Commission Directive 2004/4/EC of 15 January 2004 amending Directive 96/3/EC granting a derogation from certain provisions of Council Directive 93/43/EEC on the hygiene of foodstuffs as regards the transport of bulk liquid oils and fats by sea (Text with EEA relevance)
Date: 2004-01-15
Institutions: European Commission
Subjects: acid, bulk product, carrying capacity, chemical alcohol, derogation from EU law, fats, food hygiene, maritime transport, mineral oil, technology assessment

22.1.2004

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Official Journal of the European Union

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COMMISSION DIRECTIVE 2004/4/EC

of 15 January 2004

amending Directive 96/3/EC granting a derogation from certain provisions of Council Directive
93/43/EEC on the hygiene of foodstuffs as regards the transport of bulk liquid oils and fats by sea

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Com-
munity,

Having regard to Council Directive 93/43/EEC of 14 June 1993
on the hygiene of foodstuffs (1), and in particular Article 3(3)
thereof,

Whereas:

(1)

(2)

(3)

(4)

(5)

It is necessary to amend Commission Directive 96/3/EC
of 26 January 1996 granting a derogation from certain
provisions of Council Directive 93/43/EEC on the
hygiene of foodstuffs as regards the transport of bulk
liquid oils and fats by sea (2), in order to take account of
scientific developments.

On the basis of evaluations carried out by the Scientific
Committee on Food and, in particular, of its opinion of
20 September 1996, as amended on 12 June 1997
(107th plenary meeting), and the updated opinion of 4
April 2003 on the potential risk to human health arising
from the transport in ships' tanks of oils and fats from
substances proposed as acceptable previous cargoes, it is
necessary to amend the list of acceptable previous
cargoes set out in the Annex to Directive 96/3/EC.

In the case of cyclohexanol, 2,3-butanediol, iso-butanol
and nonane, the information available was inadequate or
needed additional clarification to allow a sound scientific
assessment of the toxicological properties and the Scien-
tific Committee on Food was unable to carry out the
requested evaluations. These substances were considered
by the Scientific Committee on Food not acceptable as
previous cargoes and therefore should be removed from
the list of acceptable previous cargoes.

In the case of methyl esters of fatty acids (laurate, palmi-
tate, stearate, oleate), acetic anhydride, ammonium poly-
phosphate, propylene tetramer, propyl alcohol, sodium
silicate, in view of data available, the assessment of the
Scientific Committee on Food has resulted in the accep-
tance of these substances as previous cargoes. These
substances should be therefore added to the list of accep-
table previous cargoes.

iso-decanol,

iso-nonanol,

In the case of
iso-octanol,
montan wax, paraffin wax and white mineral oils the
information available was inadequate to carry out a
complete evaluation. However, according to the opinion
of the Scientific Committee on Food, these substances

(1) OJ L 175, 19.7.1993, p. 1.
(2) OJ L 21, 27.1.1996, p. 42.

considered as provisionally acceptable

as
may be
previous cargoes considering their unlikely genotoxic
potential, their easy removal by tank cleaning procedures
and the very low residues expected as a result of these
factors and their likely dilution.

These provisionally acceptable substances should be
reassessed on the basis of new scientific data and the
Annex reviewed as appropriate within an adequate
period of time. The data needed for the above evaluation
should be provided, in particular, by relevant food busi-
ness operators.

The measures provided for in this Directive are in
accordance with the opinion of the Standing Committee
on the Food Chain and Animal Health,

(6)

(7)

HAS ADOPTED THIS DIRECTIVE:

Article 1

The Annex to Directive 96/3/EC is replaced by the Annex
hereto.

Article 2

iso-nonanol, iso-octanol, montan
The substances iso-decanol,
wax, paraffin wax and white mineral oils, shall be reassessed on
the basis of new scientific data and the Annex reviewed as
appropriate by 31 December 2006.

Article 3

Member States shall bring into force the laws, regulations and
administrative provisions necessary to comply with this Direc-
tive by 1 June 2004 at the latest. They shall forthwith inform
the Commission thereof.

When Member States adopt those provisions, they shall contain
a reference to this Directive or be accompanied by such a refer-
ence on the occasion of their official publication. Member
States shall determine how such reference is to be made.

Article 4

This Directive shall enter into force on the 20th day following
that of its publication in the Official Journal of the European
Union.

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This Directive is addressed to the Member States.

Article 5

Done at Brussels, 15 January 2004.

For the Commission

David BYRNE

Member of the Commission

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ANNEX

‘ANNEX

LIST OF ACCEPTABLE PREVIOUS CARGOES

Substance (synonyms)

CAS No

Acetic acid

Acetic anhydride (ethanoic anhydride)

Acetone (dimethylketone; 2-propanone)

64-19-7

108-24-7

67-64-1

Acid oils and fatty acid distillates — from vegetable oils and fats and/or mixtures thereof and animal and marine fats
and oils

Ammonium hydroxide (ammonium hydrate; ammonia solution; aqua ammonia)

1336-21-6

Ammonium polyphosphate

68333-79-9
10124-31-9

Animal, marine and vegetable and hydrogenated oils and fats (other than cashew shell nut and crude tall oil)

Beeswax (white and yellow)

Benzyl alcohol (pharmaceutical and reagent grades only)

Butyl acetates (n-; sec-; tert-)

8006-40-4
8012-89-3

100-51-6

123-86-4
105-46-4
540-88-5

Calcium chloride solution is acceptable as a previous cargo only where the immediate
previous cargo to it is on the list and is not similarly restricted.

10043-52-4

Calcium lignosulphonate

Candelilla wax

Carnauba wax — (Brazil wax)

Cyclohexane (hexamethylene; hexanaphthene; hexalhydrobenzene)

8061-52-7

8006-44-8

8015-86-9

110-82-7

Epoxidised soyabean oil (with a minimum 7 % — maximum 8 % oxirane oxygen content) 8013-07-8

Ethanol (ethyl alcohol)

Ethyl acetate (acetic ether, acetic ester, vinegar naphtha)

2-Ethylhexanol (2-ethylhexyl alcohol)

Fatty acids:

Arachidic acid (eicosanoic acid)

Behenic acid (docosanoic acid)

64-17-5

141-78-6

104-76-7

506-30-9

112-85-6

Butyric acid (n-butyric acid; butanoic acid; ethyl acetic acid; propyl formic acid)

107-92-6

Capric acid (n-decanoic acid)

Caproic acid (n-hexanoic acid)

334-48-5

142-62-1

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Substance (synonyms)

CAS No

Caprylic acid (n-octanoic acid)

Erucic acid (cis-13-docosenoic acid)

Heptoic acid (n-heptanoic acid)

Lauric acid (n-dodecanoic acid)

Lauroleic acid (dedecenoic acid)

Linoleic acid (9,12-octadecadienoic acid)

Linolenic acid (9,12,15-octadecatrienoic acid)

Myristic acid (n-tetradecanoic acid)

Myristoleic acid (n-tetradecenoic acid)

Oleic acid (n-octadecenoic acid)

Palmitic acid (n-hexadecanoic acid)

Palmitoleic acid (cis-9-hexadecenoic acid)

Pelargonic acid (n-nonanoic acid)

Ricinoleic acid (cis-12-hydroxy octadec-9-enoic acid; castor oil acid)

Stearic acid (n-octadecanoic acid)

Valeric acid (n-pentanoic acid; valerianic acid)

Fatty alcohols:

Butyl alcohol (1-Butanol; butyric alcohol)

Caproyl alcohol (1-hexanol; hexyl alcohol)

Capryl alcohol (1-n-octanol; heptyl carbinol)

124-07-2

112-86-7

111-14-8

143-07-7

4998-71-4

60-33-3

463-40-1

544-63-8

544-64-9

112-80-1

57-10-3

373-49-9

112-05-0

141-22-0

57-11-4

109-52-4

71-36-3

111-27-3

111-87-5

Cetyl alcohol (alcohol C-16; 1-hexadecanol; cetylic alcohol; palmityl alcohol, n-primary
hexadecyl alcohol)

36653-82-4

Decyl alcohol (1-decanol)

Enanthyl alcohol (1-heptanol; heptyl alcohol)

Lauryl alcohol (n-dodecanol; dodecyl alcohol)

Myristyl alcohol (1-tetradecanol; tetradecanol)

Nonyl alcohol (1-nonanol; pelargonic alcohol; octyl carbinol)

Oleyl alcohol (octadecenol)

Stearyl alcohol (1-octadecanol)

Tridecyl alcohol (1-tridecanol)

Fatty alcohol blends:

Lauryl myristyl alcohol (C12-C14)

Cetyl stearyl alcohol (C16-C18)

112-30-1

111-70-6

112-53-8

112-72-1

143-08-8

143-28-2

112-92-5

27458-92-0
112-70-9

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Substance (synonyms)

CAS No

Fatty acids esters — any ester produced by the combination of the above listed fatty acids with any of the above listed
fatty alcohols. Examples of these are butyl myristrate, oleyl palmitate and cetyl stearate

Fatty acid methyl esters:

Methyl laurate (methyl dodecanoate)

Methyl palmitate (methyl exadecanoate)

Methyl stearate (methyl octadecanoate)

Methyl oleate (methyl octadecenoate)

Glycols:

Butanediol

1,3 butanediol (1.3 butylene glycol)

1,4 butanediol (1.4 butylene glycol)

Polypropylene glycol (molecular weight greater than 400)

111-82-0

112-39-0

112-61-8

112-62-9

107-88-0

110-63-4

25322-69-4

Propylene glycol (1.2 propylene glycol; propan-1.2-diol; 1.2-dihidroxypropane; mono-
propylene glycol (MPG); methyl glycol)

57-55-6

1.3-Propylene glycol (trimethylene glycol; 1.3-propanediol)

n-Heptane

n-Hexane (technical grades)

iso-Butyl acetate

iso-Decanol (isodecyl alcohol)

iso-Nonanol (isononyl alcohol)

iso-Octanol (isooctyl alcohol)

Magnesium chloride solution

Methanol (methyl alcohol)

Methyl ethyl ketone (2-butanone)

Methyl isobutyl ketone (4-methyl-2pentanone)

Methyl tertiary butyl ether (MBTE)

Molasses

Montan wax

Paraffin wax

Pentane

Phosphoric acid (ortho phosphoric acid)

504-63-2

142-82-5

110-54-3
64742-49-0

110-19-0

25339-17-7

27458-94-2

26952-21-6

7786-30-3

67-56-1

78-93-3

108-10-1

1634-04-4

57-50-1

8002-53-7

8002-74-2
63231-60-7

109-66-0

7664-38-2

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Substance (synonyms)

CAS No

Potable water is acceptable as a previous cargo only where the immediate previous cargo to it is on the list and is not
similarly restricted

Potassium hydroxide (caustic potash)
immediate previous cargo to it is on the list and is not similarly restricted

is acceptable as a previous cargo only where the

1310-58-3

n-Propyl acetate

Propylene tetramer

Propyl alcohol (propane-1-ol; 1-propanol)

Sodium hydroxide (caustic soda) is acceptable as a previous cargo only where the immediate
previous cargo to it is on the list and is not similarly restricted

Silicon dioxide (microsilica)

Sodium silicate (water glass)

Sorbitol (D-sorbitol; hexahydric alcohol; D-sorbite)

Sulphuric acid

Urea ammonia nitrate solution (UAN)

109-60-4

6842-15-5

71-23-8

1310-73-2

7631-86-9

1344-09-8

50-70-4

7664-93-9

Wine lees (vinasses, vinaccia, argol, vini, argil, arcilla, weinstein, crude cream of tartare,
crude potassium bitartrate)

868-14-4

White mineral oils

8042-47-5’