Commission Regulation (EC) No 208/2005 of 4 February 2005 amending Regulation (EC) No 466/2001 as regards polycyclic aromatic hydrocarbonsText with EEA relevance
Date: 2005-02-04
Institutions: European Commission
Subjects: baby food, consumer protection, flavouring, food standard, foodstuff, public health, toxic substance

8.2.2005

EN

Official Journal of the European Union

L 34/3

COMMISSION REGULATION (EC) No 208/2005

of 4 February 2005

amending Regulation (EC) No 466/2001 as regards polycyclic aromatic hydrocarbons

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(4)

Having regard to the Treaty
Community,

establishing the European

Having regard to Council Regulation (EEC) No 315/93 of 8
February 1993 laying down Community procedures
for
contaminants in food (1), and in particular Article 2(3) thereof,

After consulting the Scientific Committee on Food,

Whereas:

(1)

(2)

(3)

Commission Regulation (EC) No 466/2001 (2)
sets
maximum levels for certain contaminants in foodstuffs,
including foods intended for infants and young children,
as described by Commission Directive 91/321/EEC of 14
May 1991 on infant formula and follow-on formula (3)
and Commission Directive 96/5/EC of 16 February 1996
on processed cereal-based foods and baby foods for
infants and young children (4).

Some Member States have adopted maximum levels for
polycyclic aromatic hydrocarbons (PAH) in certain foods.
In view of the disparities between Member States and the
consequent risk of distortion of competition, Community
measures are necessary in order to ensure market unity
whilst abiding by the principle of proportionality.

In laboratory studies

found to induce experimental

The Scientific Committee on Food concluded in its
opinion of 4 December 2002 that a number of PAH
are genotoxic carcinogens.
the
tumours were
levels
several fold higher than those expected to be found in
food and consumed. However,
the non-
threshold effects of genotoxic substances the levels of
PAH in foods should be reduced to as low as reasonably
achievable.

in view of

(1) OJ L 37, 13.2.1993, p. 1. Regulation as amended by Regulation (EC)
No 1882/2003 of the European Parliament and of the Council (OJ
L 284, 31.10.2003, p. 1).

(2) OJ L 77, 16.3.2001, p. 1. Regulation as last amended by Regulation

(EC) No 684/2004 (OJ L 106, 15.4.2004, p. 6).

(3) OJ L 175, 4.7.1991, p. 35. Directive as last amended by Directive

2003/14/EC (OJ L 41, 14.2.2003, p. 37).

(4) OJ L 49, 28.2.1996, p. 17. Directive as last amended by Directive

2003/13/EC (OJ L 41, 14.2.2003, p. 33).

(5)

(6)

(7)

for

to the

can be used as a marker

Scientific Committee on Food,
According
the
benzo(a)pyrene
occurrence and effect of carcinogenic PAH in food,
including also benz(a)anthracene, benzo(b)fluoranthene,
benzo(j)fluoranthene, benzo(k)fluoranthene, benzo(g,h,i)-
perylene, chrysene, cyclopenta(c,d)pyrene, dibenz(a,h)an-
thracene, dibenzo(a,e)pyrene, dibenzo(a,h)pyrene, diben-
zo(a,i)pyrene, dibenzo(a,l)pyrene,
indeno(1,2,3-cd)pyrene
and 5-methylchrysene. Further analyses of the relative
proportions of these PAH in foods would be necessary
to inform a future review of the suitability of maintaining
benzo(a)pyrene as a marker.

PAH can contaminate foods during heating and drying
processes that allow combustion products to come into
direct contact. Direct fire-drying and heating processes
used during the production of food oils, for example
olive pomace oil, can result
in high levels of PAH.
Active carbon can be used to remove benzo(a)pyrene
during the refining of oils. Whether refining processes
concern is unclear.
effectively remove all PAH of
should be used
Production and processing methods
which prevent the initial contamination of oils with PAH.

In order to protect public health, maximum levels are
necessary for benzo(a)pyrene in certain foods containing
fats and oils and in foods where smoking or drying
processes might cause high levels of contamination.
Separate lower maximum levels are necessary in foods
for infants, which are achievable through the strictly
infant
controlled manufacturing
and packaging of
and
formulae,
foods
baby
processed cereal-based foods
infants and young
children. Maximum levels are also necessary in foods
where environmental pollution may cause high levels
of contamination,
in fish and fishery
for example resulting from oil spills caused
products,
by shipping.

formulae,
for

in particular

follow-on

foods,

such as dried fruits

In some
and food
supplements, benzo(a)pyrene has been found, but
levels are
available data are inconclusive on what
reasonably achievable. Further investigation is needed to
clarify the levels that are reasonably achievable in these
foods. In the meantime, maximum levels for benzo(a)-
pyrene in relevant ingredients should apply, such as in
oils and fats used in food supplements.

L 34/4

EN

Official Journal of the European Union

8.2.2005

(8)

(9)

Regulation (EC) No 466/2001 should be amended
accordingly.

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

opinion

the

the

of

HAS ADOPTED THIS REGULATION:

Article 1

Annex I to Regulation (EC) No 466/2001 is amended as set out
in the Annex to this Regulation.

Article 2

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

It shall apply from 1 April 2005.

This regulation shall not apply to products placed on the
market before 1 April 2005 in conformity with the provisions
applicable. The burden of proving when the products were
placed on the market shall be borne by the food business
operator.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 4 February 2005.

For the Commission

Markos KYPRIANOU
Member of the Commission

8.2.2005

EN

Official Journal of the European Union

L 34/5

ANNEX

In Annex I to Regulation (EC) No 466/2001 the following Section 7 is added:

‘Section 7: Polycyclic aromatic hydrocarbons (PAH)

Product

Maximum level
(μg/kg wet
weight)

Performance criteria
for sampling

Performance criteria for
methods of analysis

7.1.

Benzo(a)pyrene (1)

7.1.1.

Oils and fats intended for direct human
consumption or use as an ingredient in
foods (2)

7.1.2.

Foods for infants and young children

7.1.2.1. Baby foods and processed cereal-based
foods for infants and young children (3)

7.1.2.2.

Infant formulae and follow-on formulae,
including infant milk and follow-on
milk (4)

7.1.2.3. Dietary

foods

for

purposes (5)
infants

intended

special medical
for
specifically

7.1.3.

7.1.4.

7.1.5.

7.1.6.

Smoked meats
products

and

smoked meat

Muscle meat of smoked fish and smoked
fishery products (6),
excluding bivalve
molluscs

Muscle meat of
smoked fish

fish (7), other

than

Crustaceans,
smoked

cephalopods, other

than

2,0

Directive 2005/10/EC (*)

Directive 2005/10/EC

1,0

Directive 2005/10/EC

Directive 2005/10/EC

5,0

Directive 2005/10/EC

Directive 2005/10/EC

5,0

Directive 2005/10/EC

Directive 2005/10/EC

2,0

5,0

Directive 2005/10/EC

Directive 2005/10/EC

Directive 2005/10/EC

Directive 2005/10/EC

7.1.7.

Bivalve molluscs

10,0

Directive 2005/10/EC

Directive 2005/10/EC

(*) See page 15 of this Official Journal.
(1) Benzo(a)pyrene, for which maximum levels are listed,

is used as a marker for the occurrence and effect of carcinogenic PAH. These
measures therefore provide full harmonisation on PAH in the listed foods across the Member States. The Commission shall review the
maximum levels for PAH in the listed food categories by 1 April 2007, taking into account the progress in scientific and technological
knowledge on the occurrence of benzo(a)pyrene and other carcinogenic PAH in food.

(2) Cocoa butter is excluded from this category whilst investigations into the presence of benzo(a)pyrene in cocoa butter are made. This

derogation will be reviewed by 1 April 2007.

(3) Baby foods and processed cereal-based foods for infants and young children as defined in Article 1 of Directive 96/5/EC. The maximum

level refers to the product as sold.
(4)
Infant formulae and follow-on formulae as defined in Article 1 of Directive 91/321/EEC. The maximum level refers to the product as sold.
(5) Dietary foods for special medical purposes as defined in Article 1(2) of Directive 1999/21/EC. The maximum level refers to the product as

sold.

(6) Fish and fishery products as defined in the categories (b), (c), and (f) of the list in Article 1 of Regulation (EC) No 104/2000.
(7) Fish as defined in the category (a) of the list in Article 1 of Regulation (EC) No 104/2000.’