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Document 02003R1831-20210327
Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (Text with EEA relevance)Text with EEA relevance
Consolidated text: Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (Text with EEA relevance)Text with EEA relevance
Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (Text with EEA relevance)Text with EEA relevance
02003R1831 — EN — 27.03.2021 — 009.001
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REGULATION (EC) No 1831/2003 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 22 September 2003 on additives for use in animal nutrition (OJ L 268 18.10.2003, p. 29) |
Amended by:
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Official Journal |
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No |
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date |
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L 59 |
8 |
5.3.2005 |
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L 118 |
66 |
13.5.2009 |
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REGULATION (EC) No 596/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 18 June 2009 |
L 188 |
14 |
18.7.2009 |
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REGULATION (EC) No 767/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 July 2009 |
L 229 |
1 |
1.9.2009 |
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L 58 |
46 |
3.3.2015 |
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L 324 |
3 |
10.12.2015 |
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L 156 |
1 |
13.6.2019 |
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REGULATION (EU) 2019/1243 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 June 2019 |
L 198 |
241 |
25.7.2019 |
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REGULATION (EU) 2019/1381 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 June 2019 |
L 231 |
1 |
6.9.2019 |
REGULATION (EC) No 1831/2003 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 22 September 2003
on additives for use in animal nutrition
(Text with EEA relevance)
CHAPTER I
SCOPE AND DEFINITIONS
Article 1
Scope
This Regulation shall not apply to:
processing aids;
veterinary medicinal products as defined in Directive 2001/82/EC ( 1 ), with the exception of coccidiostats and histomonostats used as feed additives.
Article 2
Definitions
The following definitions shall also apply:
‘feed additives’ means substances, micro-organisms or preparations, other than feed material and premixtures, which are intentionally added to feed or water in order to perform, in particular, one or more of the functions mentioned in Article 5(3);
‘feed materials’ means products as defined in Article 2(a) of Council Directive 96/25/EC of 29 April 1996 on the circulation of feed materials ( 2 );
‘compound feedingstuffs’ means products as defined in Article 2(b) of Directive 79/373/EEC;
‘complementary feedingstuffs’ means products as defined in Article 2(e) of Directive 79/373/EEC;
‘premixtures’ means mixtures of feed additives or mixtures of one or more feed additives with feed materials or water used as carriers, not intended for direct feeding to animals;
‘daily ration’ means the average total quantity of feedingstuffs, calculated on a moisture content of 12 %, required daily by an animal of a given species, age category and yield, to satisfy all its needs;
‘complete feedingstuffs’ means products as defined in Article 2(c) of Council Directive 1999/29/EC of 22 April 1999 on the undesirable substances and products in animal nutrition ( 3 );
‘processing aids’ means any substance not consumed as a feedingstuff by itself, intentionally used in the processing of feedingstuffs or feed materials to fulfil a technological purpose during treatment or processing which may result in the unintentional but technologically unavoidable presence of residues of the substance or its derivatives in the final product, provided that these residues do not have an adverse effect on animal health, human health or the environment and do not have any technological effects on the finished feed;
‘antimicrobials’ means substances produced either synthetically or naturally, used to kill or inhibit the growth of micro-organisms, including bacteria, viruses or fungi, or of parasites, in particular protozoa;
‘antibiotic’ means antimicrobials produced by, or derived from, a micro-organism, which destroys or inhibits the growth of other micro-organisms;
‘coccidiostats’ and ‘histomonostats’ means substances intended to kill or inhibit protozoa;
‘maximum residue limit’ means the maximum concentration of residue resulting from the use of an additive in animal nutrition which may be accepted by the Community as being legally permitted or recognised as acceptable in or on a food;
‘micro-organism’ means: colony-forming micro-organisms.
‘first placing on the market’ means the initial placing on the market of an additive after its manufacture, the import of an additive, or, where an additive has been incorporated into feed without being placed on the market, the first placing on the market of that feed.
CHAPTER II
AUTHORISATION, USE, MONITORING AND TRANSITIONAL MEASURES APPLICABLE FOR FEED ADDITIVES
Article 3
Placing on the market, processing and use
No person shall place on the market, process or use a feed additive unless:
it is covered by an authorisation granted in accordance with this Regulation;
the conditions for use set out in this Regulation, including the general conditions set out in Annex IV, unless otherwise provided for in the authorisation, and in the authorisation of the substance are met; and
the conditions on labelling set out in this Regulation are met.
Article 4
Authorisation
Article 5
Conditions for authorisation
The feed additive shall not:
have an adverse effect on animal health, human health or the environment,
be presented in a manner which may mislead the user,
harm the consumer by impairing the distinctive features of animal products or mislead the consumer with regard to the distinctive features of animal products.
The feed additive shall:
favourably affect the characteristics of feed,
favourably affect the characteristics of animal products,
favourably affect the colour of ornamental fish and birds,
satisfy the nutritional needs of animals,
favourably affect the environmental consequences of animal production,
favourably affect animal production, performance or welfare, particularly by affecting the gastro-intestinal flora or digestibility of feedingstuffs, or
have a coccidiostatic or histomonostatic effect.
Article 6
Categories of feed additives
A feed additive shall be allocated to one or more of the following categories, depending on its functions and properties, in accordance with the procedure set out at Articles 7, 8 and 9:
technological additives: any substance added to feed for a technological purpose;
sensory additives: any substance, the addition of which to feed improves or changes the organoleptic properties of the feed, or the visual characteristics of the food derived from animals;
nutritional additives;
zootechnical additives: any additive used to affect favourably the performance of animals in good health or used to affect favourably the environment;
coccidiostats and histomonostats.
Article 7
Application for authorisation
The Authority shall:
acknowledge receipt of the application, including the particulars and documents referred to in paragraph 3, in writing, to the applicant within 15 days of its receipt, stating the date of receipt;
make any information supplied by the applicant available to the Member States and the Commission;
make public the application and any information supplied by the applicant, in accordance with Article 18.
At the time of application, the applicant shall send the following particulars and documents directly to the Authority:
his name and address;
the identification of the feed additive, a proposal for its classification by category and functional group under Article 6, and its specifications, including, where applicable, purity criteria;
a description of the method of production, manufacturing and intended uses of the feed additive, of the method of analysis of the additive in feed according to its intended use and, where appropriate, of the method of analysis for the determination of the level of residues of the feed additive, or its metabolites, in food;
a copy of the studies which have been carried out and any other material which is available to demonstrate that the feed additive satisfies the criteria laid down in Article 5(2) and (3);
proposed conditions for placing the feed additive on the market, including labelling requirements and, where appropriate, specific conditions for use and handling (including known incompatibilities), use levels in complementary feedingstuffs and animal species and categories for which the feed additive is intended;
a written statement that three samples of the feed additive have been sent by the applicant directly to the Community reference laboratory referred to in Article 21, in accordance with the requirements set out in Annex II;
for additives which, according to the proposal under point (b), do not belong to either category (a) or category (b) referred to in Article 6(1), and for additives falling within the scope of Community legislation relating to the marketing of products consisting of, containing or produced from GMOs, a proposal for post-market monitoring;
a summary containing the information provided under points (a) to (g);
for additives falling within the scope of Community legislation relating to the marketing of products consisting of, containing or produced from GMOs, details of any authorisation granted in accordance with the applicable legislation.
Until such implementing rules are adopted, the application shall be made in accordance with the Annex to Directive 87/153/EEC.
After the Authority has been consulted, further rules for the implementation of this Article may be established.
The Commission is empowered to adopt delegated acts in accordance with Article 21a in order to supplement this Regulation by establishing rules to allow for simplified provisions for the authorisation of additives which have been authorised for use in food.
Other implementing rules may be adopted in accordance with the regulatory procedure referred to in Article 22(2). Those rules should, where appropriate, differentiate between requirements for feed additives in respect of food-producing animals and requirements in respect of other animals, in particular pets.
Article 8
Opinion of the Authority
In order to prepare its opinion, the Authority:
shall verify that the particulars and documents submitted by the applicant are in accordance with Article 7 and undertake an assessment in order to determine whether the feed additive complies with the conditions laid down in Article 5;
shall verify the report of the Community Reference Laboratory.
In the event of an opinion in favour of authorising the feed additive, the opinion shall also include the following elements:
the name and address of the applicant;
the designation of the feed additive including its categorisation and allocation within functional groups provided for in Article 6, its specification, including, where applicable, purity criteria and method of analysis;
depending on the outcome of the assessment, specific conditions or restrictions in relation to handling, post-market monitoring requirements and use, including animal species and categories of animal species for which the additive is to be used;
specific additional requirements for the labelling of the feed additive necessary as a result of conditions and restrictions imposed under (c);
a proposal for the establishment of Maximum Residues Limits (MRLs) in the relevant foodstuffs of animal origin, unless the opinion of the Authority concludes that the establishment of MRLs is not necessary for the protection of consumers or MRLs have already been established in Annex I or III to Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin ( 6 ).
Article 9
Authorisation by the Community
Where the draft is not in accordance with the opinion of the Authority, it shall provide an explanation of the reasons for the differences.
In exceptionally complex cases, the three-month deadline may be extended.
Article 10
Status of existing products
By way of derogation from Article 3, a feed additive which has been placed on the market pursuant to Directive 70/524/EEC and urea and derivatives, an amino acid, salt of an amino acid or analogous substance, which was listed in points 2.1, 3 and 4 of the Annex to Directive 82/471/EEC, may be placed on the market and used in accordance with the conditions specified in Directives 70/524/EEC or 82/471/EEC and their implementing measures, including in particular specific labelling provisions concerning compound feed and feed materials, provided that the following conditions are met:
within one year of the entry into force of this Regulation, persons first placing the feed additive on the market or any other interested parties shall notify this fact to the Commission. At the same time, the particulars mentioned in Article 7(3)(a), (b) and (c) shall be directly sent to the Authority;
within one year of the notification mentioned under (a), the Authority shall, after verification that all the information required has been submitted, notify the Commission that it has received the information required under this Article. The products concerned shall be entered in the Register. Each entry in the Register shall mention the date on which the product concerned was first entered in the Register and, where applicable, the expiry date of the existing authorisation.
Article 11
Phasing out
Article 12
Supervision
Article 13
Modification, suspension and revocation of authorisations
Article 14
Renewal of authorisations
In the case of authorisations not issued to a specific holder, any person who first places the additive on the market or any other interested party may submit the application to the Commission and shall be considered as the applicant.
In the case of authorisations issued to a specific holder, the holder of the authorisation or his legal successor or successors may submit the application to the Commission and shall be deemed to be the applicant.
At the time of application, the applicant shall send the following particulars and documents directly to the Authority:
a copy of the authorisation for placing the feed additive on the market;
a report on the results of the post-market monitoring, if such monitoring requirements are included in the authorisation;
any other new information which has become available with regard to the evaluation of the safety in use of the feed additive and the risks of the feed additive to animals, humans or the environment;
where appropriate, a proposal for amending or supplementing the conditions of the original authorisation, inter alia, the conditions concerning future monitoring.
Article 15
Urgent authorisation
In specific cases where urgent authorisation is needed to ensure the protection of animal welfare, the Commission may, in accordance with the procedure referred to in Article 22(2), provisionally authorise the use of an additive for a maximum period of five years.
CHAPTER III
LABELLING AND PACKAGING
Article 16
Labelling and packaging of feed additives and premixtures
No person shall place on the market a feed additive or a premixture of additives unless its packaging or container is labelled under the responsibility of a producer, packer, importer, seller or distributor established within the Community and bears the following information, in a conspicuous, clearly legible and indelible manner, in at least the national language or languages of the Member State in which it is marketed, in relation to each additive contained in the material:
the specific name given to the additives upon authorisation, preceded by the name of the functional group as mentioned in the authorisation;
the name or business name and the address or registered place of business of the person responsible for the particulars referred to in this Article;
the net weight or, in the case of liquid additives and premixtures, either the net volume or the net weight;
where appropriate, the approval number of the establishment manufacturing or placing on the market the feed additive or the premixture pursuant to Article 10 of Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene ( 9 ) or, as applicable, to Article 5 of Directive 95/69/EC;
directions for use, and any safety recommendations regarding the use and, where applicable, the specific requirements mentioned in the authorisation, including animal species and categories for which the additive or premixture of additives is intended;
the identification number;
the batch reference number and date of manufacture.
In the case of premixtures, points (b), (d), (e) and (g) shall not apply to the incorporated feed additives.
CHAPTER IV
GENERAL AND FINAL PROVISIONS
Article 17
Community Register of Feed Additives
Article 18
Transparency and confidentiality
In addition to the items of information referred to in Article 39(2) of Regulation (EC) No 178/2002 and pursuant to Article 39(3) thereof, the Authority may also grant confidential treatment with respect to the following items of information, where the disclosure of such information is demonstrated by the applicant to potentially harm its interests to a significant degree:
the study plan for studies demonstrating the efficacy of a feed additive in terms of the aims of its intended use as defined in Article 6(1) of, and Annex I to, this Regulation; and
specifications of the impurities of the active substance and the relevant methods of analysis developed internally by the applicant, except for impurities that may have adverse effects on animal health, human health, or the environment.
Article 19
Administrative review
Any decision taken under, or failure to exercise, the powers vested in the Authority by this Regulation may be reviewed by the Commission on its own initiative or in response to a request from a Member State or from any person directly and individually concerned.
For that purpose, a request shall be submitted to the Commission within two months after the day on which the party concerned became aware of the act or omission in question.
The Commission shall take a decision within two months requiring, if appropriate, the Authority to withdraw its decision or to remedy its failure to act within a set time limit.
Article 20
Data protection
Article 21
Reference laboratories
The Community Reference Laboratory and its duties and tasks shall be those laid down in the Annex II.
Applicants for the authorisation of additives shall contribute to supporting the cost of the tasks of the Community Reference Laboratory and the consortium of National Reference Laboratories mentioned in Annex II.
Detailed rules for implementing Annex II shall be adopted in accordance with the regulatory procedure referred to in Article 22(2).
The Commission is empowered to adopt delegated acts in accordance with Article 21a amending Annex II.
Article 21a
Exercise of the delegation
Article 22
Committee procedure
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
▼M8 —————
Article 23
Repeals
Article 24
Penalties
Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive.
Member States shall notify those rules and measures to the Commission at the latest 12 months after the date of publication of this Regulation and shall notify it without delay of any subsequent amendment affecting them.
Article 25
Transitional measures
Article 26
Entry into force
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX I
ADDITIVE GROUPS
1. In the category ‘technological additives’, the following functional groups are included:
preservatives: substances or, when applicable, micro-organisms which protect feed against deterioration caused by micro-organisms or their metabolites;
antioxidants: substances prolonging the storage life of feedingstuffs and feed materials by protecting them against deterioration caused by oxidation;
emulsifiers: substances that make it possible to form or maintain a homogeneous mixture of two or more immiscible phases in feedingstuffs;
stabilisers: substances which make it possible to maintain the physico-chemical state of feedingstuffs;
thickeners: substances which increase the viscosity of feedingstuffs;
gelling agents: substances which give a feedingstuff texture through the formation of a gel;
binders: substances which increase the tendency of particles of feedingstuffs to adhere;
substances for control of radionucleide contamination: substances that suppress absorption of radionucleides or promote their excretion;
anticaking agents: substances that reduce the tendency of individual particles of a feedingstuff to adhere;
acidity regulators: substances which adjust the pH of feedingstuffs;
silage additives: substances, including enzymes or micro-organisms, intended to be incorporated into feed to improve the production of silage;
denaturants: substances which, when used for the manufacture of processed feedingstuffs, allow the identification of the origin of specific food or feed materials;
substances for reduction of the contamination of feed by mycotoxins: substances that can suppress or reduce the absorption, promote the excretion of mycotoxins or modify their mode of action;
hygiene condition enhancers: substances or, when applicable, microorganisms which favourably affect the hygienic characteristics of feed by reducing a specific microbiological contamination;
other technological additives: substances or, when applicable, microorganisms added to feed for a technological purpose and which favourably affect the characteristics of the feed.
2. In the category ‘sensory additives’, the following functional groups are included:
colourants:
substances that add or restore colour in feedingstuffs;
substances which, when fed to animals, add colours to food of animal origin;
substances which favourably affect the colour of ornamental fish or birds;
flavouring compounds: substances the inclusion of which in feedingstuffs increases feed smell or palatability.
3. In the category ‘nutritional additives’, the following functional groups are included:
vitamins, pro-vitamins and chemically well-defined substances having similar effect;
compounds of trace elements;
amino acids, their salts and analogues;
urea and its derivatives.
4. In the category ‘zootechnical additives’, the following functional groups are included:
digestibility enhancers: substances which, when fed to animals, increase the digestibility of the diet, through action on target feed materials;
gut flora stabilisers: micro-organisms or other chemically defined substances, which, when fed to animals, have a positive effect on the gut flora;
substances which favourably affect the environment;
other zootechnical additives;
physiological condition stabilisers: substances or, when applicable microorganisms, which, when fed to animals in good health, favourably affect their physiological condition, including their resilience to stress factors.
ANNEX II
DUTIES AND TASKS OF THE COMMUNITY REFERENCE LABORATORY
1. The Community reference laboratory referred to in Article 21 is the Joint Research Centre of the Commission (JRC).
2. For the duties and tasks set out in this Annex, the CRL may be assisted by a consortium of national reference laboratories.
The CRL shall be responsible for:
the reception, storage and maintenance of the samples of the feed additive sent by the applicant as provided for in Article 7(3)(f);
evaluating the method of analysis of the feed additive, and of other relevant methods of analysis related to it, on the basis of the data provided in the application for authorisation of the feed additive as regards its suitability for official control in accordance with the requirements of the implementing rules referred to in Article 7(4) and (5) and the guidance of the Authority referred to in Article 7(6);
submitting a full evaluation report to the Authority on the results of the duties and tasks referred to in this Annex;
where necessary, the testing of the method(s) of analysis.
3. The CRL shall be responsible for coordination of the validation of the method(s) of analysis of the additive, in accordance with the procedure provided for in Article 10 of Regulation (EC) No 378/2005 ( 12 ). This task may involve the preparation of food or feed test material.
4. The CRL shall provide scientific and technical assistance to the Commission, especially in cases where Member States contest the results of analyses related to the duties and tasks referred to in this Annex, without prejudice to any role defined for it under Articles 11 and 32 of Regulation (EC) No 882/2004 of the European Parliament and of the Council ( 13 ).
5. On request by the Commission, the CRL may also be responsible for conducting special analytical or other related studies in a manner similar to the duties and tasks referred to in point 2. This may be the case, in particular, for existing products notified under Article 10 and included in the Register and for the period until an application for authorisation under Article 10(2) is submitted in accordance with Article 10(2).
6. The CRL shall be responsible for the overall coordination of the consortium of national reference laboratories. The CRL shall ensure that the relevant data concerning the applications are made available to the laboratories.
7. Without prejudice to the responsibilities of the Community reference laboratories laid down in Article 32 of Regulation (EC) No 882/2004, the CRL may create and maintain a database of methods of analysis available for control of feed additives and make it available to official control laboratories from Member States and other interested parties.
ANNEX III
1. SPECIFIC LABELLING REQUIREMENTS FOR CERTAIN ADDITIVES AND FOR PREMIXTURES.
Zootechnical additives, coccidiostats and histomonostats:
Enzymes, in addition to the abovementioned indications:
Micro-organisms:
Nutritional additives:
Technological and sensory additives with the exception of flavouring compounds:
Flavouring compounds:
2. ADDITIONAL LABELLING AND INFORMATION REQUIREMENTS FOR CERTAIN ADDITIVES CONSISTING OF PREPARATIONS AND PREMIXTURES CONTAINING SUCH PREPARATIONS.
Additives belonging to the categories referred to in Article 6(1)(a), (b) and (c) and consisting of preparations:
the indication on the packaging or container of the specific name, the identification number and the level of any technological additive contained in the preparation for which maximum levels are set in the corresponding authorisation;
the following information via any written medium or accompanying the preparation:
Premixtures containing additives belonging to the categories referred to in Article 6(1)(a), (b) and (c) and consisting of preparations:
if appropriate, the indication on the packaging or container that the premixture contains technological additives included in additive preparations, for which maximum levels are set in the corresponding authorisation;
upon request from the purchaser or the user, information on the specific name, the identification number and an indication of the level of technological additives referred to in point (i) of this paragraph included in the additive preparations.
ANNEX IV
GENERAL CONDITIONS OF USE
1. The quantity of additives that also exists in the natural state in certain feed materials shall be calculated so that the total of the elements added and the elements present naturally does not exceed the maximum level provided for in the authorisation Regulation.
2. Mixing of additives shall be permitted only in premixtures and feedingstuffs where there is physico-chemical and biological compatibility between the components of the mixture in relation to the effects desired.
3. Supplementary feedingstuffs, diluted as specified, may not contain levels of the additives which exceed those fixed for complete feedingstuffs.
4. In the case of premixtures containing silage additives the words ‘of silage additives’ must clearly be added on the label after ‘PREMIXTURE’.
5. Technological additives or other substances or products contained in additives consisting of preparations shall only modify the physico-chemical characteristics of the active substance of the preparation and shall be used in accordance with their conditions of authorisation where such provisions are provided for.
Physico-chemical and biological compatibility between the components of the preparation shall be ensured in relation to the effects desired.
( 1 ) OJ L 311, 28.11.2001, p. 1.
( 2 ) OJ L 125, 23.5.1996, p. 35. Directive as last amended by Regulation (EC) No 806/2003 (OJ L 122, 16.5.2003, p. 1).
( 3 ) OJ L 115, 4.5.1999, p. 32. Directive as last amended by Regulation (EC) No 806/2003.
( 4 ) OJ L 126, 13.5.1983, p. 23.
( 5 ) Council Directive 95/69/EC of 22 December 1995 laying down the conditions and arrangements for approving and registering certain establishments and intermediaries operating in the animal feed sector and amending Directives 70/524/EEC, 74/63/EEC, 79/373/EEC and 82/471/EEC (OJ L 332, 30.12.1995, p. 15). Directive as last amended by Regulation (EC) No 806/2003.
( 6 ) OJ L 224, 18.8.1990, p. 1. Regulation as last amended by Commission Regulation (EC) No 1490/2003 (OJ L 214, 26.8.2003, p. 3).
( 7 ) See page 24 of this Official Journal.
( 8 ) OJ L 125, 23.5.1996, p. 10.
( 9 ) OJ L 35, 8.2.2005, p. 1.
( 10 ) OJ L 229, 1.9.2009, p. 1.
( 11 ) OJ L 123, 12.5.2016, p. 1.
( 12 ) OJ L 59, 5.3.2005, p. 8.
( 13 ) OJ L 165, 30.4.2004, p. 1. Corrigendum OJ L 191, 28.5.2004, p. 1.