01999L0002 — EN — 11.12.2008 — 002.003

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►B	DIRECTIVE 1999/2/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 22 February 1999 on the approximation of the laws of the Member States concerning foods and food ingredients treated with ionising radiation (OJ L 066 13.3.1999, p. 16)

Amended by:

		Official Journal
		No	page	date
M1	REGULATION (EC) No 1882/2003 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 29 September 2003	L 284	1	31.10.2003
►M2	REGULATION (EC) No 1137/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 22 October 2008	L 311	1	21.11.2008

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▼B

DIRECTIVE 1999/2/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 22 February 1999

on the approximation of the laws of the Member States concerning foods and food ingredients treated with ionising radiation

Article 1

1.  This Directive shall apply to the manufacture, marketing and importation of foods and food ingredients, hereinafter called ‘foodstuffs’, treated with ionising radiation.

2.  This Directive shall not apply to:

Article 2

Member States shall take all measures necessary to ensure that irradiated foodstuffs can be placed on the market only if they comply with the provisions of this Directive.

Article 3

1.  The conditions which must be fulfilled for authorisation of the treatment of foodstuffs with ionising radiation are set out in Annex I. At the time of treatment such foodstuffs must be in a suitably wholesome state.

2.  Irradiation may be carried out only by means of the sources listed in Annex II and in accordance with the requirements of the Code of Practice referred to in Article 7(2). The overall average absorbed dose shall be calculated in accordance with Annex III.

Article 4

1.  The Community list of foodstuffs which may be treated with ionising radiation to the exclusion of all others and the maximum radiation doses authorised shall be defined in the implementing Directive, which shall be adopted in accordance with the procedure laid down in Article 100a of the Treaty taking account of the authorisation conditions set out in Annex I.

2.  This list shall be established in stages.

3.  The Commission shall examine the national authorisations in force and, after consulting the Scientific Committee for Food, submit in accordance with the procedure laid down in Article 100a of the Treaty proposals aiming at establishing the list.

At the latest 31 December 2000, the Commission shall, in accordance with Article 100a of the Treaty, submit a proposal intended to complete the positive list provided for in paragraph 1.

4.  Until entry into force of the Directive adopted on the basis of the proposal referred to in the second subparagraph of paragraph 3, Member States may maintain existing authorisations concerning the treatment of foodstuffs with ionising radiation provided that:

5.  Until entry into force of the Directive adopted on the basis of the proposal referred to in the second subparagraph of paragraph 3, any Member State may also authorise the treatment of foodstuffs for which authorisations have been maintained by another Member State in accordance with paragraph 4, where the conditions referred to in paragraph 4 are fulfilled.

6.  Member States shall forthwith notify the Commission and the other Member States of authorisations maintained under paragraph 4 or granted under paragraph 5 and of conditions attaching to them. The Commission shall publish these notifications in the Official Journal of the European Communities.

7.  Until the entry into force of the Directive adopted on the basis of the proposal referred to in the second subparagraph of paragraph 3, Member States may, in compliance with the rules of the Treaty, continue to apply existing national restrictions or bans on ionising radiation of foodstuffs and on trade in irradiated foodstuffs which are not included in the initial positive list established by the implementing Directive.

Article 5

1.  The maximum radiation dose for foodstuffs may be given in partial doses; however, the maximum radiation dose fixed in accordance with Article 4 must not be exceeded. Irradiation treatment may not be used in combination with any chemical treatment having the same purpose as that treatment.

▼M2

2.  Exceptions to paragraph 1 may be adopted by the Commission. 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 12(4).

▼B

Article 6

The labelling of foodstuffs treated with ionising radiation shall be governed by the following provisions:

Article 7

1.  Member States shall inform the Commission of the competent authority or authorities responsible for:

▼M2

2.  Approval shall be granted only if the facility:

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3.  Each Member State shall forward to the Commission:

Furthermore the Member States shall forward to the Commission every year:

4.  On the basis of the data supplied in accordance with paragraph 3, the Commission shall publish in the Official Journal of the European Communities:

Article 8

1.  Irradiation facilities approved in accordance with Article 7 must, for each source of ionising radiation used, keep a record showing for each batch of foodstuffs treated:

2.  The records referred to in paragraph 1 must be kept for a period of five years.

3.  Detailed rules for the application of this Article shall be adopted in accordance with the procedure laid down in ►M2  Article 12(2) ◄ .

Article 9

1.  A foodstuff treated with ionising radiation may not be imported from a third country unless it:

2.  

Article 10

Materials used for packaging foodstuffs to be irradiated must be suitable for the purpose.

Article 11

Amendments to the Annexes to take account of scientific and technical progress shall be adopted in accordance with the procedure laid down in Article 100a of the Treaty.

▼M2

Article 12

1.  The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health instituted by Regulation (EC) No 178/2002 of the European Parliament and of the Council ( 2 ).

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 provided for 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) 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 time limits provided for in Article 5a(3)(c) and (4)(b) and (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.

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Article 13

The Scientific Committee for Food shall be consulted on any matter falling within the scope of this Directive likely to have an effect on public health.

Article 14

1.  Where a Member State, as a result of new information or of a reassessment of existing information made since this Directive was adopted, has clear proof that the irradiation of certain foodstuffs endangers human health although it complies with the provisions of this Directive, that Member State may temporarily suspend or restrict application of the provisions in question in its territory. It shall immediately inform the other Member States and the Commission thereof, giving grounds for its decision.

2.  The Commission shall examine the grounds referred to in paragraph 1 as soon as possible within the Standing Committee on Foodstuffs; it shall take the appropriate measures in accordance with the procedure laid down in ►M2  Article 12(2) ◄ . The Member State which took the decision referred to in paragraph 1 may maintain it until the measures have entered into force.

▼M2

3.  Adaptations of this Directive or of its implementing directive may be made by the Commission only to the extent necessary to ensure the protection of public health and shall in any event be limited to prohibitions or restrictions as compared to the previous legal situation. 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 12(3). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 12(5).

▼B

Article 15

Member States shall bring into force their laws, regulations and administrative provisions to comply with this Directive in such a way as to:

They shall inform the Commission thereof.

When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.

Article 16

This Directive shall enter into force on the seventh day following its publication in the Official Journal of the European Communities.

Article 17

This Directive is addressed to the Member States.

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ANNEX I

CONDITIONS FOR AUTHORISING FOOD IRRADIATION

1.

Food irradiation may be authorised only if: —  there is a reasonable technological need, —  it presents no health hazard and is carried out under the conditions proposed, —  it is of benefit to the consumer, —  it is not used as a substitute for hygiene and health practices or for good manufacturing or agricultural practice.

2.

Food irradiation may be used only for the following purposes: —  to reduce the incidence of food-borne disease by destroying pathogenic organisms, —  to reduce spoilage of foodstuffs by retarding or arresting decay processes and destroying spoilage organisms, —  to reduce loss of foodstuffs by premature ripening, germination or sprouting, —  to rid foodstuffs of organisms harmful to plant or plant products.

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ANNEX II

SOURCES OF IONISING RADIATION

Foodstuffs may be treated only by the following sources of ionising radiation:

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ANNEX III

1.   DOSIMETRY

Overall average absorbed dose

It can be assumed for the purpose of the determination of the wholesomeness of foodstuffs treated with an overall average dose of 10 kGy or less that all radiation chemical effects in that particular dose range are proportional to the dose.

The overall average dose,

, is defined by the following integral over the total volume of the goods:

where

M = the total mass of the treated sample

p = the local density at the point (x,y,z)

d = the local absorbed dose at the point (x,y,z)

dV = dx dy dz, the infinitesimal volume element which in real cases is represented by the volume fractions.

The overall average absorbed dose can be determined directly for homogenous products or for bulk goods of homogenous apparent density by distributing an adequate number of dosimeters strategically and at random throughout the volume of the goods. From the dose distribution determined in this manner an average can be calculated which is the overall average absorbed dose.

If the shape of the dose distribution curve through the product is well determined, the positions of minimum and maximum dose are known. Measurements of the distribution of dose in these two positions in a series of samples of the product can be used to give an estimate of the overall average dose.

In some cases, the mean value of the average values of the minimum dose (

) and maximum dose (

) will be a good estimate of the overall dose: i.e., in these cases:

The ratio of

should not exceed 3.

2.   PROCEDURES

2.1.

Before routine irradiation of a given category of foodstuff begins at a radiation facility, the locations of the minimum and maximum doses are determined by making dose measurements throughout the product volume. These validation measurements must be carried out a suitable number of times (e.g. 3-5) in order to make allowance for variations in product density or geometry.

2.2.	Measurements must be repeated whenever the product, its geometry or the irradiation conditions are changed.

2.3.

During the process, routine dose measurements are carried out in order to ensure that the dose limits are not exceeded. Measurements should be carried out by placing dosimeters at the positions of the maximum or minimum dose, or at a reference position. The dose at the reference position must be quantitatively linked to the maximum and minimum dose. The reference position should be located at a convenient point in or on the product, where dose variations are low.

2.4.	Routine dose measurements must be carried out on each batch and at regular intervals during production.

2.5.	In cases where flowing, non-packaged goods are irradiated, the locations of the minimum and maximum doses cannot be determined. In such a case it is preferable to use random dosimeter sampling to ascertain the values of these dose extremes.

2.6.	Dose measurements should be carried out by using recognised dosimetry systems, and the measurements should be traceable to primary standards.

2.7.

During irradiation, certain facility parameters must be controlled and continuously recorded. For radionuclide facilities the parameters include product transport speed or time spent in the radiation zone and positive indication for correct position of the source. For accelerator facilities, the parameters include product transport speed and energy level, electron current and scanner width of the facility.

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( 1 ) OJ L 372, 31.12.1985, p. 50.

( 2 ) OJ L 31, 1.2.2002, p. 1.