<strong>of</strong>fe im Lebensmittelverkehr” (Plastics Used in the <strong>Food</strong> Industry) by Pr<strong>of</strong>. Dr. R. Frank and<br />

Dr. Helmut Wieczorek, Carl Heymanns Verlag KG<br />

17


Admissible additives in the EU<br />

Product Characterisation Application<br />

Licowax S Montan wax acids Additives <strong>to</strong> plastics<br />

Licowax E and/or their esters <strong>with</strong> ethylene glycol<br />

Licowax OP and/or <strong>with</strong> 1,3-butanediol<br />

Licowax KPS and/or glycerine<br />

Licowax KSL PM-Ref.-Nr. 67840<br />

Licolub WE 4<br />

Licowax C<br />

Licolub FA 1<br />

Ethylene Bisstearamide Additives <strong>to</strong> plastics<br />

Licowax E Montan wax acid ester E 912 Surface treatment <strong>of</strong> citrus fruits<br />

Licowax OP<br />

Licowax KPS<br />

Licowax KSL<br />

Licolub WE 4<br />

Licowax PED 121 Oxidized polyethylene wax Surface treatment <strong>of</strong> citrus fruits<br />

Licowax PED 1101<br />

Licowax PED 136<br />

Licowax PED 153<br />

Licowax PED 191<br />

Licowax PED 192<br />

Licowax PED 521<br />

Licowax PED 522<br />

Licolub H 12<br />

Licolub H 22<br />

E 914<br />

18


Quantity Published<br />

– Directive 95/3/EC dated Feb. 14, 1995<br />

Official Journal <strong>of</strong> the European Union<br />

No. L 41/44 dated Feb. 23, 1995<br />

– Directive 95/3/EC dated Feb. 14, 1995<br />

Official Journal <strong>of</strong> the European Union<br />

No. L 41/44 dated Feb. 23, 1995<br />

– Directive 95/2/EC dated Feb. 20, 1995<br />

on other additives <strong>to</strong> food as colorants and<br />

sweeteners<br />

– Official Journal <strong>of</strong> the European Union<br />

No. L 61/1 dated March 18, 1995<br />

19


Product Characterisation Application<br />

Licowax PE 130 Polyethylene wax Additives <strong>to</strong> plastics<br />

Licowax PE 190 PM-Ref.-No. 80000<br />

Licowax PE 520<br />

Licowax PP 230 Polypropylene wax<br />

PM-Ref.-No. 81060<br />

Additives <strong>to</strong> plastics<br />

Licowax PED 121 Oxidized polyethylene wax Additives <strong>to</strong> plastics<br />

Licowax PED 1101<br />

Licowax PED 136<br />

Licowax PED 153<br />

Licowax PED 191<br />

Licowax PED 192<br />

Licowax PED 521<br />

Licowax PED 522<br />

Licolub H 12<br />

Licolub H 22<br />

PM-Ref.-No. 80077<br />

20


Quantity Published<br />

– Directive 2005/79/EC dated Nov. 18, 2005<br />

Official Journal <strong>of</strong> the European Union<br />

No. L 302/35 dated November 19, 2005<br />

– Directive 2005/79/EC<br />

– EC Additive List, Synoptic Document<br />

and amendments<br />

21


The status <strong>of</strong> <strong>Clariant</strong> waxes <strong>with</strong> regard <strong>to</strong> food legislation in other countries<br />

The legislation on food in the USA and<br />

many other countries is similar developed<br />

<strong>to</strong> that in Germany. The FDA – the<br />

<strong>Food</strong> and Drug Administration, USA –<br />

regulate the substances permitted <strong>to</strong><br />

come “in<strong>to</strong> direct or indirect contact<br />

<strong>with</strong> food” which are codified in the<br />

Title 21, Code <strong>of</strong> Federal Regulations<br />

(21 CFR).<br />

22<br />

There are also legal requirements for<br />

processing aids permitted for use in<br />

the processing <strong>of</strong> plastics in Australia,<br />

Belgium, the Czech Republic, Britain,<br />

France, the Netherlands, Italy, Japan,<br />

Austria and Spain. In many cases,<br />

countries <strong>with</strong>out their own comprehensive<br />

food legislation refer <strong>to</strong> the<br />

legal requirements valid in the Federal<br />

Republic <strong>of</strong> Germany and the USA.<br />

Country Product Characterisation<br />

United Kingdom<br />

Rec.-No. T-141 Licowax E Montan wax ester<br />

Rec.-No. T-142 Licowax OP<br />

Rec.-No. T-137 Licowax KPS<br />

Rec.-No. T-177 Licowax PE 130 Non oxidized polyethylene waxes<br />

Rec.-No. T-178 Licowax PE 190<br />

Rec.-No. T-179 Licowax PE 520<br />

Rec.-No. T-172 Licolub C Ethylene Bisstearamide<br />

The national regulations <strong>of</strong> individual<br />

countries in the European Union are<br />

increasingly becoming replaced by the<br />

EU regulations for the whole <strong>of</strong> Europe.<br />

The legal admissibility <strong>of</strong> the <strong>Clariant</strong><br />

waxes in individual countries is summarized<br />

in the following tables.<br />

Licolub WE 4 Glycerolesters <strong>of</strong> oxidatively refined montan wax acids<br />

France Licowax E Montan wax acids and esthers <strong>with</strong> ethanediol and/or<br />

Licowax OP 1,3-butanediol and mixtures these esters <strong>with</strong> non-esterified<br />

Licowax KPS<br />

Licowax KSL<br />

Licowax S<br />

montan wax acids and their calcium salts<br />

Licowax PE 130 Polyethylene wax<br />

Licowax PE 190<br />

Licowax PE 520


Application Quantity Published<br />

Lubricant for plastic 8 % BPF/BIBRA-Code <strong>of</strong> Practice 1976<br />

Additive <strong>to</strong> plastic 8 % BPF/BIBRA-Code <strong>of</strong> Practice 1991<br />

Additive <strong>to</strong> plastic 5 % BPF/BIBRA-Code <strong>of</strong> Practice 1991<br />

Lubricant for plastic – BPF/BIBRA-Code <strong>of</strong> Practice 1988<br />

Lubricant for plastic 3 % Journal <strong>of</strong>ficiel, April 16, 1959<br />

Circulaire No. 175, March 23,1959)<br />

> Lubricant for PVC, polystyrene homopolymers – Instruction dated Nov. 30, 1987<br />

and copolymers, polyolefins, polyamides and rubber<br />

> Additive <strong>to</strong> hot melt adhesives<br />

> Paper and car<strong>to</strong>n coating<br />

> Additives <strong>to</strong> lacquers and printing inks<br />

Bulletin Officiel dated Dec. 16, 1987<br />

23


Country Product Characterisation<br />

France Licowax PED 121<br />

Licowax PED 1101<br />

Licowax PED 136<br />

Licowax PED 153<br />

Licowax PED 191<br />

Licowax PED 192<br />

Licowax PED 521<br />

Licowax PED 522<br />

Licolub H 12<br />

Licolub H 22<br />

Oxidized polythylene wax<br />

24<br />

Licowax C Ethylene Bisstearamide<br />

Licolub FA 1<br />

Italy Licowax E<br />

Licowax OP<br />

Licowax KPS<br />

Licowax KSL<br />

Esters <strong>of</strong> montan wax acids <strong>with</strong> ethanediol and 1,3-butanediol<br />

Licolub WE 4 Esters <strong>of</strong> montan wax acids <strong>with</strong> glycerine<br />

Licowax C Ethylene Bisstearamide<br />

Licolub FA 1<br />

Licowax PE 130 Polyethylene<br />

Licowax PE 190<br />

Licowax PE 520<br />

Licowax PED 191 Oxidized polyethylene wax<br />

Licowax PED 192<br />

Licolub H 12<br />

Licolub H 22


Application Quantity Published<br />

> Lubricant for PVC, polystyrene homopolymers – Instruction dated Nov. 30, 1987<br />

and copolymers, polyolefins, polyamides<br />

and rubber<br />

> Additive <strong>to</strong> hot melt adhesives<br />

> Paper and car<strong>to</strong>n coating<br />

> Additives <strong>to</strong> lacquers and printing inks<br />

Bulletin Officiel dated Dec. 16, 1987<br />

Additive <strong>to</strong> plastic 2 % Journal Officiel, June 4, 1969<br />

(Circulaire dated April 2, 1969)<br />

Additive <strong>to</strong> plastic and processing aid for – Gazzetta Ufficiale No. 104,<br />

regenerated cellulose April 20, 1973<br />

Additive <strong>to</strong> plastic – Gazzetta Ufficiale Nr. 120, 23.5.85<br />

Additive <strong>to</strong> plastic and processing aid for 0.5 % in PE Gazzetta Ufficiale No. 104,<br />

regenerated cellulose and PVC<br />

in other<br />

plastics 0.2 %<br />

April 20, 1973<br />

Utensils – Gazzetta Ufficiale No. 104,<br />

April 20, 1973<br />

Unplasticized PVC – Gazzetta Ufficiale No. 198,<br />

Aug. 25, 1994<br />

25


Country Product Characterisation<br />

Spain<br />

26<br />

Licowax E Esters <strong>of</strong> the montan wax acids <strong>with</strong> ethanediol<br />

Licowax OP and/or 1,3-butanediol or glycerine and/or<br />

Licowax KPS calcium and sodium salts<br />

Licowax KSL<br />

Licolub WE 4<br />

Licowax S Purified montan wax acids<br />

Licowax C Ethylene Bisstearamide<br />

Licolub FA 1<br />

Licowax PE 130 Polyethylene waxes, polyolefins <strong>of</strong> a low<br />

Licowax PE 520<br />

Licowax PE 190<br />

degree <strong>of</strong> polymerisation<br />

Licowax PP 230 Polypropylene wax<br />

Licowax PED 121 Oxidized polyethylene waxes<br />

Licowax PED 1101<br />

Licowax PED 136<br />

Licowax PED 153<br />

Licowax PED 521<br />

Licowax PED 522<br />

Licolub H 12<br />

Licolub H 22<br />

Licowax PED 191 Oxidized polyethylene wax<br />

Licowax PED 192<br />

Switzerland To some extent these countries follow the regulations <strong>of</strong> the EU,<br />

Denmark the Federal Republic <strong>of</strong> Germany and the USA<br />

Sweden<br />

Norway


Application Quantity Published<br />

Additive <strong>to</strong> plastic for food packaging –<br />

Positive list, Ministerio de Sanidad 1982<br />

and/or registration number,<br />

Registro Sanitario Espaniol<br />

39.16/B-109<br />

39.16/B-110<br />

39.16/B-154<br />

39.16/B-132<br />

39.16/B-396<br />

Additive <strong>to</strong> plastic for food packaging – 39.16/B-130<br />

Additive <strong>to</strong> plastic for food packaging – 39.16/B-155<br />

Additive <strong>to</strong> plastic for food packaging – 39.16/B-83<br />

39.16/B-85<br />

39.16/B-84<br />

Additive <strong>to</strong> plastic for food packaging – –<br />

Coating <strong>of</strong> citrus fruits and additive <strong>to</strong> plastic and – 39.16/B-458<br />

for food packaging 39.16/B-367<br />

39.16/B-368<br />

39.16/B-152<br />

39.16/B-1<br />

Additive <strong>to</strong> plastic for food packaging – –<br />

– – –<br />

27


Country Product Characterisation<br />

The Netherlands Licowax S Montan wax acids, esters <strong>of</strong> the montan wax acids<br />

Licowax E <strong>with</strong> ethanediol and/or 1,3-butanediol and/or<br />

Licowax OP<br />

Licowax KPS<br />

Licowax KSL<br />

Licolub WE 4<br />

glycerine, calcium salts <strong>of</strong> the montan wax acids<br />

28<br />

Licowax S Montan wax acids, esters <strong>of</strong> the montan wax acids<br />

Licowax E <strong>with</strong> ethanediol and/or 1,3-butanediol and/or calcium<br />

Licowax OP salts <strong>of</strong> the montan wax acids<br />

Licowax KPS<br />

Licowax KSL<br />

Licowax C Ethylene Bisstearamide<br />

Licolub FA 1<br />

Licowax PE 130 Polyethylene, molecular weight > 200<br />

Licowax PE 190<br />

Licowax PE 520<br />

Licowax PP 230 Polypropylene, molecular weight > 400


Application Quantity Published<br />

Additives <strong>to</strong> plastics – Verpakkingen en Gebruiksartikelen<br />

Besluit (Warenwet) 1980,<br />

7th Supplement April 1994<br />

Additive for paper and car<strong>to</strong>ns, rubber products – Verpakkingen en Gebruiksartikelen<br />

(Category II + III), metals, Besluit (Warenwet) 1980,<br />

film made <strong>from</strong> regenerated cellulose, coatings 6th Supplement June 1993<br />

Additives <strong>to</strong> plastics, metals, film made <strong>from</strong> – Verpakkingen en Gebruiksartikelen<br />

regenerated cellulose Besluit (Warenwet )1980,<br />

7th Supplement April 1994<br />

Additives <strong>to</strong> plastics, metals, paper and car<strong>to</strong>n, – Verpakkingen en Gebruiksartikelen<br />

coatings Besluit (Warenwet) 1980,<br />

7th Supplement April 1994<br />

Coatings – Warenwet 1980,<br />

5th Supplement January 1992<br />

29


Country Product Characterisation<br />

Belgium Licowax S Purified montan wax acids, esters <strong>of</strong> the montan wax<br />

Licowax E acids <strong>with</strong> ethanediol and/or 1,3-butanediol and/or<br />

Licowax OP<br />

Licowax KPS<br />

Licowax KSL<br />

Licolub WE 4<br />

glycerine<br />

30<br />

Licowax C Ethylene Bisstearamide<br />

Licolub FA 1<br />

Licowax PE 130 Polyolefins <strong>of</strong> a low degree <strong>of</strong> polymerisation<br />

Licowax PE 190<br />

Licowax PE 520<br />

Licowax PP 230<br />

Licowax PED 121 Oxidized polyethylene<br />

Licowax PED 1101<br />

Licowax PED 136<br />

Licowax PED 153<br />

Licowax PED 191<br />

Licowax PED 192<br />

Licowax PED 521<br />

Licowax PED 522<br />

Licolub H 12<br />

Licolub H 22


Application Quantity Published<br />

Additive <strong>to</strong> plastic for food packaging – Official Belgian Journal<br />

dated July 24, 1992,<br />

Royal decree dated May 11, 1992<br />

Additive <strong>to</strong> plastic for food packaging – Official Belgian Journal dated July 24,<br />

1992, Royal decree dated May 11, 1992<br />

Additive <strong>to</strong> plastic for food packaging – Official Belgian Journal<br />

dated July 24, 1992,<br />

Royal decree dated May 11, 1992<br />

Additive <strong>to</strong> plastics – Official Belgian Journal<br />

dated July 24, 1992,<br />

Royal decree dated May 11, 1992<br />

31


Country Product Characterisation<br />

Austria Licowax E Montan wax acids:<br />

Licowax OP esters <strong>of</strong> the montan wax acids <strong>with</strong> ethanediol<br />

Licowax KPS<br />

Licowax KSL<br />

and/or 1,3-butanediol<br />

32<br />

Licolub WE 4 Esters <strong>of</strong> the montan wax acids <strong>with</strong> glycerine<br />

Licowax KPE Esters <strong>of</strong> the montan wax acids <strong>with</strong> ethanediol<br />

and/or 1,3-butanediol and alkylaryl and aryl ethoxylates<br />

Licowax C Ethylene Bisstearamide<br />

Licolub FA 1<br />

Licowax PE 130 Low-molecular polyolefins<br />

Licowax PE 190<br />

Licowax PE 520<br />

Licowax PP 230<br />

Licowax PED 121 Oxidized polyethylene waxes<br />

Licowax PED 1101<br />

Licowax PED 136<br />

Licowax PED 153<br />

Licowax PED 191<br />

Licowax PED 192<br />

Licowax PED 521<br />

Licowax PED 522<br />

Licolub H 12<br />

Licolub H 22


Application Quantity Published<br />

Lubricant for plastic 2 % Austrian Health Authority Bulletin,<br />

77th year, dated March 15,1976, p. 73<br />

Lubricant for PVC max. 2 % Plastic Additive List September 1995,<br />

Austrian Chamber <strong>of</strong> Commerce<br />

Additive <strong>to</strong> plastic for food packaging 2 % Austrian Health Authority Bulletin,<br />

77th year, dated March 15, 1976, p. 73<br />

Lubricant for plastic 2 % Austrian Health Authority Bulletin,<br />

77th year, dated March 15, 1976, p. 73<br />

Additive <strong>to</strong> hard paraffin and microwax, resin – Austrian Health Authority Bulletin,<br />

and plastic for impregnated coatings and contact 77th adhesives<br />

year, dated March 15, 1976, p. 73<br />

Lubricant for PVC, polystyrene homopolymers max. 3 % Plastic Additive List September 1995,<br />

and mixed polymers Austrian Chamber <strong>of</strong> Commerce<br />

33


Country Product Characterisation<br />

Czech Republic Licowax E Vosk E<br />

Licowax OP Vosk OP<br />

Australia<br />

4) = In positive lists which use the trade name <strong>of</strong> the permitted products the old designation for polyethylene wax is still partly used, e. g. Hoechst Wax PA 520.<br />

In 1977 the nomenclature was changed. Since then, PA wax has been called PE wax, e. g. PE 520.<br />

34<br />

Licowax C Vosk C,<br />

or Ethylene Bisstearamide<br />

Licowax PE 520 Vosk PA 520 4)<br />

Licowax E Montan waxes<br />

Licowax OP<br />

Licowax KPS<br />

Licowax KSL<br />

Licolub WE 4<br />

Licowax C Ethylene Bisstearamide<br />

Licolub FA 1<br />

Licowax PE 130 Polyethylene<br />

Licowax PE 190<br />

Licowax PE 520


Application Quantity Published<br />

Lubricant for polyethylene, polyamide (basis<br />

caprolactam), PVC, polystyrene, polyvinyl<br />

acetate, polypropylene, melamine formaldehyde<br />

resin, styrene copolymers<br />

– Hygienické P`´redpisy Svazek 42/1978<br />

Lubricant for: Polyethylen 0.2 % Hygienické P`´redpisy Svazek 42/1978<br />

Polystyrene 0.2 %<br />

Styrene copolymers 0.5 %<br />

Lubricant for: PVC 1.5 % Hygienické P`´redpisy Svazek 42/1978<br />

Polystyrene –<br />

Styrene copolymers 0.5 %<br />

Additive <strong>to</strong> PVC 3 %<br />

Australian Standard<br />

AS 2070.2-1992<br />

AS 2070.8-1992<br />

Additive for PE 5 % AS 2070.1-1992<br />

PVC 5 % AS 2070.2-1992<br />

Polystyrene 0.5 % AS 2070.3-1992<br />

Polyacrylnitrile 5 % AS 2070.4-1992<br />

Polypropylene 5 % AS 2070.5-1992<br />

AS 2070.8-1992<br />

Additive <strong>to</strong> polyacrylnitrile 3 % AS 2070.4-1992<br />

AS 2070.8-1992<br />

35


Country Product Characterisation<br />

USA Licowax E Polyhydric alcohol diesters <strong>of</strong> oxidatively refined<br />

Licowax OP (Gersth<strong>of</strong>en process) montan wax acids<br />

36<br />

Licowax KPS Polyhydric alcohol diesters <strong>of</strong> oxidatively refined<br />

Licowax KPE (Gersth<strong>of</strong>en process) montan wax acids<br />

Licowax E Polyhydric alcohol diesters <strong>of</strong> oxidatively refined<br />

Licowax OP (Gersth<strong>of</strong>en process) montan wax acids<br />

Licowax KPS<br />

Licowax KPE<br />

Licolub WE 4 Polyhydric alcohol diesters <strong>of</strong> oxidatively refined<br />

(Gersth<strong>of</strong>en process) montan wax acids<br />

Licowax E Polyhydric alcohol diesters <strong>of</strong> oxidatively refined<br />

Licowax KPS (Gersth<strong>of</strong>en process) montan wax acids<br />

Licowax E Conversion product <strong>of</strong> montan wax acids <strong>with</strong><br />

Licowax KSL ethylene glycol<br />

Licowax C Ethylene Bisstearamide<br />

Licolub FA 1<br />

Licowax KP 303 Montan wax


Application Quantity Published<br />

Lubricant for food-contact utensils made <strong>of</strong> PVC – Code <strong>of</strong> Federal Regulations (FDA) Title 21<br />

§ 178.3770 (a)<br />

Release agent in resin and polymer coating for 5 % in § 178.3770 (b)<br />

polyolefin film in acc. <strong>with</strong> § 175.320 conjunction<br />

<strong>with</strong> § 178.3400<br />

Additive in aqueous PVDC dispersions – § 178.3770 (c)<br />

Lubricant in PVC – § 178.3770 (d)<br />

Coating on citrus fruits – § 172.210 (b)<br />

Additive in paper and paperboard – § 176.170<br />

§ 176.180<br />

Additive <strong>to</strong> cellophane, – § 177.1200<br />

release agent § 175.300<br />

component <strong>of</strong> adhesives, § 175.105<br />

component <strong>of</strong> paper and paperboard in contact<br />

<strong>with</strong> aqueous and fatty food<br />

§ 176.170<br />

component <strong>of</strong> paper and paperboard in contact <strong>with</strong> dry food, § 176.180<br />

additive <strong>to</strong> polymers Prior Sanction<br />

Component <strong>of</strong> adhesives – § 175.105<br />

component <strong>of</strong> rubber articles § 177.2600<br />

37


Country Product Characterisation<br />

USA Licowax PE 130<br />

Licowax PE 190<br />

Licowax PE 520<br />

Polyethylene wax<br />

38<br />

Licowax PE 130 Olefin polymers<br />

Licowax PE 190<br />

Licowax PE 520<br />

Licowax PP 230 Polypropylene


Application Quantity Published<br />

Additive for<br />

> chewing gum – § 172.615<br />

> adhesives – § 175.105<br />

> contact adhesives – § 175.125<br />

> resin and polymer coatings – § 175.300<br />

> coating <strong>of</strong> polyolefin films max. 90 % § 175.320<br />

> paper and paperboard in contact <strong>with</strong><br />

aqueous and fatty food<br />

50 % § 176.170<br />

> paper and paperboard in contact <strong>with</strong> dry food – § 176.180<br />

> cellophane – § 177.1200<br />

> closure <strong>with</strong> sealing gaskets for food containers – § 177.1210<br />

> rubber articles for repeated use max. 2 % § 177.2600<br />

> textile and textile fibres max. 50 % § 177.2800<br />

> lubricants <strong>with</strong> incidental food contact – § 178.3570<br />

> reinforced wax for packaging cheese – § 178.3850<br />

Additive for articles in contact <strong>with</strong> food – § 177.1520 (c) 2.1, 2.3<br />

– § 177.1520 (c) 2.1, 2.2, 2.3<br />

max. 50 % § 177.1520 (c) 2.3<br />

Additive for articles in contact <strong>with</strong> food – § 177.1520 (c) 1.2<br />

component <strong>of</strong> adhesives – § 175.105<br />

39


Country Product Characterisation<br />

USA Licowax PED 121 Polyethylene, oxidized<br />

Licowax PED 191<br />

Licowax PED 192<br />

Licowax PED 521<br />

Licolub H 12<br />

(acid value 9-19)<br />

40


Application Quantity Published<br />

Additive for<br />

> fruit coating – § 172.260<br />

> adhesives – § 175.105<br />

> pressure sensitive adhesives – § 175.125<br />

> resin and polymer coatings – § 175.300<br />

> coating <strong>of</strong> polyolefin films – § 175.320<br />

> paper and paperboard in contact <strong>with</strong><br />

aqueous and fatty food<br />

– § 176.170<br />

> paper and paperboard in contact <strong>with</strong> dry food – § 176.180<br />

> cellophane – § 177.1200<br />

> closures <strong>with</strong> sealing gaskets – § 177.1210<br />

> articles in contact <strong>with</strong> food – § 177.1620<br />

> rubber articles for repeated use – § 177.2600<br />

> textile and textile fibres – § 177.2800<br />

> lubricants <strong>with</strong> incidental food contact § 178.3570<br />

> reinforced wax for packaging cheese – § 178.3850<br />

41


Country Product Characterisation<br />

Japan<br />

42<br />

Licowax E Montan wax acids, ester <strong>of</strong> ethanediol<br />

Licowax OP Montan wax acids, ester <strong>of</strong> 1,3-butanediol<br />

Licowax S Montan wax acids<br />

Licowax E Montan wax acids, ester <strong>of</strong> ethanediol<br />

Licowax OP Montan wax acids, ester <strong>of</strong> 1,3-butanediol<br />

Licowax E Montan wax acids, ester <strong>of</strong> ethanediol<br />

Licowax OP Montan wax acids, ester <strong>of</strong> 1,3-butanediol<br />

Licowax E Montan wax acids, ester <strong>of</strong> ethanediol<br />

Licowax OP Montan wax acids, ester <strong>of</strong> 1,3-butanediol<br />

Licowax S Montan wax acids<br />

Licolub WE 4 Montan wax acids, glycerol ester<br />

Licowax S Montan wax acids<br />

Licomont CaV 102 Montan acids calcium salt


Application Quantity Published<br />

PVC – J-0277<br />

PE – [B] NM-0644<br />

BDR –<br />

PED 3.0 %<br />

PET 3.0 % [B] NM-0644<br />

PS – [B] NL-0611<br />

PA 2.0 %<br />

PC 0.1 %<br />

POM 0.2 %<br />

PE 3.0 % [B] NL-0645<br />

PP 2.0 %<br />

ABS 3.0 %<br />

PC 0.1 %<br />

PE 3.0 % [B] NL-0762<br />

PP 2.0 %<br />

ABS 3.0 %<br />

PC 0.1 %<br />

POM 0.2 %<br />

PBT –<br />

PS – [B] NL-1200<br />

ABS –<br />

PA 2.0 %<br />

PBT –<br />

PET –<br />

PC 0.1 %<br />

POM 0.2 %<br />

Positive lists <strong>of</strong> the Japan Hygienic PVC<br />

Association (J-XXXX) and Japan Hygienic<br />

Olefin and Styrene Plastics Association<br />

([B]XX-XXXX)<br />

43


Country Product Characterisation<br />

Japan<br />

44<br />

Licomont NaV 101 Montan acids sodium salt<br />

Licowax C Ethylene Bisstearamide<br />

Licolub FA 1<br />

Licowax C Ethylene Bisstearamide<br />

Licolub FA 1<br />

Licowax PE 130 Polyethylene wax<br />

Licowax PE 190<br />

Licowax PE 520<br />

Licowax PE 130 Polyethylene wax<br />

Licowax PE 190<br />

Licowax PE 520


Application Quantity Published<br />

PE 0.4 % [B] NL-1201<br />

PP 0.4 %<br />

PS 0.4 %<br />

PA 0.4 %<br />

PET 0.4 %<br />

POM 0.4 %<br />

PPE 0.4 %<br />

PVC – J-0278<br />

PE 0.5 % [B] NL-0648<br />

PP 2.0 %<br />

PMP 0.2 %<br />

PS 0.4 %<br />

AS 2.0 %<br />

ABS 2.0 %<br />

PMMA 0.2 %<br />

PB-1 0.2 %<br />

BDR 0.2 %<br />

PA 0.2 %<br />

PET 0.2 %<br />

PC 0.2 %<br />

PVC – J-0279<br />

PE – [B] NL-0647<br />

PP –<br />

PS –<br />

AS –<br />

ABS –<br />

PET 0.5 %<br />

PC –<br />

Positive lists <strong>of</strong> the Japan Hygienic PVC<br />

Association (J-XXXX) and Japan Hygienic<br />

Olefin and Styrene Plastics Association<br />

([B]XX-XXXX)<br />

45


Country Product Characterisation<br />

Japan<br />

46<br />

Licowax PP 230 Polypropylene<br />

Licowax PED 521 Oxidized polyethylene<br />

Licowax PED 121


Application Quantity Published<br />

PE – [B] NJ-0920<br />

PP –<br />

PMP –<br />

PS –<br />

ABS –<br />

PMMA –<br />

PB-1 –<br />

BDR –<br />

PA –<br />

PET –<br />

PC –<br />

PE – [B] NJ-0649<br />

PP –<br />

PS –<br />

AS –<br />

ABS –<br />

BDR –<br />

Positive lists <strong>of</strong> the Japan Hygienic PVC<br />

Association (J-XXXX) und Japan Hygienic<br />

Olefin and Styrene Plastics Association<br />

([B]XX-XXXX)<br />

47


Please note<br />

This information is based on our present state <strong>of</strong> knowledge and is intended <strong>to</strong> provide<br />

general notes on our products and their uses. It should not therefore be construed<br />

as guaranteeing specific properties <strong>of</strong> the products described or their suitability for<br />

a particular application. Any existing industrial property rights must be observed.<br />

The quality <strong>of</strong> our products is guaranteed under our General Conditions <strong>of</strong> Sale.<br />

® = Trademark <strong>of</strong> <strong>Clariant</strong> registered in numerous countries.<br />

Edition: November 2006<br />

www.pa.clariant.com<br />

<strong>Clariant</strong> International Ltd.<br />

Pigments & Additives Division<br />

Rothausstrasse 61<br />

4132 Muttenz<br />

Switzerland<br />

Phone: +41/61/469-7921<br />

Fax: +41/61/469-7543<br />

Exactly your chemistry.<br />

DA 8250 E_11/06

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