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Regulation (EC) No 219/2009 of the European Parliament and of the Council of 11 March 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny Adaptation to the regulatory procedure with scrutiny — Part Two
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As regards Directive 79/373/EEC, the Commission should be empowered to adopt exceptions to the prescriptions on the packaging of feedingstuffs and to amend the Annex. Since those measures are of general scope and are designed to amend non-essential elements of Directive 79/373/EEC, 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.
Accordingly, Directive 79/373/EEC is hereby amended as follows:
Article 4(2) shall be replaced by the following:
‘2.The Commission shall adopt exceptions to the principle of paragraph 1 to be authorised at Community level. Those measures, designed to amend non-essential elements of this Directive, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 13(3), provided that the identity and quality of the compound feedingstuffs concerned are ensured.’;
Article 10 shall be replaced by the following:
In the light of advances in scientific and technical knowledge, the Commission shall:
establish categories grouping several feed materials;
adopt methods of calculating the energy value of compound feedingstuffs;
adopt amendments to the Annex.
All the above measures, designed to amend non-essential elements of this Directive, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 13(3).’;
Article 13(3) shall be replaced by the following:
‘3.Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’.
As regards Directive 82/471/EEC, the Commission should be empowered to adopt amendments and to lay down the criteria required to define the products included in the Directive. Since those measures are of general scope and are designed to amend non-essential elements of Directive 82/471/EEC 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. On the grounds of urgency, it is necessary to apply the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the adoption of amendments to the Directive.
Accordingly, Directive 82/471/EEC is hereby amended as follows:
Article 6 is hereby amended as follows:
paragraph 1 shall be replaced by the following:
‘1.Amendments to be made to the Annex as a result of developments in scientific or technical knowledge shall be adopted by the Commission. Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 13(3). In the case of the products referred to in Sections 1.1 and 1.2 of the Annex, the Commission shall consult the Scientific Committee for Animal Nutrition and the Scientific Committee for Food.
However, in the case of products obtained from yeasts of the “Candida” variety and cultivated on n-alkanes, referred to in Article 4(1), the Commission shall adopt a position within two years of notification of this Directive, after consulting the Scientific Committee for Animal Nutrition and the Scientific Committee for Food.’;
paragraph 3 shall be replaced by the following:
‘3.Criteria making it possible to define the products included in this Directive, particularly the criteria of composition and purity and the physico-chemical and biological properties, may be laid down by the Commission in the light of scientific and technical knowledge. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 13(3).’;
in the second subparagraph of Article 7(2), the words ‘the procedure laid down in Article 13’ shall be replaced by the words ‘the regulatory procedure referred to in Article 13(2).’;
Article 8(3) shall be replaced by the following:
‘3.If the Commission considers that amendments to this Directive are necessary to alleviate the difficulties referred to in paragraph 1 and to ensure the protection of human or animal health, it shall adopt such measures. Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the urgency procedure referred to in Article 13(4). The Member State that has adopted safeguard measures may in that event retain them until the amendments have entered into force.’;
Article 13 shall be amended as follows:
paragraph 3 shall be replaced by the following:
‘3.Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’;
the following paragraph shall be added:
‘4.Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’;
Article 14 shall be deleted.
As regards Directive 96/25/EC, the Commission should be empowered to draw up and amend the list of materials whose circulation or use for animal nutrition purposes is restricted or prohibited and to amend the annex in the light of advances in scientific and technical knowledge. Since those measures are of general scope and are designed to amend non-essential elements of Directive 96/25/EC, 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.
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 amendment of the list of materials whose circulation or use for animal nutrition purposes is restricted or prohibited.
On grounds of efficiency, the normal time limits for the regulatory procedure with scrutiny must be curtailed for the adoption of amendments to the annex in the light of advances in scientific and technical knowledge.
Accordingly, Directive 96/25/EC is hereby amended as follows:
the second indent of Article 5(1)(g) shall be replaced by the following:
‘Community measures included on a list to be drawn up by the Commission. That measure, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 13(3);’;
Article 11 shall be replaced by the following:
1.A numerical coding system for the listed feed materials based on glossaries concerning the origin, part of the product/by-product used, processing and maturity/quality of the feed materials enabling feed to be identified at international level — in particular by name and description — may be adopted in accordance with the regulatory procedure referred to in Article 13(2).
2.The list of materials whose circulation or use for animal nutrition purposes is restricted or prohibited shall be drawn up by the Commission in order to ensure their compliance with Article 3. That measure, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 13(3).
3.The list referred to in paragraph 2 shall be amended by the Commission in the light of advances in scientific and technical knowledge. Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 13(3). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 13(5) with a view to adopting those measures.
4.Amendments to be made to the Annex as a result of developments in scientific or technical knowledge shall be adopted by the Commission. Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 13(4).’;
Article 13 shall be amended as follows:
paragraph 3 shall be replaced by the following:
‘3.Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’;
the following paragraphs shall be added:
‘4.Where reference is made to this paragraph, Article 5a(1) to (4) and (5)(b) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
The periods laid down in Article 5a(3)(c), (4)(b) and (4)(e) of Decision 1999/468/EC shall be set at two months, one month and two months respectively.
5.Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’
As regards Directive 2002/32/EC, the Commission should be empowered to amend Annexes I and II and adapt them in the light of developments in scientific and technical knowledge, and to lay down additional criteria for detoxification processes. Since those measures are of general scope and are designed to amend non-essential elements of Directive 2002/32/EC, 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.
When, on imperative grounds of urgency, the time limits normally applicable 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 adaptation of Annexes I and II in the light of developments in scientific and technical knowledge.
Accordingly, Directive 2002/32/EC is hereby amended as follows:
the first subparagraph of Article 7(2) shall be replaced by the following:
‘2.An immediate decision shall be taken as to whether Annexes I and II should be amended. Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the urgency procedure referred to in Article 11(4).’;
Article 8(1) and (2) shall be replaced by the following:
‘1.The Commission shall adapt Annexes I and II in the light of developments in scientific and technical knowledge. Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 11(3). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 11(4) with a view to adopting those amendments.
2.Furthermore the Commission:
shall periodically adopt consolidated versions of Annexes I and II incorporating any adaptations made pursuant to paragraph 1, in accordance with the regulatory procedure referred to in Article 11(2),
may define acceptability criteria for detoxification processes as a complement to the criteria provided for products intended for animal feed which have undergone such processes. Those measures, designed to amend non-essential elements of this Directive, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 11(3).’;
Article 11 shall be replaced by the following:
1.The Commission shall be assisted by the Standing Committee for Feedingstuffs set up by Article 1 of Council Decision 70/372/EEC(5).
2.Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
3.Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
4.Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’;
Article 12 shall be deleted.
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Textual Amendments
As regards Directive 2003/99/EC, the Commission should be empowered to establish coordinated monitoring programmes concerning zoonoses and zoonotic agents. Since those measures are of general scope and are designed to amend non-essential elements of Directive 2003/99/EC, 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.
On grounds of urgency, it is necessary to apply the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the adoption of amendments to Annex I to Directive 2003/99/EC in order to add zoonoses and zoonotic agents to, or delete them from, the lists provided for therein.
Accordingly, Directive 2003/99/EC is hereby amended as follows:
in Article 4, paragraph 4 shall be amended as follows:
the introductory phrase shall be replaced by the following:
‘Annex I may be amended by the Commission to add zoonoses or zoonotic agents to, or delete them from, the lists therein, taking account in particular of the following criteria:’;
the following subparagraph shall be added:
‘Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the urgency procedure referred to in Article 12(4).’;
Article 5(1) shall be replaced by the following:
‘1.If data collected through routine monitoring in accordance with Article 4 are not sufficient, coordinated monitoring programmes concerning one or more zoonoses and/or zoonotic agents may be established by the Commission, especially when specific needs are identified, to assess risks or to establish baseline values related to zoonoses or zoonotic agents at the level of Member States or at Community level. Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 12(3).’;
Article 11 shall be replaced by the following:
Annexes II, III and IV may be amended by the Commission. Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 12(3).
Transitional measures of general scope designed to amend non-essential elements of this Directive, inter alia, by supplementing it with new non-essential elements, in particular further specifications of the requirements laid down in this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 12(3).
Other implementing or transitional measures may be adopted in accordance with the regulatory procedure referred to in Article 12(2).’;
Article 12 shall be amended as follows:
paragraph 3 shall be replaced by the following:
‘3.Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’;
the following paragraph shall be added:
‘4.Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’
As regards Regulation (EC) No 852/2004, the Commission should be empowered to adopt provisions relating to specific hygiene rules and to the approval of establishments, and to grant derogations from Annexes I and II subject to certain conditions. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC) No 852/2004, 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.
Accordingly, Regulation (EC) No 852/2004 is hereby amended as follows:
Article 4(4) shall be replaced by the following:
‘4.The criteria, requirements and targets referred to in paragraph 3, and associated sampling and analysis methods shall be laid down by the Commission. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(3).’;
Article 6(3)(c) shall be replaced by the following:
by a decision adopted by the Commission. That measure, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(3).’;
Article 12 shall be replaced by the following:
Transitional measures of general scope designed to amend non-essential elements of this Regulation, inter alia, by supplementing it with new non-essential elements, in particular further specifications of the requirements laid down in this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(3).
Other implementing or transitional measures may be adopted in accordance with the regulatory procedure referred to in Article 14(2).’;
Article 13 shall be amended as follows:
paragraph 1 shall be amended as follows:
the introductory sentence shall be replaced by the following:
‘Annexes I and II may be adapted or updated by the Commission taking into account:’;
the following subparagraph shall be added:
‘Those measures, designed to amend non-essential elements of this Regulation, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(3).’;
paragraph 2 shall be replaced by the following:
‘2.Derogations from Annexes I and II may be granted by the Commission, in particular to facilitate the implementation of Article 5 for small businesses, taking into account the relevant risk factors, provided that such derogations do not affect the achievement of the objectives of this Regulation. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(3).’;
Article 14(3) shall be replaced by the following:
‘3.Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’.
As regards Regulation (EC) No 853/2004, the Commission should be empowered to adopt provisions relating to the general obligations of food business operators and to the special guarantees for placing food on the market in Sweden or Finland, and to allow derogations from the annexes subject to certain conditions. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC) No 853/2004, 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.
Accordingly, Regulation (EC) No 853/2004 is hereby amended as follows:
in Article 3(2), the first sentence shall be replaced by the following:
‘Food business operators shall not use any substance other than potable water — or, when Regulation (EC) No 852/2004 or this Regulation permits its use, clean water — to remove surface contamination from products of animal origin, unless use of the substance has been approved by the Commission. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 12(3).’;
Article 8(3) shall be replaced by the following:
‘3.(a)The requirements of paragraphs 1 and 2 may be updated by the Commission, in particular to take account of changes in Member States’ control programmes or of the adoption of microbiological criteria in accordance with Regulation (EC) No 852/2004. Those measures, designed to amend non-essential elements of this Regulation, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 12(3).
(b)In accordance with the regulatory procedure referred to in Article 12(2), the rules laid down in paragraph 2 of this Article in respect of any of the foodstuffs referred to in paragraph 1 of this Article may be extended, in whole or in part, to any Member State, or any region of a Member State, that has a control programme recognised as equivalent to that approved for Sweden and Finland in respect of the food of animal origin concerned.’;
Article 9 shall be replaced by the following:
Transitional measures of general scope designed to amend non-essential elements of this Regulation, inter alia, by supplementing it with new non-essential elements, in particular further specifications of the requirements laid down in this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 12(3).
Other implementing or transitional measures may be adopted in accordance with the regulatory procedure referred to in Article 12(2).’;
Article 10 is hereby amended as follows:
paragraph 1 shall be amended as follows:
the introductory wording shall be replaced by the following:
‘Annexes II and III may be adapted or updated by the Commission taking into account:’;
the following subparagraph shall be added:
‘Those measures, designed to amend non-essential elements of this Regulation, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 12(3).’;
paragraph 2 shall be replaced by the following:
‘2.Exemptions from Annex II and III may be granted by the Commission, provided that they do not affect the achievement of the objectives of this Regulation. Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 12(3).’;
the introductory wording of Article 11 shall be replaced by the following:
‘Without prejudice to the general application of Article 9 and Article 10(1), implementing measures may be laid down in accordance with the regulatory procedure referred to in Article 12(2), and amendments to Annex II or III, as measures designed to amend non-essential elements of this Regulation, may be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 12(3):’;
Article 12(3) shall be replaced by the following:
‘3.Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’
As regards Regulation (EC) No 854/2004, the Commission should be empowered to amend or adapt the annexes thereto and to adopt transitional measures, in particular further specifications of the requirements laid down in the provisions of that Regulation. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC) No 854/2004, 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.
Accordingly, Regulation (EC) No 854/2004 is hereby amended as follows:
Article 16 shall be replaced by the following:
Transitional measures of general scope designed to amend non-essential elements of this Regulation, inter alia, by supplementing it with new non-essential elements, in particular further specifications of the requirements laid down in this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 19(3).
Other implementing or transitional measures may be adopted in accordance with the regulatory procedure referred to in Article 19(2).’;
Article 17(1) and (2) shall be replaced by the following:
‘1.Annexes I, II, III, IV, V and VI may be amended or supplemented by the Commission to take account of scientific and technical progress. Those measures, designed to amend non-essential elements of this Regulation, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 19(3).
2.Exemptions from Annexes I, II, III, IV, V and VI may be granted by the Commission, provided that they do not affect the achievement of the objectives of this Regulation. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 19(3).’;
the introductory wording of Article 18 shall be replaced by the following:
‘Without prejudice to the general application of Article 16 and Article 17(1), implementing measures may be laid down in accordance with the regulatory procedure referred to in Article 19(2), and amendments to Annexes I, II, III, IV, V or VI, as measures designed to amend non-essential elements of this Regulation, may be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 19(3), to specify:’;
Article 19(3) shall be replaced by the following:
‘3.Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’
As regards Regulation (EC) No 183/2005, the Commission should be empowered to define the microbiological criteria and targets to be met by feed business operators, to adopt measures for the approval of establishments, to amend Annexes I, II and III, and to grant derogations from those annexes. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC) No 183/2005, 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.
Accordingly, Regulation (EC) No 183/2005 is hereby amended as follows:
the second subparagraph of Article 5(3) shall be replaced by the following:
‘The criteria and targets referred to in points (a) and (b) shall be defined by the Commission. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 31(3).’;
in Article 10, point (3) shall be replaced by the following:
‘(3)approval is required by a Regulation adopted by the Commission. This measure, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 31(3).’;
Article 27 shall be replaced by the following:
Annexes I, II and III may be amended to take account of:
the development of codes of good practice;
the experience gained from the implementation of HACCP-based systems pursuant to Article 6;
technological developments;
scientific advice, particularly new risk assessments;
the setting of feed safety targets;
and
the development of requirements relating to specific operations.
Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 31(3).’;
Article 28 shall be replaced by the following:
Derogations from Annexes I, II and III may be granted by the Commission for particular reasons, provided that such derogations do not affect the achievement of the objectives of this Regulation. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 31(3).’;
Article 31(3) shall be replaced by the following:
‘3.Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’
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