I
(Acts who publication is obligatory)
COMMISSION DIRECTIVE2006/141/EC
of22December2006
on infant formulae and follow-on formulae and amending Directive1999/21/EC
(Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive89/398/EEC of3May1989 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional us(1),and in particular Article4(1)thereof,
After consulting the European Food Safety Authority(the Authority),
Whereas:
(1)Directive89/398/EEC concerns foodstuffs intended for
particular nutritional us.The specific provisions
applicable to certain groups of foods for particular nu-
tritional us are laid down by specific Directives.
(2)Commission Directive91/321/EEC of14May1991on
infant formulae and follow-on formulae(2)is a specific
Directive adopted pursuant to Directive89/398/EEC.
That Directive has been substantially amended veral
times(3).Since further amendments are to be made,it
should be recast in the interests of clarity.
(3)In the light of discussions in international fora,in
particular Codex Alimentarius,in relation to the timing
of the introduction of complementary foods into the diet
of infants,it is appropriate to amend the current defi-
nitions of infant formulae and follow-on formulae and
certain provisions on the labelling of follow-on formulae
in Directive91/321/EEC.
(4)Infant formula is the only procesd foodstuff which
wholly satisfies the nutritional requirements of infants
during the first months of life until the introduction of
appropriate complementary feeding.In order to
safeguard the health of such infants it is necessary to
ensure that the only products marketed as suitable for
such u during the period would be infant formulae.
(5)The esntial composition of infant formulae and follow-
on formulae must satisfy the nutritional requirements of
infants in good health as established by generally
accepted scientific data.
(6)The requirements concerning the esntial composition
of infant formulae and follow-on formulae should
include detailed provisions on the protein content.
Notwithstanding that traditionally different appropriate
conversion factors have been ud for the calculation
of the protein content from the nitrogen content of
different protein sources,recent scientific advice
indicates that for the specific purpos of calculating
the protein content of infant formulae and follow-on
formulae it is appropriate to u a single conversion
factor adapted to the products.As infant formulae
and follow-on formulae are sophisticated products that
are specially formulated for their intended purpo,ad-
ditional esntial requirements on protein,including
minimum and maximum levels of protein and
minimum levels of certain amino acids,should be estab-
lished.The protein requirements specified in this
Directive should relate to the final products as such,
prepared ready for consumption.
(1)OJ L186,30.6.1989,p.27.Directive as last amended by Regulation
(EC)No1882/2003of the European Parliament and of the Council (OJ L284,31.10.2003,p.1).
(2)OJ L175,4.7.1991,p.35.Directive as last amended by the2003
Act of Accession.
(3)See Annex X,Part A.
(7)On the basis of such data,the esntial composition of
infant formulae and follow-on formulae manufactured
from cows'milk proteins and soya proteins alone or in
a mixture,as well as infant formulae bad on protein
hydrolysates,can already be defined.The same is not true
for preparations bad wholly or partly on other sources
of protein.For this reason specific rules for such
products,if necessary,should be adopted at a later date.
(8)It is important that ingredients ud in the manufacture
相声稿of infant formulae and follow-on formulae are suitable
for the particular nutritional u by infants and that their
suitability has been demonstrated,when necessary,by
appropriate studies.Guidance on the design and
conduct of appropriate studies has been published by
expert scientific groups such as the Scientific
Committee on Food,the UK Committee on the Medical
Aspects of Food and Nutrition Policy,and the European
Society for Paediatric Gastroenterology,Hepatology and
Nutrition.Such guidance should be taken into con-
sideration when ingredients are introduced into infant
formulae or follow-on formulae.
(9)A number of the substances that may be ud in the
manufacture of infant formulae and follow-on formulae
may also be ud in foodstuffs as food additives.In that
context,purity criteria have already been or are to be
adopted at Community level in accordance with
Council Directive89/107/EEC of21December1988
on the approximation of the laws of the Member
States concerning food additives authorid for u in
飞天汽车foodstuffs intended for human consumption(1).Tho
purity criteria should apply to tho substances
whatever the purpo of their u in foodstuffs.
(10)Pending the adoption of purity criteria for substances for
which such criteria have not yet been adopted at
Community level,and in order to ensure a high level
of protection for public health,generally acceptable
purity criteria recommended by international organ-
isations or agencies,such as the Joint FAO/WHO
Expert Committee on Food Additives(JECFA)or
European Pharmacopoeia(EUP),should apply.In
addition,Member States should be permitted to
maintain national rules tting stricter purity criteria.(11)Given the particular nature of infant formula,additional
means to tho usually available to monitoring bodies
should be available in order to facilitate efficient moni-
toring of tho products.
(12)Infant formulae bad on protein hydrolysates are
distinct from mi-elemental diet products bad on
high degree hydrolysates ud for the dietary
management of diagnod medical conditions,which
are not covered by this Directive.
(13)This Directive reflects current knowledge about the
products concerned.Any amendment,to allow inno-
vation bad on scientific and technical progress,
should be decided by the procedure referred to in
Article13(2)of Directive89/398/EEC.
(14)Maximum levels for pesticide residues t out in relevant
Community legislation,in particular Council Directive
76/895/EEC of23November1976relating to the
fixing of maximum levels for pesticide residues in and
on fruit and vegetables(2),in Council Directive
86/362/EEC of24July1986on the fixing of
maximum levels for pesticide residues in and on
cereals(3),in Council Directive86/363/EEC of24July
1986on the fixing of maximum levels for pesticide
residues in and on foodstuffs of animal origin(4),and
in Council Directive90/642/EEC of27November
1990on the fixing of maximum levels for pesticide
residues in and on certain products of plant origin,
including fruit and veg-
etables(5),should apply without prejudice to specific
provisions t out in this Directive.
(15)Taking into account the Community’s international obli-
gations,in cas where the relevant scientific evidence is
insufficient,the precautionary principle referred to in
Article7of Regulation(EC)No178/2002of the
European Parliament and of the Council of28January
2002laying down the general principles and
requirements of food law,establishing the European
Food Safety Authority and laying down procedures in
matters of food safety(6)allows the Community to pro-
visionally adopt measures on the basis of available
pertinent information,pending an additional asssment
of risk and a review of the measure within a reasonable
period of time.
(1)OJ L40,11.2.1989,p.27.Directive as last amended by Regulation
(EC)No1882/2003.(2)OJ L340,9.12.1976,p.26.Directive as last amended by
Commission Directive2006/92/EC(OJ L311,10.11.2006,p.31).
(3)OJ L221,7.8.1986,p.37.Directive as last amended by Directive
2006/92/EC.
乏味的英语
(4)OJ L221,7.8.1986,p.43.Directive as last amended by
Commission Directive2006/62/EC(OJ L206,27.7.2006,p.27).
(5)OJ L350,14.12.1990,p.71.Directive as last amended by Directive
2006/92/EC.
(6)OJ L31,1.2.2002,p.1.Regulation as last amended by Commission
Regulation(EC)No575/2006(OJ L100,8.4.2006,p.3).
(16)On the basis of the two opinions given by the Scientific
Committee for Food on19September1997and4June
1998,there are at prent doubts as to the adequacy of
existing acceptable daily intake(ADI)values of pesticides
and pesticide residues for the protection of the health of
infants and young children.Therefore,as far as foodstuffs
for particular nutritional us intended for infants and
young children are concerned,it is appropriate to
adopt a very low common limit for all pesticides.This
very low common limit should be fixed at0,01mg/kg
which normally is in practice the minimum detectable
level.
(17)Severe limitations on pesticide residues should be
required.With careful lection of raw materials,and
given that infant formulae and follow-on formulae
undergo extensive processing during their manufacture,
it is feasible to produce products containing very low
levels of pesticide residues.However,in the ca of a
small number of pesticides or metabolites of pesticides
even a maximum residue level of0,01mg/kg might,
under worst-ca intake conditions,allow infants and
young children to exceed the ADI.This is the ca for
pesticides or metabolites of pesticides with an ADI lower
than0,0005mg/kg body weight.
(18)This Directive should establish the principle of the pro-
hibition of the u of the pesticides in the production
of agricultural products intended for infant formulae and
follow-on formulae.However,this prohibition does not
necessarily guarantee that products are free from such
pesticides,since some pesticides contaminate the en-
vironment and their residues may be found in the
products concerned.
(19)Most of the pesticides which have ADI values lower than
0,0005mg/kg body weight are already prohibited in the
Community.The prohibited pesticides should not be
detectable in infant formulae and follow-on formulae
by state-of-the-art analytical methods.However,some
pesticides degrade slowly and still contaminate the en-
vironment.They might be prent in infant formulae and
follow-on formulae even if they have not been ud.For
the purpos of control,a harmonid approach should
be followed.
(20)Pending Commission decisions on whether they satisfy
the safety requirements of Article5of Council Directive
91/414/EEC of15July1991concerning the placing of
plant protection products on the market(1),the
continued u of authorid pesticides should be
permitted as long as their residues comply with the
maximum residue levels established in this Directive.
The latter should be t at levels ensuring that their
respective ADI values are not exceeded by infants and
young children under worst-ca intake conditions.(21)The Annexes to this Directive dealing with pesticides
should be amended following the completion of the
review programme being carried out under Directive
91/414/EEC.
(22)Pursuant to Article7(1)of Directive89/398/EEC,the
products covered by this Directive are subject to the
general rules laid down by Directive2000/13/EC of the
European Parliament and of the Council of20March
2000on the approximation of the laws of the Member
States relating to the labelling,prentation and adver-
tising of foodstuffs(2).This Directive adopts and expands
upon the additions and exceptions to tho general rules,
where it is appropriate,in order to promote and protect
breast feeding.
(23)In particular,the nature and destination of the products
covered by this Directive require nutritional labelling
showing the energy value and principal nutrients they
contain.On the other hand,the method of u should
be specified in accordance with point9of Article3(1)
and Article11(2)of Directive2000/13/EC,in order to
prevent inappropriate us likely to be detrimental to the
health of infants.
(24)Given the nature of infant formulae and follow-on
formulae the detailed rules as to nutrient declaration
on the labelling need to be clarified in order to avoid
any problems which may ari from the application of
other relevant Community legislation.
(25)Regulation(EC)No1924/2006of the European
Parliament and of the Council of20December2006
on nutrition and health claims made on food(3)estab-
lishes the rules and conditions for the u of nutrition
and health claims concerning foods.However,Article
1(5)of that Regulation states that it shall apply
without prejudice to,in particular,Directive
89/398/EEC and directives adopted relating to foodstuffs
for particular nutritional us.
(26)It is appropriate to t out specific conditions for the u
of nutrition and health claims concerning infant formulae
in this Directive.In this respect,it is necessary,in order
to supply objective and scientifically verified information,
to define the conditions under which nutrition and
health claims are authorid,and to establish a list of
authorid claims.In accordance with the third sub-
paragraph of Article4(1)of Directive89/398/EEC,modi-
fication of that list of nutrition and health claims should
be adopted,when necessary,after consultation of the
Authority.
(1)OJ L230,19.8.1991,p. 1.Directive as last amended by
Commission Directive2006/85/EC(OJ L293,24.10.2006,p.3).(2)OJ L109,6.5.2000,p.29.Directive as last amended by Directive
2003/89/EC(OJ L308,25.11.2003,p.15).
(3)OJ L404,30.12.2006,p.9.
(27)In an effort to provide better protection for the health of
infants,the rules of composition,labelling and adver-
tising laid down in this Directive should be in conformity
with the principles and the aims of the International
Code of Marketing of Breast-milk Substitutes adopted
by the34th World Health Asmbly,bearing in mind
the particular legal and factual situations existing in the
Community.
(28)Given the important role which information on infant
feeding plays in choosing,by pregnant women and
mothers of infants,the type of nourishment provided
to their children,it is necessary for Member States to
take appropriate measures in order that this information
ensures an adequate u of the products in question and
is not counter to the promotion of breast feeding.
(29)This Directive does not concern the conditions of sale of
publications specialising in baby care and of scientific
publications.
(30)Commission Directive1999/21/EC of25March1999
on dietary foods for special medical purpos(1)lays
down compositional and labelling requirements for
dietary foods for special medical purpos.The Annex
to that Directive ts out values for minerals in nu-
tritionally complete foods intended for u by infants.
There has been new scientific advice as regards the
minimum level of mangane in foods intended for
infants.Therefore,it is appropriate to amend the levels
of mangane in dietary foods for special medical
purpos intended for infants t out in that Annex.
Directive1999/21/EC should therefore be amended
accordingly.
(31)Due to the specific nature of dietary foods for special
medical purpos intended for infants and to the
necessity to asss the new formulation of such
products,manufacturers require a longer period to
adapt their products to the esntial composition that
derive from the new requirements t out in this
Directive.
(32)The obligation to transpo this Directive into national
law should be confined to tho provisions which
reprent a substantive change as compared with the
earlier Directive.The obligation to transpo the
provisions which are unchanged aris under the earlier
Directive.(33)This Directive should be without prejudice to the obli-
gations of the Member States relating to the time limits
for transposition into national law of the Directives t
out in Annex X,Part B.
垂直地带性
(34)The measures provided for in this Directive are in
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health, HAS ADOPTED THIS DIRECTIVE:
Article1
This Directive is a‘specific Directive’within the meaning of Article4(1)of Directive89/398/EEC and lays down composi-tional and labelling requirements for infant formulae and follow-on formulae intended for u by infants in good health in the Community.
It also provides for Member States to give effect to principles and aims of the International Code of Marketing of Breast-milk Substitutes dealing with marketing,information and responsi-bilities of health authorities.
Article2
For the purpos of this Directive,the definitions of‘claim’,‘nutrition claim’,‘health claim’and‘reduction of dia risk claim’in Article2(2)(1),(4),(5)and(6)of Regulation(EC) No1924/2006shall apply.
The following definitions shall also apply:
(a)‘infants’means children under the age of12months;
(b)‘young children’means children aged between one and three
years;
梦想的诗句(c)‘infant formulae’means foodstuffs intended for particular
nutritional u by infants during the first months of life and satisfying by themlves the nutritional requirements of such infants until the introduction of appropriate complementary feeding;
(1)OJ L91,7.4.1999,p.29.Directive as amended by the2003Act of
Accession.
(d)‘follow-on formulae’means foodstuffs intended for
particular nutritional u by infants when appropriate complementary feeding is introduced and constituting the principal liquid element in a progressively diversified diet of such infants;
(e)‘pesticide residue’means the residue in infant formulae and
follow-on formulae of a plant protection product,as defined in point1of Article2of Directive91/414/EEC,including its metabolites and products resulting from its degradation or reaction.
Article3
Infant formulae and follow-on formulae may be marketed within the Community only if they comply with this Directive.
No product other than infant formula may be marketed or otherwi reprented as suitable for satisfying by itlf the nutritional requirements of normal healthy infants during the first months of life until the introduction of appropriate complementary feeding.
Article4
Infant formulae and follow-on formulae shall not contain any substance in such quantity as to endanger the health of infants and young children.
Article5
Infant formulae shall be manufactured from protein sources defined in point2of Annex I and other food ingredients,as the ca may be,who suitability for particular nutritional u by infants from birth has been established by generally accepted scientific data.
Such suitability shall be demonstrated through a systematic review of the available data relating to the expected benefits and to safety considerations as well as,where necessary,appro-priate studies,performed following generally accepted expert guidance on the design and conduct of such studies.
小镇的英文Article6
Follow-on formulae shall be manufactured from protein sources defined in point2of Annex II and other food ingredients,as the ca may be,who suitability for particular nutritional u by infants aged over six months has been established by generally accepted scientific data.
Such suitability shall be demonstrated through a systematic review of the available data relating to the expected benefits and to safety considerations as well as,where necessary,appro-priate studies,performed following generally accepted expert guidance on the design and conduct of such studies.
Article7
1.Infant formulae shall comply with the compositional criteria t out in Annex I taking into account the specifications in Annex V.
In the ca of infant formulae manufactured from cows’milk proteins defined in point2.1of Annex I with a protein content between the minimum and0,5g/100kJ(2g/100kcal),the suitability of the infant formula for the particular nutritional u by infants shall be demonstrated through appropriate studies, performed following generally accepted expert guidance on the design and conduct of such studies.
In the ca of infant formulae manufactured from protein hydrolysates defined in point2.2of Annex I with a protein content between the minimum and0,56g/100kJ(2,25 g/100kcal),the suitability of the infant formula for the particular nutritional u by infants shall be demonstrated through appropriate studies,performed following generally accepted expert guidance on the design and conduct of such studies and shall be in accordance with the appropriate specifi-cations t out in Annex VI.
2.Follow-on formulae shall comply with the compositional criteria t out in Annex II taking into account the specifications t out in Annex V.
3.In order to make infant formulae and follow-on formulae ready for u,nothing more shall be required,as the ca may be,than the addition of water.
4.The prohibitions and limitations on the u of food in-gredients in infant formulae and follow-on formulae t out in Annexes I and II shall be obrved.
硬币价值
Article8
1.Only the substances listed in Annex III may be ud in the manufacture of infant formulae and follow-on formulae in order to satisfy the requirements on:
(a)mineral substances;
小孩退烧最快的方法(b)vitamins;
(c)amino acids and other nitrogen compounds;
(d)other substances having a particular nutritional purpo.
