(1)

The free movement of safe and wholesome food is an essential aspect of the internal market and contributes significantly to the health and well-being of citizens, and to their social and economic interests.

(2)

A high level of protection of human life and health should be assured in the pursuit of Community policies.

(3)

In order to protect human health, the safety of additives, enzymes and flavourings for use in foodstuffs for human consumption must be assessed before they are placed on the Community market.

(4)

Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (3), Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16 December 2008 on food enzymes (4) and Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods (5) (hereinafter referred to as the sectoral food laws) lay down harmonised criteria and requirements concerning the assessment and authorisation of these substances.

(5)

It is envisaged, in particular, that food additives, food enzymes and food flavourings, to the extent that the safety of food flavourings must be assessed in accordance with Regulation (EC) No 1334/2008 [on flavourings and certain food ingredients with flavouring properties for use in and on foods], must not be placed on the market or used in foodstuffs for human consumption, in accordance with the conditions laid down in each sectoral food law, unless they are included on a Community list of authorised substances.

(6)

Ensuring transparency in the production and handling of food is absolutely crucial in order to maintain consumer confidence.

(7)

In this context, it appears appropriate to establish for these three categories of substances a common Community assessment and authorisation procedure that is effective, time-limited and transparent, so as to facilitate their free movement within the Community market.

(8)

This common procedure must be founded on the principles of good administration and legal certainty and must be implemented in compliance with those principles.

(9)

This Regulation will thus complete the regulatory framework concerning the authorisation of the substances by laying down the various stages of the procedure, the deadlines for those stages, the role of the parties involved and the principles that apply. Nevertheless, for some aspects of the procedure, it is necessary to take the specific characteristics of each sectoral food law into consideration.

(10)

The deadlines laid down in the procedure take into account the time needed to consider the different criteria set in each sectoral food law, as well as allowing adequate time for consultation when preparing the draft measures. In particular, the nine-months deadline for the Commission to present a draft regulation updating the Community list should not preclude the possibility of this being done within a shorter period.

(11)

Upon receipt of an application the Commission should initiate the procedure and where necessary seek the opinion of the European Food Safety Authority (hereinafter referred to as the Authority) established by Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying 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) as soon as possible after the validity and applicability of the application have been assessed.

(12)

In accordance with the framework for risk assessment in matters of food safety established by Regulation (EC) No 178/2002, the authorisation to place substances on the market must be preceded by an independent scientific assessment, of the highest possible standard, of the risks that they pose to human health. This assessment, which must be carried out under the responsibility of the Authority, must be followed by a risk management decision taken by the Commission under a regulatory procedure that ensures close cooperation between the Commission and the Member States.

(13)

The authorisation to place substances on the market should be granted pursuant to this Regulation provided that the criteria for authorisation laid down under the sectoral food laws are satisfied.

(14)

It is recognised that, in some cases, scientific risk assessment alone cannot provide all the information on which a risk management decision should be based, and that other legitimate factors relevant to the matter under consideration may be taken into account, including societal, economic, traditional, ethical and environmental factors and the feasibility of controls.

(15)

In order to ensure that both business operators in the sectors concerned and the public are kept informed of the authorisations in force, the authorised substances should be included on a Community list created, maintained and published by the Commission.

(16)

Where appropriate and under certain circumstances, the specific sectoral food law may provide for protection of scientific data and other information submitted by the applicant for a certain period of time. In this case, the sectoral food law should lay down the conditions under which these data may not be used for the benefit of another applicant.

(17)

Networking between the Authority and the Member States’ organisations operating in the fields within the Authority’s mission is one of the basic principles of the Authority’s operation. In consequence, in preparing its opinion, the Authority may use the network made available to it by Article 36 of Regulation (EC) No 178/2002 and by Commission Regulation (EC) No 2230/2004 (7).

(18)

The common authorisation procedure for the substances must fulfil transparency and public information requirements while guaranteeing the right of applicants to preserve the confidentiality of certain information.

(19)

Protecting the confidentiality of certain aspects of an application should be maintained as a consideration in order to protect the competitive position of an applicant. However, information relating to the safety of a substance, including, but not limited to, toxicological studies, other safety studies and raw data as such, should under no circumstances be confidential.

(20)

Pursuant to Regulation (EC) No 178/2002, Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (8) applies to documents held by the Authority.

(21)

Regulation (EC) No 178/2002 establishes procedures for taking emergency measures in relation to foodstuffs of Community origin or imported from third countries. It authorises the Commission to adopt such measures in situations where foodstuffs are likely to constitute a serious risk to human health, animal health or the environment and where such risk cannot be contained satisfactorily by measures taken by the Member State(s) concerned.

(22)

In the interests of efficiency and legislative simplification, there should be a medium-term examination of the question whether to extend the scope of the common procedure to other legislation in the area of food.

(23)

Since the objectives of this Regulation cannot be sufficiently achieved by the Member States on account of differences between national laws and provisions and can therefore be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.

(24)

The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (9).

(25)

In particular the Commission should be empowered to update the Community lists. Since those measures are of general scope and are designed to amend non-essential elements of each sectoral food law, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

(26)

On grounds of efficiency, the normal time-limits for the regulatory procedure with scrutiny should be curtailed for the addition of substances to the Community lists and for adding, removing or changing conditions, specifications or restrictions associated with the presence of a substance on the Community lists.

(27)

When, on imperative grounds of urgency, the normal time-limits for the regulatory procedure with scrutiny cannot be complied with, the Commission should be able to apply the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the removal of a substance from the Community lists and for adding, removing or changing conditions, specifications or restrictions associated with the presence of a substance on the Community lists,

(1)

The free movement of safe and wholesome food is an essential aspect of the internal market and contributes significantly to the health and well-being of citizens, and to their social and economic interests.

(2)

A high level of protection of human life and health should be assured in the pursuit of Community policies.

(3)

Food enzymes other than those used as food additives are not currently regulated or are regulated as processing aids under the legislation of the Member States. Differences between national laws, regulations and administrative provisions concerning the assessment and authorisation of food enzymes may hinder their free movement, creating conditions for unequal and unfair competition. It is therefore necessary to adopt Community rules harmonising national provisions relating to the use of enzymes in foods.

(4)

This Regulation should only cover enzymes that are added to food to perform a technological function in the manufacture, processing, preparation, treatment, packaging, transport or storage of such food, including enzymes used as processing aids (hereinafter referred to as food enzymes). The scope of this Regulation should therefore not extend to enzymes that are not added to food to perform a technological function but are intended for human consumption, such as enzymes for nutritional or digestive purposes. Microbial cultures traditionally used in the production of food such as cheese and wine, and which may incidentally produce enzymes but are not specifically used to produce them, should not be considered food enzymes.

(5)

Food enzymes used exclusively in the production of food additives falling within the scope of Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (3) should be excluded from the scope of this Regulation, since the safety of these foods is already assessed and regulated. However, when these food enzymes are used as such in food, they are covered by this Regulation.

(6)

Food enzymes should be approved and used only if they fulfil the criteria laid down in this Regulation. Food enzymes must be safe when used, there must be a technological need for their use and their use must not mislead the consumer. Misleading the consumer includes, but is not limited to, issues related to the nature, freshness, quality of ingredients used, the naturalness of a product or of the production process, or the nutritional quality of the product. The approval of food enzymes should also take into account other factors relevant to the matter under consideration including societal, economic, traditional, ethical and environmental factors, the precautionary principle and the feasibility of controls.

(7)

Some food enzymes are permitted for specific uses, such as in fruit juices and certain similar products and certain lactoproteins intended for human consumption, and for certain authorised oenological practices and processes. The use of such food enzymes should comply with this Regulation and with the specific provisions laid down in the relevant Community legislation. Council Directive 2001/112/EC of 20 December 2001 relating to fruit juices and certain similar products intended for human consumption (4), Council Directive 83/417/EEC of 25 July 1983 on the approximation of the laws of the Member States relating to certain lactoproteins (caseins and caseinates) intended for human consumption (5) and Council Regulation (EC) No 1493/1999 of 17 May 1999 on the common organisation of the market in wine (6) should therefore be amended accordingly. Since all food enzymes should be covered by this Regulation, Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (7) should be amended accordingly.

(8)

Food enzymes the use of which is permitted within the Community should appear in a Community list that should clearly describe the enzymes and specify any conditions governing their use, including where necessary information on their function in the final food. This list should be supplemented by specifications, in particular on their origin, including where relevant information about allergenic properties, and purity criteria.

(9)

In order to ensure harmonisation, the risk assessment of food enzymes and their inclusion in the Community list should be carried out in accordance with the procedure laid down in Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (8).

(10)

Under Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (9), the European Food Safety Authority (hereinafter referred to as the Authority) is to be consulted on matters likely to affect public health.

(11)

A food enzyme which falls within the scope of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (10) should be authorised in accordance with that Regulation as well as under this Regulation.

(12)

A food enzyme already included in the Community list under this Regulation which is prepared by production methods or using starting materials significantly different from those included in the risk assessment of the Authority, or different from those covered by the authorisation and the specifications under this Regulation, should be submitted for evaluation by the Authority. ‘Significantly different’ could mean inter alia a change of the production method from extraction from a plant to production by fermentation using a micro-organism or a genetic modification of the original micro-organism, a change in starting materials, or a change in particle size.

(13)

Since many food enzymes are already on the Community market, provision should be made to ensure that the switchover to a Community list of food enzymes takes place smoothly and does not disturb the existing food enzyme market. Sufficient time should be allowed for applicants to make available the information necessary for the risk assessment of these products. An initial two-year period should therefore be allowed following the date of application of the implementing measures to be laid down in accordance with Regulation (EC) No 1331/2008 [establishing a common authorisation procedure for food additives, food enzymes and food flavourings], in order to give applicants sufficient time to submit the information on existing enzymes which may be included in the Community list to be drawn up under this Regulation. It should also be possible to submit applications for the authorisation of new enzymes during the initial two-year period. The Authority should evaluate without delay all applications for food enzymes for which sufficient information has been submitted during that period.

(14)

In order to ensure fair and equal conditions for all applicants, the Community list should be drawn up in a single step. That list should be established after completion of the risk assessment of all food enzymes for which sufficient information has been submitted during the initial two-year period. However, the risk assessments of the Authority for individual enzymes should be published as soon as they are completed.

(15)

A significant number of applications is expected to be submitted during the initial two-year period. A lengthy period may therefore be needed before the risk assessment of these has been completed and the Community list is drawn up. In order to ensure equal access to the market for new food enzymes after the initial two-year period, a transitional period should be provided for during which food enzymes and food using food enzymes may be placed on the market and used, in accordance with the existing national rules in the Member States, until the Community list has been drawn up.

(16)

The food enzymes E 1103 Invertase and E 1105 Lysozyme, that have been authorised as food additives under Directive 95/2/EC of the European Parliament and of the Council of 20 February 1995 on food additives other than colours and sweeteners (11), and the conditions governing their use should be carried over from Directive 95/2/EC to the Community list when it is drawn up by this Regulation. In addition, Council Regulation (EC) No 1493/1999 authorises the use of urease, beta-glucanase and lysozyme in wine subject to the conditions laid down in Commission Regulation (EC) No 423/2008 of 8 May 2008 on laying down certain detailed rules for implementing Council Regulation (EC) No 1493/1999 and establishing a Community code of oenological practices and processes (12). Those substances are food enzymes and they should fall within the scope of this Regulation. They should therefore also be added to the Community list when it is drawn up for their use in wine in accordance with Regulation (EC) No 1493/1999 and Regulation (EC) No 423/2008.

(17)

Food enzymes remain subject to the general labelling obligations provided for in Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs (13) and, as the case may be, in Regulation (EC) No 1829/2003 and in Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms (14). In addition, specific provisions on the labelling of food enzymes sold as such to the manufacturer or to the consumer should be contained in this Regulation.

(18)

Food enzymes are covered by the definition of food in Regulation (EC) No 178/2002 and are therefore, when used in food, required to be indicated as ingredients in the labelling of the food in compliance with Directive 2000/13/EC. Food enzymes should be designated by their technological function in food, followed by the specific name of the food enzyme. However, provision should be made for a derogation from the provisions on labelling in cases where the enzyme performs no technological function in the final product but is present in the foodstuff only as a result of carry-over from one or more of the ingredients of the foodstuff or where it is used as a processing aid. Directive 2000/13/EC should be amended accordingly.

(19)

Food enzymes should be kept under continuous observation and should be re-evaluated whenever necessary in the light of changing conditions governing their use and new scientific information.

(20)

The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (15).

(21)

In particular the Commission should be empowered to adopt appropriate transitional measures. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

(22)

In order to develop and update Community law on food enzymes in a proportionate and effective way, it is necessary to collect data, share information and coordinate work between Member States. For that purpose, it may be useful to undertake studies to address specific issues with a view to facilitating the decision-making process. It is appropriate that the Community finance such studies as part of its budgetary procedure. The financing of such measures is covered by Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (16).

(23)

Member States are to carry out official controls in order to enforce compliance with this Regulation in accordance with Regulation (EC) No 882/2004.

(24)

Since the objective of this Regulation, namely to lay down Community rules on food enzymes, cannot be sufficiently achieved by the Member States and can therefore, in the interests of market unity and a high level of consumer protection, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective,

(1)

The free movement of safe and wholesome food is an essential aspect of the internal market and contributes significantly to the health and well-being of citizens, and to their social and economic interests.

(2)

A high level of protection of human life and health should be assured in the pursuit of Community policies.

(3)

This Regulation replaces previous Directives and Decisions concerning food additives permitted for use in foods with a view to ensuring the effective functioning of the internal market whilst ensuring a high level of protection of human health and a high level of consumer protection, including the protection of consumer interests, via comprehensive and streamlined procedures.

(4)

This Regulation harmonises the use of food additives in foods in the Community. This includes the use of food additives in foods covered by Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses (3) and the use of certain food colours for the health marking of meat and the decoration and stamping of eggs. It also harmonises the use of food additives in food additives and food enzymes thus ensuring their safety and quality and facilitating their storage and use. This has not previously been regulated at Community level.

(5)

Food additives are substances that are not normally consumed as food itself but are added to food intentionally for a technological purpose described in this Regulation, such as the preservation of food. All food additives should be covered by this Regulation, and therefore in the light of scientific progress and technological development the list of functional classes should be updated. However, substances should not be considered as food additives when they are used for the purpose of imparting flavour and/or taste or for nutritional purposes, such as salt replacers, vitamins and minerals. Moreover, substances considered as foods which may be used for a technological function, such as sodium chloride or saffron for colouring and food enzymes should also not fall within the scope of this Regulation. However, preparations obtained from foods and other natural source material that are intended to have a technological effect in the final food and which are obtained by selective extraction of constituents (e.g. pigments) relative to the nutritive or aromatic constituents, should be considered additives within the meaning of this Regulation. Finally, food enzymes are covered by Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16 December 2008 on food enzymes (4), which excludes the application of this Regulation.

(6)

Substances not consumed as food itself but used intentionally in the processing of foods, which only remain as residues in the final food and do not have a technological effect in the final product (processing aids), should not be covered by this Regulation.

(7)

Food additives should be approved and used only if they fulfil the criteria laid down in this Regulation. Food additives must be safe when used, there must be a technological need for their use, and their use must not mislead the consumer and must be of benefit to the consumer. Misleading the consumer includes, but is not limited to, issues related to the nature, freshness, quality of ingredients used, the naturalness of a product or of the production process, or the nutritional quality of the product, including its fruit and vegetable content. The approval of food additives should also take into account other factors relevant to the matter under consideration including societal, economic, traditional, ethical and environmental factors, the precautionary principle and the feasibility of controls. The use and maximum levels of a food additive should take into account the intake of the food additive from other sources and the exposure to the food additive by special groups of consumers (e.g. allergic consumers).

(8)

Food additives must comply with the approved specifications, which should include information to adequately identify the food additive, including origin, and to describe the acceptable criteria of purity. The specifications previously developed for food additives included in Commission Directive 95/31/EC of 5 July 1995 laying down specific criteria of purity concerning sweeteners for use in foodstuffs (5), Commission Directive 95/45/EC of 26 July 1995 laying down specific purity criteria concerning colours for use in foodstuffs (6) and Commission Directive 96/77/EC of 2 December 1996 laying down specific purity criteria on food additives other than colours and sweeteners (7) should be maintained until the corresponding additives are entered in the Annexes to this Regulation. At that time, the specifications related to such additives should be set out in a Regulation. Those specifications should relate directly to the additives included in the Community lists in the Annexes to this Regulation. However, considering the complex character and substance of such specifications, for the sake of clarity they should not be integrated as such in the Community lists but should be set out in one or more separate Regulations.

(9)

Some food additives are permitted for specific uses for certain authorised oenological practices and processes. The use of such food additives should comply with this Regulation and with the specific provisions laid down in the relevant Community legislation.

(10)

In order to ensure harmonisation, the risk assessment and approval of food additives should be carried out in accordance with the procedure laid down in Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (8)

(11)

Under Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (9), the European Food Safety Authority (hereinafter referred to as the Authority) is to be consulted on matters likely to affect public health.

(12)

A food additive which falls within the scope of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (10) should be authorised in accordance with that Regulation as well as under this Regulation.

(13)

A food additive already approved under this Regulation which is prepared by production methods or using starting materials significantly different from those included in the risk assessment of the Authority, or different from those covered by the specifications laid down, should be submitted for evaluation by the Authority. ‘Significantly different’ could mean, inter alia, a change of the production method from extraction from a plant to production by fermentation using a micro-organism or a genetic modification of the original micro-organism, a change in starting materials, or a change in particle size, including the use of nanotechnology.

(14)

Food additives should be kept under continuous observation and must be re-evaluated whenever necessary in the light of changing conditions of use and new scientific information. Where necessary, the Commission together with the Member States should consider appropriate action.

(15)

Member States which maintained on 1 January 1992 prohibitions on the use of certain additives in certain specific foods which are considered traditional and are produced on their territory should be permitted to continue to apply those prohibitions. Moreover, as regard products such as ‘Feta’ or ‘Salame cacciatore’, this Regulation should be without prejudice to more restrictive rules linked to the use of certain denominations under Council Regulation (EC) No 510/2006 of 20 March 2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs (11) and Council Regulation (EC) No 509/2006 of 20 March 2006 on agricultural products and foodstuffs as traditional specialities guaranteed (12).

(16)

Unless subject to further restrictions, an additive may be present in food, other than by direct addition, as a result of carry-over from an ingredient in which the additive was permitted, provided that the level of the additive in the final food is no greater than would be introduced by the use of the ingredient under proper technological conditions and good manufacturing practice.

(17)

Food additives remain subject to the general labelling obligations as provided for in Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs (13) and, as the case may be, in Regulation (EC) No 1829/2003 and in Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms (14). In addition, specific provisions on the labelling of food additives sold as such to the manufacturer or to the final consumer should be contained in this Regulation.

(18)

Sweeteners authorised under this Regulation may be used in table-top sweeteners sold directly to consumers. Manufacturers of such products should make information available to the consumer by appropriate means to allow them to use the product in a safe manner. Such information could be made available in a number of ways including on product labels, Internet websites, consumer information lines or at the point of sale. In order to adopt a uniform approach to the implementation of this requirement, guidance drawn up at Community level may be necessary.

(19)

The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (15).

(20)

In particular the Commission should be empowered to amend the Annexes of this Regulation and to adopt appropriate transitional measures. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

(21)

On grounds of efficiency, the normal time-limits for the regulatory procedure with scrutiny should be curtailed for the adoption of certain amendments to Annexes II and III relating to substances already authorised under other Community law as well as any appropriate transitional measures related to these substances.

(22)

In order to develop and update Community law on food additives in a proportionate and effective way, it is necessary to collect data, share information and coordinate work between Member States. For that purpose, it may be useful to undertake studies to address specific issues with a view to facilitating the decision-making process. It is appropriate that the Community finance such studies as part of its budgetary procedure. The financing of such measures is covered by Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (16).

(23)

Member States are to carry out official controls in order to enforce compliance with this Regulation in accordance with Regulation (EC) No 882/2004.

(24)

Since the objective of this Regulation, namely to lay down Community rules on food additives, cannot be sufficiently achieved by the Member States and can therefore, in the interests of market unity and a high level of consumer protection, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.

(25)

Following the adoption of this Regulation the Commission, assisted by the Standing Committee on the Food Chain and Animal Health, should review all the existing authorisations for criteria, other than safety, such as intake, technological need and the potential to mislead the consumer. All food additives that are to continue to be authorised in the Community should be transferred to the Community lists in Annexes II and III to this Regulation. Annex III to this Regulation should be completed with the other food additives used in food additives and food enzymes as well as carriers for nutrients and their conditions of use in accordance with Regulation (EC) No 1331/2008 [establishing a common authorisation procedure for food additives, food enzymes and food flavourings]. To allow a suitable transition period, the provisions in Annex III, other than the provisions concerning carriers for food additives and food additives in flavourings, should not apply until 1 January 2011.

(26)

Until the future Community lists of food additives are established, it is necessary to provide for a simplified procedure allowing the current lists of food additives contained in the existing Directives to be updated.

(27)

Without prejudice to the outcome of the review referred to in recital 25, within one year following the adoption of this Regulation the Commission should set up an evaluation programme for the Authority to re-evaluate the safety of the food additives that were already approved in the Community. That programme should define the needs and the order of priorities according to which the approved food additives are to be examined.

(28)

This Regulation repeals and replaces the following acts: Council Directive of 23 October 1962 on the approximation of the rules of the Member States concerning the colouring matters authorised for use in foodstuffs intended for human consumption (17), Council Directive 65/66/EEC of 26 January 1965 laying down specific criteria of purity for preservatives authorised for use in foodstuffs intended for human consumption (18), Council Directive 78/663/EEC of 25 July 1978 laying down specific criteria of purity for emulsifiers, stabilizers, thickeners and gelling agents for use in foodstuffs (19), Council Directive 78/664/EEC of 25 July 1978 laying down specific criteria of purity for antioxidants which may be used in foodstuffs intended for human consumption (20), First Commission Directive 81/712/EEC of 28 July 1981 laying down Community methods of analysis for verifying that certain additives used in foodstuffs satisfy criteria of purity (21), Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption (22), Directive 94/35/EC of the European Parliament and of the Council of 30 June 1994 on sweeteners for use in foodstuffs (23), Directive 94/36/EC of the European Parliament and of the Council of 30 June 1994 on colours for use in foodstuffs (24), Directive 95/2/EC of the European Parliament and of the Council of 20 February 1995 on food additives other than colours and sweeteners (25), Decision No 292/97/EC of the European Parliament and of the Council of 19 December 1996 on the maintenance of national laws prohibiting the use of certain additives in the production of certain specific foodstuffs (26) and Commission Decision 2002/247/EC of 27 March 2002 suspending the placing on the market and import of jelly confectionary containing the food additive E 425 konjac (27). However, it is appropriate that certain provisions of those acts remain in force during a transitional period to allow time for the preparation of the Community lists in the Annexes to this Regulation,

(1)

Council Directive 88/388/EEC of 22 June 1988 on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production (3) needs to be updated in the light of technical and scientific developments. In the interests of clarity and efficiency Directive 88/388/EEC should be replaced by this Regulation.

(2)

Council Decision 88/389/EEC of 22 June 1988 on the establishment, by the Commission, of an inventory of the source materials and substances used in the preparation of flavourings (4) provides for the establishment of that inventory within 24 months of its adoption. That Decision is now obsolete and should be repealed.

(3)

Commission Directive 91/71/EEC of 16 January 1991 completing Council Directive 88/388/EEC on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production (5) lays down rules on the labelling of flavourings. Those rules are replaced by this Regulation and the Directive should now be repealed.

(4)

The free movement of safe and wholesome food is an essential aspect of the internal market and contributes significantly to the health and well-being of citizens, and to their social and economic interests.

(5)

In order to protect human health, this Regulation should cover flavourings, source materials for flavourings and foods containing flavourings. It should also cover certain food ingredients with flavouring properties which are added to food for the main purpose of adding flavour and which contribute significantly to the presence in food of certain naturally occurring undesirable substances (hereinafter referred to as food ingredients with flavouring properties), their source material and foods containing them.

(6)

Raw foodstuffs which have not undergone any processing treatment and non-compound foodstuffs such as spices, herbs, teas and infusions (e.g. fruit or herbal tea) as well as mixtures of spices and/or herbs, mixtures of tea and mixtures for infusion, as long as they are consumed as such and/or not added to the food, do not fall within the scope of this Regulation.

(7)

Flavourings are used to improve or modify the odour and/or taste of foods for the benefit of the consumer. Flavourings and food ingredients with flavouring properties should only be used if they fulfil the criteria laid down in this Regulation. They must be safe when used, and certain flavourings should, therefore, undergo a risk assessment before they can be permitted in food. Where possible, attention should be focused on whether or not the use of certain flavourings could have any negative consequences on vulnerable groups. The use of flavourings must not mislead the consumer and their presence in food should, therefore, always be indicated by appropriate labelling. Flavourings should, in particular, not be used in a way as to mislead the consumer about issues related to, amongst other things, the nature, freshness, quality of ingredients used, the naturalness of a product or of the production process, or the nutritional quality of the product. The approval of flavourings should also take into account other factors relevant to the matter under consideration including societal, economic, traditional, ethical and environmental factors, the precautionary principle and the feasibility of controls.

(8)

Since 1999, the Scientific Committee on Food and subsequently the European Food Safety Authority (hereinafter referred to as the Authority) established by Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying 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) have expressed opinions on a number of substances occurring naturally in source materials for flavourings and food ingredients with flavouring properties which, according to the Committee of Experts on Flavouring Substances of the Council of Europe, raise toxicological concern. Substances for which the toxicological concern was confirmed by the Scientific Committee on Food should be regarded as undesirable substances which should not be added as such to food.

(9)

Due to their natural occurrence in plants, undesirable substances might be present in flavouring preparations and food ingredients with flavouring properties. The plants are used traditionally as food or food ingredients. Appropriate maximum levels should be established for the presence of these undesirable substances in foods which contribute most to the human intake of these substances, taking into account both the need to protect human health and their unavoidable presence in traditional foods.

(10)

Maximum levels for certain naturally occurring undesirable substances should focus on the food or food categories which contribute most to dietary intake. Should additional naturally occurring undesirable substances pose a risk to the health of the consumer, maximum levels should be set following the opinion of the Authority. Member States should organise controls on a risk basis in line with Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (7). Food producers are obliged to take into account the presence of these substances when using food ingredients with flavouring properties and/or flavourings for preparation of all food to ensure that food which is not safe is not placed on the market.

(11)

Provisions should be established at Community level in order to prohibit, or restrict the use of, certain plant, animal, microbiological or mineral materials which raise concern for human health in the production of flavourings and food ingredients with flavouring properties and their applications in food production.

(12)

Risk assessments should be carried out by the Authority.

(13)

In order to ensure harmonisation, the risk assessment and approval of flavourings and source materials that need to undergo an evaluation should be carried out in accordance with the procedure laid down in Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (8).

(14)

Flavouring substances are defined chemical substances, which include flavouring substances obtained by chemical synthesis or isolated using chemical processes, and natural flavouring substances. An evaluation programme of flavouring substances is ongoing in accordance with Regulation (EC) No 2232/96 of the European Parliament and of the Council of 28 October 1996 laying down a Community procedure for flavouring substances used or intended for use in or on foodstuffs (9). Under that Regulation a list of flavouring substances is to be adopted within five years of adoption of that programme. A new deadline should be set for the adoption of that list. That list will be proposed for inclusion in the list referred to in Article 2(1) of Regulation (EC) No 1331/2008.

(15)

Flavouring preparations are flavourings other than defined chemical substances obtained from materials of vegetable, animal or microbiological origin, by appropriate physical, enzymatic or microbiological processes, either in the raw state of the material or after processing for human consumption. Flavouring preparations produced from food do not need to undergo an evaluation or an approval procedure for use in and on foods unless there is doubt about their safety. However, the safety of flavouring preparations produced from non-food material should be evaluated and approved.

(16)

Regulation (EC) No 178/2002 defines food as any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be, ingested by humans. Materials of vegetable, animal or microbiological origin, for which it can be sufficiently demonstrated that they have hitherto been used for the production of flavourings, are considered to be food materials for this purpose, even though some of these source materials, such as rose wood and strawberry leaves, may not have been used for food as such. They do not need to be evaluated.

(17)

Likewise, thermal process flavourings produced from food under specified conditions need not undergo an evaluation or an approval procedure for use in and on foods unless there is doubt about their safety. However, the safety of thermal process flavourings produced from non-food material or not complying with certain conditions of production should be evaluated and approved.

(18)

Regulation (EC) No 2065/2003 of the European Parliament and of the Council of 10 November 2003 on smoke flavourings used or intended for use in or on foods (10) lays down a procedure for the safety assessment and approval of smoke flavourings and aims to establish a list of primary smoke condensates and primary tar fractions the use of which is authorised to the exclusion of all others.

(19)

Flavour precursors such as carbohydrates, oligo-peptides and amino acids impart flavour to food by chemical reactions which occur during food processing. Flavour precursors produced from food do not need to undergo an evaluation or an approval procedure for use in and on foods unless there is doubt about their safety. However, the safety of flavour precursors produced from non-food material should be evaluated and approved.

(20)

Other flavourings which do not fall under the definitions of the previously mentioned flavourings may be used in and on foods after they have undergone an evaluation and approval procedure. An example could be flavourings which are obtained by heating oil or fat to an extremely high temperature for a very short period of time, resulting in a grill-like flavour.

(21)

Material of vegetable, animal, microbiological or mineral origin other than food may only be authorised for the production of flavourings after its safety has been evaluated scientifically. It might be necessary to authorise the use of only certain parts of the material or to set conditions of use.

(22)

Flavourings can contain food additives as permitted by Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (11) and/or other food ingredients for technological purposes such as for their storage, standardisation, dilution or dissolution and stabilisation.

(23)

A flavouring or a source material which falls within the scope of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (12) should be authorised in accordance with that Regulation as well as under this Regulation.

(24)

Flavourings remain subject to the general labelling obligations provided for in Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs (13) and, as the case may be, in Regulations (EC) No 1829/2003 and Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms (14). In addition, specific provisions on the labelling of flavourings sold as such to the manufacturer or to the final consumer should be contained in this Regulation.

(25)

Flavouring substances or flavouring preparations should only be labelled as ‘natural’ if they comply with certain criteria which ensure that consumers are not misled.

(26)

Specific information requirements should ensure that consumers are not misled concerning the source material used for the production of natural flavourings. In particular, if the term natural is used to describe a flavour, the flavouring components used should be entirely of natural origin. In addition, the source of the flavourings should be labelled, except when the source materials referred to would not be recognised in the flavour or taste of the food. If a source is mentioned, at least 95 % of the flavouring component should be obtained from the material referred to. As the use of flavourings should not mislead the consumer, the other maximum 5 % can only be used for standardisation or to give a, for example, more fresh, pungent, ripe or green note to the flavouring. When less than 95 % of the flavouring component derived from the source referred to has been used and the flavour of the source can still be recognised, the source should be revealed together with a statement that other natural flavourings have been added, for example cacao extract in which other natural flavourings have been added to impart a banana note.

(27)

Consumers should be informed if the smoky taste of a particular food is due to the addition of smoke flavourings. In accordance with Directive 2000/13/EC, the labelling should not confuse the consumer as to whether the product is smoked conventionally with fresh smoke or treated with smoke flavourings. Directive 2000/13/EC needs to be adapted to the definitions of flavourings, smoke flavourings and the term ‘natural’ for the description of flavourings laid down in this Regulation.

(28)

For the evaluation of the safety of flavouring substances for human health, information on the consumption and use of flavouring substances is crucial. The amounts of flavouring substances added to food should therefore be checked on a regular basis.

(29)

The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (15).

(30)

In particular the Commission should be empowered to amend the Annexes to this Regulation and to adopt appropriate transitional measures regarding the establishment of the Community list. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

(31)

When, on imperative grounds of urgency, the normal time-limits for the regulatory procedure with scrutiny cannot be complied with, the Commission should be able to apply the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the adoption of measures described in Article 8(2) and amendments to Annexes II to V to this Regulation.

(32)

Annexes II to V to this Regulation should be adapted as necessary to scientific and technical progress, taking into account the information provided by producers and users of flavourings and/or resulting from the monitoring and controls by the Member States.

(33)

In order to develop and update Community law on flavourings in a proportionate and effective way, it is necessary to collect data, share information and coordinate work between Member States. For that purpose, it may be useful to undertake studies to address specific issues with a view to facilitating the decision-making process. It is appropriate that the Community finance such studies as part of its budgetary procedure. The financing of such measures is covered by Regulation (EC) No 882/2004.

(34)

Pending the establishment of the Community list, provision should be made for the evaluation and approval of flavouring substances which are not covered by the evaluation programme provided for in Regulation (EC) No 2232/96. A transitional regime should therefore be laid down. Under that regime such flavouring substances should be evaluated and approved in accordance with the procedure laid down in Regulation (EC) No 1331/2008. However, the time periods provided for in that Regulation for the adoption by the Authority of its opinion and for the submission by the Commission to the Standing Committee on the Food Chain and Animal Health of a draft regulation updating the Community list should not apply, because priority should be given to the ongoing evaluation programme.

(35)

Since the objective of this Regulation, namely to lay down Community rules on the use of flavourings and certain food ingredients with flavouring properties in and on foods, cannot be sufficiently achieved by the Member States and can therefore, in the interests of market unity and a high level of consumer protection, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiary as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.

(36)

Council Regulation (EEC) No 1601/91 of 10 June 1991 laying down general rules on the definition, description and presentation of aromatised wines, aromatised wine-based drinks and aromatised wine-product cocktails (16) and Regulation (EC) No 110/2008 of the European Parliament and of the Council of 15 January 2008 on the definition, description, presentation, labelling and the protection of geographical indications of spirit drinks (17) need to be adapted to certain new definitions laid down in this Regulation.

(37)

Regulations (EEC) No 1601/91, (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC should be amended accordingly,

(1)

Regulation (EC) No 881/2004 of the European Parliament and of the Council (3) of 29 April 2004 established a European Railway Agency, hereinafter referred to as ‘the Agency’, to make a technical contribution to creating a European railway area without frontiers. Following developments in Community legislation on rail interoperability and safety and market developments and on the basis of the experience gained in operating the Agency and the relationship between the Agency and the Commission, certain amendments need to be made to that Regulation, and in particular certain tasks need to be added.

(2)

National rules are to be notified to the Commission both in accordance with Directive 2008/57/EC of the European Parliament and of the Council of 17 June 2008 on the interoperability of the rail system within the Community (recast) (4), (hereinafter referred to as the ‘Railway Interoperability Directive’), and Directive 2004/49/EC of the European Parliament and of the Council of 29 April 2004 on safety on the Community's railways (Railway Safety Directive) (5). The two sets of rules should therefore be examined in order to assess, in particular, if they are compatible with the common safety methods and the technical specifications for interoperability (TSIs) in force, as well as if they enable the common safety targets in force to be achieved.

(3)

In order to facilitate the procedure for authorising the placing in service of vehicles which do not conform to the relevant TSIs, all the technical and safety rules in force in each Member State should be classified into three groups and the results of this classification should be presented in a reference document. The Agency is therefore required to draw up a draft for creating and updating this document by cross-referencing the national rules for each of the relevant technical parameters and by providing ad hoc technical opinions on specific aspects of cross-accepting projects. After reviewing the list of the parameters, the Agency may recommend that it be modified.

(4)

Due to its legal competence and its high level of technical expertise, the Agency is the entity which should provide clarification on complex matters emerging from the activity in the sector. Therefore, in the context of the procedures authorising the placing in service of vehicles, it should be possible to request the Agency to issue technical opinions in the case of a negative decision by a national safety authority or on the equivalence of national rules for the technical parameters established in the Railway Interoperability Directive.

(5)

It should be possible to request the opinion of the Agency on urgent modifications to TSIs.

(6)

Under Article 13 of Regulation (EC) No 881/2004, the Agency may monitor the quality of the work of the bodies notified by the Member States. A study conducted by the Commission has shown that there is much scope for interpretation of the criteria to be applied for notifying these bodies. Without prejudice to the Member States' responsibility with regard to the bodies that they choose to notify and the checks that they make to ensure that these criteria have been met, it is important to assess the impact of such differences in interpretation and to check that they do not cause difficulties with regard to the mutual recognition of conformity certificates and the EC declaration of verification. Therefore, at the request of the Commission, the Agency should be able to monitor the activity of the notified bodies and, if justified, perform checks with a view to ensuring that the criteria referred to in the Railway Interoperability Directive are met by the relevant notified body.

(7)

Article 15 of Regulation (EC) No 881/2004 authorises the Agency to assess, at the request of the Commission and from the point of view of interoperability, applications for Community funding for railway infrastructure projects. The definition of these projects should be extended so that the coherence of the system can also be assessed, as in the case of projects implementing the European Rail Traffic Management System (ERTMS), for example.

(8)

Following developments of an international dimension, and in particular the entry into force of the 1999 Convention concerning International Carriage by Rail (COTIF), the Agency should be asked to assess the relationship between railway undertakings and keepers, particularly with regard to maintenance, as an extension of its work in the area of maintenance workshop certification. In this context, it should be possible for the Agency to address recommendations regarding the implementation of the system of certification of maintenance in accordance with Article 14a of the Railway Safety Directive.

(9)

When developing the certification schemes of entities in charge of maintenance and maintenance workshops, the Agency should make sure that these schemes are consistent with the responsibilities already allocated to railway undertakings and the future role of entities in charge of maintenance. These schemes should facilitate the safety certification procedure of railway undertakings and avoid undue administrative burden and duplication of controls, inspections and/or audits.

(10)

Following adoption of the third railway package, reference should be made to Directive 2007/59/EC of the European Parliament and of the Council of 23 October 2007 on the certification of train drivers operating locomotives and trains on the railway system in the Community (6) (hereinafter referred to as the ‘Train Drivers Directive’), which lays down various tasks to be performed by the Agency and gives it the possibility to address recommendations as well.

(11)

As far as railway staff are concerned, the Agency should also identify possible options for the certification of other crew members performing safety-critical tasks and assess the impact of these different options. It is intended that, besides train drivers and other crew members performing safety-critical tasks, the Agency reflects on specifying criteria for defining vocational competences of other staff involved in the operation and maintenance of the rail system.

(12)

The Railway Interoperability Directive and the Railway Safety Directive provide for various types of documents, namely, EC declarations of verification, licences and safety certificates and national rules notified to the Commission. Therefore, it should be the Agency's task to ensure public access to those documents as well as to the national registers on vehicles and infrastructure and to the registers kept by the Agency.

(13)

The Agency should examine the appropriate revenues for the tasks related to the accessibility of documents and registers in accordance with Article 38(2) of Regulation (EC) No 881/2004.

(14)

Since the adoption of the second railway package, several initiatives relating to the development and implementation of the ERTMS have been taken. These include the signing of a cooperation agreement between the Commission and the various stakeholders in the sector, the setting up of a steering committee for implementing this cooperation agreement, the adoption by the Commission of a Communication to the European Parliament and the Council on the deployment of the European rail signalling system ERTMS/ETCS, the appointment, by the Commission, of a European coordinator for the ERTMS project as a priority project of Community interest, the definition of the Agency's role as system authority in the context of the various annual work programmes, and the adoption of the ‘control-command and signalling’ TSI for conventional rail (7). Given the growing importance of the Agency's input in this area, its tasks should be specified.

(15)

The Agency plays a leading role in the future deployment of the ERTMS in the whole rail system. To that end, coherence of timing between national migration plans should be ensured.

(16)

The version of ERTMS adopted by the Commission on 23 April 2008 should enable railway undertakings which have invested in interoperable rolling stock to secure an adequate return on their investment. This version should be completed with harmonised test specifications. Any additional specification requested by a national safety authority should not unduly prevent the movement of rolling stock fitted with future ERTMS versions or the version adopted by the Commission on 23 April 2008 on lines which are already equipped in accordance with the latter version.

(17)

In order to promote interoperability, the Agency should assess the impact of the adaptation of any version of ERTMS installed prior to the version adopted by the Commission on 23 April 2008 towards this version.

(18)

The Agency now has a large number of experts specialising in the interoperability and safety of the European rail system. It should be authorised to carry out ad hoc tasks at the Commission's request, subject to the compatibility of those tasks with the Agency's mission and compliance with the Agency's other priorities. In that light, the Agency's Executive Director should evaluate the admissibility of this assistance and report at least once a year on its provision to the Administrative Board. The Board may assess this report in accordance with the powers attributed to it by Regulation (EC) No 881/2004.

(19)

The recruitment of project officers with a contract of a maximum of five years was intensive during the first year the Agency was established, which means that many of the technical staff have to leave the Agency within a short time span. In order to ensure an adequate quantity and quality of expertise and to anticipate possible difficulties in the recruitment procedures, the Agency should be allowed to extend the working contracts of specially qualified staff for another three years.

(20)

The date by which the Agency's annual work programme is to be adopted should be amended to allow for better synchronisation with the budgetary decision-making process.

(21)

The Agency's work programme should identify the objective of each activity and to whom it is to be addressed. The Commission should also be informed of the technical results of each activity, as this information goes well beyond the scope of the general report, which is addressed to all the institutions.

(22)

Since the objective of this Regulation, namely the extension of the Agency's mission to include its participation in the simplification of the Community procedure for the certification of railway vehicles, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale of the action, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.

(23)

Regulation (EC) No 881/2004 should therefore be amended accordingly,

1)

Article 2 shall be replaced by the following:

2)

Article 3 shall be amended as follows:

3)

Article 8 shall be deleted;

4)

the following Chapter title shall be inserted immediately after Article 9:

‘CHAPTER 2a

NATIONAL RULES, CROSS-ACCEPTANCE AND TECHNICAL OPINIONS’;

5)

the following Articles shall be inserted:

(*1)   OJ L 191, 18.7.2008, p. 1.’;"

6)

the following paragraphs shall be inserted in Article 10:

7)

Article 11 shall be deleted;

8)

Article 13 shall be replaced by the following:

9)

Article 15 shall be replaced by the following:

10)

the following Chapter title shall be inserted immediately before Article 16:

‘CHAPTER 3a

MAINTENANCE OF VEHICLES’;

11)

the following paragraph shall be added to Article 16:

‘These recommendations shall be consistent with the responsibilities already allocated to railway undertakings as provided for in Article 4 of the Railway Safety Directive and the entity in charge of maintenance as provided for in Article 14a of that Directive, and shall take full account of the certification mechanisms of railway undertakings and entities in charge of maintenance.’;

12)

the following Article shall be inserted:

13)

the following Chapter title shall be inserted immediately after Article 16a:

‘CHAPTER 3b

RAILWAY STAFF’;

14)

the following Article shall be inserted:

(*2)   OJ L 315, 3.12.2007, p. 51."

(*3)   OJ L 8, 12.1.2001, p. 1.’;"

15)

the following Article shall be inserted:

16)

in Article 17, the title and paragraph 1 shall be replaced by the following:

17)

the following Chapter title shall be inserted immediately after Article 17:

‘CHAPTER 3c

REGISTERS AND AGENCY'S PUBLIC DATABASE’;

18)

Article 18 shall be replaced by the following:

19)

Article 19 shall be replaced by the following:

20)

the title of Chapter 4 shall be replaced by the following:

‘SPECIAL TASKS’;

21)

the following Articles shall be inserted:

22)

Article 24(3) shall be replaced by the following:

23)

Article 25 shall be amended as follows:

24)

Article 26(1) shall be replaced by the following: