Regulation on the treatment of foodstuffs with electron, gamma and X-rays, neutrons or ultraviolet rays (Food irradiation ordinance-LMBestrV)

Unofficial table of contents

LMBestrV

Date of completion: 14.12.2000

Full quote:

" Foodstuffs regulation of 14 December 2000 (BGBl. 1730), as last amended by Article 7 of the Regulation of 13 December 2011 (BGBl I). 2720). "

Status:

Last amended by Art. 7 V v. 13.12.2011 I 2720

For more details, please refer to the menu under Notes

Footnote

(+ + + Text proof: 21.12.2000 + + +) 
(+ + + Official notes of the norm provider on EC law: 
 Implementation of the 
 ERL 2/99 (CELEX Nr: 399L0002) 
 ERL 3/99 (CELEX Nr: 399L0003) 
 EGRL 13/2000 (CELEX Nr: 300L0013) + + +) 

  

This Regulation shall be used to:

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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 relating to foodstuffs and food ingredients treated with ionising radiation (OJ L 327, 30.11.1999, p. EC No OJ L 66, p. 16),

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1999 /3/EC of the European Parliament and of the Council of 22 February 1999 laying down a Community list of foodstuffs and food ingredients treated with ionising radiation (OJ L 327, 30.11.1999, p. EC No L 66 p. 24)

and provisions of the Directive

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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 (OJ L 327, 30.12.2000, p. EC No L 109 p. 29)

in German law. Unofficial table of contents

Input formula

The Federal Ministry of Health is responsible for the

-

§ 13 (2) also in conjunction with Section 16 (1) sentence 2 of the German Food and Commodities Act as amended by the Notice of 9 September 1997 (BGBl. 2296), Article 13 of which is Article 13 of the Regulation of 21 September 1997 (BGBl I). 2390), in agreement with the Federal Ministries of Food, Agriculture and Forestry and for the Economy and Technology,

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Section 19 (1) (4) (b) and § 19a (3), (4) and (5) of the German Food and Commodities Act (FVO) in agreement with the Federal Ministries of Food, Agriculture and Forestry, and for the Economy and Technology,

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Section 32 (1) (9a) in conjunction with Section 3 of the German Food and Commodities Law Act, in agreement with the Federal Ministries of Food, Agriculture and Forestry, for Economics and Technology, for Labour and Social Order and for Environment, nature conservation and reactor safety,

in connection with Article 56 (1) of the Law on Jurisdiction Adaptation of 18 March 1975 (BGBl). 705) and the organisational decree of 27. October 1998 (BGBl. 3288), and

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Section 44 (1) (2) of the German Food and Commodities Act:

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§ 1 Approvals

(1) The treatment of dried aromatic herbs and spices with the electron, gamma and x-rays (irradiation) referred to in point 1 of the Appendix is authorised. (2) The irradiation referred to in paragraph 1 may only be carried out under the following conditions: Conditions are:

1.

the maximum total absorbed dose absorbed is no more than 10 kilogray,

2.

the irradiation must not be used in conjunction with a chemical treatment which is intended to serve the same objective as irradiation,

3.

the requirements of points 2 and 3 of the Annex shall be complied with.

The radiation dose within the meaning of point 1 may be administered in several doses. The packaging material used in the irradiation must be suitable for the purposes of irradiation according to the state of the art. (3) For control and measurement purposes, irradiation and the treatment of foodstuffs with neutrons are permitted. In the case of X-rays, the energy of the radiation must not exceed 10 Megaelectronvolts, in the case of neutron radiation 14 Megaelectronvolt and with other radiation 5 Megaelectronvolt shall not exceed. The absorbed dose should not exceed 0.01 Gray in the case of neutron radiation and 0.5 Gray for other radiation. (4) Treatment by direct exposure to ultraviolet rays is permitted for disinfection

1.

of drinking water,

2.

the surface of fruit and vegetable products,

3.

of hard cheese during storage.

(5) The indirect effect on food which occurs in the disinfection of air by ultraviolet rays is permitted. Unofficial table of contents

§ 2 Food products from third countries

(1) irradiated dried aromatic herbs and spices, as well as foods containing irradiated dried aromatic herbs and spices, from a third country may be placed on the market only if the irradiation is carried out in a has been carried out by the European Union and published in the Official Journal of the European Communities or the European Union. (2) The foodstuffs referred to in paragraph 1 shall also be subject to commercial requirements only in the transport is carried out when accompanied by evidence that provides information give over

1.

the name and address of the facility in which this irradiation has been carried out,

2.

the type and quantity of irradiated food;

3.

Number of the lot,

4.

Contracting authorities for radiation treatment,

5.

the recipients of irradiated foods;

6.

the date of irradiation,

7.

the packaging material used during the irradiation,

8.

Parameters for the monitoring of the irradiation procedure in accordance with Annex III to 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 relating to ionizing radiation treated food and food ingredients (OJ C 327, 28. EC No 16), information on the dosimetric controls carried out and their results, specifying in particular the lower and upper limit values of the absorbed dose and the nature of the ionizing radiation,

9.

Notes to the validation measurements carried out prior to irradiation.

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§ 3 Information

(1) irradiated dried aromatic herbs and spices, including those from a third country, must be supplied to the consumer by the person who places them on the market at the latest, with the consumer's restaurants, facilities available to Community catering, as well as the trader where they relate to food for consumption within their premises, shall be entitled "irradiated" or "treated with ionizing radiation" in accordance with the first sentence of paragraph 2 and 3 , as well as paragraphs 4, 5, first sentence, and paragraph 6. This shall also apply where the food referred to in the first sentence is included as ingredients in another foodstuff. (2) The particulars referred to in paragraph 1 shall be clearly visible, in easy-to-read lettering and indelible. (3) The information referred to in paragraph 1 shall be as shall be attached:

1.

in the case of a loose delivery of the food, on a stop or a sign above or next to the container in which the food in question is located,

2.

in the case of the supply of the food in wrapping or pre-packed packaging in accordance with Article 1 (2) of the Regulation on the labelling of foodstuffs, on a sign above or adjacent to the food, on the packaging or on the pre-packaged packaging,

3.

in the case of the release of the food in pre-packaged packaging, which is labelled in accordance with the Food labelling Regulation, on the pre-packaged package or on the label attached to it,

4.

in the case of the supply of the food in the mail order, also in the offer lists,

5.

on the supply of food in restaurants to food and drink varieties,

6.

in the case of the supply of foodstuffs in establishments for the purpose of catering, on menus or in price lists, or, in so far as no such food is interpreted or issued, in any other form or in a written notice.

In the cases referred to in points 5 and 6, the required information may be placed in footnotes if the name is referred to in the description of the transport denomination. (4) In the case of irradiated dried aromatic herbs and spices, the information must be made known in accordance with paragraph 1, in the case referred to in paragraph 3, in conjunction with the name of the transport name. (5) Where the irradiated food is an ingredient of a compound food, the ingredient shall be indicated in conjunction with the information referred to in paragraph 1; in the case referred to in paragraph 3, point 3, the indication in the list of ingredients shall be shall be carried out. Article 6 (2) (8) (b) of the Food Labelling Regulation shall not apply. (6) In the case of foods as referred to in paragraph 1, which are intended to be supplied to others as consumers, where the consumer is a host, Community catering, as well as traders in so far as they relate to the consumption of food within their premises, must be clearly visible in the accompanying documents, in easy-to-read letters and in the form of a document, shall be unwielable:

1.

an indication of the treatment of food or food ingredients,

2.

Name and address of the irradiation facility or its official reference number in accordance with § 4 (3).

(7) (omitted) Unofficial table of contents

§ 4 Admission of facilities for irradiation

(1) Bodies for irradiation within the meaning of Section 1 (1) (irradiation facilities) may only be used if they are approved for this purpose by the authorities responsible under national law. The authorisation shall be without prejudice to any other provisions of public law applicable to such bodies. (2) The authorisation may only be granted if:

1.

the Annex to the requirements of the recommended international procedural guidelines of the Codex Alimentarius Commission for the operation of irradiation facilities for the treatment of foodstuffs (Ref. FAO/WHO/CAC/Vol XV edition 1) *),

2.

for the installation, a person responsible for compliance with all the conditions necessary for the application of the procedure.

(3) The competent authorities shall issue a reference number to each approved installation.
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*) UNO-Verlag, Am Hofgarten 10, D 53113 Bonn. Unofficial table of contents

§ 5 Recording requirements

For each source of ionizing radiation, the operator of each approved irradiation facility shall have a record indicating the following for each lot of the treated food:

1.

the nature and quantity of the treated food;

2.

Number of the lot,

3.

Contracting authorities for radiation treatment,

4.

the recipient of the treated food,

5.

the date of irradiation,

6.

the packaging material used during the irradiation,

7.

Parameters for the monitoring of the irradiation procedure in accordance with Annex III to 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 relating to ionizing radiation treated food and food ingredients (OJ C 327, 28. EC No 16), provide information on the dosimetric controls and results obtained, specifying in particular the lower and upper limit values of the absorbed dose and the nature of the ionizing radiation,

8.

Notes to the validation measurements carried out prior to irradiation.

The records referred to in the first sentence shall be kept for five years by the operator of the irradiation facility; the retention period shall begin with the end of the calendar year in which the irradiation has been carried out. Unofficial table of contents

§ 6 Analytical Methods

The methods used for the detection of irradiation must be carried out in respect of the methods of sampling and analysis set out in points 1 and 2 of Council Directive 85 /591/EEC of 20 December 1985 on the introduction of Community methods of sampling and analysis, as set out in points 1 and 2 of the Annex to the the control of foodstuffs (OJ L 327, EC No 50) are to be tested. Unofficial table of contents

Section 7 Communications, reports

(1) Countries shall inform the Federal Ministry of Food, Agriculture and Consumer Protection of the competent authorities in accordance with § 4 for the authorisation. (2) The competent authorities shall transmit to the Federal Ministry for Food, Agriculture and Food (3) The competent authorities shall report to the Federal Office for Consumer Protection and Food Safety on 31 March of each year for the preceding year. Calendar year over

1.

the results of the checks carried out in the approved establishments for irradiation, in particular with regard to the groups and quantities of irradiated food and the doses administered,

2.

the results of the checks carried out at the stage of the placing on the market of foodstuffs for the detection of irradiation, including the analytical method used in each case.

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§ 8 Crime offences, administrative offences

(1) According to Article 59 (1) (21) (a) of the Food and Feed Code, it shall be punished who carries out an irradiation in accordance with § 1 (2) sentence 1 no. 1 or 2. (2) According to § 59 (1) (21) (a) of the Food and Feed Code (1) (2) (a) of the Food and The Feed Code shall be punished for who, contrary to § 3 (1) sentence 1, also in connection with sentence 2, a food referred to there, does not make it correct, not complete, not in the prescribed manner or not in time to be identified. (3) In accordance with § 59 (1) (21) (a) of the Food and Feed Code, it is punishable who, contrary to § 2 para. According to Article 59 (1) (21) (a) of the Food and Feed Code, a person who uses an irradiation facility in breach of § 4 (1) sentence 1 shall be punished. (5) According to § 60 (1) of the German Food and Feed Code (5) The Food and Feed Code acts in an orderly manner on who is negligently committing an act referred to in paragraphs 1, 2, 3 or 4. (6) Administrative offences within the meaning of Section 60 (2) (26) (a) of the Food and Feed Code Who intentionally or negligently acts

1.

, contrary to Article 2 (2), a food is placed on the market or

2.

Contrary to § 5, a record does not lead, not correct, or not, or not, or not, or not, for at least five years.

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§ 9 Transitional deadline

Until 31 December 2000, foodstuffs may still be irradiated in accordance with the rules applicable up to 21 December 2000. Unofficial table of contents

Section 10 Entry into force, expiry of the external force

This Regulation shall enter into force on the day after the date of delivery. Unofficial table of contents

Final formula

The Federal Council has agreed. Unofficial table of contents

Annex (to § 1)

(Fundstelle des Originaltextes: BGBl. I 2000, 1733)

Requirements for irradiation

1.

Sources of ionizing radiation

Foods may only be treated with the following types of ionizing radiation:

a)

Gamma rays from radionuclides (high) 60Co or (high) 137Cs.

b)

X-rays generated by devices operated with a nominal energy (maximum quantum energy) of 5 mega-electronvolts or below.

c)

Electrons produced by devices operated with a nominal energy (maximum quantum energy) of 10 mega-electronvolts or below.

2.

Dosimetry

Average absorbed dose
In determining the digestibility of foods that have been treated with an average total dose of 10 kilogray or less, it can be assumed that all chemical irradiation effects in this specific Dose range is proportional to the dose.
The average total dose D-is determined by the following integral equation for the treated food:

 -1 
 D = --- ... p (x, y, z) d (x, y, z) dV 
 M 
Where M = the total mass of the treated 
 Sample 
 p = the local density at the relevant 
 Point (x, y, z) 
 d = the one at the point in question 
 (x, y, z) absorbed local dose and 
 dV = infinitesimales volume element dx 
 dy dz   

The average total absorbed dose may be directly determined for homogeneous products or products in the loose state with a homogeneous filling density, by a corresponding number of dosimeters in a targeted manner and by a corresponding number of dosemeters. Random distribution over the entire volume of goods will be distributed. An average value corresponding to the total absorbed dose can be calculated from the dose division thus determined.
If the course of the dose distribution curve is clearly recognizable by the whole product, it can also be determined where minimum and maximum doses occur. Measurements of the dose distribution at these two points in a number of sample specimens of the product allow an estimate of the average total dose.
In some cases, the mean value of the mean of the minimum (D-min) and maximum (D-max) doses is a good estimate of the average total dose. In these cases,

 D-max + D-min 
 the average total dose = ----------- 
 2 
 D-max 
The ratio of ----- should not exceed 3. 
 D-min   

3.

Procedure

Before the routine irradiation of a given group of foods in a irradiation facility, dose measurements in the entire product volume determine at which point the maximum and minimum doses are present. A sufficient number of these validation measurements must be carried out (e.g. 3 to 5) in order to take account of fluctuations in the density or geometry of the products.
The measurements shall be repeated if the product, its geometry or the irradiation conditions are changed.
Routine dose measurements are carried out during the treatment to ensure that dose limits are not exceeded. In order to carry out the measurement, dosimeters are arranged in the probable location of the maximum and minimum doses or in a reference position.
The dose at this reference position must be linked to the maximum and minimum doses. The reference points must be chosen at a favourable point in or on the product at which the dose fluctuations are low.
Routine dose measurements should be carried out during production at each batch and at appropriate intervals.
If flowing, unpacked products are irradiated, the minimum and maximum doses cannot be determined. In these cases, the determination of the extreme values should be carried out by random sampling.
Dose measurements should be carried out using approved dosemeters and should be based on primary standards.
During irradiation, relevant parameters of the plant must be constantly monitored and recorded. In the case of radionuclide plants, the parameters include the product transport speed or the residence time in the radiation zone and the precise indication of the correct position of the source. For the acceleration systems, the parameters include the product transport speed and the energy level, the electron flow and the scan width of the plant.